Telomir Pharmaceuticals Reports Favorable IND-Enabling GLP Safety Results for Telomir-1 Supporting First-in-Human Clinical Development

Rhea-AI Summary

Telomir Pharmaceuticals (NASDAQ:TELO) reported favorable IND-enabling GLP toxicology and safety pharmacology results for lead candidate Telomir-1 (Zn-Telomir) on December 18, 2025. Across rat and dog studies and in vitro assays, the company observed no treatment-related adverse or dose-limiting toxicities and reported consistent systemic exposure following oral dosing. Key endpoints—cardiovascular, respiratory, phototoxicity, and repeat-dose toxicology—showed no clinically concerning signals. Final QA review of study reports is ongoing. Telomir expects to submit an IND in Q1 2026 and to initiate first-in-human studies in H1 2026, subject to regulatory review.

Positive

• No treatment-related adverse toxicity observed in GLP studies
• Consistent systemic exposure after oral administration
• No cardiovascular or ECG safety signals in validated GLP assays
• No phototoxicity or clinically meaningful respiratory effects
• Targeting IND submission in Q1 2026 and FIH start in H1 2026

Negative

• Final GLP study QA review is still ongoing
• Advancement to humans is subject to regulatory review and approvals
• No human clinical data available to confirm safety or efficacy

News Market Reaction

+1.48%

1 alert

+1.48% News Effect

+$677K Valuation Impact

$46M Market Cap

0.0x Rel. Volume

On the day this news was published, TELO gained 1.48%, reflecting a mild positive market reaction. This price movement added approximately $677K to the company's valuation, bringing the market cap to $46M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Planned IND timing: Q1 2026 First-in-human start: H1 2026

2 metrics

Planned IND timing Q1 2026 Targeted Investigational New Drug (IND) submission timeline

First-in-human start H1 2026 Planned initiation of first-in-human clinical studies, subject to review

Market Reality Check

Price: $1.34 Vol: Volume 150,211 is about 7...

low vol

$1.34 Last Close

Volume Volume 150,211 is about 73% below the 20-day average of 550,415, suggesting muted pre-news positioning. low

Technical Shares at $1.35 are trading below the 200-day MA of $2.01 and 75% under the 52-week high of $5.40.

Peers on Argus

TELO was down 3.57% pre-news, while several biotech peers like PEPG (-4.87%), AC...

TELO was down 3.57% pre-news, while several biotech peers like PEPG (-4.87%), ACRV (-4.55%), CALC (-3.28%) and RADX (-13.45%) also traded lower, indicating broader weakness but no scanner-flagged sector momentum.

Historical Context

5 past events · Latest: Nov 25 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 25	Preclinical prostate data	Positive	+3.1%	Preclinical data showing Telomir-1 reduced PSA in prostate cancer cells.
Nov 21	Leukemia cell data	Positive	-7.9%	In vitro data showing Telomir-1 killed aggressive human leukemia cells.
Nov 12	Iron chelation data	Positive	-4.9%	Preclinical evidence Telomir-1 reduced intracellular iron vs. deferoxamine.
Oct 23	Epigenetic prostate data	Positive	+7.3%	Mouse data showing Telomir-1 reset methylation in aggressive prostate cancer.
Oct 21	Global rights LOI	Positive	-9.6%	Binding LOI to acquire TELI and consolidate worldwide Telomir-1 rights.

Pattern Detected

Positive preclinical and strategic updates have produced mixed reactions, with more divergences than alignments.

Recent Company History

Over the last few months, Telomir has repeatedly highlighted Telomir-1 progress, including prostate cancer, leukemia and iron-modulation data, plus a binding LOI to consolidate global rights. Price reactions to these largely positive updates were inconsistent, with 3 negative and 2 positive moves over 24h. Today’s favorable GLP safety and IND-enabling results fit the pattern of steady de-risking from preclinical work toward first-in-human development.

Market Pulse Summary

This announcement details favorable IND-enabling GLP safety results for Telomir-1, with no treatment...

