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Longevity Health Holdings, Inc.

For the period ended Dec 31, 2024. Filed Mar 31, 2025.

View on SEC.gov

About this filing

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

XAGE$0.23-13.1%Stored close · as of Jul 8, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2023-12-31; filed 2024-04-01.

0000950170-24-038992

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-K

Period ended 2024-12-31; filed 2025-03-31.

0000950170-25-047891

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 61 previous paragraphs and 60 current paragraphs.

21 unchanged; 15 reworded; 24 added; 23 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 2 previous and 2 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 (24)

Current report

On January 2, 2025, we closed the 2025 Private Placement, whereby we received gross proceeds of $1,851,849 for the sale of 8,065,210 shares of Common Stock and warrants to purchase up to 8,065,210 shares of Common Stock at an exercise price of $0.23 per share.

Current report

On the APA Closing Date, we closed the Elevai Acquisition, whereby we acquired the Purchased Assets and assumed the Assumed Liabilities for a purchase price consisting of: (i) shares of Common Stock having an aggregate Market Value (as defined in the Asset Purchase Agreement (as defined below)) of $1,075,463, of which $100,000 is being withheld by us for 12 months after the APA Closing Date to secure the indemnification obligations of the Seller under the Asset Purchase Agreement, dated as of December 31, 2024 (the “Asset Purchase Agreement”), by and among the Company, a wholly owned subsidiary of the Company formed in connection with the transaction (“Buyer”), Parent and Seller.; (ii) Buyer’s assumption of the Assumed Liabilities; and (iii) $56,525 in cash to be paid within 60 days following the sale by Buyer of certain finished goods inventory (as specified in the Asset Purchase Agreement) included in the Purchased Assets as of the APA Closing Date.

Current report

Following the APA Closing Date, we will pay the following additional earnout consideration for the Purchased Assets, if and when payable: (a) for each year ending on the anniversary of the date of the APA Closing Date during the five-year period following the APA Closing Date, an amount, if any, equal to 5% of the Net Sales (calculated as the aggregate gross sales minus (i) trade discounts, credits or allowances offered to customers and (ii) credits or allowances additionally granted upon returns, rejections or recalls) generated during such year from the Seller’s existing products as of the APA Closing Date; and (b) a one-time payment of $500,000 if Buyer achieves $500,000 in net revenue from sales of the Seller’s existing haircare products as of the APA Closing Date on or before the 24-month anniversary of the APA Closing Date. The Elevai Exosomes TM product line had sales of approximately $2,500,000 for the year ended December 31, 2024.

Current report

Effective January 20, 2025, we and Kendra Bracken-Ferguson mutually agreed that Ms. Bracken-Ferguson would no longer serve as our Chief Executive Officer. In connection with Ms. Bracken-Ferguson’s separation from the Company, she and the Company entered into a separation and release of claims agreement, dated January 24, 2025, pursuant to which Ms. Bracken-Ferguson will receive cash payments in the aggregate amount of $150,000 to be paid in equal installments over the subsequent six months. Effective as of January 24, 2025, our Board of Directors appointed Rajiv Shukla, our then-current Executive Chairman, as our Chief Executive Officer.

Current report

On August 30, 2024, we received a letter from the Department of Nasdaq, notifying us that our MVLS was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq provided the Company with 180 calendar days, or until February 26, 2025, to regain compliance with the MVLS Requirement.

Current report

On September 30, 2024, we received a letter from the Department notifying us that, based upon the closing bid price of the Common Stock for the 31 consecutive business days from August 15, 2024 to September 27, 2024, we no longer meet the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq has provided us with 180 calendar days, or until March 31, 2025, to regain compliance with the Minimum Bid Price Requirement.

Current report

On March 4, 2025, the Company received written notice from the Department notifying us that we had failed to regain compliance with the MVLS Requirement by the MVLS Compliance Date and that Nasdaq would delist the Company’s securities from the Nasdaq Capital Market by March 11, 2025. On March 10, 2025, we requested an appeal of Nasdaq’s delisting determination to the Nasdaq Hearings Panel (the “Panel”), which will stay the delisting pending Nasdaq’s decision. We believe that we have a path to regaining compliance with Nasdaq's listing requirements, but no guarantee can be provided that we will be successful in doing so. Additionally, there can be no assurance that the Panel will provide a decision in our favor after the hearing or that we will be able to remain in compliance with the applicable Nasdaq listing requirements on an ongoing basis.

