Business Combination and Acquisitions - Carmell completed a business combination on July 14, 2023, with an exchange ratio of 0.06154 for Legacy Carmell common stock[14]. - The company acquired Axolotl Biologix for a total consideration of $57 million, based on a 30-day average daily VWAP of $7.05 per share[24]. - As of the closing date of the business combination, Alpha's trust account had a balance of $29,376,282 after redemptions totaling $29,374,372[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 $17,535,632[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, alongside a line of men's products and topical haircare products[13]. - The company utilizes a proprietary formulation derived from allogeneic human platelets, containing over 1000 growth factors, proteins, and peptides, to support skin and hair health[28]. - Carmell's microemulsion formulations are designed to be non-comedogenic and do not use mineral or vegetable oils across its entire product line[31]. - The first cosmetic skincare product, Carmell G.L.E.E, was launched in March 2024, with nine additional products in the pipeline[34]. - The FDA granted fast-track designation for the BHA program, indicating potential to meet significant unmet needs[42]. - The company has submitted its BHA product candidate to the FDA as an Investigational New Drug for severe open tibia fractures[40]. - The company has conducted multiple preclinical studies supporting BHA's potential to heal wounds and accelerate bone healing[40]. - The company has twenty-one patents related to BHA and THA products, which include exclusive licenses from CMU[50]. Market Overview - The skincare and haircare markets were approximately $280 billion in 2022, expected to grow at a 6.4% CAGR[35]. - The beauty industry is concentrated, with significant retail sales generated by a few large multinational companies[37]. Regulatory Compliance and Safety - The company is subject to extensive FDA regulations, which continue after product approval, particularly regarding Good Manufacturing Practices (GMP)[63]. - The company must comply with various federal, state, and international laws impacting online business operations, including consumer protection and data privacy regulations[66]. - The company recognizes the importance of employee safety at manufacturing facilities and has programs in place to ensure compliance with environmental regulations[67]. - The company may face significant user fees under the Prescription Drug User Fee Act for its Biologics License Applications (BLAs)[61]. - The company is required to conduct post-marketing clinical trials to further assess the safety and effectiveness of its products[62]. - The company maintains policies to monitor and control environmental, health, and safety risks, ensuring compliance with applicable laws[70]. Operational Aspects - The company operates in one segment focused on the development and commercialization of bio-aesthetic and bone and tissue healing products[71]. - The company has nine full-time employees and one part-time employee as of March 15, 2024[72]. - The company has experienced no disruptions in its supply chain and actively works to anticipate and respond to potential disruptions[69]. - The company collaborates with suppliers to meet stringent design and creative criteria, ensuring adequate sources of supply for all products[68]. - The company is required to meet minimum performance requirements, including CE Mark submission by December 31, 2023, and FDA BLA submission by December 31, 2026[48].
Carmell Therapeutics (CTCX) - 2023 Q4 - Annual Report