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Form 8-K

sec.gov

8-K — Telomir Pharmaceuticals, Inc.

Accession: 0001493152-26-013785

Filed: 2026-03-31

Period: 2026-03-31

CIK: 0001971532

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

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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): 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

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