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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) has appointed Simon Allen as CEO and a Board member, effective February 1, 2022. He succeeds Daniel Schneeberger, MD, who has resigned. Allen previously served as Chief Business Officer at Ambrx Biopharma (NYSE: AMAM) and brings extensive leadership experience. Anebulo's primary focus is developing ANEB-001, aimed at treating acute cannabinoid intoxication, a growing concern with rising THC concentrations. The company anticipates reporting topline results from its Phase 2 trial in the first half of 2022.
Anebulo Pharmaceuticals (Nasdaq: ANEB) has initiated a Phase 2 clinical study for ANEB-001, targeting acute cannabinoid intoxication. The first patient has been dosed, with topline results expected in the first half of 2022. After a recent FDA pre-IND meeting, the company secured guidance on its regulatory approach, with plans to submit an IND in Q1 2022. The trial involves 60 patients, examining the efficacy of varying doses of ANEB-001 against THC-induced effects. Anebulo emphasizes the growing need for treatments, noting 1.7 million cannabinoid-related emergency visits in 2018.
Tenaya Therapeutics (NASDAQ: TNYA) announced two key appointments: Karah Parschauer to its Board of Directors and Joanna Auch as Senior VP of People and Culture. These appointments aim to strengthen Tenaya's leadership amid its transition to a public company with over 100 employees. CEO Faraz Ali highlighted that both individuals bring valuable experience and will enhance the company's capabilities in drug development for heart disease. Parschauer has extensive biopharmaceutical experience and previously held roles at Ultragenyx, while Auch has over 15 years in HR.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) announced its financial results for Q1 fiscal 2022, highlighting key business developments. The company obtained a U.S. patent for ANEB-001, which is set to treat acute cannabinoid overdose. Manufacturing of ANEB-001 capsules is complete for the upcoming Phase 2 clinical trial. The company has formed a Scientific Advisory Board to guide its clinical programs. Operating expenses surged to $1.55 million, and the net loss was $1.55 million or $(0.07) per share. As of September 30, 2021, cash reserves stood at approximately $19.2 million.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) announced that the U.S. Patent and Trademark Office has granted U.S. Patent No. 11,141,404, titled 'Formulations And Methods For Treating Acute Cannabinoid Overdose'. This patent covers ANEB-001, an investigational drug designed to treat acute cannabinoid overdose, with protection extending to 2040. CEO Daniel Schneeberger highlighted the urgent need for such treatments and confirmed a Phase 2 clinical study set for Q4 2023, with topline results expected in H1 2024.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) announced its participation in the Benzinga Cannabis Capital Conference on October 14-15, 2021, in New York City. The management will present on October 15 at 3:25 p.m. Eastern Time and will engage in one-on-one meetings with investors throughout the event. Anebulo is focused on developing innovative treatments for acute cannabinoid intoxication and substance addiction, with its lead candidate, ANEB-001, demonstrating positive results in clinical trials. Investors can register for the event here.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) announced its financial results for the fiscal year ending June 30, 2021. The company reported a net loss of $30.25 million, or $(2.83) per share, compared to a net loss of $174,637, or $(0.01) per share, in the previous year. Key highlights include the manufacturing of ANEB-001 capsules for a Phase 2 clinical trial, formation of a Scientific Advisory Board, and successful IPO raising $21.5 million. Management expects to initiate the Phase 2 trial for acute cannabinoid intoxication in Q4 2021, with topline results expected in H1 2022.
Anebulo Pharmaceuticals (ANEB) announced the successful completion of manufacturing its lead drug, ANEB-001, for an upcoming Phase 2 clinical trial targeting acute cannabinoid intoxication. The capsules, available in 10mg and 50mg, comply with Good Manufacturing Practices. CEO Daniel Schneeberger highlighted the significance of ANEB-001 in addressing a growing issue, with over 1.7 million cannabinoid-related emergency visits in 2018, increasing by 15% annually. The Phase 2 study is set to commence ahead of schedule, with initial results expected in the first half of next year.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company, announced participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company will present and hold one-on-one meetings with investors. A recorded presentation will be available on-demand starting September 13 on Anebulo’s website. Anebulo focuses on developing solutions for acute cannabinoid intoxication and substance addiction, with its lead candidate, ANEB-001, showing promising results in clinical trials.
Anebulo Pharmaceuticals (Nasdaq: ANEB) announced the formation of a Scientific Advisory Board (SAB) to enhance its clinical programs, co-chaired by experts Andrew Monte, M.D., Ph.D., and Arjun Chanmugam, M.D. The SAB will focus on advancing ANEB-001, aimed at treating acute cannabis intoxication, with a Phase 2 study expected to start in Q4 2021. The rise in cannabis-related emergency visits underscores the need for effective treatments. Anebulo's lead candidate is positioned uniquely in a growing market, with no direct competitors currently in advanced development.
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