Relmada Therapeutics Reports Transformational 2025 Results, Major Advancements for Lead Oncology Asset NDV-01, and Secures Funding Through 2029

Key Highlights for Investors

• NDV-01 Demonstrates Outstanding Efficacy in Non-Muscle Invasive Bladder Cancer (NMIBC): 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months in Phase 2, with a favorable safety profile.
• 80% 12-Month CR Rate in BCG-Unresponsive Patients: These patients achieved a 94% CR rate at any time. Importantly, no progression to muscle-invasive disease or need for radical cystectomy was observed.
• Successful \$160 Million PIPE Financing: Completed in March 2026, led by prominent healthcare investors, strengthening the balance sheet and extending cash runway through 2029, including completion of the NDV-01 Phase 3 RESCUE program.
• Regulatory Alignment with FDA: Two registrational Phase 3 pathways for NDV-01 have been agreed upon with the FDA, including both adjuvant and second-line BCG-unresponsive NMIBC settings.
• Upcoming Catalysts in 2026: IND clearance and Phase 3 initiation for NDV-01, as well as Phase 2 initiation for Sepranolone in Prader-Willi syndrome (PWS). Initial Phase 3 data for NDV-01 expected by year-end 2026.
• Significant Financial Strength: Cash and investments of \$93 million as of December 31, 2025, plus \$160 million in new financing, positions Relmada to fund operations and pivotal trials through 2029.
• Reduced Operating Expenses and Net Loss: Full-year net loss narrowed to \$57.4 million from \$80 million in 2024, driven by lower R&D and administrative expenses.

Detailed Business and Pipeline Update

Relmada Therapeutics (Nasdaq: RLMD), a clinical-stage biotech focused on transformative therapies in oncology and CNS disorders, delivered a transformational year in 2025, highlighted by major progress with its lead program, NDV-01, and key financial milestones positioning the company for long-term growth.

NDV-01 in Non-Muscle Invasive Bladder Cancer (NMIBC)

• Clinical Results:
  • 12-month Phase 2 data showed a durable 76% complete response (CR) rate at 12 months, and a 95% CR rate at any time in high-risk NMIBC patients.
  • BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time.
  • No patient progressed to muscle-invasive disease or required radical cystectomy—underscoring the therapy’s potential to dramatically improve outcomes.
  • The drug exhibited a favorable safety profile, with no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions.
• Differentiation: NDV-01 is a sustained-release, ready-to-use, intravesical formulation of gemcitabine and docetaxel, allowing for a less than 5-minute in-office administration without anesthesia or special equipment. Protected by patents through 2038, this product could set a new standard of care.
• Regulatory Milestones:
  • FDA alignment on two pivotal Phase 3 pathways:
    1. Open-label RCT in adjuvant intermediate-risk NMIBC (no current approved therapies, ~75,000 US patients/year). Primary endpoint: disease-free survival (DFS).
    2. Single-arm trial in second-line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) (patients refractory to first-line therapies, ~5,000 US patients/year). Primary endpoint: CR rate at any time.
• Upcoming Milestones:
  • US IND clearance for NDV-01 anticipated mid-2026.
  • Phase 3 RESCUE program initiation mid-2026.
  • Initial 3-month Phase 3 data in 2L BCG-unresponsive setting expected by year-end 2026.

Sepranolone in Prader-Willi Syndrome

• Sepranolone, a GABA-A receptor modulator, is advancing to Phase 2 in Prader-Willi syndrome (PWS) in mid-2026. Over 335 patients have been treated with sepranolone in trials to date, with an excellent safety profile.
• PWS is a rare genetic disorder with global prevalence estimated at 350,000-400,000; current treatments only address symptoms, not underlying neurobehavioral pathology.

Financial Results and Position

• Cash Position: \$93.0 million in cash, cash equivalents, and short-term investments as of December 31, 2025. This includes \$94 million from a November 2025 stock offering. With the additional \$160 million PIPE (March 2026), Relmada is fully funded for operations and pivotal NDV-01 development through 2029.
• Operating Expenses:
  • R&D expense for 2025: \$26.9 million (down from \$46.2 million in 2024), reflecting completion of two Phase 3 REL-1017 trials and increased focus on NDV-01 and sepranolone.
  • G&A expense for 2025: \$32.2 million (down from \$37.7 million in 2024), with cost reductions in stock-based compensation and professional fees.
• Net Loss: Reduced to \$57.4 million (\$1.45 per share) for 2025, compared to \$80.0 million (\$2.65 per share) in 2024.
• Shares Outstanding: 104,890,223 as of March 16, 2026.
• Balance Sheet Strength: Total equity rose to \$86.5 million at year-end 2025 (from \$35.5 million in 2024), reflecting successful financings and reduced liabilities.

Strategic and Price-Sensitive Takeaways for Shareholders

• NDV-01’s 12-month Phase 2 data are exceptionally strong, including in the critical BCG-unresponsive population, and position the asset as a potential best-in-class therapy.
• Regulatory momentum is significant: FDA alignment on two pivotal Phase 3 pathways greatly increases the probability of regulatory success and future commercial approval.
• Balance sheet de-risked: The \$160 million PIPE and \$93 million cash position ensure Relmada is fully funded through all planned pivotal trials—removing financing risk and enabling shareholders to focus on clinical execution and value inflection points.
• Multiple near-term catalysts: IND clearance, Phase 3 initiations, and initial pivotal data are all expected within the next 12-18 months, creating a rich opportunity for share price appreciation based on clinical and regulatory milestones.
• Reduced cash burn and net loss: Reflects strong fiscal management and operational focus, which should be viewed positively by investors.

Conclusion

Relmada Therapeutics has delivered a year of major progress, both clinically and financially. NDV-01’s impressive efficacy and safety data, FDA regulatory alignment, and a robust balance sheet position the company for a pivotal 2026 and beyond. With multiple catalysts on the horizon and a fully funded balance sheet, Relmada represents a compelling story for investors seeking exposure to innovative oncology and rare disease therapeutics.

Disclaimer: This article is intended for informational purposes only and does not constitute investment advice. All forward-looking statements involve risks and uncertainties, and actual results may differ materially. Investors should review all company filings and conduct their own due diligence before making investment decisions.

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