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Correspondence 0001213900-23-065731 from CohBar, Inc. (CWBR) (CIK 0001522602)

CohBar, Inc. (CWBR) (CIK 0001522602)
Date: Aug. 10, 2023 · CIK: 0001522602 · Accession: 0001213900-23-065731

AI Filing Summary & Sentiment

File numbers found in text: 333-273101

Referenced dates: August 3, 2023

Date
August 10, 2023
Author
Not clearly detected
Form
CORRESP
Company
CohBar, Inc. (CWBR) (CIK 0001522602)

Letter

Gibson, Dunn & Crutcher LLP

555 Mission Street

San Francisco, CA 94105-0921

Tel 415.393.8200

gibsondunn.com

August 10, 2023

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

Attention: Franklin Wyman

Angela Connell

Lauren S. Hamill

Joe McCann

Re: CohBar, Inc.

Registration Statement on Form S-4

Filed July 3, 2023

File No. 333-273101

Ladies and Gentlemen:

This letter is submitted on behalf of CohBar, Inc. (the “Company” or “CohBar”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-4 (File No: 333-273101), initially filed on July 3, 2023 (the “Registration Statement”), as set forth in the Staff’s letter dated August 3, 2023 (the “Comment Letter”). The Company is concurrently submitting Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which includes changes to reflect responses to the Staff’s comments and other updates.

For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1.

Registration Statement on Form S-4

Questions and Answers About the Merger

Will the common stock of the combined company trade on an exchange?, page 5

1. You disclose that CohBar has filed a listing application for the combined company’s common stock with Nasdaq and that it is expected that such common stock will trade on the exchange. We also note Section 7.1(d) of the Merger Agreement provides that the approval of the listing of the additional shares of Parent Common Stock on Nasdaq shall have been obtained. Please revise the Q&A and the Letter to Stockholders to clarify whether the closing of the merger is conditioned upon Nasdaq’s approval of the listing application. Disclose whether this condition is waivable and if so, indicate whether Nasdaq’s determination will be known at the time that stockholders are asked to vote to approve the merger.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure in the Letter to Stockholders and in the Q&A on page 5 of Amendment No. 1 to reflect the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 2

What are the material U.S. federal income tax consequences of the Merger to holders of CohBar capital stock?, page 7

2. Please revise to clarify, if true, that the US holders of CohBar equity will not recognize any gain or loss for U.S. federal income tax purposes as a result of the merger.

RESPONSE: A new sentence has been added to this Q&A to clarify that CohBar stockholders will generally not recognize any gain or loss for U.S. federal income tax purposes as a result of the Merger. See page 8 of Amendment No. 1 to reflect the Staff’s comment.

Prospectus Summary

CohBar, page 9

3. With reference to your disclosure on page 211, please revise the Summary and the Q&A if appropriate to explain that if the merger is completed, the combined company will focus on developing Morphogenesis’ product candidates, and it is anticipated that the combined company will not continue to develop CohBar’s legacy product candidates. Also, revise the second Q&A on page 4 to provide context for the discussion of the CVRs.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 1, 4 and 11 of Amendment No. 1 to reflect the Staff’s comment.

Morphogenesis, page 10

4. We note your disclosure referencing potential FDA accelerated approval designation and entry into a Special Protocol Assessment (SPA) Agreement. Revise to balance your Summary disclosures by clarifying that Morphogenesis’ candidates have not qualified for such designation and that there is no guarantee that such designation will be granted. Also, revise to clarify that entry into an SPA Agreement with FDA may not lead to faster or less costly product development or a regulatory review or approval process, and does not increase the likelihood that your product candidate will ever receive marketing approval.

RESPONSE: The Company acknowledges the Staff’s comment and advises the Staff that a sentence has been added to the end of the paragraph that begins with “Morphogenesis is in discussions . . . .” on page 11 of Amendment No. 1 to state, among other things, that there is no guarantee that Morphogenesis will be granted an SPA for a registration-directed trial for IFx-2.0 under the accelerate approval pathway and that such an agreement will not guarantee approval or lead to a faster or less expensive approval process. Similar language has also been added on page 218 at the end of the paragraph that begins with “Morphogenesis is in discussions . . . .” Similar language has also been inserted into the risk factor captioned “The successful development of immunotherapies is highly uncertain.” on page 56 of Amendment No. 1.

