Transcend Therapeutics Presents New Data from the Open-Label Portion of the IMPACT-1 Study and Further Data Supporting the Neuroplasticity Mechanism of TSND-201

New York, Dec. 11, 2024 – Transcend Therapeutics, a clinical-stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases, today presented two posters at the American College of Neuropsychopharmacology (ACNP) Annual Meeting taking place in Phoenix, Arizona, highlighting the promise of TSND-201 for PTSD and other CNS conditions. “This additional clinical and preclinical data gives us further confidence that TSND-201 could offer a rapid-acting, durable alternative to existing PTSD treatments for the 13 million Americans who suffer from PTSD,” said Transcend Therapeutics Co-Founder and CEO Blake Mandell. “We look forward to continuing to advance our ongoing Phase 2 trial of TSND-201 for PTSD and sharing results from the randomized, placebo-controlled portion of the trial in the second quarter of 2025.” Summary of poster presentations: TSND-201 (Methylone) for the Treatment of PTSD: Improvements across each CAPS-5 Cluster and Anxiety Symptoms from the Open-Label Portion of the IMPACT-1 Study TSND-201 demonstrated rapid, robust, and consistent improvements across each PTSD symptom domain (Intrusion, Avoidance, Cognition and Mood, Arousal and Reactivity). Rapid and durable improvement on anxiety symptoms occurred concurrently with PTSD symptom improvement. TSND-201 was generally safe and well tolerated; the most common adverse events (AEs) were headache and decreased appetite. Randomized, placebo-controlled study is ongoing, with results expected in Q2 2025. TSND-201 (Methylone): A Rapid-Acting Neuroplastogen that Stimulates Neurite Outgrowth TSND-201 increases neurite outgrowth and branching via well-studied mechanisms (i.e., monoamines, neurotrophins, and mTor). Preclinical results add to understanding of TSND-201’s mechanism of action. Demonstrates direct neurotrophic effects of TSND-201 for the first time. Confirms that neuroplastic effects are mediated by TSND-201’s known pharmacological targets (serotonin, norepinephrine, dopamine transporters) – connecting the dots between primary pharmacology and long-lasting neuroplasticity. Underscores TSND-201’s potential as a rapid, robust, and long-lasting pharmacotherapy for PTSD and other CNS disorders. About TSND-201 TSND-201 – a rapid-acting neuroplastogen for post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and other mood disorders – is a proprietary formulation of methylone developed by Transcend Therapeutics. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5HT-2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD, major depressive disorder (MDD), and anxiety indications. TSND-201 is an investigational drug product not approved by the FDA. About IMPACT-1 IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder) is a 2-part trial evaluating the safety and efficacy of TSND-201 for the treatment of PTSD. Part A was open-label (positive results announced in December 2023); Part B (currently enrolling) is randomized, double-blind, and placebo-controlled, with results expected in Q2 2025. Eligible participants are adults with a confirmed diagnosis of PTSD using the DSM-5 criteria and a CAPS-5 total severity score of ≥35. Study drug is dosed once a week for 4 weeks. During each of the 4 dosing sessions, participants are accompanied by a trained mentor who provides non-directive psychological support. After the 4-week treatment period, participants attend follow-up visits at 1, 2, 3, and 6 weeks following the last dose. About Transcend Transcend Therapeutics is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for PTSD and other neuropsychiatric disorders. The company’s leadership team has made pivotal contributions to 13 FDA approvals, $3.5B in M&A, and significant public company value creation. Transcend’s goal is to develop TSND-201 across multiple blockbuster indications — PTSD, depression, and anxiety. Transcend has raised approximately $50M to date. Contact : [email protected]

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