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, 2022
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the transition period from ____ to _____
Commission file number: 000-19871
MICROBOT MEDICAL INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or Other Jurisdiction
of Incorporation or Organization)
94-3078125
(I.R.S. Employer
Identification No.)
25 Recreation Park Drive, Unit 108
Hingham, MA 02043
(Address including zip code of registrant’s Principal Executive Offices)
(781) 875-3605
(Registrant’s Telephone Number, Including Area Code)
Securities registered under Section 12(b) of the Act:
Title of each class
Common Stock, Par value $0.01
Trading Symbol(s)
MBOT
Name of each exchange on which registered
NASDAQ Capital Market
Securities registered under Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an
emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”, and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Non-accelerated filer ☒
Accelerated filer ☐
Smaller reporting company ☒
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the
filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received
by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the
common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently
completed second fiscal quarter: approximately $34,521,094.
Common stock outstanding as of March 30, 2023: 8,130,628 shares
INFORMATION CONCERNING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements. Forward-looking statements are projections in respect of future events or our future financial
performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “intends”, “expects”, “will”, “plans”,
“anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” or the negative of these terms or other comparable terminology. These
statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks listed under the section entitled
“Risk Factors” commencing on page 20 of this report, which may cause our or our industry’s actual results, levels of activity or performance to be
materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.
Table of Contents
PART I
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
PART II
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures about Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
PART III
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Item 15.
Item 16
Exhibits and Financial Statement Schedules
Form 10-K Summary
PART IV
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NOTE REGARDING REFERENCES TO OUR COMPANY
Throughout this Form 10-K, the words “we,” “us,” “our,” the “Company” and “Microbot” refer to Microbot Medical Inc., including our directly and
indirectly wholly owned subsidiary. Unless the context otherwise requires, the historical business, financial statements and operations of Microbot include
Microbot Medical Ltd., an Israeli corporation (“Microbot Israel”) which became a wholly-owned subsidiary of the Company on November 28, 2016.
Risk Factors Summary
The following is a summary of the principal risks that could adversely affect our business, operations, and financial results. A more thorough discussion of
these and other risks are listed under the section entitled “Risk Factors” commencing on page 20.
Risks Relating to Microbot’s Financial Position and Need for Additional Capital
● There is substantial doubt regarding on our ability to continue as a going concern.
● We are subject to litigation, which may divert management’s attention and, in the event of an adverse judgment or settlement for some or all of the
$6,750,000 being litigated, will have a material adverse effect on our financial condition and our ability to continue our operations.
● Microbot has had no revenue and has incurred significant operating losses since inception and is expected to continue to incur significant
operating losses for the foreseeable future. The Company may never become profitable or, if achieved, be able to sustain profitability.
● Microbot has a limited operating history outside of being a research and development-stage company, which may make it difficult to evaluate the
prospects for the Company’s future viability.
● Microbot needs additional funding. If Microbot is unable to raise capital when needed, it could be forced to delay, reduce or eliminate its product
development programs or commercialization efforts.
● An epidemic of the coronavirus disease is ongoing and may result in significant disruptions to our clinical trials or other business operations,
which could have a material adverse effect on our business.
Risks Relating to the Development and Commercialization of Microbot’s Product Candidates
● Unsuccessful animal studies, clinical trials or procedures relating to product candidates under development could have a material adverse effect on
Microbot’s prospects.
● Microbot’s business depends heavily on the success of its lead product candidate, the LIBERTY®. If Microbot is unable to commercialize the
LIBERTY, or experiences significant delays in doing so, Microbot’s business will be materially harmed.
● The results of Microbot’s research and development efforts are uncertain and there can be no assurance of the commercial success of Microbot’s
product candidates.
● Microbot’s ability to expand its technology platforms for other uses, including endovascular, cardiovascular and neurosurgery, may be limited.
● Microbot’s One & Done technology is subject to a buy-back clause which, if triggered, could cause us to lose rights to the technology and delay or
curtail the development of our products.
● If the commercial opportunity for LIBERTY and any other commercial products that may be developed by Microbot is smaller than Microbot
anticipates, Microbot’s future revenue from LIBERTY and such other products will be adversely affected and Microbot’s business will suffer.
● Customers will be unlikely to buy the LIBERTY or any other product candidates unless Microbot can demonstrate that they can be produced for
sale to consumers at attractive prices.
● Microbot will rely on third party design houses for the redesign of the One & Done guidewire to other specific indications.
● Microbot has relied on, and intends to continue to rely on, third-party manufacturers to produce its product candidates.
● If Microbot’s product candidates are not considered to be a safe and effective alternative to existing technologies, Microbot will not be
commercially successful.
● Microbot may be subject to penalties and may be precluded from marketing its product candidates if Microbot fails to comply with extensive
governmental regulations.
● If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving its product candidates
after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.
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● Clinical outcome studies for the LIBERTY may not provide sufficient data to make Microbot’s product candidates the standard of care.
● Microbot products may in the future be subject to mandatory product recalls that could harm its reputation, business and financial results.
● If Microbot’s future commercialized products cause or contribute to a death or a serious injury, Microbot will be subject to Medical Device
Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
● Microbot could be exposed to significant liability claims if Microbot is unable to obtain insurance at acceptable costs and adequate levels or
otherwise protect itself against potential product liability claims.
● If Microbot fails to retain certain of its key personnel and attract and retain additional qualified personnel, Microbot might not be able to pursue its
growth strategy effectively.
Risks Relating to Microbot’s Intellectual Property
● Termination of the license with respect to one or more of our technology platforms may result in Microbot ceasing its development efforts for the
applicable product candidate(s).
● Microbot may not meet its product candidates’ development and commercialization objectives in a timely manner or at all.
● Intellectual property litigation and infringement claims could cause Microbot to incur significant expenses or prevent Microbot from selling
certain of its product candidates.
● If Microbot or TRDF are unable to protect the patents or other proprietary rights relating to Microbot’s product candidates, or if Microbot
infringes on the patents or other proprietary rights of others, Microbot’s competitiveness and business prospects may be materially damaged.
● Dependence on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may
result in Microbot’s payment of significant monetary damages or impact offerings in its product portfolios.
Risks Relating to Operations in Israel
● Microbot has facilities located in Israel, and therefore, political conditions in Israel may affect Microbot’s operations and results.
● Political relations could limit Microbot’s ability to sell or buy internationally.
● Israel’s economy may become unstable.
● Exchange rate fluctuations between the U.S. dollar and the NIS currencies may negatively affect Microbot’s operating costs.
● Funding and other benefits provided by Israeli government programs may be terminated or reduced in the future and the terms of such funding
may have a significant impact on future corporate decisions.
● Some of Microbot’s employees and officers are obligated to perform military reserve duty in Israel.
● It may be difficult to enforce a non-Israeli judgment against Microbot or its officers and directors.
Risks Relating to Microbot’s Securities, Governance and Other Matters
● If we fail to comply with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted and the price of our
common stock and our ability to access the capital markets could be negatively impacted.
● Anti-takeover provisions in the Company’s charter and bylaws under Delaware law may prevent or frustrate attempts by stockholders to change
the board of directors or current management and could make a third-party acquisition of the Company difficult.
General Risks
● Raising additional capital may cause dilution to the Company’s investors, restrict its operations or require it to relinquish rights to its technologies
or product candidates.
● Microbot operates in a competitive industry and if its competitors have products that are marketed more effectively or develop products,
treatments or procedures that are similar, more advanced, safer or more effective, its commercial opportunities will be reduced or eliminated,
which would materially harm its business.
● Our business strategy in part relies on identifying, acquiring, and developing complementary technologies and products, which entails risks which
could negatively affect our business, operations and financial condition.
● Microbot operations in international markets involve inherent risks that Microbot may not be able to control.
● Microbot’s financial results may be affected by fluctuations in exchange rates and Microbot’s current currency hedging strategy may not be
sufficient to counter such fluctuations.
● The market price for our Common Stock may be volatile.
● The issuance of shares upon exercise of outstanding warrants and options could cause immediate and substantial dilution to existing stockholders.
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Item 1. Description of Business.
The Company
PART I
Microbot is a pre-clinical medical device company specializing in the research, design and development of next generation robotic endoluminal surgery
devices targeting the minimally invasive surgery space. Microbot is primarily focused on leveraging its robotic technologies with the goal of redefining
surgical robotics while improving surgical outcomes for patients.
Microbot’s current technological platforms, LIBERTY®, NovaCross™, One & DoneTM, ViRobTM and TipCATTM, are comprised of proprietary
innovative technologies. Utilizing the LIBERTY and One & Done platforms, Microbot is developing the first ever fully disposable robot for various
endovascular interventional procedures. In addition, the Company is focused on the development of a Multi Generation Pipeline Portfolio utilizing all of its
proprietary technologies.
Microbot has a patent portfolio of 58 issued/allowed patents and 51 patent applications pending worldwide, of which 6 issued/allowed patents and 34
patent applications relate to the LIBERTY device.
