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Microbot Medical(MBOT) - 2024 Q4 - Annual Report

Part I Business Overview Microbot Medical Inc. is a clinical-stage medical device company developing the LIBERTY Endovascular Robotic Surgical System, a disposable robot for endovascular procedures, with recent FDA 510(k) submission - The company is a clinical-stage medical device firm specializing in robotic endoluminal surgery, primarily focusing on the LIBERTY Endovascular Robotic Surgical System27 - The LIBERTY system is a unique, fully disposable robot for endovascular procedures, designed to be compact and remotely operated, eliminating the need for large capital equipment282930 - On December 10, 2024, the company submitted a 510(k) premarket notification to the FDA for the LIBERTY system, with marketing clearance anticipated in the second quarter of 20253940 - The company received ISO 13485:2016 certification for its quality management system, supporting future CE Mark approval for marketing in Europe, anticipated in the second half of 202641 - Microbot relies on third-party manufacturers for its product candidates and has entered into a Turn-Key Manufacturing Agreement to assemble and test its products7072 - The company's operations in Israel are exposed to risks from the ongoing military conflict, though no materially adverse effects have been determined as of the report filing date7475 Technological Platforms The company's core technology is the LIBERTY Endovascular Robotic Surgical System, a compact, disposable, and remotely controlled device, with successful preclinical studies and a 510(k) FDA submission - The LIBERTY system is designed to be the first fully disposable robotic system for endovascular procedures, eliminating the need for large capital equipment2833 - A pivotal preclinical study of the LIBERTY system showed 100% usability and technical success across 48 animal targets, with no observed complications, supporting the IDE submission to the FDA38 - The company submitted a 510(k) premarket notification to the FDA for the LIBERTY system on December 10, 2024, following a successful human trial39 - In October 2022, the company acquired the NovaCross technology platform, which includes intraluminal revascularization devices with an anchoring mechanism and integrated microcatheter43 Strategy Microbot's strategy focuses on establishing the LIBERTY system as the standard-of-care through product refinement, KOL engagement, R&D investment, and strategic partnerships - Establish the LIBERTY system as the standard-of-care by working with healthcare providers and systems49 - Continuously invest in R&D to refine existing products and develop new surgical robotic solutions4954 - Pursue collaborations with global medical device companies that have established sales and distribution networks54 - Seek additional IP and technologies to strengthen the current portfolio through licensing, mergers, or acquisitions54 Intellectual Property Microbot's IP portfolio includes 16 issued patents and 59 pending applications, with LIBERTY system technology co-owned with TRDF, incurring royalty obligations - The company holds an IP portfolio of 16 issued/allowed patents, 59 pending patent applications, and 14 design patents worldwide52 - The LIBERTY system technology is co-owned with TRDF, and Microbot is obligated to pay TRDF royalties of 1.5% to 3.0% of net sales of products covered by this joint invention60 - Issued U.S. patents covering the company's product candidates are set to expire between 2032 and 204058 - The company has ceased R&D on the SCS and TipCat platforms and returned the related intellectual property to TRDF59 Research and Development The company's R&D efforts focus on product enhancement, with expenses of $6.63 million in 2024, partly funded by Israeli Innovation Authority grants repayable via royalties R&D Expenses (Net) | Fiscal Year | R&D Expense (in thousands) | | :--- | :--- | | 2024 | $6,630 | | 2023 | $5,724 | - The company has received approximately $1.9 million in grants from the Israeli Innovation Authority (IIA) from 2013 through December 31, 202463 - As part of the Nitiloop asset acquisition, Microbot assumed the liability to repay Nitiloop's IIA grants, totaling approximately $925 thousand64 - Repayment of government grants is contingent on successful commercialization and will be made through royalties of 3%-5% on future product sales646668 Government Regulation Microbot's products are subject to extensive regulation, requiring FDA 510(k) clearance in the U.S., CE Mark in Europe, and Ministry of Health registration in Israel - In the U.S., the company's products are regulated by the FDA, with pipeline products expected to be classified as Class II devices, requiring 510(k) premarket clearance8284 - The company has submitted an IDE application to the FDA to commence a pivotal human clinical trial for the LIBERTY system3885 - For European commercialization, a CE Mark certificate is required under the Medical Devices Regulation (MDR 2017/745), with