SEC Form 10-Q filed by Telomir Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
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As of May 14, 2025, there were shares of registrant common stock issued and outstanding.
TELOMIR PHARMACEUTICALS, INC.
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
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TELOMIR PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
| March 31, | December 31, | |||||||
2025 (unaudited) | 2024
| |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Total current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Trade accounts payable and accrued liabilities | $ | $ | ||||||
| Due to related parties | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | $ | $ | ||||||
| Stockholders’ Equity (Deficit) | ||||||||
| Preferred Stock, par value, shares authorized and issued or outstanding. | ||||||||
| Common Stock, par value; shares authorized, and shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity (deficit) | ( | ) | ||||||
| Total liabilities and stockholders’ equity (deficit) | $ | $ | ||||||
See notes to condensed unaudited financial statements
| 3 |
TELOMIR PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Operating costs: | ||||||||
| General and administrative expenses | ||||||||
| Related party travel costs | ||||||||
| Research and development expenses | ||||||||
| Total operating costs | ||||||||
| Interest income (expense), net | ( | ) | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted loss per share | $ | ) | $ | ) | ||||
| Weighted average common stock shares outstanding | ||||||||
See notes to condensed unaudited financial statements
| 4 |
TELOMIR PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ Equity | |||||||||||||||||
| Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||
Balances, December 31, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock for cash, net | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Balances, December 31, 2024 | ( | ) | ||||||||||||||||||
| Stock based compensation | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
See notes to condensed unaudited financial statements
| 5 |
TELOMIR PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash from operating activities | ||||||||
| Amortization of debt issuance costs | ||||||||
| Stock-based compensation expense | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Trade accounts payable and accrued expenses | ( | ) | ) | |||||
| Prepaid expenses | ( | ) | ( | |||||
| Net cash flows from operating activities | $ | ( | ) | $ | ( | ) | ||
| Financing activities: | ||||||||
| Payments under related party line of credit | ( | |||||||
| Payments to related party | ( | ) | ||||||
| Proceeds from sale of common stock | ||||||||
| Net cash flows from financing activities | ||||||||
| Net change in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents, beginning of period | ||||||||
| Cash and cash equivalents, end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income taxes | $ | $ | ||||||
See notes to condensed unaudited financial statements
| 6 |
TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Note 1. Description of business and summary of significant accounting policies:
Overview
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. Oxidative stress also plays a critical role in the propagation and severity of viral infections like bird flu, where the virus triggers an imbalance between increased production of reactive oxygen species (ROS) and reduced antioxidant host responses that leads to increased redox stress, a process which ultimately excessive weakens immune defenses, increases inflammation, and enables enhanced viral replication. By reversing oxidative stress, Telomir-1 may help strengthen immune resilience and reduce disease severity, offering broad therapeutic potential across both age-related and infectious diseases. Telomeres are repetitive DNA sequences at the end of chromosomes that protect the chromosomes from becoming frayed or tangled. Each time a cell divides, the telomeres become slightly shorter, and eventually they become so short that the cell can no longer divide, with the result being that the cell dies. Effectively, telomeres protect the ends of our chromosomes by forming a cap, much like the plastic tip on shoelaces, thereby allowing the chromosome to be replaced properly during cell division. If demonstrated by future clinical trials and approved by the U.S. Food and Drug Administration, or FDA, we believe Telomir-1 may protect variable cells by elongating and stimulating the telomeres to sustain self-renewal and longevity. Based on our preclinical studies, we have gathered experimental evidence suggesting that Telomir-1 may act as a regulator of essential metal ions such as iron, zinc, and copper. While these trace elements are critical for various physiological functions, imbalances—whether due to excess or deficiency —can drive oxidative stress, leading to cellular damage, telomere shortening, and accelerated aging. This oxidative burden is also linked to age-related conditions and certain cancers. We believe Telomir-1 has the potential to protect cells in situ by mitigating metal overload, particularly of iron and copper, which are known to accelerate oxidative stress and contribute to telomere attrition. By modulating ion levels and reducing oxidative damage, Telomir-1 may help preserve telomere integrity, restore cellular homeostasis, and enhance overall cell resilience, potentially slowing down age-related degeneration. Additionally, by reversing oxidative stress, Telomir-1 may help mitigate the severity of viral infections such as bird flu by strengthening cellular defense mechanisms and improving immune system function, potentially reducing disease progression and severity.
