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United States securities and exchange commission logo
February 21, 2024
Leon O. Moulder, Jr.
Chief Executive Officer
Zenas BioPharma, Inc.
1000 Winter Street
North Building, Suite 1200
Waltham, MA 02451
Re: Zenas BioPharma,
Inc.
Draft Registration
Statement on Form S-1
Submitted January
25, 2024
CIK No. 0001953926
Dear Leon O. Moulder:
We have reviewed your
draft registration statement and have the following comments.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this
letter and your amended
draft registration statement or filed registration statement, we may
have additional comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. Please revise this
section to state that you are a clinical stage company with no
product candidates
approved for commercial sale in any country and that you have yet
to generate any revenue
from product sales.
2. We note statements
here, and throughout the prospectus, claiming that obexelimab is
"safer" and "more
effective" than anti-CD20 or other anti-CD19 targeting therapies.
Please note that
conclusions of safety and efficacy are within the sole authority of the
FDA and comparable
foreign regulators. Qualifying language that statements of safety
and efficacy are
expressions of the company's beliefs or expectations do not address this
concern. Please revise
these statements or remove them.
Leon O. Moulder, Jr.
FirstName LastNameLeon O. Moulder, Jr.
Zenas BioPharma, Inc.
Comapany21,
February NameZenas
2024 BioPharma, Inc.
February
Page 2 21, 2024 Page 2
FirstName LastName
3. Please include a brief description of IgG4-RD and wAIHA in the Summary
section,
including a statement related to the small patient population for each
of these diseases.
4. We note your statement that obexelimab has shown "favorable clinical
activity" and
"promising tolerability" across five clinical trials. Please revise
this statement, and any
others like it, to instead present the objective data resulting from
your clinical trials. In this
regard, please also revise here to clarify the quantity and types of
serious adverse events
experienced by patients in these clinical trials.
Our Pipeline, page 2
5. Please disclose the autoimmune indications you are pursuing with your
ZB002 and ZB004
programs in your pipeline table and revise your Business section to
add corresponding
narrative disclosure. If these indications have not yet been
determined, please tell us why
you believe these programs are sufficiently material to your business
to warrant inclusion
in your pipeline table. We also note that you are not using any
proceeds from this offering
to advance these programs.
6. Please revise the pipeline chart to reflect that you have not filed an
IND for obexelimab
for the treatment of MS.
Obexelimab for the Treatment of MS, page 4
7. Your statement that the role of B cells in the pathogenesis of MS has
been "clinically
validated" appears to indicate that obexelimab has already been proven
effective. Based
on your current disclosure, that you are planning to conduct clinical
trials, we believe your
use of this terminology is not appropriate. Please revise your
discussion accordingly.
Obexelimab for the Treatment of SLE, page 5
8. Please disclose that the primary endpoint for the completed Phase 2
double-blind,
randomized trial of obexelimab in SLE was not achieved with
statistical significance.
Our ZB002 Program, page 5
9. Please clarify if you have tested your ZB002 candidate in a
head-to-head study
against adalimumab. To the extent you have not, please remove any
statements comparing
your product candidate to adalimumab.
Our ZB004 Program, page 5
10. Please remove your statement claiming ZB004 will have "increased
potency" when
compared to existing therapies as it is speculative in light of the
current development
status of this candidate.
Our Team and Investors, page 6
11. We note your statement here that you have raised over $159.0 million
from certain pre-
Leon O. Moulder, Jr.
FirstName LastNameLeon O. Moulder, Jr.
Zenas BioPharma, Inc.
Comapany21,
February NameZenas
2024 BioPharma, Inc.
February
Page 3 21, 2024 Page 3
FirstName LastName
IPO investors. Please limit any discussion of pre-IPO investors to the
investors disclosed
in your Principal Stockholders table on page 176. Please also disclose
that potential
investors should not consider investments made by these pre-IPO
investors, which are
likely to have have different risk tolerances than investors in this
offering and paid
significantly less per share than the price at which these shares are
being offered.