the company having received ISO 13485 certification and engaged a Notified Body99108 - In Israel, medical devices must be registered with the Ministry of Health (MOH), with an expedited process if the device has approval from a recognized country like the U.S. or an E.U. member state109110 Risk Factors The company faces significant risks including ongoing operating losses, dependence on the LIBERTY system, reliance on third-party manufacturing, geopolitical instability in Israel, and intense market competition Risks Relating to Financial Position and Need for Additional Capital Microbot has a history of significant operating losses with no revenue, requiring substantial additional funding for development and commercialization, with future viability uncertain - The company has had no revenue and significant operating losses since inception and expects these losses to continue for the foreseeable future123 - Microbot has a limited operating history, making it difficult to evaluate its future viability126 - The company will need to raise additional capital to fund its product development and commercialization efforts, and failure to do so could force delays or reductions in its programs128129 Risks Relating to the Development and Commercialization of Product Candidates The company's success depends heavily on the LIBERTY system, facing risks in clinical trials, regulatory approval, third-party manufacturing, supply chain disruptions, and market acceptance - The company's business depends heavily on the success of its sole lead product candidate, the LIBERTY Endovascular Robotic Surgical System133 - There is no guarantee that the data submitted in the 510(k) application will satisfy all FDA requirements, creating uncertainty and potential for increased costs and delays138 - The company relies on third-party manufacturers, which entails risks related to supply availability, regulatory compliance, and potential breaches of agreements150 - Failure to obtain and maintain adequate third-party reimbursement for procedures involving its products could materially harm the business156 - The company is experiencing delays in the supply of certain components from Israeli-based vendors due to the Israel-Hamas war, which could adversely affect its development timeline144 Risks Relating to Operations in Israel The company's Israeli operations face exacerbated risks from ongoing military conflict, including supply disruptions, employee reserve duty, regional instability, currency fluctuations, and grant restrictions - Risks related to Israeli operations are being exacerbated by the military actions that commenced on October 7, 2023, affecting suppliers and logistics187188 - Political, economic, and military conditions in Israel, including ongoing hostilities and internal political situations, could directly and materially affect the company's operations189 - A significant portion of expenses are in New Israeli Shekels (NIS), exposing the company to adverse effects from currency exchange rate fluctuations against the U.S. dollar193 - The company receives funding from the Israeli Innovation Authority, which comes with royalty repayment obligations and restrictions on transferring funded technology outside of Israel195198 Cybersecurity Microbot manages cybersecurity through a third-party subcontractor, implementing various security measures, with no material breaches or impacts on pre-commercial operations to date - The company uses a third-party subcontractor to manage all Information Technology (IT) issues, including cybersecurity222 - Cybersecurity measures include endpoint security solutions, hard drive encryption, email filtering, multi-factor authentication, and cloud-based backups224 - The company's Chief Technology Officer and General Manager is responsible for assessing and managing cybersecurity risks225 - As of the report date, cybersecurity threats have not materially affected the company, and no material security breaches have been identified226 Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on NASDAQ under "MBOT", with no history or plans for cash dividends, and details on equity compensation plans are provided - The company's common stock trades on the NASDAQ Capital Market under the symbol "MBOT"231 - The company has never paid cash dividends and does not plan to in the foreseeable future232 Equity Compensation Plan Information as of December 31, 2024 | Plan Category | Number of securities to be issued upon exercise | Weighted average exercise price | Number of securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 2,357,943 | $4.59 | 886,427 | | Equity compensation plans not approved by security holders | 139,423 | $2.11 | - | | Total | 2,497,366 | | 886,427 | Management's Discussion and Analysis of Financial Condition and Results of Operations Microbot, a clinical-stage company, continues to incur net losses, with R&D and G&A expenses increasing in 2024, but recent equity raises provide sufficient funds for over one year of operations Results of Operations Comparison (in thousands) | | For the Years Ended December 31, | Change | | :--- | :--- | :--- | :--- | | | 2024 | 2023 | ($) | | Research and development expenses, net | $(6,630) | $(5,724) | $(906) | | General and administrative expenses, net | $(4,995) | $(4,131) | $(864) | | Financing income, net | $182 | $228 | $(46) | | Loss on legal settlement, net | - | $(1,111) | $1,111 | - The $0.9 million increase in R&D expenses in 2024 was driven by higher headcount, salaries, bonuses, and increased costs for clinical studies and regulatory submissions (IDE and 510k)253 - The $0.9 million increase in G&A expenses in 2024 was mainly due to the relaxation of cost reduction plans from 2023, which had temporarily lowered employee salaries and board fees254 - As of December 31, 2024, the company had net working capital of approximately $3.4 million, but raised approximately $30.6 million in additional funds in January and February 2025256259 - Management believes the company has sufficient funds for its operations for more than one year from the filing date of this report263 Summary of Net Cash Flow (in thousands) | | For the Years Ended December 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Net cash flows used in operating activities | $(8,827) | $(8,533) | | Net cash flows provided by investing activities | $1,537 | $1,973 | | Net cash flows provided by financing activities | $7,936 | $6,558 | Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are interest rate sensitivity, considered low, and foreign currency exchange risk from non-U.S. dollar operating expenses, which are not currently hedged - The company's primary market risk is interest income sensitivity, but due to the short-term nature of its investments, a sudden change in rates is not expected to have a material impact266 - The company is exposed to foreign exchange risk as a significant portion of its operating expenses are in non-U.S. dollar currencies, but its financial results are denominated in U.S. dollars267 - The company does not currently use financial instruments to hedge its foreign currency exposure268 Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no material changes identified - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective272 - Management concluded that as of December 31, 2024, the company's internal control over financial reporting was effective273 - The annual report does not include an attestation report from the registered public accounting firm regarding internal control over financial reporting, as permitted by SEC rules274 Part III Directors, Executive Officers, and Corporate Governance The company's Board of Directors comprises seven members with a classified structure and three independent committees, operating under a Code of Ethics and a clawback policy - The Board of Directors is comprised of seven members and is classified into three classes with staggered three-year terms280281 - The Board has three standing committees: Audit, Compensation, and Corporate Governance, with all members being independent293 - The company has adopted a Code of Ethics and Conduct, an insider trading policy, and a clawback policy as required by the Dodd-Frank Act301302304 - Six of the seven board members are considered independent: Messrs. Burell, Madden, Laxminarain, Wenderow, and Wilson, and Ms. Stockburger356 Executive Compensation This section details compensation for named executive officers, including CEO Harel Gadot's $1.24 million total compensation in 2024, and outlines employment agreements and non-management director compensation Summary Compensation Table for Fiscal Year 2024 (in $) | Name and Principal Position | Salary | Bonus | Option Awards | All Other Compensation | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Harel Gadot (CEO, President & Chairman) | 520,249 | 149,189 | 514,141 | 57,900 | 1,241,479 | | Simon Sharon (CTO and GM) | 241,455 | 84,754 | 123,785 | 89,435 | 539,429 | | Juan Diaz-Cartelle (CMO) | 350,000 | - | 26,478 | - | 376,478 | | Rachel Vaknin (CFO) | 162,793 | 40,816 | 105,862 | 53,694 | 363,165 | - CEO Harel Gadot's employment agreement for FY2025 provides for an annual salary of $557 thousand and a target annual cash bonus of up to 75% of base salary312313 - Non-management directors receive an annual cash fee of $35 thousand, plus additional fees for committee service, and are eligible for annual stock option grants345 - Director fees, which had been suspended as part of a May 2023 cost reduction plan, were reinstated effective January 1, 2024345 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters This section details beneficial ownership of common stock as of March 24, 2025, showing executive officers and directors as a group owning 4.76% of outstanding shares Security Ownership as of March 24, 2025 | Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Common Stock Beneficially Owned | | :--- | :--- | :--- | | Harel Gadot | 1,097,927 | 3.07% | | All current directors and executive officers as a group (10 persons) | 1,729,068 | 4.76% | - The