RLMD · Relmada Therapeutics, Inc.

Relmada Therapeutics reported first quarter 2026 financial results reflecting ongoing investment in its clinical pipeline, particularly NDV-01 for non-muscle invasive bladder cancer (NMIBC). Research and development expenses decreased to $8.1 million from $12.0 million year-over-year, driven by the absence of non-recurring acquisition and licensing costs from 2025, though partially offset by ramp-up in Phase 3 NDV-01 trials and Phase 2b sepranolone study plus added personnel. General and administrative expenses rose to $11.4 million from $6.3 million, mainly due to higher compensation costs despite lower stock-based compensation. Net cash used in operations improved to $15.1 million from $18.1 million, contributing to a net loss of $19.1 million or $0.22 per share, compared to $17.6 million or $0.58 per share last year, reflecting share count expansion from a $160 million PIPE financing announced March 9, 2026, yielding ~$150 million net proceeds. The cash position strengthened significantly to $234.0 million as of March 31, 2026, from $93.0 million at year-end 2025, providing runway through 2029 to complete the pivotal NDV-01 Phase 3 RESCUE program. CEO Sergio Traversa highlighted robust 12-month Phase 2 data for NDV-01, with 95% complete response (CR) rate at any time and 76% durable at 12 months in high-risk NMIBC, and even stronger 94%/80% in BCG-unresponsive patients, with no progressions to muscle-invasive disease or serious adverse events. This supports best-in-class potential, reinforced by FDA-aligned registrational paths in second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC, with IND filing and trial start mid-2026. Additional milestones include AUA2026 presentations, a new provisional patent filing for NDV-01 extending to 2047, and sepranolone Phase 2 initiation in Prader-Willi syndrome mid-2026. Management's conference call on May 12 at 4:30 PM ET elaborated on these updates.