Egetis participates at medical conferences to increase disease awareness about MCT8 deficiency

Stockholm, Sweden, October 22, 2024. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced that during 2024 the Company has participated at 27 international or national medical conferences, as part of its initiatives to increase disease awareness about MCT8 deficiency. During the remainder of 2024 the Company will participate at the following key medical conferences:

AACPDM- American Academy of Cerebral Palsy and Developmental Medicine
October 24-26, 2024 in Quebec City, Canada

Annual Meeting of the American Thyroid Association
October 30- November 3, 2024 in Chicago, IL, USA

Egetis will present a poster entitled
The First Robust Bioavailability/Bioequivalence (BA/BE) Study of Thyromimetic Tiratricol, a Treatment in Development for MCT8 Deficiency

Dr F. Van Geest from Erasmus Medical Center, Rotterdam, The Netherlands, will give an oral presentation entitled
Efficacy and safety of thyroid hormone analogue Triac in young patients with MCT8 deficiency: results of Triac Trial II

CNS – 53rd Child Neurology Society Annual Meeting
November 11-14, 2024 in San Diego, CA, USA

62nd Annual ESPE Meeting (European Society of Paediatric Endocrinology)
November 16-18, 2024 in Liverpool, UK

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® (tiratricol) 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 randomized, placebo-controlled pivotal study in 16 evaluable 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® (calmangafodipir) 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. The design of a pivotal Phase IIb/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The study start has been postponed until Emcitate marketing authorization submissions for MCT8 deficiency 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