Exhibit 99.1 Check-Cap Reports First Quarter 2023 Financial Results ISFIYA, Israel, May 11, 2023 -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced financial results for the first quarter ended March 31, 2023. Recent Highlights: • In March 2023, the Company ...

[Executive Summary & Recent Developments](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Developments) Check-Cap postponed its C-Scan pivotal study, secured new patents, and extended its cash runway into Q4 2024 through a $10 million offering and cost reductions [Recent Business Developments](index=1&type=section&id=1.1%20Recent%20Business%20Developments) Check-Cap announced that the current efficacy results from its C-Scan calibration studies do not meet the goal to proceed to the U.S. pivotal study, leading to a temporary postponement - Efficacy results from C-Scan calibration studies did not meet the goal for the **U.S. pivotal study**[2](index=2&type=chunk) - The company's plan includes conducting **additional clinical data analysis**, approaching the **FDA for amendments** to the U.S. pivotal study protocol, and continuing calibration studies at a slower pace[2](index=2&type=chunk)[18](index=18&type=chunk) - The initiation of the powered portion of the U.S. pivotal study, expected in mid-2023, is **temporarily postponed**[2](index=2&type=chunk) [Intellectual Property Updates](index=1&type=section&id=1.2%20Intellectual%20Property%20Updates) During 2022, Check-Cap was granted two new patents related to its C-Scan technology, enhancing its proprietary tracking and polyp detection capabilities - Two new patents were granted in 2022[17](index=17&type=chunk) - **"Position Estimation of Imaging Capsule in Gastrointestinal Tract"** granted in Israel, Japan, China, Europe, and the United States, covering C-Scan's proprietary tracking technology[4](index=4&type=chunk) - **"System and method for polyp detection through capsule dynamics"** granted in Japan, with corresponding patents filed in Europe and the United States[5](index=5&type=chunk) [Financial Outlook & Liquidity](index=1&type=section&id=1.3%20Financial%20Outlook%20%26%20Liquidity) The company completed a $10 million registered direct offering in March 2022, which, combined with a cost reduction plan, is expected to extend its cash runway into the fourth quarter of 2024, despite a decrease in cash and cash equivalents to $42.1 million by year-end 2022 - In March 2022, the Company consummated a **$10 million** registered direct offering[3](index=3&type=chunk)[22](index=22&type=chunk) - Current cash on hand, combined with a cost reduction plan, is believed to be sufficient to fund ongoing operations and plans into the **fourth quarter of 2024**[3](index=3&type=chunk) Cash and Cash Equivalents (Year-over-Year) | Metric | December 31, 2022 (in millions) | December 31, 2021 (in millions) | | :------------------------------------------------------------------ | :------------------------------ | :------------------------------ | | Cash and cash equivalents, restricted cash and short-term deposits | $42.1 | $51.9 | [Company Overview](index=1&type=section&id=Company%20Overview) Check-Cap Ltd. is a clinical-stage medical diagnostics company developing the C-Scan system, a non-invasive, preparation-free screening test for colorectal cancer [About Check-Cap and C-Scan](index=1&type=section&id=2.1%20About%20Check-Cap%20and%20C-Scan) Check-Cap Ltd. is a clinical-stage medical diagnostics company focused on redefining colorectal cancer (CRC) screening with its C-Scan® system, an investigational, patient-friendly, preparation-free, non-invasive screening test - Check-Cap is a **clinical stage medical diagnostics company** advancing **C-Scan®**, a **patient-friendly, preparation-free screening test** to detect polyps before they may transform into colorectal cancer (CRC)[1](index=1&type=chunk)[33](index=33&type=chunk) - C-Scan uses an **ultra-low dose X-ray capsule**, an integrated positioning, control and recording system, and proprietary software to generate a **3D map** of the inner lining of the colon[33](index=33&type=chunk) - The device is **non-invasive**, requires **no sedation or bowel preparation**, and is an **investigational device** not available for sale in the United States[33](index=33&type=chunk) [Financial Results for the Fourth Quarter Ended December 31, 2022](index=2&type=section&id=Financial%20Results%20for%20the%20Fourth%20Quarter%20Ended%20December%2031%2C%202022) Q4 2022 saw a reduced net loss and operating loss, driven by decreased R&D and G&A expenses