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United States securities and exchange commission logo
May 13, 2021
Hing C. Wong, Ph.D.
Chief Executive Officer
HCW Biologics Inc.
2929 N. Commerce Parkway
Miramar, FL 33025
Re: HCW Biologics Inc.
Draft Registration
Statement on Form S-1
Submitted April 16,
2021
CIK No. 0001828673
Dear Dr. Wong:
We have reviewed your draft 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 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 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 the information you provide in response to these
comments 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. We note your statement
on pages 1, 78 and 95 that you will initiate your Phase 1b/2 trial
"working with leading
institutions affiliated with the National Cancer Institute." Please
revise your disclosure
in each section to provide more detail regarding these relationships,
including the names of
the parties and a discussion of any contractual agreements in
place. In addition,
please provide the same level of disclosure in relation to your
statements that you
have "extensive relationships at NCI-Designated Comprehensive
Cancer Centers that
have high-interest in participating in [y]our clinical trials."
Hing C. Wong, Ph.D.
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
Comapany
May NameHCW Biologics Inc.
13, 2021
May 13,
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FirstName LastName
2. Given your product candidates are at the preclinical stage of
development, your belief that
your approach has the potential to "fundamentally change" the
treatment of age-related
diseases and "to improve the efficacy and safety of chemotherapies for
cancer" seems
premature. Please either provide support for these statements or
remove them from the
prospectus.
3. We note your statement on page 1 regarding your focus on developing
first-in-class
immunotherapies and additional first-in-class" references
elsewhere in the prospectus.
Use of this term suggests your product candidate will be effective and
is likely to be
approved by the FDA. Please delete these references throughout your
registration
statement.
4. In paragraph three, you disclose the investigator involved in the
potential investigator-
sponsored investigational new drug ( IND ) [sic] will be submitted
to study HCW9218 as
an adjunct to chemotherapy in patients with solid tumors (breast,
ovarian, prostate, and
colorectal cancers)." Identify any agreements with the investigator
and clarify any access
you have to the data generated during the trial or whether you have
any control over the
trial.
5. We note you describe yourself as a clinical-stage company, but in the
second and third
paragraphs you state that you are preparing your lead product
candidate for clinical trials
in the second half of 2021 and that both of your lead product
candidates, HCW9218 and
HCW9302, are preclinical. As the clinical-stage products to which you
refer are those you
have out-licensed to Wugen, HCCW9201 and HCW9206, revise to remove
them from
your pipeline table. We note that Wugen will fund all future
clinical development and
commercialization activities for any indications utilizing the
licensed molecules cell
therapy as covered by the license, as disclosed on page 106. Please
also revise your
references to the company as a "clinical stage" company to more
accurately characterize it
as a "preclinical stage" company.
6. Please revise the pipeline table to remove the lead op column.
7. In the Summary, you disclose the potential timing of clinical trials
without addressing
whether you have submitted any INDs. Revise the summary to clarify
when you plan to
submit an IND for HCW9218 for pancreatic cancer. In this regard, we
note the disclosure
on page 100 that you plan to do so in the second quarter of 2021. To
the extent this IND
will only address pancreatic cancer, as disclosed on page 104, revise
page 100 (which
includes additional indications) to clarify. Please also clarify if
you have submitted an
IND for HCW9302, or if not, when you plan to do so.
Risk Factors
Risks Related to our Financial Position and Need for Additional Capital, page
10
8. On page 13 you disclose you experienced delays in the development
of HCW9218 as a
result of the ongoing pandemic, including delays with certain third
party vendors. Please
revise to explain the nature of those delays and the degree to which
they have
Hing C. Wong, Ph.D.
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
Comapany
May NameHCW Biologics Inc.
13, 2021
May 13,
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FirstName LastName
resolved. Also clarify in what way you expect your clinical
development program
timelines may continue to be negatively affected by COVID-19 more
specifically than
the list of potential issues in the risk factor, given that you have
experienced delays thus
far and potentially continue to do so. Finally, as it has been over
one year since the
pandemic began, revise this risk factor to reflect current
information. For example,
uncertainty based on the ultimate geographic spread of the disease
is outdated.
