0001213900-26-031862
SEC filingRelmada Therapeutics, Inc. (RLMD), a clinical-stage biotech, reported a net loss of $57.4 million for FY 2025, improved 28% YoY from $80.0 million in 2024, driven by reduced R&D expenses of $26.9 million (down from $46.2 million) due to termination of esmethadone and psilocybin programs, and lower G&A of $32.2 million (down from $37.7 million) from decreased stock-based compensation. Total operating expenses fell to $59.1 million. Other income net added $1.7 million from interest and investments. Balance sheet strengthened with $94.0 million total assets, including $3.5 million cash and $89.5 million short-term investments; equity at $86.5 million. Cash flows showed $45.8 million used in operations, $48.1 million in investing (net short-term investment purchases), offset by $93.6 million financing proceeds. Strategic pivot to NDV-01 (NMIBC Phase 2 data: 76% 12-month CR) and sepranolone (Phase 2b-ready); Phase 3 initiations and IND clearance expected mid-2026, positioning for potential value creation amid $93.0 million liquidity.
Relmada Therapeutics reported FY2025 net loss of $57.4 million ($1.45 per share basic/diluted), improved from $80.0 million ($2.65 per share) in 2024. Loss from operations was $59.1 million, with R&D at $26.9 million (down from $46.2 million YoY due to program terminations) and G&A $32.2 million (down from $37.7 million, lower stock compensation). Other income net $1.7 million included $1.4 million interest and $319K net investment gains. Shares outstanding basic/diluted 39.5 million. Strategic shift post-esmethadone/REL-P11 termination; acquired NDV-01 (March 2025, $3.5M upfront + stock) and sepranolone (February 2025, €3M). 17 employees at year-end.
No revenue generated; pre-commercial biotech. Focus on pipeline advancement funds future potential. NDV-01 in-license: $3.5M upfront, 3.0M shares issued, $2.0M milestone accrued. Sepranolone acquisition: $2.8M paid. Terminated prior licenses without fees.
N/A; no revenue. Operating loss $59.1 million reflects high R&D/G&A burn. Stock-based comp $13.9 million, SARs $1.1 million. YoY op ex decline from cost cuts post-pivot.
Net cash used operating $45.8 million (net loss offset by $13.9M stock comp, changes in working capital). Investing -$48.1 million (net $48.1M short-term investments). Financing +$93.6 million (common stock issuance). Cash end $3.5 million (from $4.1M start, net decrease $360K); short-term investments $89.5M; total liquidity $93.0M. Total assets $94.0M; liabilities $7.5M (current $6.4M); equity $86.5M (accum deficit -$698.3M, APIC $784.7M).
Upcoming: NDV-01 US IND clearance, Phase 3 initiations (high-risk BCG-unresponsive, intermediate-risk adjuvant) mid-2026; Phase 2 sepranolone PWS mid-2026; NDV-01 Phase 2 12-month data showed 76% CR (83% KM), no Grade ≥3 AEs. FDA alignment on Phase 3 designs. Liquidity supports 12+ months; potential further financing. Risks: clinical success, funding, competition, regulation.