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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 its financial results for the fourth quarter and full year ended June 30, 2022. The company showed a reduced net loss of $2.3 million in Q4 compared to $29.1 million for the same period in 2021. Operating expenses for FY2022 increased to $6.8 million from $3.6 million in FY2021. Notably, Anebulo announced positive topline data from Part A of its Phase 2 trial for ANEB-001, which aims to treat acute cannabinoid intoxication. The company plans further development, including an R&D Day on September 26, 2022, to discuss future strategies.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) will host its first R&D Day on September 26, 2022, in New York City. CEO Simon Allen, along with senior executives including Founder Dr. Joseph Lawler and CSO Dr. Ken Cundy, will present updates on the company's progress, particularly on the Phase 2 study of product candidate ANEB-001. This candidate aims to address acute cannabinoid intoxication. Institutional investors and analysts are invited to register via email as seating is limited.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) announced positive topline results from Part A of its Phase 2 clinical trial for ANEB-001, targeting acute cannabinoid intoxication (ACI). The trial included 60 subjects and demonstrated a significant reduction in feelings of being high, with only 10% in the 50 mg group and 30% in the 100 mg group compared to 75% in the placebo group (p < 0.0001). ANEB-001 was well tolerated, with mild side effects noted. The company plans to initiate Part B by Q3 2022 and is collaborating with the FDA for further studies on dosing optimization.
Anebulo Pharmaceuticals (NASDAQ: ANEB) announces it will release topline data from Part A of its Phase 2 study of ANEB-001 on July 5. The study involves sixty healthy subjects exposed to THC, aiming to evaluate ANEB-001 as a treatment for acute cannabinoid intoxication (ACI). CEO Simon Allen stated that the results will inform the next steps in the drug's development, emphasizing ANEB-001 as a leading antidote for ACI, which currently lacks FDA-approved treatments. This trial is conducted in the Netherlands by the Centre for Human Drug Research.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) has appointed Dr. Kenneth Cundy as the new Chief Scientific Officer. Dr. Cundy brings over 30 years of experience in drug development, having contributed to significant therapeutic innovations including Gilead's tenofovir. His extensive background includes over 50 U.S. patents and experience with FDA regulations. CEO Simon Allen emphasized that Dr. Cundy's expertise aligns well with advancing their lead product, ANEB-001, through clinical trials for acute cannabinoid intoxication, an area of increasing medical need.
Anebulo Pharmaceuticals (ANEB) reported financial results for Q3 2022, enrolling all 60 subjects in Part A of a Phase 2 clinical trial in the Netherlands. The firm expects to release top-line data by June 30, 2022. Financial highlights include a net loss of $1.9 million, or $(0.08) per share, against a loss of $0.6 million in Q3 2021. Operating expenses rose to $1.9 million from $0.6 million year-over-year. As of March 31, 2022, the company's cash and equivalents totaled $16.5 million.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) has successfully dosed over half of the planned 60 subjects in Part A of its Phase 2 clinical trial evaluating the safety and effectiveness of ANEB-001 for acute cannabinoid intoxication (ACI). This milestone allows the company to incorporate data from Part A into an upcoming IND submission to the FDA, projected before year-end. The trial is conducted at the Centre for Human Drug Research in the Netherlands, and top-line results are expected by mid-2022, enhancing the pathway for future trials in the U.S.
Anebulo Pharmaceuticals (NASDAQ: ANEB) reported financial results for Q2 FY2022, highlighting a net loss of $1.1 million or $(0.05) per share, compared to a loss of $0.3 million or $(0.03) in Q2 FY2021. Operating expenses rose to $1.1 million from $0.3 million year-on-year. The company initiated a Phase 2 study of ANEB-001 for acute cannabinoid intoxication, expects topline results in H1 2022, and discussed clinical development with the FDA. The firm holds $18.0 million in cash as of December 31, 2021, down from $19.9 million in June 2021.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) announced the appointment of Scott L. Anderson as Head of Investor Relations and Public Relations, effective immediately. Reporting to CFO Rex Merchant, Anderson will enhance the company's communication with shareholders and the investment community. With over 20 years of experience in investor relations at companies like Qualcomm and Actavis, he aims to grow Anebulo's shareholder base and improve transparency. CEO Daniel Schneeberger emphasized the timing is critical as the company prepares to report topline Phase 2 trial results in the first half of the year.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) will present a company overview at the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. A webcast of the presentation will be available on-demand starting January 10, 2022, at 7:00 a.m. Eastern time on the Investors section of Anebulo's website. The company focuses on solutions for acute cannabinoid intoxication. Its lead candidate, ANEB-001, targets the negative effects of such intoxication and has shown promising results in clinical trials, demonstrating rapid absorption and tolerance.
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