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INTERIM REPORT Q3 2021 Back to the future Concopeptides Significant events JULY - SEPTEMBER • Updated results from the phase 3 OCEAN study were announced on July 8 : melflufen met the primary endpoint of superior PFS • FDA requested on July 8 , a partial clinical hold of all clinical studies with melflufen , based on OS data in the ITT - population • FDA issued a safety alert to patients and healthcare professionals on July 28 , regard ing an increased risk of death associated with Pepaxto® in the OCEAN study • FDA announced an ODAC meeting on September 2 , scheduled for October 28 . The meeting was later cancelled • New data from OCEAN and PORT were pre sented at the IMW meeting on September 11 AFTER THE REPORTING PERIOD • Anders Martin - Löf , CFO , resigned from Oncopeptides on October 15 ● Pepaxto was withdrawn from the US market on October 22 and as such Oncopeptides will close commercial opera tions and refocus on R & D Oncopeptides communicated focused clin ical development efforts to increase cash runway on November 4 Annika Muskantor joined as interim CFO on November 8 Jakob Lindberg was appointed CEO of Oncopeptides and Marty J Duvall left the company on November 15 * Pepaxto® ( melphalan flufenamide ) is the US trade name . It is known as melflufen during clinical development . Financial overview JULY - SEPTEMBER Net sales amounted to SEK 54.3 M ( 0.0 ) Operating loss amounted to SEK 338.9 M ( loss : 383.5 ) Loss for the period was SEK 777.5 M ( loss : 383.4 ) Loss per share , before and after dilution , was SEK 10.33 ( loss : 5.71 ) Cash and cash equivalents amounted to SEK 671.3 M ( 1,251.6 ) on September 30 16.5 Sales Jan - Sep USD M Financial overview of the group 2021 Jul - Sep 54,276 22,683 42 % -338,913 -777,547 ( SEK thousand ) Net sales Gross profit Gross margin Operating loss Loss after tax Earnings per share before and after dilution ( SEK ) Cash flow from operating activities Cash and cash equivalents at the end of the period R & D costs / operating expenses , % -10,33 -336,528 671,269 41 % JANUARY - SEPTEMBER ● Net sales amounted to SEK 140.0 M ( 0.0 ) Operating loss amounted to SEK 1,031.1 M ( loss : 1,079.7 ) Loss for the period was SEK 1,036.3 M ( loss : 1,081.7 ) Loss per share , before and after dilution , was SEK 14.27 ( loss : 17.87 ) Cash and cash equivalents amounted to SEK 671.3 M ( 1,251.6 ) on September 30 671 Cash SEK M 2020 Jul - Sep 2021 Jan - Sep 140,005 105,262 N / A 75 % -383,498 -1,031,081 -388,357 -1,036,327 -5.71 -340,841 1,251,629 50 % -14,27 -1,069,937 671,269 44 % > 380 patients treated with Pepaxto 2020 Jan - Sep N / A -1,079,706 -1,081,727 -17.87 -939,347 1,251,629 59 % 2020 Jan - Dec N / A -1,591,279 -1,594,693 -25.57 -1,296,509 840,255 54 % Disclaimer : In the event of inconsistency or discrepancy between the Swedish version and this publication , the Swedish language version shall prevail .