Telomir Pharmaceuticals Inc.

11/10/2025 | Press release | Distributed by Public on 11/10/2025 15:02

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company's actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company's other filings with the SEC. See "Cautionary Note Regarding Forward Looking Statements" below.

As used in this Management's Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms "the Company", "we", "us", "our" and similar terminology refer to Telomir Pharmaceuticals, Inc.

Telomir Pharmaceuticals (NASDAQ:TELO) is a pre-clinical stage biotechnology company developing therapies 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 patterns, which may contribute to balanced gene expression, cellular function, and genomic stability. Telomir-1 is a novel oral small molecule metal ion regulator designed to extend telomere caps, maintain cellular balance, and combat oxidative stress, a key driver of aging and disease progression. By modulating essential metal ions such as iron, and copper, Telomir-1 may help protect against age related conditions, including Progeria (a rare genetic disorder that causes rapid aging in children), Wilson's disease (a genetic disorder leading to toxic copper buildup in the body), and Age-related Macular Degeneration (AMD), as well as Type 2 diabetes, cancer, and Alzheimer's disease.

Telomir-1 Program Overview

Telomir-1 is an investigational, orally administered small-molecule candidate designed to target fundamental biological processes believed to contribute to aging, cancer, metabolic, and other age-related diseases. The compound acts as a regulator of essential metal ions and an epigenetic modulator, influencing cellular pathways that govern oxidative stress, mitochondrial function, DNA methylation, and telomere maintenance-core mechanisms broadly implicated in degenerative, inflammatory, metabolic, and oncologic conditions.

Epigenetics refers to the way cells control gene activity without altering the underlying DNA sequence. One important epigenetic process, DNA methylation, functions as a molecular "dimmer switch," turning specific genes on or off. Over time, abnormal methylation patterns can silence genes that help regulate cell repair, detoxification, or immune balance. Mitochondria are the cell's energy-producing structures and are sensitive to oxidative stress, while telomeres are protective DNA caps at the ends of chromosomes that naturally shorten with each cell division. These systems collectively influence how quickly cells age and maintain healthy function.

Preclinical studies indicate that Telomir-1 and its zinc-bound form (Telomir-Zn) exhibit selective metal-ion-binding properties. The molecule demonstrates a high affinity for iron (Fe) and copper (Cu) ions and a lower affinity for zinc (Zn), allowing it to exchange or chelate excess Fe and Cu while maintaining beneficial zinc balance. This selective exchange mechanism has been associated in laboratory models with decreased redox stress, improved mitochondrial stability, and modulation of metal-dependent epigenetic enzymes such as histone demethylases (KDM5, KDM6A/UTX, and JMJD3). These findings suggest that Telomir-1's biological activity may derive in part from the restoration of normal metal-ion homeostasis-a process believed to play a key role in oxidative stress, inflammation, and cellular aging.

In preclinical models, Telomir-1 demonstrated metal-ion-dependent effects on oxidative balance and mitochondrial protection, including normalization of intracellular calcium release and redox stress and restoration of mitochondrial activity in Progeria fibroblast models. In an in-vivo Caenorhabditis elegans (C. elegans) longevity assay, Telomir-1 extended lifespan and improved mobility, suggesting a possible impact on biological-aging rate.

Telomir-1 inhibited several iron- and copper-dependent histone demethylase enzymes (KDM5, KDM6A/UTX, and JMJD3) and in prostate-cancer xenograft model derived from PC3 cells, reversed promoter hypermethylation of tumor-suppressor and immune-regulatory genes including STAT1, CDKN2A, GSTP1, MASPIN, RASSF1A, CASP8, and TMS1, restoring pathways associated with apoptosis, detoxification, and immune signaling.

In oncology research, Telomir-1 reduced tumor growth in a murine xenograft model of aggressive human prostate cancer (PC3 cells) and decreased cancer-cell viability in vitro in prostate, pancreatic, and triple-negative breast-cancer cell lines. In aging-related models, Telomir-1 reversed telomere shortening and restored telomere length beyond wild-type levels in an accelerated-aging zebrafish model mimicking Progeria and Werner syndromes.

