Longeveron Inc.

Nine Month Periods Ended September 30, 2025 and 2024

1. Nature of Business, Basis of Presentation, and Liquidity

Nature of business:

Longeveron LLC was formed as a Delaware limited liability company on October 9, 2014, and was authorized to transact business in Florida on December 15, 2014. On February 12, 2021, Longeveron LLC converted its corporate form to a Delaware corporation, Longeveron Inc. (the “Company,” “Longeveron” or “we,” “us,” or “our”). The Company is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company operates out of its leased facilities in Miami, Florida.

The Company’s product candidates are currently in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, partners and consultants.

The accompanying interim condensed balance sheet as of September 30, 2025, and the condensed statements of operations, statements of comprehensive loss, statements of changes in stockholders’ equity, and the condensed statements of cash flows for the three and nine months ended September 30, 2025 and 2024, are unaudited. The unaudited condensed financial statements have been prepared according to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted. In the opinion of management, the accompanying unaudited condensed financial statements for the periods presented reflect all adjustments which are normal and recurring, and necessary to fairly state the financial position, results of operations, and cash flows of the Company. These unaudited condensed financial statements and notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s 2024 Annual Report on Form 10-K filed with the SEC on February 28, 2025.

Going Concern and Liquidity:

Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the U.S. Food and Drug Administration (“FDA”), and has only generated revenues from grants, the Bahamas Registry Trials and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations. The Company intends to continue its efforts to raise additional equity financing, develop its intellectual property, and secure regulatory approvals to commercialize its products. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. These financial statements do not include adjustments that might result from the outcome of these uncertainties.

The Company has incurred recurring losses from operations since its inception, including a net loss of $17.3 million and $11.9 million for the nine months ended September 30, 2025 and 2024, respectively. In addition, as of September 30, 2025, the Company had an accumulated deficit of $126.9 million. The Company expects to continue to generate operating losses for the foreseeable future.

Cash and cash equivalents as of September 30, 2025 were $9.2 million. As a result of the recently completed financing in August of 2025, and continued focus on disciplined and efficient capital allocation focused on first to market indications, the Company currently anticipates its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements late into the first quarter of 2026, based on its current operating budget and cash flow forecast. The Company also has access to an At-The-Market (ATM) equity financing vehicle for sale of up to $10.7 million aggregate market value of shares of the Company's Class A common stock. Following a successful Type C meeting with the FDA in August 2024 with respect to the Hypoplastic Left Heart Syndrome (“HLHS”) regulatory pathway, the Company has begun ramping up its biologics license application ("BLA") enabling activities, with a focus on clinical spend supporting HLHS study completion and delivering top-line results. The Company currently anticipates a potential BLA filing with the FDA in 2027 if the current ELPIS II trial in HLHS is successful. The Company expects that its current operating plan will require increased spending and additional capital investments to support these initiatives, and intends to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance the Company will be able to attain future financing at terms favorable to the Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise our current operational plan.

The Company has prepared a cash flow forecast which indicates that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern.

2. Summary of Significant Accounting Policies

Basis of Presentation:

The condensed financial statements of the Company were prepared in accordance with U.S. GAAP.

Certain reclassifications have been made to prior period amounts to conform to classifications used in the current period presentation. These reclassifications had no impact on net loss, stockholders’ equity or cash flows as previously reported.

Reverse Stock Split:

On March 26, 2024, the Company effected a reverse stock split of the outstanding shares of its Class A common stock and Class B common stock on aone-for-10 (1:10) basis (the “Reverse Stock Split”). The Reverse Stock Split became effective at 11:59 p.m. Eastern Time on March 26, 2024 via a certificate of amendment to the Company’s Certificate of Incorporation filed with the Secretary of State of the State of Delaware. At the effective time of the Reverse Stock Split, every 10 shares of the Company’s Class A common stock and Class B common stock, whether issued and outstanding or held by the Company as treasury stock, were automatically combined and converted (without any further act) into one fully paid and nonassessable share of Class A common stock or Class B common stock, respectively, subject to rounding up of fractional shares to the nearest whole number of shares resulting from the Reverse Stock Split without any change in the par value per share. All share, per share, option, warrant, equity award, and other derivative security numbers and exercise prices appearing in this Quarterly Report on Form 10-Q and the accompanying condensed financial statements have been adjusted to give effect to the Reverse Stock Split for all prior periods presented. However, the Company’s annual, other periodic, and current reports, and all other information and documents incorporated by reference into this Quarterly Report on Form 10-Q that were filed prior to March 19, 2024, do not give effect to the Reverse Stock Split.

