Financial Results - Longevity Health Holdings, Inc. announced preliminary unaudited financial results for Q1 2025, with specific figures to be finalized later[7]. - The company has not yet provided specific revenue figures for the first quarter of 2025, pending finalization of financial statements[7]. Merger Details - The company is in the process of a proposed merger with 20/20 Biolabs, Inc., with expectations regarding the ownership structure and operational synergies post-merger[10]. - The anticipated timing for the closing of the merger is still under discussion, with various conditions that need to be satisfied[10]. - The company is preparing to file relevant materials with the SEC regarding the merger, including a Form S-4 and Proxy Statement[14]. - The merger is expected to result in operational savings and synergies, although specific financial projections are not yet disclosed[10]. - Risks associated with the merger include potential delays in obtaining necessary approvals and maintaining Nasdaq listing[10]. - Management is aware of the significant uncertainties surrounding the merger and its potential impact on future operations[12]. - Investors are encouraged to review all relevant documents filed with the SEC for detailed information regarding the merger[15]. Future Focus - The company is focused on launching and commercializing new products, which is expected to enhance future revenue streams[10].

Corporate Actions - The company executed a reverse stock split at a ratio of 1:30, reducing the number of outstanding shares from approximately 30.1 million to about 1 million shares [131][132]. - The merger agreement with 20/20 Biolabs includes a requirement for the company to raise a minimum of $4 million in concurrent financing, with up to $2 million allowed as debt [134]. - The company completed the acquisition of Elevai Skincare, Inc., involving the issuance of 38,308 shares of common stock and a cash payment of $56,525 contingent on product sales [136][137]. Financial Performance - As of March 31, 2025, the company reported a negative net working capital of $3,805,736 and a net loss from continuing operations of $1,505,867, with negative cash flow from operations of $752,953 for the three months ended March 31, 2025 [149][150][158]. - Gross sales for the three months ended March 31, 2025, were $534,943, resulting in net sales of $510,353 and a gross profit of $269,823 [153][154]. - Operating expenses increased by 29% to $1,776,574 for the three months ended March 31, 2025, compared to $1,380,345 in the same period of 2024 [153]. - Research and development expenses decreased by 54% to $196,912 in the first quarter of 2025, down from $429,420 in the same period of 2024 [156]. - The company completed the Elevai Acquisition on January 16, 2025, which generated approximately $2.5 million in revenue in 2024 [151][160]. - The net loss from continuing operations decreased by 58% from $3,553,162 in the first quarter of 2024 to $1,505,867 in the first quarter of 2025 [165]. Compliance and Regulatory Issues - The company received Nasdaq delisting notices due to failing to meet the minimum market value of listed securities requirement of $35 million and the minimum bid price requirement of $1 per share [141][142]. - The Nasdaq Hearings Panel granted the company an additional compliance period until September 2, 2025, to regain compliance with listing requirements [144]. - The company believes that the merger and reverse stock split may help regain compliance with Nasdaq's listing requirements, but there are no guarantees [145]. Economic Factors - Economic uncertainties, including geopolitical tensions and inflation, could materially affect the company's financial condition and results of operations [146]. Capital and Liquidity - Net cash provided by financing activities was $1,515,861 for the three months ended March 31, 2025, compared to cash used in financing activities of $195,726 for the same period in 2024 [167]. - The company is exploring raising additional capital and out-licensing certain research and development programs to enhance liquidity [152][160]. - As of March 31, 2025, the company had outstanding debt totaling $119,409 related to insurance premium financing [163]. - The company anticipates that revenue from the continued commercialization of its cosmetic products will assist in extending its cash runway [160].

