# Longevity Health Holdings, Inc.: Form 10-K for the period ended Dec 31, 2024 - Company: [Longevity Health Holdings, Inc.](/companies/xage.md) (CIK 1842939) - Form: 10-K - Filed: 2025-03-31 - Accepted by EDGAR: Mar 31, 2025, 17:05 ET - Period: 2024-12-31 - Accession: 0000950170-25-047891 - Inline XBRL: yes - Main document: https://www.sec.gov/Archives/edgar/data/1842939/000095017025047891/xage-20241231.htm - All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1842939/000095017025047891/ ## Figures reported in this filing Standardized XBRL line items for the period ended 2024-12-31. | Line item | Period | Value | XBRL concept | | --- | --- | ---: | --- | | Revenue | 12 months, 2024-01-01 to 2024-12-31 | $50.3k | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax | | Cost of revenue | 12 months, 2024-01-01 to 2024-12-31 | $6.4k | us-gaap:CostOfGoodsAndServicesSold | | Gross profit | 12 months, 2024-01-01 to 2024-12-31 | $44.0k | us-gaap:GrossProfit | | Research and development | 12 months, 2024-01-01 to 2024-12-31 | $1.1m | us-gaap:ResearchAndDevelopmentExpense | | Operating income | 12 months, 2024-01-01 to 2024-12-31 | −$5.0m | us-gaap:OperatingIncomeLoss | | Interest expense | 12 months, 2024-01-01 to 2024-12-31 | $29.4k | us-gaap:InterestExpense | | Income tax | 12 months, 2024-01-01 to 2024-12-31 | −$97.3k | us-gaap:IncomeTaxExpenseBenefit | | Net income | 12 months, 2024-01-01 to 2024-12-31 | −$10.4m | us-gaap:NetIncomeLoss | | Diluted EPS | 12 months, 2024-01-01 to 2024-12-31 | −$0.49 | us-gaap:EarningsPerShareDiluted | | Basic EPS | 12 months, 2024-01-01 to 2024-12-31 | −$0.49 | us-gaap:EarningsPerShareBasic | | Diluted shares (weighted) | 12 months, 2024-01-01 to 2024-12-31 | 21,362,735 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding | | Operating cash flow | 12 months, 2024-01-01 to 2024-12-31 | −$4.4m | us-gaap:NetCashProvidedByUsedInOperatingActivities | | Current assets | at 2024-12-31 | $955.6k | us-gaap:AssetsCurrent | | Total assets | at 2024-12-31 | $1.5m | us-gaap:Assets | | Current liabilities | at 2024-12-31 | $5.9m | us-gaap:LiabilitiesCurrent | | Total liabilities | at 2024-12-31 | $6.2m | us-gaap:Liabilities | | Shareholders' equity | at 2024-12-31 | −$4.7m | us-gaap:StockholdersEquity | ## Business As filed, 38,084 characters. Unless the context requires otherwise, references in this Annual Report on Form 10-K (this “Annual Report”) to the “Company,” “we,” “us,” or “our,” prior to the closing of the Business Combination (as defined in Note 1 to the accompanying consolidated financial statements), are intended to refer to Carmell Regen Med Corporation (formerly Carmell Therapeutics Corporation), a Delaware corporation, (“Legacy Carmell”) and, after the closing of the Business Combination (as defined in Note 1 to the accompanying consolidated financial statements), are intended to refer to Longevity Health Holdings, Inc. (formerly Carmell Corporation), a Delaware corporation, and its consolidated subsidiaries. ### Forward-Looking Statements This Annual Report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties, and assumptions about us that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “might,” “should,” “could,” “will,” “would,” “expect,” “intend,” “plan,” “possible,” “potential,” “predict,” “project,” “anticipate,” “believe,” “estimate,” “continue,” “future,” or the negative of such terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Such statements include, but are not limited to, statements and expectations regarding our expected future growth and our ability to manage such growth, the ability to maintain the listing of our common stock, par value $0.0001 per share (the “Common Stock”), and Redeemable Warrants on the Nasdaq Capital Market, our estimates regarding anticipated operating losses, future revenue, capital requirements and our needs for, and ability to raise, financing in the future, our success in retaining or recruiting officers, key employees or directors, factors relating to our business, operations and financial performance, including our ability to commercialize our products, market acceptance of our products, our ability to compete effectively, market conditions within our industry, our ability to respond and adapt to change in technology or customer behavior as well as all other statements other than statements of historical fact included in this Annual Report. The forward-looking statements contained in this Annual Report are based on current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties, and other assumptions that may cause actual results or performance to be materially different than those expressed or implied by these forward-looking statements. These risks and uncertainties include but are not limited to, those listed under Part I, Item 1A. “Risk Factors,” Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Annual Report and those risks described in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). Given these risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. Any public statements or disclosures by us following this Annual Report that modify or impact any of the forward-looking statements contained in it will be deemed to modify or supersede such statements in this Annual Report. ### Business Overview 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 SecretomeTM and Elevai ExosomesTM, 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 we have paused further research and development. ### Recent Developments #### 2025 Private Placement On January 2, 2025, we received gross proceeds of $1,851,849 from a private placement of 8,065,210 shares of our Common Stock and warrants to purchase up to 8,065,210 shares of Common Stock at an exercise price of $0.23 per share (the “2025 Private Placement”). See Note 17 to the accompanying consolidated financial statements for additional details. #### Elevai Acquisition On January 16, 2025 (the “APA Closing Date”), we completed the purchase of substantially all of the assets (the “Purchased Assets”) of, and the assumption of certain of the liabilities (the “Assumed Liabilities”) of PMGC Holdings, Inc (formerly known as Elevai Labs Inc.) (“Parent”) and PMGC Impasse Corp. (formerly known as Elevai Skincare Inc.), a wholly owned subsidiary of Parent (the “Seller”), related to the Seller’s cosmetic skincare and haircare business (the “Elevai Acquisition”). For the year ended December 31, 2024, Elevai had net sales of approximately $2,500,000. See Note 17 to the accompanying consolidated financial statements for additional details. ### Our Product Portfolio ### Carmell SecretomeTM Cosmetic Skincare Products & Pipeline The Carmell SecretomeTM consists of a potent cocktail of growth factors, proteins, and peptides extracted from allogeneic human platelets. We have leveraged this proprietary formulation to create the world’s first cosmetic skincare line, which supports the body's own innate regenerative healing system. Our team of scientists and engineers have worked on past projects focused on the biologics and medical device space and have extensive experience and technical expertise in creating biologically active materials that are safe and effective. The Carmell SecretomeTM cosmetic skincare products are developed and manufactured in our facilities in the United States. Over the past seven years, we have extensively tested the technology underpinning the Carmell SecretomeTM, which utilizes a novel microemulsion formulation that enables the delivery of lipophilic and hydrophilic ingredients without relying on the Foul FourteenTM, 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. These fourteen chemicals and excipients that may harm human health and the environment include sulfates, silicones, silicates, phthalates, petrolatum, parabens, parfums, formaldehydes, food allergens, ethanolamines, ethyl alcohols, PFAs (per- and polyfluoroalkyls), coal tar dyes, and benzene. Additionally, our microemulsion formulations do not utilize mineral or vegetable oils across its entire product line and are designed to be non-comedogenic. Our skincare products use allogeneic platelet-rich plasma (“PRP”) sourced from U.S. Food and Drug Administration (the “FDA”)-registered and American Association of Blood Banks-accredited U.S. blood banks. Before being processed into the Carmell SecretomeTM, each unit of PRP is individually tested to ensure that it is free from blood-borne pathogens. As an additional safety precaution, the pooled plasma is heat-treated and irradiated to inactivate any viruses. Carmell SecretomeTM manufacturing is a highly controlled process with multiple in-process checks and release testing. Two additional sterilization steps, including gamma irradiation, are incorporated into every batch. Our formulation contains over a thousand growth factors, proteins, and peptides, but no live cells. Our technology is based on the premise that a healthy human body can heal itself from simple wounds and fight against microbes. Platelets play a key role in both fighting infections and in healing. Platelets contain growth factors and other proteins that play a crucial role in the body’s healing response. Growth factors and proteins in PRP have been known to stimulate collagen production, tissue repair, and cell regeneration, which can lead to improved skin texture, reduced appearance of fine lines and wrinkles, and an overall rejuvenation of the skin. When the body responds to a natural injury, platelets break apart to release proteins and growth factors to aid healing. This same natural process is utilized during the creation of Carmell SecretomeTM. Platelets are activated with calcium chloride, causing the release of their protein secretome, which is carefully processed to ensure safety and shelf stability. No intact cells or platelets remain. We have conducted protein assays to test for protein potency and stability testing under various temperature conditions to ensure that our product remains bioactive on the shelf in real-world conditions. In addition, we have also developed a novel microemulsion formulation to help support the permeability of our ingredients into the stratum corneum, which is the outermost layer of the skin. Additionally, our microemulsion formulations do not utilize mineral or vegetable oils across our entire product line and are designed to be non-comedogenic. All our products are subject to multiple quality control tests before bottling, and each lot is tested and batch numbered to enhance safety and traceability. Our Carmell SecretomeTM product portfolio and pipeline includes the following: #### Face and Neck Collection (Retail) - Regenerative Elixir – Reduces the appearance of wrinkles and blemishes - Brightening Glow – Extra strength skin brightening and anti-blemish formulation - Hydrating Dew – Intensive skin hydration and plumping crème #### ProSynergy Collection (Doctors/Medspas) - ReInforce – Soothes and repairs the skin barrier before and after aesthetic treatments - ReTone – Improves skin tone and the appearance of wrinkles - ReTexture – Extra strength plumping and hydrating formulation - ReTone HP – High potency formula to address skin tone and pigmentation concerns - Rapid Recovery Crème– Supports scar and post-aesthetic procedure recovery *(expected to launch in the second quarter of 2025)* #### Undereye Collection (expected to launch in the second quarter of 2025) - Iconic Rise & Shine – Reduces the appearance of dark circles and crepey skin for use during the day - Iconic Rest & Renew – Calms and strengthens undereye skin for use at bedtime #### Body and Décolleté Collection (expected to launch in the second quarter of 2025) - Body Velvet – Improves the appearance of mechanically stressed skin, including stretch marks - Gentle Care – Child-safe ultra-gentle formulation for sensitive skin types. ### Elevai ExosomesTM Cosmetic Skincare and Haircare Products The skincare and haircare products acquired in conjunction with the Elevai Acquisition in January 2025 utilize Elevai ExosomesTM, which are nano-sized extracellular vesicles containing growth factors, cytokines, peptides, and other small molecules involved in the body’s natural healing process. Our Elevai ExosomesTM are combined with carefully selected, high-quality active ingredients, such as hyaluronic acid and ceramides, to create our skincare and haircare products. While our products contain no living cells, they leverage the use of ethically sourced and thoroughly tested, human umbilical mesenchymal stem cells (“hUMSC”) that we culture in our lab to derive Elevai ExosomesTM. While exosomes are generated using some of the origin cell’s cellular material, the exosomes do not contain cells, nor are they explicitly cellular material. Instead, exosomes represent a powerful, nano-sized, natural delivery mechanism for protecting important biological factors, which enables them to be directed to where they are needed most. The use of exosomes has been found to penetrate the skin better, absorb more easily, and protect the active ingredients fused into our products, including stem cell derived proteins, peptides, and growth factors. To maintain quality control over our Elevai ExosomesTM commercialization and manufacturing process, we only purchase hUMSCs that are derived and banked by a third-party manufacturer in accordance with Current Good Manufacturing Practices (“cGMP”) regulations. The hUMSCs are shipped to our laboratory, where we similarly operate our lab under strict good laboratory practice (“GLP”) protocols to produce the highest quality of exosomes for our products. Every stem cell line is carefully derived and closely monitored throughout the process by highly trained personnel, to help ensure only high-quality stem cells are used to generate Elevai ExosomesTM. We produce our final products in an FDA-inspected, cGMP-compliant facility. Not only are all our ingredients and products subject to multiple quality control tests before bottling, but each lot is also tested and batch-numbered to enhance safety and traceability. The Elevai ExosomesTM skincare products include Elevai EmpowerTM and Elevai EnfinityTM and were formulated to enhance the outcome for individuals receiving aesthetic treatments who are in need of cosmetics to improve the appearance of skin in addition to receiving these treatments from a physician or medical spa. EmpowerTM was developed to provide immediate post-treatment skin support, and Elevai EnfinityTM for ongoing daily aftercare. Both products contain our patent-pending Elevai ExosomesTM. In addition, we launched our Elevai RenewTM Scalp Serum in the first quarter of 2025, which is also formulated with Elevai ExosomesTM. This product promotes healthy hair growth cycles and noticeable improvement to hair appearance, fullness, and thickness. In addition to Elevai ExosomesTM, our haircare product utilizes the proprietary compounds licensed from Yuva BioSciences, Inc. (“Yuva”). This license provides us with a non-exclusive, non-transferable, non-assignable, royalty-bearing right, with the right to sublicense, certain of Yuva’s intellectual property to develop, manufacture, and commercialize skincare products that contain Yuva’s proprietary compound and the Company's exosome-based ingredients or skincare products in which Elevai ExosomesTM serve as a carrier for Yuva’s proprietary compound, in each case, in the United States, Canada, and other mutually agreed to territories. ### Our Markets and Industry According to a May 2023 study conducted by McKinsey & Company, *State of Fashion: Beauty*, the skincare and haircare markets were approximately $280 billion in 2022 and are expected to grow at a 6.4% compound annual growth rate (“CAGR”). In addition, the aesthetics market is growing 36% faster than pharmaceuticals, according to Statista. We currently sell our cosmetics products in the United States through three distinct channels, including business-to-business, direct-to-consumer, and, in the case of Elevai products, distributor sales channels. In markets outside the United States, we sell certain of our products directly to distributors under exclusive and non-exclusive agreements. Our three sales