Harvard Apparatus Regenerative Technology, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 31, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-28.
0001493152-24-011784
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001437749-25-010213
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 72 previous paragraphs and 63 current paragraphs.
38 unchanged; 21 reworded; 4 added; 13 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
We have encountered delays in patient recruitment for our ongoing clinical trial, driven by several factors, including the existing comorbid conditions for clinical trial participants, the stringent eligibility criteria required by FDA for our studies, and logistical difficulties in enrolling participants across various sites.
Current report
Although we are actively implementing strategies to mitigate these challenges, such as increasing the number of trial sites and enhancing patient outreach efforts, there is a risk that these measures may not completely resolve the recruitment issues. Our product candidates are currently in development and have not yet received regulatory approval for sale anywhere in the world.
Current report
The Consumer Health Products business was launched in the Asia region in the third quarter of 2023. Selling and marketing expense was $0.6 million for the year ended December 31, 2024 as compared to $0.3 million for the comparable period. The Consumer Health Products business was launched in the Asia region in the third quarter of 2023.
Current report
General and administrative expense decreased approximately $0.7 million, or 12%, to approximately $5.0 million for the year ended December 31, 2024 as compared to approximately $5.7 million for the year ended December 31, 2023. This decrease was primarily due to share-based compensation expense of $1.3 million from the vesting of performance based awards in the first half of 2023 offset by the recording of expense in the current period of one-time offering costs of $0.5 million relating to the initial registered offering that did not occur in the prior year.
Removed paragraphs (13)
Previous report
We were incorporated and commenced operations on November 1, 2013 as a result of a spin-off from Harvard Bioscience, Inc., or Harvard Bioscience. On that date, we became an independent company that operates the regenerative medicine business previously owned by Harvard Bioscience. The spin-off was completed through the distribution of all the shares of common stock of Harvard Apparatus Regenerative Technology to Harvard Bioscience stockholders.
Previous report
Management
Previous report
Effective as of November 26, 2021, we appointed David Green as Chief Executive Officer. Effective as of March 1, 2023, we transitioned the role of Chief Executive Officer to Junli (Jerry) He, our existing director, and Mr. Green remains on our Board of Directors.
Previous report
On August 8, 2022, we appointed Joseph Damasio Jr. as Chief Financial Officer. In such role, Mr. Damasio serves as the Company’s principal accounting officer and principal financial officer.
Previous report
Changes in Fair Value of Warrant Liability. Changes in fair value of warrant liability represent the change in the fair value of outstanding common stock warrants that were classified as liability awards during the year ended December 31, 2022. We used the Black-Scholes pricing model to value the related warrant liability.
Previous report
Warrant Liability
Previous report
Most of the warrants to purchase shares of our common stock have been classified on our consolidated balance sheets as equity. We classify warrants as a liability in our consolidated balance sheets if the warrant is a free-standing financial instrument that may require us to transfer cash consideration upon exercise and that cash transfer event would be out of our control. Such a “liability warrant” is initially recorded at fair value on the date of grant using the Black-Scholes model, net of issuance costs, and it is subsequently re-measured to fair value at each subsequent balance sheet date. Changes in fair value of the warrant are recognized as a component of other income (expense) in the consolidated statements of operations. We continued to adjust the liability for changes in fair value until the expiration of the warrant liability in February 2022.
Previous report
Longevity Products launched its longevity products business in the second quarter of 2023 so there were no prior period costs. Selling and marketing expense was $0.3 million for the year ended December 31, 2023 as compared to zero for the comparable period.
Previous report
General and administrative expense increased approximately $1.3 million, or 30%, to approximately $5.7 million for the year ended December 31, 2023 as compared to approximately $4.4 million for the year ended December 31, 2022. This increase was primarily due to share-based compensation expense of $2.4 million and increased headcount related costs of approximately $0.6 million offset by a decrease of approximately $0.4 million for supporting our ongoing public company requirements and reduced legal and related costs of approximately $1.3 million relating to the completion of litigation for a wrongful death complaint and related matters more fully described in Note 9 to our consolidated financial statements.
