Latest news with #AlcoholUseDisorder
Toronto Star
4 days ago
- Business
- Toronto Star
Corporate Update, August 2025
NEW YORK, Aug. 04, 2025 (GLOBE NEWSWIRE) — From Dr. Neil Maresky, CEO, Psyence BioMed (NASDAQ: PBM) Dear Shareholders, Thank you for your continued support as we advance our mission to develop safe, effective, and naturally derived psychedelic therapies for people living with serious mental health challenges. Over the past few months, Psyence BioMed (PBM) has made meaningful progress across several fronts: clinical development, strategic positioning, regulatory compliance, and manufacturing stability. These developments reflect not only a shift in our momentum but also a broader evolution of the company – one I'm excited to share with you. Clinical Progress & Trial Expansion Psyence BioMed continues to advance its clinical program with key developments that set the stage for expanded patient access and accelerated enrollment: ARTICLE CONTINUES BELOW Protocol Amendment & Screening Update: A critical protocol amendment that removes the cancer diagnosis requirement to be terminal was submitted and approved by the Human Ethics Review Board (HREC). This change is expected to significantly broaden our eligible patient pool, future patients and increase the trial's clinical relevance and impact. Site Activation: Three clinical sites have successfully completed qualification visits and all have been initiated (as of August 5th). We are pleased to be executing this trial in partnership with Southern Star Research, a leading contract research organization with deep expertise in both oncology and mental health. With the service agreement finalized, full operational rollout is now underway – positioning us to initiate patient enrollment in the near term. Our commitment to scientific leadership is anchored by our exceptional Scientific Advisory Board (SAB), which brings together globally recognized experts in neuroscience, psychiatry, and psychedelic medicine. The SAB plays a critical role in shaping our research agenda and guiding the clinical development of our psychedelic therapies. In the coming weeks, we will host a dedicated webinar featuring our SAB to share deeper insights into our evolving clinical vision for natural psychedelic therapies – including their potential applications in treating PTSD, substance use disorders, and other complex mental health conditions. Stay tuned for more information. Alcohol Use Disorder: PBM has established a Steering Committee (SC) to guide the development of its early-phase study investigating the use of naturally sourced psilocybin for the treatment of Alcohol Use Disorder (AUD). The study is planned to be conducted in South Africa and the SC comprises three experts in substance and alcohol use disorders, including Professor Dan Stein from the University of Cape Town, who also serves on the Psyence BioMed SAB. The SC will provide input on protocol design, advise on key endpoints, and help identify the most appropriate patient population – particularly in light of cultural nuances surrounding alcohol use. Ibogaine: Strengthening Our Strategic Alliance with PsyLabs Psyence BioMed's partnership with PsyLabs continues to evolve as a cornerstone of our Ibogaine program. Ibogaine is an incredibly exciting molecule, with powerful psychoactive properties that not only alters perception, mood, and affect, but also interrupts addictive behaviors. Together, we are advancing several key initiatives that reinforce our position as a global leader in the development of naturally derived psychedelic therapies. Last week we announced that PsyLabs has successfully produced a GMP-aligned Ibogaine Total Alkaloid extract – a milestone that reflects the impact of our ongoing investment and collaboration in this partnership. Our collaboration is focused on: Elevating Production Standards: Work is underway to achieve GMP-grade ibogaine manufacturing with exceptional purity – a rare and highly sought-after capability as the psychedelic sector moves toward increased regulatory rigor. Expanding Global Footprint: As the only publicly listed psychedelics company with a sustainable source of ibogaine in Africa, we are uniquely positioned to lead in ethical, scalable, and locally rooted production – offering a distinct competitive advantage in the global psychedelics market. Advancing Ethical Sourcing: Strategic relationships are being developed to support responsible, community-conscious harvesting of iboga, ensuring long-term supply chain integrity. This partnership is more than operational; it is foundational to our long-term strategy. Our licensing portfolio – including a Right of First Refusal (ROFR) agreement with PsyLabs for the licensing of ibogaine-based products and associated intellectual property – reinforces our ownership stake in this emerging therapeutic category and will be prominently featured in our upcoming investor communications. All of this work is happening in parallel with global momentum, including recent legislation in Texas, where the state has committed $50 million to ibogaine research to explore its potential in treating veterans with traumatic brain injury and PTSD. This is a powerful validation of the compound's promise. