Anebulo Pharmaceuticals, Inc. ANEB, a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, released its financial results for the three months and twelve months ended June 30, 2022.
Q4 2022 Financial Highlights
Operating expenses were $2.3 million compared with $2.5 million in the same period in fiscal 2021.
Net loss was $2.3 million, or $(0.10) per share, compared with a net loss of $29.1 million, or $(1.59) per share, in the fourth quarter of fiscal 2021.
Cash burn in the fourth quarter of fiscal 2022 was $2.0 million.
Cash balance was $14.5 million as of June 30, 2022.
Fiscal Year 2022 Financial Highlights
Operating expenses were $6.8 million compared with $3.6 million in fiscal year 2021.
Net loss was $6.8 million, or $(0.29) per share, compared with a net loss of $30.3 million, or $(2.83) per share, in fiscal year 2021.
Cash burn in fiscal year 2022 was $5.4 million.
ANEB-001 Clinical Trial
The company’s lead product candidate, ANEB-001, is being developed as a potential treatment to reverse the negative effects of acute cannabinoid intoxication (ACI). The signs and symptoms of ACI include profound sedation, anxiety, panic, hallucinations, and psychosis. More than 1.7 million emergency department visits in the United States were related to cannabinoid use in 2019, which includes ACI and other cannabis-related conditions. There are currently no FDA approved drugs to treat ACI.
In July 2022, the company revealed positive topline data from Part A of its ongoing Phase 2 clinical trial evaluating the potential of ANEB-001 to treat ACI. Part A was a 60-subject randomized, double-blind, placebo-controlled trial designed to evaluate the effectiveness of a single dose of ANEB-001 in treating healthy subjects challenged with delta-9-tetrahydrocannabinol, better known as THC, the primary psychoactive constituent of cannabis. Healthy subjects received a single dose of oral THC (10.5 mg) with a single oral dose of ANEB-001 (50 mg or 100 mg) or placebo.
The topline data demonstrated a significant, robust, and sustained reduction in key symptoms of ACI, including reduction of the VAS feeling high score (p < 0.0001) and improvement in the VAS alertness scale (p < 0.01). Preliminary safety information showed all adverse events were mild and transient, except in the case of one subject in the 50 mg ANEB-001 group who experienced transient moderate nausea and vomiting.
Based on the encouraging data from Part A, the company plans to initiate Part B of the study at CHDR by the end of third quarter 2022 to evaluate lower doses of ANEB-001. Anebulo is currently collaborating with the model-informed drug development (MIDD) group at FDA to develop a PK/PD model that will potentially allow prediction of optimal doses for treatment of ACI subjects. Preparations are ongoing for an observational study in ACI subjects in the emergency department setting to further support the PK/PD model and ANEB-001 development. Submission of an investigational new drug application (IND) for ANEB-001 to initiate U.S. trials is anticipated by the end of 2022.
“2022 has been a time of diligent execution as we continue our efforts to develop the first FDA approved therapy for ACI,” stated Simon Allen, CEO of Anebulo. “The positive topline data from Part A of our ongoing Phase 2 trial provided a solid foundation for the continued development of ANEB-001. As such, we look forward to presenting our strategy and vision for this program in greater detail, including new Part B data, during our R&D Day on September 26. Operations and expenditures for this most recent quarter keep us on budget and on target to progress ANEB-001 deeper into the clinic.”
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