Basis of presentation
The accompanying unaudited condensed financial statements include the accounts of the Company and have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions to Quarterly Report on Form 10-Q, and Regulation S-X. These financial statements do not include all information and notes required by GAAP for annual financial statements. However, except as disclosed herein, there has been no material change in the information disclosed in the notes to the financial statements included in the Company’s Form 10-K for the year ended December 31, 2024. In the opinion of management, all adjustments, consisting of normal recurring adjustments considered necessary for a fair presentation of interim financial information, have been included. Operating results for the periods presented are not necessarily indicative of expected results for the full year. Additionally, certain prior period amounts have been reclassified to conform to current period presentation in accompanying unaudited condensed consolidated financial statements.
Research and development expense
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.
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from such estimates and such differences could be material. Significant estimates during the reporting periods include stock-based compensation and the deferred tax asset valuation allowance.
Cash and cash equivalents
The
Company considers all highly liquid debt instruments and other short-term investments with maturities of three months or less, when
purchased, to be cash equivalents. The Company maintains cash balances at two financial institutions that are insured by the Federal
Deposit Insurance Corporation (“FDIC”). The Company’s account at these institutions is insured by the FDIC up to
$
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TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
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.
Fair value measurements and financial instruments
The Company measures the fair value of financial instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of deferred offering costs to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:
Level 1 - quoted prices in active markets for identical assets or liabilities.
Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable.
Level 3 - inputs that are unobservable (for example cash flow modeling inputs based on assumptions).
Earnings (loss) per share is computed in accordance with ASC Topic 260, “Earnings per Share”. The basic weighted average number of shares of common stock outstanding excludes common stock equivalents such as stock options and warrants, while diluted weighted average number of shares outstanding includes such stock options and warrants. During the three months ended March 31, 2025 and 2024, outstanding aggregate stock options and warrants of and , respectively, were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
Recent accounting pronouncements not yet adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to provide more detailed disaggregation of expenses in the income statement, focusing on the nature of the expenses rather than their function. The new disclosures will require entities to separately present expenses for significant line items, including but not limited to, depreciation, amortization, and employee compensation. Entities will also be required to provide a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively, disclose the total amount of selling expenses and, in annual reporting periods, provide a definition of what constitutes selling expenses. This pronouncement is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect the adoption of this new guidance to have a material impact on the consolidated financial statements.
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TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This new standard requires a company to expand its existing income tax disclosures, specifically related to the rate reconciliation and income taxes paid. The standard will be effective beginning in fiscal year 2025, with early adoption permitted. The new standard is expected to be applied prospectively, but retrospective application is permitted. We are currently evaluating the impact of ASU 2023-09 on the consolidated financial statements and related disclosures. The Company does not expect the adoption of this new guidance to have a material impact on the consolidated financial statements.
Management has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will have a significant impact on the Company’s results of operations or financial position.
Note 2. Going concern
The accompanying financial statements have been prepared assuming the Company will continue as a going concern which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business.
As
of March 31, 2025, the Company had cash of approximately $
Historically, the Company has been primarily engaged in developing Telomir-1. During these activities, the Company sustained substantial losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations through its initial public offering in February 2024, and related party financings-see Note 4. Additional sources of financing will be required by the Company to continue operations and its Telomir-1 programs. However, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
As of the date of filing this report, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date the financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months from the issuance date of this report. Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or raise additional debt and/or equity capital. The Company is seeking to raise capital through additional debt and/or equity financings to fund our operations in the future. If the Company is unable to raise additional capital or secure additional lending in the near future, management expects that the Company will need to curtail its operations. These financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Note 3. License agreement, related party:
The Company licenses the U.S. patent rights for the use of Telomir-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an intellectual property development and holding company established by Jonnie R. Williams, Sr., the founder of the Company and the sole inventor of Telomir-1.
| 9 |
TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
On
August 11, 2023, (the “Effective Date”), the Company and MIRALOGX entered into an Amended and Restated Exclusive License
Agreement, under which the Company has the exclusive perpetual right and license under the above-described patent rights to make, have
made, use, and sell “Licensed Products” in the U.S. for human uses and preclinical studies and activities of any kind conducted
in furtherance of obtaining regulatory approval or commercialization for human uses (the “MIRALOGX License Agreement”). On
November 10, 2023, the Company and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant
to which the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals,
in addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and
commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License
Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product
containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl) pyridine or a pharmaceutically acceptable salt, ester, or solvate
thereof. The Company also has the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement
provides for the payment to MIRALOGX of an
The
MIRALOGX License Agreement provides for the payment to MIRALOGX of an
The term of the license from MIRALOGX will continue through the date of the expiration of the last-to-expire licensed patent or, if later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent rights are expected to extend through 2043, and additional patent terms may be awarded, including additional patent terms based on the time taken for regulatory review of drug products.
