HELP
CybinFDocument history
Earnings documents stored for HELP.
Investor releaseQuarter not tagged2026-08-14Helus Pharma Reports First Quarter Fiscal 2027 Financial Results and Recent Business Highlights
GlobeNewswire
Helus Pharma Reports First Quarter Fiscal 2027 Financial Results and Recent Business Highlights
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline data remain on track for Q4 20261,2 - - Completed Drug-Drug Interaction (“DDI”) study demonstrated a favorable DDI profile supporting HLP003 as a potential adjunctive treatment for MDD - - Continued enrollment in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program - - Continued participant rollover into EXTEND to generate long-term safety and durability data - - Completed USD$50 million underwritten offering in June 2026, strengthening the balance sheet to support continued execution across the Company’s clinical development programs - 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, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (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 recent business highlights and financial results for its fiscal quarter ended June 30, 2026. Unless otherwise noted, all dollar amounts are expressed in United States dollars. “Since joining Helus Pharma, I have been impressed by the quality of the Company’s science, the strength of its development programs, and the team’s disciplined execution,” said Michael Halstead, Chief Executive Officer Helus Pharma. “With enrollment in APPROACH completed and topline data expected in Q4 20261,2, we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients.” “Michael brings the strategic leadership, operational experience and commercial perspective needed to guide Helus Pharma through its next phase of growth,” said Eric So, Co-founder and Executive Chairman. “He has quickly earned…Read full documentShow less
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline data remain on track for Q4 20261,2 - - Completed Drug-Drug Interaction (“DDI”) study demonstrated a favorable DDI profile supporting HLP003 as a potential adjunctive treatment for MDD - - Continued enrollment in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program - - Continued participant rollover into EXTEND to generate long-term safety and durability data - - Completed USD$50 million underwritten offering in June 2026, strengthening the balance sheet to support continued execution across the Company’s clinical development programs - 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, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (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 recent business highlights and financial results for its fiscal quarter ended June 30, 2026. Unless otherwise noted, all dollar amounts are expressed in United States dollars. “Since joining Helus Pharma, I have been impressed by the quality of the Company’s science, the strength of its development programs, and the team’s disciplined execution,” said Michael Halstead, Chief Executive Officer Helus Pharma. “With enrollment in APPROACH completed and topline data expected in Q4 20261,2, we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients.” “Michael brings the strategic leadership, operational experience and commercial perspective needed to guide Helus Pharma through its next phase of growth,” said Eric So, Co-founder and Executive Chairman. “He has quickly earned the team’s confidence and is highly focused on successful execution as we advance HLP003 and HLP004 through important clinical, regulatory and commercial milestones.” Recently, Helus Pharma completed enrollment in APPROACH, its Phase 3 pivotal study evaluating HLP003 in MDD. Previously reported HLP003 Phase 2 data demonstrated a durable and clinically meaningful treatment effect, including an approximately 23-point reduction in MADRS score from baseline at 12 months following two 16 mg doses administered three weeks apart. Using a MADRS remission benchmark of ≤ 10, response and remission rates at 12 months were 100% and 71%, respectively. These results reinforce the potential of HLP003 to address a significant unmet need and provide a differentiated treatment option for patients with MDD. Beyond its clinical development program, Helus Pharma has developed a broad intellectual property portfolio supporting its differentiated and proprietary NSA pipeline, with more than 350 patent applications filed and more than 100 patents granted worldwide. Recent Business and Pipeline Highlights: HLP003: Continued advancement of the Phase 3 PARADIGM program APPROACH has completed enrollment, and the study is on track for topline data readout in Q4 2026.1,2 Completed DDI study results indicating that HLP003 did not meaningfully impact plasma levels of any of the six substrates tested providing evidence of no pharmacokinetic (“PK”) interaction with the CYP450 enzymes examined. These results combined with literature evidence indicate that there is a low likelihood of PK based DDI between HLP003 and Selective Serotonin Reuptake Inhibitors and Serotonin and Norepinephrine Reuptake Inhibitors. Enrollment is underway in EMBRACE, the second pivotal study in Phase 3 PARADIGM. Participant rollover is ongoing into the EXTEND study to further evaluate safety, durability of clinical effect and the potential role of redosing. HLP004: Phase 2 data demonstrated clinically meaningful improvement in patients with generalized anxiety disorder (“GAD”) Statistically significant (p<0.0001) within subject, and clinically meaningful improvement from baseline in Hamilton Anxiety Rating Scale of ~10 points on top of Standard of Care at 6 weeks. In a Phase 1 trial, 100% of participants were ready for discharge within 3 hours3; acute effects lasted ~90 minutes.4 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 2026.1,2 HLP005: Advancement toward development candidate selection As part of its continued advancement of a pipeline of novel molecules, Helus Pharma continues to advance HLP005 toward candidate selection, with a viable development candidate anticipated in the second half of 2027. 1,2 First Quarter Financial Highlights Cash totaled $166.4 million as of June 30, 2026. Net loss was $47.8 million for the quarter ended June 30, 2026, compared to a net loss of $24.6 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled $37.5 million for the quarter ended June 30, 2026, compared to $23.9 million, in the same period last year. Cash flows used in operating activities were $37.1 million for the quarter ended June 30, 2026, compared to $29.5 million in the same period last year. Operating cash flow and expenses were higher than the same period last year, driven by the continued advancement of the APPROACH, EMBRACE, and EXTEND HLP003 Phase 3 trials. About Helus Pharma Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary 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. 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 MDD that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (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. In Phase 1 study at 30 mg dose. 4. Not statistically different from placebo after 90 mins. 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 Phase 3 topline data readout for HLP003 in Q4 2026; completion of HLP004 study design in Q3, 2026; strengthening of balance sheet to support execution of the Company’s clinical development programs; advancement of HLP003 and HLP004 through important clinical, regulatory and commercial milestones; potential of HLP003 to address a significant unmet need and provide a differentiated and transformative treatment option for patients with MDD; progression of HLP005 program toward candidate selection in the second half of 2027; 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 year ended March 31, 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/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 FDA, 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 Beckastr partnersManaging Partner(917) [email protected] Gabriel FahelChief Legal OfficerHelus [email protected] – or – [email protected] Media Contact:Victoria VerdejaRXMDPublic Relations Director(212) [email protected]
Investor releaseQuarter not tagged2026-07-15Is Cybin D/B/A Helus Pharma (HELP) Stock a Psychedelic Medicine Opportunity Ahead of HLP003 Trial Results?
