U.S. Food and Drug Administration (FDA) Submission Expected by end of 2024 Clinical Data to be Presented at Medical Conference in Early 2025 BRAINTREE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. ...

Confirms the Company on Track for FDA 510(k) Submission by end of 2024 Completes All IDE required Tests and Receives Final IDE Approval from the FDA for the ACCESS-PVI Study BRAINTREE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human clinical trial for LIBERTY®. As a result of the increased rate ...

BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company expects to complete enrollment and follow up in the fourth quarter of 20 ...

Microbot Medical Inc. (MBOT) recently announced a Phase 2 collaboration agreement with Corewell Health. Under the agreement, both companies will work together to develop the capabilities to perform simulated cardiovascular interventional procedures with LIBERTY — an endovascular robotic surgical system. The agreement followed the successful completion of Phase 1, which showed LIBERTY's technical capabilities and outlined potential future applications in various endovascular interventions. Phase 1 evaluated ...

The agreement follows the successful completion of Phase 1 which evaluated the viability of LIBERTY as a remote telesurgery platform The objective of Phase 2 is to develop and demonstrate new telesurgery capabilities by performing simulated interventional procedures between two facilities within the Corewell Health system BRAINTREE, Mass., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, announces that it entered into a ...

Microbot Medical Inc. (MBOT) recently announced the receipt of ISO 13485:2016 certification for its quality management system. This certification underscores the company's commitment to excellence in the development and manufacturing of its LIBERTY Endovascular Robotic Surgical System, marking an essential step toward commercialization and regulatory compliance in both the European Union and the United States. With this certification, Microbot Medical is well-positioned to advance toward CE mark approval an ...

