Helus Pharma HLP003 results on track for Q4 2026

The planned HLP004 trial will compare 30 mg monotherapy with inactive placebo in approximately 144 adults with generalized anxiety disorder.

Rhea-AI Filing Summary

Helus Pharma Inc. (HELP) said the HLP003 APPROACH Phase 3 topline data readout remains on track for Q4 2026, while its next HLP004 Phase 2 monotherapy study for generalized anxiety disorder is expected to initiate in Q1 2027. The company completed enrollment of 223 participants in APPROACH in July 2026; enrollment continues in EMBRACE, its second pivotal HLP003 study.

The HLP004 study will assess two 30 mg administrations. Approximately 144 adults will be randomized 1:1 to 30 mg HLP004 or inactive placebo, with change in HAM-A total score assessed at Week 6 as the primary endpoint and Week 12 as the key secondary endpoint. HLP003 has FDA Breakthrough Therapy Designation. Helus cautioned that clinical-trial timelines may not be met.

Filing Explained

Helus says it has shifted HLP004’s GAD program from adjunctive therapy to monotherapy—treatment on its own—changing the treatment approach the planned Phase 2 study is meant to test; it attributes the shift to its assessment of the GAD treatment landscape.

Key Figures

APPROACH enrollment: 223 participants HLP004 study enrollment: Approximately 144 participants HLP004 dose: 30 mg +5 more

8 metrics

APPROACH enrollment 223 participants Enrollment completed in July 2026

HLP004 study enrollment Approximately 144 participants Planned Phase 2 monotherapy study in adults with GAD

HLP004 dose 30 mg Dose in the planned monotherapy study

Randomization ratio 1:1 HLP004 or inactive placebo

HLP003 topline data readout Q4 2026 APPROACH Phase 3 readout is on track for this quarter

HLP004 study initiation Q1 2027 Study is expected to initiate in this quarter

Primary endpoint assessment Week 6 Change from baseline in HAM-A total score

Key secondary endpoint assessment Week 12 Change from baseline in HAM-A total score

Key Terms

Breakthrough Therapy Designation, adjunctive treatment, monotherapy, Hamilton Anxiety Rating Scale, +1 more

5 terms

Breakthrough Therapy Designation regulatory

"HLP003 has been granted Breakthrough Therapy Designation by the FDA"

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.

adjunctive treatment medical

"potential 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.

monotherapy medical

"Phase 2 monotherapy study for the potential treatment of GAD"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

Hamilton Anxiety Rating Scale medical

"Hamilton Anxiety Rating Scale ("HAM-A") total score"

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.

topline data readout technical

"HLP003 APPROACH Phase 3 topline data readout"

A topline data readout is the initial summary of a clinical trial’s most important results, showing whether the study met its main goals. Like a headline score after a sports game, it gives investors a quick sense of success or failure that can shift a company’s outlook, affect future funding, and move the stock while more detailed analyses and regulatory reviews follow.

FAQ

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

When is HELP's HLP003 Phase 3 data readout expected?

The HLP003 APPROACH Phase 3 topline data readout is on track for Q4 2026. Helus Pharma also said enrollment continues in EMBRACE, the second pivotal study in the HLP003 Phase 3 program.

What will the HELP HLP004 Phase 2 study test?

The study will assess two 30 mg administrations of HLP004 as monotherapy in adults with generalized anxiety disorder. Approximately 144 participants will be randomized 1:1 to 30 mg HLP004 or inactive placebo; the primary endpoint is change in HAM-A total score at Week 6, with Week 12 as the key secondary endpoint.

Why is HELP developing HLP004 as a monotherapy for GAD?

Helus Pharma said it changed HLP004's development strategy from adjunctive therapy to monotherapy based on its assessment of the GAD treatment landscape, including limited availability of new treatment options and limitations associated with currently approved monotherapies.

When does HELP expect to file an NDA for HLP003?

Helus Pharma expects to file a New Drug Application with the FDA in 2028. HLP003 has received FDA Breakthrough Therapy Designation, which makes it eligible for an expedited review pathway.

