Egetis’ Capital Markets Day on October 13: Agenda and Registration Details

Stockholm, Sweden, October 6, 2022. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced the Agenda and Registration Details for the Company’s Capital Markets Day on Thursday October 13, 2022, in Stockholm, Sweden, for investors, analysts and media.

Time: Thursday, October 13, 2022, at 1:00 pm – 4:00 pm CEST
Venue: Erik Penser Bank, Apelbergsgatan 27, Stockholm, Sweden
Registration (to attend in person): Please register here
Webcast (no preregistration required): Please follow this link

During the event, the Company will provide an update and review of its strategy and pipeline. The presentations will focus on the Company’s drug candidates and the related unmet medical need they will address, development plans, commercial opportunities, and additional activities to create and enhance long-term shareholder value. Presentations will be made by members of Egetis’ management team and Board, as well as invited key opinion leaders. Presentations will be held in English. The webcast will also be available on Egetis webpage www.egetis.com after the event.

Agenda

Time	Subject	Presenter(s)
13:00	Welcome, Corporate strategy and overview	Nicklas Westerholm, CEO
13:15	MCT8 deficiency & clinical experience with Emcitate	Dr Edward Visser, Erasmus Medical Center
13:40	Development paths for Emcitate in Europe and the US	Dr Peder Walberg, Operative Director of the Board
13:55	Q&A: MCT8 deficiency & Emcitate development	Visser, Walberg, Sjöblom, Westerholm
14:10	Global plans for commercializing Emcitate	Dr Henrik Krook, VP Commercial
14:20	Market access & commercialization in the US	Sara Melton, President Egetis North America
14:30	Q&A: Emcitate commercialization	Walberg, Krook, Melton, Westerholm
14:45	Break
15:00	Paracetamol overdose & clinical experience with Aladote	Prof. James Dear, Edinburgh University
15:20	Development paths for Aladote in Europe and the US	Dr Kristina Sjöblom, CMO
15:30	Commercial opportunity for Aladote	Dr Henrik Krook, VP Commercial
15:35	Aladote Q&A	Dear, Sjöblom, Krook, Westerholm
15:45	Summary of the day	Nicklas Westerholm, CEO
15:55	Concluding remarks	Thomas Lönngren, Chair of the Board
16:00	End

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 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 T3 levels and secondary clinical endpoints. As a result of fruitful regulatory interaction Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in the first half of 2023 based on existing clinical data.
In the US, after discussions with the FDA, Egetis will conduct a small randomized, placebo-controlled 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-2023 under the Fast-Track Designation granted by FDA.
Emcitate is currently being investigated in the Triac Trial II, a Phase II/III study in very young MCT8 deficiency patients (<30 months of age) exploring potential disease modifying effects of early intervention from a neurocognitive and neurodevelopmental perspective. The recruitment target was achieved in the second quarter 2022 and 22 patients have been included in the study. Results are expected in the first half of 2024 and are expected to be submitted post-approval to regulatory authorities shortly thereafter.
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.
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 for later in 2022. 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