UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement |
License Agreement with InnoCare Pharma Inc.
On October 7, 2025, Zenas BioPharma, Inc. (“Zenas” or the “Company”) entered into a License Agreement (the “InnoCare License Agreement”) with InnoCare Pharma Inc. (“InnoCare”). Under the InnoCare License Agreement, InnoCare granted Zenas exclusive rights to develop, manufacture, and commercialize certain small molecule compounds and related products in specified fields and territories, as further described below.
License Grants
| 1. | Orelabrutinib (a BTK inhibitor): Zenas obtained exclusive rights in the multiple sclerosis (“MS”) field worldwide, and in all non-oncology indications outside mainland China, Hong Kong, Macau and Taiwan (“Greater China”) and Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam (“Southeast Asia”). |
| 2. | ZB021 (an IL-17AA/AF inhibitor): Zenas obtained exclusive rights in all fields of use worldwide, excluding Greater China and Southeast Asia. |
| 3. | ZB022 (a TYK2 inhibitor): Zenas obtained exclusive rights in all fields of use worldwide. |
Zenas also obtained certain non-exclusive rights to perform development and manufacturing activities in Greater China and Southeast Asia to support each program in its respective licensed territories.
Consideration
Zenas has agreed to pay InnoCare an upfront cash payment of $35 million and also issued to InnoCare 5,000,000 shares (the “InnoCare Upfront Shares”) of its common stock, par value $0.0001 per share (“Common Stock”), representing approximately 10.6% of Zenas’s issued and outstanding Common Stock as of October 7, 2025, after giving effect to the issuance to InnoCare, and approximately 9.3% of Zenas’s issued and outstanding Common Stock after giving effect to the further issuance of the PIPE Shares (as defined below).
Zenas has agreed to make a one-time, cash payment of $25 million and issue 2,000,000 shares of Common Stock (the “InnoCare Near-Term Milestone Shares” and, together with the InnoCare Upfront Shares, the “InnoCare Shares”) upon the earlier of (i) Zenas’ initiation of a Phase 3 clinical trial for orelabrutinib in any indication other than primary progressive MS, and (ii) March 31, 2026, upon the occurrence of certain specified events (the “Orelabrutinib Near-Term Milestone”). Additionally, Zenas has agreed to make one-time, potential near-term milestone payments of $20 million each, upon the achievement of certain regulatory milestones for ZB021 and ZB022.
Zenas is obligated to pay up to approximately $723 million in additional cash payments upon the achievement of certain regulatory and commercial sales milestones for orelabrutinib. For the ZB021 and ZB022 early-development product candidates, Zenas is obligated to pay up to approximately $656 million each, upon the achievement of certain development, regulatory and commercial sales milestones. Zenas will also pay tiered royalties on net sales at rates ranging from high-single digits to high-teens for orelabrutinib, and mid-single digits to mid-teens for ZB021 and ZB022.
Governance and Development
Zenas will assume responsibility for development and commercialization of orelabrutinib in its licensed fields and territories, including the transition of ongoing Phase 3 global trials for orelabrutinib in MS. A joint steering committee will oversee development and regulatory activities related to orelabrutinib.
Term and Termination
The InnoCare License Agreement will remain in effect on a product-by-product and country-by-country basis until expiration of the applicable royalty term, unless earlier terminated. Each party has customary termination rights, including for uncured material breach, insolvency, patent challenge, or, in the case of Zenas, for convenience.
The foregoing description of the InnoCare License Agreement does not purport to be complete and is qualified in its entirety by reference to the InnoCare License Agreement, a copy of which the Company will file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2025.
InnoCare Subscription Agreement and Registration Rights Agreement
On October 7, 2025, in connection with the InnoCare License Agreement described in Item 1.01 above, Zenas issued the InnoCare Upfront Shares (the “InnoCare Private Placement”), pursuant to the terms of a Subscription Agreement between InnoCare and Zenas (the “InnoCare Subscription Agreement”) in a private placement transaction. The InnoCare Subscription Agreement also provides that the Company will issue the Near-Term Milestone Shares upon the occurrence of the Orelabrutinib Near-Term Milestone. The InnoCare Subscription Agreement provides that InnoCare may not transfer any of the InnoCare Shares until October 7, 2026, and thereafter may not transfer InnoCare Shares during any one month in an amount the exceeds the greater of (i) one percent of the outstanding Common Stock as most recently reported by Zenas publicly and (ii) the average weekly reported volume of trading in the Common Stock during the four preceding calendar weeks. The foregoing restrictions will not apply to transfers to an affiliate of InnoCare, to Zenas or in connection with a change of control of Zenas approved by board of directors of Zenas.
In connection with the InnoCare Private Placement, the Company and InnoCare also entered into a Registration Rights Agreement on October 7, 2025 (the “InnoCare Registration Rights Agreement”). Pursuant to the terms of the InnoCare Registration Rights Agreement, the Company is obligated (i) to prepare and file with the Securities and Exchange Commission (the “SEC”) prior to October 7, 2026 a registration statement (the “InnoCare Registration Statement”) to register for resale the InnoCare Shares, and (ii) to use its reasonable best efforts to cause the Registration Statement to be declared effective by the SEC as soon as practicable thereafter.
The InnoCare Subscription Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the InnoCare Subscription Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the InnoCare Subscription Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the InnoCare Subscription Agreement is included with this Current Report on Form 8-K only to provide investors with information regarding the terms of transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the InnoCare Subscription Agreement, which subsequent information may or may not be fully reflected in public disclosures.
The foregoing descriptions of the InnoCare Subscription Agreement and the InnoCare Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the Subscription Agreement and the Registration Rights Agreement, which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
Securities Purchase Agreement
On October 7, 2025, the Company entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with (i) certain institutional and accredited investors (the "Institutional Investors") and (ii) certain directors and officers of the Company (the "Director and Officer Investors" and, together with the Institutional Investors, each, an "Investor" and, together, the "Investors"), pursuant to which the Company agreed to sell to (i) the Institutional Investors an aggregate of 6,261,893 shares of Common Stock (the "Institutional Investor PIPE Shares"), at a price of $19.00 per share, and (ii) the Director and Officer Investors an aggregate of 48,918 shares of Common Stock (the "Director and Officer Investor PIPE Shares" and, together with the Institutional Investor PIPE Shares, the "PIPE Shares") at a price of $20.85 per share, in each case in a private placement transaction (the "Investor Private Placement" and, together with the InnoCare Private Placement, the "Private Placements") for gross proceeds to the Company of approximately $120.0 million, before deducting placement agent fees and other expenses. The Closing of the Investor Private Placement is anticipated to occur on or about October 9, 2025 (the "PIPE Closing").
The Securities Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Securities Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Securities Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Securities Purchase Agreement is included with this Current Report on Form 8-K only to provide investors with information regarding the terms of transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Securities Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.
PIPE Registration Rights Agreement
In connection with the Investor Private Placement, on October 7, 2025, the Company entered into a Registration Rights Agreement (the “PIPE Registration Rights Agreement”) with the Investors, pursuant to which the Company will prepare and file, within 15 days of the PIPE Closing and subject to certain allowable delays, an initial registration statement (the “PIPE Registration Statement”) with the SEC to register for resale the PIPE Shares. The Company has granted the Investors customary indemnification rights in connection with the PIPE Registration Rights Agreement. The Investors have also granted the Company customary indemnification rights in connection with the PIPE Registration Rights Agreement.
The foregoing descriptions of the Securities Purchase Agreement and the PIPE Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the form of the Securities Purchase Agreement and the PIPE Registration Rights Agreement, forms of which are filed as Exhibits 10.3 and 10.4, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.
Item 2.02 Results of Operations and Financial Condition
The disclosure regarding the Company’s existing cash, cash equivalents and investments as of September 30, 2025 set forth under Item 8.01 of this Current Report on Form 8-K is incorporated by reference under this Item 2.02.
Item 3.02 Unregistered Sales of Equity Securities
The disclosure regarding the securities to be sold and issued pursuant to the InnoCare Subscription Agreement and the Securities Purchase Agreement set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference under this Item 3.02.
None of the securities described above under Item 1.01 has been registered under the Securities Act or any state securities laws. The Company is relying on exemptions from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof.
Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or other securities of the Company.
Item 7.01. Regulation FD Disclosure
On October 8, 2025, the Company issued a press release announcing the Agreement and the Private Placement. The Company is also hosting a conference call and webcast at 8 a.m. Eastern Time, on October 8, 2025.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the presentation the Company intends to present on the conference call and webcast is furnished as Exhibit 99.2 to this Current Report on Form 8-K, and both are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
Item 8.01 Other Events
Recent Developments
Following entry into the InnoCare License Agreement, the Company’s pipeline currently comprises four programs it is developing initially for the treatment of immunology and inflammation diseases: (1) obexelimab, a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across the B cell lineage, in order to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them, (2) orelabrutinib, a highly selective and central nervous system-penetrant, oral small molecule Bruton’s Tyrosine Kinase inhibitor, (3) ZB021, an IL-17 AA/AF inhibitor and (4) ZB022, a brain-penetrant TYK2 inhibitor.
Additional information about the Company’s current pipeline can be found in Exhibit 99.3 to this Current Report on Form 8-K, which is incorporated by reference herein.
Company Cash Update
The Company estimates that, as of September 30, 2025, it had approximately $302 million in existing cash, cash equivalents and investments. During the three months ended September 30, 2025, a $5 million deposit was paid towards the $35 million upfront cash payment due to InnoCare. This estimated amount of cash, cash equivalents and investments as of September 30, 2025 is preliminary and is subject to completion of the Company’s financial closing procedures and has not been reviewed or audited by our independent auditors. Consequently, this amount may differ materially from the amount that will be reflected in the Company’s unaudited condensed consolidated balance sheet as of September 30, 2025.
As of the date of this Current Report on Form 8-K, after giving effect to the upfront cash consideration paid to InnoCare pursuant to the InnoCare License Agreement and the anticipated proceeds from the PIPE Transaction, the Company expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026, and, assuming receipt from Royalty Pharma Investments 2019 ICAV (“Royalty Pharma”) of the potential $75 million milestone for the defined success criteria in the Phase 3 INDIGO trial of obexelimab pursuant to the Revenue Participation Right Purchase and Sale Agreement between the Company and Royalty Pharma, into the first quarter of 2027.
Forward Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this Current Report on Form 8-K are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning the Company’s milestones, expectations and intentions, including timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, and if successful, the timing of BLA submission, potential approval and commercial launch, the timing of reporting the 12-week and 24-week topline results from the MoonStone trial, the timing of the completion of enrollment and reporting the topline results from the SunStone trial, and if successful, the timing of initiating the Phase 3 trial in SLE, the timing of initiation of the Phase 3 clinical trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of ZB021 and ZB022, the timing of initial patient data in ZB021; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib’s potential as a franchise for progressive MS; the expansion of the Company’s pipeline; the expected PIPE Closing; the achievement of payment-triggering milestones pursuant to the InnoCare License Agreement and the Company’s cash guidance. The forward-looking statements in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information the Company files with the Securities and Exchange Commission. The forward-looking statements in this Current Report on Form 8-K are inherently uncertain, speak only as of the date of this Current Report on Form 8-K and may prove incorrect. These statements are based upon information available to the Company as of the date of this Current Report on Form 8-K and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZENAS BIOPHARMA, INC. | |||
| By: | /s/ Jennifer Fox | ||
| Name: | Jennifer Fox | ||
| Title: | Chief Business Officer and Chief Financial Officer | ||
Date: October 8, 2025
Exhibit 10.1
EXECUTION VERSION
Confidential
SUBSCRIPTION AGREEMENT
This Subscription Agreement (this “Subscription Agreement”) is dated as of October 7, 2025 (the “Execution Date”), by and between Zenas Biopharma, Inc., a Delaware corporation (the “Company”), and InnoCare Pharma, Inc., a Delaware corporation (the “Subscriber”). The Company and the Subscriber are sometimes referred to herein as the “Parties.”
RECITALS
A. WHEREAS, concurrently with the execution of this Subscription Agreement, the Company and the Subscriber are entering into that certain License Agreement, dated as of the date hereof (the “License Agreement”).
B. WHEREAS, the Subscriber desires to subscribe for 5,000,000 shares (the “Initial Shares”) of the Company’s common stock, $0.0001 par value per share (the “Common Stock”) at the initial closing of the Subscription contemplated hereby (the “Initial Closing”) and 2,000,000 shares of Common Stock (the “Contingent Shares” and together with the Initial Shares, the “Shares”) at the second closing of the Subscription contemplated hereby (the “Contingent Closing” and together with the Initial Closing, each a “Closing”), if any, and the Company desires to issue to Subscriber the Shares, all on the terms and subject to the conditions set forth herein.
C. WHEREAS, the Company and the Subscriber are executing and delivering this Subscription Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) or Rule 506 of Regulation D (“Regulation D”) as promulgated by the United States Securities and Exchange Commission (the “SEC”) under the Securities Act.
D. Concurrently with the execution of this Subscription Agreement, the Company and the Subscriber are entering into a separate registration rights agreement dated as of the date hereof (the “Registration Rights Agreement”).
All capitalized terms not defined herein shall have the meanings assigned to them in the License Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained in this Subscription Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Subscriber hereby agree as follows:
1. Subscription.
(a) Subject to the terms and conditions hereof, at the Initial Closing, Subscriber hereby agrees to subscribe for, and the Company hereby agrees to issue to Subscriber, the Initial Shares (such subscription and issuance, the “Initial Subscription”) and, subject to the terms and conditions hereof, at the Contingent Closing, if any, Subscriber hereby agrees to subscribe for, and the Company hereby agrees to issue to Subscriber, the Contingent Shares (such subscription and issuance, the “Contingent Subscription” and, together with the Initial Subscription, the “Subscription”).
(b) The Initial Closing shall occur on or before the third (3rd) Business Day following the Execution Date (the “Initial Closing Date”). The Subscriber shall make payment for the subscribed Initial Shares by wire transfer of immediately available funds or by bank check in U.S. dollars in the amount of $500.00 (the “Initial Subscription Proceeds”) pursuant to the written instruction of the Company. Upon receipt of such Initial Subscription Proceeds, the Company shall cause the Company’s transfer agent to issue the Initial Shares in book-entry form, free and clear of all restrictive and other legends (except as expressly provided in Section 5(c)(iv)). For purposes of this Subscription Agreement, “Business Day” means a day other than a Saturday, Sunday or any other day on which commercial banks in New York, New York are authorized or required by law to close.
(c) The Contingent Closing shall occur on or prior to the Orelabrutinib Near-Term Milestone Payment Date (as defined in the License Agreement), if any (the date on which the Contingent Closing actually occurs, the “Contingent Closing Date”). The Subscriber shall make payment for the subscribed Contingent Shares by wire transfer of immediately available funds or by bank check in U.S. dollars in the amount of $200.00 (the “Contingent Subscription Proceeds”) pursuant to the written instruction of the Company. Upon receipt of such Contingent Subscription Proceeds, the Company shall cause the Company’s transfer agent to issue the Contingent Shares in book-entry form, free and clear of all restrictive and other legends (except as expressly provided in Section 5(c)(iv)).
2
2. Representations and Warranties of the Company.
The Company represents and warrants as of the date hereof to the Subscriber as follows: (i) it is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted and described in (a) the Company’s most recently filed Annual Report on Form 10-K and (b) all Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed or furnished (as applicable) by the Company following the end of the most recent fiscal year for which an Annual Report on Form 10-K has been filed and prior to the execution of this Agreement, together in each case with any documents incorporated by reference therein or exhibits thereto (collectively, the “SEC Reports”) and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification; (ii) the disclosure of its authorized, issued and outstanding capital stock in the SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such SEC Reports. All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable. None of the outstanding shares of capital stock of the Company were issued in violation of any preemptive or other similar rights of any securityholder of the Company which have not been waived, and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. The capital stock of the Company conforms in all material respects to the description thereof contained in the SEC Reports; (iii) it has the full corporate power and authority to enter into this Subscription Agreement and to perform all of its obligations hereunder; and all corporate action on the part of the Company, its officers, directors and stockholders necessary for the authorization of the Shares, the authorization, execution, delivery and performance of the Transaction Documents (as defined below) and the consummation of the transactions contemplated herein and therein has been taken; (iv) each Transaction Document has been duly executed by, and when delivered in accordance with the terms hereof will constitute a valid and binding agreement of, the Company enforceable in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the rights and remedies of creditors generally or subject to general principles of equity; (v) the execution and delivery of any Transaction Document and the consummation of the transactions contemplated hereby or thereby do not (a) conflict with or result in a breach of the Company’s certificate of incorporation or bylaws and amendments thereto through the date hereof, (b) conflict with or result in a violation of or default (with or without notice or lapse of time, or both) under, or give rise to a right of termination, cancellation or acceleration of any obligation, a change of control right or to a loss of a benefit under any agreement or instrument, credit facility, franchise, license, judgment, order, statute, law, ordinance, rule or regulations, applicable to the Company or any of its subsidiaries or their respective properties or assets, or (c) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or any of its subsidiaries is subject (including federal and state securities laws and regulations) and the rules and regulations of any self-regulatory organization to which the Company or its securities are subject, or by which any property or asset of the Company or any of its subsidiaries is bound or affected; (vi) the Shares, when issued and paid for in accordance with the terms of this Subscription Agreement, will be duly authorized, validly issued, fully paid and non-assessable and will be issued free and clear of any liens or other restrictions (other than those as provided in the Transaction Documents or restrictions on transfer under applicable state and federal securities laws). The issuance and delivery of the Shares does not (a) obligate the Company to offer to issue, or issue, shares of Common Stock or other securities to any Person (other than the Subscriber) pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any Person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Company. Subject to the accuracy of the representations and warranties made by the Subscriber in Section 3, the offer and sale of the Shares to the Subscriber is, and will be, (i) exempt from the registration and prospectus delivery requirements of the Securities Act and (ii) exempt from (or otherwise not subject to) the registration and qualification requirements of applicable securities laws of the states of the United States; (vii) it has filed all forms, statements, certifications, reports and documents required to be filed by it with the SEC under Section 13, 14(a) and 15(d) of the Exchange Act since its inception. As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the filed SEC Reports complied in all material respects with the applicable requirements of the Exchange Act, and, as of the time they were filed, none of the filed SEC Reports contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Reports. To the Company’s knowledge, none of the SEC Reports are the subject of an ongoing SEC review; (viii) the consolidated financial statements of the Company included in the SEC Reports (collectively, the “Financial Statements”) comply in all material respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto as in effect at the time of filing (or to the extent corrected by a subsequent restatement) and fairly present in all material respects the consolidated financial position of the Company and its subsidiaries as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, and have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods therein specified ((except as otherwise noted therein, and except that any unaudited financial statements may not contain certain footnotes and are subject to normal and recurring year-end adjustments). Except as set forth in the Financial Statements filed prior to the date of this Agreement, the Company has not incurred any liabilities, contingent or otherwise, except those incurred in the ordinary course of business, consistent with past practices since the date of such financial statements or liabilities not required under GAAP to be reflected in the Financial Statements; (ix) except as set forth in the SEC Reports or as would not reasonably be expected to result in a material adverse effect, there is no action, suit, proceeding, arbitration, claim, investigation, charge, complaint or inquiry pending or, to the Company’s knowledge, threatened against the Company or any of its subsidiaries, nor are there any orders, writs, injunctions, judgments or decrees outstanding of any court or government agency or instrumentality and binding upon the Company or any of its subsidiaries; (x) except as set forth in the SEC Reports or as would not reasonably be expected to result in a material adverse effect, neither the Company nor any of its subsidiaries is in violation of, or has received any notices of violations with respect to, any laws, statutes, ordinances, rules or regulations of any governmental body, court or government agency or instrumentality, including without limitation, all applicable requirements of the Sarbanes-Oxley Act of 2002 and applicable rules and regulations promulgated by the SEC thereunder; (xi) to the Company’s knowledge, the Company and its subsidiaries own, or have rights to use, all material inventions, patent applications, patents, trademarks, trade names, service names, service marks, copyrights, trade secrets, know how (including unpatented and/or unpatentable proprietary of confidential information, systems or procedures) and other intellectual property as described in the SEC Reports necessary for, or used in the conduct of their respective businesses (including as described in the SEC Reports) (collectively, “Intellectual Property”). The Intellectual Property of the Company and its subsidiaries has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part. To the Company’s knowledge: (i) there are no third parties who have rights to any Intellectual Property, including no liens, security interests, or other encumbrances; and (ii) there is no infringement by third parties of any Intellectual Property, except as set forth in the SEC Reports. Except as set forth in the SEC Reports, no action, suit, or other proceeding is pending, or, to the Company’s knowledge, is threatened: (A) challenging the Company’s or its subsidiaries’ rights in or to any Intellectual Property; (B) challenging the validity, enforceability or scope of any Intellectual Property; or (C) alleging that the Company or any of its subsidiaries infringes, misappropriates, or otherwise violates any patent, trademark, trade name, service name, copyright, trade secret or other proprietary rights of others. The Company and its subsidiaries have complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or any of its subsidiaries in all material respects, and to the Company’s knowledge all such agreements are in full force and effect. To the Company’s knowledge, there are no material defects in any of the patents or patent applications included in the Intellectual Property. The Company and its subsidiaries have taken all reasonable steps to protect, maintain and safeguard their Intellectual Property; (xii) The issued and outstanding shares of Common Stock are registered pursuant to Section 12(b) of the Exchange Act and are listed for trading on the Nasdaq Global Select Market under the symbol “ZBIO”. The Company is in compliance with all listing requirements of Nasdaq applicable to the Company. As of the date of this Agreement, there is no suit, action, proceeding or investigation pending or, to the knowledge of the Company, threatened against the Company by Nasdaq or the SEC, respectively, to prohibit or terminate the listing of the Common Stock on the Nasdaq Global Market or to deregister the Common Stock under the Exchange Act. The Company has taken no action as of the date of this Agreement that is designed to terminate the registration of the Common Stock under the Exchange Act; (xiii) The Company has a reasonable basis for making each of the representations set forth in this Section 2. The Company acknowledges that the Subscriber will rely upon the truth and accuracy of, and the Company’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of the Company set forth herein; (xiv) neither the Company nor any of its (a) predecessors, (b) Affiliates, (c) directors, (d) executive officers, (e) beneficial owners of 20% or more of its outstanding voting equity securities (calculated on the basis of voting power), (f) promoters or (g) investment managers or general partners or managing members of such investment managers is subject to the disqualification provisions of Rule 506(d)(1)(i-viii) of Regulation D under the Securities Act; and (xv) the Company does not engage in (a) the design, fabrication, development, testing, production or manufacture of one or more “critical technologies” within the meaning of the Defense Production Act of 1950, as amended, including all implementing regulations thereof (the “DPA”); (b) the ownership, operation, maintenance, supply, manufacture, or servicing of “covered investment critical infrastructure” within the meaning of the DPA (where such activities are covered by column 2 of Appendix A to 31 C.F.R. Part 800); or (c) the maintenance or collection, directly or indirectly, of “sensitive personal data” of U.S. citizens within the meaning of the DPA. The Company has no current intention of engaging in such activities in the future.
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3. Representations, Warranties and Acknowledgments of the Subscriber.
(a) The Subscriber hereby represents and warrants as of the date hereof to the Company as follows: (i) it has or will obtain before the Initial Closing the full right, power and authority to enter into this Subscription Agreement and to perform all of its obligations hereunder; (ii) this Subscription Agreement has been duly authorized and executed by the Subscriber and, when delivered in accordance with the terms hereof, will constitute a valid and binding agreement of the Subscriber enforceable against the Subscriber in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the rights and remedies of creditors generally or subject to general principles of equity; (iii) the execution and delivery of this Subscription Agreement and the consummation of the transactions contemplated hereby do not conflict with or result in a breach of the Subscriber’s governing or organizational documents; (iv) neither the Subscriber, nor any of its affiliates (including the Guarantor), requires any consent, approval, authorization, filing with or order of any court or governmental agency or body in connection with the Subscriber’s entry into the transactions contemplated herein except as such as may have already been obtained; (v) at the time the Subscriber was offered the Shares, it was, and at the date hereof it is, and on the date of each Closing it will be, an “accredited investor” as defined in Rule 501(a) under the Securities Act; (vi) the Subscriber is knowledgeable, sophisticated and experienced in making, and is qualified to make, decisions with respect to investments in securities representing an investment decision like that involved in the purchase of the Shares; (vii) the Subscriber has received and carefully reviewed each of this Subscription Agreement, the Registration Rights Agreement, the Accredited Investor Questionnaire (as defined below and attached hereto as Exhibit A), the License Agreement and any other documents or agreements explicitly contemplated hereunder (collectively, the “Transaction Documents”) and understand the information contained therein, prior to the execution of this Subscription Agreement; (viii) the Subscriber has had a reasonable opportunity to ask questions of and receive answers from the Company’s officers and any other persons authorized by the Company to answer such questions, concerning, among other related matters, the Shares, the Transaction Documents and the business, financial condition, results of operations and prospects of the Company and all such questions have been answered by the Company to the satisfaction of the Subscriber; (ix) the Subscriber has taken no action which would give rise to any claim by any person for brokerage commissions, finders’ fees or the like relating to the Subscription or the transactions contemplated hereby; (x) the Subscriber is not relying on the Company or any of its respective employees or agents with respect to the legal, tax, economic and related considerations of an investment in the Shares, and the Subscriber has relied on the advice of, or has consulted with, only its own advisors; (xi) the Subscriber is satisfied that it has received adequate information with respect to all matters which it considers material to its decision to make an investment in the Shares; and (xii) the Subscriber is not a, and it has no direct or indirect affiliation or association with any, member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or an Associated Person (as such term is defined under the FINRA Rules) as of the date hereof.
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(b) The Subscriber hereby also represents and warrants as of the date hereof to the Company that, other than the transactions contemplated hereunder, the Subscriber has not, directly or indirectly, nor has any person acting on behalf of or pursuant to any understanding with the Subscriber, executed any transactions in securities of the Company, including “short sales” (“Short Sales”) as defined in Rule 200 of Regulation SHO under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), during the period commencing from the time that the Subscriber first became aware of the proposed transactions contemplated hereunder until the date hereof (the “Discussion Time”). The Subscriber has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).
4. Covenants of the Company.
(a) Further Assurances. Each party agrees to cooperate with each other and their respective officers, employees, attorneys, accountants and other agents, and, generally, do such other reasonable acts and things in good faith as may be necessary to effectuate the intents and purposes of this Agreement, subject to the terms and conditions of this Agreement and compliance with applicable law, including taking reasonable action to facilitate the filing of any document or the taking of reasonable action to assist the other parties hereto in complying with the terms of this Agreement.
(b) Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on the Nasdaq Global Select Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of Securities Act, Exchange Act, SEC and The Nasdaq Stock Market LLC (“Nasdaq”).
(c) Registration of the Shares. The Company shall register the Shares in accordance with the terms and conditions of the Registration Rights Agreement.
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(d) Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Securities in a manner that would require the registration under the Securities Act of the sale of the Securities to the Subscriber, or that will be integrated with the offer or sale of the Securities for purposes of the rules and regulations of any National Exchange such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
(e) Removal of Legends
(i) In connection with any sale, assignment, transfer or other disposition of the Shares by the Subscriber pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Subscriber with the requirements of this Agreement, if requested by the Subscriber by notice to the Company, the Company shall request the transfer agent to remove any restrictive legends related to the book entry account holding such shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends as soon as reasonably practicable following any such request therefor from the Subscriber, provided that the Company has timely received from the Subscriber customary representations and other documentation reasonably acceptable to the Company in connection therewith. The Company shall be responsible for the fees of its transfer agent and its legal counsel associated with such legend removal.
(ii) Subject to receipt from the Subscriber by the Company and the transfer agent of customary representations and other documentation reasonably acceptable to the Company and the transfer agent in connection therewith, upon the earliest of such time as the Shares (i) have been registered under the Securities Act pursuant to an effective registration statement; (ii) have been sold pursuant to Rule 144, or (iii) are eligible for resale under Rule 144(b)(1) without the requirement for the Company to be in compliance with the current public information requirements under Rule 144(c)(1) (or any successor provision), the Company shall, in accordance with the provisions of this Section 4(e) and as soon as reasonably practicable following any request therefor from the Subscriber accompanied by such customary and reasonably acceptable documentation referred to above, (A) deliver to the transfer agent irrevocable instructions that the transfer agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legend in accordance with the provisions of this Agreement.
5. Covenants of the Subscriber.
(a) Covenant of the Subscriber Regarding Confidentiality. The Subscriber hereby covenants that until such time as the transactions contemplated by this Subscription Agreement are publicly disclosed by the Company through a press release and/or Current Report on Form 8-K, the Subscriber will maintain the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).
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(b) Accredited Investor Questionnaire. Prior to the Initial Closing, the Subscriber shall have executed, truthfully completed and delivered to the Company an Accredited Subscriber Questionnaire substantially in the form of Exhibit A hereto (the “Accredited Investor Questionnaire”).
(c) Transfer Restrictions.
| (i) | Lock-Up. The Subscriber shall not directly or indirectly sell, dispose of or otherwise transfer (“Transfer”) any Shares until the date that is twelve (12) months following the Initial Closing Date (the “Lock-Up Expiration Date”), other than in a Permitted Transfer. A “Permitted Transfer” means (i) a Transfer of Shares to an Affiliate of the Subscriber that agrees to be bound by the terms of this Agreement in the same manner as the Subscriber, (ii) a Transfer of Shares in connection with a Change of Control of the Company approved by the Board, or (iii) a Transfer of Shares to the Company. |
| (ii) | Volume Limitations. Except for Permitted Transfer, from and after the Lock-Up Expiration Date, the Subscriber shall not Transfer shares of Common Stock if the total amount of shares of Common Stock Transferred during any month would exceed the greater of (A) one percent (1%) of the outstanding Common Stock as reporting in the most recent public report or statement published by the Company and (B) the average weekly reported volume of trading in the Common Stock on all national securities exchanges and/or reported through the automated quotation system of a registered securities association during the four preceding calendar weeks. |
| (iii) | Compliance with Laws. In addition to other restrictions set forth in this Section 5, the Subscriber covenants that the Shares may be disposed of only pursuant to an effective registration statement under, and in compliance with the requirements of, the Securities Act, or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, and in compliance with any applicable state and federal securities laws. In connection with any transfer of the Shares other than (i) pursuant to an effective registration statement, (ii) to the Company, or (iii) pursuant to Rule 144 (provided that the Subscriber provides the Company with reasonable assurances (in the form of seller and, if applicable, broker representation letters) that the Shares may be sold pursuant to such rule), the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Shares under the Securities Act. As a condition of transfer, any such transferee shall agree in writing to be bound by the terms of this Subscription Agreement by executing a joinder agreement to each of the same, and shall have the rights of the Subscriber under this Subscription Agreement with respect to such transferred Shares upon such execution. |
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| (iv) | Legends. Book entry confirmations evidencing the Shares shall bear any legend as required by the “blue sky” laws of any state and a restrictive legend in substantially the following form, until such time as they are not required, as reasonably determined by the Company: |
THESE SHARES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR APPLICABLE STATE SECURITIES LAWS. THE SHARES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SHARES UNDER THE SECURITIES ACT OR (B) AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY AND ITS TRANSFER AGENT OR (II) UNLESS SOLD PURSUANT TO RULE 144 UNDER SAID ACT.
6. Standstill. Until the Lock-Up Expiration Date, neither the Subscriber nor any of its Affiliates or any “group” (within the meaning of Section 13(d)(3) of the Exchange Act) of which the Subscriber or any of its Affiliates is a member, nor any executive officer, director or other agent acting on behalf of any of the foregoing (collectively, the “Standstill Parties”) shall (and the Subscriber shall cause the other Standstill Parties not to), except as expressly contemplated hereunder or approved or invited in writing by the Company:
(a) directly or indirectly, seek to have called any meeting of the stockholders of the Company, propose or nominate for election to the board of directors of the Company (the “Board”) any person whose nomination has not been approved by the Board or cause to be voted in favor of such person for election to the Board any shares of capital stock of the Company;
(b) propose to enter into, directly or indirectly, any merger or business combination involving the Company, or any subsidiary or Affiliate of the Company, or any material portion of the assets of the Company or any of the foregoing, or directly or indirectly, propose, encourage or support a tender, exchange or other offer or proposal by any third party (an “Offeror”) the consummation of which would result in a Change of Control of the Company or any subsidiary or Affiliate of the Company or result in the acquisition any material portion of the assets of the Company or any of the foregoing (an “Acquisition Proposal”);
(c) directly or indirectly, solicit proxies or consents or become a participant in a solicitation (as such terms are defined in Regulation 14A under the Exchange Act) in opposition to the recommendation of a majority of the members of the Board with respect to any matter, or seek to advise or influence any third party, with respect to voting of any shares of capital stock of the Company;
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(d) deposit any shares of capital stock of the Company in a voting trust or subject any shares of capital stock of the Company to any arrangement or agreement with respect to the voting of such shares;
(e) act in concert with any third party to take any action in clauses (a) through (d) above, or form, join or in any way participate in a “partnership, limited partnership, syndicate, or other “group” (within the meaning of Section 13(d)(3) of the Exchange Act) with any third party within the meaning of Section 13(d)(3) of the Exchange Act with respect to the equity securities of the Company;
(f) take any action that is reasonably likely to require the Company to make a public announcement regarding the possibility of a business combination or merger involving the Company or any of its Affiliates;
(g) enter into discussions, negotiations, arrangements or agreements with, or otherwise advise or knowingly assist or encourage, any third party, or provide any third party with information, in relation to the foregoing actions referred to in (a) through (f) above; or
(h) publicly disclose, or communicate directly with the Board regarding, any intention, plan or arrangement inconsistent with this Section 6.
