Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
This Annual Report on Form 10-K includes the certifications of our principal executive officer and principal financial officer required by Rule 13a-14 of the Securities Exchange Act of 1934, as amended, or the Exchange Act. See Exhibits 31.1 and 31.2. This Item 9A includes information concerning the controls and control evaluations referred to in those certifications.
(a) Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosures. Based on the evaluation, our principal executive and principal financial officers concluded that, as of December 31, 2025, our disclosure controls and procedures were effective.
In connection with the preparation of this Annual Report on Form 10-K, our management, under the supervision and with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2025. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and our management necessarily was required to apply its judgment in evaluating and implementing our disclosure controls and procedures. Based upon the evaluation described above, our principal executive officer and principal financial officer have concluded that they believe that our disclosure controls and procedures were effective, as of the end of the period covered by this report, in providing reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.
(b) Management ’ s Annual Report on Internal Control Over Financial Reporting
Our management, under the supervision of the principal executive officer and the principal financial officer, is responsible for establishing and maintaining an adequate system of internal control over financial reporting. Internal control over financial reporting (as defined in Rules 13a-15(f) and 15d(f) under the Exchange Act) is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.
A company’s internal control over financial reporting includes those policies and procedures that: (a) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (b) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with U.S. GAAP; (c) provide reasonable assurance that receipts and expenditures are being made only in accordance with appropriate authorization of management and the Board of Directors; and (d) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the consolidated financial statements.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In connection with the preparation of this Annual Report on Form 10-K, our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025 based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO. As a result of that evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2025.
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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, 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.
(c) Changes in Internal Controls Over Financial Reporting
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. 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
The design of any system of control is based upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated objectives under all future events, no matter how remote, that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may not deteriorate. Because of their inherent limitations, systems of control may not prevent or detect all misstatements. Accordingly, even effective systems of control can provide only reasonable assurance of achieving their control objectives.
Item 9B. Other Information.
None .
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not Applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
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. Information concerning executive officers of our company is included in Part I of this Annual Report on Form 10 K as Item 1. Business - Information about our Executive Officers and incorporated herein by reference.
Item 405 of Regulation S-K calls for disclosure of any known late filing or failure by an insider to file a report required by Section 16 (a) of the Exchange Act. To the extent disclosure for delinquent reports is being made, it can be found under the caption “Delinquent Section 16 (a) Reports” in our definitive Proxy Statement to be filed with the SEC within 120 days after the year covered by this Annual Report on Form 10 -K and is incorporated herein by reference.
We have an insider trading policy that governs the purchase, sale, and other disposition of our securities by our directors, officers, employees and other individuals associated with us, as well as by the Company itself, that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10 -K.
Item 11. Executive Compensation.
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.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
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.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
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.
Item 14. Principal Accounting Fees and Services.
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.
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a)
Documents Filed. The following documents are filed as part of this Annual Report on Form 10-K:
(1) Financial Statements. The consolidated financial statements of Harvard Apparatus Regenerative Technology, Inc. and its subsidiaries filed under this Item 15:
Page
Index to Consolidated Financial Statements
F-1
Reports of Independent Registered Public Accounting Firm s
F-2
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-5
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024
F-6
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025 and 2024
F-7
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
F-8
Notes to Consolidated Financial Statements
F-9
(2) Financial Statement Schedules: None. Financial statement schedules have been omitted since the required information is included in our consolidated financial statements contained elsewhere in this Annual Report on Form 10-K.
(3) Exhibits. The exhibits listed in the accompanying Exhibit Index are filed as a part of this Annual Report on Form 10-K.
(b)
Exhibits: The exhibits listed in the accompanying Exhibit Index are filed as a part of this Annual Report on Form 10-K.
(c)
Separate Financial Statements and Schedules: None. Financial statement schedules have been omitted since the required information is included in our consolidated financial statements contained elsewhere in this Annual Report on Form 10-K.
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
Page
Reports of Independent Registered Public Accounting Firm s
F-2
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-5
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024
F-6
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025 and 2024
F-7
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
F-8
Notes to Consolidated Financial Statements
F-9
F-1
Table of Contents
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, 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
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. 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 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 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 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 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
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Share-Based Compensation – Performance-Based Awards
Description of the Matter
As described in Note 15 to the consolidated financial statements, the Company has 923,696 unvested performance-based options outstanding for which there is unrecognized compensation expense of approximately $3.3 million at December 31, 2025. No expense has been recognized for these unvested awards as of December 31, 2025 given that the milestone achievements for these awards have not yet been deemed probable for accounting purposes. As described in Note 2 to the consolidated financial statements, 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 estimated forfeitures, over the requisite vesting period. 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.