Insider Monkey
Is Cybin D/B/A Helus Pharma (HELP) Stock a Psychedelic Medicine Opportunity Ahead of HLP003 Trial Results?
We recently compiled a list of the 7 Best Psychedelic Stocks to Buy According to Analysts. Cybin D/B/A Helus Pharma (NASDAQ:HELP) is one of the best psychedelic stocks on our list. TheFly reported on July 1 that Canaccord analyst Sumant Kulkarni lowered the price target on HELP to $42 from $45 while maintaining a Buy rating on the shares. The firm highlighted Helus Pharma’s lead candidate, HLP003, a deuterated psilocin analog currently being evaluated in a Phase 3 program for adjunctive treatment of major depressive disorder (MDD). Canaccord expects significant potential upside from upcoming Phase 3 APPROACH trial results for HLP003, which are anticipated in the fourth quarter of 2026. In other news, earlier on June 24, Cybin D/B/A Helus Pharma (NASDAQ:HELP) announced the pricing of an underwritten public offering involving 10,309,280 common shares. The shares were offered for $4.85 each, generating approximately $50 million in gross proceeds for the company. The offering was expected to close on June 25. Cantor and Barclays served as joint bookrunning managers for the transaction, while Bloom Burton Securities and Lucid Capital Markets acted as lead managers. The capital raise is intended to support HELP’s ongoing operations and advancement of its development programs. Cybin D/B/A Helus Pharma (NASDAQ:HELP) is a clinical-stage neuropsychiatry company developing psychedelic-based therapies and novel serotonergic agonists for mental health conditions such as major depressive disorder and generalized anxiety disorder. While we acknowledge the potential of HELP as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-06-29Helus Pharma Reports Recent Business Highlights and Fiscal Year 2026 Financial Results
GlobeNewswire
Helus Pharma Reports Recent Business Highlights and Fiscal Year 2026 Financial Results
- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial1,2,3, EMBRACE, for potential U.S. FDA New Drug Application in 20281,2,3 - - 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 20262,3 - - 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 ≤124,5 - - 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 20262,3 - - 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™ (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 infle…Read full documentShow less
- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial1,2,3, EMBRACE, for potential U.S. FDA New Drug Application in 20281,2,3 - - 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 20262,3 - - 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 ≤124,5 - - 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 20262,3 - - 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™ (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 20281,2,3.” 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 ≤121,2, 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 (pon 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 20263. 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 by the continued advancement of the APPROACH, EMBRACE, and EXTEND HLP003 Phase 3 trials, advancement of HLP004 through Phase 2 trials, and HLP005 program. About Helus Pharma Helus Pharma™, the commercial operating name of Cybin Inc. 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 MDD that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration 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 The Company is currently prioritizing the advancement of its HLP003 Program. 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. 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”. Popova V, Daly EJ, Trivedi M, et al. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study TRANSFORM-2. Am J Psychiatry 2019; 176: 428-438. Definium Therapeutics, “Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder,” press release, June 22, 2026. In Phase 1 study at 30 mg dose. Not statistically different from placebo after 90 mins. 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 Phase 3 readout for HLP003 in Q4 2026; completion of HLP004 study design in Q3, 2026; bolstering of balance sheet to support execution of EMBRACE Phase 3 HLP003 trial; submission of FDA New Drug Application for HLP003 in 2028; potential of HLP003 to address a significant unmet need and deliver a truly transformative treatment for patients with MDD; sustained remission having the potential to improve patient quality of life while potentially reducing the long-term burden on healthcare systems and payers; progression of HLP005 program toward candidate selection in the second half of 2027; the potential of HLP003’s positioning as an adjunctive therapy to better integrate into existing standards of care and support broader adoption in real-world settings; the potential prioritization of FDA review for psychedelic therapies with Breakthrough Therapy designation; 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 year ended March 31, 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/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 FDA, 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 Beckastr partnersManaging Partner(917) [email protected] George TzirasChief Business OfficerHelus [email protected] – or – [email protected] Media Contact:Johnny TokarczykRXMDPublic Relations [email protected] (914) 772-7562
Investor releaseQuarter not tagged2026-03-06Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
TipRanks
Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability p…Read full documentShow less
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals. Michael Cola, CEO, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.” ATAIBECKLEY ALIGNS WITH FDA ON BPL-003 PHASE 3 DESIGN: AtaiBeckley (ATAI) announced on Tuesday results of an End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration regarding the development of BPL‑003, the company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression. Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. The Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension in which participants may receive individualized retreatment with BPL-003, subject to pre-specified eligibility criteria. The core study will enroll approximately 350 participants and will evaluate a single-dose of BPL-003 across three treatment arms – 8 mg, 4 mg, and placebo. This trial is designed to replicate and extend the treatment response observed in the Phase 2b study and to further characterize the dose–response relationship for BPL-003. ReConnection 2 will enroll approximately 300 participants and will evaluate BPL-003 administered on Day 1 and Day 15 across two arms – 8 mg BPL-003 and placebo. This trial is designed to investigate a two-dose induction model of BPL-003 as a potential treatment option to increase magnitude and durability of initial response. The primary endpoint in both pivotal trials will be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 4 of the response in the 8 mg BPL-003 treatment arm compared to placebo. In the OLE, participants may receive 8 mg BPL-003 at 8‑ or 12‑week intervals, subject to certain conditions for re-treatment eligibility, with the goal of maintaining remission and assessing long‑term safety, durability of effects, and treatment patterns. “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program,” said Srinivas Rao, CEO. “This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.” CLEARMIND GETS DSMB RECOMMENDATION FOR TRIAL CONTINUATION: