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 Ltd. (NASDAQ: CHEK) provided an update on its C-Scan program in a letter from CEO Alex Ovadia. In 2022, the company enrolled over 300 patients in Israel and only 17 in the U.S. due to slow recruitment linked to state licensing for X-ray technology. The preliminary efficacy results from calibration studies did not meet goals, leading to a postponement of the powered portion of the U.S. pivotal study initially set for mid-2023. Check-Cap will conduct further data analysis, amend study protocols with the FDA, and implement a cost reduction plan to extend its cash runway.
Check-Cap Ltd. (NASDAQ: CHEK) reported financial results for Q3 2022 with a net loss of $4.7 million, compared to $4.2 million in Q3 2021. R&D expenses rose to $3.6 million from $3.0 million year-over-year, reflecting increased clinical and employee costs. The company continues efforts to expand U.S. site participation in its pivotal study for C-Scan, while experiencing slower-than-expected patient recruitment. Check-Cap executed a 1-for-20 reverse share split on November 23, 2022, resulting in approximately 5.8 million outstanding shares. Cash reserves were $46.0 million as of September 30, 2022.
Check-Cap Ltd. (NASDAQ: CHEK) reported its financial results for Q2 and six months ended June 30, 2022. The company initiated the U.S. pivotal study for C-Scan, a non-invasive colorectal cancer screening tool, at Mayo Clinic and NYU. Research and development expenses rose to $3.5 million in Q2, up from $2.8 million in 2021. Net losses increased to $4.8 million in Q2 compared to $3.9 million last year. Cash reserves decreased to $50.2 million. The company anticipates sufficient capital to fund operations through Q2 2024.
Check-Cap Ltd. (NASDAQ: CHEK) announced on June 23, 2022, that it received a 180-day extension from Nasdaq to comply with the minimum $1 bid price requirement, with a new deadline set for December 19, 2022. The company had previously failed to regain compliance after an initial notification in December 2021. If Check-Cap's share price reaches or exceeds $1 for 10 consecutive trading days before the deadline, it will regain compliance. Check-Cap is advancing its C-Scan® technology, a non-invasive colorectal cancer screening test.
Check-Cap Ltd. (NASDAQ: CHEK) reported financial results for Q1 2022, with a net loss of $5.8 million, up from $3.6 million in Q1 2021. The company initiated the U.S. pivotal study of its C-Scan® device in May 2022, aiming to enroll 1,000 subjects. R&D expenses rose to $4.1 million, influenced by increased headcount and clinical costs. General and administrative expenses also increased to $1.8 million. Cash reserves totaled $55.7 million as of March 31, 2022, ensuring operational funding through Q1 2024.
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.