Nature Medicine Publishes Helus Pharma’s Randomized, Placebo-Controlled Phase 2a Trial of SPL026 in Major Depressive Disorder

Rhea-AI Summary

Helus Pharma (Nasdaq: HELP) reported a randomized, placebo-controlled Phase 2a trial of SPL026 in major depressive disorder that met its primary endpoint at two weeks (MADRS mean difference: -7.35; p=0.023).

Single 21.5 mg dose showed antidepressant effects within one week (mean difference: -10.75; p=0.002), durability to three months for the cohort, and no treatment-related serious adverse events reported.

Positive

• Primary endpoint met: MADRS mean difference -7.35 at two weeks
• Rapid effect: statistically significant improvement by one week (mean difference -10.75)
• Durable response: treatment effect maintained up to three months in open-label follow-up
• No treatment-related SAEs reported in the trial cohort
• Response/remission rates: Week 2 response 35% vs 12%; remission 29% vs 12%

Negative

• Small sample size: randomized groups of n=17 each, limiting generalizability
• SPL026 IV not being advanced in its current form by the company

Market Reaction

+11.99% $6.82 1.9x vol

15m delay 34 alerts

+11.99% Since News

$6.82 Last Price

$6.40 $7.15 Day Range

+$36M Valuation Impact

$340M Market Cap

1.9x Rel. Volume

Following this news, HELP has gained 11.99%, reflecting a significant positive market reaction. Our momentum scanner has triggered 34 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $6.82. This price movement has added approximately $36M to the company's valuation. Trading volume is above average at 1.9x the average, suggesting increased trading activity.

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Key Figures

Primary endpoint effect: MADRS mean difference: -7.35 vs placebo at 2 weeks Statistical significance: p=0.023 Dose: 21.5 mg +5 more

8 metrics

Primary endpoint effect MADRS mean difference: -7.35 vs placebo at 2 weeks Phase 2a SPL026 in MDD, primary endpoint

Statistical significance p=0.023 Primary endpoint at 2 weeks

Dose 21.5 mg Single intravenous SPL026 dose

Sample size per arm n=17 SPL026, n=17 placebo Phase 2a randomized, placebo-controlled trial

Week 1 effect MADRS mean difference: -10.75 Between-group difference at 1 week

Week 1 p-value p=0.002 Between-group effect at 1 week

Response rates 35% SPL026 vs 12% placebo ≥50% MADRS reduction at Week 2

Remission rates 29% SPL026 vs 12% placebo MADRS ≤10 at Week 2

Market Reality Check

Price: $6.09 Vol: Volume 275,539 is 0.59x t...

low vol

$6.09 Last Close

Volume Volume 275,539 is 0.59x the 20-day average of 465,531 shares. low

Technical Price at $6.09, trading below 200-day MA at $7.06 and 32.11% under 52-week high.

Peers on Argus

No peers with notable momentum flags or same-day headlines; recent 2.87% gain in...

No peers with notable momentum flags or same-day headlines; recent 2.87% gain in HELP appears stock-specific.

Historical Context

2 past events · Latest: Feb 13 (Positive)

Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Feb 13	Earnings and pipeline	Positive	+2.9%	Q3 2026 results and updates on HLP004 and HLP003 development timelines.
Feb 10	Leadership change	Positive	+1.4%	Appointment of new CEO to lead late-stage development and commercialization.

Pattern Detected

Recent corporate and earnings updates with clinical milestones have coincided with positive next-day price moves.

Recent Company History

In the past week, Helus Pharma reported Q3 fiscal 2026 results on Feb 13, highlighting cash of US$195.1 million, a quarterly net loss of US$42.7 million, and cash-based operating expenses of US$36.7 million, alongside upcoming Phase 2 data for HLP004 in GAD and Phase 3 topline for HLP003 in MDD. On Feb 10, the company appointed Michael Cola as CEO to drive late-stage development and commercialization. Both events saw positive reactions of 2.87% and 1.42%, respectively, setting a constructive backdrop for today’s positive Phase 2a SPL026 data.

Market Pulse Summary

The stock is surging +12.0% following this news. A strong positive reaction aligns with the clearly ...

Analysis

The stock is surging +12.0% following this news. A strong positive reaction aligns with the clearly favorable Phase 2a SPL026 data, which showed statistically significant MADRS improvements and meaningful response and remission rates. Recent history, including Q3 results and a CEO transition, also coincided with positive moves, suggesting investors previously rewarded execution milestones. However, sustainability could depend on how markets weigh the modest sample size, the shift from SPL026 to HLP004, and future Phase 2 readouts in GAD.