Clearmind Medicine (CMND) announced Wednesday that its independent Data and Safety Monitoring Board has completed the second scheduled interim review of the company’s ongoing FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary, non-hallucinogenic neuroplastogen, in the treatment of Alcohol Use Disorder. Based on the additional top-line data from the second cohort, which demonstrated a favorable safety profile, the DSMB recommended that the clinical trial continue. The results of the second cohort, in which twice the dose was administered compared to a single dose in the first cohort, reinforce no serious adverse events and overall good tolerability, consistent with the results reported from the first cohort. The results support the rapid progression enabled by the DSMB’s unanimous approval to advance for the third cohort, for which the dose is 80 mg per administration, which is double the dose administered in the second cohort. GH RESEARCH REPORTS Q4 EARNINGS: GH Research (GHRS) reported FY25 loss per share of (79c) on Thursday, which compared to analyst estimates of a loss per share of (82c). Cash, cash equivalents and marketable securities were $280.7M as of December 31. In 2025, the company completed its Phase 2b trial of GH001 in treatment-resistant depression and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology Congress in Amsterdam. GH Research is now actively seeking FDA alignment on the design of its global Phase 3 pivotal program, which is intended to replicate the Phase 2b study. The Phase 2b trial met its primary endpoint with a placebo-adjusted MADRS reduction of -15.5 points at Day 8. In the double-blind portion, 57.5% of patients on GH001 achieved remission at Day 8 versus 0% on placebo. The open-label extension confirmed durable efficacy, with a 73% remission rate at six months achieved with infrequent retreatment visits and no mandated psychotherapy. The median duration of psychoactive experience was ~11 minutes, with 99% of patients deemed discharge-ready within one hour of dosing. Safety was favorable, with no treatment-related serious adverse events and no treatment emergent suicidal intent or behavior. “Our Phase 2b results reinforce our conviction that GH001 has the potential to be a practice-changing therapy for patients with TRD,” said Dr. Velichka Valcheva, CEO. “We look forward to aligning with the FDA on our global Phase 3 program, replicating phase 2b design, and advancing this innovative program with initiation targeted for 2026.” PHARMALA SIGNS SUPPLY, DATA AGREEMENT WITH NAUTILUS SANCTUARY: PharmAla Biotech Holdings (MDXXF) announced Tuesday that it has executed a supply and data agreement with Nautilus Sanctuary of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States. Under the agreement, PharmAla will supply its LaNeo MDMA to Nautilus Sanctuary for use in an open-label clinical trial entitled “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”. In consideration for the supply of LaNeo MDMA, Nautilus Sanctuary will grant PharmAla a perpetual, non-exclusive license to the clinical trial data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally. “This agreement represents a continuation of our innovative supply-for-data model, which we believe creates significant value for both parties,” said Nicholas Kadysh, CEO. “Frontline healthcare workers and first responders bear an enormous mental health burden, and we are proud to support Nautilus Sanctuary in their efforts to bring MDMA-assisted therapy to these critical populations. The clinical data generated in the United States under this agreement will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo MDMA.” PSYENCE BIOMED REPORTS PSILOCYBIN EXPORT: Psyence Biomedical (PBM) announced Tuesday the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia. The product was manufactured at the Psyence Labs GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia, a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context. The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth/ Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. “This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, CEO. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.” PRICE TARGET RAISES: Maxim raised the firm’s price target on Definium Therapeutics (DFTX) to $40 from $18 and kept a Buy rating on the shares after its Q4 results. The company’s cash on the balance sheet should provide sufficient funding into 2028, through a busy 2026 with three Phase 3 pivotal readouts for DT120, the analyst said. As the readout in major depressive disorder approaches, the firm is factoring in revenues for MDD in 2029, Maxim added. H.C. Wainwright raised the firm’s price target on Bright Minds (DRUG) to $145 from $115 and kept a Buy rating on the shares. The firm says the BREAKTHROUGH Phase 2 data “de-risks” BMB-101 and establishes 5-HT2C agonist as potentially best-in-class. H.C. Wainwright increased its probability of success for the absence epilepsy program to 60% from 25%, reflecting what it believes is a “significant efficacy signal and validation from the trial.” H.C. Wainwright also raised the firm’s price target on NRx Pharmaceuticals (NRXP) to $45 from $40 and kept a Buy rating on the shares. The firm said the Type C FDA meeting “provides a clear” application pathway for NRX-100. This is “supported by real-world evidence and a broader proposed indication, significantly de-risking the program,” the analyst said. H.C. Wainwright expanded the addressable population for NRX-100 and increased its risk-adjusted NRX-100 valuation to $15 per share from $10. OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on HELP: Disclaimer & DisclosureReport an Issue Cybin’s Helus Pharma Posts Strong Phase 2 Data for HLP004 in Hard-to-Treat Anxiety Helus Pharma announces results in Phase 2 signal detection study of HLP004 Cybin Corrects Exhibit References in Form 6-K to Align With Active F-10 Shelf Psychedelic: AtaiBeckley reports EMP-01 met primary objective in Phase 2a trial Helus Pharma Names Former Pfizer CMO Freda Lewis-Hall to Board and Scientific Advisory Role
Investor releaseQuarter not tagged2026-03-05Helus Pharma Announces Topline Results in Phase 2 Signal Detection Study for HLP004 in Patients with Generalized Anxiety Disorder
GlobeNewswire
Helus Pharma Announces Topline Results in Phase 2 Signal Detection Study for HLP004 in Patients with Generalized Anxiety Disorder
Statistically significant (p<0.0001) and clinically meaningful improvement in Hamilton Anxiety Rating Scale (“HAM-A”) of ~10 points on top of Standard of Care (“SoC”) at 6 weeks Durable effects sustained through at least 6 months In Phase 1 trial most participants were ready for discharge within 3 hours1; Acute effects lasted ~90 minutes Generally well-tolerated, adverse events were transient, with no drug related serious adverse events recorded At six months, the pooled study population showed 67% responders and 39% of patients were in remission (see Figure 1 below) Figure 1 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, March 05, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP; Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) for serious mental health conditions, today announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (“GAD”) who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. GAD affects more than 20 million adults in the United States, and approximately half of patients treated for GAD fail to respond to initial first-line therapy.2,3 No adjunctive pharmacologic treatment for GAD has ever been approved. No new monotherapy has been approved in almost two decades. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Key findings include: Clinically meaningful efficacy: P…Read full documentShow less
