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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 ☒
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
7.01 Regulation FD Disclosure.
On
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 |
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.
In
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.
A
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.
In
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.
We
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
