What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2026-03-19 compared with 2025-03-31 · 266 added, 132 removed, 749 unchanged (35% of the section changed)

22 unchanged sentences

As a smaller reporting company, we are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002.

As a result, Marcum LLP, our independent registered public accounting firm, has not audited or issued an attestation report with respect to the effectiveness of our internal control over financial reporting as of December 31, 2024.

As a result, CBIZ CPAs P.C., our independent registered public accounting firm, has not audited or issued an attestation report with respect to the effectiveness of our internal control over financial reporting as of December 31, 2025.

Our management, with the participation of the principal executive officer and the principal financial officer, has evaluated whether any change in our internal control over financial reporting occurred during the fourth quarter ended December 31, 2025.

Except as noted above, management concluded that there were no changes in our internal controls over financial reporting during the quarter ended December 31, 2024 that materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

Management concluded that there were no changes in our internal controls over financial reporting during the quarter ended December 31, 2025 that materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

(d) Inherent Limitations on Effectiveness of Controls

20 unchanged sentences

Principal Accounting Fees and Services.

Our independent public accounting firm is Marcum LLP, Boston, Massachusetts, PCAOB Auditor ID 688.

Our independent public accounting firm is CBIZ CPAs P.C., Boston, Massachusetts, PCAOB Auditor ID 199.

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2026 Annual Meeting of Stockholders.

6 unchanged sentences

Index to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm

Reports of Independent Registered Public Accounting Firm s

Consolidated Balance Sheets as of December 31, 2025 and 2024

Consolidated Statements of Operations for the years ended December 31, 2025 and 2024

Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023

Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025 and 2024

Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024

9 unchanged sentences

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

Report of Independent Registered Public Accounting Firm

Reports of Independent Registered Public Accounting Firm s

Consolidated Balance Sheets as of December 31, 2025 and 2024

Consolidated Statements of Operations for the years ended December 31, 2025 and 2024

Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023

Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025 and 2024

Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024

5 unchanged sentences

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Harvard Apparatus Regenerative Technology, Inc.

and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, changes in stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

We have audited the accompanying consolidated balance sheet of Harvard Apparatus Regenerative Technology, Inc.

and Subsidiaries (the “Company”) as of December 31, 2025, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for the year ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

As discussed in Note 11 to the financial statements, the Company adopted ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures (“ASU 2023-09”).

We have also audited the adjustments to the 2024 financial statements to retrospectively adjust the disclosures for the adoption of ASU 2023-09 in 2025.

In our opinion, such retrospective adjustments are appropriate and have been properly applied.

We were not engaged to audit, review, or apply any procedures to the 2024 financial statements of the Company other than with respect to these retrospective adjustments, and accordingly, we do not express an opinion or any other form of assurance on the 2024 financial statements taken as a whole.

Explanatory Paragraph – Going Concern

6 unchanged sentences

These financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audits.

Our responsibility is to express an opinion on the Company’s financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matter

13 unchanged sentences

Our audit procedures related to the expense recognition of share-based awards that contain performance-based vesting provisions included the following, among others, (i) obtaining and analyzing the grant agreements for outstanding share-based awards with performance-based vesting provisions, (ii) recalculated the total outstanding share-based awards with performance-based vesting provisions at year-end based upon cumulative grants, net of cumulative forfeitures, and (iii) discussed with management and evaluated their conclusions reached on the probability of achievement of the business milestones within the performance based awards by assessing the Company’s liquidity requirements needed to fund the achievement of the milestones outlined in the grant agreements and reviewed the Company’s public press releases through the issuance date of these financials.

We have served as the Company’s auditor since 2022.

/s/ CBIZ CPAs P.C.

We have served as the Company’s auditor since 2022 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C.

effective November 1, 2024).

