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. (CHEK) is a clinical-stage innovator in non-invasive screening, developing the C-Scan® ingestible capsule for colorectal cancer detection. This page provides investors and medical professionals with essential updates on the company's advancements in patient-friendly diagnostic technology.
Access authoritative updates on clinical trial progress, regulatory milestones, and strategic partnerships. Our curated news collection focuses on developments directly impacting Check-Cap's position in preventive healthcare solutions, including technological refinements to its low-dose X-ray imaging system.
Key updates cover FDA communications, trial phase results, and collaborations with healthcare institutions. All content is verified through primary sources to ensure accuracy for investment and research decisions.
Bookmark this page for streamlined access to Check-Cap's evolving role in transforming colorectal screening through preparation-free technology. Monitor critical developments in medical imaging innovation and diagnostic accessibility.
Check-Cap Ltd. (NASDAQ: CHEK) has announced the expansion of its C-Scan manufacturing capacity and production line to support its upcoming U.S. pivotal study, set to begin in Q1 2022. The initiative addresses technical issues from a supplier and enhances the company's ability to meet study demands. C-Scan offers a non-invasive, preparation-free screening test for colorectal cancer detection, aiming to improve screening adherence. This advancement is crucial for early intervention and cancer prevention, catering to patients needing less daunting screening options.
Check-Cap Ltd. (NASDAQ: CHEK) announced the appointment of Dr. Hanit Brenner-Lavie as Vice President of Clinical Affairs, effective immediately. Dr. Brenner-Lavie brings over 15 years of experience in clinical and regulatory affairs and will spearhead the clinical strategy for the company's groundbreaking C-Scan® technology, designed to detect colorectal polyps non-invasively. She takes over from Dr. Vardit Segal, who has held the position since 2019. This leadership change comes as the company nears the final stages of C-Scan's clinical development in the U.S.
Check-Cap Ltd. (NASDAQ: CHEK) reported its financial results for Q2 and the first half of 2021, highlighting a net loss of $3.9 million for Q2, up from $2.9 million in 2020. R&D expenses increased to $2.8 million, while G&A expenses rose to $1.1 million. The company secured $35 million in a registered direct offering on July 2, 2021, bolstering its capital position for ongoing operations and U.S. pivotal study funding until 2023. The total cash position reached $29.3 million as of June 30, 2021, down from $34 million at the end of Q1.
Check-Cap Ltd. (NASDAQ: CHEK) announced definitive agreements for a registered direct offering of 25,925,926 ordinary shares and short-term warrants, raising approximately $35 million. Each share has an offering price of $1.35, with accompanying warrants priced at $1.50. The offering is set to close around July 2, 2021. Proceeds will enhance clinical development of C-Scan®, a non-invasive colorectal cancer screening technology. Full exercise of the warrants could generate an additional $38.9 million.
Check-Cap Ltd. (NASDAQ: CHEK) announced Q1 2021 results, revealing a net loss of $3.6 million, matching the previous year's loss. The FDA approved the Investigational Device Exemption for its C-Scan® device, allowing it to start a pivotal study in the U.S., now projected for Q1 2022 due to manufacturing delays from a single-source supplier. Despite these delays, the company raised $19.2 million from warrant exercises, boosting cash and equivalents to $34 million as of March 31, 2021. R&D expenses slightly decreased to $2.4 million, while general and administrative expenses rose to $1.2 million.
Check-Cap Ltd. (NASDAQ: CHEK) reported its financial results for the fourth quarter and full year ending December 31, 2020. The company received FDA approval for its Investigational Device Exemption (IDE) for the C-Scan® colorectal cancer screening test, and was granted Breakthrough Device Designation. Check-Cap raised $25.9 million in 2020 and an additional $19.2 million in early 2021 through warrant exercises. The net loss for Q4 2020 was $3.9 million, with total R&D expenses of $2.8 million. As of December 31, 2020, cash reserves reached $18.1 million.
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.