and increased finance income [Key Financial Metrics (Q4 2022)](index=2&type=section&id=3.1%20Key%20Financial%20Metrics%20(Q4%202022)) In the fourth quarter of 2022, Check-Cap reported a reduced net loss and operating loss compared to the prior year, primarily driven by decreases in research and development and general and administrative expenses, alongside a significant increase in finance income Fourth Quarter Financial Highlights (in thousands USD) | Metric | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Research and development expenses, net | $2,956 | $4,126 | | General and administrative expenses | $1,259 | $1,452 | | Operating loss | $4,215 | $5,578 | | Finance Income, net | $502 | $101 | | Net loss for the period | $3,713 | $5,477 | | Net loss per ordinary share (basic and diluted) | $0.635 | $1.13 | - Research and development expenses decreased by **$1.17 million**, primarily due to a **$0.6 million** reduction in salary and related expenses and a **$0.6 million** decrease in material expenses[6](index=6&type=chunk)[31](index=31&type=chunk) - General and administrative expenses decreased by **$0.193 million**, mainly due to a **$0.3 million** decrease in salary and related expenses[19](index=19&type=chunk)[31](index=31&type=chunk) - Finance income, net, increased by **$401,000**, primarily due to a **$470,000** increase in interest income on short-term deposits[7](index=7&type=chunk)[31](index=31&type=chunk) [Financial Results for the Twelve Months Ended December 31, 2022](index=3&type=section&id=Financial%20Results%20for%20the%20Twelve%20Months%20Ended%20December%2031%2C%202022) For FY 2022, the company reported increased net and operating losses due to higher R&D and G&A expenses, despite a significant rise in finance income [Key Financial Metrics (FY 2022)](index=3&type=section&id=4.1%20Key%20Financial%20Metrics%20(FY%202022)) For the full year 2022, Check-Cap experienced an increase in net loss and operating loss compared to 2021, driven by higher research and development and general and administrative expenses, despite a significant rise in finance income Full Year Financial Highlights (in thousands USD) | Metric | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :-------------------------------------- | :---------------------- | :---------------------- | | Research and development expenses, net | $14,271 | $12,349 | | General and administrative expenses | $5,763 | $4,972 | | Operating loss | $20,034 | $17,321 | | Finance Income, net | $926 | $119 | | Net loss for the period | $19,108 | $17,202 | | Net loss per ordinary share (basic and diluted) | $3.37 | $4.15 | - Research and development expenses, net, increased by approximately **$1.922 million**, primarily due to an increase in salary and related expenses (headcount expansion), subcontractors, share-based compensation, and clinical study expenses, partially offset by a decrease in material expenses[23](index=23&type=chunk)[31](index=31&type=chunk) - General and administrative expenses increased by approximately **$0.791 million**, mainly due to increases in professional services, share-based compensation, and other general expenses, partially offset by a decrease in salaries[9](index=9&type=chunk)[31](index=31&type=chunk) - Finance income, net, increased significantly by **$807,000**, primarily due to a **$946,000** increase in interest income on short-term deposits, partially offset by a decrease in fair value of derivatives[25](index=25&type=chunk)[31](index=31&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for 2022 show decreased assets and equity, an increased net loss, and higher cash usage in operations with reduced financing activities [Consolidated Balance Sheets](index=5&type=section&id=5.1%20Consolidated%20Balance%20Sheets) Check-Cap's balance sheet as of December 31, 2022, shows a decrease in total assets and shareholders' equity compared to the previous year, primarily driven by a reduction in cash and cash equivalents Consolidated Balance Sheet Highlights (in thousands USD) | Metric | December 31, 2022 | December 31, 2021 | | :-------------------------- | :---------------- | :---------------- | | Total assets | $45,441 | $55,659 | | Cash and cash equivalents | $4,090 | $26,457 | | Short-term bank deposit | $37,609 | $25,104 | | Total current assets | $42,630 | $52,750 | | Total liabilities | $4,129 | $4,968 | | Total shareholders' equity | $41,312 | $50,691 | - Total assets decreased by **$10.218 million** from **$55.659 million** in 2021 to **$45.441 million** in 2022[14](index=14&type=chunk) - Cash