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
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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