Analysis

This announcement details favorable IND-enabling GLP safety results for Telomir-1, with no treatment-related toxicities and consistent systemic exposure, supporting advancement toward first-in-human studies. In recent months, Telomir has repeatedly released positive preclinical data, yet 24-hour price reactions have been mixed across 5 events. Investors may focus on execution of the planned IND in Q1 2026, initiation of clinical trials in H1 2026, and how future data intersect with the company’s modest $48.1M market value.

Key Terms

good laboratory practice (glp), ind-enabling, toxicology, safety pharmacology, +4 more

8 terms

good laboratory practice (glp) technical

"favorable results from a comprehensive series of IND-enabling Good Laboratory Practice (GLP) toxicology"

Good Laboratory Practice (GLP) is a set of rules and record-keeping standards that ensure nonclinical laboratory studies—such as safety and toxicity tests—are done consistently, documented fully, and traceable. For investors, GLP compliance signals that preclinical data are reliable and less likely to be rejected by regulators, reducing development and regulatory risk much like a detailed recipe and audit trail make a complex dish repeatable and verifiable.

ind-enabling regulatory

"favorable results from a comprehensive series of IND-enabling Good Laboratory Practice (GLP)"

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

toxicology medical

"evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose toxicology using a combination"

Toxicology is the science that studies how chemicals, drugs or other substances can harm people, animals or the environment and determines what exposure levels are safe. For investors, toxicology results act like a safety checklist: they influence whether a product can get regulatory approval, be sold without restrictions, or face recalls and legal risks—factors that can materially affect a company’s prospects and stock value.

safety pharmacology medical

"Good Laboratory Practice (GLP) toxicology and safety pharmacology studies for its lead"

Safety pharmacology is the set of tests that look for harmful effects a drug candidate might have on vital body functions like the heart, breathing and nervous system before it reaches people. Think of it as a safety inspection that checks whether a new product could cause dangerous side effects under realistic conditions. Investors care because poor results can delay development, increase costs, or stop regulatory approval, directly affecting a drug’s value and timeline.

electrocardiogram (ecg) medical

"no test-article-related changes in blood pressure, heart rate, electrocardiogram (ECG) parameters"

An electrocardiogram (ECG) is a noninvasive test that records the heart’s electrical signals as a series of waves, like a seismograph tracing tremors. It shows rhythm, rate and signs of strain or damage to the heart muscle. Investors care because ECG results are a standard measure in clinical trials, safety monitoring and device performance; abnormal findings can affect drug approvals, medical-device sales and perceived health risks tied to a company.

pharmacokinetic medical

"predictable pharmacokinetic behavior, supporting continued advancement toward clinical development"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

phototoxicity medical

"evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose toxicology using"

Phototoxicity is damage to skin or eyes that happens when a chemical, medicine, or product absorbs sunlight or other light and triggers a harmful reaction, similar to a sunburn made much worse by a light-activated ingredient. For investors, phototoxicity matters because it can force additional safety testing, labeling changes, restricted use, or product delays and recalls, all of which can affect regulatory approval, sales and liability risk.

investigational new drug (ind) regulatory

"anticipates submitting an Investigational New Drug (IND) application in the first quarter of 2026"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

AI-generated analysis. Not financial advice.

No treatment-related adverse toxicity was observed across completed GLP studies, with consistent systemic exposure following oral administration.

MIAMI, FL / ACCESS Newswire / December 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today announced favorable results from a comprehensive series of IND-enabling Good Laboratory Practice (GLP) toxicology and safety pharmacology studies for its lead therapeutic candidate, Telomir-1 (Zn-Telomir).

The studies were conducted as part of the Company's ongoing IND-enabling program and evaluated cardiovascular, respiratory, phototoxicity, and repeat-dose toxicology using a combination of in vitro systems and in vivo rat and dog models. While final quality assurance (QA) review of the study reports is ongoing, the Company does not expect the overall conclusions to change.

Key Safety Findings

• Overall Safety:
  Telomir-1 was well tolerated across all completed GLP safety studies, with no treatment-related adverse or dose-limiting toxicities observed.

• Cardiovascular Safety:
  In non-rodent studies, including in dogs, no test-article-related changes in blood pressure, heart rate, electrocardiogram (ECG) parameters, or body temperature were observed following oral administration. In addition, no concerning cardiac safety signals were identified in a validated GLP assay commonly used to assess arrhythmia risk.