Acquisition and Financials - The company completed the Elevai Acquisition on January 16, 2025, acquiring assets with net sales of approximately $2,500,000 for the year ended December 31, 2024[13]. - The company raised gross proceeds of $1,851,849 from a private placement of 8,065,210 shares at an exercise price of $0.23 per share on January 2, 2025[12]. - The company is obligated to pay CMU royalties at a rate of 2.07% of net sales and 25% of sublicense fees received, although no royalties have been accrued or paid as no products utilizing the licensed technology have been commercialized[42]. Market Overview - The skincare and haircare markets were approximately $280 billion in 2022, expected to grow at a 6.4% CAGR[27]. - The medical aesthetics market is growing 36% faster than pharmaceuticals, indicating a strong demand for cosmetic products[27]. Product Lines and Launches - The company has two cosmetic product lines, Carmell Secretome™ and Elevai Exosomes™, aimed at supporting skin and hair health[11]. - The Elevai Exosomes™ skincare products include Elevai Empower™ and Elevai Enfinity™, designed for post-treatment support and daily aftercare[24]. - The company’s Carmell Secretome™ utilizes a proprietary formulation with over a thousand growth factors, proteins, and peptides[16]. - The company plans to launch the Undereye Collection and Body and Décolleté Collection in the second quarter of 2025[21]. - The Elevai Renew™ Scalp Serum, promoting healthy hair growth, was launched in the first quarter of 2025[26]. Regulatory and Compliance - Legacy Carmell's BHA product candidate has been submitted to the FDA as an Investigational New Drug (IND) for severe open tibia fractures, with a fast-track designation granted due to its potential to meet significant unmet needs[38]. - The FDA requires rigorous preclinical and clinical testing for the company's biological products, including BHA and THA, before marketing approval can be obtained[55]. - The company is subject to extensive regulations by the FDA, CPSC, and FTC regarding the marketing and safety of its cosmetic products[46]. - The Amended License Agreement with CMU requires the company to meet specific milestones, including CE Mark submission by December 31, 2023, and FDA BLA submission by December 31, 2026[44]. - The last-to-expire patent related to the technology under the Amended License Agreement is expected to expire on September 2, 2030[41]. Operations and Workforce - The company has ceased clinical studies of its product candidates to focus on the near-term commercialization of its cosmetic skincare and haircare product lines following the AxoBio Acquisition[38]. - As of March 27, 2025, the company has 15 full-time employees, and it aims to maintain a positive work environment to attract and retain qualified staff[61]. - The company has experienced no disruptions in its supply chain and actively works to optimize operations as sales of its cosmetic products grow[58]. - The company focuses on selling products through business-to-business, direct-to-consumer, and distributor sales channels[28].

Financial Performance - Gross revenue for Q3 2024 was $58,915, with net revenue of $20,519 after discounts and allowances of $38,396[149] - Gross revenue for the nine months ended September 30, 2024, was $71,235, with net revenue of $32,839 after discounts and allowances of $38,396[158] - The loss from operations improved by 50% to $(1,419,789) in Q3 2024 from $(2,848,285) in Q3 2023[149] - Net loss before taxes improved by $6,460,131, or 40%, to $(9,736,181) from $(16,196,312) in the same period of 2023[166] Expenses - Research and development expenses decreased by $1,259,093 to $331,806 in Q3 2024, reflecting a strategic realignment towards cosmetic skincare products[152] - Research and development expenses decreased by $2,289,589 to $865,292, a reduction of 73% compared to the same period in 2023[160] - General and administrative expenses increased to $965,622 in Q3 2024, up from $507,948 in Q3 2023, primarily due to higher insurance costs and personnel expenses[153] - General and administrative expenses increased to $2,957,890, up 79% from $1,655,846 in the same period of 2023[161] - Total operating expenses decreased by 50% to $1,435,468 in Q3 2024 compared to $2,848,285 in Q3 2023[149] - Total operating expenses decreased