Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - FGI Industries Ltd. (FGI) is up 278% at $15.02 [3] - Senmiao Technology Limited (AIHS) is up 96% at $4.22 [3] - Conifer Holdings, Inc. (CNFR) is up 86% at $2.11 [3] - WEBTOON Entertainment Inc. (WBTN) is up 39% at $20.81 [3] - Nukkleus Inc. (NUKK) is up 18% at $6.08 [3] - Tantech Holdings Ltd (TANH) is up 12% at $2.13 [3] - Check-Cap Ltd. (CHEK) is up 9% at $2.33 [3] - Ivanhoe Electric Inc. (IE) is up 8% at $9.71 [3] - Wolfspeed, Inc. (WOLF) is up 8% at $3.21 [3] - Bolt Projects Holdings, Inc. (BSLK) is up 5% at $3.95 [3] Premarket Losers - Envirotech Vehicles, Inc. (EVTV) is down 17% at $2.27 [4] - Dave & Buster's Entertainment, Inc. (PLAY) is down 15% at $20.40 [4] - NanoVibronix, Inc. (NAOV) is down 12% at $9.37 [4] - ADTRAN Holdings, Inc. (ADTN) is down 10% at $9.37 [4] - Rain Enhancement Technologies Holdco, Inc. (RAIN) is down 10% at $6.00 [4] - CNS Pharmaceuticals, Inc. (CNSP) is down 7% at $8.50 [4] - AVITA Medical, Inc. (RCEL) is down 7% at $6.22 [4] - Vince Holding Corp. (VNCE) is down 7% at $2.60 [4] - Monte Rosa Therapeutics, Inc. (GLUE) is down 6% at $6.50 [4] - Meiwu Technology Company Limited (WNW) is down 6% at $2.06 [4]

Company Overview - Check-Cap Ltd. has entered into a definitive merger agreement with MBody AI, leading to a significant increase in its stock price [1][2] - The merger is seen as a strategic move to enter a high-growth industry while maintaining focus on its legacy business [2] Stock Performance - Check-Cap shares surged by 183% to $2.10 in pre-market trading following the merger announcement [2] - Other companies also experienced notable stock movements, with Helius Medical Technologies gaining 163.2% and InnSuites Hospitality Trust increasing by 118% in pre-market trading [6]

Core Insights - Several healthcare and biotech stocks saw significant price movements in after-hours trading on September 12, with notable gains in companies like Penumbra, Check-Cap, Adaptimmune Therapeutics, and NewAmsterdam Pharma, indicating a volatile session for the sector [1] Company Summaries Penumbra Inc. (PEN) - Penumbra's stock closed at $272.73 during regular trading, down by $3.67 or 1.33%, but rebounded to $289.86 in after-hours, gaining 6.28% [2] - The trading range for the day was $271.83 to $280.14, with a volume of 454,478 shares, slightly below its average of 472,087 [3] - The company has a market capitalization of approximately $10.64 billion and a trailing price-to-earnings ratio of 71.96 based on earnings per share of $3.79 [3] - Penumbra raised its full-year 2025 revenue guidance to $1.355 billion - $1.370 billion, reflecting a growth of 13% - 15% over 2024 revenue of $1.195 billion, and projects a 20% - 21% growth in its U.S. thrombectomy segment [5] - The company appointed Shruthi Narayan as its new president, indicating potential strategic shifts [6] Check-Cap Ltd. (CHEK) - Check-Cap's stock surged from $0.7459 to $2.1600 in after-hours trading, marking a gain of 191.22%, driven by a strategic merger announcement [6] - During regular trading, the stock gained 8.09%, closing at $0.7459, with a trading range of $0.6860 to $0.7602 and a volume of 67,178 shares [7] - The merger with MBody AI aims to enhance Check-Cap's colorectal cancer screening capabilities through AI integration [8] Adaptimmune Therapeutics plc (ADAP) - Adaptimmune's stock rose from $0.0560 to $0.0651 in after-hours trading, a gain of 16.25%, following a 10.89% increase during regular hours [8] - For Q2 2025, the company reported a net loss of $30.3 million, or $0.02 per share, with total revenue of $13.7 million, primarily from product sales of TECELRA [9] - Adaptimmune entered a definitive agreement to sell certain cell therapies for $55 million upfront, with potential future milestone payments of up to $30 million, allowing it to repay debt and restructure for value maximization [10] NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam's shares rose from $24.19 to $26.18 in after-hours trading, an 8.23% gain, following a 9.06% decline during the day [11] - The stock's recovery is attributed to optimism surrounding its lead candidate, obicetrapib, which has received regulatory review acceptance from the EMA [11] - The company reported Q2 2025 revenue of $16.45 million and a net loss of $14.92 million, improving from a $0.41 loss per share in the same quarter of 2024 [13]