U.S. Securities and Exchange Commission

August 10, 2023

Page 3

5. We note your disclosure that Morphogenesis is a Phase 2/3 clinical stage immunooncology company. In light of your disclosures on page 219 and 226-228, please remove the reference and clarify that your Phase 1b trial is on-going.

RESPONSE: The Company acknowledges the Staff’s comment and advises the Staff that the words “Phase 2/3” have been deleted from “Phase 2/3 clinical stage oncology company” on pages 11 and 218 of Amendment No. 1. Also in response to this comment from the Staff, a new third paragraph has been inserted under the “Morphogenesis” caption on page 10 to provide more detailed information regarding the Phase 1b trial (which information is already included in more detail in the “Morphogenesis’ Business” section).

6. Please revise your discussion of the Merkel cell carcinoma program to highlight and explain the following:

● Clarify the number of Merkel cell carcinoma patients that have been treated to date with the IFx-Hu2.0 cancer vaccine product candidate and briefly discuss the treatment response.

● Disclose the estimated US Merkel cell carcinoma patient population.

● Explain the term “adjunctive therapy.”.

RESPONSE: The Company acknowledges the Staff’s comment and advises the Staff that (i) in response to the first bullet of this comment, a new third paragraph has been inserted under the “Morphogenesis” caption on page 11 of Amendment No. 1 to provide information regarding the Phase 1b trial and the number of Merkel cell carcinoma patients that have been treated and (ii) in response to the second and third bullets, two new sentences have been added to the fifth paragraph under the “Morphogenesis” caption. The Company also advises the Staff that the information regarding the size of the U.S. patient population is information that was already included in the “Morphogenesis’ Business” section.

The FDA or comparable foreign regulatory authorities may disagree with Morphogenesis’ regulatory plans..., page 58

7. Please revise the risk factor to explain, if true, that Morphogenesis plans to obtain accelerated approval designation for some or all of its product candidates under the accelerated approval pathway and the impact to the company if accelerated approval does not materialize.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the first paragraph of this risk factor on page 61 of Amendment No. 1 to describe the impact associated with failure to obtain an accelerated approval pathway for IFx-2.0.

Risks Related to the Combined Company

The bylaws of the combined company will provide that..., page 94

8. We note that the bylaws of the combined company will provide that the U.S. federal district courts are the exclusive forum for any complaint asserting a cause of action arising under the Securities Act. Please revise your disclosure to state that there is uncertainty as to whether a court would enforce such provision. In this regard, we note that Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 96 of Amendment No. 1 in response to the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 4

The combined company’s ability to use net operating loss carryforwards..., page 96

9. Please revise this risk factor to quantify the NOLs and other tax attributes that are or may become subject to limitation.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 99 of Amendment No. 1 to reflect the Staff’s comment.

The Merger

Background of the Merger, page 106

10. Please revise the disclosure on page 107 to disclose the terms of Morphogenesis’ initial non-binding indication of interest. Clarify whether CohBar management identified Morphogenesis as one of the top merger candidates as of November 8 and one of the top three candidates as of November 15. To the extent that CohBar management did not view Morphogenesis as the top or one of the top candidates, please discuss the reason(s).

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 108 of Amendment No. 1 to reflect the Staff’s comment.

11. Please revise to discuss in greater detail the negotiations concerning the contingent value rights and the stock purchase agreement with K&V Investment One.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 112 through 113 and 117 of Amendment No. 1 to reflect the Staff’s comment.

12. Please also revise this section to explain the diligence that CohBar’s management, board and advisors conducted concerning Morphogenesis.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 109 and 113 of Amendment No. 1 to reflect the Staff’s comment.

13. With reference to the February 13, 2023 entry, describe the material differences between a traditional staggered sign-and-close reverse merger and simultaneous sign-and-close reverse merger structure. Explain which party sought the simultaneous sign-and-close structure and why. Also indicate when Mr. Fitzgerald first raised his concerns with this proposed structure.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 108 and 111 of Amendment No. 1 to reflect the Staff’s comment.

