What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-03-31 compared with 2024-03-28 · 548 added, 868 removed, 333 unchanged (81% of the section changed)

Controls and Procedures.

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.

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.

Evaluation of Disclosure Controls and Procedures

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, 2023, our disclosure controls and procedures were effective.

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, 2023.

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.

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.

Management’s Annual Report on Internal Control Over Financial Reporting

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.

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.

(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.

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.

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, 2023 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, 2023.

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

As a result, Marcum LLP, our independent registered public accounting firm, has not audited or issued an attestation report with respect

to the effectiveness of our internal control over financial reporting as of December 31, 2023.

Changes in Internal Controls Over Financial Reporting

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, 2023.

Except as noted above,

management concluded that there were no changes in our internal controls over financial reporting during the quarter ended December 31,

2023 that materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

Inherent Limitations on Effectiveness of Controls

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.

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.

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, 2024, 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, 2024.

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.

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.

(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, 2024 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, 2024.

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

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

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, 2024.

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

(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.

Other Information.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not Applicable.

Directors, Executive Officers and Corporate Governance.

by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our

2024 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.

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2025 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.

Executive Compensation.

by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our

2024 Annual Meeting of Stockholders.

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2025 Annual Meeting of Stockholders.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our

2024 Annual Meeting of Stockholders.

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2025 Annual Meeting of Stockholders.

Certain Relationships and Related Transactions, and Director Independence.

by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our

2024 Annual Meeting of Stockholders.

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2025 Annual Meeting of Stockholders.

Principal Accounting Fees and Services.

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

by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our

2024 Annual Meeting of Stockholders.

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

Incorporated by reference to our definitive Proxy Statement to be filed pursuant to Regulation 14A under the Exchange Act, in connection with our 2025 Annual Meeting of Stockholders.

Exhibits, Financial Statement Schedules.

Documents Filed.

The following documents are filed as part of this Annual Report on Form 10-K:

1 unchanged sentence

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

and its subsidiaries filed

under this Item 15:

and its subsidiaries filed under this Item 15:

Index to Consolidated Financial Statements

6 unchanged sentences

(2) Financial Statement Schedules:

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.

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.

Financial Statements and Schedules:

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.

TO CONSOLIDATED FINANCIAL STATEMENTS

APPARATUS REGENERATIVE TECHNOLOGY, INC.

Separate Financial Statements and Schedules:

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.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

Report of Independent Registered Public Accounting Firm

4 unchanged sentences

Notes to Consolidated Financial Statements

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Shareholders and Board of Directors of

Apparatus Regenerative Technology, Inc.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and Board of Directors of

Harvard Apparatus Regenerative Technology, Inc.

and Subsidiaries

on the Financial Statements

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

and Subsidiaries (the

“Company”) (formerly known as Biostage, Inc.) as of December 31, 2023 and 2022, the related consolidated statements of

operations, changes in stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2023, 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, 2023 and 2022, and the results of its operations and

its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of

Paragraph – Going Concern

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

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

Opinion on the Financial Statements

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

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

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

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.

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

Our responsibility is to express an opinion on the Company’s

financial statements based on our audits.

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.

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

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

Those standards require that we plan and perform the audits to obtain

reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

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

As part of our audits

we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion

on the effectiveness of the Company’s internal control over financial reporting.

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 audits.

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

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

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

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

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

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

Accordingly, we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error

or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

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

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.

Compensation – Performance-Based Awards

of the Matter

described in Note 14 to the consolidated financial statements, the Company has 773,195 unvested performance-based options outstanding

for which there is unrecognized compensation expense of approximately $2.8 million at December 31, 2023.

No expense has been recognized

for these unvested awards as of December 31, 2023 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.

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.

We Addressed the Matter in Our Audit

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.

have served as the Company’s auditor since 2022.

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

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

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

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

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 14 to the consolidated financial statements, the Company has 939,321 unvested performance-based options outstanding for which there is unrecognized compensation expense of approximately $3.3 million at December 31, 2024.

No expense has been recognized for these unvested awards as of December 31, 2024 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.

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.

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

March 31, 2025

APPARATUS REGENERATIVE TECHNOLOGY, INC.

(PCAOB ID # 688 )

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

BALANCE SHEETS

thousands, except share and par value data )

CONSOLIDATED BALANCE SHEETS

( In thousands, except share and par value data )

Current assets:

Cash and cash equivalents

$ 2,486 $ 432

Accounts receivable

6 unchanged sentences

Long-term prepaid contracts

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

$ 4,442 $ 2,614

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

1 unchanged sentence

Accrued and other current liabilities

Insurance premium financing payable

Operating lease liability, current

3 unchanged sentences

Commitments and contingencies (Note 9)

Series E convertible preferred stock, par value $ 0.01 per share, 5,000 shares authorized;

0 and 4,180 shares issued and outstanding at December 31, 2023 and 2022, respectively

Stockholders’ equity (deficit):

Stockholders’ equity:

Common stock, par value $ 0.01 per share, 60,000,000 shares authorized;

1 unchanged sentence

Additional paid-in capital

102,757 93,463

Accumulated deficit

Total stockholders’ equity (deficit)

Total liabilities and stockholders’ equity (deficit)

accompanying notes to consolidated financial statements.

APPARATUS REGENERATIVE TECHNOLOGY, INC.

( 99,688 ) ( 91,956 )

Accumulated other comprehensive loss

Total stockholders’ equity

Total liabilities and stockholders’ equity

$ 4,442 $ 2,614

See accompanying notes to consolidated financial statements.

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

STATEMENTS OF OPERATIONS

thousands, except share and per share data)

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

Product revenue

6 unchanged sentences

Operating loss

Other income (expense), net:

Sublease income

Change in fair value of warrant liability

Other (expense) income, net:

Interest income

1 unchanged sentence

Other expense

Total other income, net

Total other (expense) income, net

Preferred stock dividends

2 unchanged sentences

Weighted average common shares outstanding, basic and diluted

accompanying notes to consolidated financial statements.

APPARATUS REGENERATIVE TECHNOLOGY, INC.

Comprehensive loss:

Foreign currency translation adjustments

Comprehensive loss

Preferred stock dividends

Comprehensive loss attributable to common stockholders

See accompanying notes to consolidated financial statements.

