Form 8-K

8-K — Telomir Pharmaceuticals, Inc.

Accession: 0001493152-26-043053

Filed: 2026-09-17

Period: 2026-09-17

CIK: 0001971532

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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): September 17, 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 ☒

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

7.01 Regulation FD Disclosure.

September 17, 2026, Telomir Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the publication of a

peer-reviewed preclinical study titled “Targeted Intracellular Metal Modulation Attenuates Oxidative Stress and Preserves Retinal

Integrity and Function in a Zebrafish Model of Mitochondrial Dysfunction and Age-Related Retinal Degeneration” in International

Journal of Molecular Sciences. 2026; 27(18), 8265.

The

publication demonstrated that Telomir-Zn restored visual function and retinal structure in a model of age-related macular degeneration

(“AMD”). Following 14 days of oral treatment, Telomir-Zn significantly improved multiple measures of visual performance and

reduced retinal degeneration, with restoration of thickness across multiple retinal layers. Treatment also reduced mitochondrial oxidative

stress and was associated with a dose-dependent increase in relative telomeric DNA content toward the profile observed in healthy animals

and restoration of altered DNA methylation patterns at selected aging-associated CpG loci.

Complementary

mechanistic studies demonstrated that Telomir-Zn reduced labile intracellular Fe²⁺ while increasing intracellular zinc and

potently inhibited multiple Fe²⁺-dependent Jumonji C histone demethylases (“KDMs”), enzymes involved in the epigenetic

regulation of gene expression. These findings provide additional evidence supporting a potential relationship between Telomir-Zn’s

modulation of intracellular metal homeostasis and metal-dependent epigenetic regulation.

The

Company’s clinical development remains focused on oncology, with Telomir-Zn advancing under an FDA-cleared Investigational New

Drug application for a Phase 1/2 clinical trial in patients with advanced or metastatic triple-negative breast cancer (“TNBC”).

The retinal findings add to the Company’s growing body of published research supporting a common biological framework centered

on intracellular metal homeostasis and epigenetic regulation and demonstrate the potential broader relevance of Telomir-Zn’s underlying

biology beyond the Company’s current clinical development focus.

Cautionary

Note Regarding Forward-Looking Statements

This

report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,”

“plan,” “can,” “could,” “would,” “may,” “will,” “believe,”

“estimate,” “forecast,” “goal,” “project,” “guidance,” “potential,”

“intend,” “seek,” “target” and other words of similar meaning, although not all forward-looking statements

include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential,

mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization

prospects, market opportunity and future development of Telomir-Zn, including its potential applications in oncology and other disease

indications, and the Company’s other research and development programs.

These

forward-looking statements are based on current expectations, estimates, forecasts and projections, as well as management’s current

beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially

from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical

and clinical development; the initiation, timing, progress and results of clinical trials and other studies; the ability to recruit and

enroll patients in clinical trials; the safety and efficacy of Telomir-Zn; the Company’s ability to obtain and maintain regulatory

approvals; the timing and outcome of regulatory submissions and interactions with regulatory authorities; reliance on third-party manufacturers,

contract research organizations and other service providers; intellectual property protection; the Company’s ability to obtain

additional financing; commercialization and market acceptance of the Company’s product candidates, if approved; competition; market

conditions; and the other risks identified under the heading “Risk Factors” contained in the Company’s Annual Report

on Form 10-K and the Company’s subsequent filings with the U.S. Securities and Exchange Commission (“SEC”).

Forward-looking

statements contained in this report speak only as of the date of this report, and the Company undertakes no obligation to update or revise

these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable

law.

Investors

are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks

and uncertainties is contained in the Company’s filings with the SEC, including its Annual Report on Form 10-K and subsequent filings,

available at www.sec.gov and in the Investors section of the Company’s website at www.telomirpharma.com. Forward-looking

statements should be considered in light of these risks and uncertainties.

Item

9.01 Financial Statements and Other Exhibits.

(d)

Exhibits.

Exhibit No.

Description

99.1

Press Release of Telomir Pharmaceuticals, Inc., dated September 17, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: September 17, 2026

By:

/s/ Erez

Aminov

Name:

Erez Aminov

Title:

Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Telomir

Announces Peer-Reviewed Publication Showing Telomir-Zn Restores Visual Function and Retinal Structure in a Model of Age-Related Macular

Degeneration (AMD)

Findings

Strengthen Telomir-Zn’s Oncology-Focused Platform While Demonstrating Broader Relevance of Its Metal-Dependent Epigenetic Biology

MIAMI,

September 17, 2026 (GLOBE NEWSWIRE) – Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a clinical-stage biotechnology company

developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, today announced the peer-reviewed publication

of new preclinical research showing that Telomir-Zn significantly improved visual function, restored retinal structure, and reduced mitochondrial

oxidative stress in a model of age-related macular degeneration (AMD).

