Key insights
- Relmada Therapeutics reported a slight earnings miss for Q1 2026, with a net loss of $0.22 per share versus a forecast of $0.21. Despite this, the company highlighted a strong cash position of $150 million raised via financing and a robust current ratio of 18.26. The focus remains on its NDV-01 program for NMIBC. While the stock experienced premarket weakness, its long-term performance has been exceptional, and analysis suggests it may be undervalued.
Relmada Therapeutics reported a net loss of $0.22 per share for Q1 2026, slightly missing the forecasted loss of $0.21 per share. Despite the minor earnings miss, the company’s stock saw a 1.77% increase in after-hours trading, closing at $7.49. The stock later fell by 8.12% to $6.34 in premarket trading on May 19, 2026. The stock trades with a market cap of $665 million and remains near its 52-week high of $8.00, a remarkable turnaround from its 52-week low of $0.44. The company’s robust cash position and strategic focus on its NDV-01 program were key highlights of the earnings call.
Relmada Therapeutics demonstrated a strong financial position in Q1 2026, with a significant increase in its cash balance, thanks to a private placement financing that raised approximately $150 million. An InvestingPro tip highlights that the company holds more cash than debt on its balance sheet, while its current ratio of 18.26 reflects exceptional liquidity. The company’s strategic focus on its NDV-01 program for non-muscle invasive bladder cancer (NMIBC) was evident, as it reported promising clinical results. Despite the slight earnings miss, the company’s operational efficiency showed improvement, with a reduction in cash burn and research and development expenses.
Relmada Therapeutics reported a net loss of $0.22 per share, slightly missing the forecasted loss of $0.21 per share. This represents a negative surprise of 4.76%. The miss was minor compared to previous quarters, reflecting the company’s ongoing investment in its clinical programs.
Following the earnings announcement, Relmada’s stock rose by 1.77% in after-hours trading. The stock experienced an 8.12% decline in premarket trading, reflecting investor concerns over the earnings miss and broader market volatility. Despite recent weakness, the stock has delivered an extraordinary 1,145% return over the past year. According to InvestingPro analysis, the stock appears undervalued at current levels, with a Fair Value suggesting upside potential. Investors seeking deeper insights can access comprehensive analysis through InvestingPro’s Most Undervalued stocks list.
Relmada Therapeutics projects a sufficient cash runway to fund operations through 2029, including the completion of its Phase III RESCUE program for NDV-01. The company expects to initiate the program in mid-2026, with first response data anticipated by year-end 2026. Future earnings forecasts suggest continued losses, with expected EPS of -$0.25 in Q3 2026 and -$0.52 in FY 2027. Analysts maintain price targets ranging from $9 to $19, reflecting confidence in the NDV-01 program. For investors seeking comprehensive analysis, Relmada is one of 1,400+ US equities covered by InvestingPro’s detailed Pro Research Reports, which transform complex data into actionable intelligence.
CEO Sergio Traversa stated, "Our strengthened cash position provides us with the resources to advance our clinical programs and achieve key milestones. The promising data from our NDV-01 program positions us well to address significant unmet needs in bladder cancer treatment."
During the earnings call, analysts focused on the timeline for the NDV-01 program and the company’s strategy to mitigate competitive pressures. Executives reiterated their commitment to advancing the program and highlighted the strong clinical data as a differentiator in the market.
Operator: Good afternoon, and welcome to Relmada Therapeutics first quarter earnings conference call. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.
Brian Ritchie, IR Advisor, LifeSci Advisors: Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the three months ended 31st March 2026. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during today’s call, Relmada’s management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company’s business. These forward-looking statements are qualified by the cautionary statements contained in Relmada’s press release issued today and the company’s SEC filings, including in the 10-Q filing for the quarter ended 31st March 2026, filed after the close today.