Group 1 - U.S. stock futures are trading slightly higher, indicating a positive market sentiment [1] - Hain Celestial Group Inc. is expected to report quarterly earnings of 3 cents per share on revenue of $371.46 million, with shares gaining 1.9% to $2.19 in after-hours trading [2] - MBody AI and Check Cap Ltd. have entered into a definitive merger agreement, resulting in Check-Cap shares jumping 206.3% to $2.27 in after-hours trading [2] - High Tide Inc. is anticipated to post a quarterly loss of 1 cent per share on revenue of $107.31 million, with shares gaining 2% to $3.50 in after-hours trading [2] - Multi Ways Holdings Ltd. reported a registered direct offering of $1.49 million for 9 million shares and warrants, leading to a 17.8% dip in shares to $0.28 in after-hours trading [2] - Dave & Buster's Entertainment Inc. is expected to report quarterly earnings of 92 cents per share on revenue of $562.78 million, with shares gaining 0.3% to $23.70 in after-hours trading [2]

Core Viewpoint - The merger between MBody AI and Check-Cap aims to create a combined company focused on embodied AI for the autonomous workforce, with Check-Cap continuing its legacy research and development activities [1][3]. Company Overview - MBody AI is a leading AI company specializing in embodied AI, with a market forecast to reach $40 trillion by 2050, contributing over $16 trillion in additional value to global equity markets [2]. - The company is developing a proprietary AI stack designed to power intelligent systems that can learn, adapt, and optimize in real time, with initial applications in hospitality and plans for expansion into warehousing, office management, and healthcare [2]. Merger Details - The merger will result in MBody AI equityholders owning 90% and Check-Cap equityholders owning 10% of the combined company on a fully diluted basis [4]. - The combined entity will be named "MBody AI Ltd." and will retain Check-Cap's legacy assets, including patents and proprietary medical equipment [3]. Strategic Synergies - The merger is expected to create synergies with Check-Cap's Ghost Kitchen franchise rights in New Jersey, leveraging shared technology and operational resources [5]. Approval Process - The merger has been approved by the boards of both companies and is pending approval from Check-Cap shareholders at the Annual General Meeting scheduled for October 17, 2025 [6]. Financial Compliance - Check-Cap received a notification from Nasdaq regarding non-compliance with listing rules, requiring a plan to regain compliance by October 20, 2025, which the merger and related financing are expected to enhance [7][8].

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, 2024 (Exact name of the Registrant as specified in its charter) Israel OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO S ...

Core Viewpoint - Check-Cap Ltd. publicly condemns MediPharm Labs and its Chairman Chris Taves for spreading false and defamatory statements aimed at harming Check-Cap's reputation during a sensitive time for Israeli companies [1][2][5]. Group 1: Allegations and Responses - Check-Cap is disturbed by Taves' actions, which are seen as exploiting wartime circumstances to spread false information that could negatively impact Check-Cap's reputation and stock price [2][5]. - MediPharm Labs' May 23, 2025 press release included statements from Taves that Check-Cap believes to be false, particularly regarding alleged deficiencies in Check-Cap's public disclosures [3][4]. - Check-Cap accuses Taves of misusing his position to manipulate Check-Cap's stock price, violating U.S. securities laws [4]. Group 2: Company Background - Check-Cap is a clinical-stage medical diagnostics company focused on colorectal cancer screening through its investigational device, C-Scan, which is not yet available for sale in the U.S. [6].