Use of Estimates:

The presentation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Accounting Standard Updates:

A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s condensed financial statements.

In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, “Improvements to Income Tax Disclosures”. The amendments in this ASU change disclosure requirements for various items, including effective tax rate reconciliations and cash taxes paid. This ASU is effective for public companies for the financial reporting periods beginning on January 1, 2025, with early adoption permitted. The Company adopted ASU 2023-09 for its financial reporting period beginning on January 1, 2025. The adoption didnot have a material impact on its condensed financial statements.

In November 2024, the FASB issued ASU No. 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”. The amendments in this ASU require additional disclosure about the nature of expenses included in the expense captions presented on the face of the income statement, including research and development and other operating expenses. This ASU is effective for public companies for the financial reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The requirements will be applied prospectively, with the option for retrospective application, and early adoption is permitted. ASU

2024-03 will be effective for the Company for the annual period of its fiscal year ending December 31, 2027. The Company is currently evaluating the impact of adopting this ASU on its financial statements.

Cash and Cash Equivalents:

The Company considers cash to consist of cash and cash equivalents and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.

Fair Value Measurement:

We measure cash equivalents at fair value. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is defined as the price we would receive to sell an investment in a timely transaction or pay to transfer a liability in a timely transaction with an independent buyer in the principal market, or in the absence of a principal market, the most advantageous market for the investment or liability. A framework is used for measuring fair value utilizing a three-tier hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.

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Level 1 — Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities.

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Level 2 — Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.

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Level 3 — Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).

Money market funds are highly liquid investments and are classified as Level 1. The pricing information for these assets is readily available and can be independently validated as of the measurement date.

Accounts and Grants Receivable:

Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of September 30, 2025, and December 31, 2024 are deemed to be collectible, and no amount has been recognized for credit losses. In addition, for the clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the clinical trial revenue are recorded to deferred revenue. Advance contract manufacturing payments are recorded to deferred revenue.

Accounts and grants receivable by source, as of (in thousands):

Deferred Offering Costs:

The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering.

Property and Equipment:

Property and equipment, including improvements that extend useful lives of related assets, are recorded at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the condensed statements of operations as the assets are primarily related to the Company’s clinical programs.

Intangible Assets:

Intangible assets include payments on license agreements with the Company’s co-founder and Chief Science Officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired.

Payments for license agreements are amortized using the straight-line method over the estimated term of the agreements, which range from 5-20 years. Patents are amortized over their estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the condensed statements of operations as the assets are primarily related to the Company’s clinical programs.

Impairment of Long-Lived Assets:

The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected in the condensed statements of operations. Upon evaluation, management determined that there wasno impairment of long-lived assets during thethree and nine months ended September 30, 2025 and 2024.

Deferred revenue:

The unearned portion of advanced grant funds, contract manufacturing revenues, and prepayments for clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the accompanying condensed balance sheets. For the nine months ended September 30, 2025 and 2024, the Company recognized less than $0.1 million, respectively, of funds that were previously classified as deferred revenue.

Revenue recognition:

The Company recognizes revenue when performance obligations related to respective revenue streams are met. For grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. The Company didnot recognize any grant revenue during thethree and nine months ended September 30, 2025 and 2024.

For clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment.

For contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and/or statement of work has been satisfied. Additionally, the Company's contract manufacturing agreements include a lease component, under which customers pay a fixed monthly fee per suite to reserve and maintain a dedicated manufacturing suite with one production line. Customers may also secure additional suites based on capacity needs, which are billed at a fixed fee per suite per month. Furthermore, customers pay the Company a fixed fee per month for storage of in-process samples, vialed harvests for training, and in-process samples for product lots. As these arrangements grant customers the right to control the use of an identified space, the Company classifies the suite reservation fees and storage fees as lease revenue in accordance with ASC 842 Leases. Payment terms may vary depending on specific contract terms. In 2024 and the first three quarters of 2025, the Company derived 100% of its contract manufacturing revenue from a single customer, resulting in a significant concentration of revenue risk. Activities with this customer have substantially decreased during 2025, and no additional manufacturing or development work is currently planned. The Company does not anticipate significant future manufacturing revenue with this customer.