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

thousands, except share data)

Series E Convertible Preferred Stock

Number of Common Shares Outstanding

Additional Paid-in Capital

Accumulated Deficit

Total Stockholders Equity (Deficit)

Series E Convertible Preferred Stock

Number of Common Shares Outstanding

Additional Paid-in Capital

Accumulated Deficit

Total Stockholders’ Equity (Deficit)

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ’ EQUITY (DEFICIT)

(In thousands, except share data)

Stockholders’

Comprehensive

Balance at January 1, 2023

Share-based compensation

Issuance of series E convertible preferred stock

Preferred stock dividends

Issuance of common stock and warrants to purchase common stock

Issuance of common stock from exercise of warrants

Balance at December 31, 2022

Share-based compensation

Conversion of preferred stock for common stock

3 unchanged sentences

Balance at December 31, 2023

accompanying notes to consolidated financial statements.

APPARATUS REGENERATIVE TECHNOLOGY, INC.

Share-based compensation

Issuance of common stock

Issuance of common stock from exercise of warrants

Other comprehensive loss

Balance at December 31, 2024

See accompanying notes to consolidated financial statements.

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

STATEMENTS OF CASH FLOWS

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

Year ended December 31,

OPERATING ACTIVITIES

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

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

Share-based compensation expense

Amortization of operating right-of-use assets

Change in fair value of warrant liability

Amortization of operating lease right-of-use assets

Changes in operating assets and liabilities:

7 unchanged sentences

Accrued and other current liabilities

Insurance premium financing payable

Net cash used in operating activities

5 unchanged sentences

FINANCING ACTIVITIES

Proceeds from convertible debt – related party

Proceeds from issuance of common stock

Proceeds from exercise of warrants

Proceeds from exercise of stock options

Payments on convertible debt – related party

Net cash provided by financing activities

Net decrease in cash and cash equivalents

Effect of exchange rate changes on cash

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents at the beginning of the year

3 unchanged sentences

Supplemental disclosure of non-cash activities:

Settlement of contingency matter

Settlement of due to Harvard Bioscience included in accrued and other current liabilities

Issuance of Series E convertible preferred stock

Preferred stock dividends

Increase of right-of-use asset and liability due to lease extension

accompanying notes to consolidated financial statements.

APPARATUS REGENERATIVE TECHNOLOGY, INC.

Conversion of preferred stock into common stock

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

Insurance premium financing

See accompanying notes to consolidated financial statements.

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

AND SUBSIDIARIES

TO CONSOLIDATED FINANCIAL STATEMENTS

Ended December 31, 2023 and 2022

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.

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.

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.

of Presentation

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.

Company has incurred substantial operating losses since its inception, and as of December 31, 2023 had an accumulated deficit of

approximately $ 92.0

million and will require additional financing to fund future operations.

The Company expects that its operating cash on-hand as of

December 31, 2023 of approximately $ 0.4

million and debt financing of $ 0.5

million in gross proceeds received subsequent to December 31, 2023 will enable it to fund its operating expenses and capital

expenditure requirements only into the second quarter of 2024.

Therefore, these conditions raise substantial doubt about the

Company’s ability to continue as a going concern.

Company will need to raise additional funds to fund its operations.

In the event the Company does not raise additional capital from outside

sources during the first quarter of 2024, 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.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Years Ended December 31, 2024 and 2023

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.

Going Concern

The Company has incurred substantial operating losses since its inception, and as of December 31, 2024 had an accumulated deficit of approximately $ 99.7 million and will require additional financing to fund future operations.

The Company expects that its operating cash on-hand as of December 31, 2024 of approximately $ 2.5 million will enable it to fund its operating expenses and capital expenditure requirements only into the second quarter of 2025.

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 2025, 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.

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.

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.

Summary of Significant Accounting Policies

of Consolidation

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

(Regenerative Biotech) and its three

wholly-owned subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology

(Hangzhou) Limited (China) and Harvard Apparatus Regenerative Technology GmbH (Germany).

All intercompany balances and transactions

have been eliminated in consolidation.

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, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income

Principles of Consolidation

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

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

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.

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.

Revenue also excludes any amounts collected on behalf of third parties,

including sales and indirect taxes.

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.

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

and Development

and development costs are expensed as incurred.

and Marketing

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

and Administrative

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;

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 distributors, revenue is recognized when control of the goods is transferred to the distributor, which is either upon shipment or upon receipt of finished goods by the distributor, depending on the contract terms.

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

We identify a performance obligation as distinct if both the following criteria are true:

the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.

Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments.

Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which 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.

In October 2024, the Company entered into an exclusive distribution agreement (the “Distribution Agreement”) with Health Regen, Inc., of Pittsfield, MA (“Health Regen”).

Pursuant to the Distribution Agreement the Company granted Health Regen exclusive distribution rights to all of our Consumer Health Products globally.

The initial term of the Distribution Agreement is from November 1, 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

Company manages its operations as two separate operating segments for the purposes of assessing performance and making operating

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 longevity dietary supplements.

We have determined that our chief executive officer is the chief operating

decision maker (CODM).

The CODM reviews financial information presented by operating unit.

Resource allocation decisions are

made by the CODM based on operating unit results.

and Cash Equivalents

Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash

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.

As of December 31, 2023, the Company had

approximately $ 111,000

of cash equivalents in a money market fund.

Accounts Receivable

are provided for estimated amounts of accounts receivable which may not be collected.

December 31, 202 3 ,

we determined that no allowance against accounts receivable was necessary.

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 or net realizable value.

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 inventories.

Allowances for credit losses are provided for estimated amounts of accounts receivable which may not be collected.

At December 31, 2024 , we determined that no allowance for credit losses against accounts receivable was necessary.

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

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.

Deferred Financing Costs

We capitalized costs relating to a

registered offering that we postponed in 2023 but expect to resume in the near future.

The costs include payments made to attorneys,

accountants, regulators and consultants.

Once we complete the registered offering, the deferred financing costs will be reclassified

to stockholders’ equity (deficit) on the consolidated balance sheets to offset the proceeds from the registered offering.

prepaid contracts

have contracted with partners relating to our clinical trial activities.

Upon execution of the contracts, we made initial payments

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

Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable

based on costs incurred.

Plant and Equipment

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

Schedule of Property Plant and Equipment Estimated Useful Lives

Leasehold improvements

We capitalized costs relating to a registered offering that we postponed in 2023 but expect to resume in the near future.

