Efficacy Results - The Phase 2b REZOLVE-AA study evaluated rezpegaldesleukin (REZPEG) for alopecia areata [1, 19] - The study achieved statistical significance for both treatment arms after excluding 4 patients with major study eligibility violations [36] - The mean percentage change in SALT score from baseline to week 36 was -30% in the REZPEG arms versus -6% in the placebo arm (p<0.05), after excluding 4 patients with major study eligibility violations [92] - 42% of REZPEG-treated patients achieved a best reduction in SALT score of 30% or greater [47] - 36% of REZPEG-treated patients achieved a best reduction in SALT score of 50% or greater [47] - 17% of REZPEG-treated patients achieved a best reduction in SALT score of 75% or greater [47] Safety and Tolerability - The study showed a consistent safety profile with previously reported studies, with nearly all adverse events (AEs) being mild to moderate in severity and self-resolved [31] - The discontinuation rate due to AEs was low at 1.4% for REZPEG-exposed patients [31] - The placebo-adjusted injection site reaction (ISR) rate was consistent with prior studies, with 87% being mild in severity [31] Market and Strategic Implications - The data supports a first-in-class Treg mechanism of action with fast onset of action in moderate-to-severe patients [9] - 54% of physicians report they would try patients on alternate therapies for AA before prescribing JAKi [10] - G7 market size for Alopecia Areata is projected to reach $4 billion by 2033 [7]

Core Insights - Creative Medical Technology Holdings, Inc. has received two U.S. patents for its ImmCelz™ platform, focusing on treatments for Type 1 Diabetes and heart failure, leveraging supercharged Regulatory T cells [2][3] - The recent Nobel Prize awarded to researchers in Treg science highlights the significance of the company's research focus and its potential impact on regenerative immunotherapy [1][3] Patent Details - U.S. Patent Number 12931925B2, expiring on May 24, 2043, covers the prevention and treatment of Type 1 Diabetes through the enhancement of myeloid suppressor cell activity [2] - U.S. Patent Number 12385011B2, expiring on December 15, 2042, pertains to the treatment of heart failure and post-infarct pathological remodeling using ex vivo reprogrammed immune cells [2] Market Potential - The heart failure treatment program targets over five million patients in the U.S. at risk of heart failure, with an additional six million patients suffering from refractory angina potentially eligible for treatment [3] - The Type 1 diabetes program supports a broad, cell-based immunotherapy approach validated with cells from Type 1 diabetes patients, aligning with the ongoing CREATE-1 clinical trial [4] Technology Overview - The ImmCelz™ platform reprograms a patient's immune cells outside the body, enhancing them with optimized cell-free factors before reintroducing them, aiming to facilitate tissue repair rather than merely suppressing symptoms [5][6] - This innovative approach positions the company to address high-burden medical conditions where immune over-activation and tissue damage are prevalent [5] Company Profile - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company focused on developing regenerative medicine solutions across various indications, utilizing advanced cell therapy technologies to improve patient outcomes [7]