by $1,591,212, or 28%, to $4,019,328 compared to $5,610,540 in the prior year[160] - Other expenses, net, were $1,458,692 in Q3 2024, significantly reduced from $6,210,360 in Q3 2023, driven by changes in the fair value of the Forward Purchase Agreement[155] Cash Position - The company had cash of $1,137,325 and an accumulated deficit of $67,957,379 as of September 30, 2024[147] - Cash used in operating activities decreased by $1,320,125 to $(3,616,885) compared to $(4,937,010) in the prior year[172] - Net cash provided by financing activities was $2,590,545, a decrease of $9,344,689 from $11,935,234 in the same period of 2023[174] Strategic Initiatives - The company launched five cosmetic skincare products in 2024 and plans to launch an additional seven products in the next six months[150] - The company plans to launch seven additional cosmetic skincare products over the next six months[158] - The company is exploring raising additional capital and developing haircare products based on the Carmell Secretome™[167] - The appointment of Kendra Bracken-Ferguson as CEO is expected to enhance the company's strategic direction in the beauty and wellness industries[141] Financing Activities - The company closed a Private Placement in April 2024, receiving gross proceeds of $3,001,235[148]

Revenue Performance - Revenue for the three months ended June 30, 2024, was $12,320, reflecting a 100% increase due to the launch of the first three cosmetic skincare products [163]. - Revenue for the six months ended June 30, 2024, was $12,320, reflecting a 100% increase due to the launch of three cosmetic skincare products [172]. Gross Profit and Expenses - Gross profit for the same period was $12,028, with a cost of goods sold of $292, indicating strong initial sales performance [164]. - Gross profit for the same period was $12,028, with a cost of goods sold of $292 [172]. - Research and development expenses decreased by $719,591 to $104,066, a reduction of 87%, due to a strategic realignment focusing on near-term commercial products [166]. - Research and development expenses decreased by $1,030,496 to $533,486, a reduction of 66% compared to the same period in 2023 [174]. - General and administrative expenses increased to $1,064,874, up 67% from $637,453 in the prior year, primarily driven by higher insurance costs and personnel expenses [167]. - General and administrative expenses increased to $1,992,268, up 74% from $1,147,898 in 2023 [175]. - Other expenses, net, were $2,113,051, a decrease of 45% from $3,821,568 in the same period of 2023, reflecting improved financial management [168]. Cash Flow and Financial Position - Cash as of June 30, 2024, was $2,198,275, with an accumulated deficit of $65,078,898 and total liabilities of $6,405,627, raising concerns about the company's ability to continue as a going concern [161]. - Net cash used in operating activities increased by $1,258,117 to $2,214,254 for the six months ended June 30, 2024 [185]. - Net cash provided by financing activities was $2,248,864, significantly higher than $874,378 in the same period of 2023 [187]. - As of June 30, 2024, the company had cash of $2,198,275 and an accumulated deficit of $65,078,898 [179]. - The company faces substantial doubt about its ability to continue as a going concern due to insufficient cash to operate for the next 12 months [181]. Strategic Initiatives - The company plans to commercially launch its line of cosmetic skincare products in the first half of 2024, utilizing an omni-channel distribution strategy [151]. - The appointment of Kendra Bracken-Ferguson as Chief Executive Officer is expected to enhance the company's strategic direction and market presence [152]. - The company anticipates revenue growth from its cosmetic skincare products and is exploring haircare product development based on the Carmell Secretome™ [180]. Dispositions and Financing - The company closed a Private Placement on April 11, 2024, raising gross proceeds of $3,001,235 from the sale of 1,331,452 shares of Common Stock [156]. - The AxoBio Disposition was completed on March 26, 2024, resulting in the cancellation of $8,000,000 in notes payable and the termination of related obligations [157]. Net Loss - Net loss from continuing operations was $6,857,700, a 4% improvement from a loss of $7,137,667 in the prior year [171].

