HLP004 and HLP003 Clinical Trial Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 13 2026
0mins
Should l Buy HELP?
The company said, "HLP004 Phase 2 Program in Generalized Anxiety Disorder: Anticipated topline data readout from the Phase 2 study evaluating HLP004 in GAD in Q1 2026. HLP003 Phase 3 Program in Major Depressive Disorder: Continued execution of the APPROACH pivotal Phase 3 study evaluating HLP003 as an adjunctive treatment for MDD with topline data anticipated in Q4 2026. Continued execution of the EMBRACE complementary Phase 3 study, which initiated patient enrollment in the prior quarter, designed to reinforce efficacy findings and support the overall evidence package for HLP003 in MDD. Ongoing patient participation in the EXTEND long-term extension study, supporting the collection of long-term safety and durability data."
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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: 5.150
Low
22.00
Averages
41.17
High
55.00
Current: 5.150
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 Partners with TARA Mind to Advance Veteran Mental Health
- Collaboration Background: Helus Pharma has partnered with TARA Mind to support recruitment for its HLP003 Phase 3 clinical trial while expanding mental health awareness in veteran communities, aligning with President Trump's Executive Order on accelerating medical treatments for serious mental illness.
- Clinical Trial Recruitment: This partnership will leverage TARA Mind's extensive networks to facilitate recruitment for the HLP003 program, addressing the high rates of depression, PTSD, and suicide among veterans, showcasing Helus Pharma's commitment to improving veteran mental health outcomes.
- Innovative Treatment Solutions: HLP003, designated as a Breakthrough Therapy by the FDA, aims to provide new treatment options for patients with Major Depressive Disorder, with Helus Pharma focused on developing novel serotonergic agonists to enhance the mental health treatment landscape and meet unmet needs in the market.
- Social Responsibility: The collaboration between Helus Pharma and TARA Mind extends beyond business strategy, reflecting a commitment to addressing veteran mental health issues and demonstrating the company's dedication to patient-centric innovation and responsible clinical development.
See More
Helus Pharma CEO to Speak at Health Innovation Forum
- Executive Participation: Eric So, Interim CEO of Helus Pharma, will speak at the 29th Annual Milken Institute Global Conference on May 4, 2026, participating in a panel titled 'The Next Wave of Health Innovation,' showcasing the company's leadership in health innovation.
- Event Details: The conference will take place from May 3-6, 2026, at The Beverly Hilton and Waldorf Astoria in Los Angeles, with So's panel scheduled for 2:30 PM PDT on May 4, expected to attract significant attention from industry stakeholders.
- Strategic Focus: Helus Pharma is dedicated to developing novel serotonergic agonists (NSAs) to address the substantial unmet needs of patients suffering from depression and anxiety, and So's participation will further highlight the company's innovative efforts in mental health.
- Clinical Progress and Market Potential: Helus Pharma is currently advancing HLP003 and HLP004 in clinical trials, with the former receiving Breakthrough Therapy Designation from the FDA, while the latter is in Phase 2 development, potentially leading to significant market opportunities and business growth for the company.
See More
Helus Pharma Partners with TARA Mind to Advance Clinical Trial Recruitment
- Collaboration Background: Helus Pharma's partnership with TARA Mind aims to support recruitment for the HLP003 Phase 3 clinical trial while expanding mental health awareness in veteran communities, aligning with President Trump's Executive Order on accelerating medical treatments for serious mental illness.
- Recruitment Support: TARA Mind and VETS will leverage their extensive networks to facilitate veteran engagement, assisting Helus Pharma in recruiting more patients for the Phase 3 trial, thereby enhancing the success rate and market potential of the HLP003 program.
- Mental Health Awareness: This collaboration not only increases veterans' awareness of clinical research opportunities but also helps improve their mental health by providing access to the latest resources, reflecting national priorities on mental health issues.
- Innovative Drug Development: Helus Pharma is committed to developing novel serotonergic agonists, with HLP003 receiving FDA Breakthrough Therapy Designation, which is expected to offer more effective treatment options for depression patients and drive long-term growth in the mental health sector.
See More
FDA Accelerates Development of Psychedelic Treatments for Mental Health
- Regulatory Push: The FDA has announced plans to accelerate the development of psychedelic treatments to address serious mental health issues, particularly post-traumatic stress disorder and treatment-resistant depression, indicating strong support for innovative therapies.
