Relmada Therapeutics Inc (DE:4E2)
NASDAQ:4E2
Earnings Data
Report Date
Aug 11, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.16Last Year’s EPS
-0.26Same Quarter Last Year
Moderate Buy
Based on 2 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed predominantly positive momentum: robust phase 2 12-month efficacy and safety data for NDV-01, FDA alignment for a two-pathway Phase 3 registrational program, strengthened IP positioning via a provisional patent filing, and a materially improved balance sheet with ~$234M cash (runway into 2029). Operational advantages (office-based, short administration) and a planned Cipranolone proof-of-concept add to the upside. Key challenges include a significant rise in G&A expense, a modestly larger absolute net loss, patent prosecution uncertainty, and potential variability in Phase 3 patient populations which could affect measured efficacy. Overall, the highlights substantially outweigh the lowlights, but successful execution of the planned mid-2026 trial starts and subsequent enrollment/readouts remain critical.Company Guidance
Strong 12-Month Phase 2 Efficacy for NDV-01
NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR at 12 months in high-risk NMIBC patients; in the BCG-unresponsive subpopulation NDV-01 showed a 94% CR at any time and an 80% CR at 12 months. No patients progressed to muscle-invasive disease and no patients underwent radical cystectomy.
Favorable Safety Profile
In the 12-month dataset, there were no grade 3 or higher treatment-related adverse events, no dose interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade 1.
Regulatory Alignment and Clear Phase 3 Path
Relmada achieved FDA alignment for a Phase 3 'rescue' registrational program with two pathways (second-line BCG-unresponsive CIS single-arm study and an intermediate-risk post-TURBT randomized adjuvant trial). The company expects to file the U.S. IND and initiate the rescue program across ~80 North American sites in mid-2026 and to report initial 3-month response data around year-end.
Strong Balance Sheet and Financing
Completed a $160M private placement with net proceeds of approximately $150M; cash balance at 03/31/2026 was $234M versus $94M at 12/31/2025 — approximately a 149% increase — providing an expected runway through 2029 including completion of the Phase 3 rescue program.
Intellectual Property Advancement
Filed a U.S. provisional patent application for NDV-01 formulations and methods (April 2026); company indicated that issued patents claiming priority to this filing could extend coverage into 2047, potentially lengthening commercial exclusivity if granted.
Operational and Commercial Differentiation
NDV-01 is a ready-to-use sustained-release Gem + Docetaxel (Gemdosi) intravesical formulation designed to be delivered in-office by a nurse/LPN in under 5 minutes without specialized pharmacy/hood — positioning it as a time- and resource-sparing alternative to conventional Gemdosi.
Planned Expansion of Pipeline
Preparing to initiate a Cipranolone proof-of-concept study in Prader-Willi syndrome in mid-2026, with FDA engagement and supply chain preparations underway.
Improved Cash Flow Usage
Net cash used in operating activities decreased to $15.1M for Q1 2026 from $18.1M in Q1 2025 — an improvement of approximately 16.6%.
DE:4E2 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
DE:4E2 Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 12, 2026 | €6.00 | €6.45 | +7.50% |
Mar 19, 2026 | €5.55 | €5.30 | -4.50% |
Nov 13, 2025 | €3.34 | €3.08 | -7.78% |
Aug 07, 2025 | €0.50 | €0.49 | -1.20% |
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 Inc (DE:4E2) report earnings?
Relmada Therapeutics Inc (DE:4E2) is schdueled to report earning on Aug 11, 2026, After Close (Confirmed).
What is Relmada Therapeutics Inc (DE:4E2) earnings time?
Relmada Therapeutics Inc (DE:4E2) earnings time is at Aug 11, 2026, After Close (Confirmed).
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What is the P/E ratio of Relmada Therapeutics Inc stock?
The P/E ratio of Relmada Therapeutics is N/A.
What is DE:4E2 EPS forecast?
DE:4E2 EPS forecast for the fiscal quarter 2026 (Q2) is -0.16.