Helus PharmaNYSE: HELP
Also known as: Cybin, Cybin Inc.
Helus Pharma is the commercial operating name of Cybin Inc., a clinical-stage biopharmaceutical company developing proprietary Novel Serotonergic Agonists (NSAs) — synthetic deuterated molecules designed to activate serotonin pathways and promote neuroplasticity. Operating across Canada, the US, UK, and Ireland, Helus holds over 100 granted patents and 250+ pending applications across its NSA portfolio. Its lead asset, HLP003 (formerly CYB003, a deuterated psilocin analogue), has received FDA Breakthrough Therapy Designation for the adjunctive treatment of major depressive disorder and is in two concurrent Phase 3 trials: APPROACH™ (topline data Q4 2026) and EMBRACE™. A key differentiator is its adjunctive design — allowing patients to continue background antidepressant medications without washout. HLP004 (a deuterated DMT analogue for intramuscular use) posted encouraging Phase 2 topline results in GAD in March 2026: 10.4-point HAM-A reduction at 6 weeks, 67% responders at 6 months, and an ~90-minute in-clinic session window. US composition-of-matter patent coverage through at least 2041.
Drug Pipeline
2HLP003 (CYB003)
PsilocybinDeuterated psilocin analogue (NSA), oral. Adjunctive treatment — patients remain on background antidepressants, no washout required. FDA Breakthrough Therapy Designation for MDD. Phase 3 APPROACH™ trial ongoing, topline data Q4 2026. Phase 3 EMBRACE™ trial enrolling (complementary/replication study). EXTEND long-term extension study ongoing for durability and safety data.
HLP004 (CYB004)
DMTDeuterated DMT analogue (NSA), intramuscular. Adjunctive treatment for GAD. Phase 2 signal detection study (36 patients, 2:1 randomisation, two IM doses 3 weeks apart): 10.4-point HAM-A reduction at Week 6 (20 mg arm); 67% responders and 39% remitters at 6 months (pooled). ~90-min acute effects, ~3-hour discharge window. Topline data reported March 2026. US composition-of-matter patent through at least 2041.
Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- NYSE: HELP
- Lead Stage
- Phase III
- HQ
- Toronto, ON, Canada
- Website
- Visit