Aankondiging • Jul 23
Reunion Neuroscience Inc. Announces First Patient Dosed in Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression Reunion Neuroscience Inc. announced that the first patient has been dosed in the RECONNECT Phase 2 clinical trial of RE104 for the treatment of postpartum depression (PPD). RE104 was designed to be a safe, fast-acting, single-dose therapy to benefit patients suffering from underserved mental health disorders, including PPD. The RECONNECT Phase 2 clinical trial (NCT06342310) is a multicenter, randomized, double-blind, parallel-group, active dose-controlled clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. The primary endpoint of the trial is the change in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a 10-item clinician rated scale measuring depression severity from baseline, at Day 7. Key secondary endpoints include the change in total MADRS score from baseline at Day 1, 14 and 28, MADRS response indicating a = 50% reduction in symptoms, MADRS remission with a score of = 10, as well as safety and tolerability. 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. Reunion is actively evaluating the use of RE104 in additional neuropsychiatric indications, including adjustment disorder in cancer patients, where there remains a significant unmet need that is not addressed by the current standard of care. Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy and is estimated to affect approximately 10-15% of all mothers of newborns. PPD is a form of major depression that can severely impact women and their families. According to the Centers for Disease Control and Prevention, the leading underlying cause of pregnancy-related death during the first postpartum year are due to mental health conditions, with suicide being the leading manner of death. Women suffering from PPD often experience significant changes in mood, appetite and sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest. Aankondiging • Sep 20
Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate A Phase 2 Study of Re104 for the Treatment of Postpartum Depression Reunion Neuroscience Inc. 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 fourth quarter 2023 with a targeted data readout in late 2024. Aankondiging • Aug 19
Reunion Neuroscience Inc. Files Form 15 Reunion Neuroscience Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Shares under the Securities Exchange Act of 1934, as amended. Aankondiging • Aug 02
Reunion Neuroscience's Shares to Be De-Listed from the Toronto Stock Exchange on the Close of Markets on or Around August 2, 2023 Reunion Neuroscience Inc. and MPM BioImpact ("MPM") announced the completion of the previously announced plan of arrangement (the "Arrangement") effective August 1, 2023, whereby MPM acquired Reunion in an all-cash transaction valued at approximately USD 13.1 million by way of a court-approved plan of arrangement under Section 192 of the Canada Business Corporations Act. Pursuant to the terms and conditions of a definitive arrangement agreement entered into by Reunion and affiliates of MPM on May 31, 2023, all holders of outstanding common shares ("Shares") of Reunion are entitled to receive USD 1.12 in cash for each Share held immediately prior to the effective time of the Arrangement. As previously announced, the Arrangement was approved by shareholders of the Company at its special meeting of shareholders held on July 12, 2023 and by the Ontario Superior Court of Justice (Commercial List) on July 14, 2023. With the completion of the Arrangement, the Shares are expected to be de-listed from the Toronto Stock Exchange on the close of markets on or around August 2, 2023. The Company is in the process of applying to cease to be a reporting issuer under applicable Canadian securities laws. The Shares will be delisted from the Nasdaq Global Select Market and deregistered under the Securities Exchange Act of 1934, as amended. New Risk • Jun 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$28m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$28m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$83m net loss in 3 years). Market cap is less than US$100m (US$12.8m market cap). Aankondiging • Jun 03
MPM Asset Management, L.L.C. entered into a definitive arrangement agreement to acquire Reunion Neuroscience Inc. (TSX:REUN) for CAD 17.7 million in a going private transaction. MPM Asset Management, L.L.C. entered into a definitive arrangement agreement to acquire Reunion Neuroscience Inc. (TSX:REUN) for CAD 17.7 million in a going private transaction on May 31, 2023. MPM would
acquire Reunion in an all-cash transaction valued at approximately $13.1 million (CAD 17,809,536). Pursuant to the terms and conditions, Reunion shareholders shall receive CAD 1.52 per share. Post deal completion, Reunion will no longer be traded or listed on any public securities exchange and will be wholly-owned by affiliates of MPM. Reunion's board of directors has unanimously approved the transaction. Completion of the Arrangement remains subject to the approval of the Shareholders at the Meeting, obtaining all applicable regulatory approvals, including approval of the Ontario Superior Court of Justice (Commercial List) (the "Court") of the Arrangement and the net cash held by the Company being equal to or greater than $8 million (CAD 10,876,052) as of the close of business. Shareholders meeting is scheduled on July 12, 2023. The deal is expected to close in the calendar third quarter of 2023. Oppenheimer & Co. Inc. is serving as exclusive financial advisor to the Special Committee of the Board of Directors of Reunion and PI Financial Corp. rendered a fairness opinion to Reunion, and Bennett Jones LLP and Steven Cohen, Veronica DiCamillo and Jacqueline Berman of Morgan, Lewis & Bockius LLP are serving as legal advisors. McCarthy Tétrault LLP and Wilmer Cutler Pickering Hale and Dorr LLP are serving as legal advisors to MPM. Aankondiging • Feb 03