Additional preclinical studies demonstrated disease-specific activity in degenerative and metabolic models. In an age-related macular-degeneration (AMD) model, Telomir-1 restored visual function and retinal structure, reduced oxidative stress, and reconstituted multiple retinal layers, supporting a potential regenerative mechanism in oxidative retinal injury. In a Wilson's-disease model, Telomir-1 improved neuromotor performance, reduced liver-copper accumulation, and normalized hepatic and renal histopathology scores, indicating multi-organ protective effects distinct from traditional metal-chelating agents. In metabolic models of Type 2 diabetes, Telomir-1 improved glucose metabolism and insulin sensitivity, consistent with its observed effects on mitochondrial and redox regulation.

Collectively, these preclinical findings suggest that Telomir-1 may function as a multi-target small-molecule regulator that integrates metal-ion balance, mitochondrial protection, epigenetic remodeling, and telomere preservation-biological processes thought to underlie aging, cancer, metabolic dysfunction, and several related pathologies. Telomir-1 has not been evaluated in humans, and there is no assurance that these preclinical results will translate into clinical safety or efficacy.

Recent Developments - Binding Letter of Intent for Worldwide Rights to Telomir-1

On October 17, 2025, we executed a binding Letter of Intent (the "LOI") to acquire TELI Pharmaceuticals, Inc., thereby securing worldwide rights to the Company's lead investigational therapy, Telomir-1. The proposed transaction would align the Company's existing U.S. intellectual-property rights with TELI's ex-U.S. portfolio, consolidating ownership across key territories including Europe, Canada, Mexico, China, Japan, South Korea, India, Israel, Australia, Argentina, Uruguay, Taiwan, and the United Arab Emirates.

Under the LOI, each outstanding share of TELI common stock would be exchanged for shares of the Company's common stock, with the final exchange ratio to be determined by an independent valuation. The LOI also provides for up to $5 million in potential shareholder contributions from certain TELI shareholders, payable in cash or cash equivalents over the course of the collaboration - $1 million at closing, $2 million upon acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration, and $2 million upon initiation of a Phase 1/2 clinical trial. The closing of the proposed acquisition is not conditioned upon the funding of these milestone-based shareholder contributions.

The transaction remains subject to customary conditions, including completion of due diligence, negotiation of definitive agreements, and approval by the shareholders of both companies. There can be no assurance that the parties will enter into definitive agreements or that the transaction will be completed. If consummated, the acquisition would establish Telomir as the single global owner of Telomir-1 intellectual-property assets and is expected to enhance the Company's ability to pursue future strategic collaborations, licensing arrangements, or regional partnership opportunities.

To date, we have not generated any revenue nor do we expect to generate revenue unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a program and we do not know when, or if at all, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur significant expenses related to production of sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. We expect to incur additional costs associated with operating as a public company.

We had net losses of $1.1 million and $6.0 million for the three months ended September 30, 2025 and 2024, respectively and $8.4 million and $13.7 million for the nine months ended September 30, 2025 and 2024, respectively.

Highlights - Three Months Ended September 30, 2025 and beyond

● On May 19, 2025, Telomir Pharmaceuticals, Inc. (the "Company") entered into an agreement to raise $3 million in equity financing through a direct investment by The Bayshore Trust, an entity affiliated with the Company's largest shareholder. The transaction was structured as a straight restricted common stock deal with no warrants. The Company issued 333,334 restricted shares of its common stock, no par value (the "Common Stock") at a purchase price of $3.00 per share, representing an 18% premium to the closing share price of the Common Stock of $2.54 on the date of execution (the "Bayshore Financing"). The Company received the initial payment of $1 million for the Bayshore Financing on May 20, 2025. On July 24, 2025, an additional $2 million was received, for the issuance of 666,666 shares.

