Relmada Therapeutics, Inc.

Good afternoon and welcome to Realmada 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 1. As a reminder, this conference call is being recorded and will be available for replay on the Realmada website. I would now like to turn the call over to Brian Ritchie from Realmada. LifeSci advisors, please go ahead, Mr. Ricci.

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Ramada issued a press release providing a business update and outlining its financial results for the three months ended March 31st, 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, Real Modest 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 RoMATA's press release issued today and the company's SEC filings, including in the 10Q filing for the quarter ended March 31st, 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 12th, 2026. RoMATA 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 Elmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr. Raj Pruthi, Elmada's CMO, Urology, who will provide an MDB-01 program update, and Elmada's CFO, Maggie Chinata, who will provide an update on Cepronilone and a review of the company's Q1 financial results. After that, we will open the line for a brief Q&A session. Now, I would like to hand the call over to Sergio Traverso. Sergio?

Thank you, Brian. Good afternoon, and welcome, everyone, to the Realmada first quarter 2026 conference call. Realmada continues to make excellent progress this year, and we are excited about where we stand. The robust 12-month data for NDVO1 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 RealMada. Let me briefly describe what makes NDD-01 distinct. NDD-01 is a ready-to-use, sustained-release, intravesical formulation of gemcitabine and docetaxel, or gemdose. It's designed to build on a well-established safety and efficacy profile of conventional gemdose. 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 de-risk the development of NDVO-1 with the report of solid and durable 12-month efficacy data from the ongoing Phase III study of NDVO-1. 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 easy abuse continue to strengthen our conviction. that NDVO-1 has the potential to provide what urologists and patients with NMIDC need, a simple, durably effective treatment that readily fits into real-world practice settings. Number two, we achieved FDA alignment for our planned registration of phase three rescue programs. Number three, in April, We filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDVO-1. This application, efficient, 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 3 rescue program. Before I end the call to watch, 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 MDV-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 covered claims of MDVO-1 into 2047, providing a nine-year extension of commercial exclusivity and strengthening our competitive positions as we advanced our registrations. 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 NDU-1 in mid-2026. We are also preparing to initiate the proof-of-concept study for cipanolone in Prader-Willi syndrome, targeted for mid-2026. Maggie will speak about it in more detail shortly. Next, I will turn the call over to Dr. Raj Pruthi, who will provide a review of the NDD program, including 12-month follow-up data from the ongoing phase 2 study and the summary of our phase 3 plans. Raj?