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茶 saniona TM Saniona Starts Strong in 2021 with Orphan Drug Designation for PWS and Alignment on the Regulatory Path for Tesomet Q1 2021 ( Q1 2020 ) Revenue was SEK 3.4 M ( 2.4 M ) Operating loss was SEK -94.1 ( -27.4 M ) Net profit / loss was SEK -83.4 M ( 43.2 M ) Earnings per share were SEK -1.34 ( 1.47 ) Diluted earnings per share were SEK -1.34 ( 1.47 ) INTERIM REPORT FOR SANIONA AB ( PUBL ) 556962-5345 January - March 2021 Published May 26 , 2021 Business highlights in Q1 2021 The U.S. Food and Drug Administration ( ' FDA ' ) granted orphan drug designation to Tesomet for the treatment of Prader - Willi syndrome ( PWS ) . This designation qualifies Saniona for certain development benefits , including tax credits , elimination of certain FDA license application fees , and seven years of market exclusivity in the U.S. following approval . The U.S. FDA provided further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity ( HO ) . The FDA indicated overall agreement with Saniona's Risk Evaluation and Mitigation Strategy ( REMS ) proposal and cardiovascular monitoring proposal . Saniona continued to make progress in preparing for its Phase 2b Tesomet clinical trials , including selecting the clinical research organization ( CRO ) that will support the clinical trials , identifying clinical trial sites in the U.S. and globally , engaging the contract manufacturer to produce Tesomet for Phase 2b and Phase 3 clinical trials , and establishing partnerships with patient advocacy organizations relating to patient community education and insights . Saniona received an upfront payment of approximately USD 2.9 million ( SEK 24.2 million ) relating to Novartis AG's acquisition of Cadent Therapeutics Inc. ( ' Cadent Therapeutics ' ) , in which Saniona held an ownership stake of approximately 3 % . The acquisition may result in additional contingent consideration upon the achievement of future milestones . Saniona's Board of Directors and executive management team purchased shares of the company in the open market for a total value of approximately SEK 1.5 million . Significant events after the reporting period Saniona announced the receipt of manufacturing feedback from the FDA that will delay the start of the Tesomet Phase 2b trials into the second half of 2021 . Saniona announced a partnership with the Foundation for Prader - Willi Research ( FPWR ) to increase awareness about Saniona's upcoming Phase 2b clinical trial of Tesomet for the treatment of PWS . Saniona successfully monetized its position in the 2017 spin - out Scandion Oncology A / S ( ' Scandion Oncology ' ) , completing the sale of its remaining shares on the open market . Saniona AB ( publ ) Smedeland 26B DK - 2600 Glostrup Denmark Saniona presented preclinical data on SAN903 in a model of idiopathic pulmonary fibrosis at the American Society of Pharmacology and Experimental Therapeutics ( ASPET ) Annual Meeting at Experimental Biology ( EB ) 2021 . Saniona hosted a research and development ( R & D ) day featuring presentations highlighting its ion channel drug discovery engine , including its IONBASE ™ M database now consisting of more than 20,000 proprietary molecules targeting various ion channels , and data from ion channel modulators SAN711 and SAN903 . TM EMAIL saniona@saniona.com WEB saniona.com Saniona Inc. 500 Totten Pond Road , Suite 620 Waltham , MA 02451 USA