and cash equivalents significantly decreased from **$26.457 million** in 2021 to **$4.090 million** in 2022[14](index=14&type=chunk) - Total shareholders' equity decreased by **$9.379 million** from **$50.691 million** in 2021 to **$41.312 million** in 2022[36](index=36&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=5.2%20Consolidated%20Statements%20of%20Operations) The consolidated statements of operations reflect an increased net loss for the full year 2022 compared to 2021, primarily due to higher operating expenses, despite a decrease in net loss per share Consolidated Statements of Operations (in thousands USD, except per share data) | Metric | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :-------------------------------------- | :---------------------- | :---------------------- | :------------------------------ | :------------------------------ | | Research and development expenses, net | $14,271 | $12,349 | $2,956 | $4,126 | | General and administrative expenses | $5,763 | $4,972 | $1,259 | $1,452 | | Operating loss | $20,034 | $17,321 | $4,215 | $5,578 | | Finance Income, net | $926 | $119 | $502 | $101 | | Net loss for the period | $19,108 | $17,202 | $3,713 | $5,477 | | Net loss per ordinary share (basic and diluted) | $3.37 | $4.15 | $0.635 | $1.13 | - Net loss for the full year 2022 was **$19.108 million**, an increase from **$17.202 million** in 2021[31](index=31&type=chunk) - Operating loss for the full year 2022 was **$20.034 million**, up from **$17.321 million** in 2021[31](index=31&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=5.3%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statement indicates a significant increase in cash used in operating activities and a substantial decrease in cash provided by financing activities for the full year 2022, leading to an overall net decrease in cash and cash equivalents Consolidated Statements of Cash Flows (in thousands USD) | Metric | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :------------------------------------------------------------------ | :---------------------- | :---------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(18,707) | $(16,264) | $(4,147) | $(4,384) | | Net cash used in investing activities | $(12,508) | $(16,006) | $(1,113) | $(8,563) | | Net cash provided by financing activities | $8,850 | $51,024 | $0 | $(203) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(22,365) | $18,754 | $(5,260) | $(13,150) | - Net cash used in operating activities increased to **$18.707 million** in FY 2022 from **$16.264 million** in FY 2021[26](index=26&type=chunk)[32](index=32&type=chunk) - Net cash provided by financing activities decreased significantly to **$8.850 million** in FY 2022 from **$51.024 million** in FY 2021, primarily due to lower proceeds from the issuance of ordinary shares[32](index=32&type=chunk) - The company experienced a net decrease of **$22.365 million** in cash, cash equivalents, and restricted cash for FY 2022, contrasting with a net increase of **$18.754 million** in FY 2021[32](index=32&type=chunk) [Share Information](index=2&type=section&id=Share%20Information) As of December 31, 2022, Check-Cap had 5.84 million ordinary shares outstanding, with a significant increase in weighted average shares impacting per-share data [Outstanding Shares & Per Share Data](index=2&type=section&id=6.1%20Outstanding%20Shares%20%26%20Per%20Share%20Data) As of December 31, 2022, Check-Cap had 5,844,463 ordinary shares outstanding, with the weighted average number of ordinary shares increasing significantly year-over-year, contributing to a lower net loss per share despite an increased net loss - The number of outstanding ordinary shares as of December 31, 2022, was **5,844,463**[8](index=8&type=chunk)[36](index=36&type=chunk) Share Data Highlights | Metric | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | | :------------------------------------------------ | :---------------------- | :---------------------- | :------------------------------ | :------------------------------ | | Net loss per ordinary share (basic and diluted) | $3.37 | $4.15 | $0.635 | $1.13 | | Weighted average number of ordinary shares outstanding - basic and diluted | 5,671,786 | 4,159,870 | 5,844,163 | 4,839,930 | - All share amounts have been retroactively adjusted to reflect a **1-for-20 share reverse split**[15](index=15&type=chunk) [Legal & Investor Information](index=3&type=section&id=Legal%20%26%20Investor%20Information) This section provides a legal notice on forward-looking