# EDGAR Filing Document

**Accession Number:** 0001971532
**File Stem:** 0001493152-26-019773
**Filing Date:** 2026-4
**Character Count:** 6259
**Document Hash:** 5ec0c00aba3f8aceed51deb0a4bcdd16
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-019773.hdr.sgml**: 20260430

**ACCESSION NUMBER**: 0001493152-26-019773

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20260424

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20260430

**DATE AS OF CHANGE**: 20260430

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Telomir Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001971532
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 872606031
- **STATE OF INCORPORATION:** FL
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41952
- **FILM NUMBER:** 26920241

**BUSINESS ADDRESS:**
- **STREET 1:** 100 SE 2ND ST
- **STREET 2:** SUITE 2000 #1009
- **CITY:** MIAMI
- **STATE:** FL
- **ZIP:** 33131
- **BUSINESS PHONE:** 786-396-6723

**MAIL ADDRESS:**
- **STREET 1:** 100 SE 2ND ST
- **STREET 2:** SUITE 2000 #1009
- **CITY:** MIAMI
- **STATE:** FL
- **ZIP:** 33131

?xml version='1.0' encoding='ASCII'?

**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)**

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| | | |
|:---|:---|:---|
| **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:

<u>Title of each class</u> <u>Trading Symbol</u> <u>Name of each exchange on which registered</u> <br> 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.

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| | | |
|:---|:---|:---|
|  | **TELOMIR PHARMACEUTICALS, INC.** | **TELOMIR PHARMACEUTICALS, INC.** |
| Dated: April 30, 2026 | By: | */s/ Erez Aminov* |
|  | Name: | Erez Aminov |
|  | Title: | Chief Executive Officer |

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