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Kairos Pharma, LTD.
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-21 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2026-01-15 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 333-292686 | Read Filing View |
| 2025-04-22 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2025-01-31 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 333-284569 | Read Filing View |
| 2025-01-06 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-07661 | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-09 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-09 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-06-03 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2023-07-06 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-06654 | Read Filing View |
| 2023-04-25 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-06654 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-15 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 333-292686 | Read Filing View |
| 2025-01-31 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 333-284569 | Read Filing View |
| 2025-01-06 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-07661 | Read Filing View |
| 2023-07-06 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-06654 | Read Filing View |
| 2023-04-25 | SEC Comment Letter | Kairos Pharma, LTD. | DE | 377-06654 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-21 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2025-04-22 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-13 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-09 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-09-09 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
| 2024-06-03 | Company Response | Kairos Pharma, LTD. | DE | N/A | Read Filing View |
2026-01-21 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
KAIROS
PHARMA LTD.
2355
Westwood Blvd., #139
Los
Angeles CA 90064
(818)
404-5541
January
21, 2026
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Kairos
Pharma, Ltd.
Registration
Statement on Form S-3
File
No. 333-292686
Acceleration
Request
Requested
Date:
January
23, 2026
Requested
Time:
9:00
AM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Kairos Pharma, Ltd. hereby requests acceleration of the effective
date of its registration statement on Form S-3 (File No. 333-292686) so that it may become effective at 9:00 a.m. Eastern Time
on January 23, 2026, or as soon thereafter as is practicable.
Very
truly yours,
Kairos
Pharma, Ltd.
/s/
John S. Yu
Name:
John
S. Yu
Title:
Chief
Executive Officer and
Chairman
of the Board of Directors
cc:
Dorsey & Whitney LLP
2026-01-15 - UPLOAD - Kairos Pharma, LTD. File: 333-292686
January 15, 2026
John S. Yu, M.D.
Chief Executive Officer
Kairos Pharma, Ltd.
2355 Westwood Blvd., #139
Los Angeles CA 90064
Re:Kairos Pharma, Ltd.
Registration Statement on Form S-3
Filed January 13, 2026
File No. 333-292686
Dear John S. Yu M.D.:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick, Esq.
2025-04-22 - CORRESP - Kairos Pharma, LTD.
CORRESP 1 filename1.htm KAIROS PHARMA LTD. 2355 Westwood Blvd., #139 Los Angeles CA 90064 (818) 404-5541 April 22, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Kairos Pharma, Ltd. Registration Statement on Form S-1 File No. 333-286662 Acceleration Request Requested Date: April 24, 2025 Requested Time: 5:00 PM Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Kairos Pharma, Ltd. (the "Registrant") hereby requests acceleration of the effective date of its registration statement on Form S-1 (File No. 333-286662) so that it may become effective at 5:00 p.m. Eastern Time on April 24, 2025, or at such time as the Registrant may request by telephone to the staff (the "Staff") of the Securities and Exchange Commission. In addition, the Registrant hereby authorizes Megan J. Penick, Esq. of Dorsey & Whitney LLP, counsel for the Registrant, to make such request on the Registrant's behalf. Very truly yours, Kairos Pharma, Ltd. /s/ John S. Yu Name: John S. Yu Title: Chief Executive Officer and Chairman of the Board of Directors
2025-01-31 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
KAIROS
PHARMA LTD.
2355
Westwood Blvd., #139
Los
Angeles CA 90064
(310)
948-2356
January
31, 2025
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Kairos
Pharma, Ltd.
Registration
Statement on Form S-1
File
No. 333-284569
Acceleration
Request
Requested
Date:
February
4, 2025
Requested
Time:
5:00
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Kairos Pharma, Ltd. (the “Registrant”) hereby requests
acceleration of the effective date of its registration statement on Form S-1 (File No. 333-284569) so that it may become effective at
5:00 p.m. Eastern Time on February 4, 2025, or at such time as the Registrant may request by telephone to the staff (the “Staff”)
of the Securities and Exchange Commission. In addition, the Registrant hereby authorizes Megan J. Penick, Esq. of Dorsey & Whitney
LLP, counsel for the Registrant, to make such request on the Registrant’s behalf.
