Business
Check-Cap Reports Fourth Quarter and Full Year 2022 Financial Results
ISFIYA, Israel, March 31, 2023 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical
About this update from Check-cap Ltd.
[{"type":"text","content":"ISFIYA, Israel, March 31, 2023 /PRNewswire/ -- Check-Cap Ltd. (the \"Company\" or \"Check-Cap\") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced financial results for the fourth quarter and full year ended December 31, 2022.\n \n2022 and Recent Highlights:\nIn March 2023, the Company announced that following the Company's internal assessment of the clinical data collected to date from its calibration studies, the Company has determined that the current efficacy results do not meet its goal to proceed to the powered portion of the U.S. pivotal study. As a result, the Company has adopted a plan of actions that includes conducting additional clinical data analysis and approaching the U.S. Food and Drug Administration (\"FDA\") to make amendments to the U.S. pivotal study protocol that are expected to be part of an IDE supplement submission to the FDA, and which are subject to FDA approval. In addition, the Company plans to continue conducting its calibration studies, albeit at a slower pace, to collect additional clinical data and the Company is also implementing a cost reduction plan in order to extend its cash runway for a longer period than initially planned. The initiation of the powered portion of the U.S. pivotal study that was expected in mid-2023 is therefore temporarily postponed.In March 2022, the Company consummated a $10 million registered direct offering. Based on the abovementioned plan, the Company believes that current cash on hand will be sufficient to fund its ongoing operations and plans into the fourth quarter of 2024.Intellectual Property: During the year 2022, the Company was granted two new patents: \"Position Estimation of Imaging Capsule in Gastrointestinal Tract\" granted in Israel, covering C-Scan's proprietary tracking technology, which enables real time tracking of the capsule and its activation when it moves throughout the colon. This functionality allows for optimal scanning along the gastrointestinal (GI) tract while maintaining low energy consumption during the procedure. The patent also covers the capsule positioning data recording utilized by the C-Scan analysis suite, which ...