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HCW Biologics Inc.
Response Received
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HCW Biologics Inc.
Response Received
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HCW Biologics Inc.
Response Received
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HCW Biologics Inc.
Response Received
7 company response(s)
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HCW Biologics Inc.
Response Received
1 company response(s)
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Company responded
2021-05-26
HCW Biologics Inc.
References: May 13, 2021
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2025-05-09 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2025-05-01 | SEC Comment Letter | HCW Biologics Inc. | DE | 377-07951 | Read Filing View |
| 2025-04-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2025-04-08 | SEC Comment Letter | HCW Biologics Inc. | DE | 333-286409 | Read Filing View |
| 2022-08-25 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2022-08-24 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-16 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-16 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-05-26 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-05-13 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-01 | SEC Comment Letter | HCW Biologics Inc. | DE | 377-07951 | Read Filing View |
| 2025-04-08 | SEC Comment Letter | HCW Biologics Inc. | DE | 333-286409 | Read Filing View |
| 2022-08-24 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-05-13 | SEC Comment Letter | HCW Biologics Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2025-05-09 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2025-04-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2022-08-25 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-16 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-16 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
| 2021-05-26 | Company Response | HCW Biologics Inc. | DE | N/A | Read Filing View |
2025-05-13 - CORRESP - HCW Biologics Inc.
CORRESP
1
filename1.htm
CORRESP
May 13, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: HCWB Biologics Inc. Registration Statement on Form S-1 File No. 333-287136 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Maxim Group LLC (“Maxim”), as placement agent, hereby concurs in the request by HCW Biologics Inc. that the effective date of the above-referenced Registration Statement be accelerated to 5:00 PM, Eastern Time, on Tuesday, May 13, 2025, or as soon thereafter as may be practicable. Maxim affirms that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
Maxim Group LLC
By:
_/s/ Ritesh Veera ________________
Name: Ritesh Veera Title: Co-Head of Investment Banking
{01524529.DOCX.2}
2025-05-09 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP May 9, 2025 VIA EDGAR AND E-MAIL Mr. Jason Drory Office of Life Sciences Division of Corporate Finance U.S. Securities and Exchange Commission 100 F. Street, N.E. Washington, DC 20549-7010 Re: HCW Biologics Inc. Registration Statement on Form S-1; Commission File No. 333-287136 Dear Mr. Drory: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, HCW Biologics Inc. (the “Company”) hereby requests that the effectiveness of the Company’s Registration Statement on Form S-1 (File No. 333-287136) be accelerated by the U.S. Securities and Exchange Commission to 5:00 p.m. Eastern Time on Tuesday, May 13, 2025, or as soon thereafter is practicable. The Company hereby authorizes James Groth of Clark Hill PLC to orally modify or withdraw this request for acceleration. Please contact Mr. Groth at (312) 701-6830 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Thank you for your courtesy and cooperation in this matter. Very truly yours, HCW BIOLOGICS INC. By: /s/ Hing C. Wong Hing C. Wong, Founder and CEO HCW Biologics acceleration request for S-1 May 2025
2025-05-01 - UPLOAD - HCW Biologics Inc. File: 377-07951
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 1, 2025 Hing Wong 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 28, 2025 CIK No. 0001828673 Dear Hing Wong: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: James Groth </TEXT> </DOCUMENT>
2025-04-15 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP April 15, 2025 VIA EDGAR AND E-MAIL Mr. Jason Drory Office of Life Sciences Division of Corporate Finance U.S. Securities and Exchange Commission 100 F. Street, N.E. Washington, DC 20549-7010 Re: HCW Biologics Inc. Registration Statement on Form S-1; Commission File No. 333-286409 Dear Mr. Drory: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, HCW Biologics Inc. (the “Company”) hereby requests that the effectiveness of the Company’s Registration Statement on Form S-1 (File No. 333-286409) be accelerated by the U.S. Securities and Exchange Commission to 3:00 p.m. Eastern Time on Wednesday, April 16, 2025, or as soon thereafter is practicable. The Company hereby authorizes James Groth of Clark Hill PLC to orally modify or withdraw this request for acceleration. Please contact Mr. Groth at (312) 701-6830 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Thank you for your courtesy and cooperation in this matter. Very truly yours, HCW BIOLOGICS INC. By: /s/ Hing C. Wong Hing C. Wong, Founder and CEO HCW Biologics acceleration request for S-1 April 2025 1