Very
truly yours,
Kairos
Pharma, Ltd.
By:
/s/
John S. Yu
Name:
John
S. Yu
Title:
Chief
Executive Officer and
Chairman
of the Board of Directors
2025-01-31 - UPLOAD - Kairos Pharma, LTD. File: 333-284569
January 31, 2025
John Yu
Chief Executive Officer
Kairos Pharma, LTD.
2355 Westwood Blvd., #139
Los Angeles, CA 90064
Re:Kairos Pharma, LTD.
Registration Statement on Form S-1
Filed January 29, 2025
File No. 333-284569
Dear John Yu:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick
2025-01-06 - UPLOAD - Kairos Pharma, LTD. File: 377-07661
January 6, 2025
John S. Yu, M.D.
Chief Executive Officer
Kairos Pharma, Ltd.
2355 Westwood Blvd., #139
Los Angeles CA 90064
Re:Kairos Pharma, Ltd.
Draft Registration Statement on Form S-1
Submitted January 3, 2025
CIK No. 0001962011
Dear John S. Yu M.D.:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours
prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding
requests for acceleration. 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.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Megan J. Penick, Esq.
2024-09-13 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
September
13, 2024
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Messrs. Dillon Hagius and Tim Buchmiller
Re:
Kairos
Pharma, Ltd.
Withdrawal
of Acceleration Request - Registration Statement on Form S-1
File
No. 333-274805
Ladies
and Gentlemen,
Kairos
Pharma, Ltd. (the “Company”) hereby withdraws its request to accelerate the effectiveness of the above-referenced Registration
Statement submitted by letter via EDGAR dated September 9, 2024. The Company will file a separate request to accelerate the effectiveness
of the Registration Statement.
Please
contact Megan J. Penick, Esq. of Dorsey & Whitney LLP, counsel for the Company, if you have any questions or concerns regarding this
matter.
Very
truly yours,
KAIROS
PHARMA, LTD.
By:
/s/
John S. Yu
John
S. Yu, M.D.
Chief
Executive Officer
cc:
Megan
J. Penick, Esq.
Dorsey
& Whitney LLP
2024-09-13 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
September
13, 2024
VIA
EDGAR
Division
of Corporation Finance
U.S.
Securities & Exchange Commission
100
F Street, NE
Washington,
D.C. 20549
Attention:
Messrs. Dillon Hagius and Tim Buchmiller
Re: Kairos
Pharma, Ltd.
Registration
Statement on Form S-1
File
No. 333-274805
Ladies and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), the undersigned,
for itself and the other underwriters, hereby join in the request of Kairos Pharma, Ltd. that the effective date of the above-referenced
registration statement be accelerated so as to permit it to become effective at 9:00 a.m., Eastern time, on Monday, September 16, 2024,
or as soon thereafter as practicable.
Pursuant
to 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the preliminary prospectus dated
August 16, 2024 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of such
preliminary prospectus.
The
undersigned advises that it has complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very
truly yours,
Boustead
Securities, LLC
As
representative of the underwriters
By:
/s/
Lincoln Smith
Name:
Lincoln
Smith
Title:
Chief
Executive Officer
2024-09-13 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
September
13, 2024
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Messrs. Dillon Hagius and Tim Buchmiller
Re:
Kairos
Pharma, Ltd.
Registration
Statement on Form S-1
File
No. 333-274805
Acceleration
Request
Requested
Date:
September
16, 2024
Requested
Time:
9:00
AM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Kairos Pharma, Ltd. (the “Registrant”) hereby requests
acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-274805) (the “Registration Statement”)
so that it may become effective at 9:00 a.m. Eastern Time on September 16, 2024, or at such time as the Registrant may request by telephone
to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). In addition, the Registrant
hereby authorizes Megan J. Penick, Esq. of Dorsey & Whitney LLP, counsel for the Registrant, to make such request on the Registrant’s
behalf.
The
Registrant hereby acknowledges that:
(i)
should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not
foreclose the Commission from taking any action with respect to the Registration Statement;
(ii)
the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and
(iii)
the Registrant may not assert comments of the Commission or the Staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very
truly yours,
Kairos
Pharma, Ltd.