Revenue by source (in thousands):

The Company records cost of revenues based on expenses directly related to revenue. For grants, the Company records allocated expenses for research and development costs to a grant as a cost of revenues. For the clinical trial revenue, directly related expenses for that program are expensed as incurred. These expenses are similar to those described under “Research and development expense” below. For the contract manufacturing, the Company records costs incurred under the contract as cost of revenues.

Research and Development Expense:

Research and development costs are charged to expense when incurred in accordance with ASC 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered.

Concentrations of Credit Risk:

Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, marketable securities and accounts and grants receivable. Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts.

Income Taxes:

The Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company recordedno tax provision for thethree and nine months ended September 30, 2025 and 2024 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to uncertainty of realizing a benefit in the future.

The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination, or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of September 30, 2025 and December 31, 2024, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable.

Equity-based Compensation:

The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for equity-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model.

The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options.

Neither the Company’s options nor its restricted stock units (“RSUs”) trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the stock options granted are expected to remain outstanding. Options granted have a maximum term often years. The Company had insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life.

3. Money Market Funds and Fair Value Measurement

The following is summary of money market funds that the Company measures at fair value (in thousands):

(1)

Money market funds are included in cash and cash equivalents in the condensed balance sheet.

(1)

Money market funds are included in cash and cash equivalents in the condensed balance sheet.

As of September 30, 2025 and December 31, 2024, the Company reported accrued interest receivable related to money market funds of less than$0.1 million. These amounts are recorded in other assets on the condensed balance sheets and are not included in the carrying value of the money market funds.

4. Property and Equipment, Net

Major components of property and equipment are as follows (in thousands):

Depreciation and amortization expense amounted to approximately $0.2 million for each of the three-month periods ended September 30, 2025 and 2024, and $0.6 million and $0.5 million for the nine-month periods ended September 30, 2025 and 2024 , respectively.

5. Intangible Assets, Net

Major components of intangible assets as of September 30, 2025, are as follows (in thousands):

Major components of intangible assets as of December 31, 2024, are as follows (in thousands):

Amortization expense related to intangible assets amounted to approximately $0.1 million for each of the three-month periods ended September 30, 2025 and 2024 and $0.4 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.

Future amortization expense for intangible assets as of September 30, 2025 is as follows (in thousands):

6. Leases

The Company records a right-of-use operating lease asset and a lease liability related to its operating leases (there are no finance leases). The Company’s corporate office lease expires in March 2027. As of September 30, 2025, the operating lease asset and lease liability were approximately $0.6 million and $1.0 million, respectively. As of December 31, 2024, the operating lease asset and lease liability were approximately $0.9 million and $1.4 million, respectively.

Future minimum payments under the operating leases as of September 30, 2025, are as follows (in thousands):

During each of the three months ended September 30, 2025 and 2024, the Company incurred approximately $0.2 million of total lease costs and for the nine month periods ended September 30, 2025 and 2024, the Company incurred approximately $0.5 million and $0.6 million of total lease costs, respectively, that are included in the general and administrative expenses in the condensed statements of operations.

7. Stockholders’ Equity

Class A and Class B Common Stock

Holders of Class A common stock generally have rights identical to holders of Class B common stock, except that holders of Class A common stock are entitled toone (1) vote per share and holders of Class B common stock are entitled tofive (5) votes per share. The holders of Class B common stock may convert each share of Class B common stock into one share of Class A common stock at any time at the holder’s option. Class B common stock is not publicly tradable.

During the nine months ended September 30, 2025, stockholders convertedno shares of Class B common stock into shares of Class A common stock. During the year ended December 31, 2024, stockholders converted 1,555 shares of Class B common stock into 1,555 shares of Class A common stock.

