Reunion Neuroscience Inc. (REUN)

-- AjD Represents an Area of Significant Unmet Need; No U.S. Food and Drug Administration (FDA)-Approved Therapies Available -- -- Following Positive Topline Data in RECONNECT Phase 2 Trial, Expect to Initiate Phase 3 Trial of RE104 in Postpartum Depression (PPD) in 2026 and RECLAIM Phase 2 Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026--

-- Upsized Series A Financing Brings Total Amount Raised to $133 Million -- -- GAD Affects 3.1% of U.S. Adult Population; Minority of Patients Receive Treatment --

-- Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Score on Day 7, a 5.8-Point Greater Reduction Than Patients Treated with 1.5mg Dose (p=0.0094) -- -- Clinically Meaningful Reductions in MADRS Observed for RE104 30mg on the First Day Following Administration and Maintained Through Day 28 Follow-Up --

-- Phase 1 Data Highlight RE104 Favorable Safety Profile and Short Duration Psychoactive Experience -- -- Topline Results from RECONNECT Phase 2 Trial of RE104 in Postpartum Depression (PPD) Anticipated in Q3 2025 --

-- Enrollment Completed on Schedule; Topline Results Expected Q3 2025 -- -- Company to Present Poster Reviewing RE104 Phase 1 Results at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 28, 2025 --

-- 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 --

Reunion to Participate in the ‘New Treatment Options Panel' Discussion at the 2025 Maternal Mental Health FORUM on March 18 at 2:30 p.m. ET

Patient Enrollment Ongoing in Phase 2 RECONNECT Trial of RE104 in Postpartum Depression (PPD); Topline Data Anticipated Mid-2025

MORRISTOWN, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- 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 therapeutic solutions, presented a poster detailing RE104 Phase 1 data at the American College of Neuropsychopharmacology (ACNP) 63rd Annual Meeting in Phoenix, Arizona.

Reunion to Sponsor Scholarships that will Train Healthcare Professionals on Maternal Mental Health Disorders, including Postpartum Depression

MORRISTOWN, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- 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 therapeutic solutions, today announced the appointment of Mark Pollack, M.D., as Chief Medical Officer. Dr. Pollack previously served as a member of Reunion's Advisory Board and is a highly accomplished psychiatrist with decades of leadership experience in neuroscience-focused drug development and clinical research. Pollack replaces Dr. Robert Alexander who will continue to remain involved with Reunion as a strategic advisor.

Initiative Coincides with Start of Reunion's Phase 2 RECONNECT Study in Postpartum Depression Initiative Coincides with Start of Reunion's Phase 2 RECONNECT Study in Postpartum Depression

MORRISTOWN, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a venture backed clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced that the clinical dataset from the Company's Phase 1 study of its lead asset, RE104, will be presented in both a podium and poster at the Anxiety and Depression Association of America (ADAA) Conference taking place April 11-14, 2024, in Boston, MA. The presentations will highlight the Phase 1 findings on RE104, a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, a psilocybin-like compound. In a Phase 1 study, RE104 produced a psychedelic, psychoactive 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. Reunion is evaluating RE104 in patients with underserved mental health disorders, beginning with postpartum depression (NCT06342310).

WILMINGTON, N.C., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a venture backed clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today announced that Greg Mayes, Chief Executive Officer, will participate in the following investor conferences. Please contact your representative to schedule a 1x1 meeting with the company.

WILMINGTON, Del., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2 study of RE104, a novel serotonergic psychedelic compound, for the treatment of postpartum depression (PPD). The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD. The study is expected to begin in Q4 2023 with a targeted data readout in late 2024.

TORONTO, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (TSX: REUN, NASDAQ: REUN) ("Reunion" or the "Company"), a clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions and MPM BioImpact ("MPM") are pleased to announce the completion of the previously announced plan of arrangement (the "Arrangement") effective today, whereby MPM acquired Reunion in an all-cash transaction valued at approximately US$13.1 million by way of a court-approved plan of arrangement under Section 192 of the Canada Business Corporations Act.