In a July 10, 2019 research note, H.C. Wainwright & Co. analyst Yi Chen reported that Check-Cap Ltd.'s (CHEK:NASDAQ) C-Scan showed "statistically better polyp-detecting sensitivity than the fecal immunochemical test (FIT)."
This superiority over the FIT, a commonly used screening test, was demonstrated in the recently completed study, initiated following CE mark approval in January 2018.
Chen reviewed how the study worked and the outcome. It was a multicenter, open-label trial involving 142 patients. Ninety of them were evaluable and either had or were at average risk for polyps. Each patient ingested a C-Scan capsule, took an FIT and underwent a colonoscopy, done by independent gastroenterologists, for comparison. Results of the C-Scan and FIT were compared to those of the colonoscopy. Only mild, no serious, events were noted during the study.
As for the findings, Chen relayed that in patients with polyps greater than or equal to 10 millimeters (10 mm) in size, C-Scan had a sensitivity, or ability to correctly identify persons with polyps, of 76% (p=0.0005), more than double that of the FIT at 29% (p=0.005). Regarding specificity, the ability to correctly identity persons without polyps, C-Scan's rate was 82%; FIT's was 96%.
Also, in patients with polyps greater than or equal to 40 mm in size, C-Scan detected all four patients who had them whereas the FIT detected only one patient. Chen highlighted that these results show C-Scan has clinical value when it comes to identifying patients with large polyps, those most likely to become malignant.
Of note, however, C-Scan also showed superior sensitivity to the FIT in patients with smaller polyps, Chen pointed out. C-Scan's sensitivity among all of the study patients, even those having polyps smaller than 10 mm in size, was 66% (p=0.01) whereas the FIT's was 23% (p<0.0001).
"C-Scan has the potential to meet the unmet medical need for a patient-friendly and preparation-free screening option for precancerous polyps," the analyst added.
Chen noted that the U.S. pilot study of the C-Scan system is underway, at the New York University School of Medicine and the Mayo Clinic. The intent is to measure the number of device and procedure-related serious adverse events that occur and quantify both participant satisfaction and noncompliance. Results could be available in late 2019/early 2020.
"We believe [C-Scan] has the potential to increase the number of adults screened for colorectal cancer by eliminating common barriers and allowing for early detection of polyps without the use of colonoscopy," added Chen.
H.C. Wainwright & Co. has a Buy rating and a $15 per share price target on Check-Cap. The stock is currently trading at around $2.20 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Check-Cap Ltd., Company Update, July 10, 2019
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Check-Cap Ltd. (including, without limitation, any option, right, warrant, future, long or short position).
As of June 30 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Check-Cap Ltd.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did receive compensation from Check-Cap Ltd. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Check-Cap Ltd. during the past 12 months.
The Firm does not make a market in Check-Cap Ltd. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.