Anebulo Hits Key Milestone, Doses First Subjects in Selonabant Trial
FDA & Biotech

Anebulo Hits Key Milestone, Doses First Subjects in Selonabant Trial

Clinical-stage biotech also posts a narrower-than-expected Q1 loss, signaling disciplined execution as it advances its lead drug for acute cannabis toxicity.

Anebulo Pharmaceuticals (NASDAQ: ANEB) announced a significant step forward in its clinical program, having dosed the first subjects in a Phase 1 trial for an intravenous (IV) formulation of its lead drug candidate, selonabant. The trial is designed to treat acute cannabis toxicity, an area the company identifies as a growing unmet medical need.

The operational milestone was paired with better-than-expected financial results for the first fiscal quarter of 2026. Anebulo reported a net loss of $0.05 per share, comfortably beating Wall Street's consensus estimate of a $0.12 per share loss. This represents a 58% positive earnings surprise, signaling effective cost management as the company advances its capital-intensive research and development.

The dual announcements highlight a period of focused execution for the clinical-stage biotechnology firm. According to the company's quarterly update, the net loss for the quarter totaled $2.2 million. For a company like Anebulo with no product revenue, a narrower loss suggests a longer cash runway to fund its critical clinical trials.

Shares of Anebulo were trading around $2.37 in afternoon trading. The company, which has a market capitalization of approximately $97 million, is focused on developing treatments for cannabinoid overdose and addiction. Its 52-week trading range has been between $0.80 and $3.42, with the recent clinical progress contributing to positive momentum over the past six months.

The centerpiece of Anebulo's strategy is selonabant, a potent and selective inhibitor of the CB1 receptor, the primary mediator of marijuana's psychoactive effects. The initiation of the Phase 1 single ascending dose (SAD) study for an IV formulation is a key strategic development. An intravenous delivery method is critical for use in an emergency room setting, where patients suffering from acute cannabis-induced toxicity would likely seek treatment.

"The initiation of this trial marks an important achievement for Anebulo as we work to develop a potential first-in-class treatment for acute cannabis toxicity," a company representative noted in a press release from late September when dosing began. The study aims to evaluate the safety, tolerability, and pharmacokinetics of the IV formulation in healthy volunteers.

With the increasing potency of cannabis products and the expansion of legalization, emergency department visits related to cannabis intoxication have risen. Anebulo is positioning selonabant as a specific antidote, a novel approach compared to the current standard of care, which is primarily supportive.

Analysts have set a 12-month price target of $3.00 on the stock, reflecting cautious optimism as the company moves through the early stages of clinical development. While the path for any biotech drug is long and fraught with risk, hitting Phase 1 milestones and demonstrating financial discipline are key indicators that investors and analysts watch closely.

The company's ability to continue managing its cash burn while successfully advancing selonabant through clinical trials will be the primary driver of its valuation. Investors will now be looking ahead to the safety and tolerability data from the Phase 1 study as the next major catalyst.