Longeveron Inc.

Six Month Periods Ended June 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 (the “Corporate Conversion”) from a Delaware limited liability company 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 June 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 six months ended June 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 $10.0 million and $7.5 million for the six months ended June 30, 2025 and 2024, respectively. In addition, as of June 30, 2025, the Company had an accumulated deficit of $119.6 million. The Company expects to continue to generate operating losses for the foreseeable future.

Cash and cash equivalents as of June 30, 2025 were $10.3 million. As a result of the recently completed financing referenced in Note 13, Subsequent Events, the Company currently anticipates its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2026 based on its current operating budget and cash flow forecast. The Company have been and will remain focused on prudent and efficient capital allocation strategies to advance its development programs, which it believes are highly cost efficient, both intrinsically and relative to other development programs. Following a successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, the Company has begun ramping up its biologics license application ("BLA") enabling activities. The Company currently anticipates a potential BLA filing with the FDA in late 2026 if the current ELPIS II trial in HLHS is successful. With the significant opportunity presented with a potential BLA filing, the Company's operating expenses and capital expenditure requirements are currently expected to increase throughout the remainder of calendar 2025 and in 2026 in large part to address CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. The Company intends to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support its operating plans. Additionally, following a positive Type B meeting with the FDA in March 2025 with respect to the Alzheimer's disease regulatory pathway, the Company is focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program. 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 June 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:

Propertyand 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 six months ended June 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 six months ended June 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. 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 two quarters of 2025, the Company derived 100% of its contract manufacturing revenue from a single customer, resulting in a significant concentration of revenue risk. Should this customer terminate their business relationship, the Company’s contract manufacturing revenue could be materially adversely impacted.

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 six months ended June 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 June 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 June 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 June 30, 2025 and 2024, and $0.4 million for each of the six- month periods ended June 30, 2025 and 2024 .

5. Intangible Assets, Net

Major components of intangible assets as of June 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 the three-month periods ended June 30, 2025 and 2024 and $0.3 million and $0.1 million for the six months ended June 30, 2025 and 2024, respectively.

Future amortization expense for intangible assets as of June 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 June 30, 2025, the operating lease asset and lease liability were approximately $0.7 million and $1.1 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 June 30, 2025, are as follows (in thousands):

During each of the three months ended June 30, 2025 and 2024, the Company incurred approximately $0.2 million of total lease costs and for the six month periods ended June 30, 2025 and 2024, the Company incurred approximately $0.3 millionof 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 six months ended June 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 Warrant Issuances

As part of the Company’s initial public offering (“IPO”), the underwriter received warrants to purchase up to 10,640 shares of Class A common stock. The warrants are exercisable at any time and from time to time, in whole or in part, during thefour and a half-year period commencing August 12, 2021, at a price of $120.00 per share and the fair value of warrants was approximately $0.5 million. During 2021, the underwriters assigned 9,576 of the warrants to its employees.

As part of the Company's 2021 private placement offering of 116,935 shares of Class A common stock, the Company issued warrants to investors to purchase up to an aggregate of 116,935 shares of Class A common stock, equal to the number of shares of Class A common stock purchased by such investor in the offering, at an exercise price of $175.00 per share, which were immediately exercisable, were set to expire five years from the date of issuance, and had certain downward pricing adjustment mechanisms, subject to a floor, as set forth in greater detail therein (the "Purchaser Warrants"). In addition, the Company granted the underwriters warrants, under similar terms, to purchase 4,679 shares of Class A common stock, at an exercise price of $175.00 per share. On December 15, 2021, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-261667) registering the resale of an aggregate of 238,549 shares of Class A common stock, including (i)116,935 shares issued to purchasers in the Company’s 2021 private placement offering; (ii) up to 116,935 shares issuable upon exercise of the Purchaser Warrants; and (iii)4,679 shares issuable upon exercise of the underwriters warrants issued as part of the 2021 private placement offering. The Form S-1 was declared effective by the SEC on December 22, 2021.