The costs include payments made to attorneys, accountants, regulators and consultants.

We have changed our outlook and did not complete a registered offering in fiscal year 2024, therefore, the deferred financing costs were expensed to general and administrative expenses on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2024.

Property, Plant and Equipment

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

Furniture, machinery and equipment

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

of Long-Lived Assets

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

Computer equipment and software (in years)

Furniture, machinery and equipment (in years)

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, 2024 , no such impairment charges have been recorded.

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.

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.

performance-based grants are issued, the Company recognizes no expense until achievement of the performance requirement is deemed probable.

compensation expense is based on awards ultimately expected to vest and has been reduced for annualized estimated forfeiture where the

minimum amount of expense recorded is at least equal to the percent of an award vested.

Forfeitures are estimated based on historical

experience and weighting of various employee classes under the respective plan at the time of grant and revised, if necessary, in subsequent

periods if actual forfeitures differ from those estimates.

Until December 31, 2022, we estimated forfeitures at the time of grant

and would revise our estimate, if necessary, in subsequent periods.

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).

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 and has been reduced for annualized estimated forfeiture where the minimum amount of expense recorded is at least equal to the percent of an award vested.

Forfeitures are estimated based on historical experience and weighting of various employee classes under the respective plan at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

Until December 31, 2022, we estimated forfeitures at the time of grant and would revise our estimate, if necessary, in subsequent periods.

As of January 1, 2023, we account for forfeitures as they occur.

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.

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

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.

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 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.

Foreign Currency

Assets and liabilities of non-U.S.

operations where

the functional currency is other than the 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 income.

Transaction gains or losses are recognized in income or loss in the period in which

The cumulative translation adjustment for the year ended December 31, 2023 was less than $ 1,000 and therefore not separately

reported on the consolidated financial statements.

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.

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.

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

Loss per Share

net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding

during the period, without consideration for common stock equivalents.

Diluted net loss per share is calculated by adjusting the weighted-average

number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock

For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered

to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive

for all periods presented.

Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods

Company classifies warrants to purchase shares of its common stock as a liability on its consolidated balance sheets when the warrant

is a free-standing financial instrument that may require the Company to transfer cash consideration upon exercise and that cash transfer

event would be out of the Company’s control.

Such a “liability warrant” is initially recorded at fair value on date

of grant using the Black-Scholes model and net of issuance costs, and it is subsequently re-measured to fair value at each subsequent

balance sheet date.

Changes in the fair value of the warrant are recognized as a component of other income (expense), net in the consolidated

statements of operations.

The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise

or expiration of the warrant.

warrants that do not meet the criteria of a liability warrant and are classified on the Company’s consolidated balance sheets as

equity instruments, the Company uses the Black-Scholes model to measure the value of the warrants at issuance and then applies the relative

fair-value of the equity transaction between common stock, preferred stock and warrants.

Common stock and equity-classified warrants

each are considered permanent equity.

Concentration

of Credit Risk

investments that potentially subject the Company to credit risk consist of cash.

dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year.

Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss.

Transaction gains or losses are recognized in income or loss in the period in which they occur.

Net Loss per Share

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents.

Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the if-converted method.

For purposes of the diluted net loss per share calculation, warrants to purchase the Company’s common stock, par value $ 0.01 per share ( the “Common Stock”) and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented.

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

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.

Accounting Pronouncements

time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies we adopt as of the specified effective

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.

June 2016, the FASB issued ASU No.

2016-13, Financial Instruments - Credit Losses (Topic 326):

Measurement of Credit Losses on Financial

Instruments (ASU 2016-12) .

The new standard requires that expected credit losses relating to financial assets measured on an amortized

cost basis and available-for-sale debt securities be recorded through an allowance for credit losses.

It also limits the amount of credit

losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires

the reversal of previously recognized credit losses if fair value increases.

The Company adopted this standard on January 1, 2023, and

the adoption of ASU 2016-13 did not have a material impact on its consolidated financial statements.

The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Health Regen accounted for 54 % of total product revenue in 2024.

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

Health Regen is the only customer that accounted for greater than 10% of product revenue for the year ended December 31, 2024 and the total accounts receivable balance at December 31, 2024.

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

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 August 2020, the FASB issued Accounting Standards Update (ASU) 2020 - 06, Accounting for Convertible Instruments and Contracts in an Entity ’ s Own Equity , as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements.

Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt.

As a result, after adopting the guidance, entities will no longer account for beneficial conversion features in equity.

The guidance is effective for public business entities, other than small reporting company’s financial statements starting January 1, 2022, with early adoption permitted.

The Company is a small reporting company and adopted the new guidance on January 1, 2024, and the adoption of ASU 2020 - 06 did not have a material impact on its consolidated financial statements.

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

Improvements to Reportable Segment Disclosures .

ASU 2023 - 07 requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker(s) that are included within each reported measure of segment profit or loss.

The guidance also expands disclosure requirements for interim periods, as well as requires disclosure of other segment items, including the title and position of the entity’s chief operations decision maker(s).

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

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

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

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

Improvements to Income Tax Disclosures .

The objective of ASU 2023 - 09 is to enhance disclosures related to income taxes, including specific thresholds for inclusion within the tabular disclosure of income tax rate reconciliation and specified information about income taxes paid.

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

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

In November 2024, the FASB issued ASU No.

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

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.

Fair Value Measurements

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.

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

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

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, 2023 and 2022.

In 2023, the Company had a certificate of deposit which matured in October 2023 with the remaining

$ 1.2 million released from short-term investments into cash and cash equivalents.

The carrying value of financial instruments (consisting

of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values

due to the short-term nature of those instruments.

income is included as interest income in the accompanying consolidated statement of operations for the year ended December 31, 2023.

were no transfers between Level 1, Level 2 and Level 3 in either of the years ended December 31, 2023 and December 31, 2022.

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, 2024 and 2023 .

In 2023, the Company had a certificate of deposit which matured in October 2023 with the remaining $ 1.2 million released from short-term investments into cash and cash equivalents.

The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments.

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, 2024 and December 31, 2023 .

Prepaid Expenses and Other Current Assets

expenses and other current assets consist of the following:

of Prepaid expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:

(in thousands)

2 unchanged sentences

Property, Plant and Equipment, Net

plant and equipment, net consist of the following:

of Property Plant and Equipment Net

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

(in thousands)

4 unchanged sentences

accumulated depreciation

( 1,476 ) ( 1,462 )

Property, plant and equipment, net

expense amounted to approximately $ 35,000 and $ 52,000 for the years ended December 31, 2023 and 2022, respectively.

