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UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 9, 2025
TELOMIR
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in its Charter)
Florida |
|
001-41952 |
|
87-2606031 |
(State
or Other Jurisdiction
of Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification No.) |
100
SE 2nd St, Suite 2000, #1009
Miami,
Florida
(Address of Principal Executive Offices)
Registrant’s
telephone number, including area code: (786) 396-6723
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
|
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
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|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, no par value |
|
TELO |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
8.01 Other Events
Telomir
Pharmaceuticals Announces New Cancer Data in Aggressive Human Prostate Cancer Cells Showing Telomir-1 Resets DNA Methylation to Reactivate
CDKN2A, a Master Tumor Suppressor, Outperforming Rapamycin and Chemotherapy
New
preclinical findings highlight Telomir-1’s ability to reverse CDKN2A gene silencing by DNA methylation, reactivating this gene
— often called the body’s natural “cell cycle brake.” These results build on prior STAT1 data, supporting Telomir-1’s
profile as a potential first-in-class broad-spectrum DNA methylation reset therapy.
Telomir
Pharmaceuticals, Inc. (NASDAQ:TELO) today reported new preclinical cancer data in aggressive human prostate cancer cell models (PC3 xenografts)
showing that Telomir-1 inhibited DNA hypermethylation of CDKN2A, a master tumor suppressor gene often referred to as the body’s
natural “cell cycle brake.”
CDKN2A
plays a central role in controlling uninhibited cell growth and initiating programmed cell death, and its silencing is a well-established
hallmark of cancer progression.
Telomir-1
outperformed both Rapamycin and chemotherapy in inhibiting DNA hypermethylation of CDKN2A in the in vivo human prostate cancer
model. These findings build upon previously reported data showing that Telomir-1 also resets DNA methylation of STAT1, a master
immune regulator silenced in aggressive cancers.
Together,
the STAT1 and CDKN2A results demonstrate Telomir-1’s ability to reset epigenetic silencing across multiple tumor suppressor pathways.
This dual effect addresses two of cancer’s most fundamental escape mechanisms: unchecked cell proliferation and immune evasion.
Telomir
is actively assessing Telomir-1 across multiple aggressive cancers beyond prostate, with additional studies underway. The company’s
pre-IND program is running in full gear, with CMC activities scaling up toward GMP production and IND-enabling studies ongoing as Telomir
moves toward its first IND submission.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
TELOMIR
PHARMACEUTICALS, INC. |
|
|
Dated:
September 9, 2025 |
By: |
/s/
Erez Aminov |
|
Name:
|
Erez
Aminov |
|
Title: |
Chief
Executive Officer |