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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 announced positive results from its Phase 2 clinical trial of ANEB-001, aimed at treating acute cannabinoid intoxication (ACI). The trial, involving 134 healthy subjects, showed that a 10 mg dose of ANEB-001 significantly reduced THC-induced effects, improving metrics such as 'feeling high' (p=<0.0001) and alertness (p=0.0042). ANEB-001 was well tolerated with no serious adverse events reported. Anebulo plans to request an End of Phase 2A meeting with the FDA by mid-2023 to discuss the results and potential next steps for development.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) announced on March 8, 2023, the appointment of Sandra Gardiner as acting chief financial officer, succeeding Rex Merchant. Gardiner brings over 30 years of experience, previously serving as CFO at Pulse Biosciences until December 2022. The company is also engaging Potrero Hill Advisors for operational efficiencies and flexibility in finance and accounting. Anebulo is focused on developing treatments for acute cannabinoid intoxication, with its lead candidate, ANEB-001, nearing the release of final Phase 2 study data and preparing for an FDA meeting by the end of Q2 2023.
Anebulo Pharmaceuticals (NASDAQ: ANEB) reported its financial results for the quarter ending December 31, 2022. The company's operating expenses rose significantly to $3.8 million from $1.1 million in the same quarter of 2022. A net loss of $3.8 million was recorded, equating to a loss of $(0.15) per share, compared to a loss of $(0.05) per share in the prior year. The firm completed its Phase 2 trial for ANEB-001, targeting acute cannabinoid intoxication, with preliminary results showing symptom reduction. Final Phase 2 data is anticipated by the end of March 2023, followed by an EOP2A meeting with the FDA.
Anebulo Pharmaceuticals, Inc. has completed dosing in its Phase 2 clinical trial for ANEB-001, targeting acute cannabinoid intoxication (ACI) treatment. Preliminary results indicate that a 10 mg dose of ANEB-001 effectively reduced THC's psychotropic effects, notably at doses as high as 30 mg. The trial enrolled 134 healthy subjects and employed adaptive design across two parts. Full pharmacokinetics, pharmacodynamics, and safety data are anticipated by the end of Q1 2023, with an FDA meeting planned for the first half of 2023 to discuss future trial designs.
Anebulo Pharmaceuticals (NASDAQ: ANEB) reported financial results for Q1 FY 2023 on September 30, 2022. Key highlights include a positive interim data announcement for ANEB-001 from its Phase 2 clinical trial and a successful $6.6 million private placement financing. The company's operating expenses rose to $2.6 million, leading to a net loss of $2.6 million or $(0.11) per share, compared to a net loss of $1.6 million or $(0.07) per share in Q1 FY 2022. As of September 30, Anebulo has $19.2 million in cash, supporting its ongoing clinical trials and operational activities.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) has appointed Dr. Nat Calloway to its Board of Directors, where he will also serve on the Compensation Committee. Dr. Calloway, with extensive experience in the investment community and healthcare, is expected to contribute significantly to the development of Anebulo's lead product, ANEB-001, currently in Phase 2 trials aimed at addressing acute cannabinoid intoxication. His background includes roles at 22NW, LP and Edison Group, along with a PhD from Cornell University.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) has announced a PIPE financing agreement to sell 2,264,650 common shares and warrants to institutional accredited investors at a price of $2.935 per share. The accompanying warrants allow for the purchase of additional shares at $4.215, exercisable immediately and expiring in five years. Proceeds from this financing will be used to advance the development of ANEB-001 and for general corporate purposes. The closing of the deal is expected around September 29, 2022, pending customary conditions.
Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) announced promising interim results from its Phase 2 clinical trial evaluating ANEB-001 for acute cannabinoid intoxication (ACI). In the trial, 10 mg and 30 mg doses of ANEB-001 significantly reduced THC-induced feelings of being high and body sway compared to placebo, while higher THC doses were administered. The study aims to optimize the drug's dosage and effectiveness, with ongoing evaluation of delayed dosing to simulate real-world scenarios. Anebulo anticipates that ANEB-001 could alleviate ACI symptoms and reduce healthcare burdens.
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) is set to host its inaugural R&D Day on September 26, 2022, at the Nasdaq MarketSite in New York City, from 10:00 a.m. to 12:30 p.m. (ET). The event will also be webcast live on the Company’s website. Interested attendees can register via email. Anebulo is focused on developing solutions for acute cannabinoid intoxication and substance abuse disorder, with its lead product candidate, ANEB-001, in Phase 2 trials.
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