March 19, 2026

(PCAOB ID # 199 )

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and Board of Directors of

Harvard Apparatus Regenerative Technology, Inc.

and Subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of Harvard Apparatus Regenerative Technology, Inc.

and Subsidiaries (the “Company”) as of December 31, 2024, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for the year ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

We were not engaged to audit, review, or apply any procedures to the retrospective adjustments to the disclosures for the adoption of ASU 2023-09 as discussed in Note 11 to the financial statements and, accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are appropriate and have been properly applied.

Those retrospective adjustments were audited by CBIZ CPAs P.C.

Explanatory Paragraph – Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As more fully described in Note 1, the Company has suffered recurring losses from operations, has an accumulated deficit, uses cash flows in its operations, and will require additional financing to continue to fund its operations.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

Management’s plans in regard to these matters are also described in Note 1.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audit.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

Accordingly, we express no such opinion.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audit provides a reasonable basis for our opinion.

/s/ Marcum LLP

We have served as the Company’s auditor from 2022 through 2025.

March 31, 2025

(PCAOB ID # 688)

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

9 unchanged sentences

Right-of-use assets, net

Deferred financing costs

Long-term prepaid contracts

4 unchanged sentences

Accrued and other current liabilities

Deferred revenue

Insurance premium financing payable

Operating lease liability, current

Operating lease liability

Total current liabilities

26 unchanged sentences

Operating loss

Other (expense) income, net:

( 6,915 ) ( 7,726 )

Other income (expense), net:

Interest income

Interest expense

Other expense

Total other (expense) income, net

Preferred stock dividends

Net loss attributable to common stockholders

Basic and diluted net loss per share attributable to common stockholders

Weighted average common shares outstanding, basic and diluted

Comprehensive loss:

Total other income (expense), net

$ ( 6,869 ) $ ( 7,732 )

Foreign currency translation adjustments

Comprehensive loss

Preferred stock dividends

Comprehensive loss attributable to common stockholders

$ ( 6,875 ) $ ( 7,738 )

Net loss per common share, basic and diluted

$ ( 0.42 ) $ ( 0.52 )

Weighted average common shares outstanding, basic and diluted

16,517,126 14,789,332

See accompanying notes to consolidated financial statements.

1 unchanged sentence

AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ’ EQUITY (DEFICIT)

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ’ EQUITY

(In thousands, except share data)

Stockholders’

Comprehensive

Stockholders’

Balance at January 1, 2024

13,947,324 $ 139 $ 93,463 $ ( 91,956 ) $ — $ 1,646

— — — ( 7,732 ) — ( 7,732 )

Share-based compensation

Conversion of preferred stock for common stock

Preferred stock dividends

— — 2,402 — — 2,402

Issuance of common stock

Issuance of common stock from exercise of options

1,756,655 18 6,464 — — 6,482

Issuance of common stock from exercise of warrants

215,000 2 428 — — 430

Other comprehensive loss

— — — — ( 6 ) ( 6 )

Balance at December 31, 2024

15,918,979 $ 159 $ 102,757 $ ( 99,688 ) $ ( 6 ) $ 3,222

— — — ( 6,869 ) — ( 6,869 )

Share-based compensation

— — 2,010 — — 2,010

Issuance of common stock

Issuance of common stock from exercise of warrants

1,661,765 17 2,683 — — 2,700

Other comprehensive loss

— — — — ( 6 ) ( 6 )

Balance at December 31, 2025

17,580,744 $ 176 $ 107,450 $ ( 106,557 ) $ ( 12 ) $ 1,057

See accompanying notes to consolidated financial statements.

