CORRESP Filing
CRESCENT BIOPHARMA, INC.
Date: April 28, 2025 · CIK: 0001253689 · Accession: 0001104659-25-040399
AI Filing Summary & Sentiment
File numbers found in text: 333-285035
Referenced dates: April 22, 2025
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CORRESP
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filename1.htm
Sidley Austin LLP
787 Seventh Avenue
New York, NY 10019
+1 212 839 5300
+1 212 839 5599 Fax
AMERICA
• ASIA PACIFIC •
EUROPE
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3628
Attention: Jessica Dickerson
Re:
GlycoMimetics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed April 4, 2025
File No. 333-285035
Ladies and Gentlemen,
On behalf of GlycoMimetics, Inc. (the “Company”),
we are submitting this letter to the Securities and Exchange Commission (the “SEC”) via EDGAR in response to the comment
letter from the staff of the SEC (the “Staff”), dated April 22, 2025, pertaining to the Company’s above-referenced
Amendment No. 1 to Registration Statement on Form S-4 (the “Registration Statement”). In connection with
such responses, the Company is concurrently filing Amendment No. 2 to the Registration Statement (the “Second Amended Registration
Statement”).
For your convenience, the Staff’s comments
are summarized in this letter, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated,
page references in the responses correspond to the page numbers in the Second Amended Registration Statement. Capitalized terms
used in this letter but otherwise not defined herein shall have the meanings set forth in the Second Amended Registration Statement.
Registration Statement on Form S-4
Cover Page
1. We note your revisions in response to prior comment 1. Please tell us how your disclosure in the
third paragraph on the second page of your cover page regarding the number of securities you are offering ties to the fee table
(where it appears you are registering the offering of fewer shares of common stock than disclosed) or revise your disclosure or fee table
as appropriate.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover
Page, page iv, and in the fee table of the Second Amended Registration Statement in response to the Staff’s comment and to reflect expectations
as of April 15, 2025 regarding the number of securities to be offered.
Securities and Exchange Commission
April 28, 2025
Page 2
Questions and Answers about the Merger
What are the U.S. federal income tax considerations
of the Cayman..., page xi
2. We note your statement that you intend that the Cayman Redomestication qualify as a “reorganization”
within the meaning of Section 368(a) of the Code and that, assuming it so qualifies, a U.S. Holder of Combined Company stock
will not recognize gain or loss upon the Cayman Redomestication. Please file an appropriate tax opinion regarding this intended tax
treatment as an exhibit to the registration statement. Refer to Item 601(b)(8) of Regulation S-K and Section III of Staff Legal
Bulletin No. 19 (CF), available on our website.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has filed a form of tax opinion of Gibson,
Dunn & Crutcher LLP, counsel to Crescent, regarding the tax treatment of Cayman Redomestication as Exhibit 8.1 to the Second Amended
Registration Statement in response to the Staff’s comment.
Prospectus Summary
The Companies
Crescent, page 1
3. We note your disclosure that Crescent intends to submit an Investigational New Drug application
to the FDA for CR-001 in the fourth quarter of 2025. We also note from the disclosure on page 280 that it appears that Crescent intends
the Phase 1 trial to be open to “solid tumor all-comers.” Please specify here, and in other locations where appropriate, what
indication(s) Crescent anticipates its IND will specify. In this regard, we note your disclosure that ivonescimab demonstrated
significantly improved progression-free survival compared to pembrolizumab in the HARMONi-2 trial where the indication was for the treatment
of naïve advanced and metastatic NSCLC. If Crescent’s anticipated Phase 1 trial will study a broader indication than the HARMONi-2
trial, please clarify in an appropriate location any risks from pursuing a broader indication.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 2 and 285
of the Second Amended Registration Statement in response to the Staff’s comment. The Company further respectfully advises the Staff that Crescent continues to evaluate specific indications to designate in its IND for
CR-001. Crescent expects to identify specific indications for inclusion in the IND closer in time to the submission date of the IND, but
after the effectiveness of the Registration Statement.
Securities and Exchange Commission
April 28, 2025
Page 3
4. Please continue revising your disclosure in response to prior comment 8 to further clarify the current
state of Crescent's business. Specifically, please clarify what you mean on pages 2, 273 and 322 when you state that Crescent is
“advancing” its expected second and third programs, CR-002 AND CR-003. In this regard, we note your disclosure that Crescent
has not exercised the option for CR-002 and has not entered into an option agreement for CR-003.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 2, 278 and 329
of the Second Amended Registration Statement in response to the Staff’s comment.
5. We note your response to prior comment 9. If true, please further revise your disclosure to clarify
that Crescent’s intent to seek regulatory approvals for CR-001 to treat multiple solid tumor indications is subject to successful
completion of clinical trials, which have not yet commenced, and that it will be several years before Crescent will be able to commercialize
CR-001, assuming it is able to successfully complete clinical trials and obtain the requisite regulatory approvals.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 1, 277, 278, 282 and 329
of the Second Amended Registration Statement in response to the Staff’s comment.
6. We note your response to prior comment 10, and we reissue the comment in part. Briefly describe
the influence, if any, that Fairmount and Paragon may have over any decision by Crescent to exercise the options and in negotiating the
terms of the respective licensing agreements. In this regard, in addition to the relationship between Crescent, Paragon, Fairmount
and Parascent, we note the affiliation of two of your directors with Fairmount and the rights of preferred stockholders to elect directors
with superior voting rights.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 2, 106 and 354
of the Second Amended Registration Statement in response to the Staff’s comment.
