Invitation to Presentation of Egetis’ Second Quarter 2025 Report on August 21, 2025

Summary by AI ^BETAClose X

Egetis Therapeutics AB (publ) (NASDAQ Stockholm: EGTX) will release its second-quarter 2025 report on August 21, 2025, at 7:00 am CEST, followed by a conference call at 10:00 am CEST to discuss the results and provide a corporate update. The company's lead drug candidate, Emcitate® (tiratricol), has received European Commission approval for MCT8 deficiency and was launched in Germany on May 1, 2025. A pivotal study for Emcitate is underway in the US, aiming to verify previous clinical trial results. The company also has another drug candidate, Aladote® (calmangafodipir), in development for paracetamol overdose, but its development is currently paused pending Emcitate’s market authorization submissions in the EU and USA. Both Emcitate and Aladote hold Orphan Drug Designation in the US and EU. Emcitate also holds FDA Breakthrough Therapy Designation and Rare Pediatric Disease Designation.

Disclaimer*

Stockholm, Sweden, August 19, 2025. Egetis Therapeutics AB (publ) (NASDAQ Stockholm: EGTX) today announced that it will publish its second quarter 2025 report on Thursday, August 21, 2025, at 07:00 am CEST. Egetis will also host a conference call the same day at 10:00 am CEST to discuss the second quarter 2025 financial results and give a corporate update.
If you wish to participate via webcast, please use the link below.
https://egetis.events.inderes.com/q2-report-2025
If you wish to participate via teleconference, please register via the link below. After registration you will be provided with phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/egetis/q2-report-2025/dial-in
The conference call will be made available on the Company’s website after the call.

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.

On February 13, 2025, the European Commission approved Emcitate® (tiratricol) as the first and only treatment for MCT8 deficiency in EU. Egetis launched Emcitate in the first country, Germany, on May 1, 2025.

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.

After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled pivotal study in at least 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. As previously communicated, the Company will update the market as soon as recruitment closes, and at that time, the Company will also provide information on when to expect topline results and when the Company plans to submit the NDA application in 2025.

Tiratricol holds FDA Breakthrough Therapy Designation and 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. Tiratricol 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 development program for calmangafodipir has been parked until Emcitate marketing authorization submissions for MCT8 deficiency have been completed in the EU and the USA. Aladote has been granted ODD in the US and in the EU.

Egetis Therapeutics (Nasdaq Stockholm: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com