Key Terms

phase 2a, placebo-controlled, madrs, montgomery-åsberg depression rating scale, +3 more

7 terms

phase 2a medical

"Randomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

placebo-controlled medical

"Randomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

madrs medical

"reduction in depressive symptoms as measured by MADRS score (mean difference: -7.35)"

MADRS (Montgomery–Åsberg Depression Rating Scale) is a short, clinician‑completed questionnaire that assigns numbers to common symptoms of depression to produce a single score reflecting severity—think of it as a clinical “mood thermometer.” Investors watch MADRS results because drug trials often use changes in this score as the key measure of whether a treatment works; clear improvements or failures can strongly affect regulatory outcomes, market prospects and stock value.

montgomery-åsberg depression rating scale medical

"measured by the Montgomery-Åsberg Depression Rating Scale (“MADRS”)"

A clinician-rated scale that measures the severity of depressive symptoms, typically using a short checklist of items scored to produce an overall severity number; think of it as a thermometer that gauges how intense a patient’s depression is at a given time. Investors care because changes on this scale are often used as key outcomes in clinical trials and regulatory filings, affecting whether a treatment is seen as effective and therefore influencing approval prospects, market value and future sales expectations.

serotonergic agonists medical

"developing novel serotonergic agonists (“NSAs”) for serious mental health conditions"

Serotonergic agonists are drugs or compounds that activate the brain’s serotonin receptors, acting like keys that turn on specific cellular “locks” involved in mood, sleep, pain, and other bodily functions. Investors watch them because their ability to treat common or hard-to-treat conditions can create large markets, raise regulatory and safety questions, and affect a drug maker’s revenue and valuation depending on clinical trial results, approvals, patents and side-effect profiles.

open-label medical

"During the open-label portion of the study, the treatment effect was maintained"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dimethyltryptamine (dmt) medical

"randomized placebo-controlled IIa trial of intravenous dimethyltryptamine (DMT)"

A naturally occurring psychedelic compound that alters perception and mood when taken, producing short but intense changes in consciousness. Investors care because DMT is central to research into mental health treatments and the broader psychedelics industry; scientific results, regulatory decisions, or changes in legal status can quickly affect the value and prospects of companies developing therapies, services, or products tied to psychedelic drugs—much like a new technology can reshape an industry.

AI-generated analysis. Not financial advice.

• Randomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint demonstrating a clinically significant reduction in depressive symptoms as measured by MADRS score (mean difference: -7.35) versus placebo at two weeks
• Antidepressant treatment effects observed within one week and sustained for up to three months
• Findings reinforce the therapeutic potential of short-acting serotonergic agonists and inform Helus Pharma’s HLP004 development program, with Phase 2 topline data in generalized anxiety disorder (“GAD”) expected in Q1 2026
  
  

This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025.

BOSTON and TORONTO, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (Nasdaq: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) for serious mental health conditions, today announced the publication¹ in Nature Medicine of results from a Phase 2a randomized, placebo-controlled clinical trial evaluating SPL026, in participants with moderate-to-severe major depressive disorder (“MDD”).

The study met its primary endpoint demonstrating statistically significant and clinically meaningful reductions in depressive symptoms at two weeks, as measured by the Montgomery-Åsberg Depression Rating Scale (“MADRS”) in participants treated with SPL026 compared with placebo. Reductions in depressive symptoms were observed as early as one week following dosing and were sustained at three months, with effects lasting up to six months in some participants. The treatment was generally well tolerated, with no treatment-related serious adverse events reported.

“We have shown that a single dose of SPL026 is safe, effective and durable, with treatment effects comparable to other promising interventional treatments often requiring much longer treatment sessions.” Dr David Erritzoe, from Imperial’s Department of Brain Sciences, and lead investigator of the trial continued, “Although such early trial results should always be interpreted with some caution, these data show the promise of DMT as a potentially more cost-effective treatment for clinical depression than related serotonergic agonists with longer psychoactive action due to the shorter dosing sessions.”

This phase 2a study evaluated the efficacy and safety of SPL026. Participants receiving a single 21.5 mg dose of SPL026 (n=17) demonstrated a significant reduction in MADRS score compared to placebo (n=17) at two weeks meeting the primary endpoint (mean difference: -7.35; 95%CI, -13.62 to –1.08; p=0.023). The treatment effect of SPL026 was evident at one week (mean difference: -10.75; 95%CI, -16.95 to –4.55; p=0.002). Response rates (≥50% MADRS reduction) at Week 2 were 35% for SPL026 vs. 12% for placebo, with remission rates (MADRS ≤10) at 29% vs. 12%. During the open-label portion of the study, the treatment effect was maintained for up to three months.                 