Financial Performance - For the three months ended March 31, 2024, total operating expenses were $1,380,345, an increase of 8% from $1,274,871 in the same period of 2023[152]. - The net loss before taxes for Q1 2024 was $3,553,162, a 94% increase compared to a net loss of $1,828,715 in Q1 2023[152]. - Other expenses, net, increased significantly to $2,172,817 in Q1 2024 from $553,844 in Q1 2023, primarily due to unfavorable changes in the fair value of the Forward Purchase Agreement[156]. - Net cash used in operating activities for Q1 2024 was $(1,075,778), an increase of $599,819 compared to Q1 2023, primarily due to cash used in AxoBio's operations of $1,033,586[163][164]. - Net cash used in financing activities was $(195,726) for Q1 2024, compared to net cash provided of $375,000 in Q1 2023, reflecting a decrease of $570,726[166]. Expenses Breakdown - Research and development expenses decreased by 42% from $740,325 in Q1 2023 to $429,420 in Q1 2024, reflecting a strategic realignment towards aesthetic products with near-term commercial potential[154]. - General and administrative expenses rose by 82% from $510,445 in Q1 2023 to $927,394 in Q1 2024, primarily due to increased insurance costs and personnel expenses[155]. - The company incurred $748,796 in costs related to the AxoBio Disposition during the three months ended March 31, 2024[165]. Cash Position and Debt - The company had cash of $892,161 and an accumulated deficit of $61,774,360 as of March 31, 2024, raising substantial doubt about its ability to continue as a going concern[150]. - As of March 31, 2024, the company had outstanding indebtedness totaling $736,577, with $375,000 of Promissory Notes maturing and repaid through the issuance of 115,820 shares of Common Stock[162]. Strategic Initiatives - The company plans to launch a line of cosmetic skincare products in the second quarter of 2024, utilizing technologies developed through its research and development efforts[159]. - The company anticipates that revenue from the commercialization of its cosmetic skincare products will assist in extending its cash runway[159]. - The company is exploring out-licensing certain research and development programs to generate non-dilutive liquidity[159]. Legal and Compliance Issues - The company is facing a legal complaint from Puritan, claiming damages totaling $2,725,000 related to breaches of obligations under Convertible Notes and Warrants[167][168]. - The company qualifies as an "emerging growth company" and has opted not to "opt-out" of the extended transition period for new accounting standards[170]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[171]. Disposition and Gains - The AxoBio Disposition closed on March 26, 2024, resulting in a non-cash gain of $1,534,479 due to changes in the fair value of stock consideration[157].

Business Combinations and Acquisitions - The business combination with Alpha Healthcare Acquisition Corp. III was completed on July 14, 2023, with an exchange ratio of 0.06154 for Legacy Carmell common stock[14]. - The acquisition of Axolotl Biologix was finalized on August 9, 2023, with a total closing share consideration of $57 million based on a 30-day average daily VWAP of $7.05 per share[24]. Financial Information - The total redemption price for 12,586,223 shares of Class A Common Stock was approximately $29.37 million, with a cash redemption price of about $10.28 per share[15]. - The Forward Purchase Agreement involved the purchase of 1,705,959 shares of Class A Common Stock at a price of $10.28 per share, totaling $17.54 million[17]. - The Reset Price for the Forward Purchase Agreement is initially set at $11.50, with adjustments based on the VWAP Price of the shares[22]. Product Development and Pipeline - Carmell's product pipeline includes innovative regenerative bone and tissue healing products currently under development[13]. - The Carmell Secretome™ is derived from allogeneic human platelets and contains over 1000 growth factors, proteins, and peptides, designed to support skin and hair health[29]. - The company has developed a novel microemulsion formulation that enhances ingredient delivery without using harmful excipients or oils, ensuring non-comedogenic properties[32]. - The first cosmetic skincare product, Carmell G.L.E.E, was launched in March 2024, with nine additional products in the pipeline[35]. - The company has submitted its BHA product candidate to the FDA as an Investigational New Drug (IND) for severe open tibia fractures[42]. - The FDA granted fast-track designation for the BHA program, indicating significant unmet medical needs[44]. - The company has conducted multiple preclinical studies supporting BHA's potential to heal wounds and accelerate bone healing[42]. Market and Distribution Strategy - The skincare and haircare markets were approximately $280 billion in 2022, expected to grow at a 6.4% CAGR[37]. - The company plans to employ an omnichannel distribution strategy, focusing on both national retailers and e-commerce channels[38][43]. - The company is also expanding its product line to include men's products and topical haircare products tailored for professional care providers and retail consumers[13]. Regulatory and Compliance - The company is subject to extensive FDA regulations, which continue after product approval, particularly regarding good manufacturing practices (GMP)[65]. - The company must comply with FDA advertising and promotion requirements, including restrictions on off-label use[66]. - The company has not accrued or paid royalties under the Amended License Agreement as no products utilizing the licensed technology have been commercialized[49]. - The Amended License Agreement with Carnegie Mellon University is effective until January 30, 2028, or until the last patent expires in September 2030[48]. - The company is required to meet minimum performance requirements, including FDA BLA submission by December 31, 2026[50]. Operations and Workforce - The company operates in one segment focused on the development and commercialization of bio-aesthetic and bone and tissue healing products[73]. - The company has nine full-time employees and one part-time employee as of March 15, 2024, relying on independent organizations for regulatory approval and clinical management[74]. - The company recognizes the importance of its employees at manufacturing facilities and has programs to ensure operating safety[69]. - The company collaborates with suppliers to meet stringent design and creative criteria, believing it has adequate sources of supply for all products[70]. - The company has experienced no disruptions in its supply chain and actively works to optimize supply chain operations as cosmetic skincare products are commercialized[71]. - The company maintains compliance with numerous environmental, health, and safety laws, which has not materially affected its capital expenditures or earnings[72]. Corporate Information - The company is incorporated under the laws of Delaware and has undergone a merger to facilitate business combinations[75]. - The company’s principal corporate office is located in Pittsburgh, PA[76].