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW For additional insight, I encourage shareholders to read A New Frontier in Palliative Care in Insights Care Magazine, where PsyLabs CEO, Tony Budden, outlines a compelling case for nature-derived psychedelics in mainstream medicine. His perspective reflects the broader mission of our collaboration – one rooted in science, patient-centered care, and scalable infrastructure. Strong Financial Position & Nasdaq Compliance We are pleased to report that the Company has a strong cash balance of $11.4 million as at August 4, 2025, and is in a solid financial position with no outstanding debt. The Equity Line of Credit has enabled the Company to raise capital strategically and efficiently. This solid financial position enables us to pursue growth opportunities, accelerate our clinical programs, and navigate future market dynamics with confidence. Regaining compliance with Nasdaq listing requirements marked an important milestone in our continued growth and credibility as a public company. Psyence BioMed successfully regained full compliance with all applicable Nasdaq continued listing requirements in June 2025. As part of our compliance strategy, shareholders approved a share consolidation (reverse stock split) at a Special Meeting of Stockholders held on April 16, 2025. The proposal authorized a reverse split at a ratio of up to 1-for-50, or a lesser amount at the discretion of the Company's Board of Directors. The Board subsequently approved a final ratio of 1-for-7.97 to comply with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2). Commitment to Long-Term Value At Psyence BioMed, our commitment to long-term value is grounded in a clear strategic vision: to build a resilient, multi-asset biotechnology company that leads in the development of nature-derived psychedelic therapies. We are focused on advancing clinically validated, scalable solutions for complex mental health conditions where current treatments fall short. Our leadership team brings a unique blend of global expertise in clinical research, pharmaceutical manufacturing, regulatory strategy, and commercialization. This operational strength positions us to efficiently advance drug candidates from early development through to clinical trials and, potentially, toward market access. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW We are a multi-asset company with an integrated platform that includes proprietary IP, advanced laboratory infrastructure, CMC expertise to enhance the efficiency and consistency of psychedelic compound extraction, and GMP-compliant manufacturing capabilities. This foundation positions us to pursue a range of opportunities across the psychedelics landscape. Each asset in our pipeline is strategically selected and developed with a clear focus on medical relevance, regulatory alignment, and long-term commercial potential. As the psychedelic sector moves toward greater scientific and regulatory maturity, investor attention is shifting to companies with well-defined therapeutic targets and disciplined execution. With forecasts projecting a $3.3 billion psychedelics market by 2031, Psyence BioMed is positioned to deliver differentiated clinical outcomes and enduring shareholder value. Our long-term value creation strategy is built on three pillars: scientific rigor, strategic focus, and operational excellence. We are building not just for momentum – but for meaningful, measurable impact in the years ahead. Warm regards, Dr. Neil Maresky Chief Executive Officer Psyence BioMed (NASDAQ: PBM) Psychedelic Medicine & Policy Updates Slowing aging: Psilocybin helps extend life span in human cells by over 50% Scientists have reported evidence psilocybin may help protect the body from age-related diseases, such as neurodegeneration, heart disease, and cancer through several health-protecting qualities, via a mouse model. Read here. Texas Will Invest $50 Million in Ibogaine Research, Testing the Psychedelic Drug's Medical Potential The state's new law marks one of the largest government investments into psychedelics to date, with advocates citing the drug's potential to help veterans with traumatic brain injury and PTSD. Read here. