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SEC Comment Letter 0000000000-25-002902 to CRESCENT BIOPHARMA, INC. (CBIO)

CRESCENT BIOPHARMA, INC.
Date: March 17, 2025 · CIK: 0001253689 · Accession: 0000000000-25-002902

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File numbers found in text: 333-285035

Date
March 17, 2025
Author
Not clearly detected
Form
UPLOAD
Company
CRESCENT BIOPHARMA, INC.

Letter

March 17, 2025 Harout Semerjian President and Chief Executive Officer GlycoMimetics, Inc. P.O. Box 65 Monrovia, MD 21770 Re:GlycoMimetics, Inc. Registration Statement on Form S-4 Filed February 18, 2025 File No. 333-285035 Dear Harout Semerjian: We have reviewed your 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. Registration Statement on Form S-4 Cover Page 1.As required by Item 501(b)(2) of Regulation S-K, as referenced in Item 1 of Form S- 4, please disclose the amount of securities being offered. You state that your shares are currently listed on Nasdaq and that it is a waivable condition to the consummation of the merger that the combined company is approved for listing on Nasdaq. Given this condition, please clarify here that you are currently not in compliance with the Nasdaq listing requirements. In addition, given that this condition is waivable, please revise your disclosure to indicate whether recirculation or re-solicitation of stockholders will occur prior to the closing if the listing application is not approved but the condition is waived. If stockholders will not have certainty regarding the listing of the combined company's shares at the time they are asked to vote, please clarify this fact here and elsewhere in the proxy statement/prospectus as appropriate. Please also provide risk factor disclosure that 2.

March 17, 2025 Page 2 addresses the potential consequences of the parties waiving the condition and the closing occurring without the Nasdaq listing, including but not limited to the liquidity implications thereof. Questions and Answers about the Merger What is the Merger?, page iii 3.Please disclose the number of shares of common stock you expect to issue, or otherwise reserve for issuance, in connection with the merger. In your disclosure, separately state the number of shares you expect to underlie shares of the Series A Preferred Stock and pre-funded warrants to be issued upon consummation of the merger. What proposals will be voted on at the GlycoMimetics Special Meeting in connection with the Merger?, page v 4.You state that Proposal No. 2 must be approved to have an adequate number of authorized but unissued shares of common stock to complete the merger. Please disclose the number of additional authorized shares you expect to need to complete the merger and disclose the number of authorized shares that will be available for issuance after factoring in the number of shares to be issued in connection with the merger if this proposal is approved. What proposals are to be voted on at the GlycoMimetics Special Meeting, other than the Nasdaq Issuance Proposal..., page vi 5.We note that Proposal No. 4 is a proposal to elect directors. Given the inclusion of this proposal, please tell us why you have not also included an advisory proposal in the proxy statement/prospectus for stockholders to approve executive compensation pursuant to Exchange Act Rule 14a-21(a). Alternatively, revise the proxy statement/prospectus to include such proposal. If my GlycoMimetics shares are held in "street name" by my broker..., page ix 6.You state that if a beneficial owner does not instruct such owner's broker, bank or other agent how to vote such owner's shares, the broker, bank or other agent may still be able to vote such shares in its discretion. Please disclose for which of the proposals brokers, banks and other agents will be able to vote shares in the absence of instructions from the respective beneficial owner. Prospectus Summary The Companies Crescent, page 1 Revise your summary of Crescent to disclose the following: •that Crescent was founded in September 2024 and launched to research and develop antibody and ADC candidates from Paragon Therapeutics, Inc., an antibody discovery engine founded by Fairmount Funds Management LLC; that Crescent does not yet have any product candidates but, instead, has unexercised options under the Paragon Option Agreements to license the CR-001 •7.