Warrants

Summary of Warrants Outstanding

As of September 30, 2025, warrants exercisable for an aggregate of up to 21,920,318 shares of the Company’s Class A common stock remain outstanding. This includes:

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warrants exercisable for up to 5,536 shares of Class A common stock at an exercise price of $120.00 per share, which expire February 12, 2026.

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warrants exercisable for up to 4,679 shares of Class A common stock at an exercise price of $175.00 per share, which expire December 1, 2026.

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warrants exercisable for up to 16,971 shares of Class A common stock at an exercise price of $20.625 per share, which expire October 11, 2028.

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warrants exercisable for up to 135,531 shares of Class A common stock at an exercise price of $16.20 per share, which expire June 22, 2029.

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warrants exercisable for up to 9,489 shares of Class A common stock at an exercise price of $21.813 per share, which expire December 20, 2028.

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warrants exercisable for up to 297,872 shares of Class A common stock at an exercise price of $2.35 per share, which expire April 10, 2029.

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warrants exercisable for up to 154,894 shares of Class A common stock at an exercise price of $2.9375 per share, which expire April 8, 2029.

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warrants exercisable for up to 2,349,744 shares of Class A common stock at an exercise price of $2.35 per share, which expire April 18, 2029.

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warrants exercisable for up to 167,982 shares of Class A common stock at an exercise price of $3.25 per share, which expire April 18, 2029.

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warrants exercisable for up to 49,130 shares of Class A common stock at an exercise price of $2.9375 per share, which expire June 18, 2026.

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warrants exercisable for up to 926,596 shares of Class A common stock at an exercise price of $2.50 per share, which expire June 18, 2026.

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warrants exercisable for up to 118,852 shares of Class A common stock at an exercise price of $3.25 per share, which expire June 18, 2026.

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warrants exercisable for up to 10,500 shares of Class A common stock at an exercise price of $3.125 per share, which expire July 17, 2026.

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warrants exercisable for up to 162,344 shares of Class A common stock at an exercise price of $3.125 per share, which expire July 24, 2026.

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warrants exercisable for up to 2,236,026 shares of Class A common stock at an exercise price of $3.90 per share, which expire July 20, 2026.

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warrants exercisable for up to 156,522 shares of Class A common stock at an exercise price of $5.0313 per share, which expire July 20, 2026.

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warrants exercisable for up to 14,705,885 shares of Class A common stock at an exercise price of $0.85 per share, which expire August 11, 2027.

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warrants exercisable for up to 411,765 shares of Class A common stock at an exercise price of $1.0625 per share, which expire August 11, 2027.

8. Equity Incentive Plan

RSUs

As part of the Company’s IPO, the Company adopted and approved the 2021 Incentive Award Plan, which has been subsequently amended and restated three times (as accordingly amended and restated, the “2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company may grant cash and equity incentive awards to employees and eligible service providers in order to attract, motivate and retain the talent for which the Company competes.

RSUs are taxable upon vesting based on the market value on the date of vesting. The Company is required to make mandatory tax withholding for the payment and satisfaction of income tax, social security tax, payroll tax, or payment on account of other tax related to withholding obligations that arise by reason of vesting of an RSU. The taxable income is calculated by multiplying the number of vested RSUs for each individual by the closing share price as of the vesting date and a tax liability is calculated based on each individual’s tax bracket. During the nine months ended September 30, 2025, a total of 469,328 RSUs vested for Class A common stock shares. Of that amount, the Company withheld 182,199 Class A common stock shares to satisfy employee tax liabilities. During the year ended December 31, 2024, a total of 566,904 RSUs vested for Class A common stock shares. Of that amount, the Company withheld 142,306 Class A common stock shares to satisfy employee tax liabilities. The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan. Each RSU grant made during the nine months ended September 30, 2025 and during 2024 was expensed ratably over its respective vesting period, with prorated adjustments made as needed to align with grant dates and the applicable service periods.

As of September 30, 2025, and December 31, 2024, the Company had 1,563,266 and 806,001, respectively of RSUs outstanding (unvested).