“This publication represents an important validation of short-acting serotonergic agonists as a clinically meaningful approach in mental health treatments,” said Michael Cola, Chief Executive Officer of Helus Pharma. “The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility. We look forward to reporting topline data from our Phase 2 study of HLP004 in generalized anxiety disorder later this quarter.”

Although Helus Pharma is not advancing intravenous SPL026 in its current form, the mechanistic and clinical insights generated from this trial continue to inform the Company’s HLP004 development program. Helus is currently advancing HLP004, a proprietary NSA, that is designed to optimize pharmacology, consistency, and scalability for GAD, of which SPL026 is a nondeuterated analog.

¹Erritzoe et. al., A short-acting psychedelic intervention for major depressive disorder: randomized placebo-controlled IIa trial of intravenous dimethyltryptamine (DMT), Nature Medicine. DOI 10.1038/s41591-025-04154-z

About the Study

The study was conducted at Hammersmith Medicines Research Ltd (London), MAC Clinical Research (Liverpool), and Imperial College London. This study was conducted by Helus Pharma Corp., a wholly owned subsidiary of Helus Pharma and the successor entity to Small Pharma Inc. The study was a phase 2a randomized placebo-controlled trial evaluating the safety and efficacy of SPL026, in adults with moderate-to-severe major depressive disorder. The trial enrolled 34 participants (mean age 32.8 years, 29.4% female, predominantly white) who had experienced depression for an average of 10.5 years. Participants were randomized in a double-blind manner to receive either a single 21.5 mg intravenous infusion of SPL026 over 10 minutes or placebo, combined with supportive psychotherapy sessions focused on preparation, integration, and emotional processing.

In the blinded Stage 1, the primary endpoint was the change in MADRS scores from baseline to Week 2. Stage 2 was an open-label extension where all participants could receive a second SPL026 dose two weeks later; antidepressant effects persisted up to three months post-first dose.

About Helus Pharma

Helus Pharma™, the commercial operating name of Cybin Inc. (the “Company” or “Helus Pharma”) is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to potentially address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.

With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.

The Company operates in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Helus Pharma, visit www.helus.com or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma™ is a trademark of Cybin Corp.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s anticipated topline data readout from the Phase 2 study evaluating HLP004 in GAD in Q1 2026; the promise of SPL026 as a potentially more cost-effective treatment for clinical depression; the ability of the Company’s NSAs to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions; the Company’s notion that novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three and nine month periods ended December 31, 2025, and the Company’s annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor Contact:
Josh Barer
astr partners
Managing Director
(908) 578-6478
josh.barer@astrpartners.com

George Tziras
Chief Business Officer
Helus Pharma
1-866-292-4601
irteam@helus.com – or – media@helus.com

Media Contact:
Johnny Tokarczyk
RXMD
Public Relations Director
(914) 772-7562
jtokarczyk@rxmedyn.com

FAQ

What were the key results of Helus Pharma's SPL026 Phase 2a trial (HELP) published Feb 17, 2026?

The trial met its primary endpoint with a MADRS mean difference of -7.35 at two weeks. According to the company, effects began by one week (mean difference -10.75), with durability up to three months and no treatment-related serious adverse events.

How quickly did SPL026 show antidepressant effects in the HELP Phase 2a study?

SPL026 showed measurable benefit within one week after dosing. According to the company, the one-week MADRS mean difference was -10.75 (95% CI -16.95 to -4.55; p=0.002), indicating an early onset of effect.

What were the Week 2 response and remission rates for SPL026 in the Feb 17, 2026 publication?

Week 2 response (≥50% MADRS reduction) was 35% for SPL026 vs 12% for placebo, and remission (MADRS ≤10) was 29% vs 12%. According to the company, these figures support clinical activity after a single dose.

Did the SPL026 study report any serious adverse events in the Feb 17, 2026 release?

No treatment-related serious adverse events were reported in the trial. According to the company, the single 21.5 mg dose was generally well tolerated across participants in the randomized cohort.

Will Helus Pharma advance SPL026 intravenously after the Phase 2a results (HELP)?

Helus Pharma said it is not advancing intravenous SPL026 in its current form. According to the company, insights will inform development of HLP004, a proprietary short-acting serotonergic agonist optimized for scalability in GAD.

How do the SPL026 Phase 2a results affect Helus Pharma's HLP004 program (HELP) and timeline?

The company said SPL026 data inform HLP004 development and support clinical proof-of-concept for short-acting serotonergic agonists. According to the company, Phase 2 topline data for HLP004 in GAD are expected in Q1 2026.