Telomir gets FDA IND clearance for Telomir‑Zn trial

Telomir Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Telomir‑Zn, the company’s lead product candidate, to treat advanced or metastatic triple‑negative breast cancer.

Filing Impact

(Moderate)

Filing Sentiment

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Form Type

8-K

Rhea-AI Filing Summary

Telomir Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Telomir‑Zn, the company’s lead product candidate, to treat advanced or metastatic triple‑negative breast cancer.

The company plans a first‑in‑human Phase 1/2 trial starting in the first half of 2026, enrolling about 76 patients. Phase 1 will focus on safety, tolerability, dose‑limiting toxicities, pharmacokinetics, pharmacodynamics, and early antitumor activity to determine the recommended Phase 2 dose. Phase 2 will assess preliminary efficacy, with objective response rate as the primary endpoint and duration of response, progression‑free survival, overall survival, and safety as key secondary endpoints.

The trial will feature an extensive translational biomarker program to study epigenetic regulation, gene expression, histone modification, and telomere‑related biology, aiming to link target engagement and biomarker changes with clinical outcomes in triple‑negative breast cancer.

Positive

FDA clearance of IND for Telomir‑Zn in advanced or metastatic triple‑negative breast cancer allows the company to move its lead candidate into first‑in‑human clinical testing.
Planned Phase 1/2 trial with about 76 patients includes robust safety, efficacy, and translational biomarker assessments, potentially providing early proof of concept and mechanistic insights if results are favorable.

Negative

None.

Insights

FDA IND clearance advances Telomir-Zn into first-in-human testing in triple-negative breast cancer.

The clearance of the Investigational New Drug application allows Telomir Pharmaceuticals to begin clinical development of Telomir‑Zn in advanced or metastatic triple‑negative breast cancer. IND clearance is a key regulatory gate, confirming that preclinical and manufacturing data support human testing.

The planned Phase 1/2 design, with about 76 patients, combines dose‑escalation for safety and dose finding, followed by a dose‑expansion focused on preliminary efficacy. Using objective response rate as the primary endpoint in Phase 2 aligns with oncology standards for early proof of concept in difficult‑to‑treat tumors.

An integrated biomarker program covering epigenetic modulation, gene re‑expression, and telomere‑related biology may help explain Telomir‑Zn’s mechanism and identify predictors of response. Actual clinical benefit, however, will depend on safety and antitumor activity observed once the study begins in the first half of 2026.

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.

Key Figures

IND clearance: FDA IND cleared Planned enrollment: Approximately 76 patients Trial initiation target: 1H 2026 +1 more

4 metrics

IND clearance FDA IND cleared Telomir‑Zn in advanced or metastatic triple‑negative breast cancer

Planned enrollment Approximately 76 patients Planned Phase 1/2 Telomir‑Zn clinical trial

Trial initiation target 1H 2026 Planned start of first‑in‑human Phase 1/2 study

Primary Phase 2 endpoint Objective response rate Phase 2 portion of Telomir‑Zn trial

Key Terms

Investigational New Drug, triple-negative breast cancer, objective response rate, progression-free survival, +2 more

6 terms

Investigational New Drug regulatory

"the FDA, has cleared the Company’s Investigational New Drug (“IND”) application"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

triple-negative breast cancer medical

"for the treatment of patients with advanced or metastatic triple-negative breast cancer"

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

objective response rate medical

"with the objective response rate (ORR) as the primary endpoint"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"Secondary endpoints include duration of response (DoR), progression-free survival (PFS)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Secondary endpoints include ... overall survival (OS), and safety"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

epigenetic modulation medical

"to evaluate epigenetic modulation, gene re-expression, and telomere-related biology"

Epigenetic modulation is the deliberate change of how genes are turned on or off without altering the underlying DNA sequence, like using a dimmer switch to adjust the brightness of a room rather than rewiring the lights. For investors it matters because drugs or technologies that modify these switches can treat diseases by changing cell behavior, creating new therapeutic markets, influencing clinical trial prospects, and carrying specific development and regulatory risks tied to long-term effects and delivery methods.

FAQ

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

What did Telomir Pharmaceuticals (TELO) announce about Telomir-Zn?

