Telomir Pharma submits IND for Telomir-1 in TNBC

Telomir Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its lead candidate Telomir-1 (Telomir-Zn) to treat advanced and metastatic triple-negative breast cancer (TNBC).

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Form Type

8-K

Rhea-AI Filing Summary

Telomir Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its lead candidate Telomir-1 (Telomir-Zn) to treat advanced and metastatic triple-negative breast cancer (TNBC). If the IND is cleared, the company plans a Phase 1/2 trial of Telomir-1 as an oral monotherapy.

The Phase 1 portion is expected to use a standard 3+3 dose-escalation design to assess safety, tolerability, dose-limiting toxicities, and select a recommended Phase 2 dose. Phase 2 is expected to use a Simon two-stage design focused on objective response rate as the primary endpoint.

Telomir-1 is described as a first-in-class metal-modulating epigenetic therapy designed to reduce redox-active iron and increase zinc availability, inhibiting iron-dependent epigenetic enzymes such as histone demethylases. The company reports preclinical data showing reduced tumor growth and metastasis in TNBC models, iron-dependent tumor cell death in several human TNBC cell lines, and GLP safety studies with no treatment-related adverse or dose-limiting toxicities observed.

Positive

IND submission for lead asset in TNBC: Telomir Pharmaceuticals has submitted an Investigational New Drug application for Telomir-1 (Telomir-Zn) in advanced and metastatic triple-negative breast cancer, a key step toward initiating first-in-human clinical testing of its first-in-class metal-modulating epigenetic therapy.

Negative

None.

Insights

IND submission advances Telomir-1 into potential first-in-human TNBC testing, backed by supportive preclinical and safety data.

The disclosure shows Telomir Pharmaceuticals moving its lead asset Telomir-1 toward clinical development in advanced and metastatic TNBC by submitting an IND. The planned Phase 1/2 design, including 3+3 dose escalation and a Simon two-stage Phase 2, reflects a conventional early-oncology pathway.

Mechanistically, Telomir-1 is positioned as a first-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways, with effects on histone demethylases and histone methylation. The company highlights preclinical tumor growth reduction, decreased metastasis, and GLP safety studies without observed treatment-related or dose-limiting toxicities, which together support progressing to human trials, although ultimate clinical efficacy and safety remain unproven.

The company is continuing preclinical work, biomarker strategy development, and preparing scientific communications, including planned data presentations at the AACR Annual Meeting 2026. These steps suggest an effort to build scientific credibility and a biomarker-informed clinical strategy, but future regulatory decisions and clinical results will determine the real impact.

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 Terms

Investigational New Drug, Triple-Negative Breast Cancer (TNBC), 3+3 dose-escalation design, Simon two-stage design, +2 more

6 terms

Investigational New Drug regulatory

"announced the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration"

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 (TNBC) medical

"Telomir-1 (Telomir-Zn), for the treatment of advanced and metastatic Triple-Negative Breast Cancer (TNBC)."

A form of breast cancer that lacks three common proteins (estrogen receptor, progesterone receptor and HER2) that doctors often use as targets for standard treatments, so it is not responsive to those targeted therapies. Investors pay attention because limited treatment options make drug approvals, clinical trial results or new therapies especially valuable — like finding a new key for a locked door — and those breakthroughs can drive company value and regulatory scrutiny.

3+3 dose-escalation design medical

"expected to utilize a standard 3+3 dose-escalation design to evaluate safety, tolerability, dose-limiting toxicities"

A 3+3 dose-escalation design is an early-stage clinical trial approach where small groups of three patients receive a drug at increasing dose levels; if safety problems appear, additional patients are added before moving to the next higher dose. It identifies the highest dose that is reasonably safe (maximum tolerated dose) and gives investors an early read on safety, development risk, timelines and whether a drug program is likely to advance, like cautiously turning up a volume knob while checking for feedback.

Simon two-stage design medical

"The Phase 2 portion is expected to evaluate preliminary antitumor activity using a Simon two-stage design"

A Simon two-stage design is a clinical trial plan used early in drug development to test whether a treatment shows enough promise to continue. It works like a two-step audition: a small first group is tested and if results are poor the trial stops early to save time and money, while acceptable early results trigger a second, larger group; investors care because it limits wasted capital and reduces risk by quickly filtering out ineffective therapies.

Good Laboratory Practice (GLP) technical

"results from IND-enabling Good Laboratory Practice (GLP) safety studies in which no treatment-related adverse"

Good Laboratory Practice (GLP) is a set of rules and record-keeping standards that ensure nonclinical laboratory studies—such as safety and toxicity tests—are done consistently, documented fully, and traceable. For investors, GLP compliance signals that preclinical data are reliable and less likely to be rejected by regulators, reducing development and regulatory risk much like a detailed recipe and audit trail make a complex dish repeatable and verifiable.

histone demethylases (KDMs) medical

"inhibition of iron-dependent epigenetic enzyme activity, including histone demethylases (KDMs), which result in accumulation"

FAQ

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

What did Telomir Pharmaceuticals (TELO) announce regarding Telomir-1?