By:
/s/
John S. Yu
John
S. Yu, M.D.
Chief
Executive Officer
cc:
Megan
J. Penick, Esq.
Dorsey
& Whitney LLP
2024-09-09 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
September
9, 2024
VIA
EDGAR
Division
of Corporation Finance
U.S.
Securities & Exchange Commission
100
F Street, NE
Washington,
D.C. 20549
Attention:
Messrs. Dillon Hagius and Tim Buchmiller
Re:
Kairos
Pharma, Ltd.
Registration
Statement on Form S-1
File No. 333-274805
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), the undersigned,
for itself and the other underwriters, hereby join in the request of Kairos Pharma, Ltd. that the effective date of the above-referenced
registration statement be accelerated so as to permit it to become effective at 5:00 p.m., Eastern time, on Wednesday, September 11,
2024, or as soon thereafter as practicable.
Pursuant
to 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the preliminary prospectus dated
August 16, 2024 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of such
preliminary prospectus.
The
undersigned advises that it has complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very
truly yours,
Boustead
Securities, LLC
As
representative of the underwriters
By:
/s/
Lincoln Smith
Name:
Lincoln
Smith
Title:
Chief
Executive Officer
2024-09-09 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
September
9, 2024
Via
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549-3720
Attention:
Messrs. Dillon Hagius and Tim Buchmiller
Re:
Kairos
Pharma, Ltd.
Registration
Statement on Form S-1
File
No. 333-274805
Acceleration
Request
Requested
Date:
September
11, 2024
Requested
Time:
5:00
PM Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Kairos Pharma, Ltd. (the “Registrant”) hereby requests
acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-274805) (the “Registration Statement”)
so that it may become effective at 5:00 p.m. Eastern Daylight Time on September 11, 2024, or at such time as the Registrant may request
by telephone to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). In addition,
the Registrant hereby authorizes Megan J. Penick, Esq. of Dorsey & Whitney LLP, counsel for the Registrant, to make such request
on the Registrant’s behalf.
The
Registrant hereby acknowledges that:
(i)
should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not
foreclose the Commission from taking any action with respect to the Registration Statement;
(ii)
the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and
(iii)
the Registrant may not assert comments of the Commission or the Staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very
truly yours,
Kairos
Pharma, Ltd.
By:
/s/
John S. Yu
John
S. Yu, M.D.
Chief
Executive Officer
cc:
Megan
J. Penick, Esq.
Dorsey
& Whitney LLP
2024-06-03 - CORRESP - Kairos Pharma, LTD.
CORRESP
1
filename1.htm
Kairos
Pharma, Ltd.
2355
Westwood Blvd. #139
Los
Angeles CA 90064
June
3, 2024
Division
of Corporation Finance
Office
of Life Sciences
U.S.
Securities and Exchange Commission
Washington,
D.C. 20549
Attn:
Mr.
Dillon Hagius
Mr.
Tim Buchmiller
Re:
Kairos
Pharma, Ltd.
Amendment
No. 6 to Registration Statement on Form S-1
Filed
May 24, 2024
File
No. 333-274805
Ladies
and Gentlemen:
We
are hereby transmitting the response of Kairos Pharma, Ltd., a Delaware corporation (the “Company,” “we,”
or “our”), to the oral comment we received from the staff (the “Staff”) of the U.S.
Securities and Exchange Commission (the “Commission”) on May 30, 2024, regarding Amendment No. 6 to the Registration
Statement on Form S-1 (the “Registration Statement”), filed with the Commission on May 24, 2024. An Amendment
No. 7 to the Registration Statement (the “Amended No. 7 to the Registration Statement”) is being filed with
the Commission concurrently with this letter.
For
your convenience, we have repeated below the comments of the Staff in bold and have followed the Staff’s comments with the Company’s
response.
1.
Given
the $3.3 million award from the National Cancer Institute / National Institutes of Health to support the ongoing Phase 2 trial for
ENV105, please update the Use of Proceeds disclosure to clarify whether you still anticipate needing $1.7 million to complete the
Phase 2 trial. If the company is a beneficiary of this award, please file an exhibit of this award to the registration statement.
