This May be One of the Biggest Catalysts for Psychedelic Stocks in 2024 February 16, 2024 - Baystreet.ca About 43.8 million adults in the U.S. experience a mental health issue in a given year, according to the National Institute of Mental Health (NAMI). Nearly 16 million of those adults live with major depression. Another 18.1% live with anxiety disorders. And, according to Time.com, “From 2019 to 2022—use of mental-health services jumped by almost 40% among millions of U.S. adults with commercial insurance.” However, something isn’t working, and the state of mental health just in the U.S. is getting worse. Plus, as also noted by Time.com, “More people seem to be struggling in the wake of societal disruptions like the pandemic and the Great Recession, driving up demand on an already-taxed system such that some people can't get the support they want or need.” However, there is good news. Mental health companies, such as Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF), Compass Pathways (NASDAQ: CMPS), Seelos Therapeutics (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI), and Mind Medicine (NASDAQ: MNMD) (NEO: MMED) are finding that psychedelics, such as MDMA could be a game-changer for mental health issues, such as PTSD. It may even be one of the biggest catalysts for related psychedelics stocks this year. In fact, as noted by TheHill.com, “A federal agency may soon approve the use of MDMA, also known as ecstasy, to help treat post-traumatic stress disorder (PTSD). Advocates and lawmakers across the political spectrum are optimistic about its chances for approval and pushing for a speedy rollout of so-called “MDMA-assisted therapy,” which they say could finally reduce the more than 6,000 veterans who die by suicide each year. One of the companies that could benefit is Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF) Numinus Wellness Inc., a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, is pleased to announce the closing of its previously announced "bought deal" public offering of 50,000,000 units at a price of $0.12 per Unit for aggregate gross proceeds to Numinus of $6,000,000. Each Unit consists of one common share in the capital of Numinus and one Common Share purchase warrant of Numinus. Each Warrant is exercisable to acquire one Common Share for a period of 24 months from closing of the Offering at an exercise price of $0.18 per Common Share. "Numinus is at an important stage. As the new drug application for MDMA was recently accepted by the United States Food and Drug Administration, our clinical research team is continuing to work with exciting new drugs and treatments and our training platform is helping to address the critical need for practitioners to provide psychedelic-assisted therapy," said Payton Nyquvest, Numinus' Founder and CEO. "This financing provides us the resources to act on opportunities and demonstrates support for our work in the markets. This, along with Dr. Rick Doblin, the Founder and President of the Multidisciplinary Association for Psychedelic Studies, joining us as an unpaid, non-exclusive strategic adviser, bolsters our efforts to provide much-needed transformative care." Dr. Rick Doblin stated: "Numinus is making important strides in the mental health field with its strategic focus and thoughtful positioning. Their approach, particularly through the proposed clinical trial for experiential training, is well-designed to equip therapists with the depth of understanding needed to effectively support individuals dealing with trauma." Dane Stevens, co-founder of Optimi Health Corp, a holder of a Health Canada Dealers License, which participated in the Offering and is committed to support Numinus' future initiatives said: "We are proud to support Numinus in their strategic endeavours to ultimately expanding access to psychedelic assisted therapy. Supporting the work they are doing in their industry-leading clinics and their training efforts is an important step towards ensuring access." Numinus intends to use the proceeds of the Offering for working capital and general corporate purposes. Other related developments from around the markets include: Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, announced that that they have entered into a research collaboration agreement to inform the delivery model design of investigational COMP360 psilocybin treatment, if FDA-approved. The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved. COMP360 is Compass’s investigational proprietary formulation of synthetic psilocybin, administered in conjunction with psychological support. Seelos Therapeutics, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced the receipt of minutes from its End of Phase II Meeting with the FDA. In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS and the 24-hour Sheehan- Suicidality Tracking Scale. atai Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced a strategic investment in Beckley Psytech Limited, a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. Mind Medicine provided a corporate update and outlook for 2024. "Our strong progress in 2023 culminated in the delivery of statistically and clinically significant topline results for our lead program (MM-120) in our Phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes," said Rob Barrow, CEO and Director of MindMed. "We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into Phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our Phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel’s one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our Phase 3 development program for MM-120 in GAD and expect to hold our End-of-Phase 2 meeting with FDA in the first half of the year with initiation of our Phase 3 clinical program in the second half of the year." Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Numinus Wellness Inc. by Numinus Wellness Inc. We own ZERO shares of Numinus Wellness Inc. Please click here for disclaimer. Contact: Ty Hoffer Winning Media281.804.7972Ty@winning.media
