Relmada Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expense for the three months ended September 30, 2026, was $9.2 million, an increase from $4.0 million in the same period in 2025.
• General and administrative expense for the three months ended September 30, 2026, was $3.9 million, a decrease from $6.3 million in the same period in 2025.
• Net cash used in operating activities for the three months ended September 30, 2026, was $12.6 million, compared to $6.7 million in the same period in 2025.
• Net loss for the three months ended September 30, 2026, was $13.9 million ($0.12 per share), compared to $10.1 million ($0.30 per share) in the same period in 2025.
• Research and development expense for the nine months ended September 30, 2026, was $25.7 million, an increase from $18.8 million in the same period in 2025.
• General and administrative expense for the nine months ended September 30, 2026, was $21.9 million, an increase from $20.0 million in the same period in 2025.
• Net cash used in operating activities for the nine months ended September 30, 2026, was $37.3 million, compared to $31.2 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $45.8 million ($0.44 per share), compared to $37.5 million ($1.16 per share) in the same period in 2025.
• Cash, cash equivalents, and short-term investments totaled $202.1 million as of September 30, 2026, compared to approximately $93.0 million as of December 31, 2025.
• Total current assets were $205.0 million as of September 30, 2026, compared to $94.0 million as of December 31, 2025.
• Total liabilities were $11.6 million as of September 30, 2026, compared to $7.5 million as of December 31, 2025.
• Stockholders' equity was $193.7 million as of September 30, 2026, compared to $86.5 million as of December 31, 2025.
• There were 106,694,846 shares outstanding as of November 10, 2026.

Guidance and Future Outlook:

• The NDV-01 CMC program is on track to submit an Investigational New Drug (IND) application by year-end 2026.
• The registrational Phase 3 SPECTRUM program is expected to initiate upon IND clearance for NDV-01.
• Sepranolone stability testing for the pre-filled syringe delivery system is being finalized to enable an IND submission by year-end 2026.
• The Phase 2b trial for sepranolone in Prader-Willi Syndrome is expected to begin upon IND clearance.
• Current cash resources are expected to fund operations through 2029, including the completion of the two registrational cohorts of the NDV-01 Phase 3 SPECTRUM program.

Business Segments and Product Lines:

• NDV-01: Initial 18-month durability results from the Phase 2 TRGC-011 study show 86% (12/14) of evaluable patients who reached 18 months remained in complete response (CR). In the BCG-unresponsive subgroup, 88% (7/8) of evaluable patients remained in CR at 18 months.
• NDV-01: Updated 12-month efficacy results show an anytime CR rate of 94% (48/51) and a 12-month CR rate of 77% (24/31). In the BCG-unresponsive subgroup, the anytime CR rate was 96% (22/23) and the 12-month CR rate was 73% (11/15). Progression-free and cystectomy-free survival was 100% through 12 months.
• NDV-01: Safety data indicates no Grade ≥3 treatment-related adverse events, no treatment-related serious adverse events, and no treatment-related discontinuations to date.
• NDV-01: The Phase 3 program, renamed SPECTRUM, will pursue two independent registrational pathways in non-muscle invasive bladder cancer (NMIBC): a single-arm study in second-line high-risk BCG-unresponsive carcinoma in situ ± Ta/T1 (Cohort 2UC) and a randomized study evaluating NDV-01 as adjuvant therapy versus observation in low-grade intermediate-risk NMIBC (Cohort IRA).
• Sepranolone: The company is finalizing stability testing for the pre-filled syringe delivery system.
• Manufacturing: A manufacturing plan has been established to provide uninterrupted clinical supply for NDV-01 through the completion of the Phase 3 SPECTRUM program.

Market and Competitive Landscape:

• NMIBC represents 75-80% of all bladder cancer cases, with 63,000 incident cases per year in the U.S.
• High-risk BCG-unresponsive disease represents a significant unmet need with limited and suboptimal bladder-sparing treatment options; there are no approved therapies in the second line or later for this indication.
• Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies.
• Prader-Willi Syndrome has a global prevalence estimated at 350,000-400,000 patients.
• NDV-01 is encompassed by multiple patent applications that could provide protection until 2047 if issued.

Risks and Challenges:

• Potential for product candidates to fail to progress or for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety.
• Potential failure to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone.
• Potential changes to the design, size, or timing of the Phase 3 SPECTRUM studies.
• Failure to successfully execute manufacturing and CMC activities, including scale-up, process validation, and securing adequate drug supply.
• Failure of pending patent applications to result in issued patents or issued patents being challenged and invalidated.
• Uncertainties inherent in estimating the Company's cash runway and ability to fund future operations.

Management Commentary and Tone:

• CEO Sergio Traversa stated the company has made significant progress in advancing the NDV-01 CMC program and remains on track for the year-end 2026 IND submission, with a manufacturing plan in place for uninterrupted clinical supply.
• Chief Business Officer Bipin Dalmia noted that 18-month results demonstrate extended durability of complete response and continued favorable tolerability, and confirmed the Phase 3 program remains unchanged with two independent pathways.
• Management expressed confidence that the SPECTRUM program will begin upon IND clearance.

Other Key Points:

• The NDV-01 Phase 3 program was renamed from RESCUE to SPECTRUM to reflect the potential breadth of the therapy across the NMIBC disease spectrum.
• The Company received written FDA feedback confirming alignment on two registrational pathways for NDV-01, including study design, patient populations, and primary endpoints.
• Proceeds from the issuance of common stock, net, totaled $150.4 million for the nine months ended September 30, 2026.
• Stock-based compensation and stock appreciation rights expense were significant components of operating expenses, with fluctuations noted year-over-year.
• The Company hosted a conference call and webcast on November 12, 2026, to discuss results.