Regulatory press release

Egetis Therapeutics has 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

Stockholm, Sweden, November 7, 2023. On October 10, 2023, Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (Nasdaq Stockholm: EGTX) announced that the Company had secured a debt financing from BlackRock (formerly Kreos) (“BlackRock”) (the “Debt Financing”). The Debt Financing is divided into two tranches, EUR 10 million (“Tranche A”) and EUR 15 million (“Tranche B”) which will become available provided that the Company reaches certain milestones. A part of Tranche A is made available through the issuance of a convertible loan of EUR 3 million, which can be converted in to shares in the Company. As part of the Debt Financing, BlackRock will receive warrants, which entitles to subscription of new shares in the Company, whereof 1,090,977 warrants for Tranche A.

Egetis has delivered a drawdown notice to BlackRock for the drawdown of Tranche A of the Debt Financing on November 30, 2023. Payment will be subject to customary conditions precedent. Furthermore, the Board of Directors of Egetis has, based on the authorisation granted by the annual general meeting on April 27, 2023, resolved on a directed issue of 1,090,977 warrants and a directed issue of a convertible bond to BlackRock within the framework of Tranche A of the Debt Financing, as part of the conditions precedent for the drawdown of Tranche A of the Debt Financing. The warrants are issued free of charge and each warrant entitles the holder to subscription of one share. The warrants will be subject to customary recalculation terms and may be exercised prior to the tenth anniversary of the date of grant at a strike price of SEK 4.26 per share. The convertible bond will be subscribed for by payment of its nominal amount of EUR 3 million and the conversion price has been set to approximately EUR 0.5133 per share.

The issue of the warrants and the convertible bond entails, upon full exercise and conversion, a dilution of approximately 2.3 percent after full dilution.

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