statements and contact information for investor and media inquiries, including details on accessing the annual report [Legal Notice Regarding Forward-Looking Statements](index=3&type=section&id=7.1%20Legal%20Notice%20Regarding%20Forward-Looking%20Statements) The press release includes forward-looking statements concerning the company's future performance and plans, which are subject to inherent risks and uncertainties, advising investors to review SEC filings - The press release contains **forward-looking statements** regarding the Company's product development, business, financial condition, and strategies[34](index=34&type=chunk) - These statements are subject to **risks and uncertainties** that could cause actual performance or results to differ materially[34](index=34&type=chunk) - Investors are urged to read the "Forward-looking Statements" and "Risk Factors" sections in the Company's **Annual Report on Form 20-F** filed with the SEC[34](index=34&type=chunk) [Investor and Media Contacts](index=3&type=section&id=7.2%20Investor%20and%20Media%20Contacts) Contact information for investor relations and media inquiries is provided, along with details on accessing the company's annual report - Investor Contacts: Irina Koffler and Meirav Gomeh-Bauer of **LifeSci Advisors, LLC**[28](index=28&type=chunk)[35](index=35&type=chunk) - Media Contact: Mónica Rouco Molina of **LifeSci Communications**[29](index=29&type=chunk) - A copy of the Company's **annual report on Form 20-F** for the year ended December 31, 2022, has been filed with the SEC and is available on the Company's investor relations website[27](index=27&type=chunk)

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, 2022 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 ...

[Corporate Overview and Recent Developments](index=1&type=section&id=Corporate%20Overview%20and%20Recent%20Developments) Check-Cap Ltd. details its C-Scan product, recent operational highlights, clinical study progress, corporate actions, and CEO's strategic remarks [Company Profile and Product](index=1&type=section&id=Company%20Profile%20and%20Product) Check-Cap Ltd. is a clinical-stage medical diagnostics company focused on developing C-Scan®, a patient-friendly, preparation-free screening test designed to detect polyps before they may transform into colorectal cancer (CRC) - Check-Cap is a clinical stage medical diagnostics company[2](index=2&type=chunk) - The company is advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC)[2](index=2&type=chunk) [Third Quarter and Recent Operational Highlights](index=1&type=section&id=Third%20Quarter%20and%20Recent%20Operational%20Highlights) The company focused on expanding U.S. pivotal study sites and significantly increased patient enrollment in Israel. Challenges in U.S. site activation and patient recruitment led to extensive outreach efforts. A 1-for-20 reverse share split was effected in November 2022 - Continued effort to expand the number of U.S. sites for the C-Scan pivotal study[3](index=3&type=chunk) - Significantly increased the enrollment pace of average risk patients in Israeli sites for the calibration portion of the study[3](index=3&type=chunk) - U.S. site activation and patient recruitment rates are lower than expected, prompting extensive patient outreach efforts[3](index=3&type=chunk) - On November 23, 2022, the Company effected a reverse share split of its ordinary shares at a ratio of **1-for-20**[4](index=4&type=chunk) [Clinical Study Updates](index=1&type=section&id=Clinical%20Study%20Updates) Check-Cap is actively expanding U.S. sites for its C-Scan pivotal study and has accelerated patient enrollment in Israel for the calibration phase. Despite U.S. recruitment challenges, the company expects the second part of the U.S. pivotal study to start in mid-2023 - The calibration portion of the study is designed to provide further optimization of C-Scan functionality and patient experience[3](index=3&type=chunk) - The required lead time to activate new U.S. sites is longer than expected, and patient recruitment rate in activated U.S. sites is lower than expected[3](index=3&type=chunk) - The Company initiated an extensive patient outreach effort, expected to expedite enrollment, and continues to expect the second part of the U.S. pivotal study to start in mid-2023[3](index=3&type=chunk) [Corporate and Financial Actions](index=1&type=section&id=Corporate%20and%20Financial%20Actions) A 1-for-20 reverse share split was implemented on November 23, 2022, consolidating ordinary shares and adjusting