Helus Pharma (HELP) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Executive introductions and company overview

• CEO and CMO both have over 25 years of industry experience, with backgrounds in psychiatry, pharma, and CNS drug development.

• The company focuses on mental health, developing novel serotonergic agonists for various indications.

• Lead program CYB003 (deuterated psilocin) is in phase III for adjunctive major depressive disorder, with a readout expected in Q4.

• CYB004, a DMT compound for generalized anxiety disorder, is in phase II with new trial details forthcoming.

• Broad intellectual property portfolio with patent protection expected through at least 2041.

Rationale and strategy for lead program

• CYB003 targets adjunctive MDD, aiming to address the large population not optimally served by standard care.

• Deuteration of psilocin improves delivery, reduces variability, and increases plasma exposure, supporting efficacy.

• Phase II data showed rapid, durable symptom improvement and strong safety, justifying phase III advancement.

• Phase III program (PARADIGM) includes APPROACH and EMBRACE studies, plus a long-term extension (EXTEND).

• APPROACH compares placebo to 16mg dose; EMBRACE adds an 8mg arm to assess dose response.

Clinical trial design and execution

• Phase III design closely replicates successful phase II, with higher entry threshold for patient quality.

• EXTEND study remains blinded until retreatment is needed, tracking durability and retreatment intervals.

• Retreatment is triggered by predefined MADRS-based relapse criteria confirmed over two weeks.

• Top-line data from phase III expected in Q4, including primary and secondary endpoints and safety.

• NDA filing targeted for 2028, with breakthrough therapy designation enabling rolling submission.