Relmada Therapeutics, Inc.

My pleasure to introduce Brian Ritchie. Thank you, Brian. You may begin.

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 and year ended December 31st, 2024. 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 this call, Ramada'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 Ramada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K, for the year ended December 31st, 2024, 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, March 27th, 2024, Ramada 2025. Ramada 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 Romada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, and Romada's CFO, Maga Chinada, who will provide a review of the company's Q4 financial results. After that, we will open the line for a brief Q&A session. Now, I will hand the call over to Sergio Traversa. Sergio?

Thank you, Brian. Good afternoon and welcome everyone to the RealMada fourth quarter and year-end 2024 conference call. RealMada is focused on three priorities. Progressing our product pipeline, including NDV-01 and Cepranolon, and exploring product acquisition opportunities to maximize shareholder value. And third, maintaining careful resource priorities. Prioritization. During today's call, I will spend a moment on our strategic product acquisition efforts and provide a pipeline update. After that, Maggot will review our financial results. I will make a few closing remarks, and then we'll take your questions. At the end of last year, we initiated a process to transform the company through strategic product acquisition efforts to maximize shareholder value. I am pleased to report that the process is going well. We have always maintained an active surveillance to consider programs that have the potential to be high value assets and meet our key target criteria of innovation, established proof of concept points, near-term value creation drivers, and the potential addressed well-defined underserved markets. With the discontinuation of the Phase III studies of REL 1017 in major depression disorder, we made the exploration of strategic product acquisition our primary focus. We have been following the progress of several programs, and our recent efforts identified an additional number of attractive opportunities. After in-depth reviews of several compelling candidates, we recently announced the acquisition of rights to two product candidates, NDVOD1 in development for non-muscle-invasive bladder cancer and Cepranolone for compulsion-related disorders. While we maintain a deep understanding of diseases of the central nervous system as we evaluate strategic opportunities, The drug development expertise of our team provides flexibility to be opportunistic and consider innovative programs that meet our target criteria, regardless of the therapeutic area. Moving on to our product pipeline, I would like to provide a brief overview for NDV01 and Sopranolone, and also provide an update on our plan for RELP11. Let's start with NDV01. On March 25th, we announced an exclusive licensing agreement with Trigon Pharma Limited for NDVO1, a novel, sustainably intravascular chemotherapy for the treatment of high-grade, non-muscle-invasive bladder cancer, NMIBC, and potentially other subtypes of bladder cancer. The program is currently in a phase 2 study. We believe that NDVO-1 is an excellent fit with our four key target criteria. Number one, innovation. Trigon intravesical sustained release formulation of Gelsidabine and docetaxel could represent the true innovation in the care of high-grade non-muscle invasive bladder cancer. Number two, group of concept data. that is, support the efficacy of gencytabine and docetaxel dosing in the treatment of NMIDC. Number three, near-term value drivers. We expect the top-line safety and efficacy data for NDVO1 to be reported at the American Urological Association meeting, AUA, that will be held on April 26 to 29, 2025, in Las Vegas. And number four, the potential to address well-defined underserved markets. Sources indicate that there are about 75,000 new cases of bladder cancer diagnosed. About 50 of those cases have high-grade disease that has a high risk of recurrence. There is a very high recurrence rate for the 450,000 people in the U.S. that are living with bladder cancer. NDV01 is currently evaluated in a Phase II single-arm study to assess safety and efficacy in patients with high-grade non-muscle-invasive bladder cancer. The study was designed to evaluate safety and efficacy in subjects with localized, non-metastatic, high-grade, non-muscle-invasive bladder cancer. Top-line data from the first Approximately 20 patients in the study are expected to be presented at the American Urological Association meeting in Las Vegas on April 26 to April 29 this year. Our goal is to bring NDVO1 to patients as soon as possible. With positive results, we believe that NDVO1 could become the treatment of choice for high-grade non-muscle-invasive bladder cancer, both as First-line therapy for new patients and salvage therapy for existing patients whose disease has progressed. Let's spend a moment on the treatment of high-grade non-muscle-invasive bladder