Form 8-K

8-K — Telomir Pharmaceuticals, Inc.

Accession: 0001493152-26-019773

Filed: 2026-04-30

Period: 2026-04-24

CIK: 0001971532

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Documents

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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): 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

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 ☒

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

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Entity Registrant Name

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Entity Central Index Key

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Entity Tax Identification Number

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Entity Incorporation, State or Country Code

Entity Address, Address Line One

100

SE 2nd St

Entity Address, Address Line Two

Suite 2000

Entity Address, Address Line Three

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Entity Address, City or Town

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Entity Address, State or Province

Entity Address, Postal Zip Code

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City Area Code

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Local Phone Number

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