● On July 17, 2025, we reported new preclinical results evaluating the effects of its lead candidate, Telomir-1, in a murine xenograft model using P3 human prostate cancer cells. The data demonstrated that Telomir-1 reversed epigenetic silencing by DNA methylation of the STAT1 gene, a tumor suppressor and immune response regulator, in a dose-dependent manner.

● On July 18, 2025, we sold a total of 1,100,000 shares of our common stock, no par value, in block sales to institutional investors, at an average price of $2.6045 per share (a premium to the prior day's close), through its at-the-market equity offering facility.

● On July 23, 2025, we reported new preclinical results showing that its lead compound, Telomir-1, restored mitochondrial function without triggering oxidative stress or cell proliferation in human cells derived from a patient with Hutchinson-Gilford Progeria Syndrome (HGPS).

● On August 7, 2025, we reported new preclinical data revealing that Telomir-1 potently inhibits three key histone demethylase enzymes-JMJD3, FBXL10, and FBXL11-that regulate gene expression through epigenetic mechanisms. These enzymes are known to influence tumor progression, immune response, metabolic function, and neuroinflammation.

● On August 27, 2025, we sold a total of 350,000 shares of our common stock, no par value, in block sales to institutional investors, at an average price of $1.95 per share, (a premium to the prior day's close), through our at-the-market equity offering facility.

● On August 28, 2025, we sold a total of 1,200,000 shares of our common stock, no par value, in block sales to institutional investors, at an average price of $1.82 per share, (a premium to the prior day's close), through our at-the-market equity offering facility.

● On August 28, 2025, we announced new in vitro results that expand understanding of our lead drug candidate, Telomir-1. In studies conducted by Eurofins Discovery, Telomir-1 was shown to potently inhibit UTX (KDM6A), an enzyme that acts like an "eraser" of chemical tags on DNA packaging proteins. These tags, known as DNA methylation and histone marks, are part of the body's system for deciding which genes are turned on or off - much like switches on a circuit board.

● On September 9, 2025 we reported new preclinical cancer data showing that Telomir-1 reverses DNA methylation of CDKN2A, a master tumor suppressor gene silenced in many aggressive cancers.

● On September 18, 2025, we reported new in vitro pharmacology results demonstrating that Telomir-1 potently inhibits three members of the KDM5 histone demethylase family. Histone demethylases are upstream gene regulators that cancers exploit to silence tumor suppressors and activate inflammatory programs. Blocking these enzymes has long been viewed as scientifically important but clinically challenging, with KDM5 often described as challenging for development

● On October 7, 2025, we announced new preclinical results showing that our investigational therapy Telomir-1 reactivated two of the body's most important tumor suppressor genes, MASPIN ("tumor suppressor shield") and RASSF1A ("guardian gene"; also called SERPINB5), through DNA methylation reset in prostate cancer models. By restoring the activity of these genes, Telomir-1 may help prevent cancer spread and improve chemotherapy response

● On October 9, 2025, we announced new findings demonstrating that Telomir-1 significantly decreases the viability of aggressive triple-negative breast cancer (TNBC) cells - a highly invasive form of breast cancer that lacks hormone and HER2 receptors, offers limited treatment options, and carries one of the poorest survival rates among breast cancer subtypes.

● On October 9, 2025, we sold a total of 550,000 shares of our common stock, no par value, in block sales to institutional investors, at an average price of $1.90 per share, through our at-the-market equity offering facility, resulting in net proceeds of $1,003,120.

● On October 14, 2025, we announced new laboratory findings demonstrating that Telomir-1 kills aggressive pancreatic cancer cells. In laboratory studies using human pancreatic cancer (PANC-1) cells, Telomir-1 produced a concentration-dependent reduction in cancer cell survival and mitochondrial activity. These data suggest Telomir-1 influences cellular pathways related to energy metabolism and oxidative balance. The findings align with previously reported results in triple-negative breast and prostate cancer models, indicating that Telomir-1 may engage fundamental biological processes involved in cancer cell regulation.

