false
0001971532
0001971532
2026-06-15
2026-06-15
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): June 15, 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
June 15, 2026, Telomir Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the peer-reviewed publication
of preclinical data relating to Telomir-Zn in Biomedicine & Pharmacotherapy, in a manuscript entitled “Telomir-Zn Restores
Glucose Homeostasis and Reduces Insulin Resistance in a Diet-Induced Zebrafish Model of Type 2 Diabetes.”
The
publication reports that Telomir-Zn produced dose-dependent improvements in fasting blood glucose, glucose tolerance, fasting insulin
levels, and insulin resistance, as measured by HOMA-IR, in a diet-induced zebrafish model of Type 2 diabetes mellitus. The findings provide
additional peer-reviewed evidence supporting Telomir-Zn’s mechanism of action through modulation of intracellular metal homeostasis
and further expand the scientific foundation underlying the Company’s lead clinical program.
The
publication is the Company’s second peer-reviewed publication in 2026, supporting the biological mechanism of Telomir-Zn. Telomir-Zn
has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration for the Company’s Phase 1/2 clinical
trial (TELO-001) in patients with advanced or metastatic triple-negative breast cancer.
A
copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The
information contained in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into
any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Other Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release of Telomir Pharmaceuticals, Inc., dated June 15, 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: June 15, 2026 |
By: |
/s/ Erez
Aminov |
| |
Name: |
Erez Aminov |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Telomir
Pharmaceuticals Announces Peer-Reviewed Publication in Biomedicine & Pharmacotherapy Demonstrating Restoration of Insulin Sensitivity
with Telomir-Zn in a Preclinical Type 2 Diabetes Model
Insulin
Resistance Was Normalized Following 14 Days of Treatment, Supporting Restoration of Glucose Metabolism and Insulin Sensitivity and Further
Validating Telomir-Zn’s Metal-Homeostasis Mechanism Across Multiple Disease Models.
MIAMI,
FL / ACCESS Newswire / June 15, 2026 / Telomir Pharmaceuticals, Inc. (NASDAQ: TELO) (“Telomir” or the “Company”),
a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer and
age-related disease, today announced the peer-reviewed publication of preclinical data demonstrating restoration of insulin sensitivity
and significant improvement in glucose homeostasis with Telomir-Zn in a diet-induced zebrafish model of Type 2 diabetes mellitus (T2DM).
The
manuscript, titled “Telomir-Zn Restores Glucose Homeostasis and Reduces Insulin Resistance in a Diet-Induced Zebrafish Model
of Type 2 Diabetes,” has been published in Biomedicine & Pharmacotherapy.
The
publication is available online in Biomedicine & Pharmacotherapy.
Publication
Highlights
Type
2 diabetes mellitus is characterized by chronic hyperglycemia, impaired glucose utilization, and insulin resistance. Insulin resistance
is a central driver of disease progression and is associated with oxidative stress, mitochondrial dysfunction, and metabolic dysregulation.
In
the study, zebrafish fed a high-calorie diet developed significant metabolic dysfunction, including fasting hyperglycemia, hyperinsulinemia,
impaired glucose tolerance, and HOMA-IR values of approximately 10–12, consistent with severe insulin resistance.
According
to the publication, treatment with Telomir-Zn produced dose-dependent improvements across multiple independent measures of metabolic
health, including:
● Significant
reduction in fasting blood glucose levels to near control levels
●
Improved glucose clearance during oral glucose tolerance testing (OGTT)
●
Reduction in fasting insulin concentrations
●
Significant improvement in HOMA-IR, a widely used measure of insulin resistance
Most
notably, HOMA-IR values declined from approximately 10–12 in untreated diabetic animals to approximately 3 following 14 days of
treatment, representing a substantial reversal of insulin resistance. Improvements were observed in a dose-dependent manner and remained
consistent across both Day 7 and Day 14 assessments.
The
authors concluded that Telomir-Zn restored key metabolic parameters associated with insulin resistance and glucose dysregulation, supporting
further investigation of metal-modulating small molecules as a novel therapeutic approach for metabolic disease.
Mechanistic
Relevance to Telomir-Zn’s Clinical Development Program
The
publication adds to a growing body of peer-reviewed evidence supporting Telomir-Zn’s mechanism of action through modulation of
intracellular metal homeostasis.
Accumulating
scientific evidence suggests that dysregulation of intracellular iron and zinc balance contributes to oxidative stress, mitochondrial
dysfunction, and altered cellular signaling across multiple disease states. In metabolic disease, these processes can impair insulin
receptor signaling and glucose homeostasis. In cancer, similar pathways have been implicated in epigenetic dysregulation, treatment resistance,
tumor progression, and aggressive disease biology.
Telomir-Zn
was designed to modulate intracellular metal homeostasis and influence iron-dependent biological pathways through a zinc-coordinated
small-molecule platform.
While
Type 2 diabetes and triple-negative breast cancer represent distinct disease states, both involve oxidative stress, dysregulated metal
homeostasis, and iron-dependent cellular signaling pathways targeted by Telomir-Zn.
The
Company believes these findings provide additional independent, peer-reviewed validation of biological pathways underlying its lead clinical
program. Telomir-Zn recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the
Company’s Phase 1/2 clinical trial (TELO-001) in patients with advanced or metastatic triple-negative breast cancer.
Management
Commentary
“What
makes these findings particularly interesting is that excess intracellular iron has been implicated in both insulin resistance and cancer
biology,” said Dr. Itzchak Angel, Chief Scientific Advisor of Telomir Pharmaceuticals and corresponding author of the publication.
“In
diabetes, iron-driven oxidative stress can impair insulin signaling and glucose metabolism. In cancer, iron-dependent pathways can contribute
to epigenetic dysregulation and tumor progression. The ability of Telomir-Zn to produce meaningful biological effects in multiple disease
models further strengthens our confidence that modulation of intracellular metal homeostasis may represent an important therapeutic strategy.”
“This
publication represents our second peer-reviewed publication on Telomir-Zn in 2026, supporting the biological mechanism underlying Telomir-Zn,”
said Erez Aminov, Chairman and Chief Executive Officer of Telomir Pharmaceuticals.
“Combined
with our recently published Wilson’s disease findings and our FDA-cleared Phase 1/2 TNBC program, we continue to build a growing
body of scientific evidence supporting the broader potential of our metal-homeostasis platform. We now have an FDA-cleared IND, preparations
underway for our Phase 1/2 TNBC study, and multiple peer-reviewed publications supporting our underlying biology. Our focus remains on
execution as we advance Telomir-Zn into human clinical trials.”
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, aging, and degenerative disease. The Company’s lead program, Telomir-Zn, is designed
to modulate intracellular metal homeostasis and epigenetic regulation and has received IND clearance from the U.S. Food and Drug Administration
for a Phase 1/2 clinical trial in 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
