Full Press Release Details
Unlocking Life Changing Therapies October 2025 C O R PO R AT E O VER VI E W 2025 Relmada - All rights reserved Disclosures The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward - looking statements made by us or on our behalf . This press release contains statements which constitute "forward - looking statements" within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 . Any statement that is not historical in nature is a forward - looking statement and may be identified by the use of words and phrases such as "if", "may", "expects", "anticipates", "believes", "will", "will likely result", "will continue", "plans to", "potential", "promising", and similar expressions . 2 These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward - looking statements, including potential for Phase 2 NDV - 01 data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top - line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for sepranolone, and NDV - 01 , or that future sepranolone, or NDV - 01 clinical results will be acceptable to the FDA, failure to secure adequate sepranolone, or NDV - 01 drug supply, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time . No forward - looking statement can be guaranteed, and actual results may differ materially from those projected . Relmada undertakes no obligation to publicly update any forward - looking statement, whether as a result of new information, future events, or otherwise . Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list . This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction . 2025 Relmada - All rights reserved 3 Innovative pipeline of potential high - value assets Focused on programs with positive proof - of - concept data Status / potential next steps Potential populations Phase 3 Phase 2 Phase 1 Candidate / indication Q1 2026: 12 Month data H2 2025: FDA interaction and product supply scale up H1 2026: Initiate Phase 3 study NMIBC US prevalence: 600K patients 3 68K new US patients with NMIBC 2, 5, 6 NDV - 01 1 Non - muscle invasive bladder cancer (NMIBC) Q4 2025: Prep for next studies, including manufacturing H1 2026: Initiate Phase 2b study WW prevalence: 350K to 400K patients 4 Sepranolone Prader - Willi Syndrome (PWS) YE 2025: Identify next opportunity Including TS, Essential Tremor, OCD and other compulsivity - related indications Sepranolone Other indications 1. NDV - 01: A sustained - release intravesical formulation of gemcitabine/docetaxel (Gem/Doce); 2. Holzbeierlein et al. ("Diagnosis and Treatment of Non - Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment"); 3. Markets, Research And. "Non - muscle Invasive Bladder Cancer (NMIBC) Epidemiology Forecasts to 2034." GlobeNewswire News Room , 25 Jan. 2024; 4. Scheimann, Ann O. "Prader - Willi syndrome: Clinical features and diagnosis." UpToDate , edited by Mitchell E Geffner et al., 6 Feb. 2023