We were incorporated on August 2, 1988 in the State of Delaware under the name Cellular Transplants, Inc. The original Certificate of Incorporation was
restated on February 14, 1992 to change our name to CytoTherapeutics, Inc. On May 24, 2000, the Certificate of Incorporation as restated was further
amended to change our name to StemCells, Inc. On November 28, 2016, C&RD Israel Ltd., a wholly-owned subsidiary of ours, completed its merger with
and into Microbot Medical Ltd., or Microbot Israel, an Israeli corporation that then owned our assets and operated our current business, with Microbot
Israel surviving as a wholly-owned subsidiary of ours. We refer to this transaction as the Merger. On November 28, 2016, in connection with the Merger,
we changed our name from “StemCells, Inc.” to Microbot Medical Inc., and each outstanding share of Microbot Israel capital stock was converted into the
right to receive shares of our common stock. In addition, all outstanding options to purchase the ordinary shares of Microbot Israel were assumed by us and
converted into options to purchase shares of the common stock of Microbot Medical Inc. On November 29, 2016, our common stock began trading on the
Nasdaq Capital Market under the symbol “MBOT”. Prior to the Merger, we were a biopharmaceutical company that operated in one segment, the research,
development, and commercialization of stem cell therapeutics and related technologies. Substantially all of the material assets relating to the stem cell
business were sold on November 29, 2016.
Technological Platforms and Product Pipeline
LIBERTY®
On January 13, 2020, Microbot unveiled what it believes is the world’s first fully disposable robotic system for use in endovascular interventional
procedures, such as cardiovascular, peripheral and neurovascular. The LIBERTY robotic system features a unique compact design with the capability to be
operated remotely, reduce radiation exposure and physical strain to the physician, reduce the risk of cross contamination, as well as the potential to
eliminate the use of multiple consumables when used with its “One & Done” capabilities, which would be based in part on our One & Done and
NovaCross platforms or possibly other guidewire/microcatheter technologies.
LIBERTY is designed to maneuver guidewires and over-the-wire devices (such as microcatheters) within the body’s vasculature. It eliminates the need for
extensive capital equipment requiring dedicated Cath-lab rooms as well as dedicated staff. In addition, when combined with our One & Done technology or
possibly other guidewire/microcatheter technologies, it is being designed to streamline Cath-lab procedures with tools that combines guidewire and
microcatheter into a single device. With control over tip curvature and stiffness for maneuverability and access – and without the need for constant tool
exchanges – when integrated into the LIBERTY device, the device may drastically reduce procedure time and costs while enhancing the operator
experience.
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We believe LIBERTY’s addressable markets are the Interventional Cardiology, Interventional Radiology and Interventional Neuroradiology markets.
The unique characteristics of LIBERTY – compact, mobile, disposable and remotely controlled - open the opportunity of expanding telerobotic
interventions to patients with limited access to life-saving procedures, such as mechanical thrombectomy in ischemic stroke.
LIBERTY is being designed to have the following attributes:
● Compact size - Eliminates the need for large capital equipment in dedicated cath-lab rooms with dedicated staff.
● Fully disposable - To our knowledge, the first and only fully disposable, robotic system for endovascular procedures.
● Streamlines Cath-lab procedures – Can be made compatible with Microbot’s unique “One & Done” tool and/or NitiLoop’s NovaCross products or
possibly other guidewire/microcatheter technologies, that combines guidewire and microcatheter into a single device. The One & Done tool, when
integrated into the system, is expected to provide full control over tip curvature and stiffness for maneuverability and access without the need for
constant tool exchanges, while enhancing the operator experience.
● State of the art maneuverability - Provides linear, rotational and tip control of its One & Done tool when integrated into the system, as well as
linear motion for an additional “over the wire” device.
● Compatibility with a wide range of commercially-available guidewires, microcatheters and guide-catheters.
● Enhanced operator safety and comfort – Aims to reduce exposure to ionizing radiation and the need for heavy lead vests otherwise to be worn
during procedures, as well as reducing the exposure to Hospital Acquired Infections (HAI).
● Ease of use - LIBERTY’s intuitive remote controls aims to simplify advanced procedures while shortening the physician’s learning curve.
● Telemedicine compatible - Capable of supporting tele-catheterization, carried out remotely by highly trained specialists.
On August 17, 2020, Microbot announced the successful conclusion of its feasibility animal study using the LIBERTY robotic system. The study met all of
its end points with no intraoperative adverse events, which supports Microbot’s objectives to allow physicians to conduct a catheter-based procedure from
outside the catheterization laboratory (cath-lab), avoiding radiation exposure, physical strain and the risk of cross contamination. The study was performed
by two leading physicians in the neuro vascular and peripheral vascular intervention spaces, and the results demonstrated robust navigation capabilities,
intuitive usability and accurate deployment of embolic agents, most of which was conducted remotely from the cath-lab’s control room.
On December 22, 2021, we entered into a strategic collaboration agreement for technology co-development with Stryker Corporation, acting through its
Neurovascular Division. Pursuant to the agreement, the collaborative development program between Stryker and us aims to integrate certain of Stryker’s
instruments with our LIBERTY Robotic System to address certain neurovascular procedures. The activities contemplated by the Agreement shall be
specified in one or more development plans derived from the terms and conditions set forth in the Agreement. We are still determining scheduling to move
the collaboration forward.
In the first quarter of 2022, we filed our pre-submission package for the LIBERTY Robotic System with the FDA, addressing the regulatory pathway for
the LIBERTY® Robotic System.
In March 2022, we held a laboratory session at a Boston-based academic center, at which several interventional radiologists attended. The session was
designed to give the radiologists first-hand experience using the LIBERTY Robotic System. The system performed as expected on a vascular model and the
positive real-time commentary provided to the Company’s clinical team was invaluable.
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On October 13, 2022, we announced the completion of a pre-clinical animal study that was conducted in September 2022. The study was performed by a
team of Key Opinion Leaders (KOLs) in the endovascular space at a research laboratory with FDA-required levels of planning, controlling, monitoring,
and reporting (GLP standards), using a porcine model. During the animal study, the physicians conducted pre-determined 63 navigations to the targeted
sites using the LIBERTY Robotic System and performed an equal number of procedures manually. The performance endpoint of the LIBERTY Robotic
System after robotic navigation was successfully completed for 58 out of the 63 targets (92%), while 3 of the targets (4.8%) were not completed due to
technical issues and 2 (3.2%) were not completed due to fluoroscopy related issues (non-device related). Post navigation intra-operative selective
angiograms of the target vessels showed no definite evidence of acute vascular injury. Follow up angiograms of these vessels in post-procedure day-three
showed normal vessel anatomy without signs of injury. Initial postmortem gross pathology examination of some of the target organs showed preliminary
findings, which will be further investigated in the second quarter of 2023 in the pending histopathology analysis, and potentially an additional pre-clinical
study.
In addition to the objective measurements, the performance and usability of the LIBERTY Robotic System were subjectively graded by each of the
physicians, with their assessments accounting for features such as ease of navigation to the target, learning curve, and system stability. For the target sites
reached, the physicians graded the LIBERTY Robotic system at the highest grade. The histopathology analysis of the target vessels was completed, and we
are currently studying these results.
In October 2022, we submitted a follow-up pre-submission package for the LIBERTY® Robotic System to ensure that we remain aligned with the FDA as
we prepare for our Investigational Device Exemption (IDE) submission and first-in-human clinical trial with the system, expected in 2023.
We are continuously exploring and evaluating additional innovative guidewire/microcatheter technologies to be integrated and combined with the
LIBERTY robotic platform.
One & DoneTM Technology
On April 8, 2018, we acquired a patent-protected technology from CardioSert Ltd., a privately-held medical device company based in Israel that was part of
a technological incubator supported by the Israel Innovation Authorities. The CardioSert technology contemplates a combination of a guidewire and
microcatheter, technologies that are broadly used for surgery within a tubular organ or structure such as a blood vessel or duct. The CardioSert technology
features a unique guidewire delivery system with steering and stiffness control capabilities which when developed is expected to give the physician the
ability to control the tip curvature, to adjust tip load to varying degrees of stiffness in a gradually continuous manner. The technology was originally
developed to support interventional cardiologists in crossing chronic total occlusions (CTO) during percutaneous coronary intervention (PCI) procedures
and has the potential to be used in other spaces and applications, such as peripheral intervention, and neurosurgery. Our CardioSert tool is now trademarked
as “One & DoneTM”.
Microbot is currently exploring the integration of the One & DoneTM technology into the LIBERTY endovascular robotic system for a range of potential
applications in the cardiovascular, peripheral vascular and neurovascular spaces.
NovaCross™
On October 6, 2022, we purchased substantially all of the assets, including intellectual property, devices, components and product related materials of
Nitiloop Ltd., an Israeli limited liability company. The assets include intellectual property and technology in the field of intraluminal revascularization
devices with anchoring mechanism and integrated microcatheter, and the products or potential products incorporating the technology owned by Nitiloop
and designated by Nitiloop as “NovaCross”, “NovaCross Xtreme” and “NovaCross BTK” and any enhancements, modifications and improvements.
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ViRob
The ViRob is an autonomous crawling micro-robot which can be controlled remotely or within the body. Its miniature dimensions are expected to allow it
to navigate and crawl in different natural spaces within the human body, including blood vessels, the digestive tract and the respiratory system as well as
artificial spaces such as shunts, catheters, ports, etc. Its unique structure is expected to give it the ability to move in tight spaces and curved passages as well
as the ability to remain within the human body for prolonged time. The SCS product was developed using the ViRob technology.