5 unchanged sentences

OPERATING ACTIVITIES

$ ( 6,869 ) $ ( 7,732 )

Adjustments to reconcile net loss to net cash used in operating activities:

9 unchanged sentences

Operating lease liability

( 95 ) ( 152 )

Accrued and other current liabilities

Deferred revenue

Insurance premium financing payable

( 299 ) ( 62 )

Net cash used in operating activities

INVESTING ACTIVITIES

Purchases of short-term investments

Redemption of short-term investments

Purchases of property, plant and equipment

Net cash used in investing activities

( 3,828 ) ( 4,852 )

FINANCING ACTIVITIES

2 unchanged sentences

Proceeds from exercise of warrants

Proceeds from exercise of stock options

Payments on convertible debt – related party

1 unchanged sentence

Effect of exchange rate changes on cash

Net increase (decrease) in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

( 1,134 ) 2,054

Cash and cash equivalents at the beginning of the year

Cash and cash equivalents at the end of the year

$ 1,352 $ 2,486

SUPPLEMENTAL INFORMATION

1 unchanged sentence

Supplemental disclosure of non-cash activities:

Preferred stock dividends

Conversion of preferred stock into common stock

Right-of-use asset and lease liability (new lease)

31 unchanged sentences

The consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology, Inc.

(Regenerative Biotech) and its three wholly-owned subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China) and Harvard Apparatus Regenerative Technology GmbH (Germany).

(Regenerative Biotech) and its four 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.

10 unchanged sentences

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.

For any sales to Health Regen, revenue is recognized when goods are made available by the supplier to be transferred.

Revenue also excludes any amounts collected on behalf of third parties, including sales and indirect taxes.

13 unchanged sentences

Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities.

The Company’s subsidiary in Hong Kong, Consumer Health Products, focuses on consumer health products including dietary supplements, which are commercially marketed to the general public and initially targeted at consumers in Asia through eCommerce (online sales).

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.

Health Regen primarily facilitates distribution in coordination with the Company’s Hong Kong subsidiary.

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

16 unchanged sentences

At December 31, 2025 , we determined that no allowance for credit losses against accounts receivable was necessary.

Typical payment terms are either due in advance or within 30 days

Advance payment is required under standard terms.

Accounts receivable from contracts with customers were approximately $ 16,000 and $ 231,000 as of December 31, 2025 and December 31, 2024, respectively, and approximately $ 0 as of January 1, 2024.

These amounts are presented separately on the consolidated balance sheets.

Inventory, consisting of products available for sale, are primarily accounted for using the first -in, first -out method, and are valued at the lower of cost and net realizable value.

1 unchanged sentence

We maintain ownership of our inventory at the third -party warehouse, regardless of whether fulfillment is provided by us or the third -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 in 2023 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 did not complete a registered offering in fiscal year 2024, 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

11 unchanged sentences

Through December 31, 2025 , no such impairment charges have been recorded.

Deferred Revenue

The Company does not recognize contract assets, as revenue is not recognized prior to the satisfaction of performance obligations and the right to consideration is unconditional at the time of invoicing.

Deferred revenue represents advance payments received from our distributor for goods that will be made available to be transferred in future periods.

These payments are initially recorded as liabilities and recognized as revenue when the related goods are provided.

Contract liabilities were approximately $ 252,000 as of December 31, 2025, $ 0 as of December 31, 2024, and $ 0 as of January 1, 2024.

The Company had no deferred revenue during the year ended December 31, 2024, as no advance payments from customers were received during that period.

As of December 31, 2025, deferred revenue primarily consists of advance payments for consumer health products.

The Company expects to recognize this revenue within the next fiscal quarter, 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.

The following table summarizes the Company’s contract balances from contracts with customers as required by ASC 606 - 10 - 50 - 8:

Contract Balances

(in thousands)

Deferred revenue

Share-based Compensation

6 unchanged sentences

When performance-based grants are issued, the Company recognizes no 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.

Share-based compensation expense is based on awards ultimately expected to vest.

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.

18 unchanged sentences

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.

Basic net loss per share is calculated by dividing net loss 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.

Therefore, basic and diluted net loss per share were the same for all periods presented.

Concent ration of Credit Risk

3 unchanged sentences

The Company does not 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 in 2024.

Additionally, the distributor represented 100 % of the total accounts receivable balance.

Health Regen accounted for 96 % and 54 % of total product revenue in 2025 and 2024, respectively.

