Pre-Annual General Meeting Information • Nov 1, 2023
Pre-Annual General Meeting Information
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Stockholm, Sweden, November 1, 2023. Egetis Therapeutics AB (publ) (NASDAQ Stockholm: EGTX) today announced the composition of the Nomination Committee for the 2024 Annual General Meeting (AGM) to be held on May 6, 2024. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on April 27, 2023, comprises the following members:
Peder Walberg, appointed by Cetoros AB Peter Lindell, appointed by Cidro Förvaltning AB James Brush, appointed by Frazier Life Sciences
Thomas Lönngren, Chairman of the Board of Directors, will co-opt to the Nomination Committee.
The Committee's assignment is to present proposals regarding Chairman and other members of the Board, as well as remuneration to the Board´s members, to the AGM. The Nomination Committee shall also submit proposals for appointment and remuneration of auditors. Further, the Committee shall submit proposals regarding the process to appoint the Nomination Committee to the AGM in 2024.
Shareholders who wish to submit proposals to the Nomination Committee can do so by email to [email protected] (please label emails 'Nomination Committee'). Proposals should be submitted no later than January 19, 2024.
Nicklas Westerholm, CEO +46 (0) 733 542 062 [email protected]
Karl Hård, Head of Investor Relations & Business Development +46 (0) 733 011 944 [email protected]
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, based on existing clinical data.
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 intends to submit a new drug application (NDA) in the US for Emcitate in mid 2024 under the Fast-Track Designation granted by FDA.
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
Egetis' Nomination Committee for the 2024 Annual General Meeting
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