Telomir Pharmaceuticals announced submission of an Investigational New Drug application to the FDA for Telomir-1 (Telomir-Zn) in advanced and metastatic triple-negative breast cancer. This filing supports a planned Phase 1/2 clinical trial of Telomir-1 as an oral monotherapy in this difficult-to-treat setting.

What cancer indication is Telomir-1 targeting for Telomir Pharmaceuticals (TELO)?

Telomir-1 is being developed for advanced and metastatic triple-negative breast cancer (TNBC). The company reported preclinical data showing reduced tumor growth, decreased metastatic spread in TNBC models, and iron-dependent tumor cell mortality across several human TNBC cell lines supporting this indication focus.

How is the planned Phase 1/2 trial of Telomir-1 for TELO designed?

The planned Phase 1/2 study will start with a 3+3 dose-escalation Phase 1 to assess safety, tolerability, dose-limiting toxicities, and recommend a Phase 2 dose. Phase 2 is expected to use a Simon two-stage design with objective response rate as the primary efficacy endpoint in TNBC patients.

What mechanism of action does Telomir-1 have according to Telomir Pharmaceuticals (TELO)?

Telomir-1 is described as a small-molecule, first-in-class metal-modulating epigenetic therapy that reduces redox-active iron and increases zinc availability. This mechanism is associated with inhibition of iron-dependent histone demethylases and accumulation of histone methylation marks linked to transcriptional repression in tumor cells.

What preclinical safety data did Telomir Pharmaceuticals (TELO) report for Telomir-1?

The company reported results from IND-enabling Good Laboratory Practice safety studies in which no treatment-related adverse or dose-limiting toxicities were observed. These GLP findings, alongside pharmacology and toxicology data, were included in the IND submission to support moving Telomir-1 into clinical evaluation.

How is Telomir Pharmaceuticals (TELO) supporting further development of Telomir-1?

Telomir Pharmaceuticals is continuing to evaluate Telomir-Zn in additional TNBC preclinical models and advancing biomarker strategies to guide clinical use. It has also submitted scientific manuscripts to peer-reviewed journals and plans to present data at scientific conferences, including the AACR Annual Meeting 2026.

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

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Accepted by SEC EDGAR 03/31/2026 - 07:00 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): March 31, 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 Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer

First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a favorable GLP safety profile.

On March 31, 2026, Telomir Pharmaceuticals, Inc. (the “Company”) announced the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration for its lead investigational candidate, Telomir-1 (Telomir-Zn), for the treatment of advanced and metastatic Triple-Negative Breast Cancer (TNBC).

The IND submission includes data from completed IND-enabling pharmacology, toxicology, and manufacturing studies. Subject to clearance of the IND by the FDA, the Company plans to initiate a Phase 1/2 clinical trial evaluating Telomir-1 as an oral monotherapy in patients with advanced or metastatic TNBC.

The planned Phase 1 portion of the study is expected to utilize a standard 3+3 dose-escalation design to evaluate safety, tolerability, dose-limiting toxicities, and determination of a recommended Phase 2 dose. The Phase 2 portion is expected to evaluate preliminary antitumor activity using a Simon two-stage design, with objective response rate as the primary endpoint.

Telomir-1 is a small-molecule therapeutic designed to modulate intracellular metal homeostasis, including the reduction of redox-active iron and the increase of zinc availability. It is developed as a zinc-containing substance, called Telomir-Zn. Preclinical studies indicate that this mechanism is associated with inhibition of iron-dependent epigenetic enzyme activity, including histone demethylases (KDMs), which result in accumulation of histone methylation marks associated with transcriptional repression.

The Company reported that, in preclinical studies, Telomir-Zn demonstrated a reduction in tumor growth and metastatic dissemination in TNBC models, as well as iron-dependent tumor cell mortality across several human TNBC cell lines. The Company has also previously reported results from IND-enabling Good Laboratory Practice (GLP) safety studies in which no treatment-related adverse or dose-limiting toxicities were observed.

The Company stated that it is continuing to evaluate Telomir-Zn in additional preclinical TNBC models and is advancing biomarker strategies to support clinical development. The Company also indicated that it has submitted scientific manuscripts to peer-reviewed journals and plans to present data at scientific conferences, including the AACR Annual Meeting 2026.

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: March 31, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

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Telomir Pharma submits IND for Telomir-1 in TNBC