UPLOAD Filing
CRESCENT BIOPHARMA, INC.
Date: April 22, 2025 · CIK: 0001253689 · Accession: 0000000000-25-004254
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File numbers found in text: 333-285035
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April 22, 2025
Brian Hahn
Principal Executive and Financial Officer
GlycoMimetics, Inc.
P.O. Box 65
Monrovia, MD 21770
Re:GlycoMimetics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed April 4, 2025
File No. 333-285035
Dear Brian Hahn:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our March 17, 2025 letter.
Amendment No. 1 to 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.
Questions and Answers about the Merger
What are the U.S. federal income tax considerations of the Cayman..., page xi
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 2.
April 22, 2025
Page 2
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.
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.
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.
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.
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.
Risk Factors
Risks Related to the Combined Company, page 95
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 7.
April 22, 2025
Page 3
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.
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.
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.
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.
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.
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.
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.
April 22, 2025
Page 4
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.
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.
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.
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.
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.
Executive Officers and Directors
Director Independence, page 346
We note your disclosure that you expect that the Combined Company's board of
directors will determine that Peter Harwin is an independent director under Nasdaq
listing rules. We further note your disclosure on page 344 that Peter Harwin co-
founded and is a Managing Member at Fairmount. With a view toward disclosure,
please tell us whether, and if so, how, you expect this relationship to impact the 19.
April 22, 2025
Page 5
independence determination with respect to Peter Harwin, particularly considering
Nasdaq Listing Rule 5605(a)(2)(D). In this regard, we note the related party
disclosures regarding both Fairmount and Paragon. If Mr. Harwin would not be
considered an independent director, given that each Preferred Director, including Mr.
Harwin, will be entitled to three votes on each matter presented to the board of
directors, please tell us whether the Combined Company would have a majority
independent board.
General
20.It appears that you intend to change the jurisdiction of incorporation of the Combined
Company from Delaware to the Cayman Islands after effectiveness. Please tell us
whether the Cayman Islands entity intends to file a post-effective amendment to the
Form S-4 expressly adopting it as its own registration statement for all purposes under
the Securities Act and the Securities Exchange Act. Refer to Securities Act Rule 414.
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Kostian Ciko, Esq.