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Check Cap Check - Cap Reports First Quarter 2021 Financial Results and Corporate Update ISFIYA , Israel , May 12 , 2021 / 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 colorecta cancer ( CRC ) , today announced financial results for the first quarter ended March 31 , 2021 and provided a corporate update . Q1 2021 and Recent Highlights : • The U.S. Food and Drug Administration ( FDA ) has approved the Company's Investigational Device Exemption ( IDE ) application permitting Check - Cap to begin a pivotal study of C - Scan in the U.S. • The FDA has granted the Company Breakthrough Device Designation for C - Scan . • The Company continues to scale up manufacturing to support upcoming clinical trials , primarily the Company's U.S. pivotal study . • Due to technical issues associated with a single source supplier , the Company has recently experienced some manufacturing delays , but continues to expand its entire production process to meet its target manufacturing capacity . The Company expects a delay in its clinical trials , including the initiation of the U.S. pivotal trial , which is now projected to begin by the end of the first quarter of 2022 . • Strengthened balance sheet during the first quarter of 2021 through a total of $ 19.2 million proceeds from warrant exercises . Cash and cash equivalents , restricted cash and short - term bank deposits as of March 31 , 2021 were $ 34.0 million . " We met a crucial milestone this quarter with the FDA approval of the IDE to begin the pivotal trial of C - Scan in the U.S. , " said Alex Ovadia , chief executive officer of Check - Cap . " While we anticipate a slight delay in our clinical trials , including the U.S. pivotal trial initiation , now projected for March 2022 , we are laser - focused on advancing manufacturing activities to ensure a successful trial launch . We look forward to continuing to advance C - Scan as a colorectal cancer screening patient - friendly solution that has potential to enable early intervention and cancer prevention . " Financial Results for the First Quarter Ended March 31 , 2021 Research and development expenses were $ 2.4 million for the three months ended March 31 , 2021 , compared to $ 2.5 million for the same period in 2020. The decrease is primarily due to a $ 0.3 million grant received from the Israel Innovation Authority , which amount is reduced from research and development expenses , and $ 0.2 million decrease in other expenses and clinical - related expenses , offset in part by a $ 0.2 million increase in material and subcontractors ' expenses and $ 0.2 million increase in salary and related expense . General and administrative expenses were $ 1.2 million for the three months ended March 31 , 2021 , compared to $ 1.0 million for the same period in 2020. The increase is primarily due to a $ 0.2 million increase in professional services and other expenses . Operating loss was $ 3.6 million for the three months ended March 31 , 2021 , compared to $ 3.4 million for the same period in 2020 . Finance expense was $ 9,000 for the three months ended March 31 , 2021 , compared to $ 12,000 for the same period in 2020 . Net loss was $ 3.6 million for the three months ended March 31 , 2021 , compared to $ 3.4 million for the same period 2020 . Cash and cash equivalents , restricted cash and short - term bank deposits as of March 31 , 2021 were $ 34.0 million as compared to $ 18.1 million as of December 31 , 2020. During the first quarter of 2021 , certain warrant holders exercised warrants to purchase an aggregate 24,204,682 ordinary shares , which had been issued in 2020 , at exercis prices ranging from $ 0.75- $ 0.80 , which generated total gross proceeds of approximately $ 19.2 million to the Company . The number of outstanding ordinary shares as of March 31 , 2021 was 70,468,260 . As of May 10 , 2021 , the number o our outstanding ordinary shares was 70,472,316 . About Check - Cap Check - Cap is a clinical stage medical diagnostics company aiming to redefine colorectal cancer ( CRC ) screening