Exhibit 99.1 Check-Cap Reports Fourth Quarter and Full Year 2021 Financial Results Company anticipates initiation of the first part of its U.S. pivotal study in April 2022 ISFIYA, Israel, April 7, 2022 -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparationfree screening test to detect polyps before they may transform into colorectal cancer (CRC), toda ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the ...

PART I [ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS](index=8&type=section&id=ITEM%201.%20IDENTITY%20OF%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20ADVISERS) Information regarding the identity of directors, senior management, and advisers is not required for this report - Information on directors, senior management, and advisers is **not required** for this filing[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) [ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE](index=8&type=section&id=ITEM%202.%20OFFER%20STATISTICS%20AND%20EXPECTED%20TIMETABLE) Offer statistics and expected timetable information is not required for this report - Offer statistics and expected timetable information is **not required**[37](index=37&type=chunk) [ITEM 3. KEY INFORMATION](index=8&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section provides key information about the company, including selected financial data, capitalization, and a comprehensive overview of risk factors related to its financial position, business operations, regulatory environment, intellectual property, Israeli operations, share ownership, and taxation [A. Selected financial data](index=8&type=section&id=A.%20Selected%20financial%20data) The selected consolidated financial data, prepared in accordance with U.S. GAAP, highlights the company's historical financial performance and position for the years ended December 31, 2015-2019, showing consistent net losses and a decrease in total shareholders' equity Consolidated Statements of Operations Data (US$ in thousands, except per share data) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 | | :-------------------------------------- | :----- | :----- | :----- | :----- | :----- | | Research and development expenses, net | 10,474 | 7,618 | 6,837 | 5,491 | 5,837 | | General and administrative expenses | 3,595 | 3,445 | 3,164 | 3,571 | 6,626 | | Operating loss | 14,069 | 11,063 | 10,001 | 9,062 | 12,463 | | Finance income, net | 233 | 473 | 236 | 244 | 173 | | Loss before income tax | 13,836 | 10,590 | 9,765 | 8,818 | 12,290 | | Taxes on income | - | (1) | 6 | 8 | - | | Net loss | 13,836 | 10,589 | 9,771 | 8,826 | 12,290 | | Comprehensive loss | 13,823 | 10,602 | 9,771 | 8,826 | 12,290 | | Net loss per ordinary share, basic and diluted | 1.73 | 2.61 | 6.72 | 7.31 | 12.67 | Consolidated Balance Sheet Data (US$ in thousands, except per share data) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 |\n| :------------------------------ | :---- | :---- | :---- | :---- | :---- |\n| Cash and cash equivalents | 7,685 | 8,572 | 6,997 | 11,639| 9,392 |\n| Working capital | 5,633 | 12,763| 5,841 | 10,514| 12,856|\n| Total assets | 9,429 | 15,436| 7,906 | 12,295| 15,298|\n| Capital stock | 83,371| 76,344| 58,617| 53,348| 46,763|\n| Total shareholders' equity (deficiency) | 6,234 | 13,030| 5,905 | 10,407| 12,648| - Operating expenses include share-based compensation: **$0.5 million** (2019), **$0.7 million** (2017), **$1.2 million** (2016), **$3.7 million** (2015), and a negative **$65,000** (2018) due to forfeitures[43](index=43&type=chunk) - Research and development expenses are net of grants from the Israel Innovation Authority (IIA) and BIRD Foundation: **$0.1 million** (2019), **$0.2 million** (2018), **$1.1 million** (2017), **$0.3 million** (2016), **$0.6 million** (2015)[43](index=43&type=chunk) [B. Capitalization and indebtedness](index=9&type=section&id=B.%20Capitalization%20and%20indebtedness) Information regarding capitalization and indebtedness is not required for this report - Information on capitalization and indebtedness is **not required**[46](index=46&type=chunk) [C. Reasons for the Offer and Use of Proceeds](index=9&type=section&id=C.%20Reasons%20for%20the%20Offer%20and%20Use%20of%20Proceeds) Reasons for the offer and use of proceeds information is not required for this report - Reasons for the offer and use of proceeds information is **not required**[47](index=47&type=chunk) [D. Risk factors](index=9&type=section&id=D.