channels help us to optimize our sales reach and strategy. In addition to the business-to-business sales channels, certain of our products are available for purchase direct-to-consumer via our online retail websites. Our direct-to-consumer channel allows consumers to purchase our products without the need to visit a medically directed business to make a purchase, or if they prefer the ease of purchasing our products online. We specifically focus on selling our products directly to physicians’ offices and medically directed businesses through our direct sales force comprised of employed, and independently contracted aesthetic account managers. We believe that consumers are increasingly looking to their physicians for advice on cosmetic product selection because they are overwhelmed by the mass marketing that often creates unrealistic expectations and some degree of consumer confusion. Furthermore, we believe consumers are also looking for individualized skincare regimens and want to know from their physicians, what works and what does not. The term ‘physician-dispensed’ refers to a sales channel where cosmetics products are exclusively sold in physician clinics or medically directed businesses by licensed medical professionals or that have a medical professional on staff. We include medical spas under this category, such as standalone, or hospitality-affiliated clinics focused on cosmetic treatments such as injections, microneedling, and some plastic surgery services. We believe consumers often turn to cosmetics to enhance the appearance of dull or aging skin and to brighten the skin by lessening the appearance of a myriad of aesthetic concerns such as hyperpigmentation, acne, melasma, and rosacea because these consumers view these products as alternatives to medications and often try cosmetics products before seeking medicinal solutions. We also believe that physicians value topical skincare products formulated with our biotechnology for their complementary aesthetic effects in conjunction with medications to improve skin appearance and to enhance the benefits of in-office procedures. After the Elevai Acquisition, most of our Elevai product sales are within the physician-dispensed market, primarily including dermatologists, plastic surgeons, and other physicians who are focused on medical aesthetics and therapeutic skincare, including some physicians practicing in medical aesthetician practices. Our products complement the medical aesthetics services provided in these professional settings. Our business-to-business sales channel within the physician-dispensed cosmetics skincare market primarily utilizes our trained direct sales force comprised of employed and independently contracted aesthetic account managers. This business-to-business sales channel is distinct from our leverage of non-exclusive distribution agreements with third-party distributors or resellers, who in turn, sell our products to end customers. Under distribution agreements, our relationship with the end customer is more indirect because our distributors serve as intermediaries. However, we believe scaling our product lines through larger distribution sales channels will lead to faster brand expansion, recognition, and market reach. The objective of the medical aesthetics industry is to offer medical care and education in a setting that includes spa facilities as well as conventional, complementary, and/or alternative aesthetics-focused therapies and cosmetic treatments. These medical aesthetics services include cosmetic procedures, such as microneedling, anti-wrinkle and fine line reduction therapies, acne surgery, fillers, and facial and massage services performed with highly specialized lasers and instruments. The beauty industry is relatively concentrated, with a significant portion of retail sales in the United States generated by brands owned by a few large multinational companies, such as L’Oréal, Estée Lauder, Coty, Revlon, Shiseido, Johnson & Johnson, and Procter & Gamble. These large multinational companies typically own multiple brands. In addition to the traditional brands against which we compete, small independent companies continue to enter the market with new brands and customized product offerings. #### Bone and Tissue Healing Products Our Bone Healing Accelerant (“BHA”) and tissue healing accelerant (“THA”) product candidates are based on patents licensed from Carnegie Mellon University (“CMU”) that claim the ability to plasticize allogeneic platelet-enriched plasma and crosslink proteins with genipin, a derivative of the gardenia plant, to provide a controlled degradation profile in vivo. BHA, a biologic, has been designated by the FDA as a combination product containing the Company’s core technology of plasma-based material plus b Tri-Calcium Phosphate (“b-TCP”), an already approved medical device. Legacy Carmell’s early years were focused on discovering and formulating the plasma-based materials technology, filing for now-issued patents, conducting preclinical experiments aimed at exploring promising areas for accelerated and enhanced healing, and conducting a Phase 2 clinical trial. Beginning in 2016, Legacy Carmell focused on moving BHA and THA from research to development. BHA is designed to be used in multiple bone applications, such as trauma fixation surgeries, including severe tibia fractures, spinal fusion, foot/ankle fusion and dental bone graft substitutes. THA is designed to be used in chronic wound care and aesthetic applications and is similar in formulation to BHA minus one material, b-TCP. The form of these two product candidates would feel different to the physicians/surgeons, with BHA being a “putty” form (due to the b-TCP) and THA being a “paste” form. We have conducted multiple preclinical studies that support our belief that BHA has the potential to heal wounds and accelerate bone healing of high quality, as measured by density, vascularity, and the presence of woven bone. The Company has submitted its BHA product candidate to the FDA as an Investigational New Drug (“IND”) in severe open tibia fractures, and the FDA agreed that the Company could pursue its proposed Phase 2 clinical trial under the IND. The FDA also granted a fast-track designation for the BHA program as the product candidate has the potential to meet a significant unmet need. However, following the closing of the AxoBio Acquisition, we reprioritized further research and development and ceased clinical studies of our product candidates so that we can focus on the near-term commercialization of our cosmetic skincare and haircare product lines. The production of our product candidates and any future research and development activities related to our product candidates are subject to extensive regulation by numerous governmental authorities in the United States, including the FDA. Prior to marketing in the United States, any product candidate we develop must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetics Act (the “FDCA”). If we pursue research and development activities related to these product candidates in the future, there can be no assurance that we will not encounter problems in preclinical testing or clinical trials that will cause us or the FDA to delay or suspend the clinical trials for such product candidates or delay or prohibit us from initiating future clinical trials. The marketing of our product candidates, if approved, would also be subject to extensive regulation by numerous governmental authorities in the United States. #### CMU Exclusive License Agreement In 2008, Legacy Carmell and CMU entered into an exclusive license agreement. Under the terms of the agreement, as subsequently amended, CMU granted the Company the exclusive rights to develop and commercialize plasma-based bioactive material, also known as “Biocompatible Plasma-Based Plastics,” for all fields of use and all worldwide geographies (the “Amended License Agreement”). The Company is required to use its best efforts to introduce the licensed technology into the commercial market as soon as possible and meet certain milestones as stipulated within the Amended License Agreement. CMU retains the right to use any derivative technology developed by the Company as a result of its use of this technology and retains the intellectual property rights to the licensed technology under the Amended License Agreement, including patents, copyrights, and trademarks. The terms of the Amended License Agreement apply only to our BHA and THA products. The Amended License Agreement is effective until January 30, 2028, or until the expiration of the last-to-expire patent relating to this technology, whichever comes later, unless otherwise terminated pursuant to another provision within the Amended License Agreement. The last-to-expire patent relating to the technology is expected to expire on September 2, 2030. Failure to perform in accordance with the agreed-upon milestones is grounds for CMU to terminate the Amended License Agreement prior to the expiration date, in addition to our default in the payment of any amount required to be paid under the Amended License Agreement. CMU has the right to subscribe for additional equity securities to maintain its then percentage of ownership in the Company. The Business Combination did not qualify as a qualified initial public offering or qualified sale under the License Agreement. We have agreed to pay certain royalties to CMU under the Amended License Agreement at the rate of two and seven-hundredths percent (2.07%) of net sales of (as defined in the Amended License Agreement) until the Amended License Agreement expires or is terminated in accordance with its terms. We have also agreed to pay CMU twenty-five percent (25%) of sublicense fees received, due and payable upon receipt of sublicense fees by the Company. No royalties have been accrued or paid under the Amended License Agreement, as no products utilizing the licensed technology have been commercialized. The Company is not obligated to make milestone payments but is required to meet certain minimum performance requirements to maintain the license under the Amended License Agreement as exclusive. Such Minimum Performance Requirements include: (i) CE Mark submission under the European Medical Devices Regulation by December 31, 2023, (ii) FDA BLA submission involving the first licensed product by December 31, 2026, (iii) Biologics License Application (“BLA”) approval for the first licensed product by December 31, 2027, and (iv) introduction of a licensed product to be achieved within 12 months of receipt of FDA clearance to market. ### Trademarks and Other Intellectual Property We believe that our intellectual property has substantial value and will contribute significantly to the success of our business. Our primary trademarks and the associated branding logos are registered or have registrations pending with the U.S. Patent and Trademark Office. Our trademarks are expected to be valuable assets that reinforce the distinctiveness of our brands and our consumers’ perception of our products. In addition to trademark protection, we own several domain names, including the domain names of our e-commerce websites. We also rely on and use commercially reasonable measures to protect our unpatented proprietary technology, which includes our expertise and product formulations, continuing innovation, and other know-how to develop and maintain our competitive position. In addition, the intellectual property related to our BHA and THA products include twenty-one patents that include exclusive, worldwide licenses from CMU. ### Government Regulation #### Regulation of Cosmetics We and our products are subject to various federal, state and international laws and regulations, including regulation in the United States by the FDA, the Consumer Product Safety Commission (the “CPSC”), and the Federal Trade Commission (the “FTC”). These laws and regulations principally relate to the ingredients, proper labeling, advertising, packaging, marketing, manufacture, safety, shipment and disposal of our products. In the United States, the FDCA, defines cosmetics as articles or components of articles intended for application to the human body to cleanse, beautify, promote attractiveness, or alter the appearance, except for soap. The labeling of cosmetic products is subject to the requirements of the FDCA, the Fair Packaging and Labeling Act, the Poison Prevention Packaging Act and other FDA regulations. Cosmetics are not subject to pre-market approval by the FDA; however, certain ingredients, such as color additives, must be pre-approved for the specific intended use of the product and are subject to certain restrictions on their use. If a company has not adequately substantiated the safety of its products or ingredients by, for example, performing appropriate toxicological tests or relying on already available toxicological test data, then a specific warning label is required. The FDA may, by regulation, require other warning statements on certain cosmetic products for specified hazards associated with such products. FDA regulations also prohibit or otherwise restrict the use of certain types of ingredients in cosmetic products. In addition, the FDA requires that cosmetic labeling and claims be truthful and not misleading. Moreover, cosmetics may not be marketed or labeled for their use in treating, preventing, mitigating, or curing disease or other conditions or in affecting the structure or function of the body, as such claims would render the products to be a drug and subject to regulation as a drug. The FDA has issued warning letters to cosmetic companies alleging improper drug claims regarding their cosmetic products. In addition to FDA requirements, the FTC as well as state consumer protection laws and regulations can subject a cosmetics company to a range of requirements and theories of liability, including similar standards regarding false and misleading product claims, under which FTC or state enforcement or class-action lawsuits may be brought. In the United States, the FDA has not promulgated regulations establishing mandatory Good Manufacturing Practices (“GMPs”) for cosmetics. However, the FDA’s draft guidance on cosmetic GMPs, most recently updated in June 2013, provides recommendations related to process documentation, recordkeeping, building and facility design, equipment maintenance and personnel, and compliance with these recommendations can reduce the risk that the FDA finds such products have been rendered adulterated or misbranded in violation of applicable law. The FDA also recommends that manufacturers maintain product complaint and recall files and voluntarily report adverse events to the FDA. The FDA monitors compliance of cosmetic products through market surveillance and inspection of cosmetic manufacturers and distributors to ensure that the products are not manufactured under unsanitary conditions, or labeled in a false or misleading manner. Inspections also may arise from consumer or competitor complaints filed with the FDA. In the event the FDA identifies unsanitary conditions, false or misleading labeling, or any other violation of FDA regulation, FDA may request or a manufacturer may independently decide to conduct a recall or market withdrawal of products. In addition, under the Modernization of Cosmetic Regulation Act of 2022 (“MoCRA”), manufacturers of cosmetic products will become subject to more onerous FDA obligations once implemented via regulation, including adverse event reporting and record retention requirements, safety substantiation requirements, facility registration requirements, product listing requirements, mandatory GMP requirements and labeling requirements for certain products. Under MoCRA, the FDA was also granted new enforcement authorities over cosmetics, such as the ability to initiate mandatory recalls and to access certain product records. The FTC regulates and can bring enforcement action against cosmetic companies for deceptive advertising and lack of adequate scientific substantiation for claims. The FTC requires that companies have a reasonable basis to support marketing