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November 12 , 2021 ANEBULO PHARMACEUTICALS Anebulo Pharmaceuticals Reports First Quarter Fiscal Year 2022 Financial Results and Provides a Business Update AUSTIN , Texas -- ( BUSINESS WIRE ) -- Anebulo Pharmaceuticals , Inc. ( Nasdaq : ANEB ) , a clinical - stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction , today announced financial results for the first quarter of its fiscal year ending June 30 , 2022 and reported recent business highlights . Highlights for the quarter ended September 30 , 2021 and recent weeks include the following : • Method of use U.S. patent issued for ANEB - 001 strengthens intellectual property protection . In October the Company announced the issuance of U.S. patent No. 11,141,404 , titled " Formulations And Methods For Treating Acute Cannabinoid Overdose . " The patent provides protection through 2040 and describes use of the Company's investigational drug ANEB - 001 to treat acute cannabinoid overdose . • Completed manufacturing of ANEB - 001 capsules for upcoming Phase 2 clinical trial . In compliance with current Good Manufacturing Practice requirements , the Company delivered ANEB - 001's active pharmaceutical ingredient to its contract manufacturer to fill into 10 mg and 50 mg capsules for finished product . • Formed Scientific Advisory Board ( SAB ) with two founding co - chairs . In August Anebulo formed the SAB to advise the Company on its clinical development programs and product pipeline . The founding co - chairs are Andrew Monte , M.D. , Ph.D. and Arjun Chanmugam , M.D. , both recognized leaders in emergency medicine . • On track to commence Phase 2 proof - of - concept clinical trial with ANEB - 001 for the treatment of acute cannabinoid intoxication by year - end . The planned Phase 2 study at a single site in the Netherlands has been approved by the institution's regulatory and ethics committee . The study is expected to enroll 100 healthy volunteers with each to receive 10 mg of THC orally , and then randomized to one of three doses of ANEB - 001 or placebo . The Company expects topline results to be available in the first half of 2022 . Management Commentary " We continue to advance ANEB - 001's clinical development and are pleased with our progress to date . In addition , we affirm expectations to initiate the Phase 2 clinical study for ANEB - 001 by the end of this year and look forward to reporting topline results in the first half of 2022. Furthermore , we plan to speak with the U.S. FDA regarding ANEB - 001's domestic regulatory path before year - end , " stated Daniel Schneeberger , M.D. , Chief Executive Officer