Business Combinations and Acquisitions - The business combination with Alpha Healthcare Acquisition Corp. III was completed on July 14, 2023, with an exchange ratio of 0.06154 for Legacy Carmell common stock[14]. - The acquisition of Axolotl Biologix was finalized on August 9, 2023, with a total closing share consideration of $57 million based on a 30-day average daily VWAP of $7.05 per share[24]. Financial Information - The total redemption price for 12,586,223 shares of Class A Common Stock was approximately $29.37 million, with a cash redemption price of about $10.28 per share[15]. - The Forward Purchase Agreement involved the purchase of 1,705,959 shares of Class A Common Stock at a price of $10.28 per share, totaling $17.54 million[17]. - The Reset Price for the Forward Purchase Agreement is initially set at $11.50, with adjustments based on the VWAP Price of the shares[22]. Product Development and Pipeline - Carmell's product pipeline includes innovative regenerative bone and tissue healing products currently under development[13]. - The Carmell Secretome™ is derived from allogeneic human platelets and contains over 1000 growth factors, proteins, and peptides, designed to support skin and hair health[29]. - The company has developed a novel microemulsion formulation that enhances ingredient delivery without using harmful excipients or oils, ensuring non-comedogenic properties[32]. - The first cosmetic skincare product, Carmell G.L.E.E, was launched in March 2024, with nine additional products in the pipeline[35]. - The company has submitted its BHA product candidate to the FDA as an Investigational New Drug (IND) for severe open tibia fractures[42]. - The FDA granted fast-track designation for the BHA program, indicating significant unmet medical needs[44]. - The company has conducted multiple preclinical studies supporting BHA's potential to heal wounds and accelerate bone healing[42]. Market and Distribution Strategy - The skincare and haircare markets were approximately $280 billion in 2022, expected to grow at a 6.4% CAGR[37]. - The company plans to employ an omnichannel distribution strategy, focusing on both national retailers and e-commerce channels[38][43]. - The company is also expanding its product line to include men's products and topical haircare products tailored for professional care providers and retail consumers[13]. Regulatory and Compliance - The company is subject to extensive FDA regulations, which continue after product approval, particularly regarding good manufacturing practices (GMP)[65]. - The company must comply with FDA advertising and promotion requirements, including restrictions on off-label use[66]. - The company has not accrued or paid royalties under the Amended License Agreement as no products utilizing the licensed technology have been commercialized[49]. - The Amended License Agreement with Carnegie Mellon University is effective until January 30, 2028, or until the last patent expires in September 2030[48]. - The company is required to meet minimum performance requirements, including FDA BLA submission by December 31, 2026[50]. Operations and Workforce - The company operates in one segment focused on the development and commercialization of bio-aesthetic and bone and tissue healing products[73]. - The company has nine full-time employees and one part-time employee as of March 15, 2024, relying on independent organizations for regulatory approval and clinical management[74]. - The company recognizes the importance of its employees at manufacturing facilities and has programs to ensure operating safety[69]. - The company collaborates with suppliers to meet stringent design and creative criteria, believing it has adequate sources of supply for all products[70]. - The company has experienced no disruptions in its supply chain and actively works to optimize supply chain operations as cosmetic skincare products are commercialized[71]. - The company maintains compliance with numerous environmental, health, and safety laws, which has not materially affected its capital expenditures or earnings[72]. Corporate Information - The company is incorporated under the laws of Delaware and has undergone a merger to facilitate business combinations[75]. - The company’s principal corporate office is located in Pittsburgh, PA[76].
ALPHA HEALTHCARE(ALPA) - 2023 Q4 - Annual Report