Soleno Therapeutics, Inc.

Greetings and welcome to the Solano Second Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may press star one at any time to be placed into the question queue, and we ask that you please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Brian Ritchie of LifeSci Advisors. Please go ahead, Brian.

Thank you. Good afternoon, everyone, and thank you for joining us to discuss Celano Therapeutics' second quarter 2025 financial and operating results. Please note, we'll be making certain forward-looking statements today. We refer you to Celano's SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements. On the call with me today for Celeno are Anish Bhatnagar, Celeno's Chairman and Chief Executive Officer, Meredith Manning, Celeno's Chief Commercial Officer, and Jim McInnes, Celeno's Chief Financial Officer. With that, I will now turn the call over to Anish.

Thank you, Brian. and thank you everyone for joining us for our second quarter financial results call. For those who follow us closely, you will know that we announced results for the second quarter ending June 30th, 2025 on July 10th. Therefore, many of you will be familiar with certain key metrics we'll be discussing today. With that said, I am very pleased to share our significant progress during the second quarter, highlighted by the commercial launch of VCAT XR, and commencement of treating people living with Prader-Willi syndrome, or PWS. Meredith will review the company's commercialization progress to date, and Jim will cover the company's financial statements for the second quarter. We will then open the call for questions. We achieved a major milestone for the PWS community and for Celeno in March when we launched ViCAD XR, the first FDA-approved medicine for the treatment of hyperphagia in adults and children four years of age and older with PWS. The approval of VICAD XR was based on our comprehensive clinical development program in which participants received double-blind and or open-label VICAD XR for a mean duration of 3.3 years. Primary evidence of efficacy came from a 16-week randomized withdrawal phase three multicenter double-blind placebo-controlled trial. Following FDA approval on March 26th, Vicat XR was available on April 14th, ahead of plan. We've been extremely pleased with the initial reception and demand from the PWS community, which we believe speaks to the urgent need for an FDA-approved therapy to treat the hallmark feature of PWS, which is hyperphagia. As we announced at that time, concurrent with product availability, prescriptions of Vicat XR had been delivered to the first individuals living with PWS. Since that time, we have seen steady growth in both patient starts and unique prescribers. Total net revenue was $32.7 million in the second quarter, which in part reflects underlying demand for the drug, but also the significant efforts of our experienced commercial team, whose launch outreach efforts to patients, physicians, and payers set the stage for a strong and successful launch. As Meredith will describe in a moment, We have made steady progress with both commercial and government payers. We continue to engage with payers to ensure that they understand the severe complications and high unmet need associated with PWS and the inherent value proposition that VICAD XR offers. Establishing broad payer reimbursement is among our highest priorities going forward, and the compelling efficacy and safety data from our clinical trial program is clearly resonating. I would like to once again recognize the substantial contributions of the entire PWS community, including study participants and their families, the study investigators and study site team members, as well as the two major PWS advocacy organizations, the Foundation for Prader-Willi Research and the Prader-Willi Syndrome Association USA. I would also like to thank the Soleno team members who worked so tirelessly to get us to this point. I would now like to provide a brief update on our activities in support of potential approval of DCCR in Europe. As you know, we market DCCR in the U.S. as Vicat XR. PWS is a global disease that impacts hundreds of thousands of patients all over the world. In an effort to make DCCR available to as many of these patients as possible, in parallel with our U.S. commercial launch, we have continued to make progress along regulatory pathways and other geographies. the most important of which is the EU. As we have stated previously, Europe also has a high unmet need among patients with PWS. Based on widely cited prevalence data, it is estimated that approximately 9,000 patients living with PWS in the EU4 and the UK. We have conducted market research with many PWS experts, patient advocacy leaders, care home executives, et cetera, where we have confirmed the prevalence numbers. Today, in most major markets in the EU, early diagnosis is common. Our research suggests that there is significant structured care for people living with PWS across Europe, with variations that will impact our go-to-market strategy by country. Additionally, as with the U.S., the PWS community has strong thought leader support, and patient care is often concentrated around centers of excellence, even more so than in the U.S. In May, we were pleased to announce the submission and EMA validation of our marketing authorization application. Gaining approval to market DCCR in the EU would represent a meaningful expansion of our commercial market and remains a priority for us while we continue to progress our U.S. launch. I will now turn the call over to Meredith to provide an update on the launch.