The

findings extend the scientific understanding of Telomir-Zn beyond oncology, providing new evidence that modulation of intracellular metal

homeostasis may influence disease-associated pathways across substantially different biological settings. In the AMD model, Telomir-Zn

improved visual performance and retinal structure and was associated with restoration of altered DNA methylation patterns and a dose-dependent

increase in relative telomeric DNA content toward the profile observed in healthy animals.

Complementary

mechanistic studies showed that Telomir-Zn reduced intracellular labile iron and potently inhibited iron-dependent Jumonji C histone

demethylases (KDMs), enzymes that help regulate which genes cells turn on or off. The findings provide a potential mechanistic link between

Telomir-Zn’s effects on intracellular metals and its emerging role in epigenetic regulation. In retinal degeneration, this biology

may be particularly relevant to cellular programs involved in inflammation, senescence, DNA repair, and survival as retinal cells respond

to oxidative and mitochondrial stress.

Telomir’s

clinical development remains focused on oncology, with Telomir-Zn advancing under an FDA-cleared Investigational New Drug application

for a Phase 1/2 clinical trial in patients with advanced or metastatic triple-negative breast cancer (TNBC). The new retinal findings

add to a growing body of published research supporting a common upstream biology centered on intracellular metal homeostasis and epigenetic

regulation, while demonstrating that the biological relevance of Telomir-Zn may extend beyond the Company’s current clinical development

focus.

The

manuscript, titled “Targeted Intracellular Metal Modulation Attenuates Oxidative Stress and Preserves Retinal Integrity

and Function in a Zebrafish Model of Mitochondrial Dysfunction and Age-Related Retinal Degeneration,” was published in International

Journal of Molecular Sciences. 2026, 27(18), 8265; DOI: 10.3390/ijms27188265.

Publication

Highlights

Improved

Visual Function and Reduced Retinal Degeneration

Untreated

animals in the accelerated retinal degeneration model exhibited profound visual impairment, photoreceptor loss, retinal pigment epithelium

disruption, and degeneration of multiple retinal layers.

After

14 days of oral treatment, Telomir-Zn significantly improved central visual response, moving-object tracking, and adaptation to changes

in light intensity. Histological analysis demonstrated significant improvement in retinal degeneration, with restoration of thickness

across multiple retinal layers, including the outer and inner nuclear layers, outer plexiform layer, and ganglion cell layer.

Reduced

Mitochondrial Oxidative Stress and Protected Human Retinal Cells

The

AMD model exhibited markedly elevated oxidative stress associated with mitochondrial dysfunction. Telomir-Zn significantly reduced brain

reactive oxygen species, used in the study as a surrogate measure of mitochondrial oxidative stress, with the higher dose restoring values

toward wild-type baseline.

complementary experiments using human ARPE-19 retinal pigment epithelial cells, Telomir-Zn dose-dependently attenuated iron- and copper-induced

calcium dysregulation and reduced copper-induced intracellular reactive oxygen species toward baseline.

Together,

these findings demonstrate activity across two biologically relevant settings: reduction of mitochondrial oxidative stress in vivo and

protection against metal-induced oxidative and calcium stress in human retinal cells. This is particularly relevant because oxidative

stress, mitochondrial dysfunction, and metal dysregulation are central features of the retinal degeneration biology examined in the study.

Epigenetic

and Telomere-Associated Changes

Telomeres

are protective DNA sequences at the ends of chromosomes that are closely associated with cellular aging and genomic stability. In the

accelerated retinal degeneration model, relative telomeric DNA content was significantly reduced compared with healthy wild-type animals,

consistent with the model’s accelerated degenerative state.

Following

Telomir-Zn treatment, relative telomeric DNA content increased dose-dependently toward the healthier profile observed in wild-type animals.

Treatment was also associated with restoration of altered DNA methylation patterns at selected aging-associated CpG loci.

Together,

these findings suggest that Telomir-Zn’s biological activity may extend beyond reducing oxidative stress to broader genomic and

epigenetic processes associated with cellular aging and degeneration.

Common Metal-Dependent Epigenetic Biology

Separate

cellular studies described in the manuscript demonstrated that Telomir-Zn increased intracellular zinc while reducing labile Fe²⁺.