On August 16, 2023, the Company announced its Stock Rights Offering, which triggered the downward pricing mechanism on the Purchaser Warrants, at which time these warrants were adjusted downward to an exercise price of $52.50 for the period remaining through expiration. This resulted in a deemed dividend to common stockholders of approximately $0.8 million for the change in the fair value of the warrants using a Black-Scholes pricing model.

As part of an October 2023 registered direct offering of 236,500 shares of Class A common stockat a purchase price of $16.50 per share of common stock and pre-funded warrants to purchase up to 5,925 shares of Class A common stock at a purchase price of $16.49 per pre-funded warrant at a nominal exercise price of $0.01 per share, the Company issued Series A warrants and Series B warrants to purchase up to 242,425 and 242,425, respectively, shares of Class A common stock. Each series of warrants had an exercise price of $16.50 per share, with the Series A warrants having a term of five and one-half (5.5) years from the date of issuance, and the Series B warrants having a term of eighteen (18) months from the date of issuance. Both the Series A and Series B warrants became exercisable as of December 26, 2023, following stockholder approval. In addition, the Company granted the placement agent warrants, under similar terms, to purchase 16,971 shares of Class A common stock, at an exercise price of $20.625 per share. On November 15, 2023, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-275578) registering the resale of an aggregate of 501,821 shares of Class A common stock, including (i) up to 242,425 shares of issuable upon exercise of the Series A Warrants; (ii) up to 242,425 shares issuable upon exercise of the Series B Warrants; and (iii)16,971 shares issuable upon exercise of warrants granted to the placement agent as part of the October 2023 registered direct offering. The Form S-1 was declared effective by the SEC on November 21, 2023.

In April 2024, the Series A Warrants and Series B Warrants were amended to reduce the exercise price to $2.35 per share. The Series A Warrants and Series B Warrants were subsequently exercised in full in April 2024.

As part of a December 2023 registered direct offering of an aggregate of 135,531 shares of Class A common stock, the Company issued warrants to purchase an aggregate of 135,531 shares of Class A common stock. These warrants have an exercise price of $16.20 per share, became immediately issuable upon issuance, and expire on June 22, 2029. In addition, the Company granted the placement agent warrants, under similar terms, to purchase 9,489 shares of Class A common stock, at an exercise price of $21.813 per share. On January 29, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-276745) registering the resale of an aggregate of 145,020 shares of Class A common stock, including (i) up to 135,531 shares issuable upon the exercise of warrants issued in a concurrent private placement in connection with the December 2023 registered direct offering and (ii) up to 9,489 shares issuable upon the exercise of warrants granted to the placement agent in connection with the December 2023 registered direct offering. The Form S-1 was subsequently amended by the Company on April 16, 2024 and declared effective by the SEC on April 17, 2024.

On April 8, 2024, the Company commenced a public offering of up to 639,872 shares of the Company’s Class A common stock, along with pre-funded warrants to purchase up to an aggregate 1,572,894 shares of Class A common stock (the “Pre-Funded Warrants”). The shares and Pre-Funded Warrants were sold together with warrants to purchase up to an aggregate of 2,212,766 shares of Common Stock (the “Common Warrants”). The combined public offering price was $2.35 per share and related Common Warrant and $2.349 per Pre-Funded Warrant and related Common Warrant. Subject to certain limitations, the Pre-Funded Warrants were immediately exercisable and could be exercised at a nominal consideration of $0.001 per share of Class A common stock at any time until all the Pre-Funded Warrants were exercised in full. The Common Warrants were immediately exercisable and expire on April 10, 2029.

As compensation to the placement agent the Company also issued to designees of the placement agent warrants to purchase up to 154,894 shares of Class A common stock, which had substantially the same terms as the Common Warrants, and with an exercise price of $2.9375 per share and a term offive years from the commencement of sales in the offering.

