Egetis Therapeutics AB (publ) (EGTX) Q2 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

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 ...