We identified the Company’s expense recognition for share-based awards that contain performance-based vesting provisions as a critical audit matter. The principal considerations for our determination that the expense recognition for share-based awards that contain performance-based vesting provision awards is a critical audit matter are the assumptions and risk of bias related to the conclusion of the probability of achievement of the performance conditions impacting vesting of the awards, or more specifically, the achievement of the business milestones, as defined in the grant agreements. Auditing management’s assumptions regarding the probability of achievement of the business milestones defined in the grant agreements was complex and required a high degree of auditor judgment and increased audit effort.
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How We Addressed the Matter in Our Audit
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.
/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).
Boston, MA
March 19, 2026
(PCAOB ID # 199 )
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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. 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 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 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 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 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.
Boston, MA
March 31, 2025
(PCAOB ID # 688)
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
( In thousands, except share and par value data )
December 31,
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$ 1,352 $ 2,486
Accounts receivable
16 231
Inventory
16 80
Prepaid research and development
18 90
Prepaid expenses and other current assets
427 347
Total current assets
1,829 3,234
Property, plant and equipment, net
6 11
Right-of-use assets, net
195 293
Long-term prepaid contracts
647 904
Total assets
$ 2,677 $ 4,442
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 454 $ 452
Accrued and other current liabilities
532 221
Deferred revenue
252 —
Insurance premium financing payable
183 253
Operating lease liability
113 95
Total current liabilities
1,534 1,021
Operating lease liability, net of current portion
86 199
Total liabilities
1,620 1,220
Commitments and contingencies (Note 9)
Stockholders’ equity:
Common stock, par value $ 0.01 per share, 60,000,000 shares authorized; 17,580,744 and 15,918,979 issued and outstanding at December 31, 2025 and 2024, respectively
176 159
Additional paid-in capital
107,450 102,757
Accumulated deficit
( 106,557 ) ( 99,688 )
Accumulated other comprehensive loss
( 12 ) ( 6 )
Total stockholders’ equity
1,057 3,222
Total liabilities and stockholders’ equity
$ 2,677 $ 4,442
See accompanying notes to consolidated financial statements.
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Year Ended
December 31,
2025
2024
Product revenue
$ 704 $ 430
Operating expenses:
Cost of sales
646 270
Research and development
2,653 2,310
Sales and marketing
67 554
General and administrative
4,253 5,022
Total operating expenses
7,619 8,156
Operating loss
( 6,915 ) ( 7,726 )
Other income (expense), net:
Interest income
37 32
Interest expense
( 8 ) ( 38 )
Other income
17 —
Total other income (expense), net
46 ( 6 )
Net loss
$ ( 6,869 ) $ ( 7,732 )
Foreign currency translation adjustments
( 6 ) ( 6 )
Comprehensive loss
$ ( 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.
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ’ EQUITY
(In thousands, except share data)
Number of
Accumulated
Common
Additional
Other
Total
Shares
Common
Paid-in
Accumulated
Comprehensive
Stockholders’
Outstanding
Stock
Capital
Deficit
Loss
Equity
Balance at January 1, 2024
13,947,324 $ 139 $ 93,463 $ ( 91,956 ) $ — $ 1,646
Net loss
— — — ( 7,732 ) — ( 7,732 )
Share-based compensation
— — 2,402 — — 2,402
Issuance of common stock
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
Net loss
— — — ( 6,869 ) — ( 6,869 )
Share-based compensation
— — 2,010 — — 2,010
Issuance of common stock
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.
