Skip to main content

Harvard Apparatus Regenerative Technology, Inc.

For the period ended Dec 31, 2024. Filed Mar 31, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 31, 2025

HRGNStored price and day change unavailable

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits
Contents

Notes to Consolidated Financial Statements

Years Ended December 31, 2024 and 2023

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 its 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.

On* October 31, 2013,Harvard Bioscience, Inc., or Harvard Bioscience, contributed its regenerative medicine business assets, plus $15 million of cash, into Harvard Apparatus Regenerative Technology, or the Separation. On November 1, 2013,*the spin-off of the Company from Harvard Bioscience was completed. On that date, the Company became an independent company that operates the regenerative medicine business previously owned by Harvard Bioscience. The spin-off was completed through the distribution to Harvard Bioscience stockholders of all the shares of common stock of Harvard Apparatus Regenerative Technology, or the Distribution.

Basis of Presentation

The consolidated financial statements reflect the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States, or U.S. GAAP.

Going Concern

The Company has incurred substantial operating losses since its inception, and as of* December 31, 2024* had an accumulated deficit of approximately $99.7 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of* December 31, 2024* of approximately $2.5 million will enable it to fund its operating expenses and capital expenditure requirements only into thesecond 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 funds to fund its operations. In the event the Company doesnot raise additional capital from outside sources before or during thesecond quarter of2025, it* maybe 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 financings 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 consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the 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.

2. Summary of Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology, Inc. (Regenerative Biotech) and itsthree wholly-owned 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.

Use of Estimates

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

Revenue

We recognize revenue in accordance with 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 with 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 consolidated statements of operations and comprehensive loss.

Research and Development

Research and development costs are expensed as incurred.

F-9

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 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. The initial term of the Distribution Agreement is from November 1, 2024through December 31, 2030.*

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 (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 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* December 31, 2024*, we determined thatno allowance for credit losses against accounts receivable was necessary. Typical 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.

Deferred Financing Costs

We capitalized costs relating to a registered offering that we postponed in2023 but expect to resume in the near future. The costs include payments made to attorneys, accountants, regulators and consultants. We have changed our outlook and didnot complete a registered offering in fiscal year2024, therefore, the deferred financing costs were expensed to general and administrative expenses on the consolidated statements of operations and comprehensive loss for the year ended* December 31, 2024.*

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:

Shorter of expected useful life
Leasehold improvementsor lease term
Computer equipment and software (in years)3
Furniture, machinery and equipment (in years)5 - 7

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

F-10

Impairment of Long-Lived Assets

Assessments of long-lived assets and the remaining useful lives of such long-lived assets are reviewed for impairment whenever a triggering event occurs or changes in circumstances indicate that the carrying amount of the assets* may**not* be recoverable. An asset, or group of assets, are considered to be impaired when the undiscounted estimated net cash flows expected to be generated by the asset, or group of assets, are less than its carrying amount. The impairment recognized is the amount by which the carrying amount exceeds the fair market value of the impaired asset, or group of assets, based on the present value of the expected future cash flows associated with the use of the asset. Through* December 31, 2024*, no such impairment charges have been recorded.

Share-based Compensation

The Company measures all stock options and restricted stock awards granted to employees, directors and non-employees based on the fair value on the date of the grant and recognizes compensation expense of those awards, net of forfeitures, over the requisite vesting period, which is generally the service period of the respective award. Generally, the Company issues stock options and restricted stock awards with only service-based vesting conditions on a straight-line basis over the requisite service period for the entire award (that is, over the requisite service period of the last separately vesting portion of the award). Expense on share-based awards for which vesting is performance or milestone based is recognized on a straight-line basis from the date when it is determined that the achievement of the milestone is probable to the vesting/milestone achievement date.

The Company elected to use the Black-Scholes option-pricing model for the valuation of stock-based payment awards. The determination of the fair value of stock-based payment awards is determined on the date of grant using the Black-Scholes option-pricing model which is affected by the market price as well as assumptions regarding a number of subjective variables. These variables include, but arenot limited to, its expected stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors. When performance-based grants are issued, the Company recognizesno expense until achievement of the performance requirement is deemed probable.

