SEC Comment Letter 0000000000-23-008394 to CohBar, Inc. (CWBR) (CIK 0001522602)
CohBar, Inc. (CWBR) (CIK 0001522602)
Date: Aug. 4, 2023 · CIK: 0001522602 · Accession: 0000000000-23-008394
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File numbers found in text: 333-273101
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United States securities and exchange commission logo
August 3, 2023
Joseph J. Sarret
Chief Executive Officer and Director
CohBar, Inc.
1455 Adams Drive, Suite 1308
Menlo Park, CA 94025
Re:CohBar, Inc.
Registration Statement on Form S-4
Filed July 3, 2023
File No. 333-273101
Dear Joseph J. Sarret:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Registration Statement on Form S-4 filed July 3, 2023
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.
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 2
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
August 3, 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.
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.
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.
5.We note your disclosure that Morphogenesis is a Phase 2/3 clinical stage immuno-
oncology 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.
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."
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.
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 3
FirstName LastName
Joseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 3
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.
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.
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).
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.
12.Please also revise this section to explain the diligence that CohBar's management, board
and advisors conducted concerning Morphogenesis.
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.
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.
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 4
FirstName LastName
Joseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 4
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.
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.
Morphogenesis' Reasons for the Merger, page 120
17.Please tell us whether, and if so why, the Morphogenesis Board considered the additional
financing to be received under the Securities Purchase Agreement to consist of additional
financing "committed" from the Initial Financing and Second Financing." In this regard,
we note based on your disclosure on page 2 and elsewhere that the Second Financing
would occur, if ever, at the option of the Investor.
Opinion of CohBar's Financial Advisor, page 123
18.We note the disclosure on page 123 indicating that CohBar hired Ladenburg to render an
opinion as to the fairness of the Exchange Ratio, from a financial point of view, to the
holders of CohBar Common stock. Accordingly, please provide Ladenburg's analysis
regarding the $25 million implied valuation of CohBar or advise.
19.We note your disclosure indicating that Ladenburg reviewed relevant financial and
operating data provided by CohBar and Morphogenesis as well as "certain internal
analyses." Please revise to clarify whether Ladenburg considered or utilized any financial
or operating data to conduct one or more of the three principal financial analyses. If not,
then also explain why it did not do so and further explain if/how this data factored into
Ladenburg's fairness determination .
20.We note your references to "considerations and judgments" concerning historical and
projected financial and operating characteristics and other factors that could affect
the value of the Selected Publicly Traded Companies, Selected Precedent IPO Companies,
target companies from the Selected Precedent M&A Transactions and Morphogenesis to
which they were being compared. Please revise your disclosure in this section to describe
such considerations and judgments made by Ladenburg in its comparable company and
precedent transaction analysis.
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 5
FirstName LastName
Joseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 5
Opinion of CohBar's Financial Advisor
Transaction Overview as of the Date of the Opinion
Implied Morphogenesis Valuation, page 125
21.Please provide the following information regarding Ladenburg's derivation of an implied
valuation for Morphogenesis of $130.6 million.
•Provide a reconciliation of the number of Morphogenesis shares of common stock on
a "fully diluted, as converted treasury stock method basis" as discussed on page 125
(209,684,773 shares) to the sum of its preferred stock, common stock, warrants and
stock options that were outstanding at March 31, 2023.
•Explain how you determined the $0.62 per share value for Morphogenesis common
shares.
•Provide an illustration that shows how the 0.3114 Exchange Ratio was determined.
•Confirm expected timing for the reverse stock split, which you appear to indicate will
occur prior to or on the merger date, as discussed on page 263.
Director Positions Following the Merger, page 131
22.We note your disclosure concerning the two directors appointed by CohBar. We also note
the disclosure on page 131 concerning Mr. Fitzgerald's May 3, 2023 statement that he
would not resign from the board at closing. Please revise or advise to clarify Mr.
Fitzgerald's role, if any, in the combined company following the closing of the merger.