Current report

In the third quarter of 2023 and in the first quarter of 2024, we significantly reduced our future operating expenses by terminating certain executives serving as part-time consultants and full-time employees in non-core areas or overlapping business functions. We also terminated a lease for a redundant facility space in August 2024. These expense reductions resulted in annual savings of approximately $3,000,000 to $4,000,000, which we began to realize in 2024.

Current report

Furthermore, we closed the 2025 Private Placement on January 2, 2025, which resulted in gross proceeds to us of $1,851,849, and closed on the Elevai Acquisition on January 16, 2025. The acquired business generated revenue of approximately $2,500,000 in 2024, and we expect to grow this source of revenue in 2025.

Current report

Gross sales for the year ended December 31, 2024, was $90,829 from sales of our first five cosmetic skincare products launched in 2024. We have developed an additional seven skincare products that we expect to launch in the first half of 2025. Discounts and allowances related to these sales totaled $40,511 for the year ended December 31, 2024. Our net sales, cost of sales, and gross profit for the year ended December 31, 2024, were $50,318, $6,357, and $43,961, respectively.

Current report

Selling and marketing expenses totaled $189,323 for the year ended December 31, 2024, which were driven by our marketing efforts related to our first seven cosmetic skincare products launched in 2024.

Current report

Research and development expenses decreased by $1,442,908 to $1,054,310 for the year ended December 31, 2024, as compared to the fiscal year 2023. This decrease was partially driven by our strategic realignment that refocused our efforts on cosmetic skincare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that would take more than a year to commercialize. This decrease was also partially due to the termination of employees in non-core or overlapping business areas in the third quarter of 2023 and the first quarter of 2024 and the termination of a lease for redundant facility space.

Current report

Restructuring charges of $726,280 in the year ended December 31, 2023 were related to the post-acquisition integration of AxoBio (as defined in Note 1 to the accompanying consolidated financial statements) following its acquisition in August 2023 and consist primarily of accrued severance from the termination of certain executives serving as part-time consultants and full-time employees in non-core areas or overlapping business functions. See Note 1 to the accompanying consolidated financial statements for additional details regarding the acquisition of AxoBio.

Current report

Other expenses, net, were $5,749,245 for the year ended December 31, 2024, as compared to $10,261,696 for the fiscal year 2023. The decrease in other expenses, net, was primarily driven by an unfavorable change in the fair value of the FPA (as defined in Note 2 to the accompanying consolidated financial statements) of $5,700,451. The year ended December 31, 2023 includes an unfavorable change in the fair value of the FPA of $10,268,130 and interest expense on debt of $853,805. The decreases in the fair value of the FPA were principally related to changes in the price of our Common Stock. These expenses were partially offset by a favorable change in the fair value of derivative liabilities related to the Convertible Notes (as defined in Note 9 to the accompanying consolidated financial statements) of $826,980. See Notes 2 and 9 to the accompanying consolidated financial statements for additional details regarding the FPA and the Convertible Notes, respectively.

Current report

We had a loss from discontinued operations of $1,152,276, net of tax, for the year ended December 31, 2024, which reflects the results of the AxoBio business through the closing of the disposition of AxoBio on March 26, 2024. For the year ended December 31, 2024, we had income from discontinued operations, net of tax, of $760,165. There were no sales of AxoBio’s products from October 2023 through the closing date of the AxoBio Disposition (as define in Note 1 to the accompanying consolidated financial statements). The Company recognized a non-cash gain on the sale of AxoBio of $1,434,479 for the year ended December 31, 2024, due principally to the change in the fair value of the stock consideration between the acquisition of AxoBio in August 2023 and the subsequent disposition of AxoBio in March 2024. See Note 1 to the accompanying consolidated financial statements for additional details regarding the disposition of AxoBio.

Current report

As of December 31, 2024, we had cash of $157,139 and negative working capital of $4,921,151. In addition, we had a net loss from continuing operations of $10,650,464 and negative cash flows from operations of $4,388,948 for the year ended December 31, 2024. Since our inception, we have financed operations principally through our issuances of equity securities and debt financing. In addition to the cost savings from the elimination of non-core areas or overlapping business functions in both the third quarter of 2023 and the first quarter of 2024 and the reduction of expenses resulting from the deposition of AxoBio in March 2024, we have refocused our efforts on cosmetic skincare and haircare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that would take more than a year to commercialize.