● On October 17, 2025, we executed a binding Letter of Intent (the "LOI") to acquire TELI Pharmaceuticals, Inc., a related party company, securing worldwide rights to its lead investigational therapy, Telomir-1. The transaction aligns Telomir's U.S. rights with TELI's ex-U.S. intellectual property portfolio, which includes filings across Europe, Canada, Mexico, China, Japan, South Korea, India, Israel, Australia, Argentina, Uruguay, Taiwan, and the United Arab Emirates-creating a single global owner positioned to capture the full commercial value of Telomir-1 across oncology, metabolic, and age-related diseases. The proposed transaction also includes up to $5 million in potential contributions, in cash or cash equivalents, from certain TELI shareholders over the duration of the collaboration, with $1 million due at closing, $2 million upon IND acceptance, and $2 million upon Phase 1/2 initiation. The transaction is subject to shareholder and board approval.

● On October 23, 2025, we reported new preclinical data from an in vivo study in mice bearing human aggressive prostate cancer tumors evaluating DNA-methylation changes in two key defense genes - CASP8 and GSTP1 - following treatment with oral Telomir-1, Rapamycin, chemotherapy, and combination regimens. Apoptosis ("kill") and detoxification ("clean") pathways are two of the body's fundamental defense systems against cancer initiation and progression, and Telomir-1's observed modulation of these pathways through DNA-methylation control may represent an important area of ongoing scientific evaluation in oncology research.

Components of Our Results of Operations

Research and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

contracted research and manufacturing;
consulting arrangements; and
other expenses incurrent to advance the Company's research and development activities.

Our operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities. We expect research and development expenses to increase in the future as we advance Telomir-1 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.

Critical Accounting Policies

Research and development expenses

Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on behalf of the Company. Patent-related costs, including registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they are incurred.

Stock-based compensation

The Company accounts for stock-based compensation under the provisions of FASB ASC 718, "Compensation - Stock Compensation", which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. The Company has elected to account for forfeiture of stock-based awards as they occur.

Results of Operations

For the three and nine months ended September 30, 2025 compared to the three and nine months ended September 30, 2024

Research and Development Expenses. During the three months ended September 30, 2025, we incurred $0.8 million in research and development expenses, and incurred $0.6 million in research and development expenses during the three months ended September 30, 2024. The main driver in the increase year over year relates to costs incurred in support of our lead investigational therapy, Telomir-1.

During the nine months ended September 30, 2025, we incurred $1.1 million in research and development expenses, and incurred $1.9 million in research and development expenses during the nine months ended September 30, 2024. The main driver in the decrease year over year relates to costs incurred in 2024 with certain pharmaceutical manufacturing activities that were not performed in 2025.

Since inception, we have not earned any revenue, nor do we anticipate doing so until we successfully conclude preclinical and clinical development and obtain regulatory approval. The timing and certainty of this event remain unknown.

Our operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities. We expect research and development expenses to increase in the future as we advance Telomir-1 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.

General and Administrative Expenses. We incurred $0.4 million and $5.4 million in general and administrative expenses during the three months ended September 30, 2025 and 2024, respectively. The decrease is primarily due to stock-based compensation related to grants issued in 2024.

We incurred $7.3 million and $7.0 million in general and administrative expenses during the nine months ended September 30, 2025 and 2024, respectively. The increase is primarily due to executive stock-based compensation.

Related Party Travel Costs. We did not incur any related party travel costs during the three or nine months ended September 30, 2025. The Company incurred $0.4 million during the nine-month period ended September 30, 2024 in connection with the lease of and use of an airplane with an entity under common control. The Company has not participated in the use of the airplane since March 2024 and, pursuant to the terms of the agreement, bears no further obligation under the agreement.

Interest income (expense). We earned $0.05 million in interest income during the nine months ended September 30, 2025 relating primarily to money market interest. We incurred $4.3 million in interest expense during the nine months ended September 30, 2024. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued on the related party line of credit that is no longer open.

Liquidity and Capital Resources

Sources of Liquidity

Since the Company's inception in August 2021, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company, through a $1.0 million private placement of shares of our common stock that occurred during the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023), and through our IPO that occurred in February 2024. We intend to finance our clinical development programs and working capital needs from existing cash, and our effective shelf registration statement.