Additionally, the distributor represented 100 % of the total accounts receivable balance for both years.

Health Regen is the only customer that accounted for greater than 10% of product revenue for the year ended December 31, 2025 and the total accounts receivable balance at December 31, 2025.

There were no such concentrations in revenue for the year ended December 31, 2023 or accounts receivable at December 31, 2023.

Recent Accounting Pronouncements

1 unchanged sentence

Unless otherwise discussed below, we do not 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 will no 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 ASU 2020 - 06 did not have a material impact on its consolidated financial statements.

In November 2023, the FASB issued ASU 2023 - 07, Segment Reporting (Topic 280 ):

Improvements to Reportable Segment Disclosures .

ASU 2023 - 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).

ASU 2023 - 07 will become effective for the Company for the fiscal year ending December 31, 2024, and for interim periods starting in the Company’s first quarter of 2025.

Early adoption is permitted, and guidance is required to be applied retrospectively.

The Company adopted this standard for the year ended December 31, 2024 and the primary impact of which was the additional segment disclosures included in Note 17.

In December 2023, the FASB issued ASU 2023 - 09, Income Taxes (Topic 740 ):

Improvements to Income Tax Disclosures .

The objective of ASU 2023 - 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.

ASU 2023 - 09 is effective for public companies starting in annual periods beginning after December 15, 2024.

The Company is currently evaluating the impact that ASU 2023 - 09 will have on its consolidated financial statements.

In November 2024, the FASB issued ASU No.

2024 - 03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220 - 40 ):

Improvements to Income Tax Disclosures , which focuses on the rate reconciliation and income taxes paid.

2023 - 09 requires a public business entity (PBE) to disclose, on an annual basis, a tabular rate reconciliation using both percentages and currency amounts, broken out into specified categories with certain reconciling items further broken out by nature and jurisdiction to the extent those items exceed a specified threshold.

In addition, all entities are required to disclose income taxes paid, net of refunds received disaggregated by federal, state/local, and foreign and by jurisdiction if the amount is at least 5% of total income tax payments, net of refunds received.

For PBEs, the new standard is effective for annual periods beginning after December 15, 2024, with early adoption permitted.

For entities other than PBEs, the requirements will be effective for annual periods beginning after December 15, 2025.

An entity may apply the amendments in this ASU prospectively by providing the revised disclosures for the period ending December 31, 2025 and continuing to provide the pre-ASU disclosures for the prior periods, or may apply the amendments retrospectively by providing the revised disclosures for all periods presented.

As of December 31, 2025, the Company adopted this new ASU retrospectively and it only impacts the Company's income tax disclosures with no impact to its operations, cash flows, or financial condition.

In November 2024, the FASB issued ASU 2024 - 03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220 - 40 ):

Disaggregation of Income Statement Expenses.

4 unchanged sentences

We are currently evaluating the impact of adopting this standard on our consolidated financial statements and related disclosures.

In July 2025, the FASB issued ASU 2025 - 05, Financial Instruments — Credit Losses (Topic 326 ):

Measurement of Credit Losses for Accounts Receivable and Contract Assets .

This update provides a practical expedient and an accounting policy election for estimating expected credit losses on current accounts receivable and contract assets arising under ASC 606.

The Company plans to elect to apply the practical expedient, which assumes that current conditions as of the balance sheet date remain unchanged for the remaining life of the asset.

Given the immaterial nature of the Company’s accounts receivable and contract assets, the adoption of ASU 2025 - 05 is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.

The amendments are effective for fiscal years beginning after December 15, 2025, with early adoption permitted.

The Company intends to adopt the guidance in the first quarter of fiscal year 2026.

Fair Value Measurements

7 unchanged sentences

The Company had no assets or liabilities classified as Level 2 or Level 3 as of December 31, 2025 and 2024 .

In 2023, 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.

22 unchanged sentences

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 2024 so $ 0.9 million is remaining as deposits at December 31, 2024.