In connection with the offering, the Company also entered into an agreement with a holder of existing warrants to (i) amend the holder’s existing Series A warrants and Series B warrants to reduce the exercise price to $2.35 per share and (ii) amend the expiration date of the Series A Warrants to five and one-half (5.5) years following the closing of the public offering and the Series B warrants to eighteen (18) months following the closing of the public offering, in each case for a payment to the Company of $0.125 per amended warrant.

On April 16, 2024, the Company entered into inducement letter agreements with certain holders of its existing Series A warrants and Series B warrants, and Common Warrants issued on April 10, 2024, whereby the holders agreed to exercise the warrants for cash at the exercise price of $2.35 per share in consideration for payment of $0.125 per new warrant and for the Company’s agreement to issue new unregistered Class A common stock warrants to purchase up to 4,799,488 shares of Class A common stock at an exercise price of $2.35 per share, and which were immediately exercisable upon issuance. The warrants to purchase up to 2,399,744 shares of Class A common stock (the “Series C Warrants”) have a term of five (5) years from the issuance date, and the warrants to purchase up to 2,399,744 shares of Class A common stock (the “Series D Warrants”) have a term of twenty-four (24) months from the issuance date, with all of the Series C Warrants and Series D Warrants being immediately exercisable. All Series D Warrants were exercised in June 2024, pursuant to ordinary course exercise as well as a subsequent inducement transaction.

Additionally, the Company issued to the placement agent or its designees as compensation, warrants to purchase up to 167,982 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued upon exercise of the warrants pursuant to the inducement transaction, which had the same terms as the Series C Warrants, except that the placement agent warrants have an exercise price of $3.25 per share.

Furthermore, upon exercise, if any, of the Series D Warrants for cash, the Company agreed to issue the placement agent or its designees, within five (5) business days of the Company’s receipt of the exercise price, warrants to purchase the number of shares of Class A common stock equal to 7.0% of the aggregate number of shares underlying such Series D Warrants that have been exercised, with such warrants to be in the same form and terms as the prior placement agent warrants.

On April 29, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-278995) registering the resale of an aggregate of 4,967,470 shares of Class A common stock issuable upon exercise of certain warrants, including (i) up to 2,399,744 shares issuable upon the exercise of the Series C Warrants issued in the April 2024 warrant inducement transaction; (ii) up to 2,399,744 shares issuable upon the exercise of the Series D Warrants issued in the April 2024 warrant inducement transaction; and (iii) up to 167,982 shares issuable upon exercise of the warrants issued to the placement agent or its designees in the April 2024 warrant inducement transaction. The Form S-1 was subsequently amended by the Company and declared effective by the SEC on May 21, 2024.

On June 17, 2024, the Company entered into additional inducement letter agreements with the holders of its existing Series D Warrants to exercise the remaining 1,697,891 shares of Class A common stock underlying Series D Warrants that remained outstanding for cash at the exercise price of $2.35 per share in consideration for the Company’s agreement to issue new unregistered Class A common stock warrants (the “June Inducement Warrants”), for payment of $0.125 per new warrant, to purchase up to an aggregate of 3,395,782 shares of Class A common stock at an exercise price of $2.50 per share and which were immediately exercisable upon issuance and have a term of twenty-four (24) months from the issuance date.

The Company also issued to the placement agent or its designees as compensation, (i) warrants to purchase up to 118,852 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued upon exercise of the warrants pursuant to the June inducement transaction and (ii) warrants to purchase up to an aggregate of 49,130 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock issued upon exercise of certain Series D warrants prior to the inducement transaction, which had substantially the same terms as the June Inducement Warrants, except that the warrants exercisable for 118,852 shares had an exercise price of $3.25 per share and the warrants exercisable for 49,130 shares had an exercise price of $2.9375 per share, respectively (collectively, the “June placement agent warrants”).

Upon exercise, if any, of the June Inducement Warrants for cash, the Company agreed to issue within five (5) business days to the placement agent or its designees, warrants to purchase the number of shares of Class A common stock equal to 7.0% of the aggregate number of shares of Class A common stock underlying such June Inducement Warrants that have been exercised, with such warrants to be in the same form and terms as the June placement agent warrants.