2025-04-08 - UPLOAD - HCW Biologics Inc. File: 333-286409
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 8, 2025 Hing Wong Chief Executive Officer HCW Biologics Inc. 2929 N Commerce Parkway Miramar, FL 33025 Re: HCW Biologics Inc. Registration Statement on Form S-1 Filed April 7, 2025 File No. 333-286409 Dear Hing Wong: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jim Groth </TEXT> </DOCUMENT>
2022-08-25 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP August 25, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Conlon Danberg Re: HCW Biologics Inc. Registration Statement on Form S-3 File No. 333-266991 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, HCW Biologics Inc. (the “Company”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-referenced Registration Statement on Form S-3 to become effective on Friday, August 26, 2022, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter. The Company hereby authorizes William L. Hughes of Orrick, Herrington & Sutcliffe LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. The Company requests that it be notified of such effectiveness by a telephone call to William L. Hughes of Orrick, Herrington & Sutcliffe LLP at (415) 773-5720. Very truly yours, HCW BIOLOGICS INC. By: /s/ Hing C. Wong Name: Hing C. Wong, Ph.D. Title: Chief Executive Officer and Director cc: William L. Hughes, Orrick, Herrington & Sutcliffe LLP
2022-08-24 - UPLOAD - HCW Biologics Inc.
United States securities and exchange commission logo
August 24, 2022
Rebecca Byam
Chief Financial Officer
HCW Biologics Inc.
2929 N Commerce Parkway
Miramar, FL 33025
Re:HCW Biologics Inc.
Registration Statement on Form S-3
Filed August 19, 2022
File No. 333-266991
Dear Ms. Byam:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Conlon Danberg at 202-551-4466 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: William L. Hughes, Esq.
2021-07-16 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP 2929 N Commerce Parkway Miramar, FL 33025 July 16, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Abby Adams Laura Crotty Re: HCW Biologics Inc. Registration Statement on Form S-1 File No. 333-256510 REQUEST FOR ACCELERATION OF EFFECTIVENESS Acceleration Request Requested Date: July 19, 2021 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, HCW Biologics Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the Company’s Registration Statement on Form S-1 (File No. 333-256510) effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Company hereby authorizes William L. Hughes, who is an attorney with the Company’s outside legal counsel, Orrick, Herrington & Sutcliffe LLP, to orally modify or withdraw this request for acceleration. The Company requests that it be notified of such effectiveness by a telephone call to Mr. Hughes at (415) 773-5720. [Signature page follows] Sincerely, HCW BIOLOGICS INC. By: /s/ Rebecca Byam Name: Rebecca Byam Title: Chief Financial Officer cc: William L. Hughes, Esq, Orrick, Herrington & Sutcliffe LLP Scott M. Iyama, Esq., Orrick, Herrington & Sutcliffe LLP Hing C. Wong, HCW Biologics Inc. Rebecca Byam, HCW Biologics Inc.
2021-07-16 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP EF Hutton, Division of Benchmark Investments, LLC 590 Madison Avenue, 39th Floor New York, NY 10022 July 16, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Ms. Abby Adams Re: HCW Biologics, Inc. Registration Statement on Form S-1 Filed May 26, 2021 File No. 333-256510 Dear Ms. Adams: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), we, as representative of the underwriters of the proposed public offering of securities of HCW Biologics, Inc. (the “Company”), hereby join the Company’s request that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on Monday, July 19, 2021, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Securities Act, we, as representative of the underwriters, wish to advise you that there will be distributed to each underwriter, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, EF Hutton, Division of Benchmark Investments, LLC By: /s/ Sam Fleischman Name: Sam Fleischman Title: Supervisory Principal
2021-07-15 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP 2929 N Commerce Parkway Miramar, FL 33025 July 15, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Abby Adams Laura Crotty Re: HCW Biologics Inc. Registration Statement on Form S-1 File No. 333-256510 Ladies and Gentlemen: HCW Biologics Inc. hereby withdraws its request that the Securities and Exchange Commission declare the above-referenced Registration Statement effective as of 4:00 p.m., Eastern Time, on July 15, 2021 that was contained in its letter filed as correspondence via EDGAR on July 13, 2021. Sincerely, HCW BIOLOGICS INC. By: /s/ Rebecca Byam Name: Rebecca Byam Title: Chief Financial Officer cc: William L. Hughes, Esq, Orrick, Herrington & Sutcliffe LLP Scott M. Iyama, Esq., Orrick, Herrington & Sutcliffe LLP Hing C. Wong, HCW Biologics Inc. Rebecca Byam, HCW Biologics Inc.