Reunion Neuroscience Inc. to Report Q3, 2023 Results on Feb 14, 2023 Reunion Neuroscience Inc. announced that they will report Q3, 2023 results Pre-Market on Feb 14, 2023 Aankondiging • Jan 19
Reunion Neuroscience Appoints Robert Alexander as Chief Medical Officer Reunion Neuroscience Inc. announced that it has appointed Robert Alexander, M.D. as the Company’s Chief Medical Officer, effective immediately. Dr. Alexander will report to Greg Mayes, Reunion’s President and CEO. Dr. Alexander previously served as Vice President and Head, Clinical Science, in the Neuroscience Therapeutic Area Unit at Takeda Pharmaceuticals, managing all clinical trials in neuroscience from Phase 1 through 3. Prior to Takeda, Dr. Alexander served as Chief Medical Officer, BioTherapeutics, at Pfizer, directing clinical pharmacology and statistics groups while simultaneously holding the position of Vice President and Head of the Clinical Neuroscience and Pain Research Unit at the company. Dr. Alexander also held various other senior leadership roles at AstraZeneca, GlaxoSmithKline (GSK) and Merck & Co and received his M.D. degree from The University of Chicago Pritzker School of Medicine. He is certified by the American Board of Psychiatry and Neurology and specializes in psychopharmacology, having conducted or supervised clinical studies in a broad range of neurologic and psychiatric indications. Aankondiging • Jan 10
Reunion Neuroscience Inc. Completes Interim Data Analysis for Phase 1 Clinical Trial with Novel Serotonergic Psychedelic Re104 Reunion Neuroscience Inc. announced that the Company has completed the interim data analysis for its Phase 1 clinical trial with lead asset RE104, a unique 4-OH-DiPT prodrug. RE104 is a proprietary, novel serotonergic sychedelic compound that Reunion is developing as a potential fast-acting and durable treatment for patients suffering from postpartum depression and other mental health conditions. In this first-in-human, Phase 1 study, RE104 was shown to be safe and well tolerated, with no serious or severe adverse events. The interim analysis included 32 healthy volunteers across four ascending dose cohorts, with two of the eight subjects in each cohort receiving placebo. RE104 showed robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience relative to published data with psilocybin (approximately three to four hours for RE104 versus six to eight hours for psilocybin). Reunion also identified a dose level whereby the majority of participants receiving a single administration of RE104 achieved a "complete mystical experience," defined as a score of at least 60% in each of the four domains of the validated Mystical Experience Questionnaire (MEQ30). A complete mystical experience has been shown to correlate with psychedelic treatment responses in clinical trials of patients with depression, anxiety and substance use disorder.(3-5)Reunion plans to share results from its Phase 1 study with the U.S. Food and Drug Administration (FDA) as part of a pre-Investigational New Drug (IND) meeting in preparation for Phase 2 development in postpartum depression. The Company will also submit the data to an upcoming 2023 major medical congress. While completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee (SRC), Reunion has continued with dose escalation and initiated a fifth cohort. The Phase 1 protocol also includes the option to dose a sixth cohort with eight subjects should the SRC or the Company seek additional safety, pharmacokinetics and pharmacodynamics data. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. President, CEO & Director Greg Mayes was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Nov 03
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Co-Founder & Non-Independent Director Hannan Fleiman is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Aug 25
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Independent Director Dieter Weinand is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Apr 27
High number of new directors Independent Lead Director Barry Fishman was the last director to join the board, commencing their role in 2021. Board Change • Mar 31
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. CO-Founder, President & Director Hannan Fleiman is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Feb 17
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: CA$0.26 loss per share (down from CA$0.22 loss in 3Q 2021). Net loss: CA$15.0m (loss widened 81% from 3Q 2021). Revenue missed analyst estimates by 11%. Earnings per share (EPS) exceeded analyst estimates by 14%. Over the next year, revenue is forecast to grow 440%, compared to a 10.0% growth forecast for the industry in the US. Reported Earnings • Nov 18
Second quarter 2022 earnings released: CA$0.23 loss per share (vs CA$0.16 loss in 2Q 2021) Second quarter 2022 results: Net loss: CA$13.0m (loss widened 231% from 2Q 2021). Board Change • Sep 14
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Member of Medical Advisory Board Matt Johnson was the last director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Sep 08
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Member of Medical Advisory Board Matt Johnson was the last director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 18
First quarter 2022 earnings released: CA$0.22 loss per share (vs CA$1.69 loss in 1Q 2021) First quarter 2022 results: Net loss: CA$12.5m (loss widened 324% from 1Q 2021). Board Change • Jul 30
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Member of Medical Advisory Board Matt Johnson was the last director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.