Helus Pharma (HELP) Study update summary

HLP003 in MDD

• HLP003, deuterated psilocin, is in Phase 3 for adjunctive MDD treatment and has FDA Breakthrough Therapy Designation; an NDA filing is expected in 2028.

• APPROACH completed enrollment of 223 participants in July 2026; topline results remain on track for Q4 2026. The study assesses MADRS change at Week 6, with Week 12 as a key secondary endpoint.

• EMBRACE enrollment is ongoing; both pivotal studies assess two doses three weeks apart. APPROACH includes 8 mg and 16 mg arms, while EMBRACE evaluates 16 mg against placebo.

• EXTEND assesses long-term safety, durability and redosing among eligible APPROACH and EMBRACE participants, including nonresponders or participants who relapse.

• Phase 2 primary-endpoint MADRS changes at Week 3 were -14.11 for 12 mg and -12.99 for 16 mg; in a two-dose 16 mg post-hoc analysis, changes were -14.8 at Day 21 and -22.7 at Day 364.

HLP004 in GAD

• HLP004, deuterated DMT, is advancing to a Phase 2 monotherapy study expected to start in Q1 2027; the program shifted from an adjunctive to a monotherapy strategy.

• The randomized, double-blind, placebo-controlled study plans ~144 adults with GAD, assigned 1:1 to two 30 mg administrations three weeks apart or placebo.

• The primary endpoint is HAM-A change from baseline at Week 6; Week 12 is the key secondary endpoint.

• Deuteration is designed to extend DMT’s effect; Phase 1 data showed acute effects lasting 90 minutes, discharge readiness by ~3 hours, and mild-to-moderate adverse events across 2–30 mg.

• The 30 mg dose showed the highest intensity and MEQ and EBI scores in signal-finding and was reported as well tolerated; HLP005 preclinical candidate advancement is anticipated in H2 2027.

Market context and commercial considerations

• ~2 in 3 patients do not remit on first-line MDD therapy; existing adjunctive options have tolerability concerns, and a claims analysis found 73.2% nonadherence over 12 months.

• Rapid, robust efficacy, favorable safety, durable effects and infrequent dosing were identified as unmet needs; existing interventional psychiatry clinics are expected to be the initial delivery model.