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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製藥公司宣佈FDA對IV Selonabant的反饋,以應對兒童大麻股引起的毒性,並完成1500萬美元的融資;計劃在2025年上半年進行I期研究。
Benzinga ·  12/23 22:16

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. (納斯達克:ANEB) 是一家臨牀階段的生物製藥公司,正在開發針對急性大麻引起的毒性反應的新型解決方案("公司"或"Anebulo"),今日宣佈了一項積極的監管更新,並完成了一次資本募資。

  • 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
  • 在一項二期概念驗證研究中,Anebulo 招募了 134 名成人受試者,通過口服 Δ9-四氫大麻酚("THC"),口服賽洛班特阻斷或逆轉 THC 的關鍵中樞神經系統效應,爲靜脈輸注賽洛班特作爲急性大麻引起的兒童毒性後果快速逆轉的必要靶向治療奠定了臨牀路徑。
  • Anebulo 與 FDA 進行了會談,討論了靜脈輸注賽洛班特的開發和臨牀測試的初步計劃。
  • FDA 認可了針對接觸大麻毒性兒童的治療需求,並提議進行密切的、持續的合作,以高效推進賽洛班特在兒科適應症中的研發計劃。
  • Anebulo 計劃在 2025 年上半年開始對健康成人進行靜脈賽洛班特的一期 SAD 研究。
  • Anebulo 與 22NW 之間簽訂了一項最終股票購買協議,22NW 是由其董事之一 Nantahala Capital 和一位現有投資者控制的公司,發行和出售1520萬股普通股,籌集到1500萬美元的資金,這一定向增發的價格符合納斯達克規則。
  • 作爲私募增發中購買1000萬美元普通股的交換,Anebulo 打算修改與 22NW 和 JFL Capital Management 簽訂的貸款和安防協議(LSA),將最大貸款額度減少至約300萬美元,使LSA低於證券化門檻,且取消任何證券化。
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