Financial Performance - Total assets increased to $2,367,027 in 2025 from $1,473,980 in 2024, representing a 60.5% growth[228]. - Net sales surged to $1,912,811 in 2025, a significant increase from $50,318 in 2024, marking a 3,694.5% rise[230]. - Gross profit for 2025 was $1,094,760, compared to $43,961 in 2024, indicating a substantial increase[230]. - Operating expenses rose to $8,202,333 in 2025, up from $5,042,459 in 2024, reflecting a 62.5% increase[230]. - The net loss for 2025 was $6,905,282, an improvement from a net loss of $10,368,261 in 2024[230]. - Cash and cash equivalents at the end of 2025 were $706,740, up from $157,139 at the end of 2024, showing a 348.5% increase[234]. - Total current liabilities increased to $7,916,259 in 2025 from $5,876,705 in 2024, a rise of 34.6%[228]. - The company reported a loss from operations of $7,107,573 in 2025, compared to a loss of $4,998,498 in 2024[230]. - Research and development expenses decreased to $788,888 in 2025 from $1,054,310 in 2024, a decline of 25.2%[230]. - The Company reported a net loss of $6,905,282 for the year ended December 31, 2025, with negative net cash flow from operations of $3,329,266[291]. - The Company had negative net working capital of $5,966,168 as of December 31, 2025, raising concerns about its ability to continue as a going concern[291]. Product Development and Launches - The Elevai Exosomes™ product line includes Elevai Empower™ and Elevai Enfinity™, designed to enhance skin appearance post-aesthetic treatments[19]. - In February 2026, the company launched two new products, Elevai HOCL Allantoin Active Cleanser™ and Elevai Hyper-Hydrating Booster™, aimed at attracting new customers with a lower price point[21]. - The Elevai Renew™ Scalp Serum, launched in Q1 2025, promotes healthy hair growth and improves hair appearance, utilizing proprietary compounds from Yuva BioSciences, Inc.[20]. - The Carmell Secretome™ product line utilizes a novel microemulsion formulation, avoiding 14 potentially harmful excipients commonly used in cosmetics[24]. - The company has paused further research and development on innovative regenerative bone and tissue healing products in its pipeline[11]. - The company has deprioritized further research and development of its Bone Healing Accelerant (BHA) and Tissue Healing Accelerant (THA) products to focus on the commercialization of its cosmetic skincare and haircare product lines[45]. - The company has conducted multiple preclinical studies supporting the belief that BHA can heal wounds and accelerate bone healing, measured by density, vascularity, and woven bone presence[45]. Sales and Marketing Strategy - The company sells its products through three channels: business-to-business, direct-to-consumer, and distributor sales, optimizing sales reach and strategy[32]. - The company’s direct sales force targets physician-dispensed markets, focusing on individualized skincare regimens and enhancing the benefits of in-office procedures[36]. - The company has an established customer base for its recently acquired Elevai skin and hair care products, refocusing sales and marketing efforts on these products[39]. - Selling and marketing expenses increased significantly to $1,423,045 in 2025 from $189,323 in 2024, reflecting a growth of approximately 651%[267]. Regulatory and Compliance - The company is subject to extensive regulation by the FDA and other governmental authorities regarding the testing, manufacturing, and marketing of its products[46]. - The company believes its intellectual property, including twenty-one patents related to BHA and THA products, has substantial value and will contribute significantly to its success[47]. - The company is classified as an "emerging growth company," allowing it to take advantage of certain reporting exemptions[245]. Capital and Financing - The company closed a private placement on March 16, 2026, raising approximately $200,000 from the sale of 689,656 shares at an offering price of $0.29 per share[12]. - The company expects to raise additional capital through equity or debt issuances to alleviate liquidity concerns, although there are no guarantees[292]. - The Company raised gross proceeds of $1,959,140 from the sale of 479,621 shares of Common Stock under an at-the-market equity offering in May 2025[337]. - The Company raised approximately $1,851,849 from the 2025 Private Placement, issuing 268,840 shares of Common Stock at $6.90 per share[339]. - The Company raised gross proceeds of $3,000,950 from the sale of 44,382 shares of Common Stock in the 2024 Private Placement, incurring $313,725 in costs[342]. Assets and Liabilities - The company recorded an inventory write-down of $60,963 related to expired finished goods during 2025[256]. - Total inventory as of December 31, 2025, was $963,028, significantly up from $108,705 in 2024[303]. - Accrued expenses and other liabilities increased to $1,843,464 in 2025 from $313,713 in 2024, indicating a substantial rise in financial obligations[310]. - The Company had an outstanding SBA Loan with a principal of $2,000,000, adjusted to fair value at $1,498,000, with monthly payments of $9,953 starting December 2023[316]. - The Company had no reserves for uncollectible receivables as of December 31, 2025 and 2024[255]. Employee and Operational Insights - The company has ten full-time employees as of March 27, 2026, and aims to attract and retain qualified employees through competitive compensation packages and a positive work environment[61]. - The company has experienced no disruptions in its supply chain and actively works to anticipate and respond to potential disruptions, enhancing forecasting and planning capabilities[58]. - The company’s operations are based in Pittsburgh, Pennsylvania, and it operates as a single segment focused on bio-aesthetic products[240]. Acquisitions and Mergers - The company completed the Elevai Acquisition on January 16, 2025, with a fair value of shares issued amounting to $660,805[242]. - The total estimated value of the consideration transferred in the Elevai Acquisition was $1,180,180, which included 38,308 shares of Common Stock valued at $660,805 and earnout liabilities of $301,633[296]. - The fair value step-up of acquired inventories was approximately $410,145, recognized in cost of sales as the related products sold[300]. - The company terminated the THPlasma Merger Agreement on December 8, 2025, as the merger was not consummated by the deadline[327].
Carmell Therapeutics (CTCX) - 2025 Q4 - Annual Report