Latest news with #MajorDepressiveDisorder
Time of India
2 days ago
- Health
- Time of India
Not everyone needs magnesium supplements: Here's who should skip it
Magnesium supplements are very much praised as cure-alls; better sleep, reduced muscle cramps, improved heart health, and even lower stress levels. After all, who wouldn't want a calm mind and smooth digestion? But did you know that magnesium is not always the hero? In certain health conditions or situations, magnesium can do more harm than good. While the general belief is that it's safe because it's 'just a mineral,' the truth lies in the details. A recent trial studied 60 patients diagnosed with Major Depressive Disorder (MDD) under standard SSRI (Selective Serotonin Reuptake Inhibitor) treatment. Half of the group received magnesium supplements for six weeks, while the other half took a placebo. The results? By the fourth and sixth weeks, those who took magnesium showed significantly lower depression scores, as measured by the Beck II test. While the improvement wasn't noticeable in the initial weeks, sustained intake seemed to make a difference. The study concluded that magnesium could be a promising add-on to SSRIs in managing MDD symptoms — especially in patients who don't respond fully to antidepressants alone. However, experts caution that more extensive studies are needed before magnesium can be recommended as a standard part of depression treatment Here's all we need to know about the groups that should think twice before reaching for that magnesium bottle; not out of fear, but out of knowledge. Our kidneys perform one of the most important functions of the body, that is filtering waste and toxins from the blood, balancing fluids, and maintaining overall health. It is extremely important to keep your kidneys healthy, as long term kidney abuse can even lead to a complete and irreversible kidney failure. People with kidney troubles The kidneys are the main filter for excess magnesium in the body. When the kidneys aren't functioning properly, as in chronic kidney disease, magnesium doesn't get excreted as efficiently. This can lead to a dangerous condition called hypermagnesemia (excess magnesium in the blood). Symptoms may start mild, nausea, weakness, but can progress to slow heartbeat, confusion, or even cardiac arrest in severe cases. It's not about the magnesium being 'bad'; it's about the body being unable to handle even the good stuff when it's already struggling. Those on certain medications Magnesium supplements can mess with how certain drugs work in the body. A few examples: Antibiotics (like tetracyclines and quinolones): Magnesium can bind to them in the gut and make them less effective. Diuretics (water pills): Some can lead to magnesium loss, while others can cause magnesium levels to rise dangerously. Heart medications (like digoxin): Magnesium affects heart rhythm, which can be risky when mixed with heart drugs. Mostly, these interactions happen silently, and symptoms only show up once the balance is off. According to experts, magnesium is needed for mitochondrial energy production in liver cells, turning on enzymes that help with protein making, glucose use, fat metabolism, and building genetic material. All this is important for the liver to work properly. People with slow heart rhythms While magnesium does support heart rhythm, it can worsen bradycardia (an already slow heartbeat). For someone who has naturally slow pulses or underlying conduction issues, extra magnesium may slow things down too much, leading to dizziness, fainting, or fatigue. It's not about magnesium being harmful universally, but about how it behaves in a body that already runs a little too slow. Those with frequent loose stools or gut sensitivities Certain forms of magnesium, especially magnesium citrate and magnesium oxide, are known to have a laxative effect. For someone already dealing with IBS, sensitive digestion, or frequent diarrhoea, this can make things worse. Instead of calming the gut, it could irritate it further, leading to dehydration, electrolyte imbalances, and stomach cramping. This often goes unnoticed because people assume any discomfort is just 'cleansing.' But if the body is already trying to calm itself, magnesium may be an unwanted nudge. Habits to Boost Longevity and Health People with a history of very low blood pressure Magnesium lowers blood pressure, great news, right? Yes, magnesium can help manage high blood pressure . But in people with naturally low blood pressure, it might bring the numbers too far down. Symptoms like lightheadedness, blurred vision, or fatigue might seem vague, but they often point to an over-relaxed circulatory system. When magnesium enters the mix, it can amplify the dip, especially in combination with blood pressure medications or hot weather. One step to a healthier you—join Times Health+ Yoga and feel the change
Business Wire
3 days ago
- Health
- Business Wire
Saptalis Pharmaceuticals Launches Fluoxetine Oral Solution, USP 20 mg/5 mL
