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Helus Pharma reports news on clinical-stage pharmaceutical development for novel serotonergic agonists in mental health. Recurring updates cover HLP003 for major depressive disorder, HLP004 for generalized anxiety disorder, clinical and regulatory disclosures, research collaborations, and medical or scientific leadership.
Company news also includes governance changes, executive and advisory appointments, shareholder voting matters, capital-structure disclosure, operating and financial results, and participation in healthcare and life-sciences forums tied to the company's depression and anxiety pipeline.
Helus Pharma (Nasdaq: HELP) announced completion of enrollment, ahead of schedule, in APPROACH, its first Phase 3 pivotal study of HLP003 as an adjunctive treatment for major depressive disorder (MDD). The trial enrolled 223 adults with moderate to severe MDD (MADRS ≥24) inadequately responding to stable antidepressants and randomized them 1:1 to 16 mg HLP003 or placebo, each given as two doses three weeks apart.
According to Helus Pharma, the primary endpoint is MADRS change at six weeks versus placebo, with a key secondary endpoint at 12 weeks. Topline data are on track for Q4 2026. HLP003, a deuterated psilocin analogue, has FDA Breakthrough Therapy Designation and earlier Phase 2 data showed a ~23‑point mean MADRS reduction 12 months after dosing, with high response and remission rates. Enrollment continues in EMBRACE, the second pivotal study, and eligible participants may roll into the EXTEND long‑term extension. The company also reports a broad NSA patent portfolio with over 350 applications and more than 100 granted patents worldwide.
Helus Pharma (Nasdaq: HELP) reported fiscal 2026 results and pipeline progress. Cash was $157.3 million as of March 31, 2026, and a $50 million underwritten offering closed on June 25, 2026.
Lead asset HLP003 Phase 3 APPROACH is >88% enrolled with topline data expected in Q4 2026, while HLP004 showed ~10-point HAM-A improvement in GAD. Fiscal 2026 net loss was $148.0 million, with higher cash-based operating expenses of $131.7 million supporting late-stage trials.
Helus Pharma (Nasdaq: HELP, Cboe CA: HELP) closed a US$50 million underwritten offering of 10,309,280 common shares at US$4.85 per share. Underwriters received a US$3 million cash commission.
Net proceeds are intended to fund HLP003 (Phase 3 for major depressive disorder), HLP004 for generalized anxiety disorder, HLP005, and for working capital and general corporate purposes. Phase 3 APPROACH data for HLP003 are expected in Q4 2026.
Helus Pharma (Nasdaq: HELP) priced an underwritten offering of 10,309,280 common shares at US$4.85 per share, targeting US$50 million in gross proceeds. Cantor and Barclays are joint bookrunning managers.
Net proceeds will fund HLP003 Phase 3 for major depressive disorder, HLP004 for generalized anxiety disorder, HLP005, and general corporate purposes.
Helus Pharma (Nasdaq: HELP) reported that its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned.
HLP003 has FDA Breakthrough Therapy Designation, and topline Phase 3 data are expected in Q4 2026.
Previously reported Phase 2 data showed ~23-point MADRS reduction at 12 months after two 16 mg doses three weeks apart, with response/remission rates of 75% at week 18 and 100%/71% at 12 months.
Helus Pharma (Nasdaq: HELP), a clinical-stage pharmaceutical company focused on novel serotonergic agonists (NSAs), will participate in the H.C. Wainwright 7th Annual Neuro Perspectives Hybrid Conference on June 15-16, 2026.
Chief Medical Officer Amir Inamdar will join a fireside chat, available on-demand starting June 15, 2026, at 7:00 a.m. EDT via webcast and later as a replay on Helus Pharma’s investor relations website.
Helus Pharma (Nasdaq: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), will participate in the Jefferies Global Healthcare Conference in New York from June 2-4, 2026.
Interim CEO Eric So will join a webcast fireside chat on Thursday, June 4, 2026, at 2:35 p.m. EDT, with a replay available on the company’s investor relations site.
Helus Pharma (Nasdaq: HELP) announced a collaboration with TARA Mind to support recruitment for its PARADIGM HLP003 Phase 3 program for Major Depressive Disorder and expand veteran mental health outreach. The program is described as FDA Breakthrough Therapy-designated, and the partnership aligns with the April 18, 2026 Executive Order on accelerating treatments for serious mental illness.
The release is a correction removing prior references to Veterans Exploring Treatment Solutions and emphasizes veteran-focused engagement and patient-centric clinical development.
Helus Pharma (Nasdaq: HELP) announced that Eric So, Interim Chief Executive Officer, will speak on a panel titled “The Next Wave of Health Innovation” at the 29th Annual Milken Institute Global Conference on May 4, 2026 at 2:30 p.m. PDT.
The conference runs May 3–6, 2026 in Los Angeles; the live panel and archived webcast will be available on the company’s Events & Presentations investor relations page.
Helus Pharma (Nasdaq: HELP) announced a collaboration with TARA Mind and Veterans Exploring Treatment Solutions (VETS) to support recruitment for its PARADIGM HLP003 Phase 3 program for Major Depressive Disorder and to expand veteran mental health outreach. The program holds FDA Breakthrough Therapy designation for HLP003. The partnership aligns with the April 18, 2026 Executive Order on accelerating treatments for serious mental illness and aims to increase veteran participation in clinical research and access to emerging therapeutic options.