[Financial Statements](index=1&type=section&id=Financial%20Statements) This section presents the company's unaudited financial statements, including balance sheets, statements of operations, changes in equity, and cash flows, for recent periods [Consolidated Unaudited Balance Sheets](index=1&type=section&id=CONSOLIDATED%20UNAUDITED%20BALANCE%20SHEETS) The company's balance sheet as of June 30, 2024, shows a decrease in total assets and shareholders' equity compared to December 31, 2023, primarily driven by a significant reduction in short-term bank deposits and an increased accumulated deficit Consolidated Unaudited Balance Sheets (Amounts in thousands of US dollars) | Item | June 30, 2024 (Unaudited, in thousands of US dollars) | December 31, 2023 (Audited, in thousands of US dollars) | Change (in thousands of US dollars) | Percentage Change | | :-------------------------------- | :-------------------------- | :------------------------ | :----- | :---------------- | | **Assets** | | | | | | Cash and cash equivalents | $17,824 | $8,844 | +$8,980 | +101.5% | | Short-term bank deposit | $- | $15,912 | -$15,912 | -100.0% | | Total current assets | $17,954 | $24,856 | -$6,902 | -27.8% | | Total assets | $18,090 | $25,017 | -$6,927 | -27.7% | | **Liabilities and Shareholders' Equity** | | | | | | Total current liabilities | $913 | $1,330 | -$417 | -31.4% | | Total shareholders' equity | $17,177 | $23,687 | -$6,510 | -27.5% | | Accumulated deficit | $(151,173) | $(144,861) | -$6,312 | +4.4% | - Total assets decreased by **27.7%** from **$25,017 thousand** at December 31, 2023, to **$18,090 thousand** at June 30, 2024, largely due to a **100% decrease** in short-term bank deposits, offset by a **101.5% increase** in cash and cash equivalents[2](index=2&type=chunk) - Total shareholders' equity decreased by **27.5%** from **$23,687 thousand** to **$17,177 thousand**, primarily driven by an increase in the accumulated deficit from **$(144,861) thousand** to **$(151,173) thousand**[2](index=2&type=chunk) [Consolidated Unaudited Statements of Operations](index=2&type=section&id=CONSOLIDATED%20UNAUDITED%20STATEMENTS%20OF%20OPERATIONS) For the six months ended June 30, 2024, the company significantly reduced its net loss and operating loss compared to the same period in 2023, largely due to a substantial decrease in research and development expenses Consolidated Unaudited Statements of Operations (Amounts in thousands of US dollars) | Item | Six months ended June 30, 2024 (in thousands of US dollars) | Six months ended June 30, 2023 (in thousands of US dollars) | Change (in thousands of US dollars) | Percentage Change | | :---------------------------------- | :----------------------------- | :----------------------------- | :----- | :---------------- | | Research and development expenses, net | $(335) | $(8,151) | +$7,816 | -95.9% | | General and administrative expenses | $(6,484) | $(2,762) | -$3,722 | +134.8% | | Operating loss | $(6,819) | $(12,277) | +$5,458 | -44.5% | | Finance Income, net | $507 | $957 | -$450 | -47.0% | | Net loss for the period | $(6,312) | $(11,320) | +$5,008 | -44.2% | | Net loss per ordinary share basic and diluted | $(1.08) | $1.94 | -$3.02 | -155.7% | - Net loss for the period decreased by **44.2%** from **$(11,320) thousand** in 2023 to **$(6,312) thousand** in 2024[5](index=5&type=chunk) - Research and development expenses, net, decreased significantly by **95.9%** from **$(8,151) thousand** in 2023 to **$(335) thousand** in 2024[5](index=5&type=chunk) - General and administrative expenses increased by **134.8%** from **$(2,762) thousand** in 2023 to **$(6,484) thousand** in 2024[5](index=5&type=chunk) [Consolidated Unaudited Statements of Changes in Shareholders' Equity](index=3&type=section&id=CONSOLIDATED%20UNAUDITED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20EQUITY) The statements of changes in shareholders' equity reflect a decrease in total equity from January 1, 2024, to June 30, 2024, primarily due to the net loss incurred during the period, which increased the accumulated deficit Consolidated Unaudited Statements of Changes in Shareholders' Equity (Amounts in thousands of US dollars) | Item | Balance as of January 1, 2024 (in thousands of US dollars) | Balance as of June 30, 2024 (in thousands of US dollars) | Change (in thousands of US dollars) | | :-------------------------- | :---------------------------- | :-------------------------- | :----- | | Number of Ordinary Shares | 5,850,555 | 5,851,042 | +487 | | Share capital, Amount | $83,746 | $83,753 | +$7 | | Additional paid-in capital | $84,802 | $84,597 | -$205 | | Accumulated deficit | $(144,861) | $(151,173) | -$6,312 | | Total shareholders' equity | $23,687 | $17,177 | -$6,510 | - Total shareholders' equity decreased by **$6,510 thousand** from January 1, 2024, to June 30, 2024, primarily due to a net loss of **$6,312 thousand**[8](index=8&type=chunk) - The accumulated deficit increased by **$6,312 thousand** during the six months ended June 30, 2024[8](index=8&type=chunk) [Consolidated Unaudited Statements of Cash Flows](index=4&type=section&id=CONSOLIDATED%20UNAUDITED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2024, the company experienced a net increase in cash and cash equivalents, driven by a significant inflow from investing activities, primarily changes in short-term deposits, despite continued cash usage in operating activities Consolidated Unaudited Statements of Cash Flows (Amounts in thousands of US dollars) | Cash Flow Activity | Six months ended June 30, 2024 (in thousands of US dollars) | Six months ended June 30, 2023 (in thousands of US dollars) | Change (in thousands of US dollars) | | :------------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(6,932) | $(9,824) | +$2,892 | | Net cash provided by (used in) investing activities | $15,912 | $7,986 | +$7,926 | | Net cash provided by financing activities | $- | $- | $0 | | Net increase(decrease) in cash, cash equivalents and restricted cash | $8,980 | $(1,838) | +$10,818 | | Cash, cash equivalents and restricted cash at the end of the period | $17,824 | $2,604 | +$15,220 | - Net cash used in operating activities decreased by **29.4%** from **$(9,824) thousand** in 2023 to **$(6,932) thousand** in 2024[11](index=11&type=chunk) - Net cash provided by investing activities increased significantly by **99.2%** from **$7,986 thousand** in 2023 to **$15,912 thousand** in 2024, primarily due to changes in short-term deposits[11](index=11&type=chunk) - The company reported a net increase in cash, cash equivalents and restricted cash of **$8,980 thousand** for the six months ended June 30, 2024, compared to a decrease of **$(1,838) thousand** in the prior year period[11](index=11&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=5&type=section&id=NOTES%20TO%20UNAUDITED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed explanations and disclosures for the unaudited consolidated financial statements, covering general information, business developments, and significant events [NOTE 1 - General Information](index=5&type=section&id=NOTE%201%20-%20GENERAL%20INFORMATION) This section provides general information about Check Cap Ltd., detailing its corporate structure, the strategic shift from its original medical diagnostics business due to clinical trial setbacks, and its ongoing efforts to pursue strategic alternatives, including multiple business combination agreements and related financial transactions. It also addresses the impact of the Israel-Hamas conflict and recent litigation [General Business Overview and Strategic Shift](index=5&type=section&id=General%20Business%20Overview%20and%20Strategic%20Shift) Check Cap Ltd., an Israeli clinical-stage medical diagnostics company, discontinued its C-Scan® colorectal cancer screening program due to insufficient efficacy results, leading to a significant workforce reduction and a strategic pivot towards exploring alternative business options. The company has not generated revenue and has a substantial accumulated deficit - Check Cap Ltd. was engaged in clinical-stage medical diagnostics, aiming to redefine colorectal cancer (CRC) screening with C-Scan®[15](index=15&type=chunk) - On March 21, 2023, the Company announced that efficacy results from its calibration studies did not meet the goal to proceed to the U.S. pivotal study, leading to a postponement and cost reduction plan[16](index=16&type=chunk)[17](index=17&type=chunk) - On June 6, 2023, the Board of Directors decided to pursue strategic options, significantly reduced its workforce to two employees, discontinued calibration studies, and does not plan to commence the U.S. pivotal study[18](index=18&type=chunk)[19](index=19&type=chunk) - The Company has not yet generated revenues and, as of June 30, 2024, had an accumulated deficit of approximately **$151,173 thousand**[20](index=20&type=chunk)[2](index=2&type=chunk) [Entry into a business combination agreement with Keystone](index=5&type=section&id=Entry%20into%20a%20business%20combination%20agreement%20with%20Keystone) The company entered into a business combination agreement with Keystone Dental Holdings, Inc. in August 2023, but it was terminated in December 2023 due to the lack of requisite shareholder approval. This termination led to transaction-related expenses and a change in the Company's Board of Directors - On August 16, 2023, the Company announced entry into a business combination agreement (BCA) with Keystone Dental Holdings, Inc.[21](index=21&type=chunk) - The BCA was terminated on December 24, 2023, by Keystone, as it did not receive the requisite majority for approval by Check-Cap's shareholders at the Annual General Meeting on December 18, 2023[24](index=24&type=chunk)[25](index=25&type=chunk) - As a result of the failed business combination, the Company incurred transaction-related expenses recorded in General and Administrative expenses, and the Board of Directors was replaced by new members[26](index=26&type=chunk) [Israel-Hamas Conflict](index=6&type=section&id=Israel-Hamas%20Conflict) The ongoing Israel-Hamas conflict, which began on October 7, 2023, has not adversely affected the Company's operations to date, primarily due to its robust backup IT systems and remote work capabilities - The Israel-Hamas conflict began on October 7, 2023, with attacks on civilian and military targets[27](index=27&type=chunk) - To date, the Company's operations have not been adversely affected by the war[27](index=27&type=chunk) - The Company has back-up IT systems and remote work ability to ensure operational continuity in emergencies[27](index=27&type=chunk) [Entry into a business combination agreement with Nobul](index=6&type=section&id=Entry%20into%20a%20business%20combination%20agreement%20with%20Nobul) On March 25, 2024, the company entered into a new business combination agreement with Nobul AI Corp. If consummated, Check-Cap's ordinary shares will be delisted from Nasdaq, and its security holders are expected to own approximately 15% of Nobul. The transaction is contingent on shareholder and exchange approvals, and the Board approved an immediate payment of approximately $3,810 to Nobul for transaction costs - On March 25, 2024, the Company entered into a business combination agreement (Nobul BCA) with Nobul AI Corp[28](index=28&type=chunk) - If the Nobul Business Combination is consummated, Check-Cap's ordinary shares will be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934[28](index=28&type=chunk) - Check-Cap security holders are expected to own approximately **15%** of Nobul on a fully diluted basis, subject to adjustments based on Check-Cap's net cash at closing[33](index=33&type=chunk) - The transactions