outstanding shares from approximately 116 million to 5.8 million - Reverse share split ratio: **1-for-20**, effective November 23, 2022[4](index=4&type=chunk) - Following the reverse split, issued and outstanding shares are approximately **5.8 million** ordinary shares, down from approximately **116 million** previously[4](index=4&type=chunk) - A proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding options and warrants[4](index=4&type=chunk) [CEO's Remarks](index=1&type=section&id=CEO's%20Remarks) CEO Alex Ovadia highlighted accelerated patient enrollment in Israel due to outreach campaigns and plans to implement similar strategies in the U.S. The company also scaled up manufacturing and supplier engagement to secure the C-Scan production and supply chain - Significantly accelerated the pace of patient enrollment in Israel following an extensive patient outreach campaign[5](index=5&type=chunk) - Clinical team is working to implement similar patient outreach strategies in the U.S. to accelerate patient enrollment, pending IRB approvals[5](index=5&type=chunk) - Scaled-up manufacturing and engagement with key suppliers to secure and sustain the entire production process and robust supply chain of C-Scan devices during the trial[5](index=5&type=chunk) [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) This section analyzes Check-Cap Ltd.'s financial performance for the third quarter and nine months ended September 30, 2022, focusing on operating expenses, profitability, liquidity, and cash flow [Third Quarter 2022 Financial Results](index=2&type=section&id=Third%20Quarter%202022%20Financial%20Results) Check-Cap reported an increased operating loss of $5.0 million and a net loss of $4.7 million for Q3 2022, primarily driven by higher R&D and G&A expenses. The company maintains a strong cash position of $46.0 million, sufficient to fund operations into Q2 2024 Third Quarter 2022 Key Financials (vs. Q3 2021) | Metric | Q3 2022 (in $ thousands) | Q3 2021 (in $ thousands) | Change (YoY) | | :-------------------------------- | :----------------------- | :----------------------- | :----------- | | Research and development expenses | 3,641 | 3,036 | +$605 (+19.9%) | | General and administrative expenses | 1,404 | 1,227 | +$177 (+14.4%) | | Operating loss | 5,045 | 4,263 | +$782 (+18.3%) | | Net finance income | 291 | 22 | +$269 (+1222.7%) | | Net loss | 4,754 | 4,241 | +$513 (+12.1%) | | Net loss per ordinary share (basic and diluted) | $0.04 | $0.04 | 0% | | Weighted average number of ordinary shares outstanding | 116,454,150 | 95,853,149 | +21.5% | - Cash and cash equivalents, restricted cash and short-term bank deposits as of September 30, 2022, were **$46.0 million**[9](index=9&type=chunk) - The Company believes it has sufficient capital to fund its ongoing operations and plans into the **second quarter of 2024**[9](index=9&type=chunk) [Operating Expenses (QoQ)](index=2&type=section&id=Operating%20Expenses%20(QoQ)) Research and development expenses increased by 19.9% to $3.6 million in Q3 2022, mainly due to increased headcount and clinical/regulatory consultant expenses. General and administrative expenses rose by 14.4% to $1.4 million, driven by higher directors' and officers' liability insurance and share-based compensation - Research and development expenses increased by approximately **$0.6 million (19.9%)** YoY, primarily due to a **$0.3 million** increase in salary and related expenses (increased employee headcount) and a **$0.3 million** increase in clinical related expenses and regulatory consultants[6](index=6&type=chunk) - General and administrative expenses increased by approximately **$0.2 million (14.4%)** YoY, primarily due to a **$0.1 million** increase in other general expenses (mainly associated with directors' and officers' liability insurance) and a **$0.1 million** increase in share-based compensation[7](index=7&type=chunk) - The Company expects that clinical expenses will increase in the upcoming quarters as it progresses in its ongoing U.S. pivotal study[6](index=6&type=chunk) [Profitability (QoQ)](index=2&type=section&id=Profitability%20(QoQ)) The operating loss for Q3 2022 widened to $5.0 million from $4.3 million in Q3 2021, and net loss increased to $4.7 million from $4.2 million, reflecting the higher operating expenses - Operating loss was **$5.0 million** for Q3 2022, compared to **$4.3 million** for the same period in 2021, an increase of **$0.7 million (18.3%)**[7](index=7&type=chunk) - Net loss was **$4.7 million** for Q3 2022, compared to **$4.2 