Latest news with #CYB003
Business Wire
7 days ago
- Business
- Business Wire
Cybin Announces Additional U.S. Patent Supporting its CYB004 Program in Phase 2 Development for Generalized Anxiety Disorder
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe 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 announced that the United States Patent and Trademark Office has granted U.S. patent 12,318,477 in support of its CYB004 deuterated DMT program in development for the treatment of generalized anxiety disorder ('GAD'). The patent, which is expected to provide exclusivity until 2040, includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular ('IM') injection, including CYB004. 'Patents are extremely valuable assets, and protection for our lead product candidates is a top priority for us,' said Doug Drysdale, Chief Executive Officer of Cybin. 'We believe that our CYB004 program has the potential to deliver short-duration, rapid-acting treatment for anxiety disorders and offer more patient-friendly dosing methods such as IM administration. The issuance of this additional patent in support of CYB004 adds further validation of this important program. Dosing is currently underway in our Phase 2 study evaluating CYB004 in generalized anxiety disorder, and we expect the study to complete around mid-year. I'm proud that Cybin has amassed one of the strongest IP portfolios in the sector with more than 90 granted patents and over 230 pending applications.' 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 expectations respecting the patent exclusivity period; plans to complete the Phase 2 GAD study around mid-year 2025; 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.
Yahoo
22-05-2025
- Business
- Yahoo
Cybin to Participate in Water Tower Research Fireside Chat on May 29, 2025
TORONTO, May 22, 2025--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe 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, is pleased to announce that Doug Drysdale, Cybin's Chief Executive Officer, will participate in a Water Tower Research Fireside Chat taking place on Thursday, May 29, 2025, at 11:00 a.m. ET. The fireside chat will be hosted by Robert Sassoon, Senior Research Analyst at Water Tower Research. Covered topics will include: The evolution of interventional psychiatry clinics and the importance of Cybin's partnership with Osmind. Progress of the CYB003 Phase 3 program and the impact of recently announced strategic clinical partnerships and the Thermo Fisher collaboration. Upcoming milestones and timelines. Thoughts on the noise of psychedelics coming out of the FDA. To listen to the event, please click here to register for the webcast. The archived webcast will also be available on the Company's investor relations website on the Events & Presentations page. 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 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. View source version on Contacts Investor & Media Contact: Gabriel FahelChief Legal OfficerCybin Inc.1-866-292-4601irteam@ – or – media@ Sign in to access your portfolio
Business Wire
22-05-2025
- Business
- Business Wire
Cybin to Participate in Water Tower Research Fireside Chat on May 29, 2025
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe 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, is pleased to announce that Doug Drysdale, Cybin's Chief Executive Officer, will participate in a Water Tower Research Fireside Chat taking place on Thursday, May 29, 2025, at 11:00 a.m. ET. The fireside chat will be hosted by Robert Sassoon, Senior Research Analyst at Water Tower Research. Covered topics will include: The evolution of interventional psychiatry clinics and the importance of Cybin's partnership with Osmind. Progress of the CYB003 Phase 3 program and the impact of recently announced strategic clinical partnerships and the Thermo Fisher collaboration. Upcoming milestones and timelines. Thoughts on the noise of psychedelics coming out of the FDA. To listen to the event, please click here to register for the webcast. The archived webcast will also be available on the Company's investor relations website on the Events & Presentations page. 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 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.