March 17, 2025 Page 3 and CR-002 product candidates from Paragon; •identify Paragon, Fairmount and Parascent as related parties; •disclose, if true, that Crescent does not currently have any in-house development capabilities and that Paragon has launched other companies with intellectual property or assets that Paragon has developed in-house; •clarify if Crescent would be entitled to any improvements on CR-001 and CR-002 that Paragon develops, or if Paragon could grant the rights to any such improvements, or to any new and competing technologies, to other companies against which Crescent would compete, and include risk factor disclosure as appropriate; and •include a cross reference to a more fulsome discussion of Crescent's relationship, and the nature of these arrangements, with Paragon. 8.Given that Crescent was recently formed in September 2024 and that it has not yet exercised any options under the Paragon Option Agreements, please revise your disclosure here and throughout the proxy statement/prospectus as appropriate to clarify the current state of Crescent's business. For example, if Crescent is not yet "developing" product candidates and has not yet exercised its option for CR-001, you might clarify that Crescent "intends to develop" or "is collaborating with Paragon to develop" or "to advance" product candidates and that it "expects" CR-001 to be its initial product candidate, subject to Crescent's exercise of the option and entry into the respective license agreement. 9.We note your statement that Crescent believes the emerging data from the clinical development of ivonescimab allows for the acceleration of the development of CR- 001. Please provide a more detailed explanation of why you believe the development of ivonescimab will allow you to accelerate the development of CR-001, a new molecular entity. We further note your statement that Crescent plans to "systematically" seek regulatory approvals for CR-001 to treat multiple solid tumor indications. Please clarify what you mean by "systematically" seeking regulatory approvals, and balance these statements with the fact that Crescent has not yet begun clinical development of CR-001, that there is no guarantee Crescent will be able to accelerate development of CR-001 and that it will be several years before Crescent will be able to commercialize CR-001 if it is able to successfully complete clinical trials and obtain the requisite regulatory approvals. 10.To the extent known, please disclose if and when Crescent expects to exercise its options for CR-001 and CR-002. In addition, briefly describe the influence, if any, that Fairmount and Paragon may have over any decision 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 your Chief Executive Officer's affiliation with Fairmount and the rights of preferred stockholders to elect directors. Risk Factors, page 16 We note from Section 11.1 of the Merger Agreement that the representations and warranties of the parties contained in the Merger Agreement do not survive the 11.

March 17, 2025 Page 4 closing and that there are no indemnification rights. Please include appropriate risk factor disclosure. The Special Meeting in Lieu of Annual Meeting of GlycoMimetics Stockholders Solicitation of Proxies, page 98 12.We note that you have retained Innisfree M&A Incorporated as your proxy solicitor. Please disclose the material features of any contract or arrangement for such solicitation and the cost or anticipated cost thereof. Refer to Item 4(a)(3) of Schedule 14A. Anticipated Accounting Treatment, page 130 13.You disclose that you expect to account for the merger as a reverse recapitalization. Revise this section as well as your disclosures on pages 13 and 290 to address the following: •Disclose the extent to which you have determined that, immediately before the merger, GlycoMimetics will have no or nominal operations. •Disclose the extent to which you have determined that, immediately before the merger, GlycoMimetics will have no or nominal assets, assets consisting solely of cash and cash equivalents, or assets consisting of any amount of cash and cash equivalents and nominal other assets. Agreements Related to the Merger Lock-Up Agreements, page 151 14.You state that the Crescent stockholders who have executed lock-up agreements as of February 7, 2025 owned, in the aggregate, approximately 98.5% of the shares of Crescent's outstanding capital stock. Please also disclose the percentage of shares you expect to be subject to the lock-up agreements on a fully diluted basis immediately following consummation of the merger. Subscription Agreement, page 151 15.To the extent not already described in this section, please revise your disclosure to briefly describe the material terms of the pre-funded warrants to be issued in connection with the merger transactions, including, for example, the exercise price and duration of the warrants. Consulting Agreements and Offer Letters, page 172 16.Please disclose the term of Crescent's consulting agreement and offer letter with Dr. Violin and Mr. Doughty, respectively. In addition, given Dr. Violin's affiliation with Fairmount and the fact that Dr. Violin does not appear to be an employee of Crescent, please briefly describe any potential conflicts of interest or other risks that may arise in connection with Dr. Violin's consulting arrangement with Crescent, and to the extent material, include appropriate risk factor disclosure regarding the same.

