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11/11/2025
Good day and thank you for standing by. Welcome to CalVista Pharmaceuticals 2025 Third Quarter Financial Update and Operating Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker, Ryan Baker, Head of Investillations. Please go ahead.
Thank you, Operator. Good morning, everyone, and thank you for joining us to discuss CalVista Pharmaceuticals' 2025 third quarter financial update and operating results. Please note we'll be making certain forward-looking statements today. We refer you to CalVista's SEC filings for discussion of the risks that may cause actual results to differ from the forward-looking statements. On the call with me today from CalVista are Ben Palayko, Chief Executive Officer, Nicole Sweeney, Chief Commercial Officer, Ryan Picos, Chief Financial Officer, and Dr. Paul Audia, our Chief Medical Officer. Ben will begin with a review of the company's progress during the three months ended September 30th, including an overview of Ectorly's early launch, both in the US and abroad, as well as other regulatory updates. Paul will give an update on recently presented data from our Confident Kid trial in HAE for children ages two to 11, as well as new patient satisfaction data. Nicole will review the company's commercial progress to date, and Ryan will cover the company's financial statements for the most recent quarter. We will then open the call for questions. With that, I will now turn the call over to Ben.
Thank you, Ryan, and thank you, everyone, for joining us today. And I want to wish a happy Veterans Day to all my fellow veterans listening in. We are highly encouraged by Ectoly's first three months on the U.S. market. Adoption has been steady and linear with real world utilization tracking as we expected. The takeaways are clear. Demand for Ecterly is strong. It is being used to treat a significant number of HAE attacks, and it is meeting the expectations of people living with HAE for a highly efficacious and safe therapeutic alternative. We continue to believe that Ecterly will evolve to become the foundational treatment for HAE. In addition, We are executing on our mission to bring Ectoly to people living with HAE globally. The German launch is now underway, with initial uptake validating the ex-US interest in Ectoly. The approval footprint continues to grow, with a recent approval in Australia adding to the existing authorizations in the US, UK, EU, and Switzerland. In parallel, we continue to evaluate optimal strategies to expand access in geographies where we won't launch on our own. In addition to the collaborations we've previously announced, we anticipate that we will be completing more agreements later this year and in early 2026. We also continue to generate important new data to help educate the HAE community generally, as well as to demonstrate the real-world benefit of ECRLE to people living with HAE. Last week, during the American College of Allergy, Asthma, and Immunology meeting, we provided a report on the high satisfaction rates for patients in CONFIDENT-S who'd switched to Sevitralstat from injectable on-demand therapies. Additionally, interim results from our CONFIDENT-KID trial show that Sevitralstat enables early, effective, and safe treatment of HAE attacks in children ages 2 to 11. Paul will provide more detail on all of that in a minute. We've also continued to grow the key capabilities of the company demonstrated by the recent hires of Bilal Arif as our Chief Operating Officer and Linnea Esfizi as Chief People Officer. Both bring decades of experience that will make them important contributors as we work to evolve CalVista into a leading rare disease company. Finally, with our recent convertible node offering, we are fully financed through profitability, allowing us to remain sharply focused on executing the actively launch while evaluating additional growth opportunities. I will now turn the call over to Paul, who will update you on the latest data from Confident S and Confident KID.
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