Depreciation expense amounted to approximately $ 14,000 and $ 35,000 for the years ended December 31, 2024 and 2023 , respectively.

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.

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.

We have contracted with partners relating to our clinical trial activities.

Upon execution of the contracts, we made initial payments of $ 1.2 million as deposits recorded as long-term assets and will be applied against final invoices which are more than a year away.

The deposits will be recorded as expense when the clinical trial is substantially completed.

Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable based on costs incurred.

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

Accrued and Other Current Liabilities

and other current liabilities consist of the following:

of Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following:

(in thousands)

3 unchanged sentences

Total expenses

Warrant Liability

2016 and 2017, the Company closed a sale of shares of the Company’s common stock, the issuance of warrants to purchase shares of

common stock, and the issuance of warrants to the placement agent for each transaction.

Due to a cash put provision within the warrant

agreement, which could be enacted in certain change in control events, a liability associated with those 1,044,396 warrants were initially

recorded at fair value and subsequently re-measured each reporting period.

The changes in the fair value between issuance and the end

of each reporting period is recorded as a component of other income (expense), net in the consolidated statements of operations.

2017, the holders of 952,184 warrants agreed to a modification of the term which removed the cash put provision.

The remaining 92,212

warrants continued to be re-measured at each reporting period as long as they were outstanding and un-modified.

In February 2022, the

remaining 92,212 warrants expired unexercised.

following table presents a reconciliation of the Company’s warrant liabilities for the year ended December 31, 2022:

of Warrant Liability

as of January 1, 2022

in fair value upon re-measurement

as of December 31, 2022

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.

Commitments and Contingencies

April 14, 2017, representatives for the estate of an individual plaintiff filed a wrongful death complaint with the Suffolk Superior

Court, in the County of Suffolk, Massachusetts, against the Company and other defendants, including Harvard Bioscience, Inc., or HBIO,

the former parent of the Company that spun off the Company in 2013, as well as another third party.

The complaint sought payment for

an unspecified amount of damages and alleged that the plaintiff sustained terminal injuries allegedly caused by products provided by

certain of the named defendants and utilized in connection with surgeries performed by third parties in Europe in 2012 and 2013.

lawsuit related to the Company’s first-generation trachea scaffold technology for which the Company discontinued development in

2014, and not to the Company’s current HRGN Esophageal Implant.

April 27, 2022, the Company and HBIO executed a settlement with the plaintiffs (the “Settlement”), which resolves all claims

relating to the litigation.

The Settlement resulted in the dismissal with prejudice of the wrongful death claim, and neither the Company

nor HBIO admit any fault or liability in connection with the claim.

The Settlement also resolved any and all claims by and between the

parties and the Company’s product liability insurance carriers, which resulted in the dismissal with prejudice of all claims asserted

by or against those carriers, the Company and HBIO.

relation to the litigation, the Company paid approximately $ 5.9 million of aggregate costs related to the lawsuit.

As of December 31,

2022, all such lawsuit related costs had been paid or otherwise satisfied as provided below.

This aggregate amount included the cost

of legal and related costs incurred by the Company, which consisted of attorneys’ fees and advisor and specialist costs as part

of its defense in this matter.

On March 3, 2022, the Company received a cash payment of approximately $ 0.1 million from Medmarc, the

Company’s insurance carrier.

This amount represented a reimbursement of previously incurred legal costs and was recorded as a reduction

to general and administrative expenses during the year ended December 31, 2022.

respect to such $ 5.9 million of costs described above, the Company was required to either pay such costs directly or indemnify HBIO as

to such amounts it incurs.

Of such amounts, the Company anticipated that HBIO would pay an aggregate amount of $ 4.0 million by the end

of the second quarter of 2022.

With respect to the indemnification obligation of the Company to HBIO pertaining to such costs, the Company

and HBIO entered into a Preferred Issuance Agreement dated as of April 27, 2022 (the PIA).

In connection with the PIA, the Company and

HBIO agreed that once HBIO had paid at least $ 4.0 million in such costs, to satisfy the Company’s indemnification obligations with

respect thereto, in lieu of paying cash, the Company would issue senior 8 % convertible preferred stock to HBIO that will contain terms

as described in the PIA, including the term sheet attached thereto.

On June 10, 2022, following the execution of a subscription agreement

and HBIO providing evidence of payment of the requisite $ 4.0 million amount, the Company issued HBIO 4,000 shares of Series E 8 % Convertible

Preferred Stock at a price of $ 1,000 per share to satisfy the Company’s related indemnification obligations aggregating $ 4.0 million,

which included the accrual for contingency of $ 3.3 million and approximately $ 0.8 million of legal and related costs paid on behalf of

the Company by HBIO previously included in accrued expenses.

time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business.

the above matter, 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.

We currently have a co-development initiative

with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh.

We are required to make advance

payments of approximately $ 130,000 and $ 61,000 , respectively at inception of the contracts.

We plan to make these advance payments in

the second quarter of 2024.

The universities started preparatory work in 2023 with substantial work to be done in 2024.

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

Company leases laboratory and office space and certain equipment with remaining terms ranging from 1 year to 3 years.

laboratory and office space arrangement is under a sublease that was renewed in December of 2022 and currently extends through May 31,

This lease automatically renews annually for one-year periods unless the Company or the counterparty provides a notice of termination

within one hundred and eighty days prior to May 31st of each year.

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:

Schedule of Operating Leases in Consolidated Balance Sheets

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 March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026 ( the “Office Lease”).

The Company terminated its office lease in Beijing, China at the end of October 2024 without a penalty or any further obligation.

On August 12, 2024, the Company entered into an operating lease agreement for approximately 10,629 square feet of office, research and development and light manufacturing space located in Holliston, MA (the “HQ Lease”).

The space will continue to serve as the Company’s corporate headquarters and manufacturing facility.

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

We currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh.

We owe advance payments of approximately $ 130,000 and $ 61,000 , respectively at December 31, 2024.

We plan to make the remaining advance payment by the end of 2025.

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

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

In November 2024, the Company entered into an insurance premium financing and security agreement.