On October 11, 2022, we announced that we are planning to focus our strategic efforts on the growing endovascular space and advancing the LIBERTY
Robotic System to achieve its regulatory and commercial milestones, as well as expanding the LIBERTY ecosystem, and made a strategic decision to
suspend the continued research and development of the SCS project, effective at that date. The SCS generally performed as expected during testing, both
internally and externally, and we believe it continues to have potential clinical value as evidenced by the pre-clinical data submitted to the FDA, which
allowed us to successfully apply for the Early Feasibility Study program administered by the FDA. However, the conflicting commercialization pathways
between LIBERTY and the SCS due to different hospital call points, and the anticipated lengthier regulatory process of the SCS, led us to believe that
focusing our strategic efforts on the LIBERTY Robotic System will provide us with a greater opportunity for success and future growth. We are exploring
opportunities with the SCS assets with the focus on maximizing shareholders value, including seeking buyers for the assets, entering into joint ventures,
licensing arrangements, spinning-off the assets into a new operating company or discontinue the project altogether.
TipCAT
The TipCAT is a disposable self-propelled locomotive device that is specially designed to advance in tubular anatomies. The TipCAT is a mechanism
comprising a series of interconnected balloons at the device’s tip that provides the TipCAT with its forward locomotion capability. The device can self-
propel within natural tubular lumens such as the blood vessels, respiratory and the urinary and GI tracts. A single channel of air/fluid supply sequentially
inflates and deflates a series of balloons creating an inchworm like forward motion. The TipCAT maintains a standard working channel for treatments.
Unlike standard access devices such as guidewires, catheters for vascular access and endoscopes, the TipCAT does not need to be pushed into the patient’s
lumen using external pressure; rather, it will gently advance itself through the organ’s anatomy. As a result, the TipCAT is designed to be able to reach
every part of the lumen under examination regardless of the topography, be less operator dependent, and greatly reduce the likelihood of damage to lumen
structure. The TipCAT thus offers functionality features equivalent to modern tubular access devices, along with advantages associated with its
physiologically adapted self-propelling mechanism, flexibility, and design.
Currently, Microbot is not pursuing the development of the TipCAT as a colonoscopy tool due to its focus on the endovascular intervention spaces, and as
such it is currently exploring the use of the TipCAT for minimally invasive neurosurgical and endovascular applications to complement its other
technologies.
Industry Overview
Minimally Invasive Robot-Assisted Endovascular Interventions
Minimally Invasive Surgery, or MIS, refers to surgical procedures performed through tiny incisions instead of a single large opening. Because the incisions
are small, patients tend to have quicker recovery times and experience less trauma than with conventional surgery. The global MIS surgery is expected to
grow from $24 billion in 2020 to $42 billion in 2026, representing a CAGR of 9.85%. MIS involves three major categories of devices: surgical, monitoring
and visualization, and endoscopy. The market for surgical devices, including ablation, electrosurgery and medical robotic systems, accounts for the largest
share of revenue and is also expected to show the highest rate of growth. According to the Society of Robotic Surgery, the US market growth in
endoluminal robotic surgery is projected to be 15-25% by 2025.
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Vascular disease is the most common precursor to ischemic heart disease and stroke, which are two of the leading causes of death worldwide. Advances in
endovascular intervention in recent years have transformed patient survival rates and post-surgical quality of life. It is estimated that more than three
million percutaneous coronary interventions (PCI) and over two million of peripheral vascular interventions are performed annually worldwide. The
incidence of stroke in the US alone is estimated at 900,000 cases annually. Compared to open surgery, it has the advantages of faster recovery, reduced need
for general anesthesia, reduced blood loss and significantly lower mortality. However, the current practice of endovascular procedures, which virtually has
remained unchanged since the introduction of Intervention four decades ago, is limited by a number of factors, including physical strain and exposure to X-
Ray radiation of the operator, and involves complex maneuvering of intervention tools, such as guidewires and catheters, to reach target areas in the
vasculature. Despite recent advancements in technology and devices, manual procedures are still highly dependent on the technical skills and training of the
operator, what makes the access to expert medical centers and advanced emergent treatments, such as endovascular thrombectomy for acute ischemic
stroke, geographically limited. In addition, we believe that demand for physicians continues to grow faster than supply.
Endovascular robotic systems are aimed to increase the stability and precision of guidewires and catheters, protecting the physicians from ionizing
radiation and physical strain by removing them from the radiation source, helping in closing shortages of skilled physicians and skill gaps and enable tele-
interventions (e.g. the Hub & Spoke hospital model).
Today, there are only a few commercially available robotic systems for endovascular interventions. We believe these systems have major drawbacks, such
as limited maneuverability, the requirement to exchange and use multiple expensive surgical tools, being cumbersome to set-up and operate, and requiring
significant capital expenditures.
Navigating and placing access devices through tortuous and highly delicate brain arteries is a complex procedure that requires high-level surgical skills
with specialist training. In many procedures, surgeons exchange numerous access devices before reaching the target and applying the therapeutic agent or
device, increasing the risk of adverse events and the exposure of both patient and physician to radiation. Adverse events, such as perforation of brain
arteries or the release of embolies from a thrombus or atherosclerotic lesion can have devastating or even fatal results.
Microbot believes that with its portfolio of One & Done, NovaCross products and LIBERTY technologies, it is well-positioned to explore and develop such
technologies as neurovascular access devices, with a focus on improving the ease and access and enhancing the safety of endovascular interventions.
Strategy
Microbot’s goal is to generate sales of its products, once they have received regulatory approval, by establishing, LIBERTY and perhaps other devices from
its technological platforms, as the standard-of-care in the eyes of medical practitioners, patients and medical facilities, as well as getting the support of
payors and insurance companies. Microbot believes that it can achieve this objective by working with hospitals to demonstrate the key benefits of its
products. Microbot’s strategy includes the following key elements:
● Continue to refine existing product candidates and develop additional surgical robotic solutions. As Microbot prepares to bring its initial
product candidates through pre-clinical and clinical trials, if necessary, and eventually to market, it continues to focus on improving its product
candidates to respond to clinical data and patient and physician feedback. Microbot also expects to continue to innovate in the surgical robotics
field by continuing to find ways of using its technology to solve unmet needs, with the overarching goal of providing a safer, more effective and
more efficient surgical environment for patients and physicians.
● Establish and leverage relationships with key institutions and leading clinicians. Microbot’s objective will be to maintain clinical focus with
leading hospitals and clinics so as to establish LIBERTY, as well as possibly other future products, as the standard of care in such institutions for
their respective procedures. Microbot also expects to identify key clinicians with the relevant specialties (for instance interventional radiology)
with the expectation that such clinical focus will accelerate the adoption of its candidate products.
● Continuously invest in research and development. Microbot’s most significant expense has historically been research and development, and
Microbot expects that this will continue in the foreseeable future, including expenses it expects to incur to improve on its prototype products in
order to respond to clinical data, to develop additional applications using its technologies and to develop future product candidates.
● Explore partnerships for the introduction of Microbot’s products. Microbot intends to focus its marketing and sales efforts initially on
pursuing collaborations with global medical device companies that have established sales and distribution networks. Microbot will seek to enter
collaborations and partnerships with strategic players that offer synergies with Microbot’s product candidates and expertise.
● Seek additional IP and technologies to complement and strengthen Microbot’s current IP portfolio. Microbot intends to continue exploring
new technologies, IP and know-how to add to its current portfolio through licensing, mergers and/or acquisitions and to allow Microbot to enter
new spaces and strengthen its overall product portfolio.
7
Competition
LIBERTY Competitive Landscape
We believe the main competitor to the LIBERTY system is the CorPath GRX vascular robotics system by Corindus Vascular Robotics, a Siemens
Healthineers company. To our knowledge, CorPath GRX system is FDA-approved and CE-marked for percutaneous coronary and vascular procedures, is
CE-marked for neurovascular interventions and is pending FDA approval for neurovascular interventions. Another competitor is Robocath (CE Marked for
PCI only). We believe these systems have drawbacks, such as limited maneuverability, the requirement to exchange and use multiple expensive surgical
tools, being cumbersome to set-up and operate, and requiring significant capital expenditures. We further believe that these systems have captured a
marginal market share to date.
Microbot’s existing and planned products could also be rendered obsolete or uneconomical by technological advances developed in the future by existing
or new competitors. Some of Microbot’s competitors currently have significantly greater resources than Microbot does; have established relationships with
healthcare professionals, customers and third-party payors; and have long-term contracts with group purchasing organizations in the United States. In
addition, many of Microbot’s competitors have established distributor networks, greater resources for product development, sales and marketing, additional
lines of products and the ability to offer financial incentives such as rebates, bundled products or discounts on other product lines that Microbot cannot
provide.
One & DoneTM Competitive Landscape
Competition includes moveable-core guidewires from companies such as Boston Scientific and Rapid Medical, and steerable and deflectable sheaths and
catheters from companies such as Bendit Technologies, Agile Devices and Merit Medical. To our knowledge, the One & Done device is the only device
that combines an inner moveable guidewire and an outer microcatheter, with the ability to control the shape and stiffness of the distal tip in a continuous,
gradual manner, and intends to compete on that basis.
TipCAT Competitive Landscape
Microbot has not at this time completed its evaluation of the current competitive landscape in the endovascular space for potential uses of the TipCAT.
