Correspondence 0001493152-23-040700 from Telomir Pharmaceuticals, Inc. (TELO) (CIK 0001971532) (TELO)
Telomir Pharmaceuticals, Inc. (TELO) (CIK 0001971532)
Date: Nov. 13, 2023 · CIK: 0001971532 · Accession: 0001493152-23-040700
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ATTORNEYS
AT LAW
100
North Tampa Street, Suite 2700 Tampa,
FL
33602-5810 P.O. Box 3391
Tampa,
FL 33601-3391
813.229.2300
TEL
813.221.4210
FAX
www.foley.com
WRITER’S
DIRECT LINE 813.225.4122
ccreely@foley.com
November
13, 2023
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
Washington,
DC 20549
Attention:
Tara Harkins, Lynn Dicker, Jimmy McNamara, and Joe McCann
Re:
Telomir
Pharmaceuticals, Inc.
Amendment
No. 1 to Draft Registration Statement on Form S-1
Submitted
October 16, 2023
CIK
No. 0001971532
Dear
Ms. Harkins, Ms. Dicker, Mr. McNamara, and Mr. McCann:
On
behalf of Telomir Pharmaceuticals, Inc. (the “Company”), we are responding to the comments of the staff of the Division of
Corporation Finance of the United States Securities and Exchange Commission set forth in your letter to Dr. Christopher Chapman, the
Company’s Chief Executive Officer, dated November 1, 2023, relating to the above-referenced filing. Your comments are reproduced
below in italicized bold text, followed by our responses on behalf of the Company. Please be advised that the Company is concurrently
filing via EDGAR a Registration Statement on Form S-1 (the “Registration Statement”).
Amendment
No. 1 to Draft Registration Statement on Form S-1
Business
Summary
Overview,
page 1
1.
We
note your response to comment 1 and re-issue in part. Please revise to explain briefly at first use the term “in situ.”
Response:
Please be advised that the Company has revised the Registration Statement to include the definition of the term “in situ”
in the “Glossary of Certain Scientific Terms” on page iv.
AUSTIN
Boston
CHICAGO
dallas
DENVER
DETROIT
houston
JACKSONVILLE
LOS
ANGELES
MADISON
MEXICO
CITY
MIAMI
MILWAUKEE
NEW
YORK
ORLANDO
SACRAMENTO
salt
lake city
SAN
DIEGO
SAN
FRANCISCO
SILICON
VALLEY
TALLAHASSEE
TAMPA
WASHINGTON,
D.C.
BRUSSELS
TOKYO
November
13, 2023
Page
2 of 4
2.
We
note your disclosure that you “believe that TELOMIR-1 may effectively serve as a metal
enzyme inhibitor of essential metals such as zinc and copper[]” and that “TELOMIR-1
may protect the stem cells by elongating and stimulating the telomeres to sustain self-renewal
of stem cells.” Please revise your disclosure here and elsewhere to remove any implication
that your product candidates will be safe or effective, as such conclusions are within the
sole authority of the FDA and comparable foreign regulators.
Response:
Please be advised that the Company has revised the language in various places in the Registration Statement to make clear that
conclusions as to safety and efficacy are subject to approval by the FDA and comparable foreign regulators.
Intellectual
Property, page 3
3.
We
note your response to comment 4 and reissue our comment in part. Please revise your disclosure to provide further details about Mr.
Williams’ scientific background, such as how he “developed extensive knowledge of tobacco alkaloid chemistry in the 1990’s”
and the context surrounding how Mr. Williams came to work on the “development of techniques for preventing the formation of
[TSNAs] during the tobacco curing process.” Please also clarify whether the 85 patents or patent applications for which Mr.
Williams is a named inventor relate to the life sciences industry.
Response:
Please be advised that the Company has revised the Registration Statement to include additional details regarding Mr. Williams’
scientific background. See pages 5 and 62 for the additional information. Further, please be advised that the Company has revised
its disclosure on pages 5 and 62 relating to the patents and patent applications for which Mr. Williams is a named inventor
and that relate to the life sciences industry.
Summary
Risk Factors, page 4
4.
We
note your response to comment 9. Please specify in the seventh bullet point that Dr. Chapman will be working on an as-needed basis.