are subject to approval by the Company's and Nobul's shareholders, Nasdaq listing approval for Nobul Common Shares, and TSX listing approval[34](index=34&type=chunk) - On April 21, 2024, the Board approved an immediate payment of approximately **$3,810 thousand** to Nobul for reimbursement of Transaction Costs[35](index=35&type=chunk) [Transfer of Company Funds to Canadian Subsidiary](index=8&type=section&id=Transfer%20of%20Company%20Funds%20to%20Canadian%20Subsidiary) On June 20, 2024, the Board approved transferring approximately $17,250 of the Company's funds from Israeli banks to its Canadian subsidiary's bank account, retaining $750 in Israel - On June 20, 2024, the Board approved transferring approximately **$17,250 thousand** of the Company's funds from Israeli banks (Bank Leumi and Discount Bank) to its Canadian subsidiary's account at Royal Bank of Canada[36](index=36&type=chunk) - Approximately **$750 thousand** of the Company's funds will remain in its accounts at Bank Leumi in Israel[36](index=36&type=chunk) [Approval to Enter into a Loan Agreement with Nobul](index=8&type=section&id=Approval%20to%20Enter%20into%20a%20Loan%20Agreement%20with%20Nobul) On July 28, 2024, the Board approved a $6,000 loan to Nobul, subsequently ratified on September 8, 2024. This loan bears an annual interest rate of 5% and is due 30 days after the Nobul Business Combination Agreement is either terminated or completed, with provisions for set-off against termination fees - On July 28, 2024, the Board approved a loan to Nobul in the principal amount of **$6,000 thousand**, which was ratified on September 8, 2024[37](index=37&type=chunk)[38](index=38&type=chunk) - The loan bears interest at **5%** per annum, payable annually in arrears[39](index=39&type=chunk) - The aggregate amount of the loan is due 30 days following the termination or completion of the Nobul Business Combination Agreement, with a provision for set-off against termination fees[38](index=38&type=chunk)[40](index=40&type=chunk) [Creation of Segregated Account](index=8&type=section&id=Creation%20of%20Segregated%20Account) An amending letter to the Nobul BCA, approved on September 8, 2024, obligates the Company to deposit $11,000 into a segregated, interest-bearing bank account. These funds are designated for Nobul's acquisition targets or growth initiatives, reducing the Net Cash Target, and would revert to Check-Cap if the BCA terminates. The $11,000 was transferred in August 2024 - On September 8, 2024, the Board approved an amending letter to the Nobul BCA, obligating the Company to deposit **$11,000 thousand** into a designated, segregated, and interest-bearing bank account[41](index=41&type=chunk) - Funds in this account are for Nobul's accretive acquisition targets or other growth initiatives and reduce the Net Cash Target on a dollar-for-dollar basis[41](index=41&type=chunk) - If the BCA is terminated, remaining funds in the segregated account, plus interest, will accrue to the Company[41](index=41&type=chunk) - In August 2024, the Company transferred **$11,000 thousand** into an account held at Royal Bank of Canada in Toronto, Canada, under the name of Nobul AI Corp[42](index=42&type=chunk) [Entry into a Second Loan Agreement with Nobul](index=10&type=section&id=Entry%20into%20a%20Second%20Loan%20Agreement%20with%20Nobul) On December 23, 2024, the Board approved a second $6,000 loan to Nobul, funded from the previously established segregated account. This loan, bearing 5% annual interest, is intended for identified acquisition targets and growth initiatives, with approximately $2,100 already used for these purposes and $700 for Company expenses from the segregated account - On December 23, 2024, the Board approved a Second Loan Agreement with Nobul for a principal amount of **$6,000 thousand**[45](index=45&type=chunk) - The Second Loan will be funded from the previously created designated, segregated, and interest-bearing bank account[46](index=46&type=chunk) - The loan bears interest at **5%** per annum and is for identified acquisition targets and growth initiatives of Nobul[45](index=45&type=chunk)[46](index=46&type=chunk) - As of the filing date, approximately **$2,100 thousand** from the Segregated Account has been used for acquisition targets and growth initiatives, and approximately **$700 thousand** for certain Company expenses[46](index=46&type=chunk) [Litigation](index=10&type=section&id=Litigation) On October 7, 2024, the Company received a derivative claim exceeding NIS 2.5 Million ($690k) against its directors and Nobul AI, alleging corporate governance issues, validity of board decisions, and legality of the Nobul BCA and cash transactions. The Company considers these claims frivolous and intends to vigorously defend itself - On October 7, 2024, the Company received a derivative claim against its directors and Nobul AI for a total amount above **NIS 2.5 Million** (approximately **$690 thousand**)[47](index=47&type=chunk) - The main claims relate to corporate governance issues, entity level control, validity of board decisions, and legality of the Nobul BCA and certain cash transactions[47](index=47&type=chunk) - The Company believes all claims in the derivative action are frivolous and strongly denies them, intending to vigorously defend itself[48](index=48&type=chunk)[49](index=49&type=chunk)

● We are substantially dependent on our remaining key employees to facilitate the consummation of a strategic transaction; and ● If the Business Combination is not completed, and we do not pursue an alternative strategic option or liquidation, we expect that we will require significant additional funding in order to complete the development, scale up manufacturing and commercialization of C-Scan or any new products and technology. If additional capital is not available, we may have to cease operations. Risk ...