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year ended December 31,
2025
2024
OPERATING ACTIVITIES
Net loss
$ ( 6,869 ) $ ( 7,732 )
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense
2,010 2,402
Depreciation
5 14
Amortization of operating lease right-of-use assets
98 153
Changes in operating assets and liabilities:
Accounts receivable
215 ( 227 )
Inventory
64 ( 30 )
Prepaid research and development
72 120
Prepaid expenses and other current assets
149 55
Deferred financing costs
— 544
Long-term prepaid contracts
257 310
Accounts payable
2 7
Operating lease liability
( 95 ) ( 152 )
Accrued and other current liabilities
311 ( 254 )
Deferred revenue
252 —
Insurance premium financing payable
( 299 ) ( 62 )
Net cash used in operating activities
( 3,828 ) ( 4,852 )
FINANCING ACTIVITIES
Proceeds from convertible debt – related party
— 500
Proceeds from issuance of common stock
2,700 6,482
Proceeds from exercise of warrants
— 430
Payments on convertible debt – related party
— ( 500 )
Net cash provided by financing activities
2,700 6,912
Effect of exchange rate changes on cash
( 6 ) ( 6 )
Net (decrease) increase in cash and cash equivalents
( 1,134 ) 2,054
Cash and cash equivalents at the beginning of the year
2,486 432
Cash and cash equivalents at the end of the year
$ 1,352 $ 2,486
SUPPLEMENTAL INFORMATION
Interest paid in cash
$ 9 $ 38
Supplemental disclosure of non-cash activities:
Right-of-use asset and lease liability (new lease)
$ — $ 398
Insurance premium financing
$ 229 $ 315
See accompanying notes to consolidated financial statements.
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Years Ended December 31, 2025 and 2024
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, 2025 had an accumulated deficit of approximately $ 106.6 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of December 31, 2025 of approximately $ 1.4 million will enable it to fund its operating expenses and capital expenditure requirements only into the second quarter of 2026. 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 does not raise additional capital from outside sources before or during the second quarter of 2026, it may be forced to curtail or cease its operations. Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for the Company’s product candidates that are currently under development. The Company is currently seeking and will continue to seek financings from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. The Company may also 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 may materially 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 do not 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 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.
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 are not 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 ASC 606, Revenue from Contracts with Customers . We offer consumer products primarily through a third -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 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.
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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 may vary 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 will not 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.
Sales and Marketing
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.
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 as two separate operating segments for the purposes of assessing performance and making operating decisions. The Company has one 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 of three 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, 2025 , we determined that no allowance for credit losses against accounts receivable was necessary. 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
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. 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 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.
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 improvements
or lease term
Computer equipment and software (in years)
3
Furniture, machinery and equipment (in years)
5 - 7
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Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.
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, 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:
December 31,
Contract Balances
2025
2024
(in thousands)
Deferred revenue
$ 252 $ —
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 are not 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 recognizes no expense until achievement of the performance requirement is deemed probable.
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. 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 than not that some or all of the net deferred tax assets will not 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 positions not 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.
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Foreign Currency
Assets and liabilities of non-U.S. operations where the functional currency is other than the U.S. dollar are translated from the functional currency into U.S. dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year. Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss. Transaction gains or losses are recognized in income or loss in the period in which they occur.
Net Loss per Share
Basic net loss per share is calculated by dividing net loss 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 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 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 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.
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 do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements.
In December 2023, the FASB issued ASU 2023 - 09, Income Taxes (Topic 740 ): Improvements to Income Tax Disclosures , which focuses on the rate reconciliation and income taxes paid. ASU No. 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. ASU 2024 - 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.
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.
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 into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 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. Level 3 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 had no assets or liabilities classified as Level 2 or Level 3 as of December 31, 2025 and 2024 . The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments.
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Investment income is included as interest income.
There were no transfers between Level 1, Level 2 and Level 3 in either of the years ended December 31, 2025 and December 31, 2024 .
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following:
December 31,
2025
2024
(in thousands)
Insurance
$ 191 $ 263
Prepaid contracts
236 84
Total prepaid expenses and other current assets
$ 427 $ 347
5. Property, Plant and Equipment, Net
Property, plant and equipment, net consist of the following:
December 31,
2025
2024
(in thousands)
Leasehold improvements
$ 35 $ 35
Furniture, machinery and equipment
1,414 1,414
Computer equipment and software
38 38
Total property, plant and equipment
1,487 1,487
Less: accumulated depreciation
( 1,481 ) ( 1,476 )
Property, plant and equipment, net
$ 6 $ 11
Depreciation expense amounted to approximately $5 ,000 and $14 ,000 for the years ended December 31, 2025 and 2024 , 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. 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.
7. Accrued and Other Current Liabilities
Accrued and other current liabilities consist of the following:
December 31,
2025
2024
(in thousands)
Advisory costs
$ 96 $ 82
Audit services
73 69
Payroll
363 70
Total expenses
$ 532 $ 221
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 did not 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.
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9. Commitments and Contingencies
From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. 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 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.
