Interim report
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Cantargia INTERIM REPORT January - September 2021 Important milestones and strong results THIRD QUARTER ● Significant events in the third quarter New positive interim data on treatment of patients with non - small cell lung cancer ( NSCLC ) in the CANFOUR study were presented at the ESMO conference ; next steps were initiated for expansion of the clinical development of nadunolimab and platinum - based chemotherapy in non squamous NSCLC ● ● Net sales : SEK 0 ( 0 ) million Operating loss : SEK - 104.7 ( -39.9 ) million Loss after tax : SEK - 103.8 ( -39.6 ) million Loss per share : before and after dilution , SEK -1.04 ( -0.43 ) ● The CIRIFOUR study was fully recruited ; next steps were also initiated for expansion in non - squamous NSCLC evaluating nadunolimab in combination with platinum based chemotherapy and immunotherapy ● Patient recruitment was completed for the extension cohort in pancreatic cancer in CANFOUR and nadunolimab was granted orphan drug status by the FDA for treatment of pancreatic cancer The first patient was treated in CAPAFOUR , approval was obtained to start the CESTAFOUR study and an application to start the TRIFOUR study was submitted and approved by the Spanish authorities Preclinical data were presented demonstrating the benefits of nadunolimab's mechanism of action over blockade of IL - 1ẞ alone The opposition against one of Cantargia's European patents was rejected by the European Patent Office Significant events after the end of the period Nadunolimab received a positive opinion from the EMA on orphan drug status for the treatment of pancreatic cancer The first patient was treated in CESTAFOUR Progress in the manufacturing process development for CAN 10 was reported and start of the first clinical study for CAN 10 was adjusted to Q3 2022 Cantargia AB | 556791-6019 | INTERIM REPORT January - September 2021 JANUARY - SEPTEMBER Net sales : SEK 0 ( 0 ) million Operating loss : SEK -264.5 ( -117.5 ) million Loss after tax : SEK -262.3 ( -116.6 ) million ● ● ● ● Loss per share : before and after dilution , SEK -2.62 ( -1.33 ) Equity / assets ratio : 91 ( 93 ) per cent Cash and cash equivalents : SEK 335.9 ( 282.0 ) million Short - term investments : SEK 312.0 ( 135.0 ) million Comments on significant events New positive interim data for 27 patients with NSCLC in CANFOUR were presented at the ESMO conference . The data show that 48 per cent of patients experienced a response with a median progression - free survival of 7.2 months for nadunolimab with chemotherapy . The most pronounced effect was noted in patients with non - squamous NSCLC . Safety was good , despite a higher occurrence of neutropenia and febrile neutropenia . This can be managed by treatment with G - CSF or dose modifications . There were no observations of serious cases of neuro pathy , a common side effect of chemotherapy . As a first step in a focus ed strategy for late - stage clinical development , Cantargia announced that CANFOUR will be expanded to an additional 40 patients with non squamous NSCLC to assess nadunolimab with carboplatin / pemetrexed . Recruitment to the extension cohort in pancreatic cancer in CANFOUR and the initial treatment arm in CIRIFOUR was completed . Preliminary data from the 15 patients treated in CIRIFOUR show that naduno limab and pembrolizumab are well tolerated . Cantargia announced that CIRIFOUR will also be expanded in non - squamous NSCLC to evaluate nadunolimab with pembrolizumab and chemotherapy . Progress has also been made in other studies with nadunolimab . An application to start TRIFOUR was submitted and approved . Approval was also obtained to initiate CESTAFOUR and the first patient received treatment . The first patient in CAPAFOUR was also treated . In addition , nadunolimab was granted orphan drug status in the US for the treat hent of pancreatic cancer , which provides benefits for continued clinical development in this form of cancer . The European Medicines Agency also issued a positive opinion on orphan drug status , and the European Commission is therefore expected to approve the application . In a further success , the opposition initiated against one of Cantargia's European patents for the treatment of solid tumors was rejected after oral proceedings at the European Patent Office . Thus , Cantargia's broad patent protection for IL1RAP - binding therapies remains unchanged . Finally , data were presented showing that nadunolimab , which blocks IL - 1α and IL - 1B , both forms of IL - 1 , has an advantage over antibodies that only block IL - 1ß . Nadunolimab increased the effect of the chemotherapy docetaxel in tumor - bearing mice , which was not achieved by IL - 1ẞ blockade alone . These data confirm the benefits of the mechanism of action of nadunolimab . For CAN10 , progress in the manufacturing process development was reported . Due to a global shortage in supply of raw materials and consumables , caused partly by a high demand for COVID - 19 vaccine , the production of CAN 10 for clinical study has been adjusted . The first clinical study for CAN10 will thus start in the third quarter of 2022 . PAGE 1