Cybin Inc.

Helus Pharma is a clinical-stage pharmaceutical company dedicated to advancing mental health treatments through the development of proprietary novel serotonergic agonists (NSAs). The company's mission is to help minds heal by creating synthetic molecules designed to activate serotonin pathways, which are believed to promote neuroplasticity. Founded in 2019, Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland, with its headquarters located in Toronto, Canada.

The company's pipeline primarily focuses on addressing significant unmet needs in depression, anxiety, and other mental health conditions. Its lead drug candidates include HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Additionally, Helus Pharma is developing HLP004, another proprietary NSA, currently in Phase 2 for generalized anxiety disorder. The company leverages proprietary drug delivery systems and patent-protected molecules, holding over 350 patent applications and more than 100 granted patents.

In recent corporate developments, Michael Cola stepped down as Chief Executive Officer on April 20, 2026, with co-founder Eric So resuming the role of Interim CEO. Helus Pharma recently partnered with TARA Mind to support recruitment for its HLP003 Phase 3 clinical trial, particularly within the veteran community, aligning with a White House Executive Order aimed at accelerating mental health treatments. The company, formerly known as Cybin Inc., rebranded to Helus Pharma in December 2025 and transferred its U.S. stock listing to Nasdaq in January 2026, reflecting its evolution towards a commercial-ready pharmaceutical entity focused on late-stage clinical development.

Latest updates

Helus Pharma CEO to Address Milken Institute Conference Amidst Clinical Trials

Event summary

  • Helus Pharma Interim CEO Eric So will speak at the Milken Institute Global Conference on May 4, 2026.
  • So’s panel will focus on “The Next Wave of Health Innovation,”.
  • Helus Pharma is developing HLP003 (Phase 3 for major depressive disorder) and HLP004 (Phase 2 for generalized anxiety disorder).
  • The company has Breakthrough Therapy Designation for HLP003 from the FDA.
  • Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland.

The big picture

Helus Pharma’s participation in the Milken Institute conference underscores the growing investor interest in novel treatments for mental health conditions, a market estimated to be worth billions annually. The company’s reliance on Breakthrough Therapy Designation for HLP003 highlights the competitive landscape and the pressure to deliver clinical results. The conference provides a platform to communicate progress and potentially attract further investment, but also exposes the company to scrutiny regarding its clinical pipeline and leadership structure.

What we're watching

Clinical Progress
The visibility afforded by the Milken Conference could accelerate investor interest, but the success of HLP003’s Phase 3 trial remains the critical determinant of Helus Pharma’s near-term valuation.
Leadership Stability
Eric So’s role as Interim CEO suggests ongoing leadership uncertainty; the conference appearance may signal a search for a permanent replacement or a strategic shift in direction.
Regulatory Landscape
Given the forward-looking statements regarding approvals, the company’s ability to navigate the regulatory pathway for NSAs will be a key factor in determining long-term commercial viability.

Helus Pharma Gains Veteran Outreach Via TARA Mind Partnership

Event summary

  • Helus Pharma has partnered with TARA Mind and VETS to support recruitment for its Phase 3 PARADIGM HLP003 clinical trial for Major Depressive Disorder (MDD).
  • The collaboration is intended to expand mental health awareness and access within the veteran community.
  • The partnership is directly linked to President Trump’s April 18, 2026 Executive Order focused on accelerating mental health treatment research.
  • HLP003 is an FDA Breakthrough Therapy-designated NSA (novel serotonergic agonist).

The big picture

This partnership highlights the growing recognition of the unmet mental health needs within the veteran community and the increasing pressure on pharmaceutical companies to address these needs, particularly given government incentives. The collaboration leverages a niche organization, TARA Mind, which may offer a cost-effective alternative to traditional recruitment methods. Helus Pharma's reliance on Executive Orders for strategic advantage introduces a degree of political risk.

What we're watching

Recruitment Success
The efficacy of this partnership in accelerating Phase 3 recruitment for HLP003 will be a key indicator of its value, given the challenges of clinical trial enrollment.
Executive Order Impact
The long-term influence of the Executive Order on Helus Pharma’s ability to access veteran populations and secure favorable regulatory pathways warrants monitoring.
Commercialization Risk
The success of Helus Pharma's NSA platform hinges on securing regulatory approvals and demonstrating durable efficacy, which remains a significant risk despite the Breakthrough Therapy designation.

Helus Pharma Bolsters Pipeline Expertise with Langer, Brannan Advisory Appointments

Event summary

  • Helus Pharma added Robert Langer and Stephen Brannan to its Scientific Advisory Board, effective April 23, 2026.
  • Dr. Langer, a prolific inventor and founder of multiple biotech companies, brings extensive drug delivery expertise.
  • Dr. Brannan, formerly of Karuna Pharmaceuticals and Takeda, specializes in CNS therapeutic development.
  • The board is chaired by Dr. Freda Lewis-Hall, former CMO of Pfizer, focusing on clinical development and regulatory strategy.
  • HLP003 (major depressive disorder) is in Phase 3 trials, and HLP004 (generalized anxiety disorder) is in Phase 2.

The big picture

This move signals Helus Pharma’s intent to bolster its scientific credibility and de-risk its pipeline as it approaches critical inflection points. Securing advisors of Langer and Brannan’s stature is a common tactic for smaller biopharma companies seeking to attract investment and validate their approach in a crowded market. The appointments also highlight the ongoing demand for novel treatments in the large and underserved mental health space, where existing therapies often prove inadequate.

What we're watching

Execution Risk
The success of Helus Pharma’s pipeline hinges on the ability of the expanded advisory board to accelerate clinical development and navigate regulatory hurdles, particularly given the competitive landscape in CNS therapeutics.
Regulatory Headwinds
The Breakthrough Therapy Designation for HLP003 provides a near-term catalyst, but the FDA’s ultimate decision will depend on Phase 3 trial data and could be influenced by broader trends in mental health treatment guidelines.
Governance Dynamics
The presence of high-profile advisors like Langer and Brannan may increase investor scrutiny of Helus Pharma’s management team and strategic direction, potentially impacting the interim CEO’s tenure and future leadership appointments.
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