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3 € saniona Saniona Achieves Key Milestones in Q3 2021 and Subsequent Period , including Orphan Drug Designation and Phase 2b Trial Initiation INTERIM REPORT FOR SANIONA AB ( PUBL ) 556962-5345 January - September 2021 Published November 18 , 2021 Three Months Ended September 30 , 2021 ( 2020 ) Nine Months Ended September 30 , 2021 ( 2020 ) Revenue was SEK 2.3 M ( 2.2 M ) Revenue was SEK 7.6 M ( 6.6 M ) Operating loss was SEK -286.7 M ( -90.8 M ) Net loss was SEK -281.8 M ( -29.0 M ) Operating loss was SEK -88.2 M ( -37.3 M ) Net loss was SEK -93.7 M ( -48.3 M ) Basic loss per share was SEK -1.50 ( -1.14 ) Diluted loss per share was SEK -1.50 ( -1.14 ) Basic loss per share was SEK -4.52 ( -0.86 ) Diluted loss per share was SEK -4.52 ( -0.86 ) Business highlights in Q3 2021 Saniona achieved orphan drug designation ( ODD ) from the FDA for Tesomet for the treatment of hypothalamic obesity ( HO ) . Tesomet is the first and only investigational treatment for HO to receive ODD , and it previously received ODD for Prader - Willi syndrome ( PWS ) . ODD qualifies Saniona for certain benefits including tax credits , elimination of certain FDA license application fees , and seven years of market exclusivity in the U.S. following approval . Saniona entered into a non - dilutive term loan agreement for SEK 87 million ( $ 10 million ) with Formue Nord Fokus A / S to support new activities aimed at accelerating clinical development programs . Saniona appointed Wendy Dwyer as Chief Business Officer to focus on out - licensing of assets in non - core markets and / or non - core therapeutic areas in order to generate non - dilutive capital while expanding the potential reach of Saniona's medicines globally . Finance veteran Robert E. Hoffman was appointed as a member of the board of directors and Chairman of the Audit Committee , as resolved at an extraordinary shareholders ' meeting . Significant events after the reporting period Saniona completed the submission of all information previously requested by the U.S. Food and Drug Administration ( FDA ) regarding its chemistry , manufacturing and controls program for Tesomet capsules . Saniona initiated a Phase 2b clinical trial of Tesomet in patients with HO . The company also confirmed , and continues to confirm , that it remains on track to initiate its Phase 2b clinical trial of Tesomet for PWS before the end of 2021 , as planned . Comments from the CEO " With two clinical trials now underway and a third poised to begin before the end of this year , Saniona has made significant progress on our mission to discover , develop and ultimately commercialize our medicines to treat rare diseases , ” said Rami Levin , President & Chief Executive Officer of Saniona . " This progress is a direct result of the hard work by the talented and experienced team we have hired , and it positions us well to continue to achieve important milestones in the fourth quarter of 2021 as well as throughout 2022 and 2023. " For more information , please contact Trista Morrison , Chief Communications Officer , Saniona . Office : +1 ( 781 ) 810-9227 . Email : trista.morrison@saniona.com Saniona AB ( publ ) Smedeland 26B DK - 2600 Glostrup Denmark EMAIL saniona@saniona.com WEB saniona.com Saniona Inc. 500 Totten Pond Road , Suite 620 Waltham , MA 02451 USA