Previous report
Sublease Income
Previous report
On January 5, 2022, the Company executed a four-month sublease agreement for certain laboratory and office space at its Holliston, Massachusetts facility. The Company further extended the sublease agreement to a month-to-month basis until August 31, 2022, when the other party vacated the premises. For the year ended December 31, 2022, the Company recorded sublease income of approximately $87,000 relating to this agreement. We had no sublease agreements generating sublease income for the year ended December 31, 2023.
Previous report
Change in Fair Value of Warrant Liability
Previous report
For the year ended December 31, 2022, the change in fair value of our warrant liability resulted in other income of approximately $2,000. These warrants expired unexercised in February of 2022.
Reworded paragraphs (21)
Previous wording
In some cases, you can identify forward-looking statements by terms such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “could,” “would,” “target,” “seek,” “aim,” “believe,” “predicts,” “think,” “objectives,” “optimistic,” “new,” “goal,” “strategy,” “potential,” “is likely,” “will,” “expect,” “plan” “project,” “permit” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in Item 1A.”Risk Factors” of this Annual Report on Form 10-K. You should carefully review all of these factors, as well as the comprehensive discussion of forward-looking statements on page ii of this Annual Report on Form 10-K.
Current wording
In some cases, you can identify forward-looking statements by terms such as“believe,”* “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “could,” “would,” “target,” “seek,” “aim,” “believe,” “predicts,” “think,” “objectives,” “optimistic,” “new,” “goal,” “strategy,” “potential,” “likely,” “will,” “expect,” “plan” “project,” “permit” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in Item 1A.* Risk Factors* of this Annual Report on Form 10-K. You should carefully review all of these factors, as well as the comprehensive discussion of forward-looking statements on page ii of this Annual Report on Form 10-K.*
Previous wording
We have contracted with IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, as the contract research organization (CRO) to manage our first clinical trial. We activated the first clinical trial site and started screening patients in the third quarter of 2023. Our product candidates are currently in development and have not yet received regulatory approval for sale anywhere in the world.
Current wording
We have contracted with IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, as the contract research organization ("CRO") to manage our first clinical trial. We activated the first clinical trial site and started screening patients in the third quarter of 2023.
Previous wording
In addition to our development of regenerative medicine treatments, we also sell longevity dietary supplements. In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or Longevity Products, started focusing on longevity products. Longevity Products plans to include a broad range of products focused on personal healthcare including longevity dietary supplements. Longevity Products started selling longevity supplements in the third quarter of 2023. These products are marketed to the general public and initially targeted at consumers in the Great China Region through eCommerce (online sales).
Current wording
In addition to our development of regenerative medicine treatments, we also sell dietary supplements. In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Consumer Health Products started focusing on consumer health products. Consumer Health Products plans to include a broad range of products focused on personal healthcare including dietary supplements. Consumer Health Products started selling consumer health supplements in the third quarter of 2023. These products are commercially marketed to the general public and initially targeted at consumers in Asia through eCommerce (online sales).
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 and preferred stock.
Previous wording
We have incurred substantial operating losses since our 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. We expect that our operating cash on-hand as of December 31, 2023 of approximately $0.4 million and debt financing of $0.5 million received in gross proceeds subsequent to December 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2024. We expect to continue to incur operating losses and negative cash flows from operations in future years. Therefore, as disclosed in Note 1 to our Consolidated Financial Statements, 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 December 31, 2024 had an accumulated deficit of approximately $99.7 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of December 31, 2024 of approximately $2.5 million will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025. We expect to continue to incur operating losses and negative cash flows from operations in future years. Therefore, as disclosed in Note 1 to our Consolidated Financial Statements, these conditions raise substantial doubt about our ability to continue as a going concern.
Previous wording
We will need to raise additional funds to fund our operations. In the event we do not raise additional capital from outside sources during the first quarter of 2024, we may be forced to curtail or cease our 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 our products that are currently under development. We are 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. We may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. We may not be able to obtain additional financing on favorable terms, if at all.
Current wording
We will need to raise additional funds to fund our operations. In the event we do not raise additional capital from outside sources before or during the second quarter of 2025, we may be forced to curtail or cease our 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 our products that are currently under development. We are 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. We may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. We may not be able to obtain additional financing on favorable terms, if at all.
