Latest news with #PARADIGM
Business Insider
3 days ago
- Business
- Business Insider
Cybin reports Q1 results
Q1 net loss was $24.6M vs. $10.8M in the same period last year. Cash totaled $118.7M as of June 30, 2025. 'With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,' said CEO Doug Drysdale. 'Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder. PARADIGM is a significantly larger program than the completed Phase 2 study, with anticipated combined enrollment of approximately 550 participants. Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, and whose symptoms are uncontrolled with existing antidepressant treatment. Our Phase 2 study evaluating CYB004 in generalized anxiety disorder is expected to complete patient enrollment this month. Cybin (CYBN) is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector – both from a clinical and regulatory perspective'. Elevate Your Investing Strategy:
Business Wire
3 days ago
- Business
- Business Wire
Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported unaudited financial results for its first quarter ended June 30, 2025, and is pleased to provide an update on key business milestones. 'With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder. PARADIGM is a significantly larger program than the completed Phase 2 study, with anticipated combined enrollment of approximately 550 participants. Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, and whose symptoms are uncontrolled with existing antidepressant treatment. Our Phase 2 study evaluating CYB004 in generalized anxiety disorder is expected to complete patient enrollment this month.' 'Cybin is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector - both from a clinical and regulatory perspective,' concluded Drysdale. Recent Business and Pipeline Highlights: Received European approval and MHRA approval for EMBRACE, the second Phase 3 study within the PARADIGM program evaluating CYB003 for the adjunctive treatment of MDD, on schedule. The Company has received CTA approval from the Irish Medicines Board for the EMBRACE study in Ireland, Poland, and Greece, as well as approval from the MHRA. EMBRACE is a 12-week, randomized, double-blind, placebo-controlled study in 330 participants with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but with inadequate response. EMBRACE will evaluate two doses of CYB003 (8 mg, 16 mg) three weeks apart, compared to an inactive placebo. The primary endpoint is change in depressive symptoms as measured by the change in MADRS from baseline six weeks after the first dose. Making strong progress on CYB003 development through the APPROACH and EXTEND studies. Dosing is currently ongoing in the first pivotal study, APPROACH, which is expected to enroll 220 patients across 45 U.S. clinical sites. We are pleased to report that patient rollovers continue into EXTEND, the long-term extension study. Clinical Program Summary CYB003: Deuterated psilocin program Phase 3 PARADIGM program is underway, with topline data from first pivotal study, APPROACH, expected in 2026 1. CYB003 program accomplishments: Received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD. A completed Phase 2 study of CYB003 in MDD demonstrated durability of effect at 12 months: 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two 16 mg doses. CYB004: Deuterated dimethyltryptamine program The Phase 2 CYB004 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with generalized anxiety disorder, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. Patient enrollment is expected to be completed this month 1. Change in Presentation Currency Effective April 1, 2025, the Company changed its presentation currency from the Canadian dollar to the United States dollar (' USD '). The change in presentation currency was made to better reflect the Company's operations, align with the currency in which the majority of cash-based expenses are denominated, and improve comparability of its financial results with other publicly traded businesses in the industry. As a result, all amounts presented in this press release are in USD unless otherwise stated. First-Quarter Financial Highlights Cash totaled $118.7 million as of June 30, 2025. Net loss was $24.6 million for the quarter ended June 30, 2025, compared to a net loss of $10.8 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled $23.9 million for the quarter ended June 30, 2025, compared to $11.9 million, in the same period last year. Cash flows used in operating activities were $29.5 million for the quarter ended June 30, 2025, compared to $19.9 million in the same period last year. About Cybin Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Note: 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'. 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 EMBRACE study to enroll 330 participants at approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia; the Company's expectation to enroll 220 participants at approximately 45 clinical sites across the United States for the APPROACH study; the Company's expectation to complete enrollment in CYB004 Phase 2 study in August 2025; the Company's expectation to receive topline data from APPROACH in 2026; 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 psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 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 and with the U.S. Securities and Exchange Commission on EDGAR at 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. Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.
