Harvard Apparatus Regenerative Technology, Inc.

Previous wording

This Quarterly Report on Form 10-Q contains statements that are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the“Exchange Act”). The forward-looking statements are principally, but not exclusively, contained in“Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.”* Forward-looking statements include, but are not limited to, statements about management*’s confidence or expectations and our plans, objectives, expectations and intentions that are not historical facts and the potential impact of COVID-19 on our business and operations. In some cases, you can identify forward-looking statements by terms such as“may,”* “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “goal,” “see,” “estimate,” “project,” “predict,” “intend,” “think,” “potential,” “objective,” “optimistic,” “strategy,” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause our actual results to differ materially from those in the forward-looking statements include our ability to access debt and equity markets and raise additional capital when needed; the success of our collaborations, clinical trials and pre-clinical development efforts and programs, which success may not be achieved on a timely basis or at all; our ability to obtain and maintain regulatory approval for our implant products, bioreactors, scaffolds and other devices we pursue, including for the esophagus or airway, which approvals may not be obtained on a timely basis or at all; the number of patients who can be treated with our products; the amount and timing of costs associated with our development of implant products, bioreactors, scaffolds and other devices; our failure to comply with regulations and any changes in regulations; unpredictable difficulties or delays in the development of new technology; our collaborators or other third parties we contract with, including with respect to conducting any clinical trial or pre-clinical development efforts, not devoting sufficient time and resources to successfully carry out their duties or meet expected deadlines; our ability to attract and retain qualified personnel and key employees and retain senior management; potential liability exposure with respect to our products; the availability and price of acceptable raw materials and components from third-party suppliers; difficulties in obtaining or retaining the management and other human resource competencies that we need to achieve our business objectives; increased competition in the field of regenerative medicine and bioengineering…

Excerpt shortened here; the source contains the full paragraph.

Current wording

The following section of this Quarterly Report on Form 10-Q entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”contains statements that are not statements of historical fact and are forward-looking statements within the meaning of federal securities laws. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties.

Previous wording

Since our incorporation, we have devoted substantially all of our resources to developing our programs, building our intellectual property portfolio, business planning, raising capital and providing selling, general and administrative support for these operations. To date, we have financed our operations with proceeds from the sales of Common Stock and Preferred Stock. In December 2017, we sold the inventory and rights to manufacture and sell research-only versions of our bioreactors to Harvard Bioscience.

Current wording

Since our incorporation, we have devoted substantially all of our resources to developing our programs, building our intellectual property portfolio, business planning, raising capital and providing selling, general and administrative support for these operations. To date, we have financed our operations with proceeds from the sales of Common Stock, Preferred Stock and warrants. In December 2017, we sold the inventory and rights to manufacture and sell research-only versions of our bioreactors to Harvard Bioscience.

Previous wording

The Company has two separate reportable segments. The Company has one segment, Harvard Apparatus Regenerative Technology, Inc., or Regenerative Biotech, 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 segment, Consumer Health Products, is focused on personal healthcare including dietary supplements.

Current wording

We have two separate reportable segments. One segment, Harvard Apparatus Regenerative Technology, Inc., or Regenerative Biotech, is focused on the development and commercialization of therapies to treat cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other segment, Consumer Health Products, is focused on personal healthcare, including dietary supplements.

Previous wording

We expect to continue to incur operating losses and negative cash flows from operations for 2025 and in future years.

Current wording

We expect to continue to incur operating losses and negative cash flows from operations during 2025 and in future years.

Previous wording

We have incurred substantial operating losses since our inception, and as of March 31, 2025, had an accumulated deficit of approximately $101.3 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of March 31, 2025 of approximately $1.7 million will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2025. We expect to continue to incur operating losses and negative cash flows from operations for 2025 and in future years. Therefore, as disclosed in Note 1 to our Condensed Consolidated Financial Statements appearing elsewhere in this Quarterly Report on Form 10-Q, these conditions raise substantial doubt about our ability to continue as a going concern.