Telomir Pharmaceuticals announced that the FDA cleared its Investigational New Drug application for Telomir‑Zn in advanced or metastatic triple‑negative breast cancer. This clearance lets the company begin a first‑in‑human Phase 1/2 clinical trial evaluating safety, dosing, and early signs of efficacy.

What is the planned design of Telomir Pharmaceuticals’ Phase 1/2 trial for Telomir-Zn?

The planned trial will enroll about 76 patients with advanced or metastatic triple‑negative breast cancer. It includes a Phase 1 dose‑escalation stage to assess safety and determine the recommended Phase 2 dose, followed by a Phase 2 expansion focused on preliminary efficacy and detailed biomarker analyses.

When will Telomir Pharmaceuticals (TELO) start the Telomir-Zn clinical trial?

Telomir Pharmaceuticals plans to initiate the first‑in‑human Phase 1/2 clinical trial of Telomir‑Zn in the first half of 2026. The schedule is described as subject to standard clinical and operational considerations, which typically include site activation, enrollment, and logistics preparations.

What are the primary and secondary endpoints in Telomir’s Phase 2 Telomir-Zn study?

In the Phase 2 portion, the primary endpoint will be objective response rate, measuring tumor shrinkage in treated patients. Secondary endpoints include duration of response, progression‑free survival, overall survival, and safety, providing a broader picture of clinical benefit and risk.

How will biomarkers be used in Telomir Pharmaceuticals’ Telomir-Zn trial?

The study incorporates a translational biomarker program assessing epigenetic regulation, global DNA methylation, gene expression, histone modifications, and telomere dynamics. These analyses aim to evaluate pharmacodynamic activity, target engagement, and potential predictors of response in triple‑negative breast cancer patients.

Which disease area is Telomir-Zn targeting in this IND-cleared program?

Telomir‑Zn is being developed for patients with advanced or metastatic triple‑negative breast cancer, a challenging breast cancer subtype. The cleared IND and planned Phase 1/2 trial specifically focus on this population to explore safety, dosing, and early antitumor activity in that setting.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 04/30/2026 - 08:15 AM

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): April 24, 2026

TELOMIR PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Florida	001-41952	87-2606031
(State or Other Jurisdiction	(Commission	(IRS Employer
of Incorporation)	File Number)	Identification No.)

100 SE 2nd St, Suite 2000, #1009

Miami, Florida 33131

(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 FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer

Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical Center

Telomir Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”), has cleared the Company’s Investigational New Drug (“IND”) application for its lead product candidate, Telomir-Zn, for the treatment of patients with advanced or metastatic triple-negative breast cancer.

The Company’s IND submission included preclinical pharmacology and toxicology data, pharmacokinetic data, manufacturing information, and a Phase 1/2 clinical study protocol, as well as preclinical data supporting biological activity in models of triple-negative breast cancer.

The planned Phase 1/2 study is expected to enroll approximately 76 patients and will consist of a dose-escalation Phase 1 portion followed by a dose-expansion Phase 2 portion.

The Phase 1 portion of the study is designed to evaluate safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, and to determine the maximum tolerated dose and recommended Phase 2 dose. The study will include integrated biomarker analyses to evaluate epigenetic modulation, gene re-expression, and telomere-related biology associated with cellular aging and genomic stability.

The Phase 2 portion of the study is designed to evaluate preliminary efficacy, with the objective response rate (ORR) as the primary endpoint. Secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. The study will also incorporate pharmacokinetic, pharmacodynamic, and biomarker analyses to evaluate target engagement and explore potential correlations between biomarker modulation and clinical outcomes.

The study includes a translational biomarker program designed to evaluate pharmacodynamic activity, target engagement, and potential predictors of response. Biomarker analyses will assess epigenetic regulation, including global DNA methylation, gene expression, and histone modification patterns, as well as exploratory biomarkers related to cellular aging and genomic stability, including telomere dynamics.

The Company plans to initiate the Phase 1/2 clinical trial in the first half of 2026, subject to standard clinical and operational considerations.

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: April 30, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

Source: View Original Filing on SEC EDGAR

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Telomir gets FDA IND clearance for Telomir‑Zn trial