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. 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. Under the agreement, the Company financed $ 228,685 of certain premiums at an 7.60 % annual interest rate. As of December 31, 2025, the outstanding balance on the financing and security agreement was $ 183,436 and is included on the balance sheet in insurance premium financing payable. The final payment is due in August 2026.
10. Leases
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. The Company accounts for the HQ Lease under the provisions of ASU No. 2021 - 09, ASU 2018 - 10, and ASC 842. 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 $ 194,922 at D ecember 31, 2025. T he operating lease obligations total ed $ 198,799 at December 31, 2025 of which $ 112,924 is included under current liabilities and $ 85,875 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, 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.
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:
December 31,
Balance Sheet Classification
2025
2024
(in thousands)
Assets:
Operating lease assets
Right-of-use asset, net
$ 195 $ 293
Liabilities:
Current portion of operating lease liabilities
Current portion of operating lease liabilities
113 95
Operating lease liabilities, net of current portion
Operating lease liabilities, net of current portion
86 199
Total operating lease liabilities
$ 199 $ 294
Cash paid for leases during each of the years ended December 31, 2025 and 2024 amounted to approximately $ 129,000 and $ 144,000 , respectively.
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The weighted average remaining lease terms and weighted average discount rates as of December 31, 2025 and 2024 were as follows:
Year ended December 31,
2025
2024
Remaining lease term (in years)
1.67 2.67
Discount rate
13.29 % 13.29 %
The following table summarizes the effect of lease costs in the Company’s consolidated statements of operations:
For the Year Ended December 31,
2025
2024
(in thousands)
Operating lease expense
Research and development
$ 44 $ 67
Sales and marketing
— 24
General and administrative
88 53
Total
$ 132 $ 144
The minimum lease payments for future years are as follows:
As of
December 31, 2025
(in thousands)
2026
$ 133
2027
90
Total lease payments
223
Less: imputed interest
( 24 )
Present value of operating lease liabilities
$ 199
11. Income Taxes
The components of net loss before income tax expense are as follows (in thousands):
Years ended December 31,
2025
2024
Domestic
$ ( 6,868 ) $ ( 7,246 )
Foreign
( 1 ) ( 486 )
Total
$ ( 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.
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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,
Year Ended December 31,
2025
2024
Amount
Percent
Amount
Percent
Pretax Loss
$ ( 6,869 ) $ ( 7,732 )
U.S. Federal Statutory Tax Rate
( 1,442 ) 21 % ( 1,624 ) 21 %
State and Local Income Taxes, net of Federal Income Tax Effect
— — % — — %
Foreign Tax Effects:
China
Changes in valuation allowances
( 36 ) — % 113 ( 1 )%
Other
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:
Tax Credits - Other
( 44 ) 1 % ( 75 ) 1 %
Change in valuation allowance
840 ( 12 )% 1,403 ( 18 )%
Nontaxable or Nondeductible Items:
Other
2 — % 4 — %
Stock Compensation
644 ( 9 )% 274 ( 4 )%
Changes in Unrecognized Tax Benefits
— — % — — %
Other Adjustments:
Return to Provision - Other
— — % ( 84 ) 1 %
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,
2025
2024
(in thousands)
Deferred tax assets:
Net operating loss carryforwards
$ 21,872 $ 20,058
Tax credit carryforwards
2,445 2,387
Capitalized research and development
972 1,553
Stock-based compensation
2,520 2,809
Lease liabilities
54 80
Accruals & Others
96 7
Total deferred tax assets
27,959 26,894
Less: valuation allowance
( 27,906 ) ( 26,814 )
Deferred tax assets
53 80
Deferred tax liability:
Operating lease assets
( 53 ) ( 80 )
Total deferred tax liability
( 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. The valuation allowance increased by approximately $ 1.1 million and $ 1.9 million for the years ended December 31, 2025 and 2024 , respectively, primarily as a result of operating losses generated with no corresponding financial statement benefit.
As of December 31, 2025 , the Company had federal net operating loss carryforwards, or NOLs, of approximately $ 79.6 million to offset future federal taxable income and state NOLs of approximately $ 78.9 million to offset future state taxable income. The federal and state NOLs generated for annual periods prior to January 1, 2018 begin to expire in 2033. The Company’s federal NOL generated for the years ended December 31, 2018 through December 31, 2025 , which amount to $ 53.1 million, can be carried forward indefinitely, however, are limited to be utilized to offset 80% of taxable income in each successive year. As of December 31, 2025 , 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 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.