million** for the same period in 2021, an increase of **$0.5 million (12.1%)**[8](index=8&type=chunk) - Net finance income significantly increased to **$0.3 million** for Q3 2022, compared to **$22,000** for the same period in 2021[8](index=8&type=chunk) [Liquidity and Capital Position](index=2&type=section&id=Liquidity%20and%20Capital%20Position) Cash and cash equivalents, restricted cash, and short-term bank deposits decreased to $46.0 million as of September 30, 2022, from $50.2 million at June 30, 2022, and $51.9 million at December 31, 2021. The company raised $8.9 million net from a registered direct offering in March 2022 and projects sufficient capital until Q2 2024 Cash and Cash Equivalents Trend | Date | Amount (in $ millions) | | :---------------- | :--------------------- | | Sep 30, 2022 | 46.0 | | Jun 30, 2022 | 50.2 | | Dec 31, 2021 | 51.9 | - A registered direct offering on March 3, 2022, resulted in gross proceeds of **$10.0 million**, or approximately **$8.9 million** net of offering expenses[9](index=9&type=chunk) - The Company believes it has sufficient capital to fund its ongoing operations and plans into the **second quarter of 2024**[9](index=9&type=chunk) [Nine Months Ended September 30, 2022 Financial Results](index=2&type=section&id=Nine%20Months%20Ended%20September%2030%2C%202022%20Financial%20Results) For the nine months ended September 30, 2022, Check-Cap's operating loss increased to $15.8 million and net loss to $15.4 million, primarily due to higher R&D and G&A expenses. Net cash used in operating activities also increased to $14.6 million Nine Months Ended September 30, 2022 Key Financials (vs. 9M 2021) | Metric | 9M 2022 (in $ thousands) | 9M 2021 (in $ thousands) | Change (YoY) | | :-------------------------------- | :----------------------- | :----------------------- | :----------- | | Research and development expenses | 11,315 | 8,223 | +$3,092 (+37.6%) | | General and administrative expenses | 4,504 | 3,520 | +$984 (+27.9%) | | Operating loss | 15,819 | 11,743 | +$4,076 (+34.7%) | | Net finance income | 424 | 18 | +$406 (+2255.6%) | | Net loss | 15,395 | 11,725 | +$3,670 (+31.3%) | | Net loss per ordinary share (basic and diluted) | $0.14 | $0.15 | -$0.01 (-6.7%) | | Weighted average number of ordinary shares outstanding | 111,884,046 | 78,238,314 | +43.0% | - Net cash used in operating activities was **$14.6 million** for the nine months ended September 30, 2022[13](index=13&type=chunk) [Operating Expenses (YoY)](index=2&type=section&id=Operating%20Expenses%20(YoY)) R&D expenses for the nine months increased by 37.6% to $11.3 million, driven by a $1.5 million increase in salary and related expenses, a $1.0 million increase in other R&D expenses (clinical/regulatory), and a $0.2 million increase in share-based compensation. G&A expenses rose by 27.9% to $4.5 million, mainly due to higher professional services, directors' and officers' liability insurance, and share-based compensation - Research and development expenses increased by approximately **$3.1 million (37.6%)** YoY, primarily due to a **$1.5 million** increase in salary and related expenses (increased employee headcount), a **$1.0 million** increase in other R&D expenses (including clinical related expenses and regulatory consultants), and a **$0.2 million** increase in share-based compensation[10](index=10&type=chunk) - General and administrative expenses increased by approximately **$1.0 million (27.9%)** YoY, primarily due to a **$0.4 million** increase in professional services, a **$0.3 million** increase in other general expenses (mainly associated with directors' and officers' liability insurance), and a **$0.3 million** increase in share-based compensation[11](index=11&type=chunk) - The increase in net R&D expenses between 2022 and 2021 is also due to a **$0.3 million** grant from the Israel Innovation Authority, which was recorded as a deduction from R&D expenses in 9M 2021[10](index=10&type=chunk) [Profitability (YoY)](index=2&type=section&id=Profitability%20(YoY)) The operating loss for the nine months ended September 30, 2022, increased by 34.7% to $15.8 million, and the net loss increased by 31.3% to $15.4 million, reflecting the significant rise in operating expenses - Operating loss was **$15.8 million** for the nine months ended September 30, 2022, compared to **$11.7 million** for the same period in 2021, an increase of **$4.1 million (34.7%)**[12](index=12&type=chunk) - Net loss was **$15.4 million** for the nine months ended September 30, 2022, compared to **$11.7 