A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year

Issued on behalf of Helus Pharma™

Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., says its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in Q4 2026.

NEW YORK and TORONTO, June 26, 2026 /PRNewswire/ — USA News Group News Commentary, In drug development, enrollment is the quiet variable that decides whether a promising therapy ever reaches a data readout on schedule. Late-stage psychiatric trials are notoriously hard to fill, which is why a clean enrollment update is meaningful. On June 24, 2026, Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned, keeping the program on course for a topline data readout in the fourth quarter of 2026.

Key Takeaways

• Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP) reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) has surpassed 86% enrollment and is progressing as planned.
• HLP003 has previously been granted Breakthrough Therapy Designation by the U.S. FDA, and the Company says it remains on track for a topline data readout in Q4 2026.
• Company-reported Phase 2 results showed a ~23-point MADRS reduction from baseline at 12 months (after two 16 mg doses three weeks apart), with response/remission rates of 75% at week 18 improving to 100% response and 71% remission at 12 months — figures that have not been evaluated by the FDA.

An Enrollment Milestone That Matters

“We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment,” said Eric So, Interim Chief Executive Officer of Helus Pharma. “This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD.”

APPROACH is one of the Company’s Phase 3 studies evaluating HLP003, its lead proprietary novel serotonergic agonist (NSA). The trial sits within a broader Phase 3 program Helus calls PARADIGM, which also includes the EMBRACE study and the EXTEND long-term extension study — a multi-trial structure designed to build the efficacy and safety package required to advance HLP003 toward potential commercialization.

What HLP003 Is, and Why
‘
Breakthrough
‘ Status Matters

Helus describes its proprietary NSAs as synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity — the brain’s capacity to form new neural connections — with the aim of delivering durable improvements rather than the symptom-by-symptom maintenance of traditional antidepressants. HLP003 is the lead candidate, now in Phase 3 for the adjunctive treatment of MDD; the Company is also developing HLP004, an NSA in Phase 2 for generalized anxiety disorder, alongside a broader portfolio of investigational NSAs.

The FDA’s Breakthrough Therapy Designation, which HLP003 has received, is granted to investigational therapies intended to treat serious conditions where preliminary clinical evidence suggests a substantial improvement over available options. The designation is meant to expedite development and review through more intensive FDA guidance — it is a signal of regulatory engagement and perceived promise, not a guarantee of approval. For a clinical-stage company, it is among the more meaningful validations a program can carry into late-stage trials.

The Phase 2 Data Behind the Story

The reason HLP003 has drawn attention is the strength of its earlier-stage results. In previously reported Phase 2 data, the Company says HLP003 demonstrated long-term efficacy with an approximately 23-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months, following two 16 mg doses administered three weeks apart. The MADRS is the standard clinician-rated instrument for measuring depression severity, and a reduction of that magnitude, if it holds up in a larger controlled trial, would be clinically substantial.

The Company further reported that Phase 2 response and remission rates were 75% at week 18, and that by the 12-month mark response and remission rates improved to 100% and 71%, respectively. These are striking figures — but important caveats apply, and Helus Pharma itself flags them: Phase 2 studies are typically small and may lack the controls of a pivotal trial, results from a Phase 2 study may not be predictive of Phase 3 outcomes, and the FDA has not evaluated these results or confirmed any efficacy claims for HLP003. The APPROACH Phase 3 trial exists precisely to test whether the early signal can be reproduced rigorously at larger scale.

A Market Hungry for Something New

The opportunity backdrop is significant. Major depressive disorder affects hundreds of millions of people worldwide and remains a leading cause of disability, yet the workhorse treatments — SSRIs and SNRIs — are built on chemistry that is decades old, can take weeks to work, and leave a large share of patients with inadequate relief. That gap is why the depression field is, in the words of one 2026 industry analysis, undergoing its most significant therapeutic transformation in decades, as mechanistically novel drugs reach the market and late-stage pipeline at the same time.

Helus is positioning HLP003 squarely in that opening: a fast-acting, durable, neuroplasticity-oriented option intended to work adjunctively for patients whose depression is not adequately controlled. The thesis is that an adjunctive treatment requiring only periodic dosing could reshape how MDD is managed — if the Phase 3 data deliver. The Company operates across Canada, the United States, the United Kingdom, and Ireland.

The Closest Comparisons

A handful of clinical-stage developers are pursuing novel-mechanism therapies for depression using the same pivotal-trial yardstick Helus relies on — the MADRS. Three are worth watching as the most direct points of comparison, though each carries its own risk profile, targets its own patient population, and none is a proxy for Helus. Compass Pathways (NASDAQ: CMPS) is among the most advanced: its synthetic psilocybin candidate, COMP360, is in Phase 3 for treatment-resistant depression, and in early 2026 the company reported achieving the primary endpoint in both of its pivotal Phase 3 trials using the same MADRS-based measurement. It offers the clearest read on how regulators and markets are treating late-stage, novel-mechanism depression programs.

