Helus Pharma (HELP) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Pipeline and milestones

• 003 is deuterated psilocin for adjunctive MDD treatment and is in Phase III; first APPROACH readout anticipated later this quarter.

• APPROACH enrollment completed in July; management said the study remains on track for the expected readout later this quarter.

• EMBRACE is ongoing; more precise timing is expected after further enrollment information. APPROACH and EMBRACE participants may roll into the 52-week EXTEND study.

• 004 is deuterated DMT for GAD; a 144-patient Phase II monotherapy trial is planned to start in Q1 2027.

• 005 is a preclinical compound library, with a lead candidate targeted to move forward in 2027.

003 trial and treatment context

• The Phase III adjunctive trial keeps patients on a stable antidepressant dose throughout; this differs from monotherapy studies that wash patients off background treatment.

• Phase III doses patients at baseline and week 3, measures the primary endpoint at week 6, and assesses durability at week 12 without another dose.

• Phase II showed efficacy and durability after two doses, with reported benefit out to a year; Phase III incorporates both doses into its primary endpoint.

• In the U.S., MDD affects ~22 million people; management cited five approved adjunctive options, all atypical antipsychotics, with significant side-effect burdens.

• Phase II adverse events were mild to moderate, primarily transient on treatment day, including nausea, headache and elevated blood pressure.

Regulatory and development outlook

• Management anticipates an NDA filing in 2028 and expects a rolling submission under the program’s Breakthrough Therapy Designation; approval is also anticipated in 2028.

• EXTEND will run for 52 weeks, with up to three additional doses, to provide long-term safety, durability and dosing information for clinicians.

• Phase II placebo response was ~3 points; management cited 1–5 points in larger late-stage psychedelic trials and noted EMBRACE includes an 8 mg active comparator alongside 16 mg and placebo.