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3 € saniona Saniona Achieves Clinical Progress in Q2 2021 and Subsequent Period , with Orphan Status for Tesomet in HO and Start of Phase 1 for SAN711 Three Months Ended June 30 , 2021 ( 2020 ) Revenue was SEK 1.9 M ( 2.0 M ) Operating loss was SEK -103.6 M ( -26.0 M ) Net loss was SEK -103.9 M ( -23.9 M ) Basic loss per share was SEK -1.67 ( -0.81 ) Diluted loss per share were SEK -1.67 ( -0.81 ) ● Business highlights in Q2 2021 Saniona achieved a key milestone with the initiation of a Phase 1 clinical trial of SAN711 , an ion channel modulator that may be applicable in the treatment of rare neuropathic disorders . This is the first wholly - owned asset from Saniona's proprietary ion channel drug discovery engine to advance into a clinical trial . Data from the trial are expected in the first half of 2022 . INTERIM REPORT FOR SANIONA AB ( PUBL ) 556962-5345 January - June 2021 Published August 26 , 2021 Six Months Ended June 30 , 2021 ( 2020 ) Revenue was SEK 5.3 M ( 4.4 M ) Operating loss was SEK -197.7 M ( -53.5 M ) Net profit ( loss ) was SEK -187.3 M ( 19.3 M ) Basic earnings ( loss ) per share was SEK -3.00 ( 0.65 ) Diluted earnings ( loss ) per share were SEK -3.00 ( 0.65 ) Saniona provided multiple updates on its progress toward initiating Phase 2b clinical trials of Tesomet in hypothalamic obesity ( HO ) and Prader - Willi syndrome ( PWS ) , announcing a partnership with the Foundation for Prader Willi Research to increase clinical trial awareness and the receipt of manufacturing feedback from the U.S. Food and Drug Administration ( FDA ) on the transition from tablets to capsules . Both Phase 2b clinical trials are expected to start in the second half of 2021 , with top - line data expected from the PWS clinical trial in the first half of 2023 and from the HO clinical trial in the second half of 2023 . Saniona presented preclinical data from its ion channel program SAN903 in a model of idiopathic pulmonary fibrosis at the American Society of Pharmacology and Experimental Therapeutics ( ASPET ) Annual Meeting . SAN903 is expected to enter Phase 1 in the second half of 2022. Saniona also presented SAN711 preclinical data in a model of facial neuropathic pain at the prestigious European Academy of Neurology ( EAN ) Congress . TM 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 . Saniona provided an update from its partner Medix that additional information requested by a Mexican regulatory committee may delay the anticipated final decision in Mexico regarding tesofensine for obesity into 2022 . Saniona successfully monetized its position in the 2017 spin - out Scandion Oncology , completing the sale of its remaining shares on the open market . Saniona received a minority ownership stake in Cephagenix , as per the terms of the previously announced February 2020 collaboration agreement through which the company was formed to explore ion channel modulators for the treatment of migraine . Significant events after the reporting period Saniona achieved orphan drug designation from the FDA for Tesomet for the treatment of HO . Tesomet is the first and only investigational treatment for HO to receive orphan drug designation . 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 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