false
0001971532
0001971532
2026-05-20
2026-05-20
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): May 20, 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
May 20, 2026, Telomir Pharmaceuticals, Inc. issued a press release announcing publication of a peer-reviewed
preclinical study titled “Intracellular copper redox modulation disrupts ROS–Ca²⁺ amplification in an ATP7B-deficient
zebrafish model of Wilson’s disease” in the journal Advances in Redox Research.
The
publication reported preclinical findings evaluating Telomir-1 (Telomir-Zn) in cellular systems and a zebrafish model of Wilson’s
disease, including findings demonstrating reductions in oxidative stress signaling, intracellular calcium dysregulation, hepatic copper
accumulation, liver injury biomarkers, histopathological degeneration, and improvements in locomotor performance and survival outcomes.
In accordance with General
Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, shall
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any
registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange
Act, except as shall be expressly set forth by specific reference in such a filing.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits
| 99.1 |
|
Press Release dated May 20, 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:
May 20, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Telomir
Pharmaceuticals Reports Peer-Reviewed Publication of Telomir-Zn Data Demonstrating Improved Survival and Multiple Endpoint Benefits in
Wilson’s Disease
Study
Published in Advances in Redox Research Demonstrated Dose-Dependent Survival Improvement, Reduced Hepatic Copper Burden, Improved
Liver Biomarkers, and Reduced Tissue Degeneration in a Preclinical Wilson’s Disease Model.
MIAMI,
FL / ACCESS Newswire / May 20, 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 showing that Telomir-Zn produced dose-dependent
survival improvement across multiple endpoints in a Wilson’s disease model, supporting the biological activity of Telomir-Zn in
Wilson’s disease. The study, titled “Intracellular copper redox modulation disrupts ROS–Ca²⁺ amplification
in an ATP7B-deficient zebrafish model of Wilson’s disease,” was published in Advances in Redox Research.
The
publication reports that Telomir-Zn produced dose-dependent improvements across multiple endpoints in the preclinical Wilson’s
Disease model, including reduced copper-associated oxidative stress, reduced hepatic copper burden, improved liver injury biomarkers,
attenuated intracellular calcium dysregulation, improved locomotor function, reduced tissue degeneration, and enhanced survival.
The
publication is available online at:
Advances in Redox Research Publication
Wilson’s
disease is a rare genetic disorder caused by mutation in the ATP7B gene, resulting in impaired copper excretion and toxic copper accumulation
in the liver, brain, and other organs. The condition leads to progressive oxidative stress, mitochondrial dysfunction, inflammation,
and multi-organ tissue injury. Current standard-of-care treatments, primarily copper chelation agents, address systemic copper levels
but do not directly target the downstream oxidative and mitochondrial injury pathways associated with disease progression.
According
to the publication, Telomir-Zn demonstrated improvements across cellular and in vivo endpoints in the Wilson’s disease model,
including:
| ● | Reduction
of copper-induced reactive oxygen species (ROS) amplification |
| ● | Attenuation
of intracellular calcium dysregulation associated with oxidative stress signaling |
| ● | Preservation
of metabolic viability under copper and peroxide challenge |
| ● | Reduction
of hepatic copper accumulation |
| ● | Improvement
in locomotor and neuromotor performance |
| ● | Reduction
of liver injury biomarkers, including ALT, AST, and bilirubin |
| ● | Reduction
of hepatorenal histopathological degeneration |
| ● | Improved
survival in a dose-dependent manner in the Wilson’s disease model |
The
authors concluded that targeted modulation of labile intracellular copper pools disrupted ROS–Ca²⁺ feedback amplification,
mitigated mitochondrial-associated tissue injury associated with copper overload, and produced dose-dependent improvements in survival.
This
publication represents Telomir-Zn’s first peer-reviewed publication in Wilson’s disease and adds independently validated
preclinical data across biochemical, functional, histological, and survival endpoints to the Company’s scientific package. The
findings further support the mechanistic relevance of Telomir-Zn’s approach across pathways involving oxidative stress and dysregulated
metal homeostasis, including its lead program in Triple-Negative Breast Cancer, for which the Company received FDA IND clearance in April
2026.
“This
study demonstrated that modulation of intracellular copper-driven redox activity can disrupt ROS–Ca²⁺ amplification
cascades associated with copper toxicity and mitochondrial injury.” said Dr. Itzchak Angel, Chief Scientific Advisor of Telomir
Pharmaceuticals and corresponding author of the publication.
Dr.
Angel continued, “The findings support intracellular metal homeostasis and redox regulation as potentially important biological
pathways across diseases involving oxidative stress, mitochondrial dysfunction, and epigenetic dysregulation, including oncology.”
“This
peer-reviewed publication is an important scientific milestone for Telomir-Zn. The data demonstrated meaningful improvements across a
comprehensive set of endpoints in the Wilson’s disease model, and we believe the findings are consistent with the broader mechanistic
profile of Telomir-Zn as we advance our lead program in Triple-Negative Breast Cancer toward Phase 1/2 clinical initiation,” said
Erez Aminov, CEO of Telomir Pharmaceuticals.
Telomir
Pharmaceuticals will continue evaluating the Wilson’s disease program and potential regulatory considerations alongside advancement
of its lead TNBC program toward Phase 1/2 clinical initiation.
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-1 (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. 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 in the Company’s 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