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, Longevity Products, is focused on personal healthcare including longevity dietary supplements.
Current 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.
Previous wording
As of December 31, 2023, our consolidated business employed 18 individuals.
Current wording
As of December 31, 2024, our consolidated business employed 8 individuals.
Previous wording
Product revenue. Product revenue consists of longevity product sales, launched in the Asia region in the third quarter of 2023. We had not generated any revenue prior to the launch of our longevity products.
Current wording
Product revenue. Product revenue consists of consumer health product sales, launched in Asia in the third quarter of 2023. We had not generated any revenue prior to the launch of our consumer health products.
Previous wording
Total share-based compensation expense for each of the years ended December 31, 2023 and 2022 was approximately $3.5 million and $1.0 million, respectively. Share-based compensation is further described in Note 15 to our Consolidated Financial Statements included in Item 15 of this Annual Report on Form 10-K.
Current wording
Total share-based compensation expense for each of the years ended December 31, 2024 and 2023 was approximately $2.4 million and $3.5 million, respectively. Share-based compensation is further described in Note 15 to our Consolidated Financial Statements included in Item 15 of this Annual Report on Form 10-K.
Previous wording
Product revenue was $103,000 and zero for the year ended December 31, 2023 and 2022, respectively. Product revenue consists of longevity product sales launched in the Asia region in the third quarter of 2023. We had not generated any revenue prior to the launch of our longevity products.
Current wording
Product revenue was $430,000 and $103,000 for the year ended December 31, 2024 and 2023, respectively. Product revenue consists of consumer health product sales launched in the Asia region in the third quarter of 2023. Sales grew as a result of broadening our distribution channels to access a larger consumer base.
Previous wording
Cost of sales was $24,000 and zero for the year ended December 31, 2023 and 2022, respectively. Cost of sales consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs.
Current wording
Cost of sales was $270,000 and $24,000 for the year ended December 31, 2024 and 2023, respectively. Cost of sales consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs. The gross profit margin on our products decreased in 2024 primarily due to discounted sales aimed at achieving market penetration for our newly introduced product.
Previous wording
Research and development expense increased approximately $1.3 million, or 76%, to approximately $3.1 million for the year ended December 31, 2023 as compared to approximately $1.7 million for the year ended December 31, 2022. This was due primarily to higher headcount and preclinical trial activities to increase our product pipeline and clinical trial activities resulting in our first site activation in the third quarter of 2023.
Current wording
Research and development expense decreased approximately $0.8 million, or 25%, to approximately $2.3 million for the year ended December 31, 2024 as compared to approximately $3.1 million for the year ended December 31, 2023. This decrease was due primarily to significant initial clinical trial activities in the prior period resulting in our first site activation in the third quarter of 2023.
Previous wording
During the year ended December 31, 2023, we recorded interest income of approximately $64,000 earned from our money market account and certificate of deposit. During the year ended December 31, 2022, we received minimal interest income from cash accounts.
Current wording
During the year ended December 31, 2024, we recorded interest income of approximately $32,000 earned from our money market account. During the year ended December 31, 2023, we recorded interest income of approximately $64,000 earned from our money market account and certificate of deposit.
Previous wording
During the year ended December 31, 2023, we recorded interest expense of approximately $14,000 on insurance installment payments. During the year ended December 31, 2022, we recorded interest expense of approximately $9,000 on insurance installment payments.
Current wording
During the year ended December 31, 2024, we recorded interest expense of approximately $23,000 on convertible debt and approximately $15,000 on insurance installment payments. During the year ended December 31, 2023, we recorded interest expense of approximately $14,000 on insurance installment payments.
Previous wording
Sources of Liquidity. We have incurred operating losses since inception and as of December 31, 2023, we had an accumulated deficit of approximately $92.0 million. We are currently investing significant resources in the development and commercialization of our product candidates for use by clinicians and researchers in the field of regenerative medicine. As a result, we expect to incur operating losses and negative operating cash flows for the foreseeable future.
