Cybin Conference: Helus CEO Eyes Q4 Phase III Depression Data for HLP003

Key Points

• Helus expects fourth-quarter top-line results from the first Phase III trial of HLP003, an adjunctive treatment for major depressive disorder; enrollment was completed in August and the study uses a two-dose induction design.
• CEO Michael Halstead highlighted encouraging Phase II findings, including a 13- to 14-point MADRS improvement after one dose, further improvement after a second dose and reported 12-month durability, while cautioning that results must be replicated in Phase III.
• Helus is also advancing HLP004 in Phase II for generalized anxiety disorder and building its patent portfolio around HLP003, HLP004 and the earlier-stage HLP005 platform.

Helus Pharma CEO Michael Halstead said the company is preparing for a potentially pivotal period as it expects top-line results in the fourth quarter from its first Phase III trial of HLP003 as an adjunctive treatment for major depressive disorder.

Speaking at a Canaccord Genuity event, Halstead, who said he had been CEO for eight days, described Helus as a developer of novel serotonergic agonists for mental health conditions. He said the company’s pipeline includes the late-stage HLP003 program, HLP004 in Phase II for generalized anxiety disorder and the earlier-stage HLP005 platform.

Halstead joined Helus after serving at Intra-Cellular Therapies, a CNS-focused company that he said grew from about 20 employees when he joined to roughly 1,000 employees by 2025. Intra-Cellular Therapies was acquired by Johnson & Johnson in 2025, according to Halstead.

Focus on Adjunctive Depression Treatment

Halstead said Helus selected adjunctive major depressive disorder as the target for HLP003 because it reflects how psychiatrists commonly manage patients who do not achieve an optimal response from standard treatments such as SSRIs and SNRIs.

He said approximately one-third of depression patients respond to standard care, while the remaining patients may require an additional therapy. Halstead cited an estimated 21 million people in the United States with major depressive disorder.

“They don’t have to take these patients off of their background therapy,” Halstead said of the adjunctive approach. “They stay on standard of care. You’re not starting over again, as you would in this switch situation.”

The company’s Phase III program incorporates a two-dose induction approach. Halstead said he viewed that design as important to the durability observed in the company’s earlier Phase II study.

Phase II Results and Phase III Execution

Halstead highlighted Phase II results for HLP003, stating that the study showed a 13- to 14-point improvement on the Montgomery-Åsberg Depression Rating Scale, or MADRS, after three weeks and one dose. He contrasted those results with what he described as a two- to four-point improvement that can support an approved adjunctive therapy and a four- to five-point improvement that could represent a strong product candidate.

Following a second dose in the Phase II study, Halstead said participants saw an additional five-point improvement on the MADRS scale. He said the study’s durability findings extended to 12 months, with a 100% response rate and remission above 70%, as he described the data.

He also cited the program’s safety observations, saying there were no drug-related serious adverse events and that observed adverse events were mild to moderate, largely temporary and generally resolved on the day of treatment.

Halstead cautioned that the Phase II findings must be replicated in the larger Phase III population. Still, he said the earlier results provided confidence as the company approaches its upcoming data release.

Helus completed enrollment in the Phase III trial in August, according to Halstead. He said the company’s Phase III design closely follows its Phase II approach and that Helus has remained hands-on in overseeing trial conduct at the site level.

• Top-line data from the first HLP003 Phase III trial are expected in the fourth quarter.
• The trial includes a two-dose approach as part of its primary design.
• Helus has completed enrollment for the study, Halstead said.

Patent Position and Pipeline Expansion

During the discussion, Halstead said Helus has established a broad intellectual-property portfolio covering HLP003, HLP004 and HLP005. He said the company’s patent strategy includes composition, method-of-treatment and formulation patents.

HLP003 is a deuterated form of psilocin, according to the event discussion. Halstead said deuteration may offer potential patient-related benefits, including a lower drug load, stability and less variability in pharmacokinetic and pharmacodynamic characteristics.

Beyond depression, Halstead said Helus has completed a Phase II study of HLP004 in generalized anxiety disorder and is designing the program’s next trial. He said the company expects to provide additional details on the next steps for HLP004 in the near future.

Halstead said his priority is execution rather than potential strategic transactions. He said Helus intends to focus on the Phase III readout, infrastructure development, advancement of its other clinical programs and its longer-term goal of becoming a fully integrated commercial company.

He also pointed to what he characterized as a supportive regulatory and industry environment for the broader field, including recent FDA guidance and growing interest from larger pharmaceutical companies. Halstead said the company’s clinical design, Phase II results, intellectual property and team were among the factors that supported his decision to join Helus.

About Cybin (NASDAQ:HELP)

Cybin Inc is a clinical-stage biopharmaceutical company focused on the development of psychedelic-based therapeutics for the treatment of mental health disorders. Headquartered in Toronto and listed on the NASDAQ under the symbol HELP, Cybin pursues research and development programs intended to harness the therapeutic potential of psychedelic compounds to address conditions with significant unmet need.

The company operates a drug discovery and development platform aimed at creating novel small-molecule psychedelic analogs and tailored formulations.

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