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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 may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three -year period in excess of 50%, as defined under Sections 382 and 383 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 may further 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 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 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. 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 Section 174 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 over five years and costs for foreign R&D activities must be amortized over 15 years—both using a midyear convention.
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 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 years ended December 31, 2025 and 2024 .
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, 2025 ; currently, no federal or state income tax returns are under examination by the respective taxing authorities.
The Company does not pay any income taxes.
12. Employee Benefit Plan
The Company sponsors a retirement plan for its U.S. employees, which includes an employee savings plan established under Section 401 (k) of the U.S. Internal Revenue Code, or the 401 (k) Plan. The 401 (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 $ 80,000 and $ 78,000 for the years ended December 31, 2025 and 2024 , respectively.
13. Convertible Preferred Stock
There were no shares of any of the classes of preferred stock outstanding as of December 31, 2025 . There were no changes to authorized shares for the years ending December 31, 2024 and 2025 . Authorized shares for each preferred stock class are as follows:
Authorized
Undesignated Preferred Stock
979,000
Series B Convertible Preferred Stock
1,000,000
Series C Convertible Preferred Stock
4,000
Series D Convertible Preferred Stock
12,000
Series E Convertible Preferred Stock
5,000
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14. Common Stock
The Company has 60,000,000 shares authorized as of December 31, 2025 and 36,878,949 shares of common stock available for issuance.
The following represent the Company’s common stock transactions during December 31, 2025 and 2024 :
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”).
The August Purchase Agreement required the Company to increase the size of the Board by one 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 “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”).
Warrants to purchase common stock activity for the year ended December 31, 2025 was as follows:
Weighted-average
Amount
exercise price
Outstanding at January 1, 2024
1,113,622 $ 4.69
Exercised
( 215,000 ) 2.00
Outstanding at December 31, 2024
898,622 5.33
Outstanding at December 31, 2025
898,622 $ 5.33
There was no warrant activity during the year ended December 31, 2025 .
Employee Stock Purchase Plan
The Company maintains the 2013 Employee Stock Purchase Plan, or the ESPP Plan, whereas participating employees can authorize the Company to withhold a portion of their base pay during consecutive six -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 the six -month periods ending June 30 and 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, 2025 . 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 .
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 is ten years. Canceled and forfeited options and awards are available to be reissued under the Plan.
As of December 31, 2025 , the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There are 4,370,364 shares available for issuance under the Plan as of December 31, 2025 .
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Stock option activity under the Plan for the years ended December 31, 2024 and 2025 was as follows:
Weighted-
Weighted-
average
Aggregate
average
contractual
intrinsic value
Amount
exercise price
life (years)
(in thousands)
Outstanding at January 1, 2024
3,977,289 $ 4.64 7.70 $ 5,728
Granted
408,188 5.81
Outstanding at December 31, 2024
4,385,477 4.54 6.9 1,307
Granted
292,489 1.60
Canceled / forfeited
( 36,281 ) 85.80
Outstanding at December 31, 2025
4,641,685 $ 3.72 6.2 $ 200
Options exercisable at December 31, 2025
3,462,114 $ 3.63 6.2 $ 178
Options vested or expected to vest at December 31, 2025
4,620,139 $ 3.71 6.2 $ 200
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 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 . As of December 31, 2025 , unrecognized compensation cost related to unvested non-performance-based awards amounted to $ 0.7 million, which will be recognized over a weighted-average period of 0.7 years.
The weighted average assumptions for valuing the Company’s stock options granted were as follows:
Year Ended December 31,
2025
2024
Risk-free interest rate
3.85 % 4.09 %
Expected volatility
116.11 % 117.23 %
Expected term (in years)
5.2 5.6
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 has not paid and do not 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 $ 1.33 and $ 3.01 per share for the years ended December 31, 2025 and 2024 , 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.
