Acquisition and Financials - The company completed the Elevai Acquisition on January 16, 2025, acquiring assets with net sales of approximately $2,500,000 for the year ended December 31, 2024[13]. - The company raised gross proceeds of $1,851,849 from a private placement of 8,065,210 shares at an exercise price of $0.23 per share on January 2, 2025[12]. - The company is obligated to pay CMU royalties at a rate of 2.07% of net sales and 25% of sublicense fees received, although no royalties have been accrued or paid as no products utilizing the licensed technology have been commercialized[42]. Market Overview - The skincare and haircare markets were approximately $280 billion in 2022, expected to grow at a 6.4% CAGR[27]. - The medical aesthetics market is growing 36% faster than pharmaceuticals, indicating a strong demand for cosmetic products[27]. Product Lines and Launches - The company has two cosmetic product lines, Carmell Secretome™ and Elevai Exosomes™, aimed at supporting skin and hair health[11]. - The Elevai Exosomes™ skincare products include Elevai Empower™ and Elevai Enfinity™, designed for post-treatment support and daily aftercare[24]. - The company’s Carmell Secretome™ utilizes a proprietary formulation with over a thousand growth factors, proteins, and peptides[16]. - The company plans to launch the Undereye Collection and Body and Décolleté Collection in the second quarter of 2025[21]. - The Elevai Renew™ Scalp Serum, promoting healthy hair growth, was launched in the first quarter of 2025[26]. Regulatory and Compliance - Legacy Carmell's BHA product candidate has been submitted to the FDA as an Investigational New Drug (IND) for severe open tibia fractures, with a fast-track designation granted due to its potential to meet significant unmet needs[38]. - The FDA requires rigorous preclinical and clinical testing for the company's biological products, including BHA and THA, before marketing approval can be obtained[55]. - The company is subject to extensive regulations by the FDA, CPSC, and FTC regarding the marketing and safety of its cosmetic products[46]. - The Amended License Agreement with CMU requires the company to meet specific milestones, including CE Mark submission by December 31, 2023, and FDA BLA submission by December 31, 2026[44]. - The last-to-expire patent related to the technology under the Amended License Agreement is expected to expire on September 2, 2030[41]. Operations and Workforce - The company has ceased clinical studies of its product candidates to focus on the near-term commercialization of its cosmetic skincare and haircare product lines following the AxoBio Acquisition[38]. - As of March 27, 2025, the company has 15 full-time employees, and it aims to maintain a positive work environment to attract and retain qualified staff[61]. - The company has experienced no disruptions in its supply chain and actively works to optimize operations as sales of its cosmetic products grow[58]. - The company focuses on selling products through business-to-business, direct-to-consumer, and distributor sales channels[28].
ALPHA HEALTHCARE(ALPA) - 2024 Q4 - Annual Report