GEP44 / SureNano Science - LARVOL DELTA

SureNano Science (CSE: SURE) (OTCQB: SURNF) Accelerates Development Strategy for Lead Candidate (Business Insider) - "'The company is initiating a Good Laboratory Practice (‘GLP’) toxicology and pharmacology program aligned with U.S. Food and Drug Administration (‘FDA’) requirements, intended to support an Investigational New Drug (‘IND’) application and represents a necessary step before first-in-human clinical trials.'"

Preclinical • Obesity • Type 2 Diabetes Mellitus

SureNano Science Initiates FDA Stage GLP Toxicology and Pharmacology Studies for GLP GEP-44... (Newsfile) - "The Program is expected to be conducted in collaboration with a premier global Clinical Research Organization (CRO)...This pivotal, GLP-compliant package is specifically designed to assess safety, toxicology, and pharmacology across multiple species, including rodents and non-rodent primates, to evaluate the safety and feasibility of the approach for human clinical application...Following the successful completion of these studies, SureNano intends to submit a Clinical Trial Notification (CTN) in Australia to begin U.S. Food and Drug Administration (FDA) Phase I testing in patients. Australia is chosen for its efficient regulatory framework, high-quality research infrastructure, and accelerated path to first-in-human studies."

New P1 trial • Preclinical • Obesity

SureNano Science Ltd. Acquires GlucaPharm Inc., Advancing Second-Generation FDA Pathway GLP-1 Drug Development (Newsfile) - "GlucaPharm's GEP44 developments directly align with SureNano's strategy of next-generation solutions that improve performance, tolerability, and delivery, mirroring SureNano's core value proposition: to improve how advanced therapeutics are delivered and experienced by patients....GlucaPharm is advancing GEP44 in collaboration with an experienced Australian contract research organization (CRO), with an IND-enabling FDA study followed by Phase I Clinical Trial expected to commence in Australia in the coming months. Key development milestones are anticipated over the next six to nine months, including IND progression and early clinical validation."

M&A • New P1 trial • Obesity