Save the Date: Egetis to host Investor Day on December 18, 2024

Stockholm, Sweden, November 25, 2024. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced that the Company will host an Investor Day on Wednesday, December 18, 2024, in Stockholm, Sweden, for investors and analysts.

Time: Wednesday, December 18, 2024, at 15:00 – 18:00 CET (9:00 am – 12:00 pm ET)
Venue: Redeye, Mäster Samuelsgatan 42, Stockholm, Sweden

The event will also be accessible through a live webcast.

During the event, the Company will provide an update and review of its strategy and pipeline. The presentations will focus on the unmet medical need, development plans, pre-launch activities and commercialization plans for the investigational drug tiratricol (Emcitate®), being developed as a possible treatment for MCT8 deficiency, as well as additional activities to create and enhance long-term shareholder value. Presentations will be made by members of Egetis’ management team and invited key opinion leaders.

A complete agenda and a link to the live webcast will be shared in advance of the event.
Presentations will be held in English.

If you would like to attend the event in person in Stockholm, please register by email to [email protected]

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 tiratricol (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) tiratricol has shown highly significant and clinically relevant results on serum thyroid hormone T3 concentrations and secondary clinical endpoints. In June 2024, topline results were presented from the Phase 2 study, Triac Trial II, with tiratricol for the treatment of MCT8 deficiency. The study investigated a potential additional treatment effect on neurocognitive development in young children under 30 months with MCT8 deficiency. The study did not show a statistically significant improvement compared to historical controls.

Egetis submitted a marketing authorisation application (MAA) for tiratricol 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 at least 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. As previously communicated, the Company will update the market as soon as recruitment closes, and at that time, the Company will also provide information on when to expect topline results and when the Company plans to submit the NDA application.

Tiratricol 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. Tiratricol 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 calmangafodipir (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. 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 development program for calmangafodipir has been parked until tiratricol marketing authorization submissions for MCT8 deficiency have been completed in the EU and the USA. Calmangafodipir 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