Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the "Company" or "Anebulo"), today announced a positive regulatory update and the close of a capital raise.
- In a Phase 2 proof-of-concept study, Anebulo enrolled 134 adult subjects challenged with oral delta-9-tetrahydrocannabinoil ("THC"), oral selonabant blocked or reversed key CNS effects of THC, establishing the clinical path for intravenous selonabant for a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children
- Anebulo met with FDA to discuss the development of intravenous selonabant and the initial plan for clinical testing
- FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity, and proposed a close, ongoing collaboration to efficiently advance the selonabant program for the pediatric indication
- Anebulo plans to begin its Phase I SAD study of IV selonabant in healthy adults in 1H25
- Anebulo entered into a definitive stock purchase agreement with 22NW, a company controlled by one of its directors, Nantahala Capital and an additional existing investor for the issuance and sale of 15.2 million shares of common stock for gross proceeds of $15 million in a private placement offering priced at-the-market under Nasdaq rules
- In exchange for purchasing $10 million of shares of common stock in the private placement, Anebulo intends to modify the Loan and Security Agreement (LSA) that was entered into with 22NW and JFL Capital Management by reducing the maximum loan size to approximately $3 million, which reduces the LSA to just under the securitization threshold, and the removal of any securitization