As of December 31, 2025 , the Company’s clinical trial partner applied approximately $ 0.6 million of these deposits against invoices reducing the long-term prepaid contracts balance to $ 0.6 million.

In addition to the clinical trial deposits, the company has $ 0.1 million in other deposits paid to its landlord as a security deposit and to a university for future esophageal implant production.

The other deposits are not expected to be expensed within the next twelve months and are therefore classified as long term.

Accrued and Other Current Liabilities

3 unchanged sentences

Audit services

Other liabilities

Total expenses

7 unchanged sentences

There are no 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, 2024 through 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”).

1 unchanged sentence

The term of the HQ lease ends on August 31, 2027.

As of December 31, 2025 and 2024 , the Company had an outstanding amount of approximately $ 8,942 and $ 133,000 , respectively, owed to former employees of the Company, which is included in accounts payable.

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 of 2025.

The universities started preparatory work in 2023 with substantial work being performed in 2024 and completing in 2025.

Either party can terminate the contract with reasonable notice and any incurred costs will be reimbursed by us to the universities.

As of December 31, 2025, the Company had an outstanding balance of approximately $ 130,000 related to the final phase of the co‑development, which was subsequently paid in January 2026.

In April 2025, the Company entered into a Master Service Agreement with uBriGene (Boston) Biosciences, Inc., a contract development and manufacturing organization, pursuant to which uBriGene will provide development, manufacturing, and related regulatory support services for the Company’s investigational programs.

Services are performed under statements of work and are milestone‑based.

Under the applicable statement of work, contractual milestones include:

(i) execution of the agreement and initiation of technology transfer activities;

(ii) completion of multiple technology transfer production runs and related quality control testing;

(iii) completion of stability testing using materials produced from the technology transfer runs;

(iv) initiation of investigational batch production;

and (v) completion of investigational batch production and associated regulatory support activities.

Fees are payable upon the achievement of these milestones.

The Company may terminate the agreement or any statement of work upon prior written notice.

Upon termination, the Company is not obligated to pay for services not performed prior to the effective date of termination but remains responsible for amounts incurred for services performed and certain non‑cancelable costs.

Payments made in advance of services being rendered are recorded as prepaid expenses and expensed as the related services are performed.

As of December 31, 2025, the Company had no minimum remaining non‑cancelable purchase commitments under this agreement, as all future payments are contingent upon the achievement of development and manufacturing milestones and the Company’s authorization of continued services.

On July 1, 2025, the Company entered into a services agreement with Beijing Quarkmed Technology Co., Ltd.

with a total contract value of approximately $ 206,000 related to regulatory and clinical support activities.

Payments are due on contract signing, three months after signing, and upon a successful regulatory filing.

As of December 31, 2025 , the Company had incurred approximately $ 72,000 , included in research and development expense.

The Company evaluates progress and recognizes expense as services are performed;

amounts paid in advance are recorded as prepaid and expensed upon performance.

If services are not performed, prepaid amounts are subject to the contract’s refund provisions.

In November 2025, the Company entered into an insurance premium financing and security agreement.

2 unchanged sentences

The final payment is due in August 2026.

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.

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

The Company leases laboratory and office space and certain equipment.

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, 2024 through August 31, 2027.

8 unchanged sentences

As of December 31, 2025 , 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 initial two -year term from April 1, 2024 through 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.

28 unchanged sentences

Present value of operating lease liabilities

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

The components of net loss before income tax expense are as follows (in thousands):

Years ended December 31,

Computed “expected” income tax benefit

$ ( 6,868 ) $ ( 7,246 )

State income tax benefit, net of federal income tax benefit

Foreign rate differential

( 1 ) ( 486 )

$ ( 6,869 ) $ ( 7,732 )

The Company recorded no current or deferred income tax expense for the period due to cumulative historical losses and the maintenance of a full valuation allowance against its deferred tax assets.

