Harvard Apparatus Regenerative Technology, Inc.

1. Organization

Overview

Harvard Apparatus Regenerative Technology, Inc. (“Harvard Apparatus Regenerative Technology” or the “Company”) is a biotechnology company with a mission to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The Company believes its technology is likely to be used to treat esophageal cancer, esophageal injuries, and birth defects in the esophagus. The Company believes additional product candidates in our development pipeline* may*treat intestinal cancer and colon cancer. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets.

Consumer Health Products

In thesecond quarter of2023, the Company’s subsidiary in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or Consumer Health Products, started focusing on sales of consumer health products.

Consumer Health Products plans to include a broad range of products focused on personal healthcare including dietary supplements. The Company currently sells dietary supplements through Consumer Health Products. These products are commercially marketed to the general public and initially targeted at consumers in Asia through eCommerce (online sales).

Going Concern

The Company has incurred substantial operating losses since its inception, and as of* March 31, 2025*, had an accumulated deficit of approximately $101.3 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of* March 31, 2025* of approximately $1.7 million will enable it to fund its operating expenses and capital expenditure requirements into thethird quarter of2025. Therefore, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

The Company will need to raise additional capital to fund its current operations. In the event the Company is unable to raise additional capital from outside sources during thesecond quarter of2025, it* may*be forced to curtail or cease its operations.

Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for the Company’s product candidates that are currently under development. The Company is currently seeking and will continue to seek financing from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. The Company* mayalso pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. The Company may**not* be able to obtain additional financing on favorable terms, if at all.

The Company’s operations will be adversely affected if it is unable to raise or obtain needed funding and* maymaterially affect the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the condensed consolidated financial statements donot* include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications of liabilities that* may*result from the outcome of this uncertainty.

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2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

Summary of Significant Accounting Policies

The accounting policies underlying the accompanying condensed consolidated financial statements are those set forth in Note2 to the condensed consolidated financial statements for the year ended* December 31, 2024* included in the Company’s Annual Report on Form10-K filed with the SEC on* March 31, 2025 (the “Form10*-K”).

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology and its subsidiaries; Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), and Harvard Apparatus Regenerative Technology GmbH (Germany). All intercompany balances and transactions have been eliminated in consolidation.

Basis of Presentation

The condensed consolidated financial statements reflect the Company’s financial position, results of operations and comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Form10-K.

Use of Estimates

The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but arenot limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates.

Revenue

We recognize revenue in accordance with Financial Accounting Standards Board (“FASB”) ASC606, Revenue from Contracts with Customers. We offer consumer products primarily through athird-party online store. Revenue is recognized at a point in time when control of the goods is transferred to the customer, which generally occurs upon the delivery to the customer. For any company direct sales to customers, revenue is recognized at a point in time upon shipment of product or hand-delivery to customer. In* October 2024,the Company entered into an exclusive distribution agreement (the “Distribution Agreement”) with Health Regen, Inc., of Pittsfield, MA (“Health Regen”) . Pursuant to the Distribution Agreement the Company granted Health Regen exclusive distribution rights to all of our Consumer Health Products globally. For any sales to distributors, revenue is recognized when control of the goods is transferred to the distributor, which is either upon shipment or upon receipt of finished goods by the distributor, depending on the contract terms. Revenue also excludes any amounts collected on behalf ofthird* parties, including sales and indirect taxes.

We identify a performance obligation as distinct if both the following criteria are true: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments. Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which* mayvary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates. While changes in the allocation of the SSP between performance obligations willnot* affect the amount of total revenue recognized for a particular contract, any material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.

Cost of Sales

Cost of sales primarily consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs. Shipping costs to receive products from our suppliers are recognized as cost of sales when incurred. E-commerce processing and related transaction costs, including those associated with seller transactions, are classified in sales and marketing on our condensed consolidated statements of operations and comprehensive loss.

Research and Development

Research and development costs are expensed as incurred.

Sales and Marketing

Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities. In* October 2024,the Company entered into the Distribution Agreement with Health Regen, pursuant to which the Company granted Health Regen exclusive distribution rights to all of our Consumer Health Products globally. The initial term of the Distribution Agreement is from November 1, 2024through December 31, 2030.*

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General and Administrative

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses; facilities and equipment expenses, such as depreciation and amortization expense and rent; and professional fees.

Segment Information

The Company manages its operations astwo separate operating segments for the purposes of assessing performance and making operating decisions. The Company hasone operating unit focused on the development and commercialization of therapies to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other operating unit is focused on personal healthcare through dietary supplements. We have determined that our chief executive officer is the chief operating decision maker (the “CODM”). The CODM reviews separate discrete financial information presented by operating segment. Resource allocation decisions are made by the CODM based on operating segment cash used in operations, revenues and net income (loss).