2021-07-13 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP 2929 N Commerce Parkway Miramar, FL 33025 July 13, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Abby Adams Laura Crotty Re: HCW Biologics Inc. Registration Statement on Form S-1 File No. 333-256510 REQUEST FOR ACCELERATION OF EFFECTIVENESS Acceleration Request Requested Date: July 15, 2021 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, HCW Biologics Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the Company’s Registration Statement on Form S-1 (File No. 333-256510) effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Company hereby authorizes William L. Hughes, who is an attorney with the Company’s outside legal counsel, Orrick, Herrington & Sutcliffe LLP, to orally modify or withdraw this request for acceleration. The Company requests that it be notified of such effectiveness by a telephone call to Mr. Hughes at (415) 773-5720. [Signature page follows] Sincerely, HCW BIOLOGICS INC. By: /s/ Rebecca Byam Name: Rebecca Byam Title: Chief Financial Officer cc: William L. Hughes, Esq, Orrick, Herrington & Sutcliffe LLP Scott M. Iyama, Esq., Orrick, Herrington & Sutcliffe LLP Hing C. Wong, HCW Biologics Inc. Rebecca Byam, HCW Biologics Inc.
2021-07-13 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP EF Hutton, Division of Benchmark Investments, LLC 590 Madison Avenue, 39th Floor New York, NY 10022 July 13, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Ms. Abby Adams Re: HCW Biologics, Inc. Registration Statement on Form S-1 Filed May 6, 2021 File No. 333-256510 Dear Ms. Adams: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), we, as representative of the underwriters of the proposed public offering of securities of HCW Biologics, Inc. (the “Company”), hereby join the Company’s request that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on Thursday, July 15, 2021, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Securities Act, we, as representative of the underwriters, wish to advise you that there will be distributed to each underwriter, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, EF Hutton, Division of Benchmark Investments, LLC By: /s/ Sam Fleischman Name: Sam Fleischman Title: Supervisory Principal
2021-06-15 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP June 15, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Orrick, Herrington & Sutcliffe LLP The Orrick Building 405 Howard Street San Francisco, CA 94105-2669 +1 415 773 5700 orrick.com Attn: Christine Torney Brian Cascio Abby Adams Laura Crotty Re: HCW Biologics Inc. Registration Statement on Form S-1 Filed May 26, 2021 File No. 333-256510 Ladies and Gentlemen: On behalf of HCW Biologics Inc. (“HCW” or the “Company”), we submit this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated June 10, 2021 (the “Comment Letter”) with respect to the Company’s above referenced Registration Statement on Form S-1 (the “Registration Statement”). Concurrently with the submission of this response letter, the Company has revised the Registration Statement and is filing via EDGAR Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”). In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Amended Registration Statement to update other disclosures. For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter, the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s response. In the responses below, page number references are to the Amended Registration Statement. Draft Registration Statement on Form S-1 General Prospectus Summary Overview 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. June 15, 2021 Page Two Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 2, 81, 101 and 106 of the Amended Registration Statement as requested. 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 and research without including conclusions or speculation related to safety or efficacy. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 2, 3, 5, 75, 80, 81, 88, 99, 105, 106, 108, 109 and 112 of the Amended Registration Statement as requested. 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. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 2, 8, 81, 82, 99, 101, 104, 106, 108 and 110 of the Amended Registration Statement as requested. 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. Response: In light of the Staff’s comment, the Company has changed references to “clinical stage” to “preclinical stage” on pages 1, 80, 100, F-7 and F-3 of the Amended Registration Statement and removed the Phase 2 clinical trials for HCW9201 from the Pipeline chart that appears on pages 3 and 108 of the Amended Registration Statement. 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 June 15, 2021 Page Three 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 Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 1, 81, 100, 109, and 111 of the Amended Registration Statement as requested. In addition, the Company has expanded on language in the Risk Factors to the Development and Clinical Testing of our Products to further explain risks associated with FDA delaying approval of an IND or outright rejection of IND, failure to reach agreements with 7 NCI designated clinical sites we are negotiating with, delay or failure to reach an agreement with sponsor for basket trial to evaluate HCW9218 in solid tumors in the revised disclosures on pages 22-24 and 26 of the Amended Registration Statement. 