As filed with the Securities and Exchange Commission on February 2, 2026 Registration No. 333-293109 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ Amendment No. 1 to Form F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________ CHECK-CAP LTD. (Exact name of registrant as specified in its charter) ____________________ | (State or other jurisdiction of | | --- | | incorporation or organization) | (Primary Standard Industrial Classification ...

As filed with the Securities and Exchange Commission on January 30, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CHECK-CAP LTD. (Exact name of registrant as specified in its charter) ____________________ Israel 3844 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 29 ...

Core Insights - MBody AI has secured over 98% shareholder approval for its merger with Check-Cap, positioning it as a leading player in the embodied AI sector on Nasdaq [2][9] - The merger is expected to close in the coming weeks, subject to customary conditions, marking a significant transformation for Check-Cap into a dedicated embodied AI company [2][9] Industry Trends - U.S. enterprises are rapidly adopting full-facility embodied AI systems, driven by the need for significant cost savings and addressing labor volatility and compliance pressures [4] - Automation is becoming a strategic necessity rather than an experimental endeavor, indicating a shift in how businesses view robotics and AI integration [4] Company Overview - MBody AI operates the MBody AI Orchestrator™, a hardware-agnostic platform that integrates various robotic and sensor systems, facilitating automation across multiple industries [5][6] - The platform allows for reduced risk, fast deployment, and measurable ROI in sectors such as hospitality, healthcare, logistics, retail, and data centers [6] Leadership Insights - David Lontini, Chairman of Check-Cap, emphasized the significance of the 98% approval rate, highlighting the merger's potential to create a unique embodied AI company at a critical time for enterprise adoption [7] - John Fowler, CEO of MBody AI, noted that the demand for a unified orchestration platform is growing, as customers seek comprehensive solutions rather than fragmented hardware [7] Company Positioning - MBody AI is recognized as a global leader in embodied AI, aiming to create an autonomous workforce and already serving Fortune 500 companies [8] - The merger with Check-Cap will enhance MBody AI's market presence and capabilities in the embodied AI landscape [9]

Core Insights - MBody AI and Check-Cap Ltd. are merging to enhance the adoption of embodied artificial intelligence, positioning Check-Cap shareholders for significant value creation through MBody AI's established success [1][4] - The MBody AI Orchestrator™ platform is being utilized by Fortune 500 companies, serving as a critical integration tool for various robotic and intelligent devices, promoting a unified, self-learning network [2][3] - MBody AI's technology is transforming physical environments into intelligent, self-optimizing systems, with reported benefits including up to 40% labor reduction and 80% uptime improvement [3][4] Company Overview - MBody AI is recognized as a leader in embodied artificial intelligence, providing a hardware-agnostic platform that integrates robotic and sensor systems across multiple industries [6] - Check-Cap Ltd. is set to become a global leader in embodied AI through its merger with MBody AI, enhancing its market position and potential for stock appreciation [6][4] Market Potential - Industry analysts predict that the embodied AI and AI robotics sectors will generate over $16 trillion in shareholder value in the near future, with MBody AI positioned as a foundational player in this ecosystem [5]

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].