The issuance under the inducement offers represented $8.5 million in additional value provided to the investors, which was recorded as a deemed dividend to common stockholders. The June Inducement Warrants expire on June 18, 2026.

On June 28, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-280577) registering the resale of an aggregate of 3,563,764 shares of Class A common stock issuable upon exercise of certain warrants, including (i) up to 3,395,782 shares issuable upon the exercise of the June Inducement Warrants and (ii) up to 167,982 shares issuable upon the exercise of the June placement agent warrants. The Form S-1 was subsequently declared effective by the SEC on July 9, 2024.

On July 10, 2024, a holder exercised Series C warrants for 50,000 shares of Class A common stock for cash (the “July Series C warrant exercise”).

On July 10, 2024, certain holders of warrants issued in June of 2024 exercised warrants to purchase an aggregate of 150,000 shares of Class A common stock for cash (the “July 10 warrant exercise”). In addition, on July 17, 2024, the Company issued to the placement agent warrants to purchase up to 10,500 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued in the July 10 warrant exercise (the “first tranche July ordinary course placement agent warrants”). The first tranche July ordinary course placement agent warrants have substantially the same terms as the June placement agent warrants, except that the first tranche July ordinary course placement agent warrants (i) have an exercise price of $3.125 per share and (ii) expire July 17, 2026.

On July 17, 2024, a holder of the June Inducement Warrants exercised the same to purchase 2,319,186 shares of Class A common stock for cash (the “July 17 warrant exercise” and together with the July 10 warrant exercise and the July Series C warrant exercise, collectively, the “July warrant exercises”). Accordingly, on July 24, 2024, the Company issued to the placement agent warrants to purchase up to 162,344 shares of Class A common stock, equal to 7.0% of the aggregate number of shares of Class A common stock issued in the July 17 warrant exercise (the “second tranche July ordinary course placement agent warrants”, and together with the first tranche July ordinary course placement agent warrants, the “July ordinary course placement agent warrants”, and collectively with the July offering placement agent warrants, the “July placement agent warrants”). The second tranche July ordinary course placement agent warrants have substantially the same terms as the first tranche July ordinary course placement agent warrants, except that the second tranche July ordinary course placement agent warrants expire July 24, 2026.

The gross proceeds to the Company from the July warrant exercises, inclusive of the payment consideration for such Series C warrants and June Inducement Warrants, were approximately $6.3 million, inclusive of the payment consideration for such warrants, before deducting placement agent fees payable by the Company.

On July 18, 2024, the Company entered into a securities purchase agreement with institutional and accredited investors relating to the registered direct offering and sale of an aggregate of 2,236,026 shares of our Class A common stock at a purchase price of $4.025 per share of Class A common stock and associated warrant (the “July registered direct offering”).

In a concurrent private placement (the “July private placement” and together with the July registered direct offering, the “July offering”), the Company also sold unregistered Class A common stock warrants to purchase up to an aggregate of 2,236,026 shares of our Class A common stock (the “July private placement warrants”). The unregistered July private placement warrants have an exercise price of $3.90 per share, became exercisable on July 19, 2024, and expire on July 20, 2026. In addition, the Company granted the placement agent warrants, under similar terms, to purchase 156,522 shares of Class A common stock, at an exercise price of $5.0313 (the “July offering placement agent warrants”). The gross proceeds to the Company from the July offering were approximately $9.0 million, before deducting placement agent fees and other offering expenses payable by the Company. On August 6, 2024, the Company filed a registration statement with the SEC on Form S-1 (File No. 333-281299) registering the resale of an aggregate of 2,565,392 shares of Class A common stock issuable upon exercise of certain warrants, of which (i) up to 2,236,026 shares are issuable upon the exercise of the July private placement warrants issued to the purchasers upon the closing of the July private placement; (ii)156,522 shares are issuable upon exercise of the July offering placement agent warrants issued to Wainwright, or its designees, pursuant to the terms of the current engagement Letter with Wainwright; and (iii)172,844 shares are issuable upon exercise of the July ordinary course placement agent warrants issued to Wainwright, or its designees, pursuant to the terms of a then-applicable engagement letter with Wainwright, in connection with previously exercised June Inducement Warrants. The Form S-1 was declared effective by the SEC on August 12, 2024.