RSU activity for thenine months ended September 30, 2025, was as follows:

Stock Options

Stock options may be granted under the 2021 Incentive Plan. The exercise price of options is equal to the fair market value of the Company’s Class A common stock as of the grant date. Options historically granted have generally become exercisable over three orfour years and expireten years from the date of grant.

The fair value of the options issued in 2025 were estimated using the Black-Scholes option-pricing model and had the following assumptions: a dividend yield of 0%; an expected life of 5 years; volatility of 75.94%; and risk-free interest rate based on the grant date of 3.84%. The fair value of the options issued during 2024 were estimated using the Black-Scholes option-pricing model and had the following assumptions: a dividend yield of 0%; an expected life of 10 years; volatility ranging from 79%-95%; and risk-free interest rate based on the grant date ranging from of 3.79% to 4.52%. Each option grant is being expensed ratably over the option vesting periods, with prorated adjustments made as needed to align with grant dates and applicable service period.

As of September 30, 2025 and December 31, 2024, the Company has recorded issued and outstanding options to purchase a total of 755,967 and 121,186 shares of Class A common stock, respectively, pursuant to the 2021 Incentive Plan, at a weighted average exercise price of$3.54 and $15.09 per share, respectively.

For thenine months ended September 30, 2025:

For the year ended December 31, 2024:

Stock option activity for thenine months ended September 30, 2025, was as follows:

For the three months ended September 30, 2025 and 2024, the equity-based compensation expense amounted to approximately $0.4 million and $1.4 million, respectively, and for thenine months ended September 30, 2025 and 2024, the equity-based compensation expense amounted to approximately $1.3 million and $1.9 million, respectively, which is included in the research and development and general and administrative expenses in the condensed statements of operations for thethree and nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, the remaining unrecognized RSUs compensation of approximately $2.2 million will be recognized over approximately 2.13 years. The remaining unrecognized stock options compensation of approximately $0.2 million will be recognized over approximately 1.58 years.

9. Commitments and Contingencies

Master Services and Clinical Studies Agreements:

During 2024, the Company terminated its active master services agreements with third parties that were previously engaged to conduct its clinical trials and manage clinical research programs and clinical development services in Japan. This termination was due to the Company’s decision in April 2024 to discontinue trial activities in Japan.

Consulting Services Agreement:

On November 20, 2014, the Company entered into a ten-year consulting services agreement with Dr. Joshua Hare, its Chief Science Officer (CSO), under which the Company has agreed to pay the CSO $265,000 annually for his part-time services. The initial term of the agreement ended on November 22, 2024; however, with regard to the annual compensation paid to Dr. Hare, the Company continues at present to operate under the same terms on a month-to-month basis.

In addition, the Company entered into a deferred compensation agreement with the CSO to defer payment of the consulting fees earned for services rendered during 2024, which fees will be paid in a lump sum distribution in February 2027. A similar arrangement was also entered into for 2025. On March 4, 2025 and April 11, 2025, the Company entered into stock option agreements with the CSO as part of a Cash-for-Equity Program. These agreements represent settlement of (i) approximately $45,000 in previously accrued consulting fees, and (ii) the CSO's 2024 performance bonus of approximately $131,000, respectively. Pursuant to the Company's Cash-for-Equity Program, the CSO elected to receive this amount in the form of options to purchase 71,254 and 184,878 shares of the Company’s Class A Common Stock, respectively. Each award fully vested on July 1, 2025, following stockholder approval at the Company's 2025 annual meeting of stockholders on June 13, 2025, increasing the pool of the shares available for awards under the 2021 Incentive Plan. On July 1, 2025, the Company entered into an additional stock option agreement with the CSO as part of the Cash-for-Equity Program, with such agreement representing settlement of $30,000 in consulting fees earned for services rendered during the three months ended June 30, 2025. Pursuant to the Cash-for-Equity Program, the CSO elected to receive this amount in the form of fully vested options to purchase 49,219 shares of the Company’s Class A Common Stock. On July 15, 2025, the Company granted the CSO options to purchase 109,000 shares of the Company's Class A Common Stock at an exercise price of $1.47 per share, as part of his annual compensation package, with the options vesting quarterly over three years.

As of September 30, 2025 and December 31, 2024, the Company had accrued balances due to the CSO of approximately $0.3 million, included in other long-term liabilities in the accompanying condensed balance sheets.