Current report

Net cash used in operating activities for the year ended December 31, 2024 decreased by $3,959,260 as compared to the same period of 2023. This decrease was primarily driven by the cost reductions related to our restructuring activities, as discussed above.

Current report

For the year ended December 31, 2024, we paid $748,796 of costs in connection with the disposition of AxoBio.
Removed paragraphs (23)

Previous report

We are developing and plan to begin the commercial launch of our line of cosmetic skincare products in the first half of 2024. We plan to employ an omni-channel distribution strategy and sell our products online through direct e-commerce channels and through retailers and distributors in the United States.

Previous report

On the Closing Date, we consummated the Business Combination pursuant to the Business Combination Agreement, following which Legacy Carmell became a wholly owned subsidiary of the Company. Pursuant to the Business Combination Agreement, on the Closing Date, Alpha changed its name to “Carmell Therapeutics Corporation” and Legacy Carmell changed its name to “Carmell Regen Med Corporation.” See “Recent Developments” in Part I, Item 1. “Business” in this Annual Report for additional information regarding the Business Combination.

Previous report

On August 9, 2023, we completed the AxoBio Acquisition pursuant to the Merger Agreement. At the Merger Effective Time, each share of AxoBio Common Stock (other than Dissenting Shares (as defined in the Merger Agreement) and shares held as treasury stock) issued and outstanding as of immediately prior to the Merger Effective Time was canceled and converted into the right to receive a pro rata share of:

Previous report

$8.0 million in cash, or the “Closing Cash Consideration, payable upon delivery of AxoBio’s audited financial statements;

Previous report

3,845,337 shares of Common Stock and 4,243 shares of Series A Preferred Stock, or the Closing Share Consideration, issued upon the Merger Closing Date; and

Previous report

up to $9 million in cash and up to $66 million in shares of Common Stock that, in each case, were subject to the Earnout.

Previous report

See “Recent Developments” in Part I, Item 1. “Business” in this Annual Report for additional information regarding the AxoBio Acquisition.

Previous report

On March 20, 2024, we entered into the Purchase Agreement with the Buyers, the former stockholders of AxoBio, for the AxoBio Disposition. The AxoBio Disposition, as contemplated by the Purchase Agreement, closed on March 26, 2024. In connection with the AxoBio Disposition, upon the terms and subject to the conditions set forth in the Purchase Agreement, we will sell all of the outstanding limited liability company interests of AxoBio to the Buyers in exchange for the return of the Closing Share Consideration, the cancellation of the notes payable by the Company to the Buyers in an aggregate principal amount of $8 million issued as the Closing Cash Consideration and termination of the Company’s obligations with respect to the Earnout. AxoBio did not produce any revenue from its products from November 2023 onward, and revenue from such products is not anticipated in the future. See “Recent Developments” in Part I, Item 1. “Business” in this Annual Report for additional information regarding the AxoBio Disposition.

Previous report

In accordance with Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements, Discontinued Operations, Other Presentation Matters, the assets and liabilities of AxoBio are classified as available for sale on the accompanying consolidated balance sheets, and the results of its operations are reported as discontinued operations in the accompanying consolidated statements of operations.

Previous report

Total operating expenses were $5,943,556 and $5,507,641 for the years ended December 31, 2023 and 2022, respectively. This increase reflects a higher level of expenses in 2023 resulting from the execution of our strategic plan to commercialize our technologies.

Previous report

Research and development expenses were $2,497,218 and $2,196,063 for the years ended December 31, 2023, and 2022, respectively. This increase was principally due to an increase in salaries and benefits of our research and development personnel.

Previous report

Depreciation and amortization expense was $97,113 for the year ended December 31, 2023, in line with $94,298 for the comparable period of 2022.

Previous report

Restructuring charges of $726,280 for the year ended December 31, 2023, were related to our strategic realignment and consist of severance from the termination of employees in non-core areas or overlapping business functions (see “Restructuring” below).

Previous report

Other expenses, net were $10,261,696 for the year ended December 31, 2023, as compared to $3,543,693 in 2022. The increase between periods was primarily due to an unfavorable change in the fair value of the Forward Purchase Agreement of $10,268,130 since the Closing Date, partially offset by a decrease of $2,859,950 in interest expense and the amortization of debt discount, reflecting a lower level of average debt outstanding in 2023. In addition, the 2022 fiscal year includes a loss on debt extinguishment of $1,064,692.

