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] Market Overview - The skincare and haircare markets were approximately $280 billion in 2022, with an expected growth rate of 6.4% CAGR[27] Product Launches and Innovations - 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] - The Carmell Secretome product line utilizes a novel microemulsion formulation, avoiding 14 potentially harmful excipients[15] - The Elevai Exosomes skincare products are designed to enhance outcomes for individuals receiving aesthetic treatments[24] Regulatory and Compliance - The company operates under strict quality control measures, including cGMP and GLP protocols, for the production of Elevai Exosomes[23] - The company is subject to extensive regulation by the FDA and other governmental authorities, which impacts the testing, manufacturing, and marketing of its products[39] - 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 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] - The last-to-expire patent related to the technology under the Amended License Agreement is expected to expire on September 2, 2030[41] Research and Development - The Bone Healing Accelerant (BHA) and tissue healing accelerant (THA) are based on patented technology from Carnegie Mellon University[36] - 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 company has a total of 21 patents related to its BHA and THA products, which include exclusive, worldwide licenses from CMU[45] Operations and Workforce - 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 operates in one segment focused on the development and commercialization of bio-aesthetic and bone and tissue healing products[60] Strategic Focus - 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] - The company focuses on physician-dispensed sales channels, targeting dermatologists and plastic surgeons for its products[32]
Carmell Therapeutics (CTCX) - 2024 Q4 - Annual Report