This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on 12th May 2026. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today’s call are Relmada’s CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr. Raj Pruthi, Relmada’s CMO, Urology, who will provide an NDV-01 program update, and Relmada’s CFO, Maged Shenouda, who will provide an update on sepranolone and a review of the company’s Q1 financial results. After that, we will open the line for a brief Q&A session. I would like to hand the call over to Sergio Traversa. Sergio.
Dr. Sergio Traversa, Chief Executive Officer, Relmada Therapeutics: Thank you, Brian. Good afternoon, and welcome everyone to the Relmada first quarter 2026 conference call. Relmada continues to make excellent progress this year, and we are excited about where we stand. The robust 12-month data for NDV-01 in non-muscle invasive bladder cancer, or NMIBC, and the successful completion of a $160 million private placement financing, meaningful milestones that reflect the strengths of our progress. Importantly, we remain on track to initiation the phase III RESCUE program in mid-2026, which we believe will be a transformational moment for Relmada. Let me briefly describe what makes NDV-01 distinct. NDV-01 is a ready-to-use, sustained-release, intravesical formulation of gemcitabine and docetaxel, or Gem/Doce. It’s designed to build on a well-established safety and efficacy profile of conventional Gem/Doce and deliver a best-in-class therapy for patients living with NMIBC.
We remain focused on maximizing its potential for success for patients, the urology community, and our investors. Let me walk you through four milestones that speak to the momentum we have built this year. Number one, we have continued to de-risk the development of NDV-01 with the report of solid and durable 12-month efficacy data from the ongoing phase II study of NDV-01. We will be presenting this data and an overview of the phase III RESCUE program at the American Urological Association 2026 annual meeting later this week. High response rates, a favorable safety profile, and ease of use continue to strengthen our conviction that NDV-01 has the potential to provide what urologists and patients with NMIBC need, a simple, durably effective treatment that readily fits into real-world practice setting.
Number one, we achieved FDA alignment for our planned registration of phase III RESCUE programs. Number three, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings and have a term into 2047. Lastly, we have fortified our balance sheet. With the private financing that was completed in March, we have the resources to support completion of the phase III RESCUE program. Before I hand the call to Raj, I want to underscore the significance of the patent filing. The provisional application is directed to both the formulations and method of treatment, reflecting the breadth and novelty of the NDV-01 platform. If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection.
Most importantly, it would meaningfully extend the coverage, covered claims of NDV-01 into 2047, providing a nine year extension of commercial exclusivity and strengthening our competitive positions as we advance toward registration. Looking ahead, as we enter the second half of 2026, our focus is on execution. We remain on track to initiate the registration of phase III RESCUE program for NDV-01 in mid-2026. We are also preparing to initiate approval concept study for sepranolone in Prader-Willi syndrome, targeted for mid-2026. Maged will speak about it in more detail shortly. Next, I’ll turn the call over to Dr. Raj Pruthi, who will provide a review of the NDV program, including 12 months follow-up data from the ongoing phase II study and the summary of our phase III plans. Raj?
Dr. Raj Pruthi, Chief Medical Officer, Urology, Relmada Therapeutics: Thank you, Sergio. Good afternoon, everyone. I’m delighted to provide an update of NDV-01 and our upcoming presentations at the AUA meeting this coming weekend. The AUA is an important platform for us as we look forward to introducing NDV-01 to the broader urology community, building awareness of NDV-01 as a differentiated sustained release Gem/Doce, and generating investigator interest in the phase III RESCUE program. Bladder cancer is one of the most common cancers we see, and its impact on the patients is significant. Most are diagnosed in their mid-seventies. The disease often comes with high recurrence rates and intensive treatments that can greatly affect quality of life during a stage of life when preserving it is especially important. I want to touch on three topics during today’s call. First, a recap of the NDV-01 12-month data. Second, a summary of our planned phase III program.
Third, a discussion of how NDV-01 might fit in the real-world practice of a urologist. As Sergio Traversa noted, NDV-01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel. It builds on ph