Welcome to our dedicated page for Check Cap news (Ticker: CHEK), a resource for investors and traders seeking the latest updates and insights on Check Cap stock.
Check-Cap Ltd. reports developments as an Israel-incorporated clinical-stage medical diagnostics company with Nasdaq-listed ordinary shares. Recurring news for CHEK centers on shareholder voting matters, governance actions, material agreements, capital-structure proposals, clinical or regulatory disclosures, and operating and financial results.
Company updates also include annual meeting outcomes, board and proxy matters, transaction-related disclosures, and public-company status issues tied to its reporting obligations and exchange listing requirements.
Check-Cap (NASDAQ: CHEK) announced FDA approval for its Investigational Device Exemption (IDE), allowing the initiation of a pivotal study for its revolutionary C-Scan® colorectal cancer screening test. This patient-friendly, preparation-free method targets individuals at average risk who are poor candidates for traditional colonoscopy. The study aims to assess C-Scan's safety and performance, with plans to enroll 250 patients across clinical sites in Israel. The FDA also granted Breakthrough Device Designation for C-Scan, emphasizing its potential in addressing unmet needs for CRC screening.
Check-Cap Ltd. (NASDAQ: CHEK) updated shareholders on its progress with the C-Scan technology, a unique screening test for colorectal cancer. In 2020, the company finalized its pivotal study design and submitted an IDE to the FDA. Manufacturing is underway, supported by a $750,000 grant from the Israel Innovation Authority. The company regained NASDAQ compliance as of January 26, 2021, and raised funds totaling approximately $34.8 million for its U.S. initiatives. The C-Scan aims to enhance screening adherence, with ongoing studies and patent protections bolstering its market presence.
Check-Cap Ltd. (NASDAQ: CHEK) submitted an Investigational Device Exemption application to the FDA for its C-Scan® pivotal study on November 18, 2020. The IDE submission marks a significant milestone as the company aims to advance its non-invasive colorectal cancer screening solution. Financially, Check-Cap reported a net loss of approximately $3.6 million in Q3 2020, similar to Q3 2019, with cash reserves of approximately $21.7 million. Research and development expenses remained stable, totaling $2.7 million. The company anticipates providing updates on study timelines in 2021.
Check-Cap Ltd. (NASDAQ: CHEK) reported financial results for Q2 2020, showing a net loss of $2.9 million, down from $3.4 million in Q2 2019. The company raised $16.3 million through offerings and has a cash position of $16.4 million as of June 30, 2020. With the Investigational Device Exemption submission to the FDA planned for late 2020 and a U.S. pivotal study beginning in 2021, Check-Cap aims to advance its C-Scan® colon cancer screening technology. Despite challenges posed by COVID-19, operations have resumed, aided by successful fundraising efforts.
Check-Cap Ltd. (NASDAQ: CHEK) announced a definitive agreement with institutional investors to exercise outstanding warrants for 16,054,223 ordinary shares at $0.60 per share, generating approximately $9.6 million in gross proceeds. The warrants, issued from November 2017 to May 2020, had previously higher exercise prices. The funds will be used to advance the clinical development of their C-Scan®, a non-invasive colorectal cancer screening test, and for general corporate purposes. Closing is expected around July 27, 2020, subject to customary conditions.