Relmada Therapeutics, Inc.

Good afternoon and welcome to RealMada Therapeutics' second quarter earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will 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 Joyce Longergan. Please go ahead.

Thanks a lot, Krater. Good day everyone and thank you for joining us today. This afternoon, Ramada issued a press release providing the business update and outlining its financial results for the three and six months ended June 30, 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. Ramada's management team will be making forward-looking statements during this call. 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 Mada's press release issued today and the company's SEC filings, including the company's 10-Q filing for the quarter ended June 30, 2026, filed after the close today. This conference call also contains time-sensitive information that is accurate only at the date of this live broadcast on August 6, 2026. Ramada undertakes no obligation to revise or update any forelooking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Ramada's Chief Executive Officer, Sergio Traversa, will provide a business update. Vipin Dalmia, Valmada's Chief Business Officer, will offer his perspective on NDV-01 and the non-muscle invasive bladder cancer landscape. And Valmada's Chief Financial Officer, Maged Shenouda, will review the second quarter 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 Traversa,

Thank you, Joyce. Good afternoon, everyone, and welcome to the RealMada Second Quarter 2026 Conference Call. RealMada has entered a critical execution phase. We have a strong balance sheet, an experienced and strengthened leadership team, and a clear plan to move any of your want into registrational development. I would like to use this time today to tell you where we stand and why we are confident in the path ahead. Let me start with a brief recap. NDVO-1 is a novel, sustained-release, intravesical formulation of gencytabine-endocetaxel, or GENDOSY, that builds on the well-established safety and efficacy profile of conventional GENDOSY. We believe NDVO-1 has the potential to be a best-in-class therapy for patients with non-muscle invasive bladder cancer, or NMIBC, a disease affecting more than 744,000 people in the United States alone. Our clinical and regulatory foundation is strong. The 12-month Phase II data are compelling. 95% of patients achieved a complete response at any time, 76% had a durable complete response at 12 months, and safety has been favorable throughout. We have FDA alignment on the two planned registrational pathways, and we continue to see strong interest from the uro-ontology community. Let me go directly to manufacturing because it is our immediate priority. Any of your one is a novel, sustained release therapy that combines two chemotherapies in a single delivery system. Manufacturing a product like this to a scalable and registration of standards is demanding work. It requires a specialized capability, coordination across several supply chain partners, and a scale up from a laboratory prototype to a full Good Manufacturing Practice, or GMP Production. We have done the work to understand what that requires. We also have planned the remaining activities needed to support the IND, and we are executing against a clear plan to complete them. This is work driven to quality, and we are dedicated to getting it done right. Importantly, all the components around manufacturing are ready. We have FDA alignment, a robust data set, and clinical trial sites that are engaged and prepared to begin enrolling patients as soon as the IND is cleared and clinical material is available. Manufacturing is the final piece, and we are confident in our plan and in our team. We plan to file the IND, NDDO1, by year end of 2026, and to initiate the Phase III Rescue Registration Program upon IND clearance. The same discipline applies to Sopranolone. Our program in Prader-Willi Syndrome, or PWS, a rare and underserved condition, estimated to affect 350,000 to 400,000 people worldwide. Here, the formulation development is complete, and the one remaining step is finalizing the Preference Service Delivery System. We expect to file the Sopranol on IMD by year end 2026 as well, and to initiate phase two proof of concept study upon an IMD clearance. So on both programs, we have characterized what is required, we have a clear plan in place, and we are executing on it. Before we turn to our financial results, I would like to have the privilege to introduce Bipin Daunia, our new Chief Business Officer. Bipin joined us this quarter and brings nearly three decades of experience in uro-oncology, business development, and manufacturing oversight, including leading the U.S. launch of the first FDA-approved intravesical gene therapy for NMIVC. Leaping also brings strong industry relationship and an outstanding track record of value creation. Leaping, call on you.