March 17, 2025 Page 5 Matters Being Submitted to a Vote of GlycoMimetics Stockholders Proposal No. 2 - The Authorized Share Increase Proposal Background and Reasons for the GlycoMimetics Share Increase Amendment, page 177 17.In the fourth paragraph, you disclose the number of shares outstanding and reserved for issuance as of the Record Date, as well as the number of shares that will remain available for issuance upon effectiveness of the Share Increase Amendment. Please also provide corresponding disclosures regarding the number of shares expected to be outstanding, reserved for issuance and available for issuance following consummation of the merger. Possible Effects of the GlycoMimetics Share Increase Amendment, page 178 18.Please revise your disclosure in this section to also address any potential anti-takeover effects the Share Increase Amendment may have if effected. Proposal No. 3 - The Reverse Stock Split Proposal Requirements for Listing on Nasdaq, page 181 19.Please revise your disclosure in this section to clarify that you are currently not in compliance with Nasdaq's minimum bid price requirement and to disclose the deadline by which you are required to regain compliance to maintain the listing of your common stock on Nasdaq. In addition, clarify here that the condition to closing of the merger that the shares of common stock to be issued in the merger be approved for listing on Nasdaq is a waivable condition. Proposal No. 5 - The Auditor Ratification Proposal, page 188 20.Please include the disclosures required by Item 9(e) of Schedule 14A. Crescent's Business, page 216 21.We note your discussions regarding third-party product candidates, including ivonescimab, as well as certain statements regarding the safety and efficacy of ivonescimab (e.g., that ivonescimab "demonstrate[d] improved clinical efficacy compared to pembrolizumab (Keytruda) in a head-to-head Phase 3 clinical trial"). We further note that Crescent intends to design a Phase 1 clinical trial of CR-001 based on the clinical profile of ivonescimab. Please revise your disclosures to address the following: •Clarify that the clinical trials described were third-party trials and, to the extent known, briefly describe the clinical trial protocols, including the number of participants, primary and secondary endpoints and the objective results from the clinical trials. •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. •Clearly state that neither Crescent nor Paragon has conducted any clinical trials with CR-001 and that there is no guarantee that clinical trials with CR-001 will have similar results as compared to clinical trials with other products and product candidates.

March 17, 2025 Page 6 22.We note your disclosure that "[b]inding of VEGF, an angiogenic growth factor that stimulates the growth of blood vessels and is overexpressed in many tumors, to CR- 001 leads to the formation of molecular complexes through polymerization of CR- 001" ... and that "[t]his increases its binding to PD-1 on immune cells and is designed to lead to more potent antitumor activity." Please clarify if this statement is based on the disclosure from page 221 that is related to the in vitro studies of ivonescimab that you indicate were reported by Akeso Biopharma and Summit Therapeutics. If so, please caution investors that pre-clinical or other studies of CR-001 may not show similar results. Crescent's Pipeline, page 217 23.Please revise the pipeline table to include a column for each of Phase 1, Phase 2 and Phase 3 clinical trials. 24.We note the inclusion of CR-002 and CR-003 in Crescent's pipeline table. Given the early stage of development and limited disclosure related to these programs, please explain why they are sufficiently material to Crescent's business to warrant inclusion in the pipeline table. If they are material, please expand your disclosure to provide a more fulsome discussion of these programs, including a description of development activities conducted. Alternatively, remove any programs that are not currently material from the pipeline table. The breakthrough potential of ivonescimab, an anti-PD-1/anti-VEGF bispecific molecule, page 219 25.We note your disclosure that "[i]n a Phase 3 clinical trial in NSCLC, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS compared to pembrolizumab." Please clarify if this refers to the HARMONi-2 trial described in the next paragraph, and disclose where such study was conducted and where regulatory approval is being sought for ivonescimab as a result of such trial. The design of CR-001, page 222 26.In the first paragraph, you state that Crescent has filed composition of matter claims for the CR-001 sequence based in part on Crescent's proprietary scFv engineering. Please reconcile this statement with your disclosure on page 228 that, prior to entry into a License Agreement, Paragon is responsible for the prosecution, defense, maintenance and enforcement of patents related to a Research Program. In vitro activity, page 222 27.Please provide the p-values for the results shown in the tables in this section. Clinical potential for CR-001, page 223 28.You refer to the potential to establish CR-001 as a "first-in-class" therapy. Given that ivonescimab is in Phase 3 clinicals trials, your early stage of development and the length of the drug development process, such characterization appears to be inapplicable or premature. Accordingly, please remove the statement or otherwise advise.

