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.
Development Programmes
2HLP003 (CYB003)
PsilocybinDeuterated psilocin analogue (novel serotonergic agonist / NSA) for adjunctive treatment of MDD. Oral administration. Designed for a compressed 4–6 hour session vs standard psilocybin. Phase 2 (EMBARK, NCT05385783): −14.08-point placebo-adjusted MADRS at Week 3; 71% remission at 12 months after two 16 mg doses. FDA Breakthrough Therapy Designation (March 2024). Phase 3 PARADIGM programme: APPROACH (NCT06793397) and EMBRACE studies ongoing. Cybin rebranded to Helus Pharma, Nasdaq: HELP, January 2026.
Programme Tracker
Major Depressive Disorder (MDD)
Forecast
Phase III topline - Approval eventual: 55%
APPROACH (NCT06793397, ~220 pts, 45 US sites) dosing ongoing; EMBRACE (~330 pts, multi-national) initiated across US, UK, Europe, Australia. Topline results expected Q4 2026.
Milestones
Phase II completed
CompletedActual: Oct 3, 2023
EMBARK Phase 2 (NCT05385783) dosing complete; all 60+ patients dosed
Why it matters: Enabled subsequent BTD application and Phase 3 programme design
Watch next: Topline data and Breakthrough Therapy Designation
Phase III started
CompletedActual: Nov 13, 2024
PARADIGM Phase 3 programme initiated: APPROACH (NCT06793397) and EMBRACE pivotal studies launched across US, Europe, UK, and Australia
Why it matters: Pivotal programme that, if successful, will form the basis of an NDA for HLP003 in MDD — a multi-billion dollar indication
Watch next: Enrollment milestones, regulatory approvals per country, topline Q4 2026
Phase III topline
PlannedLikely: Q4 2026
APPROACH topline data expected Q4 2026 per company guidance
Why it matters: First pivotal data readout for HLP003; if positive, triggers NDA preparation
Watch next: EMBRACE topline to follow APPROACH
Regulatory review accepted
CompletedActual: Mar 13, 2024
FDA granted Breakthrough Therapy Designation to CYB003/HLP003 for adjunctive treatment of MDD — first BTD for an adjunctive psychedelic therapy for MDD
Why it matters: BTD provides more frequent FDA guidance, rolling review, and expedited development; strongly de-risks the regulatory pathway
Watch next: End-of-Phase 2 meeting with FDA and Phase 3 launch
Company milestone
CompletedActual: Jan 5, 2026
Cybin rebrands to Helus Pharma and commences trading on Nasdaq (ticker: HELP)
Why it matters: Corporate rebrand signals transition from clinical-stage to near-commercial; also reflects expanded pipeline focus
Watch next: Phase 3 topline results (APPROACH) expected Q4 2026
Recorded Events
Jan 5, 2026: Company milestone
Nov 13, 2024: Phase III started
Mar 13, 2024: Regulatory review accepted
Oct 3, 2023: Phase II completed
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
trial-registry - ClinicalTrials.gov - Verified
company-website - Helus Pharma - Verified
HLP004 (CYB004)
DMTDeuterated DMT analogue administered intramuscularly for generalised anxiety disorder. Two IM doses of 20 mg, 3 weeks apart; ~4-hour session. Phase 2 proof-of-concept (NCT06051721): 36 participants, enrollment completed September 2025. Topline data expected Q1 2026.
Programme Tracker
Anxiety Disorders
Forecast
Phase II topline - Approval eventual: 20%
Enrollment complete (Sep 2025); topline results expected Q1 2026
Milestones
Phase II started
CompletedActual: Mar 15, 2024
Phase 2 GAD study (NCT06051721) initiated; first patient dosed
Why it matters: First clinical trial of a deuterated DMT analogue in an anxiety indication
Watch next: Enrollment completion and topline data
Phase II topline
PlannedLikely: Q1 2026
Topline data expected Q1 2026 per company guidance
Why it matters: Proof-of-concept readout for deuterated DMT in GAD — could open a new indication pathway
Watch next: Press release with HAM-A score results at 6 weeks
Enrollment complete
CompletedActual: Sep 8, 2025
All 36 participants enrolled in Phase 2 GAD study
Why it matters: Enrollment completion unlocks topline data timeline of Q1 2026
Watch next: Topline data announcement
Recorded Events
Sep 8, 2025: Enrollment complete
Mar 15, 2024: Phase II started
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- NYSE: HELP
- Lead Stage
- Phase III
- HQ
- Toronto, ON, Canada
- Website
- Visit