Risks Related to Our Dependence on Third Parties, page 42
9. Please disclose the third-party manufacturer you rely on to produce
your drug product
candidates, as discussed on page 45. Refer to Item 101(h)(4)(v) of
Regulation S-K. As it
appears you are substantially dependent on this supplier, file the
agreement with this
manufacturer as an exhibit pursuant to Item 601(b)(10)(ii)(B) of
Regulation S-K or
explain why such filing is not required.
Risks Related to Ownership of our Common Stock, page 59
10. Please revise this risk factor on page 66-67 to disclose that there is
a risk that your
exclusive forum provisions may result in increased costs for investors
to bring a claim,
and that the provisions may discourage claims or limit investors
ability to bring a claim in
a judicial forum that they find favorable.
Use of Proceeds, page 72
11. You disclose one amount of funds to advance the development of
both your lead
product candidates together, specifying some uses of those funds for
HCW9218. Please
revise your disclosure to quantify the amount of proceeds you expect
to use to fund each
of your product candidates and indicate how far it will allow you to
proceed with the
continued development of each of your product candidates. Please also
disclose the
sources of other funds needed to reach regulatory approval and
commercialization for
each product candidate. Refer to Instruction 3 to Item 504 of
Regulation S-K.
Critical Accounting Policies, Significant Judgements and Estimates
Determination of Fair Value of Common Stock, page 92
12. 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. Please
discuss with the staff
how to submit your response.
Intellectual Property, page 107
13. Please revise your intellectual property disclosure to clearly
describe on an individual or
patent family basis the type of patent protection granted for each
product, the expiration
Hing C. Wong, Ph.D.
HCW Biologics Inc.
May 13, 2021
Page 4
year of each patent held, and the jurisdiction of each patent. Please
clearly distinguish
between owned patents and patents out-licensed to third parties. In
this regard it may be
useful to provide tabular disclosure.
License Agreements, page 109
14. We note the following statement on page 110: "We retained all other
rights and use of the
licensed molecules not granted under the Wugen License, including
regulatory T cell-
based cellular therapy, injectable rights, and manufacturing rights."
Please revise
this disclosure to clarify what aspect of the technology was
out-licensed. In addition, we
note the termination of the Wugen license agreement is tied to the
last-to-expire valid
patent claim. Please either disclose the out-licensed patent
expiration here or in the
Intellectual Property section immediately preceding the license
discussion.
Executive Compensation
Employment, Severance, and Change of Control Agreements, page 135
15. We note your statement on page 135 that you have no offer letter or
employment
agreement with Dr. Hing Wong. However, the exhibit index lists exhibit
10.6 as an offer
letter between Hing C. Wong and the registrant. Please reconcile.
Principal Stockholders, page 149
16. Please revise the footnotes to your table to identify the natural
persons who are
the beneficial owners of the shares held by the 5% or greater
stockholders.
Exhibits
17. We note that you have agreed to issue warrants to Kingswood Capital
Markets upon the
closing of the offering. Please file the warrant agreement as an
exhibit.
General
18. Please provide us with copies of all written communications, as defined
in Rule 405 under
FirstName LastNameHing C. Wong, Ph.D.
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
Comapany NameHCW
potential Biologics
investors Inc.on Section 5(d) of the Securities Act,
whether or not they
in reliance
May 13,retain
2021copies
Page 4of the communications.
FirstName LastName
Hing C. Wong, Ph.D.
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
Comapany
May NameHCW Biologics Inc.
13, 2021
May 13,
Page 5 2021 Page 5
FirstName LastName
You may contact Christine Torney at (202) 551-3652 or Brian Cascio at
(202) 551-
3676 if you have questions regarding comments on 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,
Division of
Corporation Finance
Office of Life
Sciences
cc: William L. Hughes, Esq.