claims. What constitutes a reasonable basis can vary depending on the strength or type of claim made, or the market in which the claim is made, but objective evidence substantiating the claim is generally required. #### Regulation of BHA and THA In the United States, biological products, including our BHA and THA products, are licensed by the FDA for marketing under the Public Health Service Act (the “PHS Act”) and regulated under the FDCA. Both the FDCA and the PHS Act and their corresponding regulations govern, among other things, the testing, manufacturing, safety, purity, potency, efficacy, labeling, packaging, storage, record keeping, distribution, marketing, sales, import, export, reporting, advertising and other promotional practices involving drug and biological products. FDA clearance of an IND must be obtained before initiating clinical testing of biologic products. FDA licensure also must be obtained before marketing biological products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. #### Other Government Regulation We are also subject to a number of federal, state, and international laws and regulations that impact companies conducting business on the Internet, including regulations related to consumer protection, the promotion and sale of merchandise, privacy, use and protection of consumer and employee personal information and data (including the collection of data from minors), behavioral tracking, and advertising and marketing activities, including sweepstakes, contests, and giveaways. ### Supply Chain We purchase the raw materials for all our products from various third parties. We also purchase packaging components that are manufactured to our design specifications. We collaborate with our suppliers to meet our stringent design and creative criteria. We believe that we currently have adequate sources of supply for all our products. We review our supplier base periodically with the specific objectives of improving quality, increasing innovation and speed-to-market, ensuring supply sufficiency, and reducing costs. We have experienced no disruptions in our supply chain, and we actively work to anticipate and respond to actual and potential disruptions. We continually benchmark the performance of our supply chain, augment our supply base, enhance our forecasting and planning capabilities, and adjust our inventory strategy based on the business’s changing needs. We also continue to explore options to optimize our supply chain operations further as the sales of our cosmetic products grow. ### Environmental Compliance We are subject to numerous federal, state, municipal, and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship, and environmental protection, including those relating to emissions to the air, discharges to land and surface waters, generation, handling, storage, transportation, treatment and disposal of hazardous substances and waste materials, and the evaluation of chemicals. We maintain policies and procedures to monitor and control environmental, health, and safety risks and to monitor compliance with applicable environmental, health, and safety requirements. Compliance with such laws and regulations pertaining to the discharge of materials into the environment or otherwise relating to the protection of the environment has not had a material effect on our capital expenditures, earnings, or competitive position. ### Segments Operating and reportable segments (referred to as “segments”) reflect the way the Company is managed and for which separate financial information is available and evaluated regularly by the Company’s chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance. Our chief executive officer, who is our CODM, views the Company’s operations and manages its business in one operating segment, which is principally the business of development and commercialization of bio-aesthetic and our bone and tissue healing products. ### Employees and Human Capital As of March 27, 2025, we have fifteen full-time employees. Our future performance depends in part on our ability to attract, retain, and motivate qualified employees. We endeavor to offer employees competitive compensation packages and a positive, dynamic, and creative work environment. We believe that we maintain a good working relationship with our employees and have not experienced any difficulty in recruiting staff for our operations. ### Corporate Information Legacy Carmell was incorporated under the laws of the State of Delaware on November 5, 2008. Upon the closing of the Business Combination on July 14, 2023, Legacy Carmell became a wholly owned subsidiary of Alpha Healthcare Acquisition Corp. III, a Delaware corporation incorporated on January 21, 2021 (“Alpha”), and Alpha subsequently changed its “Carmell Corporation” on August 1, 2023. We filed an amendment to our Third Amended and Restated Certificate of Incorporation, as amended, with the Delaware Secretary of State on March 6, 2025, to change our name from “Carmell Corporation” to “Longevity Health Holdings, Inc.” Our principal corporate office is located at 2403 Sidney Street, Suite 300, Pittsburgh, PA 15293, and our telephone number is (412) 894-8248. Our website is www.carmellcorp.com. The information contained in or accessible from our website is not incorporated by reference in this Annual Report or in any other filings we make with the SEC. We have included our website address in this Annual Report solely as an inactive textual reference ## Risk factors As filed, 90,324 characters. *A description of the risks and uncertainties associated with our business and industry is set forth below. You should carefully consider the risks and uncertainties described below, together with all of the other information in this Annual Report, including our audited consolidated financial statements and notes thereto and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this Annual Report before deciding whether to purchase shares of our Common Stock. If any of the following risks are realized, our business, financial condition, operating results, and prospects could be materially and adversely affected. In that event, the price of our Common Stock could decline, perhaps significantly. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.* ### Summary of Risk Factors The following is a summary of principal risks to which our business, operations, and financial performance are subject. Each of these risks is more fully described in the individual risk factors immediately following this summary. - We have limited experience as a commercial company, and the marketing and sale of our cosmetic products may be unsuccessful, and we may be unable to generate meaningful product revenue. - Our commercial success depends upon attaining and maintaining significant market acceptance of our current products among consumers, physicians, patients, and others buying or selling our products. - Certain of the products we process are derived from human tissue and, therefore, have the potential for disease transmission. - If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial condition, and results of operations could be adversely impacted. - Product liability lawsuits against us could cause us to incur substantial liabilities and limit the commercialization of any products that we may develop. - Our success depends largely upon consumer satisfaction with the aesthetic results of our products. - We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management. - If we fail to protect or enforce our intellectual property or confidential proprietary information relating to cosmetic products or product candidates, we may not be able to compete effectively, which may negatively affect our business as well as limit our partnership or acquisition appeal. - We may not be able to protect our proprietary technology, which could harm our ability to operate profitably. - We cannot be certain we will be able to obtain patent protection to protect our product technology. - If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business. - Our intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal. - Our future success is dependent, in part, on the performance and continued service of our officers and directors. - We will need substantial additional capital to support our growth plans, and such capital may not be available on terms acceptable to us, if at all. This could hamper our growth and adversely affect our business. - Management has concluded that there is substantial doubt about our ability to continue as a going concern. - We may become involved in litigation that may materially adversely affect us. - We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do. - The current economic downturn may harm our business and results of operations. - We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth. - If we were to be delisted from Nasdaq, it could reduce the visibility, liquidity, and price of our Common Stock. - We expect the price of our Common Stock may be volatile and may fluctuate substantially. ### Risks Related to Our Business and Operations ***We have limited experience as a commercial company, and the marketing and sale of our cosmetic products may be unsuccessful.*** Due to our limited history and experience as a commercial company, we face significant risks and uncertainties relating to the commercialization of our cosmetic products. In order to successfully commercialize our products, we must continue to build on our marketing, sales, distribution, managerial, and other capabilities or make arrangements with third parties to perform these services. We may face challenges that will inhibit our efforts, including: - our inability to recruit, train, and retain adequate numbers of effective sales and marketing personnel; - our inability to supply the market with our products, including manufacturing or distribution challenges; and - unforeseen costs and expenses associated with creating an independent sales and marketing organization. If we are unable to accomplish our commercialization objectives and manage these challenges, we will not be able to generate operating revenue from our cosmetic products. ***The cosmetics industry is highly competitive, and if we are unable to compete effectively, our results will suffer.*** We face vigorous competition from companies throughout the world, including large multinational consumer products companies that have many cosmetics brands under ownership and standalone beauty and skincare brands, including those that may target the latest trends or specific distribution channels. Competition in the cosmetics industry is based on the introduction of new products, pricing of products, quality of products and packaging, brand awareness, perceived value and quality, innovation, in-store presence and visibility, promotional activities, advertising, editorials, e-commerce and mobile-commerce initiatives, and other activities. We must compete with a high volume of new product introductions as well as existing products by diverse companies across several different distribution channels. Many of the multinational consumer companies with which we compete have greater financial, technical, or marketing resources, longer operating histories, greater brand recognition, or larger customer bases than we do and may be able to respond more effectively to changing business and economic conditions than we can. We also expect to encounter increased competition as we enter new markets and as we attempt to penetrate existing markets with new products. Our competitors may attempt to gain market share by offering products at prices at or below the prices at which our products are typically offered, including through the use of large percentage discounts. Competitive pricing may require us to reduce our prices, which would decrease our profitability or result in lost sales. Our competitors may be better able to withstand these price reductions and lost sales. In addition, our competitors may develop products that are safer, more effective, and more widely used, and may be more successful than us in manufacturing and marketing their products. It is difficult to predict the timing and scale of our competitors’ activities or whether new competitors will emerge in the cosmetics industry. Technological breakthroughs, including new and enhanced technologies that increase competition in the online retail market, new product offerings by competitors, and the strength and success of our competitors’ marketing programs, may further impede our growth and the implementation of our business strategy. Our ability to compete depends on the continued strength of our brands and products, the success of marketing, innovation and execution strategies, the continued diversity of product offerings, the successful management of new product introductions and innovations, strong operational execution, including in order fulfillment, and success in entering new markets and expanding our business in existing geographies. If we are unable to continue to compete effectively, it could have a material adverse effect on our business, financial condition, and results of operations. ### Our new product introductions may not be as successful as we anticipate. The cosmetics industry is driven in part by skincare and haircare trends, which may shift quickly. Our continued success depends on our ability to anticipate, gauge, and react in a timely and cost-effective manner to changes in consumer preferences for skincare and haircare products, consumer attitudes toward our industry and brands, and where and how consumers shop for and use these products. With the launch of our first seven skincare products in 2024, our acquisition of the Elevai ExosomesTM products in January 2025, and the anticipated launch of our remaining five skincare products during the first half of 2025, we must continually establish and enhance the recognition of our brands, maintain a favorable mix of products that are acceptable to the market, continue to develop our approach as to how and where we market and sell our products and work to develop, produce and market new products. We have an established process for the development, evaluation, and validation of our new product concepts. Nonetheless, each new product launch involves risks, as well as the possibility of unexpected results. For example, the acceptance of new product launches and sales to our consumers may not be as high as we anticipate, due to a lack of acceptance of the products themselves or their price, or the limited effectiveness of our marketing strategies. In addition, our ability to launch new products may be limited by our ability to timely manufacture, distribute, and ship new products. In the future, we may also experience a decrease in sales of our existing products as a result of newly launched products. Any of these occurrences could delay or impede our ability to achieve our sales objectives, which could have a material adverse effect on our business, financial condition, and results of operations. ***Acceptance of our formulations or products in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenue.