- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial(1) (,) (2) (,3) , EMBRACE, for potential U.S. FDA New Drug Application in 2028(1,2,3) -
- Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder ("MDD") has surpassed 88% enrollment and is on track for topline data readout in Q4 2026(2,) (3) -
- HLP003 Phase 2 data demonstrated durability at 12 months following two 16mg doses, with 100% response and 71% remission based on a MADRS benchmark of <=10, with remission rising to 100% based on recent peer benchmarks of <=12(4) (,) (5) -
- Reported topline results in Phase 2 signal detection study for HLP004 in Generalized Anxiety Disorder ("GAD") showing 10-point improvement from baseline in HAM-A on top of Standard of Care at 6 weeks -
- The Company intends to complete design of next HLP004 study by the end of Q3 2026(2,) (3) -
- Strengthened scientific and medical leadership with addition of globally recognized experts in clinical development, translational science, and medical affairs -
This news release constitutes a "designated news release" for the purpose of the Company's prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025.
NEW YORK and TORONTO, June 29, 2026 (GLOBE NEWSWIRE) -- Helus Pharma$(TM)$ (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 reported audited financial results for its fiscal year ended March 31, 2026, and recent business highlights. Unless otherwise noted, all dollar amounts are expressed in United States dollars.
"Over the past year, Helus Pharma has strengthened its position as a segment-leading, clinical-stage pharmaceutical company, advancing HLP003 toward a critical Phase 3 readout in Q4 2026 and progressing HLP004 to its next study design by the end of Q3 2026," said Eric So, Interim Chief Executive Officer of Helus Pharma.
"We are pleased to report that our Phase 3 APPROACH study has surpassed 88% enrollment, with recruited participants at approximately the same level of baseline severity as in Phase 2," continued Mr. So. "With topline data anticipated later this year, Helus Pharma is at an inflection point as we move toward commercialization, subject to regulatory approval. Our recently closed $50 million underwritten offering represents a strong vote of confidence in our clinical strategy from top-tier institutional investors and bolsters our balance sheet for execution of our second Phase 3 HLP003 trial, EMBRACE, with potential U.S. FDA New Drug Application in 2028(1) (,) (2) (,3) ."
Previously reported Phase 2 data for HLP003 demonstrated a durable and clinically meaningful treatment effect, including a 23-point reduction in MADRS score from baseline at 12 months after two 16 mg doses administered three weeks apart, with response and remission rates improving to 100% and 71% respectively at 12 months based on a MADRS scale threshold for remission of <=10. Based on recent peer remission criteria of MADRS <=12(1,2) , both response and remission rates were 100% at 12 months. These results reinforce the potential of HLP003 to address a significant unmet need and deliver a transformative treatment for patients with MDD.
Helus Pharma is focused on transforming patient outcomes, with remission, response rate and durability serving as key measures of clinical success. Sustained remission has the potential to improve patient quality of life while potentially reducing the long-term burden on healthcare systems and payers. The Company believes HLP003's positioning as an adjunctive therapy --and, to its knowledge, the only late-stage adjunctive potential treatment in this emerging class -- may better integrate into existing standards of care and support broader adoption in real-world settings.
"As we advance our clinical trials, we continue to expand our roster of globally recognized scientific leaders and network of strategic partnerships to bring these therapies to patients," added Mr. So. "Amid growing clinical need and increasing regulatory support, our late-stage programs are poised to potentially transform the mental health treatment landscape. This is an exciting time at Helus Pharma as we execute toward key clinical, regulatory and strategic milestones."
Recent Business and Pipeline Highlights:
HLP003: Continued to progress enrollment in Phase 3 PARADIGM program.
-- APPROACH has surpassed 88% enrollment, and the study is on track for
topline data readout in Q4 20262,3.
-- Enrollment is underway in EMBRACE, the second pivotal study.
-- Participant rollover is ongoing into the EXTEND study to generate
long-term safety and durability data.
