Helus Pharma (Nasdaq: CYBN) aligns late-stage NSA pipeline with U.S. psychedelic policy push
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Cybin Inc., operating as Helus Pharma, filed a Form 6-K featuring a news update on a White House Executive Order intended to accelerate research, regulation, and patient access for psychedelic-based treatments for serious mental health conditions.
The company states that this policy focus aligns with its portfolio of novel serotonergic agonists. Its lead drug candidate, HLP003, is in Phase 3 clinical development as an adjunctive treatment for major depressive disorder and has received U.S. FDA Breakthrough Therapy designation. A second candidate, HLP004, is in Phase 2 development for generalized anxiety disorder.
The update emphasizes that Helus Pharma continues to advance late-stage trials and broader NSA research while engaging regulators, clinicians, and partners. It also reiterates that none of its investigational products are approved and that extensive clinical and regulatory work remains before any potential commercialization.
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Key Figures
Form type: Form 6-K
HLP003 development stage: Phase 3
HLP004 development stage: Phase 2
+2 more
5 metrics
Form type
Form 6-K
Report of foreign private issuer for April 2026
HLP003 development stage
Phase 3
Adjunctive treatment of major depressive disorder
HLP004 development stage
Phase 2
Generalized anxiety disorder program
FDA designation
Breakthrough Therapy
Granted to HLP003 for major depressive disorder
Executive Order date reference
April 20, 2026
Press release timing for U.S. psychedelic policy update
Key Terms
novel serotonergic agonists, Breakthrough Therapy designation, Executive Order, Phase 3 clinical development, +1 more
5 terms
novel serotonergic agonists medical
"developing proprietary NSAs - novel serotonergic agonists: synthetic molecules designed to activate serotonin pathways"
Breakthrough Therapy designation regulatory
"HLP003... has received Breakthrough Therapy designation for the adjunctive treatment of major depressive disorder"
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.
Executive Order regulatory
"welcomed the White House Executive Order aimed at accelerating research, regulatory pathways, and patient access"
An executive order is a formal directive issued by a country’s chief executive (for example, a president or prime minister) that tells government agencies how to apply or enforce laws and policies without waiting for new legislation. It matters to investors because these orders can quickly change rules, permits, taxes, trade or regulatory enforcement—like a manager changing company policy overnight—creating risks or opportunities that can affect company costs, revenues and share prices.
Phase 3 clinical development medical
"HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of major depressive disorder"
Phase 3 clinical development is the large, late-stage testing of a medical treatment in diverse patient populations to confirm whether it works, to gather more safety information, and to compare it with current standard treatments. Think of it like a final dress rehearsal before a product’s public launch: regulators rely on Phase 3 results to decide approval, so clear success can sharply increase a product’s commercial value while failure can materially reduce a company’s prospects.
adjunctive treatment medical
"HLP003... in Phase 3 clinical development for the adjunctive treatment of major depressive disorder"
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.
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 April, 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: | April 20, 2026 | By: | /s/ Greg Cavers | |||||||||||
| Name: | Greg Cavers | |||||||||||||
| Title: | Chief Financial Officer | |||||||||||||
EXHIBIT INDEX
| 99.1 | News Release dated April 20, 2026 | ||||
Helus Pharma Expresses Support for Executive Order Advancing Psychedelic Research and Regulatory Pathways for Serious Mental Health Conditions
NEW YORK & TORONTO – April 20, 2026 Helus PharmaTM (Nasdaq: HELP) (Cboe CA: HELP), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today welcomed the White House Executive Order aimed at accelerating research, regulatory pathways, and patient access to psychedelic treatments.
“The Executive Order reflects growing recognition of the urgent need for new treatment options in serious mental health conditions and the importance of advancing innovative therapies through rigorous, research-based development,” said Eric So, Interim Chief Executive Officer of Helus Pharma. “Policy momentum is meaningful, but the future of this field will ultimately be determined by the strength of the clinical evidence and the ability to deliver safe, reliable treatments at scale.”