Share-based compensation expense related to the Plan for the years ended December 31, 2025 and 2024 was allocated as follows:
Years Ended December 31,
2025
2024
(in thousands)
Research and development
$ 221 $ 489
Selling, general and administrative
1,789 1,913
Total stock-based compensation
$ 2,010 $ 2,402
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16. Net Loss per Share
Basic and diluted net loss per share was calculated as follows:
Years Ended December 31,
2025
2024
(in thousands, except shares and per share data)
Net loss
$ ( 6,869 ) $ ( 7,732 )
Basic and diluted weighted average common shares outstanding
16,517,126 14,789,332
Basic and diluted net loss per share
$ ( 0.42 ) $ ( 0.52 )
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, 2025 and 2024 because including them would have had an anti-dilutive effect:
Years Ended December 31,
2025
2024
Warrants to purchase common stock
898,622 898,622
Options to purchase common stock
4,641,685 4,385,477
Total
5,540,307 5,284,099
17. Segments and Geographical Information
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 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: 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 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
Regenerative Biotech
Consumer Health Products
Consolidated Total
Revenue
Product revenue
$ — $ 704 $ 704
Significant Expense Categories (provided to CODM)
Cost of sales
— 646 646
Research and development
2,653 — 2,653
Sales and marketing
23 44 67
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)
45 1 46
Segment net loss
$ ( 6,869 ) $ — $ ( 6,869 )
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Year Ended December 31, 2024
Regenerative Biotech
Consumer Health Products
Consolidated Total
Revenue
Product revenue
$ — $ 430 $ 430
Significant Expense Categories (provided to CODM)
Cost of sales
— 270 270
Research and development
2,310 — 2,310
Sales and marketing
4 550 554
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:
December 31,
2025
2024
Cash and cash equivalents:
Regenerative Biotech
$ 1,206 $ 2,405
Consumer Health Products
146 81
Total
$ 1,352 $ 2,486
Total assets:
Regenerative Biotech
$ 2,277 $ 3,978
Consumer Health Products
400 464
Total
$ 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.
18. Subsequent Events
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").
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Item 16. Form 10-K Summary.
None.
EXHIBIT INDEX
The following exhibits are filed as part of this Annual Report on Form 10-K. Where such filing is made by incorporation by reference to a previously filed document, such document is identified.
Exhibit
Number
Description of Exhibit
2.1§
Separation and Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc. dated as of October 31, 2013 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on November 6, 2013, and incorporated by reference thereto).
3.1
Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
3.2
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. dated March 30, 2016 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on March 31, 2016, and incorporated by reference thereto).
3.3
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. dated May 26, 2016 (previously filed as an exhibit to the Company’s Annual Report on Form 10-K, filed on March 17, 2017, and incorporated by reference thereto).
3.4
Certificate of Designations, Preferences and Rights of Series A Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series A Junior Participating Cumulative Preferred Stock (previously filed as an exhibit to the Company’s Registration Statement on Form 8-A, filed October 31, 2013, and incorporated by reference thereto).
3.5
Certificate of Designation of Series B Convertible Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series B Convertible Preferred Stock (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on February 12, 2015, and incorporated by reference thereto).
3.6
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. dated April 26, 2017 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on April 27, 2017, and incorporated by reference thereto).
3.7
Certificate of Designations, Preferences, Rights and Limitations of Series C Convertible Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series C Convertible Preferred Stock (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on August 17, 2017, and incorporated by reference thereto).
3.8
Certificate of Elimination of Series A Junior Participating Cumulative Preferred Stock (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on August 17, 2017, and incorporated by reference thereto).
3.9
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. dated December 22, 2017 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on December 22, 2017, and incorporated by reference thereto).
3.10
Certificate of Designations, Preferences, Rights and Limitations of Series D Convertible Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series D Convertible Preferred Stock (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 3, 2018, and incorporated by reference thereto).
3.11
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc. dated May 24, 2019 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on May 28, 2019, and incorporated by reference thereto).
3.12
Amended and Restated By-laws of the Harvard Apparatus Regenerative Technology, Inc. (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on March 31, 2016, and incorporated by reference thereto).
3.13
Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).
3.14
Third Amended and Restated Bylaws (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).
4.1
Specimen Stock Certificate evidencing shares of common stock (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
4.2
Specimen Series B Convertible Preferred Stock Certificate (previously filed as an exhibit to the Company’s Annual Report on Form 10-K, filed on March 27, 2015, and incorporated by reference thereto).
4.3
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 3, 2018, and incorporated by reference thereto).
4.4
Form of Amendment to Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on December 18, 2019, and incorporated by reference thereto).
4.5
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 2, 2020, and incorporated by reference thereto).
4.6
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on June 22, 2021, and incorporated by reference thereto).
4.7
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on September 8, 2021, and incorporated by reference thereto).