Share-based compensation expense is based on awards ultimately expected to vest and has been reduced for annualized estimated forfeiture where the minimum amount of expense recorded is at least equal to the percent of an award vested. Forfeitures are estimated based on historical experience and weighting of various employee classes under the respective plan at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Until* December 31, 2022,we estimated forfeitures at the time of grant and would revise our estimate, if necessary, in subsequent periods. As of January 1, 2023,*we account for forfeitures as they occur.

The fair value of Restricted Stock Units, or RSUs, is based on the number of shares granted and market price of the stock on the date of grant and is recorded as compensation expense ratably over the applicable service period, which is generally four years. Unvested restricted stock units and vested and unvested stock options are forfeited in the event of termination of employment.

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating losses and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to be applied 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. Deferred tax assets and liabilities are recorded net as long-term on the consolidated balance sheets.

A valuation allowance is recorded when it is more likely thannot that some or all of the net deferred tax assets willnot be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce net deferred tax assets to the amount that is expected to be realized.

Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positionsnot deemed to meet a “more-likely-than-not” threshold would be recorded as a tax expense in the current year.

When necessary, the Company recognizes interest and penalties related to uncertain tax positions in income tax expense.

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.

F-11

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.

Concent**ration 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 (FDIC) 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 54% of total product revenue in2024. Additionally, the distributor represented 100% of the total accounts receivable balance. Health Regen is the only customer that accounted for greater than10% of product revenue for the year ended* December 31, 2024and the total accounts receivable balance at December 31, 2024.There wereno* such concentrations in revenue for the year ended* December 31, 2023or accounts receivable at December 31, 2023.*

F-12

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies we adopt as of the specified effective date. Unless otherwise discussed below, we donot believe that the adoption of recently issued standards have or* may*have a material impact on our consolidated financial statements.

In* August 2020,the FASB issued Accounting Standards Update (ASU)2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt. As a result, after adopting the guidance, entities willno* longer account for beneficial conversion features in equity. The guidance is effective for public business entities, other than small reporting company’s financial statements starting* January 1, 2022,with early adoption permitted. The Company is a small reporting company and adopted the new guidance on January 1, 2024,and the adoption of ASU2020*-06 didnot have a material impact on its consolidated financial statements.

In* November 2023,the FASB issued ASU2023*-07, Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures*. ASU2023-07 requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker(s) that are included within each reported measure of segment profit or loss. The guidance also expands disclosure requirements for interim periods, as well as requires disclosure of other segment items, including the title and position of the entity’s chief operations decision maker(s). ASU2023-07 will become effective for the Company for the fiscal year ending* December 31, 2024,and for interim periods starting in the Company’sfirst* quarter of2025. Early adoption is permitted, and guidance is required to be applied retrospectively. The Company adopted this standard for the year ended* December 31, 2024and the primary impact of which was the additional segment disclosures included in Note17.*

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 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 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. This hierarchy prioritizes the inputs intothree broad levels as follows. 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* December 31, 2024and2023*. In2023, the Company had a certificate of deposit which matured in* October 2023*with the remaining $1.2 million released from short-term investments into cash and cash equivalents. 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.

There wereno transfers between Level1, Level2 and Level3 in either of the years ended* December 31, 2024and December 31, 2023*.

F-13

4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:

December 31,
20242023
(in thousands)
Insurance$263$8
Prepaid contracts8479
Total prepaid expenses and other current assets$347$87

5. Property, Plant and Equipment, Net

Property, plant and equipment, net consist of the following:

December 31,
20242023
(in thousands)
Leasehold improvements$35$35
Furniture, machinery and equipment1,4141,414
Computer equipment and software3838
Total property, plant and equipment1,4871,487
Less: accumulated depreciation(1,476)(1,462)
Property, plant and equipment, net$11$25

Depreciation expense amounted to approximately $14,000 and $35,000 for the years ended* December 31, 2024and2023*, respectively.

