On Tuesday, Relmada Therapeutics (NASDAQ:RLMD) discussed first-quarter financial results during its earnings call. The full transcript is provided below.
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The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1760811&tp_key=4a374687cc
Summary
Relmada Therapeutics reported progress with NDV01, a sustained release formulation for bladder cancer, highlighting robust 12-month efficacy data and a favorable safety profile.
The company completed a $160 million private placement financing to support the Phase 3 Rescue Program, slated to begin mid-2026.
Relmada filed a provisional patent for NDV01, potentially extending patent protection into 2047, and remains focused on executing its strategic initiatives, including a study for Sopranolone in Prader Willi Syndrome.
Financially, the company ended Q1 2026 with a cash balance of $234 million, expecting this to fund operations through 2029, despite a slight increase in net loss compared to the previous year.
Management expressed confidence in the potential of NDV01 to address unmet needs in bladder cancer and emphasized the significance of upcoming presentations at the American Urological Association meeting.
Full Transcript
OPERATOR
Good afternoon and welcome to Relmada Therapeutics first Quarter Earnings Conference call. At this time all participants are in a listen only mode. After the prepared remarks, we’ll conduct a question and answer session. To ask a question, please press star one. As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ricci from LifeSci Advisors. Please go ahead. Mr. Ricci.
Brian Ricci
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 March 31, 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 10Q filing for the quarter ended March 31, 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 May 12, 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 CEO Dr. Sergio Traversa who will briefly provide a summary of Recent business highlights Dr. Raj Pruthi, Relmada CMO Urology, who will provide an NDB 01 program update and Relmada CFO Magn Cinauda who will provide an update on Supranolone and a review of the company’s Q1 financial results. After that we will open the line for a brief Q and A session. Now I would like to hand the call over to Sergio Traversa.
Sergio Traversa (Chief Executive Officer)
Sergio. 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 NDB01 in non-muscle invasive bladder cancer or NMIBC and the successful completion of 160 million private placement financing meaningful milestones that reflect the strengths of our progress. Importantly, we remain on track to initiate the Phase 3 Rescue Program in mid-2026, which we believe will be a transformational moment for Relmada. Let me briefly describe what makes NDV01 distinct. NDV01 is a ready to use sustained release intravesical formulation for gemcitabine and docetaxel or gemdosy. It’s designed to build on a well established safety and efficacy profile of conventional gemdosing and deliver a best in class therapy for patients living with nmibc. We remain focused on maximizing its potential for success for patients, their 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 derisk the development of NDV01 with the report of solid and durable 12 months efficacy data from the ongoing phase two study of NDV01. We will be presenting this data an an overview of the Phase 3 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 NDV01 has the potential to provide what urologists and patients with NMIBC need: a simple, durably effective treatment that readily fits into a real world practice setting. Number two we achieved FTA alignment for our plan Registration of Phase three Rescue programs Number three In April we filed a provisional patent application in the US directed to formulations and methods of treatment for NDV01. This application, efficient, could form the basis for worldwide patent filings and EBITERM 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 three rescue program. Before I end 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 NDV01 platform. If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection. Most importantly would meaningfully extend the covered claims of NDB1 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 3 Rescue Program for NDVO1 in mid-2026. We are also preparing to initiate approval Counsel study for Supranolone in Prader Willi Syndrome targeted for mid-2026 Maget will speak about it in more detail shortly. Next we’ll turn the call over to Dr. Raj Pruti who will provide a review of the MDV program including 12 months follow up data from the ongoing phase two study and the summary of our phase three plans. Raj
Dr. Raj Pruthi
thank you Sergio and good afternoon everyone. I’m delighted to provide an update of NDV01 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 NDV01 to the broader urology community, building awareness of NDV01 as a differentiated sustained release gemdosi and generating investigator interest in the Phase three 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-70s. 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 NDV01 12 month data, second, a summary of our planned phase three program and third, a discussion of how NDV01 might fit in the real world practice of a urologist. As Sergio noted, NDV01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel. It builds on physicians established familiarity with conventional GEM dosing. This is particularly meaningful for patients who are unresponsive to BCG where bladder sparing options that avoid radical cystectomy can be life changing. Turning to the 12 month data, NDV01 has demonstrated high response rates and durable efficacy in our ongoing Phase two study. We believe these results compare favorably to other programs in this space and support NDV01’s potential as a best in class treatment for patients with bladder cancer if approved. The Phase two study is an open label single arm trial in patients with high risk NMIBC. Patients receive 6 biweekly doses that is every other week followed by monthly maintenance for up to one year. Regular assessments include cystoscopy, cytology and biopsy if needed. The study was designed to enroll up to 70 patients. Primary endpoints are safety and complete response rate at 12 months. The data demonstrated a 95% complete response rate at any time and a durable 76% Complete Response (CR) at 12 months in the high risk NMIBC patients and a 94% Complete Response (CR) at any time and a durable 80% Complete Response (CR) rate at 12 months in the difficult to treat BCG unresponsive subpopulation, reinforcing its best in class potential. In nmibc, no patients had progression to muscle invasive disease and no patients underwent a radical cystectomy. On the strength of these findings, we are advancing NDV01 into a Phase 3 Rescue …
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