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 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). Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 84 of the Amended Registration Statement to clarify why the Company did not deliver the materials and the implications thereof. In addition, the Company supplementally advises the Staff that the orders placed during the three months ended March 31, 2021 were not delivered because the manufacturing process was not complete and delivery, and acceptance did not occur. The mutual arrangement between the Company and Wugen related to these materials (provided for under the terms of the Wugen license) allows for a delivery date subsequent to March 31, 2021. Accordingly, the Company believes there are no implications with respect to the ongoing satisfaction of its performance obligation at March 31, 2021. 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. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 161-162 of the Amended Registration Statement as requested. June 15, 2021 Page Four If you have any questions regarding this letter, please do not hesitate to contact me at (415) 773-5720 with any questions or further comments. Sincerely, /s/ William L. Hughes, Esq. William L. Hughes, Esq. cc: Scott M. Iyama, Esq., Orrick, Herrington & Sutcliffe LLP Richard A. Friedman, Esq., Sheppard Mullin, LLP Stephen A. Cohen, Esq., Sheppard Mullin, LLP Hing C. Wong, HCW Biologics Inc. Rebecca Byam, HCW Biologics Inc.
2021-06-10 - UPLOAD - HCW Biologics Inc.
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
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
June 10, 2021 Page 2
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
June 10, 2021
Page 2
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
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
June 10, 2021 Page 3
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: William L. Hughes, Esq.
2021-06-04 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP June 4, 2021 Orrick, Herrington & Sutcliffe LLP The Orrick Building 405 Howard Street San Francisco, CA 94105-2669 +1 415 773 5700 orrick.com U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Christine Torney Brian Cascio Abby Adams Laura Crotty Re: HCW Biologics Inc. Registration Statement on Form S-1 Filed May 26, 2021 File No. 333-256510 Ladies and Gentlemen: On behalf of HCW Biologics Inc. (the “Company”), in response to Comment 12 contained in the letter dated May 13, 2021 (the “Comment Letter”) of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) we provide the proposed preliminary price range of the shares of the Company’s common stock (“Common Stock”) to be offered in the Company’s proposed initial public offering (“IPO”) pursuant to the Company’s Registration Statement on Form S-1 (No. 333-256510), initially filed with the Commission on May 26, 2021 (the “Registration Statement”). The numbered paragraph below corresponds to the numbered comment in the Comment Letter and the Staff’s comments are presented in bold italics. The Company is requesting confidential treatment of the responses set forth in Attachment A to this letter (as detailed in the Company’s written confidential treatment request accompanying Attachment A, which has been submitted under separate cover), pursuant to Regulation 200.83 of the Commission (17 C.F.R. §200.83). 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. June 4, 2021 Page Two Response: To assist the Staff in its evaluation of the Company’s determination of the fair value of its Common Stock, stock compensation disclosures, and certain other matters, the Company supplementally advises the Staff that on May 27, 2021, Kingswood Capital Markets, a division of Benchmark Investments, Inc. (the “Lead Underwriter”), the lead underwriter for the IPO advised the Company that, based on a number of factors, including the progress of the Company’s preclinical studies and IND-enabling activities, impending clinical trials, other developments in the Company’s business, and current market conditions, it anticipated that the underwriters would recommend to the Company a preliminary price range of $[A1] to $[A2] per share (the “Preliminary Price Range”).1 The Preliminary Price Range does not take into account any discount for the current lack of liquidity for the Common Stock and assumes a successful IPO with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately-held company or being sold in an acquisition transaction. As is typical for initial public offerings, the Preliminary Price Range was not derived using a formal determination of fair value, but was determined as a result of discussions among representatives of the Company and the Lead Underwriter. During these discussions, the parties considered quantitative factors, as well as non-quantitative factors, such as the valuations of recently completed public offerings and evaluating those issuers’ respective stages of development as compared to the Company, the current valuations of public companies at a similar stage of development as the Company taking into account the number of programs of those companies as compared to the Company and recent market conditions. Prior to May 27, 2021, the Lead Underwriter had not provided the Company with any specific estimated price range. The Company has historically