Regulatory press release

Interim report Q3 2023

Egetis submitted a marketing authorisation application for Emcitate for the treatment of MCT8 deficiency to the EMA

· Egetis secured approximately SEK 462 million in a combined financing comprising a SEK 172 million equity private placement and SEK 290 million debt financing
· ReTRIACt study progressing with results expected during the first half of 2024

Financial overview July-September
·        Quarterly Revenue MSEK 12.2 (5.1)
·        Quarterly loss MSEK -86,2 (-53.9)
·        Cash at the end of the quarter amounted to MSEK 85.0 (190.1)
·        Cash flow for the quarter was MSEK -94.2 (-43.2)
·        Earnings per share before/after dilution SEK -0.3 (‑0.3)

Financial overview January-September
·        Revenue for the period MSEK 25.0 (16.9)
·        Net loss for the period MSEK -240.7 (-115.9)
·        Cash at the end of the period amounted to MSEK 85.0 (190.1)
·        Cash flow for the period MSEK -43.2 (43.3)
·        Earnings per share before/after dilution SEK -1.0 (‑0.6)

Significant events during the quarter
Emcitate
· Announced first patient included and second site activated in the ReTRIACt trial, which is pivotal for the US NDA submission
· ReTRIACt trial design presented at the Annual Meeting of the European Society for Paediatric Endocrinology

Significant events after the period
·        Secured approximately SEK 462 million in a combined financing comprising a SEK 172 million equity private placement and SEK 290 million debt financing
·        Resolved on directed issues of warrants and a convertible bond within the framework of the drawdown of Tranche A of the previously communicated debt financing
·        Recruited Desiree Luthman as Vice President Global Regulatory Affairs
Emcitate
·        Submitted marketing authorisation application (MAA) for Emcitate for the treatment of MCT8 deficiency to the EMA

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 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 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