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Microbot Medical Enrolled the First Patient in its Pivotal Human Clinical Trial
GlobeNewswire News Room· 2024-07-08 12:20
BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women's Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company's pivotal human clinical trial. About Microbot Medical Further information about Microbot Medical is available at http://www.microbotmedical ...
Microbot Medical Announces Brigham and Women's Hospital as a Site for its Pivotal Human Clinical Trial
Newsfilter· 2024-06-17 12:30
"We are pleased to work with Dr. Rabkin and the team at Brigham and Women's Hospital on this clinical study." commented Harel Gadot, CEO, President and Chairman of Microbot Medical. "We believe their commitment to research and the advancement of science make them an ideal clinical study site." Microbot Medical Inc. (NASDAQ:MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasin ...
Microbot Medical Announces Brigham and Women's Hospital as a Site for its Pivotal Human Clinical Trial
GlobeNewswire News Room· 2024-06-17 12:30
"We are pleased to work with Dr. Rabkin and the team at Brigham and Women's Hospital on this clinical study." commented Harel Gadot, CEO, President and Chairman of Microbot Medical. "We believe their commitment to research and the advancement of science make them an ideal clinical study site." 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, cu ...
Microbot Medical Announces Closing of $2.35 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules
Newsfilter· 2024-06-04 20:20
HINGHAM, Mass., June 04, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 1,566,669 shares of the Company's common stock at a purchase price of $1.50 per share of common stock . In addition, in a concurrent private placement, the Company has issued unregistered series F preferred investment options. The series F preferred investment options ...
Microbot Medical Announces $2.35 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules
Newsfilter· 2024-06-03 16:11
HINGHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,566,669 shares of the Company's common stock at a purchase price of $1.50 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series F preferred investment options. The series F preferred investment o ...
Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial
Newsfilter· 2024-06-03 12:20
The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial. BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration's ("FDA") approval ...
Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial
GlobeNewswire News Room· 2024-06-03 12:20
BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration's ("FDA") approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption ("IDE") application for its LIBERTY® Endovascular Robotic Surgical System. The study will be conducted in the U.S., and the Company has already signed a cli ...
Microbot Medical(MBOT) - 2024 Q1 - Quarterly Report
2024-05-15 12:45
[Part I - Financial Information](index=4&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements](index=4&type=section&id=Item%201%20-%20Financial%20Statements) The company reported a reduced net loss in Q1 2024, with assets decreasing but shareholders' equity increasing due to financing and a legal settlement [Interim Consolidated Balance Sheets](index=4&type=section&id=Interim%20Consolidated%20Balance%20Sheets) Total assets decreased to $7.37 million while liabilities significantly reduced, leading to an increase in shareholders' equity to $6.17 million Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $1,162 | $2,468 | | Total Assets | $7,367 | $8,327 | | Total Liabilities | $1,200 | $3,826 | | Total Shareholders' Equity | $6,167 | $4,501 | - The number of common shares issued and outstanding increased to **14,398,964** as of March 31, 2024, from **11,707,317** as of December 31, 2023[10](index=10&type=chunk) [Interim Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Interim%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a net loss of $2.37 million for Q1 2024, an improvement from $2.85 million in Q1 2023, driven by reduced expenses Statement of Comprehensive Loss (in thousands, except per share data) | Metric | Q1 2024 (Unaudited) | Q1 2023 (Unaudited) | | :--- | :--- | :--- | | Research and development, net | $(1,169) | $(1,617) | | General and administrative | $(1,215) | $(1,302) | | Operating loss | $(2,384) | $(2,919) | | Net loss | $(2,371) | $(2,853) | | Basic and diluted net loss per share | $(0.17) | $(0.36) | [Interim Consolidated Statements of Shareholders' Equity](index=6&type=section&id=Interim%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) Shareholders' equity increased to $6.17 million due to common stock issuance for financing and a legal settlement, partially offset by net loss - Issued **1,685,682** shares of common stock and warrants, raising **$2.397 million**, net of issuance costs[16](index=16&type=chunk) - Issued **1,005,965** shares of common stock valued at **$1.111 million** as part of a settlement agreement[16](index=16&type=chunk)[17](index=17&type=chunk) - Share-based compensation for the quarter amounted to **$529,000**[16](index=16&type=chunk) [Interim Consolidated Statements of Cash Flows](index=7&type=section&id=Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to $2.42 million, while financing activities provided $2.40 million, resulting in a $1.31 million decrease in cash Cash Flow Summary (in thousands) | Activity | Q1 2024 (Unaudited) | Q1 2023 (Unaudited) | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,420) | $(3,203) | | Net cash provided by (used in) investing activities | $(1,284) | $2,883 | | Net cash provided by financing activities | $2,397 | $- | | **Decrease in cash, cash equivalents and restricted cash** | **$(1,307)** | **$(320)** | - A significant non-cash financing activity was the settlement of a legal liability through the issuance of common stock valued at **$1.111 million**[20](index=20&type=chunk) [Notes to Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Interim%20Consolidated%20Financial%20Statements) Notes detail the company's pre-clinical medical device business, 'going concern' risks, royalty obligations, and a significant legal settlement - The company is a pre-clinical medical device company focused on robotic endoluminal surgery devices[22](index=22&type=chunk) - The financial statements were