Relmada Therapeutics earnings date
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Relmada Therapeutics (RLMD) Q3 2026 Earnings Report
RLMD Q3 2026 EPS Results
- Actual EPS
- -$0.12
- Consensus EPS
- -$0.15
- Beat/Miss
- Beat by +$0.02
- One Year Ago EPS
- -$0.30
RLMD Q3 2026 Revenue Results
- Actual Revenue
- $0
- Expected Revenue
- $0
- Beat/Miss
- Met expectations
- YoY Revenue Growth
- ―
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/12/2026
- Time
- After Close
- Conference Call
- Thursday, November 12, 2026
Relmada Therapeutics's next earnings date is estimated for March 23, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
Q3 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q3 2026 Earnings Call Summary
The call was broadly positive, driven by continued NDV-01 manufacturing progress, expected year-end 2026 IND filings, strong reported complete response rates, durable 18-month responses, a favorable safety profile, and cash resources expected to fund operations through 2029. The main negatives were two progressions to muscle-invasive disease, the limited evaluable 18-month cohort, ongoing manufacturing and stability work, the absence of a completed analysis for the second-line target population, and higher research and development spending and operating cash use.
Relmada expects to submit the IND for NDV-01 by year-end 2026, initiate the Phase 3 SPECTRUM program upon IND clearance, and file the sepranolone IND by year-end 2026, with the Phase 2 proof-of-concept study expected to begin upon IND clearance; if the IND gets cleared in a reasonable amount of time, that can be 30, 45 days, including the holidays in between, the company should be able to enroll the first patient within the first quarter of next year, and its current cash position is expected to fund company operations through 2029, including completion of the registrational Phase 3 NDV-01 SPECTRUM studies.
- NDV-01 Manufacturing Progress and IND TimelineRelmada made significant progress in the NDV-01 manufacturing process and remains on track to submit the IND by year-end 2026. The company said IND clearance would allow it to begin the registrational Phase 3 program.
- Clinical Supply and Commercial Readiness PlanningRelmada established a manufacturing plan intended to provide uninterrupted clinical supply through Phase 3 and support commercial readiness.
- Sepranolone IND PreparationThe company is finalizing stability testing of the sepranolone pre-filled syringe for Prader-Willi syndrome, with IND submission anticipated by year-end 2026 and a Phase 2 proof-of-concept study expected to begin upon IND clearance.
- Durable 18-Month Phase 2 ResponsesAmong 23 high-risk NMIBC patients who were in complete response at 12 months and continued into the long-term extension, 12 of 14 evaluable patients, or 86%, remained in complete response at 18 months. In the BCG-unresponsive subgroup, 7 of 8 patients, or 88%, remained in complete response.
- Updated 12-Month Efficacy ResultsThe expanded dataset of 51 high-risk NMIBC patients showed an anytime complete response rate of 94% and a 12-month complete response rate of 77%. In the BCG-unresponsive subgroup, the anytime complete response rate was 96% and the 12-month complete response rate was 73%.
- Favorable Phase 2 Safety and TolerabilityTo date, the Phase 2 study has reported no Grade 3 or higher treatment-related adverse events, no treatment-related serious adverse events, and no treatment-related discontinuations.
- SPECTRUM Phase 3 Program StructureThe registrational program was renamed SPECTRUM, while the program itself remained unchanged with two FDA-aligned independent registration pathways: a single-arm study in second-line, high-risk BCG-unresponsive NMIBC patients with CIS, with or without papillary disease, and a randomized study of NDV-01 following TURBT versus observation in low-grade intermediate-risk NMIBC.
- Additional Exploratory CohortSPECTRUM will include a separate exploratory cohort for second-line, high-risk BCG-unresponsive papillary-only disease.
- Ready-to-Use In-Office Product DesignManagement described NDV-01 as a novel sustained-release intravesical formulation combining gemcitabine and docetaxel, designed for quick and convenient administration in the urology office as a ready-to-use sustained-release biodegradable product.
- Cash Position and Operating RunwayRelmada ended the third quarter with $202.1 million in cash, cash equivalents, and short-term investments, compared with $93 million at December 31, 2025. Management expects the current cash position to fund operations through 2029, including completion of the registrational Phase 3 NDV-01 SPECTRUM studies.
- Lower General and Administrative ExpenseThird-quarter general and administrative expense decreased to $3.9 million from $6.3 million in the prior-year period, primarily due to lower stock-based compensation and lower stock appreciation rights expense.
- Improved Loss Per ShareThe third-quarter net loss was $13.9 million, or $0.12 per basic and diluted share, compared with a net loss of $10.1 million, or $0.30 per share, in the third quarter of 2025.
- Positive Stability Data from Manufacturing EffortsRelmada said stability data from both its U.S. effort with Piramal and its Israeli effort with Scinai looked good. The company reported that GMP batches had approximately nine weeks of stability data and appeared to be well within FDA requirements.
- Progress Toward First Patient DosingThe company said it had evaluated various clinical sites and made significant progress on contract execution. If the NDV-01 IND is cleared in a reasonable amount of time, management expects to enroll the first patient within the first quarter of next year, estimating approximately 30 to 45 days from clearance, including the holidays.
- Re-Induction Results and Phase 3 DesignIn the overall Phase 2 population, 6 patients were re-induced at 3 months, and 3 converted from non-complete response at 3 months to complete response at 6 months. For Phase 3, re-induction will be allowed only at the 3-month study point as agreed with the FDA.
RLMD Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Mar 23, 2027 | 2026 (Q4) | -0.13- | -0.27 | ― | ― |
| Nov 12, 2026 | 2026 (Q3) | -0.14-0.12 | -0.3 | 60.00% (+0.18) | |
| Aug 06, 2026 | 2026 (Q2) | -0.20-0.11 | -0.3 | 63.33% (+0.19) | |
| May 12, 2026 | 2026 (Q1) | -0.20-0.22 | -0.58 | 62.07% (+0.36) | |
| Mar 19, 2026 | 2025 (Q4) | -0.15-0.27 | -0.62 | 56.45% (+0.35) | |
| Nov 13, 2025 | 2025 (Q3) | -0.42-0.30 | -0.72 | 58.33% (+0.42) | |
| Aug 07, 2025 | 2025 (Q2) | -0.46-0.30 | -0.59 | 49.15% (+0.29) | |
| May 12, 2025 | 2025 (Q1) | -0.48-0.58 | -0.72 | 19.44% (+0.14) | |
| Mar 27, 2025 | 2024 (Q4) | -0.67-0.62 | -0.84 | 26.19% (+0.22) | |
| Nov 07, 2024 | 2024 (Q3) | -0.68-0.72 | -0.73 | 1.37% (+0.01) |
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
