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Helus Pharma™ (Nasdaq: HELP, Cboe CA: HELP), a clinical-stage pharmaceutical company focused on innovative mental health treatments, has announced the pricing of a US$50 million underwritten public offering. The company is offering approximately 10.3 million common shares at US$4.85 per share.
The proceeds from this significant funding round will be strategically deployed to advance Helus Pharma's pipeline of proprietary novel serotonergic agonists (NSAs)-synthetic molecules designed to activate serotonin pathways and promote neuroplasticity.
Accelerating Clinical Trials for Depression
A primary focus for the newly secured capital is the progression of HLP003, the company's lead proprietary NSA. HLP003 is currently in Phase 3 clinical development as an adjunctive treatment for major depressive disorder (MDD) and has already been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).
Helus Pharma also announced a major milestone today: its APPROACH Phase 3 clinical trial of HLP003 has surpassed 86% enrollment. The company remains firmly on track for a topline data readout in the fourth quarter of 2026. The APPROACH trial is a core component of the Phase 3 PARADIGM program, which also includes the EMBRACE study and EXTEND long-term extension study. To bolster recruitment efforts, the company has partnered with TARA Mind and Veterans Exploring Treatment Solutions, specifically expanding outreach within the veteran community.
Strong Phase 2 Data Foundation
Confidence in the Phase 3 program is underpinned by compelling Phase 2 results. Previously reported data demonstrated that HLP003 achieved a reduction of approximately 23 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months (following two 16 mg doses administered three weeks apart). Response and remission rates reached 75% at week 18, eventually climbing to a remarkable 100% response rate and 71% remission rate by the 12-month mark.
Leadership and Advisory Expansion
"This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout," stated Eric So, Co-founder, Executive Chairman, and recently appointed Interim Chief Executive Officer of Helus Pharma, following the departure of former CEO Michael Cola.
To support its advancing pipeline, Helus Pharma has also strengthened its leadership team and advisory boards. Dr. Ken Kramer has been appointed as Senior Vice President, Medical Affairs, bringing over 20 years of neuroscience experience from his previous role leading medical strategy at Bristol Myers Squibb. Additionally, the company expanded its Scientific Advisory Board with the addition of industry veterans Dr. Robert Langer and Dr. Stephen Brannan.
Looking Ahead
Beyond HLP003, the new funding will also support HLP004, currently in Phase 2 trials for generalized anxiety disorder, and earlier-stage HLP005 programs. Cantor and Barclays are acting as joint bookrunning managers for the offering, which is expected to close on June 25, 2026.
With a bolstered balance sheet, expanded leadership, and highly encouraging clinical momentum, Helus Pharma is well-positioned to address the substantial unmet needs of patients suffering from severe depression, anxiety, and other mental health conditions.