In September 2024, the Company entered into additional inducement letter agreements with certain holders of its existing Purchaser Warrants issued as part of the Company’s 2021 private placement offering to amend and reduce the exercise price of the Purchaser Warrants to $1.00 per share in consideration for the holders’ cash exercise of all Purchaser Warrants held by such holder on or before September 27, 2024. In connection with the September 2024 inducement transaction, Purchaser Warrants were exercised for 114,077 shares of Class A common stock, resulting in gross proceeds to the Company of $114,077.

In October 2024, the Company entered into additional inducement letter agreements with the remaining holders of its existing Purchaser Warrants issued as part of the Company’s 2021 private placement offering to amend and reduce the exercise price of the Purchaser Warrants to $1.00 per share in consideration for the holders’ cash exercise of all Purchaser Warrants held by such holder. In connection with the October 2024 inducement transaction, Purchaser Warrants were exercised for 2,858 shares of Class A common stock, resulting in gross proceeds to the Company of $2,858. The Purchaser Warrants have been exercised in full.

Summary of Warrants Outstanding

As of June 30, 2025, warrants exercisable for an aggregate of up to 6,802,668 shares of the Company’s Class A common stock remain outstanding. This includes:

•

IPO underwriter 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.

•

Underwriter warrants issued in connection with the 2021 private placement offering 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.

•

Placement agent warrants issued in connection with the October 2023 registered direct offering 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.

•

Investor warrants issued in connection with the December 2023 registered direct offering 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.

•

Placement agent warrants issued in connection with the December 2023 registered direct offering 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.

•

Common Warrants issued in connection with the April 2024 public offering 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.

•

Placement agent warrants issued in connection with the April 2024 public offering 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.

•

Series C Warrants issued in connection with the April 2024 inducement transaction 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.

•

Placement agent warrants issued in connection with the April 2024 inducement transaction 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.

•

June placement agent warrants issued in the ordinary course prior to the June 2024 inducement transaction 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.

•

June Inducement 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.

•

Placement agent warrants issued in connection with the June 2024 inducement transaction 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.

•

First tranche July ordinary course placement agent 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.

•

Second tranche July ordinary course placement agent 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.

•

July private placement 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.

•

July offering placement agent 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.

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 six months ended June 30, 2025, a total of 352,927 RSUs vested for Class A common stock shares. Of that amount, the Company withheld 136,057 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 six months ended June 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 June 30, 2025, and December 31, 2024, the Company had 704,817 and 806,001, respectively of RSUs outstanding (unvested).

RSU activity for thesix months ended June 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.

As of June 30, 2025, other than two awards, discussed below, granted to the Company's CSO, there have been no stock options granted during 2025 under the 2021 Incentive Plan. The fair value of the options issued to the Company's CSO 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 75.86%; and risk-free interest rate based on the grant date of 4.02%. 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 June 30, 2025 and December 31, 2024, the Company has recorded issued and outstanding options to purchase a total of 375,618 and 121,186 shares of Class A common stock, respectively, pursuant to the 2021 Incentive Plan, at a weighted average exercise price of$5.77 and $15.09 per share, respectively.

