Helus Pharma Presents New Analyses on HLP003 in Major Depressive Disorder at Psych Congress 2026

Helus Pharma highlighted Phase 1/2a follow-up analyses and its ongoing Phase 3 PARADIGM program for HLP003 in major depressive disorder.

Rhea-AI Summary

Helus Pharma (HELP) presented four posters on its investigational oral deuterated psilocin analog HLP003 for major depressive disorder (MDD) at Psych Congress 2026, held September 15–19, 2026, in New Orleans.

Three posters extend findings from a completed Phase 1/2a randomized, double-blind study of HLP003 as an adjunctive MDD therapy, including 12‑month efficacy data, and explore effects on MADRS item scores, anhedonia, psychedelic experience assessment, and expanded safety. A fourth poster provides a trial‑in‑progress overview of PARADIGM, the ongoing Phase 3 clinical program evaluating the efficacy and safety of HLP003 as an adjunctive treatment for MDD.

Key Figures

Poster presentations: 4 posters Efficacy follow-up: 12-month efficacy results Prior study phase: Phase 1/2a +1 more

Poster presentations

4 posters

HLP003 at Psych Congress 2026

Efficacy follow-up

12-month efficacy results

HLP003 clinical analyses

Prior study phase

Phase 1/2a

Completed randomized, double-blind HLP003 study

Clinical program phase

Phase 3

PARADIGM program for major depressive disorder

Key Terms

mdd, deuterated psilocin analog, adjunctive treatment, madrs

4 terms

mdd medical

"adjunctive treatmentfor major depressive disorder (“MDD”)"

Major depressive disorder (MDD) is a medical condition characterized by persistent low mood, loss of interest in daily activities, and impaired functioning similar to carrying a heavy backpack that makes ordinary tasks much harder. For investors, MDD matters because treatments and therapies for it are a large market regulated by health authorities; clinical trial outcomes, approvals, or safety concerns can strongly affect a drugmaker’s sales prospects, valuation, and risk profile.

deuterated psilocin analog medical

"an investigational oral deuterated psilocin analog"

A deuterated psilocin analog is a chemical variant of psilocin (the active molecule related to certain psychedelic compounds) in which one or more hydrogen atoms are replaced by deuterium, a heavier isotope of hydrogen. The small atomic swap can change how long the molecule lasts in the body or how it is broken down, which matters to investors because these changes can affect clinical profiles, intellectual property, development timelines, and potential market value for drug candidates.

adjunctive treatment medical

"being developed as an adjunctive treatment for MDD"

An adjunctive treatment is a therapy given in addition to a primary treatment to improve overall effectiveness or manage side effects—think of it as a booster or supportive sidekick to the main medicine. For investors, adjunctive therapies matter because they can expand a product’s market use, create additional revenue streams, affect regulatory pathways and clinical trial design, and influence competitive positioning and pricing in a therapeutic area.

madrs medical

"Effects of HLP003 on MADRS Individual Items"

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.

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Poster presentations further characterize clinical profile of HLP003 and 
Phase 3 PARADIGM program evaluating HLP003 as a potential adjunctive treatment
for major depressive disorder (“MDD”)

NEW YORK and TORONTO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the presentation of four posters evaluating HLP003, an investigational oral deuterated psilocin analog being developed as an adjunctive treatment for MDD, at Psych Congress 2026, September 15–19, 2026, at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

Three of the poster presentations build on findings from Helus Pharma’s completed Phase 1/2a randomized, double-blind study of HLP003 as a potential adjunctive therapy in participants with MDD. Data presented includes 12-month efficacy results. A trial-in-progress overview of PARADIGM, the ongoing Phase 3 clinical program of HLP003 was also presented.

Poster #1

• Title: Effects of HLP003 on MADRS Individual Items and Anhedonia Subscale in Adults With Major Depressive Disorder: Post Hoc Analysis of a Phase 1/2a Study 
• Authors: Atul R. Mahableshwarkar, MD; Ken Kramer, PhD; Alexandra Kulikova, PhD; Amir Inamdar, MBBS, DNB (Psych), MFPM
• Poster Number:124
  
  

Poster #2

• Title: Understanding and Assessing the Psychedelic Experience From a Phase 1/2a Study of the Deuterated Psilocin Analog HLP003 in Adults With Major Depressive Disorder
• Authors: Atul R. Mahableshwarkar, MD; Sunita Shinde, MD; Ken Kramer, PhD; Alexandra Kulikova, PhD; Amir Inamdar, MBBS, DNB (Psych), MFPM
• Poster Number: 123
  
  

Poster #3

• Title: Expanded Safety Analysis of the Deuterated Psilocin Analog HLP003 From a Phase 1/2a Study of Adult Participants With Major Depressive Disorder
• Authors: Sunita Shinde, MD; Alexandra Kulikova, PhD; Atul Mahableshwarkar, MD; Ken Kramer, PhD; Amir Inamdar, MBBS, DNB (Psych), MFPM
• Poster Number: 122
  
  

Poster #4

• Title: A Phase 3 Clinical Program Evaluating the Efficacy and Safety of the Deuterated Psilocin Analog HLP003 as an Adjunctive Treatment for Major Depressive Disorder (PARADIGM)
• Authors: Amir Inamdar, MBBS, DNB (Psych), MFPM; Annette Massa, PharmD; Ken Kramer, PhD; Heather Prichard, PhD; Sunita Shinde, MD; Atul Mahableshwarkar, MD
• Poster Number: 121
  
  

About Helus Pharma

Helus Pharma, the commercial operating name of Cybin Inc., 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 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 MDD 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 Helus Pharma 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 HLP003 as a potential adjunctive treatment for MDD; 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 months ended June 30, 2026, and the Company’s annual information form for the year ended March 31, 2026, 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:
Matthew Beck
astr partners
Managing Partner
(917) 415-1750
Matthew.beck@astrpartners.com

Gabriel Fahel
Chief Legal Officer
Helus Pharma
1-866-292-4601
irteam@helus.com – or – media@helus.com

Media Contact:
Victoria Verdeja
RXMD
Public Relations Director
(212) 537-9495
vverdeja@rxmedyn.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What aspects of HLP003 were highlighted from the Phase 1/2a study?

The Phase 1/2a posters covered 12‑month efficacy results, post hoc analyses of MADRS individual items and anhedonia, assessment of the psychedelic experience, and an expanded safety analysis in adults with major depressive disorder receiving HLP003 as a potential adjunctive treatment.

What is the PARADIGM program mentioned in the Helus Pharma posters?

PARADIGM is described as an ongoing Phase 3 clinical program evaluating the efficacy and safety of HLP003 as an adjunctive treatment for major depressive disorder, and a poster at Psych Congress 2026 presented a trial‑in‑progress overview of this program.