Statistically significant (p<0.0001) and clinically meaningful improvement in Hamilton Anxiety Rating Scale (“HAM-A”) of ~10 points on top of Standard of Care (“SoC”) at 6 weeks Durable effects sustained through at least 6 months In Phase 1 trial most participants were ready for discharge within 3 hours1; Acute effects lasted ~90 minutes Generally well-tolerated, adverse events were transient, with no drug related serious adverse events recorded At six months, the pooled study population showed 67% responders and 39% of patients were in remission (see Figure 1 below) Figure 1 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, March 05, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP; Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) for serious mental health conditions, today announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (“GAD”) who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. GAD affects more than 20 million adults in the United States, and approximately half of patients treated for GAD fail to respond to initial first-line therapy.2,3 No adjunctive pharmacologic treatment for GAD has ever been approved. No new monotherapy has been approved in almost two decades. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Key findings include: Clinically meaningful efficacy: Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points (p<0.0001) in the HAM-A from baseline at six weeks. Efficacy in difficult to treat population: Study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. Durable remission and robust response over time: At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. Commercially scalable clinic time: Short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours1, fitting within the treatment paradigm of existing interventional psychiatry clinics. Well tolerated: Favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals. “These Phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience for this patient population with limited options,” noted Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma. Michael Cola, Chief Executive Officer of Helus Pharma, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.” For additional information, please access our webcast, which is available on the Company's investor relations website on the Events and Presentations page. About HLP004 HLP004 is an investigational intramuscular deuterated serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. The program is being developed as a potential adjunctive treatment for patients with generalized anxiety disorder who remain symptomatic despite existing pharmacologic therapies. 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. Notes 1. In Phase 1 study at 30 mg dose. 2. Ringeisen H, et al. Mental and Substance Use Disorders Prevalence Study: Findings Report. RTI International; 2023. 3. Fagan H, et al. Pharmacological Treatment of Generalized Anxiety Disorder: Current Practice and Future Directions. Expert Review of Neurotherapeutics. 2023. Figure 1 Notes: 1) Gueorguieva, et.al. Lancet Psychiatry, 2017. 4(3):230-237. 2) Rutherford, et al. Depress Anxiety, 2015. 32(12):944-57. 3) Berwian, I.M., et al. Psychol Med, 2017. 47(3):426-437. 4) Jones, B.D.M., et al.JAMA Network Open, 2021. 4(9):e2125531-e2125531. 5) Davidson, et al. Eur Neuropsychopharmacol, 2008. 18(9):p. 673-81. 6) Quitkin, et al. Arch GenPsychiatry, 1984. 41:p. 782-786. 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 expectations of progressing the HLP004 program toward development; the potential of HLP004 as a scalable treatment option for patients living with GAD; 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. 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: Josh Barer astr partners Managing Director (908) 578-6478 [email protected] George Tziras Chief Business Officer Helus Pharma 1-866-292-4601 [email protected] – or – [email protected] Media Contact: Johnny Tokarczyk RXMD Public Relations Director [email protected] (914) 772-7562 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/728bf286-24d0-40b0-a151-beaced3735d7.
Investor releaseQuarter not tagged2026-02-13HELUS Pharma Reports Third Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights
GlobeNewswire
HELUS Pharma Reports Third Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights
- Cash position of US$195 million as of December 31, 2025, before adjustment for post quarter events - - Topline data readout from the Phase 2 study evaluating HLP004 in generalized anxiety disorder (“GAD”) expected in Q1 2026 - This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. BOSTON and TORONTO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- HELUS PharmaTM (Nasdaq: HELP) (Cboe CA: HELP), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today reported unaudited financial results for its third quarter ended December 31, 2025, and recent business highlights. “The third quarter reflects continued disciplined execution across Helus Pharma’s clinical and operational priorities,” said Michael Cola, Chief Executive Officer of Helus Pharma. “We are advancing a differentiated, multi-asset neuroscience portfolio with programs spanning multiple stages of development and indications. With a strong balance sheet, continued progress across our HLP003 Phase 3 and HLP004 Phase 2 programs, and a focus on scalable, repeatable clinical architectures, Helus Pharma is well positioned as we move toward upcoming clinical catalysts and long-term value creation.” Recent Business and Pipeline Highlights: Leadership transition completed with the appointment of Michael Cola as Chief Executive Officer to lead the Company’s transition to a potential first commercial product launch. Continued advancement of HLP003, the Company’s lead proprietary NSA, through its Phase 3 clinical development program for the adjunctive treatment of major depressive disorder (“MDD”), including ongoing activities across both the APPROACH™ and EMBRACE™ pivotal studies and the EXTEND long-term extension study. Continued progress in the HLP004 Phase 2 program for GAD, with study activities supporting an upcoming topline data readout in Q1 2026.¹ Executed the rebranding to “Helus Pharma”. Reframed the Company’s focus on engineered serotonergic agonists designed for controlled pharmacokinetics and potential future commercial scalability, which management of the Company believes more appropriately reflects the Company's transition from a clinical stage entity to a potent…Read full documentShow less