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

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Available on EDGAR 10/21/2026 - 04:34 PM EDT Accepted by SEC EDGAR 10/21/2026 - 04:33 PM EDT Learn about SEC filing dates

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

For the month of October, 2026.

Commission File Number: 001-40673

Helus Pharma 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 ⊠

INCORPORATION BY REFERENCE

Exhibit 99.1 of this Form 6-K of Helus Pharma Inc. (formerly, "Cybin Inc.") (the "Company") is hereby incorporated by reference into the Registration Statement on Form F-10 (File No. 333-292294) of the Company, as amended or supplemented.

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.

HELUS PHARMA INC.

(Registrant)

Date:

October 21, 2026

By:

/s/ Greg Cavers

Name:

Greg Cavers

Title:

Chief Financial Officer

EXHIBIT INDEX

99.1 News Release dated October 21, 2026

Helus Pharma Highlights Clinical Program Advancements at Investor Presentation Held on October 21, 2026

Topline data readout from APPROACH Phase 3 study of HLP003 in development for the potential adjunctive treatment of major depressive disorder ("MDD") on track for Q4 2026^1,2

HLP004 Program progressing with Phase 2 monotherapy study for the potential treatment of generalized anxiety disorder ("GAD") expected to initiate in Q1 2027^1,,2,3

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 - October 21, 2026 - Helus Pharma Inc. (Nasdaq: HELP) (Cboe CA: HELP) ("Helus Pharma" or the "Company"), a clinical-stage pharmaceutical company committed to improving the treatment landscape in mental health through the development of novel serotonergic agonists ("NSAs"), today provided highlights on the advancement of its lead programs HLP003 and HLP004 as detailed in the investor presentation held by the Company on October 21, 2026 (the "Investor Presentation").

The Company reiterated that HLP003 APPROACH Phase 3 topline data readout is on track for Q4 2026^1,2 and provided an overview of the competitive landscape and commercial opportunity in the adjunctive treatment of MDD. The Company also shared details of the next HLP004 Phase 2 monotherapy study for the potential treatment of GAD, which is expected to initiate in Q1 2027.^1,2,3

"The continued advancement of our two lead candidates represents an important period for Helus Pharma, with several key catalysts anticipated in the near term. We remain focused on achieving our key development milestones and advancing these programs towards regulatory approval and potential commercialization, positioning the Company for its next stage of growth," said Michael Halstead, Chief Executive Officer of Helus Pharma.

The Company previously announced completion of enrollment of 223 participants in its APPROACH Phase 3 pivotal study in July 2026. Enrollment is continuing in EMBRACE, the second pivotal study in the Phase 3 HLP003 program. Eligible participants from APPROACH and EMBRACE may also roll into EXTEND, Helus Pharma's long-term extension study, which is designed to further evaluate safety, durability of clinical effect and the potential role of redosing. 

Adjunctive therapy is a well-established treatment approach for patients who do not achieve an adequate response to first-line anti-depressants. However, available U.S. Food and Drug Administration ("FDA") approved adjunctive treatment options remain limited and are often associated with tolerability and safety challenges that can impact long-term use. The Company believes that HLP003 may offer a differentiated approach that can build upon the benefits of a patient's existing antidepressant regimen with a potentially favorable safety profile.

HLP003 has been granted Breakthrough Therapy Designation by the FDA, which makes HLP003 eligible for an expedited review pathway, with the potential to reduce drug development timelines. Helus Pharma expects to file a New Drug Application with the FDA in 2028. ^1,2

In GAD, FDA-approved treatment options remain limited, and approximately half of patients do not respond to initial therapy.⁴ The Company believes that this significant unmet need supports the evaluation of HLP004 as a potential monotherapy treatment. Accordingly, the Company's upcoming Phase 2 study will assess the efficacy of two 30 mg administrations of HLP004 as monotherapy in adults with GAD.