[Corporate Update & Business Combination](index=1&type=section&id=Corporate%20Update%20%26%20Business%20Combination) Check-Cap is pursuing a business combination with Keystone Dental, leading to operational changes and impacting its liquidity position [Proposed Business Combination Agreement with Keystone Dental](index=1&type=section&id=Proposed%20Business%20Combination%20Agreement%20with%20Keystone%20Dental) Check-Cap shareholders are scheduled to vote on a definitive Business Combination Agreement with Keystone Dental on December 18, 2023. If completed, Keystone stockholders will become the majority holders of the combined company, which will be headquartered in Irvine, CA, focus on Keystone Dental's comprehensive portfolio of dental solutions, and trade on NASDAQ under the symbol "KSD" - Check-Cap shareholders to vote on the proposed Business Combination Agreement with Keystone Dental at the Annual General Meeting on Monday, December 18, 2023[2](index=2&type=chunk)[17](index=17&type=chunk) - If completed, Keystone Dental stockholders will become the majority holders of the combined company, which will be headquartered in Irvine, CA[3](index=3&type=chunk) - The combined company will focus on advancing commercial execution and market development of Keystone Dental's comprehensive portfolio of implants, full arch restorations, and other tooth replacement solutions, in addition to biomaterial and digital dentistry capabilities[3](index=3&type=chunk) - Upon closing, the combined company will trade on NASDAQ under the symbol "**KSD**" and be led by Melker Nilsson, Keystone's Chief Executive Officer[3](index=3&type=chunk) [Keystone Dental Recent Business Developments](index=2&type=section&id=Keystone%20Dental%20Recent%20Business%20Developments) Keystone Dental has recently expanded its product offerings and intellectual property, launching a new software solution for implant scans, securing a patent for its innovative IOS solution, and commercially launching a new implant system - Keystone Dental launched Nexus Connect, a unique software solution utilizing proprietary technology and a machine-learning model to analyze implant scans performed with an intraoral scanner[4](index=4&type=chunk) - Osteon Medical, a Keystone Dental subsidiary, was granted a patent for the Nexus IOS solution, which allows implant dentists to perform direct full-arch implant scans using an Intraoral Scanner (IOS)[18](index=18&type=chunk) - Keystone Dental announced the commercial launch of the GENESIS ACTIVE™ Implant System, a state-of-the-art surgical and prosthetic solution designed to transform implant placement and restoration[40](index=40&type=chunk) [Check-Cap Operational Changes](index=2&type=section&id=Check-Cap%20Operational%20Changes) In anticipation of the strategic development plan, Check-Cap terminated the majority of its research and development activities and clinical trials, leading to a significant reduction in R&D expenses and an impairment of fixed assets - Management terminated the majority of the Company's research and development activities and clinical trials in anticipation of the strategic development plan[5](index=5&type=chunk)[22](index=22&type=chunk) Research and Development Expenses (YoY Change) | Period | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (YoY) | | :----------------------------------- | :------------------- | :------------------- | :----------- | | Three months ended Sep 30 | $30 | $3,641 | -99.18% | | Nine months ended Sep 30 | $8,181 | $11,315 | -27.69% | Impairment of Fixed Assets | Period | 2023 (Thousands USD) | 2022 (Thousands USD) | | :----------------------------------- | :------------------- | :------------------- | | Three months ended Sep 30 | $60 | $0 | | Nine months ended Sep 30 | $1,426 | $0 | [Liquidity and Cash Position](index=2&type=section&id=Liquidity%20and%20Cash%20Position) Check-Cap's cash and cash equivalents, restricted cash, and short-term bank deposits decreased by approximately 33% from December 31, 2022, to September 30, 2023 Cash and Cash Equivalents, Restricted Cash and Short-Term Bank Deposits | Date | Amount (Millions USD) | | :--------------- | :-------------------- | | Sep 30, 2023 | $28.2 | | Jun 30, 2023 | $32.4 | | Dec 31, 2022 | $42.1 | [Financial Results Overview](index=2&type=section&id=Financial%20Results%20Overview) This section summarizes Check-Cap's financial performance for the third quarter and nine months ended September 30, 2023 [Third Quarter Ended September 30, 2023](index=2&type=section&id=Third%20Quarter%20Ended%20September%2030%2C%202023) For the third quarter of 2023, Check-Cap reported a significant reduction in operating loss and net loss compared to the prior year, primarily driven by a drastic decrease in R&D expenses, despite an increase in general and administrative expenses due to transaction-related professional services Key