Helus Pharma

What Helus Pharma does

Helus Pharma (formerly Cybin Inc., rebranded January 2026) is a clinical-stage biopharmaceutical company founded in 2019 and headquartered in Toronto, Canada, that develops novel serotonergic agonists (NSAs) for mental health conditions. The company's core technology platform applies deuteration chemistry to serotonin receptor agonist scaffolds to produce drug candidates with improved pharmacokinetics, bioavailability, dosing control, and shorter treatment duration compared with traditional psychedelic compounds. Its lead clinical programs are HLP003, a deuterated psilocin analog in Phase 3 development as an adjunctive treatment for Major Depressive Disorder (with FDA Breakthrough Therapy Designation and a 2028 projected launch), and HLP004, a deuterated DMT analog in Phase 2 for Generalized Anxiety Disorder. The company also markets EMBARK, a proprietary transdiagnostic psychotherapy model used as supportive care within its clinical trials.

The company is publicly traded on Nasdaq and Cboe Canada under ticker HELP, operates research subsidiaries in Ireland and the United Kingdom following its 2023 acquisition of Small Pharma, and protects its portfolio with over 350 filed patent applications and over 100 granted patents, including U.S. composition of matter patents expected to provide coverage until at least 2041. Helus Pharma holds $195.1 million in cash and is pre-revenue, generating no product sales; all operating capital has been sourced from equity and convertible debt financings, including a $175 million registered direct offering (October 2025), a $100 million at-the-market equity program, and a $50 million underwritten offering (June 2026). Its target patient populations are adults with treatment-resistant or moderate-to-severe Major Depressive Disorder and Generalized Anxiety Disorder, with a strategic focus on underserved veteran communities through a partnership with TARA Mind. Leadership transitions in 2026, including the brief appointment and departure of CEO Michael Cola and the addition of multiple senior executives and scientific advisors, signal active organizational scaling ahead of the Q4 2026 Phase 3 data readout and projected 2028 commercial launch.

Name

Helus Pharma

Legal name

Cybin Inc.

Website

https://helus.com

Company type

Public

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Helus Pharma is a clinical-stage biopharmaceutical company developing deuterated novel serotonergic agonists for mental health conditions, with lead programs HLP003 (Phase 3 for MDD) and HLP004 (Phase 2 for GAD) targeting adult patients with treatment-resistant depression and anxiety disorders.

Ownership category

akta.pro rank

Product category

Clinical-Stage Neuropsychiatric Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Drug Discovery (Target ID/Validation & Hit Discovery) (HLAIALAA), Lead Optimization & Preclinical Candidate Selection (HLAIALAB)

Keywords

• Psychedelic therapeutics
• Deuterated psilocin
• Mental health treatments
• Serotonergic agonists
• Clinical-stage biopharmaceutical

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage company. Expected to generate revenue from commercialized pharmaceutical products following FDA approval. HLP003 projected for 2028 launch with peak U.S. sales of $1.3 billion.

Go-to-market motion3 records

Distribution channels1 record

Marketing channels5 records

Core offering

Helus Pharma develops proprietary deuterated novel serotonergic agonists (NSAs) targeting mental health conditions. The company's lead candidate HLP003 is a deuterated psilocin analog in Phase 3 clinical trials as an adjunctive treatment for Major Depressive Disorder, with FDA Breakthrough Therapy Designation. HLP004, a deuterated DMT analog for Generalized Anxiety Disorder, is in Phase 2 development. The pipeline leverages proprietary deuteration chemistry to improve dosing control, onset of action, bioavailability, and treatment duration.

Product overview

Helus Pharma is a clinical-stage pharmaceutical company developing a portfolio of novel serotonergic agonists (NSAs) for mental health conditions. The company's lead products are HLP003 (a deuterated psilocin analog in Phase 3 for major depressive disorder with FDA Breakthrough Therapy Designation) and HLP004 (a deuterated DMT analog in Phase 2 for generalized anxiety disorder). These are complemented by HLP005 in preclinical development. The company also developed EMBARK, a proprietary transdiagnostic therapy model providing psychological support for clinical trial participants. The technology platform leverages deuteration to improve dosing control, onset of action, and treatment duration compared to traditional serotonergic compounds.

Differentiator

Problem solved

Functional benefit

Brands

• EMBARK: A transdiagnostic treatment model incorporating evidence-based therapies and empirically-supported treatments for psychedelic-assisted therapy sessions in clinical trials. Features six domains: Existential-spiritual, Mindfulness, Body-aware, Affective-cognitive, Relational, and Keeping momentum.