March 17, 2025 Page 7 Planned clinical development of CR-001, page 223 29.Please disclose the regulatory jurisdictions where Crescent intends to conduct its proposed Phase 1 clinical trial for CR-001. Paragon Option Agreements, page 227 30.We note your discl

Show Raw Text
March 17, 2025
Harout Semerjian
President and Chief Executive Officer
GlycoMimetics, Inc.
P.O. Box 65
Monrovia, MD 21770
Re:GlycoMimetics, Inc.
Registration Statement on Form S-4
Filed February 18, 2025
File No. 333-285035
Dear Harout Semerjian:
            We have reviewed your 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.
Registration Statement on Form S-4
Cover Page
1.As required by Item 501(b)(2) of Regulation S-K, as referenced in Item 1 of Form S-
4, please disclose the amount of securities being offered.
You state that your shares are currently listed on Nasdaq and that it is a waivable
condition to the consummation of the merger that the combined company is approved
for listing on Nasdaq. Given this condition, please clarify here that you are currently
not in compliance with the Nasdaq listing requirements. In addition, given that this
condition is waivable, please revise your disclosure to indicate whether recirculation
or re-solicitation of stockholders will occur prior to the closing if the listing
application is not approved but the condition is waived. If stockholders will not have
certainty regarding the listing of the combined company's shares at the time they are
asked to vote, please clarify this fact here and elsewhere in the proxy
statement/prospectus as appropriate. Please also provide risk factor disclosure that 2.

March 17, 2025
Page 2
addresses the potential consequences of the parties waiving the condition and the
closing occurring without the Nasdaq listing, including but not limited to the liquidity
implications thereof.
Questions and Answers about the Merger
What is the Merger?, page iii
3.Please disclose the number of shares of common stock you expect to issue, or
otherwise reserve for issuance, in connection with the merger. In your disclosure,
separately state the number of shares you expect to underlie shares of the Series A
Preferred Stock and pre-funded warrants to be issued upon consummation of the
merger.
What proposals will be voted on at the GlycoMimetics Special Meeting in connection with
the Merger?, page v
4.You state that Proposal No. 2 must be approved to have an adequate number of
authorized but unissued shares of common stock to complete the merger. Please
disclose the number of additional authorized shares you expect to need to complete
the merger and disclose the number of authorized shares that will be available for
issuance after factoring in the number of shares to be issued in connection with the
merger if this proposal is approved.
What proposals are to be voted on at the GlycoMimetics Special Meeting, other than the
Nasdaq Issuance Proposal..., page vi
5.We note that Proposal No. 4 is a proposal to elect directors. Given the inclusion of this
proposal, please tell us why you have not also included an advisory proposal in the
proxy statement/prospectus for stockholders to approve executive compensation
pursuant to Exchange Act Rule 14a-21(a). Alternatively, revise the proxy
statement/prospectus to include such proposal.
If my GlycoMimetics shares are held in "street name" by my broker..., page ix
6.You state that if a beneficial owner does not instruct such owner's broker, bank or
other agent how to vote such owner's shares, the broker, bank or other agent may still
be able to vote such shares in its discretion. Please disclose for which of the proposals
brokers, banks and other agents will be able to vote shares in the absence of
instructions from the respective beneficial owner.
Prospectus Summary
The Companies
Crescent, page 1
Revise your summary of Crescent to disclose the following:
•that Crescent was founded in September 2024 and launched to research and
develop antibody and ADC candidates from Paragon Therapeutics, Inc., an
antibody discovery engine founded by Fairmount Funds Management LLC;
that Crescent does not yet have any product candidates but, instead, has
unexercised options under the Paragon Option Agreements to license the CR-001 •7.