%20Risk%20factors) This section outlines various significant risks that could materially and adversely affect the company's business, financial condition, and results of operations, categorized by financial position, business operations, regulatory compliance, intellectual property, Israeli operations, share ownership, and taxation [Risks Related to Our Financial Position](index=10&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) Persistent net losses and a **$77.1 million** accumulated deficit raise going concern doubts, requiring additional funding for C-Scan system development - The company has incurred net losses of **$13.8 million** in 2019, **$10.6 million** in 2018, and **$9.8 million** in 2017[52](index=52&type=chunk) - As of **December 31, 2019**, the accumulated deficit was **$77.1 million**[52](index=52&type=chunk)[53](index=53&type=chunk) - Recurring operating losses raise substantial doubt about the company's ability to continue as a going concern, as noted by its independent registered public accounting firm[53](index=53&type=chunk) - Additional funding is required to complete development and commercialization of the C-Scan system, with current capital projected to fund operations only into **July 2020**[54](index=54&type=chunk)[55](index=55&type=chunk) [Risks Related to Our Business](index=10&type=section&id=Risks%20Related%20to%20Our%20Business) The company faces significant challenges in commercializing its C-Scan system, including obtaining regulatory approvals, demonstrating clinical effectiveness, scaling manufacturing, establishing sales channels, and achieving market acceptance against established competitors - The company has CE Mark approval for the C-Scan system in the European Union (valid until **January 1, 2023**) and approval in Israel (valid until **March 31, 2022**), but has not yet received approvals in other key jurisdictions like the United States[58](index=58&type=chunk)[59](index=59&type=chunk) - Future success depends on completing product development, demonstrating sufficient clinical evidence, obtaining regulatory approvals, generating significant revenues, and manufacturing at acceptable costs[59](index=59&type=chunk) - The company relies on single-source suppliers for critical C-Scan system components (motor, X-ray detectors, X-ray source, batteries, ASIC), posing risks of supply disruption and delays[87](index=87&type=chunk) - The company depends on third parties (CROs, clinical investigators) to manage clinical studies, data collection, and patient enrollment, which can lead to costs and delays beyond its control[93](index=93&type=chunk)[94](index=94&type=chunk) [Risks Related to Regulations](index=13&type=section&id=Risks%20Related%20to%20Regulations) The company's C-Scan system is subject to extensive and costly regulatory processes, particularly in the U.S. (FDA clearance/approval via de novo reclassification or PMA) and internationally, with potential delays or non-compliance severely impacting commercialization - The company plans to submit a direct de novo reclassification petition for its C-Scan system in the U.S., aiming to demonstrate low to moderate risk, but FDA may require the more costly and lengthy PMA process[120](index=120&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - Clinical trials are expensive, lengthy, and uncertain; failure at any stage or inadequate data can prevent regulatory approval or market acceptance[135](index=135&type=chunk)[136](index=136&type=chunk)[141](index=141&type=chunk) - Modifications to the C-Scan system or future products may require new regulatory clearances or approvals, potentially leading to recalls or marketing cessation[146](index=146&type=chunk)[147](index=147&type=chunk) - The C-Scan system's use of iodinated oral contrast medium may classify it as a drug-device combination product, complicating regulatory review and potentially requiring drug approvals for the contrast agent[1

Overview - Check-Cap aims to prevent colorectal cancer (CRC) through precancerous polyp detection using a prep-free capsule-based alternative [3, 4] - The company's C-Scan system has received CE Mark approval and is approved for sale in Israel, with a U S clinical study underway [4] - CRC is the third most diagnosed cancer worldwide, with approximately 18 million new cases and 881000 deaths annually [7] Market Opportunity - The global market opportunity for CRC screening is estimated to be multi-billion dollar, with potential markets of approximately $9 billion in the United States, $20 billion in Europe, and $30 billion in China [7, 10, 11, 12] - Screening rates remain low in the US, Germany and China [6] - The American Cancer Society (ACS) recommends screening every 10 years for average-risk patients aged 50-75, with revised guidelines recommending screening to begin at age 45 [13] C-Scan Technology and Clinical Data - C-Scan is a prep-free polyp detection system consisting of a capsule, tracking system, and post-processing suite [14] - Post-CE approval study results showed C-Scan sensitivity of 76% for polyps ≥10mm and 100% for polyps ≥40mm [19] - C-Scan demonstrated 82% specificity in the post-CE approval study [20] Commercialization and Intellectual Property - GE Healthcare has completed the manufacturing line for C-Scan [22, 25] - Pilot sales are planned to initiate in Israel in 2020 and in the EU in 2021 [23, 24] - Check-Cap has a strong global intellectual property portfolio with 41 patents granted and 22 pending [27] Financial Information - As of June 30, 2019, Check-Cap had $147 million in cash and equivalents [34]

