Anebulo Pharmaceuticals Reports Q2 Financial Results, Plans To Develop Therapy For Acute Cannabinoid Intoxication

Anebulo Pharmaceuticals, Inc. ANEB announced financial results for the three months ended December 31, 2021 and recent updates.

Q2 2022 Financial Highlights

• Operating expenses in the second quarter of fiscal 2022 were $1.1 million compared with $0.3 million in the same period in fiscal 2021.
• Net loss in the second quarter of fiscal 2022 was $1.1 million, or $(0.05) per share, compared with a net loss of $0.3 million, or $(0.03) per share, in the second quarter of fiscal 2021.
• Cash burn in the second quarter of fiscal 2022 was $1.2 million compared with $0.4 million in the same period in fiscal 2021.
• Cash and cash equivalents were $18 million as of December 31, 2021.

Q2 2022 Operational Highlights & Recent Moves

• Initiated a Phase 2 proof-of-concept clinical study to investigate ANEB-001 as a potential treatment for acute cannabinoid intoxication. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study at the Centre for Human Drug Research in, Leiden, the Netherlands to evaluate ANEB-001 in the inhibition of THC-induced effects.
• Participated in a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) during which the company received guidance regarding the clinical development of ANEB-001 in the United States.
• Named Simon Allen as CEO and a member of the board of directors.  Allen joined Anebulo on February 1, 2022. Previously he served as chief business officer of Ambrx Biopharma Inc., where he helped prepare and conclude its NYSE IPO and establishing multiple partnerships with pharmaceutical companies such as Bristol Myers Squibb, Pfizer, Merck, Eli Lilly, Astellas, BeiGene and Sino Biopharma.
• Appointed Scott L. Anderson as head of investor relations and public relations. Mr. Anderson joined Anebulo on January 1, 2022 and is responsible for Anebulo’s global investor relations and public relations programs. With more than 20 years of public company IR and PR experience, Anderson continues to enhance the companies outreach programs while managing investor and corporate relationships.
• Issued U.S. method-of-use patent for ANEB-001. The company strengthened its intellectual property with the issuance of U.S. patent No. 11,141,404, titled "Formulations And Methods For Treating Acute Cannabinoid Overdose."

Management Commentary

“There is a significant and pressing need to treat acute cannabinoid intoxication as hospital emergency department visits for this condition reached 1.7 million in 2018 and continue to increase by approximately 15% annually as more states legalize the use of marijuana,” Allen said. “In January, we announced the initiation of our Phase 2 clinical study of ANEB-001 in the Netherlands and expect to report topline results in the first half of this year, an important step in achieving our goal of developing the first FDA-approved therapy for acute cannabinoid intoxication.”

Photo: Courtesy of Tim Foster on Unsplash