Definium Therapeutics (NASDAQ: DFTX), the company formerly known as Mind Medicine (MindMed) and renamed in January 2026, is an especially timely comparison. In June 2026 it reported positive topline results from its Phase 3 Emerge study of DT120 (lysergide) orally disintegrating tablet in MDD: the study met its primary endpoint with a placebo-adjusted MADRS reduction of 8.1 points at week 6 (p<0.0001) and, the company reported, met all key secondary endpoints, with DT120 generally well tolerated and no serious adverse events. Alongside the data, Definium priced an upsized US$700 million public offering. As a single-dose, novel-mechanism MDD program measured on the MADRS, it is among the most directly relevant readouts for how a program like HLP003 may be received — while also illustrating the competitive intensity Helus faces in the space.

GH Research (NASDAQ: GHRS), a Dublin-based clinical-stage company developing its own novel-mechanism candidate for treatment-resistant depression, rounds out the set as another developer racing to convert an early efficacy signal into pivotal data. It is pre-revenue and carries the binary clinical risk inherent to late-stage biotech. Together, these names illustrate a depression field being remade around new mechanisms — and the distance a clinical-stage company like Helus must still travel, through its Q4 2026 readout and beyond, to convert promise into an approved product.

The Bottom Line

An 86% enrollment milestone is an execution signal, not a result — it says the trial is on track to read out, not what it will show. But for a Breakthrough-designated program with eye-catching Phase 2 data and a Q4 2026 topline readout in sight, hitting enrollment targets on schedule is exactly what de-risks the path to that catalyst. The questions that matter now are whether APPROACH completes enrollment cleanly, whether the Phase 3 data reproduce the Phase 2 results, and how the FDA ultimately views the package. For investors tracking the next generation of depression therapeutics, the Q4 readout is the date to circle — with the clear understanding that HLP003 is investigational, unapproved, and unproven until that data arrives.

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CONTACT
USA News Group
[email protected]

SOURCES

[1] Helus Pharma™ (Cybin Inc.), “Helus Pharma Provides Update on APPROACH Phase 3 Trial Enrollment Progress,” June 24, 2026.
[2] Compass Pathways plc (Nasdaq: CMPS), Phase 3 COMP005 and COMP006 (COMP360 psilocybin for treatment-resistant depression) primary-endpoint disclosures, 2025–2026.
[3] Definium Therapeutics, Inc. (Nasdaq: DFTX), “Positive Topline Results from Phase 3 Emerge Study of DT120 ODT in MDD” and “Pricing of $700 Million Upsized Public Offering,” June 2026.
[4] GH Research PLC (Nasdaq: GHRS), corporate and clinical-program disclosures, 2026.
[5] Depressive-disorder competitive-landscape analysis, 2026.

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MEDICAL & FORWARD-LOOKING STATEMENTS: HLP003 and HLP004 are investigational product candidates that have not been approved by the U.S. Food and Drug Administration, Health Canada, or any other regulatory authority. The FDA and other regulators have not evaluated the claims regarding the Company’s novel serotonergic agonists, and the efficacy and safety of these candidates have not been established; Breakthrough Therapy Designation does not guarantee that a product will be approved. Clinical results, including the Phase 2 results referenced herein, are preliminary, may not be predictive of results in larger or later-stage trials, and should not be relied upon as evidence of safety or efficacy. References to other companies, including their clinical results and financings, are based on those companies’ public disclosures, are provided for industry context only, and should not be interpreted as a comparison of safety or efficacy or as investment advice regarding any company. This publication contains forward-looking statements, including statements regarding the progress, enrollment, timing and anticipated topline data readout (Q4 2026) of the APPROACH Phase 3 trial and the broader PARADIGM program; the potential of HLP003 as a treatment for major depressive disorder; and the Company’s development and commercialization plans. Forward-looking statements are subject to risks and uncertainties, including clinical-trial, regulatory, financing, and commercialization risks, that could cause actual results to differ materially, as detailed in the Company’s filings available on SEDAR+ (www.sedarplus.ca) and EDGAR (www.sec.gov/edgar). This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Readers are cautioned not to place undue reliance on forward-looking statements, and the publisher undertakes no obligation to update or revise them except as required by applicable law. Neither Cboe Canada nor the Nasdaq Global Market has approved or disapproved the contents herein.

 

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