The study will be a multi-center, randomized, double-blind, placebo-controlled study, evaluating the efficacy and safety of HLP004 versus inactive placebo in adult patients with GAD. The study will enroll adult participants using the Diagnostic and Statistical Manual of Mental Disorders fifth edition primary diagnosis of GAD, who have a minimum Hamilton Anxiety Rating Scale ("HAM-A") total score of ≥ 20 at screening and baseline. Approximately 144 participants will be randomized in a 1:1 ratio to either 30 mg of HLP004 or inactive placebo. The primary endpoint and key secondary endpoint are change from baseline in HAM-A total score at Week 6 and Week 12, respectively. During the presentation, Amir Inamdar, Chief Medical Officer of Helus Pharma, highlighted the key evidence that supported the selection of 30 mg as the optimum dose for further development in a monotherapy GAD study.

In addition to Helus Pharma executives, the Investor Presentation featured distinguished key opinion leaders, who shared perspectives on the current and evolving landscape in depression and anxiety treatment.

Featured key opinion leaders included:

• Rakesh Jain, M.D., MPH, Clinical Professor Department of Psychiatry, at Texas Tech University School of Medicine.

• Martha B. Koo, M.D., FASAM, FCTMSS, LFAPA, Board-certified psychiatrist, addiction specialist, psychoanalyst, and certified psychedelic-assisted therapist.

• Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology at the University of Toronto.

Presentation materials and the webcast of the Investor Presentation are available on the Company's website on the Events & Presentations page.

About Helus Pharma

Helus Pharma is a clinical stage pharmaceutical company committed to improving the treatment landscape in mental health through the development of 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.

Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the potential adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the FDA and HLP004, also a proprietary NSA in Phase 2 for GAD. 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.

Notes

1. There is no assurance that this timeline will be met or that the program will advance clinical trials, at all. Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development and recruitment of patients for participation in clinical trials are dependent on various factors and are based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, eligibility and exclusion criteria for the trial, design of the clinical trial, competition with other companies for clinical sites or patients, perceived risks and benefits of the prescription drug product candidate, the number, availability, location and accessibility of clinical trial sites, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date.

2. There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See "Cautionary Notes and Forward-Looking Statements".

3. The Company had previously disclosed that the HLP004 Program was being developed as an adjunctive therapy for GAD.  This program is now being developed as a monotherapy. The decision to pursue a monotherapy development strategy reflects the Company's assessment of the current GAD treatment landscape, including the limited availability of new treatment options and limitations associated with currently approved monotherapies.

4. Ansara, E. D. (2020). Management of treatment-resistant generalized anxiety disorder. Mental Health Clinician, 10(6), 326-334. https://doi.org/10.9740/ mhc.2020.11.326.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are 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, uncertainties, and other important factors 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", "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 plans to readout topline APPROACH Phase 3 study data in Q4 2026; initiate next Phase 2 HLP004 monotherapy study  in Q1 2027; roll eligible participants from APPROACH and EMBRACE into the EXTEND long-term extension study; the Company's belief that HLP003 may offer a differentiated approach that can build upon the benefits of a patient's existing antidepressant regimen with a favorable safety profile; file a New Drug Application with the FDA in 2028; leverage FDA Breakthrough Therapy Designation towards expedited review and resulting reduced drug development timelines; obtain regulatory review or approval; enroll approximately 144 eligible participants in the Company's next Phase 2 GAD monotherapy study; commercialize the Company's programs following receipt of regulatory approval and the related competitive landscape; the Company's next stage of growth; 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, and the timing of any of the foregoing.

Any forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Forward-looking statements involve known and unknown risks, uncertainties, and other important 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: regulatory requirements and approvals; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics 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. 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 and information 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 any of 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

Paul Glavine

Chief Growth Officer

Helus Pharma

1-866-292-4601 x724

irteam@helus.com - or - media@helus.com

Media Contact:

Victoria Verdeja

RXMD

Public Relations Director

(212) 537-9495

vverdeja@rxmedyn.com

Filing Exhibits & Attachments

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