The agreement also provides that Telomir may bring suit in its own name to enforce patent rights. MIRALOGX will control the prosecution of the patent applications for Telomir-1. Telomir is required to be kept informed by
MIRALOGX of patent prosecution activities and may select identified countries for patent protection. Telomir is to reimburse MIRALOGX for patent prosecution and maintenance costs.
Note 4. Related party transactions:
Due
to related parties- The Company received working capital advances from companies under common control. These advances are due on
demand and are non-interest bearing. During the year ended December 31, 2024, there were advances received by the Company in the amount
of $
Starwood Trust Line of Credit-
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 $
| 10 |
TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Further,
on December 9, 2024, Starwood Trust entered into a stock purchase agreement with the Company to purchase shares of unregistered
common stock at $ a share for a total of $
License agreement - See Note 3.
Note 5. Stockholders’ equity (deficit):
Capital stock
The Company has the authority to issue shares of capital stock, consisting of shares of Common Stock and shares of undesignated preferred stock, whose rights and privileges will be defined by the Board of Directors when a series of preferred stock is designated.
ATM Agreement
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 $
Warrants
In connection with various transactions and the IPO summarized below, the Company issued stock warrants. Warrant activity for the three months ended March 31, 2025 and 2024 is summarized below:
| Weighted | ||||||||||||||||
| Weighted | Average | |||||||||||||||
| Number of | Average Exercise | Remaining Contractual | Aggregate Intrinsic | |||||||||||||
| Warrants | Price | Term (Years) | Value | |||||||||||||
| Outstanding as December 31, 2023 | $ | (1) | ||||||||||||||
| Granted | $ | - | ||||||||||||||
| Outstanding as March 31, 2024 | $ | |||||||||||||||
| Outstanding as December 31, 2024 | $ | (2) | ||||||||||||||
| Granted | $ | - | - | |||||||||||||
| Outstanding as March 31, 2025 | $ | (2) | ||||||||||||||
| Exercisable, March 31, 2025 | $ | (2) | ||||||||||||||
| 1) |
| (2) |
| 11 |
TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
Underwriter warrants
In
connection with the IPO in February 2024, the Company issued
2023 Omnibus Incentive Plan
In December 2023, the Company’s Board of Directors adopted the Company’s 2023 Omnibus Incentive Plan, (“2023 Omnibus Plan”). The 2023 Omnibus Plan authorizes the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors, and consultants and any of its future subsidiary corporations’ employees and consultants
The 2023 Omnibus Plan provides that shares of the Company’s Common Stock are reserved for issuance under the 2023 Omnibus Plan, all of which may be issued pursuant to the exercise of incentive stock options.
Stock-based compensation
The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected price volatility is based on the historical volatilities of a peer group as the Company does not have a multi-year trading history for its shares. Industry peers consist of several public companies in the biotech industry similar to the Company in size, stage of life cycle and product indications. The Company intends to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of the Company’s own stock price becomes available, or unless circumstances change such that the identified companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.
Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant. The Company recognizes forfeitures as they occur.
| Number of Shares | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding as December 31, 2024 | $ | $ | ||||||||||||||
| Options granted | $ | - | $ | - | ||||||||||||
| Forfeitures | ( | ) | $ | $ | - | |||||||||||
| Outstanding as March 31, 2025 | $ | $ | ||||||||||||||
| Exercisable, March 31, 2025 | $ | $ | ||||||||||||||
| 12 |
TELOMIR PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(Unaudited)
As of March 31, 2025, options exercisable totaled . The Company recognized approximately $ million in stock-based compensation in the three months ended March 31, 2025. There is approximately $ million of unrecognized compensation cost related to non-vested share-based compensation awards, which will be expensed through 2026.
Note 7. Segment Information
The
Company operates in
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies within Note 1. The CEO assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that is also reported on the statement of operations as net loss. The measure of segment assets is reported on the balance sheets as total assets.