Intellectual Property
General
The SCS and TipCAT are based on technological platforms licensed from The Technion Research and Development Foundation Ltd., or TRDF, as further
discussed below. The LIBERTY platform core technology is co-owned by Microbot and TRDF. The One & DoneTM device is based on technologies
acquired by Microbot from CardioSert. The NovaCross® device is based on technologies acquired by Microbot from Nitiloop Ltd. Microbot plans to
develop other medical-robotic solutions through internal research and development, to strengthen its intellectual property position, and to continue
exploring strategic collaborations and accretive acquisition opportunities. Microbot currently holds an intellectual property portfolio of 58 patents
issued/allowed and 48 patent applications pending worldwide. Microbot also holds 5 design patents issued/allowed and 6 design patents pending
worldwide. It also has registered trademarks in Israel, Europe and the US relating to its LIBERTY platform, and also has trademarks relating to its
proprietary Microbot Medical tradename and logo registered in Israel, Europe, and the UK, and pending in the US and China, in addition to having
registered trademarks for the “One & Done” name in Israel, Europe and Japan, and pending in the US, UK, China, and Japan. Microbot also has a
registered trademark in the US for the newly acquired NovaCross trademark.
8
Microbot relies or intends to rely on intellectual property licensed or developed, including patents, trade secrets, trademarks, technical innovations, laws of
unfair competition and various licensing agreements, to provide its future growth, to build its competitive position and to protect its technology. As
Microbot continues to expand its intellectual property portfolio, it is critical for Microbot to continue to invest in filing patent applications to protect its
technology, inventions, and improvements.
Microbot requires its employees and consultants to execute confidentiality agreements in connection with their employment or consulting relationships
with Microbot. Microbot also requires its employees and consultants who work on its product candidates to agree to disclose and assign to Microbot all
inventions conceived during the term of their service, while using Microbot property, or which relate to Microbot’s business.
Patent applications in the United States and in foreign countries are maintained in secrecy for a period of time after filing, which results in a delay between
the filing date of the patent applications and the time when they are published. Patents issued and patent applications filed relating to medical devices are
numerous, and there can be no assurance that current and potential competitors and other third parties have not filed or in the future will not file
applications for, or have not received or in the future will not receive, patents or obtain additional proprietary rights relating to product candidates,
products, devices or processes used or proposed to be used by Microbot. Microbot believes that the technologies it employs in its products and systems do
not infringe the valid claims of any third-party patents. There can be no assurance, however, that third parties will not seek to assert that Microbot devices
and systems infringe their patents or seek to expand their patent claims to cover aspects of Microbot’s products and systems.
The medical device industry in general has been characterized by substantial litigation regarding patents and other intellectual property rights. Any such
claims, regardless of their merit, could be time-consuming and expensive to respond to and could divert Microbot’s technical and management personnel.
Microbot may be involved in litigation to defend against claims of infringement by other patent holders, to enforce patents issued to Microbot, or to protect
Microbot’s trade secrets. If any relevant claims of third-party patents are upheld as valid and enforceable in any litigation or administrative proceeding,
Microbot could be prevented from practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of
each such patent, or to redesign Microbot’s products, devices or processes to avoid infringement. There can be no assurance that such licenses would be
available or, if available, would be available on terms acceptable to Microbot or that Microbot would be successful in any attempt to redesign products or
processes to avoid infringement. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses,
could potentially prevent Microbot from manufacturing and selling its products.
Microbot’s issued U.S. patents, which cover Microbot’s product candidates, will expire between 2026 and 2040, not including any patent term adjustments
that may be available. Issued patents outside of the United States directed to Microbot’s product candidates will expire between 2026 and 2040.
License Agreement with the Technion
In June 2012, Microbot entered into a license agreement with TRDF, the technology transfer subsidiary of The Technion Institute of Technology, pursuant
to which it obtained an exclusive, worldwide, royalty-bearing, sub-licensable license to certain patents and inventions relating to the SCS and TipCAT
technology platforms invented by Professor Moshe Shoham, a former director of and an advisor to the Company, and in certain circumstances other TRDF-
related persons. Pursuant to the terms of the license agreement, in order to maintain the license with respect to each platform, Microbot must use
commercially reasonable efforts to develop products covered by the license, including meeting certain agreed upon development milestones. The milestone
for the TipCAT include commencing first in human clinical trials in December 2023. The milestones for the SCS include commencing first in human
clinical trials by December 2024, and commencing a pivotal study by June 2027. Failure to meet any development milestone will give TRDF the right to
terminate the license with respect to the technology underlying the missed milestone.
As partial consideration for the grant of the licenses under the agreement, Microbot issued a number of shares to TRDF equal to 3% of its issued and
outstanding shares at such time on a fully diluted basis. Such shares were initially subject to antidilution protections but are no longer subject to adjustment.
In addition, as partial consideration for the licenses granted, Microbot agreed to pay TRDF royalties of between 1.5% and 3.0% of net sales of products
covered by the licenses, subject to certain reductions, and certain percentages of amounts received by Microbot in the event of sublicensing.
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In the case of termination of the license by Microbot without cause or by TRDF for cause, TRDF has the right to receive a non-exclusive license from
Microbot with respect to improvements to the licensed technologies made by Microbot. In such cases, TRDF would pay a royalty of 10% of the income
received by TRDF in connection its sublicensing of such patent right and related intellectual property. If the license from TRDF were to be terminated with
respect with either of the technology platforms underlying the SCS or the TipCAT, Microbot would no longer be able to continue its development of the
related product candidate. However, Microbot believes that its current intellectual property portfolio, and its ongoing efforts to expand into other micro-
robotic surgical technologies, will give it the flexibility to shift its resources towards developing and commercializing related products.
In addition to the licensed SCS and TipCAT technologies, the LIBERTY platform, which was invented by employees of Microbot together with Professor
Moshe Shoham of the Technion, in his capacity as a consultant to Microbot, is co-owned by Microbot and TRDF, and the parties established the LIBERTY
platform as a “Joint Invention” in accordance with the terms of the License Agreement. Once the Joint Invention is established, Microbot will have to pay
TRDF royalties of between 1.5% and 3.0% of net sales of products covered by this Joint Invention.
Research and Development
Microbot’s research and development programs are generally pursued by engineers and scientists employed by Microbot in its offices in Israel on a full-
time basis or as consultants, or through partnerships with industry leaders in manufacturing and design and researchers in academia. Microbot is also
working with subcontractors in developing specific components of its technologies.
The primary objectives of Microbot’s research and development efforts are to continue to introduce incremental enhancements to the capabilities of its
candidate products and to advance the development of proposed products.
Microbot Israel has received grants from the Israeli Innovation Authority (“IIA”) for participation in research and development since 2013 through
December 31, 2022 totaling approximately $1,500,000. In addition, on January 4, 2018, Microbot Israel assumed the repayment obligations under
CardioSert’s IIA grants in the aggregate amount of approximately $530,000, and on October 6, 2022, Microbot Israel assumed the repayment obligations
under Nitiloop’s IIA grants in the aggregate amount of approximately $925,000.
In relation to the IIA grants described above, we are obligated to pay royalties amounting to 3.0%-3.5% of our future sales of the products relating to such
grants. The grants are linked to the exchange rate of the dollar to the New Israeli Shekel and bear interest of Libor per annum.
The repayment of the grants is contingent upon the successful completion of the Company’s research and development programs and generating sales. The
Company has no obligation to repay these grants, if the project fails, is unsuccessful or aborted or if no sales are generated. The financial risk is assumed
completely by the Government of Israel. The grants are received from the Government on a project-by-project basis.
Microbot expects to continue to access government funding in the future.
For the fiscal years ended December 31, 2022 and 2021, respectively, Microbot incurred research and development expenses of approximately $7,736,000
and $6,153,000.
Strategic collaboration agreement with Stryker
On December 22, 2021, the Company entered into a strategic collaboration agreement for technology co-development with Stryker Corporation, acting
through its Neurovascular Division. Pursuant to the agreement, the collaborative development program between the Company and Stryker aims to integrate
certain of Stryker’s instruments with the Company’s LIBERTY® Robotic System to address certain neurovascular procedures. The parties conducted
discussions to define the development plan and are considering next steps.
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LIBERTY
The LIBERTY prototype system was tested at our laboratories in an in-vitro silicone model, using off-the-shelf guidewires and microcatheters, and
showing an ability to successfully provide linear and rotational movements of the guidewires and linear motion of the microcatheters. During 2022, we
conducted several simulated trials using silicone models as well as animal trials to validate the design and obtain valuable feedback.
The LIBERTY prototype is designed to control the One & DoneTM tool; however, the One & DoneTM tool is not currently expected to be integrated into
the current version of the LIBERTY device. Future versions are expected to control the NovaCross products that were acquired by us in 2022. Additionally,
we are exploring and evaluating additional innovative guidewire/microcatheter technologies to be integrated and combined with the LIBERTY robotic
platform to further enhance the performance of the system.
Since the One & DoneTM tool was originally designed for chronic total occlusion, we are currently working with subcontractors and guidewire design-
houses to perfect the performance of the One & DoneTM tool to the indication that will be selected for the LIBERTY platform. These may include
procedures in the peripheral, coronary or neurovascular spaces.
SCS
See “–Technological Platforms and Product Pipeline–ViRob” above with respect to the SCS technology and research and development status.
