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Biotech Could Launch Trial of Polyp Screening Test in March
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The Quick Take

  • H.C. Wainwright & Co. has a Buy rating and a $3 per share price target on Check-Cap.
  • H.C. Wainwright ranks Check-Cap Buy on news the company submitted an amended design of the planned pivotal trial of its C-Scan polyp screening test.
  • The amended trial design adds a second component that is to take place first, reported H.C. Wainwright analyst Yi Chen in a Jan. 14 research note.
  • Should the U.S. Food and Drug Administration approve the revised study design, Check-Cap could launch the first part of the trial in March or April 2022 and the second part in Q4/22.
  • Start of the trial would be a major milestone for Check-Cap.
  • The previous U.S. pilot study of C-Scan showed the test to be safe and preferred by patients over a colonoscopy, primarily because it does not require advance bowel preparation.
  • C-Scan's CE Mark was renewed in late 2021 for five years.
  • The medical diagnostics firm has sufficient capital to fund operations well into 2023.

In the amended C-Scan pivotal trial design that Check-Cap Ltd. (CHEK:NASDAQ) submitted to the U.S. Food and Drug Administration, the medical diagnostics company added a second component which would be conducted before the existing part, H.C. Wainwright & Co. analyst Yi Chen reported. The added component would involve further calibrating the system and enhancing the algorithm for the U.S. population that is at average risk of developing polyps.

In the subsequent, second trial component, C-Scan performance would be compared to that of colonoscopy and analyzed for statistical significance.  

Chen highlighted that with the previously conducted U.S. pivotal C-Scan study of 40 patients, neither serious events nor capsule retention occurred. Abdominal cramping was the most commonly reported side effect.

Patients were significantly (p=0.001) more likely to recommend the C-Scan than colonoscopy, which received scores of 4.1 and 2.8, out of 5, respectively.

"Bowel preparation is one of the most important deterrents to colorectal cancer screening," Chen wrote. "Therefore, C-Scan's preparation-free approach offers an accessible alternative that facilitates the detection of precancerous colorectal polyps and may increase screening rates in subjects who are at average risk for colorectal cancer."


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Disclosures for H.C. Wainwright & Co. LLC, Check-Cap Ltd., Jan. 14, 2022

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules.
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.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
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 December 31, 2021 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 knows or has reason to know of any other material conflict of interest 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.
.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.
The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.
H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.
H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in 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.
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