determined the fair value of its Common Stock using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. In addition, the Company’s Board of Directors (the “Board”) considered numerous objective and subjective factors, along with input from management and third-party valuations, to determine the fair value of the Common Stock as further disclosed on page 96 of the Registration Statement. Historical Fair Value Determination and Methodology To facilitate the Staff’s review, the table below contains a complete list of shares of Common Stock underlying all stock options granted since the beginning of the Company’s most recently completed fiscal year, the year ended December 31, 2020, together with the exercise price per share and the underlying Common Stock fair value per share used for financial reporting purposes. 1 The Company will include a narrower bona fide price range in an amendment to the Registration Statement that will precede the commencement of the Company’s road show, which the Company expects to be a two-dollar range within the Price Range (after giving effect to a reverse stock split prior to commencement of the road show). The parameters of the bona fide price range to be included in the Registration Statement at the time of the commencement of the Company’s road show will be subject to then-current market conditions, continuing discussions with the Lead Underwriter and material business developments impacting the Company, and due to the volatility in the securities markets. June 4, 2021 Page Three Grant date Number of shares Exercise or Purchase Price per share Estimated fair value of common stock per share on grant date 1 March 31, 2020 30,000 $ 0.06 $ 0.06 2 June 16, 2020 8,000 $ 0.06 $ 0.06 3 September 29, 20202 12,000 $ 0.06 $ 0.06 4 September 29, 2020 10,000 $ 0.09 $ 0.09 5 December 22, 2020 481,000 $ 0.09 $ 0.09 6 December 24, 2020 75,000 $ 0.09 $ 0.09 Total 616,000 The Board determined the fair value of the Common Stock based on several factors, which may include any or all of the listed factors on page 96 of the Registration Statement. Beginning with the issuance of shares of Series B Preferred Stock (the “Series B Financing”) in December 2019, as a factor in its determination, the Board obtained contemporaneous valuation assessments utilizing the assistance of an independent third-party valuation specialist whenever it anticipated granting a material amount of stock options. At each grant date when the Board did not obtain a contemporaneous third-party valuation assessment, the Board considered whether any events occurred that would trigger any material changes to the Company’s business or would require adjustment to the estimated fair value from the previous valuation date and incorporated, as appropriate, these events into each of its valuation determinations. March and June 2020 Option Grants Prior to granting stock options in 2020, in connection with the Series B Financing in December 2019, the Board conducted a contemporaneous valuation assessment with the assistance of a third-party valuation specialist (the “December 2019 Valuation Assessment”). Based on a number of factors including a valuation analysis using the Option Pricing Method (“OPM”), the Board determined that the fair value of the Common Stock for stock options granted on December 19, 2019 was $0.06 per share. At the time of such valuation, in addition to the independent third-party valuation assessment and the recent completion of the arm’s-length Series B Financing, the Board also considered the following factors: • Including the shares issued in the Series B Financing, the Company had a cumulative liquidation preference of $18.2 million attributable to its outstanding shares of redeemable preferred stock (in addition to redemption rights and other rights, preference and privileges) pursuant to its certificate of incorporation; • Unaffiliated third parties negotiated the terms of, and purchased $9.5 million of the $12.6 million of shares of Series B preferred stock sold in, the Series B Financing at a purchase price of $0.45 per share. • All of the Company’s programs were pre-clinical. • The Company was in a discovery phase of building molecules under its internally-developed immunotherapy platform, and had not yet identified its lead product candidates or narrowed its strategic focus. 2 This grant was documented on September 29, 2020 but the terms of the grant were agreed to between the Company and the employee in January 6, 2020. June 4, 2021 Page Four • The Company had made significant progress toward building and protecting its intellectual property through provisional patent filings. • The Company began cGMP manufacturing, including master cell banking and feasibility runs. • The Company had grown headcount from 11 to 39, including the hiring of its Chief Scientific Officer, Senior Vice President of Business Development, Vice President of Development, Chief Financial Officer and other senior administrative personnel. Accordingly, at each grant date in March and June 2020, the Board determined that the fair value of the Common Stock was $0.06 per share because no major event had occurred since December 2019 that would trigger a change in the fair value of the Common Stock. In particular, the Company had not completed a material financing. The difference between the fair values for the Common Stock as of March 