Current wording

We have incurred substantial operating losses since our inception, and as of June 30, 2025, had an accumulated deficit of approximately $103.2 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of June 30, 2025 of approximately $0.8 million and equity financing of $2 million in gross proceeds received subsequent to June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We expect to continue to incur operating losses and negative cash flows from operations for 2025 and in future years. Therefore, as disclosed in Note 1 to our Condensed Consolidated Financial Statements appearing elsewhere in this Quarterly Report on Form 10-Q, these conditions raise substantial doubt about our ability to continue as a going concern.

Previous wording

We will need to raise additional capital to fund our current operations. In the event we do not raise additional capital from outside sources during the second quarter of 2025, we may be forced to curtail or cease our operations.

Current wording

We will need to raise additional capital to fund our current operations. In the event we do not raise additional capital from outside sources during the third quarter of 2025, we may be forced to curtail or cease our operations.

Previous wording

Other (expense) income, net. Other (expense) income, net, consists primarily of interest expense on convertible debt and finance charges on insurance installment payments offset by interest income.

Current wording

Other income (expense), net. Other income (expense), net, consists primarily of interest expense on convertible debt and finance charges on insurance installment payments offset by interest income.

Previous wording

The following table summarizes the results of our operations for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table summarizes the results of our operations for the three and six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

Cost of sales was $33,000 and $12,000 for the three months ended March 31, 2025 and 2024, respectively. The gross profit margin on our products decreased primarily due to wholesale pricing to our distributor compared to retail pricing to consumers in the prior quarter.

Current wording

Cost of sales was $302,000 and $13,000 for the three months ended June 30, 2025 and 2024, respectively. The gross profit margin on our products decreased primarily due to wholesale pricing to our distributor compared to retail pricing to consumers in the comparable prior quarter.

Previous wording

Research and development expense decreased approximately $0.2 million, or 28%, to approximately $0.6 million for the three months ended March 31, 2025 as compared to approximately $0.8 million for the three months ended March 31, 2024. This decrease was primarily due to reduced clinical trial and preclinical trial activities.

Current wording

Research and development expense increased approximately $0.06 million, or 9%, to approximately $0.7 million for the three months ended June 30, 2025 as compared to approximately $0.6 million for the three months ended June 30, 2024. This increase was primarily due to increased clinical trial and preclinical trial activities.

Previous wording

During the three months ended March 31, 2025, we recorded interest income of approximately $13,000 earned from our money market account. During the three months ended March 31, 2024, we generated no interest income.

Current wording

During the three months ended June 30, 2025, we recorded interest income of approximately $7,000 earned from our money market account. During the three months ended June 30, 2024, we generated no interest income.

Previous wording

During the three months ended March 31, 2025, we recorded interest expense of approximately $2,000 on insurance installment payments. During the three months ended March 31, 2024, we recorded interest expense of approximately $6,000 on convertible debt and approximately $3,000 on insurance installment payments.

Current wording

During the three months ended June 30, 2025, we recorded interest expense of approximately $3,000 on insurance installment payments. During the three months ended June 30, 2024, we recorded interest expense of approximately $10,000 on convertible debt and approximately $7,000 on insurance installment payments.

Previous wording

General and administrative expense decreased approximately $0.04 million, or 4%, to approximately $1.1 million for the three months ended March 31, 2025 as compared to approximately $1.1 million for the three months ended March 31, 2024. This decrease was primarily due to reduced share-based compensation expense during the current quarter.

Current wording

Research and development expense decreased approximately $0.2 million, or 12%, to approximately $1.3 million for the six months ended June 30, 2025 as compared to approximately $1.5 million for the six months ended June 30, 2024. This decrease was primarily due to reduced share-based compensation expense during the current period.

Previous wording

Selling and marketing expense decreased approximately $0.1 million, or 105%, to approximately $0.01 million for the three months ended March 31, 2025 as compared to approximately $0.1 million for the three months ended March 31, 2024 The decrease was primarily due to a decrease in employee compensation.