Response:
In response to the Staff’s comment, we revised our disclosure on pages 4 and 82 to clarify that the recipient of the NIH grant
is to Cedars-Sinai Medical Center to support the study conducted by Neil Bhowmick’s laboratory and that such funding, while beneficial
to our overall efforts, will not directly reduce the costs of our Phase 2 clinical trial. As a result, we have removed the disclosure
that the funding will in any way reduce our own expenditures related to our Phase 2 clinical trial. Further, as the funding does not
go to us, but is being made to Cedars-Sinai Medical Center to support corollary studies related to our Phase 2 clinical trial, we do
not believe it is appropriate, and we do not believe we would be given permission by Cedars-Sinai, to file the grant award as an exhibit
to our registration statement.
We
thank the Staff in advance for its review of the foregoing in relation to the Company’s filing of Amendment No. 7 to the Registration
Statement. We respectfully request that you provide us with any additional comments as soon as possible. Should you have any questions
or concerns, please kindly contact our counsel, Megan J. Penick, Esq. of Dorsey & Whitney, LLP, by telephone at (201) 892-9525.
Sincerely,
/s/
John S. Yu
John
S. Yu
Chief
Executive Officer
Kairos
Pharma, Ltd.
2023-07-06 - UPLOAD - Kairos Pharma, LTD. File: 377-06654
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.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
July 6, 2023 Page 2
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
July 6, 2023
Page 2
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."
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
July 6, 2023 Page 3
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
July 6, 2023
Page 3
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.
2023-04-25 - UPLOAD - Kairos Pharma, LTD. File: 377-06654
United States securities and exchange commission logo
April 25, 2023
John Yu, M.D.
Chief Executive Officer
Kairos Pharma, Ltd.
2355 Westwood Blvd. #139
Los Angeles CA 90064
Re:Kairos Pharma, Ltd.
Draft Registration Statement on Form S-1
Submitted March 29, 2023
CIK No. 0001962011
Dear John Yu:
We have reviewed your 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.
Draft Registration Statement on Form S-1
Cover Page
1.We note your disclosure on page 4 that "[w]hile we have applied to have our common
stock approved for listing on The Nasdaq Global Market, we may not successfully achieve
listing of our common stock on that or any other exchange..." Disclose whether your
offering is contingent upon final approval of your NASDAQ listing on your cover page
and revise your disclosure on page 4 as appropriate. Please ensure your revised disclosure
is consistent with your underwriting agreement.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 2
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 2
Our Science, page 1
2.As your product candidates have not been approved by the FDA or any other comparable
foreign regulator as safe and effective, please revise the statement here and on page 82
that ENV-105 has "demonstrated safety measures" to remove safety implications.
Relatedly, please revise the following statements here and on pages 75 and 82 to
remove efficacy implications:
•"We are developing small molecules that target these central checkpoints to induce
the immune system into attacking cancer cells";
•"[W]e are developing an activated T cell therapy that transforms a patient’s T cells
into killer activated T cells against cancerous stem cells";
•"The mechanism of action for ENV105 outsmarts a difficult-to-target resistance
mechanism of tumor dormancy";
•"ENV105 can extend and even restore sensitivity to standard-of-care chemotherapy,
radiation therapy, androgen targeted therapy, EGFR inhibitors, or checkpoint
inhibition when given in combination"; and
•"[T]he co-administration of ENV105 serves in asynthetic lethal mechanism of tumor-
selective tumor killing...."
Prospectus Summary
Overview, page 1
3.Please balance your disclosure that your proprietary technologies are licensed "in part
from Cedars-Sinai Medical Center" with disclosure, if true, that all of your patent rights
are in-licensed from third parties under license agreements that require you to meet certain
milestones for continuation of those agreements. We note disclosure to this effect on
pages 89 and 90. Please also balance your disclosure that you "have leveraged molecular
insights to develop a new class of novel drugs that reverse drug resistance and checkpoints
of immune suppression" with disclosure that your product candidates have not been
approved as safe or effective by the FDA or any other comparable foreign regulator.
Our In-Development Products and Pipeline, page 2
4.Please revise the statement that "[i]n the earlier Phase 2 trial involving a heavily pre-
treated population, the 43% progression free survival rate was extraordinary" to include a
broader discussion of the primary endpoint(s) and result(s) of that trial, including the type
of pre-treatment and why you believe the 43% rate was extraordinary.