Research and Development - Research and development expenses for the years ended December 31, 2018, 2017, and 2016 were approximately $7.6 million, $6.8 million, and $5.5 million, respectively[382]. - As of December 31, 2018, the company had 36 granted patents, 1 allowed patent application, and 23 pending patent applications worldwide[385]. Product Commercialization - The company plans to initiate commercialization of its C-Scan system during the second half of 2019 in selected markets in Europe and Israel, targeting major markets in Europe[397]. - The company expects to launch the C-Scan system in the U.S. market following successful completion of clinical trials and initial FDA clearance[400]. Manufacturing and Supply Chain - Manufacturing operations are conducted at a facility in Isfiya, Israel, with plans to expand manufacturing capacity to meet expected demand[402]. - The company has entered into an agreement with GE Healthcare for high-volume manufacturing of the X-ray source for the C-Scan capsule[404]. - The company is exploring options to assemble components of the C-Scan system outside of Israel while complying with government grant restrictions[406]. - The company currently relies on single source suppliers for key components of its C-Scan system, including motors and customized X-ray detectors, which poses a risk to production continuity[408]. - The supplier of batteries for the C-Scan system is expected to cease manufacturing by mid-2019, necessitating the search for alternative sources[408]. - The company is planning to maintain a strategic inventory of key components, but this may not be sufficient to meet demand in case of supply interruptions[408]. - The company is seeking alternate manufacturers for some components, which requires significant resources and investment[408]. - Any delays in identifying new suppliers could harm the company's ability to manufacture the C-Scan system on time and within budget[408]. Regulatory Compliance - The FDA requires either 510(k) clearance or PMA approval for the commercial distribution of medical devices, which can take 6 to 18 months depending on the pathway[415][424]. - The company aims to submit a direct de novo reclassification petition for its C-Scan system, which could take 9 to 12 months for clearance[419][420]. - Compliance with environmental health and safety laws in Israel is mandatory, and failure to obtain necessary permits could adversely affect business operations[409][410]. - The company has not yet been inspected by the FDA, which could lead to enforcement actions if compliance issues arise[429]. - Regulatory requirements continue to apply after market placement, including quality system regulations and medical device reporting[426][428]. - The C-Scan system must comply with FCC regulations due to its wireless components, and the company expects it will meet the necessary technical requirements for authorization[436]. - The C-Scan system includes a radioactive source, necessitating compliance with NRC regulations, and the company must obtain appropriate licenses for distribution[445]. - The company may petition the NRC for an exemption to allow broader distribution of the C-Scan system, similar to a precedent set by another medical device company[450]. - The C-Scan system is expected to provide comparable radiation exposure to existing diagnostic tools, potentially qualifying it for regulatory exemptions[451]. Market and Competition - The company does not currently generate revenues but expects to do so through sales of the C-Scan system after obtaining regulatory approvals[396]. - The company faces competition from established manufacturers in the CRC screening market, which have greater financial resources and distribution channels[393]. - The company is working on obtaining reimbursement coverage from third-party payors for procedures using the C-Scan system[396]. - Coverage and reimbursement for the C-Scan system will depend on various third-party payors, including Medicare, which currently does not provide separate reimbursement for many devices[437]. - The company must adhere to extensive federal and state regulations, including the Anti-Kickback Statute and the False Claims Act, which could impact its marketing and sales strategies[440]. International Approvals - The company obtained CE mark of conformity for the C-Scan system as of January 9, 2018[454]. - The company received AMAR approval for marketing the C-Scan system in Israel in September 2018, valid until February 28, 2019[455]. - In Japan, the marketing clearance process for medical devices can take from twelve months to a few years depending on the product[457]. - The company must obtain regulatory approvals in various countries to market its products, which can significantly affect revenue generation[458]. Financial Information - As of December 31, 2018, total assets linked to the NIS amounted to $1.2 million, while total liabilities linked to the NIS were $1.5 million[883]. - A 10% depreciation of the dollar in relation to the NIS would result in an exchange rate loss of $29,000[883]. - The exchange rate between the U.S. dollar and the NIS increased by 8.1% during the year ended December 31, 2018[884].