Products and services

• HLP003 (Deuterated Psilocin Analog) Proprietary deuterated novel serotonergic agonist designed to target the 5-HT2A receptor, being developed as an adjunctive treatment for Major Depressive Disorder (MDD). Has received FDA Breakthrough Therapy Designation. Currently in Phase 3 PARADIGM program with topline data expected Q4 2026 and projected 2028 commercial launch.
• HLP004 (Deuterated DMT Analog) Proprietary deuterated novel serotonergic agonist being developed for Generalized Anxiety Disorder (GAD). Administered via intramuscular injection with short acute effects (~90 minutes). Phase 2 study enrollment complete with topline data readout expected Q1 2026. Demonstrated 67% responder rate and 39% remission rate at 6 months, with a 10.4-point mean reduction in HAM-A scores at 6 weeks (p<0.0001) in prior studies.
• HLP005 (Phenethylamines and Tryptamines Program) Phenethylamines and tryptamines program targeting CNS Disorders. Currently in preclinical development stage as part of the broader novel serotonergic agonist pipeline.
• EMBARK Transdiagnostic Therapy Model Proprietary transdiagnostic treatment model incorporating evidence-based therapies (EBTs) and empirically-supported treatments (ESTs) used to support participants safely and effectively through treatment sessions in clinical trials. Features six domains (Existential-spiritual, Mindfulness, Body-aware, Affective-cognitive, Relational, Keeping momentum) and four cornerstones of care (Trauma-informed, Culturally competent, Ethically rigorous, Collective care).
• SPL026 (DMT Fumarate) Intravenous/intramuscular dimethyltryptamine fumarate compound. Phase 2a trial demonstrated statistically significant reduction in MADRS depression scores with effects sustained for up to three months and no drug-related serious adverse events. Acquired via the 2023 acquisition of Small Pharma and serves as a research compound informing the company's deuterated DMT development.

Quantifiable outcome

• 100% response rate and 71% remission rate at 12 months after two doses of HLP003 (16mg)
• +4 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• TARA MindcoreStrategic or Co-development Partner · 28 April 2026Collaboration to support recruitment for PARADIGM HLP003 Phase 3 clinical trial for Major Depressive Disorder, leveraging TARA Mind's veteran community networks through its partnership with Veterans Exploring Treatment Solutions. Partnership aligns with Trump executive order on accelerating treatments for underserved veteran populations.
• Veterans Exploring Treatment SolutionsminorStrategic or Co-development Partner · 28 April 2026Partnership through TARA Mind to facilitate engagement with veteran communities for clinical trial recruitment.
• Institute for Integrative Therapies (IIT)coreStrategic or Co-development Partner · 20 November 2025Clinical trial site for EMBRACE and EXTEND psilocin studies evaluating treatments for Major Depressive Disorder. Enrollment expected to begin February 2026.

Scale indicators12 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• GH Research: Clinical-stage biopharmaceutical company developing mebufotenin and other serotonergic agents for psychiatric and neurological disorders. Comparable psychedelic-agonist approach with Phase 2/3-stage assets.
• Compass Pathways: Clinical-stage company developing psilocybin-based therapies for treatment-resistant depression, the same core indication as HLP003. Most directly comparable psychedelic therapeutics peer with a publicly disclosed Phase 3 program.
• ATAI Life Sciences: Clinical-stage biopharmaceutical company developing psychedelic and other novel therapies for mental health conditions including depression and anxiety. Competes in the same therapeutic area with overlapping pipeline programs.
• MindMed: Clinical-stage company developing psychedelic-inspired therapies for CNS disorders including anxiety and depression. Direct competitor with publicly traded psychedelic pipeline targeting similar indications.

Broad incumbents

• Janssen Pharmaceuticals (Johnson & Johnson): Developer of Spravato (esketamine), the only FDA-approved psychedelic-adjacent therapy for treatment-resistant depression. Represents the established standard of care and the closest commercial-stage benchmark in psychedelic-inspired CNS treatment.
• Sage Therapeutics: Commercial-stage CNS biopharmaceutical company with Zurzuvae approved for postpartum depression. Provides a benchmark for what successful CNS specialty pharma commercialization looks like and was named in executive biographies as relevant prior experience.
• Karuna Therapeutics: CNS-focused biopharmaceutical company acquired by Bristol Myers Squibb for its schizophrenia treatment xanomeline-trospium. Comparable CNS specialty pharma trajectory and advisory board member Dr. Brannan was previously Karuna's CMO.
• Axsome Therapeutics: Commercial-stage CNS biopharmaceutical company with approved products for depression (Auvelity) and migraine. Closest publicly traded specialty pharma with commercial-stage CNS franchise as Helus targets.
• Boehringer Ingelheim (CNS Pipeline): Major pharmaceutical company with a CNS pipeline including depression programs. Represents a potential large-pharma acquirer or partner for late-stage CNS assets like HLP003.

Emerging players

• Praxis Precision Medicines: Clinical-stage CNS company developing therapies for depression and other neurological disorders. Comparable stage and indication focus with publicly traded CNS pipeline.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/heluspharma
• YouTubeyoutube.com/@heluspharma
• Facebookfacebook.com/heluspharma
• LinkedInlinkedin.com/company/helus-pharma
• Instagraminstagram.com/heluspharma

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds14 records

Investors29 records

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M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Helus Pharma