Relmada Therapeutics(RLMD) - 2025 Q3 - Quarterly Results

Clinical Development - NDV-01 program achieved a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC) with favorable safety[1] - FDA alignment secured for Phase 3 program with two independent paths for approval in high-risk BCG-unresponsive and intermediate-risk NMIBC settings[5] - Expected milestones include the initiation of Phase 3 trials for NDV-01 in high-risk and intermediate-risk NMIBC in the first half of 2026[14] - Sepranolone's Phase 2 proof of concept clinical trial for Prader-Willi Syndrome is also expected to initiate in the first half of 2026[14] Financial Performance - Net loss for Q3 2025 was $10.1 million or $0.30 per share, compared to a net loss of $21.7 million or $0.72 per share in Q3 2024[14] - Net loss for the nine months ended September 30, 2025, was $37,517,403, a reduction of 38.7% compared to a net loss of $61,322,218 for the same period in 2024[29] - Total operating expenses for the nine months ended September 30, 2025, were $38,767,088, down 40.3% from $64,815,482 for the same period in 2024[29] - Cash and cash equivalents at the end of the period were $1,384,484, down from $3,857,026 at the beginning of the period, indicating a decrease of 64.1%[33] - Net cash used in operating activities for the nine months ended September 30, 2025, was $31,190,765, a reduction of 27.0% from $42,956,164 for the same period in 2024[33] Expenses - R&D expenses for Q3 2025 were $4.0 million, down from $11.1 million in Q3 2024, primarily due to reduced trial costs[14] - General and administrative expenses for the nine months ended September 30, 2025, were $19,960,421, down 32.8% from $29,639,951 for the same period in 2024[29] - The company incurred stock-based compensation expenses of $11,534,002 for the nine months ended September 30, 2025, compared to $23,458,012 for the same period in 2024, a decrease of 50.8%[33] - G&A expenses for Q3 2025 were $6.3 million, down from $11.9 million in Q3 2024, mainly due to lower stock-based compensation[14] Assets and Equity - Cash, equivalents, and short-term investments totaled $13.9 million as of September 30, 2025, down from $44.9 million at December 31, 2024[14] - Total current assets decreased from $45,795,843 as of December 31, 2024, to $14,854,269 as of September 30, 2025, representing a decline of approximately 67.6%[27] - Stockholders' equity decreased from $35,521,961 as of December 31, 2024, to $9,465,539 as of September 30, 2025, a decline of approximately 73.3%[27] Shares Outstanding - Shares outstanding were 73,333,622 as of November 10, 2025[14] - The company reported a weighted average number of common shares outstanding of 32,274,238 for the nine months ended September 30, 2025, compared to 30,160,242 for the same period in 2024, reflecting an increase of 7.0%[29]