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Relmada Therapeutics (RLMD)
NASDAQ:RLMD
Earnings Data
Report Date
May 13, 2026After Close (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.21Last Year’s EPS
-0.58Same Quarter Last Year
Strong Buy
Based on 3 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong clinical and corporate progress: compelling Phase II 12-month efficacy and a favorable safety profile for NDV-01, FDA-aligned Phase III plans with two registrational pathways, a strengthened leadership team, and substantial financing that extends runway through 2029. Offsetting items include higher G&A and operating cash burn, a modestly larger net loss in Q4, competitive enrollment risks in a crowded NMIBC landscape, and limited subgroup sizes in the Phase II dataset which introduce some uncertainty. On balance, the positives—particularly the best-in-class efficacy signals, regulatory alignment, and significant financing—outweigh the near-term financial and competitive challenges.Company Guidance
Strong 12-Month Phase II Efficacy for NDV-01
NDV-01 demonstrated a 12-month complete response (CR) rate of 76% in the Phase II study and an 80% 12-month CR in the BCG-unresponsive population. CR anytime was 95% in the overall population (n=38) and 94% in the BCG-unresponsive subgroup.
Favorable Safety Profile
No patients progressed to muscle-invasive disease, no radical cystectomies occurred, no grade 3 or higher treatment-related adverse events were observed, no treatment interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade 1.
Regulatory Alignment and Planned Phase III RESCUE Program
Company achieved FDA alignment on a two-pathway registrational strategy (intermediate-risk adjuvant post-TURBT and second-line BCG-unresponsive). Expect U.S. IND clearance and initiation of the Phase III RESCUE program in mid-2026; plan to run ~80 sites in North America.
Potential Large Addressable Populations
Estimated U.S. patient populations: ~70,000–75,000 intermediate-risk patients for adjuvant use post-TURBT and ~5,000 BCG-unresponsive second-line patients, supporting potential commercial opportunity if approved.
Significant Financing and Extended Runway
Closed a $160 million private financing on March 9, 2026 (net proceeds ~ $150M). Company had $93M cash at December 31, 2025 (up from ~$45M at Dec 31, 2024), and management expects these funds plus existing cash to provide runway through 2029 and through completion of the planned NDV-01 Phase III program.
Pipeline Progress: Cipranolone PoC in Prader-Willi
Cipranolone (GABA-modulating steroid antagonist) has prior proof-of-concept in Tourette syndrome; company planning to initiate a proof-of-concept Phase II study in Prader-Willi syndrome in mid-2026 and is engaged with FDA on trial design.
Leadership and Scientific Support Strengthened
Appointment of Dr. Raj S. Pruthi as Chief Medical Officer, Oncology, and establishment of a scientific advisory board with recognized urologic oncology experts to support NDV-01 development.
Planned Data Readouts and Disclosure Cadence
Updated 12-month Phase II data accepted for presentation at AUA; plan to report initial three-month response data from the Phase III BCG-unresponsive study by end of 2026 and provide additional updates at roughly three-month intervals (3-, 6-, 9-, 12-month follow-ups).
RLMD Earnings History
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.
Beat
Missed
RLMD Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Mar 19, 2026 | $6.25 | $6.07 | -2.88% |
Nov 13, 2025 | $3.88 | $3.95 | +1.80% |
Aug 07, 2025 | $0.60 | $0.59 | -1.67% |
May 12, 2025 | $0.40 | $0.39 | -2.50% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Relmada Therapeutics (RLMD) report earnings?
Relmada Therapeutics (RLMD) is schdueled to report earning on May 13, 2026, After Close (Confirmed).
What is Relmada Therapeutics (RLMD) earnings time?
Relmada Therapeutics (RLMD) earnings time is at May 13, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is RLMD EPS forecast?
RLMD EPS forecast for the fiscal quarter 2026 (Q1) is -0.21.