Risk Factors
We rely on a single third-party manufacturer to supply our product
candidates..., page 58
12. Please identify the single third-party manufacturer that you currently
rely on to
manufacture your clinical candidates. Please also clarify if they hold
any of the necessary
know-how required to manufacture your clinical candidates and if you
have entered into
any supply agreements with this manufacturer.
Use of Proceeds, page 74
13. Please revise to specify how far you expect the proceeds from this
offering will enable
you to reach in Phase 2 and 3 trials of obexelimab for each indication
listed.
Capitalization, page 76
14. Please revise to include your convertible notes outstanding as part of
your total
capitalization and indebtedness.
Critical Accounting Policies and Significant Judgments and Estimates
Determination of Fair Value of Common Stock, page 97
15. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the initial public offering and the estimated offering price.
This information will
help facilitate our review of your accounting for equity issuances,
including stock
compensation. Please discuss with the staff how to submit your
response.
Business
Clinical Development, page 105
16. Please revise the discussion of your clinical trials to disclose the
primary and secondary
endpoints for each trial, where the trials were conducted, which of
your trials
were powered for statistical significance and if any serious adverse
events were observed
while conducting each trial.
INDIGO Trial - Our Ongoing Phase 3 Trial in IgG4-RD, page 109
17. Please disclose the number of patients enrolled in the INDIGO trial to
date. Please provide
similar information for the SApHiAre Trial on page 111.
Leon O. Moulder, Jr.
FirstName LastNameLeon O. Moulder, Jr.
Zenas BioPharma, Inc.
Comapany21,
February NameZenas
2024 BioPharma, Inc.
February
Page 4 21, 2024 Page 4
FirstName LastName
License Agreements
License Agreements with Xencor, page 123
18. Please revise to disclose the aggregate amounts you have paid or
received to date under
your licensing agreements with Xencor and Bristol-Myers Squib. Please
also revise your
disclosure of the Xencor agreements to disclose if the 2020 Xencor
Agreement included
any development or regulatory milestones and, if applicable, quantify
them.
Certain Relationships and Related Party Transactions, page 172
19. Please revise to discuss the material terms of your agreements with
Dianthus Therapeutics
Inc. and Viridian Therapeutics Inc., including the aggregate amounts
paid or received to
date under these agreements, any regulatory or developmental
milestones, and applicable
royalty rates or royalty rate ranges not to exceed ten percentage
points. Please also file
these agreements as exhibits to your registration statement, or tell
us why you believe such
a filing is not required.
Notes to Condensed Consolidated Financial Statements for the Nine Months Ended
September
30, 2023
7. Collaboration Revenue
Bristol Myers Squibb, page F-43
20. For your license agreement with Bristol Myers Squibb, please provide
us an analysis how
you have concluded that the global development activities under the
agreement do not
represent a transaction with a customer under ASC 606 and thus
payments received by the
Company for global development activities are accounted for as a
reduction of the related
research and development expenses. In your response, please explain
how you determined
that your contractual obligations with respect to the global
development activities are not
an output of your ordinary activities. Please also include more
detailed descriptions for the
rights and obligations (e.g. cost and profit sharing percentages)
between the two parties, at
their respective territories, with regard to the ongoing Phase 3
clinical trial for IgG4-RD as
well as other future development. Revise your disclosures where
necessary.
General
21. We note disclosure throughout your prospectus stating you have
in-licensed the greater
China rights for development, manufacturing and commercialization of
certain of your
preclinical candidates and that you have office space in Shanghai,
China. Please revise,
where appropriate, to quantify the extent of your operations in China.
As an example only,
disclose the portion of your development activities currently located
in China.
22. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Leon O. Moulder, Jr.
Zenas BioPharma, Inc.
February 21, 2024
Page 5
Please contact Li Xiao at 202-551-4391 or Angela Connell at 202-551-3426
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
FirstName LastNameLeon O. Moulder, Jr.
Division of
Corporation Finance
Comapany NameZenas BioPharma, Inc.
Office of Life
Sciences
February 21, 2024 Page 5
cc: Nicholas Roper, Esq.
FirstName LastName