cancer. Intravesicular therapy is a mainstay of treatment intended to reduce the risk of recurrence following surgery. Previously, the immunotherapy Bacillus Calmetgerin, BCG, was the cornerstone of treatment. However, significant supply constraints prompted the evaluation of intravesical chemotherapy. The medical community evaluated a number of chemotherapy agents, and published studies suggested that the use of intravesical gemcitabine and docetaxel, known as Gemdosi, is to be the preferred combination, with improved response rate and promising tolerability. Frequent gene dosing is required, and the chemotherapy agents have a short blood retention time, which limits the exposure to the chemotherapy. Together, this factor increased the risk of treatment failure and discontinuation and prompted the development of NDVO1. NDVO1 is administered in a simple two-step process in the urologist's office. It is designed for intravesical dosing and intended to be an in-office, ready-to-use therapy that is administered rapidly, within 10 minutes, and requires no anesthesia or new or dedicated equipment to employ. NDVO1 forms a spherical soft matrix within the bladder that sequesters drugs and releases it in a matrix gradually dissolved over a 10-day period. NDVO1 formulation is specifically designed to maximize local drug concentration and prolong exposure to gem dosing while minimizing systemic toxicity. Unlike conventional intravesical installation, NDVO1 is designed to avoid peaks and tops in drug concentration, ensuring a gradual and sustained release of gem dosing over a 10-day period. This approach may improve overall efficacy, reduce side effects, and reduce the frequency of dosing to improve patient compliance and outcomes. We believe that NDV-01 has the potential to improve on the published GEM dosing results with less frequent dosing, ease of administration, and improved treatment compliance, which could lead to improved clinical outcomes in high-grade, non-muscle-invasive bladder cancers. Our positive perspective is supported by primary field research with our care providers. The next step includes to present the top-line Phase II results in four weeks, meeting with the FDA to align on a regulatory path to approval, completing the production of the next batch of material, and finalizing the design of registration studies intended to begin in late 2025 or early 2026. Moving on to Cepranolone. On February 6th, we acquired Cepranolone as a potential therapy for Tourette's syndrome and other compulsion-related conditions from Azarina Pharma. We believe that Cepranolone is also an excellent fit with our four key target criteria. Number one innovation, Cepranolone or iso-albopregnanolone is a first-class compound from a new subgroup of neurosteroids known as GAMSAs, or GABA-A modulating steroid antagonists. GAMSAs act selectively on the GABA-A pathway to alleviate the symptoms or compulsive disorder. Number two, proof of constant data. Phase IIa results from Azarina signal improvement in Tourette's syndrome, quality of life, and robust overall safety. These data support cephanolin as a new potential first-line treatment option for Tourette's syndrome and opened the door to evaluation in other compulsion-related disorders. Number three, near-term value drivers. With promising Phase IIa data and safe information from more than 350 subjects, cephanolin is a Phase IIb-ready product. Number four, the potential to address well-defined underserved markets. Tourette's syndrome impacts more than 350,000 children in the U.S. No, sorry, not children. Impacts more than 350,000 patients in the U.S. have Tourette's syndrome. Existing treatments include dopamine, B2 blockers, and a typical antipsychotic are often limited by significant side effects. Stepping back for a moment, Cepranolone is a neurosteroid and the first in class, Gamsa. or GABA-A modulating steroid antagonistic acts. By selective inhibiting GABA, neurotransmitter included allopregnanolone, a neurosteroid implicated in Tourette syndrome and other compulsive disorders. Our evaluation of cecranolone has also included a review of other prominent compulsion-related disorders, and we identified Prader-Willis syndrome, or PWS, as another potential indication. as it is often defined by persistent hunger and overeating, apophagia, that may have a strong compulsion-related element. The estimated global prevalence is approximately 350,000 to 400,000, and current treatment is focused on improving obsessive-compulsive behavior and other medical conditions. The Pradalon might be ideally suited for Prader-Willi syndrome, given its good overall tolerability, and unique impact on compulsibility disorder, which would enable it to be incorporated into existing comprehensive treatment regimen for Prader-Willi syndrome. Next step include meeting with the FDA to align on the regulatory path to approval, further development of the product supply plans, and finalizing the design of a Phase IIb study intended to begin late 2025 or early 2026. Now I would like to turn the call over to our CFO, Nagit Shenouda, to talk about our portfolio prioritization efforts and financial results. Nagit?