On September 24, 2024 the Company entered into an unsecured Promissory Note and Loan Agreement ("the Starwood Note") with the Starwood Trust, a separate related party trust established by the Company's founder for the benefit of the founder's family. Under the Starwood Note, the Company has the right to borrow up to an aggregate of $5 million from the Starwood Trust at any time up until the second anniversary of the note. The Company's right to borrow funds under the Starwood Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Starwood Note, together with accrued interest, is to become due and payable on the second anniversary of the issuance of the note, provides for prepayment at any time without penalty, and accrues simple interest at a rate equal 7% per annum. As of September 30, 2025, the Company has not borrowed any amounts under the Starwood Note.

On May 19, 2025, Telomir Pharmaceuticals, Inc. the Company entered into an agreement to raise $3 million in equity financing through a direct investment by The Bayshore Trust, an entity affiliated with the Company's largest shareholder. The transaction was structured as a straight restricted common stock deal with no warrants. The Company issued 333,333 restricted shares of its common stock, no par value (the "Common Stock") at a purchase price of $3.00 per share, representing an 18% premium to the closing share price of the Common Stock of $2.54 on the date of execution (the "Bayshore Financing"). The Company received the initial payment of $1 million for the Bayshore Financing on May 20, 2025. In July 2025, an additional $2 million was received, for the issuance of 666,666 shares.

On February 14, 2025, the Company filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At The Market Offering Agreement (the "ATM Agreement") with Rodman & Renshaw LLC under which the Company may offer and sell shares of its Common Stock, with an aggregate offering amount sold of up to $100,000,000. As of the date of filing of this Form 10-Q, the Company has sold a total of 3,218,300 shares of its common stock, at a weighted average price of $2.12 for total proceeds of $6,553,207, net of costs of $272,092

We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash flow from operations of approximately $2.5 million for the nine months ended September 30, 2025. As of September 30, 2025, we had cash and cash equivalents of approximately $7.3 million and an accumulated deficit of approximately $38.9 million.

We currently expect that our cash and cash equivalents will only be sufficient to fund our operations, development plans, and capital expenditures through the third quarter of 2026. As such, there is substantial doubt about the Company's ability to continue as a going concern.

We did not have any material non-cancellable contractual obligations as of September 30, 2025.

Cash Flows

The following table provides information regarding our cash flows for the periods presented:

Nine Months Ended
September 30,
2025 2024
Net cash provided by (used in):
Operating activities $ (2,486,841 ) $ (4,464,620 )
Financing activities 8,550,008 5,298,027
Net change in cash $ 6,063,167 $ 833,407

Net Cash from Operating Activities

The cash used in operating activities resulted primarily from our net losses, stock-based compensation expenses and changes in components of accounts payable, accrued liabilities, and prepaid expenses.

For the nine months ended September 30, 2025, operating activities used $2.5 million of cash, primarily due to a net loss of $8.4 million, stock compensation costs of $6.1 million and a $0.3 million change in accounts payable, accrued liabilities and prepaid expenses. Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs, legal and accounting expenses.

For the nine months ended September 30, 2024, operating activities used $4.5 million of cash, primarily due to a net loss of $13.6 million offset by $0.03 million change in accounts payable, accrued and prepaid expenses. In the nine months ended September 30, 2024, we recognized $4.3 million in the amortization of debt issuance costs and $4.8 million in stock-based compensation.

Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs, legal and accounting expenses.

Net Cash from Financing Activities

For the nine months ended September 30, 2025, financing activities provided $8.6 million of cash, resulting primarily from net proceeds from the sale of common stock.

For the nine months ended September 30, 2024, financing activities provided $5.3 million of cash, resulting primarily from $5.8 million in proceeds from sale of common stock, less offering costs, offset by $0.4 million payments to related parties, and $0.1 million of repayments under related party line of credit.

Telomir Pharmaceuticals Inc. published this content on November 10, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 10, 2025 at 21:02 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]