Regulatory press release

Bulletin from Egetis Therapeutics’ Extraordinary General Meeting 2024

Stockholm, Sweden, October 25, 2024. Egetis Therapeutics AB (publ) (STO: EGTX) today announced that the Extraordinary General Meeting has been held on October 25, 2024, at which the submitted proposals were passed. The complete proposals are stated in the notice to the Extraordinary General Meeting.
The Extraordinary General Meeting was held by physical presence of shareholders and with the option for shareholders to exercise their voting rights by advance voting (postal voting).
The Extraordinary General Meeting resolved to approve the Board of Directors’ resolution from September 30, 2024, to issue no more than 22,780,949 new ordinary shares at a subscription price of the shares’ quota value, entailing an increase in the share capital of not more than SEK 1,198,997.763080. The share issue constitutes the second tranche of the directed share issuances announced by the Company on September 30, 2024. The right to subscribe for the new shares shall, with deviation from the shareholders’ pre-emption rights, be granted to Svenska Handelsbanken AB (publ) solely, which acts as settlement bank in the new issue and will subscribe for the shares on behalf of a number of international and Swedish institutional investors. The reasons for the deviation from the shareholders’ pre-emption rights are that the Company shall, in a timely manner, be able to secure the capital need for the Company’s operations, as well as to broaden the ownership structure of the Company with international and Swedish institutional investors.
Minutes with complete resolutions from the Extraordinary General Meeting will be made available on the Company´s website, www.egetis.com.

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

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