*** Our future financial performance will depend, at least in part, upon the introduction and consumer acceptance of our products. Even if approved for marketing by the necessary regulatory authorities, our formulations or products may not achieve market acceptance. The degree of market acceptance will depend upon a number of factors, including: - receipt of any necessary regulatory approval of marketing claims for the uses that we are developing; - establishment and demonstration of the advantages, safety, and efficacy of our formulations, products, and technologies; - our ability to attract corporate partners to assist in commercializing our proposed products; and - our ability to market our products. Further, any loss of confidence on the part of consumers in our products or in the ingredients used in or with such products could materially harm the image of our brands and cause consumers to choose other products. Allegations regarding any of the above, even if untrue, may require us to expend significant time and resources investigating and responding to such allegations and could, from time to time, result in a recall or market withdrawal of a product from any or all of the markets in which the affected product was distributed. See “Our products may cause or contribute to undesirable side effects that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, and results of operations” below. Consumers or those within the medical community in general may be unwilling to accept, utilize, or recommend any of our products or proposed formulations. If we are unable to obtain or maintain the confidence of consumers or those who may otherwise utilize or recommend our products, or if required, obtain regulatory approval for, or commercialize and market, our proposed formulations or products when planned, we may not achieve market acceptance or generate any revenue. ***Certain of the products we process are derived from human tissue and therefore have the potential for disease transmission.*** The utilization of human tissue creates the potential for transmission of communicable disease, including, without limitation, human immunodeficiency virus, viral hepatitis, syphilis, and other viral, fungal, or bacterial pathogens. We are required to comply with federal and state regulations intended to prevent communicable disease transmission. We maintain strict quality controls designed in accordance with GMP to ensure the safe procurement and processing of our tissue, including terminal sterilization of our products. These controls are intended to prevent the transmission of communicable disease. However, risks exist with any human tissue implantation. In addition, negative publicity concerning disease transmission from other companies’ improperly processed donated tissue could have a negative impact on the demand for our products and adversely affect our business, financial condition, and results of operations. ***If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial condition, and results of operations could be adversely impacted.*** In the course of conducting our business, we must adequately address quality issues that may arise with our products, as well as defects in third-party components included in our products, as any quality issues or defects may negatively impact consumer use of our products. Although we have established internal procedures to minimize risks that may arise from quality issues, we may not be able to eliminate or mitigate occurrences of these issues and associated liabilities. If the quality of our products does not meet the expectations of our consumers or the cosmetics market generally, then our brand reputation could suffer, and our business could be adversely impacted. We must also ensure that any promotional claims made for our products conform with government regulations. ***Our success depends largely upon consumer satisfaction with the aesthetic results of our products.*** In order to generate repeat business from consumers, our consumers must be satisfied with the aesthetic results of our cosmetic products. Our products are cosmetic in nature, and the success of the results is highly subjective. Accordingly, cosmetics consumers’ perception of their aesthetic results may greatly vary even if our products and systems associated therewith are shown to be objectively successful. If cosmetics consumers are not satisfied with the aesthetic benefits of our products or feel that they are too expensive for the aesthetic results obtained, our reputation and future sales could suffer. ***We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants.*** As of March 27, 2025, we have fifteen full-time employees. Losing key personnel or failing to recruit necessary additional personnel would impede our ability to attain our development objectives. There is intense competition for qualified personnel in the aesthetics and biomedical field, and we may not be able to attract and retain the qualified personnel we need to develop our business. We rely on independent organizations, advisors, and consultants to perform certain services for us, including handling substantially all aspects of regulatory compliance and conducting our clinical validation and testing, and we expect to rely on organizations and individuals for the marketing and sales of our products. We expect that this will continue to be the case. Such services may not always be available to us on a timely basis, which may limit or delay our ability to develop or commercialize our products. Certain of our directors and scientific advisors serve as officers, directors, scientific advisors, or consultants of other healthcare and life science companies, or institutes that might be developing competitive products. None of our directors are obligated under any agreement or understanding with us to make any additional products or technologies available to us. Similarly, we can give no assurances, and we do not expect, and investors should not expect, that any biomedical or pharmaceutical product or technology identified by any of our directors or affiliates in the future would be made available to us other than corporate opportunities. We can give no assurances that any such other companies will not have interests that are in conflict with their interests. ***We rely on third parties to supply certain raw materials and packaging components and to manufacture and package our products, and, if our third-party vendors do not timely supply these products or perform these services, it may delay or impair our ability to develop, manufacture, market, and deliver our products.*** We purchase the raw materials and packaging components that are designed to our specifications for all our cosmetic products from various third parties. In addition, we rely on a third-party manufacturer to formulate and package certain of our products. We collaborate with these vendors to meet our stringent design and creative criteria. While we believe that we currently have adequate sources of supply and services for all our products, we and our vendors may, in the future, not be able to (i) perform under any definitive manufacturing, supply or service agreements or (ii) remain in business for a sufficient time to successfully produce and market our cosmetic products. If we do not maintain important vendor relationships, we may fail to find a replacement vendor, which could delay or impair our ability to commercialize, produce, and distribute our cosmetic products and substantially increase our costs or deplete profit margins, if any. If we do find replacement vendors, we may not be able to enter into agreements with vendors on favorable terms and conditions. \[LB1\] In addition, we do not have complete control over the ability of our third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Although we require our third-party manufacturers to supply us with components and products that meet our specifications and comply with applicable legal and regulatory requirements in our agreements, and we perform incoming inspection, testing or other acceptance activities to ensure the components and products meet our requirements, there is a risk that our manufacturers will not always act consistent with our best interests, and may not always supply components and products that meet our requirements or supply components and products in a timely manner. If any of our manufacturers fails to meet our expectations or to comply with applicable legal or regulatory requirements, we may need to find an alternative manufacturer, which could significantly impact our ability to develop and market our products. Any failure on the part of our manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, recalls, criminal prosecutions or damage to our reputation, any of which could significantly and adversely harm our business and results of operations. ***To be commercially successful, we must educate physicians, where appropriate, on how and when our products are proper alternatives to existing treatments and that our products should be used in their procedures.*** We believe physicians will only use our products if they determine, based on their independent medical judgment and experience, clinical data, and published peer-reviewed journal articles, that the use of our products in a particular procedure is a favorable alternative to other treatments. Physicians may be hesitant to change their existing medical treatment practices for the following reasons, among others: - their lack of experience with advanced therapeutics, such as our products; - lack of evidence supporting additional patient benefits of advanced therapeutics, such as our products, over conventional methods in certain therapeutic applications; - perceived liability risks generally associated with the use of new products and procedures; and - limited availability of reimbursement from third-party payers. ***If we do not manage inventory in an effective and efficient manner, it could adversely affect our results of operations.*** Many factors affect the efficient use and planning of inventory of certain components and other materials used in our manufacturing processes to manufacture our marketed products, such as the effectiveness of predicting demand, the effectiveness of preparing manufacturing to meet demand, efficiently meeting product demand requirements, and the expiration of materials in inventory. We may be unable to manage our inventory efficiently, keep inventory within expected budget goals, keep inventory on hand or manage it efficiently, control expired inventory, or keep sufficient inventory of materials to meet product demand due to our dependence on third-party suppliers. Finally, we cannot provide assurances that we can keep inventory costs within our target levels. Failure to do so may harm our long-term growth prospects. ***We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.*** We expect to devote substantial financial resources to our ongoing and planned activities, particularly in order to develop and commercialize our cosmetic products going forward and to make significant investments to support our business growth. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we launch our additional skincare products throughout 2025. We also expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. To obtain such funding, we may need to engage in equity, equity-linked, or debt financings, including for possible use in acquisitions. If we raise additional funds through future issuances of equity, equity-linked, or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences, and privileges superior to those of holders of our Common Stock. Given current uncertainty in the capital markets and other factors, such funding may not be available on terms favorable to us or at all. Any additional debt financing that we secure in the future could involve offering additional security interests and undertaking restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. Additionally, if we seek to access additional capital or increase our borrowing, there can be no assurance that debt or equity financing may be available to us on favorable terms, if at all. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, our ability to continue to support our business growth and to respond to business challenges could be significantly impaired, and our business, results of operations, and financial condition may be harmed. In addition, disputes may also arise between us and our investors or lenders. For example, the Holders (as defined in Note 9 to the accompanying consolidated financial statements) have alleged that, among other claims, we owe additional payment of principal and interest on the Convertible Notes (as defined in Note 9 to the accompanying consolidated financial statements) and that, under the terms of the Convertible Note Warrants (as defined in Note 9 to the accompanying consolidated financial statements), we are required to repurchase such Convertible Note Warrants at a purchase price equal to the Black-Scholes Value of the unexercised portion of such Convertible Note Warrants as of the closing of the Business Combination. One of the Holders has filed suit seeking to recover such amounts allegedly owed. See Notes 9 and 11 to the accompanying consolidated financial statements for additional details. There can be no assurance that these or similar matters will not result in expensive arbitration, litigation, or other dispute resolution, including, but not limited to, the litigation filed by Puritan, which may not be resolved in our favor and may adversely impact our financial condition. ***We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management.*** From time to time, we may consider strategic transactions, such as acquisitions of companies, business combinations, asset purchases, and out-licensing or in-licensing of products, product candidates, or technologies. Additional potential transactions that we may consider include a variety of different business arrangements, including strategic partnerships, joint ventures, restructurings, divestitures, business combinations, and investments. Any such transaction may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures, and may pose significant integration challenges or disrupt our management or business, which could adversely affect our business, financial condition, and results of operations. These transactions may entail numerous operational and financial risks, including: - exposure to unknown liabilities; - disruption of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates, or technologies; - incurrence of substantial debt or dilutive issuances of equity securities to pay for such transactions; - higher-than-expected transaction and integration costs; - write-downs of assets or goodwill or impairment charges; - increased amortization expenses; - difficulty and cost in combining the operations and personnel of any acquired businesses or product lines with our operations and personnel; - impairment of relationships with key suppliers or customers of any acquired businesses or product lines due to changes in management and ownership; and - inability to retain key employees of any acquired businesses. Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and could have a material adverse effect on our business, financial condition, and results of operations. ***Our financial condition, results of operations, and cash flow may be adversely affected by changing economic conditions, including interest rates and inflation.*** In recent years, the U.S. market has experienced cyclical or episodic downturns, and worldwide economic conditions remain uncertain and volatile, as a result of current geopolitical conditions including the Israel-Hamas war, the ongoing Russia-Ukraine war and conflict geopolitical tensions between the United States and China, proposed tariffs and other trade restrictions by the U.S. government and foreign governments, instability in the U.S. and global banking systems, high levels of inflation, high interest rates, the downgrading of the U.S.’s credit rating and the possibility of a recession. A decline in economic conditions, such as recession, economic downturn, and/or inflationary conditions in the U.S., could adversely and negatively impact our financial condition, results of operations, and cash flow. ### Risks Related to Legal and Regulatory Matters ***New laws, regulations, enforcement trends, or changes in existing regulations governing the introduction, marketing, and sale of our products to consumers could harm our business.