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

Year Ended December 31,

$ ( 6,869 ) $ ( 7,732 )

Federal Statutory Tax Rate

( 1,442 ) 21 % ( 1,624 ) 21 %

State and Local Income Taxes, net of Federal Income Tax Effect

Foreign Tax Effects:

Changes in valuation allowances

( 36 ) — % 113 ( 1 )%

6 — % ( 18 ) — %

Other foreign jurisdictions

30 ( 1 )% 7 — %

Effect of Changes in Tax Laws or Rates

Effect of Cross-Border Tax Laws:

Net CFC tested income

Tax Credits - Other

( 44 ) 1 % ( 75 ) 1 %

Change in valuation allowance

840 ( 12 )% 1,403 ( 18 )%

Nontaxable or Nondeductible Items:

Stock Compensation

644 ( 9 )% 274 ( 4 )%

Changes in Unrecognized Tax Benefits

Other Adjustments:

Return to Provision - Other

— — % ( 84 ) 1 %

Total income taxes

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

Effective Tax Rate

$ — — % $ — — %

The Company’s effective tax rate differs from the statutory rate primarily due to continued losses and the maintenance of a full valuation allowance on deferred tax assets, resulting in zero income tax expense for the period.

The components of the Company's deferred tax assets and liabilities are as follows (in thousands):

Years ended December 31,

18 unchanged sentences

( 53 ) ( 80 )

Net deferred tax assets (liabilities)

The Company has recorded a valuation allowance against its deferred tax assets for the years ended December 31, 2025 and 2024 , because the Company’s management believes that it is more likely than not that these assets will not be realized.

5 unchanged sentences

The federal and state research and development tax credit carryforwards begin to expire in 2033 and 2029, respectively.

The Company has foreign subsidiaries that are in cumulative loss positions.

Accordingly, no U.S.

federal, state, or applicable foreign income and withholding taxes have been provided on the outside basis differences related to these foreign subsidiary investments as of December 31, 2025 .

To the extent any taxable outside basis differences exist, the Company intends and has the ability to indefinitely reinvest the earnings of its foreign subsidiaries.

Therefore, deferred taxes have not been recorded with respect to these investments.

The Company evaluates its ability and intent to indefinitely reinvest foreign earnings each reporting period.

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.

4 unchanged sentences

The Company has recently completed several equity financings transactions which have either individually or cumulatively resulted in a change in control as defined by Sections 382 and 383 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.

The Company expects the impact of any limitation on the use of its net operating loss or credit carryforwards would not 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, 2025 , the Company generated research credits but has not conducted a study to document the qualified activities.

5 unchanged sentences

Specifically, costs for U.S.-based R&D activities must be amortized over five years and costs for foreign R&D activities must be amortized over 15 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.

The Company has determined that any uncertain tax positions would have no material impact on the consolidated financial statements of the Company and there are no unrecognized tax benefits or related interest and penalties accrued for the period for the years ended December 31, 2024 and 2023 .

For tax years beginning after December 31, 2024, the One Big Beautiful Bill Act enacted a new rule under Section 174A allowing companies to immediately expense any domestic R&D expenditures.

For domestic R&D, companies may either immediately expense or elect to capitalize and amortize over at least 60 months under Section 174A.

However, foreign R&D continues to require capitalization subject to the mandatory 15 -year amortization period under Section 174.

For domestic R&D expenditures that were previously capitalized in tax years 2022 - 2024 under the previous TCJA, companies may elect to recover the remaining unamortized balance by either expensing ( 1 ) fully in the first year beginning after December 31, 2024 or ( 2 ) ratably over two years beginning after December 31, 2024.

The Company has elected to immediately expense any domestic R&D expenditures and will continue amortizing the previously capitalized costs over their remaining life.

The Company is subject to U.S.

2 unchanged sentences

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 are not 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 did not have a material impact on the Company’s income tax provision.

The Company does not pay any income taxes.