March 17, 2025
Page 3
and CR-002 product candidates from Paragon;
•identify Paragon, Fairmount and Parascent as related parties;
•disclose, if true, that Crescent does not currently have any in-house development
capabilities and that Paragon has launched other companies with intellectual
property or assets that Paragon has developed in-house;
•clarify if Crescent would be entitled to any improvements on CR-001 and CR-002
that Paragon develops, or if Paragon could grant the rights to any such
improvements, or to any new and competing technologies, to other companies
against which Crescent would compete, and include risk factor disclosure as
appropriate; and
•include a cross reference to a more fulsome discussion of Crescent's relationship,
and the nature of these arrangements, with Paragon.
8.Given that Crescent was recently formed in September 2024 and that it has not yet
exercised any options under the Paragon Option Agreements, please revise your
disclosure here and throughout the proxy statement/prospectus as appropriate to
clarify the current state of Crescent's business. For example, if Crescent is not yet
"developing" product candidates and has not yet exercised its option for CR-001, you
might clarify that Crescent "intends to develop" or "is collaborating with Paragon to
develop" or "to advance" product candidates and that it "expects" CR-001 to be its
initial product candidate, subject to Crescent's exercise of the option and entry into the
respective license agreement.
9.We note your statement that Crescent believes the emerging data from the clinical
development of ivonescimab allows for the acceleration of the development of CR-
001. Please provide a more detailed explanation of why you believe the development
of ivonescimab will allow you to accelerate the development of CR-001, a new
molecular entity. We further note your statement that Crescent plans to
"systematically" seek regulatory approvals for CR-001 to treat multiple solid tumor
indications. Please clarify what you mean by "systematically" seeking regulatory
approvals, and balance these statements with the fact that Crescent has not yet begun
clinical development of CR-001, that there is no guarantee Crescent will be able to
accelerate development of CR-001 and that it will be several years before Crescent
will be able to commercialize CR-001 if it is able to successfully complete clinical
trials and obtain the requisite regulatory approvals.
10.To the extent known, please disclose if and when Crescent expects to exercise its
options for CR-001 and CR-002. In addition, briefly describe the influence, if any,
that Fairmount and Paragon may have over any decision 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 your Chief Executive Officer's affiliation with Fairmount and the rights of
preferred stockholders to elect directors.
Risk Factors, page 16
We note from Section 11.1 of the Merger Agreement that the representations and
warranties of the parties contained in the Merger Agreement do not survive the 11.

March 17, 2025
Page 4
closing and that there are no indemnification rights. Please include appropriate risk
factor disclosure.
The Special Meeting in Lieu of Annual Meeting of GlycoMimetics Stockholders
Solicitation of Proxies, page 98
12.We note that you have retained Innisfree M&A Incorporated as your proxy solicitor.
Please disclose the material features of any contract or arrangement for such
solicitation and the cost or anticipated cost thereof. Refer to Item 4(a)(3) of Schedule
14A.
Anticipated Accounting Treatment, page 130
13.You disclose that you expect to account for the merger as a reverse
recapitalization. Revise this section as well as your disclosures on pages 13 and 290 to
address the following:
•Disclose the extent to which you have determined that, immediately before the
merger, GlycoMimetics will have no or nominal operations.
•Disclose the extent to which you have determined that, immediately before the
merger, GlycoMimetics will have no or nominal assets, assets consisting solely of
cash and cash equivalents, or assets consisting of any amount of cash and cash
equivalents and nominal other assets.
Agreements Related to the Merger
Lock-Up Agreements, page 151
14.You state that the Crescent stockholders who have executed lock-up agreements as of
February 7, 2025 owned, in the aggregate, approximately 98.5% of the shares of
Crescent's outstanding capital stock. Please also disclose the percentage of shares you
expect to be subject to the lock-up agreements on a fully diluted basis immediately
following consummation of the merger.
Subscription Agreement, page 151
15.To the extent not already described in this section, please revise your disclosure to
briefly describe the material terms of the pre-funded warrants to be issued in
connection with the merger transactions, including, for example, the exercise price
and duration of the warrants.
Consulting Agreements and Offer Letters, page 172
16.Please disclose the term of Crescent's consulting agreement and offer letter with Dr.
Violin and Mr. Doughty, respectively. In addition, given Dr. Violin's affiliation with
Fairmount and the fact that Dr. Violin does not appear to be an employee of Crescent,
please briefly describe any potential conflicts of interest or other risks that may arise
in connection with Dr. Violin's consulting arrangement with Crescent, and to the
extent material, include appropriate risk factor disclosure regarding the same.