7. Closing Conditions. No Closing shall occur unless and until all of the following conditions are satisfied or waived in writing by the Subscriber:
(a) The Company’s Common Stock is listed and trading on the Nasdaq Global Select Market.
(b) The Company shall have furnished all required materials to the transfer agent to reflect the issuance of the applicable Shares at the applicable Closing.
(c) The Company shall have executed and delivered the Registration Rights Agreement to the Subscriber.
(d) No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Company’s Common Stock. The Company’s Common Stock shall be listed on Nasdaq and shall not have been suspended, as of the Initial Closing Date or the Contingent Closing Date, as applicable, by the SEC or Nasdaq from trading thereon nor shall suspension by the SEC or Nasdaq have been threatened, as of the Initial Closing Date or the Contingent Closing Date, as applicable, in writing by the SEC or Nasdaq; and the Company shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares and Nasdaq shall have raised no objection to such notice and the transactions contemplated hereby.
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8. Termination.
(a) The obligations of the Company, on the one hand, and the Subscriber, on the other hand, to effect any Closing shall terminate as follows:
(i) upon the mutual written consent of the Company and the Subscriber prior to the applicable Closing;
(ii) by the Subscriber if any of the conditions set forth in Section 7 shall have become incapable of fulfillment, and shall not have been waived by the Subscriber; or
(iii) by the Company or Subscriber if the License Agreement is terminated or if the other party, as applicable, materially breaches this Subscription Agreement or the Registration Rights Agreement.
(b) To the extent applicable, termination of this Subscription Agreement shall not affect any rights or liabilities that have accrued to either party as of the effective date of termination.
9. Miscellaneous.
(a) Neither the Company nor the Subscriber shall make any public announcement with respect to the existence or terms of this Agreement or the transactions provided for herein without the prior consent of the other party (which consent shall not be unreasonably withheld). Notwithstanding the foregoing, nothing in this Section 9(a) shall prevent any party from making any public announcement it considers necessary in order to satisfy its obligations under the law, including applicable securities laws, or under the rules of any national securities exchange or securities market, in which case the Company shall allow the Subscriber reasonable time to comment on such release or announcement in advance of such issuance, and the Company will consider in good faith any Subscriber comments.
(b) This Subscription Agreement constitutes the entire understanding and agreement among the parties with respect to its subject matter, other than the Registration Rights Agreement and the applicable provisions of the License Agreement explicitly referenced herein, there are no agreements or understandings with respect to the subject matter hereof which are not contained in this Subscription Agreement.
(c) This Subscription Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and shall become effective when counterparts have been signed by each party and delivered to the other party hereto, it being understood that the parties need not sign the same counterpart. Execution may be made by delivery by facsimile or by e-mail delivery of a “.pdf” format data file.
(d) The provisions of this Subscription Agreement are severable and, in the event that any court or officials of any regulatory agency of competent jurisdiction shall determine that any one or more of the provisions or part of the provisions contained in this Subscription Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Subscription Agreement and this Subscription Agreement shall be reformed and construed as if such invalid or illegal or unenforceable provision, or part of such provision, had never been contained herein, so that such provisions would be valid, legal and enforceable to the maximum extent possible, so long as such construction does not materially adversely affect the economic rights of either party hereto.
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(e) All communications hereunder, except as may be otherwise specifically provided herein, shall be in writing and shall be mailed, hand delivered, sent by a recognized overnight courier or sent via facsimile or by e-mail delivery and confirmed by letter, to the party to whom it is addressed at the following addresses or such other address as such party may advise the other in writing:
If to the Company: Zenas Biopharma, Inc.
852 Winter St.
Waltham, MA 02451
Attention: Chief Legal Officer
Email: [***]
With a copy to (which shall not constitute notice):
Sidley Austin LLP
2850 Quarry Lake Dr.
Suite 280 Baltimore, MD 21209
Attn: Asher Rubin
If to the Subscriber: InnoCare Pharma Inc.
103 Carnegie Center, Suite 209
Princeton, NJ 08540, USA
Attn: Lisa Ren; Chief Legal Officer
Email: [***]
With a copy to (which shall not constitute notice):
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304, USA
Attn: Lila Hope
Email: lhope@cooley.com
All notices hereunder shall be effective upon receipt by the party to which it is addressed.
(f) No provision of this Subscription Agreement may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment, by the Company and the Subscriber or, in the case of a waiver, by the party against whom enforcement of any such waiver is sought. No waiver of any default with respect to any provision, condition or requirement of this Subscription Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of either party to exercise any right hereunder in any manner impair the exercise of any such right.
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(g) This Subscription Agreement shall be governed by and interpreted in accordance with the laws of the State of New York for contracts to be wholly performed in such state and without giving effect to the principles thereof regarding the conflict of laws.
(h) None of the parties may assign its rights or obligations under this Agreement or designate another person (i) to perform all or part of its obligations under this Agreement or (ii) to have all or part of its rights and benefits under this Agreement, in each case without the prior written consent of the other party, provided that the Subscriber may, without the prior consent of the Company, assign its rights to purchase the Shares hereunder to any of its affiliates. In the event of any assignment in accordance with the terms of this Agreement, the assignee shall specifically assume and be bound by the provisions of this Agreement by executing a writing agreeing to be bound by and subject to the provisions of this Agreement and shall deliver an executed counterpart signature page to this Agreement and, notwithstanding such assumption or agreement to be bound hereby by an assignee, no such assignment shall relieve any party assigning any interest hereunder from its obligations or liability pursuant to this Agreement.
(i) The covenants, representations and warranties made by each party hereto contained in this Agreement shall survive each Closing and the delivery of the Shares in accordance with their respective terms.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, each of the Company and Subscriber has executed or caused this Subscription Agreement to be executed by its duly authorized representative as of the date set forth below.
| ZENAS BIOPHARMA, INC. | ||
| By: | /s/ Leon O. Moulder, Jr. | |
| Name: Leon O. Moulder, Jr. | ||
| Title: Chief Executive Officer | ||
Accepted and agreed this 7th day of October 2025.
SUBSCRIBER: INNOCARE PHARMA, INC.
| Signature of Subscriber: | ||
| By: | /s/ Jasmine Cui | |
| Name: | Jasmin Cui | |
| Title: | Chairperson and CEO | |
Name in which securities are to be registered (if different from the name of Subscriber listed directly above):
EXHIBIT A
ACCREDITED INVESTOR QUESTIONNAIRE
| A. | INSTITUTIONAL ACCREDITED INVESTOR STATUS (Please check the applicable subparagraphs): |
| 1. | ¨ We are an “accredited investor” (within the meaning of Rule 501(a) under the Securities Act) or an entity in which all of the equity holders are accredited investors within the meaning of Rule 501(a) under the Securities Act, and have marked and initialed the appropriate box on the following page indicating the provision under which we qualify as an “accredited investor.” |
| 2. | ¨ We are not a natural person. |
*** AND ***
B. AFFILIATE STATUS
(Please check the applicable box) SUBSCRIBER:
¨ is:
¨ is not:
an “affiliate” (as defined in Rule 144 under the Securities Act) of the Company or acting on behalf of an affiliate of the Company.
This page should be completed by Subscriber and constitutes a part of the Subscription Agreement.
Rule 501(a) under the Securities Act, in relevant part, states that an “accredited investor” shall mean any person who comes within any of the below listed categories, or who the issuer reasonably believes comes within any of the below listed categories, at the time of the sale of the securities to that person. Subscriber has indicated, by marking and initialing the appropriate box below, the provision(s) below which apply to Subscriber and under which Subscriber accordingly qualifies as an “accredited investor.”
| ¨ | Any bank as defined in section 3(a)(2) of the Securities Act, or any savings and loan association or other institution as defined in section 3(a)(5)(A) of the Securities Act whether acting in its individual or fiduciary capacity; |
| ¨ | Any broker or dealer registered pursuant to section 15 of the Securities Exchange Act of 1934, as amended; |
| ¨ | Any insurance company as defined in section 2(a)(13) of the Securities Act; |
| ¨ | Any investment company registered under the Investment Company Act of 1940, as amended (the “Investment Company Act”) or a business development company as defined in section 2(a)(48) of the Investment Company Act; |
| ¨ | Any Small Business Investment Company licensed by the U.S. Small Business Administration under section 301(c) or (d) of the Small Business Investment Act of 1958, as amended; |
| ¨ | Any Rural Business Investment Company as defined in section 384A of the Consolidated Farm and Rural Development Act, as amended; |
| ¨ | Any plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has total assets in excess of $5,000,000; |
| ¨ | Any employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), if (i) the investment decision is made by a plan fiduciary, as defined in section 3(21) of ERISA, which is either a bank, a savings and loan association, an insurance company, or a registered investment adviser, (ii) the employee benefit plan has total assets in excess of $5,000,000 or, (iii) such plan is a self-directed plan, with investment decisions made solely by persons that are “accredited investors”; |
| ¨ | Any private business development company as defined in section 202(a)(22) of the Investment Advisers Act of 1940, as amended; |
| ¨ | Any (i) corporation, limited liability company or partnership, (ii) Massachusetts or similar business trust, or (iii) organization described in section 501(c)(3) of the Internal Revenue Code of 1986, as amended, not formed for the specific purpose of acquiring the securities offered, and with total assets in excess of $5,000,000; |
| ¨ | Any director, executive officer, or general partner of the issuer of the securities being offered or sold, or any director, executive officer, or general partner of a general partner of that issuer; |
| ¨ | Any natural person whose individual net worth, or joint net worth with that person’s spouse, exceeds $1,000,000. For purposes of calculating a natural person’s net worth: (a) the person’s primary residence shall not be included as an asset; (b) indebtedness that is secured by the person’s primary residence, up to the estimated fair market value of the primary residence at the time of the sale of securities, shall not be included as a liability (except that if the amount of such indebtedness outstanding at the time of sale of securities exceeds the amount outstanding sixty (60) days before such time, other than as a result of the acquisition of the primary residence, the amount of such excess shall be included as a liability); and (c) indebtedness that is secured by the person’s primary residence in excess of the estimated fair market value of the primary residence at the time of the sale of securities shall be included as a liability; |
| ¨ | Any natural person who had an individual income in excess of $200,000 in each of the two most recent years or joint income with that person’s spouse in excess of $300,000 in each of those years and has a reasonable expectation of reaching the same income level in the current year; |
| ¨ | Any trust, with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the securities offered, whose purchase is directed by a sophisticated person as described in Section 230.506(b)(2)(ii) of Regulation D; |
| ¨ | Any entity in which all of the equity owners are “accredited investors”; |
| ¨ | Any natural person holding in good standing one or more professional certifications or designations or credentials from an accredited educational institution that the SEC has designated as qualifying an individual for accredited investor status, such as a General Securities Representative license (Series 7), a Private Securities Offerings Representative license (Series 82) and an Investment Adviser Representative license (Series 65); |
| ¨ | Any “family office” as defined in Rule 202(a)(11)(G)-1 under the Investment Advisers Act of 1940 which was not formed for the purpose of investing in the Company, has assets under management in excess of $5,000,000 and whose prospective investment is directed by a person who has such knowledge and experience in financial and business matters that such family office is capable of evaluating the merits and risks of the prospective investment; or |
| ¨ | Any “family client,” as defined in rule 202(a)(11)(G)-1 under the Investment Advisers Act of 1940, of a family office, whose prospective investment in the Company is directed by such family office, and such family office is one (i) with assets under management in excess of $5,000,000, (ii) that was not formed for the specific purpose of investing in the Company, and (iii) whose prospective investment in the Company is directed by a person who has such knowledge and experience in financial and business matters that such family office is capable of evaluating the merits and risks of such prospective investment. |
Exhibit 10.2
EXECUTION VERSION
Confidential
REGISTRATION RIGHTS AGREEMENT
This Registration Rights Agreement (this “Agreement”) is made and entered into as of October 7, 2025, by and among Zenas Biopharma, Inc., a Delaware corporation (the “Company”), and InnoCare Pharma, Inc., a Delaware corporation (the “Investor”).
This Agreement is made in connection with the Subscription Agreement (the “Subscription Agreement”), dated as of the date hereof, by and between the Company and the Investor. All capitalized terms not defined herein shall have the meanings assigned to them in the Subscription Agreement.
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Investor agree as follows:
1. Definitions. As used in this Agreement, the following terms shall have the following meanings:
“Advice” has the meaning set forth in Section 6(d).
“Affiliate” means, with respect to any Person, any other person which directly or indirectly controls, is controlled by, or is under common control with, such Person; as such terms are used in and construed under Rule 405 of the Securities Act.
“Agreement” has the meaning set forth in the Preamble.
“Business Day” means any day except Saturday, Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Commission” means the Securities and Exchange Commission.
“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any securities into which such common stock may hereinafter be reclassified.
“Company” has the meaning set forth in the Preamble.
“Equity Securities” means any and all (i) shares, interests, participations or other equivalents (however designated) of capital stock or other voting securities of a corporation, any and all equivalent or analogous ownership (or profit) or voting interests in a Person (other than a corporation), (ii) securities convertible into or exchangeable for shares, interests, participations or other equivalents (however designated) of capital stock or voting securities of a corporation, and securities convertible into or exchangeable for any equivalent or analogous ownership (or profit) or voting interests in a Person (other than a corporation), and (iii) any and all warrants, rights or options to purchase any of the foregoing, whether voting or nonvoting, and, in each case, whether or not such shares, interests, participations, equivalents, securities, warrants, options, rights or other interests are authorized or otherwise existing on any date of determination; provided that Equity Securities shall not include preference shares (or depositary shares representing interests in preference shares) that are not convertible or exchangeable for common shares in a corporation.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.
“FINRA” has the meaning set forth in Section 3(h).
“Indemnified Party” has the meaning set forth in Section 5(c).
“Indemnifying Party” has the meaning set forth in Section 5(c).
“Investor” has the meaning set forth in the Preamble.
“Losses” has the meaning set forth in Section 5(a).
“Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.
“Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an investigation or partial proceeding, such as a deposition), whether commenced or threatened.
“Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.
“Registrable Securities” means all of the Shares and any securities issued or issuable upon any stock split, dividend or other distribution, recapitalization or similar event with respect to the foregoing; provided, that the Investor has completed and delivered to the Company a Selling Stockholder Questionnaire; and provided, further, that the Shares shall cease to be Registrable Securities upon the earliest to occur of the following a sale pursuant to a Registration Statement or Rule 144 under the Securities Act (in which case, only such security sold by the Investor shall cease to be a Registrable Security).
“Registration Statement” means any one or more registration statements of the Company filed under the Securities Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement, including (in each case) the amendments and supplements to such Registration Statements, including pre- and post-effective amendments thereto, all exhibits and all material incorporated by reference or deemed to be incorporated by reference in such Registration Statements.
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“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule.
“Rule 424” means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule.
“Securities Act” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.
“Selling Stockholder Questionnaire” means a questionnaire in the form attached as Annex A hereto, or such other form of questionnaire as may reasonably be adopted by the Company from time to time.
“Shares” means the shares of Common Stock issued or issuable to the Investor pursuant to the Subscription Agreement.
“Subscription Agreement” has the meaning set forth in the Preamble.
2. Registration.
(a) The Company shall, as promptly as reasonably practicable and in any event no later than September 7, 2026 (the “Filing Deadline”), prepare and file with the Commission an initial Registration Statement (the “Initial Registration Statement”) covering the resale of all Registrable Securities. Before filing the Registration Statement, the Company shall furnish to the Investor a copy of the Registration Statement. The Investor and their counsel shall have at least three Business Days prior to the anticipated filing date of a Registration Statement to review and comment upon such Registration Statement and any amendment or supplement to such Registration Statement and any related prospectus, prior to its filing with the SEC. Subject to any Commission comments, such Registration Statement shall include the plan of distribution substantially in the form attached hereto as Exhibit A. Such Registration Statement also shall cover, to the extent allowable under the Securities Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. Such Registration Statement shall not include any shares of Common Stock or other securities for the account of any other holder of securities of the Company without the prior written consent of the Investor. The Company shall (a) use commercially reasonable efforts to address in each such document prior to being so filed with the Commission such comments as the Investor or its counsel reasonably proposed by the Investor, and (b) not file any Registration Statement or related prospectus or any amendment or supplement thereto containing information regarding the Investor to which Investor reasonably objects, unless such information is required to comply with any applicable law or regulation. The Investor shall furnish all information reasonably requested by the Company and as shall be reasonably required in connection with any registration referred to in this Agreement.
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(b) The Company shall use its reasonable best efforts to have the Initial Registration Statement and any amendment declared effective by the Commission at the earliest possible date but no later than the earlier of the 75th calendar day following the initial filing date of the Initial Registration Statement if the Commission notifies the Company that it will “review” the Initial Registration Statement and (b) the fifth Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the Commission that the Initial Registration Statement will not be “reviewed” or will not be subject to further review (the “Effectiveness Deadline”). The Company shall notify the Investor by e-mail as promptly as practicable, and in any event, within 24 hours, after the Registration Statement is declared effective or is supplemented and shall provide the Investor with copies of any related prospectus to be used in connection with the sale or other disposition of the securities covered thereby. The Company shall use reasonable best efforts to keep the Initial Registration Statement continuously effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by the Investor of all of the Registrable Securities covered thereby at all times until the earliest to occur of the following events: (i) the date on which the Investor shall have resold all the Registrable Securities covered thereby; and (ii) the date on which the Registrable Securities may be resold by the Investor without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect (the “Registration Period”). The Initial Registration Statement (including any amendments or supplements thereto and prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading.
(c) In the event the number of shares available under the Initial Registration Statement at any time is insufficient to cover the Registrable Securities, the Company shall, to the extent necessary and permissible, amend the Initial Registration Statement or file a new registration statement (together with any prospectuses or prospectus supplements thereunder, a “New Registration Statement”), so as to cover all of such Registrable Securities as soon as reasonably practicable, but in any event not later than ten Business Days after the necessity therefor arises (the “New Registration Filing Deadline”). The Company shall use its reasonable best efforts to have such amendment and/or New Registration Statement become effective as soon as reasonably practicable following the filing thereof but no later than the earlier of the 75th calendar day following the initial filing date of the New Registration Statement if the Commission notifies the Company that it will “review” the New Registration Statement and (b) the fifth Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the Commission that the New Registration Statement will not be “reviewed” or will not be subject to further review (the earlier of such dates, the “New Registration Effectiveness Deadline”). The provisions of Section 2(a) and (b) shall apply to the New Registration Statement, except as modified hereby.
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(d) On no more than two occasions and for not more than 45 consecutive days or for a total of not more than 90 days in any 12 month period, the Company may delay the effectiveness of the Initial Registration Statement or any other Registration Statement, or suspend the use of any prospectus included in any Registration Statement, in the event that the Company determines in good faith and upon advice of reputable legal counsel that such delay or suspension is necessary to (A) delay the disclosure of material non-public information concerning the Company, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company or (B) amend or supplement the affected Registration Statement or the related prospectus so that such Registration Statement or prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the case of the prospectus in light of the circumstances under which they were made, not misleading (an “Allowed Delay”); provided, that the Company shall promptly (a) notify each Investor in writing of the commencement of an Allowed Delay, but shall not (without the prior written consent of an Investor) disclose to such Investor any material non-public information giving rise to an Allowed Delay, (b) advise the Investor in writing to cease all sales under the Registration Statement until the end of the Allowed Delay and (c) use reasonable best efforts to terminate an Allowed Delay as promptly as practicable.
(e) The Investor agrees to furnish to the Company a completed Selling Stockholder Questionnaire and, if reasonably requested by the Company, all other information as shall be reasonably required in connection with the registration of the Registrable Securities. The Investor acknowledges and agrees that the information in the Selling Stockholder Questionnaire or request for further information as described in this Section 2(e) will be used by the Company in the preparation of the Registration Statement and hereby consents to the inclusion of such information in the Registration Statement.
3. Registration Procedures.
In connection with the Company’s registration obligations hereunder, the Company shall:
(a) (i) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement (subject to the terms of this Agreement), and, as so supplemented or amended, to be filed pursuant to Rule 424; (ii) respond as promptly as reasonably practicable to any comments received from the Commission with respect to each Registration Statement or any amendment thereto; and (iii) comply with the provisions of the Securities Act and the Exchange Act with respect to the disposition of all Registrable Securities covered by a Registration Statement until such time as all of such Registrable Securities cease to be Registrable Securities or shall have been disposed of (subject to the terms of this Agreement) in accordance with the intended methods of disposition by the Investor as set forth in such Registration Statement as so amended or in such Prospectus as so supplemented; provided, however, that in the event the Company informs the Investor in writing that it does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Investor is required to deliver a Prospectus in connection with any disposition of Registrable Securities, the Investor shall be responsible for the delivery of the Prospectus to the Persons to whom Investor sells any of the Registrable Securities, and the Investor agrees to dispose of Registrable Securities in compliance with the “Plan of Distribution” described in the Registration Statement and otherwise in compliance with applicable federal and state securities laws.
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(b) Notify the Investor (which notice shall be accompanied by an instruction to suspend the use of the Prospectus until the requisite changes have been made) as promptly as reasonably practicable via facsimile or electronic mail: (i) of the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement covering any or all of the Registrable Securities or the initiation of any Proceedings for that purpose; (ii) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction, or the initiation or threatening of any Proceeding for such purpose; and (iii) of the occurrence of any event or passage of time that makes the financial statements included in a Registration Statement ineligible for inclusion therein or any statement made in such Registration Statement or Prospectus or any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires any revisions to such Registration Statement, Prospectus or other documents so that, in the case of such Registration Statement or the Prospectus, as the case may be, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or amendment or supplement thereto, in light of the circumstances under which they were made), not misleading.
(c) Use reasonable best efforts to avoid the issuance of, or, if issued, obtain the withdrawal of (i) any order suspending the effectiveness of a Registration Statement, or (ii) any suspension of the qualification (or exemption from qualification) of any of the Registrable Securities for sale in any jurisdiction, as soon as reasonably practicable.
(d) If requested by the Investor, furnish to the Investor, without charge, at least one conformed copy of each Registration Statement and each amendment thereto and all exhibits to the extent requested by the Investor (including those previously furnished or incorporated by reference) promptly after the filing of such documents with the Commission; provided, that the Company shall have no obligation to provide any document pursuant to this clause that is available on the Commission’s EDGAR system.
(e) If reasonably requested by the Investor at any time in respect of any Registration Statement, the Company shall deliver to the Investor a written confirmation from Company’s counsel of whether or not the effectiveness of such Registration Statement has lapsed at any time for any reason (including, without limitation, the issuance of a stop order) and whether or not such Registration Statement is currently effective and available to the Company for sale of Registrable Securities.
(f) Prior to any resale of Registrable Securities by the Investor, use its reasonable best efforts to register or qualify or cooperate with the Investor in connection with the registration or qualification (or exemption from the registration or qualification) of such Registrable Securities for resale by the Investor under the securities or “blue sky” laws of such jurisdictions within the United States as the Investor reasonably requests in writing and to do any and all other acts or things reasonably necessary to enable the disposition in such jurisdictions of the Registrable Securities covered by each Registration Statement; provided, that the Company shall not be required to qualify generally to do business in any jurisdiction where it is not then so qualified, subject the Company to any material tax in any such jurisdiction where it is not then so subject, or file a general consent to service of process in any such jurisdiction.
(g) If requested by the Investor, cooperate with Investor to facilitate the timely preparation and delivery of certificates representing Registrable Securities to be delivered to a transferee pursuant to the Registration Statement, which certificates shall be free, to the extent permitted by the applicable Subscription Agreement and under law, of all restrictive legends, and to enable such Registrable Securities to be in such denominations and registered in such names as the Investor may reasonably request.
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(h) Following the occurrence of any event contemplated by Section 3(b), as promptly as reasonably practicable (taking into account the Company’s good faith assessment of any adverse consequences to the Company and its stockholders of the premature disclosure of such event), prepare a supplement or amendment, including a post-effective amendment, to the affected Registration Statements or a supplement to the related Prospectus or any document incorporated or deemed to be incorporated therein by reference, and file any other required document so that, as thereafter delivered, no Registration Statement nor any Prospectus will contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or amendment or supplement thereto, in light of the circumstances under which they were made), not misleading. If the Company notifies the Investor in accordance with Section 3(b) above to suspend the use of any Prospectus until the requisite changes to such Prospectus have been made, then the Investor shall suspend use of such Prospectus. The Company will use its reasonable best efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable.
(i) The Company shall use commercially reasonable to cause all Registrable Securities covered by a Registration Statement to be listed on the Nasdaq Global Select Market.
(j) The Company may require the Investor to furnish to the Company a certified statement as to (i) the number of shares of Common Stock beneficially owned by the Investor and any Affiliate thereof, (ii) any Financial Industry Regulatory Authority, Inc. (“FINRA”) affiliations, (iii) any natural persons who have the power to vote or dispose of the common stock, and (iv) any other information as may be requested by the Commission, FINRA or any state securities commission.
(k) The Company shall register or qualify or cooperate with the Investor and their counsel in connection with the registration or qualification of such Registrable Securities for the offer and sale under the securities or blue sky laws of such jurisdictions reasonably requested by the Investor; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(k), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(k), or (iii) file a general consent to service of process in any such jurisdiction.
(l) With a view to making available to the Investor the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the Commission that may at any time permit the Investor to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep adequate current public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Registrable Securities may be sold without restriction by the holders thereof pursuant to Rule 144 or any other rule of similar effect or (B) such date as there are no longer Registrable Securities; and (ii) file with the Commission in a timely manner all reports and other documents required of the Company under the Exchange Act; (iii) furnish electronically to the Investor upon request, as long as such Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the Exchange Act, (B) a copy of or electronic access to the Company’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, and (C) such other information as may be reasonably requested in order to avail the Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration.
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4. Registration Expenses. All fees and expenses incident to the Company’s performance of or compliance with its obligations under this Agreement (excluding any underwriting discounts and selling commissions and all legal fees and expenses of legal counsel for the Investor) shall be borne by the Company whether or not any Registrable Securities are sold pursuant to a Registration Statement. In addition, the Company shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Agreement (including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties), the expense of any annual audit and the fees and expenses incurred in connection with the listing of the Registrable Securities on any securities exchange as required hereunder. In no event shall the Company be responsible for any underwriting, broker or similar fees or commissions of the Investor or any legal fees or other costs of the Investor.
5. Indemnification.
(a) Indemnification by the Company. The Company shall, notwithstanding any termination of this Agreement, indemnify, defend and hold harmless the Investor, its officers, directors, agents and employees , each Person who controls the Investor (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, agents and employees of each such controlling Person, to the fullest extent permitted by applicable law, from and against any and all losses, claims, damages, liabilities, costs (including, without limitation, reasonable costs of preparation and reasonable attorneys’ fees) and expenses (collectively, “Losses”), as incurred, that arise out of or are based upon any untrue or alleged untrue statement of a material fact contained in any Registration Statement, Prospectus, form of prospectus or amendment or supplement thereto, or arising out of or relating to any omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or amendment or supplement thereto, in light of the circumstances under which they were made) not misleading, except to the extent, but only to the extent that (A) such untrue statements, alleged untrue statements, omissions or alleged omissions are based solely upon information regarding the Investor furnished in writing to the Company by the Investor, or to the extent that such information relates to the Investor or its proposed method of distribution of Registrable Securities and was reviewed and approved in writing by the Investor expressly for use in the Registration Statement, Prospectus, form of prospectus or in any amendment or supplement thereto or (B) in the case of an occurrence of an event of the type specified in Section 3(b), related to the use by the Investor of an outdated or defective Prospectus after the Company has notified the Investor in writing that the Prospectus is outdated or defective and prior to the receipt by the Investor of the Advice contemplated and defined in Section 6(d) below, or (C) any such Losses arise out of the Investor’s (or any other indemnified Person’s) failure to send or give a copy of the Prospectus or supplement (as then amended or supplemented), if required pursuant to Rule 172 under the Securities Act (or any successor rule), to the Persons asserting an untrue statement or alleged untrue statement or omission or alleged omission at or prior to the written confirmation of the sale of Registrable Securities to such Person, if such statement or omission was corrected in such Prospectus or supplement. The Company shall notify the Investor promptly of the institution, threat or assertion of any Proceeding arising from or in connection with the transactions contemplated by this Agreement of which the Company is aware.
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(b) Indemnification by the Investor. The Investor shall and notwithstanding any termination of this Agreement, indemnify and hold harmless the Company, its directors, officers, agents and employees, each Person who controls the Company (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, agents or employees of such controlling Persons, to the fullest extent permitted by applicable law, from and against all Losses, as incurred, arising out of or are based solely upon (i) the Investor’s failure to comply with the prospectus delivery requirements of the Securities Act, or (ii) any untrue or alleged untrue statement of a material fact contained in any Registration Statement, Prospectus, form of prospectus or amendment or supplement thereto, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or amendment or supplement thereto, in light of the circumstances under which they were made) not misleading to the extent, but only to the extent, that (A) such untrue statements or omissions are based upon information regarding the Investor furnished in writing to the Company by the Investor expressly for use therein or (B) such information relates to the Investor and was reviewed and approved in writing by the Investor expressly for use in any Registration Statement, Prospectus, form of prospectus or amendment or supplement thereto, or (C) in the case of an occurrence of an event of the type specified in Section 3(b), such Losses are related to the use by the Investor of an outdated or defective Prospectus after the Company has notified the Investor in writing that the Prospectus is outdated or defective and prior to the receipt by the Investor of the Advice contemplated in Section 6(d). In no event shall the liability of the Investor be greater in amount than the dollar amount of the net proceeds received by the Investor upon the sale of the Registrable Securities giving rise to such indemnification obligation.
(c) Conduct of Indemnification Proceedings. If any Proceeding shall be brought or asserted against any Person entitled to indemnity hereunder (an “Indemnified Party”), such Indemnified Party shall promptly notify the Person from whom indemnity is sought (the “Indemnifying Party”) in writing, and the Indemnifying Party shall have the right to assume the defense thereof, including the employment of counsel reasonably satisfactory to the Indemnified Party and the payment of all reasonable fees and expenses incurred in connection with the defense thereof; provided, that the failure of any Indemnified Party to give such notice shall not relieve the Indemnifying Party of its obligations or liabilities pursuant to this Agreement, except (and only) to the extent that it shall be finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) that such failure shall have materially and adversely prejudiced the Indemnifying Party.
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An Indemnified Party shall have the right to employ separate counsel in any such Proceeding and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties unless: (i) the Indemnifying Party has agreed in writing to pay such fees and expenses; (ii) the Indemnifying Party shall have failed promptly to assume the defense of such Proceeding and to employ counsel reasonably satisfactory to such Indemnified Party in any such Proceeding; or (iii) the named parties to any such Proceeding (including any impleaded parties) include both such Indemnified Party and the Indemnifying Party, and such Indemnified Party shall have been advised by counsel that a conflict of interest would exist if the same counsel were to represent such Indemnified Party and the Indemnifying Party (in which case, if such Indemnified Party notifies the Indemnifying Party in writing that it elects to employ separate counsel at the expense of the Indemnifying Party, the Indemnifying Party shall not have the right to assume the defense thereof and such counsel shall be at the expense of the Indemnifying Party); provided, that the Indemnifying Party shall not be liable for the fees and expenses of more than one separate firm of attorneys at any time for all Indemnified Parties. The Indemnifying Party shall not be liable for any settlement of any such Proceeding effected without its prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, effect any settlement of any pending Proceeding in respect of which any Indemnified Party is a party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such Proceeding and such settlement does not include any non-monetary limitation on the actions of any Indemnified Party or any of its affiliates or any admission of fault or liability on behalf of any such Indemnified Party. Notwithstanding any other provision of this Section 5(c), if an Indemnified Party withholds its consent to a bona fide settlement offer, where but for such action the Indemnifying Party could have settled a Proceeding, the Indemnifying Party will be required to indemnify the Indemnified Party only up to the amount of the bona fide settlement offer for which the Indemnifying Party could have settled such Proceeding.