Under the agreement, the Company financed $ 315,008 of certain premiums at an 7.85 % annual interest rate.

As of December 31, 2024, the outstanding balance on the financing and security agreement was $ 252,613 and is included on the balance sheet in insurance premium financing payable.

The final payment is due in August 2025.

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

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

On August 12, 2024, the Company entered into the HQ Lease, an operating lease agreement for laboratory and office space in Holliston, MA, with an initial three -year term from September 1, 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 $ 292,856 at D ecember 31, 2024.

T he operating lease obligations total ed $ 294,144 at December 31, 2024 of which $ 95,345 is included under current liabilities and $ 198,799 is included under non-current liabilities.

The HQ Lease contains escalating payments during the lease term.

Upon execution of the HQ Lease, the Company paid a security deposit, which will be held in escrow and credited at the termination of the lease.

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

On March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China with an initial two -year term from April 1, 2024 through April 10, 2026.

We recorded approximately $ 75,000 as a right-of-use asset and a corresponding operating lease liability on the Company’s consolidated balance sheets upon the accounting commencement date on April 1, 2024.

The lease liability was measured at the accounting commencement date utilizing a 8 % discount rate.

The Company terminated its office lease in Beijing, China at the end of October 2024 without a penalty or any further obligation.

All of the Company’s leases qualify as operating leases.

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

Balance Sheet Classification

7 unchanged sentences

Total operating lease liabilities

paid for leases during each

of the years ended December 31, 2023 and 2022 amounted to approximately $ 127,000 and $ 121,000 , respectively.

weighted average remaining lease terms and weighted average discount rates as of December 31, 2023 and 2022 were as follows:

of Weighted Average Lease Term and Discount Rates

Cash paid for leases during each of the years ended December 31, 2024 and 2023 amounted to approximately $ 144,000 and $ 127,000 , respectively.

The weighted average remaining lease terms and weighted average discount rates as of December 31, 2024 and 2023 were as follows:

Year ended December 31,

1 unchanged sentence

Discount rate

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

of Operating Lease Expense Categories in Consolidated Statements of Operations

13.29 % 14.66 %

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

For the Year Ended December 31,

4 unchanged sentences

General and administrative

minimum lease payments for the next year is as follows:

of Minimum Lease Payments

The minimum lease payments for future years are as follows:

December 31, 2024

3 unchanged sentences

Present value of operating lease liabilities

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

Schedule of Effective Income Tax

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

Years ended December 31,

Computed “expected” income tax benefit

21.0 % 21.0 %

State income tax benefit, net of federal income tax benefit

Foreign rate differential

Change in valuation allowance

( 24.8 )% 0.0 %

Stock Compensation

( 3.5 )% 0.0 %

1.1 % ( 27.9 )%

Total income taxes

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

of Deferred tax Assets and Liabilities

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

Years ended December 31,

1 unchanged sentence

Deferred tax assets:

Operating loss and credit carryforwards

Net operating loss carryforwards

$ 20,058 $ 18,799

Tax credit carryforwards

Capitalized research and development

1 unchanged sentence

Lease liabilities

Accruals & Others

Total deferred tax assets

26,894 24,919

valuation allowance

( 26,814 ) ( 24,906 )

Deferred tax assets

1 unchanged sentence

Operating lease assets

( 80 ) ( 13 )

Total deferred tax liability

Company has recorded a valuation allowance against its deferred tax assets for the years ended December 31, 2023 and 2022, because the

Company’s management believes that it is more likely than not that these assets will not be realized.

The valuation allowance decreased

by approximately $ 0.2

million for the year ended December 31, 2023 and increased by approximately $ 2.9 million

for the year ended December 31, 2022, respectively, primarily as a result of operating losses generated with no corresponding financial

statement benefit.

of December 31, 2023, the Company had federal net operating loss carryforwards, or NOLs, of approximately $ 68.7 million to offset future

federal taxable income and state NOLs of approximately $ 68.1 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, 2023, which amount to $ 42.3 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, 2023, the Company also has federal and state

tax research and development credit carryforwards of approximately $ 1.5 million and $ 1.0 million, respectively, to offset future income

( 80 ) ( 13 )

The Company has recorded a valuation allowance against its deferred tax assets for the years ended December 31, 2024 and 2023 , 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 $ 1.9 million and $ 1.8 million for the years ended December 31, 2024 and 2023 , respectively, primarily as a result of operating losses generated with no corresponding financial statement benefit.

As of December 31, 2024 , the Company had federal net operating loss carryforwards, or NOLs, of approximately $ 72.9 million to offset future federal taxable income and state NOLs of approximately $ 72.2 million to offset future state taxable income.

The federal and state NOLs generated for annual periods prior to January 1, 2018 begin to expire in 2033.

The Company’s federal NOL generated for the years ended December 31, 2018 through December 31, 2024 , which amount to $ 46.5 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, 2024 , the Company also has federal and state tax research and development credit carryforwards of approximately $ 1.6 million and $ 1.0 million, respectively, to offset future income taxes.

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

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.

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.

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 does not believe the impact of any limitation on the use of its

net operating loss or credit carryforwards will have a material impact on the Company’s consolidated financial statements since

the Company has a full valuation allowance against its net deferred tax assets due to the uncertainty regarding future taxable income

for the foreseeable future.

all years through December 31, 2023, the Company generated research credits but has not conducted a study to document the qualified activities.

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 will have a material impact on the Company’s consolidated financial statements since the Company has a full valuation allowance against its net deferred tax assets due to the uncertainty regarding future taxable income for the foreseeable future.

For all years through December 31, 2024 , the Company generated research credits but 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.

Bioscience received a Supplemental Ruling to the Private Letter Ruling dated March 22, 2013 from the IRS to the effect that, among other

things, the Separation and Distribution by Harvard Bioscience will qualify as a transaction that is tax-free for U.S.

federal income

tax purposes under Section 355 and 368(a)(1)(D) of the Internal Revenue Code continuing in effect.

The private letter and supplemental

rulings and the tax opinion that Harvard Bioscience received from legal counsel to Harvard Bioscience rely on certain representations,

assumptions and undertakings, including those relating to the past and future conduct of the Harvard Apparatus Regenerative Technology

business, and neither the private letter and supplemental rulings nor the opinion would be valid if such representations, assumptions

and undertakings were incorrect.

Moreover, the private letter and supplemental rulings do not address all the issues that are relevant

to determining whether the Distribution will qualify for tax-free treatment.