Previous report

Excluding the impact of a $13,482,292 reduction in the Earnout liability, the Company had a loss from discontinued operations of $12,722,127, net of tax, in 2023, which reflects the results of the AxoBio business from the closing of the AxoBio Acquisition through December 31, 2023. Quarterly sales from AxoBio's products for the fourth quarter of 2023 were only $800,000, and there has been no revenue from the sale of AxoBio's products since October 2023. This decrease was driven by uncertainty relating to Medicare reimbursement for numerous wound healing products, including AxoBio’s products. See Note 1 and Note 15 to the accompanying consolidated financial statements.

Previous report

As of December 31, 2023, we had cash of $2,912,461 and an accumulated deficit of $58,503,401. Since inception through December 31, 2023, we have financed operations principally through public and private issuances of equity securities and debt financing. Further, we received $13,415,542 in proceeds from the Business Combination, net of $17,535,632 remitted to Meteora under the Forward Purchase Agreement and tax obligations assumed. We incurred approximately $1,600,000 of transaction costs related to the Business Combination, consisting of banking, legal, and other professional fees, which were recorded as a reduction of proceeds to additional paid-in capital. See Note 1 to the accompanying consolidated financial statements.

Previous report

During the third quarter of 2023, we significantly reduced our future operating expenses by terminating certain executives serving as part-time consultants and full-time employees in non-core areas or overlapping business functions. This workforce reduction is expected to result in $2,000,000 to $3,000,000 in annual savings. In addition, we have refocused our research and development efforts on aesthetic products that have near-term commercial potential and have reprioritized further development and ceased clinical studies of product candidates that will take more than a year to commercialize. We also expect to further reduce our expenses as a result of the AxoBio Divestiture. Management anticipates that these cost-saving efforts will assist us in extending our cash runway.

Previous report

Net cash used in operating activities for the year ended December 31, 2023 increased by $4,919,501 as compared to 2022. This increase was primarily driven by a higher net loss, an increase in prepaid expenses, and decreases in accounts payable and accrued expenses and other liabilities.

Previous report

Net cash used in investing activities was $30,470 for the year ended December 31, 2023, as compared to $7,164 for the year ended December 31, 2022 due to slightly higher purchases of equipment.
Reworded paragraphs (15)

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying audited consolidated financial statements and the related notes contained in Part II, Item 8 of this Annual Report. Certain information in this discussion and analysis or as set forth elsewhere in this Annual Report contains forward-looking statements that involve numerous risks and uncertainties, including, but not limited to, those described under the section entitled “Forward-Looking Statements” in Part I, Item 1. “Business” in this Annual Report and under Part I, Item 1A. “Risk Factors” in this Annual Report. We assume no obligation to update any of these forward-looking statements. Actual results may differ materially from those contained in any forward-looking statements.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying consolidated financial statements and the related notes contained in Part II, Item 8 of this Annual Report. Certain information in this discussion and analysis or as set forth elsewhere in this Annual Report contains forward-looking statements that involve numerous risks and uncertainties, including, but not limited to, those described under the section entitled “Forward-Looking Statements” in Part I, Item 1. “Business” in this Annual Report and under Part I, Item 1A. “Risk Factors” in this Annual Report. We assume no obligation to update any of these forward-looking statements. Actual results may differ materially from those contained in any forward-looking statements.

Previous wording

Carmell is a bio-aesthetics company that utilizes the Carmell Secretome TM to support skin and hair health. The Carmell Secretome TM consists of a potent cocktail of growth factors and proteins extracted from allogeneic human platelets sourced from U.S. Food and Drug Administration-approved tissue banks. Over the past 7 years, Carmell has extensively tested the technology underpinning the Carmell Secretome TM. In addition, we have developed a novel microemulsion formulation that enables delivery of lipophilic and hydrophilic ingredients without relying on the Foul Fourteen TM, which are 14 potentially harmful excipients that are commonly used by other companies to impart texture, stability, and other desirable physicochemical attributes to cosmetic products. Additionally, Carmell’s microemulsion formulations do not utilize mineral or vegetable oils across its entire product line and are designed to be non-comedogenic. We are also developing a line ofmen’s products and a line of topical haircare products. All of our cosmetic skincare and haircare products are tailored to meet the demanding technical requirements of professional care providers and discerning retail consumers. Our product pipeline also includes innovative regenerative bone and tissue healing products that are under development.