Subject to the terms of this Agreement, all fees and expenses of the Indemnified Party (including reasonable fees and expenses to the extent incurred in connection with investigating or preparing to defend such Proceeding in a manner not inconsistent with this Section 5) shall be paid to the Indemnified Party, as incurred, within 20 Business Days of written notice thereof to the Indemnifying Party; provided, that the Indemnified Party shall promptly reimburse the Indemnifying Party for that portion of such fees and expenses applicable to such actions for which such Indemnified Party is finally judicially determined to not be entitled to indemnification hereunder. The failure to deliver written notice to the Indemnifying Party within a reasonable time of the commencement of any such action shall not relieve such Indemnifying Party of any liability to the Indemnified Party under this Section 5, except to the extent that the Indemnifying Party is materially and adversely prejudiced in its ability to defend such action.
(d) Contribution. If a claim for indemnification under Section 5(a) or 5(b) is unavailable to an Indemnified Party (by reason of public policy or otherwise), then each Indemnifying Party, in lieu of indemnifying such Indemnified Party, shall contribute to the amount paid or payable by such Indemnified Party as a result of such Losses, in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and Indemnified Party in connection with the actions, statements or omissions that resulted in such Losses as well as any other relevant equitable considerations. The relative fault of such Indemnifying Party and Indemnified Party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission of a material fact, has been taken or made by, or relates to information supplied by, such Indemnifying Party or Indemnified Party, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action, statement or omission. The amount paid or payable by a party as a result of any Losses shall be deemed to include, subject to the limitations set forth in this Agreement, any reasonable attorneys’ or other reasonable fees or expenses incurred by such party in connection with any Proceeding to the extent such party would have been indemnified for such fees or expenses if the indemnification provided for in this Section 5 was available to such party in accordance with its terms.
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The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 5(d) were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. Notwithstanding the provisions of this Section 5(d), (A) the Investor shall not be required to contribute, in the aggregate, any amount in excess of the amount by which the net proceeds actually received by the Investor from the sale of the Registrable Securities subject to the Proceeding exceeds the amount of any damages that the Investor has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission and (B) no contribution will be made under circumstances where the maker of such contribution would not have been required to indemnify the Indemnified Party under the fault standards set forth in this Section 5. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.
The indemnity and contribution agreements contained in this Section 5 are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties and are not in diminution or limitation of the indemnification provisions under the Subscription Agreement.
6. Miscellaneous.
(a) Remedies. Subject to the limitations set forth elsewhere in this Agreement, in the event of a breach by the Company or by the Investor of any of their obligations under this Agreement, the Investor or the Company, as the case may be, in addition to being entitled to exercise all rights granted by law and under this Agreement, including recovery of damages, will be entitled to specific performance of its rights under this Agreement. The Company and the Investor agree that monetary damages would not provide adequate compensation for any losses incurred by reason of a breach by it of any of the provisions of this Agreement and hereby further agree that, in the event of any action for specific performance in respect of such breach, it shall waive the defense that a remedy at law would be adequate.
(b) Compliance. The Investor covenants and agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it (unless an exemption therefrom is available) in connection with sales of Registrable Securities pursuant to the Registration Statement, and shall sell the Registrable Securities only in accordance with a method of distribution described in the Registration Statement.
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(c) Discontinued Disposition. By its acquisition of Registrable Securities, the Investor agrees that, upon receipt of a notice from the Company of the occurrence of any event of the kind described in Section 3(b), the Investor will forthwith discontinue disposition of such Registrable Securities under a Registration Statement until it is advised in writing (the “Advice”) by the Company that the use of the applicable Prospectus (as it may have been supplemented or amended) may be resumed. The Company will use its reasonable best efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable. The Company may provide appropriate stop orders to enforce the provisions of this paragraph.
(d) Amendments and Waivers. The provisions of this Agreement may not be amended, modified or supplemented, and waivers or consents to departures from the provisions hereof may not be given, unless the same shall be in writing and signed by the Company and the Investor, and any amendment to any provision of this Agreement made in accordance with this Section 6(e) shall be binding .
(e) Assignment. The Company shall not assign this Agreement or any rights or obligations hereunder (whether by operation of law or otherwise) without the prior written consent of the Investor; provided, however, that in any transaction, whether by merger, reorganization, restructuring, consolidation, financing or otherwise, whereby the Company is a party and in which the Registrable Securities are converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Registrable Securities” shall be deemed to include the securities received by the Investor in connection with such transaction unless such securities are otherwise freely tradable by the Investor after giving effect to such transaction, and the prior written consent of the Investor shall not be required for such transaction. The Investor may transfer or assign its rights hereunder, in whole or from time to time in part, to one or more Persons in connection with the transfer of not fewer than 100,000 Registrable Securities by the Investor to such Person, provided that such Investor complies with all laws applicable thereto, and the provisions of the Subscription Agreement, and provides written notice of assignment to the Company promptly after such assignment is effected, and such Person agrees in writing to be bound by all of the provisions contained herein.
(f) Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be delivered as set forth in the Subscription Agreement.
(g) Successors and Assigns. This Agreement shall inure to the benefit of and be binding upon the successors and permitted assigns of each of the parties and shall inure to the benefit of the Investor. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. Neither the Company nor the Investor may assign its rights (except by merger or in connection with another entity acquiring all or substantially all of the Company’s assets) or obligations hereunder without the prior written consent of the other party hereto.
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(h) Execution and Counterparts. This Agreement may be executed in two or more counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same Agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature were the original thereof.
(i) Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the State of New York for contracts to be wholly performed in such state and without giving effect to the principles thereof regarding the conflict of laws.
(j) Cumulative Remedies. Except as provided herein, the remedies provided herein are cumulative and not exclusive of any other remedies provided by law.
(k) Severability. If any provision of this Agreement is held to be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Agreement shall not in any way be affected or impaired thereby and the parties will attempt to agree upon a valid and enforceable provision that is a reasonable substitute therefor, and upon so agreeing, shall incorporate such substitute provision in this Agreement.
(l) Non-Recourse. Notwithstanding anything that may be expressed or implied in this Agreement, the Company covenants, agrees and acknowledges that no recourse under this Agreement or any documents or instruments delivered in connection with this Agreement shall be had against any current or future director, officer, employee, shareholder, general or limited partner or member of the Investor or of any affiliates or assignees thereof, whether by the enforcement of any assessment or by any legal or equitable proceeding, or by virtue of any statute, regulation or other applicable law, it being expressly agreed and acknowledged that no personal liability whatsoever shall attach to, be imposed on or otherwise be incurred by any current or future director, officer, employee, shareholder, general or limited partner or member of the Investor or of any affiliates or assignees thereof, as such for any obligation of the Investor under this Agreement or any documents or instruments delivered in connection with this Agreement for any claim based on, in respect of or by reason of such obligations or their creation.
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(m) Construction. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof. Any references to paragraphs, subparagraphs, sections or subsections are to those parts of this Agreement, unless the context clearly indicates to the contrary. The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party. This Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
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IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date first written above.
| COMPANY | ||
| Zenas Biopharma, Inc., | ||
| a Delaware corporation | ||
| By: | /s/ Leon O. Moulder, Jr. | |
| Name: | Leon O. Moulder, Jr. | |
| Title: | Chief Executive Officer | |
[SIGNATURE PAGE OF Investor FOLLOWS]
[Signature Page to Registration Rights Agreement]
IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date first written above.
| INVESTOR: | ||
| INNOCARE PHARMA, INC. | ||
| By: | /s/ Jasmine Cui | |
| Name: | Jasmine Cui | |
| Title: | Chairperson and CEO | |
[Signature Page to Registration Rights Agreement]
Annex A
ZENAS BIOPHARMA, INC.
SELLING STOCKHOLDER NOTICE AND QUESTIONNAIRE
The undersigned beneficial owner of common stock (the “Registrable Securities”) of Zenas Biopharma, Inc., a Delaware corporation (the “Company”), understands that the Company has filed or intends to file with the Securities and Exchange Commission (the “Commission”) a registration statement (the “Registration Statement”) for the registration and resale under Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), of the Registrable Securities, in accordance with the terms of the Registration Rights Agreement (the “Registration Rights Agreement”) to which this document is annexed. All capitalized terms not otherwise defined herein shall have the meanings ascribed thereto in the Registration Rights Agreement.
Certain legal consequences arise from being named as a selling stockholder in the Registration Statement and the related prospectus. Accordingly, holders and beneficial owners of Registrable Securities are advised to consult their own securities law counsel regarding the consequences of being named or not being named as a selling stockholder in the Registration Statement and the related prospectus.
NOTICE
The undersigned beneficial owner (the “Selling Stockholder”) of Registrable Securities hereby elects to include the Registrable Securities owned by it in the Registration Statement.
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The undersigned hereby provides the following information to the Company and represents and warrants that such information is accurate:
QUESTIONNAIRE
| 1. | Name. |
| (a) | Full Legal Name of Selling Stockholder |
| (b) | Full Legal Name of Registered Holder (if not the same as (a) above) through which Registrable Securities are held: |
| (c) | Full Legal Name of Natural Control Person (which means a natural person who directly or indirectly alone or with others has power to vote or dispose of the securities covered by this Questionnaire): |
2. Address for Notices to Selling Stockholder:
| Telephone: | |
| E-Mail: | |
| Contact Person: | |
3. Broker-Dealer Status:
| (a) | Are you a broker-dealer? |
Yes ¨ No ¨
| (b) | If “yes” to Section 3(a), did you receive your Registrable Securities as compensation for investment banking services to the Company? |
Yes ¨ No ¨
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| Note: | If “no” to Section 3(b), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement. |
| (c) | Are you an affiliate of a broker-dealer? |
Yes ¨ No ¨
| (d) | If you are an affiliate of a broker-dealer, do you certify that you purchased the Registrable Securities in the ordinary course of business, and at the time of the purchase of the Registrable Securities to be resold, you had no agreements or understandings, directly or indirectly, with any person to distribute the Registrable Securities? |
Yes ¨ No ¨
| Note: | If “no” to Section 3(d), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement. |
4. Beneficial Ownership of Securities of the Company Owned by the Selling Stockholder.
Except as set forth below in this Item 4, the undersigned is not the beneficial or registered owner of any securities of the Company other than the securities issuable pursuant to the Purchase Agreement.
| (a) | Type and Amount of other securities beneficially owned by the Selling Stockholder: |
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5. Relationships with the Company:
Except as set forth below, neither the undersigned nor any of its affiliates, officers, directors or principal equity holders (owners of 5% of more of the equity securities of the undersigned) has held any position or office or has had any other material relationship with the Company (or its predecessors or affiliates) during the past three years.
State any exceptions here:
The undersigned agrees to promptly notify the Company of any material inaccuracies or changes in the information provided herein that may occur subsequent to the date hereof at any time while the Registration Statement remains effective; provided, that the undersigned shall not be required to notify the Company of any changes to the number of securities held or owned by the undersigned or its affiliates.
By signing below, the undersigned consents to the disclosure of the information contained herein in its answers to Items 1 through 5 and the inclusion of such information in the Registration Statement and the related prospectus and any amendments or supplements thereto. The undersigned understands that such information will be relied upon by the Company in connection with the preparation or amendment of the Registration Statement and the related prospectus and any amendments or supplements thereto.
IN WITNESS WHEREOF the undersigned, by authority duly given, has caused this Notice and Questionnaire to be executed and delivered either in person or by its duly authorized agent.
| Date: | Beneficial Owner: |
| By: | ||
| Name: | ||
| Title: |
PLEASE EMAIL A .PDF COPY OF THE COMPLETED AND EXECUTED NOTICE AND QUESTIONNAIRE TO:
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Exhibit A
Plan of Distribution
The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:
| · | distributions to members, partners, stockholders or other equityholders of the selling stockholders; |
| · | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| · | block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction; |
| · | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| · | an exchange distribution in accordance with the rules of the applicable exchange; |
| · | privately negotiated transactions; |
| · | short sales and settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
| · | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| · | broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; |
| · | a combination of any such methods of sale; and |
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| · | any other method permitted pursuant to applicable law. |
The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling stockholders for purposes of this prospectus.
In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering.
The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule, or another available exemption from the registration requirements under the Securities Act.
The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act (it being understood that the selling stockholders shall not be deemed to be underwriters solely as a result of their participation in this offering). Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(a)(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.
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To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agent, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.
In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.
We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, to the extent applicable, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.
We have agreed with the selling stockholders to use reasonable best efforts to cause the registration statement of which this prospectus constitutes a part to become effective and to remain continuously effective until the earlier of: (i) the date on which the selling stockholders shall have resold or otherwise disposed of all the shares covered by this prospectus and (ii) the date on which the shares covered by this prospectus no longer constitute “Registrable Securities” as such term is defined in the Registration Rights Agreement, such that they may be resold by the selling stockholders without registration and without regard to any volume or manner-of-sale limitations and without current public information pursuant to Rule 144 under the Securities Act or any other rule of similar effect.
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Exhibit 10.3
FORM OF SECURITIES PURCHASE AGREEMENT
This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of October 7, 2025, by and among Zenas BioPharma, Inc., a Delaware corporation (the “Company”), and each of the investors listed on Exhibit A and Exhibit B attached to this Agreement (each, an “Investor” and together, the “Investors”).
WHEREAS, the Company and the Investors are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act;
WHEREAS, the Company desires to sell to the Investors, and each Investor desires to purchase from the Company, severally and not jointly, upon the terms and subject to the conditions stated in this Agreement, shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”); and
WHEREAS, contemporaneously with the sale of the Shares, the parties hereto will execute and deliver a Registration Rights Agreement, substantially in the form attached hereto as Exhibit C, pursuant to which the Company will agree to provide certain registration rights in respect of the Shares under the Securities Act and applicable state securities laws.
NOW THEREFORE, in consideration of the mutual agreements, representations, warranties and covenants herein contained, the Company and each Investor, severally and not jointly, agree as follows:
1. Definitions. As used in this Agreement, the following terms shall have the following respective meanings:
“Affiliate” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediates, controls, is controlled by or is under common control with such Person. For the avoidance of doubt, with respect to any Investor that is an investment fund or other investment vehicle, such Investor shall be deemed not to be an Affiliate of (i) any portfolio company of such Investor or its Affiliates or (ii) any limited partner of any such Investor or its Affiliates.
“Agreement” has the meaning set forth in the recitals.
“Amended and Restated Bylaws” means the Bylaws of the Company, as currently in effect.
“Amended and Restated Certificate of Incorporation” means the Certificate of Incorporation of the Company, as currently in effect.
“Anti-Money Laundering Laws” has the meaning set forth in Section 3.31.
“Benefit Plan” or “Benefit Plans” means employee benefit plans as defined in Section 3(3) of ERISA and all other employee benefit practices or arrangements, including, without limitation, any such practices or arrangements providing severance pay, sick leave, vacation pay, salary continuation for disability, retirement benefits, deferred compensation, bonus pay, incentive pay, stock options or other stock-based compensation, hospitalization insurance, medical insurance, life insurance, scholarships or tuition reimbursements, maintained by the Company or to which the Company or any of its subsidiaries is obligated to contribute for employees or former employees of the Company and its subsidiaries.
“Board of Directors” means the board of directors of the Company.
“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“CCPA” has the meaning set forth in Section 3.34.
“Closing” has the meaning set forth in Section 2.1.
“Closing Date” has the meaning set forth in Section 2.1.
“Code” means the U.S. Internal Revenue Code of 1986, as amended.
“Common Stock” has the meaning set forth in the recitals.
“Common Stock Equivalents” means any securities of the Company that would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Company” has the meaning set forth in the recitals.
“Company Intellectual Property” has the meaning set forth in Section 3.12.
“Company Personnel” has the meaning set forth in Section 3.12.
“Disclosure Document” has the meaning set forth in Section 5.3.
“Disclosure Time” means, (i) if this Agreement is signed after 9:00 a.m. (New York City time) and before midnight (New York City time) on any Business Day, 9:01 a.m. (New York City time) on the Business Day immediately following the date hereof, or (ii) if this Agreement is signed between midnight (New York City time) and 9:00 a.m. (New York City time) on any Business Day, no later than 9:01 a.m. (New York City time) on the date hereof.
“Drug Regulatory Agency” means the U.S. Food and Drug Administration (“FDA”) or other foreign, state, local or comparable governmental authority responsible for regulation of the research, development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or biological products and drug or biological product candidates.
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“Environmental Laws” has the meaning set forth in Section 3.15.
“ERISA” means the U.S. Employee Retirement Income Security Act of 1974, as amended.
“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended, and all of the rules and regulations promulgated thereunder.
“Financial Statements” has the meaning set forth in Section 3.8(b).
“Fundamental Representations” means the representations and warranties made by the Company in Sections 3.1 (Organization and Power), 3.2 (Capitalization), 3.4 (Authorization), 3.5 (Valid Issuance), 3.6 (No Conflict), 3.7 (Consents), 3.8 (SEC Filings; Financial Statements), 3.18 (Nasdaq Stock Market), 3.19 (Sarbanes-Oxley Act), 3.23 (Price Stabilization of Common Stock), 3.24 (Investment Company Act), 3.25 (General Solicitation; No Integration or Aggregation), 3.26 (Brokers and Finders), 3.27 (Reliance by the Investors) and 3.28 (No Additional Agreements).
“GAAP” has the meaning set forth in Section 3.8(b).
“GDPR” has the meaning set forth in Section 3.34.
“Governmental Authorizations” has the meaning set forth in Section 3.11.
“Health Care Laws” has the meaning set forth in Section 3.21.
“Health Care Permits” has the meaning set forth in Section 3.21.
“HIPAA” has the meaning set forth in Section 3.21.
“Indemnified Person” has the meaning set forth in Section 5.9.
“Insider Share Price” means $20.85.
“Investor” and “Investors” have the meanings set forth in the recitals.
“IT Systems” has the meaning set forth in Section 3.33.
“Material Adverse Effect” means any change, event, circumstance, development, condition, occurrence or effect that, individually or in the aggregate, (a) was, is, or would reasonably be expected to be, materially adverse to the business, financial condition, properties, assets, liabilities, stockholders’ equity or results of operations of the Company and its subsidiaries, taken as a whole, or (b) materially delays or materially impairs the ability of the Company to comply, or prevents the Company from complying, with its obligations under this Agreement, the other Transaction Agreements, or with respect to the Closing, or would reasonably be expected to do so.
“Nasdaq” means the Nasdaq Stock Market LLC.
“National Exchange” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question, together with any successor thereto: the NYSE American, The New York Stock Exchange, The Nasdaq Global Market, The Nasdaq Global Select Market and The Nasdaq Capital Market.
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“Person” means an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or any other entity or organization.
“Personal Data” has the meaning set forth in Section 3.34.
“Placement Agents” means Jefferies LLC and Evercore Group L.L.C.
“Policies” has the meaning set forth in Section 3.34.
“Privacy and Security Obligations” has the meaning set forth in Section 3.34.
“Registration Rights Agreement” has the meaning set forth in Section 6.1(j).
“Rule 144” means Rule 144 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such Rule.
“Sanctions” has the meaning set forth in Section 3.32.
“SEC” means the U.S. Securities and Exchange Commission.
“SEC Reports” means (a) the Company’s most recently filed Annual Report on Form 10-K and (b) all Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed or furnished (as applicable) by the Company following the end of the most recent fiscal year for which an Annual Report on Form 10-K has been filed and prior to the execution of this Agreement, together in each case with any documents incorporated by reference therein or exhibits thereto.
“Securities Act” means the U.S. Securities Act of 1933, as amended, and all of the rules and regulations promulgated thereunder.
“Sensitive Data” has the meaning set forth in Section 3.34.
“Share Price” means $19.00.
“Shares” has the meaning set forth in the recitals.
“Short Sales” include, without limitation, (a) all “short sales” as defined in Rule 200 promulgated under Regulation SHO under the Exchange Act, whether or not against the box, and all types of direct and indirect stock pledges, forward sale contracts, options, puts, calls, short sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the Exchange Act) and similar arrangements (including on a total return basis), and (b) sales and other transactions through non-U.S. broker dealers or non-U.S. regulated brokers (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock).
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“Standard Settlement Period” means the standard settlement period, expressed in a number of trading days, on the Company’s primary National Exchange with respect to the Common Stock as in effect on the date of delivery of the applicable request to remove legends of Shares.
“Studies” has the meaning set forth in Section 3.20.
“Tax” or “Taxes” means any and all federal, state, local, foreign and other taxes, levies, fees, imposts, duties and charges of whatever kind (including any interest, penalties or additions to the tax imposed in connection therewith or with respect thereto), whether or not imposed on the Company or its subsidiaries (if any) including, without limitation, taxes imposed on, or measured by, income, franchise, profits or gross receipts, and also ad valorem, value added, sales, use, service, real or personal property, capital stock, license, payroll, withholding, employment, social security, workers’ compensation, unemployment compensation, utility, severance, production, excise, stamp, occupation, premium, windfall profits, transfer and gains taxes and customs duties.
“Tax Returns” means returns, reports, information statements and other documentation (including any additional or supporting material) filed or maintained, or required to be filed or maintained, in connection with the calculation, determination, assessment or collection of any Tax and shall include any amended returns required as a result of examination adjustments made by the Internal Revenue Service or other Tax authority.
“Transaction Agreements” means this Agreement and the Registration Rights Agreement.
“Transfer Agent” means, with respect to the Common Stock, Computershare Trust Company, N.A. or such other financial institution that provides transfer agent services as the Company may engage from time to time.
2. Purchase and Sale of Shares.
2.1 Purchase and Sale to Investors. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Investors set forth on Exhibit A, severally and not jointly, agree to purchase, the number of Shares, for the aggregate purchase price, set forth opposite the Investor’s name on Exhibit A. The purchase price per Share is equal to the Share Price.
2.2 Purchase and Sale to Insiders. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Investors set forth on Exhibit B, severally and not jointly, agree to purchase, the number of Shares, for the aggregate purchase price, set forth opposite the Investor’s name on Exhibit B. The purchase price per Share to be sold to each Investor set forth on Exhibit B is equal to the Insider Share Price.
2.3 Closing. Subject to the satisfaction or waiver of the conditions set forth in Section 5.6 of this Agreement, the closing of the purchase and sale of the Shares (the “Closing” and the date on which the Closing occurs, the “Closing Date”) shall occur remotely via the exchange of documents and signatures at such time as agreed to by the Company and the Investors but (i) in no event earlier than the second Business Day after the date of this Agreement and (ii) in no event later than the fifth Business Day after the date of this Agreement. At the Closing, the Shares shall be issued and registered in the name of each respective Investor, or in such nominee name(s) as designated by such Investor, representing the number of Shares to be purchased by the Investor at such Closing as set forth in Exhibit A or Exhibit B, as applicable, in each case against payment to the Company of the purchase price therefor (the “Aggregate Purchase Amount”) in full, by wire transfer to the Company of immediately available funds, at or prior to the Closing, in accordance with wire instructions provided by the Company to the Investors at least one Business Day prior to the Closing. On the Closing Date, the Company will cause the Transfer Agent to issue the Shares in book-entry form, free and clear of all restrictive and other legends (except as expressly provided in Section 4.10 hereof) and the Company shall provide evidence of such issuance from the Company’s Transfer Agent as soon as reasonably practical following the Closing Date to each Investor. In the event that the Closing has not occurred within one Business Day after the expected Closing Date, unless otherwise agreed by the Company and such Investor, the Company shall promptly (but no later than one Business Day thereafter) return the previously wired Aggregate Purchase Amount to each respective Investor by wire transfer of United States dollars in immediately available funds to the account specified by each Investor, and any book entries for the Shares shall be deemed cancelled; provided that, unless this Agreement has been terminated pursuant to Section 7, such return of funds shall not terminate this Agreement or relieve such Investor of its obligation to purchase, or the Company of its obligation to issue and sell, the Shares at the Closing.
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Notwithstanding the foregoing and anything in this Agreement to the contrary, as may be agreed to among the Company and one or more Investors, if an Investor notifies the Company on or prior to the date hereof that it is (i) an investment company registered under the Investment Company Act of 1940, as amended, (ii) advised by an investment adviser subject to regulation under the Investment Advisers Act of 1940, as amended, or (iii) otherwise subject to internal policies and/or procedures relating to the timing of funding and issuance of securities that would require it, such Investor shall not be required to wire its Aggregate Purchase Amount until the Closing Date and until it confirms receipt from the Transfer Agent of evidence of the issuance of such Investor’s Shares on the Closing Date in form and substance reasonably acceptable to the Investor.
3. Representations and Warranties of the Company. Except as set forth in the SEC Reports (other than as to the Fundamental Representations, which are not so qualified), the Company hereby represents and warrants to each of the Investors and the Placement Agents that the statements contained in this Section 3 are true and correct as of the date of this Agreement and as of the Closing Date (except for the representations and warranties that speak as of a specific date, which shall be made as of such date).
3.1 Organization and Power. The Company has been duly incorporated, is validly existing as a corporation in good standing under the laws of the State of Delaware, has the corporate power and authority necessary to own or lease its property and to conduct its business as described in the SEC Reports and is duly qualified to transact business and is in good standing in each jurisdiction (to the extent such concept of good standing is applicable in such jurisdiction) in which the conduct of its business or its ownership or leasing of property requires such qualification, except to the extent that the failure to be so qualified or be in good standing or have such power or authority would not reasonably be expected to have a Material Adverse Effect.
3.2 Capitalization. The Company’s disclosure of its authorized, issued and outstanding capital stock in the SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such SEC Reports. All of the issued and outstanding shares of Common Stock have been duly authorized and are validly issued, fully paid and non-assessable. None of the outstanding shares of capital stock of the Company were issued in violation of any preemptive or other similar rights of any securityholder of the Company which have not been waived, and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. There are no outstanding rights (including, without limitation, pre-emptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other equity interest in the Company or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any capital stock of the Company or any such subsidiary, any such convertible or exchangeable securities or any such rights, warrants or options; the capital stock of the Company conforms in all material respects to the description thereof contained in the SEC Reports; and all the outstanding shares of capital stock or other equity interests of each subsidiary owned, directly or indirectly, by the Company have been duly and validly authorized and issued, are fully paid and non-assessable (except, in the case of any foreign subsidiary, for directors’ qualifying shares) and are owned directly or indirectly by the Company, free and clear of any lien, charge, encumbrance, security interest, restriction on voting or transfer or any other claim of any third party.
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3.3 Registration Rights. Except as set forth in the Transaction Agreements, pursuant to that certain License Agreement by and between the Company and InnoCare Pharma Inc. dated October 7, 2025 (the “Royale Agreement”), or as disclosed in the SEC Reports, there are no contracts, agreements or understandings between the Company and any person granting such person the right to require the Company to file a registration statement under the Securities Act with respect to any securities of the Company or to require the Company to include such securities with the registration statement required to be filed pursuant to the Registration Rights Agreement, except as otherwise have been validly waived in connection with the issuance and sale of the Shares contemplated hereby or as described in the SEC Reports.
3.4 Authorization. The Company has all requisite corporate power and authority to enter into the Transaction Agreements and to carry out and perform its obligations under the terms of the Transaction Agreements, including the issuance and sale of the Shares. All corporate action on the part of the Company, its officers, directors and stockholders necessary for the authorization of the Shares, the authorization, execution, delivery and performance of the Transaction Agreements and the consummation of the transactions contemplated herein, including the issuance and sale of the Shares has been taken, including, without limitation, the approval of the Board of Directors (or a committee thereof). This Agreement has been duly executed and delivered by the Company and, assuming the due authorization, execution and delivery by each Investor of this Agreement and that this Agreement constitutes the legal, valid and binding agreement of each Investor, this Agreement constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium and similar laws relating to or affecting creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law). Upon its execution by the Company and the other parties thereto and assuming that it constitutes legal, valid and binding agreements of the other parties thereto, the Registration Rights Agreement will constitute a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium and similar laws relating to or affecting creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
3.5 Valid Issuance. The Shares have been duly authorized and, when issued, delivered and paid for in accordance with the terms of this Agreement, will be validly issued, fully paid and non-assessable, and the issuance of the Shares will not be subject to any preemptive or similar rights that have not been validly waived. The issuance and delivery of the Shares does not, (a) obligate the Company to offer to issue, or issue, shares of Common Stock or other securities to any Person (other than the Investors) pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any Person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Company. Subject to the accuracy of the representations and warranties made by the Investors in Section 4, the offer and sale of the Shares to the Investors is, and will be, (i) exempt from the registration and prospectus delivery requirements of the Securities Act and (ii) exempt from (or otherwise not subject to) the registration and qualification requirements of applicable securities laws of the states of the United States.
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3.6 No Conflict. The execution and delivery by the Company of, and the performance by the Company of its obligations under, this Agreement will not contravene (i) any provision of applicable law, (ii) the Amended and Restated Certificate of Incorporation or Amended and Restated Bylaws of the Company, (iii) any agreement or other instrument binding upon the Company or any of its subsidiaries that is material to the Company and its subsidiaries, taken as a whole, or (iv) any judgment, order or decree of any governmental body, agency or court having jurisdiction over the Company or any subsidiary, except in the case of clauses (i), (iii) and (iv), where such contravention would not reasonably be expected to have a Material Adverse Effect.
3.7 Consents. Assuming the accuracy of the representations and warranties of each Investor set forth in Section 4 hereof, no consent, approval, authorization or order of, or qualification with, any governmental body, agency or court having jurisdiction over the Company or any subsidiary is required for the performance by the Company of its obligations under the Transaction Agreements, except (a) as have been or will be obtained or made under the Securities Act or the Exchange Act, (b) the filing of any requisite notices and/or application(s) to the National Exchange for the issuance and sale of the Shares and the listing of the Shares for trading or quotation, as the case may be, thereon in the time and manner required thereby, (c) customary post-closing filings with the SEC or pursuant to state securities laws in connection with the offer and sale of the Shares by the Company in the manner contemplated herein, which will be filed on a timely basis, (d) the filing of the registration statement required to be filed by the Registration Rights Agreement, or (e) such that the failure of which to obtain would not reasonably be expected to have a Material Adverse Effect. All notices, consents, authorizations, orders, filings and registrations which the Company is required to deliver or obtain prior to the Closing pursuant to the preceding sentence have been obtained or made or will be delivered or obtained or effected, and shall remain in full force and effect, on or prior to the Closing.
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3.8 SEC Filings; Financial Statements.
(a) The Company has filed all forms, statements, certifications, reports and documents required to be filed by it with the SEC under Section 13, 14(a) and 15(d) of the Exchange Act for the one year preceding the date of this Agreement and is in compliance with General Instruction I.A.3 of Form S-3. As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the filed SEC Reports complied in all material respects with the applicable requirements of the Exchange Act , and, as of the time they were filed , none of the filed SEC Reports contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Reports. To the Company’s knowledge, none of the SEC Reports are the subject of an ongoing SEC review. The interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and has been prepared in accordance with the SEC’s rules and guidelines applicable thereto. The Company is not, and has never been, an issuer subject to Rule 144(i) under the Securities Act.
(b) The consolidated financial statements of the Company included in the SEC Reports (collectively, the “Financial Statements”) comply in all material respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto as in effect at the time of filing (or to the extent corrected by a subsequent restatement) and fairly present in all material respects the consolidated financial position of the Company and its subsidiaries as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, and have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods therein specified ((except as otherwise noted therein, and except that any unaudited financial statements may not contain certain footnotes and are subject to normal and recurring year-end adjustments). Except as set forth in the Financial Statements filed prior to the date of this Agreement, the Company has not incurred any liabilities, contingent or otherwise, except (i) those incurred in the ordinary course of business, consistent with past practices since the date of such financial statements or (ii) liabilities not required under GAAP to be reflected in the Financial Statements, in either case, none of which, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.
3.9 Absence of Changes. Since December 31, 2024, (a) the Company has conducted its business only in the ordinary course of business and there have been no material transactions entered into by the Company or any of its subsidiaries (except for the execution and performance of this Agreement and the discussions, negotiations and transactions related thereto and other than as disclosed to the Investors); (b) no material change to any material contract or arrangement by which the Company or any of its subsidiaries is bound or to which any of its assets or properties is subject has been entered into that has not been disclosed in the SEC Reports; and (c) there has not been any other event or condition of any character that would reasonably be expected to have a Material Adverse Effect; provided, however, that none of the following will be deemed in themselves, either alone or in combination, to constitute, and that none of the following will be taken into account in determining whether there will be, a Material Adverse Effect under this Section 3.9:
(i) any change generally affecting the economy, financial markets or political, economic or regulatory conditions in the United States or any other geographic region in which the Company conducts business, provided that the Company is not disproportionately affected thereby;
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(ii) general financial, credit or capital market conditions, including interest rates or exchange rates, or any changes therein, provided that the Company is not disproportionately affected thereby;
(iii) any change that generally affects industries in which the Company and its subsidiaries conduct business, provided that the Company is not disproportionately affected thereby;
(iv) earthquakes, hurricanes, tsunamis, tornadoes, floods, mudslides, fires or other natural disasters, weather conditions, global pandemics, including the COVID-19 pandemic and related strains, epidemic or similar health emergency, and other force majeure events in the United States or any other location, provided that the Company is not disproportionately affected thereby;
(v) national or international political or social conditions (or changes in such conditions), whether or not pursuant to the declaration of a national emergency or war, or the occurrence of any military or terrorist attack, provided that the Company is not disproportionately affected thereby;
(vi) material changes in laws after the date of this Agreement; and
(vii) in and of itself, any material failure by the Company to meet any published or internally prepared estimates of revenues, expenses, earnings or other economic performance for any period ending on or after the date of this Agreement (it being understood that the facts and circumstances giving rise to such failure may be deemed to constitute, and may be taken into account in determining whether there has been, a Material Adverse Effect to the extent that such facts and circumstances are not otherwise described in clauses (i)-(v) of this definition).