14. We refer to the May 10, 2023 entry. Please revise to quantify the expected reduction to the net cash that CohBar would deliver under the staggered sign-and-close structure relative to the previously planned simultaneous sign-and-close structure. Explain how the parties concluded that Morphogenesis’s valuation should be increased from $125 million to $130.6 million based on this decision. In this regard, it is unclear why the structural change resulted in an increase to the Morphogenesis valuation as opposed to a decrease in the CohBar valuation.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 115 of Amendment No. 1 to reflect the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 5

The Merger

CohBar’s Reasons for the Merger; Recommendation of the CohBar Board, page 114

15. Please revise to provide additional context as to how the $25 million enterprise value ascribed to CohBar was derived.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 118 of Amendment No. 1 to reflect the Staff’s comment.

16. Please tell us why the expected cash balances are blank. In this regard, please clarify whether the disclosure in the section reflects the board’s view as of May 23 when it approved the merger agreement or whether the disclosure reflects its expectations at a different point in time.

RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 119 of Amendment No. 1 to reflect the Staff’s comment. The Company advises the Staff that the disclosure pertaining to the Company’s Board’s consideration of the expected cash balances of the combined company as of the closing of the Merger reflects the Company’s Board’s view as of Ma

Show Raw Text
CORRESP
1
filename1.htm

    Gibson, Dunn & Crutcher LLP

    555 Mission Street

    San Francisco, CA 94105-0921

    Tel 415.393.8200

    gibsondunn.com

August 10, 2023

VIA
EDGAR

United States
Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

    Attention:
    Franklin Wyman

    Angela Connell

    Lauren S. Hamill

    Joe McCann

    Re:
    CohBar, Inc.

    Registration Statement on Form S-4

    Filed July 3, 2023

    File No. 333-273101

Ladies and
Gentlemen:

This letter
is submitted on behalf of CohBar, Inc. (the “Company” or “CohBar”) in response to the comments
of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the
“Commission”) with respect to the Company’s Registration Statement on Form S-4 (File No: 333-273101), initially
filed on July 3, 2023 (the “Registration Statement”), as set forth in the Staff’s letter dated August 3, 2023
(the “Comment Letter”). The Company is concurrently submitting Amendment No. 1 to the Registration Statement (“Amendment
No. 1”), which includes changes to reflect responses to the Staff’s comments and other updates.

For reference
purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience,
we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions
of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All
capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1.

Registration
Statement on Form S-4

Questions
and Answers About the Merger

Will the
common stock of the combined company trade on an exchange?, page 5

 1. You
                                            disclose that CohBar has filed a listing application for the combined company’s common
                                            stock with Nasdaq and that it is expected that such common stock will trade on the exchange.
                                            We also note Section 7.1(d) of the Merger Agreement provides that the approval of the listing
                                            of the additional shares of Parent Common Stock on Nasdaq shall have been obtained. Please
                                            revise the Q&A and the Letter to Stockholders to clarify whether the closing of the merger
                                            is conditioned upon Nasdaq’s approval of the listing application. Disclose whether
                                            this condition is waivable and if so, indicate whether Nasdaq’s determination will
                                            be known at the time that stockholders are asked to vote to approve the merger.

RESPONSE:
The Company acknowledges the Staff’s comment and has revised the disclosure in the Letter to Stockholders and in the Q&A on
page 5 of Amendment No. 1 to reflect the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 2

What are
the material U.S. federal income tax consequences of the Merger to holders of CohBar capital stock?, page 7

 2. Please
                                            revise to clarify, if true, that the US holders of CohBar equity will not recognize any gain
                                            or loss for U.S. federal income tax purposes as a result of the merger.

RESPONSE: A new sentence has been added
to this Q&A to clarify that CohBar stockholders will generally not recognize any gain or loss for U.S. federal income tax purposes
as a result of the Merger. See page 8 of Amendment No. 1 to reflect the Staff’s comment.

Prospectus
Summary

CohBar,
page 9

 3. With
                                            reference to your disclosure on page 211, please revise the Summary and the Q&A if appropriate
                                            to explain that if the merger is completed, the combined company will focus on developing
                                            Morphogenesis’ product candidates, and it is anticipated that the combined company
                                            will not continue to develop CohBar’s legacy product candidates. Also, revise the second
                                            Q&A on page 4 to provide context for the discussion of the CVRs.