- Cash position of US$195 million as of December 31, 2025, before adjustment for post quarter events - - Topline data readout from the Phase 2 study evaluating HLP004 in generalized anxiety disorder (“GAD”) expected in Q1 2026 - This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. BOSTON and TORONTO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- HELUS PharmaTM (Nasdaq: HELP) (Cboe CA: HELP), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today reported unaudited financial results for its third quarter ended December 31, 2025, and recent business highlights. “The third quarter reflects continued disciplined execution across Helus Pharma’s clinical and operational priorities,” said Michael Cola, Chief Executive Officer of Helus Pharma. “We are advancing a differentiated, multi-asset neuroscience portfolio with programs spanning multiple stages of development and indications. With a strong balance sheet, continued progress across our HLP003 Phase 3 and HLP004 Phase 2 programs, and a focus on scalable, repeatable clinical architectures, Helus Pharma is well positioned as we move toward upcoming clinical catalysts and long-term value creation.” Recent Business and Pipeline Highlights: Leadership transition completed with the appointment of Michael Cola as Chief Executive Officer to lead the Company’s transition to a potential first commercial product launch. Continued advancement of HLP003, the Company’s lead proprietary NSA, through its Phase 3 clinical development program for the adjunctive treatment of major depressive disorder (“MDD”), including ongoing activities across both the APPROACH™ and EMBRACE™ pivotal studies and the EXTEND long-term extension study. Continued progress in the HLP004 Phase 2 program for GAD, with study activities supporting an upcoming topline data readout in Q1 2026.¹ Executed the rebranding to “Helus Pharma”. Reframed the Company’s focus on engineered serotonergic agonists designed for controlled pharmacokinetics and potential future commercial scalability, which management of the Company believes more appropriately reflects the Company's transition from a clinical stage entity to a potential commercial stage pharmaceutical company. Continued expansion and defense of the Company’s intellectual property portfolio supporting multiple programs and indications and providing protection around lead programs HLP003 and HLP004 until at least 2041, reinforcing long-term differentiation, strategic flexibility and potential blocking position within the field. Upcoming Milestones and Catalysts¹ 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. Third-Quarter Financial Highlights Cash totaled US$195.1 million as of December 31, 2025, before any adjustments for post quarter events. Net loss was US$42.7 million for the quarter ended December 31, 2025, compared to a net loss of US$7.5 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled US$36.7 million for the quarter ended December 31, 2025, compared to US$20 million, in the same period last year. Cash flows used in operating activities were US$31.9 million for the quarter ended December 31, 2025, compared to US$18.6 million in the same period last year. About Helus Pharma Helus PharmaTM, 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: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to potentially 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. Note: 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 continued execution of the APPROACH and EMBRACE pivotal Phase 3 studies evaluating HLP003 as an adjunctive treatment for MDD with topline data anticipated in Q4 2026; the Company’s ongoing patient participation in the EXTEND long-term extension study, supporting the collection of long-term safety and durability data; the Company’s anticipated topline data readout from the Phase 2 study evaluating HLP004 in GAD in Q1 2026; the ability of the Company’s NSAs to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions; the Company’s ability to transition to a potential commercial stage pharmaceutical company; the Company’s ability establish an intellectual property blocking position around lead programs HLP003 and HLP004; 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. 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: Josh Barer astr partners Managing Director (908) 578-6478 [email protected] George Tziras Chief Business Officer Helus Pharma 1-866-292-4601 [email protected] – or – [email protected] Media Contact: Johnny Tokarczyk RXMD Public Relations Director (914) 772-7562 [email protected]
TranscriptFY2026 Q22025-11-13FY2026 Q2 earnings call transcript
Earnings source - 40 paragraphs
FY2026 Q2 earnings call transcript
Good morning, and thank you for joining us. This is an important quarter for Cybin, one that sets the stage for an active year of milestones. In September, Doug Drysdale stepped down as Chief Executive Officer. On behalf of the Board and the company, I want to thank Doug for his contributions. As Co-Founder and Executive Chair, I stepped in as Interim CEO while maintaining continuity and momentum. The Board's search for a permanent CEO is underway. Through this transition, our priorities remain the same: patient-focused rigorous science, disciplined education as our execution and clear communication. We have tightened operational cadence and disclosure discipline, and we'll be adding targeted talent and scientific advisory board expertise to support late-stage execution and launch readiness. Our strategy starts where care happens in the clinic. What I mean by this is that we are designing therapy days that fit within existing schedules with short predictable sessions and a staff-light workflow that clinic teams can run without new infrastructure. From there, we focus -- our focus turns to maintaining wellness. Durability is built into the plan with an efficient retreatment approach that aims to reduce visit burden compared with today's multi-visit standards, so clinics can scale capacity and patients can plan their lives. Progress with regulators follows the same discipline. We move step by step anchored in data rather than speculation, and we'll communicate milestones as they are achieved. The capital plan matches that pace. Following our recent $175 million financing, we are focusing on advancing our programs towards major data readouts. With that context, let me turn to the quarter and the progress we've made. Before we proceed to the agenda, a brief overview of our pipeline. For those of you who are new to the Cybin story, we have 2 lead programs. CYB003, our proprietary deuterated psilocin analog is in Phase III studies for potential adjunctive treatment of major depressive disorder. And CYB004, our deuterated dimethyltryptamine or DMT program for the potential treatment of generalized anxiety disorder is in Phase II. Clinically, our Phase III CYB003 program, which is an a breakthrough therapy designation in major depressive disorder has continued to progress, including being granted additional clearances to commence EMBRACE, our second Phase III study in new geographies. In generalized anxiety disorder, the Phase II 004 study completed enrollment and remains on track for our first calendar quarter 2026 top line readout. Amir will share more details about both programs shortly. At the same time, we advanced preparations for scale, including manufacturing and commercial groundwork aligned to a practical clinic workflow. We also strengthened our capital position with the closing of a significant registered direct offering, which provides flexibility to execute through upcoming milestones with clear internal decision dates by program. Across both programs, we are deploying capital with discipline. We are prioritizing global site activation and conduct for EMBRACE and APPROACH, database lock and analysis for CYB004 and manufacturing readiness for CYB003. With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Inamdar, to review our clinical and regulatory process. He'll begin with CYB003 in major depressive disorder, focusing on that study status, global footprint and how the design supports real-world clinic operations and durable outcomes. Dr. Inamdar will then review CYB004 in generalized anxiety disorder, including trial design, operational status following enrollment completion and the timing and scope of the next data update.