Cash Concentrations

The Company maintains its cash balances with a financial institution in federally insured accounts and* mayperiodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company hasnot* experienced any losses to date and believes that it isnot exposed to any significant credit risk on cash.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity ofthree months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds.

Accounts Receivable

Allowances for credit losses are provided for estimated amounts of accounts receivable which* may**not* be collected. At* March 31, 2025* and* December 31, 2024*, we determined thatno allowance for credit losses against accounts receivable was necessary. Standard, butnot all, payment terms are either due in advance or within30 days.

Inventory

Inventory, consisting of products available for sale, are primarily accounted for using thefirst-in,first-out method, and are valued at the lower of cost and net realizable value. This valuation requires us to make judgments, based on currently available information, about the likely method of disposition, such as through sales to individual customers, returns to product vendors, or liquidations, and expected recoverable values of each disposition category.

We maintain ownership of our inventory at thethird-party warehouse, regardless of whether fulfillment is provided by us or thethird-party e-commerce seller, and therefore these products are included in our inventory.

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Long-term Prepaid Contracts

We have contracted with partners relating to our clinical trial activities. Upon execution of the contracts, we made initial payments of $1.2 million as deposits recorded as long-term assets and will be applied against final invoices which are more than a year away. The deposits will be recorded as expense when the clinical trial is substantially completed. Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable based on costs incurred. As of* March 31, 2025,*Our clinical trial partner applied $0.4 million of the $1.2 million deposits against outstanding invoices so $0.8 million is remaining as deposits.

Property, Plant and Equipment

Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.

Deferred Revenue

Deferred revenue represents advance payments received from customers for goods or services to be delivered in future periods. These payments are initially recorded as liabilities and recognized as revenue when the related goods or services are provided. As of* March 31, 2025,the Company had deferred revenue of approximately $299,000, which primarily consists of advance payments for consumer health products. The Company expects to recognize this revenue over the nextthree* months, as the performance obligations are satisfied.

Management regularly reviews the deferred revenue balance to ensure that revenue is recognized in accordance with the Company's revenue recognition policy and applicable accounting standards.

Foreign Currency

Assets and liabilities of non-U.S. operations where the functional currency is other than the U.S. dollar are translated from the functional currency into U.S. dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year. Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss. Transaction gains or losses are recognized in income or loss in the period in which they occur.

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the if-converted method. For purposes of the diluted net loss per share calculation, warrants to purchase the Company’s common stock, par value $0.01 per share ( the “Common Stock”) and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.

Concentration of Credit Risk

Financial investments that potentially subject the Company to credit risk consist of cash. The Company has all cash at accredited financial institutions. Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation up to*$250,000.* The Company doesnot believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Health Regen accounted for 90% and 0% of total product revenue for thethree months ended* March 31, 2025and2024,* respectively. Health Regen is the only customer that accounted for greater than10% of product revenue for thethree months ended* March 31, 2025and the total accounts receivable balance at December 31, 2024.There wasno customer that accounted for greater than10%* of the total accounts receivable at* March 31, 2025or more than10%* in product revenue for thethree months ended* March 31, 2024.*

Unaudited Interim Financial Information

The accompanying interim condensed consolidated balance sheet as of* March 31, 2025*, condensed consolidated interim statements of operations and comprehensive loss and condensed consolidated statements of stockholders’ equity for thethree months ended* March 31, 2025and2024*, and cash flows for thethree months ended* March 31, 2025and2024* are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of* March 31, 2025*, its condensed consolidated results of operations and stockholders’ equity for thethree months ended* March 31, 2025and2024*, and cash flows for thethree months ended* March 31, 2025and2024*. The financial data and other information disclosed in these notes related to thethree months ended* March 31, 2025and2024* are unaudited. The results for thethree months ended* March 31, 2025* arenot necessarily indicative of results to be expected for the year ending* December 31,*2025, any other interim periods or any future year or period.

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Recent Accounting Pronouncements

Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that donot require adoption until a future date arenot expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

In* December 2023,the FASB issued ASU2023*-09, Income Taxes (Topic740*): Improvements to Income Tax Disclosures*. The objective of ASU2023-09 is to enhance disclosures related to income taxes, including specific thresholds for inclusion within the tabular disclosure of income tax rate reconciliation and specified information about income taxes paid. ASU2023-09 is effective for public companies starting in annual periods beginning after* December 15, 2024.The Company is currently evaluating the impact that ASU2023*-09 will have on its condensed consolidated financial statements.

