Check-Cap Ltd. (NASDAQ:CHEK) lost ~20% on Wednesday after the clinical stage medical diagnostics company indicated a potential delay for its U.S. pivotal study of C-Scan, a screening test designed to detect early stages of colorectal cancer.
The first part of the study has already started at Mayo Clinic in Rochester, Minnesota, and New York University (NYU) School of Medicine involving the average risk U.S. population.
Announcing its financials for Q2 2022, Israel-based CHEK said that the second part of the trial could start in mid-2023, a delay from its previous timeline of Q4 2022.
For the quarter, CHEK reported $4.8M of net loss, indicating a ~23% YoY rise from the prior-year period driven by a ~28% YoY increase in R&D expenses that stood at ~$3.5M. Meanwhile, cash and cash equivalents dropped ~56% from 2021 year-end to $11.6M.
Concurrently, CHEK announced that on Aug. 11, the company’s investors approved a reverse share split in the range of 1 for 10 to 1 for 20. The terms are yet to be finalized.
The U.S. trial for C-Scan was expected to enroll about 1,000 subjects aged 50 – 75 years across 15 sites, the company said in May, announcing its initiation.