6. 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. Our clinical trial partner applied $0.3 million of the $1.2 million deposits against outstanding invoices in* July 2024so $0.9 million is remaining as deposits at December 31, 2024.*

7. Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following:

December 31,
20242023
(in thousands)
Advisory costs$82$325
Audit services6970
Payroll7079
Other liabilities—1
Total expenses$221$475

8. Convertible Debt–** Related Party**

On* February 1, 2024,the Company entered into a loan arrangement with Junli He, the Chairman and Chief Executive Officer of the Company (the “Lender”), pursuant to which the Lender loaned the Company an aggregate amount of $500,000 as evidenced by a Bridge Note executed by the Company in favor of, and accepted by, the Lender (the “Bridge Note”). The Bridge Note accrued interest at an annual fixed rate of 8%. The Company evaluated the convertible note for derivative liability treatment and has determined that the components of the Bridge Note didnot* qualify for derivative accounting treatment. The principal balance and accrued interest of $22,889 on the Bridge Note were settled in full in cash on* August 29, 2024.*

F-14

9. 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* March 25, 2024,the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024through April 10, 2026 (the “Office Lease”). The Company terminated its office lease in Beijing, China at the end of October 2024*without a penalty or any further obligation.

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 $61,000, respectively at* December 31, 2024.We plan to make the remaining advance payment by the end of2025.* The universities started preparatory work in2023 with substantial work being performed in2024 and completing in2025. 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. Under the agreement, the Company financed $315,008 of certain premiums at an 7.85% annual interest rate. As of December 31, 2024,the outstanding balance on the financing and security agreement was $252,613 and is included on the balance sheet in insurance premium financing payable. The final payment is due in August 2025.*

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

10. 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 under the provisions of ASUNo.* 2021-09, ASU2018-10, and 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 right-of-use asset had a balance of $292,856 at December31,* 2024. The operating lease obligations totaled $294,144 at* December 31, 2024*of which $95,345 is included under current liabilities and $198,799 is included under non-current liabilities.

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* December 31, 2024,*a security deposit of approximately $14,000 was included in long-term prepaid contracts on the Company’s consolidated balance sheet related to the HQ Lease.

On* March 25, 2024,the Company entered into an operating lease agreement for office space in Beijing, China with an initialtwo-year term from April 1, 2024through April 10, 2026.We recorded approximately $75,000 as a right-of-use asset and a corresponding operating lease liability on the Company’s consolidated balance sheets upon the accounting commencement date on April 1, 2024.The lease liability was measured at the accounting commencement date utilizing a 8% discount rate. The Company terminated its office lease in Beijing, China at the end of October 2024*without a penalty or any further obligation.

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

F-15

December 31,
Balance Sheet Classification · 2024 · 2023
(in thousands)
Assets:
Operating lease assetsRight-of-use asset, net$293$48
Liabilities:
Current portion of operating lease liabilitiesCurrent portion of operating lease liabilities9548
Operating lease liabilities, net of current portionOperating lease liabilities, net of current portion199—
Total operating lease liabilities$294$48

Cash paid for leases during each of the years ended* December 31, 2024and2023* amounted to approximately $144,000 and $127,000, respectively.

The weighted average remaining lease terms and weighted average discount rates as of* December 31, 2024and2023* were as follows:

Year ended December 31,
20242023
Remaining lease term (in years)2.670.48
Discount rate13.29%14.66%

The following table summarizes the effect of lease costs in the Company’s consolidated statements of operations:

For the Year Ended December 31,
2024 · 2023
(in thousands)
Operating lease expenseResearch and development$67$68
Sales and marketing2415
General and administrative5344
Total$144$127

The minimum lease payments for future years are as follows:

As of
(in thousands)
2025$129
2026133
202790
Total lease payments352
Less: imputed interest(58)
Present value of operating lease liabilities$294

F-16

11. Income Taxes

A reconciliation of taxes utilizing the expected federal tax rate of 21% and the effective tax rate is as follows:

Years ended December 31,
20242023
Computed “expected” income tax benefit21.0%21.0%
State income tax benefit, net of federal income tax benefit5.0%6.3%
Tax credits1.0%0.6%
Foreign rate differential0.2%0.0%
Change in valuation allowance(24.8)%0.0%
Stock Compensation(3.5)%0.0%
Other1.1%(27.9)%
Total income taxes—%—%

The components of the Company’s deferred tax assets and liabilities are as follows:

Years ended December 31,
20242023
(in thousands)
Deferred tax assets:
Net operating loss carryforwards$20,058$18,799
Tax credit carryforwards2,3872,315
Capitalized research and development1,5531,288
Stock-based compensation2,8092,504
Lease liabilities8013
Accruals & Others7—
Total deferred tax assets26,89424,919
Less: valuation allowance(26,814)(24,906)
Deferred tax assets8013
Deferred tax liability:
Operating lease assets(80)(13)
Total deferred tax liability(80)(13)
$—$—

The Company has recorded a valuation allowance against its deferred tax assets for the years ended* December 31, 2024and2023*, because the Company’s management believes that it is more likely thannot that these assets willnot be realized. The valuation allowance increased by approximately $1.9 million and $1.8 million for the years ended* December 31, 2024* and2023, respectively, primarily as a result of operating losses generated withno corresponding financial statement benefit.

As of* December 31, 2024*, the Company had federal net operating loss carryforwards, or NOLs, of approximately $72.9 million to offset future federal taxable income and state NOLs of approximately $72.2 million to offset future state taxable income. The federal and state NOLs generated for annual periods prior to* January 1, 2018begin to expire in2033.* The Company’s federal NOL generated for the years ended* December 31, 2018through December 31, 2024*, which amount to $46.5 million, can be carried forward indefinitely, however, are limited to be utilized to offset80% of taxable income in each successive year. As of* December 31, 2024*, the Company also has federal and state tax research and development credit carryforwards of approximately $1.6 million and $1.0 million, respectively, to offset future income taxes. The federal and state research and development tax credit carryforwards begin to expire in2033 and2029, respectively.

F-17

Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards* maybecome subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over athree*-year period in excess of50%, as defined under Sections382 and383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes* mayfurther affect the limitation in future years. The Company has recently completed several equity financings transactions which have either individually or cumulatively resulted in a change in control as defined by Sections382* and383 of the Internal Revenue Code or could result in a change in control in the future. The Company expects the impact of any limitation on the use of its net operating loss or credit carryforwards will have a material impact on the Company’s consolidated financial statements since the Company has a full valuation allowance against its net deferred tax assets due to the uncertainty regarding future taxable income for the foreseeable future.

For all years through* December 31, 2024*, the Company generated research credits but hasnot conducted a study to document the qualified activities. This study* may*result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known,no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance.

The Tax Cuts and Jobs Act (TCJA) resulted in significant changes to the treatment of research and developmental (R&D) expenditures under Section174 of the IRC. For tax years beginning after* December 31, 2021,taxpayers are required to capitalize and amortize all R&D expenditures that are paid or incurred in connection with their trade or business. Specifically, costs for U.S.-based R&D activities must be amortized overfive* years and costs for foreign R&D activities must be amortized over15 years—both using a midyear convention. As of* December 31, 2024,*the Company capitalized a substantial amount of R&D expenditures primarily related to research and development activities performed in the US.

F-18

The Company has determined that any uncertain tax positions would haveno material impact on the consolidated financial statements of the Company and there areno unrecognized tax benefits or related interest and penalties accrued for the period for the years ended* December 31, 2024and2023*.

The Company is subject to U.S. federal income tax and Massachusetts state income tax. The statute of limitations for assessment by the IRS and state tax authorities is open for all periods from inception through* December 31, 2023*; currently,no federal or state income tax returns are under examination by the respective taxing authorities.