million** for the same period in 2021, an increase of **$3.7 million (31.3%)**[12](index=12&type=chunk) - Net finance income significantly increased to **$0.4 million** for the nine months ended September 30, 2022, compared to **$18,000** for the same period in 2021[12](index=12&type=chunk) [Cash Flow from Operating Activities (YoY)](index=2&type=section&id=Cash%20Flow%20from%20Operating%20Activities%20(YoY)) Net cash used in operating activities for the nine months ended September 30, 2022, increased to $14.6 million, up from $11.9 million in the prior year, reflecting the higher net loss - Net cash used in operating activities was **$14.6 million** for the nine months ended September 30, 2022, compared to **$11.9 million** for the same period in 2021, an increase of **$2.7 million (22.7%)**[13](index=13&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section presents Check-Cap Ltd.'s consolidated unaudited balance sheets, statements of comprehensive loss, statements of changes in shareholders' equity, and statements of cash flows [Consolidated Unaudited Balance Sheets](index=4&type=section&id=Consolidated%20Unaudited%20Balance%20Sheets) As of September 30, 2022, total assets decreased to $49.5 million from $55.7 million at December 31, 2021, primarily due to a reduction in cash and cash equivalents. Total liabilities also decreased slightly, while total shareholders' equity declined to $44.9 million from $50.7 million Consolidated Unaudited Balance Sheet Highlights (in $ thousands) | Metric | Sep 30, 2022 | Dec 31, 2021 | Change | | :-------------------------------- | :----------- | :----------- | :------- | | Cash and cash equivalents | 9,348 | 26,457 | (17,109) | | Short-term bank deposit | 36,249 | 25,104 | 11,145 | | Total current assets | 46,542 | 52,750 | (6,208) | | Total assets | 49,547 | 55,659 | (6,112) | | Total current liabilities | 3,834 | 4,041 | (207) | | Total non-current liabilities | 788 | 927 | (139) | | Total liabilities and shareholders' equity | 49,547 | 55,659 | (6,112) | | Total shareholders' equity | 44,925 | 50,691 | (5,766) | - The financial information for the three and nine months ended September 30, 2022, does not reflect the impact of the reverse split which became effective on November 25, 2022[14](index=14&type=chunk) [Consolidated Unaudited Statements of Comprehensive Loss](index=5&type=section&id=Consolidated%20Unaudited%20Statements%20of%20Comprehensive%20Loss) The statements show a net loss of $4.75 million for Q3 2022 and $15.40 million for the nine months ended September 30, 2022, both higher than the respective prior-year periods, driven by increased R&D and G&A expenses Consolidated Unaudited Statements of Comprehensive Loss (in $ thousands) | Metric | 9M Sep 2022 | 9M Sep 2021 | Q3 Sep 2022 | Q3 Sep 2021 | | :-------------------------------- | :---------- | :---------- | :---------- | :---------- | | Research and development expenses, net | 11,315 | 8,223 | 3,641 | 3,036 | | General and administrative expenses | 4,504 | 3,520 | 1,404 | 1,227 | | Operating loss | 15,819 | 11,743 | 5,045 | 4,263 | | Finance income, net | 424 | 18 | 291 | 22 | | Net loss for the period | 15,395 | 11,725 | 4,754 | 4,241 | | Net loss per ordinary share basic and diluted | $0.14 | $0.15 | $0.04 | $0.04 | [Consolidated Unaudited Statements of Changes in Shareholders' Equity](index=6&type=section&id=Consolidated%20Unaudited%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Total shareholders' equity decreased to $44.9 million as of September 30, 2022, from $50.7 million at December 31, 2021, primarily due to the net loss for the period, partially offset by proceeds from the issuance of ordinary shares Changes in Shareholders' Equity (9M 2022 vs 9M 2021) (in $ thousands) | Metric | Balance as of Jan 1, 2022 | Issuance of ordinary shares (net) | Share-based compensation | Net loss | Balance as of Sep 30, 2022 | | :-------------------------------- | :------------------------ | :-------------------------------- | :----------------------- | :------- | :------------------------- | | Total shareholders' equity | 50,691 | 8,850 | 779 | (15,395) | 44,925 | Changes in Shareholders' Equity (Q3 2022) (in $ thousands) | Metric | Balance as of Jun 30, 2022 | RSU's vesting | Share-based compensation | Net loss | Balance as of Sep 30, 2022 | | :-------------------------------- | :------------------------- | :------------ | :----------------------- | :------- | :------------------------- | | Total shareholders' equity | 49,424 | - | 255 | (4,754) | 44,925 | [Consolidated Unaudited