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Drugs reduced anxiety and PTSD in Nova festival survivors, study finds Study finds survivors of the Nova music festival massacre who consumed classic psychedelics in the hours before the massacre reported significantly lower anxiety and PTSD symptoms, offering real-world insights into potential therapeutic applications. Listen here. Promising' psychedelic therapy aims to help cancer patients More than $5 million from the Canadian Cancer Society will go toward research on treating feelings of anxiety, depression and hopelessness in people with advanced cancer. Read more. Psychedelics may boost mental health by dampening inflammation Psychedelic drugs like MDMA and psilocybin may help treat depression, anxiety and other mental health conditions by reducing the number of inflammatory cells around the brain. Read more. Psychedelics Rewire Brain-Immune Circuits New research reveals that psychedelics like psilocybin do more than alter brain activity — they reshape how the brain and immune system communicate. Scientists identified a pathway where chronic stress disrupts amygdala signaling, triggering immune responses that increase fear and anxiety. Read more. Australia: Government Reimburses MDMA Therapy for Veterans Australia's Department of Veterans' Affairs (DVA) has begun reimbursing MDMA-assisted therapy for veterans with PTSD. This initiative utilizes MDMA capsules supplied by Optimi Health and administered through Mind Medicine Australia's Authorized Prescriber network. The move signifies a significant endorsement of psychedelic-assisted therapies at the governmental level. Read more. Psilocybin Shows Promise in Parkinson's Disease Treatment A pilot study conducted by the University of California, San Francisco, indicates that psilocybin may alleviate symptoms of Parkinson's disease. Participants reported improvements in mood, cognition, and motor function, with benefits lasting for weeks post-treatment. The study also suggests psilocybin may reduce brain inflammation and enhance neuroplasticity. Read more. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Global Psilocybin Therapy Market Projected to Reach $3.3 Billion by 2031 According to a report by Forbes, the global market for psilocybin-assisted therapy is projected to grow from $1.5 billion in 2024 to $3.3 billion by 2031. This growth is driven by increasing acceptance of psychedelic therapies and the rising prevalence of mental health disorders. Read more. FDA Releases Draft Guidance on AI in Drug Development The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining considerations for the use of artificial intelligence (AI) in drug and biological product development. The guidance proposes a risk-based framework to assess the credibility of AI models used in regulatory decision-making processes. Read more. U.S. Surgeon General Nominee Supports Psychedelic Therapy Dr. Casey Means, nominated for U.S. Surgeon General, has publicly endorsed the use of psychedelic therapies, including psilocybin-assisted treatment. Her stance reflects a growing interest in alternative mental health treatments at the highest levels of government. Read more. Republican Lawmaker Advocates for Psychedelic Therapy Congressman Morgan Luttrell (R-Texas), a former Navy SEAL, has become a vocal advocate for psychedelic therapy following his personal experience with ibogaine and DMT treatments for PTSD. His support highlights a bipartisan shift towards considering psychedelic-assisted therapies for mental health conditions, particularly among veterans. Read more. Learn more at and on LinkedIn. Contact Information for Psyence Biomedical Ltd. Email: ir@ Media Inquiries: media@ General Information: info@ Phone: +1 416-477-1708 Investor Contact: Michael Kydd Investor Relations Advisor michael@ Forward Looking Statements This communication contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as 'will likely result,' 'are expected to,' 'will continue,' 'is anticipated,' 'estimated,' 'believe,' 'intend,' 'plan,' 'projection,' 'outlook' or words of similar meaning. Forward-looking statements in this communication include statements regarding the progress of the Phase IIb clinical trial, preparations for the Company's second development indication, the growth of the psychedelic mushroom market and the Company's growth potential. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, topline data from this trial will be positive, there will be no obstacles to the launch of the Company's second indication, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed's business and changes in Psyence BioMed's capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the 'Risk Factors' section of the Company's final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the 'SEC') on January 24, 2025 and other documents filed by Psyence BioMed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements. The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company 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.