On* March 27, 2020,the Coronavirus Aid, Relief, and Economic Security, or CARES, Act was signed into law making several changes to the Internal Revenue Code. The changes include but arenot* limited to increasing the limitation on the amount of deductible interest expense, allowing companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the CARES Act didnot have a material impact on the Company’s income tax provision.

12. Employee Benefit Plan

The Company sponsors a retirement plan for its U.S. employees, which includes an employee savings plan established under Section401(k) of the U.S. Internal Revenue Code, or the401(k) Plan. The401(k) Plan covers substantially all full-time employees who meet certain eligibility requirements. Contributions to the retirement plan are at the discretion of management. The Company’s matching contributions to the plan were approximately $78,000 and $66,000 for the years ended* December 31, 2024and2023*, respectively.

13. Convertible Preferred Stock

In connection with the private placement, as of* April 12, 2023,*the Company had received $6.0 million in aggregate proceeds in such private placement. The private placement resulted in gross proceeds of at least $4.0 million which triggered the mandatory conversion of all the Company’s outstanding Series E Preferred Stock and related accrued dividends into shares of common stock at a conversion price of $6.00 per share. The conversion resulted in 674,693 shares of common stock being issued to the holder of the Series E Preferred Stock. Following such conversion, there areno shares of Series E Preferred Stock outstanding.

F-19

There wereno shares of any of the classes of preferred stock outstanding as of* December 31, 2024.There wereno* changes to authorized shares for the years ending* December 31, 2023and2024.* Authorized shares for each preferred stock class are as follows:

Authorized
Undesignated Preferred Stock979,000
Series B Convertible Preferred Stock1,000,000
Series C Convertible Preferred Stock4,000
Series D Convertible Preferred Stock12,000
Series E Convertible Preferred Stock5,000

14. Common Stock

The Company has 60,000,000 shares authorized as of* December 31, 2024* and 38,796,922 shares of common stock available for issuance.

The following represent the Company’s common stock transactions during* December 31, 2024and2023*:

2024 Capital Transactions

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”).

2023 Capital Transactions

On* April 12, 2023and on March 31, 2023,*the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and existing investors, the Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 1,000,967 shares of common stock for the aggregate purchase price of approximately $6 million with a purchase price per unit of $6.00.

Warrants to purchase common stock activity for the year ended* December 31, 2024* was as follows:

Weighted-average
Amountexercise price
Outstanding at January 1, 20231,113,622$4.69
Outstanding at December 31, 20231,113,6224.69
Exercised(215,000)2.00
Outstanding at December 31, 2024898,6225.33

There wasno warrant activity during the year ended* December 31, 2023.*

Employee Stock Purchase Plan

The Company maintains the2013 Employee Stock Purchase Plan, or the ESPP Plan, whereas participating employees can authorize the Company to withhold a portion of their base pay during consecutivesix-month payment periods for the purchase of shares of the Company’s common stock. At the conclusion of the period, participating employees can purchase shares of the Company’s common stock at 85% of the lower of the fair market value of the Company’s common stock at the beginning or end of the period. Shares are issued under the plan for thesix-month periods ending* June 30and December 31.Under this plan,7,500 shares of common stock are authorized for issuance of which 4,534 shares have been issued as of December 31, 2024*. There are 2,966 shares available for issuance as of* December 31, 2024and December 31, 2023*. There wasno ESPP Plan activity in2024 or2023.

15. 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 the Company’s 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* December 31, 2024*, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There are 4,629,538 shares available for issuance under the Plan as of* December 31, 2024*.

F-20

Stock option activity under the Plan for the years ended* December 31, 2023* and2024 was as follows:

Weighted-
Weighted- · average · Aggregate
average · contractual · intrinsic value
Amountexercise pricelife (years)(in thousands)
Outstanding at January 1, 20232,516,9243.957.686,917
Granted2,130,0075.81
Exercised(65,264)2.29
Canceled / forfeited(604,378)6.13
Outstanding at December 31, 20233,977,2894.647.75,728
Granted408,1883.55
Outstanding at December 31, 20244,385,477$4.546.9$1,307
Options exercisable at December 31, 20242,907,296$4.596.7$1,135
Options vested or expected to vest at December 31, 20244,362,128$4.546.9$1,307

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 remaining performance-based awards is approximately $3.3 million.No expense has been recognized for these awards as of* December 31, 2024* given that the milestone achievements for these awards havenot yet been deemed probable for accounting purposes.

