Helus Pharma (HELP) Study result summary

Platform and Pipeline Overview

• Two proprietary clinical programs, CYB003 and CYB004 (also referred to as HLP004), target major depressive disorder (MDD) and generalized anxiety disorder (GAD), both with positive Phase II data.

• CYB003 has FDA Breakthrough Therapy status and is in Phase III for adjunctive MDD treatment.

• Over 350 patents filed, with 100+ granted, and composition of matter protection through 2041.

Study Design and Patient Population

• Phase II double-blind, adjunctive trials enrolled adults aged 18–65 with moderate-to-severe GAD, stable on standard of care, with average baseline HAM-A of 22.

• Patients were partial responders to existing pharmacotherapy, diagnosed with GAD for over 10 years, and not in remission.

• Two-to-one randomization between 20 mg and 2 mg IM doses, with dosing at baseline and week 3, and follow-up through 6 months to one year.

• Population was predominantly female (83%), mean age 37, with challenging, inadequately responding profiles.

Key Efficacy and Clinical Outcomes

• Clinically meaningful ~10-point reduction in HAM-A at 6 weeks (p<0.0001), with rapid onset by day two.

• At six months, approximately 70% responders and 40% remitters, with durable effects sustained up to one year in some patients.

• 20 mg arm showed 59% response and 32% remission at week 6; 2 mg arm showed 30% for both.

• No regression to baseline observed, contrasting with typical placebo responses.