Egetis Therapeutics AB (publ)

Welcome to Agedis Therapeutics Q1 Report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. If you are listening to the presentation via webcast, you can ask written questions using the form below. Now I will hand the conference over to CEO Nicholas Westerholm. Please go ahead.

Good morning, and a warm welcome to our quarter one results plan for the coming 30 minutes. For those who haven't had the privilege to meet before, my name is Nick Rousseff, and I'm the CEO of the company. With me today, we also have Yilmaz Mashi, Chief Financial Officer, Henrik Lund, Vice President, Commercial Operations, Annie Bedard, President of our U.S. business, and Karl Hahn, Vice President and Head of Investor Relations. Let's turn our attention to the topics covered today, depicted on the slide in front of you. To summarize, Quarter 1 has been historical for EGTIS, with several key milestones delivered. Amongst others, and most importantly, the FDA acceptance of our new drug application for the treatment of MCTA deficiency. Where the Agency also granted us a priority review, with a so-called PDUFA target action date, i.e. decision date, set to September 28, 2026. We will also provide an update on the launch preparations in the U.S., as well as the commercialization in the European Union. And furthermore, a financial update will be covered by our CFO. And we aim to leave ample time for Q&A at the end of the session. So let's turn our attention to the highlights of the quarter. The very strong execution continued in quarter one, building on the great momentum in 2025. And positionals well for the MC-8 US launch in quarter four this year. We completed the US new drug application, i.e. NDA, for MC-8 in January. The MDA for MCTA was accepted by the FDA on the 27th of March. We were also granted a priority review and the PDUFA target action date set to 28th of September. Furthermore, the agency stated that it's not currently planning to hold an advisory committee meeting to discuss our application. So all in all, this is a major achievement and represents an important step in making an incitate available to MCT deficiency patients in the U.S. with an expected launch in Q4 this year. Furthermore, in March, the U.S. Patent and Trademark Office issued a notice of allowance for an MCT deficiency composition patent They allow claims to cover, among other things, a method of treating MCT deficiency with a pharmaceutical composition, encompassing theoretical, including dosing regimens, a theoretical composition with specific excipients. This represents a significant milestone in strengthening our intellectual property, and we expect the resulting patent to be listed in the Orange Book, with an anticipated expiration date in 2045. Last but not least, in April, we successfully carried out an oversubscribed directed share issue amounting to 350 million Swedish kronor. The issue was priced at 525 Swedish kronor per share, corresponding to zero discount to market close, and more importantly, with very strong participation from new and existing investors, focused on the U.S. biotech investors like Fraser Life Sciences, InWoods, Woodline Partners, and Parkman Healthcare Partners. This means that we are now all placed to execute on our strategy of progressing our lead asset, MCTA, through U.S. approval and launch. And with that, I'll now hand over to Annie Bedard to provide an update on our launch preparations in the U.S., our most important market. Annie, please.

Good day, everyone. So let's now turn to the United States, our most important commercial market and a key driver of long-term growth. As Dick said, the U.S. launch is on track for Q4 2026. and this is supported by expanding patient identification, increasing experience with Teratricol in early access program, and continued progress on market access readiness. Starting with patient identification, we've now identified more than 140 genetically confirmed patients, and that number continues to grow each quarter. Our field medical team is now fully deployed engaging specialist centers that are central to patient identification and treatment. They're engaging with physicians across endocrinology, neurology, and clinical genetics with a focus on centers already managing known patients, increasing disease awareness, and enabling meaningful clinical dialogue and accelerating diagnosis and referral pathways. We're also expanding our presence at key scientific meetings, including the American College of Medical Genetics, which took place in the first quarter, and the Pediatric Endocrine Society, which is taking place this week and is our most important meeting. These engagements are critical to connecting with healthcare professionals, sharing emerging data, advancing the earlier recognition and diagnosis of MCTA deficiencies. Just as importantly, we continue to build strong relationships with the MCTA caregiver and advocacy community. This engagement helps us better understand the patient journey, ensure caregiver perspectives inform our plans, and strengthen the trust with the families. Our U.S. Early Access Program continues to expand with 50 patients now receiving treatment across 20 specialist centers. This program enables access for patients with significant unmet need, while also providing physicians with real-world experience managing teraprical. These insights are helping us inform our implementation approach, deepen engagement with specialist centers, and better define the support that will be required for both patients and providers over time. We're also making solid progress in building the access and patient support infrastructure that are needed for launch. Our work has now moved from implementation to execution, with national account directors now engaging Medicaid and commercial payers to communicate the seriousness of the disease, the lack of approved treatment options, and to strengthen our clinical and real-world evidence. In parallel, we've selected our 3PL and specialty pharmacy partners, and we're advancing our patient support program, which will include the specialty pharmacy integration, benefit verification, and the patient services to ensure that we have seamless access for both patients and physicians from day one. Finally, we're building the team to deliver on this opportunity. We're establishing a U.S. organization led by experienced rare disease experts across medical affair, market access, and commercial with a strong track record in rare disease and first-in-class launches. Over the past quarter, we've continued to expand these functions to ensure launch readiness, and we remain on track to reach approximately 25 U.S. colleagues at launch. what we believe is the right scale to capture the opportunity while maintaining capital discipline. So together, this progress is translating into strong launch readiness. We're gaining greater visibility into the patient population, seeing strong engagement from specialists. We're addressing the needs of patients with high unmet medical need with terapicals. and having constructive early discussions with payers. This supports our confidence in a successful launch at approval, and over time, establishing Teratrical as the standard of care with MCTA deficiency. Thanks for your attention, and I'll now turn it over to Henrik for an update on commercialization in Europe.