Egetis recruits Laetitia Szaller as General Counsel and Head of Compliance

Stockholm, Sweden, December 22, 2023. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced the recruitment of Laetitia Szaller as General Counsel and Head of Compliance. Laetitia will be a member of the Company’s Executive Leadership Team, and report to the CEO Nicklas Westerholm.

Laetitia has over 16 years of experience in the pharmaceutical sector. She holds dual qualifications to practice law in both the UK and Belgium, reflecting her international scope and ability to navigate complex, multi-jurisdictional operations. Her career has spanned across various sectors including pharma, medical devices, and the automotive industry, where she has managed global legal and compliance departments.

Prior to joining Egetis Laetitia was General Counsel and VP Business Development at AM Pharma in the Netherlands. She was a member of the senior leadership team, overseeing both legal and compliance operations, business development activities, as well as Company secretary. Before that Laetitia worked at UCB, where she led significant projects in the US, EU, UK, and Asia as an Associate General Counsel. She started her career in the pharmaceutical sector at Abbott and has also worked at Zoetis.

Nicklas Westerholm, CEO of Egetis, commented: “I’m delighted to welcome Laetitia to Egetis and proud that we have been able to attract such a talented and experienced General Counsel to our Company. Laetitia’s experience in successfully leading corporate Compliance operations will also be invaluable for Egetis, as we continue our journey aiming at bringing the first treatment for MCT8 deficiency patients to the market.”

About Egetis Therapeutics

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.

The Company’s lead drug candidate Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) Emcitate has shown highly significant and clinically relevant results on serum thyroid hormone T3 levels and secondary clinical endpoints. Egetis submitted a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in October 2023.

After a dialogue with the FDA, Egetis is conducting a small randomized, placebo-controlled pivotal study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis will update the market as soon as recruitment has been completed and at that point inform about the timing of availability of top-line results, and the expected timing of the subsequent NDA filing.

Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor.

The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase Iib/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after completed interactions with FDA, EMA and MHRA and study start is planned after Emcitate submissions have been completed. Aladote has been granted ODD in the US and in the EU.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com