3.10 Absence of Litigation. There is no action, suit, proceeding, arbitration, claim, investigation, charge, complaint or inquiry pending or, to the Company’s knowledge, threatened against the Company or any of its subsidiaries which, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect, nor are there any orders, writs, injunctions, judgments or decrees outstanding of any court or government agency or instrumentality and binding upon the Company or any of its subsidiaries that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any subsidiary, nor to the knowledge of the Company, any director or officer of the Company or any subsidiary, is, or within the last ten years has been, the subject of any action involving a claim of violation of or liability under federal or state securities laws relating to the Company or such subsidiary or a claim of breach of fiduciary duty relating to the Company or such subsidiary.
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3.11 Compliance with Law; Permits. There are no legal or governmental proceedings pending or, to the Company’s knowledge, threatened to which the Company or any of its subsidiaries is a party or to which any of the properties of the Company or any of its subsidiaries is subject (i) other than proceedings accurately described in all material respects in the SEC Reports and proceedings that would not reasonably be expected to have a Material Adverse Effect or (ii) that are required to be described in the SEC Reports and are not so described; and there are no statutes, regulations, contracts or other documents to which the Company is subject or by which the Company is bound that are required to be described in the SEC Reports or to be filed as exhibits to the SEC Reports that are not described in all material respects or filed as required.
3.12 Intellectual Property. The Company and its subsidiaries own or have valid, binding and enforceable licenses or other rights to practice and use all technology, patents and patent applications, copyrights, trademarks, trademark registrations, service marks, service mark registrations, trade names, service names and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures) and all other technology and intellectual property rights necessary for, or used in the conduct, or the proposed conduct, of the business of the Company and its subsidiaries (including as described in the SEC Reports) (collectively, the “Company Intellectual Property”), or to the development, manufacture, operation, and sale of any products and services sold or proposed to be sold by the Company and its subsidiaries. To the Company’s knowledge, the conduct of the Company’s and its subsidiaries’ respective business and the proposed conduct of its business (including the development and commercialization of the product candidates described in the SEC Reports) has not and will not infringe, misappropriate or otherwise conflict in any material respect with any valid intellectual property rights of others; there are no rights of third parties to any of the intellectual property owned by the Company or any of its subsidiaries, and such intellectual property is owned by the Company or its subsidiary free and clear of all liens, security interests, or encumbrances; to the Company’s knowledge, the patents, trademarks and copyrights held or licensed by the Company and its subsidiaries included within the Company Intellectual Property are valid, enforceable and subsisting, and the patent, trademark, and copyright applications included within the Company Intellectual Property are subsisting and have not been abandoned; and there is no infringement by third parties of any of the Company Intellectual Property. The Company and its subsidiaries are not obligated or under any material liability to pay a royalty, grant a license, or provide other material consideration to any third party in connection with the Company Intellectual Property. No action, suit, claim or other proceeding is pending or, to the Company’s knowledge, is threatened, alleging that the Company or any of its subsidiaries is infringing, misappropriating, diluting or otherwise violating, or would, upon the commercialization of any product or service proposed in the SEC Reports to be conducted, infringe, misappropriate, dilute, or otherwise violate, any valid intellectual property rights of others with respect to any of the Company’s product candidates, processes or intellectual property, and the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim. No action, suit, claim or other proceeding is pending or, to the Company’s knowledge, is threatened, challenging the validity, enforceability, scope, registration, ownership or use of any of the Company Intellectual Property, and the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim. No action, suit, claim or other proceeding is pending or, to the Company’s knowledge, is threatened, challenging the Company’s rights in or to any Company Intellectual Property, and the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim. The Company has not received notice of any claim of infringement, misappropriation or conflict with any asserted rights of others with respect to any of the Company’s products, proposed products, processes or Company Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such claim. To the Company’s knowledge, the development, manufacture, sale, and any currently proposed use of any of the products, proposed products or processes of the Company referred to in the SEC Reports, in the current or proposed conduct of the business of the Company, do not infringe any right or valid patent claim of any third party. To the Company’s knowledge, no employee, consultant or independent contractor of the Company or any of its subsidiaries (“Company Personnel”) is in or has ever been in violation in any respect of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement or any restrictive covenant to or with a former employer or counterparty to such agreements, where the basis of such violation relates to such Company Personnel’s employment or independent contractor’s engagement with the Company or any of its subsidiaries, actions undertaken while employed or engaged with the Company or any of its subsidiaries, or the ownership by the Company of any Company Intellectual Property. The Company has taken reasonable steps in accordance with normal industry practice to maintain the confidentiality of all Company Intellectual Property, including the execution of appropriate nondisclosure and confidentiality agreements. The Company and its subsidiaries have complied with the material terms of each agreement pursuant to which intellectual property has been licensed to the Company or any of its subsidiaries, and all such agreements are in full force and effect. None of the Company Intellectual Property or technology (including information technology and outsourced arrangements) employed by the Company or its subsidiaries has been obtained or is being used by the Company or its subsidiary in violation of any contractual obligation binding on the Company or its subsidiaries or any of their respective officers, directors or employees or otherwise in violation of the rights of any persons. The product candidates described in the SEC Reports as under development by the Company fall within the scope of the claims of one or more patents or patent applications owned by, or exclusively licensed to, the Company. The duties of candor and good faith required by the United States Patent and Trademark Office during the prosecution of the United States patents and patent applications included in the Company Intellectual Property have been complied with.
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3.13 Employee Benefits. Except as would not reasonably be expected to have a Material Adverse Effect, (A) each Plan (as defined below) has been maintained in compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited to ERISA and the Code; (B) no non-exempt prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred, or is reasonably expected to occur, with respect to any Plan; (C) for each Plan, no failure to satisfy the minimum funding standards (within the meaning of Section 412 of the Code or Section 302 of ERISA), whether or not waived, has occurred or is reasonably expected to occur; (D) no “reportable event” (within the meaning of Section 4043(c) of ERISA, other than those events as to which the thirty day notice period is waived) has occurred or is reasonably expected to occur; and (E) neither the Company nor any member of its “Controlled Group” (defined as any organization which is a member of a controlled group of corporations within the meaning of Section 414 of the Code) has incurred, nor is reasonably expected to incur, any liability under Title IV of ERISA (other than contributions to any Plan or any Multiemployer Plan or premiums to the PBGC, in the ordinary course and without default) in respect of a Plan or a Multiemployer Plan. For purposes of this paragraph, (x) the term “Plan” means an employee benefit plan, within the meaning of Section 3(3) of ERISA, subject to Title IV of ERISA, but excluding any Multiemployer Plan, for which the Company or any member of its “Controlled Group” has any liability and (y) the term “Multiemployer Plan” means a multiemployer plan within the meaning of Section 4001(a)(3) of ERISA.
3.14 Taxes. The Company and each of its subsidiaries have filed all federal, state, local and foreign tax returns required to be filed through the date of this Agreement or have requested extensions thereof (except where the failure to file would not reasonably be expected to have a Material Adverse Effect) and have paid all taxes required to be paid whether or not reported thereon (except for cases in which the failure to file or pay would not reasonably be expected to have a Material Adverse Effect or except as currently being contested in good faith and for which reserves required by GAAP have been created in the financial statements of the Company), and no tax deficiency has been determined adversely to the Company or any of its subsidiaries which, singly or in the aggregate, has had (nor does the Company nor any of its subsidiaries have any notice or knowledge of any tax deficiency which would reasonably be expected to be determined adversely to the Company or its subsidiaries and which would reasonably be expected to have) a Material Adverse Effect. There are no outstanding agreements or waivers extending the statutory period of limitation applicable to any federal, state, local or foreign tax return for any period, other than pursuant to automatic extensions of the due date for filing a tax return obtained in the ordinary course of business.
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3.15 Environmental Laws. The Company and each of its subsidiaries (i) are in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) have received all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (iii) are in compliance with all terms and conditions of any such permit, license or approval, except, in each case of (i) through (iii) above, where such noncompliance with applicable Environmental Laws, failure to receive required permits, licenses or other approvals or failure to comply with the terms and conditions of such permits, licenses or approvals would not reasonably be expected to have a Material Adverse Effect. There are no costs or liabilities of the Company or its subsidiaries arising under applicable Environmental Laws (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval required under applicable Environmental Laws, any related constraints on operating activities and any potential liabilities to third parties) which would reasonably be expected to have a Material Adverse Effect.
3.16 Title. The Company does not own any real property. The Company and each of its subsidiaries have good and marketable title to all personal property (other than intellectual property which is addressed exclusively in Section 3.12 hereof) owned by them which is material to the business of the Company and its subsidiaries, in each case free and clear of all liens, encumbrances and defects except such as are described in the SEC Reports or except such as do not materially and adversely affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and its subsidiaries; and any real property and buildings held under lease by the Company and its subsidiaries are held by them under valid, subsisting and, to the Company’s knowledge, enforceable leases with such exceptions as are not material and do not materially interfere with the use made and proposed to be made of such real property and buildings by the Company and its subsidiaries.
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3.17 Insurance. The Company and each of its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are, in the Company’s reasonable judgment, generally deemed adequate and customary for the businesses in which they are engaged; neither the Company nor any of its subsidiaries has been refused any insurance coverage sought or applied for; and neither the Company nor any of its subsidiaries has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not reasonably be expected to have a Material Adverse Effect.
3.18 Nasdaq Stock Market. The issued and outstanding shares of Common Stock are registered pursuant to Section 12(b) of the Exchange Act and are listed for trading on the Nasdaq Global Select Market under the symbol “ZBIO”. The Company is in compliance with all listing requirements of Nasdaq applicable to the Company. As of the date of this Agreement, there is no suit, action, proceeding or investigation pending or, to the knowledge of the Company, threatened against the Company by Nasdaq or the SEC, respectively, to prohibit or terminate the listing of the Common Stock on the Nasdaq Global Select Market or to deregister the Common Stock under the Exchange Act. The Company has taken no action as of the date of this Agreement that is designed to terminate the registration of the Common Stock under the Exchange Act.
3.19 Sarbanes-Oxley Act. The Company is, and since January 1, 2025 has been, in compliance in all material respects with all applicable requirements of the Sarbanes-Oxley Act of 2002 and applicable rules and regulations promulgated by the SEC thereunder.
3.20 Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “Studies”) that are described in, or the results of which are referred to in, the SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies and with all Health Care Laws. Each description of the results of the Studies is accurate and complete in all material respects and fairly presents the data derived from such Studies, and to the Company’s knowledge, there are no other Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the SEC Reports. The Company has not received any notice of, or correspondence from, the FDA or any other governmental entity or institutional review board which would require the termination, suspension or material modification or partial or full clinical hold of any clinical trials that are described or referred to in the SEC Reports.
3.21 Compliance with Health Care Laws. The Company and its subsidiaries are and at all times have been in compliance with all applicable Health Care Laws, as defined below, in all material respects. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. False Statements Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. § 3729 et seq.), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the exclusions law (42 U.S.C. § 1320a-7), and the regulations promulgated thereunder; (iii) Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (v) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated thereunder; (vi) any and all other healthcare laws, statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import or export of any product manufactured or distributed by the Company; and (vii) all amendments to any of the foregoing. Neither the Company nor its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that the Company or its subsidiaries are in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened in writing. Neither the Company, nor any of its subsidiaries, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. The Company and its subsidiaries (i) possess all material licenses, certificates, approvals, clearances, exemptions, authorizations and permits required under the Health Care Laws (“Health Care Permits”); (ii) are in material compliance with and have fulfilled and performed their respective material obligations with respect to such Health Care Permits; and (iii) to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would reasonably be expected to allow, revocation or termination of any Health Care Permit; and (iv) have filed, obtained, maintained or submitted all material reports, applications, records, submissions, supplements or amendments as required by the Health Care Laws or the Health Care Permits, and all such reports, applications, records, submissions, supplements or amendments were timely, complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission) in all material respects. The Company has not received (i) any warning letter, untitled letter or other material notice from the FDA or other governmental entity alleging or asserting material noncompliance with any Health Care Laws or (ii) any notice that the FDA or any governmental entity has taken or is taking action to limit, suspend, modify or revoke any material Health Care Permits .
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3.22 Accounting Controls and Disclosure Controls and Procedures. The Company and each of its subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Since December 31, 2024, there has been (i) no material weakness in the Company’s internal control over financial reporting (whether or not remediated) and (ii) no change in the Company’s internal control over financial reporting that has materially and adversely affected, or is reasonably likely to materially and adversely affect, the Company’s internal control over financial reporting. The Company and each of its subsidiaries have filed all federal, state, local and foreign tax returns required to be filed through the date of this Agreement or have requested extensions thereof (except where the failure to file would not reasonably be expected to have a Material Adverse Effect) and have paid all taxes required to be paid whether or not reported thereon (except for cases in which the failure to file or pay would not reasonably be expected to have a Material Adverse Effect on the Company or except as currently being contested in good faith and for which reserves required by GAAP have been created in the financial statements of the Company), and no tax deficiency has been determined adversely to the Company or any of its subsidiaries which, singly or in the aggregate, has had (nor does the Company nor any of its subsidiaries have any notice or knowledge of any tax deficiency which would reasonably be expected to be determined adversely to the Company or its subsidiaries and which would reasonably be expected to have) a Material Adverse Effect. There are no outstanding agreements or waivers extending the statutory period of limitation applicable to any federal, state, local or foreign tax return for any period, other than pursuant to automatic extensions of the due date for filing a tax return obtained in the ordinary course of business.
3.23 Price Stabilization of Common Stock. The Company has not taken, directly or indirectly, any action designed to or that would reasonably be expected to cause or result in any stabilization or manipulation of the price of the Shares.
3.24 Investment Company Act. The Company is not, and after giving effect to the issuance and sale of the Shares and the application of the proceeds thereof will not be, required to register as an “investment company” as such term is defined in the Investment Company Act of 1940, as amended.
3.25 General Solicitation; No Integration or Aggregation. Neither the Company nor any other person or entity authorized by the Company to act on its behalf has engaged in a general solicitation or general advertising (within the meaning of Regulation D of the Securities Act) of investors with respect to offers or sales of Shares pursuant to this Agreement. The Company has not, directly or indirectly, sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which, to its knowledge, is or will be (i) integrated with the offer and sale of the Shares pursuant to this Agreement for purposes of the Securities Act or (ii) aggregated with prior offerings by the Company for the purposes of the rules and regulations of the Nasdaq Global Select Market. Assuming the accuracy of the representations and warranties of the Investors set forth in Section 4, neither the Company nor any of its Affiliates, its subsidiaries nor any Person acting on their behalf has, directly or indirectly, made any offers or sales of any Company security or solicited any offers to buy any Company security, under circumstances that would adversely affect reliance by the Company on Section 4(a)(2) for the exemption from registration for the transactions contemplated hereby.
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3.26 Brokers and Finders. Other than the Placement Agents, neither the Company nor any other Person authorized by the Company to act on its behalf has retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Agreement.
3.27 Reliance by the Investors. The Company has a reasonable basis for making each of the representations set forth in this Section 3. The Company acknowledges that each of the Investors will rely upon the truth and accuracy of, and the Company’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of the Company set forth herein.
3.28 No Additional Agreements. There are no agreements or understandings between the Company and any Investor with respect to the transactions contemplated by the Transaction Agreements other than (i) as specified in the Transaction Agreements and (ii) any side letter agreements with any of the Investors, which side letters the Company has shared with all Investors.
3.29 Anti-Bribery and Anti-Money Laundering Laws. The operations of the Company and each of its subsidiaries are and have been conducted at all times in material compliance with all applicable financial recordkeeping and reporting requirements, including those of the Bank Secrecy Act, as amended by Title III of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act), and the applicable anti-money laundering statutes of jurisdictions where the Company and each of its subsidiaries conduct business, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental or regulatory agency (collectively, the “Anti-Money Laundering Laws”), and no action, suit or proceeding by or before any court or governmental or regulatory agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Anti-Money Laundering Laws is pending or, to the Company’s knowledge, threatened.
3.30 Sanctions.
(i) None of the Company, any of its subsidiaries, or any director, or employee thereof, or, to the Company’s knowledge, any agent, controlled affiliate or representative of the Company or any of its subsidiaries, is a Person that is, or is owned or controlled by one or more Persons that are:
| (A) | the subject of any sanctions administered or enforced by the U.S. Department of the Treasury’s Office of Foreign Assets Control, the United Nations Security Council, the European Union, His Majesty’s Treasury, or other relevant sanctions authority (collectively, “Sanctions”), or |
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| (B) | located, organized or resident in a country or territory that is the subject of Sanctions (including, without limitation, Crimea, Cuba, Iran, North Korea, Syria (before July 1, 2025), and the Donetsk People’s Republic and Luhansk People’s Republic located in Ukraine). |
(ii) The Company will not, directly or indirectly, use the proceeds of the offering, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other Person:
| (A) | to fund or facilitate any activities or business of or with any Person or in any country or territory that, at the time of such funding or facilitation, is the subject of Sanctions; or |
| (B) | in any other manner that will result in a violation of Sanctions by any Person (including any Person participating in the offering, whether as underwriter, advisor, investor or otherwise). |
(iii) For the past five years, the Company and each of its subsidiaries have not knowingly engaged in, are not now knowingly engaged in, and will not engage in, any dealings or transactions with any Person, or in any country or territory, that at the time of the dealing or transaction is or was the subject of Sanctions.
3.31 Cybersecurity. The Company’s, its subsidiaries’, and, to the knowledge of the Company, its third party providers’ information technology assets and equipment, computers, technology systems and other systems, networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of the Company and its subsidiaries as currently conducted, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. The Company, its subsidiaries, and, to the knowledge of the Company, its third party service providers have implemented and maintained physical, technical and administrative controls, policies, procedures, and safeguards designed to maintain and protect its confidential information and the integrity, continuous operation, redundancy and security of all IT Systems (including all Sensitive Data) and data used in connection with the operation of the Company or its subsidiaries. The Company and its subsidiaries have used reasonable efforts to establish, and have established, commercially reasonable disaster recovery and security plans, procedures and facilities for the business, including, without limitation, for the information technology systems and data held or used by or for the Company or any of its subsidiaries. There have been no internal or external security breaches or attacks, outages or unauthorized uses of or accesses to the confidential data, or any other compromises of or relating to any such information technology system or data.
3.32 Compliance with Data Privacy Laws. Except as would not reasonably be expected to have a Material Adverse Effect, the Company and each of its subsidiaries are, and at all prior times in the past six years were, in compliance in all respects with all applicable data privacy and security laws and regulations or contractual obligations regarding the collection, use, transfer, storage, processing, protection, disposal or disclosure of all Personal Data, including, without limitation, and in each case only to the extent applicable, the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) and the California Consumer Privacy Act (“CCPA”) of 2018, as amended by the California Privacy Rights Act of 2020 (collectively, the “Privacy and Security Obligations”). “Personal Data” means (i) a natural person’s name, street address, telephone number, e-mail address, photograph of the natural person, social security number or tax identification number, driver’s license number, passport number, credit card number, bank information, or customer or account number; (ii) “personal data” as defined by GDPR or “personal information” as defined by the CCPA; and (iii) any other piece of information that reasonably allows the identification of such natural person, except any “protected health information” as defined by HIPAA or other information that has been explicitly exempted by an applicable Privacy and Security Obligation. The Company and its subsidiaries have in place, comply with, and take appropriate steps designed to ensure compliance in all material respects with their policies and procedures relating to data privacy and security and the collection, storage, processing, use, disclosure, handling, and analysis of all sensitive, confidential, or regulated data (collectively “Sensitive Data”) and Personal Data (collectively all such policies, procedures comprising, the “Policies”). The Company has (i) provided accurate notice of its privacy practices then in effect to appropriate data subjects, which contain materially accurate and sufficient notice of the Company’s then-current privacy practices relating to its subject matter and do not contain any material omissions of the Company’s then-current privacy practices and (ii) made all disclosures to appropriate data subjects required by applicable Privacy and Security Obligations in all material respects. None of such disclosures made have been inaccurate, misleading, deceptive or in violation of any Privacy and Security Obligations or Policies in any material respect. The execution, delivery and performance of this Agreement or any other agreement referred to in this Agreement will not result in a breach of violation of any Privacy and Security Obligations or Policies. The Company further certifies that neither it nor any subsidiary: (i) has received notice of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy and Security Obligations, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy and Security Obligation; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy and Security Obligation.
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3.33 Transactions with Affiliates and Employees. No relationship, direct or indirect, exists between or among the Company or any of its subsidiaries, on the one hand, and the directors, officers, stockholders, customers or suppliers of the Company, on the other hand, that is required to be described in the SEC Reports that is not so described.
4. Representations and Warranties of Each Investor. Each Investor, severally for itself and not jointly with any other Investor, represents and warrants to the Company and the Placement Agents that the statements contained in this Section 4 are true and correct as of the date of this Agreement and the Closing Date:
4.1 Organization. If the Investor is an entity, the Investor is, or is a series of a trust that is, duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted.
4.2 Authorization. If the Investor is an entity, the Investor has all requisite corporate or similar power and authority to enter into this Agreement and the other Transaction Agreements to which it will be a party and to carry out and perform its obligations hereunder and thereunder. If the Investor is an entity, all corporate, member or partnership action on the part of such Investor or its stockholders, members or partners necessary for the authorization, execution, delivery and performance of this Agreement and the other Transaction Agreements to which it will be a party and the consummation of the other transactions contemplated in this Agreement has been taken. If the Investor is an entity, the execution, delivery and performance by such Investor of the Transaction Agreements to which such Investor is a party has been duly authorized and each has been duly executed. Assuming this Agreement constitutes the legal and binding agreement of the Company, this Agreement constitutes a legal, valid and binding obligation of such Investor, enforceable against such Investor in accordance with its respective terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
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4.3 No Conflicts. The execution, delivery and performance of the Transaction Agreements by the Investor, the purchase of the Shares in accordance with their terms and the consummation by the Investor of the other transactions contemplated hereby will not conflict with or result in any violation of, breach or default by such Investor (with or without notice or lapse of time, or both) under, conflict with, or give rise to a right of termination, cancellation or acceleration of any obligation, a change of control right or to a loss of a material benefit under (i) if the Investor is an entity, any provision of the organizational documents of the Investor, including, without limitation, its incorporation or formation papers, bylaws, indenture of trust or partnership or operating agreement, as may be applicable or (ii) any agreement or instrument, undertaking, credit facility, franchise, license, judgment, order, ruling, statute, law, ordinance, rule or regulations, applicable to such Investor or its respective properties or assets, except, in the case of clause (ii), as would not, individually or in the aggregate, be reasonably expected to materially delay or hinder the ability of the Investor to perform its obligations under the Transaction Agreements.
4.4 Residency. The Investor’s residence (if an individual) or offices in which its investment decision with respect to the Shares was made (if an entity) are located at the address immediately below the Investor’s name on the pertinent signature page of this Agreement, except as otherwise communicated by the Investor to the Company.
4.5 Brokers and Finders. The Investor has not retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Agreement whose fees the Company would be required to pay.
4.6 Investment Representations and Warranties. The Investor hereby represents and warrants that, it (i) as of the date of this Agreement is, if an entity, a “qualified institutional buyer” (as defined in Rule 144A under the Securities Act) or an institutional “accredited investor” as that term is defined in Rule 501(a) under Regulation D promulgated pursuant to the Securities Act; or (ii) if an individual, is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D of the Securities Act and has such knowledge and experience in financial and business matters as to be able to protect its own interests in connection with an investment in the Shares. The Investor further represents and warrants that (x) it is capable of evaluating the merits and risk of such investment, and (y) that it has not been organized for the purpose of acquiring the Shares and is an “institutional account” as defined by FINRA Rule 4512(c). The Investor understands and agrees that the offering and sale of the Shares has not been registered under the Securities Act or any applicable state securities laws and is being made in reliance upon federal and state exemptions for transactions not involving a public offering which depend upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein.
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4.7 Intent. The Investor is purchasing the Shares solely for the Investor’s own account and not for the account of others, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Investor has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Investor’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Notwithstanding the foregoing, if the Investor is purchasing the Shares as a fiduciary or agent for one or more investor accounts, the Investor has full investment discretion with respect to each such account, and the full power and authority to make the acknowledgements, representations and agreements herein on behalf of each owner of each such account. The Investor has no present arrangement to sell the Shares to or through any person or entity. The Investor understands that the Shares must be held indefinitely unless such Shares are resold pursuant to a registration statement under the Securities Act or an exemption from registration is available. Nothing contained herein shall be deemed a representation or warranty by the Investor to hold the Shares for any period of time.
4.8 Investment Experience; Ability to Protect Its Own Interests and Bear Economic Risks. The Investor acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has knowledge and experience in finance, securities, taxation, investments and other business matters as to be capable of evaluating the merits and risks of investments of the kind described in this Agreement and contemplated hereby, and the Investor has had an opportunity to seek, and has sought, such accounting, legal, business and tax advice as the Investor has considered necessary to make an informed investment decision. The Investor acknowledges that the Investor (i) is a sophisticated investor, experienced in investing in private placements of equity securities and capable of evaluating investment risks independently, both in general and with regard to all transactions and investment strategies involving a security or securities and (ii) has exercised independent judgment in evaluating its participation in the purchase of the Shares. The Investor acknowledges that the Investor is aware that there are substantial risks incident to the purchase and ownership of the Shares, including those set forth in the Company’s filings with the SEC. Alone, or together with any professional advisor(s), the Investor has adequately analyzed and fully considered the risks of an investment in the Shares and determined that the Shares are a suitable investment for the Investor. The Investor is, at this time and in the foreseeable future, able to afford the loss of the Investor’s entire investment in the Shares and the Investor acknowledges specifically that a possibility of total loss exists.
4.9 Independent Investment Decision. The Investor understands that nothing in the Transaction Agreements or any other materials presented by or on behalf of the Company to the Investor in connection with the purchase of the Shares constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and investment advisors as it, in such Investor’s sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
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4.10 Securities Not Registered; Legends. The Investor acknowledges and agrees that the Shares are being offered in a transaction not involving any public offering within the meaning of the Securities Act, and the Investor understands that the Shares have not been registered under the Securities Act, by reason of their issuance by the Company in a transaction exempt from the registration requirements of the Securities Act, and that the Shares must continue to be held and may not be offered, resold, transferred, pledged or otherwise disposed of by the Investor unless a subsequent disposition thereof is registered under the Securities Act or is exempt from such registration and in each case in accordance with any applicable securities laws of any state of the United States. The Investor understands that the exemptions from registration afforded by Rule 144 (the provisions of which are known to it) promulgated under the Securities Act depend on the satisfaction of various conditions including, but not limited to, the time and manner of sale, the holding period and on requirements relating to the Company which are outside of the Investor’s control and which the Company may not be able to satisfy, and that, if applicable, Rule 144 may afford the basis for sales only in limited amounts. The Investor acknowledges and agrees that it has been advised to consult legal counsel prior to making any offer, resale, transfer, pledge or disposition of any of the Shares. The Investor acknowledges that no federal or state agency has passed upon or endorsed the merits of the offering of the Shares or made any findings or determination as to the fairness of this investment.
The Investor understands that any certificates or book entry notations evidencing the Shares may bear the following legend:
“THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”). THE SHARES HAVE BEEN ACQUIRED FOR INVESTMENT AND MAY NOT BE SOLD, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THESE SECURITIES UNDER THE ACT OR AN EXEMPTION FROM SUCH REGISTRATION THEREUNDER”
In addition, the Shares may contain a legend regarding affiliate status of the Investor, if applicable.
4.11 No General Solicitation. The Investor acknowledges and agrees that the Investor is purchasing the Shares directly from the Company. Investor became aware of this offering of the Shares solely by means of direct contact from the Placement Agents or directly from the Company as a result of a pre-existing, substantive relationship with the Company or the Placement Agents, and/or their respective advisors (including, without limitation, attorneys, accountants, bankers, consultants and financial advisors), agents, control persons, representatives, Affiliates, directors, officers, managers, members, and/or employees, and/or the representatives of such persons. The Shares were offered to Investor solely by direct contact between Investor and the Company, the Placement Agents and/or their respective representatives. Investor did not become aware of this offering of the Shares, nor were the Shares offered to Investor, by any other means, and none of the Company, the Placement Agents and/or their respective representatives acted as investment advisor, broker or dealer to Investor. The Investor is not purchasing the Shares as a result of any general or public solicitation or general advertising, or publicly disseminated advertisement, article, notice or other communication regarding the Shares published in any newspaper, magazine or similar media or broadcast over television, radio or the internet or presented at any seminar or any other general solicitation or general advertisement, including any of the methods described in Section 502(c) of Regulation D under the Securities Act.
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4.12 Access to Information. In making its decision to purchase the Shares, such Investor has relied solely upon independent investigation made by such Investor, upon the SEC Reports and upon the representations, warranties and covenants set forth herein. Such Investor acknowledges and agrees that such Investor and the Investor’s professional advisor(s), if any, have had the opportunity to ask such questions, receive such answers and obtain such information from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares as the Investor and the Investor’s professional advisor(s), if any, have deemed necessary to make an investment decision with respect to the Shares and that the Investor has independently made its own analysis and decision to invest in the Company. Neither such inquiries nor any other due diligence investigation conducted by the Investor shall modify, limit or otherwise affect the Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.
4.13 Certain Trading Activities. Other than consummating the transaction contemplated hereby, the Investor has not, nor has any Person acting on behalf of or pursuant to any understanding with the Investor, directly or indirectly executed any purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time that the Investor was first contacted by the Company or any other Person regarding the transaction contemplated hereby, and the Company’s name was disclosed therewith, and ending immediately prior to the date of this Agreement. Notwithstanding the foregoing, in the case of an Investor that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Investor’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of such Investor’s assets, the representation set forth above shall only apply with respect to the portion of the assets managed by the portfolio manager that made the investment decision to purchase the Shares covered by this Agreement. Furthermore, in the case of an Investor whose investment advisor utilized an information barrier with respect to the information regarding the transactions contemplated hereunder after first being contacted by the Company or its representatives, the representation set forth above shall only apply after the point in time when the portfolio manager who manages such Investor’s assets was informed of the information regarding the transactions contemplated hereunder and, with respect to the Investor’s investment advisor, the representation set forth above shall only apply with respect to any purchases or sales, including Short Sales, of the securities of the Company on behalf of other funds or investment vehicles for which the Investor’s investment advisor is also an investment advisor or sub-advisor after the point in time when the portfolio manager who manages the assets of such other funds or investment vehicles for which the Investor’s investment advisor is also an investment advisor or sub-advisor was informed of the information regarding the transactions contemplated hereunder. Other than to other Persons party to this Agreement and to its advisors and agents who had a need to know such information, the Investor has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction). Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability of, or securing of, available shares to borrow in order to effect Short Sales or similar transactions in the future.
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5. Covenants.
5.1 Further Assurances. Each party agrees to cooperate with each other and their respective officers, employees, attorneys, accountants and other agents, and, generally, do such other reasonable acts and things in good faith as may be necessary to effectuate the intents and purposes of this Agreement, subject to the terms and conditions of this Agreement and compliance with applicable law, including taking reasonable action to facilitate the filing of any document or the taking of reasonable action to assist the other parties hereto in complying with the terms of this Agreement. The Investor acknowledges that the Company and the Placement Agents will rely on the acknowledgments, understandings, agreements, representations and warranties contained in this Agreement. Prior to the Closing, the Investor agrees to promptly notify the Company if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Section 4 of this Agreement are no longer accurate.
5.2 Listing. The Company shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on the Nasdaq Global Select Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of Nasdaq.
