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EGETIS THERAPEUTICS Interim report January - September 2021 Emcitate® receives FDA Fast Track Designation Financial overview July - September Quarterly net revenue MSEK 6.2 ( 2.6 ) Quarterly loss MSEK -22.5 ( -24.7 ) Cash and cash equivalents MSEK 173.2 ( 159.4 ) Cash flow for the period MSEK - 34.5 ( -24.6 ) Loss per share before / after dilution SEK -0.1 ( -0.5 ) Significant events during the period July - September Emcitate Egetis receives approval in Turkey for compassionate use of Emcitate® for MCT8 deficiency . Egetis Therapeutics launches disease awareness initiatives to support identification of subjects with suspected MCT8 deficiency . Financial overview Net revenues , KSEK Result after tax , KSEK Cash flow , KSEK Cash , KSEK Equity ratio % Earnings per share , SEK Earnings per share after dilution , SEK Average number of employees 2021 Jul - Sep 6,210 -22,530 -34,491 173,150 71 % -0.1 -0.1 11 About Egetis Therapeutics Egetis Therapeutics is an innovative , unique , and integrated pharmaceutical drug development company , focusing on projects in late - stage development for treatment of serious diseases with significant unmet medical needs in the orphan drug segment . The drug candidate Emcitate is developed as the first potential treatment for patients with MCT8 deficiency , a rare disease with high unmet medical need and no available treatment . A Phase IIb clinical trial has been completed with significant and clinically relevant effects . A pivotal Phase IIb / III early intervention study has been initiated with the first patient dosed in Dec 2020 and interim results are expected in 2022. Emcitate holds Orphan Drug Designation ( ODD ) in the US and EU and has been Financial overview January - September Net revenue for the period MSEK 35.0 ( 35.8 ) Loss for the period MSEK -76.2 ( -103.7 ) Cash and cash equivalents MSEK 173.2 ( 159.4 ) Cash flow for the period MSEK -115.4 ( -95.8 ) Loss per share before / after dilution SEK -0.5 ( -1.9 ) Aladote Preparation for the pivotal Phase IIb / III study for Aladote continues targeting study start early 2022 , pending the COVID - 19 pandemic situation . Significant events after the reporting period Egetis Therapeutics receives FDA Fast Track Designation for Emcitate® for MCT8 deficiency . New data published confirms long - term efficacy and safety of Emcitate® ( tiratricol ) in MCT8 deficiency patients . 2020 Jul - Sep 2,572 -24,726 -24,599 159,424 86 % -0.5 -0.5 9 2021 Jan - Sep 35,032 2020 Jan - Sep 35,772 -76,171 -103,710 -115,400 -95,776 173,150 159,424 71 % -0.5 -0.5 11 86 % -1.9 -1.9 9 2020 Jan - Dec 40,662 -179,120 34,223 287,850 70 % -2.7 -2.7 9 granted Rare Pediatric Disease Designation and Fast Track Designation by the US FDA . The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol poisoning . A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb / III study for Aladote has been finalized after completed interactions with FDA , EMA and MHRA . Aladote has been granted Orphan Drug Designation in the US and an application for ODD was submitted in Europe in Q1 2021. There is an ongoing dialogue with EMA on the appropriate indication for an ODD in the EU . Egetis Therapeutics ( STO : EGTX ) is listed on the Nasdaq Stockholm main market . For more information , see http://www.egetis.com/ Egetis Therapeutics Interim report January - September 2021 1