false
0001971532
0001971532
2026-09-14
2026-09-14
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): September 14, 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 14, 2026, Telomir Pharmaceuticals, Inc. (the “Company”) issued a press release announcing new research findings
from The Ohio State University College of Veterinary Medicine demonstrating that Telomir-Zn produces inhibition of cell growth across
human and canine osteosarcoma models.
The
study examined Telomir-Zn across three osteosarcoma cell line models: HOS (human), D17 (canine), and Abrams (canine). Researchers evaluated
the dose-dependent anti-tumor activity of Telomir-Zn across all three models, with all three osteosarcoma cell lines demonstrating growth
inhibition at similar low drug concentrations. The findings support further translational investigation.
The
Company’s immediate clinical focus remains its Telomir-Zn program in advanced or metastatic triple-negative breast cancer (“TNBC”),
which is advancing toward site initiation and Phase 1/2 patient enrollment under an active Investigational New Drug application cleared
by the U.S. Food and Drug Administration. In parallel, based on the osteosarcoma findings, the Company is in discussions with The Ohio
State University College of Veterinary Medicine and is assessing next steps for a potential in vivo efficacy study in canine osteosarcoma.
Such a study could support potential veterinary indication development while also providing translational insight relevant to human osteosarcoma.
The Company believes this parallel development pathway may provide an additional opportunity to explore the potential applicability of
Telomir-Zn across multiple oncology indications while the TNBC program advances clinically.
A
copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information contained in this Item 7.01, including Exhibit 99.1, 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 incorporated by reference into any filing of the Company,
except as expressly set forth by specific reference in such filing.
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 14, 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 14, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Telomir
Announces Research with The Ohio State University Demonstrating In-Vitro Anti-Cancer Activity in Human and Canine Osteosarcoma
Models
Preclinical
Findings Support Parallel Development Pathway in Canine Osteosarcoma as TNBC Program Advances Toward Site Initiation
MIAMI,
Sept. 14 (GLOBE NEWSWIRE) — Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a clinical-stage biotechnology company developing
small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, announced new research findings from The Ohio State
University College of Veterinary Medicine demonstrating that Telomir-Zn produces inhibition of cell growth across human and canine osteosarcoma
models. The findings establish a translational foundation for evaluating the compound in a naturally occurring disease setting while
the company’s TNBC program simultaneously advances toward site initiation and Phase 1/2 patient enrollment.
Research
Findings
Conducted
under the direction of Shay Bracha, DVM, MS, DACVIM (Oncology) at Ohio State’s College of Veterinary Medicine, the study examined
Telomir-Zn across three osteosarcoma cell line models: HOS (human), D17 (canine), and Abrams (canine). Researchers evaluated the dose-dependent
anti-tumor activity of the compound across all three models.
All
three osteosarcoma cell lines demonstrated growth inhibition at similar low drug concentrations. “Osteosarcoma in large-breed dogs
remains devastating, with limited treatment options and poor outcomes,” noted Bracha, an associate professor at The Ohio State
University College of Veterinary Medicine. “These findings suggest Telomir-Zn may offer a meaningful therapeutic opportunity
for veterinary patients. The consistency of anti-tumor activity across both canine and human cell lines is particularly compelling because
it positions us to explore efficacy in naturally occurring canine osteosarcoma—a model that could accelerate development for both
animals and humans.”
These
results validate the therapeutic potential of Telomir-Zn in osteosarcoma and support further translational investigation.
Osteosarcoma:
An Unmet Clinical Need
Osteosarcoma
is the most common primary bone malignancy in children and young adults. Despite decades of chemotherapy-based treatment, survival rates
for metastatic disease remain below 30%, with minimal improvement over three decades. In veterinary medicine, osteosarcoma is similarly
devastating in large-breed dogs, accounting for the majority of primary bone tumors.
The
biological similarities between canine and human osteosarcoma, including genetics, tumor biology, and therapeutic response patterns,
make the canine model one of the most clinically predictive disease models available for translational research.
Strategic
Development Pathway
Based
on these findings, Telomir is assessing osteosarcoma development in canine models as a potential therapeutic pathway, which could support
both veterinary indication development and translational advancement toward human osteosarcoma:
| ● | Track
1: TNBC in Humans — The company’s TNBC program is advancing toward site initiation
and Phase 1/2 patient enrollment under an active IND cleared by the FDA, targeting advanced
or metastatic triple-negative breast cancer. |
| | |
| ● | Track
2: Osteosarcoma in Dogs — Based on these preclinical findings, Telomir is in conversations
with The Ohio State University College of Veterinary Medicine and assessing next steps for
a potential in vivo efficacy study in canine osteosarcoma. Such research could accelerate
clinical development in canine and human osteosarcoma. |
While
the company’s immediate focus remains advancing TNBC toward site initiation and Phase 1/2 patient enrollment, these preclinical
findings position potential osteosarcoma development in canine models as a strategic opportunity. If pursued, such a dual-pathway approach
could expand the therapeutic indication profile while advancing our platform.
The
Iron-Modulation Platform
Telomir-Zn
targets intracellular iron and copper homeostasis to modulate epigenetic pathways. The mechanism involves disruption of intracellular
labile iron pools and inhibition of iron-dependent histone demethylases (KDMs), which reverses cancer-associated epigenetic silencing.
The
company’s strategic focus is triple-negative breast cancer, where the TNBC program is advancing toward site initiation and Phase
1/2 patient enrollment. The osteosarcoma preclinical findings provide an additional translational opportunity to validate the mechanism
in a naturally occurring disease model (canine) while simultaneously advancing the lead TNBC indication.
Forward
Outlook
Erez
Aminov, Chairman and CEO of Telomir Pharmaceuticals, said: “This research opens a strategic opportunity to develop Telomir-Zn
across multiple oncology indications. Our TNBC program is advancing toward site initiation and Phase 1/2 patient enrollment, and we are
assessing next steps for potential osteosarcoma development. If successful with either indication, this multi-pronged approach could
establish Telomir-Zn as a platform therapy targeting aggressive malignancies, meaningfully expanding our therapeutic scope.”
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 (IND) 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/.
Telomir Pharmaceuticals 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.
Telomir
Pharmaceuticals Contact Information
Krystina Quintana
Email:
info@telomirpharma.com
Phone: (786) 396-6723