Financial Metrics (Q3 2023 vs. Q3 2022) | Metric | Q3 2023 (Thousands USD) | Q3 2022 (Thousands USD) | Change (YoY) | | :-------------------------- | :---------------------- | :---------------------- | :----------- | | Research & Development, net | $30 | $3,641 | -99.18% | | General & Administrative | $2,833 | $1,404 | +101.78% | | Impairment of fixed assets | $62 | $0 | N/A | | Operating loss | $(2,925) | $(5,045) | -42.02% | | Finance Income, net | $335 | $291 | +15.12% | | Net loss | $(2,590) | $(4,754) | -45.51% | | Net loss per ordinary share | $0.44 | $0.81 | -45.68% | [Nine Months Ended September 30, 2023](index=3&type=section&id=Nine%20Months%20Ended%20September%2030%2C%202023) For the first nine months of 2023, Check-Cap experienced a decrease in both operating loss and net loss, largely due to reduced R&D activities. General and administrative expenses increased due to professional services related to the pending business combination, while net finance income saw a substantial increase Key Financial Metrics (9M 2023 vs. 9M 2022) | Metric | 9M 2023 (Thousands USD) | 9M 2022 (Thousands USD) | Change (YoY) | | :-------------------------- | :---------------------- | :---------------------- | :----------- | | Research & Development, net | $8,181 | $11,315 | -27.69% | | General & Administrative | $5,595 | $4,504 | +24.22% | | Impairment of fixed assets | $1,426 | $0 | N/A | | Operating loss | $(15,202) | $(15,819) | -3.89% | | Finance Income, net | $1,292 | $424 | +204.72% | | Net loss | $(13,910) | $(15,395) | -9.64% | | Net loss per ordinary share | $2.38 | $2.74 | -13.14% | Cash Flow Highlights (9M 2023 vs. 9M 2022) | Metric | 9M 2023 (Thousands USD) | 9M 2022 (Thousands USD) | Change (YoY) | | :----------------------------------------------- | :---------------------- | :---------------------- | :----------- | | Net cash used in operating activities | $(13,415) | $(14,560) | -7.86% | | Net cash used in investing activities | $12,486 | $(11,395) | N/A (swing) | | Net cash provided by financing activities | $0 | $8,850 | -100% | | Net decrease in cash, cash equivalents and restricted cash | $(929) | $(17,105) | -94.57% | [Company Information & Legal Disclosures](index=3&type=section&id=Company%20Information%20%26%20Legal%20Disclosures) This section provides company overviews for Keystone Dental and Check-Cap, alongside legal disclosures and investor contact details [About Keystone Dental Group](index=3&type=section&id=About%20Keystone%20Dental%20Group) Keystone Dental Group is a global commercial-stage medical technology company focused on providing comprehensive tooth replacement solutions, including innovative implant systems, biomaterials, and digital workflow capabilities, with operations in California, Israel, and Australia - Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners[25](index=25&type=chunk) - The company's product portfolio includes proprietary offerings such as Genesis Active, Molaris™, and Prima Plus™ implant systems, the Paltop value brand, and DYNA biomaterials[25](index=25&type=chunk) - Keystone Dental acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding prosthetic solutions on implants and digital workflow capabilities, including the Nexus iOS digital workflow solution[25](index=25&type=chunk) [About Check-Cap](index=4&type=section&id=About%20Check-Cap) Check-Cap is a clinical-stage medical diagnostics company dedicated to redefining colorectal cancer (CRC) screening through its investigational C-Scan® test, designed for early polyp detection - Check-Cap is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening[32](index=32&type=chunk) - The company's primary product is C-Scan®, a screening test designed to detect polyps before they may transform into colorectal cancer and enable early intervention[32](index=32&type=chunk) - C-Scan is an investigational device and is not available for sale in the United States[32](index=32&type=chunk) [Legal Disclosures & Investor Information](index=4&type=section&id=Legal%20Disclosures%20%26%20Investor%20Information) This section includes standard legal disclaimers regarding forward-looking statements, clarifies that the communication does not constitute an offer to sell securities, and identifies potential participants in the proxy solicitation for the business combination - The press release contains "forward-looking statements" subject to risks and uncertainties, and investors are urged to read the "Forward-looking Statements" and "Risk Factors" in the Company's Annual Report on Form 20-F[33](index=33&type=chunk) - This communication is not an offer to buy or sell securities, or a solicitation of any vote or approval[13](index=13&type=chunk)[34](index=34&type=chunk) - Check-Cap, Keystone Parent, and their respective directors and executive officers may be deemed participants in the solicitation of proxies from Check-Cap shareholders