Cybin (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, providing composition of matter protection through 2041.

• Seven clinical trials conducted with DMT, building significant institutional knowledge.

Study Design and Patient Population

• Phase II double-blind, adjunctive studies enrolled adults aged 18–65 with moderate to severe GAD, stable on standard of care, with an 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.

• The population was predominantly female (83%), mean age 37, with a challenging, inadequately responding profile.

• Observational follow-up extends up to one year.

Key Efficacy and Safety Results

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

• Approximately 70% response and 40% remission rates sustained through six months, with some patients maintaining benefits up to one year.

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

• Both doses were well tolerated; all adverse events were mild or moderate, transient, and resolved without sequelae, with no drug-related serious AEs or suicidality.

• Most adverse events occurred on the day of dosing and included mild perceptual changes.