Thank you, Eric. Our Phase III PARADIGME program is moving forward as planned. Dosing is underway in approach across U.S. sites and participants have rolled over into extend to generate durability data once the double-blind period concludes. In parallel, EMBRACE has been cleared to commence in the United States, U.K., multiple countries in the European Union and Australia, giving us a truly global footprint. The study targets approximately 330 participants across about 60 clinical sites and is structured with 3 arms to evaluate 2 active doses against placebo in patients with depression whose symptoms remain inadequately controlled on background therapy. The primary endpoint is the change from baseline in MADRS total score at 6 weeks after the first dose. The design is built for clinical reality. CYB003 is intended to run as a predictable staff-light session that fits within existing clinic infrastructure. Prior clinical data showed sustained response and remission at 12 months after 2 16-milligram doses, and our extension work is aimed at translating that durability into an efficient retreatment approach that reduces visit burden compared with today's multi-visit standards. On the regulatory front, our posture remains conservative and specific. Near-term touch points focus on clean study conduct, global site activation and data quality reviews as we advance towards pivotal readouts. In anxiety, the work is tracking on schedule. We have completed enrollment in the randomized double-blind Phase II study of CYB004 and remain on track for top line data in the first calendar quarter of 2026. The study evaluates 2 intramuscular doses given 3 weeks apart with efficacy assessed at 6 and 12 weeks and optional follow-up out to 12 months. The design permits concomitant antidepressants or anxiolytics and allows comorbid depression, which helps the results reflect real clinical populations. Just as important, intramuscular administration supports short, predictable sessions that fit a standard clinic day, so sites can manage throughput with existing rooms and personnel. The protocol also captures information to guide an efficient treatment -- retreatment approach if patients need it. aligning durability with practical clinic operations. I will now turn the call back to Eric to discuss the platform and commercial readiness.
Thank you, Amir. Our focus is to make these therapies workable in the real world, not just on paper. Achieving that goal begins with dependable supply. With Thermo Fisher in place for both drug substance and capsule drug product in the United States, we have a manufacturing footprint size for Phase III and commercialization, which gives sites the predictability to plan therapy days within their existing 4 walls. From there, we extend into the clinic. Through our partnership with Osmind, we have access to a broad network of psychiatric practices, point-of-care software and real-world data, so clinics can map out our protocols onto the schedules they already run. Staggered starts, defined observation windows and clear rule definitions are intended to support predictable session scheduling within existing rooms and teams without requiring new infrastructure. Throughput only matters if the session itself is practical. CYB003 is designed to live inside a standard interventional psychiatry day, offering predictable timing for patients and staff. CYB004 delivered intramuscularly targets a briefing clinic experience that simplifies room turnover and staffing compared with all-day alternatives. The combination is intentional, one program suited to establish clinic rhythms, another built for speed and simplicity, both aiming to raise capacity without raising complexity. Durability is the other half of practicality. Phase II CYB003 data showed sustained response and remission at 12 months after just 2 doses. And our extension work is there to translate that durability into an efficient retreatment approach. The goal is fewer visits and more efficient planning for clinics and payers alike with clear criteria for when patients should return, how long a session should take and how that fits across a full clinic day. We're advancing this platform with a conservative regulatory posture and a disciplined capital plan. Underpinning it all is steady leadership. We manage the CEO transition in an orderly way. The permanent CEO search is active and our governance cadence and disclosure discipline keep the organization aligned as we execute towards the next 2 major data events. Before I turn the call over to Greg Cavers, our CFO, let me touch on our capital structure. Last month, we closed a registered direct offering with participation from prominent institutional health care investors. The structure paired common shares with prefunded warrants with a partial warrant, aligning capital to near-term objectives and giving us the flexibility to execute. As noted earlier, this was an important step for Cybin. The financing provides the resource to advance our ongoing Phase II and Phase III trials towards key data readouts. We have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to High Trail. For the avoidance of any doubt, this debt has been fully retired in full. We believe that participation from such high-quality institutions in the financing reflects confidence in our science, our programs and our ability to deliver. I'd like to take this opportunity to thank our new investors as well as existing shareholders and investors for their continued support of our mission. We could not be happier with the partners that came into this financing and all prior financings that drive our programs forward. Capital deployment is paced to measurable milestones. For CYB003, funds support global Phase III execution and manufacturing readiness, so sites have reliable supply and predictable therapy days. For CYB004, resources moved to database lock, protocol-specified analysis and operational lift to top line. Corporate use remains limited and targeted. The plan bridges us to the next 2 major data events while preserving flexibility. From the path, we will adjust with discipline and continue to communicate clearly about our progress and next steps. I will now hand it off to Greg Cavers, our CFO, to walk through our second quarter financial results.
Thank you, Eric. During the quarter, cash-based operating expenses consisting of research, general and administrative costs totaled $28.5 million for the quarter ended September 30, 2025, compared to $18.2 million in the same period last year. Net loss was $33.7 million for the quarter ended September 30, 2025, compared to a net loss of $41.9 million in the same period last year. Cash flows used in operating activities were $34.5 million for the quarter ended September 30, 2025, again, compared to $19.1 million in the same period last year. Operating loss was $28.9 million and net loss for the quarter was $33.7 million or $1.39 per basic and diluted share based on a weighted average share count of 24.2 million shares. We ended the quarter with cash, cash equivalents and investments of $83.8 million. Subsequent to quarter end, we closed a financing of $175 million, which together with our quarter end balance provides flexibility to execute our plan. We continue to allocate capital to measurable milestones and corporate uses remain limited and targeted. Based on our current operating plan, we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027. I will now hand it back over to Eric for closing remarks.
Thank you, Greg. In the quarters ahead, our focus is execution against measurable milestones across the business. For CYB003, we will continue dosing and approach and expand EMBRACE site activation across clear geographies, keeping study conduct and data quality at the center of the plan as we progress towards a Phase III top line in Q4 of 2026. For CYB004, the path runs through database lock protocol-specified analysis and preparation of a clear top line package in the first quarter of 2026. In parallel, we will advance commercial and manufacturing readiness, so sites have reliable supply and a practical clinic day model as data matures, and we will continue to pace investment to milestones. This forward plan also includes leadership. The CEO search is active and progressing, and we'll provide an update when there is news. Day-to-day execution remains stable under the current structure with operating cadence and disclosure discipline intact. Taken together, clinical progress, measured capital deployment, commercial preparation and leadership continuity position the company to navigate the next 2 data events and the steps that follow. To summarize, we have executed through a leadership transition, advanced our late-stage programs, strengthened the balance sheet and prepared for scale with a model built for clinical reality. The work ahead is clear: deliver clean data on time, maintain a conservative and specific regulatory posture and keep capital focused on milestones that move the programs forward. I want to thank all of our employees, investigators, investors, partners and most importantly, the patients and families who make this progress possible. We look forward to updating you as we meet our milestones. Operator, please open the phone line for questions.[ id="-1" name="Operator" /> [Operator Instructions] And we'll take our first question from Pete Stavropoulos with Cantor Fitzgerald.