in connection with the business combination[12](index=12&type=chunk)[26](index=26&type=chunk) [Investor & Media Contacts](index=5&type=section&id=Investor%20%26%20Media%20Contacts) Contact information for investor relations and media inquiries is provided through LifeSci Advisors and LifeSci Communications - Investor contacts include Irina Koffler and Meirav Gomeh-Bauer from LifeSci Advisors, LLC[14](index=14&type=chunk)[34](index=34&type=chunk) - Media contact is Mónica Rouco Molina, Ph.D., Account Supervisor - Europe, LifeSci Communications[27](index=27&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) This section presents Check-Cap's consolidated unaudited balance sheets, statements of comprehensive loss, shareholders' equity, and cash flows [Balance Sheets](index=6&type=section&id=Balance%20Sheets) Check-Cap's consolidated unaudited balance sheets show a significant decrease in total assets and shareholders' equity from December 31, 2022, to September 30, 2023, primarily due to reductions in short-term bank deposits and property and equipment, alongside a decrease in total liabilities Consolidated Unaudited Balance Sheet Highlights (Thousands USD) | Metric | Sep 30, 2023 | Dec 31, 2022 | Change (YoY) | | :-------------------------- | :----------- | :----------- | :----------- | | Cash and cash equivalents | $3,383 | $4,090 | -17.30% | | Restricted cash | $130 | $352 | -63.07% | | Short-term bank deposit | $24,684 | $37,609 | -34.38% | | Total current assets | $28,774 | $42,630 | -32.52% | | Property and equipment, net | $183 | $1,751 | -89.50% | | Total non-current assets | $256 | $2,811 | -90.86% | | Total assets | $29,030 | $45,441 | -36.12% | | Total current liabilities | $1,635 | $3,408 | -52.03% | | Total non-current liabilities | $0 | $721 | -100% | | Total shareholders' equity | $27,395 | $41,312 | -33.69% | [Statements of Comprehensive Loss](index=7&type=section&id=Statements%20of%20Comprehensive%20Loss) The consolidated unaudited statements of comprehensive loss provide a detailed breakdown of revenues and expenses, leading to the net loss for the three and nine months ended September 30, 2023 and 2022. Key metrics and changes are summarized in the 'Financial Results Overview' section - The statements detail the components of net loss, including research and development expenses, general and administrative expenses, impairment of fixed assets, operating loss, and finance income, net[35](index=35&type=chunk)[45](index=45&type=chunk) - Net loss for the three months ended September 30, 2023, was **$2,590 thousand**, and for the nine months ended September 30, 2023, was **$13,910 thousand**[45](index=45&type=chunk) [Statements of Changes in Shareholders' Equity](index=8&type=section&id=Statements%20of%20Changes%20in%20Shareholders%27%20Equity) The consolidated unaudited statements of changes in shareholders' equity illustrate the movements in share capital, additional paid-in capital, and accumulated deficit, reflecting the impact of RSU vesting, share-based compensation, and net loss on total equity for the periods presented Shareholders' Equity Changes (Thousands USD) | Metric | As of Jan 1, 2023 | As of Sep 30, 2023 | | :----------------------------------- | :---------------- | :----------------- | | Total shareholders' equity | $41,312 | $27,395 | | Net loss (9 months ended Sep 30, 2023) | N/A | $(13,910) | | Share-based compensation (9 months ended Sep 30, 2023) | N/A | $(7) | Shareholders' Equity Changes (Q3 2023, Thousands USD) | Metric | As of Jun 30, 2023 | As of Sep 30, 2023 | | :----------------------------------- | :----------------- | :----------------- | | Total shareholders' equity | $30,190 | $27,395 | | Net loss (3 months ended Sep 30, 2023) | N/A | $(2,590) | | Share-based compensation (3 months ended Sep 30, 2023) | N/A | $(205) | [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows) The consolidated unaudited statements of cash flows indicate that for the nine months ended September 30, 2023, Check-Cap primarily used cash in operating activities, which was largely offset by cash provided by investing activities, resulting in a net decrease in cash, cash equivalents, and restricted cash Consolidated Unaudited Cash Flow Highlights (9M 2023 vs. 9M 2022, Thousands USD) | Cash Flow Activity | 9M 2023 | 9M 2022 | | :--------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(13,415) | $(14,560) | | Net cash used in investing activities | $12,486 | $(11,395) | | Net cash provided by financing activities | $0 | $8,850 | | Net decrease in cash, cash equivalents and restricted cash | $(929) | $(17,105) | | Cash, cash equivalents and restricted cash at end of period | $3,513 | $9,702 | - The significant swing in investing activities from cash used in 2022 to cash provided in 2023 was primarily due to investment in short-term bank and other deposits[30](index=30&type=chunk)