5.3 Disclosure of Transactions.
(a) The Company shall, by the Disclosure Time, issue a press release and/or file with the SEC a Current Report on Form 8-K (including, if applicable, all exhibits thereto, the “Disclosure Document”) disclosing (i) all material terms of the transactions contemplated hereby and by the other Transaction Agreements and, if the Disclosure Document is a Current Report on Form 8-K, attaching this Agreement and the other Transaction Agreements as exhibits to such Disclosure Document, and (ii) all material non-public information concerning the Company disclosed to the Investors. Following the issuance or filing of the Disclosure Document, no Investor shall be in possession of any material non-public information concerning the Company disclosed to the Investors by the Company or its representatives. From and after the issuance of the Disclosure Document, the Company shall not provide material non-public information to any Investor (except with respect to an Investor that is a member of the Board of Directors or an affiliate of the Company), unless otherwise specifically agreed in writing by such Investor prior to any such disclosure. The Company understands and confirms that the Investors will rely on the foregoing representation in effecting securities transactions. In addition, unless it has already done so by filing the Disclosure Document, on or before the fourth (4th) Business Day following the date of this Agreement, the Company shall file with the SEC a Current Report on Form 8-K disclosing all material terms of the transactions contemplated by this Agreement. Notwithstanding anything in this Agreement to the contrary, the Company shall not publicly disclose the name of any Investor or any of its Affiliates or advisors, or include the name of any Investor or any of its Affiliates or advisors in any press release, marketing materials or filing with the SEC (other than any registration statement contemplated by the Registration Rights Agreement) or any regulatory agency, without the prior written consent of the Investor, except (i) as required by the federal securities law in connection with (A) any registration statement contemplated by the Registration Rights Agreement and (B) the filing of final Transaction Agreements with the SEC or pursuant to other routine proceedings of regulatory authorities, or (ii) to the extent such disclosure is required by law, at the request of the staff of the SEC or regulatory agency or under the regulations of the Nasdaq Global Select Market, in which case the Company shall allow such Investor, to the extent reasonably practicable in the circumstances, reasonable time to comment on such disclosure.
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5.4 Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Investors, or that will be integrated with the offer or sale of the Shares for purposes of the rules and regulations of any National Exchange such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
5.5 Removal of Legends.
(a) In connection with any sale, assignment, transfer or other disposition of the Shares by an Investor pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Investor with the requirements of this Agreement, if requested by the Investor by notice to the Company, the Company shall use commercially reasonable efforts to request the Transfer Agent to remove any restrictive legends related to the book entry account holding such shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends within the earlier of (i) one (1) Business Day and (ii) the Standard Settlement Period, in each case, of following any such request therefor from the Investor, provided that the Company has timely received from the Investor customary representations and other documentation reasonably acceptable to the Company in connection therewith. The Company shall be responsible for the fees of its Transfer Agent and its legal counsel associated with such legend removal.
(b) Subject to receipt from the Investor by the Company and the Transfer Agent of customary representations and other documentation reasonably acceptable to the Company and the Transfer Agent in connection therewith, upon the earliest of such time as the Shares (i) have been sold under the Securities Act pursuant to an effective registration statement; (ii) have been sold pursuant to Rule 144, or (iii) are eligible for resale under Rule 144(b)(1) without the requirement for the Company to be in compliance with the current public information requirements under Rule 144(c)(1) (or any successor provision), the Company shall, in accordance with the provisions of this Section 5.5(b) and within the earlier of (i) one (1) Business Day and (ii) the Standard Settlement Period, in each case, of any request therefor from an Investor accompanied by such customary and reasonably acceptable documentation referred to above, use commercially reasonable efforts to (A) deliver to the Transfer Agent irrevocable instructions that the Transfer Agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the Transfer Agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the Transfer Agent to effect the removal of the legend in accordance with the provisions of this Agreement.
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5.6 Withholding Taxes. Each Investor agrees to furnish the Company with any information, representations and forms as shall reasonably be requested by the Company from time to time to assist the Company in complying with any applicable tax law (including any withholding obligations).
5.7 Fees and Commissions. The Company shall be solely responsible for the payment of any placement agent’s fees, financial advisory fees, or broker’s commissions (other than for Persons engaged by an Investor) relating to or arising out of the transactions contemplated hereby, including, without limitation, any fees or commissions payable to the Placement Agents.
5.8 No Conflicting Agreements. The Company will not take any action, enter into any agreement or make any commitment that would conflict or interfere in any material respect with the Company’s obligations to the Investors under the Transaction Agreements.
5.9 Indemnification.
(a) The Company agrees to indemnify and hold harmless each Investor and its Affiliates, and their respective directors, officers, trustees, members, managers, employees, investment advisors and agents (collectively, the “Indemnified Persons”), from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out-of-pocket expenses reasonably incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Company under the Transaction Agreements, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.
(b) Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement unless such judgment or settlement (i) imposes no liability or obligation on, (ii) includes as an unconditional term thereof the giving of a complete, explicit and unconditional release from the party bringing such indemnified claims of all liability of the indemnified party in respect of such claim or litigation in favor of, and (iii) does not include any admission of fault, culpability, wrongdoing or malfeasance by or on behalf of, the indemnified party. No indemnified party will, except with the consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement.
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5.10 Subsequent Equity Sales. From the date of this Agreement until the earlier of (a) sixty (60) days after the Closing Date and (b) the Business Day immediately following the effective date of the registration statement filed pursuant to the Registration Rights Agreement, the Company shall not (A) issue shares of Common Stock or Common Stock Equivalents, (B) effect a reverse stock split, recapitalization, share consolidation, reclassification or similar transaction affecting the outstanding Common Stock or (C) file with the SEC a registration statement under the Securities Act relating to any shares of Common Stock or Common Stock Equivalents, except pursuant to the terms of the Registration Rights Agreement. Notwithstanding the foregoing, the provisions of this Section 5.10 shall not apply to (i) the issuance of the Shares hereunder, (ii) the issuance of Common Stock or Common Stock Equivalents upon the conversion, exercise or vesting of any securities of the Company outstanding on the date of this Agreement or outstanding pursuant to clause (iii) below, (iii) the issuance of any Common Stock or Common Stock Equivalents pursuant to any Company stock-based compensation plans or in accordance with Nasdaq Stock Market Rule 5635(c)(4), (iv) the filing of a registration statement on Form S-8 under the Securities Act to register the offer and sale of securities on an equity incentive plan or employee stock purchase plan, or (v) the filing of an automatically effective registration statement on Form S-3 under the Securities Act to register an indeterminate number of (1) shares of Common Stock, (2) shares of the Company’s preferred stock, $0.0001 par value per share (“Preferred Stock”), (3) senior and/or subordinated debt securities (“Debt Securities”) (4) warrants to purchase shares of Common Stock, shares of Preferred Stock or Debt Securities (the “S-3 Warrants”), and (5) units to purchase any combination of Common Stock, Preferred Stock, Debt Securities or S-3 Warrants, including a prospectus with respect to an at-the-market program for up to $200,000,000 of Common Stock or (vi) the filing of a registration statement on Form S-3 under the Securities Act to register up to 7,000,000 shares of Common Stock to be issued to InnoCare Pharma Inc. pursuant to the Royale Agreement.
6. Conditions of Closing.
6.1 Conditions to the Obligation of the Investors. The several obligations of each Investor to consummate the transactions to be consummated at the Closing, and to purchase and pay for the Shares being purchased by it at the Closing pursuant to this Agreement, are subject to the satisfaction or waiver in writing of the following conditions precedent:
(a) Representations and Warranties. The representations and warranties of the Company contained herein shall be true and correct in all material respects, except for those representation and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects, as of the date of this Agreement and as of the Closing Date, as though made on and as of such date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date, except for those representations and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects as of such earlier date.
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(b) Performance. The Company shall have performed in all material respects the obligations and conditions herein required to be performed or observed by the Company on or prior to the Closing Date.
(c) No Injunction. The purchase of and payment for the Shares by each Investor shall not be prohibited or enjoined by any law or governmental or court order or regulation and no such prohibition shall have been threatened in writing.
(d) Consents. The Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for the consummation of the purchase and sale of the Shares, all of which shall be in full force and effect.
(e) Transfer Agent. The Company shall have furnished all required materials to the Transfer Agent to reflect the issuance of the Shares at the Closing.
(f) Adverse Changes. Since the date of this Agreement, no event or series of events shall have occurred that would reasonably be expected to have a Material Adverse Effect.
(g) Opinion of Company Counsel. The Company shall have delivered to the Investors and the Placement Agents the opinion of Ropes & Gray LLP, dated as of the Closing Date, in customary form and substance to be reasonably agreed upon with the Investors and addressing such legal matters as the Investors and the Company reasonably agree.
(h) Compliance Certificate. An authorized officer of the Company shall have delivered to the Investors at the Closing Date a certificate certifying that the conditions specified in Sections 6.1(a) (Representations and Warranties), 6.1(b) (Performance), 6.1(c) (No Injunction), 6.1(d) (Consents), 6.1(e) (Transfer Agent), 6.1(f) (Adverse Changes), 6.1(k) (Listing Requirements) and 6.1(l) (No Injunction) of this Agreement have been fulfilled.
(i) Secretary’s Certificate. The Secretary of the Company shall have delivered to the Investors at the Closing Date a certificate certifying (i) the Amended and Restated Certificate of Incorporation; (ii) the Amended and Restated Bylaws; and (iii) resolutions of the Company’s Board of Directors (or an authorized committee thereof) approving this Agreement, the other Transaction Agreements, the transactions contemplated by this Agreement and the issuance of the Shares.
(j) Registration Rights Agreement. The Company shall have executed and delivered the Registration Rights Agreement in the form attached hereto as Exhibit C (the “Registration Rights Agreement”) to the Investors.
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(k) Listing Requirements. No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock. The Common Stock shall be listed on a National Exchange and shall not have been suspended, as of the Closing Date, by the SEC or the National Exchange from trading thereon nor shall suspension by the SEC or the National Exchange have been threatened, as of the Closing Date, in writing by the SEC or the National Exchange; and the Company shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares and Nasdaq shall have raised no objection to such notice and the transactions contemplated hereby.
(l) No Injunction. No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any Governmental Entity, shall have been issued, and no action or proceeding shall have been instituted by any Governmental Entity, enjoining or preventing the consummation of the transactions contemplated hereby or in the other Transaction Agreements.
(m) Payment. Except as may be agreed to among the Company and one or more Investors in accordance with Section 2.2, the Company shall have received payment, by wire transfer of immediately available funds, in the full amount of the purchase price for the number of Shares being purchased by each other Investor at the Closing as set forth in Exhibit A and Exhibit B, respectively.
6.2 Conditions to the Obligation of the Company. The obligation of the Company to consummate the transactions to be consummated at the Closing, and to issue and sell to each Investor the Shares to be purchased by it at the Closing pursuant to this Agreement, is subject to the satisfaction or waiver in writing of the following conditions precedent:
(a) Representations and Warranties. The representations and warranties of each Investor in Section 4 hereto shall be true and correct on and as of the Closing Date, with the same force and effect as though made on and as of the Closing Date and consummation of the Closing shall constitute a reaffirmation by the Investor of each of the representations, warranties, covenants and agreements of the Investor contained in this Agreement as of the Closing Date.
(b) Performance. Each Investor shall have performed or complied with in all material respects all obligations and conditions herein required to be performed or observed by such Investor on or prior to the Closing Date.
(c) Injunction. The purchase of and payment for the Shares by each Investor shall not be prohibited or enjoined by any law or governmental or court order or regulation.
(d) Registration Rights Agreement. Each Investor shall have executed and delivered the Registration Rights Agreement to the Company in the form attached as Exhibit C.
(e) Payment. Except as may be agreed to among the Company and such Investor in accordance with Section 2.2, the Company shall have received payment, by wire transfer of immediately available funds, in the full amount of the purchase price for the number of Shares being purchased by each Investor at the Closing as set forth in Exhibit A and Exhibit B, respectively.
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7. Termination.
7.1 Termination. The obligations of the Company, on the one hand, and the Investors, on the other hand, to effect the Closing shall terminate as follows:
(i) Upon the mutual written consent of the Company and the Investors prior to the Closing;
(ii) By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment, and shall not have been waived by the Company;
(iii) By an Investor (with respect to itself only) if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment, and shall not have been waived by such Investor; or
(iv) By either the Company or an Investor (with respect to itself only) if the Closing has not occurred on or prior to the fifth Business Day following the date of this Agreement;
provided, however, that, in the case of clauses (ii) and (iii) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in the Transaction Agreements if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing.
7.2 Notice. In the event of termination by the Company or the Investor of its obligations to effect the Closing pursuant to Section 7.1, written notice thereof shall be given to the other Investors by the Company. Nothing in this Section 7 shall be deemed to release any party from any liability for any breach by such party of the other terms and provisions of the Transaction Agreements or to impair the right of any party to compel specific performance by any other party of its other obligations under the Transaction Agreements.
8. Miscellaneous Provisions.
8.1 Public Statements or Releases. Except as set forth in Section 5.3, neither the Company nor any Investor shall make any public announcement with respect to the existence or terms of this Agreement or the transactions provided for herein without the prior consent of the other party (which consent shall not be unreasonably withheld). Notwithstanding the foregoing, and subject to compliance with Section 5.3, nothing in this Section 8.1 shall prevent any party from making any public announcement it considers necessary in order to satisfy its obligations under the law, including applicable securities laws, or under the rules of any national securities exchange or securities market, in which case the party making such public announcement shall allow the other party reasonable time to comment on such release or announcement in advance of such issuance, and the party making such public announcement will consider in good faith any comments from such other party.
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8.2 Notices. Any notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to be given (a) when delivered if personally delivered to the party for whom it is intended, (b) when delivered, if sent by electronic mail during normal business hours of the recipient, and if not sent prior to 5:00 p.m. Eastern Time, then on the recipient’s next Business Day, (c) three (3) days after having been sent by certified or registered mail, return-receipt requested and postage prepaid, or (d) one (1) Business Day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt:
(a) If to the Company, addressed as follows:
Zenas BioPharma, Inc.
852 Winter Street, Suite 250
Waltham, MA 02451
Attention: Jeff Held, Chief Legal Officer
Email: jeff.held@zenasbio.com
with a copy (which shall not constitute notice):
Ropes & Gray LLP
Prudential Tower
800 Boylston Street
Boston, MA 02199
Attention: Thomas Danielski
Email: thomas.danielski@ropesgray.com
(b) If to any Investor, at its address or e-mail address set forth on the signature page hereto, or such address as subsequently modified by written notice given in accordance with this Section 8.2.
Any Person may change the address to which notices and communications to it are to be addressed by notification as provided for herein.
8.3 Consent to Electronic Notice. Each Investor consents to the delivery of any stockholder notice pursuant to this Agreement, at the e-mail address set forth below the Investor’s name on the signature page or Exhibit A or Exhibit B, as applicable, as updated from time to time by notice to the Company. To the extent that any notice given by means of electronic mail is returned or undeliverable for any reason, the foregoing consent shall be deemed to have been revoked until a new or corrected e-mail address has been provided, and such attempted electronic notice shall be ineffective and deemed to not have been given. Each party agrees to promptly notify the other parties of any change in its e-mail address, and that failure to do so shall not affect the foregoing.
8.4 Severability. If any part or provision of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction, the invalid or unenforceable part or provisions shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the parties hereto.
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8.5 Governing Law; Submission to Jurisdiction; Venue; Waiver of Trial by Jury.
(a) This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York without regard to choice of laws or conflicts of laws provisions thereof that would require the application of the laws of any other jurisdiction, except to the extent that mandatory principles of Delaware law may apply.
(b) The Company and each of the Investors hereby irrevocably and unconditionally:
(i) submits for itself and its property in any legal action or proceeding relating solely to this Agreement or the transactions contemplated hereby, to the general jurisdiction of the any state court or United States Federal court sitting in the Borough of Manhattan, City of New York in the State of New York;
(ii) consents that any such action or proceeding may be brought in such courts, and waives any objection that it may now or hereafter have to the venue of any such action or proceeding in any such court or that such action or proceeding was brought in an inconvenient court and agrees not to plead or claim the same to the extent permitted by applicable law;
(iii) agrees that service of process in any such action or proceeding may be effected by mailing a copy thereof by registered or certified mail (or any substantially similar form of mail), postage prepaid, to the party, as the case may be, at its address set forth in Section 8.2 or at such other address of which the other party shall have been notified pursuant thereto;
(iv) agrees that nothing herein shall affect the right to effect service of process in any other manner permitted by law or shall limit the right to sue in any other jurisdiction for recognition and enforcement of any judgment or if jurisdiction in the courts referenced in the foregoing clause (i) are not available despite the intentions of the parties hereto;
(v) agrees that final judgment in any such suit, action or proceeding brought in such a court may be enforced in the courts of any jurisdiction to which such party is subject by a suit upon such judgment, provided that service of process is effected upon such party in the manner specified herein or as otherwise permitted by law;
(vi) agrees that to the extent that such party has or hereafter may acquire any immunity from jurisdiction of any court or from any legal process with respect to itself or its property, such party hereby irrevocably waives such immunity in respect of its obligations under this Agreement, to the extent permitted by law; and
(vii) irrevocably and unconditionally waives trial by jury in any legal action or proceeding in relation to this Agreement.
8.6 Waiver. No waiver of any term, provision or condition of this Agreement, whether by conduct or otherwise, in any one or more instances, shall be deemed to be, or be construed as, a further or continuing waiver of any such term, provision or condition or as a waiver of any other term, provision or condition of this Agreement.
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8.7 Expenses. Except as expressly set forth in the Transaction Agreements to the contrary, each party shall pay its own out-of-pocket fees and expenses, including the fees and expenses of attorneys, accountants and consultants employed by such party, incurred in connection with the proposed investment in the Shares and the consummation of the transactions contemplated thereby; provided, however, that the Company shall pay all Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company), stamp taxes and other taxes (other than income taxes) and duties levied in connection with the delivery of any Shares to the Investors. The Company shall pay all Placement Agents fees relating to or arising out of the transactions contemplated by this Agreement.
8.8 Assignment. None of the parties may assign its rights or obligations under this Agreement or designate another person (i) to perform all or part of its obligations under this Agreement or (ii) to have all or part of its rights and benefits under this Agreement, in each case without the prior written consent of (x) the Company, in the case of an Investor, and (y) the Investors, in the case of the Company, provided that an Investor may, without the prior consent of the Company, assign its rights to purchase the Shares hereunder to any of its Affiliates or to any other investment funds or accounts managed or advised by the investment manager who acts on behalf of such Investor (provided each such assignee agrees to be bound by the terms of this Agreement and makes the same representations and warranties set forth in Section 4 ). In the event of any assignment in accordance with the terms of this Agreement, the assignee shall specifically assume and be bound by the provisions of this Agreement by executing a writing agreeing to be bound by and subject to the provisions of this Agreement and shall deliver an executed counterpart signature page to this Agreement and, notwithstanding such assumption or agreement to be bound hereby by an assignee, no such assignment shall relieve any party assigning any interest hereunder from its obligations or liability pursuant to this Agreement.
8.9 Confidential Information.
(a) Each Investor covenants that until such time as the transactions contemplated by this Agreement and any material non-public information provided to such Investor are publicly disclosed by the Company, in accordance with Section 5.3 (or the earlier termination of this Agreement), such Investor will maintain the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction), other than to such Investor’s outside attorney, accountant, auditor or investment advisor only to the extent necessary to permit evaluation of the investment, and the performance of the necessary or required tax, accounting, financial, legal, or administrative tasks and services and other than as may be required by law.
(b) The Company may request from the Investors such reasonable and customary additional information as the Company may deem necessary to evaluate the eligibility of the Investor to acquire the Shares, and the Investor shall promptly provide such information as may reasonably be requested to the extent readily available; provided, that the Company agrees to keep any such information provided by the Investor confidential, except (i) as required by the federal securities laws, rules or regulations and (ii) to the extent such disclosure is required by other laws, rules or regulations, at the request of the staff of the SEC or regulatory agency or under the regulations of Nasdaq. The Investor acknowledges that the Company may file a copy of this Agreement and the Registration Rights Agreement with the SEC as exhibits to a periodic report or a registration statement of the Company.
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8.10 Reliance by and Exculpation of Placement Agents.
(a) Each Investor agrees for the express benefit of the Placement Agents, their respective affiliates and their respective representatives that (i) it is not relying upon, and has not relied upon, any statement, representation or warranty made by the Placement Agents, any of their respective affiliates or any of their or their respective representatives, in making its investment or decision to invest in the Company, (ii) the Placement Agents are acting solely as placement agents in connection with the transactions contemplated hereby and are not acting as underwriters, initial purchasers, dealers or in any other such capacity and are not and shall not be construed as a fiduciary for such Investor, (iii) the Placement Agents, their respective affiliates and their respective representatives have not made, and will not make any representations or warranties with respect to the Company or the offer and sale of the Shares or any other matter concerning the Company or the transactions contemplated hereby, and the Investor will not rely on any statements made by the Placement Agents, orally or in writing, to the contrary, (iv) the Investor will be responsible for conducting its own due diligence investigation with respect to the Company and the offer and sale of the Shares, (v) the Investor will be purchasing Shares based on the results of its own due diligence investigation of the Company and the Placement Agents and each of their respective directors, officers, employees, representatives, and controlling persons have made no independent investigation with respect to the Company, the Shares, or the accuracy, completeness, or adequacy of any information supplied to the Investor by the Company, (vi) the Investor has negotiated the offer and sale of the Shares directly with the Company, and the Placement Agents will not be responsible for the ultimate success of any such investment and (vii) the decision to invest in the Company will involve a significant degree of risk, including a risk of total loss of such investment. Each Investor further represents and warrants to the Placement Agents that it, including any fund or funds that it manages or advises that participates in the offer and sale of the Shares, is permitted under its constitutive documents (including, without limitation, all limited partnership agreements, charters, bylaws, limited liability company agreements, all applicable side letters with investors, and similar documents) to make investments of the type contemplated by this Agreement. This Section 8.10 shall survive any termination of this Agreement.
(b) The Company agrees and acknowledges that the Placement Agents may rely on its representations, warranties, agreements and covenants contained in this Agreement and each Investor agrees that the Placement Agents may rely on such Investor’s representations and warranties contained in this Agreement as if such representations and warranties, as applicable, were made directly to the Placement Agents.
(c) Neither the Placement Agents nor any of their respective Affiliates or representatives (1) shall be liable for any improper payment made in accordance with the information provided by the Company; (2) makes any representation or warranty, or has any responsibilities as to the validity, enforceability, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to the Transaction Agreements or in connection with any of the transactions contemplated therein; or (3) shall be liable (x) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon it by the Transaction Agreements or (y) for anything which any of them may do or refrain from doing in connection with the Transaction Agreements, except in each case for such party’s own gross negligence or willful misconduct.
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(d) The Company agrees that the Placement Agents, their respective affiliates and their respective representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as the Placement Agents hereunder pursuant to the indemnification provisions set forth in the applicable letter agreement between the Company and the Placement Agents.
8.11 Third Parties. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the parties to this Agreement any rights, remedies, claims, benefits, obligations or liabilities under or by reason of this Agreement, and no Person that is not a party to this Agreement (including, without limitation, any partner, member, shareholder, director, officer, employee or other beneficial owner of any party to this Agreement, in its own capacity as such or in bringing a derivative action on behalf of a party to this Agreement) shall have any standing as a third party beneficiary with respect to this Agreement or the transactions contemplated hereby. Notwithstanding the foregoing, (i) the Placement Agents are intended third-party beneficiaries of the representations and warranties of the Company and of each Investor set forth in Section 3, Section 4 and Section 6.1(h), Section 8.10 and Section 8.19 respectively, of this Agreement and (ii) the Indemnified Persons are intended third-party beneficiaries of Section 5.9.
8.12 Independent Nature of Investors’ Obligations and Right. The obligations of each Investor under this Agreement are several and not joint with the obligations of any other Investor, and no Investor shall be responsible in any way for the performance obligations of any other Investor under this Agreement. Nothing contained herein, and no action taken by any Investor pursuant hereto, shall be deemed to constitute the Investors as, and the Company acknowledges that the Investors do not so constitute, a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Investors are in any way acting in concert or as a group, and the Company will not assert any such claim with respect to such obligations or the transactions contemplated by this Agreement. The Company acknowledges and each Investor confirms that it has independently participated in the negotiation of the transaction contemplated hereby with the advice of its own counsel and advisors. Each Investor also acknowledges that Ropes & Gray LLP has not rendered legal advice to such Investor. Each Investor shall be entitled to independently protect and enforce its rights, including, without limitation, the rights arising out of this Agreement, and it shall not be necessary for any other Investor to be joined as an additional party in any proceeding for such purpose. The Company has elected to provide all Investors with the same terms and Transaction Agreements for the convenience of the Company and not because it was required or requested to do so by any Investor.
8.13 Headings. The titles, subtitles and headings in this Agreement are for convenience of reference and shall not form part of, or affect the interpretation of, this Agreement.
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8.14 Counterparts. This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party; provided that a facsimile or pdf signature including any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com shall be considered due execution and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or pdf (or other electronic reproduction of a) signature.
8.15 Entire Agreement; Amendments. This Agreement and the other Transaction Agreements (including all schedules and exhibits hereto and thereto), together with any side letter agreements with any of the Investors, constitute the entire agreement between the parties hereto respecting the subject matter of this Agreement and supersedes all prior agreements, negotiations, understandings, representations and statements respecting the subject matter of this Agreement, whether written or oral. No amendment, modification, alteration, or change in any of the terms of this Agreement shall be valid or binding upon the parties hereto unless made in writing and duly executed by the Company and the Investors of at least a majority in interest of the Shares then held by the Investors, provided that prior to the Closing the consent of all Investors shall be required Notwithstanding the foregoing, this Agreement may not be amended and the observance of any term of this Agreement may not be waived with respect to any Investor without the written consent of such Investor unless such amendment or waiver applies to all Investors in the same fashion. The Company, on the one hand, and each Investor, on the other hand, may by an instrument signed in writing by such parties waive the performance, compliance or satisfaction by such Investor or the Company, respectively, with any term or provision of this Agreement or any condition hereto to be performed, complied with or satisfied by such Investor or the Company, respectively. Notwithstanding the foregoing or anything else herein to the contrary, no amendment, modification, alteration, change or waiver of this Section 8.15 shall be valid without the prior written consent of the Placement Agents, which consent may be granted or withheld in the sole discretion of the Placement Agents.
8.16 Survival. The covenants, representations and warranties made by each party hereto contained in this Agreement shall survive the Closing and the delivery of the Shares in accordance with their respective terms. Each Investor shall be responsible only for its own representations, warranties, agreements and covenants hereunder.
8.17 Contract Interpretation. This Agreement is the joint product of each Investor and the Company and each provision of this Agreement has been subject to the mutual consultation, negotiation and agreement of such parties and shall not be construed for or against any party hereto.
8.18 Arm’s Length Negotiations. For the avoidance of doubt, the parties acknowledge and confirm that the terms and conditions of the Shares were determined as a result of arm’s-length negotiations.
8.19 Acknowledgements Regarding Placement Agents. For the avoidance of doubt, the parties acknowledge and confirm that the terms and conditions of the Shares were determined as a result of arm’s-length negotiations.
(a) Each Purchaser acknowledges that each of the Placement Agents is acting as a placement agent on a “best efforts” basis for the Shares being offered hereby and will be compensated by the Company for acting in such capacity. Each Purchaser represents that such Purchaser was contacted regarding the sale of the Shares by a Placement Agent or the Company (or an authorized agent or representative thereof) with whom the Purchaser entered into a verbal or written confidentiality agreement.
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(b) Each Purchaser represents that it is making this investment based on the results of its own due diligence investigation of the Company, and has not relied on any information or advice furnished by or on behalf of either of the Placement Agents in connection with the transactions contemplated hereby. Each Purchaser acknowledges that neither of the Placement Agents has made, and will not make, any representations and warranties with respect to the Company or the transactions contemplated hereby, and the Purchaser will not rely on any statements made by either of the Placement Agents, orally or in writing, to the contrary.
[Remainder of Page Intentionally Left Blank.]
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
| COMPANY: | |||
| ZENAS BIOPHARMA, INC. | |||
| By: | |||
| Name: | [●] | ||
| Title: | [●] | ||
[Signature Page to Securities Purchase Agreement]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
| INVESTOR: | ||
| [NAME] | ||
| By: | ||
| Name: | ||
| Title: | ||
| Address: | ||
| [●] | ||
| Email: [●] | ||
[Signature Page to Securities Purchase Agreement]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
| INVESTOR: | ||
| [NAME] | ||
| By: | ||
| Name: | ||
| Title: | ||
| Address: | ||
| [●] | ||
| Email: [●] | ||
[Signature Page to Securities Purchase Agreement]
EXHIBIT A
INVESTORS
A-1
EXHIBIT B
INSIDER INVESTORS
B-1
EXHIBIT C
FORM OF REGISTRATION RIGHTS AGREEMENT
C-1
Exhibit 10.4
FORM OF REGISTRATION RIGHTS AGREEMENT
THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of October 7, 2025, is entered into by and among Zenas BioPharma, Inc., a Delaware corporation (the “Company”), and the several investors signatory hereto (individually as an “Investor” and collectively together with their respective permitted assigns, the “Investors”). Capitalized terms used herein and not otherwise defined herein shall have the respective meanings set forth in the Securities Purchase Agreement by and among the parties hereto, dated as of the date hereof (as amended, restated, supplemented or otherwise modified from time to time, the “Purchase Agreement”).
WHEREAS:
A. Upon the terms and subject to the conditions of the Purchase Agreement, the Company has agreed to issue to the Investors, and the Investors have agreed to purchase, severally and not jointly, an aggregate of up to $119,995,907.30 of shares (the “Shares”) of the Company's common stock, par value $0.0001 per share (the “Common Stock”) pursuant to the Purchase Agreement.
B. To induce the Investors to enter into the Purchase Agreement, the Company has agreed to provide certain registration rights under the U.S. Securities Act of 1933, as amended, and the rules and regulations thereunder, or any similar successor statute (collectively, the “Securities Act”), and applicable state securities laws.
NOW, THEREFORE, in consideration of the promises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investors hereby agree as follows:
| 1. | DEFINITIONS. |
For purposes of this Agreement, the following terms shall have the following meanings:
(a) “Person” means an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or any other entity or organization.
(b) “Prospectus” means (i) the prospectus included in any Registration Statement, as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus, and (ii) any “free writing prospectus” as defined in Rule 405 under the Securities Act, relating to the terms of the offering of any portion of the Registrable Securities.
(c) “Register,” “Registered,” and “Registration” refer to a registration effected by preparing and filing one or more registration statements of the Company in compliance with the Securities Act and providing for offering securities on a continuous basis, and the declaration or ordering of effectiveness of such registration statement(s) by the U.S. Securities and Exchange Commission (the “SEC”).
(d) “Registrable Securities” means the Shares and any Common Stock issued or issuable with respect to the Shares as a result of any stock split or subdivision, stock dividend, recapitalization, exchange or similar event. Registrable Securities shall cease to be Registrable Securities with respect to each Investor upon the earlier of (i) the date on which such Investor shall have resold all the Registrable Securities held by such Investor covered by the Registration Statement and (ii) the date on which the Registrable Securities may be sold by such Investor under Rule 144(b)(1)(i) of the Securities Act in any ninety (90) day period without volume or manner of sale limitations.
(e) “Registration Expenses” means all registration and filing fee expenses incurred by the Company in effecting any registration pursuant to this Agreement, including (i) all registration, qualification, and filing fees, printing expenses, and any other fees and expenses associated with filings required to be made with the SEC, FINRA or any other regulatory authority, (ii) all fees and expenses in connection with compliance with or clearing the Registrable Securities for sale under any securities or “Blue Sky” laws, (iii) all printing, duplicating, word processing, messenger, telephone, facsimile and delivery expenses, and (iv) all fees and disbursements of counsel for the Company and of all independent certified public accountants of the Company (including the expenses of any special audit and cold comfort letters required by or incident to such performance).
(f) “Registration Statement” means any registration statement of the Company filed with, or to be filed with, the SEC under the Securities Act, that Registers Registrable Securities, including the related Prospectus, amendments and supplements to such registration statement, including pre- and post-effective amendments, and all exhibits and all material incorporated by reference in such registration statement as may be necessary to comply with applicable securities laws. “Registration Statement” shall also include a New Registration Statement, as amended when each became effective, including all documents filed as part thereof or incorporated by reference therein, and including any information contained in a Prospectus subsequently filed with the SEC.
(g) “Required Investors” means the Investors holding a majority of the Registrable Securities outstanding from time to time.