Partnered with TARA Mind to advance veteran access to mental health treatment. Collaboration with leading mental health organizations to support HLP003 Phase 3 recruitment and expand outreach in veteran communities.
HLP004: Reported topline results from Phase 2 signal detection study in patients with GAD.
-- Statistically significant (p<0.0001) within subject, and clinically
meaningful improvement from baseline in Hamilton Anxiety Rating Scale
("HAM-A") of 10 points on top of Standard of Care at 6 weeks
-- In Phase 1 trial, 100% of participants were ready for discharge within 3
hours6; acute effects lasted 90 minutes7
-- Durable effects sustained through at least six months, with the pooled
study population showed 67% responders and 39% of patients were in
remission
-- Generally well-tolerated, adverse events were transient, with no
drug-related serious adverse events recorded
The Company intends to complete the design of the next HLP004 study by the end of Q3 2026(3) .
HLP005: Advancement towards candidate selection
As part of its continued advancement of a pipeline of novel molecules, the Company is progressing the HLP005 program toward candidate selection, with a viable development candidate anticipated in the second half of 2027.
Leadership Update
Eric So, Co-Founder and Executive Chairman, returned to the role of Interim Chief Executive Officer to maintain continuity and operational momentum while the Board's search for a permanent Chief Executive Officer is actively underway.
Strengthened scientific and medical team with the addition of globally recognized leaders in clinical development, translational science, and medical affairs.
-- Appointed Dr. Freda Lewis-Hall, former Pfizer Executive Vice President
and Chief Medical Officer, to senior governance roles as a member of the
Board of Directors and Chair of the Scientific Advisory Board overseeing
research and development programs.
-- Appointed Dr. Ken Kramer, former Vice President and Head of Medical
Neuroscience at Bristol Myers Squibb, as Senior Vice President, Medical
Affairs.
-- Appointed Dr. Susan Learned, a 29-year pharmaceutical R&D executive and
most recently Senior Vice President of Global Medicines Development at
Indivior, as Strategic Research and Development Leader.
-- Named Dr. Robert Langer, co-founder of Moderna, to the Company's
Scientific Advisory Board.
-- Named Dr. Stephen Brannan, former Chief Medical Officer at Karuna
Therapeutics, to Scientific Advisory Board.
-- Retained Dr. Andrew Cutler, Chief Medical Officer of the Neuroscience
Education Institute and principal investigator on over 400 psychiatric
and medical clinical trials, as Senior Advisor.
-- Retained Dr. Michael Thase, Professor of Psychiatry and Chief, Division
of Mood and Anxiety Disorders Treatment and Research Program at the
Perelman School of Medicine University of Pennsylvania, as Senior
Advisor.
Positive regulatory signals and growing acceptance of therapeutic value of psychedelics The White House Executive Order in the spring of 2026 provided for 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 and the Department of Veterans Affairs. Helus Pharma was recognized in a White House press release accompanying the Executive Order.
Fourth Quarter and Fiscal Year 2026 Financial Highlights
-- Cash totaled $157.3 million as of March 31, 2026. On June 25, 2026, the
Company completed a $50 million underwritten offering.
-- Net loss was $47.0 million for the quarter ended March 31, 2026, compared
to a net loss of $21.3 million in the same period last year.
-- Net loss was $148.0 million for the year ended March 31, 2026, compared
to a net loss of $81.6 million in the same period last year.
-- Cash-based operating expenses consisting of research, general, and
administrative costs totaled $42.6 million for the quarter ended March
31, 2026, compared to $21.7 million, in the same period last year.
-- Cash-based operating expenses consisting of research, general, and
administrative costs totaled $131.7 million for the year ended March 31,
2026, compared to $71.8 million, in the same period last year.
-- Cash flows used in operating activities were $37.3 million for the
quarter ended March 31, 2026, compared to $14.7 million in the same
period last year.
-- Cash flows used in operating activities were $133.3 million for the year
ended March 31, 2026, compared to $72.3 million in the same period last
year.
-- Operating cash flow and expenses were higher than the prior year, driven
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