Risk Factors
Risks Related to the Combined Company, page 95
7. To the extent appropriate, please revise your risk factors in this section to distinguish between
risks related to the Combined Company before and after the Cayman Redomestication. For example only, we note some of these risk factors
address provisions of Delaware law and the Combined Company’s certificate of incorporation and bylaws under Delaware law without
acknowledging that such law and documents will no longer govern the Combined Company following the Cayman Redomestication.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 15, 96-97 and 103-105
of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange Commission
April 28, 2025
Page 4
The Merger
Crescent Restricted Stock Units, page 144
8. We note your disclosure that each restricted stock unit representing the right to receive shares
of Crescent common stock will be converted into restricted stock units representing the right to receive shares of GlycoMimetics common
stock. Please revise your disclosures on the prospectus cover page, in the “Explanatory Note” and elsewhere (e.g., on pages iii,
iv and vi) as appropriate to reflect this exchange or otherwise advise.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure throughout
the Second Amended Registration Statement, including on the Cover Page, in the Explanatory Note, and pages iii, iv, vi and viii, in response to the Staff’s comment and to reflect expectations as of
April 15, 2025 regarding the number of securities to be offered and the amendment of the merger agreement to convert Crescent
restricted stock units into GlycoMimetics restricted stock units.
GlycoMimetics Directors, Officers and Corporate
Governance, page 174
9. Please clarify in this section that Brian Hahn ceased employment with you in February 2025
and now serves as your Principal Executive and Financial Officer in his capacity as a consultant. In this regard, we note your disclosure
on page 184 regarding these arrangements.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 180
of the Second Amended Registration Statement in response to the Staff’s comment.
GlycoMimetics Executive Compensation
Executive Officer Separation and Consulting
Agreements, page 184
10. We note your disclosure regarding separation and consulting agreements you entered into with each
of Harout Semerjian and Brian Hahn. Please file these agreements as exhibits to the registration statement. Refer to Item 601(b)(10)(iii)(A) of
Regulation S-K.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has filed the requested agreements as Exhibits 10.30-10.33
to the Second Amended Registration Statement in response to the Staff’s comment.
Crescent Executive Compensation, page 192
11. Please identify Jonathan Violin as one of Crescent's named executive officers for the 2024 fiscal
year and revise your officer and director compensation disclosures accordingly. Refer to Item 402(m)(2)(i) of Regulation S-K, which
specifies that all individuals serving as the principal executive officer during the last completed year are named executive officers.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages
197-200 of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange Commission
April 28, 2025
Page 5
Crescent's Business, page 272
12. Please continue revising your disclosure in this section in response to prior comment 21 to remove
statements that may imply that a product candidate is safe or effective as such determinations are solely within the authority of the
FDA and corresponding regulatory authorities. For example only, we note your statement on page 277 that “[t]he design of ivonescimab
drives its effectiveness” as well as your reference to “increased effectiveness” on the same page.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 282, 283 and 286
of the Second Amended Registration Statement in response to the Staff’s comment.
13. Refer to the WuXi Biologics MSA and Charles River MSA agreements described on pages 285-287. For
each of these agreements, please revise to disclose the amounts and dates of any consideration or fees exchanged related to
these agreements, and disclose the extent to which any work orders have commenced pursuant to these agreements.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 292 and 293
of the Second Amended Registration Statement in response to the Staff’s comment.
The design of CR-001, page 278
14. We note your revised disclosure in response to prior comment 26 that, pursuant to the Paragon Option
Agreements, Crescent holds options to acquire the intellectual property rights to the composition of matter claims filed by Paragon for
the CR-001 sequence. If true, please revise your disclosure to clarify that Crescent has exercised its option for these intellectual property
rights and expects to enter into a license agreement with Paragon for the same prior to effectiveness of the registration statement. Alternatively,
clarify whether such intellectual property is subject to options other than the option already exercised by Crescent.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page
283 of the Second Amended Registration Statement in response to the Staff’s comment.
In vitro activity, page 278
15. We note your response to prior comment 27. Please further revise your disclosure to provide the
p-value for the data presented in the second graph in this section or otherwise advise.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page
284 of the Second Amended Registration Statement in response to the Staff’s comment to clarify that the p-value relates solely to the data presented in the graph on the left in this section, and that the increase in binding
reflected in the graph on the right in this section was not statistically significant.
Securities and Exchange Commission
April 28, 2025
Page 6
Clinical potential for CR-001, page 279
16. We note your response to prior comment 28. Specifically, we note that you now refer to the potential
for CR-001 to receive “first-in-class” approval in select indications. Given Crescent’s early stage of development and
the length of the drug development process, such characterization appears to be premature. Accordingly, please remove the statement or
otherwise advise.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 285
of the Second Amended Registration Statement in response to the Staff’s comment.
Planned clinical development of CR-001,
page 279
17. We note your response to prior comment 29. Please further revise your disclosure to disclose
the “other jurisdictions” where Crescent intends to conduct its proposed Phase 1 clinical trial for CR-001.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 285
of the Second Amended Registration Statement in response to the Staff’s comment.
Management Following the Merger, page 342
18. Although we note your revisions in response to prior comment 35, given that each Preferred Director
shall be entitled to three votes on each matter presented to the board of directors, please disclose whether those provisions will effectively
give the Preferred Directors control over decisions to be made by the board following the merger and include risk factor disclosure as
appropriate. In this regard, we note that it appears from your current disclosure that each of the four non-Preferred Directors will have
one vote and that each of the two Preferred Directors will have three votes, such that of the total of 10 votes, the Preferred Directors
would have 6 votes and may have effective control over decisions to be made by the board following the merger.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 2, 106 and 354
of the Second Amended Registration S