• Repeated-Dose Toxicology:
  Repeated oral administration in both rats and dogs were well tolerated. Observed findings were limited, reversible, and considered non-adverse, with no serious toxicological findings identified.

• Respiratory Safety:
  No clinically meaningful effects on respiratory function were observed.

• Phototoxicity:
  Telomir-1 demonstrated no evidence of phototoxic potential under simulated sunlight conditions.

Across oral administration studies, Telomir-1 demonstrated consistent systemic exposure and predictable pharmacokinetic behavior, supporting continued advancement toward clinical development.

Overall Conclusion

Collectively, these IND-enabling GLP data demonstrate a favorable safety and tolerability profile and consistent systemic exposure upon oral administration for Telomir-1. No treatment-related adverse toxicity was observed, and no findings were identified that would preclude advancement into first-in-human clinical studies, subject to applicable regulatory pathways.

CEO Perspective

"Safety is often the factor that determines whether a drug program can advance," said Erez Aminov, Chief Executive Officer of Telomir. "Many development programs encounter safety limitations that prevent clinical progression. Achieving a broad IND-enabling GLP safety profile with no treatment-related adverse toxicity observed is a critical milestone as we prepare Telomir-1 for first-in-human evaluation."

Scientific Perspective

"In oncology, therapeutic activity must be balanced against tolerability, as safety limitations frequently constrain dosing, duration of therapy, and patient quality of life," said Dr. Itzchak Angel, Chief Scientific Advisor at Telomir. "The GLP safety profile observed with Telomir-1, together with its consistent pharmacologic behavior and good oral absorption across studies, supports continued advancement into first-in-human clinical evaluation, pending regulatory review."

Next Steps

Telomir plans to continue advancing Telomir-1 through its IND-enabling activities and broader regulatory preparations. In parallel, the Company is conducting ongoing preclinical animal model studies evaluating Telomir-1 across multiple oncology and age-related disease settings, including triple-negative breast cancer, to further characterize its biological activity and therapeutic potential.

In addition, Telomir is actively preparing scientific manuscripts for publication submission and is targeting abstract submissions and presentations at multiple oncology-focused scientific conferences in 2026, as part of its ongoing efforts to share data and engage with the scientific and clinical research community.

Based on current expectations and subject to regulatory review and other factors, the Company anticipates submitting an Investigational New Drug (IND) application in the first quarter of 2026 and initiating first-in-human clinical studies in the first half of 2026.

About Telomir Pharmaceuticals

Telomir Pharmaceuticals (NASDAQ:TELO) is a preclinical biotechnology company developing small-molecule therapeutics designed to target the root epigenetic mechanisms underlying cancer, aging, and degenerative disease. The Company's lead candidate, Telomir-1, has demonstrated activity in preclinical studies involving modulation of DNA and histone methylation, restoration of redox balance, and normalization of cellular function.

Cautionary Note Regarding Forward-Looking Statements

This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1.

Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which are on file with the SEC and available at www.sec.gov. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact Information
info@telomirpharma.com
(786) 396-6723

SOURCE: Telomir Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Telomir (TELO) report about Telomir-1 GLP safety on December 18, 2025?

Telomir reported favorable IND-enabling GLP safety results with no treatment-related adverse toxicities and consistent systemic exposure after oral dosing.

Does Telomir-1 show any cardiovascular or ECG safety signals in the GLP studies for TELO?

No; non-rodent GLP studies, including dogs, showed no test-article-related changes in blood pressure, heart rate, ECG parameters, or concerning cardiac signals.

When does Telomir expect to submit an IND for Telomir-1 (TELO)?

The company is targeting an IND submission in Q1 2026, subject to regulatory review and other factors.

When could first-in-human Telomir-1 studies (TELO) begin?

Telomir anticipates initiating first-in-human studies in H1 2026, pending regulatory clearance.

Were there any phototoxicity or respiratory safety concerns for Telomir-1 in GLP testing?

No; Telomir-1 showed no phototoxic potential under simulated sunlight and no clinically meaningful respiratory effects.

What caveats did Telomir (TELO) note about the GLP study results?

The company noted that final QA review of study reports is ongoing and that clinical advancement remains subject to regulatory review.