Stockholm, Sweden, October 31, 2024. The number of shares and votes in Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (STO: EGTX) has increased in the month of October as a result of the directed issuances of a total of 66,666,667 ordinary shares as announced on September 30, 2024.
The total number of shares and votes has increased by 66,666,667, from 292,571,459 to 359,238,126. The share capital has increased by approximately SEK 3,508,773.256328, from approximately SEK 15,398,503.586561 to approximately SEK 18,907,276.842889.

For further information, please contact

Nicklas Westerholm, CEO
nicklas.westerholm@egetis.com
+46 (0) 733 542 062

Yilmaz Mahshid, CFO
yilmaz.mahshid@egetis.com
+46 (0) 722 316 800

Karl Hård, Head of Investor Relations & Business Development
karl.hard@egetis.com
+44 (0) 7500 525 084

This information is information that Egetis Therapeutics is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 2024-10-31 08:25 CET.

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® (tiratricol) 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 randomized, placebo-controlled pivotal study in 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis will update the market as soon as recruitment has been completed and at that point inform about the timing of availability of top-line results, and the expected timing of the subsequent NDA filing.

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® (calmangafodipir) 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 study start has been postponed until Emcitate marketing authorization submissions for MCT8 deficiency 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

Attachments

Change in the number of shares and votes in Egetis Therapeutics