The table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Less segment expenses: | ||||||||
| Research and development | ||||||||
| Related party travel costs | ||||||||
| General and administrative | ||||||||
| Loss from operations | $ | |||||||
| Plus: | ||||||||
| Interest income (expense),net | ( | ) | ||||||
| Segment net loss | $ | ( | ) | $ | ( | ) | ||
Note 8. Subsequent Events
ATM Offering
From
April 1, 2025 through May 13, 2025, under the ATM Agreement, the Company sold and issued
shares of Common Stock at a weighted average price per share
of $,
and received net proceeds of approximately $
Executive Incentive Compensation Program
On May 14, 2025, the compensation committee (the “Committee”) of Telomir Pharmaceuticals, Inc. (the “Company”) adopted the Company’s Executive Incentive Compensation Plan (the “EICP”) for Erez Aminov, its Chairman and Chief Executive Officer. The EICP was approved by the Committee following greater presentation of the EICP to the board of directors of the Company (the “Board”). The specific terms of the EICP were prepared by the Board’s independent compensation consultant.
Under the EICP, Mr. Aminov will be eligible until 2032 for certain long-term incentives based upon the Company reaching certain market capitalization values, raising capital, and the progress of the Company’s drug candidates. Any awards or grants received by Mr. Aminov under the EICP is subject to prior board approval. As the awards have not been granted officially through board approval, there is no grant date under ASC 718, and therefore no measurement date for the value of such awards
Mr. Aminov will also be entitled to an amount equal to 3% of the total value of any mergers and acquisition or strategic transactions completed by the Company.
The Board and the Committee, each in its sole discretion, generally retain the right to amend, supplement, supersede or cancel any awards under the EICP for any reason, and reserve the right to determine whether and when to pay out any bonus amounts pursuant to or outside of the EICP, regardless of the achievement of the performance targets.
| 13 |
Item 2. 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.
Background of the Company
Telomir-1 is a novel oral small molecule designed to regulate essential metal ions—such as iron, copper, and zinc—that are associated with oxidative stress, telomere shortening, and cellular aging. By modulating these ions, Telomir-1 is intended to support metal homeostasis, reduce oxidative imbalance, and help preserve telomere integrity. This approach is based on emerging research indicating that metal ion dysregulation can accelerate oxidative stress and contribute to cellular decline. Preclinical studies have shown that Telomir-1 may influence pathways involved in telomere maintenance and cellular protection, supporting its potential as a therapeutic candidate for further development in age-related conditions.
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 $2.2 million and $6.3 million for the three months ended March 31, 2025 and 2024, respectively.
Highlights-Three Months Ended March 31, 2025
● On January 7, 2025, we announced a preclinical progeria lifespan study conducted in collaboration with Nagi Bioscience SA. Utilizing C. elegans (nematode) models, in which the study demonstrated restoration of shortened lifespan and normalization of accelerated aging with Telomir-1.
● On January 28, 2025, we announced that our studies demonstrated the ability of Telomir-1 to fully reverse copper-induced elevation of ROS and provide robust cellular protection against copper toxicity.
● On February 18, 2025, we announced that our studies had demonstrated the ability of Telomir-1 to significantly reverse copper and iron-induced elevation of Reactive Oxygen Species (ROS).
● On February 21, 2025, we announced that Telomir-1 had successfully captured and stabilized both Silver(I) (Ag⁺) and the highly reactive Silver(II) (Ag²⁺) in a biologically compatible form.
● On February 26, 2025, we announced that Telomir-1 fully reverses calcium dysregulation-an often-overlooked yet fundamental driver of cell death, aging, and disease progression-in multiple human cell lines.
● On March 19, 2025, we announced that Telomir-1 reduces tumor size by approximately 50% in a prostate cancer animal model using highly aggressive human prostate cancer cells.
● On May 7, 2025, we announced new preclinical data showing that our lead oral drug candidate, Telomir-1, reverses multiple hallmarks of cellular decline across several human cell lines. The findings include improved mitochondrial activity, reduced oxidative stress, restored calcium balance, and protection from toxic metal effects-offering a mechanistic foundation for our new research initiatives in autism spectrum disorder (ASD) and spasmodic dysphonia (SD
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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 incurred 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 months ended March 31, 2025 compared to the three months ended March 31, 2024
Research and Development Expenses. During the three months ended March 31, 2025, we incurred $0.4 million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research projects. We incurred $0.8 million in research and development expenses during the three months ended March 31, 2024, relating to initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities. The main driver in the decrease year over year relates to the Company making a focused effort to conserve cash until additional funding is secured.
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.