Aggregate intrinsic value for outstanding options for the year ended* December 31, 2024* was approximately $1.3 million and calculated as the difference between the Company’s closing stock price of $2.98 per share as of* December 31,2024 and the weighted average exercise price of $4.54. As of December 31, 2024*, unrecognized compensation cost related to unvested non-performance-based awards amounted to $2.3 million, which will be recognized over a weighted-average period of 1.4 years.

The weighted average assumptions for valuing the Company’s stock options granted were as follows:

Year Ended December 31,
20242023
Risk-free interest rate4.09%3.82%
Expected volatility117.23%125.35%
Expected term (in years)5.65.8
Expected dividend yield—%—%

The grant date fair value of stock options is estimated using the Black-Scholes option pricing model that takes into account the fair value of its common stock, the exercise price, the expected life of the option, the expected volatility of its common stock, expected dividends on its common stock, and the risk-free interest rate over the expected life of the option. The risk-free interest rate assumption is based upon observed treasury bill interest rates (risk-free) appropriate for the expected term of the Company’s employee stock options. The computation of expected volatility is based on the historical volatility of the Company’s common stock. The simplified method of estimating expected term was used. The Company hasnot paid and donot anticipate paying cash dividends on the Company’s shares of common stock; therefore, the expected dividend yield is assumed to be zero.

The weighted average estimated fair value of stock options granted using the Black-Scholes model was $3.01 and $5.12 per share for the years ended* December 31, 2024and2023*, respectively.

The Company also estimated the fair value of non-employee share options using the Black-Scholes option pricing model reflecting the same assumptions as applied to employee and director options in each of the reporting periods, other than the expected life, which is assumed to be the remaining contractual life of the options.

F-21

Share-based compensation expense related to the Plan for the years ended* December 31, 2024and2023* was allocated as follows:

Years Ended December 31,
20242023
(in thousands)
Research and development$489$327
Selling, general and administrative1,9133,134
Total stock-based compensation$2,402$3,461

16. Net Loss per Share

Basic and diluted net loss per share was calculated as follows:

Years Ended December 31,
20242023
(in thousands, except shares and per share data)
Net loss$(7,732)$(8,945)
Preferred stock dividends—(77)
Net loss attributable to common stockholders(7,732)(9,022)
Basic and diluted weighted average common shares outstanding14,789,33213,455,666
Basic and diluted net loss per share attributable to common stockholders$(0.52)$(0.67)

The Company’s potentially dilutive securities, which include stock options, unvested restricted common stock units and warrants, have been excluded from the computation of diluted net loss per share whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the years ended* December 31, 2024and2023* because including them would have had an anti-dilutive effect:

Years Ended December 31,
20242023
Warrants to purchase common stock898,6221,113,622
Options to purchase common stock4,385,4773,977,289
Total5,284,0995,090,911

17. Segments and Geographical Information

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 our revenue was generated in Asia. The following table represents selected financial information for our segments for the years ended* December 31, 2024* and2023, in thousands:

Year Ended December 31,
20242023
Product revenue:
Regenerative Biotech$—$—
Consumer Health Products430103
Total$430$103
Net loss:
Regenerative Biotech$(7,247)$(8,677)
Consumer Health Products(485)(268)
Total$(7,732)$(8,945)
December 31,
20242023
Cash and cash equivalents:
Regenerative Biotech$2,405$371
Consumer Health Products8161
Total$2,486$432
Total assets:
Regenerative Biotech$3,978$2,426
Consumer Health Products464188
Total$4,442$2,614

18. Subsequent Events

The Company performed a review of events subsequent to the balance sheet through the date the financial statements were issued and determined that there wereno such events requiring recognition or disclosure in the financial statements.

F-22

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.