4.8
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on November 30, 2021, and incorporated by reference thereto).
4.9
Description of Securities (previously filed as an exhibit to the Company’s Annual Report on Form 10 K, filed on March 27, 2020, and incorporated by reference thereto).
4.10
Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on May 13, 2022, and incorporated by reference thereto).
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10.1
Sublease by and between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc. dated as of October 31, 2013 (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on November 6, 2013, and incorporated by reference thereto).
10.2
Form of Indemnification Agreement for Officers and Directors (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.3#
Third Amended and Restated Equity Incentive Plan, as amended (previously filed as exhibit to the Company’s Quarterly Report on Form 10-Q, filed on November 13, 2023, and incorporated by reference thereto).
10.4
Employee Stock Purchase Plan (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.5#
Form of Incentive Stock Option Agreement (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.6#
Form of Non-Qualified Stock Option Agreement for executive officers (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.7#
Form of Non-Qualified Stock Option Agreement for directors (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.8#
Form of Deferred Stock Award Agreement (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).
10.9†
Sublicense Agreement dated as of December 7, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc., and related Trademark License Agreement, dated December 19, 2002, by and between Harvard Bioscience, Inc. and President and Fellows of Harvard College (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on March 7, 2023, and incorporated by reference thereto).
10.10#
Offer Letter, dated June 4, 2018, between Harvard Apparatus Regenerative Technology, Inc. and William Fodor, PhD (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on July 10, 2018, and incorporated by reference thereto).
10.11
Form of Securities Purchase Agreement (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on April 6, 2023 and incorporated herein by reference).
10.12#
Employment Agreement, dated August 8, 2022, between Harvard Apparatus Regenerative Technology, Inc. and Joseph L. Damasio, Jr. (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on August 9, 2022 and incorporated by reference thereto).
10.13#
Employment Agreement, effective as of March 1, 2023, by and between Harvard Apparatus Regenerative Technology, Inc. and Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on March 14, 2023, and incorporated herein by reference).
10.14#
Amendment to Employment Agreement, dated as of July 10, 2023, by and between Harvard Apparatus Regenerative Technology, Inc. and Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 10, 2023, and incorporated herein by reference).
10.15
Form of Securities Purchase Agreement (previously filed as an exhibit to the Current Report on Form 8-K, filed on April 17, 2024, and incorporated herein by reference).
10.16
Securities Purchase Agreement (previously filed as an exhibit to the Current Report on Form 8-K, filed on August 21, 2024, and incorporated herein by reference).
10.17
Exclusive Distribution Agreement, between Harvard Apparatus Regenerative Technology, Inc. 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).
10.18
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).
10.19
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)
16.1
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).
19.1*#
Insider Trading Policy.
21.1*
Subsidiaries of Harvard Apparatus Regenerative Technology, Inc.
23.1*
Consent of CBIZ CPAs P.C.
23.2*
Consent of Marcum LLP.
31.1*
Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101)
*
Filed herewith.
**
This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
#
Management contract or compensatory plan or arrangement.
§
The schedules and exhibits to the Separation and Distribution Agreement have been omitted. A copy of any omitted schedule or exhibit will be furnished to the SEC supplementally upon request. The Company will furnish to stockholders a copy of any exhibit without charge upon written request.
†
Certain identified information has been excluded from the exhibit because it is both not material and is of the type that the registrant treats as private or confidential.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Harvard Apparatus Regenerative Technology, Inc.
Date: March 19, 2026
By:
/s/ Junli (Jerry) He
Junli (Jerry) He
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
Signature
Title
Date
/s/ Junli (Jerry) He
Chief Executive Officer, Director, and Chairman
Junli (Jerry) He
(principal executive officer)
March 19, 2026
/s/ Joseph Damasio Jr.
Chief Financial Officer
Joseph Damasio Jr.
(principal financial officer and principal accounting officer)
March 19, 2026
/s/ Jason Jing Chen
Jason Jing Chen
Vice Chairman
March 19, 2026
/s/ David Green
David Green
Director
March 19, 2026
/s/ Ting Li
Ting Li
Director
March 19, 2026
/s/ Ronald Packard
Ronald Packard
Director
March 19, 2026
/s/ Herman Sanchez
Herman Sanchez
Director
March 19, 2026
/s/ James Shmerling
James Shmerling
Director
March 19, 2026
/s/ Mao Zhang
Mao Zhang
Director
March 19, 2026
52