Form 8-K
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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