Current wording
Sources of Liquidity. We have incurred operating losses since inception and as of December 31, 2024, despite the Company's revenue from our consumer health products, we had an accumulated deficit of approximately $99.7 million. We are currently investing significant resources in the development and commercialization of our product candidates for use by clinicians and researchers in the field of regenerative medicine. As a result, we expect to incur operating losses and negative operating cash flows for the foreseeable future.
Previous wording
Net cash used in operating activities of approximately $5.1 million for the year ended December 31, 2022 was primarily a result of our net loss of approximately $6.1 million and $0.6 million for deferred financing costs, offset by approximately $1.1 million of non-cash items related to share-based compensation, depreciation and amortization, and an increase of approximately $0.5 million of cash provided from working capital due to the timing of prepaid expenses, accounts payable, and accrued and other current liabilities.
Current wording
*Operating Activities.*Net cash used in operating activities of approximately $4.9 million for the year ended December 31, 2024 was due primarily to our net loss of approximately $7.7 million offset by adjustments for non-cash items of approximately $2.6 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $0.3 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
*Operating Activities.*Net cash used in operating activities of approximately $6.9 million for the year ended December 31, 2023 was due primarily to our net loss of approximately $8.9 million offset by adjustments for non-cash items of approximately $3.6 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $1.6 million decrease 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 $6.9 million for the year ended December 31, 2023 was due primarily to our net loss of approximately $8.9 million offset by adjustments for non-cash items of approximately $3.6 million due to non-cash expenses for share-based compensation, depreciation and amortization, and an approximately $1.6 million decrease 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
*Investing Activities.*Net cash used in investing activities for the years ended December 31, 2023 and 2022 totaled $11,000 and $5,000, respectively, and represented purchases of property, plant and equipment. During the year ended December 31, 2023, we invested in a certificate of deposit for $2.5 million. We withdrew $1.3 million from the certificate of deposit prior to the maturity date to pay clinical trial related deposits. The certificate of deposit matured in October 2023 with the remaining $1.2 million released from short-term investments into cash and cash equivalents.
Current wording
*Investing Activities.*Net cash used in investing activities for the years ended December 31, 2024 and 2023 totaled zero and $11,000, respectively, and represented purchases of property, plant and equipment. During the year ended December 31, 2023, we invested in a certificate of deposit for $2.5 million. We withdrew $1.3 million from the certificate of deposit prior to the maturity date to pay clinical trial related deposits. The certificate of deposit matured in October 2023 with the remaining $1.2 million released from short-term investments into cash and cash equivalents.
Previous wording
Financing Activities. Net cash generated from financing activities was approximately $6.1 million during the year ended December 31, 2023 and consisted of net proceeds received from a private placement transaction for the issuance of common stock and stock option exercises. Net cash generated from financing activities was approximately $5.1 million during the year ended December 31, 2022 and consisted of net proceeds received from private placement transactions for the issuance of common stock and warrants to purchase common stock.
Current wording
Financing Activities. Net cash generated from financing activities was approximately $6.9 million during the year ended December 31, 2024 and included net proceeds of $0.5 million from debt financing, $0.4 million from stock warrant exercises, and $6.5 million from private placement transactions, which resulted in the issuance of 1,756,655 shares of our Common Stock to a group of investors. The $0.5 million in debt was repaid in August 2024. Net cash generated from financing activities was approximately $6.1 million during the year ended December 31, 2023 and consisted of net proceeds received from a private placement transaction for the issuance of common stock and stock option exercises.
Previous wording
We have incurred substantial operating losses since our 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. We expect that our operating cash on-hand as of December 31, 2023 of approximately $0.4 million and debt financing of $0.5 million received in gross proceeds subsequent to December 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2024. We expect to continue to incur operating losses and negative cash flows from operations in future years. Therefore, as disclosed in Note 1 to our Consolidated Financial Statements, 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 December 31, 2024 had an accumulated deficit of approximately $99.7 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of December 31, 2024 of approximately $2.5 million will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025. We expect to continue to incur operating losses and negative cash flows from operations in future years. Therefore, as disclosed in Note 1 to our Consolidated Financial Statements, these conditions raise substantial doubt about our ability to continue as a going concern.