Time Business News
7 days ago
- Health
- Time Business News
How Cognitive Behavioral Therapy Plays a Key Role in Alcohol Addiction Treatment
Alcohol addiction, clinically referred to as Alcohol Use Disorder (AUD), is not merely a matter of willpower or poor decision-making. It is a complex interplay of genetic predisposition, neurological imbalances, psychological distress, and maladaptive behavioral conditioning. Individuals struggling with alcohol addiction often face distorted perceptions of control, impaired judgment, and deep-seated emotional conflicts that perpetuate the cycle of abuse. Recognizing this intricate framework is crucial to understanding why cognitive-based therapies, particularly Cognitive Behavioral Therapy (CBT), are instrumental in addressing alcohol addiction at its psychological roots. Overcoming dependency on alcohol is a deeply personal journey that requires structured guidance and consistent encouragement. With the right tools and mindset, individuals can rebuild a life once overwhelmed by substance use. Alcohol Addiction Treatment involves a combination of medical supervision, behavioral therapies, and peer support groups to address both physical withdrawal and psychological triggers. Family involvement, relapse prevention plans, and lifestyle changes all contribute to lasting recovery. Although each person's path is different, professional help dramatically increases the chances of success. Commitment and patience, paired with expert care, can lead to a healthier, more fulfilling future. Cognitive Behavioral Therapy emerged from the groundbreaking work of Dr. Aaron T. Beck in the 1960s. It is a structured, time-limited, and goal-oriented form of psychotherapy designed to dismantle dysfunctional thought processes and behavioral patterns. Unlike psychoanalytic approaches that delve into the unconscious or purely behaviorist models focused on external reinforcement, CBT operates at the nexus of cognition and behavior. It posits that negative thought cycles directly influence actions, and by altering these cognitive distortions, behavioral change becomes attainable and sustainable. This rational, evidence-based framework makes CBT uniquely suited for addressing the cognitive traps inherent in alcohol dependency. CBT tackles the psychological underpinnings of alcohol addiction through several targeted mechanisms. First, it identifies automatic negative thoughts—those spontaneous, irrational beliefs that often serve as precursors to drinking episodes. These might include catastrophic thinking ('I can't cope without alcohol') or overgeneralizations ('I always fail at everything'). CBT empowers individuals to challenge and replace these thoughts with realistic, constructive alternatives. Second, CBT enhances emotional regulation. Many individuals drink to escape or dull painful emotions. By learning to process discomfort in a healthy manner, clients reduce their reliance on alcohol as a coping mechanism. The therapy's systematic approach fosters metacognitive awareness—where individuals observe their thoughts and emotional triggers without succumbing to them, creating space for more deliberate decision-making. CBT applies a suite of pragmatic techniques tailored specifically to alcohol recovery. Cognitive restructuring is at the heart of the process. This involves dissecting and disputing harmful beliefs related to alcohol use and replacing them with evidence-based rational thoughts. For instance, the belief 'a drink will calm me down' is challenged by examining the long-term consequences of that drink and exploring healthier alternatives for stress reduction. Behavioral activation is another core element, encouraging individuals to engage in positive, fulfilling activities that reinforce sobriety. This not only fills the time once occupied by drinking but also reconditions the brain to associate pleasure with non-alcohol-related experiences. Exposure and response prevention, though more common in anxiety treatments, can also be adapted for alcohol triggers. Individuals are gradually exposed to environments or situations where they previously drank, while practicing alternative coping mechanisms, thereby desensitizing the urge and building resilience. CBT is often most effective when integrated into a comprehensive treatment plan. For individuals with severe AUD, combining CBT with pharmacotherapy—such as naltrexone or acamprosate—can yield synergistic effects. While medications target the neurochemical aspects of addiction, CBT addresses the behavioral and cognitive components, resulting in a holistic approach to recovery. Group-based CBT also offers distinct benefits. Sharing experiences with others in recovery fosters accountability, collective insight, and mutual encouragement. However, individual CBT allows for more personalized treatment plans, especially for those with co-occurring mental health disorders. Therapists can adapt interventions based on the client's cognitive style, emotional triggers, and recovery pace. The clinical efficacy of CBT in treating alcohol addiction is