Helus Pharma Publishes SPL026 Clinical Trial Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 17 2026
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Should l Buy HELP?
Helus Pharma announced the publication in Nature Medicine of results from a Phase 2a randomized, placebo-controlled clinical trial evaluating SPL026, in participants with moderate-to-severe major depressive disorder. The study met its primary endpoint demonstrating statistically significant and clinically meaningful reductions in depressive symptoms at two weeks, as measured by the Montgomery-Asberg Depression Rating Scale in participants treated with SPL026 compared with placebo. Reductions in depressive symptoms were observed as early as one week following dosing and were sustained at three months, with effects lasting up to six months in some participants. The treatment was generally well tolerated, with no treatment-related serious adverse events reported.
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Analyst Views on HELP
Wall Street analysts forecast HELP stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.350
Low
22.00
Averages
41.17
High
55.00
Current: 7.350
Low
22.00
Averages
41.17
High
55.00
About HELP
Cybin Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company creates psychedelic-based therapeutics to address the unmet need for treatment options for people who suffer from mental health conditions. Its N, N-dimethyltryptamine (DMT) and dDMT programs create a dataset of systematic research on these psychedelic molecules. The Company is developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder, and CYB004, a proprietary deuterated dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds. CYB003 moves to Phase III and CYB004 moves to Phase II.CYB005 is in Preclinical stage. It has an intellectual property portfolio in the psychedelic drug development sector with over 80 patents granted and over 230 patent applications pending. The Company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Helus Pharma Advances Mental Health Drug Development
- Clinical Trial Progress: Helus Pharma's SPL026 showed significant efficacy in a randomized Phase 2 trial for major depressive disorder, with a mean MADRS score reduction of 7.35 in the 21.5 mg dose group among 34 participants, indicating its potential in the mental health sector.
- New Drug Development: The company is advancing HLP003 through Phase 3 trials, which has received FDA Breakthrough Therapy Designation, with preliminary data showing a 100% response rate and 71% remission rate at 12 months, highlighting its importance in treating major depressive disorder.
- Financial Support: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing strong financial backing for the continued advancement of its multi-asset clinical pipeline, ensuring sustainability for future R&D efforts.
- Market Outlook: As regulatory approvals for mental health drugs draw closer, Helus Pharma and its peers are reshaping the market perception of psychedelic drugs, which is expected to create significant commercial opportunities and enhance market share for the company.
See More
Helus Pharma Advances Psychedelic Drug Clinical Trials
- Clinical Trial Progress: Helus Pharma's SPL026 achieved a mean MADRS difference of -7.35 (p=0.023) in a randomized Phase 2 trial involving 34 participants with major depressive disorder, indicating significant efficacy and potential in the mental health sector.
- Drug Development Strategy: Helus Pharma's HLP003 has received FDA Breakthrough Therapy Designation and is advancing through two pivotal Phase 3 studies, with topline data expected in Q4 2026, showcasing the company's ongoing innovation and competitiveness in depression treatment.
- Financial Support: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement across its multi-asset clinical pipeline, demonstrating a strong financial foundation for R&D efforts.
- Industry Recognition: A consensus statement from the U.S. National Network of Depression Centers indicates that academia is preparing to integrate psychedelics into routine clinical practice, reflecting the growing acceptance of Helus Pharma and its peers in the mental health treatment landscape.
See More
Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
See More
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
See More
Mental Health Treatment Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, indicating a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of experience to enhance the company's clinical development and regulatory strategy in the mental health sector.
- Innovative Drug Prospects: Compass Pathways' COMP360 has shown significant results in clinical trials for treatment-resistant depression, demonstrating efficacy in symptom reduction, which is expected to propel the company's further development in the mental health treatment market.
- Strategic Investment Opportunities: As large pharmaceutical companies seek to refresh their CNS drug pipelines, NSAs are viewed as a high-impact category with expansion potential, attracting investor attention towards clinical milestones and commercialization signals, indicating strong future returns.