*** There has been an increase in regulatory activity in the United States related to cosmetic products and consumer protections, and the regulatory landscape is becoming more complex with increasingly strict requirements. If this trend continues, we may find it necessary to alter some of the ways we have traditionally manufactured and marketed our products in order to stay in compliance with a changing regulatory landscape, and this could add to the costs of our operations and have an adverse impact on our business. To the extent federal, state, and local regulatory changes regarding consumer protection, or the ingredients, claims or safety of our products occur in the future, they could require us to reformulate or discontinue certain of our products, revise the product packaging or labeling, or adjust operations and systems, any of which could result in, among other things, increased costs, delays in product launches, product returns or recalls and lower net sales, and therefore could have a material adverse effect on our business, financial condition and results of operations. Noncompliance with applicable regulations could result in enforcement action by the FDA or other regulatory authorities within or outside the United States, including but not limited to product seizures, injunctions, product recalls and criminal or civil monetary penalties, all of which could have a material adverse effect on our business, financial condition and results of operations. In the United States, with the exception of color additives, the FDA does not currently require pre-market approval for products intended to be sold as cosmetics. However, the FDA may in the future require pre-market authorization for certain cosmetic products, establishments, or manufacturing facilities. Moreover, such products could also be regulated as both drugs and cosmetics simultaneously, as the categories are not mutually exclusive. The statutory and regulatory requirements applicable to drugs are extensive and require significant resources and time to ensure compliance. For example, if any of our products intended to be sold as cosmetics were to be regulated as drugs, we might be required to conduct, among other things, clinical trials to demonstrate the safety and efficacy of these products. We may not have sufficient resources to conduct any required clinical trials or to ensure compliance with the manufacturing requirements applicable to drugs. If the FDA determines that any of our products intended to be sold as cosmetics should be classified and regulated as drug products, and we are unable to comply with applicable drug requirements, we may be unable to continue to market those products. Any inquiry into the regulatory status of our cosmetics and any related interruption in the marketing and sale of these products could damage our reputation and image in the marketplace. In recent years, the FDA has issued warning letters to several cosmetic companies alleging improper claims regarding their cosmetic products. If the FDA determines that we have disseminated inappropriate drug claims for our products intended to be sold as cosmetics, we could receive a warning or untitled letter, be required to modify our product claims, or take other actions to satisfy the FDA. In addition, plaintiffs’ lawyers have filed class action lawsuits against cosmetic companies after receipt of these types of FDA warning letters. There can be no assurance that we will not be subject to state and federal government actions or class action lawsuits, which could harm our business, financial condition, and results of operations. Additional state and federal requirements may be imposed on consumer products as well as cosmetics, cosmetic ingredients, or the labeling and packaging of products intended for use as cosmetics. For example, on December 29, 2022, Congress enacted the MoCRA. MoCRA created new compliance requirements for manufacturers of cosmetic products in the United States and also significantly expanded the FDA's authority to oversee and regulate cosmetics. Under MoCRA, companies must comply with new requirements for cosmetics, such as new labeling requirements for certain products, safety substantiation, facility registration, product listing, adverse event reporting, good manufacturing practice requirements, and mandatory recalls. In addition, MoCRA provided the FDA with new enforcement authorities over cosmetics, such as the ability to initiate mandatory recalls and to obtain access to certain product records. Many of the requirements become applicable on December 29, 2023, with some of the requirements, such as those relating to labeling, scheduled to become applicable later in 2024 and 2025. The FDA was required under MoCRA to propose mandatory GMPs for cosmetics by December 29, 2024, which was subsequently delayed until October 2025, and parties that operate facilities engaged in the manufacturing or processing of cosmetic products are required to register such facilities and submit product listing information to FDA by the same deadline. While we expect to meet the registration and GMP requirements, we are unable to ascertain at this time the full impact that complying with any new MoCRA requirements will have on our business. Compliance with the new requirements may further increase the cost of manufacturing certain of our products and could have a material adverse effect on our business, financial condition, and results of operations. Our products are also subject to state laws and regulations, such as the California Safe Drinking Water and Toxic Enforcement Act, also known as “Prop 65,” and various state PFAS regulations, and failure to comply with such laws may also result in lawsuits and regulatory enforcement that could have a material adverse effect on our business, financial condition and results of operations. We are, and may in the future be, involved in litigation related to such state laws and regulations. ***Government regulations and private party actions relating to the marketing and advertising of our products and services may restrict, inhibit, or delay our ability to sell our products and harm our business, financial condition, and results of operations.*** Government authorities regulate advertising and product claims regarding the performance and benefits of our products. These regulatory authorities typically require a reasonable basis to support any marketing claims. What constitutes a reasonable basis for substantiation can vary widely from market to market, and there is no assurance that the efforts that we undertake to support our claims will be deemed adequate for any particular product or claim. A significant area of risk for such activities relates to improper or unsubstantiated claims about our products and their use or safety. If we are unable to show adequate substantiation for our product claims, or our promotional materials make claims that exceed the scope of allowed claims for the classification of the specific product, whether cosmetics, over-the-counter drug products, or other consumer products that we offer, the FDA, the FTC or other regulatory authorities could take enforcement action or impose penalties, such as monetary consumer redress, requiring us to revise our marketing materials, amend our claims or stop selling certain products, all of which could harm our business, financial condition and results of operations. Any regulatory action or penalty could lead to private party actions, or private parties could seek to challenge our claims even in the absence of formal regulatory actions, which could harm our business, financial condition, and results of operations. ***Our products may cause or contribute to undesirable side effects that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, and results of operations.*** The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us. The FDA regulates our cosmetic products. In the United States, FDA regulations govern, among other things, the activities that we perform, including product development, product testing, product labeling, product storage, manufacturing, advertising, promotion, product sales, reporting of certain product adverse events and failures, and distribution. The FDA has the authority to require the recall or recommend the market withdrawal, as applicable, of commercialized products in the event that a product has a reasonable probability of causing a serious adverse health risk due to adulteration or misbranding. Companies may also choose to voluntarily recall a product if any material deficiency or regulatory violation is discovered. A government-mandated or voluntary recall could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects, or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future. Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals, clearances, or certifications for the product before we may market or distribute the corrected product. Seeking such approvals, clearances, or certifications may delay our ability to replace the recalled products in a timely manner. Moreover, if we do not adequately address problems associated with our products, we may face additional regulatory enforcement action, including warning letters or untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals or clearances; seizures or recalls of products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for products; clinical holds; refusal to permit the import or export of products; and criminal prosecution. Companies are required to maintain certain records of recalls and corrective actions, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, it could require that we report those actions as recalls, and we may be subject to enforcement action. A future recall announcement could harm our reputation, potentially lead to product liability claims against us, and negatively affect our sales. ***Product liability lawsuits could divert our resources, result in substantial liabilities, and reduce the commercial potential of our products.*** Our business exposes us to the risk of product liability claims that are inherent to the development, clinical validation studies, and testing to demonstrate aesthetic improvement and marketing of aesthetic, skincare, and haircare products. These lawsuits may divert our management from pursuing our business strategy and may be costly to defend. In addition, if we are held liable in any of these lawsuits, we may incur substantial costs and may be forced to limit or forgo further commercialization of those products. Although we maintain general liability insurance in an amount that we believe is reasonably adequate to insulate us from potential claims, this insurance may not fully cover potential liabilities. In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercial production and sale of our products, which could adversely affect our business. In addition, our business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing, and marketing of human tissue products. We may be subject to such claims if our products cause, or appear to have caused, an injury. Claims may be made by consumers, healthcare providers, patients, or others buying or selling our products. Product liability claims can be expensive to defend (regardless of merit), divert our management’s attention, result in substantial damage awards against us, harm our reputation, and generate adverse publicity, which could result in the withdrawal of, or reduced acceptance of, our products in the market. ***We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.*** We may employ individuals who were previously employed at universities or pharmaceutical or cosmetics companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject to such claims. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. ***Business interruptions could adversely affect future operations and financial conditions, and may increase our costs and expenses.*** Our operations, and those of our directors, employees, advisors, contractors, consultants, and collaborators, could be adversely affected by earthquakes, floods, hurricanes, typhoons, other extreme weather conditions, fires, water shortages, power failures, business systems failures, medical epidemics or pandemics, such as the COVID-19 pandemic, and other natural and man-made disaster or business interruptions, many of which are beyond our and such third parties’ control. Our phones, electronic devices, and computer systems, and those of our directors, employees, advisors, contractors, consultants, and collaborators, are vulnerable to damages, theft and accidental loss, negligence, unauthorized access, terrorism, war, electronic and telecommunications failures, and other natural and man-made disasters. These locations may be subject to additional security and other risk factors due to the limited control of our employees. If such an event as described above were to occur in the future, it may cause interruptions in our operations, delay research and development programs, clinical validation, regulatory compliance activities, manufacturing and quality assurance activities, sales and marketing activities, hiring, training of employees and persons within associated third parties, and other business activities. Likewise, we rely and will continue to rely on third parties to conduct clinical trials, and similar events as those described in the prior paragraph relating to their business systems, equipment, and facilities could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development, commercialization, marketing, and sales of our products could be delayed or altogether terminated. ***Our employees or others acting on our behalf may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.*** We may be exposed to the risk that our employees, independent contractors, consultants, distributors and vendors, and other individuals or entities with whom we have arrangements to act on our behalf may engage in unethical, fraudulent, or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws and regulations of the FDA, including those laws requiring the reporting of true, complete and accurate information to the FDA; (ii) manufacturing standards; or (iii) laws that require the true, complete and accurate reporting of financial information or data. Misconduct by employees or others acting on our behalf could also involve the improper use of information obtained in the course of clinical validation studies or other testing of our cosmetic products, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter such misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions or investigations are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions or investigations could result in government investigations, legal proceedings, the imposition of significant fines or other sanctions, including the imposition of monetary penalties, damages, monetary fines, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition, and results of operations. ### Risks Related to Our Intellectual Property ***We may not be able to protect our proprietary technology, which could harm our ability to operate profitably.*** The patent positions of biologics and cosmetics companies are uncertain and involve complex legal and factual questions. These industries place considerable importance on obtaining patent and trade secret protection for new technologies, cosmetic products, and processes. We may incur significant expenses in protecting our intellectual property and defending or assessing claims with respect to intellectual property owned by others. Any patent or other infringement litigation by or against us could cause us to incur significant expenses and divert the attention of our management. Others may file patent applications or obtain patents on similar technologies that compete with our products. We cannot predict how broad the claims in any such patents or applications will be and whether they will be allowed. Once claims have been issued, we cannot predict how they will be construed or enforced. We may infringe upon the intellectual property rights of others without being aware of it. If another party claims we are infringing their technology, we could have to defend an expensive and time-consuming lawsuit, pay a large sum if we are found to be infringing, or be prohibited from selling or licensing our products unless we obtain a license or redesign our products, which may not be possible. We also rely on trade secrets and proprietary know-how to develop and maintain our competitive position. Some of our current or former employees, consultants, scientific advisors, contractors, current or prospective corporate collaborators may unintentionally or willfully disclose our confidential information to competitors or use our proprietary technology for their own benefit. Furthermore, enforcing a claim alleging the infringement of our trade secrets would be expensive and difficult to prove, making the outcome uncertain. Our competitors may also independently develop similar knowledge, methods, and know-how or gain access to our proprietary information through some other means. ***We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits.*** If any other person filed patent applications, or is issued patents, claiming technology also claimed by us, we may be required to participate in interference or derivation proceedings in the U.S. Patent and Trademark Office to determine priority and/or ownership of the invention. Our licensors or we may also need to participate in interference proceedings involving issued patents and pending applications of another entity. The intellectual property environment in our industry is particularly complex, constantly evolving, and highly fragmented. Other companies and institutions have issued patents and have filed or will file patent applications that may issue into patents that cover or attempt to cover products, processes, or technologies similar to ours. We have not conducted freedom-to-use patent searches on all aspects of our cosmetic products, and may be unaware of relevant patents and patent applications of third parties. In addition, the freedom-to-use patent searches that have been conducted may not have identified all relevant issued patents or pending patent applications. We cannot provide assurance that our cosmetic products or proposed products will not ultimately be held to infringe one or more valid claims owned by third parties, which may exist or come to exist in the future, or that in such case we will be able to obtain a license from such parties on acceptable terms. We cannot guarantee that our technologies will not conflict with the rights of others. We may also face frivolous litigation or lawsuits from various competitors or from litigious securities attorneys. The cost of any litigation or other proceeding relating to these areas, even if deemed frivolous or resolved in our favor, could be substantial and could distract management from its business. Uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to continue our operations. ***If we infringe the rights of others, we could be prevented from selling products or forced to pay damages.*** Our research, development, and commercialization activities may infringe or otherwise violate or be alleged to infringe or otherwise violate patents owned or controlled by other parties. Competitors in the field of aesthetics and cosmetics have developed large portfolios of patents and patent applications in fields relating to our business. Additionally, there may also be patent applications that have been filed but not published that, when issued as patents, could be asserted against us. These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages and/or we could be forced to stop or delay research, development, manufacturing, or sales of the product that is the subject of the suit. Further, if a patent infringement suit were brought against us, during the pendency of the litigation, we could be forced to stop or delay research, development, manufacturing, or sales of the product that is the subject of the suit. If our products, methods, processes, and other technologies are found to infringe the rights of other parties, we could be required to pay damages, or may be required to cease using the technology or to license rights from the prevailing party. Any prevailing party may be unwilling to offer us a license on commercially acceptable terms. ***We cannot be certain we will be able to obtain and maintain patent protection to protect our products and technology.*** We cannot be certain that all patents applied for will be issued or that our existing patents can be maintained. If a third party has also filed a patent application relating to an invention claimed by us or one or more of our licensors, we may be required to participate in an interference or derivation proceeding declared or instituted by the U.S. Patent and Trademark Office, which could result in substantial uncertainties and cost for us, even if the eventual outcome is favorable to us. The degree of future patent protection for our cosmetic products and technology is uncertain. For example: - we or our licensors might not have been the first to make the inventions covered by our issued patents, or pending or future patent applications; - we or our licensors might not have been the first to file patent applications for the inventions; - others may independently develop duplicative, similar, or alternative technologies; - it is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted by any patents arising from our patent applications will be significantly narrower than expected; - any patents under which we hold ultimate rights may not provide us with a basis for commercially-viable products, may not provide us with any competitive advantages, or may be challenged by third parties as not infringed, invalid, or unenforceable under U.S. or foreign laws; - any patent issued to us in the future or under which we hold rights may not be valid or enforceable; or - we may develop additional technologies that are not patentable and which may not be adequately protected through trade secrets; for example, if a competitor independently develops duplicative, similar, or alternative technologies. ***We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our cosmetic products.*** Our success will depend in part on our ability to operate without infringing, misappropriating, or otherwise violating the trademarks, patents, copyrights, trade secrets, and other proprietary rights of others. We cannot guarantee that our cosmetic products, or the manufacture or use of our cosmetic products, will not infringe, misappropriate, or otherwise violate such third-party rights. From time to time, we may receive allegations of trademark or patent infringement, and third parties have filed claims against us with allegations of intellectual property infringement. In addition, third parties may involve us in intellectual property disputes as part of a business model or strategy to gain competitive advantage. Defending against such allegations and litigation could be costly, affect our results of operations, divert the attention of managerial and scientific personnel, and have an adverse impact on our ability to bring products to market. Some of these third parties may be better capitalized and have more resources than us. In that event we are to infringe or violate a third party’s intellectual property rights, we may need to halt commercialization of the relevant cosmetic product(s), obtain a license, which may not be available to us on commercially reasonable terms, and redesign or rebrand our marketing strategy or cosmetic products, which may not be possible or may be costly. In addition, there is a risk that a court will order us to pay the other party damages for having violated or infringed upon the other party’s intellectual property rights. Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any such litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. ***If we fail to protect or enforce our intellectual property or confidential proprietary information relating to cosmetic products, we may not be able to compete effectively, which may negatively affect our business as well as limit our partnership or acquisition appeal.*** Our success depends in part on our ability to protect our intellectual property rights. We rely on a combination of trademarks, trade secrets, confidential proprietary information, domains, licensed patent rights, and other intellectual property rights to protect our intellectual property. We may be subject to competition despite the existence of intellectual property we license or own. We can give no assurances that our intellectual property will be sufficient to prevent third parties from designing around the patents we own or license and developing and commercializing competitive products. The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third parties to partner, collaborate, or otherwise transact with us, if third parties perceive a higher than acceptable risk to the commercialization of our products or future products. We may elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names, or other intellectual property rights that we either own or license. If we do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to: - paying monetary damages related to the legal expenses of the third party; - facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our products; and - restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical validation, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness. A third party may also challenge the validity, enforceability, or scope of the intellectual property rights that we license or own, and the result of these challenges may narrow the claim scope of or invalidate intellectual property rights that are integral to our cosmetic products in the future. There can be no assurance that we will be able to successfully defend our intellectual property rights in an action against third parties due to the unpredictability of litigation and the high costs associated with intellectual property litigation, among other factors. Changes to patent law, for example the Leahy-Smith America Invests Act, AIA or Leahy-Smith Act, of 2011 and the Patent Reform Act of 2009 and other future article of legislation in the U.S., may substantially change the regulations and procedures surrounding patent applications, issuance of patents, prosecution of patents, challenges to patent validity, and patent enforcement. We can give no assurances that our patents and those of our licensor(s) can be defended or will protect us against future intellectual property challenges, particularly as they pertain to changes in patent law and future patent law interpretations. In addition, enforcing and maintaining our intellectual property protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by the U.S. Patent and Trademark Office and courts, and protection of our intellectual property rights could be reduced or eliminated for non-compliance with these requirements. ***If we are not able to protect and control our unpatented trade secrets, know-how, and other proprietary technology, we may suffer competitive harm.*** We also rely on proprietary trade secrets and unpatented know-how to protect our research and development activities, particularly when we do not believe that patent protection is appropriate or available. However, trade secrets are difficult to protect. We will attempt to protect our trade secrets and unpatented know-how by requiring our employees, consultants, collaborators, and advisors to execute a confidentiality and non-use agreement. We cannot guarantee that these agreements will provide meaningful protection, that these agreements will not be breached, that we will have an adequate remedy for any such breach, or that our trade secrets will not otherwise become known or independently developed by a third party. Our trade secrets, and those of our present or future collaborators with which we have agreements authorizing our use or access to such trade secrets, may become known or may be independently discovered by others, which could adversely affect the competitive position of our products. ***If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our target markets, and our business may be adversely affected.*** Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic, or determined to be infringing on other marks. We may not be able to protect our rights in these trademarks and trade names, which we need in order to build name recognition with potential partners or consumers in our target markets. If we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. ### Risks Related to Our Financial Condition ***Our future success is dependent, in part, on the performance and continued service of our officers and directors.*** We are presently dependent largely upon the experience, abilities, and continued services of our senior management, including our Chief Executive Officer, Rajiv Shukla. The loss of services of Mr. Shukla could have a material adverse effect on our business, financial condition, or results of operation. Other key executives are important to our ongoing capability to develop, commercialize, and, if necessary, obtain regulatory approval for our cosmetic products. The competition for executive talent may make it difficult to replace any of these key positions in a timely manner. We do not maintain “key employee” insurance policies on any of our executive officers that would compensate us for the loss of their services. The time and cost required to replace a key employee may have a material adverse effect on our results of operations and financial condition. ***Management has concluded that there is substantial doubt about our ability to continue as a going concern.*** The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern, which assumes the realization of assets and the satisfaction of liabilities in 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 historically relied on raising capital to fund our operations. Based on our working capital balance as of December 31, 2024 and projected cash needs for the next twelve months, our management estimates that we will need to raise additional capital to cover operating and capital requirements. Management will need to raise the additional funds through issuing additional shares of Common Stock or other equity securities or obtaining debt financing. There can be no assurance that any required future financing can be successfully completed on a timely basis or on terms acceptable to us. Based on these circumstances, management has determined there is substantial doubt about our ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. ### We may become involved in litigation that may materially adversely affect us. From time to time, we may become involved in various legal proceedings relating to matters incidental to the ordinary course of our business, including intellectual property, commercial, product liability, employment, class action, whistleblower, shareholder derivative suits, and other litigation and claims, and governmental and other regulatory investigations and proceedings. The Holders of the Convertible Notes have alleged that we owe additional principal and interest thereon and are required to repurchase the Convertible Note Warrants. Puritan has filed suit seeking to recover such amounts allegedly owed. Our management believes that our obligations under the Convertible Notes have been satisfied and that no additional payments are due to the Holders, and we have conveyed our position to the Holders. Nevertheless, we cannot assure you that we will prevail. Such matters can be time-consuming, divert management’s attention and resources, cause us to incur significant expenses or liability, or require us to change our business practices. Because of the potential risks, expenses, and uncertainties of litigation, we may, from time to time, settle disputes, even where we believe that we have meritorious claims or defenses. Because litigation is inherently unpredictable, we cannot assure you that the results of any of these actions will not have a material adverse effect on our business. ***We have a history of net losses, and we may not be able to achieve or maintain profitability in the future.*** We have incurred net losses each year since our inception, and we may not be able to achieve or maintain profitability in the future. For the years ended December 31, 2024 and 2023, we had a loss from continuing operations of $10,650,464 and $16,205,252, respectively, and negative cash flows from operations of $4,388,948 and $8,348,208, respectively. To date, we have financed our operations primarily through the sale of equity securities and convertible debt. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials, and we anticipate that our expenses will continue to increase over the next several years as we continue to develop and launch our cosmetic products, expand into new markets and increase our sales and marketing efforts. These efforts may be more costly than we expect and may not result in increased revenue or growth in our business. Accordingly, we expect to continue to incur substantial operating losses for the foreseeable future, which may fluctuate significantly from quarter to quarter and year to year. Any failure to increase our revenue sufficiently to keep pace with our investments and other expenses could prevent us from achieving or maintaining profitability or positive cash flow on a consistent basis. If we are unable to successfully address these risks and challenges as we encounter them, our business, financial condition, results of operations, and prospects could be adversely affected. If we are unable to generate adequate revenue and manage our expenses, we may continue to incur significant losses in the future and may not be able to achieve or maintain profitability. In addition, even if we do achieve profitability, we may not be able to sustain or increase profitability. Our failure to become and remain profitable would depress the value of our company and could impair our ability to maintain our research and development efforts, expand our business, diversify our product offerings, or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment. ### An economic downturn may harm our business and the results of our operations. Our overall performance depends, in part, on worldwide economic conditions. The U.S. and global markets have experienced cyclical or episodic downturns, and worldwide economic conditions remain uncertain and volatile, as a result of current geopolitical conditions including the Israel-Hamas war, the ongoing Russia-Ukraine war and geopolitical tensions between China and the U.S., proposed tariffs and other trade restrictions by the U.S. government and foreign governments, instability in the U.S. and global banking systems, high levels of inflation, high interest rates, the downgrading of the U.S.’s credit rating and the possibility of a recession. Impacts of such economic weakness include: - falling overall demand for goods and services, leading to reduced profitability; - reduced credit availability; - higher borrowing costs; - reduced liquidity; - volatility in credit, equity, and foreign exchange markets; and - bankruptcies. These developments could lead to supply chain disruptions, decreased consumer spending, and uncertainty about business continuity, which may adversely affect our business and our results of operations. ***Future increases in interest rates may increase our borrowing costs and may also affect our ability to obtain working capital through borrowings such as bank credit lines and public or private sales of debt securities, which may result in lower liquidity, reduced working capital, and other adverse impacts on our business.*** Any continued increases in interest rates in the future will increase the cost of new indebtedness/servicing our outstanding indebtedness/refinancing our outstanding indebtedness, and could materially and adversely affect our results of operations, financial condition, liquidity, and cash flows. ***Significant disruptions of information technology systems, computer system failures, or breaches of information security could adversely affect our business.*** We rely to a large extent upon information technology systems to operate our business. In the ordinary course of business, we collect, store, and transmit large amounts of confidential information (including, but not limited to, personal information and intellectual property). The size and complexity of our information technology and information security systems, and those of our third-party vendors with whom we may contract, make such systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage and market manipulation) and expertise. While we intend to invest in the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches. Our internal computer systems, and those of our business vendors on which we may rely, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, fire, terrorism, war, and telecommunication and electrical failures. We exercise little or no control over these third parties, which increases our vulnerability to problems with their systems. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs. Any interruption or breach in our systems could adversely affect our business operations or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us or allow third parties to gain material, inside information that they use to trade in our securities. To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development of our cosmetic products could be delayed, and our business could be otherwise adversely affected. ***We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.*** As of March 27, 2025, we have fifteen full-time employees. We will need to grow the size of our organization in order to support our continued development and commercialization of our cosmetic products. As our development and commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial, and other resources will increase. Our management, personnel, and systems currently in place will not be adequate to support this future growth. Future growth would impose significant added responsibilities on members of management, including: - Managing our clinical validation effectively; - identifying, recruiting, maintaining, motivating, and integrating additional employees; - managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors, and other third parties; and - improving our managerial, development, operational, information technology, and finance systems; and expanding our facilities. If our operations expand, we will also need to manage additional relationships with various strategic partners, suppliers, and other third parties. Our future financial performance and our ability to commercialize our cosmetic products and to compete effectively will depend, in part, on our ability to manage any future growth effectively, as well as our ability to develop a sales and marketing force when appropriate for our company. To that end, we must be able to manage our development efforts effectively and hire, train, and integrate additional management, research and development, manufacturing, administrative, and sales and marketing personnel. The failure to accomplish any of these tasks could prevent us from successfully growing our company. ### Risks Related to Our Common Stock ***If we were to be delisted from Nasdaq, it could reduce the visibility, liquidity, and price of our Common Stock.*** On September 30, 2024, we received notification from the Nasdaq’s Listing Qualifications Department (the “Department”) indicating that 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) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq has provided us with 180 calendar days, or until March 31, 2025 (the “Minimum Bid Compliance Date”), to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid price of the Common Stock must be at least $1 per share for a minimum of ten consecutive business days at any time during this 180-day period, after which Nasdaq will provide written confirmation of compliance to us, and the matter will be closed. If we do not regain compliance with the Minimum Bid Price Requirement by the Minimum Bid Compliance Date, Nasdaq may grant us an additional compliance period of 180 calendar days to regain compliance with the Minimum Bid Price Requirement if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provide written notice to Nasdaq of our intent to cure the deficiency during this second compliance period. However, if it appears to the Nasdaq staff that we will not be able to cure the deficiency or if we do not qualify for the second compliance period or fail to regain compliance during the second 180-day compliance period, Nasdaq will provide notice to us that our Common Stock will be subject to delisting. At that time, we may appeal any such delisting determination to a Nasdaq hearings panel. On March 24, 2025, our stockholders approved a reverse stock split of our Common Stock at a ratio in the range of 1-for-15 to 1-for-30 (the “Reverse Stock Split”), with such ratio to be determined at the discretion of our Board of Directors (the “Board”). Even if our Board determines to implement the Reverse Stock Split, the effect of the Reverse Stock Split upon the market price of our Common Stock cannot be predicted with any certainty, and the history of similar stock splits for companies in like circumstances is varied. It is possible that (i) the per share price of our Common Stock after the Reverse Stock Split will not rise in proportion to the reduction in the number of shares of our Common Stock outstanding resulting from the Reverse Stock Split, (ii) the market price per post-reverse stock split share may not exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time or (iii) the Reverse Stock Split may not result in a per share price that would attract brokers and investors who do not trade in lower priced stocks. Even if we effect the Reverse Stock Split, the market price of our Common Stock may decrease due to factors unrelated to the Reverse Stock Split. In any case, the market price of our Common Stock will be based on other factors that may be unrelated to the number of shares outstanding, including our future performance. If the Reverse Stock Split is consummated and the trading price of the Common Stock declines, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of the Reverse Stock Split. Even if the market price per post-Reverse Stock Split share of our Common Stock remains in excess of $1.00 per share, we may be delisted due to a failure to meet other continued listing requirements, including Nasdaq requirements related to the minimum number of shares that must be in the public float and the minimum market value of the public float. On August 30, 2024, we received notice from the Department that we are not in compliance with Nasdaq Listing Rule 5550(b)(2) as a result of our Market Value of Listed Securities (the “MVLS”) falling below the minimum of $35 million required for continued listing on the Nasdaq Capital Market (the “MVLS Requirement”) from July 15, 2024 to August 29, 2024. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided us with 180 calendar days, or until February 26, 2025 (the “MVLS Compliance Date”), to regain compliance with the MVLS Requirement. To regain compliance during the 180-day period, our MVLS must be at least $35 million for a minimum of ten consecutive business days at any time during this period, after which Nasdaq will provide written confirmation of compliance to us, and the matter will be closed. We did not regain compliance with the MVLS Requirement by the MVLS Compliance Date. Accordingly, on March 4, 2025, we received written notice from the Department notifying us that we had failed to regain compliance with the MVLS Requirement by the MVLS Compliance Date. As such, we have requested an appeal of Nasdaq’s determination to delist our securities from the Nasdaq Capital Market. However, there can be no guarantee that we will be successful in appealing this determination and that our securities will continue to be listed on the Nasdaq Capital Market. A request for an appeal will stay the delisting of our securities pending Nasdaq’s decision. In addition, even if we are successful in our appeal and able to regain and maintain compliance with the Minimum Bid Price Requirement, we may still be delisted if we do not regain compliance with the MVLS Requirement or otherwise maintain compliance with Nasdaq’s other continued listing requirements. ***We expect the price of our Common Stock may be volatile and may fluctuate substantially.*** The stock market in general and the market for cosmetics companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our Common Stock may be influenced by many factors, including: - commercialization and sales of our products; - the results of our efforts to discover, develop, acquire, or in-license products, if any; - failure or discontinuation of any of our research programs; - actual or anticipated results from, and any delays in, any future clinical validation; - the level of expenses related to any products that we may choose to develop or clinical development programs we may choose to pursue; - disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; - announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, and capital commitments; - additions or departures of key scientific or management personnel; - variations in our financial results or those of companies that are perceived to be similar to us; - new products or new uses for existing products introduced or announced by our competitors, and the timing of these introductions or announcements; - results of clinical validation, testing, or clinical trials of products or product candidates of our competitors; - general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies; - regulatory or legal developments in the U.S. and other countries; - changes in the structure of healthcare payment systems; - conditions or trends in the cosmetics industry; - actual or anticipated changes in earnings estimates, development timelines, or recommendations by securities analysts; - announcement or expectation of additional financing efforts; - sales of Common Stock by us or our stockholders in the future, as well as the overall trading volume of our Common Stock; and - the other factors described in this “Risk Factors” section. In the past, following periods of volatility in companies’ stock prices, securities class-action litigation has often been instituted against such companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business and financial condition. ***Future resales of Common Stock may cause the market price of our securities to drop significantly, even if our business is doing well.*** Sales of a substantial number of shares of our Common Stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our Common Stock. As restrictions on resale end and registration statements for the sale of the shares held by parties who have contractual registration rights are available for use, the sale or possibility of sale of these shares could have the effect of increasing the volatility in the market price of our Common Stock or decreasing the market price itself. As a result of any such decreases in the price of our Common Stock, purchasers who acquire shares of our Common Stock may lose some or all of their investment. Any significant downward pressure on the price of our Common Stock as the selling stockholders sell the shares of our Common Stock, or the prospect of such shares, could encourage short sales by the selling stockholders or others. Any such short sales could place further downward pressure on the price of our Common Stock. ***We are required to register the issuance of the shares underlying the warrants issued in the IPO. We may incur substantial costs in connection with such registration statement, and the issuance of such shares may result in dilution to holders of our Common Stock, and the issuance of any such shares upon a cashless exercise of the warrants would not result in the receipt by us of any cash proceeds thereof.