well-documented. Numerous longitudinal studies show that individuals who complete a course of CBT have higher abstinence rates and reduced relapse frequency compared to those receiving non-specific counseling. One of the most potent benefits of CBT is its role in relapse prevention. By equipping individuals with durable cognitive tools and coping strategies, CBT extends its impact far beyond the therapy sessions. Moreover, CBT encourages a sense of agency. Patients learn that they are not passive victims of their addiction but active participants in their recovery. This psychological shift fosters long-term motivation and self-efficacy, essential components of lasting sobriety. Despite its robust framework, CBT is not a panacea. It requires a baseline level of cognitive engagement and introspection, which may be limited in individuals with severe neurocognitive impairments due to chronic alcohol use. In such cases, preliminary stabilization or adjunct therapies may be necessary before CBT can be effectively implemented. Another challenge lies in patient readiness. CBT demands consistent participation and the willingness to confront uncomfortable thoughts and behaviors. If the individual lacks motivation or insight, the therapy's benefits may remain untapped. Thus, motivational interviewing techniques are often employed as a precursor to CBT to enhance treatment engagement. Cognitive Behavioral Therapy stands as a foundational pillar in the treatment of alcohol addiction, addressing the cognitive distortions and behavioral patterns that fuel substance misuse. Through structured interventions, individuals gain the capacity to challenge destructive beliefs, regulate their emotions, and cultivate healthier habits. When paired with other modalities and tailored to the individual's needs, CBT offers a scientifically validated and profoundly empowering path toward lasting recovery. TIME BUSINESS NEWS
Associated Press
24-07-2025
- Health
- Associated Press
Discover Health Group Expands Insurance Network to Improve Access to Addiction Treatment Services
New partnerships with major insurers make comprehensive care more accessible and affordable for patients in New Hampshire. Nashua, New Hampshire--(Newsfile Corp. - July 24, 2025) - Discover Health Group, a trusted rehab center serving New Hampshire, announced significant expansions to its insurance network that will dramatically increase access to care for individuals seeking substance abuse treatment. The organization has established new in-network partnerships with Carelon, Blue Cross Blue Shield, WellSense, and Uprise Health with additional coverage through Point32Health beginning August 1, 2025. 'We're thrilled to expand our network partnerships because we know that insurance coverage can be a significant barrier to accessing the addiction treatment services people desperately need,' said Greg Moulton, Founder and Managing Partner at Discover Health Group. 'These new relationships align perfectly with our mission - ensuring that well-being and recovery are accessible to as many people as possible.' The expanded network partnerships represent a major step forward in Discover Health Group's commitment to removing financial barriers to addiction treatment. The organization already accepts most major insurance plans and offers flexible, affordable self-pay options to accommodate different financial situations. Key Network Expansion Details: 'Addiction doesn't discriminate based on insurance status or financial means, and neither should access to quality treatment,' added Greg Moulton. 'These partnerships ensure that more individuals and families can focus on recovery rather than worrying about the cost of care.' For patients currently covered by these insurance plans, the transition to in-network status means reduced out-of-pocket costs and simplified billing processes. Prospective patients are encouraged to verify their specific coverage details and benefits. About Discover Health Group Discover Health Group is a trusted rehab center in Nashua, New Hampshire, offering expert treatment for drug and alcohol addiction. Licensed by the State of NH DHHS, the facility also holds prestigious Joint Commission (JCAHO) accreditation. Services include substance abuse recovery, relapse prevention, behavioral therapy, and care for co-occurring disorders like depression, anxiety, and PTSD, utilizing methods such as Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and holistic options like mindfulness meditation and art therapy. Discover Health Group offers specialized Medication-Assisted Treatment (MAT) for Alcohol Use Disorder (AUD) and Substance Use Disorder (SUD), using FDA-approved medications like Suboxone, Vivitrol, etc. With in-network contracts such as Blue Cross Blue Shield (BCBS), they ensure accessible, affordable care across New Hampshire, Massachusetts, Maine, and Vermont. A professional team guides your journey to a healthier, substance-free life. For more information about Discover Health Group's services or to verify insurance coverage, visit website or call (603) 316-6148. Contact Details: Greg Moulton Mail: [email protected] Phone: (603) 316-6148 To view the source version of this press release, please visit