Notwithstanding the private letter and supplemental rulings

and opinion, the IRS could determine the Distribution should be treated as a taxable transaction for U.S.

federal income tax purposes

if, among other reasons, it determines any of the representations, assumptions or undertakings that were included in the request for

the private letter and supplemental rulings are false or have been violated or if it disagrees with the conclusions in the opinion that

are not covered by the IRS ruling.

preserve the tax-free treatment to Harvard Bioscience of the Separation and Distribution, for the two-year period following the Distribution,

which such period ended November 1, 2015, the Company was limited, except in specified circumstances, from entering into certain transactions

pursuant to which all or a portion of the Company’s stock would be acquired, whether by merger or otherwise;

issuing equity securities

beyond certain thresholds;

repurchasing the Company’s common stock;

and ceasing to actively conduct the Company’s regenerative

medicine business.

In addition, at all times, including during and following such two-year period, the Company may not take or fail to

take any other action that prevents the Separation and Distribution and related transactions from being tax-free.

the Distribution fails to qualify for tax-free treatment, in general, Harvard Bioscience would be subject to tax as if it had sold the

Company’s common stock in a taxable sale for its fair market value, and Harvard Bioscience stockholders who received shares of

Harvard Apparatus Regenerative Technology common stock in the Distribution would be subject to tax as if they had received a taxable

Distribution equal to the fair market value of such shares.

the tax sharing agreement between Harvard Bioscience and the Company, the Company would generally be required to indemnify Harvard Bioscience

against any tax resulting from the Distribution to the extent that such tax resulted from (i) an acquisition of all or a portion of the

Company’s stock or assets, whether by merger or otherwise, (ii) other actions or failures to act by the Company, or (iii) any of

the Company’s representations or undertakings being incorrect or violated.

The Company’s indemnification obligations to Harvard

Bioscience and its subsidiaries, officers and directors are not limited by any maximum amount.

If the Company is required to indemnify

Harvard Bioscience or such other persons under the circumstances set forth in the tax sharing agreement, the Company may be subject to

substantial liabilities.

deferred tax assets prior to the Separation remained with Harvard Bioscience.

Company has determined that any uncertain tax positions would have no material impact on the consolidated financial statements of the

Company and there are no unrecognized tax benefits or related interest and penalties accrued for the period for the years ended December

31, 2023 and 2022.

Company is subject to U.S.

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.

As of December 31, 2024, the Company capitalized a substantial amount of R&D expenditures primarily related to research and development activities performed in the US.

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

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, 2022;

currently, no federal or state income tax

returns are under examination by the respective taxing authorities.

March 27, 2020, the Coronavirus Aid, Relief, and Economic Security, or CARES, Act was signed into law making several changes to the Internal

Revenue Code.

The changes include but are not limited to increasing the limitation on the amount of deductible interest expense, allowing

companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations

can use to offset taxable income.

The tax law changes in the CARES Act did not have a material impact on the Company’s income tax

The statute of limitations for assessment by the IRS and state tax authorities is open for all periods from inception through December 31, 2023 ;

currently, no federal or state income tax returns are under examination by the respective taxing authorities.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security, or CARES, Act was signed into law making several changes to the Internal Revenue Code.

The changes include but are not limited to increasing the limitation on the amount of deductible interest expense, allowing companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income.

The tax law changes in the CARES Act did not have a material impact on the Company’s income tax provision.

Employee Benefit Plan

Company sponsors a retirement plan for its U.S.

employees, which includes an employee savings plan established under Section 401(k) of

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.

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 $ 66,000 and $ 35,000 for the years ended December 31, 2023 and 2022, respectively.

Series E Convertible Preferred Stock

April 28, 2022, the Company entered into a Preferred Issuance Agreement, or PIA, with Harvard Bioscience, Inc., or HBIO, dated as of

April 27, 2022.

Pursuant to the PIA, the Company and HBIO agreed that once HBIO has paid at least $ 4.0 million in certain settlement

and related legal expenses, to satisfy the Company’s indemnification obligations with respect thereto, in lieu of paying cash,

the Company would issue senior convertible preferred stock to HBIO that will contain terms as described in the PIA.

June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite $ 4.0 million

amount, the Company issued HBIO 4,000 shares of Series E Convertible Preferred Stock, or Series E Preferred, at a price of $ 1,000 per

share to satisfy the Company’s related indemnification obligations pertaining to the $ 4.0 million, in lieu of paying cash.

January 18, 2023, HBIO converted 200 Series E Preferred Shares with accrued dividends of $ 9,545 into 31,933 shares of common stock.

connection with the private placement, as of April 12, 2023, the Company had received $ 6.0 million in aggregate proceeds in such private

The private placement resulted in gross proceeds of at least $ 4.0 million which triggered the mandatory conversion of all

the Company’s outstanding Series E Preferred Stock and related accrued dividends into shares of common stock at a conversion price

of $ 6.00 per share.

The Company’s matching contributions to the plan were approximately $ 78,000 and $ 66,000 for the years ended December 31, 2024 and 2023 , respectively.

Convertible Preferred Stock

In connection with the private placement, as of April 12, 2023, the Company had received $ 6.0 million in aggregate proceeds in such private placement.

The private placement resulted in gross proceeds of at least $ 4.0 million which triggered the mandatory conversion of all the Company’s outstanding Series E Preferred Stock and related accrued dividends into shares of common stock at a conversion price of $ 6.00 per share.

The conversion resulted in 674,693 shares of common stock being issued to the holder of the Series E Preferred Stock.

Following such conversion, there are no shares of Series E Preferred Stock outstanding.

shares of any of the classes of preferred stock outstanding as of December 31, 2023.

There were no changes to authorized shares for

the years ending December 31, 2022 and 2023.

There were no shares of any of the classes of preferred stock outstanding as of December 31, 2024.

There were no changes to authorized shares for the years ending December 31, 2023 and 2024.

Authorized shares for each preferred stock class are as follows:

of Categories of Preferred Stock

Undesignated Preferred Stock

3 unchanged sentences

Series E Convertible Preferred Stock

Company has 60,000,000 shares authorized as of December 31, 2023 and 40,961,765 shares of common stock available for issuance.

following represent the Company’s common stock transactions during December 31, 2023 and 2022:

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

The following represent the Company’s common stock transactions during December 31, 2024 and 2023 :

2024 Capital Transactions

April 12, 2023 and on March 31, 2023, the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and

existing investors, the Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 1,000,967

shares of common stock for the aggregate purchase price of approximately $ 6 million with a purchase price per unit of $ 6.00 .