Cash and Cash Equivalents - Cash and cash equivalents decreased slightly to $2.465 million as of June 30, 2024, compared to $2.468 million as of December 31, 2023[4] - The company's cash, cash equivalents, and restricted cash decreased by $4 thousand to $2,513 thousand as of June 30, 2024, from $2,517 thousand at the beginning of the period[9] - Cash, cash equivalents, and restricted cash decreased by $4,000 to $2.513 million as of June 30, 2024, from $2.517 million at the beginning of the period[9] - As of June 30, 2024, the company had cash and cash equivalents of $2.465 million, marketable securities of $3.997 million, and total current assets of $7.138 million[4] Marketable Securities - Marketable securities increased to $3.997 million as of June 30, 2024, up from $3.917 million as of December 31, 2023[4] - The company's financial assets, including money market mutual funds, are classified as Level 1 in the fair value hierarchy, with a total value of $3,997 thousand as of June 30, 2024[19] - Money market mutual funds as of June 30, 2024, totaled $3,997, classified as Level 1 fair value assets[19] - U.S. treasury securities as of December 31, 2023, amounted to $2,497, also classified as Level 1 fair value assets[20] Total Current Assets - Total current assets decreased to $7.138 million as of June 30, 2024, from $7.921 million as of December 31, 2023[4] - As of June 30, 2024, the company had cash and cash equivalents of $2.465 million, marketable securities of $3.997 million, and total current assets of $7.138 million[4] Net Loss - Net loss for the six months ended June 30, 2024, was $4.836 million, compared to $5.140 million for the same period in 2023[6] - Net loss for the six months ended June 30, 2024, was $4,836 thousand, compared to $5,140 thousand in the same period in 2023, showing a reduction in losses[9] - The company reported a net loss of $2.465 million for the three months ended June 30, 2024, and a net loss of $4.836 million for the six months ended June 30, 2024[6] - Net loss for the six months ended June 30, 2024, was $4.836 million, compared to $5.140 million for the same period in 2023[9] Shareholders' Equity - Total shareholders' equity increased to $6.055 million as of June 30, 2024, from $4.501 million as of December 31, 2023[5] - Total shareholders' equity as of June 30, 2024, was $6.055 million, compared to $4.848 million as of March 31, 2023[7] Research and Development Expenses - Research and development expenses decreased to $2.586 million for the six months ended June 30, 2024, from $2.982 million for the same period in 2023[6] General and Administrative Expenses - General and administrative expenses increased to $2.309 million for the six months ended June 30, 2024, from $2.261 million for the same period in 2023[6] Total Liabilities - Total liabilities decreased significantly to $1.379 million as of June 30, 2024, from $3.826 million as of December 31, 2023[5] Share Issuance and Warrants - The company issued 1,566,669 shares of common stock and warrants during the six months ended June 30, 2024, net of issuance costs[7] - The company issued common stock and warrants, net of issuance costs, totaling $4,471 thousand in the six months ended June 30, 2024, compared to $6,719 thousand in the same period in 2023[9] - The company issued common stock and warrants, net of issuance costs, raising $4.471 million in financing activities during the six months ended June 30, 2024[9] - In June 2024, the company issued 1,566,669 shares of common stock at $1.50 per share, generating aggregate gross proceeds of approximately $2.35 million before deducting placement agent fees and related offering expenses of approximately $328,000[52] - The company issued 1,005,965 shares of common stock as part of a settlement agreement[53] - From July 1, 2024, through August 9, 2024, the company issued 538,800 shares of common stock under the ATM Agreement for aggregate gross proceeds of approximately $584,000[57] Net Cash Flows - Net cash flows used in operating activities for the six months ended June 30, 2024, were $4,377 thousand, compared to $5,057 thousand in the same period in 2023[9] Government Grants and Royalties - Microbot Israel received government grants totaling approximately $1,878 from the Israeli Innovation Authority (IIA) for R&D projects, including $74 in Q1 2024[28] - The company is obligated to pay royalties of 3.0%-5.0% on future sales related to IIA grants, contingent on successful R&D and sales generation[29] - The company received a grant of NIS 300,000 ($83) from the Ministry of Economy, with $50 received as of June 30, 2024, and royalties of 3.0% on future sales of the LIBERTY system[30] - The company received $1,878 in government grants from the Israeli Innovation Authority (IIA) for R&D from 2013 through June 30, 2024[28] - A grant of approximately $83 from the Ministry of Economy was approved for the LIBERTY Endovascular Robotic Surgical System, with $50 received as of June 30, 2024[30] - The company is obligated to pay royalties of 3.0%-5.0% on future sales related to IIA grants[29] Litigation and Settlements - The company settled a lawsuit for $2,154, including $1,100 in cash and 1,005,965 shares of restricted common stock, with insurance covering $1,335 of the settlement[41][43] - The company recorded a contingent liability of $2,211 and an asset of $1,335 as of December 31, 2023, related to the settlement[43] - The company received a judgment of $485 against Joseph Mona, with collection efforts ongoing as of May 10, 2024[46][48] - The company settled a lawsuit by paying $2,154, including $1,100 in cash and 1,005,965 shares of restricted common stock[41] Executive Compensation - Microbot Israel's CEO is eligible for a contingent cash bonus of $298, tied to raising $3,000 by June 30, 2024, and $6,000 by September 30, 2024[49] - Other executives are entitled to a contingent bonus of approximately $61, payable upon raising at least $3,000 by September 30, 2024[50] - In July 2024, the company approved contingent bonus