Hepion Pharmaceuticals(US:HEPA)2020-10-31 00:10Company Highlights - Hepion Pharmaceuticals has a clinical phase 2a NASH program underway[7] - The company utilizes an Artificial Intelligence and Smart Algorithms Platform (AIPOWR ™) to identify and optimize responder outcomes[7] - As of June 30, 2020, the company had $17.6 million in cash[7] - As of June 30, 2020, the company had 9.0 million shares outstanding and 13.1 million fully diluted shares[7] - The company has robust IP protection in major markets with exclusivity until 2039, potentially extending to 2044[7] Pipeline Development - CRV431 is being developed for NASH, with a projected NDA filing in 2025[19] - Preclinical studies identified CRV431 as a lead molecule after screening approximately 200 molecules[19] - Preclinical efficacy models for CRV431 included 5 in vivo, 5 in vitro fibroblast, and 2 human explants (liver and lung) studies[19] - Phase 1 trials for CRV431 have been completed, showing drug exposure in the range where efficacy was demonstrated in preclinical models[19, 28] AI-POWR™ Platform - The AI-POWR™ platform analyzes multi-omic data to improve drug development efficiency and reduce costs[10, 11] - Novartis reported a 10-15% reduction in patient enrolment times in pilot trials using AI to predict and monitor trial costs[16] - AI-POWR™ identified key NASH-related genes altered by CRV431, such as TM6SF2 (+4.2 fold change, p=0.0007) and ApoB (+10.9 fold change, p=0.0001)[30]