Helus Pharma Announces Topline Results in Phase 2 Signal Detection Study for HLP004 in Patients with Generalized Anxiety Disorder

Rhea-AI Summary

Helus Pharma (Nasdaq: HELP) reported topline Phase 2 signal detection results for HLP004 in adults with moderate-to-severe generalized anxiety disorder on standard-of-care therapy. Patients given 20 mg showed a mean 10.4-point HAM-A reduction at six weeks (p<0.0001), with 67% responders and 39% remitters at six months. The randomized 36-patient study (2:1 active:placebo) found acute effects lasting ~90 minutes and discharge readiness within ~3 hours, and noted no drug-related serious adverse events.

Positive

• Mean HAM-A reduction of 10.4 points at six weeks
• 67% responders in pooled population at six months
• 39% remitters at six months
• No drug-related serious adverse events reported
• Short clinic time: acute effects ~90 minutes, discharge ~3 hours

Negative

• Small randomized sample size: 36 patients
• Limited controlled duration: primary six-week endpoint with observational follow-up
• Results are adjunctive to ongoing SoC, not monotherapy approval data

News Market Reaction – HELP

-33.88% 10.7x vol

63 alerts

-33.88% Session close to close

-33.0% Trough in 5 hr 32 min

$426.81M Market Cap

10.7x Rel. Volume

In the Mar 5 session, HELP declined 33.88%, reflecting a significant negative market reaction. Argus tracked a trough of -33.0% from its starting point during tracking. Our momentum scanner triggered 63 alerts that day, indicating high trading interest and price volatility. Trading volume was exceptionally heavy at 10.7x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -33.9% in the session following this news. A negative reaction despite positive Ph...

Analysis

The stock dropped -33.9% in the session following this news. A negative reaction despite positive Phase 2 data would contrast with prior patterns, where four recent announcements each saw positive price moves. The HLP004 study reported a 10.4-point HAM-A reduction with p<0.0001 and notable responder and remitter rates, but markets sometimes discount early-stage, small-sample data or focus on broader portfolio and funding needs. In such a scenario, the divergence would highlight sensitivity to perceived development risks rather than the headline efficacy metrics alone.

Key Figures

HAM-A improvement: 10.4-point reduction P-value: p<0.0001 Sample size: 36 patients +5 more

8 metrics

HAM-A improvement 10.4-point reduction 20 mg HLP004 adjunctive to SoC at 6 weeks

P-value p<0.0001 HAM-A reduction at 6 weeks

Sample size 36 patients Phase 2 signal detection study in GAD

Responders at 6 months 67% Pooled study population

Remitters at 6 months 39% Pooled study population

Response rate 20 mg arm 59% responders, 32% remitters Week 6 vs SoC in GAD

Response rate 2 mg arm 30% responders and remitters Week 6 vs SoC in GAD

Baseline HAM-A 22 Average baseline score in study participants

Historical Context

4 past events · Latest: Feb 24 (Positive)

Pattern 4 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 24	Board appointment	Positive	+9.5%	Appointment of experienced former Pfizer CMO to board and advisory role.
Feb 17	Clinical data	Positive	+11.0%	Phase 2a MDD trial met primary endpoint with significant antidepressant effects.
Feb 13	Earnings & pipeline	Positive	+2.9%	Q3 results with strong cash and guidance on HLP004 and HLP003 timelines.
Feb 10	CEO appointment	Positive	+1.4%	New CEO installed to lead late-stage development and commercialization plans.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive clinical and corporate updates have aligned with positive price moves in 4 of 4 recent events.

Recent Company History

Over recent months, Helus Pharma has reported multiple positive developments, including CEO and board appointments, encouraging Phase 2a data in major depressive disorder, and solid cash of US$195.1 million with IP protection through at least 2041. Clinical milestones previously flagged included Phase 2 HLP004 data in GAD and Phase 3 HLP003 topline in Q4 2026. Each of these announcements was followed by a positive price reaction, and today’s Phase 2 GAD topline readout continues that trajectory of clinically oriented, data-driven catalysts.

Key Terms

hamilton anxiety rating scale, ham-a, intramuscular, randomized, +4 more

8 terms

hamilton anxiety rating scale medical

"improvement in Hamilton Anxiety Rating Scale (“HAM-A”) of ~10 points"

A clinician-administered questionnaire that measures the severity of a person's anxiety symptoms by scoring signs like tension, worry, and sleep trouble; think of it as a thermometer or ruler for anxiety used by doctors in clinical trials. Investors watch changes in this score because drug candidates that produce meaningful declines on the scale can drive regulatory approval, prescribing decisions, and market value, while weak or mixed results can hurt a company's prospects.

ham-a medical

"achieved mean reduction of 10.4-points (p<0.0001) in the HAM-A"

HAM-A (Hamilton Anxiety Rating Scale) is a clinician-administered questionnaire that scores the severity of a person's anxiety by rating common physical and mental symptoms on a standardized scale. Investors watch HAM-A results in clinical trials because clear changes on the scale can indicate whether a treatment effectively reduces anxiety, which influences regulatory approval, market adoption and the commercial value of a therapy—like a ruler showing how much progress a drug achieved.

intramuscular medical

"received two intramuscular doses three weeks apart"

A way of giving a medicine or vaccine by injecting it deep into a muscle, typically using a syringe and needle so the drug is absorbed into the bloodstream more steadily than a skin shot but faster than swallowing a pill. Investors care because this delivery method affects how quickly and reliably a treatment works, the type of manufacturing and packaging needed, clinical trial design and regulatory requirements, and patient or provider preferences that influence market uptake.