Manufacturing
Microbot does not have any manufacturing facilities or manufacturing personnel. Microbot currently relies, and expects to continue to rely, on third parties
for the manufacturing of its product candidates for preclinical and clinical testing, as well as for commercial manufacturing if its product candidates receive
marketing approval.
During 2022 Microbot initiated the transfer to production by means of designing and building molds for plastic injection of parts which is a more cost-
effective method for producing high quantities compared to conventional machined production of these parts. Some molds are already operative while
others are being designed and built. We expect completing the molds during 2023.
Also, Microbot Medical initiated discussions with subcontractor that we believe are suited to assemble and test our products under applicable regulatory
requirements and regulations.
Commercialization
Microbot has not yet established a sales, marketing or product distribution infrastructure for its product candidates, which are still in development stages.
Microbot plans to access the U.S. markets with its initial device offerings through strategic partnerships but may develop its own focused, specialized sales
force or distribution channels once it has several commercialized products in its portfolio. Microbot has not yet developed a commercial strategy outside of
the United States.
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Government Regulation
General
Microbot’s medical technology products and operations are subject to extensive regulation in the United States and other countries. Most notably, if
Microbot seeks to sell its products in the United States, its products will be subject to the Federal Food, Drug, and Cosmetic Act (FDCA) as implemented
and enforced by the U.S. Food and Drug Administration (FDA). The FDA regulates the development, bench and clinical testing, manufacturing, labeling,
storage, record-keeping, promotion, marketing, sales, distribution and post-market support and reporting of medical devices in the United States to ensure
that medical products distributed domestically are safe and effective for their intended uses. Regulatory policy affecting its products can change at any
time.
Advertising and promotion of medical devices in the United States, in addition to being regulated by the FDA, are also regulated by the Federal Trade
Commission and by state regulatory and enforcement authorities. Recently, promotional activities for FDA-regulated products of other companies have
been the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the federal
Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims.
Foreign countries where Microbot wishes to sell its products may require similar or more onerous approvals to manufacture or market its products.
Government agencies in those countries also enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising,
marketing and distribution, and market surveillance of medical device products. These regulatory requirements can change rapidly with relatively short
notice.
Other regulations Microbot encounters in the United States and in other jurisdictions are the regulations that are common to all businesses, such as
employment legislation, implied warranty laws, and environmental, health and safety standards, to the extent applicable. In the future, Microbot will also
encounter industry-specific government regulations that would govern its products, if and when they are developed for commercial use.
U.S. Regulation
The FDA governs the following activities that Microbot performs, will perform, upon the clearance or approval of its product candidates, or that are
performed on its behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses:
● product design, and development;
● product safety, testing, labeling and storage;
● record keeping procedures; and
● product marketing.
There are numerous FDA regulatory requirements governing the approval or clearance and subsequent commercial marketing of Microbot’s products.
These include:
● the timely submission of product listing and establishment registration information, along with associated establishment user fees;
● continued compliance with the Quality System Regulation, or QSR, which require specification developers and manufacturers, including third-
party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the
manufacturing process;
● labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
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● clearance or approval of product modifications that could significantly affect the safety or effectiveness of the device or that would constitute a
major change in intended use;
● Medical Device Reporting regulations (MDR), which require that manufacturers keep detailed records of investigations or complaints against their
devices and to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would
likely cause or contribute to a death or serious injury if it were to recur;
● adequate use of the Corrective and Preventive Actions process to identify and correct or prevent significant systemic failures of products or
processes or in trends which suggest same;
● post-approval restrictions or conditions, including post-approval study commitments;
● post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness
data for the device; and
● notices of correction or removal and recall regulations.
Unless an exemption applies, before Microbot can commercially distribute medical devices in the United States, Microbot must obtain, depending on the
classification of the device, either prior 510(k) clearance, 510(k) de-novo clearance or premarket approval (PMA), from the FDA. The FDA classifies
medical devices into one of three classes based on the degree of risk associated with each medical device and the extent of regulatory controls needed to
ensure the device’s safety and effectiveness:
● Class I devices, which are low risk and subject to only general controls (e.g., registration and listing, medical device labeling compliance, MDRs,
Quality System Regulations, and prohibitions against adulteration and misbranding) and, in some cases, to the 510(k) premarket clearance
requirements;
● Class II devices, which are moderate risk and generally require 510(k) or 510(k) de-novo premarket clearance before they may be commercially
marketed in the United States as well as general controls and potentially special controls like performance standards or specific labeling
requirements; and
● Class III devices, which are devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or
devices deemed not substantially equivalent to a predicate device. Class III devices generally require the submission and approval of a PMA
supported by clinical trial data.
Microbot expects the medical products in its pipeline currently to be classified as Class II. Class II devices are those for which general controls alone are
insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish special controls. Special controls can
include performance standards, post-market surveillance, patient histories and FDA guidance documents. Premarket review and clearance by the FDA for
these devices is generally accomplished through the 510(k) or 510(k) de-novo premarket notification process. As part of the 510(k) or 510(k) de-novo
notification process, FDA may require the following:
● Development of comprehensive product description and indications for use;
● Comprehensive review of predicate devices and development of data supporting the new product’s substantial equivalence to one or more
predicate devices; and
● If appropriate and required, certain types of clinical trials (IDE submission and approval may be required for conducting a clinical trial in the US).
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Clinical trials involve use of the medical device on human subjects under the supervision of qualified investigators in accordance with current Good
Clinical Practices (GCPs), including the requirement that all research subjects provide informed consent for their participation in the clinical study. A
written protocol with predefined end points, an appropriate sample size and pre-determined patient inclusion and exclusion criteria, is required before
initiating and conducting a clinical trial. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with
the FDA’s Investigational device Exemption, or IDE, regulations that among other things, govern investigational device labeling, prohibit promotion of the
investigational device, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents
a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application, which must become effective prior to
commencing human clinical trials. The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or
notifies the company that the investigation is on hold and may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE
that requires modification, the FDA may permit a clinical trial to proceed under a conditional approval. In addition, the study must be approved by, and
conducted under the oversight of, an Institutional Review Board (IRB) for each clinical site. If the device presents a non-significant risk to the patient, a
sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but it must still
follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and
record-keeping requirements. 510(k) clearance typically involves the following:
●
●
●
●
●
Assuming successful completion of all required testing, a detailed 510(k) premarket notification or 510(k) de-novo is submitted to the FDA
requesting clearance to market the product. The notification includes all relevant data from pertinent preclinical and clinical trials, together
with detailed information relating to the product’s manufacturing controls and proposed labeling, and other relevant documentation.
A 510(k) clearance letter from the FDA will authorize commercial marketing of the device for one or more specific indications for use.
After 510(k) clearance, Microbot will be required to comply with a number of post-clearance requirements, including, but not limited to,
Medical Device Reporting and complaint handling, and, if applicable, reporting of corrective actions. Also, quality control and manufacturing
procedures must continue to conform to QSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QSRs,
which impose extensive procedural, substantive, and record keeping requirements on medical device manufacturers. In addition, changes to
the manufacturing process are strictly regulated, and, depending on the change, validation activities may need to be performed. Accordingly,
manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with
QSRs and other types of regulatory controls.
After a device receives 510(k) clearance from the FDA, any modification that could significantly affect its safety or effectiveness, or that
would constitute a major change in its intended use or technological characteristics, requires a new 510(k) clearance or could require a PMA.
The FDA requires each manufacturer to make the determination of whether a modification requires a new 510(k) notification or PMA in the
first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k)
clearance or PMA for a particular change, the FDA may retroactively require the manufacturer to seek 510(k) clearance or PMA. The FDA
can also require the manufacturer to cease U.S. marketing and/or recall the modified device until additional 510(k) clearance or PMA
approval is obtained.
The FDA and the Federal Trade Commission, or FTC, will also regulate the advertising claims of Microbot’s products to ensure that the
claims Microbot makes are consistent with its regulatory clearances, that there is scientific data to substantiate the claims and that product
advertising is neither false nor misleading.
To obtain 510(k) clearance, Microbot must submit a notification to the FDA demonstrating that its proposed device is substantially equivalent to a predicate
device (i.e., a device that was in commercial distribution before May 28, 1976, a device that has been reclassified from Class III to Class I or Class II, or a
510(k)-cleared device). The FDA’s 510(k) clearance process generally takes from three to 12 months from the date the application is submitted but also can
take significantly longer. If the FDA determines that the device or its intended use is not substantially equivalent to a predicate device, the device is
automatically placed into Class III, requiring the submission of a PMA.
There is no guarantee that the FDA will grant Microbot 510(k) clearance for its pipeline medical device products, and failure to obtain the necessary
clearances for its products would adversely affect Microbot’s ability to grow its business. Delays in receipt or failure to receive the necessary clearances, or
the failure to comply with existing or future regulatory requirements, could reduce its business prospects.
