Stockholm, May 6, 2022. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) announced today that since there will be no opportunity for shareholders to physically attend the Annual General Meeting on May 30, Egetis invites shareholders to an informal digital information meeting on May 16, 2022, at 10:00am-11:00am (CEST). The information meeting will be attended by Thomas Lönngren, Chairman of the Board, Nicklas Westerholm, CEO and Yilmaz Mahshid, CFO, who will answer questions that may be asked during the meeting. The Company's CEO Nicklas Westerholm will also give some prepared remarks about the Company's operations and development during 2021 and the first quarter of 2022. Shareholders who wish to participate in the information meeting are asked to register no later than May 13, 2022, via email to [email protected]. A link to the information meeting and meeting instructions will then be sent out via email to the shareholders who have registered for the meeting.
For further information, please contact:
Karl Hård, Head of Investor Relations and Communications
+46 (0) 733 011 944
[email protected]
About Egetis Therapeutics AB
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 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 of 16 patients was reached in the beginning of April 2022. Results are expected in the first quarter 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- β) in the US and the EU. Emcitate has been granted Rare Pediatric Disease Designation (RPD) 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) poisoning. 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. Aladote has been granted ODD in the US and an application for ODD was submitted in the EU in the first quarter of 2021. There is an ongoing dialogue with EMA on the appropriate scope of the indication for an ODD in the EU.
Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com