prepared under the assumption of the company continuing as a 'going concern', but recurring losses and the need for future funding raise substantial doubt about this ability[26](index=26&type=chunk)[27](index=27&type=chunk) - On January 26, 2024, the company settled a lawsuit from a 2017 financing, paying **$1.1 million** in cash (covered by insurance) and issuing **1,005,965** shares of restricted common stock[63](index=63&type=chunk)[64](index=64&type=chunk) - The company has royalty obligations of **3.0%-5.0%** on future sales related to grants received from the Israeli Innovation Authority (IIA)[50](index=50&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202%20-%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the LIBERTY® Endovascular Robotic Surgical System's FDA submission, decreased Q1 2024 expenses, and ongoing 'going concern' risks due to limited liquidity - The company is developing the LIBERTY® Endovascular Robotic Surgical System, described as the world's first fully disposable robotic system for endovascular procedures[85](index=85&type=chunk)[86](index=86&type=chunk) - An Investigational Device Exemption (IDE) application was submitted to the U.S. FDA on January 29, 2024, to begin human clinical trials[93](index=93&type=chunk) - The company anticipates receiving **510(k) clearance** from the FDA in the first half of 2025 and CE Mark approval in the second half of 2025[95](index=95&type=chunk) - Management believes current funds are sufficient for operations for less than one year, which raises substantial doubt about the company's ability to continue as a going concern[121](index=121&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Net research and development expenses decreased by $0.45 million and general and administrative expenses by $0.09 million in Q1 2024 compared to Q1 2023 Comparison of Operating Results (in thousands) | Expense Category | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses, net | $(1,169) | $(1,617) | $448 | | General and administrative expenses | $(1,215) | $(1,302) | $87 | - The decrease in R&D expenses was mainly due to a reduction in payroll from increased vacation utilization, government grant deductions, and lower expenses for outsourcing the manufacturing of the LIBERTY product[111](index=111&type=chunk) - The decrease in G&A expenses was primarily due to lower travel and payroll expenses, offset by increases in stock-based compensation and professional services[112](index=112&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity relies on stock issuances and grants, with $5.8 million net working capital, but current funds are sufficient for less than one year - As of March 31, 2024, the company had a net working capital of approximately **$5.8 million**[114](index=114&type=chunk) - The company raised approximately **$2.7 million** in gross proceeds from financing activities in January 2024[120](index=120&type=chunk) - The company has received a total of approximately **$1.9 million** in grants from the Israeli Innovation Authority (IIA) through March 31, 2024[116](index=116&type=chunk) - Management concludes that current cash is sufficient for less than one year, raising substantial doubt about the company's ability to continue as a going concern[121](index=121&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks primarily from foreign exchange fluctuations on operating expenses, with interest rate risk deemed low and inflation impact insignificant - Primary market exposure is to interest rate sensitivity on cash and cash equivalents, but the impact of rate changes is not expected to be material due to the short-term nature of these instruments[124](index=124&type=chunk) - The company is exposed to foreign exchange risk because a substantial portion of its operating expenses are payable in currencies other than the U.S. dollar[125](index=125&type=chunk) - The company does not believe inflation had a significant impact on its results of operations[127](index=127&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting - Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[128](index=128&type=chunk) - No changes in internal control over financial reporting occurred during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) [Part II - Other Information](index=24&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=24&type=section&id=Item%201%20-%20Legal%20Proceedings) A significant lawsuit related to 2017 financing was settled in January 2024 for $1.1 million cash and over 1 million shares, leading to its discontinuation - On January 26, 2024, the company entered into a settlement agreement to resolve a lawsuit related to its 2017 equity financing[132](index=132&type=chunk) - The settlement consisted of a **$1.1 million** cash payment (covered by the company's insurance carrier) and the issuance of **1,005,965** shares of restricted common stock[133](index=133&type=chunk) - The lawsuit was formally discontinued with prejudice in February 2024[134](index=134&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A%20-%20Risk%20Factors) This section is not required for a smaller reporting company - Not required for a smaller reporting company[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[138](index=138&type=chunk) [Other Information](index=25&type=section&id=Item%205%20-%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q1 2024 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three months ended March 31, 2024[141](index=141&type=chunk) [Exhibits](index=26&type=section&id=Item%206%20-%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements, corporate governance documents, and officer certifications
Microbot Medical Announces Positive Results from the First Phase of its Collaboration with Corewell Health™
Newsfilter· 2024-04-29 12:30
BRAINTREE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today reports that the first phase of the previously announced collaboration with Corewell Health has been completed, which demonstrated the LIBERTY® System's technical capabilities and outlines potential future applications in a range of endovascular interventions. The objective of the collaboration, which will take place in multiple phases, is ...
Microbot Medical(MBOT) - 2023 Q4 - Annual Report
2024-03-27 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. MICROBOT MEDICAL INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 94-3078125 (I.R.S. Employer Identification No.) ...