RESPONSE: The Company acknowledges the
Staff’s comment and has revised the disclosure on pages 1, 4 and 11 of Amendment No. 1 to reflect the Staff’s comment.

Morphogenesis,
page 10

 4. We
                                            note your disclosure referencing potential FDA accelerated approval designation and entry
                                            into a Special Protocol Assessment (SPA) Agreement. Revise to balance your Summary disclosures
                                            by clarifying that Morphogenesis’ candidates have not qualified for such designation and
                                            that there is no guarantee that such designation will be granted. Also, revise to clarify
                                            that entry into an SPA Agreement with FDA may not lead to faster or less costly product development
                                            or a regulatory review or approval process, and does not increase the likelihood that your
                                            product candidate will ever receive marketing approval.

RESPONSE: The Company acknowledges the Staff’s comment
and advises the Staff that a sentence has been added to the end of the paragraph that begins with “Morphogenesis is in discussions
. . . .” on page 11 of Amendment No. 1 to state, among other things, that there is no guarantee that Morphogenesis will be granted
an SPA for a registration-directed trial for IFx-2.0 under the accelerate approval pathway and that such an agreement will not guarantee
approval or lead to a faster or less expensive approval process. Similar language has also been added on page 218 at the end of the
paragraph that begins with “Morphogenesis is in discussions . . . .” Similar language has also been inserted into the risk
factor captioned “The successful development of immunotherapies is highly uncertain.” on page 56 of Amendment No. 1.

U.S. Securities and Exchange Commission

August 10, 2023

Page 3

 5. We
                                            note your disclosure that Morphogenesis is a Phase 2/3 clinical stage immunooncology company.
                                            In light of your disclosures on page 219 and 226-228, please remove the reference and clarify
                                            that your Phase 1b trial is on-going.

RESPONSE: The Company acknowledges the Staff’s
comment and advises the Staff that the words “Phase 2/3” have been deleted from “Phase 2/3 clinical stage oncology
company” on pages 11 and 218 of Amendment No. 1. Also in response to this comment from the Staff, a new third paragraph has
been inserted under the “Morphogenesis” caption on page 10 to provide more detailed information regarding the Phase 1b
trial (which information is already included in more detail in the “Morphogenesis’ Business” section).

 6. Please
                                            revise your discussion of the Merkel cell carcinoma program to highlight and explain the
                                            following:

 ● Clarify
                                            the number of Merkel cell carcinoma patients that have been treated to date with the IFx-Hu2.0
                                            cancer vaccine product candidate and briefly discuss the treatment response.

 ● Disclose
                                            the estimated US Merkel cell carcinoma patient population.

 ● Explain
                                            the term “adjunctive
                                            therapy.”.

RESPONSE: The Company acknowledges the
Staff’s comment and advises the Staff that (i) in response to the first bullet of this comment, a new third paragraph has been
inserted under the “Morphogenesis” caption on page 11 of Amendment No. 1 to provide information regarding the Phase 1b
trial and the number of Merkel cell carcinoma patients that have been treated and (ii) in response to the second and third bullets, two
new sentences have been added to the fifth paragraph under the “Morphogenesis” caption. The Company also advises the Staff
that the information regarding the size of the U.S. patient population is information that was already included in the “Morphogenesis’
Business” section.

The FDA
or comparable foreign regulatory authorities may disagree with Morphogenesis’ regulatory plans..., page 58

 7. Please
                                            revise the risk factor to explain, if true, that Morphogenesis plans to obtain accelerated
                                            approval designation for some or all of its product candidates under the accelerated approval
                                            pathway and the impact to the company if accelerated approval does not materialize.

RESPONSE: The Company acknowledges the
Staff’s comment and has revised the first paragraph of this risk factor on page 61 of Amendment No. 1 to describe the impact
associated with failure to obtain an accelerated approval pathway for IFx-2.0.

Risks
Related to the Combined Company

The bylaws
of the combined company will provide that..., page 94

 8. We
                                            note that the bylaws of the combined company will provide that the U.S. federal district
                                            courts are the exclusive forum for any complaint asserting a cause of action arising under
                                            the Securities Act. Please revise your disclosure to state that there is uncertainty as to
                                            whether a court would enforce such provision. In this regard, we note that Section 22 of
                                            the Securities Act creates concurrent jurisdiction for federal and state courts over all
                                            suits brought to enforce any duty or liability created by the Securities Act or the rules
                                            and regulations thereunder.

