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Anebulo Pharmaceuticals, Inc. Common Stock (symbol: ANEB) is a clinical-stage biopharmaceutical company dedicated to developing innovative solutions for individuals suffering from cannabinoid overdose and substance addiction. Anebulo's primary focus is on its lead product candidate, ANEB-001, a potent, small molecule cannabinoid receptor antagonist. ANEB-001 is designed to rapidly reverse the negative effects of cannabinoid overdose, which can range from severe sedation to anxiety, panic, and even psychosis with hallucinations, within one hour of administration.
Recent achievements include positive feedback from the FDA on the path forward for ANEB-001's approval. A Phase 2 trial's Part C extension was completed, exploring up to 60 mg THC challenge doses. The FDA has provided favorable input, suggesting that a single well-controlled study in acute cannabinoid intoxication (ACI) patients combined with a larger THC challenge study could support a new drug application.
Financially, Anebulo reported a net loss but continues to invest in its developmental programs. The company has secured a credit facility to support future studies and has maintained strong engagement with both investors and regulatory bodies. Anebulo remains committed to advancing ANEB-001 through its clinical trials with the goal of initiating Phase 3 registrational studies in the first half of 2024.
The company's partnerships with research institutions like the Centre for Human Drug Research in the Netherlands have been instrumental in progressing clinical trials. Anebulo aims to provide an effective treatment for the increasing number of patients presenting with cannabinoid-related intoxication in emergency departments.
For more detailed information, visit www.anebulo.com.
Anebulo Pharmaceuticals (Nasdaq: ANEB) reported financial results for Q4 and FY 2024, ending June 30, 2024. Key highlights include:
1. Awarded first tranche of a $1.9 million grant from NIDA/NIH
2. Prioritizing development of selonabant IV formulation for unintentional cannabis poisoning in children
3. Q4 FY2024 operating expenses: $1.3 million (vs $2.5 million in Q4 FY2023)
4. Q4 FY2024 net loss: $1.3 million or $(0.05) per share
5. FY2024 operating expenses: $8.3 million (vs $11.8 million in FY2023)
6. FY2024 net loss: $8.2 million or $(0.32) per share
7. Cash and cash equivalents: $3.1 million as of June 30, 2024
8. Access to additional $10 million through Loan and Security Agreement
Anebulo Pharmaceuticals (Nasdaq: ANEB) has been awarded a two-year cooperative grant of up to $1.9 million from the National Institute on Drug Abuse (NIDA) to support the development of intravenous selonabant. This potential emergency treatment targets acute cannabis-induced toxicities, particularly cannabis-induced CNS depression in children.
The grant is structured in two tranches: an initial $0.9 million award, followed by approximately $1 million subject to meeting certain milestones. This funding acknowledges the growing unmet medical need for a cannabis antidote, especially for children who are more susceptible to cannabis toxicity due to their underdeveloped endocannabinoid system.
Anebulo's CSO, Ken Cundy, emphasized that this grant provides validation for their work, while CEO Richie Cunningham highlighted how it aligns with their recent decision to prioritize the development of the intravenous formulation of selonabant.
Anebulo Pharmaceuticals (Nasdaq: ANEB) reported financial results for Q3 fiscal year 2024 and provided updates on its development projects.
Key focus is on the IV formulation of selonabant for unintentional cannabis poisoning in children, driven by a growing medical need and upcoming DEA reclassification of marijuana. The company's operating expenses dropped to $1.7 million from $2.9 million year-over-year. Net loss decreased to $1.7 million, or $(0.06) per share, from $2.8 million, or $(0.11) per share. As of March 31, 2024, the company holds $5.1 million in cash and cash equivalents.
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