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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 $1.9 million and $0.7 million in general and administrative expenses during the three months ended March 31, 2025 and 2024, respectively. The increase is primarily due to an increase in stock compensation expense of $1.4 million related to Company management and employees, insurance costs of $0.1 million, wage expense of $0.2 million, and legal, accounting, and filing fees of $0.2 million. General and administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Related Party Travel Costs. We did not incur any related party travel costs during the three months ended March 31, 2025. We incurred $0.4 million during the same period ended March 31, 2024 in connection with the lease of and use of an airplane with an entity under common control. The Company will not participate in the use of the airplane after March of 2024 and, pursuant to the terms of the agreement, constitutes no further obligation under the agreement.
Interest income (expense). We earned $0.01 million in interest income during the three months ended March 31, 2025 relating primarily to money market interest. We incurred $4.3 million in interest expense during the three months ended March 31, 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 March 31, 2025, the Company has not borrowed any amounts under the Starwood Note.
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 $0.9 million for the three months ended March 31, 2025. As of March 31, 2025, we had cash and cash equivalents of approximately $0.4 million and an accumulated deficit of approximately $32.8 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 second quarter of 2025. 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 March 31, 2025.
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Cash Flows
The following table provides information regarding our cash flows for the periods presented:
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | (863,132 | ) | $ | (1,939,415 | ) | ||
| Financing activities | - | 5,212,498 | ||||||
| Net change in cash | $ | (863,132 | $ | 3,273,083 | ||||
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 and prepaid expenses.
For the three months ended March 31, 2025, operating activities used $0.9 million of cash, primarily due to a net loss of $2.2 million, stock compensation costs of $1.4 million offset by $0.06 million change in accounts payable, accrued 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 three months ended March 31, 2024, operating activities used $1.9 million of cash, primarily due to a net loss of $6.3 million, debt issuance costs of $4.3 million offset by $0.02 million change in accounts payable, accrued 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.
Net Cash from Financing Activities
For the three months ended March 31, 2025, there were no financing activities.
For the three months ended March 31, 2024, financing activities provided $5.2 million of cash, resulting primarily from $5.8 million in proceeds from sale of common stock, less offering costs, offset by $0.5 million payments to related parties, and $0.1 million of repayments under related party line of credit.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information under this item per Item 305(e) of Regulation S-K.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report, our management, with the participation of our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.
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Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.
Based on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective as of March 31, 2025.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, during our first quarter of 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. In particular, statements about the markets in which we operate, including growth of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” are forward-looking statements. We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this quarterly report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:
● our use of the net proceeds from our recent offering;
● our ability to obtain and maintain regulatory approval of our product candidates;
● our ability to successfully commercialize and market our product candidates, if approved;
● our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;
● the potential market size, opportunity, and growth potential for our product candidates, if approved;
● our ability to obtain additional funding for our operations and development activities;
● the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;
● the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;
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● the timing of anticipated regulatory filings;
● the timing of availability of data from our clinical trials;
● our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements;
● our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
● our ability to advance product candidates into, and successfully complete, clinical trials;
● our ability to recruit and enroll suitable patients in our clinical trials;
● the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;
● the pricing and reimbursement of our product candidates, if approved;
● the rate and degree of market acceptance of our product candidates, if approved;
● the implementation of our business model and strategic plans for our business, product candidates, and technology;
● the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
● developments relating to our competitors and our industry; and
● other risks and factors listed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2024.
Given the risks and uncertainties set forth in this quarterly report, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this quarterly report are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this quarterly report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate are consistent with the forward-looking statements contained in this quarterly report, they may not be predictive of results or developments in future periods.
Any forward-looking statement that we make in this quarterly report speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this quarterly report.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.
We anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.
Item 1A. Risk Factors.
As a smaller reporting company, information under this “Item 1A. Risk Factors” is not required to be presented.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
Item 6. Exhibits.
| Number | Description | |
| 31.1* | Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* | |
| 31.2* | Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* | |
| 32.1* | Certification of Principal Executive Officer and Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101.INS* | Inline XBRL Instance Document | |
| 101.SCH* | Inline XBRL Taxonomy Extension Schema | |
| 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase | |
| 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase | |
| 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase | |
| 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase | |
| 104* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
| * | Furnished herewith |
| ^ | Previously filed. |
| + | Denotes management contract or compensatory plan or arrangement. |
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SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TELOMIR PHARMACEUTICALS, INC. | ||
| Date: May 14, 2025 | By: | /s/ Erez Aminov |
| Erez Aminov | ||
| Chief Executive Officer & Chairman | ||
| (Principal Executive Officer) | ||
| Date: May 14, 2025 | By: | /s/ Michelle Yanez |
| Michelle Yanez | ||
| Chief Financial Officer, Treasurer and Secretary | ||
| (Principal Financial Officer) | ||
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