*** Pursuant to the warrant agreement entered into upon closing of the IPO, we agreed to file a registration statement with the SEC to register the issuance of the shares of Common Stock upon exercise of the warrants issued in the IPO. We prepared and filed such registration statement on August 7, 2023. The registration statement was not declared effective by the 60th business day following the closing of the Business Combination. As a result, until such registration statement is declared effective by the SEC, such warrants may be exercised by the holders thereof on a cashless basis. We have incurred substantial costs in connection with the filing of the registration statement. We will be required to amend the registration statement to include certain financial statements of AxoBio and to update certain financial and other information since the date of the original filing of the registration statement. We may incur substantial costs in connection with such amendment and completion of the SEC review process. In addition, for as long as the warrants remain exercisable on a cashless basis until the effectiveness of the registration statement, we would not be able to receive any cash proceeds from the exercise thereof, preventing such potential proceeds from improving our liquidity position. Any shares issuable upon exercise of the warrants, for cash or on a cashless basis, would also increase the number of shares outstanding and available for sale, which could result in downward pressure on the price of our Common Stock. ***We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock less attractive to investors.*** We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). For so long as we remain an emerging growth company, we will be permitted to and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include: - not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; - not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; - reduced disclosure obligations regarding executive compensation; and - exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We may choose to take advantage of some, but not all, of the available exemptions. We cannot predict whether investors will find our Common Stock less attractive if we rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock, and the price of our Common Stock may be more volatile. ***We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our Common Stock.*** We have never declared or paid cash dividends on shares of our Common Stock. We currently plan to retain all of our future earnings, if any, and any cash received as a result of future financings to finance the growth and development of our business. Accordingly, capital appreciation, if any, of our Common Stock will be the sole source of gain for holders of our Common Stock for the foreseeable future. ***Provisions in our amended and restated certificate of incorporation and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the future for our Common Stock and could entrench management.*** Our amended and restated certificate of incorporation contains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests. These provisions include a staggered board of directors and the ability of the board of directors to designate the terms of and issue new series of preferred shares, which may make the removal of management more difficult and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities. We are also subject to anti-takeover provisions under Delaware law, which could delay or prevent a change of control. Together, these provisions may make the removal of management more difficult and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities. ## Cybersecurity As filed, 4,522 characters. Managing cybersecurity risk is a crucial part of our overall strategy for safely operating our business. We incorporate cybersecurity practices into our Enterprise Risk Management (“ERM”) approach, which is subject to oversight by our Board. Consistent with our overall ERM program and practices, our cybersecurity program includes: - *Vigilance:* We maintain a cybersecurity program that endeavors to identify risks, protect assets, detect threats, respond to incidents, and recover from damaging events in a prompt and effective manner with the goal of minimizing business disruptions through effective governance of people, processes, and technologies. - *External Collaboration:* We collaborate with a third-party service provider to identify, assess, and mitigate cybersecurity risks. - *Systems Safeguards:* We deploy technical safeguards that are designed to protect our information systems, products, operations, and sensitive information from cybersecurity threats, including compromises of our information systems and our data’s confidentiality, integrity, and availability. These include firewalls, disaster recovery capabilities, malware and ransomware prevention, access controls, and encryption. - *Education:* We provide monthly training for all personnel regarding cybersecurity threats, with such training appropriate to the roles, responsibilities, and access of the relevant Company personnel. Our policies require all workers to report any actual or suspected cybersecurity events. - *Incident Response Planning:* We have established and maintain incident response plans that direct our response to cybersecurity events and incidents. Such plans include the protocol by which a material incident would be communicated to executive management, our Board, external regulators, and shareholders. - *Governance:* Our Board's oversight of cybersecurity risk management is led by the Board's audit committee (the “Audit Committee”), which oversees our ERM program. The Audit Committee reviews cybersecurity threats, risks, and mitigation on at least an annual basis, and such reviews include internal and independent assessments of risks, controls, and overall program effectiveness. Our risk assessment efforts have indicated that we are a potential target for theft of intellectual property, financial resources, personal information, and trade secrets from a wide range of actors, including nation-states, organized criminal groups, malicious insiders, and activists. The impacts of attacks, abuse, and misuse of the Company’s systems and information include, without limitation, loss of assets, operational disruption, and damage to the Company’s reputation. A key element of managing cybersecurity risk is the ongoing assessment and testing of our processes and practices through assessments, and other exercises focused on evaluating the sufficiency and effectiveness of our cybersecurity risk management efforts. If a material weakness in our cybersecurity risk management program is identified, it will be reported to the Audit Committee and the Board, as appropriate, and we will make adjustments to our cybersecurity processes and practices as necessary to eliminate or compensate for that weakness. Our CFO is principally responsible for overseeing our cybersecurity risk management program in partnership with other Company management. We believe our business leaders, including our CFO, have the appropriate expertise, background, and depth of experience to manage risks arising from cybersecurity threats. Our CFO collaborates with other Company business leaders and our third-party service provider to maintain a program designed to manage our exposure to cybersecurity risks and to respond to cybersecurity incidents promptly. The Audit Committee oversees cybersecurity risk management, including the policies, processes, and practices that management implements to operationalize our cybersecurity risk management program. The Audit Committee will promptly receive information regarding any material cybersecurity incident that may occur, including any ongoing updates. The Audit Committee periodically discusses our approach to cybersecurity risk management with our CFO, who oversees the Company’s information systems. As of the date of this Form 10-K, we are not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company, including our business strategy, results of operations, or financial condition at this time. ## Properties As filed, 429 characters. Our corporate headquarters, research and development, and manufacturing facilities are located in Pittsburgh, Pennsylvania, where we lease approximately 6,432 square feet of space. This lease expires in 2028. In addition, we sublease approximately 2,988 square feet of office and manufacturing space in Folsom, CA. This sublease expires in May 2025. We believe that our existing facilities are adequate to support our operations. ## Legal proceedings As filed, 216 characters. The information under the headings “January 2022 Convertible Notes” in Note 9 - Debt and Note 11 - Contingencies in the notes to the accompanying consolidated financial statements is incorporated herein by reference. ## Management's discussion and analysis As filed, 26,763 characters. *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.* ### Overview 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 SecretomeTM and Elevai ExosomesTM, 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. ### Recent Developments #### Private Placement 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. #### Elevai Acquisition 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. 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 ExosomesTM product line had sales of approximately $2,500,000 for the year ended December 31, 2024. #### Name Change 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.” #### Chief Executive Officer Transition 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. #### Nasdaq Delisting Notices 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. 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. 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. ### Impact of Macroeconomic Events 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. ### Critical Accounting Policies and Estimates This discussion and analysis of our financial condition and results of operations is based on our audited consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these audited consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the audited consolidated financial statements, as well as the reported revenue expenses and net loss incurred during the reporting periods. Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. ### Going Concern and Management Plan 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. 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. 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. We are also exploring out-licensing certain research and development programs to enhance our liquidity. ### Comparison of Results of Operations for the Years Ended December 31, 2024 and 2023 The following table sets forth our results of operations for the years ended December 31, 2024 and 2023: | | For the Year Ended December 31,% 2024 | 2023 | Change | Change | | --- | ---: | ---: | ---: | ---: | | Gross sales | $90,829 | $— | $90,829 | 100% | | Discounts and allowances | (40,511) | — | (40,511) | 100% | | Net sales | 50,318 | — | 50,318 | 100% | | Cost of sales | 6,357 | — | 6,357 | 100% | | Gross profit | 43,961 | — | 43,961 | 100% | | Operating expenses: | | | | | | Selling and marketing | 189,323 | — | 189,323 | 100% | | Research and development | 1,054,310 | 2,497,218 | (1,442,908) | (58)% | | General and administrative | 3,715,340 | 2,622,945 | 1,092,395 | 42% | | Depreciation and amortization of intangibles | 83,486 | 97,113 | (13,627) | (14)% | | Restructuring charges | — | 726,280 | (726,280) | (100)% | | Total operating expenses | 5,042,459 | 5,943,556 | (901,097) | (15)% | | **Loss from operations** | **(4,998,498)** | **(5,943,556)** | **945,058** | (16)% | | Other expenses, net | (5,749,245) | (10,261,696) | 4,512,451 | (44)% | | **Loss from continuing operations before income taxes** | **(10,747,743)** | **(16,205,252)** | **5,457,509** | (34)% | | Income tax benefit | (97,279) | — | (97,279) | 100% | | **Loss from continuing operations** | **(10,650,464)** | **(16,205,252)** | **5,554,788** | (34)% | | (Loss) income from discontinued operations | (1,152,276) | 760,165 | (1,912,441) | (252)% | | Gain on sale of discontinued operations | 1,434,479 | — | 1,434,479 | 100% | | **Net loss** | **$(10,368,261)** | **$(15,445,087)** | **$5,076,826** | (33)% | #### Gross Sales/Gross Profit 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. #### Operating Expenses 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. 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. 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. 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. #### Other Expenses, Net 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. #### Discontinued Operations, Net 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. ### Liquidity, Capital Resources, and Going Concern 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. 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. 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. 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. ### Debt 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. ### Cash Flows The following table summarizes our cash flows for the years ended December 31, 2024, and 2023: | | Year Ended December 31, 2024 | 2023 | Change | | --- | ---: | ---: | ---: | | Net cash used in operating activities | $(4,388,948) | $(8,348,208) | $3,959,260 | | Net cash used in investing activities | (748,796) | (30,470) | (718,326) | | Net cash provided by financing activities | 2,382,422 | 11,162,990 | (8,780,568) | #### Operating Activities 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. #### Investing Activities For the year ended December 31, 2024, we paid $748,796 of costs in connection with the disposition of AxoBio. #### Financing Activities 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. ### Contingencies 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. ### Contractual Obligations and Commitments 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. ### Emerging Growth Company and Smaller Reporting Company Status The JOBS Act permits an “emerging growth company” to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. Although we qualify as an emerging growth company, we have elected not to “opt-out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt-out” of such extended transition period or (ii) no longer qualify as an emerging growth company. 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. ## Controls and procedures As filed, 3,301 characters. Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Management identified a material weakness in its internal controls over the accounting treatment for a complex transaction. We have addressed this weakness by adopting a policy requiring formal documentation to substantiate the accounting treatment of all material transactions, including references to the relevant authoritative guidance. ### Evaluation of Disclosure Controls and Procedures As required by Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer and Chief Financial Officer carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2024. Based upon their evaluation, our Chief Executive Officer and Chief Financial Officer concluded that during the period covered by this report, our disclosure controls and procedures were not effective as described above. ### Management’s Report on Internal Control over Financial Reporting As required by SEC rules and regulations implementing Section 404 of the Sarbanes-Oxley Act, our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external reporting purposes in accordance with GAAP. Because of its inherent limitations, internal control over financial reporting may not prevent or detect errors or misstatements in our financial statements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree or compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of our internal control over financial reporting at December 31, 2024. In making these assessments, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013). Based on our assessments and those criteria, management concluded that, as of December 31, 2024, our internal control over financial reporting were not effective as described above. ### Changes in Internal Control Over Financial Reporting Except as described above, there has been no change in our internal control over financial reporting during the most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Filed Mar 31, 2025. Source: SEC EDGAR, the filing index for accession 0000950170-25-047891. Last ingested by Listed: Oct 24, 2026, 15:15 ET. No prices; not investment advice.