For thesix months ended June 30, 2025:

For the year ended December 31, 2024:

Stock option activity for thesix months ended June 30, 2025, was as follows:

For the three months ended June 30, 2025 and 2024, the equity-based compensation expense amounted to approximately $0.5 million and $0.2 million, respectively, and for thesix months ended June 30, 2025 and 2024, the equity-based compensation expense amounted to approximately $0.9 million and $0.5 million, respectively, which is included in the research and development and general and administrative expenses in the condensed statements of operations for thethree and six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, the remaining unrecognized RSUs compensation of approximately $1.2 million will be recognized over approximately 1.65 years. The remaining unrecognized stock options compensation of approximately $0.2 million will be recognized over approximately 1.66 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. 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 the agreement, the Company has agreed to pay the CSO $265,000 annually. The compensation payments are for scientific knowledge, medical research, technical knowledge, skills, and abilities to be provided by the CSO to further develop the intellectual property rights assigned by the CSO to the Company. This agreement required the CSO to also assign to the Company the exclusive right, title, and interest in any work product developed from his efforts during the term of this agreement. On November 16, 2022, the Company accounted for but had not issued 48,140 RSUs convertible to shares of Class A common stock, with an aggregate value of $207,000 as payment for accrued expenses under a consulting agreement with the CSO. These shares were issued on May 24, 2023. The initial term of the agreement ended on November 22, 2024; however, the Company continues to operate under the same terms on a month-to-month basis until a new agreement is executed.

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. The 2024 consulting fees will be paid in the form of 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. As of June 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 and accrued expenses, and less than $0.1 million and $0.1 million, respectively, included in accrued expense and accounts payable 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 received an initial start-up payment of $242,400 upon signing of the Secretome Agreement, which was comprised of (a) technology transfer, documentation preparation, training, and testing costs of $210,000, (b) a ten-hour prepayment of project management fees of $2,400, and (c) a first month suite reservation fee of $30,000. The Company will bill Secretome on a variable fee basis for quality control, in process, release, and stability testing service items. For each Product lot, Secretome will pay the Company $55,000 per lot as well as a $30,000 for each additional Product lot in excess of two initial “training run” lots. Secretome will also pay a $30,000 monthly manufacturing suite reservation fee to the Company as well as a $240 per hour hourly fee for project management services.

Secretome has also agreed to compensate the Company for the value of all materials involved in manufacturing and quality control testing the Product, plus a 20 percent markup on these materials. For any outsourced testing, Secretome will be billed directly by the laboratory conducting the testing, plus a fee of $500 per batch payable to the Company. Furthermore, Secretome will pay the Company $2,000 monthly for storage of in-process samples, vialed harvests for training, and in-process samples for Product lots. The Company will receive certain variable payments related to product packing, handling and shipping, with a standard fee of $750, with an increased fee of $1,500 for expedited or special hour service.

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. In addition, either party may terminate the agreement immediately in the event the other party seeks the protection of any bankruptcy court, becomes insolvent, makes an assignment for the benefit of creditors, or any debarment activity occurs with respect to that party. A force majeure provision also permits termination of the Secretome Agreement upon written notice to the other party as a result of a delay or interference of performance continuing for more than 60 days. The Company is also a party to a Mutual Nondisclosure Agreement with Secretome (the “Nondisclosure Agreement”), by which both parties have agreed to maintain the strict confidentiality of, restrict access to, and not to disclose any intellectual property, trade secrets, business dealings, customers, operations, products, research, clinical data, or other competitively sensitive or proprietary confidential information shared between them, subject to certain customary carve-outs.

For the three and six months ended June 30, 2025, the Company has earned revenues of less than $0.1 million and $0.1 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”), biologics license application (“BLA”), or other marketing or licensing application for the product; and (c) the first sale following product approval. “Approval” refers to product approval, licensure, or other marketing authorization by the U.S. Food and Drug Administration, or any successor agency. The amendments also provided for the Company’s license of additional technology, to the extent not previously included in the UM License and granted the Company an exclusive option to obtain an exclusive license for (a) the HLHS investigational new drug application (“IND”) with ckit+ cells; and (b) UMP-438 titled “Method of Determining Responsiveness to Cell Therapy in Dilated Cardiomyopathy.”The additional technology included a family of patent applications based on PCT Application No. PCT/US2015/060624, for “Materials and Methods for Treating Endothelial Dysfunction and Methods for Monitoring Efficacy of Therapy in a Subject.” Patents have since been granted in that family in South Korea, Brazil, and Europe (with validation in France, Germany, Italy, Spain, Sweden, Switzerland, and the United Kingdom), and applications are pending in Europe and Hong Kong.