Financial Performance - For the three months ended September 30, 2023, the company reported revenue of $3,728,816, a significant increase compared to the previous year[165]. - Gross profit for the same period was $2,184,990, reflecting a strong performance in revenue generation[165]. - The company incurred a loss from operations of $5,137,373, compared to a loss of $851,923 in the same period last year, indicating increased operational challenges[165]. - Net loss before taxes for the quarter was $11,464,769, which is a decline of $5,397,467 compared to the previous year[165]. - Revenue for the nine months ended September 30, 2023, was $3,728,816, reflecting a significant increase compared to the previous year[175]. - Gross profit for the same period was $2,184,990, indicating a strong performance in the company's commercial activities[175]. - The company reported a net loss of $18,602,436 for the nine months ended September 30, 2023, compared to a loss of $5,936,114 in the same period of 2022[175]. Operating Expenses - Total operating expenses reached $7,322,363, an increase of $6,470,440 from the previous year, primarily driven by research and development and selling and marketing expenses[165]. - Total operating expenses for the nine months ended September 30, 2023, were $10,084,618, up from $7,364,979 in 2022, primarily due to the inclusion of AxBio's expenses[179]. - Research and development expenses increased to $3,235,888 for the nine months ended September 30, 2023, compared to $1,554,602 in 2022, driven by clinical expenses related to Legacy Carmell's BHA product[180]. - Selling and marketing expenses were $3,069,520 for the nine months ended September 30, 2023, reflecting the inclusion of AxBio's costs from August 9, 2023[181]. - Restructuring efforts are expected to yield annual savings of $2,000,000 to $3,000,000 by reducing operating expenses through workforce reductions[192]. Cash and Financing - The company has approximately $7,900,000 in cash and cash equivalents as of September 30, 2023, with an accumulated deficit of approximately $61,171,378[163]. - Cash as of September 30, 2023, was $7,968,502, a significant increase from $128,149 at the end of 2022[186]. - Net cash provided by financing activities increased to $12,411,625 for the nine months ended September 30, 2023, compared to $1,131,631 for the same period in 2022, primarily due to proceeds of $31,050,882 from a Business Combination[197]. Acquisitions and Strategic Changes - The company completed the AxBio Acquisition on August 9, 2023, issuing 3,845,337 shares of common stock and 4,243 shares of Series A Preferred Stock as part of the transaction[154]. - The AxBio Acquisition included up to $8,000,000 in cash and performance-based earn-out considerations totaling up to $66,000,000 in shares of common stock[152]. - A strategic realignment led to the resignation of several executive officers, including the CEO, to streamline operations post-acquisition[158]. Future Plans - The company plans to launch a new line of skin care products in the first quarter of 2024, focusing on aesthetic products with near-term commercial potential[160]. - The company expects continued revenue erosion in Q4 2023 due to uncertainty regarding Medicare reimbursements, which constitute the majority of its revenue stream[178]. - The company plans to launch a line of skin care products in Q1 2024 based on its research and development activities[189]. Legal and Compliance - The company is facing a legal complaint asserting damages totaling $2,725,484 related to breaches of obligations under Convertible Notes and Warrants[198]. - As of September 30, 2023, the company reported no off-balance sheet arrangements[200]. - The company qualifies as an "emerging growth company" and has opted to adopt new accounting standards at the same time as private companies[202]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates expected to be less than $700 million and annual revenue below $100 million[203].

