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.
Joseph J. Sarret
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
Comapany
August NameCohBar, Inc.
3, 2023
August
Page 2 3, 2023 Page 2
FirstName LastName
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.
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
FirstName LastNameJoseph J. Sarret
$130.6 million based on this decision. In this regard, it is unclear why
the structural
Comapany NameCohBar,
change Inc.
resulted in an increase to the Morphogenesis valuation as
opposed to a decrease in
Augustthe CohBar
3, 2023 valuation.
Page 3
FirstName LastName
Joseph J. Sarret
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
Comapany
August NameCohBar, Inc.
3, 2023
August
Page 4 3, 2023 Page 4
FirstName LastName
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.
Joseph J. Sarret
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
Comapany
August NameCohBar, Inc.
3, 2023
August
Page 5 3, 2023 Page 5
FirstName LastName
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.
Joseph J. Sarret
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
Comapany
August NameCohBar, Inc.
3, 2023
August
Page 6 3, 2023 Page 6
FirstName LastName
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
Joseph J. Sarret
FirstName LastNameJoseph J. Sarret
CohBar, Inc.
Comapany
August NameCohBar, Inc.
3, 2023
August
Page 7 3, 2023 Page 7
FirstName LastName
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 plan to seek accelerated approval. In this regard, please
clarify whether you
will seek approval by (i) establishing that the drug product has an
effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit and/or
(ii) that the drug
product has an effect on an intermediate clinical endpoint that can be
measured earlier
than an effect on irreversible morbidity or mortality, or IMM. Also,
revise the table on
page 227 to specify the primary and secondary endpoints, or advise.
Explain the
references to FPI , LPI and TLR.
Intellectual Property, page 233
36. Please revise your patent tables on pages 235 and 236 to include the
type of patent
protection granted for the products or technologies in each disclosed
patent family (i.e.,
composition of matter, use, or process).
Licensed Intellectual Property Rights Relating to Delta Receptor Technology,
page 235
37. Please revise your disclosure regarding Morphogenesis' license
agreements with Moffitt
Cancer Center and the West Virginia University Research Corporation to
include a
discussion of all material payment terms, including quantification of
potential milestone
payments segregated by development and commercial milestone payments,
and the
applicable royalty rates to be paid by each party. In the event a
range is provided in place
of the actual royalty rate, such range should be within ten percentage
points.
Morphogenesis' Management's Discussion and Analysis of Financial Condition and
Results of
Operations
Results of Operations, page 265
38. Please provide a discussion and analysis of financial condition and
results of operations
Joseph J. Sarret
CohBar, Inc.
August 3, 2023
Page 8
for the years ended December 31, 2022 and 2021. Refer to Item 303(b) of
Regulation S-K.
Unaudited Pro Forma Condensed Combined Financial Information, page 279
39. Please correct the heading on page 282 to reference the unaudited
proforma condensed
combined balance sheet.
40. Please explain why the Contingent Value Rights to be issued in
conjunction with the
planned merger are not reflected in your pro forma financial statements.
41. Please revise your disclosure on page 285 to quantitatively illustrate
how the Exchange
Ratio was calculated.
Morphogenesis Inc. and Subsidiary
Notes to the financial statements
Note 9 - TuHURA acquisition, page F-50
42. Please describe and quantify the methods and assumptions used to
determine the $15
million value for Morphogenesis common shares issued to acquire certain
assets of
TuHURA Biopharma, Inc.
Exhibits
43. Please file your license agreements with the Moffitt Cancer Center, and
WVURC. Also
file the Tuhura BioPharma Inc. asset acquisition agreement.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Franklin Wyman at (202) 551-3660 or Angela Connell at
(202) 551-
3426 if you have questions regarding comments on the financial statements and
related
matters. Please contact Lauren S. Hamill at (303) 844-1008 or Joe McCann at
(202) 551-6262
with any other questions.
Sincerely,
FirstName LastNameJoseph J. Sarret
Division of
Corporation Finance
Comapany NameCohBar, Inc.
Office of Life
Sciences
August 3, 2023 Page 8
cc: Branden Berns
FirstName LastName