Current wording

We are focused on longevity and healthy aging, encompassing the latest scientific advances in regenerative bio-aesthetics. Our products are aimed to help people look and feel their best at any age. We currently have two cosmetic product lines, Carmell Secretome TM and Elevai Exosomes TM, that support skin and hair health. All of our cosmetic skincare and haircare products are tailored to meet the demanding technical requirements of professional care providers and discerning retail consumers. Our product pipeline also includes innovative regenerative bone and tissue healing products on which further research and development has been paused.

Previous wording

On August 1, 2023, the Company filed an amendment to its Third Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to change its name to “Carmell Corporation.”

Current wording

On March 6, 2025, we filed an amendment to our Third Amended and Restated Certificate of Incorporation, as amended, with the Delaware Secretary of State to change our name from “Carmell Corporation” to “Longevity Health Holdings, Inc.”

Previous wording

Economic uncertainty in various global markets caused by political instability and conflicts, such as the ongoing conflicts in Ukraine and Israel, and economic challenges have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability, and supply chain interruptions, which have caused record inflation globally. Our business, financial condition, and results of operations could be materially and adversely affected by further negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Although, to date, our results of operations have not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations may be impacted in the short and long term. The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, the effects of the Russian sanctions, the conflict between Israel and Hamas, geopolitical tensions, inflation, or otherwise, are impossible to predict. Any such disruptions may also magnify the impact of other risks described or incorporated by reference in this Annual Report.

Current wording

Economic uncertainty in various global markets caused by political instability and conflicts, such as the Russia-Ukraine war, the regional conflict in the Middle East (including the Israel-Hamas war), geopolitical tensions between the United States and China, and proposed tariffs and other trade restrictions by the U.S. government and foreign governments have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability, supply chain interruptions, high levels of inflation and fluctuating interest rates. Our business, financial condition, and results of operations could be materially and adversely affected by further negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Although, to date, our results of operations have not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations may be impacted in the short and long term. The extent and duration of these market disruptions are impossible to predict. Any such disruptions may also magnify the impact of other risks described or incorporated by reference in Part I, Item 1A. "Risk Factors" in this Annual Report.

Previous wording

The audited consolidated financial statements included elsewhere herein for the year ended December 31, 2023, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. However, as of December 31, 2023, we had cash and cash equivalents of $2,912,461, an accumulated deficit of $58,503,401 and liabilities of $39,199,793. We have incurred substantial recurring losses from continuing operations, have used, rather than provided, cash from our continuing operations and are dependent on additional financing to fund future operations. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. The audited consolidated financial statements included elsewhere herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

Current wording

The audited consolidated financial statements included elsewhere herein for the year ended December 31, 2024, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. As of December 31, 2024, we had negative net working capital of $4,921,151, a net loss from continuing operations of $10,650,464, and negative net cash flow from operations of $4,388,948. We have incurred substantial recurring losses from continuing operations, have used, rather than provided, cash from our continuing operations, and are dependent on additional financing to fund future operations. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. The audited consolidated financial statements included elsewhere herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

Previous wording

In the third quarter of 2023, we significantly reduced our future operating expenses by terminating certain executives serving as part-time consultants and full-time employees in non-core areas or overlapping business functions. This workforce reduction is expected to result in $2,000,000 to $3,000,000 in annual savings. In addition, we have refocused our research and development efforts on aesthetic products that have near-term commercial potential and have reprioritized further development and ceased clinical studies of product candidates that will take more than a year to commercialize. We are also exploring out-licensing certain research and development programs to generate non-dilutive liquidity. Furthermore, we expect the sale of AxoBio will further reduce our operating expenses, which is anticipated to assist us in extending our cash runway.

Current wording

We are also exploring out-licensing certain research and development programs to enhance our liquidity.

Previous wording

General and administrative expenses were $2,622,495 and $3,217,280 for the years ended December 31, 2023 and 2022, respectively. This decrease was primarily driven by the $1,278,062 write-off of costs associated with the Company's aborted initial public offering in October 2022, prior to pursuing the Business Combination. The decrease in general and administrative expenses was partially offset by an increase in salaries and benefits for personnel.

Current wording

General and administrative expenses were $3,715,340 and $2,622,945 for the years ended December 31, 2024 and 2023, respectively. This increase was primarily driven by an increase in insurance costs and salaries and benefits for personnel. In addition, we began to realize savings from the cost reductions discussed above which partially offset the increase in expenses.