Yahoo
15-05-2025
- Business
- Yahoo
Thermo Fisher Scientific (NYSE:TMO) Partners With Cybin For Phase 3 Depression Treatment
Thermo Fisher Scientific recently partnered with Cybin Inc. to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, a promising treatment for Major Depressive Disorder. Despite this partnership news, the company's stock price was flat last week, in contrast to a positive broader market trend marked by a 5.1% rise. Factors such as the overall market sentiment driven by strong economic data and earnings reports likely influenced stock movements more significantly, while Thermo Fisher's recent developments added a counterbalancing weight to the modest movement. Be aware that Thermo Fisher Scientific is showing 2 possible red flags in our investment analysis. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. The partnership between Thermo Fisher Scientific and Cybin Inc. is a significant development with potential implications for the company's future revenue and earnings forecasts. By supporting the Phase 3 clinical supply of CYB003, Thermo Fisher is positioning itself in a promising treatment area for Major Depressive Disorder. This partnership could potentially enhance future revenue streams if CYB003 gains commercial traction. However, the immediate flat response in Thermo Fisher's share price suggests that broader market influences and other news might have played a more significant role in recent stock movements. Over the past five years, Thermo Fisher's total return, including both share price appreciation and dividends, amounted to 20.47%. This is an indicator of the company's ability to deliver shareholder value over a more extended period, despite short-term fluctuations. In comparison, on a one-year basis, the company's shares matched the US Life Sciences industry's return of 31.9% decline, reflecting broader sector challenges. With the company's current share price at US$407.02 and analysts' consensus price target sitting at US$570.17, there is an anticipated upside potential of 28.6%. This highlights market expectations for Thermo Fisher's growth prospects as they integrate new acquisitions and pursue innovation within the life sciences sphere. As analysts project revenue to grow at 5.3% annually over the next three years, supported by innovations like the Vulcan Automated Lab, partnerships like that with Cybin Inc. poise Thermo Fisher to capitalize on emerging opportunities, potentially adjusting forward-looking revenue and earnings estimates upward. The analysis detailed in our Thermo Fisher Scientific valuation report hints at an deflated share price compared to its estimated value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:TMO. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Business Wire
15-05-2025
- Business
- Business Wire
Cybin Engages Thermo Fisher Scientific to Provide U.S.-Based Manufacturing for its CYB003 Program for the Adjunctive Treatment of Major Depressive Disorder
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe 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 announced that it has engaged Thermo Fisher Scientific ('Thermo Fisher'), the world leader in serving science, to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, the Company's proprietary deuterated psilocin program in Phase 3 development for the adjunctive treatment of Major Depressive Disorder ('MDD'). 'This is an exciting time for Cybin as we focus on the execution of our Phase 3 CYB003 pivotal program,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Thermo Fisher, which offers leading Contract Development and Manufacturing Organization (CDMO) services, has a successful track record across the manufacturing spectrum, and their expertise will help to accelerate our drug development trajectory. We are pleased to broaden our existing strong relationship with Thermo Fisher for both the drug substance and drug product capsules for CYB003. Cybin has established its manufacturing operations in the United States, including partnering with Thermo Fisher's pharma services sites in Florence, South Carolina, for Phase 3 clinical supply and future commercialization, and Cincinnati, Ohio, for Phase 3 capsule production and commercialization.' 'Affiliating with a world-class manufacturing partner is critical for us as we advance this important program and address a significant unmet medical need in the treatment of mental health disorders,' said Aaron Bartlone, Chief Operating Officer of Cybin. Vincent Hingot, President Drug Substance, Pharma Services, at Thermo Fisher added, 'We are proud to partner with Cybin on their groundbreaking CYB003 program. Our collaboration underscores our commitment to leveraging our advanced manufacturing capabilities to support innovative treatments that address significant unmet medical needs in mental health." In March 2024, CYB003 received U.S. Food and Drug Administration ('FDA') Breakthrough Therapy Designation. Among its many benefits, this designation provides an expedited review pathway and the potential to accelerate drug development timelines. It also includes all 'fast track' program features and acknowledges the significant unmet medical need for more effective treatments of MDD. The Company's Phase 2 study results of CYB003 in MDD showed remarkable efficacy at 12 months, including a 100% response rate and a 71% remission rate among participants who received two 16 mg doses. Based on the strength of the Phase 2 study results, Cybin initiated PARADIGM™, its multinational pivotal Phase 3 program evaluating CYB003 in a broader population of MDD patients, in November 2024. 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 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. 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', '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 commercial manufacturing of CYB003; the potential for FDA Breakthrough Therapy Designation to accelerate drug development timelines; 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 and nine months 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+ 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.
