Creative Medical Technology (CELZ) - 2024 Q4 - Annual Report

Clinical Trials and Efficacy - The company received FDA clearance to initiate a Phase I/II clinical trial for AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), enrolling 30 individuals[26]. - The company reported a 93% overall efficacy in treated patients with Type 2 Diabetes using CELZ-001, demonstrating at least a 50% reduction in insulin requirement after one year[25]. - The FDA cleared the company's Type I Diabetes (CELZ-201 CREATE-1) IND application, allowing the start of a Phase I/II clinical trial[20]. - The company achieved a significant milestone by generating human iPSC-derived islet cells that produce human insulin, with potential for clinical translation[28]. - The company reported positive three-year follow-up data for the StemSpine® pilot study, showing continued efficacy for treating chronic lower back pain[21]. - The Data Safety Monitoring Board (DSMB) endorsed the continuation of the CELZ-201 ADAPT clinical trial, confirming the safety profile of CELZ-201[39]. - The first cohort of the CELZ-201 ADAPT clinical trial included 10 participants, with 8 receiving CELZ-201-DDT and 2 receiving placebo, showing no dose-limiting toxicities or serious adverse events[33]. - Preliminary blinded data from the CELZ-201 ADAPT trial suggest potential therapeutic benefits in alleviating chronic back pain associated with degenerative disc disease[39]. - The AlloStemSpine® treatment for chronic lower back pain has received FDA approval for a Phase I/IIa study, with initial data showing no serious adverse events in the first cohort of 10 participants[45]. - The StemSpine® procedure has shown a continued efficacy rate of 87% in treating chronic lower back pain over a three-year follow-up period[57]. - The OvaStem™ technology for treating infertility has demonstrated significant efficacy in a pilot study, resulting in the successful birth of healthy babies[63]. - The CELZ-201 CREATE-1 therapy for Type I Diabetes is currently in a Phase I/IIa FDA study, with a treatment group of 12 and a control group of 6[44]. Intellectual Property and Licensing - The company has a robust intellectual property portfolio with four issued patents and fifty pending applications related to stem cell therapies[68]. - The company acquired U.S. Patent No. 9,598,673 for the use of various stem cells in treating lower back pain, with an initial payment of $100,000 made in cash and stock[75]. - The company has made various payments to CMH totaling$ 300,000 related to the patent agreement, with the remaining obligations settled through stock issuance[77]. - The company entered a Patent License Agreement with Jadi Cell, LLC, granting access to proprietary processes for expanding master cell banks, with an initial license fee of $250,000 paid in stock[78]. - The company has trademark registrations for CaverStem®, StemSpine®, AlloStemSpine®, and FemCelz®, with pending applications for several other brands[81]. - The company has multiple pending patent applications in immunology, including 15/617,813 for immunotherapy of recurrent spontaneous abortions and 63/340,450 for protection from ovarian failure[71]. - The company intends to comply with all applicable FDA regulations to avoid potential enforcement actions that could impact operations[115]. - The company has established a framework for royalty payments of 5% from gross sales of products derived from its patents, ensuring ongoing revenue from successful commercialization[79]. Regulatory Compliance and FDA Interaction - The FDA regulates the company's stem cell treatments under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, requiring compliance with stringent regulations[86]. - The company’s CaverStem® and FemCelz® procedures are exempt from FDA premarket review under the Same Surgical Procedure Exception, while ImmCelz™ requires standard drug approval[91]. - The FDA has broad regulatory authority over drugs and biologics marketed in the United States, including research, clinical testing, manufacturing, and distribution[93]. - The process for FDA approval of a drug or biologic typically involves multiple phases of clinical trials, including Phase 1, Phase 2, and Phase 3, which can take many years and require significant resources[96][102]. - Approval of a New Drug Application (NDA) or Biologics License Application (BLA) requires demonstrating that the product is safe and effective for its intended use[95]. - The FDA may expedite the review of NDAs and BLAs through programs such as Fast Track, Breakthrough Therapy, and Priority Review, which can significantly shorten the review timeline[105][108]. - The FDA requires that post-marketing clinical trials may be necessary to confirm the effectiveness of a product candidate after approval[97]. - Medical devices are classified into three classes based on risk, with Class III devices subject to the highest regulatory scrutiny and requiring premarket approval[112][113]. - The FDA premarket clearance and approval process for medical devices can take from three months to several years, depending on the type of submission[114]. - Compliance with Current Good Manufacturing Practices (cGMP) is essential for products regulated as drugs, biological products, or devices to ensure quality and safety[116]. - The FDA can impose various enforcement actions for non-compliance, including fines, product seizures, and criminal prosecutions, which could materially adversely affect the company[104][117]. - Non-compliance with FDA regulations can lead to severe enforcement actions, including fines and product recalls, which could materially affect the company[92]. - The FDA regulates the entire lifecycle of drugs and biological products, including research, clinical testing, and manufacturing processes[93]. - The approval process for drugs typically involves multiple phases of clinical trials, with Phase 3 requiring statistically significant evidence of efficacy[100]. - If products are regulated as drugs or biological products, significant resources will be needed for regulatory compliance, and the approval process can be lengthy and unpredictable[102]. - The company must submit an IND to begin clinical trials, and an NDA or BLA for marketing approval, which requires demonstrating safety and efficacy[94]. - Phase 4 clinical trials may be required post-approval to address safety issues identified by the FDA[97]. - Changes to approved applications require submission and approval of new NDAs or BLAs, which can involve extensive clinical data[98]. Financial Performance and Investments - The company secured approximately$ 1.6 million in net proceeds from a registered direct offering and concurrent private placement of common stock[34]. - Research and development expenses for the year ended December 31, 2024, totaled $2,400,777, an increase from$ 1,970,639 in 2023, reflecting ongoing clinical trials and product development efforts[124]. - The company sold 418,552 shares of common stock at $4.42 per share, generating net proceeds of approximately$ 1.6 million from the offering[34]. - The company has ongoing obligations totaling $300,000 related to the patent, with payments made in cash and stock over several years[77]. - The company is competing with larger pharmaceutical and biotechnology firms in the regenerative medicine sector, which is rapidly evolving[82]. - The company has made significant investments in research and development, focusing on innovative therapies and technologies in the regenerative medicine field[84].