Statements of Cash Flows](index=8&type=section&id=Consolidated%20Unaudited%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities increased to $14.6 million, and net cash used in investing activities was $11.4 million. Net cash provided by financing activities was $8.9 million, primarily from a registered direct offering. Overall, cash, cash equivalents, and restricted cash decreased by $17.1 million Consolidated Unaudited Statements of Cash Flows (in $ thousands) | Metric | 9M Sep 2022 | 9M Sep 2021 | | :-------------------------------- | :---------- | :---------- | | Net cash used in operating activities | (14,560) | (11,880) | | Net cash used in investing activities | (11,395) | (7,443) | | Net cash provided by financing activities | 8,850 | 51,227 | | Net (decrease) increase in cash, cash equivalents and restricted cash | (17,105) | 31,904 | | Cash, cash equivalents and restricted cash at end of period | 9,702 | 39,957 | - Net cash provided by financing activities in 9M 2022 was primarily from the issuance of ordinary shares in registered direct offerings, net of issuance expenses (**$8.85 million**)[29](index=29&type=chunk) - Supplemental disclosure for 2022 includes **$89 thousand** in purchase of property and equipment included in accounts payable and **$307 thousand** in assets acquired under operating lease[31](index=31&type=chunk) [Supplementary Information](index=3&type=section&id=Supplementary%20Information) This section provides the basis of financial presentation, detailed information about Check-Cap and its C-Scan product, and essential legal disclosures including forward-looking statements and contact information [Basis of Financial Presentation](index=3&type=section&id=Basis%20of%20Financial%20Presentation) The financial information presented in the press release for the three and nine months ended September 30, 2022, does not reflect the impact of the reverse share split that became effective on November 25, 2022 - The financial information for the three and nine months ended September 30, 2022, included in this press release doesn't reflect the impact of the reverse split which became effective on November 25, 2022[14](index=14&type=chunk) [About Check-Cap (Detailed)](index=3&type=section&id=About%20Check-Cap%20(Detailed)) Check-Cap is a clinical-stage medical diagnostics company focused on redefining colorectal cancer (CRC) screening with C-Scan®, a non-invasive, preparation-free, ultra-low dose X-ray capsule technology. C-Scan generates a 3D map of the colon and is intended for early polyp detection, not as a replacement for colonoscopy, and is currently an investigational device not available for sale in the U.S - C-Scan® is the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention[15](index=15&type=chunk) - C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon[15](index=15&type=chunk) - C-Scan is non-invasive, requires no sedation or bowel preparation, is not intended to replace colonoscopy (a positive result should be followed by colonoscopy), and is an investigational device not available for sale in the United States[15](index=15&type=chunk) [Legal Disclosures and Contacts](index=3&type=section&id=Legal%20Disclosures%20and%20Contacts) This section includes a legal notice regarding forward-looking statements, advising readers that such statements are subject to risks and uncertainties detailed in the company's SEC filings. It also provides contact information for investor and media relations - This press release contains 'forward-looking statements' about the Company's expectations, beliefs or intentions regarding its product development efforts, business, financial condition, results of operations, strategies or prospects[16](index=16&type=chunk) - Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially, as discussed in the 'Forward-looking Statements' and 'Risk Factors' in the Company's Annual Report on Form 20-F and other SEC filings[16](index=16&type=chunk) - Provides contact information for Investor Contacts (Irina Koffler, Meirav Gomeh-Bauer) and Media Contact (Mónica Rouco Molina)[16](index=16&type=chunk)

Exhibit 99.1 Check-Cap Reports First Quarter 2022 Financial Results and Corporate Update Company initiated first part of its U.S. pivotal study in early May 2022 ISFIYA, Israel, June 1, 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), today announced ...

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, 2021 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 ...

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]