Helus Pharma (HELP) H.C. Wainwright 28th Annual Global Investment Conference summary

Pipeline overview and development updates

• Lead candidate HLP003, a deuterated psilocin analog, is in phase III for adjunctive treatment of major depressive disorder (MDD), with top-line data expected in Q4 2026.

• HLP004, a deuterated DMT compound, completed a phase II signal-finding study for generalized anxiety disorder; next trial design will be announced soon.

• Early-stage program HLP005, a library of compounds for mental health, will advance its lead candidate in 2027.

• Strong intellectual property portfolio with anticipated patent protection through at least 2041 for key programs.

• The company is positioned as a platform with late, mid, and early-stage assets targeting multiple mental health indications.

HLP003 clinical program and differentiation

• HLP003's deuteration stabilizes the molecule, reduces variability, and improves delivery efficiency.

• Phase II data showed 13–14 point improvement at three weeks after a single dose, with a second dose adding about five points; over 70% remission at one year after two doses.

• Phase III PARADIGM program includes APPROACH and EMBRACE (short-term studies) and EXTEND (long-term extension), assessing efficacy, durability, and retreatment needs.

• HLP003 is administered adjunctively with standard of care, aligning with current clinical practice for MDD.

• The product aims for efficacy, durability (potentially four doses/year), and favorable safety/tolerability compared to antipsychotics.

Market opportunity, regulatory, and financial outlook

• MDD affects about 23 million in the US; 70% are on standard care, but many do not achieve optimal relief.

• HLP003 targets adjunctive MDD, a larger population than treatment-resistant depression, with a differentiated safety profile.

• NDA filing for HLP003 is anticipated in 2028, with potential approval the same year, leveraging Breakthrough Therapy designation and supportive FDA guidance.

• Infrastructure for interventional psychiatry is expanding, with 8,000 clinics and established models from peers.

• $166 million cash on hand as of June 30, 2026, provides runway through near-term catalysts; further financial guidance forthcoming.