Previous wording

In addition to the anticipated cost savings from the restructuring detailed below and the completed sale of AxoBio, we plan to launch a line of cosmetic skincare products in the first half of 2024 based on the technologies we developed through our research and development activities. Management anticipates that revenue from the commercialization of its cosmetic skincare products and the anticipated cost savings from the restructuring will assist us in extending our cash runway. In addition, we are exploring out-licensing of certain research and development programs to generate non-dilutive liquidity.

Current wording

Late in the second quarter of 2024, we began the launch of our cosmetic skincare products based on the Carmell Secretome™. In addition, we completed the Elevai Acquisition on January 16, 2025. The acquired business had revenue of approximately $2,500,000 in 2024. Management anticipates that revenue from the continued commercialization of its cosmetic products and the anticipated cost savings from the restructuring activities detailed above will assist us in extending our cash runway. In addition, we are exploring raising additional capital and the out-licensing of certain research and development programs to enhance our liquidity.

Previous wording

However, the cash available to us may not be sufficient to allow us to operate for the next 12 months due to our current and potential liabilities. We may need to raise additional capital through equity or debt issuances. If we are unable to raise additional capital, we may be required to take additional measures to conserve liquidity, which could include, but not necessarily be limited to, curtailing operations and reducing overhead expenses. We cannot provide any assurance that new financing will be available on commercially acceptable terms, if at all, or will be completed on a timely basis. These conditions raise substantial doubt about our ability to continue as a going concern.

Current wording

However, the cash available to us may not be sufficient to allow us to operate for the next 12 months due to our current and potential liabilities. We may need to raise additional capital through equity or debt issuances. If we are unable to raise additional capital, we may be required to take additional measures to conserve liquidity, which could include, but not necessarily be limited to, curtailing operations and reducing overhead expenses. We cannot provide any assurance that any new financing will be available on commercially acceptable terms, if at all, or will be completed on a timely basis. These conditions raise substantial doubt about our ability to continue as a going concern.

Previous wording

The accompanying audited consolidated financial statements have been prepared in conformity with GAAP, which contemplates the continuation of the Company as a going concern, the realization of assets, and the satisfaction of liabilities in the ordinary course of business. The audited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty, or that may be necessary should we be unable to continue as a going concern.

Current wording

The accompanying consolidated financial statements have been prepared in conformity with GAAP, which contemplates the continuation of the Company as a going concern, the realization of assets, and the satisfaction of liabilities in the normal course of business. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty, or that may be necessary should we be unable to continue as a going concern.

Previous wording

As of December 31, 2023, we had outstanding indebtedness with principal totaling $1,308,147 as of December 31, 2023 (Note 8 to the accompanying consolidated financial statements). In addition, the Holders of the Convertible Notes have demanded additional payment of principal and interest on the Convertible Notes and certain payments with respect to the Convertible Note Warrants, as more fully described under the section Contingencies below.

Current wording

As of December 31, 2024, we had outstanding debt totaling $241,158 related to the financing of premiums on our insurance programs. In the first quarter of 2024, the Board elected to repay all of the 2023 Promissory Notes (as defined in Note 9 to the accompanying consolidated financial statements) maturing in 2024 in shares of Common Stock in accordance with the terms of the 2023 Promissory Notes. During the year ended December 31, 2024, all of the 2023 Promissory Notes with an aggregate principal amount of $848,500 were repaid through the issuance of an aggregate of 328,707 shares of Common Stock (see Note 9 to the accompanying consolidated financial statements for additional information). In addition, the Holders (as defined in Note 9 to the accompanying consolidated financial statements) of the Convertible Notes have demanded additional payment of principal and interest on the Convertible Notes and certain payments with respect to the Convertible Note Warrants (as defined in Note 9 to the accompanying consolidated financial statements), as more fully described in Note 11 to the accompanying consolidated financial statements.

Previous wording

Net cash provided by financing activities was $11,162,990 for the year ended December 31, 2023, as compared to $3,551,658 for the year ended December 31, 2022. This increase was primarily due to the proceeds of $30,951,174 from the Business Combination and $1,859,980 in proceeds from the issuance of debt in 2023, partially offset by the cash transferred in connection with the Forward Purchase Agreement of $17,535,632 and $2,649,874 of payments on the Company's Convertible Notes.