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Devices that cannot be cleared through the 510(k) process due to lack of a predicate device but would be considered low or moderate risk may be eligible
for the 510(k) de-novo process. In 1997, the Food and Drug Administration Modernization Act, or FDAMA added the de novo classification pathway now
codified in section 513(f)(2) of the FD&C Act. This law established an alternate pathway to classify new devices into Class I or II that had automatically
been placed in Class III after receiving a Not Substantially Equivalent, or NSE, determination in response to a 510(k) submission. Through this regulatory
process, a sponsor who receives an NSE determination may, within 30 days of receipt, request FDA to make a risk-based classification of the device
through what is called a “de novo request.” In 2012, section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration
Safety and Innovation Act (FDASIA), in order to provide a second option for de novo classification. Under this second pathway, a sponsor who determines
that there is no legally marketed device upon which to base a determination of substantial equivalence can submit a de novo request to FDA without first
submitting a 510(k).
In the event that Microbot receives a Not Substantially Equivalent determination for either of its device candidates in response to a 510(k) submission, the
Microbot device may still be eligible for the 510(k) de-novo classification process.
Devices that cannot be cleared through the 510(k) or 510(k) de-novo classification process require the submission of a PMA. The PMA process is much
more time consuming and demanding than the 510(k) notification process. A PMA must be supported by extensive data, including but not limited to data
obtained from preclinical and/or clinical studies and data relating to manufacturing and labeling, to demonstrate to the FDA’s satisfaction the safety and
effectiveness of the device. After a PMA application is submitted, the FDA’s in-depth review of the information generally takes between one and three
years and may take significantly longer. If the FDA does not grant 510(k) clearance to its products, there is no guarantee that Microbot will submit a PMA
or that if Microbot does, that the FDA would grant a PMA approval of Microbot’s products, either of which would adversely affect Microbot’s business.
Foreign Regulation
In addition to regulations in the United States, Microbot will be subject to a variety of foreign regulations governing clinical trials, marketing authorization
and commercial sales and distribution of its products in foreign countries. The approval process varies from country to country, and the time may be longer
or shorter than that required for FDA approval or clearance. The requirements governing the conduct of clinical trials, product licensing, pricing and
reimbursement vary greatly from country to country.
International sales of medical devices are subject to foreign governmental regulations which vary substantially from country to country. Whether or not
Microbot obtains FDA approval or clearance for its products, Microbot will be required to make new regulatory submissions to the comparable regulatory
authorities of foreign countries before Microbot can commence clinical trials or marketing of the product in such countries. The time required to obtain
certification or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.
Below are summaries of the regulatory systems for medical devices in Europe and Israel, where Microbot currently anticipates marketing its products.
However, its products may also be marketed in other countries that have different systems or minimal requirements for medical devices.
Europe. The primary regulatory body in Europe is the European Union, or E.U., which consists of 27 member states and has a coordinated system for the
authorization of medical devices.
The E.U. has adopted legislation, in the form of directives to be implemented in each member state, concerning the regulation of medical devices within the
European Union. The directives include, among others, the Medical Device Regulation, or MDR, that establishes certain requirements with which medical
devices must comply before they can be commercialized in the European Economic Area, or EEA (which comprises the member states of the E.U. plus
Norway, Liechtenstein and Iceland). Under the MDR, medical devices are classified into four Classes, I, IIa, IIb, and III, with Class I being the lowest risk
and Class III being the highest risk.
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all
regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). The CE approval process in Europe is
summarized below:
1. To obtain CE Marking certification, comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device
Regulation (MDR).
2. Appoint a Person Responsible for Regulatory Compliance (PRRC). Determine classification of device - Class I (self-certified); Class I (sterile,
measuring or reusable surgical instrument); Class IIa, Class IIb, or Class III.
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3. For all devices, implement a Quality Management System (QMS) in accordance with the MDR. Companies usually apply the EN ISO 13485
standard to achieve compliance. The QMS must include Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up
(PMCF) plans. Make arrangements with suppliers about unannounced Notified Body audits. For Class I (self-certified), implement a QMS though
Notified Body intervention is not required.
4. Prepare a CE Technical Documentation or Design Dossier (Class III) providing information about the device and its intended use plus testing
reports, Clinical Evaluation Report (CER), risk management file, Instruction For Use (IFU), labeling and more. Obtain a Unique Device Identifier
(UDI) for the device. All devices, even legacy products in use for decades, will require clinical data. Most of these data should refer to the subject
device. Clinical studies are generally required for implantable and Class III devices. Existing clinical data may be acceptable. Clinical trials in
Europe must be pre-approved by a European Competent Authority.
5.
If the company does not have a location in Europe, appoint an Authorized Representative (EC REP) located in the EU who is qualified to handle
regulatory issues. Place the EC REP name and address on device label. Obtain a Single Registration Number from the regulators.
6. For all devices except Class I (self-certified), the QMS and Technical Documentation or Design Dossier must be audited by a Notified Body, a
third party accredited by European authorities to audit medical device companies and products.
7. For all devices except Class I (self-certified), the company will be issued a European CE Marking Certificate for the device and an ISO 13485
certificate for the company’s facility following successful completion of the Notified Body audit. ISO 13485 certification must be renewed every
year. CE Marking certificates are typically valid for a maximum of 5 years, but are typically reviewed during the annual surveillance audit.
8. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the
applicable European requirements. At this time, the CE Marking may be affixed.
9. Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. UDI must be on label and associated with the regulatory
documents.
10. For Class I (self-certified), annual NB audits are not required. However, CER, Technical File, and PMS activities must be kept updated. For all
other classes, the company will be audited each year by a Notified Body to ensure ongoing compliance with the MDR. Failure to pass the audit
will invalidate the CE Marking certificate. The company must perform Clinical Evaluation, PMS, and PMCF.
Microbot intends to apply for the CE Mark for each of its medical device products. There is no guarantee that Microbot will be granted a CE Mark for all or
any of its pipeline products and failure to obtain the CE Mark would adversely affect its ability to grow its business.
Israel. Israel’s Medical Devices Law generally requires the registration of all medical products with the Ministry of Health, or MOH, Registrar as a
precondition for production and distribution in Israel. Special exemptions may apply under limited circumstances and for purposes such as the provision of
essential medical treatment, research and development of the medical device, and personal use, among others.
Registration of medical devices requires the submission of an application to the Ministry of Health Medical Institutions and Devices Licensing Department,
or AMAR. An application for the registration of a medical device includes the following:
● Name and address of the manufacturer, and of the importer as applicable;
● Description of the intended use of the medical device and of its medical indications;
● Technical details of the medical device and of its components, and in the event that the device or the components are not new, information should
be provided on the date or renovation;
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● Certificate attesting to the safety of the device, issued by a competent authority of one of the following countries: Australia, Canada, European
Community (EC), Member States (MSs), Israel, Japan, or the United States;
● Information on any risk which may be associated with the use of the device (including precautionary measures to be taken);
● Instructions for use of the device in Hebrew; the MOH may allow the instructions to be in English for certain devices;
● Details of the standards to which the device complies;
● Description of the technical and maintenance services, including periodic checks and inspections; and
● Declaration, as appropriate: of the local manufacturer/importer, and of the foreign manufacturer.
If the application includes a certificate issued by a competent authority of one of the following “recognized” countries: Australia, Canada, European
Community (CE) Member States (MSs), Japan, or the United States, the registration process is generally expedited, but could still take 6-9 months for
approval. If such certificate is not available, the registration process will take significantly longer and a license is rarely issued. Furthermore, the MOH will
determine what type of testing is needed. In general, in the case of Israeli manufactured devices that are not registered or authorized in any “recognized”
country, the application requires presentation of a risk analysis, a clinical evaluation, a summary of the clinical trials, and expert opinions regarding the
device’s safety and effectiveness. Additional requirements may apply during the registration period, including follow-up reviews, to improve the quality
and safety of the devices.
According to regulations issued by Israel’s Minister of Health in June 2013, a decision on a request to register a medical device must be delivered by
AMAR within 120 days from the date of the request, although this rarely occurs. The current rules for the registration of medical devices do not provide for
an expedited approval process.
Once granted by the MOH, a license (marketing authorization) for a medical device is valid for five years from the date of registration of the device, except
for implants with a life-supporting function, for which the validity is for only two years from the date of registration. Furthermore, the holder of the license,
the Israeli Registration Holder, or IRH, must do the following to maintain its license:
● Reside and maintain a place of business in Israel and serve as the regulatory representative.
● Respond to questions from AMAR concerning the registered products.
● Report adverse events to AMAR.
● Renew the registration on time to keep the market approval active.
Comply with post-marketing requirements, including reporting of adverse and unexpected events occurring in Israel or in other countries where the device
is in use.
Getting a device listed on Israel’s four major Sick Funds (health insurance entities) is also necessary in order for Israeli hospitals and health care providers
to order such products.
Microbot intends to apply for a license from the MOH for each of its medical devices. There is no guarantee that Microbot will be granted licenses for its
pipeline products and failure to obtain such licenses would adversely affect its ability to grow its business.
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Human Capital
Employees
As of March 30, 2023, we had 21 employees (including full-time and hourly employees)
Microbot’s Chief Executive Officer, President and Chairman, Harel Gadot, along with 4 full-time employees, are based in the United States, with
Microbot’s U.S. office located in Hingham, Massachusetts. Additionally, Microbot had 14 full-time employees and 2 hourly employees based in its office
located in Yokneam, Israel. These employees oversee day-to-day operations of the Company and leading engineering, manufacturing, intellectual property
and administration functions of the Company. As required, Microbot also engages consultants to provide services to the Company, including regulatory,
legal and corporate services. We are subject to labor laws and regulations within our locations in the U.S. and Israel. These laws and regulations principally
concern matters such as pensions, paid annual vacation, paid sick days, length of the workday and work week, minimum wages, overtime pay, insurance
for work-related accidents, severance pay and other conditions of employment. Microbot has no unionized employees.