ownership percentages are based on 34,744,476 shares of common stock outstanding as of March 24, 2025350 - Beneficial ownership includes shares an individual has the power to vote or dispose of, and shares acquirable within 60 days of March 24, 2025, primarily through stock options350 Certain Relationships and Related Transactions, and Director Independence The company has procedures for reviewing related party transactions, with no disclosable transactions for the period, and a majority of its directors are independent under NASDAQ standards - The company has policies and procedures, including a code of ethics and committee oversight, to review potential conflicts of interest and related party transactions353 - There were no related party transactions required to be disclosed for the period354 - The independent members of the Board are Messrs. Burell, Madden, Laxminarain, Wenderow, and Wilson, and Ms. Stockburger, constituting a majority of the board356 Principal Accountant Fees and Services The company's independent auditor is Brightman Almagor Zohar & Co. (Deloitte), with total fees of $200 thousand in 2024, primarily for audit services, under Audit Committee pre-approval policies Accountant Fees (for years ended December 31) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $150,000 | $140,000 | | Tax Fees | - | $11,250 | | All Other Fees | $50,000 | $65,000 | | Total | $200,000 | $216,250 | - The independent accounting firm is Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network358 - The Audit Committee has adopted policies and procedures for pre-approving all audit and non-audit services performed by the independent auditors361 Part IV Exhibits and Financial Statement Schedules This section lists documents filed as part of the Form 10-K, including financial statements, corporate governance documents, material contracts, and Sarbanes-Oxley certifications - The financial statements are filed as part of the report, while financial statement schedules are omitted as they are not applicable362 - Key exhibits filed or incorporated by reference include the company's Restated Certificate of Incorporation, Amended and Restated By-Laws, various warrant forms, employment agreements with executive officers, and the Code of Ethics364366 - Certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act are included as exhibits369 Financial Statements Report of Independent Registered Public Accounting Firm The independent auditor issued an unqualified opinion on the financial statements, highlighting a Critical Audit Matter regarding going concern, which was addressed by subsequent financing of approximately $30 million - The auditor issued an unqualified opinion, stating the financial statements are fairly presented in accordance with U.S. GAAP377 - A Critical Audit Matter was identified regarding the evaluation of the company's ability to continue as a going concern381383 - The going concern issue was addressed by auditing the significant funds (approx. $30 million) raised in January and February 2025, which management concluded were sufficient to fund operations for more than one year385386391 Consolidated Financial Statements The consolidated financial statements report a net loss of $11.4 million in 2024, with total assets of $6.0 million and total liabilities of $2.5 million as of year-end Consolidated Balance Sheet Data (in thousands) | | As of Dec 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,114 | $2,468 | | Total current assets | $5,819 | $7,921 | | Total assets | $6,031 | $8,327 | | Total current liabilities | $2,460 | $3,786 | | Total liabilities | $2,501 | $3,826 | | Total shareholders' equity | $3,530 | $4,501 | Consolidated Statement of Comprehensive Loss Data (in thousands) | | For the Year Ended Dec 31, 2024 | For the Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Operating loss | $(11,625) | $(9,855) | | Net loss | $(11,443) | $(10,740) | | Basic and diluted net loss per share | $(0.73) | $(1.05) | Notes to Consolidated Financial Statements The notes detail financial statement support, including management's going concern assessment, royalty obligations, lawsuit settlement, share capital activities, and $30.6 million in subsequent financing - Management concluded that available funds, combined with capital raised subsequent to the balance sheet date, are sufficient to fund operations for more than twelve months (Note 1)411 - The company is obligated to pay royalties of 3.0%-5% on future sales to the IIA and 1.5%-3.0% to TRDF for licensed technology (Note 9)477481 - In January 2024, a lawsuit was settled with a payment of $1.1 million in cash (covered by insurance) and 1,005,965 shares of restricted common stock (Note 9G)499500 - In January and February 2025, the company raised approximately $30 million in gross proceeds through a series of registered direct offerings and private placements (Note 17A)565567569 - In January 2025, the company raised an additional $916 thousand from the exercise of outstanding preferred investment options (Note 17B)572