Manufacturing Services Agreement:

On February 21, 2024, the Company entered into afive-year Supply Agreement with a third-party biotechnology company developing multiple, novel secretomes (“Secretome”), to address a spectrum of diseases driven by pathological processes, to manufacture, test, release, and supply Secretome with cardiac stem cells (the “Product”) to be used in Phase 1 and Phase 2 clinical trials (the “Secretome Agreement”). The Company bills Secretome on a variable fee basis for quality control, in process, release, and stability testing service items. Secretome also pays a monthly manufacturing suite reservation fee and hourly fee for project management services.

Following the initial five-year term, the Secretome Agreement may be renewed for additional successive two-year terms upon the mutual written agreement of the parties. Either party may terminate the agreement for cause and upon notice in the event of a material breach, within (i) 30 days of an uncured material breach that is not a payment default or (ii) 10 days for an uncured payment default. The Secretome Agreement further provides that either party may terminate the agreement at any time upon 90 days’ notice to the other party.

During 2025, activities under the Secretome Agreement have substantially decreased, and the Company is now only performing limited stability and other contract testing. No additional manufacturing or development activities are planned, and the Company does not anticipate significant future revenue under this arrangement.

For the three and nine months ended September 30, 2025, the Company has earned revenues of less than $0.1 million and $0.2 million, respectively, under the Secretome Agreement.

Exclusive Licensing Agreements:

UM Agreements

On November 20, 2014, the Company entered into an Exclusive License Agreement with UM (the “UM License”) for the use of certain Aging-related Frailty Mesenchymal Stem Cell (“MSC”) technology rights developed by our CSO at UM. The UM License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how specifically related to the development of the culture-expanded mesenchymal stem cells for Aging-related Frailty used at the Human-induced pluripotent stem cell-derived mesenchymal stem cells (“IMSCs”), all standard operating procedures used to create the IMSCs, and all data supporting isolation, culture, expansion, processing, cryopreservation and management of the IMSCs.

The Company is required to pay UM (i) a license issue fee of $5,000, (ii) a running royalty in an amount equal to three percent of annual net sales on products or services developed from the technology, payable on a country-by-country basis beginning on the date of first commercial sale through termination of the UM License Agreement, and which may be reduced to the extent we are required to pay royalties to a third party for the same product or process, (iii) escalating annual cash payments of up to $50,000, subject to offset. The agreement extends for up to 20 years from the last date a product or process is commercialized from the technology and was amended in 2017 to modify certain milestone completion dates as detailed below. In 2021 the license fee was increased by an additional $100,000, to defray patent costs. In addition, the Company issued 11,039 unregistered shares of Class A common stock to UM.

The milestone payment amendments shifted the triggering payments to three payments of $500,000, to be paid within six months of: (a) the completion of the first Phase 3 clinical trial of the products (based upon the final data unblinding); (b) the receipt by the Company of approval for the first new drug application (“NDA”), BLA, or other marketing or licensing application for the product; and (c) the first sale following product approval.

The Company has the right to terminate the UM License upon 60 days’ prior written notice, and either party has the right to terminate upon a breach of the UM License. To date, the Company has made payments totaling $487,500 to UM, and as of September 30, 2025 and December 31, 2024, the Company had accrued $30,000 and $45,000 in milestone fees payable to UM, respectively and $15,000, respectively for patent related reimbursements based on the estimated progress to date.

The Company also entered into an additional Exclusive License Agreement with UM, signed and effective as of July 18, 2024, for technology rights developed by our CSO at UM. This License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how, SOPs, data and other all other rights related to UMP-144, entitled “A method to derive GHRHR+ cardiomyogenic cells from pluripotent stem cells (PSCs) for therapeutic and pharmacologic applications”. UM retained a non-exclusive, royalty-free, perpetual, irrevocable, worldwide right to practice, make, and use the Patent Rights or Technology for any non-profit purposes, including educational, and research purposes. In addition to those certain other royalty payments that would be due should the Company’s sublicense of the technology result in revenue, the Company also agreed to the following additional milestones and payments: $150,000 upon completion of the first Phase 3 Clinical Trial; and $250,000 upon issuance of a biologics license application or new drug application based on the licensed technology. The Company has the right to terminate the new UM License for convenience upon 90 days’ prior written notice, and both parties have additional termination rights for material breach of the agreement.