randomized medical

"36 patients were randomized 2-to-1 active-to-placebo"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

placebo medical

"randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

phase 2 medical

"topline results from a Phase 2 signal detection study evaluating HLP004"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

generalized anxiety disorder-7 medical

"average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score"

A seven-question screening tool that measures how often someone has experienced common symptoms of generalized anxiety over the past two weeks and gives a single score indicating severity. Investors care because it is widely used in clinical studies, employee health programs and regulatory assessments to track treatment effects, workplace wellbeing and market need for therapies or services — like a quick thermometer that signals when mental-health issues may affect clinical outcomes or business performance.

suicidality medical

"no drug-related serious adverse events or suicidality-related safety signals"

Suicidality describes thoughts, plans, or behaviors related to taking one’s own life, ranging from fleeting ideas to concrete attempts. For investors, evidence of suicidality tied to a drug, device, or treatment is like a flashing warning light — it can trigger safety investigations, regulatory actions, costly label changes, trial delays or market pullbacks, and therefore materially affect a company’s prospects and valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Statistically significant (p<0.0001) and clinically meaningful improvement in Hamilton Anxiety Rating Scale (“HAM-A”) of ~10 points on top of Standard of Care (“SoC”) at 6 weeks
• Durable effects sustained through at least 6 months
• In Phase 1 trial most participants were ready for discharge within 3 hours¹; Acute effects lasted ~90 minutes
• Generally well-tolerated, adverse events were transient, with no drug related serious adverse events recorded
• At six months, the pooled study population showed 67% responders and 39% of patients were in remission (see Figure 1 below)
  
  

Figure 1

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

NEW YORK and TORONTO, March 05, 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 topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (“GAD”) who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents.

GAD affects more than 20 million adults in the United States, and approximately half of patients treated for GAD fail to respond to initial first-line therapy.^2,3 No adjunctive pharmacologic treatment for GAD has ever been approved. No new monotherapy has been approved in almost two decades.

In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening.

All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment.

Key findings include:

• Clinically meaningful efficacy: Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points (p<0.0001) in the HAM-A from baseline at six weeks.
• Efficacy in difficult to treat population: Study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. 
• Durable remission and robust response over time:
  • At six months, the pooled study population showed 67% responders and 39% remitters. 
  • Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6.
• Commercially scalable clinic time: Short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours¹, fitting within the treatment paradigm of existing interventional psychiatry clinics.
• Well tolerated: Favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals.
  
  

“These Phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience for this patient population with limited options,” noted Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma.

Michael Cola, Chief Executive Officer of Helus Pharma, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.”

For additional information, please access our webcast, which is available on the Company's investor relations website on the Events and Presentations page.

About HLP004

HLP004 is an investigational intramuscular deuterated serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. The program is being developed as a potential adjunctive treatment for patients with generalized anxiety disorder who remain symptomatic despite existing pharmacologic therapies.

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 - novel serotonergic agonists: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to 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^TM is a trademark of Cybin Corp.

Notes 
1. In Phase 1 study at 30 mg dose​.
2. Ringeisen H, et al. Mental and Substance Use Disorders Prevalence Study: Findings Report. RTI International; 2023. 
3. Fagan H, et al. Pharmacological Treatment of Generalized Anxiety Disorder: Current Practice and Future Directions. Expert Review of Neurotherapeutics. 2023. 

Figure 1 Notes:
1) Gueorguieva, et.al. Lancet Psychiatry, 2017. 4(3):230-237.
2) Rutherford, et al. Depress Anxiety, 2015. 32(12):944-57.
3) Berwian, I.M., et al. Psychol Med, 2017. 47(3):426-437.
4) Jones, B.D.M., et al.JAMA Network Open, 2021. 4(9):e2125531-e2125531.
5) Davidson, et al. Eur Neuropsychopharmacol, 2008. 18(9):p. 673-81.
6) Quitkin, et al. Arch GenPsychiatry, 1984. 41:p. 782-786.

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 expectations of progressing the HLP004 program toward development; the potential of HLP004 as a scalable treatment option for patients living with GAD; 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
jtokarczyk@rxmedyn.com
(914) 772-7562

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/728bf286-24d0-40b0-a151-beaced3735d7.

FAQ

What were the key Phase 2 HLP004 results reported by Helus Pharma (HELP) on March 5, 2026?

The trial showed a 10.4-point mean HAM-A reduction at six weeks, statistically significant (p<0.0001). According to the company, the pooled population reached 67% responders and 39% remitters at six months, with favorable tolerability.

How many patients were enrolled in the HLP004 Phase 2 study for HELP and what was the design?

A total of 36 patients were randomized 2:1 active-to-placebo to 20 mg or 2 mg dosing. According to the company, participants received two intramuscular doses three weeks apart and were followed through Week 12.

What efficacy did the 20 mg HLP004 arm achieve in the HELP Phase 2 study at week 6?

The 20 mg arm achieved a mean 10.4-point HAM-A reduction from baseline at six weeks (p<0.0001). According to the company, 59% met response criteria and 32% met remission criteria in that arm at week 6.

What safety and tolerability findings did Helus Pharma report for HLP004 (HELP)?

HLP004 was described as generally well tolerated with no drug-related serious adverse events reported. According to the company, adverse events were transient and there were no suicidality-related safety signals.

How quickly do HLP004 treatment effects appear and how long is in-clinic time for HELP's therapy?

Acute subjective effects lasted approximately 90 minutes with discharge readiness around three hours. According to the company, this fits existing interventional psychiatry clinic workflows for outpatient administration.

Does the HLP004 Phase 2 study for HELP test monotherapy or adjunctive treatment for GAD?

The study evaluated HLP004 as an adjunctive treatment added to ongoing standard-of-care antidepressant therapy. According to the company, all participants continued their existing SoC medications throughout the trial.