Employee Benefit Plan

6 unchanged sentences

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 are no shares of Series E Preferred Stock outstanding.

There were no shares of any of the classes of preferred stock outstanding as of December 31, 2025 .

9 unchanged sentences

2025 Capital Transactions

On December 30, 2025, the Company entered into securities purchase agreements with certain investors each named therein (the “December Investor,” and collectively the “December Investors”) pursuant to which each of the December Investors agreed to purchase in a private placement an aggregate of 411,765 shares of Common Stock for the aggregate gross proceeds of approximately $ 0.7 million at a purchase price per share of $ 1.70 .

On July 11, 2025, the Company entered into securities purchase agreements with certain investors each named therein (the “July Investor,” and collectively the “July Investors”) pursuant to which each of the July Investors agreed to purchase in a private placement an aggregate of 1,250,000 shares of Common Stock for the aggregate gross proceeds of approximately $ 2.0 million at a purchase price per share of $ 1.60 .

2024 Capital Transactions

On August 19, 2024, the Company entered into a securities purchase agreement ( “August Purchase Agreement”) with an investor (the “August Investor”) pursuant to which the August Investor 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”).

2 unchanged sentences

On April 15, 2024, the Company entered into securities purchase agreements (each an “April Purchase Agreement,” collectively the “April Purchase 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, 2023 and 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, 2025 was as follows:

3 unchanged sentences

1,113,622 $ 4.69

Outstanding at December 31, 2023

( 215,000 ) 2.00

Outstanding at December 31, 2024

Outstanding at December 31, 2025

898,622 $ 5.33

There was no warrant activity during the year ended December 31, 2025 .

4 unchanged sentences

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, 2025 .

There are 2,966 shares available for issuance as of December 31, 2024 and December 31, 2023 .

There were 2,966 shares available for issuance as of December 31, 2025 and December 31, 2024 .

There was no ESPP Plan activity in 2025 or 2024 .

14 unchanged sentences

3,977,289 $ 4.64 7.70 $ 5,728

2,130,007 5.81

Outstanding at December 31, 2024

4,385,477 4.54 6.9 1,307

3 unchanged sentences

4,641,685 $ 3.72 6.2 $ 200

Outstanding at December 31, 2024

4,385,477 $ 4.54 6.9 $ 1,307

Options exercisable at December 31, 2025

3 unchanged sentences

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 have not yet been deemed probable for accounting purposes.

Total unrecognized compensation expense for the remaining 923,696 unvested performance-based awards is approximately $ 3.3 million.

The Company recognized approximately $ 0.05 million and $ 0.12 million of share-based compensation for the years ended December 31, 2025 and 2024 , respectively, related to awards for which the achievement of certain performance milestones was deemed probable.

Aggregate intrinsic value for outstanding options for the year ended December 31, 2025 was approximately $ 0.2 million and calculated as the difference between the Company’s closing stock price of $ 1.84 per share as of December 31, 2025 and the weighted average exercise price of $ 3.72 .

28 unchanged sentences

$ ( 6,869 ) $ ( 7,732 )

Preferred stock dividends

Net loss attributable to common stockholders

( 7,732 ) ( 9,022 )

Basic and diluted weighted average common shares outstanding

16,517,126 14,789,332

Basic and diluted net loss per share attributable to common stockholders

Basic and diluted net loss per share

$ ( 0.42 ) $ ( 0.52 )

9 unchanged sentences

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).

The Company’s chief operating decision maker (“CODM”) is its Chief Executive Officer.

The Company’s CODM evaluates the operating results of the Company’s reportable segments based on cash used in operations, revenues and net loss.

We follow the accounting guidance of ASC 280, Segment Reporting (“ASC 280” ).

Reportable operating segments are determined based on the management approach.

The management approach, as defined by ASC 280, 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 in two reportable segments, each with different operating and potential revenue generating characteristics.

