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● INTERIM REPORT JANUARY - SEPTEMBER 2021 Hansa on track to achieve key 2021 objectives : Agreements on funding obtained in three countries ; HTA submissions in ten countries ; and Marketing Authorization Applications filed in Switzerland and Israel Growing number of patient candidates identified as leading transplantation centers get clinically ready to transplant this underserved population Enrollment in AMR and GBS programs accelerated by initiation of additional centers ; On track for completion according to previous guidance Dialogue with FDA on regulatory path in anti - GBM expected to be concluded later this year as previously guided U.S. RCT study - site initiation progressing with first site open for recruitment in San Antonio , TX ● ● Highlights for the third quarter 2021 Launch and Market Access efforts for Idefirix® in Europe are progressing as planned in early launch countries . Reimbursement has been secured in Sweden , the Netherlands , Finland . Health Technology Assessment ( HTA ) dossiers have been submitted in ten countries , including UK , Germany , Norway and Israel and most recently in Italy and Scotland during the third quarter . Hansa expects to complete HTA filings in all EU5 by year - end , with France and Spain expected to be submitted in Q4 2021 . Growing number of patient candidates identified as select leading transplantation centers get clinically ready to transplant this underserved population and prioritization programs and policies are adjusted to HLA incompatible kidney patients , who cannot access an organ through existing allocation systems . Marketing Authorization Application for Idefirix® submitted in Switzerland and Israel . European Society for Organ Transplantation ( ESOT ) Congress in Milan - Hansa - sponsored symposium and KOL meetings with very strong interest across entire European transplant community . An ESOT workstream with leading transplantation KOLs has been formed to advance European clinical guidelines for desensitization practices in incompatible kidney transplant patients . Workstream expected to be concluded by year - end . Patient recruitment in the Phase 2 clinical studies in active antibody mediated rejection ( AMR ) and Guillain Barré Syndrome ( GBS ) has been accelerated by initiation of new centers . In the AMR and GBS trials , 19 and 14 patients , respectively , out of a target of 30 patients in each of the studies have now been enrolled . Completion of enrollment continues to be expected by H2'21 / H1'22 , with a first data read - out in both studies expected in the second half of 2022 , as previously guided . bezb stl #F OOZ Financial Summary Solid cash position of SEK 1,007m at the end of September 2021. With its existing cash position Hansa expects its operations to be financed into 2023 . SG & A expenses Investments in R & D in the third quarter amounted to SEK 61m ( Q3'20 : SEK 71m ) and to SEK 163m for the first nine months of 2021 ( first nine months'20 : SEK 177m ) . SG & A expenses amounted to SEK 83m in Q3 2021 ( Q3'20 : SEK 52m ) and to SEK 224m for the first nine months of the year 2021 ( first nine months'20 : SEK 140m ) , in line with plans . SEKM , unless otherwise stated - unaudited Revenue R & D expenses Cash flow from operating activities for the third quarter ended at SEK -132m ( Q3'20 : SEK 5m ) and SEK -365m for the first nine months of 2021 ( first nine months'20 : -194m ) . Operating profit / loss Net profit / loss Cash flow from operating activities Cash and short - term investments Shareholders ' equity EPS before and after dilution ( SEK ) Number of outstanding shares Weighted avg . number of shares before and after dilution Number employees at the end of the period Q3 2021 4.9 -82.8 -60.6 -148.2 -148.4 -131.5 1,006.7 HANSA BIOPHARMA 899.6 -3.34 Q3 2020 0.8 127 -51.7 -71.3 -123.4 -122.4 4.8 1,476.2 1,338.2 -2.77 9M 2021 18.5 -224.1 80 -162.5 -384.2 -384.9 V -364.9 Anti - Glomerular Basement Membrane ( Anti - GBM ) : In the U.S. , dialogue with FDA initiated regarding regulatory path forward , which is expected to conclude later this year as previously guided . In Europe , constructive regulatory advice meeting held with German health authorities BfArM ; Hansa is now preparing for dialogue with the European Medicines Agency ( EMA ) . Partnership with Sarepta and preclinical collaboration with argenx moving forward according to plan . Hansa Biopharma awarded " Great Place to Work " certification for second consecutive year . Events after the end of the reporting period US Randomized Controlled Trial in kidney transplant : First site open for recruitment in San Antonio , Tx . Additional centers are expected to be initiated in the coming months and patient enrollment to start in Q4 2021. The U.S. trial targets 64 patients with the highest unmet medicalneed and is expected to support a BLA submission under the accelerated approval pathway in H1 2024 . Hansa Biopharma is a pioneering commercial - stage biopharmaceutical company on a mission to develop and commercialize innovative , lifesaving and life altering treatments for patients with rare immunological conditions . Hansa has developed a first - in - class immunoglobulin G ( IgG ) antibody cleaving enzyme therapy , which has been shown to enable kidney transplantation in highly sensitized patients . Hansa has a rich and expanding research and development program , based on the Company's proprietary IgG - cleaving enzyme technology platform , to address serious unmet medical needs in transplantation , autoimmune diseases , gene therapy and cancer . Hansa Biopharma is based in Lund , Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA . Find out more at www.hansabiopharma.com 1,006.7 899.6 -8.65 9M 2020 127 2.3 -139.8 -176.8 -316.6 -315.0 -193.8 44,473,452 44,473,452 44,473,452 44,473,452 44,473,452 44,135,067 44,473,452 41,405,758 1,476.2 1,338.2 -7.61 80 1