Uy Ear

Basma Radwan Ibrahim

Andrea Newkirk

Andrew Tsai

Charles

Lin Tsai

Matthew Barcus

- Relmada Therapeutics has shifted its strategy to acquire lower-risk programs, with a primary focus on **NDB-01** for non-muscle invasive bladder cancer (NMIBC).  **[1553643_2147283_1]** 
- The Phase 2 study for NDB-01 showed **90% of patients were cancer-free at six months**, which the company believes is the highest number ever seen for preventing bladder cancer recurrence.  **[1553643_2147283_4]** 
- NDB-01 is an extended-release gel combining gemcitabine and docetaxel, designed for easy administration in a doctor's office, addressing current treatment limitations.  **[1553643_2147283_3]** 
- Competitor products from UroGen and Johnson & Johnson are priced between **$120,000 and $690,000 annually**, indicating significant revenue potential for NDB-01.  **[1553643_2147283_5]** 
- As of the end of the second quarter, the company held **$20.6 million in cash and cash equivalents** and had 33.2 million shares outstanding, with plans to start NDB-01's registration study in Q2 2026.  **[1553643_2147283_5]** **[1553643_2147283_6]**

Relmada Therapeutics Provides Update on NDB-01 Phase 2 Results and Strategic Direction

- RELMADA THERAPEUTICS, INC. filed a Form 8-K on **September 17, 2025**, furnishing an updated corporate presentation.  **[1553643_0001213900-25-088360_ea0257659-8k_relmada.htm:0]** **[1553643_0001213900-25-088360_ea025765901ex99-1_relmada.htm:0]** 
- The company's NDV-01 program, a sustained-release intravesical formulation for Non-muscle invasive bladder cancer (NMIBC), demonstrated strong efficacy in its ongoing Phase 2 TRCG-011 study, reporting an **anytime Complete Response Rate of 91%** and a **6-month Complete Response Rate of 90%**.     Relmada plans to initiate a Phase 3 study for NDV-01 in **H1 2026**.  **[1553643_0001213900-25-088360_ea025765901ex99-1_relmada.htm:0]**  
- Sepranolone, a candidate for Prader-Willi Syndrome (PWS), has positive Phase 2 data  **[1553643_0001213900-25-088360_ea025765901ex99-1_relmada.htm:0]** **[1553643_0001213900-25-088360_ea025765901ex99-1_relmada.htm:8]** , and the company expects to initiate a pilot Phase 2 study in PWS in **H1 2026**.    
- As of **June 30, 2025**, Relmada Therapeutics reported **$20.6 million** in cash, cash equivalents, and short-term investments, with **no outstanding debt**.

RELMADA THERAPEUTICS (RLMD)