HAUPPAUGE, N.Y.--(BUSINESS WIRE)--Saptalis Pharmaceuticals, LLC. is pleased to announce the commercial launch of Fluoxetine Oral Solution, USP 20 mg/5 mL, a prescription-only selective serotonin reuptake inhibitor (SSRI) developed to treat a range of mental health conditions effectively. This oral formulation is designed to support flexible and individualized treatment, particularly for patients who experience difficulty swallowing solid dosage forms. This launch reflects our ongoing commitment to providing high-quality, accessible medications that meet the evolving needs of both patients and healthcare professionals. Share Fluoxetine Oral Solution is indicated for the following conditions: Acute and maintenance treatment of Major Depressive Disorder (MDD) Acute and maintenance treatment of Obsessive-Compulsive Disorder (OCD) Acute and maintenance treatment of Bulimia Nervosa Acute treatment of Panic Disorder, with or without agoraphobia 'We are excited to expand our product portfolio with the introduction of Fluoxetine Oral Solution,' said Polireddy Dondeti, Ph.D., President and CEO, of Saptalis Pharmaceuticals, LLC. 'This launch reflects our ongoing commitment to providing high-quality, accessible medications that meet the evolving needs of both patients and healthcare professionals.' Fluoxetine Oral Solution, USP 20 mg/5 mL is available by prescription and should only be used under the guidance of a licensed healthcare provider to ensure safe and effective treatment. For full prescribing information or to learn more, please visit or contact us at info@ About Saptalis Pharmaceuticals, LLC. Saptalis Pharmaceuticals, LLC. is a rapidly growing company focused on the development, manufacturing, and commercialization of specialty pharmaceutical products, including complex and high-quality generics, with particular expertise in liquid and semi-solid dosage forms. Headquartered in Hauppauge, New York, Saptalis operates fully equipped R&D laboratories and a state-of-the-art commercial manufacturing facility compliant with U.S. FDA cGMP standards. The company is dedicated to delivering innovative solutions that enhance patient care and improve treatment outcomes.
Business News Wales
3 days ago
- Business
- Business News Wales
£107m For Health Spinout is 'Most Significant Commercial Investment in Welsh Research To Date'
A clinical-stage spinout company is launching with a $140 million (£107 million) investment – the most significant commercial investment into Welsh research to date. Cardiff University spinout Draig Therapeutics will launch with the investment from leading international venture investors to advance the development of novel therapies for major neuropsychiatric disorders such as major depressive disorder. The university said this represents the most significant commercial investment into Welsh research to date. Founded on the research and expertise of Professor John Atack and Professor Simon Ward from Cardiff University's Medicines Discovery Institute, the new company will translate the latest research into new treatments for neuropsychiatric conditions. Draig Therapeutics will target key processes in the brain – the Glutamate and GABA pathways – to develop new and more effective treatment options. Professor Simon Ward, Cardiff University's Medicines Discovery Institute and Draig Therapeutics, said: 'We have unique scientific expertise in safely and effectively modulating the core Glutamate and GABA pathways in the brain, which play a critical role in neuropsychiatric disorders. Our knowledge of balancing the chemical neurotransmitters in the brain in neuropsychiatric conditions underpins Draig's pipeline of novel treatments. With the launch of Draig, we can test and develop these new treatments, to bring them into clinical practice and make genuine impacts on the lives of patients around the world.' Draig was formed through a partnership between Cardiff University's Medicine Discovery Institute and SV Health Investors and was founded in 2024. Draig Therapeutics is due to launch on June 18, 2025, with investment led by Access Biotechnology, alongside SV Health Investors and ICG, and including Canaan Partners, SR One, Sanofi Ventures and Schroders Capital. Liam Ratcliffe, Head of Access Biotechnology, said: 'Despite numerous treatments available for neuropsychiatric disorders, a significant unmet need remains with many patients continuing to experience inadequate symptom relief and high rates of relapse. Draig's differentiated approach, which targets core mechanisms underlying these complex conditions, has the potential to deliver a real breakthrough for patients.' Ruth McKernan, co-founder and Executive Chair of Draig, added: 'Making the best molecules to rebalance brain networks has been John and Simon's life work. It has been a professional highlight for me to be part of creating this hugely promising company.' The new funds will enable Draig Therapeutics to advance its lead candidate drug, DT-101, into Phase 2 trials in 2025 for Major Depressive Disorder. The funding will also enable Draig Therapeutics to advance two other drugs towards clinical development in 2026, with best-in-class potential across a range of neuropsychiatric disorders. Rhodri Turner, Research Commercialisation Manager in Cardiff University's Research and Innovation Services, said: 'This investment in Draig Therapeutics is the largest into a Cardiff University spinout company and represents an