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United States securities and exchange commission logo
June 10, 2021
Hing C. Wong, Ph.D.
Chief Executive Officer
HCW Biologics Inc.
2929 N. Commerce Parkway
Miramar, FL 33025
Re: HCW Biologics Inc.
Registration
Statement on Form S-1
Filed May 26, 2021
File No. 333-256510
Dear Dr. Wong:
We have reviewed your registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary, page 1
1. We note your response
to our prior comment 1. To the extent your discussions with these
seven potential
partners are too preliminary to name them in the prospectus, please
balance your disclosure
by noting the uncertainty of whether you will be able to finalize
agreements with any of
these institutions and the implications thereof.
2. We note your response
to our prior comment 2 regarding your statements of safety and
efficacy. However, as
previously stated, safety and efficacy determinations are solely
within the FDA's
authority and they continue to be evaluated throughout all phases of
clinical trials.
Because the company's product candidates have not been evaluated by the
FDA in clinical trials,
please remove these and any such references in your prospectus. In
the Business section,
you may present objective data resulting from your animal models
Hing C. Wong, Ph.D.
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
Comapany
June NameHCW Biologics Inc.
10, 2021
June 10,
Page 2 2021 Page 2
FirstName LastName
and research without including conclusions or speculation related to
safety or efficacy.
3. We note your response to our prior comment 4. Please revise the
disclosure to clarify, if
true, that one of the institutions with whom you are in preliminary
discussions regarding
your clinical trials will also sponsor your IND, if those discussions
are successful. If this is
not the case, please identify the "investigator" who will sponsor your
trials.
4. We note your response to our prior comment 5 and we reissue the
comment. Your
response does not sufficiently establish a collaboration between the
company and Wugen,
with your disclosure making clear that the company has retained only
manufacturing and
supply rights, in addition to the economic terms of the out-license
agreement.
Therefore, these out-licensed products do not appear to be a part of
the
company's pipeline. In this regard, we note your disclosure on page
109 that "[a]ccording
to the terms of the Wugen license, Wugen will fund all future clinical
development and
commercialization activities for any indications utilizing the
licensed molecules for cell
therapy as covered by the license. We have the opportunity to receive
additional payments
for development and commercialization milestones as well as
single-digit royalties." We
also note from disclosure in the MD&A section and the notes to your
financial statements,
particularly Notes 7 and 12, that the Wugen License is accounted for
and characterized as
a license, not a collaboration agreement.
5. We note your response to our prior comment 7 and the related revisions
on pages 2 and
104. However, it remains unclear from this disclosure whether you have
an effective IND
related to the pancreatic cancer trials discussed. We further note
your statement on page
108 that you are planning to submit an IND in the second half of 2021
to initiate the Phase
1b/2 clinical trial of HCW9218 in patients with advanced and
metastatic pancreatic
cancer, clarifying that no effective IND exists. In light of this
statement, please revise your
disclosure in each place that you discuss the Phase 1b/2 trials to
make clear that you have
not yet submitted and the FDA has not yet accepted an IND related to
these trials, and the
implications thereof. Your disclosure should be balanced in stating
that the FDA may not
accept the IND and the process to follow if such is the case.
Further, your disclosure throughout the prospectus that you "are
preparing to initiate"
clinical trials creates the impression that the company is further
along in the development
process than it is (i.e., that effective INDs are in place). Revise
your disclosure in all
places in which potential clinical trials are discussed to accurately
characterize the process
leading up to the commencement of human trials and the prerequisites
thereto.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Components of our Results of Operations--Revenues , page 83
6. We note the following statement in the newly added disclosure on page
83: "As of March
31, 2021, Wugen ordered research and clinical grade materials, but
they were not
delivered." We also note that the company recognized deferred revenue
in relation to this
Hing C. Wong, Ph.D.
HCW Biologics Inc.
June 10, 2021
Page 3
order. Please clarify why the company did not deliver the materials and
the implications
thereof (e.g., breach of contract, financial penalties, cancellation of
order and return of
payment).
Principal Stockholders, page 159
7. We reissue comment 16 to the extent you have not identified the
beneficial owners of the
shares held by Pacific Treasure Global Limited or Axone Capital.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Christine Torney at (202) 551-3652 or Brian Cascio at
(202) 551-
3676 if you have questions regarding the financial statements and related
matters. Please contact
Abby Adams at (202) 551-6902 or Laura Crotty at (202) 551-7614 with any other
questions.
Sincerely,
FirstName LastNameHing C. Wong, Ph.D.
Division of
Corporation Finance
Comapany NameHCW Biologics Inc.
Office of Life
Sciences
June 10, 2021 Page 3
cc: William L. Hughes, Esq.
FirstName LastName