(h) “Selling Expenses” means all underwriting discounts and selling commissions applicable to the sale of Registrable Securities and all similar fees and commissions relating to the Investors’ disposition of the Registrable Securities.
| 2. | REGISTRATION. |
(a) Mandatory Registration. The Company shall, as promptly as reasonably practicable and in any event no later than 15 days after the Closing Date (the “Filing Deadline”), prepare and file with the SEC an initial Registration Statement (the “Initial Registration Statement”) covering the resale of all Registrable Securities. The Initial Registration Statement shall be designated by the Company as an “automatic shelf registration statement” (as defined in Rule 405 of the Securities Act) if the Company is a “well-known seasoned issuer” (as defined in Rule 405 of the Securities Act) at the time of filing of the Initial Registration Statement with the SEC. Before filing the Registration Statement, the Company shall furnish to the Investors a copy of the Registration Statement. The Investors and their counsel shall have at least three Business Days prior to the anticipated filing date of a Registration Statement to review and comment upon such Registration Statement and any amendment or supplement to such Registration Statement and any related Prospectus, prior to its filing with the SEC. Subject to any SEC comments, such Registration Statement shall include the plan of distribution substantially in the form attached hereto as Exhibit A. Such Registration Statement also shall cover, to the extent allowable under the Securities Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. Such Registration Statement shall not include any shares of Common Stock or other securities for the account of any other holder of securities of the Company without the prior written consent of the Required Investors. The Company shall (a) use commercially reasonable efforts to address in each such document prior to being so filed with the SEC such comments as the Investor or its counsel reasonably proposed by the Investor, and (b) not file any Registration Statement or Prospectus or any amendment or supplement thereto containing information regarding the Investor to which Investor reasonably objects, unless such information is required to comply with any applicable law or regulation. The Investors shall furnish all information reasonably requested by the Company and as shall be reasonably required in connection with any registration referred to in this Agreement.
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(b) Effectiveness. The Company shall use its reasonable best efforts to have the Initial Registration Statement and any amendment declared effective by the SEC at the earliest possible date but no later than the earlier of the 75th calendar day following the initial filing date of the Initial Registration Statement if the SEC notifies the Company that it will “review” the Initial Registration Statement and (b) the fifth Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the Initial Registration Statement will not be “reviewed” or will not be subject to further review (the “Effectiveness Deadline”). The Company shall notify the Investor by e-mail as promptly as practicable, and in any event, within 24 hours, after the Initial Registration Statement is declared effective or is supplemented and shall provide the Investor with copies of any Prospectus to be used in connection with the sale or other disposition of the securities covered thereby. The Company shall use reasonable best efforts to keep the Initial Registration Statement continuously effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by the Investors of all of the Registrable Securities covered thereby at all times until the earlier to occur of the following events: (i) the date on which the Investors shall have resold all the Registrable Securities covered thereby; and (ii) the date on which the Registrable Securities may be resold by the Investors without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect (the “Registration Period”). The Initial Registration Statement (including any amendments or supplements thereto and prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading.
(c) Sufficient Number of Shares Registered. In the event the number of shares available under the Initial Registration Statement at any time is insufficient to cover the Registrable Securities, the Company shall, to the extent necessary and permissible, amend the Initial Registration Statement or file a new registration statement (together with any prospectuses or prospectus supplements thereunder, a “New Registration Statement”), so as to cover all of such Registrable Securities as soon as reasonably practicable, but in any event not later than ten Business Days after the necessity therefor arises (the “New Registration Filing Deadline”). The Company shall use its reasonable best efforts to have such amendment and/or New Registration Statement become effective as soon as reasonably practicable following the filing thereof but no later than the earlier of the 75th calendar day following the initial filing date of the New Registration Statement if the SEC notifies the Company that it will “review” the New Registration Statement and (b) the fifth Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the New Registration Statement will not be “reviewed” or will not be subject to further review (the earlier of such dates, the “New Registration Effectiveness Deadline”). The provisions of Section 2(a) and (b) shall apply to the New Registration Statement, except as modified hereby.
(d) Allowable Delays. On no more than two occasions and for not more than 30 consecutive days or for a total of not more than 60 days in any 12 month period, the Company may delay the effectiveness of the Initial Registration Statement or any other Registration Statement, or suspend the use of any Prospectus, in the event that the Company or Board of Directors determines, in good faith and upon advice of legal counsel, that such delay or suspension is necessary to (A) delay the disclosure of material non-public information concerning the Company, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company or (B) amend or supplement the affected Registration Statement or the related Prospectus so that such Registration Statement or Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the case of the Prospectus in light of the circumstances under which they were made, not misleading (an “Allowed Delay”); provided, that the Company shall promptly (a) notify each Investor in writing of the commencement of an Allowed Delay, but shall not (without the prior written consent of an Investor) disclose to such Investor any material non-public information giving rise to an Allowed Delay, (b) advise the Investors in writing to cease all sales under the applicable Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable.
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(e) Rule 415; Cutback. If at any time the SEC takes the position that the offering of some or all of the Registrable Securities in any Registration Statement is not eligible to be made on a delayed or continuous basis under the provisions of Rule 415 under the Securities Act (provided, however, the Company shall be obligated to use reasonable best efforts to advocate with the SEC for the registration of all of the Registrable Securities) or requires any Investor to be named as an “underwriter,” the Company shall (i) promptly notify each holder of Registrable Securities thereof and (ii) make commercially reasonable efforts to persuade the SEC that the offering contemplated by such Registration Statement is a valid secondary offering and not an offering “by or on behalf of the issuer” as defined in Rule 415 and that none of the Investors is an “underwriter.” The Investors shall have the right to select one legal counsel, which counsel shall be selected by the Required Investors (provided that an Investor may elect to be represented by its own legal counsel at such Investor’s own expense), to review and oversee any registration or matters pursuant to this Section 2(f), including participation in any meetings or discussions with the SEC regarding the SEC’s position and to comment on any written submission made to the SEC with respect thereto. No such written submission with respect to this matter shall be made to the SEC to which any Investor’s counsel reasonably objects. In the event that, despite the Company’s reasonable best efforts and compliance with the terms of this Section 2(f), the SEC refuses to alter its position, the Company shall (i) remove from such Registration Statement such portion of the Registrable Securities (the “Cut Back Shares”) and/or (ii) agree to such restrictions and limitations on the registration and resale of the Registrable Securities as the SEC may require to assure the Company’s compliance with the requirements of Rule 415 (collectively, the “SEC Restrictions”); provided, however, that the Company shall not name any Investor as an “underwriter” in such Registration Statement without the prior written consent of such Investor (provided that, in the event an Investor withholds such consent, the Company shall have no obligation hereunder to include any Registrable Securities of such Investor in any Registration Statement covering the resale thereof until such time as the SEC no longer requires such Investor to be named as an “underwriter” in such Registration Statement or such Investor otherwise consents in writing to being so named). Any cut-back imposed on the Investors pursuant to this Section 2(f) shall be allocated among the Investors on a pro rata basis and shall be applied first to any of the Registrable Securities of such Investor as such Investor shall designate, unless the SEC Restrictions otherwise require or provide or the Investors otherwise agree.
| 3. | RELATED COMPANY OBLIGATIONS. |
With respect to the Registration Statement and whenever any Registrable Securities are to be Registered pursuant to Section 2, including on the Initial Registration Statement or on any New Registration Statement, the Company shall use its reasonable best efforts to effect the registration of the Registrable Securities in accordance with the intended method of disposition thereof and, pursuant thereto, the Company shall have the following obligations:
(a) Notifications. The Company will promptly notify the Investors of the time when any subsequent amendment to the Initial Registration Statement or any New Registration Statement, other than documents incorporated by reference, has been filed with the SEC and/or has become effective or where a receipt has been issued therefor or any subsequent supplement to a Prospectus has been filed and of any request by the SEC for any amendment or supplement to the Registration Statement, any New Registration Statement or any Prospectus or for additional information.
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(b) Amendments. The Company will prepare and file with the SEC any amendments, post-effective amendments or supplements to the Initial Registration Statement, any New Registration Statement or any Prospectus, as applicable, that, (a) as may be necessary to keep such Registration Statement effective for the Registration Period and to comply with the provisions of the Securities Act and the Securities Exchange Act of 1934, as amended (the “Exchange Act”) with respect to the distribution of all of the Registrable Securities covered thereby, or (b) in the reasonable opinion of the Investors and the Company, as may be necessary or advisable in connection with any acquisition or sale of Registrable Securities by the Investors.
(c) Investor Review. The Company will not file any amendment or supplement to the Registration Statement, any New Registration Statement or any Prospectus, other than documents incorporated by reference, relating to the Investors, the Registrable Securities or the transactions contemplated hereby unless (A) the Investors and their counsel shall have been advised and afforded the opportunity to review and comment thereon at least three (3) Business Days prior to filing with the SEC and (B) the Company shall have given reasonable due consideration to any comments thereon received from the Investors or their counsel.
(d) Copies Available. The Company will furnish to any Investor whose Registrable Securities are included in any Registration Statement and its counsel copies of the Initial Registration Statement, any Prospectus thereunder (including all documents incorporated by reference therein), any Prospectus supplement thereunder, any New Registration Statement and all amendments to the Initial Registration Statement or any New Registration Statement that are filed with the SEC during the Registration Period (including all documents filed with or furnished to the SEC during such period that are deemed to be incorporated by reference therein), each letter written by or on behalf of the Company to the SEC or the staff of the SEC, and each item of correspondence from the SEC or the staff of the SEC, in each case relating to such Registration Statement (other than any portion thereof which contains information for which the Company has sought confidential treatment) and such other documents as Investor may reasonably request in order to facilitate the disposition of the Registrable Securities owned by Investor that are covered by such Registration Statement, in each case as soon as reasonably practicable upon such Investor’s request and in such quantities as such Investor may from time to time reasonably request; provided, however, that the Company shall not be required to furnish any document to the Investor to the extent such document is available on EDGAR.
(e) Notification of Stop Orders; Material Changes. The Company shall use commercially reasonable efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order as soon as practicable. The Company shall advise the Investors promptly (but in no event later than 24 hours) and shall confirm such advice in writing, in each case: (i) of the Company’s receipt of notice of any request by the SEC or any other federal or state governmental authority for amendment of or a supplement to the Registration Statement or any Prospectus or for any additional information; (ii) of the Company’s receipt of notice of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of the Initial Registration Statement or prohibiting or suspending the use of any Prospectus or Prospectus supplement, or any New Registration Statement, or of the Company’s receipt of any notification of the suspension of qualification of the Registrable Securities for offering or sale in any jurisdiction or the initiation or contemplated initiation of any proceeding for such purpose; and (iii) of the Company becoming aware of the happening of any event, which makes any statement of a material fact made in any Registration Statement or any Prospectus untrue or which requires the making of any additions to or changes to the statements then made in any Registration Statement or any Prospectus in order to state a material fact required by the Securities Act to be stated therein or necessary in order to make the statements then made therein (in the case of any Prospectus, in light of the circumstances under which they were made) not misleading, or of the necessity to amend any Registration Statement or any Prospectus to comply with the Securities Act or any other law. The Company shall not be required to disclose to the Investors the substance of specific reasons of any of the events set forth in clause (i) to (iii) of the immediately preceding sentence (each, a “Suspension Event”), but rather, shall only be required to disclose that the event has occurred. If at any time the SEC, or any other federal or state governmental authority shall issue any stop order suspending the effectiveness of any Registration Statement or prohibiting or suspending the use of any Prospectus or Prospectus supplement, the Company shall use its reasonable best efforts to obtain the withdrawal of such order at the earliest practicable time. The Company shall furnish to the Investors, without charge, a copy of any correspondence from the SEC or the staff of the SEC, or any other federal or state governmental authority to the Company or its representatives relating to the Initial Registration Statement, any New Registration Statement or any Prospectus, or Prospectus supplement as the case may be. In the event of a Suspension Event set forth in clause (iii) of the first sentence of this Section 3(e), the Company will use its commercially reasonable efforts to publicly disclose such event as soon as reasonably practicable, or otherwise resolve the matter such that sales under Registration Statements may resume; provided, however, that if the Company has a bona fide business purpose for not making such information public, the Company may suspend the use of all Registration Statements for up to 60 consecutive calendar days; provided, further, that the Company may not suspend the use of all Registration Statements more than twice, or for more than 90 total calendar days, in each case during any twelve-month period.
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(f) Confirmation of Effectiveness. If reasonably requested by an Investor at any time in respect of any Registration Statement, the Company shall deliver to such Investor a written confirmation (email being sufficient) from Company’s counsel of whether or not the effectiveness of such Registration Statement has lapsed at any time for any reason (including, without limitation, the issuance of a stop order) and whether or not such Registration Statement is currently effective and available to the Company for sale of Registrable Securities.
(g) Listing. The Company shall use best efforts to cause all Registrable Securities covered by a Registration Statement to be listed on the Nasdaq Global Select Market.
(h) Compliance. The Company shall otherwise use best efforts to comply with all applicable rules and regulations of the SEC under the Securities Act and the Exchange Act, including, without limitation, Rule 172 under the Securities Act, file any final prospectus, including any supplement or amendment thereof, with the SEC pursuant to Rule 424 under the Securities Act, promptly inform the Investor in writing if, at any time during the Registration Period, the Company does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Investor is required to deliver a prospectus in connection with any disposition of Registrable Securities and take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder, and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least 12 months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the Securities Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(h), “Availability Date” means the 45th day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the 90th day after the end of such fourth fiscal quarter).
(i) Blue-Sky. The Company shall register or qualify or cooperate with the Investor and their counsel in connection with the registration or qualification of such Registrable Securities for the offer and sale under the securities or blue sky laws of such jurisdictions reasonably requested by the Investor; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(i), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(i), or (iii) file a general consent to service of process in any such jurisdiction.
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(j) Rule 144. With a view to making available to the Investors the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investors to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep adequate current public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Registrable Securities may be sold without restriction by the holders thereof pursuant to Rule 144 or any other rule of similar effect or (B) such date as there are no longer Registrable Securities; and (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the Exchange Act; (iii) furnish electronically to each Investor upon request, as long as such Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the Exchange Act, (B) a copy of or electronic access to the Company’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, and (C) such other information as may be reasonably requested in order to avail such Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration.
(k) Cooperation. The Company shall cooperate with the holders of the Registrable Securities to facilitate the timely preparation and delivery of certificates or uncertificated shares representing the Registrable Securities to be sold pursuant to such Registration Statement or Rule 144 free of any restrictive legends and representing such number of shares of Common Stock and registered in such names as the holders of the Registrable Securities may reasonably request to the extent permitted by such Registration Statement or Rule 144 to effect sales of Registrable Securities; for the avoidance of doubt, the Company may satisfy its obligations hereunder without issuing physical stock certificates through the use of The Depository Trust Company’s Direct Registration System.
| 4. | OBLIGATIONS OF THE INVESTORS. |
(a) Investor Information. Each Investor shall provide a completed Investor Questionnaire in the form attached hereto as Exhibit B or such other form or information required by the Company in connection with the registration of the Registrable Securities. If the Company has not received such completed Questionnaire from an Investor within three Business Days of the Company’s request, the Company may file the Registration Statement without including such Investor’s Registrable Securities.
(b) Suspension of Sales. Each Investor, severally and not jointly with any other Investor, agrees that, upon receipt of any notice from the Company of the existence of an Allowed Delay or a Suspension Event as set forth in Section 3(e), the Investor will promptly discontinue disposition of Registrable Securities pursuant to any Registration Statement covering such Registrable Securities until the Investor's receipt of a notice from the Company confirming the resolution of such Allowed Delay or Suspension Event and that such dispositions may again be made; provided, for the avoidance of doubt, that the foregoing shall not limit the right of the Investor to sell or otherwise dispose of the Registrable Securities pursuant to Rule 144 or any other exemption from the registration requirements of the Securities Act or to settle a transaction pursuant to a Registration Statement as to which a contract for such sale was entered into prior to such Investor’s receipt of the notice from the Company of the existence of the Allowed Delay or Suspension Event. The Company shall cause its transfer agent to deliver unlegended shares of Common Stock to a transferee of an Investor in accordance with any sale of Registrable Securities pursuant to a Registration Statement with respect to which such Investor has entered into a contract for sale prior to such Investor’s receipt of the notice from the Company of the existence of the Allowed Delay or Suspension Event.
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(c) Investor Cooperation. Each Investor, severally and not jointly with any other Investor, agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of any amendments and supplements to any Registration Statement or New Registration Statement hereunder, unless such Investor has notified the Company in writing of its election to exclude all of its Registrable Securities from such Registration Statement.
| 5. | EXPENSES OF REGISTRATION. |
All Registration Expenses incurred in connection with registrations pursuant to this Agreement shall be borne by the Company. All Selling Expenses relating to securities registered on behalf of an Investor shall be borne by such Investor.
| 6. | INDEMNIFICATION. |
(a) To the fullest extent permitted by law, the Company will, and hereby does, indemnify, hold harmless and defend the Investors, each Person, if any, who controls the Investors, the members, the directors, officers, partners, employees, members, managers, agents, representatives and advisors of the Investors and each Person, if any, who controls the Investors within the meaning of the Securities Act or the Exchange Act (each, an “Indemnified Person”), against any losses, obligation, claims, damages, liabilities, contingencies, judgments, fines, penalties, charges, costs (including, without limitation, court costs and costs of preparation), reasonable and documented attorneys’ fees, amounts paid in settlement or reasonable and documented expenses, (collectively, “Claims”) reasonably incurred in investigating, preparing or defending any action, claim, suit, inquiry, proceeding, investigation or appeal taken from the foregoing by or before any court or governmental, administrative or other regulatory agency or body or the SEC, whether pending or threatened, whether or not an indemnified party is or may be a party thereto (“Indemnified Damages”), to which any of them may become subject insofar as such Claims (or actions or proceedings, whether commenced or threatened, in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement or omission or alleged omission of any material fact contained in any Registration Statement, any preliminary prospectus or final prospectus, or any amendment or supplement thereof, or (ii) any violation or alleged violation by the Company or any of its Subsidiaries of the Securities Act, Exchange Act or any other state securities or other “blue sky” laws of any jurisdiction in which Registrable Securities are offered or any rule or regulation promulgated thereunder applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration of the Registrable Securities (the matters in the foregoing clauses (i) and (ii) being, collectively, “Violations”). The Company shall reimburse each Indemnified Person promptly as such expenses are incurred and are due and payable, for any reasonable out-of-pocket legal fees or other reasonable and documented expenses incurred by them in connection with investigating or defending any such Claim. Notwithstanding anything to the contrary contained herein, the indemnification agreement contained in this Section 6(a): (A) shall not apply to a Claim by an Indemnified Person arising out of or based upon a Violation which occurs in reliance upon and in conformity with information furnished in writing to the Company by the Investors or such Indemnified Person specifically for use in such Registration Statement or prospectus and was reviewed and approved in writing by such Investor or such Indemnified Person expressly for use in connection with the preparation of any Registration Statement, any prospectus or any such amendment thereof or supplement thereto, if such in each case if the foregoing was timely made available by the Company; (B) with respect to any superseded prospectus, shall not inure to the benefit of any such Person from whom the Person asserting any such Claim purchased the Registrable Securities that are the subject thereof (or to the benefit of any other Indemnified Person) if the untrue statement or omission of material fact contained in the superseded prospectus was corrected in the revised prospectus, as then amended or supplemented, and the Indemnified Person was promptly advised in writing not to use the outdated, defective or incorrect prospectus prior to the use giving rise to a Violation; (C) shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the prior written consent of the Company, which consent shall not be unreasonably withheld, conditioned or delayed. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of the Indemnified Person and shall survive the transfer of the Registrable Securities by the Investor pursuant to Section 8.
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(b) In connection with the Initial Registration Statement, any New Registration Statement or any Prospectus, the Investors, severally and not jointly, agree to indemnify, hold harmless and defend, the Company, each of its directors, each of its officers who signed the Initial Registration Statement or signs any New Registration Statement, each Person, if any, who controls the Company within the meaning of the Securities Act or the Exchange Act (each, an “Indemnified Party”), against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any Violation, in each case to the extent, and only to the extent, that such Violation occurs in reliance upon and in conformity with information about an Investor furnished in writing by such Investor to the Company and reviewed and approved in writing by such Investor or such Indemnified Person expressly for use in connection with the preparation of the Registration Statement, any New Registration Statement, any prospectus or any such amendment thereof or supplement thereto. In no event shall the liability of an Investor be greater in amount than the dollar amount of the proceeds (net of all expense paid by such Investor in connection with any claim relating to this Section 6 and the amount of any damages such Investor has otherwise been required to pay by reason of such untrue statement or omission) received by such Investor upon the sale of the Registrable Securities included in such Registration Statement giving rise to such indemnification obligation. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such Indemnified Party and shall survive the transfer of the Registrable Securities by any Investor pursuant to Section 8.
(c) Promptly after receipt by an Indemnified Person or Indemnified Party under this Section 6 of notice of the commencement of any action or proceeding (including any governmental action or proceeding) involving a Claim, such Indemnified Person or Indemnified Party shall, if a Claim in respect thereof is to be made against any indemnifying party under this Section 6, deliver to the indemnifying party a written notice of the commencement thereof, and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume control of the defense thereof with counsel mutually satisfactory to the indemnifying party and the Indemnified Person or the Indemnified Party, as the case may be, and upon such notice, the indemnifying party shall not be liable to the Indemnified Person or the Indemnified Party for any legal or other expenses subsequently incurred by the Indemnified Person or the Indemnified Party in connection with the defense thereof; provided, however, that an Indemnified Person or Indemnified Party (together with all other Indemnified Persons and Indemnified Parties that may be represented without conflict by one counsel) shall have the right to retain its own counsel with the reasonable fees and expenses to be paid by the indemnifying party, if, in the reasonable opinion of counsel retained by the indemnifying party, the representation by such counsel of the Indemnified Person or Indemnified Party and the indemnifying party would be inappropriate due to actual or potential differing interests between such Indemnified Person or Indemnified Party and any other party represented by such counsel in such proceeding. The Indemnified Party or Indemnified Person shall cooperate with the indemnifying party in connection with any negotiation or defense of any such action or claim by the indemnifying party and shall furnish to the indemnifying party all information reasonably available to the Indemnified Party or Indemnified Person which relates to such action or claim. The indemnifying party shall keep the Indemnified Party or Indemnified Person fully apprised as to the status of the defense or any settlement negotiations with respect thereto. No indemnifying party shall be liable for any settlement of any action, claim or proceeding effected without its written consent, provided, however, that the indemnifying party shall not unreasonably withhold, delay or condition its consent. No indemnifying party shall, without the consent of the Indemnified Party or Indemnified Person, consent to entry of any judgment or enter into any settlement or other compromise unless such judgment or settlement (i) imposes no liability or obligation on, (ii) includes as an unconditional term thereof the giving of a complete, explicit and unconditional release from the party bringing such indemnified claims of all liability of the Indemnified Party or Indemnified Person in respect to or arising out of such claim or litigation in favor of, and (iii) does not include any admission of fault, culpability, wrongdoing, or wrongdoing or malfeasance by or on behalf of, the Indemnified Party or Indemnified Person. Following indemnification as provided for hereunder, the indemnifying party shall be subrogated to all rights of the Indemnified Party or Indemnified Person with respect to all third parties, firms or corporations relating to the matter for which indemnification has been made. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action shall not relieve such indemnifying party of any liability to the Indemnified Person or Indemnified Party under this Section 6, except to the extent that the indemnifying party is prejudiced in its ability to defend such action.
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(d) The indemnification required by this Section 6 shall be made by periodic payments of the amount thereof during the course of the investigation or defense, as and when bills are received or Indemnified Damages are incurred. Any Person receiving a payment pursuant to this Section 6 which person is later determined to not be entitled to such payment shall return such payment (including reimbursement of expenses) to the person making it.
(e) The indemnity agreements contained herein shall be in addition to (i) any cause of action or similar right of the Indemnified Party or Indemnified Person against the indemnifying party or others, and (ii) any liabilities the indemnifying party may be subject to pursuant to the law.
| 7. | CONTRIBUTION. |
To the extent any indemnification by an indemnifying party is prohibited or limited by law, the indemnifying party agrees to make the maximum contribution with respect to any amounts for which it would otherwise be liable under Section 6 to the fullest extent permitted by law; provided, however, that: (i) no seller of Registrable Securities guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any seller of Registrable Securities who was not guilty of fraudulent misrepresentation; and (ii) contribution by any seller of Registrable Securities shall be limited in amount to the net amount of proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 7 and the amount of any damages such holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by such seller from the sale of such Registrable Securities giving rise to such contribution obligation.
| 8. | ASSIGNMENT OF REGISTRATION RIGHTS. |
The Company shall not assign this Agreement or any rights or obligations hereunder (whether by operation of law or otherwise) without the prior written consent of the Required Investors; provided, however, that in any transaction, whether by merger, reorganization, restructuring, consolidation, financing or otherwise, whereby the Company is a party and in which the Registrable Securities are converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Registrable Securities” shall be deemed to include the securities received by the Investor in connection with such transaction unless such securities are otherwise freely tradable by the Investor after giving effect to such transaction, and the prior written consent of the Required Investors shall not be required for such transaction.
10
An Investor may transfer or assign its rights hereunder, in whole or from time to time in part, to one or more Persons in connection with the transfer of Registrable Securities (including Registrable Securities issuable upon exercise of Warrants) by such Investor to such Person, provided that such Investor complies with all laws applicable thereto, and the provisions of the Purchase Agreement, and provides written notice of assignment to the Company promptly after such assignment is effected, and such Person agrees in writing to be bound by all of the provisions contained herein.
The provisions of this Agreement shall be binding upon and inure to the benefit of the Investor and its successors and permitted assigns.
| 9. | AMENDMENTS AND WAIVERS. |
The provisions of this Agreement, including the provisions of this sentence, may be amended, modified or supplemented, or waived only by a written instrument executed by (i) the Company and (ii) the Required Investors, provided that (1) any party may give a waiver as to itself, (2) any amendment, modification, supplement or waiver that disproportionately and adversely affects the rights and obligations of any Investor relative to the comparable rights and obligations of the other Investors shall require the prior written consent of such adversely affected Investor or each Investor, as applicable, and (3) any amendments to Section 6 or to the definitions of “Filing Deadline,” “Effectiveness Deadline,” or “Registration Period” shall require the written consent of each Investor. Notwithstanding the foregoing, a waiver or consent to depart from the provisions hereof with respect to a matter that relates exclusively to the rights of one or more Investors and that does not adversely directly or indirectly affect the rights of other Investors may be given by Investors holding all of the Registrable Securities to which such waiver or consent relates.
| 10. | MISCELLANEOUS. |
(a) Notices. Any notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to be given (a) when delivered if personally delivered to the party for whom it is intended, (b) when delivered, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next business day, (c) three days after having been sent by certified or registered mail, return-receipt requested and postage prepaid, or (d) one business day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt:
i. If to the Company, addressed as follows:
Zenas BioPharma, Inc.
852 Winter Street, Suite 250
Waltham, MA 02451
Attention: Jeff Held, Chief Legal Officer
Email: jeff.held@zenasbio.com
with a copy (which shall not constitute notice):
Ropes & Gray LLP
Prudential Tower
800 Boylston Street
Boston, MA 02199
Attention: Thomas Danielski
Email: thomas.danielski@ropesgray.com
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ii. If to any Investor, at its e-mail address or address set forth on its signature page to the Purchase Agreement or to such e-mail address, or address as subsequently modified by written notice given in accordance with this Section 10.
Any Person may change the address to which notices and communications to it are to be addressed by notification as provided for herein.
(b) Consent to Electronic Notice. Each Investor consents to the delivery of any stockholder notice pursuant to this Agreement at the e-mail address set forth below the Investor’s name on its signature page to the Purchase Agreement, as updated from time to time by notice to the Company. To the extent that any notice given by means of electronic mail is returned or undeliverable for any reason, the foregoing consent shall be deemed to have been revoked until a new or corrected e-mail address has been provided, and such attempted electronic notice shall be ineffective and deemed to not have been given. Each party agrees to promptly notify the other parties of any change in its e-mail address, and that failure to do so shall not affect the foregoing.
(c) Waiver. No waiver of any term, provision or condition of this Agreement, whether by conduct or otherwise, in any one or more instances, shall be deemed to be, or be construed as, a further or continuing waiver of any such term, provision or condition or as a waiver of any other term, provision or condition of this Agreement.
(d) Governing Law. The provisions of Section 8.6 of the Purchase Agreement are incorporated by reference herein mutatis mutandis.
(e) Headings. The titles, subtitles and headings in this Agreement are for convenience of reference and shall not form part of, or affect the interpretation of, this Agreement.
(f) Counterparts. This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party; provided that a facsimile or pdf signature including any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com shall be considered due execution and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or pdf (or other electronic reproduction of a) signature.
(g) Further Assurances. Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
(h) Contract Interpretation. This Agreement is the joint product of each Investor and the Company and each provision hereof has been subject to the mutual consultation, negotiation and agreement of such parties and shall not be construed for or against any party hereto.
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(i) No Third Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the parties to this Agreement any rights, remedies, claims, benefits, obligations or liabilities under or by reason of this Agreement, and no Person that is not a party to this Agreement (including, without limitation, any partner, member, shareholder, director, officer, employee or other beneficial owner of any party to this Agreement, in its own capacity as such or in bringing a derivative action on behalf of a party to this Agreement) shall have any standing as a third party beneficiary with respect to this Agreement or the transactions contemplated hereby.
(j) Severability. If any part or provision of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction, the invalid or unenforceable part or provisions shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the parties hereto.
(k) Non-Recourse. Notwithstanding anything that may be expressed or implied in this Agreement, the Company covenants, agrees and acknowledges that no recourse under this Agreement or any documents or instruments delivered in connection with this Agreement shall be had against any current or future director, officer, employee, stockholder, general or limited partner or member of the Investors or of any affiliates or assignees thereof, whether by the enforcement of any assessment or by any legal or equitable proceeding, or by virtue of any statute, regulation or other applicable law, it being expressly agreed and acknowledged that no personal liability whatsoever shall attach to, be imposed on or otherwise be incurred by any current or future director, officer, employee, stockholder, general or limited partner or member of the Investors or of any affiliates or assignees thereof, as such for any obligation of the Investors under this Agreement or any documents or instruments delivered in connection with this Agreement for any claim based on, in respect of or by reason of such obligations or their creation.
(l) Specific Performance. In addition to any and all other remedies that may be available at law in the event of any breach of this Agreement, each Investor shall be entitled to specific performance of the agreements and obligations of the Company hereunder and to such other injunction or other equitable relief as may be granted by a court of competent jurisdiction.
(m) Cumulative Remedies. The remedies provided herein are cumulative and not exclusive of any remedies provided by law.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
| COMPANY: | ||
| ZENAS BIOPHARMA, INC. | ||
| By: | ||
| Name: | ||
| Title: | ||
[Signature Page to Registration Rights Agreement]
IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
| INVESTOR: | ||
| [NAME] | ||
| By: | ||
| Name: | ||
| Title: | ||
[Signature Page to Registration Rights Agreement]
Exhibit A
PLAN OF DISTRIBUTION
The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:
| • | distributions to members, partners, stockholders or other equityholders of the selling stockholders; |
| • | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| • | block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction; |
| • | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| • | an exchange distribution in accordance with the rules of the applicable exchange; |
| • | privately negotiated transactions; |
| • | short sales and settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
| • | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| • | broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; |
| • | a combination of any such methods of sale; and |
| • | any other method permitted pursuant to applicable law. |
The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling stockholders for purposes of this prospectus.
1
In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering.
The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule, or another available exemption from the registration requirements under the Securities Act.
The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act (it being understood that the selling stockholders shall not be deemed to be underwriters solely as a result of their participation in this offering). Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(a)(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agent, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.
In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.
2
We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, to the extent applicable, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.
We have agreed with the selling stockholders to use commercially reasonable efforts to cause the registration statement of which this prospectus constitutes a part to become effective and to remain continuously effective until the earlier of: (i) the date on which the selling stockholders shall have resold or otherwise disposed of all the shares covered by this prospectus and (ii) the date on which the shares covered by this prospectus no longer constitute “Registrable Securities” as such term is defined in the Registration Rights Agreement, such that they may be resold by the selling stockholders without registration and without regard to any volume or manner-of-sale limitations and without current public information pursuant to Rule 144 under the Securities Act or any other rule of similar effect.
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Exhibit B
Investor Questionnaire
The undersigned hereby provides the following information to the Company and represents and warrants that such information is accurate:
QUESTIONNAIRE
| 1. | Name. |
| (a) | Full Legal Name of Investor |
| (b) | Full Legal Name of Registered Holder (if not the same as (a) above) through which Registrable Securities are held: |
| (c) | Full Legal Name of Natural Control Person (which means a natural person who directly or indirectly alone or with others has power to vote or dispose of the securities covered by this Questionnaire): |
2. Address for Notices to Investor:
| Telephone: | ||
| E-Mail: | ||
| Contact Person: |
4
3. Broker-Dealer Status:
| (a) | Are you a broker-dealer? |
Yes ¨ No ¨
| (b) | If “yes” to Section 3(a), did you receive your Registrable Securities as compensation for investment banking services to the Company? |
Yes ¨ No ¨
| Note: | If “no” to Section 3(b), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement. |
| (c) | Are you an affiliate of a broker-dealer? |
Yes ¨ No ¨
| (d) | If you are an affiliate of a broker-dealer, do you certify that you purchased the Registrable Securities in the ordinary course of business, and at the time of the purchase of the Registrable Securities to be resold, you had no agreements or understandings, directly or indirectly, with any person to distribute the Registrable Securities? |
Yes ¨ No ¨
| Note: | If “no” to Section 3(d), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement. |
4. Beneficial Ownership of Securities of the Company Owned by the Investor.
Except as set forth below in this Item 4, the undersigned is not the beneficial or registered owner of any securities of the Company other than the securities issuable pursuant to the Purchase Agreement.
| (a) | Type and Amount of other securities beneficially owned by the Investor: |
5
5. Relationships with the Company:
Except as set forth below, neither the undersigned nor any of its affiliates, officers, directors or principal equity holders (owners of 5% of more of the equity securities of the undersigned) has held any position or office or has had any other material relationship with the Company (or its predecessors or affiliates) during the past three years.