Current wording

Net cash provided by financing activities was $2,382,422 for the year ended December 31, 2024, as compared to $11,162,990 for the year ended December 31, 2023. During the year ended December 31, 2024, we closed the 2024 Private Placement (as defined in Note 13 to the accompanying consolidated financial statements), which provided net proceeds of $2,687,225. Financing activities in 2023 were driven by the proceeds of $30,951,174 from the Business Combination (as defined in Note 1 to the accompanying consolidated financial statements) and $1,859,980 in proceeds from the issuance of debt and warrants, partially offset by the cash transferred in connection with the FPA of $17,535,632. During the year ended December 31, 2023, we repaid $2,649,874 to the Holders of the Convertible Notes upon the closing of the Business Combination.

Previous wording

On November 8, 2023, Puritan filed a complaint captioned Puritan Partners LLC v. Carmell Regen Med Corporation et al., No. 655566/2023 (New York Supreme Court, New York County) naming the Company as defendant. In the complaint, Puritan asserts that the Company breached its obligations under the Convertible Notes and the Convertible Note Warrants. Puritan also asserts the Company did not comply with its obligations to provide Puritan with 25,000 freely tradeable shares on a timely basis. Puritan asserts claims for declaratory judgment, breach of contract, conversion, foreclosure of its security interest, replevin, unjust enrichment, and indemnification, and seeks remedies including damages totaling $2,725,000 through November 1, 2023, additional fees and interest thereafter, costs and attorney’s fees, an order of foreclosure on its security interest, and other declaratory relief. The Company has moved to dismiss the complaint and intends to defend itself vigorously against this litigation.

Current wording

On November 8, 2023, Puritan filed a complaint captioned Puritan Partners LLC v. Carmell Regen Med Corporation et al., No. 655566/2023 (New York Supreme Court, New York County) naming the Company as defendant. In the complaint, Puritan asserts that we breached our obligations under the Convertible Notes and the Convertible Note Warrants. Puritan also asserts we did not comply with our obligation to provide Puritan with 25,000 freely tradeable shares of Common Stock on a timely basis. Puritan asserts claims for declaratory judgment, breach of contract, conversion, foreclosure of its security interest, replevin, unjust enrichment, and indemnification, and seeks remedies including damages totaling $2,725,000 through November 1, 2023, additional fees and interest thereafter, costs and attorney’s fees, an order of foreclosure on its security interest, and other declaratory relief. The Company carried an accrual for interest payable of $1,175,845 as of December 31, 2024 and 2023, related to the Convertible Notes. In July 2024, the Court dismissed four of the eight claims in the complaint without prejudice. The case is currently in the discovery phase with respect to the remaining claims, which is expected to last through June 2025. We intend to defend ourselves vigorously against this litigation. However, there can be no assurance that this matter will be resolved in our favor, and an adverse outcome could have a material adverse effect on our financial condition.

Previous wording

In addition to financing obligations under our debt agreements, our contractual and commercial commitments include expenditures for operating leases and royalty payments. For further information on our license agreement (see Note 10 to the accompanying consolidated financial statements included herein).

Current wording

In addition to financing obligations under our debt agreements, our contractual and commercial commitments include expenditures for operating leases and royalty payments. In accordance with the terms of the Yuva License, the Company is obligated to pay minimum royalties (as specified in the agreement) to Yuva based on the completion of a joint clinical trial and earned royalties based on net sales of Elevai products. Also, see Note 11 to the accompanying consolidated financial statements for information on our Amended License Agreement with CMU related to our bone and tissue healing products on which further research and development has been paused.

Previous wording

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million, and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year, and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time that we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our

Current wording

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million, and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year, and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time that we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Economic uncertainty in various global markets caused by political instability and conflicts, such as the ongoing conflicts in Ukraine and Israel, and economic challenges, including those related to the COVID-19 pandemic, have led to market disruptions, such as significant volatility in commodity prices, credit and capital market instability, and supply chain interruptions, which have caused record inflation globally. Our business, financial condition, and results of operations could be materially and adversely affected by further negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Although, to date, our results of operations have not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations may be impacted in the short and long term. The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, the effects of the Russian sanctions, the conflict between Israel and Hamas, geopolitical tensions, inflation, or otherwise, are impossible to predict. Any such disruptions may also magnify the impact of other risks described or incorporated by reference in this Annual Report. See Part I, Item 1A, “Risk Factors” in this Annual Report for further discussion of the potential impact of these general macroeconomic factors and other risks on our business.

Previous report — wording carried elsewhere

Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.