Response:
Please be advised that the Company has revised the seventh bullet point on page 4 to specify that Dr. Chapman will be working for the
Company on a part-time and as-needed basis. Further, the Company has revised the title of the corresponding risk factor on page 12 to
specify that Dr. Chapman will be working for the Company on a part-time and as-needed basis.
Risks
Related to Our Operations and Financial Condition
Conflicts
of interest may arise between us and MIRALOGX. , page 12
5.
We
note your response to comment 11 and re-issue in part. Please tell us whether any other officers, directors or principal shareholders
are affiliated with MIRALOGX.
Response:
Please be advised that the Company has revised the Registration Statement to provide that Christos Nicholoudis, our General Counsel and
a member of our board of directors, performs certain consulting work for MIRALOGX on an as-needed basis through his law firm. None of
the other officers, directors, or principal shareholders are affiliated with MIRALOGX.
Risks
Related to Our Intellectual Property
We
may not be able to adequately protect our product candidates or our proprietary technology in the marketplace. , page 29
6.
We
note your response to comment 5 and your revised disclosure on page 30 noting that you do
not own the rights to the intellectual property and technology that will be used to commercially
develop TELOMIR-1 and that MIRALOGX holds those patent rights through a “pending patent
application.” Please revise your risk factor disclosure to explain the risks associated
with not having patent coverage for the work you are conducting. Please also clarify here
and elsewhere, as appropriate, that MIRALOGX has filed a nonprovisional patent application.
Response:
Please be advised that the Company has revised the Registration Statement to include a risk factor associated with not having patent
coverage for the work the Company is conducting. The Company has further revised the Registration Statement to clarify that MIRALOGX
has filed a nonprovisional patent application.
November
13, 2023
Page
3 of 4
Management’s
Discussion and Analysis of Financial Condition and Results of Operations, page 41
7.
Once
you have an estimated offering price or range, please explain to us how you determined the
fair value of the common stock underlying your equity issuances including any stock options
issued and the reasons for any differences between the recent valuations of your common stock
leading up to the initial public offering and the estimated offering price. This information
will help facilitate our review of your accounting for equity issuances including stock compensation.
Please discuss with the staff how to submit your response.
Response:
For the information of the Staff, the Company has not to date granted any stock options or other equity compensation, and
its historical financial statements do not include any stock compensation expense.
Business
Overview,
page 46
8.
We
note your response to prior comment 14 and your revised disclosure regarding the results of the study comparing the complexing abilities
of TELOMIR-1 and doxycycline. Please revise your disclosure further to explain why TELOMIR-1 was compared with doxycycline in this
regard.
Response:
Please be advised that the Company has revised the Registration Statement to further explain why TELOMIR-1 was compared to doxycycline.
9.
We
note your response to prior comment 15 and your revised disclosure regarding the results of your studies comparing the anti-cancer
activities of TELOMIR-1 versus rapamycin. Please revise your disclosure further to explain why TELOMIR-1 was compared with rapamycin
in this regard.
Response:
Please be advised that the Company has revised the Registration Statement to further explain why TELOMIR-1 was compared to rapamycin.
In
silico Affinity Studies, page 52
10.
We
note your disclosure on page 52 that “[p]re-clinical studies demonstrate that TELOMIR-1 . . . turn[s] off the underlying cause
of cancer development and growth.” Please revise your disclosure here to remove the implication that your product is safe or
effective as such conclusions are within the sole authority of the FDA and comparable foreign regulators..
Response:
Please be advised that the Company has revised the Registration Statement to make clear that conclusions as to safety and efficacy
are within the sole authority of the FDA and comparable foreign regulators.
11.
We
note your response to prior comment 18. We reissue our comment in part. Please revise your disclosure to clarify whether the pre-clinical
studies described in this section were conducted with the assistance of any third parties.
Response:
Please be advised that the Company has revised the Registration Statement to clarify that all pre-clinical studies were conducted with
the assistance of third parties.
General
12.
Please
ensure the writing is legible in the visual depictions throughout your draft registration statement. For example only, certain text
on pages 48-50 is not legible.
Response:
Please be advised that the Company has revised the Registration Statement to replace the illegible visual depictions and graphics with
images and tables that are clearly legible.
November
13, 2023
Page
4 of 4
Should
you have any additional questions, please do not hesitate to contact the undersigned at 813.225.4122.
Best
regards,
/s/
Curt P. Creely
Curt
P. Creely