Check Cap Stock Price, News & Analysis

Check-Cap Ltd. (NASDAQ: CHEK) has initiated its U.S. pivotal trial for C-Scan®, a non-invasive screening test for colorectal cancer detection, at Mayo Clinic. Having received Institutional Review Board approval, the trial aims to enroll approximately 1,000 participants aged 50-75 across 15 sites. The study will assess C-Scan's accuracy in identifying polyp risks, with the first part focusing on calibration. Check-Cap's innovative approach seeks to enhance screening participation, addressing the common aversion to traditional colonoscopy procedures.

Check-Cap Ltd. (NASDAQ: CHEK) announced its Q4 and full-year 2021 financial results, revealing a net loss of $5.5 million for Q4 and $17.2 million for the full year. The company is advancing its C-Scan® test, aiming for a pivotal U.S. trial startup in April 2022. FDA approved an amended Investigational Device Exemption, facilitating this trial's initiation. Cash reserves stand at $51.9 million as of year-end 2021, bolstered by a $10 million offering in March 2022. Check-Cap believes it can sustain operations into Q1 2024, focusing on expanding colorectal cancer screening options.

Check-Cap Ltd. (NASDAQ: CHEK) has entered into agreements to sell 20 million ordinary shares and warrants to purchase 15 million additional shares for $10 million in gross proceeds. Each share is priced at $0.50, accompanied by a warrant exercisable at $0.65 for five years. Additionally, certain existing warrants from July 2021 will be modified to reduce their exercise price to $0.65 and extend their term to January 2025. The funds will be used to advance the clinical development of C-Scan®, a non-invasive screening test for colorectal cancer.

Check-Cap Ltd. (NASDAQ: CHEK) announced FDA approval for its amended Investigational Device Exemption (IDE) application, paving the way for a pivotal study of its C-Scan® technology. This screening test is designed to detect precancerous polyps in patients without the need for preparation, representing a significant advancement in colorectal cancer (CRC) diagnostics. The U.S. pivotal study will commence between March and April 2022, comprising two phases: calibration for average-risk individuals and a randomized comparison against traditional colonoscopy methods.

Check-Cap Ltd. (NASDAQ: CHEK) issued a letter from CEO Alex Ovadia highlighting 2021 achievements and updates on the C-Scan program. The FDA approved their Investigational Device Exemption (IDE) for a pivotal study, expected to begin in Q1 2022, focusing on device calibration and comparative performance against colonoscopy. The company enhanced manufacturing capacity and strengthened its clinical team. Financially, Check-Cap raised $31.8 million from a registered offering, ensuring operations funding into 2023. The FDA granted Breakthrough Device Designation, and the CE mark was renewed for C-Scan in Europe.

Check-Cap Ltd. (NASDAQ: CHEK) received a letter from Nasdaq indicating it is not compliant with the minimum bid price requirement of $1.00 per share. The company has 180 days from December 23, 2021, to regain compliance, which requires its closing bid price to reach at least $1.00 for ten consecutive business days. If compliance is not achieved, Check-Cap may face delisting. Despite this, there is no immediate effect on its Nasdaq listing or trading of its shares during the grace period.

Check-Cap Ltd. (NASDAQ: CHEK) has published research in Digestive Diseases and Sciences confirming the safety and patient satisfaction of its C-Scan® colorectal cancer screening test. The study, involving 40 patients, indicated no serious adverse events and an average satisfaction score of 4.1 out of 5, significantly higher than the 2.8 score for traditional colonoscopy (p=0.001). The findings support the need for less invasive screening alternatives. Check-Cap plans to initiate a multicenter pivotal study in the U.S. to further validate C-Scan's performance.

Check-Cap Ltd. (NASDAQ: CHEK) announced its financial results for Q3 and nine months ending September 30, 2021. The company reports a net loss of $4.2 million for Q3, up from $3.6 million in Q3 2020, driven by increased R&D and administrative expenses. Cash reserves rose significantly to $56.8 million, bolstered by a $35 million direct offering completed in July. The firm is focused on its U.S. pivotal trial for C-Scan®, enhanced by a new patent for its tracking technology. Leadership changes and manufacturing expansions are aimed at supporting these efforts.

Check-Cap Ltd. (NASDAQ: CHEK) announced the granting of a patent from the USPTO for its C-Scan® tracking technology, enabling real-time tracking of its capsule within the gastrointestinal tract. This patent enhances the company's proprietary technology, which facilitates optimal scanning with low energy consumption. The C-Scan® system aims to revolutionize colorectal cancer screening by providing a non-invasive, preparation-free option. The patent is valid until May 2034, with additional patents granted in Japan, China, and pending approval in Europe and Israel.