In* November 2024,the FASB issued ASUNo.* 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220*-40): Disaggregation of Income Statement Expenses.* ASU2024-03 improves disclosures about a public business entity’s expenses by requiring disaggregated disclosures of certain types of expenses, including purchases of inventory, employee compensation, depreciation, intangible amortization and depletion, as applicable, for each income statement caption that includes those expenses. In addition, the standard will require entities to define and disclose total selling expenses. The standard is effective for public business entities for annual periods beginning after* December 15, 2026,and interim periods beginning after December 15, 2027.Early adoption is permitted, and entities may*apply the standard prospectively or retrospectively. We are currently evaluating the impact of adopting this standard on our condensed consolidated financial statements and related disclosures.

3. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value that prioritizes the inputs intothree broad levels. Level1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

The Company hadno assets or liabilities classified as Level2 or Level3 as of* March 31, 2025* and* December 31, 2024*. The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. Investment income is included as interest income.

4. Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following:

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5. Capital Stock

Preferred Stock

The Company has authorized a total of 2,000,000 shares of preferred stock, par value $0.01 per share (the “Preferred Stock”), none of which were outstanding at* March 31, 2025* and* December 31, 2024*. The Company’s Board of Directors (the “Board”) has the authority to issue Preferred Stock and to determine the rights, preferences, privileges, and restrictions, including voting rights.

Common Stock

On* August 19, 2024,the Company entered into a securities purchase agreement ( “AugustPurchase Agreement”) with an investor (the “AugustInvestor”) pursuant to which the AugustInvestor agreed to purchase in a private placement an aggregate of 1,388,888 shares of Common Stock for the aggregate purchase price of approximately $5.0 million and a purchase price per share of $3.60 (the “August*Private Placement”).

The* AugustPurchase Agreement required the Company to increase the size of the Board byone* member, to appoint a designee selected by the* August*Investor to the Board, and to take certain actions to ensure that the designee remains on the Board. The Company also agreed to use its reasonable best efforts to obtain approval from its stockholders at the next annual meeting of stockholders to amend the Company’s Amended and Restated Certificate of Incorporation (the “Charter”) to eliminate classification of directors and to amend the Charter and the Company’s Third Amended and Restated Bylaws to permit special stockholder meetings to be called by holders of at least 35% of the Company’s voting power.

On* April 15, 2024,the Company entered into securities purchase agreements (each an “AprilPurchase Agreement,” collectively the “AprilPurchase Agreements”) with certain investors each named therein (the “Investor,” collectively the “Investors”) pursuant to which each of the Investors agreed to purchase in a private placement an aggregate of 367,767 shares of Common Stock for the aggregate gross proceeds of approximately $1.5 million at a purchase price per unit of $4.03 (the“2024* Private Placement”).

Pursuant to the* AprilPurchase Agreements, if the Company closes an equity financing in a registered public offering of its securities on or beforesix* (6) months from the date of the* AprilPurchase Agreements, and the public offering price per share was less than the per share purchase price of the2024* Private Placement, then the Company shall promptly following such closing issue to each Investor additional shares of Common Stock in an amount equal to the difference between (i) the shares issued in the2024 Private Placement, and (ii) result of dividing (a) the subscription amount for each* AprilPurchase Agreement, by (b) the public offering per share. As of October 15, 2024,the Company hadnot* completed an equity financing through a registered public offering of its securities since* April 15, 2024.*

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Warrants

The Company had 898,622 warrants to purchase Common Stock outstanding as of* March 31, 2025* and* December 31, 2024* with a weighted-average exercise price of $5.33.

6. Share-Based Compensation

Harvard Apparatus Regenerative Technology Amended and Restated Equity Incentive Plan

The Company maintains the Amended and Restated Equity Incentive Plan, or the Plan, for the benefit of certain officers, employees, non-employee directors, and other key persons (including consultants and advisory board members). All options and awards granted under the Plan consist of shares of Common Stock. The Company’s policy is to issue stock available from its registered but unissued stock pool through its transfer agent to satisfy stock option exercises and the vesting of restricted stock units. The vesting period for awards is generally four years and the contractual life isten years. Canceled and forfeited options and awards are available to be reissued under the Plan.

As of* March 31, 2025*, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There were 4,626,572 shares available for issuance as of* March 31, 2025*.

The following table summarizes information concerning options outstanding and exercisable:

The Company’s outstanding stock options include 993,835 performance-based awards that have vesting provisions subject to the achievement of certain business milestones. Total unrecognized compensation expense for the performance-based awards is approximately $3.3 million. The Company recognized approximately $0.02 million and $0.04 million in stock-based compensation during thethree months ended* March 31, 2025* and2024, respectively given that some milestone achievements for these awards have been deemed probable for accounting purposes.