payments of approximately $149,000 to the CEO and $61,000 to the CFO and CTO[58] - The CEO is entitled to a contingent cash bonus of $298, payable upon raising $3,000 by June 30, 2024, and $6,000 by September 30, 2024[49] - The company approved contingent bonus payments of $149 to the CEO and $61 to the CFO and CTO in July 2024[58] Stock Options and Grants - In February 2024, the company granted fully vested options to purchase 130,000 shares of common stock at an exercise price of $1.2684 per share, and performance-based options to purchase 132,500 shares at $1.25 per share, recording a total expense of $8,000 in Q2 2024[55] - The company granted options to purchase 195,000 shares of common stock at $1.2684 per share with a three-year vesting period, and paid the CEO 25% of his 2023 annual bonus through the grant of fully vested options to purchase 79,567 shares at $1.25 per share[56] - The company granted 130,000 fully vested stock options at $1.2684 per share and 132,500 performance-based options at $1.25 per share[55] Technology and Asset Transfers - Microbot Israel terminated the CardioSert Agreement, resulting in a $300 cash payment and 6,738 shares of common stock ($74) for technology acquisition[33] - Microbot Israel transferred technology back to CardioSert, resulting in the transfer of a liability to repay CardioSert's IIA grants in the aggregate amount of approximately $530,000[59] - The company terminated the CardioSert Agreement in August 2023, resulting in a reacquisition of technology for nominal consideration[33] - The company transferred technology assets back to CardioSert, relieving a liability of $530 related to IIA grants[59] ATM Agreement - The company has an ATM agreement allowing it to sell up to $10,000 in common stock, but no shares were sold through June 30, 2024[34] - The company entered into an ATM agreement allowing the sale of up to $10,000 in common stock, but no shares were sold as of June 30, 2024[34] - From July 1, 2024, through August 9, 2024, the company issued 538,800 shares of common stock under the ATM Agreement for aggregate gross proceeds of approximately $584,000[57] Royalties and Licensing - Microbot Israel acquired Nitiloop's assets for royalties not exceeding $8,000, with rates of 3.0% on net revenue from device sales and 1.5% on integrated product commercialization[39] - The company signed a license agreement with TRDF, paying royalties of 1.5%-3.0% on net sales and sublicense income for the LIBERTY Endovascular Robotic Surgical System[31] - The company acquired Nitiloop's assets for royalties not exceeding $8,000, with rates of 3% and 1.5% on net revenue from device sales and technology commercialization, respectively[39] Financing Activities - The company received aggregate gross proceeds of approximately $2.73 million from the exercise of Existing Preferred Investment Options and the sale of Inducement Investment Options, before deducting placement agent fees and other offering expenses of approximately $333,000[51] - The company raised $2,730 from the exercise of preferred investment options and issued new series E options at $1.50 per share[51] - The company raised $2,350 from a registered direct offering of 1,566,669 shares at $1.50 per share and issued series F preferred options[52] Share-Based Compensation - Share-based compensation expense for the six months ended June 30, 2024, was $784 thousand, compared to $761 thousand in the same period in 2023[9] - Share-based compensation for the six months ended June 30, 2024, was $784,000, compared to $761,000 for the same period in 2023[9] Operational Risks and Future Outlook - The company is closely monitoring the impact of the military operation in Israel on its operations, including potential disruptions to supply chains and international flights[13][14] - The company expects to continue to incur additional losses for the foreseeable future due to ongoing research and development activities[12] - The company has not generated revenues from its operations and expects to continue incurring losses, raising substantial doubt about its ability to continue as a going concern[12] - The company's operations are primarily based in Israel, and it is monitoring risks related to the ongoing military operations in the region[13] - The company's ability to raise additional capital is dependent on market demand for its stock and other development and business risks[12] Technology Development - The company is focused on leveraging its micro-robotic technologies to develop next-generation robotic endoluminal surgery devices[10] Litigation and Legal Matters - The company is involved in litigation related to the 2017 financing, with plaintiffs seeking rescission of the SPA and a return of $6,750[40]

BRAINTREE, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced it has entered into an agreement with Emory University, which will allow the parties to evaluate and explore the potential for a future collaboration in connection with autonomous robotics in endovascular procedures. Under the terms of the agreement, Emory University will assume the responsibility of exploring the feasibility of integrating the LIBERTY® Endovascular Robotic Surgical System with an imagin ...

BRAINTREE, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced it has entered into an agreement with Emory University, which will allow the parties to evaluate and explore the potential for a future collaboration in connection with autonomous robotics in endovascular procedures. Under the terms of the agreement, Emory University will assume the responsibility of exploring the feasibility of integrating the LIBERTY® Endovascular Robotic Surgical System with an imagin ...

"We are excited to have a hospital the caliber of Memorial Sloan Kettering Cancer Center partnering with us to complete the enrollment of the clinical sites in our trial," commented Harel Gadot, CEO, President and Chairman of Microbot Medical. About Microbot Medical The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while re ...