Anebulo Pharmaceuticals announces positive update and capital raise for Selonabant
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company focused on developing innovative treatments for acute cannabinoid-induced toxicities, has announced a positive regulatory update and the successful completion of a capital raise.
Anebulo Pharmaceuticals has made significant strides in advancing its lead product, selonabant, which is a potential treatment for pediatric cannabis toxicity. Anebulo Pharmaceuticals recently shared key updates on its regulatory progress and financing efforts, marking a pivotal moment in the company’s journey to address a critical unmet medical need.
Phase 2 Proof-of-Concept Success and FDA Engagement
Anebulo Pharmaceuticals conducted a Phase 2 proof-of-concept study that enrolled 134 adult subjects who were challenged with oral delta-9-tetrahydrocannabinol (THC). The study demonstrated that oral selonabant effectively blocked or reversed key central nervous system (CNS) effects of THC, confirming its potential as a targeted treatment for acute cannabinoid intoxication (ACI). The success of this study establishes a promising clinical path for intravenous (IV) selonabant, which Anebulo Pharmaceuticals plans to develop for pediatric patients suffering from acute cannabis-induced toxicity. Anebulo Pharmaceuticals believes that the intravenous formulation could provide a much-needed solution for rapidly reversing the serious and life-threatening effects of cannabis poisoning in children.
Following this success, Anebulo Pharmaceuticals engaged with the U.S. Food and Drug Administration (FDA) to discuss development plans for IV selonabant, focusing on its clinical testing and regulatory pathway. The FDA acknowledged the unmet need for a pediatric treatment for cannabis toxicity and expressed its willingness to collaborate closely with Anebulo Pharmaceuticals to efficiently advance the program. This collaboration is seen as a crucial step toward bringing IV selonabant to market for pediatric use.
Plans for Phase I Clinical Study
Anebulo Pharmaceuticals plans to initiate its Phase I Single Ascending Dose (SAD) study of IV selonabant in healthy adults in the first half of 2025. This study is a critical step in assessing the safety and pharmacokinetics of the intravenous formulation, paving the way for future studies in pediatric populations. Anebulo Pharmaceuticals is committed to advancing the development of selonabant to provide an effective antidote for acute cannabis toxicity, particularly in children.
Successful Financing and Stock Purchase Agreement
Anebulo Pharmaceuticals has also secured funding to support its clinical trials and ongoing development efforts. The company entered into a definitive stock purchase agreement with 22NW, a company controlled by one of its directors, along with Nantahala Capital and another existing investor. This agreement will result in the issuance and sale of 15.2 million shares of common stock, raising gross proceeds of $15 million through a private placement offering.
The offering, priced at $0.99 per share, is expected to close by December 24, 2024, subject to customary closing conditions. The funds raised will support Anebulo Pharmaceuticals’ ongoing clinical studies and the development of IV selonabant. In exchange for purchasing $10 million of shares in the private placement, Anebulo Pharmaceuticals will modify its Loan and Security Agreement (LSA), reducing the maximum loan size to approximately $3 million and removing the securitization threshold. This adjustment will help streamline the company’s financial structure and reduce debt.
Strategic Support and Market Opportunity
Richie Cunningham, CEO of Anebulo Pharmaceuticals, expressed gratitude for the continued support from current investors and emphasized that the successful financing, secured without issuing stock at a discount or including warrants, reflects strong confidence in the company’s future. Cunningham also highlighted the FDA’s acknowledgment of the unmet need for a treatment for children exposed to cannabis toxicity. It has hired a top pharmaceutical consulting firm to assess the commercial viability of the pediatric cannabis toxicity market. According to the consultants, acute cannabis-induced toxicity in children is a rare but viable market opportunity, with fewer than 200,000 cases per year.