The management approach, as defined by ASC 280, is based on the way that the CODM 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 CODM manages the enterprise in two reportable segments, each with different operating and potential revenue generating characteristics.

The Company has two operating and reportable segments:

1 unchanged sentence

All our revenue was generated in Asia.

The following table represents selected financial information for our segments for the years ended December 31, 2024 and 2023 , in thousands:

The following tables present segment revenues, significant expense categories provided to the Company’s CODM at least quarterly, other segment items, and net loss for the years ended December 31, 2025 and 2024 , in thousands:

Year Ended December 31, 2025

Product revenue:

Regenerative Biotech

Consumer Health Products

Regenerative Biotech

Consolidated Total

Product revenue

$ — $ 704 $ 704

Significant Expense Categories (provided to CODM)

Cost of sales

Research and development

2,653 — 2,653

Sales and marketing

General and administrative (a)

4,238 15 4,253

Total significant segment expenses

6,914 705 7,619

Other Segment Items

Other segment items (b)

Segment net loss

$ ( 6,869 ) $ — $ ( 6,869 )

Year Ended December 31, 2024

Regenerative Biotech

Consumer Health Products

Consolidated Total

Product revenue

$ — $ 430 $ 430

Significant Expense Categories (provided to CODM)

Cost of sales

Research and development

2,310 — 2,310

Sales and marketing

General and administrative (a)

4,927 95 5,022

Total significant segment expenses

7,241 915 8,156

Other Segment Items

Other segment items (b)

( 6 ) — ( 6 )

Segment net loss

$ ( 7,247 ) $ ( 485 ) $ ( 7,732 )

The following table presents cash and cash equivalents and total assets by segment as of December 31, 2025 and 2024 , in thousands:

Cash and cash equivalents:

8 unchanged sentences

$ 2,677 $ 4,442

(a) Certain general and administrative costs (including executive compensation, corporate legal fees, audit fees, investor relations, and insurance) are shared across both segments.

For internal reporting purposes, such costs are allocated to each segment based on an estimate of the proportion of management time and corporate resources utilized by each segment.

Costs directly attributable to a segment are charged directly to that segment.

For the years ended December 31, 2025 and 2024 , the Regenerative Biotech segment bore substantially all general and administrative expense, as the Consumer Health Products segment incurred minimal shared corporate overhead.

(b) “Other segment items” for the Regenerative Biotech segment consists primarily of net interest income earned on money market balances and other miscellaneous income, partially offset by interest expense on insurance premium financing.

For the Consumer Health Products segment, other segment items consist of foreign currency transaction effects and other minor income items.

The other segment items line represents the arithmetic difference between segment revenues, less the significant expense categories disclosed above, and the reported segment net loss, in accordance with ASC 280 - 10 - 50 - 26B.

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 were no such events requiring recognition or disclosure in the financial statements.

Subsequent to the balance sheet date, on January 9, 2026, the Company formed a wholly-owned subsidiary, Harvard Apparatus Regenerative Technology Incorporated, a California corporation, in connection with the submission of a grant application to the California Institute for Regenerative Medicine ("CIRM").

Form 10-K Summary.

68 unchanged sentences

and Health Regen, Inc., dated October 31, 2024 (previously filed as an exhibit to the Current Report on Form 8-K, filed on November 6, 2024, and incorporated herein by reference).

Form of Securities Purchase Agreement, dated July 11, 2025 (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 14, 2025, and incorporated herein by reference).

Form of Securities Purchase Agreement, dated December 30, 2025 (previously filed as an exhibit to the Current Report on Form 8-K, filed on January 6, 2026, and incorporated herein by reference)

Letter from Marcum LLP dated April 14, 2025 (previously filed as an exhibit to the Current Report on Form 8-K, filed on April 14, 2025, and incorporated herein by reference).

Insider Trading Policy.

Subsidiaries of Harvard Apparatus Regenerative Technology, Inc.

Consent of CBIZ CPAs P.C.

Consent of Marcum LLP.

55 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures