Egetis Therapeutics AB (publ)

Welcome to AGEDIS Therapeutics Q2 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 five on their telephone keypad. Now I will hand the conference over to CEO Nicholas Westerholm. Please go ahead.

Thank you, EVOperator. Good afternoon, good morning and a warm welcome to Aegitis Therapeutics Quarter 2 Results webcast, planned for the coming 30 minutes. For those who I haven't had the privilege to meet before, my name is Niklas Westerholm and I am the CEO of the company. I will start today's session with a short business update. This will be followed by Annie Bedard, President of our US and North American business, who will discuss the launch preparations for the planned MC-Tate launch in the US, subject to approval. Then Henrik Krook, Vice President Commercial Operations, will give a commercialization update of MC-Tate in the European Union, as well as other international markets. Finally, Yilmaz Masheed, Chief Financial Officer, will provide a financial update before we're looking ahead to the exciting upcoming key value enhancing milestones. We're aimed to leave ample time for Q&A at the end of the session. The most significant event during the first half of 2026 was the acceptance of our US New Drug Application, NDA, for MCTAID. The grant of a priority review by the FDA with a PDUFA date set for the 28th of September. So far, it has been a collaborative dialogue with the agency throughout the review. The FDA has confirmed that it expects to finish its review by the PDUFA date on the 28th of September and does not plan to hold an Advisory Committee meeting. Subject to approval, the MCTA launch in the US is planned for the fourth quarter this year. During the second quarter, we were also granted our first patent for MCT8 by the US Patent and Trademark Office. The patent provides protection for a novel composition with teratricol as the active ingredient. The claims cover, amongst other things, a method of treating MCT8 deficiency with the claimed pharmaceutical composition that encompasses teratricol, dosing regimes, and theoretical composition with specific excipients. This patent is a significant milestone in strengthening our intellectual property portfolio. We expect the granted patent to be Orange Book listable with an expiration date of 2045. The revenue for the fourth quarter was 17.4 million Swedish kronors, corresponding to year-on-year growth of 23% at constant exchange rate. As Henrik will describe further, the MCTA price negotiations within the German reimbursement process, Amnog, was successfully concluded in the second quarter. Furthermore in the quarter were also successfully carried out a substantially oversubscribed directed share issue amounting to 350 million Swedish kronor approximately 38 million US dollars at the closing price on Nasdaq Stockholm on the day of the raise We were particularly pleased to see strong participation from both existing shareholders and several new international specialist healthcare investors, which will further broaden our shareholder base. Last but not least, We're pleased to welcome Tiago Nunes, a very seasoned drug developer, as our new chief medical officer in May. One of Tiago's main tasks will be to drive MCT8's exciting indication expansion opportunity in resistance to thyroid hormone type beta forward in the short-term future. I will now hand over to Annie. Annie, please go ahead.

Thank you, Nick. Good afternoon and good morning, everyone. We're approaching an exciting milestone, one that could bring the first approved therapy to a community that has waited a long time for it. With fewer than 30 business days to the PDUFA date, our focus is now on disciplined execution to enable a US launch in Q4. Since our Q1 update, we've completed the build out of our US commercial organization. Our medical affairs and field team are fully trained and deployed, and an experienced team of rare disease professionals is now executing a single integrated launch plan. The organization is just over 20 employees to date, supplemented by specialized consultants and will scale to around 25 at launch. Launch readiness activities are advancing across all critical work streams depicted on this slide. The patient support services operating model has been established, payer engagements and value communication activities are underway, and specialty distribution and supply partners have been contracted. We continue to expand engagement with the specialist physicians most likely to diagnose and treat MCT8 deficiency. These are the pediatric endocrinologists, pediatric neurologists and geneticists, while expanding patient identification efforts to increase diagnosis and support long-term market development. Our continued engagement with patient advocacy organization helps increase disease awareness, support patient identification efforts, and inform our understanding of community needs. Our top priority at launch will be continuity of care for patients currently receiving Teratricol through the expanded access. ensuring a seamless transition to commercial supply, reduces the risk of treatment interruption, and supports initial commercial adoption. Today, approximately 60 patients across 17 sites nationwide are being treated under the Expanded Access Program, a number that continues to grow month over month. We're prepared to support each patient's transition across the key touchpoints, confirming the treating physicians, enabling prescription, and coordinating access support. This includes prescriber and caregiver education ahead of approval, along with affordability programs and bridging support designed to keep treatment access uninterrupted throughout the transition. We're also establishing coordination across physicians, the specialty pharmacy, patient services, and payers so any potential barrier can be identified and resolved quickly. In parallel, we'll continue to engage known patients not yet on therapy while expanding diagnosis and patient identification. With the organization built, the infrastructure being activated, and patient transition plans advancing, we believe the US business is positioned to execute at approval and deliver on a successful launch in Q4. Most importantly, we're doing this for a patient community that has had no approved therapy options to date, and we're really energized by the opportunity to change that. Thank you, and I will now turn it over to Henrik for an update on commercialization in Europe and international markets.