This is Sarah on for Pete. Two questions from us. One on the CYB004 and the other one on the 003 program. First off, around 004 and GAD, you completed enrollment in early September. Congratulations on that. And you have a readout on 1Q '26, where you enrolled a total of 36 patients. What would you like to see from this study that would give you confidence to move forward into P3s? Is it statistical significance on the primary endpoint? Is it directional data suggesting improvement sufficient? And then what can we expect to see in 1Q? Are you going to provide the 6-week data for the primary endpoint, HAM-A? Or will you provide efficacy data through 12 weeks?
I can take that one. Thank you, Sarah, for the question. And yes, we've completed enrollment in that study. As you probably know, it's a study with 2 arms, 1 low dose arm, which potentially is sub-psychedelic and a full threshold dose. We look at that as a sort of dose response type of study. We would love to see some separation between the 2. As you state there, directional data is what we are looking for, a trend in change or trend in separation between the 2 and also within subject differences in change from baseline, at least with the threshold dose. This is a proof-of-concept study, not necessarily designed as a fully powered study. But if we see a statistically significant difference, we'll be thrilled. But as you say, directional data, trend in improvement and a dose response between the 2 arms is what we are looking for. And we'll share this in first quarter. We will aim to share HAM-A data out through 12 [Technical Difficulty].
Awesome. And then one more question from me. The P2 CYB003 data suggests that 2 doses may keep patients in remission for up to a year commercially. And then taking into account the psychologic experience associated with psilocin, what do you see as the minimum durability threshold needed to compete with SPRAVATO? And how are you thinking about the trade-off between durability versus time spent in clinics from both a payer perspective reimbursement? [ id="-1" name="Operator" /> One moment please while we reconnect Dr. Amir.
Can you hear me now? Sorry, I'm back. [ id="-1" name="Operator" /> Yes, sir, loud and clear.
Apologies for that. Can you repeat the question?
The P2 CYB003 data suggests that 2 doses may keep patients in remission for up to a year commercially and taking into account the psychedelic experience associated with psilocin, like what do you see as the minimum durability threshold needed to compete with SPRAVATO?
Yes. I mean when you look at the guidance that the agency provides for evaluation of these therapies, they want data up to 12 weeks, which is 3 months. We will be thrilled to see effects that are maintained out to 3 months. We are hoping for better. As you know, with our Phase II data, we showed durability out to a year. But based on what is the expectation of the agency, 12 weeks at a minimum would be great. [ id="-1" name="Operator" /> Our next question will come from Patrick Trucchio with H.C. Wainwright.
Congrats on all the progress. I just wanted to get a clarification on the CYB004 program, just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful HAM-A improvement? And then separately, I'm just wondering for CYB003, what operational milestones remain to complete enrollment in APPROACH and our site activations tracking to plan?
[Technical Difficulty] As I stated earlier, it's not a formally powered study. We would, however, be looking at an improvement from baseline within subject within the arms. A clinically meaningful effect would be somewhere around 4 to 5 points on the HAM-A. A trend to difference between the 2 arms would be important as well because we want to look at some dose response between the 2 arms. [Technical Difficulty] study in the sense that it's not a pivotal study, those statistical significance would be amazing. You had a question on CYB003 as well. CYB003 is tracking as to plan. So we remain on target to complete enrollment by mid of next year and deliver top line data by the end of next year.
Great. And if I could, just a separate question on -- as these programs are advancing into later stage and are in late-stage development, I'm just wondering what has been your engagement with payers at this stage and CYB003 and CYB004 and as well with the product profile that's emerging for both of these compounds, how you would expect positioning of them in the market relative to what's already available in TRD with SPRAVATO, given that this is with CYB003, we're looking at MDD, CYB004 GAD. But I'm just wondering how you're thinking about this early payer engagement and as well the product profile positioning against both compounds available, but also those that are in development.
Thanks for that, Patrick. I'll take this one. So I mean, as you might imagine, at this stage, it's a little bit early, but payer engagement, of course, has begun. Commenting further, I guess, on how that develops and how ultimately with SPRAVATO, you could compare to the commercial... [ id="-1" name="Operator" /> All right. One moment. It looks like he has disconnected. If anybody else wants to take this question, while we reconnect him.
So while George is dialing back in, so we have been doing some preliminary market research. But as George reiterated, it is a bit early for -- at least for CYB004. And both the programs, we see them fitting into what is emerging now as an interventional psychiatry paradigm, which really has been spearheaded with SPRAVATO, creating the infrastructure out there. We see these as intermittent treatments that will fit right into that model where patients come in for treatment on an intermittent basis, have the treatment in the clinic and then return for their additional dosing as and when necessary. The infrastructure is there. And we believe with the GAD for CYB004 and with adjunctive and inadequate responder for CYB003, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice. [ id="-1" name="Operator" /> And George has reconnected. We'll go to the next question from Jim Molloy with Alliance Global Partners.
This is Laura Suriel on for Jim Molly. So for the ongoing APPROACH trial, you mentioned how you're planning to have a total of 45 clinical trial sites within the U.S. So you may just provide a bit more detail on the criteria behind choosing these sites and the activation process involved and also as well as when you might think you have all 45 of these sites fully activated and onboard for the study?
