Anebulo Pharmaceuticals, Inc., is a clinical-stage biotechnology company, developing therapeutic compounds for the management of acute cannabinoid intoxication (ACI) and substance addiction. The lead asset, ANEB-001 is a small molecule cannabinoid receptor antagonist being investigated as a specific anti-dote for ACI. To date, no specific treatment or drugs are available for ACI, which remains a highly unmet need.
As the legalization of medical and recreational cannabis use becomes more prevalent in the United States and other countries, habitual use, addiction, and overdose are becoming more common.
Inexperienced cannabis users are particularly susceptible to cannabis poisoning, as a standard dosage (often quoted as 1-5mg for edibles) may not be appropriate for everyone. This can lead to users attempting to adjust their dosage on their own, which can sometimes result in emergency room visits due to symptoms such as palpitations, lack of coordination, high blood pressure, and flushing. In some cases, cannabis poisoning can even result in death. With an increasing number of cannabis poisoning-related emergency room visits, it is crucial to have a reliable and specific treatment to reverse the symptoms of cannabinoid poisoning.
ANEB-001 is a cannabinoid antagonist compound that reverses the effect of cannabinoid intoxication in less than 60 minutes. The non-availability of ACI-specific treatment drugs and the fast-acting mechanism of ANEB-001 make the drug stand out as a forerunner in the cannabinoid toxicity therapy race.
Despite, neutral CB1R antagonists appearing more promising than CB1R competitive/orthosteric antagonists/inverse agonists for the treatment of drug abuse and addiction, the rapid onset of ANEB-001 drug action that lasts up to 4.5 to 6 hours (without psychiatric side effects) makes it a perfect and preferable treatment option for cannabinoid overdose.
THC overdose or synthetic marijuana intoxication treatment requires ER admission and short-term treatment with ANEB-001 will likely achieve the treatment goal with lesser likelihood or absolutely no risk of anxiety/depression-like side effects. Even if this occurs, the side effects are temporary (4-6 hours), as the treatment may not exceed one or two doses, underscoring the drug safety.
The phase 2 study was nearing the study completion date, at the end of December 2022.
January 9, 2023 -Anebulo Pharmaceuticals Announces Completion of Dosing and Preliminary Data from Part B of its Phase 2 Study of ANEB-001 for Acute Cannabinoid Intoxication. “Completing the dosing in this Phase 2 trial represents an important milestone for the company. Preliminary data showed that a single 10 mg dose of ANEB-001 reduced key symptoms of ACI induced with 30 mg of THC” said Simon Allen, CEO of Anebulo.
November 10, 2022 – Anebulo Pharmaceuticals reported the first-quarter fiscal year 2023 financial results and recent updates
November 2, 2022 – Anebulo Pharmaceuticals announced the appointment of Nat Calloway, Ph.D., to the Board of directors
September 26, 2022 – Lower doses of Anebulo’s pipeline ANEB-001 reduced the negative effects of higher doses of THC, ANEB reported
July 5th, 2022 – Anebulo Pharmaceuticals reported ANEB-001 reduced cannabis intoxication in healthy participants
The global cannabis market is estimated to be around USD 22.5 billion in 2021 and is expected to grow to USD 82.3 by 2027, accounting for both medical and recreational use. While no data are available a 2016 study that reported cannabis poisoning contributed to 0.014% of ED visits. After 6 years and widespread legalization of medical marijuana and recreational use incidence looks to be on the increase.
The Federal Government legalized medical cannabis in 35 states and recreational marijuana use in 15 states. There is no reliable data about street use of spice and/or THC, which increases the overdose risk and accounts for most of the ER visits of spice addicts and occasional recreational marijuana users. If the Federal Government passes the bill to decriminalize marijuana, the upside opportunity of ANEB-001 would naturally multiply.
If gets approved (ANEB-001 would likely be the first approved drug for ACI) the commercial potential is extremely high given there isn’t any available treatments specific to this indication.
As on September 2022, ANEB had USD 19m as cash and no debt. After extrapolating on last year’s cash burn of USD 6.7m, the cash runway could be in the range of 2 to 2.5 years from January 2023. ANEB is prudent with finances but would need to find capital to kickstart a bigger Phase III study.
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Indivor is working to treat patients for treatment of cannabis use disorder, substance abuse treatment and mental disorders. The cannabis use disorder asset AEF0117 is in Phase II clinical trial and is expected to be completed by November 2023.
Opiant’s OPNT004 Drinabant (CB-1 antagonist) is being developed jointly by Opiant pharmaceuticals and Sanofi. The pipeline is early stages of development and yet to initiate the human Phase-I clinical trial studies.
ANEB-001 looks like an effective treatment for short-term cannabinoid poisoning and has significant commercial potential for growth. With dosing for the Phase 2 trial complete, the next major step for the compound will be the initiation of a phase 3 clinical trial, which is planned to start in the second quarter of 2023. Among the CB1R-antagonists, ANEB-001 should be considered a frontrunner asset in a space with high unmet need. Holding ANEB at these levels is risky – with just $19M i the bank a dilutive event is expected despite the leadership being prudent with their capital. Though there is a plausible scenario in which a dilutive event does not happen; M&A. High risk. High reward. Like always when investing in these small cap biotech stocks.