Anebulo Pharmaceuticals Announces FDA Feedback For IV Selonabant To Address Cannabis-Induced Toxicity In Children And Completes $15M Capital Raise; Phase I Study Planned For 1H25
Anebulo Pharmaceuticals Announces FDA Feedback For IV Selonabant To Address Cannabis-Induced Toxicity In Children And Completes $15M Capital Raise; Phase I Study Planned For 1H25
Anebulo制药公司宣布FDA对IV Selonabant的反馈，以应对儿童大麻股引起的毒性，并完成1500万美元的融资；计划在2025年上半年进行I期研究。
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.
Anebulo Pharmaceuticals, Inc. (纳斯达克:ANEB) 是一家临床阶段的生物制药公司，正在开发针对急性大麻引起的毒性反应的新型解决方案（"公司"或"Anebulo"），今日宣布了一项积极的监管更新，并完成了一次资本募资。
- 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
- 在一项二期概念验证研究中，Anebulo 招募了 134 名成人受试者，通过口服 Δ9-四氢大麻酚（"THC"），口服赛洛班特阻断或逆转 THC 的关键中枢神经系统效应，为静脉输注赛洛班特作为急性大麻引起的儿童毒性后果快速逆转的必要靶向治疗奠定了临床路径。
- Anebulo 与 FDA 进行了会谈，讨论了静脉输注赛洛班特的开发和临床测试的初步计划。
- FDA 认可了针对接触大麻毒性儿童的治疗需求，并提议进行密切的、持续的合作，以高效推进赛洛班特在儿科适应症中的研发计划。
- Anebulo 计划在 2025 年上半年开始对健康成人进行静脉赛洛班特的一期 SAD 研究。
- Anebulo 与 22NW 之间签订了一项最终股票购买协议，22NW 是由其董事之一 Nantahala Capital 和一位现有投资者控制的公司，发行和出售1520万股普通股，筹集到1500万美元的资金，这一定向增发的价格符合纳斯达克规则。
- 作为私募增发中购买1000万美元普通股的交换，Anebulo 打算修改与 22NW 和 JFL Capital Management 签订的贷款和安防协议（LSA），将最大贷款额度减少至约300万美元，使LSA低于证券化门槛，且取消任何证券化。