Current wording

Selling and marketing expense decreased approximately $0.3 million, or 97% for the six months ended June 30, 2025 as compared to approximately $0.3 million for the six months ended June 30, 2024 The decrease was primarily driven by a strategic shift from direct in-house sales to a distributor-based model.

Previous wording

Sources of liquidity. We have incurred operating losses since inception, and as of March 31, 2025, we had an accumulated deficit of approximately $101.3 million. We are currently investing significant resources in the development and commercialization of our product candidates for use by clinicians and researchers in the fields of regenerative medicine and bioengineering. As a result, we expect to incur operating losses and negative operating cash flows for the foreseeable future. Therefore, as disclosed in Note 1 to our Condensed Consolidated Financial Statements, these conditions raise substantial doubt about our ability to continue as a going concern.

Current wording

Sources of liquidity. We have incurred operating losses since inception, and as of June 30, 2025, we had an accumulated deficit of approximately $103.2 million. We are currently investing significant resources in the development and commercialization of our product candidates for use by clinicians and researchers in the fields of regenerative medicine and bioengineering. As a result, we expect to incur operating losses and negative operating cash flows for the foreseeable future. Therefore, as disclosed in Note 1 to our Condensed Consolidated Financial Statements, these conditions raise substantial doubt about our ability to continue as a going concern.

Previous wording

The following table sets forth the primary uses of cash for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table sets forth the primary uses of cash for the six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

Operating activities. Net cash used in operating activities of approximately $0.8 million for the three months ended March 31, 2025 was due primarily to our net loss of approximately $1.7 million offset by adjustments for non-cash items of approximately $0.5 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $0.4 million increase to cash from changes in working capital due to the timing of payments for accounts receivable, inventory, prepaid expenses, long-term prepaid contracts, accounts payable, deferred revenue and accrued expenses.

Current wording

Operating activities. Net cash used in operating activities of approximately $1.7 million for the six months ended June 30, 2025 was due primarily to our net loss of approximately $3.5 million offset by adjustments for non-cash items of approximately $1.1 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $0.7 million increase to cash from changes in working capital due to the timing of payments for accounts receivable, inventory, prepaid expenses, long-term prepaid contracts, accounts payable, deferred revenue and accrued expenses.

Previous wording

Net cash used in operating activities of approximately $1.0 million for the three months ended March 31, 2024 was due primarily to our net loss of approximately $2.0 million offset by adjustments for non-cash items of approximately $0.5 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $0.5 million increase to cash from changes in working capital due to the timing of payments for accounts receivable, inventory, prepaid expenses, deferred financing costs, long-term prepaid contracts, accounts payable and accrued expenses.

Current wording

Net cash used in operating activities of approximately $2.3 million for the six months ended June 30, 2024 was due primarily to our net loss of approximately $4.5 million offset by adjustments for non-cash items of approximately $1.1 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $1.1 million increase to cash from changes in working capital due to the timing of payments for accounts receivable, inventory, prepaid expenses, deferred financing costs, long-term prepaid contracts, accounts payable and accrued expenses.

Previous wording

Financing activities. During the three months ended March 31, 2025, we did not generate cash from financing activities. In comparison, net cash generated from financing activities during the three months ended March 31, 2024, of approximately $0.8 million consisted of net proceeds of $0.5 million received from debt financing and $0.3 million from a group of investors who each entered into securities purchase agreements with the Company pertaining to the private placement transaction closing on April 15, 2024.

Current wording

Financing activities. During the six months ended June 30, 2025, we did not generate cash from financing activities. In comparison, net cash provided by financing activities during the six months ended June 30, 2024 totaled approximately $2.0 million. This amount consisted of $0.5 million in net proceeds from debt financing and $1.5 million from a private placement transaction that resulted in the issuance of 367,767 shares of our common stock at a purchase price of $4.03 per share to a group of investors.