5.Please balance your disclosure here and on page 83 that you "believe ENV 205 to be a
first-of-its-kind biologic that restores sensitivity of prostate cancers that have become
otherwise resistant to chemotherapy" with disclosure that ENV 205 has not been approved
by the FDA or any other comparable foreign regulator. Similarly, revise the statement
here and on page 83 that your companion biomarkers are "paving the way to lower the bar
to Phase 3 success" to remove safety and efficacy implications.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 3
FirstName LastNameJohn Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 3
6.We note your disclosure that Enviro Therapeutics will strive to co-develop companion
biomarkers with all drugs in its portfolio. Please clarify 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. Please also include appropriate risk factor disclosure regarding
development and approval of companion diagnostic tests.
Pipeline Table, page 3
7.There are six separate columns in the pipeline table related to pre-clinical development.
Please combine them into one or two columns. Additionally, revise the pipeline table to:
•add a column showing the indication for each drug candidate;
•add separate columns for each clinical trial stage;
•more clearly depict the current pre-clinical or clinical stage for each product
candidate; and
•update your "next milestone" column to remove previously completed tasks.
8.Your pipeline table states Janssen and AstraZeneca are "clinical trial partner[s]." Please
disclose the nature of your partnership with these two companies in the prospectus
summary and in the business section.
Corporate Information, page 4
9.We note your disclosure that your "corporate address" is in Los Angeles, CA. Please
revise to clarify whether you conduct corporate operations at this address or whether
this is the address of your registered agent. If you are unable to use this location to
conduct operations, please revise your disclosures on pages 3, 83, and 107 concerning
"working virtually, when possible" and "partially operating virtually" to clarify, if true,
that your operations are all conducted virtually or clarify where your operations are
conducted. In this regard, we note your disclosure on page 107 that you do not currently
lease any properties.
The Offering, page 6
10.When you provide the "[other]" disclosure in the second bullet on this page, please ensure
that it includes all sources of potential dilution to investors such as those indicated in the
bullet points at the bottom of page 72.
Risk Factors
Provisions in our corporate charter documents and under Delaware law could make an
acquisition of our company. . ., page 61
11.Your statement that you are incorporated in Delaware conflicts with disclosure on the
cover page and page 4 that you are incorporated in California. In this regard, we note
other references to Delaware incorporation and/or Delaware law throughout the filing.
Please revise or advise.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 4
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 4
Our amended and restated certificate of incorporation will provide that the Court of Chancery of
the State of Delaware. . ., page 61
12.Please revise this risk factor to disclose that there is also a risk that your exclusive forum
provision may result in increased costs for investors to bring a claim.
Use of Proceeds, page 70
13.Please update the first bullet in this section, when possible, to state how far in the
development process you estimate the proceeds from this offering will enable you to reach
for each of your candidates.
Business, page 82
14.We note the following statements on page 86:
•"ENV 105 is an antibody therapeutic with demonstrated efficacy in prostate cancer
patients resistant to androgen-targeted therapy"; and
•"ENV205, an antibody fragment targeting mitochondrial DNA with demonstrated
efficacy for chemotherapy resistant prostate cancer, is in the preclinical stage of
development."
Please revise these statements to remove the implication of efficacy as such statements are
too early given the status of the regulatory approval for these candidates.
Enviro and Enviro-Licensed or -Acquired Products, page 86
15.Please revise the statement that ENV 105's IND has been "cleared by the FDA" to remove
any implication that the FDA has approved ENV 105. We note your disclosure on page
95 that, barring safety concerns, an IND automatically becomes effective 30 days after
receipt by the FDA.
16.Your statement that ENV 105 was "reasonably well-tolerated" implies that there were
prior preclinical and/or clinical trials of ENV 105. If true, please present data from these
trials and their 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. If you are referring to the Phase 2 trial
mentioned on pages 2 and 83, please also make that clear. Moreover, please explain
what it means that "no grade 3-4 toxicities were observed." If you are referring to serious
adverse events, please so specify and ensure that all material adverse events observed in
prior clinical trials of ENV 105 are disclosed.