31, 2020 and June 16, 2020 and the Preliminary Price Range is attributable to the factors identified by the Board in the December 2019 Valuation Assessment, including without limitation the fact that the Company issued a total of $18.2 million of redeemable preferred stock, with redemption and liquidation preferences (in addition to other rights, preferences and privileges), and the Series B Financing was led by new investors, who purchased $9.5 million of the $12.6 million of shares of Series B preferred stock sold at a purchase price of $0.45 per share. Additionally, the Company further notes that it did not contemplate commencing an initial public offering process at either grant date. September 2020 Option Grant The next date on which stock options were granted coincided with the first closing of the Company’s Series C preferred stock financing (the “Series C Financing”) on September 29, 2020. The Series C Financing was completed in series of closings from September to November 2020, with the majority of the capital raised from existing investors, including a minority investment by Dr. Hing C. Wong, the Company’s founder and Chief Executive Officer, at a purchase price of $0.88 per share (the “Series C Preferred Stock Price”). In connection with its grant of options to purchase 10,000 shares, the Board conducted a valuation assessment of the Common Stock without the use of a third-party valuation specialist, and determined that the fair value of a share of Common Stock on the grant date was $0.09 per share. The difference between the fair values for the Common Stock as of September 29, 2020 and the Preliminary Price Range is attributable to the stage of the Company’s development and the substantial liquidation preferences of the redeemable preferred stock, as described above. The Company further notes that it did not contemplate commencing an initial public offering process at the grant date. December 2020 Option Grants Based on a number of factors including a valuation analysis using the OPM, the Board conducted a contemporaneous valuation assessment with the assistance of a third-party valuation specialist and determined that the fair value of the Common Stock for equity awards granted on December 22, 2020 and December 24, 2020 was $0.09 per share. At the time of the valuation, in addition to the independent third-party valuation assessment and the recent completion of the Series C Financing, the Board also considered the following factors: June 4, 2021 Page Five • Including the shares issued in the Series C Financing, the Company had a cumulative liquidation preference of $29.2 million attributable to its outstanding shares of redeemable preferred stock (in addition to redemption rights and other rights, preference and privileges) pursuant to its certificate of incorporation; • Series C Financing was primarily led by existing investors, with a minority of the funding coming from new investors. • The Company had recently pivoted its strategy to focus on injectable immunotherapeutics and out-license applications or molecules that were outside its focus area, such as cell therapy based applications for HCW9201 and HCW9206, which had been licensed to Wugen, Inc. in December 2020, generating revenues and other value for the Company. • The Company initiated IND-enabling studies for one of its lead product candidates, HCW9218. • The Company’s other programs were pre-clinical or discovery stage. • The Company had begun to make progress with cGMP manufacturing and building up its supply of clinical materials for upcoming clinical trials. The difference between the fair values for the Common Stock as of December 22, 2020 and December 24, 2020 and the Preliminary Price Range is attributable to, among other things, the stage of the Company’s development, including its then-recent change in strategy to begin focusing on injectable immunotherapeutics, the substantial redemption rights and liquidation preferences of the redeemable preferred stock, and the other factors as described above. While the Company out-licensed compounds to Wugen, Inc. at the time of the valuation assessment, the Board did not believe this event meaningfully impacted the fair value of the Common Stock because the entry into the license with Wugen, Inc. had been contemplated at the time of the Series C Financing. The Company further notes that it did not contemplate commencing an initial public offering process at either grant date. The information identified as [A1] and [A2] in the Company’s response to the Staff’s comment are set forth in Attachment A, which has been provided to the Staff under separate cover. Confidential treatment has been requested for Attachment A pursuant to Regulation 200.83 of the Commission (17 C.F.R. §200.83). June 4, 2021 Page Six If you have any questions regarding this letter, please do not hesitate to contact me at (415) 773-5720 with any questions or further comments. Sincerely, /s/ William L. Hughes, Esq. William L. Hughes, Esq. cc: Hing C. Wong, HCW Biologics Inc. Rebecca Byam, HCW Biologics Inc. Nicole Valdivieso, HCW Biologics Inc. Becky Linnett, Grant Thornton LLP Scott M. Iyama, Esq., Orrick, Herrington & Sutcliffe LLP Richard A. Friedman, Esq., Sheppard Mullin, LLP Stephen A. Cohen, Esq., Sheppard Mullin, LLP Exhibit: Attachment A (provided under separate cover)
2021-05-26 - CORRESP - HCW Biologics Inc.
