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Relmada Therapeutics (RLMD) investor relations material
Relmada Therapeutics Q1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Reported robust 12-month Phase 2 data for NDV-01 in NMIBC, showing high complete response rates and durable efficacy, especially in BCG-unresponsive patients, with no progression to muscle-invasive disease or need for radical cystectomy.
Completed $160 million private placement/PIPE financing, strengthening the balance sheet and providing funding runway through 2029, including phase III RESCUE program completion.
Filed a provisional U.S. patent for NDV-01 in April 2026, potentially extending exclusivity to 2047 and enabling global filings.
Preparing to initiate phase III RESCUE program for NDV-01 and a proof-of-concept/Phase 2b study for sepranolone in Prader-Willi syndrome, both targeted for mid-2026.
Terminated esmethadone and psilocybin programs in 2025 after strategic review.
Financial highlights
Ended Q1 2026 with $234 million in cash, cash equivalents, and short-term investments, up from $93 million at year-end 2025, reflecting $150 million in net proceeds from March private financing.
Net loss for Q1 2026 was $19.1 million ($0.22 per share), compared to $17.6 million ($0.58 per share) in Q1 2025.
Research and development expense decreased to $8.1 million from $12 million year-over-year, mainly due to non-recurrent prior year costs and program terminations.
General and administrative expense rose to $11.4 million from $6.3 million year-over-year, mainly due to higher compensation and consulting costs.
Net cash used in operating activities was $15.1 million, down from $18.1 million in Q1 2025.
Outlook and guidance
On track to initiate phase III RESCUE program for NDV-01 and sepranolone Phase 2b study in Prader-Willi syndrome in mid-2026, with initial three-month NDV-01 Phase 3 data expected by year-end 2026.
Current cash resources expected to fund operations through 2029, including completion of key clinical programs.
Key milestones in 2026 include NDV-01 IND filing, Phase 3 trial initiations, and sepranolone Phase 2b start.
- NDV-01 demonstrates high efficacy in NMIBC, with robust financials supporting late-stage trials.RLMD
Corporate presentation12 May 2026 - NDV-01 demonstrates high response rates in NMIBC, with pivotal trials and strong financial backing ahead.RLMD
Company presentation12 May 2026 - NDV-01 delivers strong efficacy and safety in bladder cancer, with pivotal trials and funding secured.RLMD
Leerink Global Healthcare Conference 202630 Apr 2026 - A strategic pivot and successful financing in 2025 set the stage for renewed growth and shareholder value.RLMD
Proxy filing17 Apr 2026 - Key votes include director elections, equity plan expansion, and increasing authorized shares.RLMD
Proxy filing17 Apr 2026 - Shareholders will vote on key governance, compensation, and capital structure changes after a pivotal turnaround.RLMD
Proxy filing6 Apr 2026 - Biotech pivots pipeline, raises $160M, and registers 33.7M shares for investor resale.RLMD
Registration filing3 Apr 2026 - NDV-01 demonstrates high efficacy in NMIBC; Phase 3 trials and strong cash position support growth.RLMD
Corporate presentation1 Apr 2026 - NDV-01 phase II shows 76% 12-month CR and $160M financing supports phase III launch.RLMD
Q4 202520 Mar 2026
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