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 $480,000 to UM, and as of June 30, 2025 and December 31, 2024, the Company had accrued $25,000 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” and having inventors Joshua Hare and Konstantinos Chatzistergos. 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. Pursuant to the terms of the license agreement, the Company must pay to UM: (a) $5,000 within 30 days of the Effective Date; (b) reimbursement of $21,307 within 90 days of the Effective Date for previously incurred patent expenses; and (c) an annual $10,000 fee which is both creditable against other royalty payments for the applicable license year and is waived so long as the Company is current on annual fee payments in accordance with the Exclusive License Agreement entered into November 20, 2014 between the Company and UM. In addition to certain 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: (d) $150,000 upon completion of the first Phase 3 Clinical Trial; and (e) $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 June 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. The Company recorded the value of the cash consideration and membership units issued to obtain this license agreement as an intangible asset. 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, which amounts are 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 from the 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. The Company is also required to pay an initial fee and, by the first day of each anniversary of the Agreement, starting with the second anniversary, a minimum royalty often thousand dollars. JMHMD also received an equity grant equal toone-half of one percent of the then outstanding units of the Company on a fully-diluted basis. If the Company sublicenses the technology, the Company is also required to pay an amount equal to 10% of the net sales of the sub-licensees.

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 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. Failure to achieve these milestones within five years of the effective date triggers a right of termination by JMHMD. Otherwise, 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. Further, each party has the right to terminate upon sixty days’ prior written notice, or in the event of breach. 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.

On December 23, 2016, as required by the license agreement, the Company paid an initial fee of $250,000 to JMHMD, and issued to it 10,000 Series C Units, valued at $250,000. The $0.5 million of value provided to JMHMD for the license agreement, along with professional fees of approximately $27,000, were recorded as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. Further, expenses related to the furtherance of the CD271+ technology are being capitalized and amortized as incurred over 20 years. There wereno license fees due for June 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 June 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 $0.1 to the Plan during the six months ended June 30, 2025 and 2024, respectively, and $49,600 and $47,000 to the Plan during the three months ended June 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 June 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

On August 8, 2025, the Company commenced a public offering (the “Offering”) of 5,617,648 shares of our Class A common stock and pre-funded warrants to purchase up to an aggregate of 264,706 shares of Class A common stock (the “Pre-Funded Warrants”). The Class A common stock and Pre-Funded Warrants were sold together with Class A common warrants to purchase up to an aggregate of 14,705,885 shares of Class A common stock (the “Common Warrants”). Each share of Class A common stock or Pre-Funded Warrant was sold together withtwo and one-half Common Warrants, each to purchaseone share of our Class A common stock. The combined public Offering price was $0.85 per share of Class A common stock and related Common Warrants and $0.849 per Pre-Funded Warrant and related Common Warrants. Subject to certain limitations, the Pre-Funded Warrants are immediately exercisable and may be exercised at a nominal consideration of $0.001 per share of Class A common stock at any time until all of the Pre-Funded Warrants are exercised in full. The Common Warrants are immediately exercisable at an exercise price of $0.85 per share and expire twenty-four (24) months from the date of issuance.

As compensation to the placement agent in the Offering, the Company also issued to designees of the placement agent warrants to purchase up to 411,765 shares of Class A common stock (the “Placement Agent Warrants”). The Placement Agent Warrants have substantially the same terms as the Common Warrants, except that the Placement Agent Warrants have an exercise price of $1.0625 per share.

The Offering closed on August 11, 2025, and the gross proceeds to the Company were $5.0 million, including the aggregate exercise price of the Pre-Funded Warrants, which were exercised in full concurrently with the closing of the Offering. Net proceeds were$4.5 million after placement agent fees but before other offering expenses payable by the Company.