Aggregate intrinsic value for outstanding options as of* March 31, 2025* was approximately $0.2 million and calculated as the difference between the Company’s closing stock price of $1.93 per share as of* March 31, 2025* and the weighted average exercise price of $4.54. As of* March 31, 2025*, unrecognized compensation cost related to unvested non-performance-based awards amounted to $1.8 million, which will be recognized over a weighted-average period of 1.2 years.

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The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during thethree months ended* March 31, 2025and2024* were as follows:

The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:

7. Commitments and Contingencies

From time to time, the Company* maybe involved in various claims and legal proceedings arising in the ordinary course of business. There areno* such matters pending that the Company expects to be material in relation to its business, financial condition, results of operations, or cash flows.

On* August 12, 2024,the Company entered into an operating lease agreement for approximately 10,629 square feet of office, research and development and light manufacturing space located in Holliston, MA (the “HQ Lease”). The space will continue to serve as the Company’s corporate headquarters and manufacturing facility. The term of the HQ lease ends on August 31, 2027.*

We currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. We owe advance payments of approximately $130,000 and $31,000, respectively at* March 31, 2025.We plan to make the remaining advance payment by the end of2025.* The universities performed approximately90% of the work to date. Either party can terminate the contract with reasonable notice and any incurred costs will be reimbursed by us to the universities.

In* November 2024,the Company entered into an insurance premium financing and security agreement (the “Financing and Security Agreement”). Under the Financing and Security Agreement, the Company financed $315,008 of certain premiums at an 7.85% annual interest rate. As of March 31, 2025*, the outstanding balance on the Financing and Security Agreement was approximately $158,000 and is included on the balance sheet in insurance premium financing payable. The final payment is due in* August 2025.*

As of* March 31, 2025* and* December, 31, 2024,*we had an outstanding amount of approximately $74,000 and $133,000, respectively, owed to former employees of the Company, which is included in accounts payable.

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8. Leases

The Company leases laboratory and office space and certain equipment with a remaining term of 1 year.

On* August 12, 2024,the Company entered into the HQ Lease, an operating lease agreement for laboratory and office space in Holliston, MA, with an initial three-year term from September 1, 2024through August 31, 2027.The Company accounts for the HQ Lease in accordance with ASC Topic842,* Leases ("ASC842"). We recorded approximately $323,000 as a right-of-use asset and a corresponding operating lease liability on the Company’s condensed consolidated balance sheets upon the accounting commencement date on* September 1, 2024.*The lease liability was measured at the accounting commencement date utilizing a 13.3% discount rate.

The HQ Lease contains escalating payments during the lease term. Upon execution of the HQ Lease, the Company paid a security deposit, which will be held in escrow and credited at the termination of the lease. As of* March 31, 2025*, a security deposit of approximately $14,000 was included in long-term prepaid contracts on the Company’s condensed consolidated balance sheet related to the HQ Lease.

All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets:

The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations and comprehensive loss:

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Cash paid included in the computation of the operating lease assets and lease liability during thethree months ended* March 31, 2025and2024* amounted to approximately $32,000 and $27,000, respectively.

The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:

The minimum lease payments for future years are as follows:

9. Net Loss Per Share

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for thethree months ended* March 31, 2025and2024* because including them would have had an anti-dilutive effect:

10. Income Taxes

The Company didnot record a federal or state income tax provision or benefit for thethree months ended* March 31, 2025and2024*, respectively, due to the expected loss before income taxes to be incurred for the years ended* December 31,*2025 and2024, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.

11. Segments

The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker evaluates the operating results of the Company’s reportable segments based on cash used in operations, revenues and net income (loss).

We follow the accounting guidance of ASC280, Segment Reporting (“ASC280”). Reportable operating segments are determined based on the management approach. The management approach, as defined by ASC280, is based on the way that the chief operating decision maker organizes the segments within an enterprise for making operating decisions and assessing performance. While our results of operations are primarily reviewed on a consolidated basis, the chief operating decision maker manages the enterprise intwo reportable segments, each with different operating and potential revenue generating characteristics.

The Company hastwo operating and reportable segments: i) Regenerative Biotech focused on the development of regenerative medicine treatments with operations currently in the United States and ii) Consumer Health Products relating to consumer health products with operations currently in Asia. All of our revenue was generated in Asia for thethree months ended* March 31, 2025and March 31, 2024.*The following tables represent selected financial information for our segments:

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