Psilocybin

-- AjD is a Mental Health Condition Triggered By a Stressful Life Event; Particularly Common in People with Serious Medical Illness -- -- AjD Represents an Area of Significant Unmet Need; No FDA-Approved Therapies Currently Available -- -- Expansion of Clinical Development Program into AjD in Cancer and Other Medical Illnesses Reflects Broad Potential of RE104 to Revolutionize Mental Health Treatment -- -- Initiation of REKINDLE Phase 2 Trial Expected Mid-2025 -- April 07, 2025 -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, presented the study design for the REKINDLE Phase 2 clinical trial, which will evaluate the safety and efficacy of RE104 for the treatment of adjustment disorder (AjD) in patients with cancer and other medical illnesses. The study design was presented in a poster session at the Anxiety & Depression Association of America (ADAA) 2025 Conference, held April 3-5, 2025, in Las Vegas, NV. A copy of the poster is available at www.reunionneuro.com/science/#publications. AjD is a mental health condition defined as a disproportionate reaction to a stressful life event or change, which impacts the ability to function and is characterized by depression, anxiety and/or other behavioral and mood disturbances. Serious medical illnesses are known to be a key precipitant of AjD; it is estimated that approximately 500,000 people in the United States are diagnosed with AjD each year following a medical or health-related stressor. Depressive and anxiety symptoms in medically ill patients with AjD can be associated with poorer medical outcomes, treatment compliance and quality of life as well as increased health care utilization. Current treatments for AjD are not consistently effective, and there are no therapies presently approved by the U.S. Food and Drug Administration (FDA) for its treatment. With RE104, the only psychedelic therapeutic in advanced clinical development for an AjD indication in the United States, Reunion Neuroscience aims to offer patients an effective, safe and fast-acting psychotropic medication to relieve distress and dysfunction in patients with AjD. “The unveiling of our REKINDLE Phase 2 clinical trial marks an important step in our efforts to expand the clinical development of RE104. Similar to postpartum depression (PPD), where we are currently evaluating RE104 in the RECONNECT Phase 2 clinical trial, AjD is a devastating psychiatric condition that meaningfully impacts quality of life and is often marked by depression and/or anxiety,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “With RE104, we believe we can leverage the power of 4-OH-DIPT to offer a rapid onset, short duration psychedelic experience that delivers immediate, substantial and sustained improvement to patients with AjD. We look forward to initiating REKINDLE in mid-2025 as we pursue our mission of transforming the care and treatment of mental health disorders through the advancement of next-generation psychedelic-inspired solutions.” The REKINDLE Phase 2 clinical trial is a randomized, double-blind, parallel-group, dose-controlled clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. The primary endpoint of the trial is the change in total Montgomery-Asberg Depression Rating Scale (MADRS) score, a clinician rated scale measuring depression severity from baseline, at Day 14. A key secondary endpoint of the trial is the change in Hamilton Anxiety Scale (HAM-A), a clinician rated scale measuring anxiety severity from baseline, at Day 14. The study will also assess safety and tolerability of RE104. “AjD represents a significant unmet need -- it is debilitating both in its own right, and in the impact it can have on overall health outcomes in patients suffering from medical illnesses,” said Mark Pollack, M.D., Chief Medical Officer of Reunion Neuroscience. “The importance of treating mental health in parallel with serious diseases is becoming increasingly well-recognized, and we are eager to introduce RE104 as an innovative solution, which can potentially rescue patients from the impact depression and anxiety may otherwise have on their physical well-being and recovery. As we approach mid-2025, we look forward to announcing initial data for RE104 in PPD, a disease that manifests much like AjD, and to initiating the REKINDLE trial.” Reunion Neuroscience is also evaluating RE104 in RECONNECT (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit www.ppdreconnectstudy.com. The Company’s lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin. In a Phase 1 clinical trial, RE104 produced a psychedelic state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours), while demonstrating a similar, favorable safety profile. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe postpartum depression (PPD) patients. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit www.ppdreconnectstudy.com. Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in AjD in cancer and other medical illnesses in mid-2025. Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In 2023, Reunion Neuroscience became a private company and in 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression and adjustment disorder, as well as in additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. The content above comes from the network. if any infringement, please contact us to modify.

The University of Pennsylvania-sponsored trial will study PEX010 for the treatment of opioid use disorder and the effect on neurocognitive, behavioural, and clinical outcomes Vancouver, British Columbia, April 9, 2025 – Filament Health Corp. (OTCQB:FLHLF) (CBOE:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announces that the United States Food and Drug Administration (FDA) has authorized a phase 2 clinical trial study of its lead drug candidate, PEX010, at the University of Pennsylvania. The trial will study the effects of psychedelic-assisted psychotherapy (PAP) in the treatment of opioid use disorder (OUD), and is funded by the Wellcome Leap, a non-profit organization focused on accelerating breakthroughs in human health, as part of its Untangling Addiction Program. “Opioid use disorder is a significant public health issue and a major contributor to the growing overdose crisis in North America,” said Dr. Anna Rose Childress, Director of the Brain-Behavioral Vulnerabilities Laboratory at the Perelman School of Medicine and Principal Investigator for the trial. “This trial will assess the safety and feasibility of delivering natural psilocybin in the treatment of OUD, and evaluate potential changes in participants’ opioid use. We are grateful to Filament Health for facilitating this important research.” Escalating cases of OUD worldwide emphasize a critical need for the development of innovative treatments that address associated challenges, including neurocognitive difficulties and poor clinical outcomes such as relapse and non-adherence to life-saving opioid medications. Preliminary findings with PEX010 in alcohol use disorder have encouraged testing in the opioid domain, where overdose deaths in the US exceed 80,000 per year. The studies with PEX010 in OUD will be an important initial step in determining the medication’s promise in addressing the opioid crisis. The clinical trial at the University of Pennsylvania will focus on the impact of PEX010 on clinical outcomes, with additional measures (e.g., neurocognition) to help predict which patients may be most likely to benefit from this treatment option. “We’re thrilled to announce FDA authorization for the study of PEX010 at one of the world's most esteemed medical institutions,” said Lisa Ranken, Chief Operating Officer at Filament Health. “This significant achievement highlights our key role in facilitating psychedelic research as a leading supplier of clinical-grade natural psilocybin.” “This trial reflects the kind of bold, high-impact work we envisioned when launching the Untangling Addiction program,” said Dr. Kevin Jones, Program Director at Wellcome Leap. “Dr. Childress and her team are renowned leaders in addiction neuroscience, and we’re proud to support their effort to explore psilocybin-assisted therapy for opioid use disorder. This study is a key part of our mission to advance innovative, neuroscience-driven approaches to understanding and treating addiction.” The trial at the University of Pennsylvania is expected to begin dosing in by Q3 2025. PEX010 is authorized for investigation in 51 clinical trials worldwide for 14 mental health indications. Closing of Private Placement Filament Health also announces that further to its press release dated April 3, 2025, it has completed its previously announced financing for total net proceeds of over C$960,000, an increase from its planned offering of C$900,000. ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS) Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates. Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn. Anna Cordon, Vice President, Marketing & Communications anna@filament.health ir@filament.health Certain statements and information contained in this press release and the documents referred to herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws. ‍