Material U.S. Federal Income Tax Consequences of the Merger, page 136
23.Please include a tax opinion covering the material tax consequences of: (i) the merger to
United States holders of Morphogenesis capital stock, (ii) the merger to United States
holders of CohBar capital stock and (iii) the issuance of CVRs to US holders of CohBar
capital stock. For guidance, refer to Staff Legal Bulletin No. 19 (Oct. 14, 2011).
24.With reference to the disclosure on page 137, please tell us whether there is significant
doubt regarding whether the Merger qualifies as either a "reorganization" or a
"contribution."
Material U.S. Federal Income Tax Consequences of the CVRs..., page 138
25.To the extent that there is a lack of authority directly addressing the tax consequences of
the transaction, conflicting authority or significant doubt about the tax consequences of
the transaction, counsel or accountant may issue a “should” or “more likely than not”
opinion to make clear that the opinion is subject to a degree of uncertainty. For guidance
please refer to Staff Legal Bulletin No. 19. Also, revise the Q&A disclosure on page 8 to
highlight the tax consequences to the prospective CVR holders as opposed to the
company's conclusion that the CVRs are a distribution of property.
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 6
FirstName LastName
Joseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 6
Nasdaq Stock Market Listing, page 140
26.Please revise this section to disclose the "certain period of time" following the proposed
reverse stock split wherein the combined company must maintain a minimum bid price of
$4.00 in order for the Nasdaq listing application to be accepted.
Morphogenesis Executive Compensation
Summary Compensation Table, page 180
27.The sum of the compensation does not equal the amount in the "Total" column for Dr.
Bianco in 2022. Please revise or explain your calculations.
Morphogenesis Pipeline, page 217
28.The pipeline table here and on page 225 should graphically reflect the actual, and not the
anticipated, status of your product candidates as of the latest practicable date, as well as
the material stages you will need to complete before marketing your products.
Accordingly, please revise the tables to reflect that your IFx-2.0 candidate targeting
advanced or metastatic Merkel cell carcinoma (“MCC”) remains in Phase 1b. In this
regard, your disclosures on pages 219 and 227-228 indicate that this trial is on-going and
that you only have preliminary results from that trial. Similarly, the arrow for IFx-2.0 in
metastatic cancers indicates that the Phase 2 basket trial is underway even though your
disclosure on page 218 indicates that Morphogenesis is "planning" the Phase 2 basket
trial for Q4 2024. Also, revise the "Highlights" column to reflect that Morphogenesis must
identify a lead candidate for IFx-3.0.
Cancer Vaccines
IFx Technology , page 221
29.Please revise the figure at the bottom of page 221 to ensure that all text is legible without
the need for magnification.
Morphogenesis Development Program and Development Strategy, page 225
30.With respect to IFx-2.0, please revise the "Highlight" column of this table to be consistent
with the table on page 217. Clarify, if true, that Morphogenesis plans to enter the Phase
2/3 and Phase 2 basket studies in 2024.
31.With reference to the pro forma information disclosed on page 282, please revise to
discuss the planned allocation for the cash that will be available to the combined company
upon closing.
Clinical Data
IFx-2.0 Clinical Trials , page 226
32.We note that your disclosures throughout this section include terms such as "complete
FirstName LastNameJoseph J. Sarret
Comapany NameCohBar, Inc.
August 3, 2023 Page 7
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 7
response," "partial response," "stable disease," "progressive disease," and "overall
response rate." Please revise to define such terms, including how such responses were
measured. Also, clarify the acronyms for these responses and explain the reference to
"pCR" which appears on page 228. Additionally, please revise here, and elsewhere as
appropriate, to explain that evidence of clinical activity and/or clinical response does not
mean that the product candidate has or will demonstrate clinical efficacy or that it will
prove to be safe as required to receive regulatory approval.
Phase 2/3 registration trial to be conducted under Accelerated Approval Pathway, page 226
33.Please revise the heading so that it does not imply that you have reached agreement with
FDA concerning the accelerated approval pathway.
34.Explain briefly why you identify the prospective trial as a Phase 2/3 as opposed to a Phase
2 trial.
35.With reference to your disclosure on pages 243-244, please revise to disclose the basis on
which you