Stockholm, Sweden, May 5, 2025. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), a pharmaceutical company dedicated to developing therapies for treatments of serious diseases with significant unmet medical needs in the orphan drug segment, today confirms the availability of its first approved product, Emcitate® (tiratricol) in Germany, as of May 1. This follows the European Commission’s approval of Emcitate® on February 13, 2025 for the treatment of MCT8 deficiency — a rare and serious condition. Emcitate® is the first and only approved treatment in the EU for MCT8 deficiency.

Nicklas Westerholm, CEO of Egetis, commented: “The EU approval and now the first commercial launch of Emcitate in Germany are historical milestones for Egetis and for the entire MCT8 deficiency community.

“I am incredibly proud of what our team and partners have accomplished. Bringing the first and only approved treatment for this devastating condition to patients is the result of years of dedication, innovation, and belief in our mission. A heartfelt thank you goes to everyone who made this possible — especially to Professor Edward Visser and his team at Erasmus University Medical Center in Rotterdam, the Netherlands. Today marks the beginning of a new chapter for patients and families across Europe.”

The German launch marks a major step in Egetis’ journey from an emerging biotech to a commercial-stage company. It is the first of several planned launches in EU with initial focus on the EU4 countries — Germany, France, Spain, and Italy — with pricing and reimbursement dossiers submitted in both Germany and France.

Since acquiring the rights to Emcitate, Egetis has made significant scientific, clinical, and manufacturing investments, totaling over EUR 100 million, to advance Emcitate® from concept to commercialization. These include:

• Clinical Development: Sponsoring two key clinical trials to demonstrate efficacy and safety in patients with MCT8 deficiency and bioavailability / bioequivalence in healthy volunteers, alongside an ongoing pivotal trial supporting the upcoming New Drug Application (NDA) to the US FDA.
• Non-Clinical Studies: Execution of comprehensive in vivo and in vitro studies to satisfy safety requirements.
• Formulation Development: Development of a new patient-friendly tablet to meet regulatory requirements and current quality standards. The new tablet also offers greater delivery convenience for patients and caregivers.
• Manufacturing Upgrades: Major investments in manufacturing infrastructure to meet current Good Manufacturing Practice (GMP) and regulatory standards.

Broad Access and Future Vision

Egetis is committed to ensuring patients have access to Emcitate as quickly and equitably as possible. As part of this mission, it has implemented one of the largest managed access programs relative to its size, providing early access to over 230 patients in more than 25 countries.