Financial Performance - For the three months ended June 30, 2023, the company reported a net income of $317,511, primarily due to $1,867,614 in dividend and interest income earned in the Trust Account[144]. - For the six months ended June 30, 2023, the company achieved a net income of $893,578, driven by $3,542,896 in dividend and interest income, offset by $1,917,944 in general and administrative costs[145]. - The increase in dividend and interest income for the three months ended June 30, 2023, compared to the same period in 2022, was attributed to rising interest rates[144]. - The company has not generated any operating revenues since its inception and has primarily relied on non-operating income from the Trust Account[143]. Acquisitions and Transactions - The company completed the AxBio Acquisition on August 9, 2023, issuing 3,845,337 shares of common stock and 4,243 shares of Series A Convertible Voting Preferred Stock as part of the consideration[141]. - The total consideration for the AxBio Acquisition included up to approximately $8.0 million in cash and up to $66.0 million in shares of common stock subject to performance-based earn-out[139]. - The company completed the Business Combination on July 14, 2023, receiving $29,376,282 from the Trust Account after redemptions[150]. - The company incurred $9,897,599 in transaction costs during its IPO, which generated gross proceeds of $150,000,000[147]. Financial Position - As of June 30, 2023, the company had a cash balance of $10,243 available for working capital needs, with a working capital deficit of $4,045,630[146]. - Cash available may not be sufficient to operate for at least 12 months, necessitating potential additional capital raises through equity or debt[151]. - The company has no long-term debt or significant liabilities other than a monthly fee of $10,000 for administrative services[149]. Compliance and Regulatory Matters - The company received a notice from Nasdaq regarding non-compliance with the Minimum Public Holders Rule but regained compliance by the Closing Date[152][153]. - There are substantial doubts about the company's ability to continue as a going concern, with no adjustments made in financial statements for potential recovery of assets[154]. Accounting and Reporting - No significant changes to critical accounting estimates and assumptions were noted during the three and six months ended June 30, 2023[155]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards[157]. - The company is evaluating the benefits of reduced reporting requirements under the JOBS Act, which may exempt it from certain disclosures for five years post-IPO[159]. Administrative Costs - The company’s general and administrative costs increased due to activities related to the Business Combination and the AxBio Acquisition[145].

Financial Performance - For the three months ended March 31, 2023, the company reported a net income of $576,067, primarily due to $1,675,392 in dividend and interest income earned in the Trust Account [127]. - The company incurred $9,897,599 in transaction costs related to its IPO, including $3,000,000 in underwriting fees [129]. - As of March 31, 2023, the company had cash of $16,133, negative working capital of $2,495,637, and an accumulated deficit of $6,713,509 [138]. - The company raised gross proceeds of $150,000,000 from its IPO by issuing 15,000,000 Units at a price of $10.00 per Unit [129]. - The company has not generated any operating revenues to date and does not expect to do so until the completion of its initial Business Combination [126]. Business Combination and Compliance - The company has until July 29, 2023, to consummate its initial Business Combination, or it will face mandatory liquidation [139]. - The company intends to use substantially all funds held in the Trust Account to complete its Business Combination [132]. - The company may need to raise additional capital through loans or investments to meet its working capital needs [138]. - The company received a notice from Nasdaq indicating non-compliance with the Minimum Public Holders Rule, giving it 45 days to submit a compliance plan [140]. Administrative Costs and Reporting - The company has incurred general and administrative costs of $756,466 for the three months ended March 31, 2023, an increase from $535,142 for the same period in 2022 [127]. - The company is evaluating the benefits of reduced reporting requirements under the JOBS Act as an "emerging growth company" for a period of five years post-IPO [148]. - The company may not be required to provide an auditor's attestation report on internal controls over financial reporting under Section 404 of the Sarbanes-Oxley Act [148]. - The company is exempt from certain executive compensation disclosures required for non-emerging growth public companies under the Dodd-Frank Act [148]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures [149].