Helus Pharma Inc. (NASDAQ: HELP) (NEO: HELP)

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Helus Pharma Inc. (NASDAQ: HELP) (NEO: HELP), originally founded as Cybin Inc. in 2019, is a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) for the treatment of mental health disorders. The company recently commenced trading on the Nasdaq Global Market and continues to trade on Cboe Canada, reflecting its evolution toward a commercial-ready pharmaceutical organization.

Helus Pharma is focused on engineering proprietary deuterated and non-deuterated NSAs designed to target specific serotonin receptors. Its programs are intended to address major depressive disorder (“MDD”) and generalized anxiety disorder (“GAD”), where treatment resistance, incomplete response, and tolerability remain ongoing challenges. The company’s discovery platform modifies serotonin receptor agonist scaffolds to create proprietary active pharmaceutical ingredients designed for improved pharmacokinetic and dosing profiles.

The company is advancing two lead clinical programs, HLP003 and HLP004, supported by an intellectual property portfolio of over 350 filed patents with more than 100 granted. Helus Pharma is preparing for potential commercialization of HLP003, subject to regulatory approval.

The company is headquartered in Toronto, Ontario.

Portfolio

HLP003 – Phase 3 Program in Major Depressive Disorder

HLP003 is a proprietary, deuterated novel serotonergic agonist designed to target the 5-HT2A receptor and is being developed as an adjunctive treatment for major depressive disorder. It has been granted U.S. Food and Drug Administration (“FDA”) Breakthrough Therapy Designation and is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041.

HLP003 is currently in Phase 3 development under the PARADIGM program in participants with moderate to severe MDD. The pivotal program consists of three studies: APPROACH, a two-arm study evaluating two doses versus placebo; EMBRACE, a three-arm study evaluating high dose, mid-dose, and placebo; and EXTEND, a long-term extension study allowing open-label dosing or re-dosing. Topline data from APPROACH are expected in the fourth quarter of 2026.

Twelve-month data following two 16 mg doses demonstrated a mean reduction of approximately 23 points in Montgomery-Asberg Depression Rating Scale (“MADRS”) scores from an average baseline of approximately 32. In that analysis, 100% of patients were responders and 71% were in remission at 12 months. All reported adverse events were mild to moderate, with no adverse events or serious adverse events reported in the 12-month follow-up.

HLP004 – Phase 2 Program in Generalized Anxiety Disorder

HLP004 is a proprietary deuterated NSA program in development for generalized anxiety disorder. The Phase 2 study is a randomized, double-blind trial in 36 participants with moderate to severe GAD (GAD-7 score ≥10) in the United States, evaluating two intramuscular doses administered three weeks apart versus low-dose controls.

The primary endpoint is change from baseline in Hamilton Anxiety Rating Scale (“HAM-A”) score at six weeks following the first dose. Participants are followed for 12 weeks, with optional follow-up assessments up to one year. Phase 2 topline safety and efficacy data are expected in the coming months.

HLP004 is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041 and is supported by more than 50 patents directed to composition of matter, methods of use, formulation, and synthesis. Exploratory analyses of studies of SPL026, an undeuterated analog of HLP004, demonstrated improvements in anxiety measures, including a mean 23-point improvement from baseline on the State-Trait Anxiety Inventory – Trait version (STAI-T) at two weeks in participants receiving SPL026 in combination with SSRIs.

Market Opportunity

Major depressive disorder and generalized anxiety disorder represent significant global and U.S. health burdens. In the United States, 21 million adults are affected by major depressive disorder. More than 300 million people worldwide suffer from anxiety disorders.

In the United States, GAD has a 12-month prevalence of 2.9%, and approximately 77% of adults with GAD experience moderate to severe impairment. Approximately 50% of patients with GAD do not respond to first-line treatment with antidepressants such as SSRIs and SNRIs.

Helus Pharma has indicated that the broader addressable market across depression, anxiety disorders, PTSD, bipolar disorder, substance use disorders, eating disorders, migraine, and chronic pain management affects more than 200 million people in the United States, underscoring the scale of unmet need across mental health indications.

Leadership Team

Eric So, Interim Chief Executive Officer, is a veteran owner, operator, and investor with more than 20 years of experience in corporate strategy, development, and finance across the full business life cycle, from start-up through multinational growth stages.

Aaron Bartlone, Chief Operating Officer, previously served as Chief Quality, Patient Safety, HSE & Risk Officer at UCB, Inc., leading more than 1,500 colleagues in 54 countries, and as President of UCB, Inc., overseeing U.S. commercial operations.

Amir Inamdar MBBS, DNB (Psych), MFPM, Chief Medical Officer, is a qualified psychiatrist and pharmaceutical physician with more than 20 years of clinical and drug development experience, having progressed numerous candidate drugs through preclinical and early-phase clinical development.