10-Q: Microbot Medical Reports First Quarter 2025 Results, Cites Progress on LIBERTY Robotic System

Sentiment:

Quarterly Report 14 May 2025 8:15 PM

Microbot Medical Inc. announces its financial results for the first quarter of 2025, highlighting advancements in its LIBERTY Endovascular Robotic Surgical System and recent capital raising activities.

Capital raiseThe company completed several registered direct offerings and at-the-market offerings in January and February 2025.The company raised approximately $15.6 million in gross proceeds from institutional investors in January 2025.The company raised approximately $13.0 million in gross proceeds from institutional investors in February 2025.The company raised approximately $916,000 in gross proceeds from the exercise of certain outstanding Series E preferred investment options in January 2025.The company raised approximately $2.3 million in gross proceeds from the exercise of outstanding Series E and Series F preferred investment options in April 2025.The company raised approximately $262,500 in gross proceeds from the exercise of 175,000 outstanding Series F preferred investment options in May 2025.The company intends to continue to raise capital through future public and private issuances of debt and/or equity securities.

Worse than expectedThe company's net loss per share increased from $0.17 to $0.08 year over year.

Summary

Microbot Medical Inc. is a pre-commercial, clinical-stage medical device company focused on robotic endoluminal surgery devices.
The company's primary focus is on its LIBERTY Endovascular Robotic Surgical System.
As of March 31, 2025, Microbot had approximately $30.39 million in cash equivalents and marketable securities.
The company expects to continue incurring losses for the foreseeable future due to ongoing research and development and pre-commercialization activities.
For the three months ended March 31, 2025, Microbot reported a net loss of $2.601 million, or $0.08 per share, compared to a net loss of $2.371 million, or $0.17 per share, for the same period in 2024.
Research and development expenses for the quarter were $1.459 million, compared to $1.169 million in 2024.
General and administrative expenses were $1.562 million, compared to $1.215 million in 2024.
The company has raised capital through various offerings, including registered direct offerings and at-the-market offerings.
Microbot anticipates FDA marketing clearance for the LIBERTY system in the second quarter of 2025 and CE Mark approval in the second half of 2026.
The company is monitoring the impact of the Israel-Hamas war on its operations.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company is still incurring losses, it has made progress on its LIBERTY system and has successfully raised capital. The anticipated FDA clearance in Q2 2025 is a positive catalyst.

Positives

The company has a significant amount of cash and marketable securities ($30.39 million) to fund operations.
The LIBERTY Endovascular Robotic Surgical System is progressing towards commercialization, with a 510(k) submission to the FDA.
The company anticipates FDA marketing clearance in Q2 2025.
Microbot has secured ISO 13485:2016 certification for its quality management system.
The company has successfully raised capital through various offerings.
The company received a favorable judgement in the Mona litigation, resulting in $316,000 in other income.

Negatives

The company has not generated revenues from its operations.
Microbot has incurred net losses since inception and expects to continue incurring losses for the foreseeable future.
Research and development expenses increased for the three months ended March 31, 2025.
General and administrative expenses increased for the three months ended March 31, 2025.
The company is monitoring the potential impact of the Israel-Hamas war on its operations.

Risks

The company's ability to achieve and sustain profitability is uncertain.
The company's ability to obtain regulatory approvals for its products is not guaranteed.
The company's ability to commercialize its products successfully is subject to various risks.
The company's operations are subject to the risks associated with the Israel-Hamas war.
The company may need to raise additional capital in the future, which may not be available on favorable terms or at all.
The company is dependent on key personnel, and the loss of such personnel could harm its business.

Future Outlook

Microbot anticipates FDA marketing clearance for the LIBERTY system during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance. The company anticipates CE Mark approval in the second half of 2026.

Management Comments

The company's management has concluded that the available funds as of the balance sheet date, combined with the capital raises completed as described in Note 6, are sufficient to fund the Company's operations for more than twelve months from the issuance date of these financial statements.

Industry Context

Microbot Medical operates in the growing surgical robotics market, which is driven by the demand for minimally invasive procedures, improved surgical outcomes, and reduced healthcare costs. The LIBERTY system targets the endovascular interventional procedures market, which is a significant segment within the broader surgical robotics landscape. Competitors include companies developing robotic systems for various surgical specialties, such as Intuitive Surgical (da Vinci Surgical System) and Stryker (Mako Robotic-Arm Assisted Technology).

Comparison to Industry Standards

It is difficult to compare Microbot's financial results directly to industry standards due to its pre-commercial stage.
Companies like Intuitive Surgical, which have established robotic surgery platforms, generate significant revenue from system sales, disposable instruments, and service contracts.
Microbot's focus on a fully disposable robotic system for endovascular procedures differentiates it from some competitors.
The company's success will depend on its ability to obtain regulatory approvals, commercialize its products effectively, and gain market share in the competitive surgical robotics market.

Legal Proceedings

In March 2025, an appellate court held in favor of the Company with respect to a 2019 action against Alliance Investment Management, Ltd., later amended to add Joseph Mona (Mona) as a defendant, in the Southern District of New York under Section 16(b) of the Securities Exchange Act of 1934 (the Exchange Act), to compel Alliance and/or Mona to disgorge short swing profits realized from purchases and sales of the Companys securities within a period of less than six months.