See More
Mental Health Drug Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, highlighting a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of industry experience to drive clinical strategy and regulatory engagement in the development of novel serotonergic agonists (NSAs).
- Investment Appeal: As awareness of new serotonin therapies increases, NSAs are viewed as prime targets for acquisition and partnerships by large pharmaceutical companies, capable of supporting multiple indications and creating long-term investment return potential.
- Clear Regulatory Pathways: The Scientific Advisory Committee at Helus Pharma will provide leadership in clinical and regulatory governance, ensuring that patient outcomes and clinical rigor remain central to the company's growth strategy as it advances its drug pipeline.
See More
Helus Pharma Advances Mental Health Drug Development
- Clinical Trial Progress: Helus Pharma's SPL026 showed significant efficacy in a randomized Phase 2 trial for major depressive disorder, with a mean MADRS score reduction of 7.35 in the 21.5 mg dose group among 34 participants, indicating its potential in the mental health sector.
- New Drug Development: The company is advancing HLP003 through Phase 3 trials, which has received FDA Breakthrough Therapy Designation, with preliminary data showing a 100% response rate and 71% remission rate at 12 months, highlighting its importance in treating major depressive disorder.
- Financial Support: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing strong financial backing for the continued advancement of its multi-asset clinical pipeline, ensuring sustainability for future R&D efforts.
- Market Outlook: As regulatory approvals for mental health drugs draw closer, Helus Pharma and its peers are reshaping the market perception of psychedelic drugs, which is expected to create significant commercial opportunities and enhance market share for the company.
See More
Helus Pharma Advances Psychedelic Drug Clinical Trials
- Clinical Trial Progress: Helus Pharma's SPL026 achieved a mean MADRS difference of -7.35 (p=0.023) in a randomized Phase 2 trial involving 34 participants with major depressive disorder, indicating significant efficacy and potential in the mental health sector.
- Drug Development Strategy: Helus Pharma's HLP003 has received FDA Breakthrough Therapy Designation and is advancing through two pivotal Phase 3 studies, with topline data expected in Q4 2026, showcasing the company's ongoing innovation and competitiveness in depression treatment.
- Financial Support: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement across its multi-asset clinical pipeline, demonstrating a strong financial foundation for R&D efforts.
- Industry Recognition: A consensus statement from the U.S. National Network of Depression Centers indicates that academia is preparing to integrate psychedelics into routine clinical practice, reflecting the growing acceptance of Helus Pharma and its peers in the mental health treatment landscape.
See More
Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
See More
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
See More
Mental Health Treatment Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, indicating a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of experience to enhance the company's clinical development and regulatory strategy in the mental health sector.
- Innovative Drug Prospects: Compass Pathways' COMP360 has shown significant results in clinical trials for treatment-resistant depression, demonstrating efficacy in symptom reduction, which is expected to propel the company's further development in the mental health treatment market.
- Strategic Investment Opportunities: As large pharmaceutical companies seek to refresh their CNS drug pipelines, NSAs are viewed as a high-impact category with expansion potential, attracting investor attention towards clinical milestones and commercialization signals, indicating strong future returns.
See More
Mental Health Drug Market Set for Accelerated Growth
- Surging Market Demand: With over 970 million people affected by mental health disorders globally, the mental health therapeutics market is projected to exceed $40 billion in the coming years, highlighting a strong demand for new treatment options, particularly in depression and anxiety.
- Clinical Milestone: Helus Pharma has appointed former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to its Board and as Chair of the Scientific Advisory Committee, leveraging her 40 years of industry experience to drive clinical strategy and regulatory engagement in the development of novel serotonergic agonists (NSAs).
- Investment Appeal: As awareness of new serotonin therapies increases, NSAs are viewed as prime targets for acquisition and partnerships by large pharmaceutical companies, capable of supporting multiple indications and creating long-term investment return potential.
- Clear Regulatory Pathways: The Scientific Advisory Committee at Helus Pharma will provide leadership in clinical and regulatory governance, ensuring that patient outcomes and clinical rigor remain central to the company's growth strategy as it advances its drug pipeline.
See More
