Relmada Therapeutics(US:RLMD)2025-11-13 21:07Financial Performance - Relmada reported a net loss of approximately $37.5 million for the nine months ended September 30, 2025, with an accumulated deficit of about $678.4 million[147]. - The net loss for the three months ended September 30, 2025, was approximately $10.09 million, compared to a net loss of $21.73 million for the same period in 2024, representing a decrease of about 53%[156]. - The net loss for the nine months ended September 30, 2025, was approximately $37.52 million, compared to $61.32 million for the same period in 2024, a decrease of about 39%[163]. - The company incurred negative operating cash flows of $31.19 million for the nine months ended September 30, 2025, compared to $42.96 million for the same period in 2024, a reduction of about 27%[170]. - The company reported a decrease in interest/investment income to approximately $247,000 for the three months ended September 30, 2025, down from $856,500 in 2024, a decline of about 71%[155]. - The company had a cash decrease of $2.47 million for the nine months ended September 30, 2025, compared to a decrease of $2.61 million for the same period in 2024[170]. - The company expects to incur additional losses until it can generate significant revenue from the commercialization of its product candidates[167]. Research and Development - The lead product NDV-01 is currently in a Phase 2 clinical trial for aggressive non-muscle invasive bladder cancer (NMIBC), with a complete response rate of 92% at any time and 85% at nine months[139][138]. - Sepranolone, a novel neurosteroid, is expected to initiate a Phase IIb study in Prader-Willi Syndrome in the first half of 2026[125][132]. - The company plans to initiate Phase III programs for NDV-01 targeting high-risk, second-line BCG-unresponsive NMIBC and intermediate-risk patients in the adjuvant setting in the first half of 2026[143]. - NDV-01 allows for a single administration in less than 10 minutes, providing sustained localized chemotherapy for up to 10 days, enhancing therapeutic effects while improving patient convenience[134][135]. - In a Phase 2a study, Sepranolone demonstrated a 28% reduction in tic severity as measured by the YGTSS scoring system, with no off-target CNS effects observed[131][130]. - The ongoing Phase 2 study of NDV-01 involved 36 patients, with 61% experiencing treatment-related adverse events, primarily transient dysuria[138]. Intellectual Property - The company has over 40 issued patents related to Sepranolone and more than 10 issued patents related to NDV-01, potentially providing market exclusivity beyond 2030 and 2038, respectively[149][150]. Strategic Changes - Relmada has restructured its development strategy to focus on acquiring new candidates while pausing work on esmethadone, aiming to diversify its development pipeline[122]. - The FDA has provided feedback indicating that a single-arm trial for NDV-01 in BCG-unresponsive patients may be acceptable, with further discussions planned[141]. Expenses - Research and development expenses for the three months ended September 30, 2025, decreased to approximately $4.04 million from $11.15 million for the same period in 2024, a reduction of about 64%[154]. - General and administrative expenses for the three months ended September 30, 2025, decreased to approximately $6.29 million from $11.86 million for the same period in 2024, a reduction of about 53%[154]. - For the nine months ended September 30, 2025, research and development expenses were approximately $18.81 million, down from $35.18 million in 2024, a decrease of about 53%[161]. Financing Activities - The company closed an underwritten offering of 40,142,000 shares at an offering price of $2.20 per share, generating net proceeds of approximately $94 million[168].