March 17, 2025
Page 5
Matters Being Submitted to a Vote of GlycoMimetics Stockholders
Proposal No. 2 - The Authorized Share Increase Proposal
Background and Reasons for the GlycoMimetics Share Increase Amendment, page 177
17.In the fourth paragraph, you disclose the number of shares outstanding and reserved
for issuance as of the Record Date, as well as the number of shares that will remain
available for issuance upon effectiveness of the Share Increase Amendment. Please
also provide corresponding disclosures regarding the number of shares expected to be
outstanding, reserved for issuance and available for issuance following consummation
of the merger.
Possible Effects of the GlycoMimetics Share Increase Amendment, page 178
18.Please revise your disclosure in this section to also address any potential anti-takeover
effects the Share Increase Amendment may have if effected.
Proposal No. 3 - The Reverse Stock Split Proposal
Requirements for Listing on Nasdaq, page 181
19.Please revise your disclosure in this section to clarify that you are currently not in
compliance with Nasdaq's minimum bid price requirement and to disclose the
deadline by which you are required to regain compliance to maintain the listing of
your common stock on Nasdaq. In addition, clarify here that the condition to closing
of the merger that the shares of common stock to be issued in the merger be approved
for listing on Nasdaq is a waivable condition.
Proposal No. 5 - The Auditor Ratification Proposal, page 188
20.Please include the disclosures required by Item 9(e) of Schedule 14A.
Crescent's Business, page 216
21.We note your discussions regarding third-party product candidates, including
ivonescimab, as well as certain statements regarding the safety and efficacy of
ivonescimab (e.g., that ivonescimab "demonstrate[d] improved clinical efficacy
compared to pembrolizumab (Keytruda) in a head-to-head Phase 3 clinical trial"). We
further note that Crescent intends to design a Phase 1 clinical trial of CR-001 based on
the clinical profile of ivonescimab. Please revise your disclosures to address the
following:
•Clarify that the clinical trials described were third-party trials and, to the extent
known, briefly describe the clinical trial protocols, including the number of
participants, primary and secondary endpoints and the objective results from the
clinical trials.
•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.
•Clearly state that neither Crescent nor Paragon has conducted any clinical trials
with CR-001 and that there is no guarantee that clinical trials with CR-001 will
have similar results as compared to clinical trials with other products and product
candidates.

March 17, 2025
Page 6
22.We note your disclosure that "[b]inding of VEGF, an angiogenic growth factor that
stimulates the growth of blood vessels and is overexpressed in many tumors, to CR-
001 leads to the formation of molecular complexes through polymerization of CR-
001" ... and that "[t]his increases its binding to PD-1 on immune cells and is designed
to lead to more potent antitumor activity." Please clarify if this statement is based on
the disclosure from page 221 that is related to the in vitro studies of ivonescimab that
you indicate were reported by Akeso Biopharma and Summit Therapeutics. If so,
please caution investors that pre-clinical or other studies of CR-001 may not show
similar results.
Crescent's Pipeline, page 217
23.Please revise the pipeline table to include a column for each of Phase 1, Phase 2 and
Phase 3 clinical trials.
24.We note the inclusion of CR-002 and CR-003 in Crescent's pipeline table. Given the
early stage of development and limited disclosure related to these programs, please
explain why they are sufficiently material to Crescent's business to warrant inclusion
in the pipeline table. If they are material, please expand your disclosure to provide a
more fulsome discussion of these programs, including a description of development
activities conducted. Alternatively, remove any programs that are not currently
material from the pipeline table.
The breakthrough potential of ivonescimab, an anti-PD-1/anti-VEGF bispecific molecule,
page 219
25.We note your disclosure that "[i]n a Phase 3 clinical trial in NSCLC, ivonescimab
demonstrated a statistically significant and clinically meaningful improvement in PFS
compared to pembrolizumab." Please clarify if this refers to the HARMONi-2 trial
described in the next paragraph, and disclose where such study was conducted and
where regulatory approval is being sought for ivonescimab as a result of such trial.
The design of CR-001, page 222
26.In the first paragraph, you state that Crescent has filed composition of matter claims
for the CR-001 sequence based in part on Crescent's proprietary scFv engineering.
Please reconcile this statement with your disclosure on page 228 that, prior to entry
into a License Agreement, Paragon is responsible for the prosecution, defense,
maintenance and enforcement of patents related to a Research Program.
In vitro activity, page 222
27.Please provide the p-values for the results shown in the tables in this section.
Clinical potential for CR-001, page 223
28.You refer to the potential to establish CR-001 as a "first-in-class" therapy. Given that
ivonescimab is in Phase 3 clinicals trials, your early stage of development and the
length of the drug development process, such characterization appears to be
inapplicable or premature. Accordingly, please remove the statement or otherwise
advise.

March 17, 2025
Page 7
Planned clinical development of CR-001, page 223
29.Please disclose the regulatory jurisdictions where Crescent intends to conduct its
proposed Phase 1 clinical trial for CR-001.
Paragon Option Agreements, page 227
30.We note your discl