State any exceptions here:
The undersigned agrees to promptly notify the Company of any material inaccuracies or changes in the information provided herein that may occur subsequent to the date hereof at any time while the Registration Statement remains effective; provided, that the undersigned shall not be required to notify the Company of any changes to the number of securities held or owned by the undersigned or its affiliates.
By signing below, the undersigned consents to the disclosure of the information contained herein in its answers to Items 1 through 5 and the inclusion of such information in the Registration Statement and the related prospectus and any amendments or supplements thereto. The undersigned understands that such information will be relied upon by the Company in connection with the preparation or amendment of the Registration Statement and the related prospectus and any amendments or supplements thereto.
IN WITNESS WHEREOF the undersigned, by authority duly given, has caused this Notice and Questionnaire to be executed and delivered either in person or by its duly authorized agent.
| Date: | Beneficial Owner: |
| By: | ||
| Name: | ||
| Title: | ||
PLEASE EMAIL A .PDF COPY OF THE COMPLETED AND EXECUTED QUESTIONNAIRE TO: chase.jayasekera@zenasbio.com
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Exhibit 99.1
 |  |
Zenas BioPharma and InnoCare Pharma Announce License Agreement Granting Zenas Rights for Three Autoimmune Product Candidates, Including Orelabrutinib, a BTK Inhibitor in Phase 3 Development for Multiple Sclerosis
- Orelabrutinib, a highly selective CNS-penetrant, oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with best-in-class potential now in Phase 3 development for progressive forms of Multiple Sclerosis (MS) -
- Pivotal Phase 3 clinical trial evaluating orelabrutinib in patients with Primary Progressive MS (PPMS) initiated; Pivotal Phase 3 clinical trial in patients with Secondary Progressive MS (SPMS) expected to initiate in 1Q 2026 -
- A novel oral IL-17AA/AF inhibitor, and an oral, brain-penetrant, TYK2 inhibitor, expected to begin Phase 1 clinical trials in 2026 -
- Zenas also announces $120.0 million private placement financing -
- Zenas to host a conference call today, October 8, 2025, at 8:00 a.m. ET -
- InnoCare to host a conference call on October 9, 2025, at 8:30 a.m. Beijing time -
WALTHAM, Mass. and Beijing, October 8, 2025 (GLOBE NEWSWIRE) – Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO) and InnoCare Pharma Limited (“InnoCare” or “InnoCare Pharma”) (HKEX: 09969; SSE: 688428) today announced a transformational license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis (MS) and across all therapeutic areas other than oncology. Zenas also secured rights to a novel, oral, IL-17AA/AF inhibitor, and an oral, brain-penetrant, TYK2 inhibitor.
Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor with the potential to address compartmentalized inflammation and disease progression in MS. A global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of orelabrutinib dosed 80 mg once daily (QD) in patients with Primary Progressive MS (PPMS) has been initiated. Zenas plans to initiate a second global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating orelabrutinib in patients with Secondary Progressive MS (SPMS) in the first quarter of 2026.
In a previously completed global Phase 2 clinical trial in patients with Relapsing-Remitting MS (RRMS), orelabrutinib demonstrated significant reductions in new Gd+ T1 lesions versus placebo at weeks 12 and 24, with sustained reductions in inflammatory activity through week 96 as demonstrated by meaningful impact on endpoints indicative of disease progression. The safety and tolerability profile of orelabrutinib is consistent with other BTK inhibitors in development for MS and is well characterized across multiple prior autoimmune disease and hematologic cancer trials.
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“InnoCare is a globally recognized company with a successful track record of drug discovery, development and commercialization. This transformative collaboration with InnoCare further positions Zenas to execute on its vision to become a global, fully integrated development and commercial-stage autoimmune-focused biopharmaceutical company. With global rights to orelabrutinib, we are advancing a potential blockbuster franchise for progressive MS. Orelabrutinib, with its best-in-class potential, is strongly positioned to address disease progression independent of relapse activity, the highest unmet medical need in MS, and to improve the lives of patients living with progressive MS. We are also excited to add two potentially best-in-class molecules, a novel, oral, IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor, to our pipeline. We plan to advance each of these programs to human clinical trials in 2026 and expect to have initial patient data from the oral IL-17AA/AF clinical program in 2027,” said Lonnie Moulder, Founder and Chief Executive Officer (CEO) of Zenas.
“We are delighted to partner with Zenas BioPharma. The partnership with Zenas BioPharma represents a significant milestone in our journey, and we will continue to enhance and advance our globalization efforts in the future,” said Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare Pharma. “Orelabrutinib has a differentiated mechanism of action and strong clinical data underscoring its promising potential as a treatment for patients with progressive forms of MS. We are confident in Zenas’ management team given their exceptional track record of successful drug development, global regulatory approvals and commercial launches, and their commitment to driving innovation for autoimmune diseases.”
Mr. Moulder continued, “With this transaction, we have established a balanced portfolio of complementary mechanisms and modalities with best-in-class blockbuster potential across multiple therapeutic areas. With our two franchise programs, obexelimab concluding Phase 3 development for IgG4-RD, and now orelabrutinib for progressive forms of MS, Zenas is well positioned to meaningfully impact the lives of patients living with autoimmune diseases. We are prioritizing the tremendous opportunity ahead with orelabrutinib in PPMS and SPMS. We expect to report obexelimab topline 12-week primary endpoint results from the Phase 2 MoonStone trial in patients with RMS early in the fourth quarter of 2025 and 24-week data in the first quarter of 2026. We anticipate making a program decision based on these data and the evolving landscape for the development of new therapies for RMS in early 2026.”
“This strategic collaboration will leverage our shared focus to accelerate the development of orelabrutinib and help maximize its clinical and commercial potential on a global scale, particularly in MS,” added Dr. Cui, “Given the statistically significant and clinically meaningful data from the Phase 2 trial, and promising blood-brain barrier penetration capability, orelabrutinib has the potential to transform the treatment paradigm for this devastating disease. In addition to orelabrutinib, we have fortified our powerful discovery engine to focus on cutting-edge targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet medical needs and strong market potential in China and worldwide.”
“BTK inhibition is a validated mechanism for the treatment of progressive forms of MS, and there is immense scientific interest in its potential to impact inflammation compartmentalized in the CNS and thereby potentially impact disability progression independent of relapse activity. We believe the differentiated, potentially best-in-class profile of orelabrutinib could make a meaningful difference for patients with PPMS and SPMS, which have few treatment options. With our late-stage development capabilities and expertise in MS, we are well positioned to execute on the pivotal, global, Phase 3 development of orelabrutinib, as well as advance two early candidates into clinical development,” said Lisa von Moltke, M.D., Head of Research and Development and Chief Medical Officer of Zenas.
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Pipeline Overview
Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function
| · | Immunoglobulin G4-Related Disease (IgG4-RD) Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025. |
| · | Relapsing Multiple Sclerosis (RMS) Phase 2 MoonStone trial, a multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with RMS. Zenas expects to report results from this trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025. |
| · | Systemic Lupus Erythematosus (SLE) Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas expects to complete enrollment of the Phase 2 SunStone trial around year-end 2025 and report topline results in mid-2026. |
Orelabrutinib, a highly selective CNS-penetrant, oral, small molecule BTK inhibitor
| · | PPMS Phase 3 trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of orelabrutinib for patients with PPMS initiated in the third quarter of 2025. |
| · | SPMS Phase 3 trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of orelabrutinib for patients with SPMS is expected to initiate in the first quarter of 2026. |
Oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and IL-17AF heterodimer signaling
| · | Currently in Investigational New Drug (IND) enabling studies. Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026. |
Oral, brain-penetrant, TYK2 inhibitor
| · | Currently in IND enabling studies. Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026. |
License Agreement
Under the license agreement, Zenas will pay InnoCare upfront and near-term milestone payments of up to $100 million in cash, including milestone achievements expected in 2026, and up to 7,000,000 shares of Zenas common stock, including shares issuable upon a milestone expected to be achieved in early 2026. The total of the upfront payment, near term milestone and potential development and regulatory milestone payments, along with potential commercial sales achievement milestone payments for all three programs, exceeds $2 billion.
In addition, InnoCare is entitled to receive tiered royalties of up to high teens percentages on annual net sales of the licensed products.
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Zenas will have the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of MS globally, and non-oncology fields in all territories outside Greater China and Southeast Asia, while InnoCare retains full global rights in the field of oncology. Zenas will also have the exclusive right to develop, manufacture and commercialize the oral, IL-17AA/AF inhibitor in all territories outside Greater China and Southeast Asia, and the oral, brain-penetrant, TYK2 inhibitor globally.
Private Placement Financing
Zenas has entered into a securities purchase agreement for a private placement financing of shares of its common stock (the "Private Placement"). The Private Placement is expected to result in gross proceeds to Zenas of approximately $120.0 million, before deducting placement agent fees and other Private Placement expenses payable by Zenas.
Pursuant to the terms of the securities purchase agreement, at the closing of the Private Placement, Zenas will issue approximately 6.3 million shares of its common stock to (i) certain institutional and accredited investors at a price of $19.00 per share and (ii) certain directors and officers of the Company at a price of $20.85 per share. The closing of the Private Placement is expected to occur on or about October 9, 2025, subject to the satisfaction of customary closing conditions.
Jefferies and Evercore ISI served as exclusive placement agents for the Private Placement.
The Private Placement included participation from a syndicate of new and existing investors, including mutual funds and healthcare dedicated funds.
Upon closing of the Private Placement, Zenas expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026, and assuming receipt of the potential $75 million milestone from Royalty Pharma for the defined success criteria in the Phase 3 INDIGO trial, into the first quarter of 2027.
The sale and issuance of the foregoing shares are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). The shares being issued in the Private Placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. Zenas has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares acquired by the investors in the Private Placement.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the shares under the resale registration statement will only be by means of a prospectus.
Conference Call Information
Zenas BioPharma will host a conference call and webcast today, October 8, 2025, at 8:00 a.m. ET to discuss the transformational license agreement and to provide an update on the Company’s business and strategy. To access the live webcast of the call, please visit the “Events and Presentations” page in the Investor & Media Relations section of the Zenas BioPharma website. A replay of the webcast will be available following the call.
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InnoCare will host a conference call at 8:30 a.m. Beijing time on October 9, 2025, in Chinese. To access the conference call, please register in advance through the link: https://s.comein.cn/fufgvbun.
About Orelabrutinib
Orelabrutinib is a late-stage, potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. In Multiple Sclerosis (MS), InnoCare initiated a Phase 3 trial for Primary Progressive MS (PPMS) in the third quarter of 2025. A Phase 3 trial for Secondary Progressive MS (SPMS) is expected to initiate in the first quarter of 2026. The Phase 3 PPMS and SPMS trials have obtained U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) alignment. Orelabrutinib is approved for B cell malignancies in mainland China and Singapore.
About
Obexelimab
Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across
B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism
of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of the B cell
lineage in chronic autoimmune disease.
Obexelimab has been evaluated in six clinical trials in a total of 208 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials, providing the Company with an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases. Zenas is conducting a fully enrolled Phase 3 trial in Immunoglobulin G4-Related Disease and Phase 2 trials for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus.
About Zenas BioPharma, Inc.
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
About InnoCare Pharma
InnoCare (SSE: 688428; HKEX: 09969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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InnoCare has established a comprehensive platform with strong in-house innovation capabilities focused on liquid and solid cancers as well as autoimmune diseases. To date, the company has developed a robust product pipeline comprising two approved drugs, more than ten innovative drug candidates in clinical development, and multiple programs in preclinical and IND-enabling stages. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.
Zenas BioPharma Forward-Looking Statements
This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning Zenas’s milestones, expectations and intentions, including milestones under the license agreement, timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, the timing of reporting the 12-week and 24-week topline results from the MoonStone trial, the timing of the completion of enrollment and reporting the topline results from the SunStone trial, the timing of initiation of the Phase 3 clinical trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of two preclinical assets, the timing of initial patient data from the first preclinical asset; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib’s potential as a blockbuster franchise for progressive MS; expansion of the Zenas pipeline; the Company’s cash runway; and the expected closing of the Private Placement. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; the risk that the conditions to closing of the Private Placement are not satisfied; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies.
InnoCare Pharma Forward-Looking Statements
This release contains certain forward-looking statements. All statements, other than statements of fact, could be considered forward-looking statements, meaning statements regarding actions, events, or developments that we or our management intend, expect, project, believe, or anticipate will or may occur in the future. These statements are based on assumptions and estimates made by our management in light of their experience and perception of historical trends, current conditions, expected future developments, and other relevant factors. Forward-looking statements are not guarantees of future performance, and actual results, developments, and business decisions may differ materially from those contemplated by these forward-looking statements. Our forward-looking statements are subject to a number of risks and uncertainties that could affect our near- and long-term performance.
Zenas BioPharma Investor and Media Contact:
Argot Partners
Zenas@argotpartners.com
InnoCare Investor Contact:
Bonnie Yuan
86-10-66609999
IR@innocarepharma.com
InnoCare Media Contact:
Chunhua Lu
86-10-66609879
chunhua.lu@innocarepharma.com
Exhibit 99.2
1 Transformational Global Collaboration With InnoCare Pharma Conference Call October 8, 2025
2 Disclaimer FORWARD - LOOKING STATEMENTS: This presentation contains “forward - looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of Zenas BioPharma, Inc. (the “ Company” or “Zenas”), which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this presentation are forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward - looking statements contain these words. Forward - looking statements include statements concerning Zenas’s plans, objectives, expectations and intentions; its future financial or business performance; the timing and results of ongoing and future clinical trials and potential regulatory approval and commercialization, including timing of results and data from clinical trials, including the INDIGO trial, and if successful, the timing of BLA submission, potential approval and commercial launch, the 12 - week and 24 - week topline results from the MoonStone trial, the completion of enrollment and reporting the topline results from the SunStone trial, and if successful, the timing of initiating the Phase 3 trial in SLE, the timing of initiati on of the Phase 3 trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of ZB021 and ZB022; its ability to identify strategic partners f or its pipeline programs; the potential commercial opportunities for its product candidates; the potential competition for its product candidates; the potential commercial attributes for its product candidates; the Company ’s cash guidance; and the Company’s license agreement with InnoCare and achievement of payment triggering milestones. The forward - looking statements in this presentation speak only as of the date of t his presentation and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in th e f orward - looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial a nd increasing losses for the foreseeable future; and the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy an d e xpensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s curr ent product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side ef fects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consumma te future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may b e f or a more narrow indication than the Company seeks; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report for the quarter ended June 30, 2025, and subsequent reports filed with the Securities and Exchange Commission (SEC). The forward - looking statements in this presentation are inherently uncertain, speak only as of the date of this presentation, ma y prove incorrect and are not guarantees of future events. These statements are based upon information available to the Company as of the date of this presentation and while the Company believes such infor mat ion forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inqu iry into, or review of, all potentially available relevant information. Because forward - looking statements are inherently subject to risks and uncertainties , some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward - looking statements. The events and circumstances reflected in the forward - looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward - looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. MARKET AND INDUSTRY DATA: Unless otherwise indicated, market and industry data contained in this presentation, including potential commercial opportuni tie s, is based on the Company’s management’s estimates and research, as well as industry and general publications and research and studies conducted by third parties. Alt hou gh the Company believes that the information from these third - party publications, research and studies included in this presentation is reliable, the Company has not independently verified the acc uracy or completeness of this information. Management’s estimates are derived from publicly available information, their knowledge of the Company’s industry and their assumptions based on such informatio n a nd knowledge, which the Company believes to be reasonable. This data involves a number of assumptions and limitations and the industry in which the Company operates is subject to a high degree o f u ncertainty and risk due to a variety of factors. TRADEMARKS: This presentation may include references to the Company’s trademarks and trademarks belonging to other entities. The Zenas Bi oPh arma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. Solely for convenience, some of the trademarks and trade na mes referred to in this presentation, including logos, artwork and other visual displays, may be listed without the ® or symbols, but such references are not intended to indicate in any way that Zenas will not assert, to the fullest extent under ap plicable law, Zenas’s rights or the rights of the applicable licensor to these trademarks and trade names. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale o f t hese securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdictio n .
3 Today’s agenda and speakers Lonnie Moulder CEO & Chairman Joe Farmer President & COO Jennifer Fox CFO & CBO Lisa von Moltke, M.D. Head of R&D & CMO Haley Laken, Ph.D. CSO 1. Transaction overview and financial support 2. BTKi and progressive forms of MS 4. Oral IL - 17AA/AF and brain - penetrant TYK2 programs 7. Q&A BTKi = Bruton’s Tyrosine Kinase inhibitor 3. Orelabrutinib, a potentially best - in - class BTKi 5. Obexelimab development updates 6. Summary
4 Transformative InnoCare Collaboration Agreement
5 Collaboration agreement with InnoCare, an established, globally recognized, fully - integrated, biopharmaceutical company • $ 35 million cash, 5 million shares of Zenas common stock issued upfront and: » Orelabrutinib: up to an additional 2 million shares of Zenas stock and up to $240 million in development and regulatory miles ton e payments across major territories, as well as commercial sales milestone payments and tiered royalties on net sales » IL - 17AA/AF program: development and regulatory milestone payments, as well as commercial sales milestone payments and tiered royalties on net sales » TYK2 program: development and regulatory milestone payments, as well as commercial sales milestone payments and tiered royalties on net sales • Transaction closed on October 7, 2025, Eastern Standard Time InnoCare Pharma: Market cap >$4.5B USD; two marketed products; >10 candidates in clinical development Orelabrutinib and ZB022 rights: Global; ZB021 rights: Global excluding China and Southeast Asia ; InnoCare retains global rights to orelabrutinib in oncology indications; InnoCare listed on HKEX, Market Cap 36.61B HKD as of 10 /2/2025; InnoCare products marketed in China and Singapore; ITP = Immune Thrombocytopenia; SLE = Systemic Lupus Erythematosus; RRMS = Relapsing Remitting MS; PPMS= Primary Progressive MS SPMS= Secondary Progressive MS Development and commercialization rights for 3 autoimmune programs InnoCare Pharma to receive: • Orelabrutinib: highly selective CNS - penetrant BTK inhibitor with best - in - class potential supported by strong Phase 2 RMS data » Phase 3 PPMS registration - directed trial initiated in U.S.; Phase 3 SPMS registration - directed trial expected to initiate in 1Q2 6 ▪ Positive Phase 3 data for a peer BTKi program in SPMS validates BTK as a target for progressive MS ▪ Approved for B cell malignancies in China; second most prescribed BTKi in China • ZB021, an oral IL - 17AA/AF inhibitor: IND clearance and enrollment of first patient expected in 2026 • ZB022, a brain penetrant TYK2 inhibitor: IND clearance and enrollment of first patient expected in 2026
6 Transaction expected to accelerate Zenas’ goal to become a multi - franchise, global, fully - integrated, commercial - stage biopharmaceutical company □ Two late - stage franchise programs for four I&I indications □ Global development and commercialization capabilities □ Two early - stage programs with best - in - class potential Potential approval of three 1 best - in - class franchise molecules across five indications in three therapeutic areas » Rheumatology » Multiple Sclerosis » Dermatology □ Experienced team with strong track record of success 2025 2031 x Global commercial presence in indications representing markets of >$50B 2 x Driven by our values, inspired by our patients 1 Obexelimab, orelabrutinib, and ZB021; 2 Company estimate based on published reports and disease prevalence and pricing of advanced therapies within indication
7 Building compelling I&I and MS franchises consisting of four potentially best - in - class programs Territory Phase 3 Phase 2 Phase 1 Preclinical Indication Compound Global excluding JPN, SK, TWN, HK , SGP, AUS 1 IgG4 - RD Obexelimab (CD19 and Fc ɣ RIIb bifunctional mAb) ) RMS SLE Global PPMS Orelabrutinib (BTK inhibitor) SPMS Global excl. China & SE Asia 3 I&I ZB021 (Oral IL - 17AA/AF inhibitor) Global I&I ZB022 (Brain - penetrant TYK2 inhibitor) Phase 3 INDIGO trial enrolled: data expected around YE 2025 Phase 2 SunStone trial enrolling Phase 3 initiated in Q3 2025 Phase 3 expected to initiate in Q1 2026 2 IND filing and Phase 1 expected in 2026 2 IND filing and Phase 1 expected in 2026 2 Phase 2 MoonStone data expected early Q4 2025 Comprehensive and balanced I&I portfolio of small & large molecules in multiple indications with significant commercial potential and recognized regulatory paths to approval IgG4 - RD= IgG4 - Related Disease SLE= Systemic Lupus Erythematosus PPMS= Primary Progressive MS SPMS= Secondary Progressive MS; 1 BMS territories; 2 Expected timing based on program timelines; 3 InnoCare Territories
8 Numerous potentially value - creating milestones expected in the next 24 months 2025 2027 2026 Obexelimab Early 4 th quarter: Phase 2 RMS 12 - week data ~Year - end: Phase 3 IgG4 - RD topline data Obexelimab 2 nd quarter: IgG4 - RD BLA submission Mid - year: Phase 2 SLE topline data Obexelimab First half: IgG4 - RD BLA approval & launch Phase 3 SLE start (gated on Phase 2) Orelabrutinib 3 rd quarter: Phase 3 PPMS initiated Orelabrutinib 1 st quarter: Phase 3 SPMS start 2026: IND filing and Phase 1 initiation 2026: IND filing and Phase 1 initiation 2027: Phase 1 patient data 2027: Phase 1 data Obexelimab Obexelimab Obexelimab Orelabrutinib Orelabrutinib IL - 17AA/AF TYK2 IL - 17AA/AF TYK2
9 BTK: A Compelling Target for Progressive Multiple Sclerosis
10 SPMS and PPMS have the highest unmet need across MS subtypes and limited therapeutic options SPMS (>125K diagnosed patients in U.S.) 1,2 RRMS treatments used off - label 4 Therapies that prevent disability progression Initially RRMS followed by steady increase in disability without relapses Disability Time One anticipated by year - end 2025 4 ~650K patients with MS in the U.S. alone 1 Subtype Preferred treatments Unmet medical need Clinical characteristics Approved therapies PPMS (~60 - 100K diagnosed patients in U.S.) 1,3 Ocrevus approved; higher efficacy agents are desired More effective therapies that prevent disability progression Steady increase in disability without relapses / attacks One Disability Time PPMS SPMS 1 National MS Society 2025, Wallin et al. 2019, Campbell et al 2014, Zenas BioPharma analysis; 2 Milliman et al 2019, Lo et al. 2022, Zenas BioPharma analysis; 3 National MS Society 2025, Zenas BioPharma analysis; 4 First anticipated drug approval for patients with non - relapsing SPMS; SPMS = non - relapsing Secondary Progressive MS; PPMS = Primary Progressive MS; RRMS = Relapsing remitting MS
11 BTK is a validated target in MS with unique potential to address compartmentalized inflammation and disease progression 1 Reich DS et al. NEJM 2018. 2 Gandhi R et al. J Neuroimmunol . 2010; 3 Saberi et al . 2023, Vong et al. 2022 Greenberg 2024, Krämer et al. 2023; 4 Oh et al. NEJM 2025, Fox et al. NEJM 2025; Image adapted from: Krämer et al. 2023; PMS = Progressive Multiple Sclerosis Peripheral Compartmentalized Significant unmet need in MS for: • CNS - penetrant mechanisms that address compartmentalized local inflammation and directly impact the biology of progressive disease and neurodegeneration RMS (active inflammation) (neurodegeneration) PMS BTKi addresses underlying biology of progressive disease • Impacts peripherally and centrally located pathogenic B cells and macrophages, and directly inhibits microglia A BTKi is under FDA review as the first therapy for “non - relapsing/active SPMS” • Significantly reduced disability progression independent of relapse activity” in both SPMS & RRMS 4 1 1,2
12 CNS penetrant BTK inhibitor potential to prevent disease progression in MS; confirmed in Phase 3 SPMS and RRMS Trials SPMS: Fox et al . Tolebrutinib in Non - relapsing Secondary Progressive Multiple Sclerosis. NEJM April 2025 RRMS: Oh et al . Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis. NEJM April 2025 CDP: Confirmed Disability Progression; CDW: Confirmed Disability Worsening The BTKi, tolebrutinib, is the first therapy ever to succeed in a Phase 3 SPMS trial; and significantly impacted “disease progression independent of relapse activity” in both SPMS & RRMS Tolebrutinib Phase 3 SPMS Trial: Time to 6 - month CDP Tolebrutinib Phase 3 RRMS Trial: Time to 6 - month CDW
13 Quarter and year reflect clinical trial primary completion dates from clinicaltrials.gov or as projected by sponsor Orelabrutinib Phase 3 SPMS trial is expected to initiate in 1Q 2026 Orelabrutinib is a potential best - in - class therapy for progressive MS and is well - positioned to take advantage of an underdiagnosed and growing market Phase III SPMS PPMS PPMS & SPMS Tolebrutinib BTK inhibitor Sanofi Fenebrutinib BTK inhibitor Roche Masitinib Tyrosine kinase inhibitor AB Science Oral BID Oral QD Oral BID PPMS (3Q25) PPMS (4Q25) & SPMS (3Q24) PPMS (4Q28) & SPMS (4Q28) Frexalimab Anti - CD40L Sanofi IV Infusion SPMS (4Q26) Orelabrutinib BTK inhibitor InnoCare Pharma Oral QD PPMS (2Q30) & SPMS (2Q30) Orelabrutinib has the potential to be the best - in - class BTKi for PMS Ocrevus Anti - CD20 Roche IV/SC Infusion Marketed PPMS (3Q15) SPMS Only PPMS Only PPMS & SPMS • Only one drug approved for PPMS • Only three other programs in late - stage development for SPMS and PPMS • Orelabrutinib is a potential best - in - class molecule for SPMS and PPMS and is well positioned for a commercial opportunity that is expected to expand 2 • No drugs approved for SPMS 1 1 For non - active forms of SPMS (~70% of all SPMS); 2 Pending regulatory approvals
14 Orelabrutinib: a Potentially Best - in - Class BTKi
15 Orelabrutinib’s pharmacologic attributes impart best - in - class potential combining high selectivity and CNS penetrant activity Non - covalent / 200mg BID Covalent / 60mg QD Covalent / 80mg QD Binding / dosing 1 Selectivity 2 ( scanMAX (Eurofins ) kinome scan at 1µM) High Lower High CNS concentration 3 Lower High High Potency 4 (IC 90 ) Lower Lower High CNS concentration to IC 90 ratio High selectivity High CNS penetration Low IC 90 High CNS conc. to IC 90 ratio 1 InnoCare Pharma, Sanofi, and Roche published reports; 2 Darragh et al . ACS Pharm. & Trans. Sci 2025; 3 Data on file (orelabrutinib), calculated from Cabanis et al. Clinical and Translational Science 2024 (tolebrutinib), American Academy of Neurology Annual Meeting 2024 (fenebrutinib); 4 Data on file (orelabrutinib), Turner et al. Drugs R D. 2024 (tolebrutinib and fenebrutinib); Notes: Orelabrutinib 80 mg data inferred from 150 mg dosing; Potency based on kinase activity; Based on comparisons of published data for tolebrutinib and fenebrutinib, no head - to - head comparison studies were conducted Orelabrutinib Tolebrutinib Fenebrutinib x x x x
16 Phase 2 RRMS Trial Summary: • Design: double - blind, randomized, placebo - controlled with placebo crossover at week 12 • Treatment: 4 different doses of orelabrutinib vs. placebo control through week 12 • MRI endpoint assessing new T1 Gd - enhancing lesions at week 12 • Secondary endpoints included T1 Gd - enhancing lesions and new or enlarging T2 lesions at weeks 12, 16, 20, and 24 and safety SCREENING Diagnosis of relapsing remitting MS : • Age 18 - 55 years • Diagnosis of relapsing - remitting MS • EDSS score ≤ 5.5 • Neurological stable for ≥ 30 days • ≥1 relapses within 2 years with o ≥1 relapse within the last year o ≥1 Gd+ T1 lesion within 6 months 96 - week open label extension (50 mg QD) 12 - week blinded treatment: Primary endpoint: Number of new T1 Gd - enhancing lesions 24 - w eek blinded extension: Number of new T1 Gd - enhancing lesions and additional endpoints Week 12 Week 24 Orelabrutinib Phase 2 RRMS trial Standard design with MRI measurements; highly predictive of successful outcome in large randomized trials Orelabrutinib 50 mg QD (n=40) Placebo QD (n=40) Orelabrutinib (50 mg QD) Orelabrutinib 80 mg QD (n=40) Orelabrutinib 50 mg BID (n=40) 1:1:1:1 Randomization Source: Xu et al. ACTRIMS Forum 2025
17 Orelabrutinib Phase 2 trial baseline characteristics 35.4 (9.8) • Age, mean (SD), years 100 (63.4%) • Female, n (%) 5.8 (5.8) • Time since diagnosis at screening, mean (SD), years 2.6 (1.5) • EDSS score, median (SD) 1.8 (4.3) • # of GdE T1 hyperintense lesions at baseline, mean (SD) 53 (33.5%) • Patients with GdE T1 hyperintense lesions at screening, n (%) Orelabrutinib Phase 2 RRMS Source: Xu et al. ACTRIMS Forum 2025
18 Orelabrutinib treatment resulted in a rapid and deep reduction in new GdE+ T1 lesions across all evaluated doses 4.34 1.14 0.82 0.42 0.0 1.5 3.0 4.5 Placebo (n=27) 50mg QD (n=30) 50mg BID (n=29) 80mg QD (n=29) 74% 81% > 90% (P=0.0018) (P=0.0073) (P=0.0278) 0.0 1.5 3.0 4.5 0 4 8 12 Placebo Orelabrutinib 50mg QD Orelabrutinib 50mg BID Orelabrutinib 80mg QD Orelabrutinib Weeks of treatment Significant reduction in new GdE+ T1 lesions observed for all orelabrutinib doses at week 12 (primary endpoint) Meaningful and sustained reduction in new GdE+ T1 lesions observed as early as week 4 Cumulative number of new GdE+ T1 lesions Cumulative number of new GdE+ T1 lesions Source: Xu et al. ACTRIMS Forum 2025
19 Orelabrutinib data out to 96 - week support sustained clinical activity and potential impact on disability progression 20.5 9.3 0 6 12 18 24 Baseline Week 96 - 55% 2.7 2.5 0.0 1.5 3.0 Baseline Week 96 - 9% Serum NfL: Indicative of disease activity and progression EDSS Score: Indicative of neurological disability and disease progression SEL Volume: Indicative of smoldering disease and progression Data shown for 80 mg QD dose (switched to 50mg QD dose, week 24 through 96 for OLE, n=36 - 37) NfL = Neurofilament Light chain; EDSS = Expanded Disability Status Scale; SEL = Slowly Expanding Lesions Source: InnoCare Pharma 627.0 377.0 0 50 100 150 200 250 300 350 400 450 500 550 600 650 Week 48 Week 96 - 40% NfL (ng/ml) EDSS Score SEL Volume (mm 3 )