Yes. So I can take that. So we are using a mixture of sites that are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials. We also have a mixture of sites that are experienced in conducting trials with psychedelics. And then there are other sites that we have included that are experienced in CNS trials in general, but not necessarily psychedelics. As you can imagine, with the number of clinical trials ongoing right now in psychedelics, there is, of course, competition for resources at sites, and we've been very careful in selecting sites that one either have a proven track record of delivering high-quality data or have the -- if they are not experienced in psychedelics, they have the necessary experience and expertise in the psychiatry space in general in other trials, and we are confident that they will deliver good quality data. You referred to the number of sites. Yes, we've got 45 sites selected for this study. Virtually all of them are onboarded by now. What's important is with the number of sites that we have activated, we still remain on track to deliver or complete enrollment by mid of next year with top line data by the end of the year.
Great. And then also, I know the current focus right now is on the CYB003 and the 004 programs. But can you just provide a bit more color on the preclinical 005 program, maybe just on the status of the preclinical studies and any potential partnership opportunities that you may be in discussions with?
Yes. For CYB005, we are doing a number of preclinical profiling studies to characterize the receptor profile, the brain penetration as well as the primary and secondary pharmacodynamics with a range of compounds in that class, which we believe would be well suited to -- actually with some of the neuropsychiatric conditions where there is significant unmet need. So that work is ongoing. And when there is information to share with the market, we will do so. [ id="-1" name="Operator" /> Our next question will come from Eddie Hickman with Guggenheim.
Congrats on all the progress. Just 2 for me. How much visibility do you have into the blinded baseline patient characteristic data from the APPROACH study? And can you talk at all about how this patient population will differ from a TRD population as it relates to baseline? And secondly, what agreement do you have with the FDA related to the safety database for 003 and what you'll need to provide a regulatory filing? Is there a minimum number of retreatments per year needed in extend?
I missed the second one. Can you repeat the second question? [ id="-1" name="Operator" /> Dr. Amir, you're cutting in and out. connect Dr. Amir...
Can you hear me now?
Yes, I can hear you.
Sorry, do you mind Eddie repeating that question?
Yes. So I was asking the first question is how much visibility do you have into the blinded baseline patient characteristic data from the APPROACH study and how this population may differ from a TRD population? And then on the safety database, what you'll need in a regulatory filing, is there a minimum number of retreatments per year needed in the EXTEND trial?
Yes. Thank you. So the safety -- as the trial is ongoing, the data is blinded. We are performing checks as necessary or as possible with blinded data, which essentially are quality checks in a blinded manner. And since this is a pivotal trial, we are, of course, being very careful with the data. There are other checks built into the database, which ensures that there any flags with respect to data quality. They are raised to us immediately if there is a reason for concern. So far, we haven't had anything flagged in the database. So we are confident that the data quality is being maintained. In terms of how this is different from the TRD population. So this group of patients is earlier in the treatment cycle. So these are patients who are inadequately responding. And they may have failed 1 treatment or they may have failed 1 and been on their second treatment, but not adequately responding, but not fully failed. So they are not that 1/3 of the patient population that remains after multiple treatment trials. So it's about 2/3 of -- if you think of the depression population as a whole, this is the first 2/3 of those patients in the treatment cycle, whereas TRD would be the last 2/3 left after multiple treatment cycles. In terms of ends, the -- or safety database, the safety database really is a function of the frequency of administration. Given that this is an intermittent treatment, what we have discussed with the agency as part of our BTD discussions is that the data that we will provide to them, the numbers that we provide to them across the 3 studies would be sufficient to support an NDA. But of course, again, it depends on what we find out in the long-term extension study with respect to treatment frequency. [ id="-1" name="Operator" /> Our next question will come from Elemer Piros with Lucid Capital Partners.
Yes. I just wanted to get maybe just one tiny detail on the loan repayment. If you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees?
Thank you. Yes, we repaid High Trail $20 million and the repayment fee ended up being 10%.
10%, so it wasn't a $50 million loan.
The loan -- yes, the loan was structured as a convertible debt, and they had converted the other $30 million. Approximately.
Converted the other. [ id="-1" name="Operator" /> Our next question will come from Sumant Kulkarni with Canaccord Genuity.
Nice to see the progress. I have 3. On CYB003, during your pivotal trial program, how important is it that patients remain compliant with their background antidepressant use?
Sorry, I was speaking on mute, Sumant, taking that question. The -- so for our patients in the APPROACH study and EMBRACE because this is adjunctive, the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medication. We do not expect them or advise them to come off their antidepressant medication during the treatment period.
Got it. And then on 004, do you see an eventual pivotal program involving an intramuscular route of delivery? And what are some of the key challenges of developing an oral formulation? And my last question is, what are some of the specific qualities that you believe are must-haves for an incoming CEO?
I can take the first 2. Eric can take the last one. So right now, yes, intramuscular is the route of administration that we plan to progress in Phase III. It's a very convenient form of administration, which also gives us what we need in terms of the plasma exposures and the acute experience, which cannot be achieved with something like oral. With oral, the elimination is pretty rapid. And DMP or CYB004 does not reach the plasma PK levels, the threshold that is necessary for a breakthrough experience, which, as we know, is necessary for therapeutic efficacy. That we are achieving with intramuscular. It's well tolerated. So that is what we are going to take into Phase III.
And maybe I can also add, Amir, that the intramuscular route is one that as we are aware from our market research with the interventional psychiatry clinics is one that is also being used currently by interventional psychiatrists administering ketamine. And so that gives us some confidence that it is a route that will get -- will reach adoption in the market.
And with regards to your question regarding CEO qualities, I mean, obviously, we've been at it for only about 8 weeks right now. The Board is spearheading that process. And at the moment, we're looking for the qualities that this company and its shareholders deserve, a successful steward of capital that investors can feel confident in, someone that has executed in the past, bringing a novel drug to market ideally through commercialization, an individual that has transacted and dealt with big pharma in the past as well. These are all table stakes for us and the next individual that will be sitting in the chair. [ id="-1" name="Operator" /> At this time, there are no further questions in the queue. So I'd like to turn the call back over to Eric for any additional or closing remarks.
No further remarks. I just want to thank everybody for attending the call today. It's been a very exciting time for Cybin, and we look forward to delivering some fantastic updates for everybody in the future. Thank you all for your support. [ id="-1" name="Operator" /> Thank you, ladies and gentlemen. This does conclude today's program, and we appreciate your participation. You may disconnect at any time.

