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( 131 ) INFANT BACTERIAL THERAPEUTICS Infant Bacterial Therapeutics AB ( publ ) Interim report January 1 - September 30 , 2021 Third quarter ( Jul - Sep ) 2021 • Net sales KSEK 0 ( 0 ) Operating income KSEK 228 * ( -18,586 * ) Earnings per share before and after dilution SEK -0.01 ( -1.66 ) ● Reporting period ( Jan - Sep ) 2021 • Net sales KSEK 0 ( 0 ) Operating income KSEK -28,485 * ( -45,294 * ) • Earnings per share before and after dilution SEK -2.56 ( -4.04 ) ● * Operational income includes exchange rate effects on foreign currency deposits for the purpose of securing future outflows during the third quarter amounting to KSEK 7,313 ( -3,872 ) and during the reporting period to KSEK 13,550 ( 3,384 ) . Significant events during the third quarter ( Jul - Sep ) • Marie - Louise Alamaa assumed the position as new CFO on August 16 • On August 25 , IBT announced that recruitment of the smallest infants in the Connection Study was paused . IBT started to recruit infants in Stratum A ( birth weight of 500g - 749g ) in The Connection Study on April 29 , 2021. At that point in time , 68 infants had been recruited to the group . In accordance with the study protocol and clinical observations , enrolment of infants to Stratum A was paused awaiting a safety review by the Data Monitoring Committee ( DMC ) . Infants that had already been randomized were allowed to continue treatment as per protocol , and infants in Stratum B ( 750g - 1000g ) were allowed to continue . On September 10 , IBT announced that the Mexican Patent Office has granted a patent entitled : " A method of activating lactic acid bacteria " , which protects the formulation of Lactobacillus reuteri including IBP - 9414 . IBT is currently developing its drug candidate IBP - 9414 in Phase III . The ambition for IBP - 9414 is to become the world's first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach - and bowel development in this population . • On September 22 , IBT announced that the company opened the study recruitment in Stratum A ( birthweight of 500 - 749 g ) after the independent DMC had completed an additional safety review , in which the DMC had no objections to continue the study . • On September 30 , IBT announced that the company has reached the next important milestone after recruitment of 600 premature infants in the ongoing Clinical Phase III study of IBP - 9414 . According to the study protocol , a safety and futility analysis will now be performed during which the recruitment will continue . Significant events during Jan - Jun • On February 9 , IBT announced that the Japan Patent Office has issued a decision to grant a patent entitled : " A method of activating lactic acid bacteria " , which protects the formulation of Lactobacillus reuteri including IBP - 9414 . The Japanese patent is valid until 2036 and IBP - 9414 is intended for marketing in Japan upon market approval . • On February 10 , IBT reached the important milestone after recruitment of 300 premature infants to the ongoing clinical Phase III study of IBP - 9414 . A safety assessment of the data was conducted and infants with very low birthweights ( Stratum A , birthweight of 500g - 749gwas thereafter allowed to be recruited to the study • IBT has during Q2 , 2021 finished the analysis of the pilot study that IBT had agreed with FDA to perform after recruitment of 300 infants in The Connection Study . The result from the pilot study was that the second primary endpoint called " sustained feeding tolerance " was validated . • On April 15 , we announced that the Chinese Patent Office has issued a decision to grant a patent entitled : " A method of activating lactic acid bacteria " , which protects the formulation of Lactobacillus reuteri . The Chinese patent is valid until 2036 and IBP - 9414 is intended for marketing in China upon market approval . Infant Bacterial Therapeutics AB ( publ ) • On April 29 , we announced that inclusion criteria of The Connection Study have been expanded to include 500-1000 g birthweight in premature infants ( from earlier 750g -1000 g ) after the Data Monitoring Committees ' planned review of safety data and performing futility - analysis regarding NEC . Interim report January 1 - September 30 , 2021 1