CORRESP 1 filename1.htm CORRESP May 26, 2021 U.S. Securities and Exchange Commission Orrick, Herrington & Sutcliffe LLP The Orrick Building 405 Howard Street San Francisco, CA 94105-2669 +1 415 773 5700 orrick.com Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Christine Torney Brian Cascio Abby Adams Laura Crotty Re: HCW Biologics Inc. Draft Registration Statement on Form S-1 Submitted April 16, 2021 CIK No. 0001828673 Ladies and Gentlemen: On behalf of HCW Biologics Inc. (“HCW” or the “Company”), we submit this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 13, 2021 (the “Comment Letter”) with respect to the Company’s above referenced Draft Registration Statement on Form S-1 (the “Draft Registration Statement”). Concurrently with the submission of this response letter, the Company has revised the Draft Registration Statement and is publicly filing via EDGAR a revised Registration Statement on Form S-1 (the “Registration Statement”). In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Registration Statement to update other disclosures. For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter, the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s response. In the responses below, page number references are to the Registration Statement. Draft Registration Statement on Form S-1 General Prospectus Summary Overview 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 May 26, 2021 Page Two 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.” Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 1, 2, 80, 99 and 105 of the Registration Statement to clarify its working relationships with these institutions. The Company supplementally advises the Staff that it is actively working with seven leading National Cancer Institute-Designated Comprehensive Cancer Centers to, among other things, establish clinical development strategies for the Company’s drug product candidates and to refine study protocols for pancreatic, ovarian, breast, prostate and colorectal cancer trials. The related clinical trial agreements are not expected to be entered into prior to the acceptance of the investigator-initiated IND against breast, ovarian, prostate, and colorectal cancers by the FDA. As such, the Company believes it would be premature to name these institutions prior to entry into clinical trial agreements. 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 1, 2, 81, 99 and 101 of the Registration Statement to revise usage of “fundamentally change” as requested. To support the statement “to improve the efficacy and safety of chemotherapies for cancer,” the Company supplementally advises the Staff that, as further explained below, the Company has demonstrated the role of its immunotherapeutic molecule, HCW9218, in eliminating TIS cells and reducing the SASP in tumors and normal tissues in multiple animal models. In addition, the Company has demonstrated that when HCW9218 is combined with checkpoint inhibitors, there is potential to achieve superior tumor growth control. The Company has concurrently submitted to the Staff under separate cover a scientific paper on a supplemental basis pursuant to Rule 418(b) as promulgated under the Securities Act of 1933, as amended (the “Securities Act”), for the use of the Staff in evaluating this support and requests that the Staff destroy this supplemental information upon completion of its review. The Company employed HCW9218, comprised of TGF-ß receptor II and IL-15/IL-15 receptor α domain, in combination with docetaxel (DTX) in a syngeneic B16F10 murine melanoma model. DTX induced TIS B16F10 cells in vitro and in vivo and these TIS tumor cells can re-enter the cell cycle with greatly enhanced invasiveness and stemness characteristics. Similar results were seen with a xenograft human SW1990 pancreatic tumor model following treatment with gemcitabine plus nab-paclitaxel. TIS B16F10 and SW1990 cells were susceptible to HCW9218-activated natural killer cell cytotoxicity and HCW9218 treatment significantly enhanced anti-tumor chemotherapy activity in these models. HCW9218 treatment also increased CD8+ T cell infiltration into DTX-treated B16F10 tumors to potentiate the efficacy of anti-PD-L1 therapy. Collectively, the Company’s findings uncover a novel therapeutic strategy by targeting TIS cancer cells with an immunotherapeutic in tandem with immune checkpoint blockade. The Company is also submitting evidence that HCW9218 treatment was able to decrease TIS and lower SASP factors in normal tissues in tumor-bearing mice caused by off-target effects of chemotherapy. Thus, the Company believes HCW9218 has the potential to enhance the anti-tumor efficacy of chemotherapy while reducing its TIS-mediated adverse effects on normal tissues. May 26, 2021 Page Three 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 1, 81, 99, 104 and F-7 of the Registration Statement as requested. 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on page 2 of the Registration Statement as requested. The Company further refers the Staff to its response to Comment 1 above. 