Creative Medical Technology (CELZ) - 2025 Q3 - Quarterly Report

Clinical Trials and Research - The company has received FDA clearance for the Type I Diabetes (CELZ-201 CREATE-1) IND application, allowing the initiation of a Phase I/II clinical trial [80]. - In April 2023, the company reported a 93% overall efficacy in a study of 30 patients treated with CELZ-001 for Type 2 Diabetes, demonstrating at least a 50% reduction in insulin requirement [84]. - The ImmCelz™ (CELZ-100) platform requires 75% fewer donor patient cells compared to industry standards, with a final product purity greater than 95% [86]. - The company has successfully generated human induced pluripotent stem cells (iPSCs)-derived islet cells that produce human insulin, indicating potential for clinical translation [88]. - The company initiated a program combining AI with its proprietary iPSC to diagnose and treat patients exposed to biological and chemical weapons, enhancing research efficiency and innovation [89]. - The company completed dosing the second cohort of 10 patients in the CELZ-201 ADAPT clinical trial, with no dose-limiting toxicities reported [91]. - The company has filed for Orphan Drug Designation for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ platform, receiving the designation in March 2024 [83]. - The AlloStemSpine® Chronic Lower Back Pain trial will enroll 30 individuals, evaluating safety, efficacy, and tolerability of the treatment [85]. - The company has expanded its development and acquisition of intellectual property beyond urology to include treatments for neurologic disorders and other diseases [76]. Financial Performance - There was no revenue generated for the three-month periods ended September 30, 2025, and 2024 [96]. - No gross profits were reported for the three-month periods ended September 30, 2025, and 2024 [100]. - General and administrative expenses for the three-months ended September 30, 2025, totaled $776,821, an increase of $278,214 or 56% compared to the same period last year [101]. - Research and development expenses for the three-months ended September 30, 2025, totaled $465,154, a decrease of $116,642 or 20% from the previous year [103]. - The operating loss for the three-months ended September 30, 2025, was $1,273,034, compared to $1,109,674 for the same period last year [104]. - The net loss for the three-months ended September 30, 2025, was $1,235,934, compared to a net loss of $1,040,135 for the same period last year [105]. - Gross revenue for the nine-months ended September 30, 2025, was $3,000, down from $8,000 for the comparable period last year [107]. - General and administrative expenses for the nine-months ended September 30, 2025, totaled $2,396,735, an increase of $550,558 or 30% compared to the previous year [109]. - Research and development expenses for the nine-months ended September 30, 2025, totaled $1,709,719, a decrease of $219,218 or 11% from the previous year [111]. - The operating loss for the nine-months ended September 30, 2025, was $4,197,032, compared to $3,858,127 for the same period last year [112]. - The net cash used in operating activities for the nine-months ended September 30, 2025, was $3,918,891, an increase of $567,135 or 17% from the previous year [115].