Summary of Relmada Therapeutics Conference Call Company Overview - **Company Name**: Relmada Therapeutics - **Ticker Symbol**: RLMD - **Public Listing**: NASDAQ since 2019, public since 2014 - **Focus Area**: Central nervous system and oncology, specifically bladder cancer treatment [2][3] Key Developments - **Strategic Shift**: The company has adopted a new strategy to lower risk while maintaining upside potential, leading to the acquisition of two programs [3] - **NDB-01**: The most advanced program, focusing on non-muscle invasive bladder cancer, which constitutes about 75% of bladder cancer cases [4][5] - **Sopranolol**: An early-stage program for treating compulsive disorders, with potential applications in Tourette's syndrome and Prader-Willi syndrome [25][26] Bladder Cancer Insights - **Prevalence**: Bladder cancer accounts for 1 in 25 cancers in the U.S., with approximately 70,000 to 80,000 new cases annually [5][6] - **Patient Demographics**: Primarily affects older men, with an average disease duration of around 10 years [5] - **Recurrence Rate**: High recurrence, with 50% of patients experiencing recurrence within one year and 70-80% within two years [6] Treatment Landscape - **Current Treatments**: Include surgery (TURBT), BCG immunotherapy, and chemotherapy [7][9] - **Challenges with BCG**: BCG is difficult to tolerate and has been in shortage for several years [9] - **Emerging Chemotherapy**: The combination of gemcitabine and docetaxel (referred to as Gendoza) is effective but has limitations in administration and preparation [12][13] NDB-01 Advantages - **Delivery Method**: NDB-01 is an extended-release gel that allows for easier administration of chemotherapy directly in the bladder [14][15] - **Efficacy**: Early data shows a 90% cancer-free rate at six months in the ongoing phase 2 study [19][20] - **Market Position**: Competes with products from Johnson & Johnson and UroGen, which have higher treatment costs [21][22][23] Financial Overview - **Cash Position**: As of the end of Q2, the company had $20.6 million in cash and equivalents [28] - **Share Structure**: 33.2 million shares outstanding, indicating a clean balance sheet [28] - **Future Financing**: The company acknowledges the need for future financing to support clinical trials but does not anticipate immediate needs [41] Market Potential - **Treatment Costs**: UroGen's treatment costs $21,000 per treatment, while Johnson & Johnson's is $69,000, indicating a significant market opportunity for NDB-01 [22][23] - **Annual Procedures**: There are approximately 100,000 surgeries annually for non-muscle invasive bladder cancer in the U.S., suggesting substantial revenue potential [23] Conclusion - **Regulatory Path**: Plans to discuss with the FDA in Q4 and aim to start registration studies in Q2 2026 [24] - **Insider Confidence**: Recent insider buying by executives indicates confidence in the company's future [45][46] This summary encapsulates the key points from the Relmada Therapeutics conference call, highlighting the company's strategic direction, product developments, market landscape, and financial positioning.