- Presidential Directive: Last week, President Trump signed an executive order directing health agencies to expedite research on psychedelic substances like psilocybin, MDMA, and ibogaine, aiming to swiftly tackle the national mental health crisis, especially for veterans.
- Market Reaction: Following the FDA's new policy, shares of Compass Pathways Plc. (CMPS), Helus Pharma Inc. (HELP), and Enveric Biosciences Inc. (ENVB) rose between 2% and 7% in Friday's opening trade, reflecting investor optimism about the psychedelic drug market's potential.
- Industry Outlook: This FDA initiative not only paves the way for clinical applications of psychedelics but may also encourage more companies to enter this emerging market, thereby driving innovation and growth among related firms.
See More
Helus Pharma Expands Scientific Advisory Board with Industry Leaders
- Advisory Board Expansion: Helus Pharma has appointed renowned leaders in translational science and clinical development, Dr. Robert Langer and Dr. Stephen Brannan, to its Scientific Advisory Board, aiming to enhance its innovation capabilities in mental health through disciplined drug development.
- Clinical Development Strategy: The new advisors will provide expertise for Helus Pharma's novel serotonergic agonists (NSAs), particularly HLP003 for major depressive disorder and HLP004 for generalized anxiety disorder, which are expected to accelerate the clinical advancement of these key programs.
- Industry Influence: Dr. Langer, with over 1,600 scientific papers and 1,500 patents, has co-founded more than 40 biotech companies, and his extensive experience will provide a strong scientific foundation for Helus Pharma to drive breakthroughs in mental health treatments.
- Market Demand Alignment: Dr. Brannan emphasized the significant unmet needs in psychiatric disorders, and Helus Pharma's commitment to scientific rigor and scalable treatment models will help it stand out in a competitive market, addressing urgent patient needs.
See More
Trump Signs Executive Order to Accelerate Psychedelic Research
- Research Acceleration Policy: President Trump's executive order aims to expedite research on psychedelics like psilocybin and MDMA, although it does not alter drug scheduling, reflecting a focus on a medical-first framework that may pave the way for future cannabis rescheduling.
- Positive Market Reaction: Following the signing of the order, psychedelic developers like AtaiBeckley saw stock prices rise approximately 25%, indicating a positive market response to the policy shift and growing investor confidence in the psychedelic sector.
- Safety Concerns: The inclusion of ibogaine in the order raises safety concerns due to its potential cardiac risks, despite its applications being studied for PTSD and addiction, highlighting significant barriers to commercialization.
- Industry Outlook: While the psychedelic industry lacks a commercial market, the rise of clinical-stage developers suggests that the executive order provides crucial support for the legitimacy of psychedelics, potentially fostering broader acceptance of plant-based alternative medicines in the future.
See More
Helus Pharma Partners with TARA Mind to Advance Veteran Mental Health
- Collaboration Background: Helus Pharma has partnered with TARA Mind to support recruitment for its HLP003 Phase 3 clinical trial while expanding mental health awareness in veteran communities, aligning with President Trump's Executive Order on accelerating medical treatments for serious mental illness.
- Clinical Trial Recruitment: This partnership will leverage TARA Mind's extensive networks to facilitate recruitment for the HLP003 program, addressing the high rates of depression, PTSD, and suicide among veterans, showcasing Helus Pharma's commitment to improving veteran mental health outcomes.
- Innovative Treatment Solutions: HLP003, designated as a Breakthrough Therapy by the FDA, aims to provide new treatment options for patients with Major Depressive Disorder, with Helus Pharma focused on developing novel serotonergic agonists to enhance the mental health treatment landscape and meet unmet needs in the market.
- Social Responsibility: The collaboration between Helus Pharma and TARA Mind extends beyond business strategy, reflecting a commitment to addressing veteran mental health issues and demonstrating the company's dedication to patient-centric innovation and responsible clinical development.
See More
Helus Pharma CEO to Speak at Health Innovation Forum
- Executive Participation: Eric So, Interim CEO of Helus Pharma, will speak at the 29th Annual Milken Institute Global Conference on May 4, 2026, participating in a panel titled 'The Next Wave of Health Innovation,' showcasing the company's leadership in health innovation.
- Event Details: The conference will take place from May 3-6, 2026, at The Beverly Hilton and Waldorf Astoria in Los Angeles, with So's panel scheduled for 2:30 PM PDT on May 4, expected to attract significant attention from industry stakeholders.