20 Orelabrutinib was generally well tolerated; safety in - line with other BTKi in development for MS 1 • TEAEs for orelabrutinib (n=118) vs. placebo (n=40) during the 12 - week RCP » All TEAEs: 53% vs. 30% » Serious TEAEs: 2% vs. 0% » Liver - related TEAEs: 10% vs. 7.5% o Observed within first 8 weeks of treatment o Occurred primarily in the first eight weeks of treatment, most were present as lab abnormalities only without clinical symptoms • Orelabrutinib was placed on partial clinical hold by FDA (but not EMA) for studies in RMS after 2 cases of DILI meeting Hy’s Law criteria » Safety profile similar to other BTKi in development for MS; three other BTKi programs in development for RMS were also placed on partial clinical hold by the FDA • For high unmet need for progressive MS development, FDA has cleared protocols to proceed with risk mitigation including weekly LTFs and stopping rules • Routinely prescribed oral therapies for MS are also associated with elevated LFTs RCP = Randomized Controlled Period; DILI = Drug - Induced Liver Injury; LFT = Liver Function Test 1 Based on comparisons of published data for to other BTKi in development for MS, no head - to - head comparison studies were conduct ed
21 Orelabrutinib Phase 3 protocols cleared with FDA and positive EMA Scientific Advice PPMS Study Design; trial initiated in U.S. Primary Endpoint: Time to onset of 12 - week cCDP Primary Endpoint: Time to onset of 24 - week CDP SPMS Study Design; trial expected to initiate 1Q 2026
22 Global MS market expected to reach >$30B with approval of new therapies; SPMS and PPMS represent >$12B+ Diagnosed prevalence of MS in the US: ~640K 1 Patients with SPMS and PPMS: 30 - 35%+ 2 Current SPMS and PPMS prevalence: 190 - 225K Non - DMT treated (~30%) 3 ~60K - 70K DMT treated (~70%) 3 ~130 - 155K SPMS currently estimated to account for at least 20% of all MS subtypes 2 PPMS currently estimated to account for 10 - 15% of all MS subtypes 2 Diagnosed prevalence of SPMS and PPMS are expected to increase as new therapeutic option are approved SPMS often diagnosed as RMS for access to approved therapies; SPMS and PPMS could represent >40% of all MS diagnoses Current SPMS and PPMS commercial opportunity in the U.S. alone projected to be >$12B+ 4 and expected to grow significantly with approval of effective therapies that impact disease progression x x x x 1 National MS Society 2025, Wallin et al 2019, Campbell et al 2014, Zenas BioPharma analysis; 2 Milliman et al 2019, Lo et al. 2022, National MS Society 2025, Zenas BioPharma analysis; 3 Zenas BioPharma analysis; 4 Zenas estimate based on reported prevalence and current pricing of B cell therapies approved for MS
23 Orelabrutinib registration - directed trials to begin in largely untapped progressive MS market segments Highly positive Phase 2 results in RMS with 96 weeks of data; Phase 3 PPMS trial initiated and Phase 3 trial for SPMS expected to initiate in 1Q 2026 Peer BTKi under FDA review for SPMS; an accumulation of data supports potential to address neurodegeneration and “silent progression” MS market anticipated to exceed $30B by 2030 3 ; progressive forms accounting for >40% - expansion accommodates several agents for each indication Potential Best in category pharmacology 2 with potential for best - in - class efficacy and convenience – 2 nd most prescribed BTKi in China for B cell malignancies Clear path forward with FDA and EMA on Phase 3 PPMS registration trial initiated in the U.S.; Phase 3 SPMS registration trial expected to initiate in 1Q26 MoA uniquely targets both peripherally and centrally located pathogenic B cells and centrally located microglial cells 1 Zenas estimate based on reported prevalence and current pricing of B cell therapies approved for MS; 2 Based on comparisons of published data for other BTKi programs, no head - to - head comparison studies were conducted; 3 GlobalData, Zenas analysis >200K Patients with Progressive MS in U.S. alone representing a commercial market 1 of $12B+
24 Oral IL - 17AA/AF and Brain Penetrant TYK2 Programs
25 • Currently a $10B global market with ~50% average annual growth since first approval » Three biologics approved for seven rheumatic and dermatologic autoimmune indications * » Market expected to grow with additional IL - 17 approvals and launches in other indications ZB021: a novel oral IL - 17AA/AF provides opportunity to expand pipeline within rheumatology and into other therapeutic areas including dermatology Eli Lilly acquisition of DICE Therapeutics for $2.4B for oral IL - 17 portfolio Eli Lilly partnership with Protagonist Therapeutics on oral IL - 23 program with up to $990M in total deal value Anti - IL - 17 Biologics: a blockbuster drug class for rheumatic and dermatologic diseases * Plaque Psoriasis; Psoriatic Arthritis; Ankylosing Spondylitis; Non - Radiographic Axial Spondyloarthritis; Enthesitis - Related Art hritis; Hidradenitis Suppurativa Growing interest in small molecules against targets established by biologics • IND submission planned and Phase 1 expected to initiate in 2026 ZB021 is an oral IL - 17AA/AF inhibitor with best - in - class potential
26 ZB021’s best - in - class potential is supported by robust in vitro and in vivo activity 0 2 4 6 8 10 12 14 0 3 4 5 6 7 8 9 Normal control Vehicle Anti - IL - 17 biologic ICP - 054 0.3 mg/kg ICP - 054 1 mg/kg ICP - 054 3 mg/kg ICP - 054 10 mg/kg Days post - treatment Clinical Score Robust efficacy: achieves comparable activity in vivo to a reference anti - IL - 17 biologic in rat CIA model High potency in vitro combined with strong ADME properties Inhibition of IL - 17 – IL17RA binding (IC 50 ; nM ) IL - 17 signaling inhibition (IC 50 ; nM ) 2.6 ± 1.7 IL17AA: 6.5 ± 3.1 IL17AF: 18.4 ± 16.2 Inhibition of IL - 17 signaling from Th17 supernatant (IC 50 ; nM ) 2.8 ± 2.4 High oral bioavailability (~80% in monkey) Low clearance High metabolic stability x x x
27 ZB022: a brain - penetrant TYK2 inhibitor with significant opportunity in neuroinflammatory and neurodegenerative diseases • Complementary mechanism to expand upon potential neurology franchise led by orelabrutinib » Allosteric JH2 inhibition improves selectivity and specificity » Favorable PK/PD observed in preclinical studies » High activity in preclinical neurological disease model • IND submission planned and Phase 1 expected to initiate in 2026 TYK2 is a well - established mechanism across a range of autoimmune diseases • Brain penetrant molecules may provide opportunity to extend benefit to neurological diseases » Increasing evidence implicating TYK2’s role in neuroinflammatory and neurodegenerative diseases » Partial loss - of - function variants protect against various autoimmune diseases including MS » TYK2 shown to stabilize tau in Alzheimer's disease ZB022: a TYK2 inhibitor with best - in - class potential
28 Obexelimab: a Potential I&I Franchise Molecule
29 Obexelimab: Phase 3 and multiple Phase 2 data readouts expected Territory Next Milestone Phase 3 Phase 2 Phase 1 Preclinical Indication Compound Global excluding JPN, SK, TWN, HK, SGP, AUS 3 Phase 3 Topline Results expected around year end 2025 IgG4 - RD Obexelimab 1 (CD19 and Fc ɣ RIIb bifunctional mAb) Primary endpoint (12 - week) data expected early Q4 2025 RMS Primary endpoint (24 - week) data expected mid - 2026 SLE Phase 3 INDIGO trial fully enrolled 2 Phase 2 SunStone trial enrolling 2 Phase 2 MoonStone trial fully enrolled 2 1 Zenas acquired exclusive worldwide rights to obexelimab from Xencor, Inc. 2 Randomized versus placebo 3 Bristol Myers Squibb & Co. holds exclusive development and commercialization rights in JPN, SK, TWN, HK, SGP, AUS
30 Obexelimab is a potentially differentiated B cell targeted therapy with a novel bifunctional MoA 1 Chu et al . Molecular Immunology 2008 & Zenas data on file 2 Szili et al . mAbs 2014 3 Chu et al . Journal of Translational Autoimmunity 2021 4 Chu et al. Arthritis & Rheumatology 2014 5 Abeles et al . Annual Review of Immunology 2024; Verbeek et al. Front. Immunol 2019 Source: Zenas BioPharma • CD19 broadly expressed across B cell lineage , including pro - B cells , pre - B cells , B cells , plasmablasts and select plasma cells 5 • Fc γ RIIb engagement mimics the activity of natural antigen - antibody complex • Fc engineered to increase FcγRIIb affinity ~230 - fold vs. native IgG1 2 • Designed to avoid ADCC / CDC - mediated depletion with activity independent of immune effector cell presence • Potent inhibition of B cell antibody production, proliferation, cytokine secretion, and antigen presentation to T cells 1,2 • Persistent inhibitory activity in peripheral blood and within tissues 3 Obexelimab’s co - engagement of CD19 and Fc γ RIIb results in an inhibition of B cells , rather than effector cell - dependent depletion 1,2,3,4
31 Obexelimab for Relapsing Multiple Sclerosis
32 MoonStone Trial Summary: • Design: double - blind, randomized, placebo - controlled with placebo crossover at week 12 • Treatment: obexelimab 250mg SC weekly vs. placebo control (through week 12) • MRI endpoint assessing T1 Gd - enhancing lesions at week 12 • Secondary and exploratory endpoints: utilizing standardized assessments, imaging and biomarkers to evaluate impact on disease progression/silent progression through week 24 SCREENING Active RMS (relapsing remitting MS or relapsing secondary progressive MS): • EDSS <5.5 * Open label extension 2:1 Randomization Obexelimab Q1W Placebo Q1W Obexelimab Q1W Week 12 Primary endpoint: Number of new T1 Gd - enhancing lesions Week 24 Additional endpoints: including disease progression endpoints Week 12 Week 24 * EDSS 5.5 = disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m Phase 2 MoonStone RMS trial (n=116) Standard design with MRI measurements; highly predictive of successful outcome in large randomized trials
33 MoonStone baseline characteristics 42 (9.5) • Age, mean (SD), years 81 (70%) • Female, n (%) 7.54 (8.6) • Time since diagnosis at screening, mean (SD), years 3 (0.0 - 5.5) • EDSS score, median (range) 0.71 (2.2) • # of GdE T1 hyperintense lesions at screening, mean 25 (21.6) • Patients with GdE T1 hyperintense lesions at screening, n (%) Notes: • All data are summarized according to the nominal visit at the time of the data cut. • Data cutoff date: 18Sep2025 • Study remains blinded MoonStone (n=116)
34 Historical benchmarks for GdE+ T1 lesions from Phase 2 RMS trials Baseline GdE+ T1 lesions and baseline characteristics most similar to fenebrutinib Assessment GdE T1 Lesions* Phase 2 Program At week 12 0.27 vs. 0.03 • Fenebrutinib (BTKi) Cumulative week 12 4.34 vs. 0.42 • Orelabrutinib (BTKi) At week 12 1.03 vs. 0.13 • Tolebrutinib (BTKi) At week 12 1.40 vs. 0.20 • Frexalimab (CD40L) At week 12 1.3 vs. 0.10 • Ofatumumab (CD20) Cumulative week 24 6.6 vs. 0.80 • Ocrelizumab (CD20) * Mean per scan; Data are cross - trial comparisons, may not reflect the trials primary endpoint, and should therefore be considere d directions
35 Blinded review of MoonStone’s randomized controlled data shows rapid decline in new and new/existing lesions per scan up to week 12 0.71 0.09 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 Baseline * 0.53 Week 4 0.13 Week 8 Week 12 0.71 0.60 0.18 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 Baseline Week 4 0.35 Week 8 Week 12 Obexelimab and placebo (blinded data; 2:1 randomization ) Obexelimab and placebo (blinded data; 2:1 randomization ) (n=116) (n=114) (n=112) (n=115) (n=116) (n=114) (n=113) (n=115) Notes: • Data presented as the unadjusted lesion rate per scan is the total number of lesions divided by the total number of scans • Data cutoff date: 18Sep2025 • Study remains blinded * Baseline data include all GdE T1 lesions at screening. Post - baseline data represent new GdE T1 lesions relative to the last visi t. Number of new GdE+ T1 hyperintense lesions per scan Number of new and existing GdE+ T1 hyperintense lesions per scan
36 Approval of new drugs for RMS is challenging due to the evolving treatment landscape and current pivotal trial endpoints • Shifting clinical trial recruitment dynamics » Slower recruitment » Patients now have less active disease • Challenging to show benefit given less active population » Agents evaluated in recent trials showed substantial reductions in ARR along with teriflunomide • Alternative endpoints under discussion » May improve likelihood of success in future • RMS pivotal trials require substantial investment Available Therapies Highly effective in controlling relapse rates Regulatory Endpoints Improvement in annualized relapse rate (ARR) vs. active comparator required for approval Capital Requirements Two large randomized trials needed for approval RMS program decision based on MoonStone data and the evolving landscape for the development of new therapies for RMS anticipated in early 2026
37 Obexelimab for IgG4 - RD
38 Patients with IgG4 - RD are likely to experience disease progression independent of flares with cumulative organ damage Subclinical / smoldering disease Disease course over time Clinically evident disease flares Repeated disease flares can damage new or existing disease sites 1 Subclinical inflammatory processes left untreated can lead to fibrosis and irreversible organ damage 1 Obexelimab once - weekly, self - administered, subcutaneous injection could potentially address the underlying disease burden, if approved 2 1 Perugino, C. et al. Nature Reviews Rheumatology . 16, 702 – 714 (2020); 2 As measured by secondary endpoints in ongoing Phase 3 INDIGO trial ACR /EULAR threshold for classification of IgG4 - RD IgG4 - RD is a debilitating chronic fibro - inflammatory disease affecting multiple organ systems 1 Subclinical / smoldering disease activity can meaningfully contribute to organ damage
39 Obexelimab’s Phase 2 IgG4 - RD results demonstrated rapid, robust, and sustained reduction in IgG4 - RD disease activity 1 • Rapid induction of remission and sustained reduction in disease activity (IgG4 - RD RI) • 100% of patients who completed trial met primary endpoint (2 - point IgG4 - RD RI reduction) • 93% with ongoing remission at end of trial • 80% with prior rituximab achieved complete remission with obexelimab • Well tolerated ; no obexelimab - related SAEs Obexelimab Induction and Maintenance Trial (obexelimab 5mg/kg IV Q2W x 12 doses; n=15) 0 5 10 15 20 25 30 1 15 29 57 85 113 141 169 197 Completed Early termination IgG4 - RD RI Score Da y 1 Perugino et al. Lancet Rheumatology 2023. Open - label, single - arm Phase 2 PoC trial in 15 obexelimab - treated patients with moderate to severe disease as induction and maintenance, one or more organ systems involved and an IgG4 - RD Responder Index (RI) of ≥ 3 Note rituximab comparaisons not head - to - head and reference data reported by Carruthers MN et al. Ann Rheum Dis. 2015. Rituximab trial patients (n=30) had similar baseline characteristics
40 SCREENING • 20 - 60 mg GC Tx for flare • 20mg GC at trial entry Placebo SC Q1W for 52 weeks (n=~100) Open label extension 1:1 Obexelimab SC Q1W for 52 weeks (n=~100) GC taper to 0mg by week 8 GC taper to 0mg by week 8 1 Stone, et al. Inebilizumab for Treatment of IgG4 - Related Disease. NEJM . Nov 2024. GC = glucocorticoid; SC = subcutaneous INDIGO Trial Summary: • Design: randomized, double - blind, placebo - controlled • Primary endpoint: time to disease flare through week 52 • Secondary endpoints include: 52 - week flare rate, Achievement of complete remission, Use and quantity of rescue medication, Change in GC - associated toxicity as measured by the Glucocorticoid Toxicity Index (GTI) 60% PBO rate for MITIGATE (Uplizna ® Phase 3) a derisking event for INDIGO assumptions; MITIGATE and INDIGO study designs are substantially similar 1 Phase 3 INDIGO IgG4 - RD trial enrollment complete Trial of over 190 patients, the largest ever conducted, with topline results expected around year - end 2025
41 Obexelimab has the potential to become a best - in - class therapy in the evolving IgG4 - RD treatment landscape Potential to achieve faster responses and higher complete remission rates No premedication and no risk of infusion - related reactions Potential to allow for vaccinations or management of intercurrent illness Patient preference for at home, subcutaneous injection SC dosing chosen for optimal pharmacokinetic and clinical activity Possibility for lower out - of - pocket expense (Medicare Part D vs. B) x We believe obexelimab’s potential product attributes support its differentiation in the IgG4 - RD treatment landscape; validated through strategic collaboration with Bristol Myers Squibb 1 x x x x x 1 Bristol Meyers Squibb hold an exclusive license to develop, manufacture, and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kon g a nd Australia
42 Obexelimab represents a compelling $1billion+ commercial revenue opportunity in the U.S. alone 1 Estimated U.S. prevalence: ~30 - 40K 2 Current U.S. diagnosed prevalence: ~20K 1 Patients treated with systemic therapies: ~20K 3 Stable remission: ~8K - 10K Chronic disease ~10K - 12K x Diagnosed prevalence for IgG4 - RD expected to increase with introduction of first approved therapies x Attractive orphan pricing creates a market opportunity of ~$3 billion in the U.S. alone 3 x Similar prevalence and potential for orphan pricing in Europe creates a significant commercial opportunity x Zenas management team has extensive track record successfully building commercial organizations and launching drugs in the U.S. and Europe Currently diagnosed patients eligible for maintenance therapies = $3 billion U.S. commercial opportunity 4 x x x x 1 Pending FDA approval; 2 Wallace et al 2023 and Zenas BioPharma research; 3 GCs, immunosuppressants, DMARDs and now Uplizna; 4 Company estimate based on disease prevalence and pricing of advanced therapies within indication Opportunity supported by robust early Uplizna ® launch
43 Obexelimab for Systemic Lupus Erythematosus
44 Potential for improved clinical activity with an optimized obexelimab subcutaneous dosing regimen 17% 35% 52% 0% 10% 20% 30% 40% 50% 60% Intention - to - treat population 1 Optimized exposure (C trough ) population 2 Biomarker positive population 3 Patients at W32 without loss of improvement (∆" vs. PBO") Source: Merrill et al. Arthritis Rheumatol . 2023 1 Defined as all randomized patients receiving at least one dose of study medication 2 C trough Quartiles 3 & 4 in efficacy evaluable analysis 3 Biomarker positive defined as patients in predefined lupus phenotypic gene expression clusters 3 & 6 (~38% of evaluated popul ati on) Higher clinical activity observed with obexelimab in a Phase 2 SLE trial with optimized exposure (C trough ), and in a potential biomarker positive population Screening Placebo IV Q2W for 32 weeks (n=52) 1:1 Obexelimab 5mg/kg IV Q2W for 32 weeks (n=52) Current approved therapies demonstrate modest effect sizes of 12 – 17% over placebo on SRI - 4/BICLA assessments
45 Phase 2 SunStone SLE trial enrolling Designed to confirm obexelimab activity in all - comer and biomarker populations SCREENING Active SLE: • BILAG ≥1A or ≥2B • SLEDAI ≥6 • PI confirmation Stable steroids Placebo Q1W for 24 weeks (n= 95 ) Follow - up 1:1 Obexelimab Q1W for 24 weeks (n= 95 ) • SC dosing to improve PK (steady state C trough above Phase 2 top (4 th ) quartile for all patients) • Powered on appropriate placebo response and effect size assumptions • Strict adjudication for eligibility and assessment (moderate/severe patients only); strict corticosteroid tapering rules to reduce placebo responses Incorporates learnings from previous Phase 2 trial to increase POS • Design: randomized, double - blind, placebo - controlled • Primary Endpoint: Reduction of SLE disease activity at week 24 by BILAG - Based Composite Lupus Assessment (BICLA)
46 Future Catalysts and Corporate Summary
47 Numerous potentially value - creating milestones expected in the next 24 months 2025 2027 2026 Obexelimab Early 4 th quarter: Phase 2 RMS 12 - week data ~Year - end: Phase 3 IgG4 - RD topline data Obexelimab 2 nd quarter: IgG4 - RD BLA submission Mid - year: Phase 2 SLE topline data Obexelimab First half: IgG4 - RD BLA approval & launch Phase 3 SLE start (gated on Phase 2) Orelabrutinib 3 rd quarter: Phase 3 PPMS initiated Orelabrutinib 1 st quarter: Phase 3 SPMS start 2026: IND filing and Phase 1 initiation 2026: IND filing and Phase 1 initiation 2027: Phase 1 patient data 2027: Phase 1 data Obexelimab Obexelimab Obexelimab Orelabrutinib Orelabrutinib IL - 17AA/AF TYK2 IL - 17AA/AF TYK2
48 Obexelimab; an I&I franchise molecule A potentially best - in - class B cell therapeutic with Phase 3 data for IgG4 - RD expected year - end, SLE Phase 2 trial enrolling, and RMS Phase 2 data expected early 4Q 2025; each representing a potential multi - billion - dollar commercial opportunity 1 Experienced team and a deep pipeline Established global capabilities advancing two Phase 3 potential franchise product candidates and innovative, validated pipeline programs: oral IL - 17AA/AF modulator and brain penetrant TYK2 inhibitor 2 Orelabrutinib; a Progressive MS franchise molecule A validated mechanism and potentially best - in - class profile in Phase 3 registration - directed trial for PPMS and initiating Phase 3 registrational trial for SPMS expected in 1Q 2026; each representing potential blockbuster opportunities 2 Significant value - creating milestones over the next 2 years Pipeline delivers late - stage data and proof - of - concept readouts across multiple programs including potential commercialization of obexelimab for IgG4 - RD, pending FDA approval Zenas: Creating a global, immunology - based development and commercial biotechnology company Enabling patients with autoimmune diseases to reimagine life 1 Company estimate based on disease prevalence and pricing of advanced therapies within indication, pending regulatory approval
49 Q&A Session
Exhibit 99.3
Zenas BioPharma, Inc.
Recent Developments
This document contains information about Zenas BioPharma, Inc. and its consolidated subsidiaries. You also should read and consider the information contained in other reports and documents that we file with the Securities and Exchange Commission (the “SEC”), including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and our financial statements and the related notes included therein. Except where the context otherwise requires or where otherwise indicated, the terms "Zenas," “we,” “us,” “our,” and “the Company,” refer to Zenas BioPharma, Inc. and its consolidated subsidiaries.
Overview
On October 7, 2025, we entered into a License Agreement (the “InnoCare License Agreement”) with InnoCare Pharma Inc. (“InnoCare”), pursuant to which Zenas was granted exclusive rights to develop, manufacture, and commercialize orelabrutinib, a Bruton’s Tyrosine Kinase (“BTK”) inhibitor, for multiple sclerosis (“MS”) worldwide, and in all non-oncology indications worldwide excluding mainland China, Hong Kong, Macau and Taiwan (“Greater China”) and Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam (“Southeast Asia”), as well as two early-development product candidates: ZB021, an IL-17AA/AF inhibitor, in all fields of use worldwide excluding Greater China and Southeast Asia, and ZB022, a TYK2-JH2 inhibitor, in all fields of use worldwide. Our pipeline comprises four programs, which we are developing initially for the treatment of immunology and inflammation (“I&I”) diseases, as summarized in the figure below.
We estimate that the commercial markets represented by indications across these programs are greater than $50 billion in the aggregate globally.
Obexelimab Recent Developments
Our Global Phase 2 Trial in RMS – MoonStone
In the second quarter of 2025, we completed enrollment of our Phase 2, double-blind, randomized, placebo controlled trial (the “MoonStone” trial) for obexelimab as a treatment for relapsing multiple sclerosis (“RMS”) and expect to report results from the MoonStone trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025. The MoonStone trial, which remains blinded, enrolled 116 patients, with baseline characteristics including: a mean age of 42, 81 (70%) female, a median Expanded Disability Status Scale (“EDSS”) score of 3, and 25 patients with GdE T1 hyperintense lesions at screening, including a mean of .71 GdE T1 hyperintense lesions. Preliminary blinded review of MoonStone’s randomized controlled data (obexelimab and placebo 2:1 randomized) up to week 12 showed a rapid decline in new GdE T1 hyperintense lesions from .71 to .09 and new and existing lesions from .71 to .18. These are preliminary observations from an ongoing blinded study and are subject to change upon final unblinding and analysis.
In early 2026, we expect to decide whether and how to advance obexelimab for RMS based on a variety of factors, including our analysis of MoonStone trial data, including the 12 and 24-week data, the evolving landscape for the development of new therapies for RMS, including available therapies and regulatory endpoints, and allocation of capital.
Our Global Phase 2 Trial in SLE – SunStone
We expect to complete enrollment in our Phase 2, double-blind, randomized, placebo controlled trial (the “SunStone” trial) for obexelimab as a treatment for Systemic Lupus Erythematosus (“SLE”) around year-end 2025, and we expect to report topline results from the SunStone trial in mid-2026. Based on the outcome of the SunStone trial, and considering other factors, we may initiate a Phase 3 program in patients with SLE in the first half of 2027.
Our Global Phase 3 Trial in IgG4-RD – INDIGO
In the fourth quarter of 2024, we completed the target enrollment of our registration-directed Phase 3 trial (the “INDIGO” trial) for obexelimab as a treatment for IgG4-RD, and we expect to report topline results from the INDIGO trial around year-end 2025. If the topline results are positive, we expect to file a Biologics License Application with the U.S. Food and Drug Administration (“FDA”) in the first half of 2026, followed by a Marketing Authorization Application with the European Medicines Agency, and, if approved, commence the commercial launch initially in the U.S. and then in Europe.
Orelabrutinib Overview
Orelabrutinib, also known as ZB020, is a highly selective and central nervous system (“CNS”)-penetrant, oral small molecule BTK inhibitor. Orelabrutinib is designed to bind irreversibly to BTK with minimal off-target effects, compared to certain other BTK inhibitors, which may potentially reduce certain side effects. We believe orelabrutinib is designed to efficiently cross the blood-brain barrier, reaching therapeutic levels within the CNS to directly target inflammation in diseases like MS. This CNS penetration may be important for addressing the underlying disease pathology of progressive forms of MS, which is characterized by compartmentalized neuroinflammation and neurodegeneration. The mechanism of action of BTK inhibitors targets not only pathogenic B cells in the periphery, but also those in the CNS, as well as macrophages and microglial cells addressing the key pathogenic drivers of progressive MS, as shown below.
Orelabrutinib for the Treatment of MS
A significant unmet need exists in MS for CNS-penetrant mechanisms that address compartmentalized local inflammation and directly impact the biology of progressive disease and neurodegeneration. BTK inhibition could potentially address the underlying biology of progressive disease by impacting peripherally and centrally located pathogenic B cells and macrophages, and directly inhibiting microglia in the CNS.
We estimate a diagnosed prevalence of over 125,000 patients with secondary progressive multiple sclerosis (“SPMS”) and approximately 60,000 to 100,000 patients with primary progressive multiple sclerosis (“PPMS”) in the U.S. SPMS and PPMS have the highest unmet need across MS subtypes, with limited therapeutic options. Currently no treatments are approved for non-relapsing/non-active SPMS and only one approved treatment, Ocrevus, for PPMS. We estimate that the commercial opportunity for MS could exceed $30 billion, with in excess of $12 billion attributable to progressive forms of MS.
Phase 2 Study in RMS
In late 2024, the results of the Phase 2 trial of orelabrutinib for the treatment of RMS were announced. The Phase 2 trial was a global, double-blind, placebo-controlled trial. The primary endpoint was the cumulative number of new gadolinium-enhancing (“Gd+”) T1 brain lesions at Week 12 (based on new Gd+ T1 lesions at Weeks 4, 8, and 12) compared to placebo. The results of the Phase 2 trial demonstrated that treatment with orelabrutinib resulted in a rapid and deep reduction in new Gd+ T1 lesions across all evaluated doses. In the trial, 158 eligible RRMS patients were randomized in a 1:1:1:1 ratio to one of four treatment groups: placebo, orelabrutinib 50 mg once daily (“QD”), orelabrutinib 80 mg QD, and orelabrutinib 50 mg twice daily (“BID”). Subjects in the placebo group were switched to orelabrutinib 50 mg QD at Week 13.
At Week 12, all three treatment groups showed statistically significant reductions in the cumulative number of new Gd+ T1 lesions and new/enlarging T2 lesions compared to the placebo group (p < 0.05), while the 80 mg QD and 50 mg BID groups showed statistically significant reductions throughout 24 weeks compared to the placebo/50 mg QD group (p < 0.05). The 80 mg QD group demonstrated the highest reductions of 90.4% at Week 12 compared to placebo and 92.3% at Week 24 compared to the placebo/50 mg QD group. New lesion control in each orelabrutinib group occurred at the earliest assessment timepoint of Week 4 and was sustained through Week 24.
Safety Summary
Orelabrutinib was generally well tolerated in the Phase 2 study of patients with RMS.
The known potential risks of orelabrutinib, as observed in clinical trials in patients with B-cell malignancies and autoimmune disease, include those associated with BTK inhibitor treatment such as hepatotoxicity, hemorrhage, cytopenia, infection, malignancy, hypertension, and arrhythmia.
In the Phase 2 RRMS trial, 151 patients received at least one dose of orelabrutinib. Treatment emergent adverse events(“TEAEs”) leading to drug discontinuation occurred in 2.6% of patients. The majority of TEAEs were Grades 1 or 2. Observed Grade 3 or higher events primarily included hematologic toxicities and infections, which are mechanism-related and commonly reported with BTK inhibitor treatment.
Elevation of liver enzyme levels classified as hepatotoxicity were observed in the Phase 2 RMS trial (ICP-CL-00112), as well as in Phase 1/2 trials in patients with SLE (ICP-CL-00109 and ICP-CL-00124) and Phase 2/3 trials in patients with Immune Thrombocytopenia (ICP-CL-00116 and ICP-CL-00126). Two cases of elevated liver enzymes and bilirubin met Hy’s Law criteria, one in the Phase 2 RMS trial and the other in the SLE trial. Both affected patients were asymptomatic and their liver markers normalized after treatment was discontinued. FDA issued a partial clinical hold for the conduct of the ongoing RMS trial. Three other BTK inhibitors, including those currently in development for progressive MS, were also placed on a partial clinical hold while under development in the U.S. for RMS. No development restrictions were placed by the European Medicines Agency. In the Phase 3 progressive MS trials, weekly liver function monitoring will be conducted during the first 12 weeks of treatment, which will be implemented through an established hepatotoxicity management scheme. In addition, the safety of the study, including hepatotoxicity, will be monitored by an Independent Data Monitoring Committee (IDMC) and a Hepatoxicity Assessment Committee (HAC) through periodic or ad hoc reviews of study safety observations.
Orelabrutinib has been approved for commercial use for chronic lymphocytic leukemia and small lymphocytic lymphoma in China since December 2020.
Phase 3 Studies for PPMS and SPMS
In September 2024, InnoCare and the FDA reached an agreement to initiate a Phase 3 trial of orelabrutinib in patients with PPMS. The FDA also encouraged InnoCare to initiate a second Phase 3 clinical trial of orelabrutinib in Progressive Multiple Sclerosis (“PMS”) within the Secondary Progressive Multiple Sclerosis (“SPMS”) population. In February 2025, InnoCare reached alignment with the FDA on the Phase 3 clinical trial protocol for SPMS.
In September 2025, the Phase 3 study of orelabrutinib in patients with PPMS was initiated. The Phase 3 study is a global, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of orelabrutinib dosed 80 mg once daily QD compared to placebo in patients with PPMS, with a primary endpoint of time to onset of 12-week composite confirmed disability progression (cCDP), with a goal to report topline results in 2030.
In the first quarter of 2026, we plan to initiate a second global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating orelabrutinib dosed 80 mg QD compared to placebo in patients with SPMS, with a primary endpoint of time to onset of 24-week CDP, with a goal to report topline results in 2030.
Early-Development Product Candidates: ZB021 and ZB022
We also in-licensed from InnoCare certain exclusive rights to two early-development product candidates: ZB021, an oral IL-17AA/AF inhibitor designed to block both IL-17AA homodimer and IL-17AF heterodimer signaling, and ZB022, an oral, brain-penetrant TYK2-JH2 inhibitor.
We believe ZB021 provides an opportunity for Zenas to expand its pipeline within rheumatology and into other therapeutic areas including dermatology. Anti-IL-17 biologics are a drug class focused on the treatment of rheumatic and dermatologic diseases that we estimate currently represents an approximately $10 billion commercial opportunity, with an average of approximately 50% annual growth since the first approval of a product was obtained. Preclinical studies for ZB021 have shown favorable PK and ADME properties. ZB021 achieved comparable activity in vivo to a reference anti-IL-17 biologic in a rat CIA model. Subject to the results of Investigational New Drug (“IND”)-enabling studies, Zenas expects to submit an IND application for ZB021, and if cleared, initiate a Phase 1 clinical study in 2026, with the potential for initial data in 2027.
ZB022 is currently in IND-enabling studies. Subject to the results of IND-enabling studies, Zenas expects to submit an IND application for ZB022, and if cleared, initiate a Phase 1 clinical study in 2026, with the potential for initial data in 2027.
Forward Looking Statements
This document contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this document are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning the Company’s milestones, expectations and intentions, including timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial and if successful, the timing of BLA submission, potential approval and commercial launch, the timing of reporting the 12-week and 24-week topline results from the MoonStone trial, the timing of the completion of enrollment and reporting the topline results from the SunStone trial, and if successful, the timing of initiating the Phase 3 trial in SLE, the timing of initiation of the Phase 3 trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of ZB021 and ZB022, the timing of initial patient data in ZB021; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib’s potential as a franchise for progressive MS; the expansion of the Company’s pipeline; and the achievement of payment-triggering milestones pursuant to the InnoCare License Agreement. The forward-looking statements in this document speak only as of the date of this document and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates, including the FDA’s partial clinical hold on the orelabrutinib RMS trial due to hepatotoxicity events; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information the Company files with the Securities and Exchange Commission. The forward-looking statements in this document are inherently uncertain, speak only as of the date of this document and may prove incorrect. These statements are based upon information available to the Company as of the date of this document and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.