outstanding success for the university's Medicines Discovery Institute and will significantly accelerate the delivery of much-needed therapeutics to patients.' The Medicines Discovery Institute was launched at Cardiff University in 2017, with supportive funding from the European Regional Development Fund through the Welsh Government's Sêr Cymru scheme, to translate the latest biomedical research into new therapies. Professor Roger Whitaker, Pro Vice-Chancellor for Research, Innovation and Enterprise at Cardiff University, said: 'Draig Therapeutics is an excellent example of how our research ecosystem is driving innovation-led growth and real-world commercialisation. In collaboration with government, the private sector and other stakeholders, we look forward to further building on this success to strengthen the sector's wider role in driving inward investment to Wales. 'Translating our fundamental research into innovative solutions for global challenges is at the heart of what we do. Combined with support for innovation, it is important to remember just how vital Sêr Cymru and other targeted research funding has been in making a step change for Wales. Together we can do much more.' Professor Wendy Larner, Vice-Chancellor and President at Cardiff University, said: 'This achievement exemplifies the huge impact from Cardiff's outstanding research. Our strategy for 2035 reaffirms our global-civic ambitions and the partnership approach that is vital for Wales and the UK. Through our new strategy, Cardiff will continue to strengthen its position for future innovation across the portfolio, for continued economic, social and health benefits.'
National Post
13-06-2025
- Business
- National Post
Cybin Provides Corporate Update and Highlights Positive Regulatory Signals for Psychedelic Therapeutics
Article content Article content – Patient dosing is underway in the Phase 3 CYB003 PARADIGM program in Major Depressive Disorder ('MDD') with expected combined enrollment of approximately 550 participants across three studies (APPROACH™, EMBRACE™, and EXTEND) – Article content Article content – Partnerships with Osmind and Thermo Fisher Scientific strengthen the Company's commercialization and manufacturing capabilities – Article content – Positive regulatory signals from U.S. Agencies amid expanding media coverage could expedite regulatory pathways across Cybin's clinical-stage pipeline – Article content TORONTO — 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 provided a corporate update. Article content 'It is especially gratifying that at a time when we are advancing our clinical pipeline programs, with our lead program CYB003 in Phase 3 development, the path toward approval and eventual commercialization of psychedelic therapeutics is gaining clarity,' said Doug Drysdale, Chief Executive Officer of Cybin. 'With our expanded intellectual property portfolio, and a number of key partnerships in place, we believe our rigorous research and novel clinical approach can lead to a transformation in how mental health disorders are treated. Now is the time to address the mental health crisis, and we are encouraged by recent sentiment in favor of expediting the regulatory review process for product candidates in development.' Article content Continued to expand its strategic clinical site partnership ('SPA') program in support of the Phase 3 PARADIGM program. The SPA program is designed to facilitate collaboration among sites, enhance efficiency in trial operations, and improve overall site performance. Partnered with Thermo Fisher Scientific, a world-class manufacturing partner, to provide U.S.-based manufacturing for the CYB003 program. Cybin broadened its existing strong relationship with Thermo Fisher Scientific to include the development of both the drug substance and drug product capsules for CYB003. Partnered with Osmind, a leading service provider to psychiatry practices in the U.S., with the objective of accelerating commercial preparation for clinical-stage pipeline. Osmind advances psychiatry through technology and services to bring innovative mental health treatments to patients in need. Cybin will leverage Osmind's 800-clinic network, point-of-care software, and real-world data to support commercial preparation for its clinical-stage pipeline. Continued to expand intellectual property portfolio with two additional U.S. patents supporting lead programs CYB003 and CYB004, bringing the total to over 90 granted patents and over 230 pending applications. The recently issued patents are as follows: U.S. patent 12,291,499 includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041. U.S. patent 12,318,477 is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular ('IM') injection, including CYB004. Article content Positive Regulatory Signals and Evolving Acceptance of Potential Therapeutic Value of Psychedelics Article content Recent statements and hiring decisions by senior U.S. Health and Human Services ('HHS') and FDA officials, in addition to ongoing signs of bipartisan congressional support, suggest an improved forward regulatory environment for psychedelic medicine and therapies, including the potential for accelerated approval pathways. Article content The Company