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, HCW9201 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. Response: While the Company acknowledges that it has out-licensed its molecules (HCW9201 and HCW9206) that are in the clinical stage, the Company respectfully submits that it is a clinical stage company due to its involvement in the clinical development of these molecules. In this regard, the Company’s license agreement with Wugen provides that the Company and Wugen are close partners in the development of HCW9201 and HCW9206 for the ex-vivo generation of memory-like natural killer cells for cancer treatment, making the agreement more like a collaboration agreement than a typical out-license arrangement. By way of background, the Company’s relationship with Wugen is structured with the following attributes: • The current trial strategies for Acute Myeloid Leukemia (AML) were initially developed by the Company and Washington University in St. Louis (“WashU”), Wugen’s lead clinical site. May 26, 2021 Page Four Both phase 2 clinical trials for AML are currently taking place under an amendment to an IND application submitted by WashU many years ago. The Company will have access to all of the clinical data from these and other clinical studies performed using the licensed molecules. This data will be used by the Company to inform its future development of HCW9201 and HCW9206 for applications based on rights not transferred to Wugen under the terms of the license. The Company refers the Staff to its response to Comment 14 below for further discussion of rights not granted to Wugen under the terms of its license with the Company. • As the inventor of HCW9201 and HCW9206, the Company possesses the R&D know-how necessary to continue the clinical development of these molecules. Until commercialization begins, the Company will participate in the R&D of the licensed molecules providing its expertise. In addition, the Company continues to provide the proprietary process required for cGMP manufacturing for the licensed molecules, supported by quality control, quality assurance, drug product stability assessment, and Drug Master File submissions to the FDA. The Company will remain involved in the development of the licensed molecules through the Company’s participation on a Joint Steering Committee. Under the terms of the license agreement with Wugen, the Joint Steering Committee influences the clinical design, drug development strategies, and indications for the licensed molecules as well as receives updates of the status and results of on-going clinical studies. As further evidence of the Company’s on-going involvement in the development of the molecules under clinical trials, the Company supplementally advises the Staff that has co-authored a paper with Dr. Todd Fehniger on HCW9201, which was recently accepted by a peer-reviewed scientific publication, the AACR Journal Cancer Immunology Research. The paper describes the Company’s proprietary platform technology and characterization of the HCW9201 and its related molecules for cancer therapy. The Company has concurrently submitted to the Staff under separate cover a copy of this paper on a supplemental basis pursuant to Rule 418(b) as promulgated under the Securities Act for the use of the Staff in evaluating its claims as a clinical stage company and requests that the Staff destroy this supplemental information upon completion of its review. 6. Please revise the pipeline table to remove the “lead op” column. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the pipeline table on pages 3 and 106 of the Registration Statement as requested. 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 2 and 104 of the Registration Statement as requested. May 26, 2021 Page Five 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 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 15-16 of the Registration Statement as requested. 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on page 111 of the Registration Statement and has filed the Master Services Agreement as an exhibit to the Registration Statement as requested. 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. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on pages 68-69 of the Registration Statement as requested. 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 foreach product candidate. Refer to Instruction 3 to Item 504 of Regulation S-K. Response: The Company acknowledges the Staff’s comment and advises the Commission that it has revised the disclosure on page 74 of the Registration Statement as requested. May 26, 2021 Page Six 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
2021-05-13 - UPLOAD - HCW Biologics Inc.
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."
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
May 13, 2021 Page 2
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
May 13, 2021
Page 2
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
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
May 13, 2021 Page 3
FirstName LastNameHing C. Wong, Ph.D.
HCW Biologics Inc.
May 13, 2021
Page 3
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
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
May 13, 2021 Page 4
FirstName LastName
Hing C. Wong, Ph.D.
HCW Biologics Inc.
May 13, 2021
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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
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.
FirstName LastNameHing C. Wong, Ph.D.
Comapany NameHCW Biologics Inc.
May 13, 2021 Page 5
FirstName LastName
Hing C. Wong, Ph.D.
HCW Biologics Inc.
May 13, 2021
Page 5
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.