The Executive Order introduces several key initiatives, including the potential prioritization of U.S. Food and Drug Administration (“FDA”) review for psychedelic therapies with Breakthrough Therapy designation, expanded access for eligible patients, increased federal funding to support state-level programs, and strengthened coordination between the Department of Health and Human Services, the FDA, and the Department of Veterans Affairs. It also calls for timely rescheduling of therapies that successfully complete late-stage clinical development and receive regulatory approval, reinforcing a policy framework that supports continued innovation across the psychedelic treatment landscape.
“At Helus Pharma, we are contributing to that progress through disciplined research and late-stage clinical development,” Mr. So added. “Our lead program, HLP003, currently in Phase 3 development, has received FDA Breakthrough Therapy designation for the adjunctive treatment of major depressive disorder, reflecting the urgent need for improved treatments for depression, including the ongoing epidemic of suicide in the United States.”
Helus Pharma believes these actions will help advance the development of novel treatment options for patients living with mental health conditions including major depressive disorder and generalized anxiety disorder, where existing therapies are often insufficient. Millions of patients living with serious mental health conditions continue to experience inadequate response to existing therapies, underscoring the importance of responsible innovation in this area.
Helus Pharma continues to advance its pipeline of investigational therapies and to engage with regulators, clinicians, and research partners to advance its innovative treatments.
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 PharmaTM 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 belief that the Executive Order will help advance the development of novel treatment options for mental health conditions including major depressive disorder; expectation that the Executive Order may accelerate research, regulatory pathways, and patient access to psychedelic treatments; and 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:
Matthew Beck
astr partners
Managing Partner
(917) 415-1750
Matthew.beck@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
FAQ
What does Cybin (CYBN) disclose in this Form 6-K about Helus Pharma?
Cybin, operating as Helus Pharma, reports a U.S. Executive Order supporting psychedelic research and access. It highlights alignment with its pipeline of novel serotonergic agonists and emphasizes continued late-stage clinical development in major depressive disorder and generalized anxiety disorder, without announcing new financial results.
What stage is Helus Pharma’s HLP003 program mentioned in the Cybin (CYBN) filing?
HLP003 is described as a proprietary NSA in Phase 3 clinical development. It targets adjunctive treatment for major depressive disorder and has received U.S. FDA Breakthrough Therapy designation, underscoring the serious unmet need in depression treatment and the potential importance of further clinical evidence and regulatory review.
How does the U.S. Executive Order relate to Cybin’s Helus Pharma pipeline?
The Executive Order aims to accelerate research, regulatory pathways, and patient access for psychedelic treatments. Helus Pharma believes these initiatives support development of its novel serotonergic agonists, including programs for major depressive disorder and generalized anxiety disorder, within a policy framework that emphasizes rigorous, evidence-based therapeutic innovation.
What mental health conditions is Helus Pharma, part of Cybin (CYBN), focusing on?
Helus Pharma is developing proprietary novel serotonergic agonists for serious mental health conditions. The filing highlights major depressive disorder as the focus of Phase 3 candidate HLP003 and generalized anxiety disorder as the target for Phase 2 candidate HLP004, reflecting areas where existing treatments can be insufficient for many patients.
Does Cybin’s Helus Pharma have any FDA designations for its drug candidates?
Yes. The filing notes that HLP003, Helus Pharma’s lead NSA program, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration. This designation recognizes preliminary evidence of potential benefit in major depressive disorder and may support an expedited regulatory review process, subject to successful late-stage trials.
What cautions does Cybin (CYBN) include about Helus Pharma’s investigational therapies?
Cybin states that Helus Pharma’s NSAs, including HLP003 and HLP004, are investigational and not approved to diagnose, treat, cure, or prevent any disease. The filing stresses that rigorous scientific research and clinical trials are required, and lack of necessary approvals could materially affect the company’s operations and performance.