believes that these developments, together with increased political recognition and public understanding of the science underpinning these programs, have the potential to expedite regulatory pathways and reduce overall risk across its clinical portfolio. Highlights include: Article content In a recent interview, FDA Commissioner Dr. Marty Makary stated that psychedelic-drug review is a 'top priority' and promised an 'expeditious and rapid review' of clinical data. 1 Article content Drug-policy lawyer, Matthew Zorn, has joined HHS as Deputy General Counsel to work on psychedelics policy. He previously challenged the government on matters such as allowing research on cannabis for veterans with PTSD, preventing tryptamines from being scheduled, and fighting for patient access to psilocybin under Right to Try laws. 2 Article content Navy-SEAL-turned-Congressman Morgan Luttrell recently urged the GOP to 'embrace' compounds such as psilocybin, MDMA and ibogaine to help veterans with PTSD. 3 Article content President Trump's new pick for surgeon general, Dr. Casey Means, wrote in a recent book that people should consider guided-psychedelic therapy. 4 Article content On June 19, 2025, Doug Drysdale will speak in a panel discussion focused on the regulatory landscape and next steps for potential commercialization, at the Psychedelic Science 2025 Conference taking place June 16-20, 2025, in Denver, Colorado. The panel details are as follows: Article content Panel Title: Article content Date and Time: Article content About Cybin Article content 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. Article content 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. Article content 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. Sources Article content NewsNation, 'FDA Commissioner Says Research on Psychedelic Treatment 'Top Priority',' interview with FDA Commissioner Dr. Marty Makary, video posted May 16, 2025, (accessed June 9, 2025). Politico, 'A Psychedelics Hire at HHS,' newsletter article, published May 28 2025, (accessed June 9 2025). The Wall Street Journal, 'Lawmaker 'Reborn' Through Psychedelic Therapy Wants the GOP to Embrace It,' news article, published May 17 2025, (accessed June 9 2025). The Associated Press, 'Trump Surgeon General Pick Praised Unproven Psychedelic Therapy, Said Mushrooms Helped Her Find Love,' news article, published May 14 2025, (accessed June 9 2025). Fox News. 'Trump Administration Exploring Potential Benefits of Psychedelic Treatments.' America's Newsroom, correspondent Alexandria Hoff, broadcast June 5 2025. Video clip, 1:58. Article content 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 plans to enroll participants and add additional clinical sites for the PARADIGM program; regulatory statements that suggest an expedited regulatory pathway for Cybin programs; the anticipated approval and commercialization of CYB003 and CYB004; the ability to accelerate commercial preparation of clinical-stage programs through the Company's partnership with Osmind; 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. Article content 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 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+ 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. Article content 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. Article content Article content Article content Article content Article content Contacts Article content Investor & Media: Article content Article content Gabriel Fahel Article content Article content Chief Legal Officer Article content Article content Cybin Inc. Article content Article content Article content Article content
Yahoo
13-06-2025
- Business
- Yahoo
Cybin Provides Corporate Update and Highlights Positive Regulatory Signals for Psychedelic Therapeutics
- Patient dosing is underway in the Phase 3 CYB003 PARADIGM program in Major Depressive Disorder ("MDD") with expected combined enrollment of approximately 550 participants across three studies (APPROACH™, EMBRACE™, and EXTEND) - - Partnerships with Osmind and Thermo Fisher Scientific strengthen the Company's commercialization and manufacturing capabilities - - Positive regulatory signals from U.S. Agencies amid expanding media coverage could expedite regulatory pathways across Cybin's clinical-stage pipeline - TORONTO, June 13, 2025--(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 provided a corporate update. "It is especially gratifying that at a time when we are advancing our clinical pipeline programs, with our lead program CYB003 in Phase 3 development, the path toward approval and eventual commercialization of psychedelic therapeutics is gaining clarity," said Doug Drysdale, Chief Executive Officer of Cybin. "With our expanded intellectual property portfolio, and a number of key partnerships in place, we believe our rigorous research and novel clinical approach can lead to a transformation in how mental health disorders are treated. Now is the time to address the mental health crisis, and we are encouraged by recent sentiment in favor of expediting the regulatory review process for product candidates in development." Recent Corporate Highlights Continued to expand its strategic clinical site partnership ("SPA") program in support of the Phase 3 PARADIGM program. The SPA program is designed to facilitate collaboration among sites, enhance efficiency in trial operations, and improve overall site performance. Partnered with Thermo Fisher Scientific, a world-class manufacturing partner, to provide U.S.