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”).

2023 Capital Transactions

May 12, 2022, the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and existing investors, the

Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 854,771 shares of common stock and

warrants to purchase 427,390 shares of common stock, subject to adjustment as provided in the warrant agreement, the Warrants, for the

aggregate purchase price of approximately $ 5.1 million with a purchase price per unit of $ 5.92 , the Private Placement.

Each unit consisted

of one share of common stock and a warrant to purchase one half of one share of common stock, subject to adjustment, as provided in the

The Company received an aggregate of $ 5.1 million gross and net proceeds from the Private Placement by May 16, 2022.

$ 5.1 million of gross and net proceeds were allocated $ 3.6 million and $ 1.5 million to the common stock and warrants, respectively.

The Company classified these warrants on its consolidated balance sheets as equity as the warrants do not have any redemption features

nor a right to put for cash that is outside the control of the Company, and valued using the Black-Scholes model based on the following

weighted average assumptions:

of Black-Scholes Model Based on Weighted Average Assumptions

Risk-free interest rate

Expected volatility

Expected term

Expected dividend yield

Exercise price

Market value of common stock

June 2022, the Company issued 4,000 shares of Series E Convertible Preferred Stock at a price of $ 1,000 per share to satisfy certain

indemnification obligations in the amount of $ 4.0 million, in lieu of paying cash.

The Company issued an aggregate of 180 shares of Series

E Convertible Preferred Stock relating to accrued dividends during the year ended December 31, 2022.

to purchase common stock activity for the year ended December 31, 2022 was as follows:

Schedule of Warrant to Purchase Common Stock

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

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

Weighted-average

3 unchanged sentences

Outstanding at December 31, 2023

1,113,622 4.69

( 215,000 ) 2.00

Outstanding at December 31, 2024

There was no warrant activity during the year ended December 31, 2023.

Stock Purchase Plan

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, 2023.

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

and December 31, 2022.

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, 2024 .

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

There was no ESPP Plan activity in 2024 or 2023 .

Share-based Compensation

Apparatus Regenerative Technology Amended and Restated Equity Incentive Plan

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.

of December 31, 2023, the Company’s Plan has 9,098,000

authorized shares to be issued under the Plan.

There are 5,034,760

shares available for issuance under the Plan as of December 31, 2023.

option activity under the Plan for the years ended December 31, 2022 and 2023 was as follows:

Schedule of Stock Option Activity

Weighted-average

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, 2024 , the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan.

There are 4,629,538 shares available for issuance under the Plan as of December 31, 2024 .

Stock option activity under the Plan for the years ended December 31, 2023 and 2024 was as follows:

intrinsic value

exercise price

Weighted-average contractual life (years)

Aggregate intrinsic value (in thousands)

(in thousands)

Outstanding at January 1, 2023

2,516,924 3.95 7.68 6,917

2,130,007 5.81

( 65,264 ) 2.29

Canceled / forfeited

( 604,378 ) 6.13

Outstanding at December 31, 2023

Canceled / forfeited

3,977,289 4.64 7.7 5,728

Outstanding at December 31, 2024

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

Options exercisable at December 31, 2024

2,907,296 $ 4.59 6.7 $ 1,135

Options vested or expected to vest at December 31, 2024

Company’s outstanding stock options include 773,195 performance-based awards that have vesting provisions subject to the achievement

of certain business milestones.

Total unrecognized compensation expense for the remaining performance-based awards is approximately $ 2.8

No expense has been recognized for these awards as of December 31, 2023 given that the milestone achievements for these awards

have not yet been deemed probable for accounting purposes.

intrinsic value for outstanding options for the year ended December 31, 2023 was approximately $ 5.7

million and calculated as the difference between the Company’s closing stock price of $ 4.99

per share as of December 29, 2023 and the weighted average exercise price of $ 4.64 .

As of December 31, 2023, unrecognized compensation cost related to unvested non-performance-based awards amounted to $ 3.9

million, which will be recognized over a weighted-average period of 2.2

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

Schedule of Weighted Average Assumptions

4,362,128 $ 4.54 6.9 $ 1,307

The Company’s outstanding stock options include 993,835 performance-based awards that have vesting provisions subject to the achievement of certain business milestones.

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

No expense has been recognized for these awards as of December 31, 2024 given that the milestone achievements for these awards have not yet been deemed probable for accounting purposes.

Aggregate intrinsic value for outstanding options for the year ended December 31, 2024 was approximately $ 1.3 million and calculated as the difference between the Company’s closing stock price of $ 2.98 per share as of December 31, 2024 and the weighted average exercise price of $ 4.54 .

As of December 31, 2024 , unrecognized compensation cost related to unvested non-performance-based awards amounted to $ 2.3 million, which will be recognized over a weighted-average period of 1.4 years.

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

Year Ended December 31,

Risk-free interest rate

4.09 % 3.82 %

Expected volatility

117.23 % 125.35 %

Expected term (in years)

Expected dividend yield

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

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;

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.

weighted average estimated fair value of stock options granted using the Black-Scholes model was $ 5.12 and $ 4.23 per share for the years

ended December 31, 2023 and 2022, respectively.

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.

compensation expense related to the Plan for the years ended December 31, 2023 and 2022 was allocated as follows:

of Share-based Compensation Expense

The weighted average estimated fair value of stock options granted using the Black-Scholes model was $ 3.01 and $ 5.12 per share for the years ended December 31, 2024 and 2023 , 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, 2024 and 2023 was allocated as follows:

Years Ended December 31,

3 unchanged sentences

Total stock-based compensation

$ 2,402 $ 3,461

Net Loss per Share

and diluted net loss per share was calculated as follows:

Schedule of Basic and Diluted Net Loss Per Share

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

Years Ended December 31,

(in thousands, except shares and per share data)

$ ( 7,732 ) $ ( 8,945 )

Preferred stock dividends

Net loss attributable to common stockholders

( 7,732 ) ( 9,022 )

Basic and diluted weighted average common shares outstanding

14,789,332 13,455,666

Basic and diluted net loss per share attributable to common stockholders

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

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.

