Relmada Therapeutics(US:RLMD)2025-05-12 20:06Clinical Programs - Relmada has paused the REL-1017 program for Major Depressive Disorder (MDD) after interim analysis indicated it was unlikely to meet primary efficacy endpoints[113]. - NDV-01 is currently in a Phase 2 clinical trial, with initial data showing a 100% disease-free status in evaluable patients at the 6-month assessment[132]. - Sepranolone demonstrated a 28% reduction in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) in a Phase 2a study[123]. - The company anticipates key milestones over the next 12 months, including the initiation of clinical trials for Sepranolone in Prader-Willi syndrome in the first half of 2026[119]. - NDV-01 allows for a single administration of chemotherapy in less than 10 minutes, providing sustained localized treatment for up to 10 days[126]. - The overall response rate for NDV-01 in the ongoing Phase 2 study is reported at 85% with no treatment-related adverse events greater than Grade 1[139]. - Relmada has terminated the psilocybin program due to strategic review and changing regulatory landscapes[137]. Financial Performance - The company reported a net loss of approximately $17,559,500 for the three months ended March 31, 2025, compared to a net loss of $21,828,100 for the same period in 2024, representing a decrease of approximately 19%[153]. - Total operating expenses decreased to $18,218,435 for the three months ended March 31, 2025, down from $22,987,860 in 2024, a reduction of approximately 21%[149]. - Research and development expenses were approximately $11,951,000 for the three months ended March 31, 2025, down from $13,305,300 in 2024, a decrease of approximately 10%[150]. - General and administrative expenses decreased to approximately $6,267,400 for the three months ended March 31, 2025, compared to $9,682,600 in 2024, a reduction of approximately 65%[150]. - Cash used in operating activities was $18,067,033 for the three months ended March 31, 2025, compared to $13,036,748 in 2024, indicating an increase in cash outflow of approximately 39%[157]. - The company had an accumulated deficit of approximately $658,441,500 as of March 31, 2025[142]. Strategic Focus - The company aims to prioritize mid- to late-stage programs to concentrate resources on assets with clear paths to commercialization[118]. - Relmada's strategic review has led to a refined approach focused on maximizing shareholder value through pipeline diversification and addressing unmet medical needs[115]. Intellectual Property and Regulatory Designations - The company has more than 40 issued patents and pending patent applications related to Sepranolone, potentially providing market exclusivity beyond 2030[144]. - The company has secured an Orphan Drug Designation from the FDA for d-methadone, which carries 7-year marketing exclusivity upon potential NDA approval[146]. Liquidity Concerns - The company is projecting insufficient liquidity to sustain operations through one year following the issuance of the financial statements[155]. - Management is evaluating financing strategies, including public or private sales of equity or debt securities, to address liquidity concerns[156].