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United States securities and exchange commission logo
July 6, 2023
John Yu, M.D.
Chief Executive Officer
Kairos Pharma, Ltd.
2355 Westwood Blvd. #139
Los Angeles CA 90064
Re: Kairos Pharma, Ltd.
Amendments No. 1
and No. 2 to Draft Registration Statement on Form S-1
Submitted June 28,
2023
CIK No. 0001962011
Dear John Yu:
We have reviewed your amended draft 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 providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. 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 the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendments No. 1 and No. 2 to Draft Registration Statement on Form S-1
Cover Page
1. We note your response
to comment 1 that the closing of the offering is contingent on
Nasdaq s approval of
your listing application. Please reconcile your disclosure on page 5
that the failure to
list your common stock would adversely affect the liquidity of [the]
investment and may also
adversely affect the [share] price[.] Ensure your revised
disclosure is
consistent with your underwriting agreement.
John Yu, M.D.
FirstName LastNameJohn Yu, M.D.
Kairos Pharma, Ltd.
Comapany
July 6, 2023NameKairos Pharma, Ltd.
July 6,2 2023 Page 2
Page
FirstName LastName
Prospectus Summary
Our In-Development Products and Pipeline, page 2
2. We note your reference to the "earlier Phase 2 trial involving a
heavily pre-treated
population suffering from prostate cancer[.]" Please present data from
this trial and its
results that would be material to investors, including, but not
limited to, primary
endpoints, who conducted the trials and when, the regulatory
jurisdictions of the trials,
and why they were not continued.
3. We note your response to comment 4. Please revise to clarify who
considered the
findings from the earlier Phase 2 trial extraordinary. If this
is your own opinion, please
so specify. We note disclosure to this effect on page 83. Please also
specify the
"numerous publications" that have "demonstrat[ed] hormone therapy
resistance develops
through the induction of CD105[.]"
4. We note your response to comment 6 and re-issue in part. Please
clarify in the
prospectus summary whether there are currently any approved companion
diagnostic tests
available to be used in connection with your product candidates and,
if there are not,
please revise to clarify that separate approval would be required, or
advise. In this regard,
we note your revised disclosure on page 83 that, as of the date of
this prospectus, your
companion diagnostics are in development and have not been approved by
the FDA.
Business
Enviro and Enviro-Licensed or -Acquired Products, page 86
5. We note your response to comment 16 and re-issue in part. Please
clarify which clinical
trial of ENV105 demonstrated that it was "reasonably well-tolerated."
In this regard, your
correspondence states you are referring to the "completed Phase 2
(NCT03418324) trial
referenced on pages 2 and 85[,]" but, on page 86, you state ENV105 is
"presently in a
Phase 2 clinical trial (NCT03418324)". Moreover, disclose whether
there were
any material adverse events observed in any prior clinical trial of
ENV 105, not just those
that concerned grade 3-4 toxicities.
Kairos Intellectual Property Agreements with Cedars-Sinai Medical Center, page
89
6. We note your response to comment 18. It appears you removed the
subheading entitled
"Enviro Intellectual Property Agreements with Cedars-Sinai Medical
Center." In the
absence of this sub-heading or additional defined terms, it is not
clear which
exclusive license agreements concern Kairos and which concern Enviro.
Please revise.
7. We note your response to comment 20. For the exclusive license
agreement connected to
the patent concerning the method of generating activated T cells for
cancer therapy,
specifically quantify the aggregate total milestone payments beyond
"low-to-mid seven-
figures."
John Yu, M.D.
FirstName LastNameJohn Yu, M.D.
Kairos Pharma, Ltd.
Comapany
July 6, 2023NameKairos Pharma, Ltd.
July 6,3 2023 Page 3
Page
FirstName LastName
Choice of Forum, page 125
8. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any "derivative
action." Please disclose whether this provision applies to actions
arising under the
Securities Act or Exchange Act. In that regard, we note that Section
27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to
enforce any duty or
liability created by the Exchange Act or the rules and regulations
thereunder, and 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. If the provision applies to Securities Act
claims, as indicated in
your risk factor on page 62, please also revise your prospectus to
state that there is
uncertainty as to whether a court would enforce such provision and
that investors cannot
waive compliance with the federal securities laws and the rules and
regulations
thereunder. If this provision does not apply to actions arising under
the Securities Act or
Exchange Act, please also ensure that the exclusive forum provision in
the governing
documents states this clearly, or tell us how you will inform
investors in future filings that
the provision does not apply to any actions arising under the
Securities Act or Exchange
Act. Please ensure your related risk factor on page 62 reconciles to
your revised
disclosure.
Exhibits
9. Please ensure that each exhibit has been filed in the proper
text-searchable format. Refer
to Item 301 of Regulation S-T.
10. We note your disclosure on page 117 that you intend to enter into
employment agreements
with your executive officers prior to completion of this initial
public offering. When
available, please file each of these agreements as exhibits to your
registration statement.
You may contact Christine Torney at 202-551-3652 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Megan Penick, Esq.