- Strategic Focus: Helus Pharma is dedicated to developing novel serotonergic agonists (NSAs) to address the substantial unmet needs of patients suffering from depression and anxiety, and So's participation will further highlight the company's innovative efforts in mental health.
- Clinical Progress and Market Potential: Helus Pharma is currently advancing HLP003 and HLP004 in clinical trials, with the former receiving Breakthrough Therapy Designation from the FDA, while the latter is in Phase 2 development, potentially leading to significant market opportunities and business growth for the company.
See More
Helus Pharma Partners with TARA Mind to Advance Clinical Trial Recruitment
- Collaboration Background: Helus Pharma's partnership with TARA Mind aims to support recruitment for the HLP003 Phase 3 clinical trial while expanding mental health awareness in veteran communities, aligning with President Trump's Executive Order on accelerating medical treatments for serious mental illness.
- Recruitment Support: TARA Mind and VETS will leverage their extensive networks to facilitate veteran engagement, assisting Helus Pharma in recruiting more patients for the Phase 3 trial, thereby enhancing the success rate and market potential of the HLP003 program.
- Mental Health Awareness: This collaboration not only increases veterans' awareness of clinical research opportunities but also helps improve their mental health by providing access to the latest resources, reflecting national priorities on mental health issues.
- Innovative Drug Development: Helus Pharma is committed to developing novel serotonergic agonists, with HLP003 receiving FDA Breakthrough Therapy Designation, which is expected to offer more effective treatment options for depression patients and drive long-term growth in the mental health sector.
See More
FDA Accelerates Development of Psychedelic Treatments for Mental Health
- Regulatory Push: The FDA has announced plans to accelerate the development of psychedelic treatments to address serious mental health issues, particularly post-traumatic stress disorder and treatment-resistant depression, indicating strong support for innovative therapies.
- Presidential Directive: Last week, President Trump signed an executive order directing health agencies to expedite research on psychedelic substances like psilocybin, MDMA, and ibogaine, aiming to swiftly tackle the national mental health crisis, especially for veterans.
- Market Reaction: Following the FDA's new policy, shares of Compass Pathways Plc. (CMPS), Helus Pharma Inc. (HELP), and Enveric Biosciences Inc. (ENVB) rose between 2% and 7% in Friday's opening trade, reflecting investor optimism about the psychedelic drug market's potential.
- Industry Outlook: This FDA initiative not only paves the way for clinical applications of psychedelics but may also encourage more companies to enter this emerging market, thereby driving innovation and growth among related firms.
See More
Helus Pharma Expands Scientific Advisory Board with Industry Leaders
- Advisory Board Expansion: Helus Pharma has appointed renowned leaders in translational science and clinical development, Dr. Robert Langer and Dr. Stephen Brannan, to its Scientific Advisory Board, aiming to enhance its innovation capabilities in mental health through disciplined drug development.
- Clinical Development Strategy: The new advisors will provide expertise for Helus Pharma's novel serotonergic agonists (NSAs), particularly HLP003 for major depressive disorder and HLP004 for generalized anxiety disorder, which are expected to accelerate the clinical advancement of these key programs.
- Industry Influence: Dr. Langer, with over 1,600 scientific papers and 1,500 patents, has co-founded more than 40 biotech companies, and his extensive experience will provide a strong scientific foundation for Helus Pharma to drive breakthroughs in mental health treatments.
- Market Demand Alignment: Dr. Brannan emphasized the significant unmet needs in psychiatric disorders, and Helus Pharma's commitment to scientific rigor and scalable treatment models will help it stand out in a competitive market, addressing urgent patient needs.
See More
Trump Signs Executive Order to Accelerate Psychedelic Research
- Research Acceleration Policy: President Trump's executive order aims to expedite research on psychedelics like psilocybin and MDMA, although it does not alter drug scheduling, reflecting a focus on a medical-first framework that may pave the way for future cannabis rescheduling.
- Positive Market Reaction: Following the signing of the order, psychedelic developers like AtaiBeckley saw stock prices rise approximately 25%, indicating a positive market response to the policy shift and growing investor confidence in the psychedelic sector.
- Safety Concerns: The inclusion of ibogaine in the order raises safety concerns due to its potential cardiac risks, despite its applications being studied for PTSD and addiction, highlighting significant barriers to commercialization.
- Industry Outlook: While the psychedelic industry lacks a commercial market, the rise of clinical-stage developers suggests that the executive order provides crucial support for the legitimacy of psychedelics, potentially fostering broader acceptance of plant-based alternative medicines in the future.
See More