Stakeholder Impact

Shareholders: The company's financial performance and progress on its LIBERTY system will impact shareholder value.
Employees: The company's operations and financial stability will impact employee job security and compensation.
Customers: The company's products have the potential to improve surgical outcomes for patients.
Suppliers: The company's operations will impact demand for supplier products and services.
Creditors: The company's financial stability will impact its ability to repay its debts.

Next Steps

The company anticipates FDA marketing clearance for the LIBERTY system in Q2 2025.
The company expects to commence U.S. commercialization activities after FDA clearance.
The company anticipates CE Mark approval for the LIBERTY system in the second half of 2026.
The company will continue to monitor the impact of the Israel-Hamas war on its operations.
The company will continue to pursue research and development efforts for its products.

Key Dates

Date	Description
2012-06-01	Microbot Israel signed an agreement with the Technion Research and Development Foundation (TRDF).
2013	Microbot Israel has received grants from the IIA for participation in research and development since 2013.
2016-08-15	Agreement and Plan of Merger and Reorganization, dated as of August 15, 2016, by and among StemCells, Inc., C&RD Israel Ltd. and Microbot Medical Ltd.
2016-11-28	The Company consummated a transaction pursuant to an Agreement and Plan of Merger, dated August 15, 2016, with Microbot Medical Ltd.
2020-08-17	Microbot announced the successful conclusion of its feasibility animal study using the LIBERTY Endovascular Robotic Surgical System.
2021-06-10	The Company entered into an At-the-Market Offering Agreement (the ATM Agreement) with H.C. Wainwright & Co. LLC (Wainwright).
2022-10-03	The Company entered into engagement letters (the Engagement Letters) with Wainwright on October 3, 2022.
2022-10-06	Microbot Israel purchased substantially all of the assets, including intellectual property, devices, components and product related materials (the Assets), of Nitiloop Ltd.
2023-05-03	Microbot announced that the LIBERTY Endovascular Robotic Surgical System has surpassed its 100th catheterization during multiple preclinical studies.
2023-06-01	The IIA approved an additional grant from the IIA in the amount of approximately NIS 1,620,000 (approximately $ 447 ) approved by the IIA on June 1, 2023, to further finance the development of the manufacturing process of the LIBERTY Endovascular Robotic Surgical System.
2023-06-29	Microbot announced the successful completion of a two-day preclinical study held by leading key opinion leaders at a New York-based research lab.
2023-10-07	The State of Israel, where our research and development and other operations are primarily based, suffered a surprise attack by hostile forces from Gaza.
2023-10	Microbot announced the successful initial outcomes from our pivotal preclinical study with the LIBERTY Endovascular Robotic Surgical System.
2023-12	Microbot announced that the final histopathology and lab report supplements our previous findings, and that the results of the study will support our Investigational Device Exemption (IDE) submission to the FDA to commence a human clinical study.
2024-01-26	The Company entered into a settlement agreement and release with the Plaintiffs (the Settlement Agreement), effectively resolving the Lawsuit.
2024-01-29	The Company submitted an IDE application with the U.S. Food and Drug Administration, in order to commence its pivotal clinical trial in humans.
2024-07-01	The Company entered into an amendment, dated July 1, 2024, to the ATM Agreement with Wainwright dated June 10, 2021.
2024-08-13	Microbot announced that we received ISO 13485:2016 certification for our quality management system.
2024-12-10	Microbot announced that we submitted a 510(k) premarket notification to the FDA for our LIBERTY Endovascular Robotic System.
2025-01-06	The Company entered into Securities Purchase Agreements with institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under the rules of the Nasdaq Stock Market, an aggregate of 4,000,001 shares of the Companys common stock, par value $ 0.01 per share, at an offering price of $ 1.75 per share.
2025-01-07	The Company entered into Securities Purchase Agreements with institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under the rules of the Nasdaq Stock Market, an aggregate of 3,788,550 shares of the Companys common stock, par value $ 0.01 per share, at an offering price of $ 2.27 per share.
2025-02-09	The Company entered into Securities Purchase Agreements with institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under the rules of the Nasdaq Stock Market, an aggregate of 6,103,289 shares of the Companys common stock, par value $ 0.01 per share, at an offering price of $ 2.13 per share.
2025-03	In March 2025, an appellate court held in favor of the Company with respect to a 2019 action against Alliance Investment Management, Ltd., later amended to add Joseph Mona (Mona) as a defendant.
2025-03-31	End of the quarterly period.
2025-04	In April 2025, the Company raised approximately $ 2,300 in gross proceeds from the exercise of an aggregate of 1,533,336 outstanding Series E and Series F preferred investment options.
2025-05	In May 2025, the Company raised approximately $ 263 in gross proceeds from the exercise of an aggregate of 175,000 outstanding Series F preferred investment options.
2025-05-12	Latest practicable date for share information.
2025-05-14	Date of report signatures.

Keywords

LIBERTY Endovascular Robotic Surgical System, Microbot Medical, Financial Results, Robotic Surgery, Medical Device, FDA, Capital Raise, Innovation Authority

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