Anebulo Pharmaceuticals, Inc.

What they do

Anebulo develops selonabant (formerly ANEB-001), a small molecule cannabinoid receptor type-1 (CB1) antagonist intended to rapidly reverse cannabis-induced toxicity, including acute cannabinoid intoxication (ACI) in adults and cannabis poisoning in pediatric patients. The company has completed a Phase 2 proof-of-concept trial of oral selonabant in the Netherlands (NCT05282797), in which THC-challenged adults received the drug, and has formulated selonabant for both oral and intravenous administration. It has no approved products and no revenue; operations consist of clinical development, regulatory interactions and formulation work funded by equity and a loan facility.

Revenue drivers

• Selonabant for adult ACI — Lead program, but pre-revenue. FDA indicated in 2023 that a single well-controlled study in ACI patients presenting to the emergency department plus a larger THC challenge study in volunteers could potentially provide substantial evidence for a new drug application.
• Selonabant IV for pediatric cannabis poisoning — The company said it is prioritizing advancement of an IV formulation as a potential treatment for pediatric patients rather than proceeding directly to Phase 3 studies of oral selonabant in adults with ACI.
• No product or partnership revenue — 10-K risk factors state the company has not generated any revenue since inception and does not anticipate revenue from product sales in the near term.

Recent performance

For the three months ended December 31, 2025, total operating expenses were $2.6 million, flat versus $2.6 million in the prior-year quarter, and net loss was $2.0 million, or $(0.05) per share, versus a net loss of $2.5 million, or $(0.09) per share, a year earlier. Cash and cash equivalents were $9.0 million as of December 31, 2025, with access to an additional $3.0 million under a Loan Agreement. Full-year fiscal 2025 net loss was $8.5 million, with operating cash use of $6.3 million, and the 10-K reported an accumulated deficit of $73.9 million as of June 30, 2025.

Strategy

The company is prioritizing a selonabant IV formulation as a potential treatment for pediatric patients with cannabis poisoning instead of proceeding directly to Phase 3 studies of oral selonabant in adult ACI, while an observational study in emergency department patients with acute cannabis-induced toxicity continues. Management intends to maximize value from selonabant and is funding operations from existing cash plus a $3.0 million loan facility. On February 6, 2026, the Board approved voluntary delisting from Nasdaq and deregistration with the SEC, citing the cost and management time of public reporting; a Form 25 was expected to be filed on or about February 17, 2026.

Risks

• No revenue and continuing losses — The 10-K states the company has not generated any revenue since inception and expects future losses and negative cash flow, with an accumulated deficit of $73.9 million as of June 30, 2025.
• Clinical and regulatory uncertainty — Selonabant remains clinical-stage with no approved treatment for cannabis-induced toxicity; the adult ACI path depends on FDA agreement that one emergency-department study plus a THC challenge study could support an NDA.
• Funding constraints — The company held $9.0 million in cash at December 31, 2025, plus $3.0 million available under a Loan Agreement, against quarterly operating expenses of $2.6 million.
• Delisting and loss of public market — Following voluntary Nasdaq delisting and deregistration, trading in the common stock would occur only in privately negotiated sales and potentially on the over-the-counter market, and periodic SEC reporting obligations would be suspended.

Outlook

Management states it is in compliance with Nasdaq listing requirements but concluded the cost of SEC reporting outweighs the benefits, and expects delisting to become effective around February 27, 2026 with reporting obligations immediately suspended upon filing a Form 15. The company describes continuing efforts to maximize value from selonabant, with the IV pediatric program as the stated priority. No revenue guidance or product launch timeline is provided; the 10-K states no product sales revenue is anticipated in the near term.