Telomir-1 shows tumor suppressor reactivation in prostate cancer

Rhea-AI Filing Summary

Telomir Pharmaceuticals reported new preclinical results in aggressive human prostate cancer cell models showing that its investigational therapy Telomir-1 reverses DNA methylation–driven silencing of CDKN2A, a key tumor suppressor often described as the body’s natural “cell cycle brake.” In these PC3 xenograft models, Telomir-1 inhibited DNA hypermethylation of CDKN2A and outperformed both Rapamycin and chemotherapy on this measure.

The company notes that earlier data showed Telomir-1 also resets DNA methylation of STAT1, a master immune regulator. Together, the STAT1 and CDKN2A findings suggest Telomir-1 can reset epigenetic silencing across multiple tumor suppressor and immune pathways. Telomir is evaluating Telomir-1 in several aggressive cancer types and continues its pre-IND work, including CMC scale-up toward GMP production and IND-enabling studies ahead of a planned first IND submission.

Insights

Oncology & Biotech Development Analyst

Preclinical data strengthen Telomir-1’s mechanistic profile but remain early-stage.

The disclosure centers on Telomir-1 showing reversal of DNA methylation–mediated silencing of CDKN2A in aggressive human prostate cancer PC3 xenograft models, and outperforming Rapamycin and chemotherapy in inhibiting CDKN2A hypermethylation. CDKN2A is described as a master tumor suppressor that restrains cell-cycle progression and can trigger programmed cell death, so reactivating it is mechanistically meaningful at the biology level.

The company also highlights prior preclinical data where Telomir-1 reset methylation of STAT1, a master immune regulator. Together, these results support the concept of Telomir-1 as a broad epigenetic “reset” therapy across tumor suppressor and immune pathways. However, all findings are preclinical; there is no human safety or efficacy data described.

Operationally, Telomir states that its pre-IND program is active, with CMC scaling toward GMP production and IND-enabling studies underway as it moves toward a first IND submission. Future company disclosures will be needed to detail any IND filing, clinical trial design, and whether these mechanistic advantages translate into clinical benefit.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Telomir Pharmaceuticals (TELO) report about Telomir-1 in this 8-K?

Telomir Pharmaceuticals reported new preclinical data in aggressive human prostate cancer PC3 xenograft models showing that Telomir-1 inhibits DNA hypermethylation of CDKN2A, a master tumor suppressor gene, and reactivates its expression.

How did Telomir-1 compare with Rapamycin and chemotherapy in the TELO prostate cancer models?

In the disclosed preclinical in vivo human prostate cancer model, Telomir-1 outperformed both Rapamycin and chemotherapy in inhibiting DNA hypermethylation of the CDKN2A tumor suppressor gene.

Why is CDKN2A important in the Telomir Pharmaceuticals (TELO) update?

The filing describes CDKN2A as a master tumor suppressor and the body’s natural “cell cycle brake,” explaining that it controls uninhibited cell growth and can initiate programmed cell death. Its silencing is characterized as a hallmark of cancer progression, so reactivating it is a key mechanistic goal.

What role does STAT1 play in Telomir-1’s mechanism according to TELO?

The company notes prior data showing Telomir-1 resets DNA methylation of STAT1, described as a master immune regulator silenced in aggressive cancers. Along with CDKN2A reactivation, this suggests Telomir-1 can impact both tumor suppressor and immune pathways.

What development stage is Telomir-1 in based on this Telomir (TELO) filing?

Telomir-1 is described in the context of preclinical data. The company states that its pre-IND program is underway, with CMC activities scaling up toward GMP production and IND-enabling studies ongoing as it moves toward its first IND submission.

Is Telomir-1 being studied only in prostate cancer according to Telomir Pharmaceuticals?

No. Telomir states it is actively assessing Telomir-1 across multiple aggressive cancers beyond prostate, with additional studies underway, though specific additional cancer types are not listed in this content.

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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)
	☐	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