RESPONSE: The Company acknowledges the Staff’s comment
and has revised the disclosure on page 96 of Amendment No. 1 in response to the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 4

The combined
company’s ability to use net operating loss carryforwards..., page 96

 9. Please
                                            revise this risk factor to quantify the NOLs and other tax attributes that are or may become
                                            subject to limitation.

RESPONSE: The Company acknowledges the
Staff’s comment and has revised the disclosure on page 99 of Amendment No. 1 to reflect the Staff’s comment.

The
Merger

Background
of the Merger, page 106

 10. Please
                                            revise the disclosure on page 107 to disclose the terms of Morphogenesis’ initial non-binding
                                            indication of interest. Clarify whether CohBar management identified Morphogenesis as one
                                            of the top merger candidates as of November 8 and one of the top three candidates as of November
                                            15. To the extent that CohBar management did not view Morphogenesis as the top or one of
                                            the top candidates, please discuss the reason(s).

RESPONSE: The Company acknowledges the Staff’s comment
and has revised the disclosure on page 108 of Amendment No. 1 to reflect the Staff’s comment.

 11. Please
                                            revise to discuss in greater detail the negotiations concerning the contingent value rights
                                            and the stock purchase agreement with K&V Investment One.

RESPONSE: The Company acknowledges the Staff’s comment
and has revised the disclosure on pages 112 through 113 and 117 of Amendment No. 1 to reflect the Staff’s comment.

 12. Please
                                            also revise this section to explain the diligence that CohBar’s management, board and advisors
                                            conducted concerning Morphogenesis.

RESPONSE: The Company acknowledges the Staff’s comment
and has revised the disclosure on pages 109 and 113 of Amendment No. 1 to reflect the Staff’s comment.

 13. With
                                            reference to the February 13, 2023 entry, describe the material differences between a traditional
                                            staggered sign-and-close reverse merger and simultaneous sign-and-close reverse merger structure.
                                            Explain which party sought the simultaneous sign-and-close structure and why. Also indicate
                                            when Mr. Fitzgerald first raised his concerns with this proposed structure.

RESPONSE: The Company acknowledges
the Staff’s comment and has revised the disclosure on pages 108 and 111 of Amendment No. 1 to reflect the Staff’s
comment.

 14. We
                                            refer to the May 10, 2023 entry. Please revise to quantify the expected reduction to the
                                            net cash that CohBar would deliver under the staggered sign-and-close structure relative
                                            to the previously planned simultaneous sign-and-close structure. Explain how the parties
                                            concluded that Morphogenesis’s valuation should be increased from $125 million to $130.6
                                            million based on this decision. In this regard, it is unclear why the structural change resulted
                                            in an increase to the Morphogenesis valuation as opposed to a decrease in the CohBar valuation.

RESPONSE: The Company acknowledges the
Staff’s comment and has revised the disclosure on page 115 of Amendment No. 1 to reflect the Staff’s comment.

U.S. Securities and Exchange Commission

August 10, 2023

Page 5

The Merger

CohBar’s Reasons for the Merger; Recommendation of the CohBar Board, page 114

 15. Please
                                            revise to provide additional context as to how the $25 million enterprise value ascribed
                                            to CohBar was derived.

RESPONSE: The Company acknowledges the
Staff’s comment and has revised the disclosure on page 118 of Amendment No. 1 to reflect the Staff’s comment.

 16. Please
                                            tell us why the expected cash balances are blank. In this regard, please clarify whether
                                            the disclosure in the section reflects the board’s view as of May 23 when it approved
                                            the merger agreement or whether the disclosure reflects its expectations at a different point
                                            in time.

RESPONSE: The Company acknowledges the Staff’s comment
and has revised the disclosure on page 119 of Amendment No. 1 to reflect the Staff’s comment. The Company advises the Staff that
the disclosure pertaining to the Company’s Board’s consideration of the expected cash balances of the combined company as
of the closing of the Merger reflects the Company’s Board’s view as of Ma