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, 2023 and 2022 because including them would have had an anti-dilutive effect:

of Antidilutive Securities Excluded from Computation of Earnings per Share

$ ( 0.52 ) $ ( 0.67 )

The Company’s potentially dilutive securities, which include stock options, unvested restricted common stock units and warrants, have been excluded from the computation of diluted net loss per share whenever the effect of including them would be to reduce the net loss per share.

In periods where there is a net loss, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2024 and 2023 because including them would have had an anti-dilutive effect:

Years Ended December 31,

Warrants to purchase common stock

898,622 1,113,622

Options to purchase common stock

Series E convertible preferred stock

4,385,477 3,977,289

5,284,099 5,090,911

Segments and Geographical Information

Company’s chief operating decision maker is its Chief Executive Officer.

The Company’s chief operating decision maker evaluates

the operating results of the Company’s reportable segments based on revenues and net income (loss).

The Company’s chief operating decision maker is its Chief Executive Officer.

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

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

Reportable operating segments are determined based on the management approach.

The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker organizes the segments within an enterprise for making operating decisions and assessing performance.

While our results of operations are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in two reportable segments, each with different operating and potential revenue generating characteristics.

The 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) Longevity Products

relating to longevity products with operations currently in Asia.

The following table presents the Company’s reportable

segment results for the year ended 2023:

Schedule of Reportable Segments

i) Regenerative Biotech focused on the development of regenerative medicine treatments with operations currently in the United States and ii) Consumer Health Products relating to consumer health products with operations currently in Asia.

All our revenue was generated in Asia.

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

Year Ended December 31,

Product revenue:

Regenerative Biotech

Longevity Products

Consumer Health Products

Regenerative Biotech

$ ( 7,247 ) $ ( 8,677 )

Consumer Health Products

( 485 ) ( 268 )

$ ( 7,732 ) $ ( 8,945 )

Cash and cash equivalents:

Regenerative Biotech

$ 2,405 $ 371

Consumer Health Products

$ 2,486 $ 432

Total assets:

Regenerative Biotech

$ 3,978 $ 2,426

Consumer Health Products

$ 4,442 $ 2,614

Subsequent Events

In March 2024, the Company received cash deposits

in escrow of approximately $ 0.3 million from a group of prospective investors pertaining to a potential private placement transaction.

These funds remain the respective investor’s property and are being held by the Company in its bank account with Bank of America

until the execution of a common stock purchase agreement.

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 has agreed to loan 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”).

Bridge Note accrues interest at an annual fixed rate of 8 % , and the principal amount thereof will be due and payable in full, together

with all accrued and unpaid interest thereon, on the earlier to occur of a) the closing date (or later date of capital being provided

pertaining to such continued offering that the following threshold is tripped) of the Company’s next capital raise that includes

gross proceeds of at least $ 5,000,000 or b) February 1, 2025.

The Bridge Note provides for optional conversion at the discretion of the

Lender, contains covenants, and provides for certain events of default including if the Company fails to pay when due any amount owed

thereunder, fails to comply with any agreement, covenant, condition, provision or term contained therein and other customary events of

The Company performed a review of events subsequent to the balance sheet through the date the financial statements were issued and determined that there were no such events requiring recognition or disclosure in the financial statements.

Form 10-K Summary.

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 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.

Description of Exhibit

Separation and Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc.

18 unchanged sentences

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).

of Designations, Preferences, Rights and Limitations of Series D Convertible Preferred Stock of Harvard Apparatus Regenerative Technology,

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).

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).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of Harvard Apparatus Regenerative Technology, Inc.

14 unchanged sentences

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).

Intellectual Property Matters 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).

Product 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).

Tax Sharing 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).

Sublease by and between Harvard Apparatus Regenerative Technology, Inc.

11 unchanged sentences

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).

Patent Rights Assignment dated December 21, 2012 between Harvard Apparatus Regenerative Technology, Inc.

Paolo Macchiarini (previously filed as an exhibit to the Company’s Registration Statement on Form 10-12B, filed July 31, 2013, and incorporated by reference thereto).

Offer Letter, dated June 4, 2018, between Harvard Apparatus Regenerative Technology, Inc.

4 unchanged sentences

(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).

Amended and Restated Employment Agreement, dated January 11, 2023, between Harvard Apparatus Regenerative Technology, Inc.

and David Green (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 12, 2023 and incorporated by reference thereto).

Employment Agreement, effective as of March 1, 2023, by and between Harvard Apparatus Regenerative Technology, Inc.

2 unchanged sentences

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).

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).

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).

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).

Insider Trading Policy.

Subsidiaries of Harvard Apparatus Regenerative Technology, Inc.

6 unchanged sentences

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

XBRL Instance Document.

XBRL Taxonomy Extension Schema Document.

XBRL Taxonomy Extension Calculation Linkbase Document.

XBRL Taxonomy Extension Definition Linkbase Document.

XBRL Taxonomy Extension Label Linkbase Document.

XBRL Taxonomy Extension Presentation Linkbase Document.

Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101)

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.

contract or compensatory plan or arrangement.

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.

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.

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.

Apparatus Regenerative Technology, Inc.

Inline XBRL Instance Document.

Inline XBRL Taxonomy Extension Schema Document.

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

Inline XBRL Taxonomy Extension Definition Linkbase Document.

Inline XBRL Taxonomy Extension Label Linkbase Document.

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

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.

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.

March 31, 2025

/s/ Junli (Jerry) He

Junli (Jerry) He

Executive Officer

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:

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:

/s/ Junli (Jerry) He

Chief Executive Officer, Director, and Chairman

Junli (Jerry) He

Executive Officer, Director, and Chairman

executive officer)

(principal executive officer)

March 31, 2025

/s/ Joseph Damasio Jr.

Chief Financial Officer

Joseph Damasio Jr.

Financial Officer

financial officer and principal accounting officer)

(principal financial officer and principal accounting officer)

March 31, 2025

/s/ Jason Jing Chen

Jason Jing Chen

Vice Chairman

March 31, 2025

/s/ David Green

March 31, 2025

/s/ Ronald Packard

Ronald Packard

March 31, 2025

/s/ Herman Sanchez

Herman Sanchez

March 31, 2025

/s/ James Shmerling

James Shmerling

March 31, 2025

/s/ Mao Zhang

March 31, 2025

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

What changed 10-K

Item 9A. Controls and Procedures