17.Please revise the following statements on pages 86 and 87 to remove the implication that
your product candidates will ultimately be approved or become first-in-class:
•"We believe ENV 205 is a first in class drug targeting endoglin"; and
•"ENV 205 is a first-in-class molecule found to limit the process of muscle wasting...."
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 5
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 5
Enviro Intellectual Property Agreements with Cedars-Sinai Medical Center, page 89
18.Please revise your disclosure about the terms of Enviro's agreements with Cedars-Sinai
Medical Center in the following ways:
•disclose the milestones that must be met and when;
•quantify the aggregate potential fees that Enviro may have to pay in exchange for the
licenses;
•revise your description of the "non-royalty sublicense revenue" to clarify a range that
is within ten percentage points (e.g., a double-digit percentage in the teens);
•specifically quantify the maximum aggregate milestone payments; and
•disclose when the last-to-expire licensed patents are scheduled to expire.
Intellectual Property, page 89
19.Please revise your intellectual property disclosure to disclose for each material patent and
patent application the specific products or technologies to which such patents or patent
applications relate. Also clearly describe on an individual basis the type of patent
protection granted for each product or technology (composition of matter, use, or process),
the expected expiration of each patent, and the jurisdiction, including any foreign
jurisdiction, of each pending or issued patent. In this regard, it may be useful to provide
this disclosure in tabular form to support the narrative already included.
Kairos Intellectual Property Agreements with Cedars-Sinai Medical Center, page 89
20.Please revise your disclosure about the terms of your agreements with Cedars-Sinai
Medical Center in the following ways:
•For agreement 1: revise your description of the "non-royalty sublicense fees" to
clarify a range that is within ten percentage points (e.g., a double-digit percentage in
the teens) and specifically quantify the maximum aggregate milestone payments;
•For agreements 2, 3, and 4: specifically quantify the "initial license fee[;]" and
•For all agreements: disclose patent expiration dates, royalty and non-royalty
payment expiration dates, and the specific jurisdictions of foreign patents, and
specifically quantify the maximum aggregate milestone payments.
Enviro License and Supply Agreement with Tracon Pharmaceuticals, Inc., page 90
21.Please revise your disclosure in this section as follows:
•Disclose when the royalty and non-royalty payments would terminate;
•Clarify the percentage of ownership that the Tracon-Enviro Equity represents; and
•As it concerns the patents underlying your agreement with Tracon
Pharmaceuticals, please disclose the type of patent protection (such as composition of
matter, use, or process), when the patents are scheduled to expire, and the
specific jurisdictions of the foreign patents.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 6
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 6
Management, page 108
22.We note your disclosure that Drs. Mazanet and Keyoung will become members of your
board of directors upon the consummation of your offering. Please file the consents of
these director nominees to be named in your registration statement as exhibits. Refer to
Securities Act Rule 438.
23.We note your disclosure on page 120 that you will have a classified board. Please identify
which class each director will belong to and when each class’s term will expire.
Executive Compensation
Equity Benefit Plans, page 114
24.Please file the 2022 Equity Incentive Plan and the 2022 Employee Stock Purchase Plan
as exhibits pursuant to Regulation S-K, Item 601(b)(10)(iii).
Principal Stockholders, page 119
25.Please identify in a footnote to the table all natural persons who have voting and/or
investment power over the shares held by Technomedics Management and Systems.
Certain Material U.S. Federal Income Tax Consequences to Non-U.S. Holders, page 126
26.Please remove the disclaimer indicating that the discussion of material tax considerations
is provided for informational purposes only.
Signatures, page II-5
27.Please indicate by parenthetical disclosure who is signing the registration statement in
their capacity as your principal executive officer, principal financial officer, and principal
accounting officer or controller. Refer to Instruction 1 to Signatures on Form S-1.
General
28.Please furnish the information required by Item 505 of Regulation S-K in your
prospectus. See Item 5 of Form S-1.
29.Please provide us with copies of all written communications, as defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act, whether or not they
retain copies of the communications.
FirstName LastNameJohn Yu, M.D.
Comapany NameKairos Pharma, Ltd.
April 25, 2023 Page 7
FirstName LastName
John Yu, M.D.
Kairos Pharma, Ltd.
April 25, 2023
Page 7
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.