To date, the Company has made payments totaling $5,000 to UM, and as of September 30, 2025, the Company had not yet accrued any milestone fees payable to UM.

CD271

On December 22, 2016, the Company entered into an exclusive license agreement with an affiliated entity of Dr. Joshua Hare, JMH MD Holdings, LLC (“JMHMD”), for the use of CD271 cellular therapy technology, pursuant to which the Company is required to pay JMHMD a running royalty in an amount equal toone percent of the annual net sales of the licensed product(s) used, leased, or sold by or for the Company by any sub-licensees, payable on a country-by-country basis beginning on the date of first commercial sale and ending on the latter of expiration of the last to expire patent rights in such country orten years fromthe first commercial sale in such country(provided that if all claims within the patent rights have expired or been finally deemed invalid then the royalty will be reduced by 50%), and which may also be reduced to the extent the Company is required to pay royalties to a third party for the same product or process.

Under the agreement, the Company is required to use commercially reasonable efforts to achieve the following milestones: (i) submit an investigational new drug application to FDA (or international equivalent) within one year of the effective date of agreement, (ii) initiate a clinical trial utilizing bone marrow derived CD271+ Precursor Cells within three years of the effective date; provided, that any of the milestones may be extended for up to six months for a total of three times by notice and payment of afive thousand dollar extension fee. The agreement is to remain in effect until either the date all issued patents and filed patent applications have expired or been abandoned, or 20 years after the date of FDA approval of the last commercialized product or process arising from the patent rights whichever comes later. If the Company sublicenses the technology, it is also required to pay an amount equal to 10% of the net sales of the sub-licensees.

There wereno license fees due as of September 30, 2025 and December 31, 2024 pertaining to this agreement.

Other Royalty

Under the grant award agreement with the Alzheimer’s Association, the Company may be required to make revenue sharing or distribution of revenue payments for products or inventions generated or resulting from this clinical trial program. The potential payments, although not currently defined, could result in a maximum payment of five times (5x) the award amount of $3.0 million.

Contingencies – Legal

From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. As of September 30, 2025, the Company is not aware of any legal proceedings or material developments requiring disclosure.

10. Employee Benefits Plan

The Company sponsors a defined contribution employee benefit plan (the “Plan”) under the provisions of Section 401(k) of the Internal Revenue Code. The Plan covers substantially all full-time employees of the Company who are eligible upon date of hire. Contributions to the Plan by the Company are at the discretion of the Board of Directors.

The Company contributed approximately $0.2 million and $0.1 million to the Plan during the nine months ended September 30, 2025 and 2024, respectively, and less than $0.1 million to the Plan during the three months ended September 30, 2025 and 2024, respectively.

11. Loss Per Share

Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. We have outstanding equity-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive.

The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive:

12. Segment Information

Operating segments are defined as components of an entity for which discrete financial information is available and regularly reviewed by the Chief Operating Decision Maker (“CODM”) to allocate resources and assess performance. The Company’s CODM is its Chief Executive Officer ("CEO"), and the Company manages its operations as asingle operating segment focused on developing regenerative medicines to address unmet medical needs. The company’s measure of segment profit or loss is net loss. The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources, and setting incentive targets. Operating expenses are used to monitor budget versus actual results. All material long-lived assets of the Company are located in the United States and Company’s revenues are derived from the United States, the Bahamas and Israel. The total assets of the one reporting segment are disclosed on the condensed balance sheets as of September 30, 2025 and December 31, 2024.

The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reportable segment:

(1)Includes Contract Manufacturing and Clinical Trial revenue

(2)Includes Clinical Development, Research & Discovery, CMC

(3)Includes Executive, Finance, Legal, Business Operations

(4)Includes compensation, benefits and equity-based compensation

(5)Includes depreciation and amortization, (interest income) and other specific charges

13. Subsequent Events

The Company performed a review of events subsequent to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring recognition or disclosure in the financial statements.