We believe we are able to attract and retain top talent by creating a culture that challenges and engages our employees, offering them opportunities to learn,
grow and achieve their career goals.
Compensation, Benefits and Wellbeing
We provide competitive compensation for our employees. We offer annual bonuses and stock-based compensation for eligible employees.
Leadership, Training and Development
We aim to provide our employees with advanced professional and development skills, so that they can perform effectively in their roles and build their
capabilities and career prospects for the future.
Diversity, Equity and Inclusion
We strive to encourage a diversity of views and to create an equal opportunity workplace. During the past year, we have increased the total number of
women in management positions.
Item 1A. Risk Factors
This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. Our business, operating results, financial
performance, and share price may be materially adversely affected by a number of factors, including but not limited to the following risk factors, any one
of which could cause actual results to vary materially from anticipated results or from those expressed in any forward-looking statements made by us in this
Annual Report on Form 10-K or in other reports, press releases or other statements issued from time to time. Additional factors that may cause such a
difference are set forth elsewhere in this Annual Report on Form 10-K. Forward-looking statements speak only as of the date of this report. We do not
undertake any obligation to publicly update any forward-looking statements.
Risks Relating to Microbot’s Financial Position and Need for Additional Capital
There is substantial doubt regarding on our ability to continue as a going concern.
As stated elsewhere in this Annual Report on Form 10-K, we have not generated any revenues, have sustained losses and have accumulated a significant
deficits since our inception. Also, we estimate that our cash resources are only sufficient to fund our operations for approximately 4 months from the date
of this Annual Report and as a result, our continued existence is dependent upon our ability to obtain additional debt or equity financing and to ultimately
become a commercially viable organization.
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There can be no assurance that the additional necessary debt or equity financing will be available, or will be available on terms acceptable to us, in which
case we may be unable to meet our obligations or fully implement our business plan, if at all, beyond such 4 month period. Additionally, should we be
unable to realize our assets and discharge our liabilities in the normal course of business, the net realizable value of our assets may be materially less than
the amounts recorded in our financial statements. As a result of the foregoing and our current cash position, these conditions raise substantial doubt about
Microbot’s ability to continue as a going concern beyond approximately the next 4 months, which could adversely affect our ability to raise capital, expand
our business and develop our planned products.
We are subject to litigation, which may divert management’s attention and, in the event of an adverse judgment or settlement for some or all of the
$6,750,000 being litigated, have a material adverse effect on our financial condition and our ability to continue our operations.
We are the defendant in a lawsuit captioned Empery Asset Master Ltd., Empery Tax Efficient, LP, Empery Tax Efficient II, LP, Hudson Bay Master Fund
Ltd., Plaintiffs, against Microbot Medical Inc., Defendant, in the Supreme Court of the State of New York, County of New York (Index No. 651182/2020).
The complaint alleged, among other things, that we breached multiple representations and warranties contained in the Securities Purchase Agreement (the
“SPA”) related to our June 8, 2017 equity financing (the “Financing”), of which the Plaintiffs participated. The complaint seeks rescission of the SPA and
return of the Plaintiffs’ $6.75 million purchase price with respect to the Financing.
Management is unable to assess the likelihood that we would be successful in any trial with respect to the SPA or the Financing, having previously lost
another lawsuit with respect to the Financing. Accordingly, no assurance can be given that if we go to trial and ultimately lose, or if we decide to settle at
any time, such an adverse outcome would not be material to our consolidated financial position. Additionally, in any such case, we will likely be required
to use available cash, or the proceeds from future offerings, towards the rescission or settlement, that we otherwise would have used to build our business
and develop our technologies into commercial products. In such event, we would be required to raise additional capital sooner than we otherwise would, of
which we can give no assurance of success, or delay, curtail or cease the commercialization of some or all of our product candidates.
Microbot has had no revenue and has incurred significant operating losses since inception and is expected to continue to incur significant operating
losses for the foreseeable future. The Company may never become profitable or, if achieved, be able to sustain profitability.
Microbot has incurred significant operating losses since its inception and expects to incur significant losses for the foreseeable future as Microbot continues
its preclinical and clinical development programs for its existing product candidates, primarily the LIBERTY device; its research and development of any
other future product candidates; and all other work necessary to obtain regulatory clearances or approvals for its product candidates in the United States and
other markets. In the future, Microbot intends to continue conducting micro-robotics research and development; performing necessary animal and clinical
testing; working towards medical device regulatory compliance; and, if LIBERTY or other future product candidates are approved or cleared for
commercial distribution, engaging in appropriate sales and marketing activities that, together with anticipated general and administrative expenses, will
likely result in Microbot incurring further significant losses for the foreseeable future.
Microbot is a development-stage medical device company and currently generates no revenue from product sales, and may never be able to commercialize
LIBERTY or other future product candidates. Microbot does not currently have the required approvals or clearances to market or test in humans the
LIBERTY or any other future product candidates and Microbot may never receive them. Microbot does not anticipate generating significant revenues until
it can successfully develop, commercialize and sell products derived from its product pipeline, of which Microbot can give no assurance. Even if Microbot
or any of its future development partners succeed in commercializing any of its product candidates, Microbot may never generate revenues significant
enough to achieve profitability.
Because of the numerous risks and uncertainties associated with its product development pipeline and strategy, Microbot cannot accurately predict when it
will achieve profitability, if ever. Failure to become and remain profitable would depress the value of the Company and could impair its ability to raise
capital, which may force the Company to curtail or discontinue its research and development programs and/or day-to-day operations. Furthermore, there
can be no assurance that profitability, if achieved, can be sustained on an ongoing basis.
Microbot has a limited operating history outside of being a development-stage, pre-clinical, research and development company, which may make it
difficult to evaluate the prospects for the Company’s future viability.
Microbot has a limited operating history upon which an evaluation of its business plan or performance and prospects can be made. The business and
prospects of Microbot must be considered in the light of the potential problems, delays, uncertainties and complications that may be encountered in
connection with a newly established business. The risks include, but are not limited to, the possibility that Microbot will not be able to develop functional
and scalable products, or that although functional and scalable, its products will not be economical to market; that its competitors hold proprietary rights
that may preclude Microbot from marketing such products; that its competitors market a superior or equivalent product; that Microbot is not able to
upgrade and enhance its technologies and products to accommodate new features and expanded service offerings; or the failure to receive necessary
regulatory clearances or approvals for its products. To successfully introduce and market its products at a profit, Microbot must establish brand name
recognition and competitive advantages for its products. There are no assurances that Microbot can successfully address these challenges. If it is
unsuccessful, Microbot and its business, financial condition and operating results could be materially and adversely affected.
Microbot’s operations to date have been limited to organizing the company, entering into licensing arrangements to initially obtain rights to its
technologies, developing and securing its technologies, raising capital, developing regulatory and reimbursement strategies for its product candidates,
preparing for pre-clinical and clinical trials of product candidates from time to time and, most recently, commencing pre-commercialization planning for
the LIBERTY device. Microbot has not yet demonstrated its ability to successfully complete development of any product candidate, obtain marketing
clearance or approval, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities
necessary for successful product commercialization. Consequently, any predictions made about Microbot’s future success or viability may not be as
accurate as they could be if Microbot had a longer operating history.
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Microbot will need additional funding. If Microbot is unable to raise capital when needed, it could be forced to delay, reduce or eliminate its product
development programs or commercialization efforts.
To date, Microbot has funded its operations primarily through offerings of debt and equity securities and grants. Microbot does not know when, or if, it will
generate any revenue, but does not expect to generate significant revenue unless and until it obtains regulatory clearance or approval of and commercializes
one of its current or future product candidates. It is anticipated that the Company will continue to incur losses for the foreseeable future, and that losses will
increase as it continues the development of, and seeks regulatory review of, its product candidates, and begins to commercialize any approved or cleared
products following a successful regulatory review.
Microbot expects the research and development expenses of the Company to continue to increase substantially in future periods as it conducts pre-clinical
studies in large animals and potentially clinical trials for its product candidates, and especially if it initiates additional research programs for future product
candidates. This is the case even with the recent suspension of the research and development program relating to the SCS device. In addition, if the
Company obtains marketing clearance or approval for any of its product candidates, it expects to incur significant commercialization expenses related to
product manufacturing, marketing and sales. Microbot may also require additional funds for operations if it loses its current lawsuit with Empery and
Hudson Bay, discussed in great detail elsewhere in this Annual Report on Form 10-K. Furthermore, Microbot incurs substantial costs associated with
operating as a public company in the United States. Accordingly, the Company may need to obtain substantial additional funding in connection with its
continuing operations through its projected profitability, of which it can give no assurance of success. If the Company is unable to raise capital when
needed or on attractive terms, it could be forced to delay, reduce or eliminate its research and development programs or any future commercialization
efforts.