Biochemical assays also demonstrated potent inhibition of multiple Fe²⁺-dependent Jumonji C histone demethylases across the

KDM2, KDM5, and KDM6 families, with the strongest activity observed against KDM5B at an IC50 of 63 nM.

Most

KDMs are iron-dependent enzymes that help regulate which genes cells turn on or off through changes in histone methylation. These enzymes

influence cellular programs involved in inflammation, senescence, DNA repair, and cell survival. Because the KDMs evaluated in the study

require Fe²⁺ for catalytic activity, reducing labile intracellular Fe²⁺ provides a potential upstream mechanism

through which Telomir-Zn may influence disease-associated epigenetic programs.

retinal degeneration, this may be particularly relevant because oxidative and mitochondrial stress can alter cellular programs governing

inflammation, senescence, DNA repair, and survival. By changing the intracellular metal environment and inhibiting iron-dependent epigenetic

enzymes, Telomir-Zn may help shift stressed cells toward a more protective epigenetic state.

The

findings build upon Telomir-Zn’s previously published oncology research, where intracellular labile iron reduction and inhibition

of iron-dependent KDMs were associated with epigenetic reprogramming and anti-tumor activity. In TNBC cells, iron-rescue experiments

showed that adding iron back significantly reversed Telomir-Zn’s anti-cancer effect, directly linking iron availability to the

compound’s activity.

Together,

the published findings support an emerging biological framework in which Telomir-Zn modulates the intracellular metal environment to

influence epigenetic machinery and downstream disease-associated cellular programs. The biological consequences may differ by disease—potentially

disrupting pathways supporting tumor growth and survival in cancer while contributing to a more protective cellular environment under

conditions of oxidative and mitochondrial stress in retinal degeneration.

This

common metal-dependent epigenetic biology provides a potential explanation for why Telomir-Zn has demonstrated biological activity across

substantially different preclinical disease settings, while the Company remains focused on advancing its clinical development program

in oncology.

Management

Commentary

“This

study gives us an important new view of the relationship between intracellular metal balance, oxidative stress, epigenetic regulation

and retinal degeneration,” said Dr. Itzchak Angel, Chief Scientific Advisor of Telomir. “Telomir-Zn significantly

improved visual function, reduced retinal degeneration, and restored key retinal-layer thicknesses, supporting the potential relevance

in a devastating disease such as AMD, beyond oncology.”

“Our

clinical priority remains oncology, beginning with our FDA-cleared Phase 1/2 program in TNBC, but we believe the potential opportunity

for Telomir-Zn could extend well beyond a single indication,” said Erez Aminov, CEO of Telomir. “As we build evidence

across different disease models, we are seeing a common biology centered on intracellular metal homeostasis and epigenetic regulation.

We believe this creates meaningful platform potential for Telomir-Zn across additional cancers and, over time, other diseases where this

biology may play an important role.”

About

Telomir Pharmaceuticals

Telomir

Pharmaceuticals, Inc. (NASDAQ: TELO) is a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic

and metabolic pathways implicated in cancer. The Company’s lead program, Telomir-Zn, is designed to modulate intracellular metal

homeostasis and epigenetic regulation and has received Investigational New Drug clearance from the U.S. Food and Drug Administration

for a Phase 1/2 clinical trial in patients with advanced or metastatic triple-negative breast cancer. For more information, please visit

https://telomirpharma.com/.

Forward-Looking

Statements

This

press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of

1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,”

“plan,” “can,” “could,” “would,” “may,” “will,” “believe,”

“estimate,” “forecast,” “goal,” “project,” “guidance,” “potential,”

“intend,” “seek,” “target” and other words of similar meaning, although not all forward-looking statements

include these words.

Forward-looking

statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans,

regulatory pathway, safety profile, clinical utility, market opportunity, and future development of Telomir-1 (Telomir-Zn) and the Company’s

other product candidates. Forward-looking statements may also include statements regarding the significance of the published preclinical

findings, the relevance of such findings to the Company’s oncology development programs, the advancement of the Company’s

Phase 1/2 TNBC clinical trial, and the potential applicability of Telomir-Zn across multiple disease areas.

These

forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management’s beliefs

and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those

expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical

development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property

protection, financing needs, market conditions, and the other risks identified under the heading “Risk Factors” contained

in the Company’s Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission

(“SEC”).

Forward-looking

statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise

such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to

read our filings with the SEC, available at the SEC website and in the “Investors” section of our website, for a discussion

of these and other risks and uncertainties.

Contact

Information

Krystina

Quintana

Email:

info@telomirpharma.com

Phone:

(786) 396-6723

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