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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): August 27, 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) |
|
|
|
|
☐ |
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 Reports In Vitro Data Supporting the Potential of Telomir-1 as a First-in-Class Epigenetic Therapy Influencing DNA Methylation
Pathways in Cancer, Aging, and Age-Related Diseases
In
vitro findings reveal Telomir-1’s dual action: targeting DNA methylation switches and cutting into the Wnt “fuel line”
that drives cancer growth.
Telomir
Pharmaceuticals, Inc. (NASDAQ: TELO), a preclinical-stage biotechnology company developing therapies that target the root mechanisms
of cancer, aging, and age-related diseases, today announced new in vitro results that expand understanding of its lead drug candidate,
Telomir-1.
The
studies, conducted by Eurofins Discovery, showed that Telomir-1 potently inhibits UTX (KDM6A), a histone demethylase that interacts closely
with DNA methylation to control which genes are switched on or off. Abnormal UTX activity has been linked to silencing of tumor suppressors
and inappropriate activation of disease-driving genes. This dysregulation is observed in cancer, autoimmune disease, aging, neurodegeneration,
autism spectrum disorder, and metabolic dysfunction. By inhibiting UTX, Telomir-1 demonstrated the potential to reset faulty DNA methylation
patterns and restore more normal gene regulation.
As
previously reported, Telomir-1 also inhibited additional epigenetic enzymes — FBXL10, FBXL11, and JMJD3 — that are implicated
in tumor progression, inflammation, metabolic dysfunction, and neurodevelopmental disorders. In prior prostate cancer studies in vivo,
Telomir-1 reactivated silenced tumor suppressors STAT1 and TMS1 by reversing abnormal DNA methylation, providing functional evidence
of its ability to reset gene programs that are often disabled in cancer.
Importantly,
Telomir-1 showed no activity against GCN5L2 (KAT2A), a broad acetyltransferase enzyme whose inhibition has been associated with widespread
toxicity. This selectivity may provide Telomir-1 with a cleaner safety margin compared to other epigenetic drugs.
The
new in vitro data also showed that Telomir-1 had low-level inhibitory activity against Tankyrases (PARP5A and PARP5B). Tankyrases regulate
the Wnt/β-catenin pathway, one of the body’s master growth-control circuits that cancers frequently hijack as a “fuel
line” for unchecked proliferation and treatment resistance. Unlike potent Tankyrase inhibitors, which can shorten telomeres and
pose systemic safety risks, Telomir-1’s modest activity may allow disruption of cancer’s fuel line without compromising telomere
biology. Supporting this distinction, previously reported data from a validated Werner Syndrome accelerated-aging in vivo model showed
that Telomir-1 significantly elongated telomeres beyond healthy levels while also reversing abnormal DNA methylation, restoring youthful
gene regulation, and resetting the epigenetic clock.
Taken
together, the results support Telomir-1’s emerging profile as a potential first-in-class epigenetic therapy with a dual mechanism
of action:
|
1. |
Resetting
DNA methylation across several pathways that regulate gene expression. |
|
2. |
Modestly
interfering with Wnt/Tankyrase signaling — the “fuel line” cancers rely on for growth. |
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:
August 27, 2025 |
By: |
/s/
Erez Aminov |
|
Name:
|
Erez
Aminov |
|
Title: |
Chief
Executive Officer |