Financial Performance and Expenses - Research and development expenses for the years ended December 31, 2024, 2023, and 2022 were approximately $0, $8.3 million, and $14.3 million, respectively[285]. - A significant workforce reduction was announced in June 2023 to reduce cash burn and focus on essential research activities[332]. - The company does not currently have any outstanding investments and aims to preserve principal while maximizing interest income[713]. - The company is exposed to market risks from changes in interest rates related to financial investments in cash and deposits[714]. - The company does not use derivative financial instruments to limit exposure to interest rate risk[714]. Regulatory and Compliance - The company is subject to extensive regulation by the FDA and other regulatory bodies for the C-Scan medical device, which includes product design, testing, and compliance with safety standards[306]. - The FDA's 510(k) clearance process typically takes approximately 6 to 9 months, although it can take significantly longer[307]. - Special 510(k)s are processed within 30 days of receipt, aimed at devices with established evaluation methods[308]. - Class II devices generally require 510(k) premarket clearance before commercial marketing in the U.S.[309]. - A PMA application must be supported by extensive data, and the review process may take at least 12 to 18 months[314][315]. - The FDA has 45 days to determine if a PMA application is complete for substantive review[315]. - The Breakthrough Device Program allows expedited access for devices that provide significant advantages or represent breakthrough technology[318]. - Clinical trials are almost always required to support a PMA application or de novo reclassification petition[319]. - The FDA requires manufacturers to report any device-related deaths or serious injuries[321]. - Compliance with Quality Systems Regulation (QSR) is necessary to maintain FDA clearance or approval[322]. - The FDA has broad regulatory compliance and enforcement powers, including the ability to conduct inspections and impose sanctions[323]. - The company is subject to extensive regulatory scrutiny, including the federal Anti-Kickback Statute and the False Claims Act, which could impact operations[337]. Product Development and Clinical Trials - The company has expanded its manufacturing capacity to support larger clinical volumes expected in the early commercialization stage during 2022 and 2023[302]. - The company received an IIA grant approval in January 2021 amounting to $620,000 to support the transition from research and development to manufacturing[302]. - The C-Scan system has received FCC authorization, ensuring compliance with radio frequency emission standards[335]. - The C-Scan capsule is currently undergoing clinical trials in the U.S., with engagement at various sites progressing slower than expected due to compliance with regulatory requirements[346]. - In December 2019, a pilot study of C-Scan enrolled 45 patients, with 39 completing the procedure and reporting higher satisfaction compared to colonoscopy[326]. - The U.S. pivotal study design includes two parts: a calibration study with up to 200 patients and a randomized study comparing C-Scan to colonoscopy with up to 800 patients[328]. - As of March 2023, the initiation of the powered portion of the U.S. pivotal study was postponed due to efficacy results not meeting goals[331]. Market and Competitive Landscape - The company faces competition from established manufacturers of CRC screening technologies, including Olympus, GE Healthcare, and Exact Sciences, which have greater financial resources and distribution channels[289]. - The company must obtain reimbursement coverage from third-party payors for procedures using C-Scan to ensure commercial viability[300]. - Coverage and reimbursement for C-Scan will depend on various third-party payors and their interpretations of what is considered "reasonable and necessary" for coverage[336]. - The cost-effectiveness of CRC screening devices is influenced by patient adherence, which is crucial for obtaining third-party payer reimbursement[363]. Licensing and Agreements - The company has entered into an exclusive license agreement with the University of Missouri, agreeing to pay royalties ranging from $0.30 to $5.00 per C-Scan unit, with a total cap of $15 million[288]. - The company entered into a business combination agreement with Nobul on March 25, 2024, after previous agreements did not receive shareholder approval[332]. Regulatory Approvals and Market Potential - The company received the CE mark for C-Scan on January 9, 2018, and the renewal of this mark is valid until December 1, 2026[349]. - The AMAR approval for marketing and sale of C-Scan in Israel is valid until December 31, 2024[350]. - As of December 31, 2023, approximately 300 million people in the U.S. have coverage for capsule endoscopy of the small bowel, but there is currently no reimbursement for colon capsule endoscopy for CRC screening[368]. - Colorectal cancer (CRC) is expected to cause over 52,900 deaths in the U.S. in 2025, highlighting the importance of effective screening methods[358]. - The 5-year relative survival rate for localized CRC is 91.5%, emphasizing the critical nature of early detection[359]. - COVID-19 caused a significant decrease in CRC screening, with estimates of 1,176,942 to 2,014,164 fewer screenings between 2020 and 2023[360]. Financial Exchange Rates - The exchange rate between the U.S. dollar and the NIS increased by 1.09% in 2024, while the Euro increased by 5.25%[712]. - The exchange rate between the U.S. dollar and the NIS increased by 3.07% in 2023, while the Euro decreased by 4.26%[712]. - The exchange rate between the U.S. dollar and the NIS increased by 13.15% in 2022, while the Euro increased by 6.12%[712].