-based manufacturing for the CYB003 program. Cybin broadened its existing strong relationship with Thermo Fisher Scientific to include the development of both the drug substance and drug product capsules for CYB003. Partnered with Osmind, a leading service provider to psychiatry practices in the U.S., with the objective of accelerating commercial preparation for clinical-stage pipeline. Osmind advances psychiatry through technology and services to bring innovative mental health treatments to patients in need. Cybin will leverage Osmind's 800-clinic network, point-of-care software, and real-world data to support commercial preparation for its clinical-stage pipeline. Continued to expand intellectual property portfolio with two additional U.S. patents supporting lead programs CYB003 and CYB004, bringing the total to over 90 granted patents and over 230 pending applications. The recently issued patents are as follows: U.S. patent 12,291,499 includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041. U.S. patent 12,318,477 is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular ("IM") injection, including CYB004. Positive Regulatory Signals and Evolving Acceptance of Potential Therapeutic Value of Psychedelics Recent statements and hiring decisions by senior U.S. Health and Human Services ("HHS") and FDA officials, in addition to ongoing signs of bipartisan congressional support, suggest an improved forward regulatory environment for psychedelic medicine and therapies, including the potential for accelerated approval pathways. The Company believes that these developments, together with increased political recognition and public understanding of the science underpinning these programs, have the potential to expedite regulatory pathways and reduce overall risk across its clinical portfolio. Highlights include: In a recent interview, FDA Commissioner Dr. Marty Makary stated that psychedelic-drug review is a "top priority" and promised an "expeditious and rapid review" of clinical data.1 Drug-policy lawyer, Matthew Zorn, has joined HHS as Deputy General Counsel to work on psychedelics policy. He previously challenged the government on matters such as allowing research on cannabis for veterans with PTSD, preventing tryptamines from being scheduled, and fighting for patient access to psilocybin under Right to Try laws.2 Navy-SEAL-turned-Congressman Morgan Luttrell recently urged the GOP to "embrace" compounds such as psilocybin, MDMA and ibogaine to help veterans with PTSD.3 President Trump's new pick for surgeon general, Dr. Casey Means, wrote in a recent book that people should consider guided-psychedelic therapy.4 Cybin's Chief Executive Officer Doug Drysdale recently appeared on Fox News and is increasingly sought by media outlets as a trusted commentator.5 On June 19, 2025, Doug Drysdale will speak in a panel discussion focused on the regulatory landscape and next steps for potential commercialization, at the Psychedelic Science 2025 Conference taking place June 16-20, 2025, in Denver, Colorado. The panel details are as follows: Panel Title: The Home Stretch: Pivotal Trials and Preparing for LaunchDate and Time: Thursday, June 19, 2025, at 9:30 a.m. MDT (11:30 a.m. EDT) 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. Sources NewsNation, "FDA Commissioner Says Research on Psychedelic Treatment 'Top Priority'," interview with FDA Commissioner Dr. Marty Makary, video posted May 16, 2025, (accessed June 9, 2025). Politico, "A Psychedelics Hire at HHS," newsletter article, published May 28 2025, (accessed June 9 2025). The Wall Street Journal, "Lawmaker 'Reborn' Through Psychedelic Therapy Wants the GOP to Embrace It," news article, published May 17 2025, (accessed June 9 2025). The Associated Press, "Trump Surgeon General Pick Praised Unproven Psychedelic Therapy, Said Mushrooms Helped Her Find Love," news article, published May 14 2025, (accessed June 9 2025). Fox News. "Trump Administration Exploring Potential Benefits of Psychedelic Treatments." America's Newsroom, correspondent Alexandria Hoff, broadcast June 5 2025. Video clip, 1:58. 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 plans to enroll participants and add additional clinical sites for the PARADIGM program; regulatory statements that suggest an expedited regulatory pathway for Cybin programs; the anticipated approval and commercialization of CYB003 and CYB004; the ability to accelerate commercial preparation of clinical-stage programs through the Company's partnership with Osmind; 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 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+ 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. Neither 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. View source version on Contacts Investor & Media: Gabriel FahelChief Legal OfficerCybin Inc.1-866-292-4601irteam@ – or – media@ 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