Yahoo
29-07-2025
- Business
- Yahoo
Anteris (AVR) Welcomes Two Directors as Major Trial Approaches
Anteris Technologies Global Corp. (NASDAQ:AVR) is one of the 11 Best New Penny Stocks to Buy Right Now. On June 9, Anteris Technologies Global Corp. (NASDAQ:AVR) announced that two new members, Mr. David Roberts and Mr. Gregory Moss, have joined its Board of Directors. Mr. Gregory Moss is the Chief Business and Legal Officer, Corporate Secretary and Chief Compliance Officer at Evommune, Inc. On the other hand, Mr. David Roberts has been the President of LeMaitre Vascular, Inc. since 2007. A scientist in a lab coat looking through a microscope, evaluating an advanced medical device. The company welcomed Mr. Roberts and Mr. Moss as it prepares to start the pivotal clinical trial for the DurAVR THV global, called the PARADIGM Trial. The two new directors are highly accomplished healthcare executives based in the US, and they will help the company transition to its next phase of growth. The PARADIGM study is scheduled for the third quarter of 2025. With the help of Mr. Roberts and Mr. Moss, Anteris Technologies Global Corp. (NASDAQ:AVR) aims to take this important step and move towards getting approval from the US and European regulators for the DurAVR THV for patients with aortic stenosis. Anteris Technologies Global Corp. (NASDAQ:AVR) is a global structural heart company focused on designing, developing, and commercializing cutting-edge medical devices for cardiac care. While we acknowledge the potential of AVR 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: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
Why This Nano-Cap Stock Might Skyrocket To $14, Per Analyst Insights
Last Wednesday, NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) said it scaled up its production of PrimeC to a commercial scale. PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease. NeuroSense said it bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements. Additionally, the company partnered with a global contract development and manufacturing organization (CDMO) that currently manufactures PrimeC clinical batches and will support its future commercial data support a shelf life of at least 36 months at room temperature, and formulation IP granted in 2023 provides protection through 2042. NeuroSense is working to advance discussions with Health Canada to pursue early market entry through the Notice of Compliance with Conditions (NOC/c) pathway. Commercial forecasts suggest a potential peak annual revenue of $100–150 million in Canada. D. Boral Capital initiated coverage on NeuroSense on Monday with a Buy rating and a price forecast of $14. Analyst Jason Kolbert says, 'The mechanistic rationale is supported by both preclinical and translational research, positioning PrimeC as a multimodal therapy in a field still dominated by marginally effective monotherapies.' D. Boral writes that the ongoing Phase 2b PARADIGM trial is designed to provide further validation and is expected to report topline results in the second half of 2025. In April, NeuroSense shared new findings from its Phase 2b PARADIGM clinical trial. The data highlights the impact of PrimeC on microRNA (miRNA) modulation, representing a significant development in understanding how the therapy may slow disease progression. It reveals the consistent effect of PrimeC on altering the expression of miRNAs associated with ALS, aligning with the previously reported clinical benefits, including a 33% reduction in disease progression and a 58% improvement in survival rates observed with PrimeC treatment. The analyst notes that NeuroSense is expanding its platform into Alzheimer's and Parkinson's disease, leveraging the same pathophysiologic targets with modified drug combinations. This modular approach could significantly broaden the company's addressable market while maintaining development efficiency. 'We believe NeuroSense is at an inflection point where clinical proof-of-concept data, coupled with upcoming catalysts, could drive substantial value creation,' Kolbert adds. In August 2024, NeuroSense Therapeutics said it was in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize PrimeC for ALS. Price Action: NRSN stock is up 6.34% at $1.11 at the last check on Monday. Image via Shutterstock Date Firm Action From To Jan 2022 Maxim Group Initiates Coverage On Buy View More Analyst Ratings for NRSN View the Latest Analyst Ratings Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Why This Nano-Cap Stock Might Skyrocket To $14, Per Analyst Insights originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Business Wire
23-04-2025
- Business
- Business Wire
Cybin Announces Additional Strategic Clinical Site Partnerships to Support PARADIGM, a Multinational Phase 3 Program Evaluating CYB003
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry platform company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced additional strategic partnership agreements ('SPAs'), bringing the total to 18 clinical sites engaged to advance Cybin's multinational Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD. The APPROACH study is expected to include approximately 45 clinical sites. 'This SPA model serves to take advantage of the deep expertise of each individual site and ensure that protocols and best practices are shared consistently,' said Doug Drysdale, Chief Executive Officer of Cybin. 'This level of cooperation will streamline trial operations and has the potential to reduce time to completion. We are especially pleased that Kimball A. Johnson, M.D., Medical Director of CenExel iResearch Atlanta, who served as the principal investigator for our successful Phase 1/2a CYB003 trial, and Paul Thielking, Chief Scientific Officer, Cedar Clinical Research, are participating in the SPA program. Our SPA partners are experienced in neuropsychiatric drug trials and share Cybin's deep commitment to the highest quality standards of investigational clinical work, and to developing safe and effective next-generation treatments to improve patient outcomes.' 'I am delighted that iResearch Atlanta is participating in this next exciting stage of development for CYB003, and that we will be part of a consortium of sites working to advance its Phase 3 program,' said Kimball A. Johnson, M.D., Medical Director of CenExel iResearch Atlanta. 'Cedar Clinical Research has extensive experience in this space, and we are eager to join the other sites supporting Cybin's PARADIGM program and address the global crisis in mental health,' said Paul Thielking, Chief Scientific Officer, Cedar Clinical Research, a Numinus Wellness Inc. company. Cybin initiated the SPA program earlier this year with Segal Trials, a leading clinical research network located in South Florida. Each of the 18 U.S.-based SPA sites bring decades of clinical experience and a commitment to excellence to support and expedite the Company's Phase 3 PARADIGM program. About Cybin Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin program, in Phase 3 development for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks 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', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's plans to enroll patients across clinical sites in the United States and Europe; the potential reduction in drug development timeline afforded by its SPA program; the eventual inclusion of approximately 45 clinical sites; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. 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: implications of the spread of a pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; 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, 2024 and the Company's annual information form for the year ended March 31, 2024, which are available under the Company's profile on SEDAR+ and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Neither the Cboe Canada nor the NYSE American LLC 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.