This May be One of the Biggest Catalysts for Psychedelic Stocks in 2024 February 16, 2024 - Baystreet.ca About 43.8 million adults in the U.S. experience a mental health issue in a given year, according to the National Institute of Mental Health (NAMI). Nearly 16 million of those adults live with major depression. Another 18.1% live with anxiety disorders. And, according to Time.com, “From 2019 to 2022—use of mental-health services jumped by almost 40% among millions of U.S. adults with commercial insurance.” However, something isn’t working, and the state of mental health just in the U.S. is getting worse. Plus, as also noted by Time.com, “More people seem to be struggling in the wake of societal disruptions like the pandemic and the Great Recession, driving up demand on an already-taxed system such that some people can't get the support they want or need.” However, there is good news. Mental health companies, such as Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF), Compass Pathways (NASDAQ: CMPS), Seelos Therapeutics (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI), and Mind Medicine (NASDAQ: MNMD) (NEO: MMED) are finding that psychedelics, such as MDMA could be a game-changer for mental health issues, such as PTSD. It may even be one of the biggest catalysts for related psychedelics stocks this year. In fact, as noted by TheHill.com, “A federal agency may soon approve the use of MDMA, also known as ecstasy, to help treat post-traumatic stress disorder (PTSD). Advocates and lawmakers across the political spectrum are optimistic about its chances for approval and pushing for a speedy rollout of so-called “MDMA-assisted therapy,” which they say could finally reduce the more than 6,000 veterans who die by suicide each year. One of the companies that could benefit is Numinus Wellness Inc. (TSX: NUMI) (OTC: NUMIF) Numinus Wellness Inc., a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, is pleased to announce the closing of its previously announced "bought deal" public offering of 50,000,000 units at a price of $0.12 per Unit for aggregate gross proceeds to Numinus of $6,000,000. Each Unit consists of one common share in the capital of Numinus and one Common Share purchase warrant of Numinus. Each Warrant is exercisable to acquire one Common Share for a period of 24 months from closing of the Offering at an exercise price of $0.18 per Common Share. "Numinus is at an important stage. As the new drug application for MDMA was recently accepted by the United States Food and Drug Administration, our clinical research team is continuing to work with exciting new drugs and treatments and our training platform is helping to address the critical need for practitioners to provide psychedelic-assisted therapy," said Payton Nyquvest, Numinus' Founder and CEO. "This financing provides us the resources to act on opportunities and demonstrates support for our work in the markets. This, along with Dr. Rick Doblin, the Founder and President of the Multidisciplinary Association for Psychedelic Studies, joining us as an unpaid, non-exclusive strategic adviser, bolsters our efforts to provide much-needed transformative care." Dr. Rick Doblin stated: "Numinus is making important strides in the mental health field with its strategic focus and thoughtful positioning. Their approach, particularly through the proposed clinical trial for experiential training, is well-designed to equip therapists with the depth of understanding needed to effectively support individuals dealing with trauma." Dane Stevens, co-founder of Optimi Health Corp, a holder of a Health Canada Dealers License, which participated in the Offering and is committed to support Numinus' future initiatives said: "We are proud to support Numinus in their strategic endeavours to ultimately expanding access to psychedelic assisted therapy. Supporting the work they are doing in their industry-leading clinics and their training efforts is an important step towards ensuring access." Numinus intends to use the proceeds of the Offering for working capital and general corporate purposes. Other related developments from around the markets include: Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, announced that that they have entered into a research collaboration agreement to inform the delivery model design of investigational COMP360 psilocybin treatment, if FDA-approved. The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved. COMP360 is Compass’s investigational proprietary formulation of synthetic psilocybin, administered in conjunction with psychological support. Seelos Therapeutics, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced the receipt of minutes from its End of Phase II Meeting with the FDA. In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS and the 24-hour Sheehan- Suicidality Tracking Scale. atai Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced a strategic investment in Beckley Psytech Limited, a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. Mind Medicine provided a corporate update and outlook for 2024. "Our strong progress in 2023 culminated in the delivery of statistically and clinically significant topline results for our lead program (MM-120) in our Phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes," said Rob Barrow, CEO and Director of MindMed. "We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into Phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our Phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel’s one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our Phase 3 development program for MM-120 in GAD and expect to hold our End-of-Phase 2 meeting with FDA in the first half of the year with initiation of our Phase 3 clinical program in the second half of the year." Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Numinus Wellness Inc. by Numinus Wellness Inc. We own ZERO shares of Numinus Wellness Inc. Please click here for disclaimer. Contact: Ty Hoffer Winning Media281.804.7972Ty@winning.media