View:
United States securities and exchange commission logo
May 28, 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.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted May 16,
2024
CIK No. 0001953926
Dear Leon O. Moulder:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your response
to prior comment 4 and reissue in part. Please revise this section to
disclose the quantity
and types of serious adverse events observed while conducting your
clinical trials of
obexelimab.
Risk Factors
We currently rely on a single third-party manufacturer, WuXi Biologics,
to supply our product
candidates..., page 58
2. Please revise this risk
factor to clarify if WuXi Biologics solely holds any of the necessary
Leon O. Moulder, Jr.
Zenas BioPharma, Inc.
May 28, 2024
Page 2
intellectual property, technology or know-how required to manufacture
your product
candidates.
The operations of our suppliers, many of which are located outside of the
United States,
including our current sole CMO..., page 62
3. We note your statement that you would be potentially restricted from
entering into long-
term "commercial arrangements" with WuXi Biologics if the proposed
BIOSECURE Act
is enacted. Please clarify if that would include sourcing drug product
from WuXi
Biologics for clinical or commercial use and disclose the resulting
risks to investors. Your
revisions should also discuss any steps you have taken to mitigate these
risks, such as
evaluating potential replacement contract manufacturing organizations in
the United
States or European Union.
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
May 28, 2024 Page 2
cc: Nicholas Roper, Esq.
FirstName LastName