Slide 1: NDV-01 12-Month Phase 2 Data
NDV - 01 12 - Month Phase 2 Data March 2026
Slide 2: Disclosures
©2026 Relmada - All rights reserved Disclosures 2 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 Se
Slide 3: TRCG-011 for High-Risk NMIBC Study Design
©2026 Relmada - All rights reserved Inclusion Criteria • High - risk disease with CIS, Ta/T 1 tumors 1, 2 • BCG - naive, BCG - unresponsive, intolerant and experienced patients Purpose Evaluate the potential of NDV - 01 as a safe and effective treatment for patients with high - risk NMIBC Primary En
Slide 4: Demographic Data
©2026 Relmada - All rights reserved Demographic Data 4 % N=48 Characteristics Age 75 (52 - 93) yr Median (range) Sex 87.5% 42 Male 12.5% 6 Female BCG doses 9 (0 - 23) Median BCG doses (range) BCG - status 47.9% 23 BCG - naive 10.4% 5 BCG - exposed 41.7% 20 BCG - unresponsive Stage 25.0% 12 CIS +/ -
Slide 5: Durable Response Over Time
©2026 Relmada - All rights reserved 45. T1 BCG - naive Pending 46. Ta BCG - UR Pending 01 - 044 Ta BCG - naive Pending 01 - 001 T1 BCG - naive Discontinued 01 - 047 Ta BCG - naive Pending 01 - 049 Ta BCG - naive Pending 01 - 050 Ta BCG - naive Pending 01 - 051 Ta BCG - exposed Pending 01 - 052 Ta BC
Slide 6: Efficacy and Tolerability
©2026 Relmada - All rights reserved Efficacy and Tolerability 6 % n/N 95% 36/38 Anytime 87% 33/38 3 - month 86% 25/29 6 - month 85% 22/26 9 - month 76% 19/25 12 - month 83% - 12 - month KM analysis • No patient had progression to muscle invasive disease • No patient underwent a radical cystectomy •
Slide 7: Treatment-Related AE and Tolerability
©2026 Relmada - All rights reserved Treatment - Related AE and Tolerability 7 No patient had ≥ Grade 3 TRAE No patients discontinued treatment due to AEs Of the 48 patients who received ≥ 1 dose of NDV - 01, 30 (63%) had a TRAE • 54% transient uncomfortable urination (dysuria) • 8% asymptomatic posi
Slide 8: BCG-Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS
©2026 Relmada - All rights reserved • Steinberg et al. (2020): n=276; heavily - pre - treated with BCG • 12 - month RFS: • Any CIS = 60% • HG papillary alone = 61% • Cox regression analysis for risk factors: • Presence of CIS does NOT Impact RFS (p=0.15) BCG - Unresponsive NMIBC: The Presence of CIS
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Slide 10: Two Independent Approval Pathways Provide Significant Market Opportunity
©2026 Relmada - All rights reserved Two Independent NDV - 01 Approval Pathways Provide Significant Market Opportunity 10 1. Based on Internal estimates. 2. Grabe - Heyne et al. Front Oncol. 2023. 3. FDA approval summaries; company disclosures; published clinical trial data. NMIBC: Non - muscle invas
Slide 11: Cohort 1: Adjuvant Intermediate-Risk NMIBC Registrational
©2026 Relmada - All rights reserved Cohort 1: Adjuvant Intermediate - Risk NMIBC 11 Registrational Randomized study of TURBT + NDV - 01 vs. TURBT in IR NMIBC Inclusion Criteria • IR NMIBC • IBCG risk factors ≥ 1 Primary Endpoint • DFS* • Safety Intravesical NDV - 01 Induction 6 biweekly instillation
Slide 12: Cohort 2A: 2L BCG-Unresponsive NMIBC
©2026 Relmada - All rights reserved Cohort 2A: 2L BCG - Unresponsive NMIBC 12 Open - label, single - arm study to evaluate safety and efficacy of NDV - 01 in BCG - UR refractory to first - line therapy Study design PHASE 3 RESCUE TRIAL Inclusion Criteria Purpose • HR BCG - UR with CIS refractory to