Cybin highlights Phase 3 psychedelic depression drug
Cybin Inc., under its Helus Pharma brand, highlights new clinical and safety analyses and a Phase 3 program overview for HLP003 in major depressive disorder.
Rhea-AI Filing Summary
Cybin Inc. (operating commercially as Helus Pharma) reports that Helus Pharma presented four scientific posters on its lead candidate HLP003 for major depressive disorder at Psych Congress 2026. The presentations covered detailed efficacy analyses, psychedelic-experience assessment, expanded safety data from a completed Phase 1/2a study, and a trial-in-progress overview of the ongoing Phase 3 program.
HLP003 is described as an investigational oral deuterated psilocin analog being developed as an adjunctive treatment for major depressive disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Cybin also highlights HLP004, another proprietary NSA in Phase 2 development for generalized anxiety disorder, and notes an extensive broader research portfolio of investigational serotonergic agonists.
Positive
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Filing Explained
The update concerns an ongoing Phase 3 program, not an approved treatment: the company states that efficacy has not been confirmed by approved research and regulators have not evaluated claims about HLP003.
Key Figures
Number of HLP003 posters presented: 4 posters
Psych Congress 2026 dates: September 15–19, 2026
HLP003 development phase: Phase 3
+3 more
6 metrics
Number of HLP003 posters presented
4 posters
Presented at Psych Congress 2026 on HLP003 for major depressive disorder
Psych Congress 2026 dates
September 15–19, 2026
Conference dates where HLP003 posters were presented
HLP003 development phase
Phase 3
Clinical development stage for adjunctive treatment of major depressive disorder
HLP004 development phase
Phase 2
Clinical development stage for generalized anxiety disorder
Poster numbers
121, 122, 123, 124
Identification numbers of the four HLP003 posters at Psych Congress 2026
FDA status of HLP003
Breakthrough Therapy Designation
Regulatory designation for HLP003 as adjunctive treatment for MDD
Key Terms
Breakthrough Therapy Designation, novel serotonergic agonists, adjunctive treatment, Major Depressive Disorder, +1 more
5 terms
Breakthrough Therapy Designation regulatory
"HLP003 ... in Phase 3 ... that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
novel serotonergic agonists medical
"developing novel serotonergic agonists (“NSAs”)"
adjunctive treatment medical
"HLP003 ... 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.
Major Depressive Disorder medical
"as a potential adjunctive treatment for major depressive disorder (“MDD”)"
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
generalized anxiety disorder medical
"HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder"
Generalized anxiety disorder is a chronic mental health condition marked by persistent, excessive worry about everyday things that is hard to control and interferes with daily life. Think of it like a smoke alarm that stays on for weeks or months, making work, decision-making and productivity harder; for investors it matters because it drives demand for treatments, affects workforce performance and can influence regulatory scrutiny, clinical trial design and healthcare spending.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Cybin Inc. (HELP) announce regarding HLP003 at Psych Congress 2026?
Cybin, through Helus Pharma, announced four poster presentations on HLP003, including post hoc efficacy analyses, psychedelic-experience assessment, expanded safety data from a Phase 1/2a study, and a trial-in-progress overview of the ongoing Phase 3 program in major depressive disorder.
What stage of development is HLP003 in for Cybin Inc. (HELP)?
HLP003 is in Phase 3 clinical development as an adjunctive treatment for major depressive disorder, following a completed Phase 1/2a randomized, double-blind study whose 12‑month efficacy, safety, and experience data are being further characterized in the reported posters.
What regulatory status does HLP003 have according to Cybin Inc. (HELP)?
Cybin states that HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its development as an adjunctive treatment for major depressive disorder, highlighting its potential clinical importance and expedited regulatory pathway.
What other pipeline programs did Cybin Inc. (HELP) mention besides HLP003?
Cybin, via Helus Pharma, mentions HLP004, a proprietary novel serotonergic agonist in Phase 2 for generalized anxiety disorder, and notes an extensive research portfolio of additional investigational NSAs targeting depression, anxiety, and other mental health conditions.
Where and when were Cybin Inc. (HELP) HLP003 data presented?
The HLP003 data were presented at Psych Congress 2026, held September 15–19, 2026, at the Ernest N. Morial Convention Center in New Orleans, Louisiana, through four separate scientific posters numbered 121 through 124.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September, 2026.
Commission File Number: 001-40673
Cybin Inc.
(Exact Name of Registrant as Specified in Charter)
100 King Street West, Suite 5600, Toronto, Ontario, M5X 1C9
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F □ Form 40-F ⊠
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CYBIN INC. | ||||||||||||||
| (Registrant) | ||||||||||||||
| Date: | September 21, 2026 | By: | /s/ Greg Cavers | |||||||||||
| Name: | Greg Cavers | |||||||||||||
| Title: | Chief Financial Officer | |||||||||||||
EXHIBIT INDEX
| 99.1 | News Release dated September 21, 2026 | ||||
Helus Pharma Presents New Analyses on HLP003 in Major Depressive Disorder at Psych Congress 2026
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 & TORONTO — September 21, 2026 — 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 HPL003 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