Yahoo
15-07-2025
- Business
- Yahoo
Thermo Fisher Scientific (TMO) Inks Deal to Manufacture Adial Pharmaceuticals ADO4
Thermo Fisher Scientific Inc. (NYSE:TMO) is one of Goldman Sachs' top healthcare stock picks. On June 25, the company confirmed it had inked a strategic partnership with Adial Pharmaceuticals (NASDAQ:ADIL). A scientist peering into a microscope, exploring innovative diagnostics techniques. Under the terms of the agreement, Thermo Fisher is to become the Contract Development and Manufacturing Organization (CDMO) for AD04 Drug products. The product is being developed as a targeted therapeutic agent for the treatment of Alcohol Use Disorder. On the other hand, Cambrex is to become the drug substance CDMO and supplier of Ondansetron API. The agreements cover all phases of manufacturing for both clinical supplies for ADO4. In addition, the agreements mark the initial steps AS Adial Pharmaceutical plants to conduct ADO4 clinical trials. 'The combination of Thermo Fisher and Cambrex makes for a strong collaboration for Adial in our quest to develop AD04 for the treatment of AUD. Choosing a contract manufacturer that can meet our timelines for starting the clinical program is paramount,' Cary Claiborne, President and Chief Executive Officer of Adial, commented. Thermo Fisher Scientific Inc. (NYSE:TMO) is a healthcare company that provides analytical instruments, specialty diagnostics, laboratory equipment, pharmaceutical and biotechnology services, and clinical development solutions. While we acknowledge the potential of TMO 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: 11 Best Green Energy Penny Stocks to Buy Right Now and 10 Most Popular AI Penny Stocks to Buy According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Associated Press
03-07-2025
- Business
- Associated Press
Clearmind Medicine Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center
Vancouver, Canada, July 03, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) ('Clearmind' or the 'Company'), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable patient enrollment at TASMC, a leading clinical site in Israel, prior to commencing this first-in-human trial at the site. The trial includes other first-in-class institutions, such as Yale School of Medicine's Department of Psychiatry, Johns Hopkins University School of Medicine and Hadassah-University Medical Center in Jerusalem, Israel. The study at TASMC will be led by Dr. David Zeltser, Director of the Emergency Medicine Department and Deputy Director R&D and Innovation. Clearmind recently announced the dosing of the first participant in the trial, marking a historic step toward developing a novel therapy for the millions affected by AUD worldwide. IRB approval from TASMC follows Clearmind's prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application and IRB approvals from other clinical sites. 'We are pleased to receive IRB approval from Tel Aviv Sourasky Medical Center, a renowned institution, for our Phase 1/2a clinical trial,' said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. 'This milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a condition that devastates millions of lives. With TASMC's participation, alongside leading centers like Yale and Johns Hopkins, we believe that we are well-positioned to advance our mission of developing safe, effective, and innovative psychedelic-derived therapies.' Clearmind's clinical trial is a critical step in addressing the global burden of AUD, which accounts for 4.7% of all deaths worldwide, according to the World Health Organization. The Company anticipates further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. The Phase 1/2a clinical trial, a multinational, multi-center study, is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD. About Clearmind Medicine Inc. Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company's intellectual portfolio currently consists of nineteen patent families including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol 'CMND' and the Frankfurt Stock Exchange under the symbol 'CWY0.' For further information visit: or contact: Investor Relations [email protected] Telephone: (604) 260-1566 US: [email protected] General Inquiries [email protected] Forward-Looking Statements: This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as 'expects,' 'anticipates,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates' and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses potentially offering a transformative treatment for individuals struggling with Alcohol Use Disorder, its belief that it is well-positioned to advance its mission of developing safe, effective, and innovative psychedelic-derived therapies and its anticipation of further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ('SEC'), including, but not limited to, the risks detailed in the Company's annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.