The Company intends to continue to opportunistically strengthen its balance sheet by raising additional funds through equity offerings, including possibly
through its existing At-the-Market offering, or otherwise in order to meet expected future liquidity needs, including the introduction of LIBERTY. The
Company’s future capital requirements, generally, will depend on many factors, including:
● the timing and outcomes of the product candidates’ regulatory reviews, subsequent approvals or clearances, or other regulatory actions;
● the final outcome of the Company’s existing lawsuit with Empery and Hudson Bay;
● the costs, design, duration and any potential delays of the clinical trials that could be conducted at the FDA’s request using Microbot’s product
candidates;
● the costs of acquiring, licensing or investing in new and existing businesses, product candidates and technologies;
● the costs to maintain, expand and defend the scope of Microbot’s intellectual property portfolio;
● the costs to secure or establish sales, marketing and commercial manufacturing capabilities or arrangements with third parties regarding same;
● the Company’s need and ability to hire additional management and scientific and medical personnel; and
● the costs to operate as a public company in the United States.
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We may still be subject to significant disruptions to our clinical trials or other business operations as a result of the COVID-19 pandemic, which
could have a material adverse effect on our business.
Although we have not yet commenced clinical trials, in the event the coronavirus pandemic or another pandemic is continuing when we are prepared to
commence such trials, the coronavirus disease may cause significant delays and disruptions to our clinical trials and our interactions with the FDA. If the
patients involved with any such clinical trials become infected with the coronavirus disease, we may have more AEs and deaths in our clinical trials as a
result. We may also face difficulties enrolling patients in our clinical trials if the patient populations that are eligible for our clinical trials are impacted by
the coronavirus or other disease. Additionally, if our clinical trial patients are unable to travel to our clinical trial sites as a result of quarantines or other
restrictions resulting from the coronavirus or other disease, we may experience higher drop-out rates or delays in our clinical trials, and some patients may
not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which could impact our ability
to determine the efficacy or safety of our LIBERTY device. Site initiation and patient enrollment may also be delayed due to prioritization of hospital
resources toward the coronavirus disease outbreak.
Additionally, travel restrictions and expanded screenings may be implemented locally or worldwide in an effort to contain the coronavirus or other disease.
As such, we and our contract research organizations may be unable to visit our trial sites and monitor the data from our trials on timely basis. Our
employees may also face travel restrictions, which would impact our business. Furthermore, some of our manufacturers and suppliers are in Europe and
Asia and may be impacted by port closures and other restrictions resulting from any such outbreak, which may disrupt our supply chain or limit our ability
to obtain sufficient materials for our products.
The ultimate impact of the coronavirus disease outbreak or a similar health epidemic is highly uncertain and subject to change, and we cannot presently
predict the scope and severity of any further potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage,
including the suppliers, clinical trial sites, contract research organizations, regulators, including the FDA health care providers and other third parties with
whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business and operations could be
materially and negatively impacted, which could prevent or delay us from obtaining approval for our LIBERTY device.
Risks Relating to the Development and Commercialization of Microbot’s Product Candidates
Unsuccessful animal studies, clinical trials or procedures relating to product candidates under development could have a material adverse effect on
Microbot’s prospects.
The regulatory approval process for new products and new indications for existing products requires extensive data and procedures, including the
development of regulatory and quality standards and, potentially, certain clinical studies. Unfavorable or inconsistent data from current or future clinical
trials or other studies conducted by Microbot or third parties, or perceptions regarding such data, could adversely affect Microbot’s ability to obtain
necessary device clearance or approval and the market’s view of Microbot’s future prospects.
Failure to successfully complete the studies or trials in a timely and cost-effective manner could have a material adverse effect on Microbot’s prospects
with respect to the LIBERTY device or other product candidates. Because animal trials, clinical trials and other types of scientific studies are inherently
uncertain, there can be no assurance that these trials or studies will be completed in a timely or cost-effective manner or result in a commercially viable
product. Clinical trials or studies may experience significant setbacks even if earlier preclinical or animal studies have shown promising results.
Furthermore, preliminary results from clinical trials may be contradicted by subsequent clinical analysis. Results from clinical trials may also not be
supported by actual long-term studies or clinical experience. If preliminary clinical results are later contradicted, or if initial results cannot be supported by
actual long-term studies or clinical experience, Microbot’s business could be adversely affected. Clinical trials also may be suspended or terminated by us,
the FDA or other regulatory authorities at any time if it is believed that the trial participants face unacceptable health risks. The FDA may disagree with our
interpretation of the data from our clinical trials, or may find the clinical trial design, conduct or results inadequate to demonstrate safety and effectiveness
of the product candidate. The FDA may also require additional pre-clinical studies or clinical trials which could further delay approval of our product
candidates.
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Microbot’s business depends heavily on the success of its sole lead product candidate, the LIBERTY. If Microbot is unable to commercialize the
LIBERTY, or experiences significant delays in doing so, Microbot’s business will be materially harmed.
Generally, after all necessary clinical and performance data supporting the safety and effectiveness of the LIBERTY device, or any other product candidate,
are collected, Microbot must still obtain FDA clearance or approval to market the device and those regulatory processes can take several months to several
years to be completed. Therefore, Microbot’s ability to generate product revenues will not occur for at least the next few years, if at all, and will depend
heavily on the successful commercialization of the LIBERTY device, or any of our other product candidates from time to time. The success of
commercializing any of our product candidates, include the LIBERTY device, will depend on a number of factors, including the following:
● our ability to obtain additional capital;
● successful completion of animal studies and, if necessary, human clinical trials and the collection of sufficient data to demonstrate that the device
is safe and effective for its intended use;
● receipt of marketing approvals or clearances from the FDA and other applicable regulatory authorities;
● establishing commercial manufacturing arrangements with one or more third parties;
● obtaining and maintaining patent and trade secret protections;
● protecting Microbot’s rights in its intellectual property portfolio;
● establishing sales, marketing and distribution capabilities;
● generating commercial sales, if and when approved, whether alone or in collaboration with other entities;
● acceptance of our product candidates, if and when commercially launched, by the medical community, patients and third-party payors;
● effectively competing with existing and competitive products on the market and any new competing products that may enter the market; and
● maintaining quality and an acceptable safety profile of our products following clearance or approval.
We recently suspended our SCS research and development program as a result of, among other things, some of the above factors, and our short and
medium term success is no longer tied to multiple product candidates but rather just the LIBERTY device. If Microbot does not achieve one or more of
these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize the LIBERTY or any other
product candidate, which would materially harm its business.
The results of Microbot’s research and development efforts are uncertain and there can be no assurance of the commercial success of Microbot’s
product candidates.
Microbot believe that its success will depend in part on its ability to expand its product offerings and continue to improve its existing product candidates in
response to changing technologies, customer demands and competitive pressures. As such, Microbot expects to continue dedicating significant resources in
research and development. The product candidates and services being developed by Microbot may not be technologically successful. In addition, the length
of Microbot’s product candidates and service development cycle may be greater than Microbot originally expected.
Microbot’s ability to expand its technology platforms for other uses may be limited.
After spending time working with experts in the field, Microbot has decided to no longer pursue the use of TipCAT in colonoscopy and has instead
committed to focus on expanding all of its technology platforms for use in segments of the endovascular, cardiovascular and neurosurgery markets.
Microbot’s ability to expand its technology platforms for use in such markets will be limited by its ability to develop and/or refine the necessary
technology, obtain the necessary regulatory approvals for their use on humans, and the marketing of its products and otherwise obtaining market acceptance
of its product in the United States and in other countries.
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At this time, Microbot does not know the extent of the clinical trial that the FDA will require it to submit in support of its future marketing applications
for its LIBERTY product candidate, which creates uncertainty for Microbot as well as the possibility of increased product development costs and time
to market.
Microbot has identified a predicate device for the LIBERTY device, which it intended to use in its 510(k) application. However, , there is no guarantee that
the FDA will agree with the Company’s determination or that the FDA would accept the predicate device that Microbot intends to submit in its 510(k). The
FDA also may request additional data in response to a 510(k) or require Microbot to conduct further testing or compile more data in support of its 510(k). It
is unclear at this time whether and how various activities initiated or announced by the FDA to modernize the U.S. medical device regulatory system could
affect the marketing pathway or timeline for our product candidate, given their nature.
The FDA requires clinical data to be submitted as part of the LIBERTY marketing submission, any type of clinical study performed in humans will require
the investment of substantial expense, professional resources and time. In order to conduct a clinical investigation involving human subjects for the purpose
of demonstrating the safety and effectiveness of a medical device, a company must, among other things, apply for and obtain Institutional Review Board, or
IRB, approval of the proposed investigation. In addition, the sponsor of the investigation must also submit and obtain FDA approval of an Investigational
Device Exemption, or IDE, application. Microbot may not be able to obtain FDA and/or IRB approval to undertake clinical trials in the United States for
any new devices Microbot intends to market in the United States in the future. Moreover, the timing of the commencement, continuation and completion of
any future clinical trial may be subject to significant delays attributable to various causes, including scheduling conflicts with participating clinicians and
clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility criteria, failure of patients to complete the clinical trial, delay
in or failure to obtain IRB approval to conduct a clinical trial at a prospective site, and shortages of supply in the investigational device.
Thus, the addition of one or more mandatory clinical trials to the development timeline for the LIBERTY or any other product candidate would
significantly increase the costs associated with developing and commercializing the product and delay the timing of U.S. regulatory authorization. The
current uncertainty regarding near-term medical device regulatory changes by the FDA could further affect our development plans for the LIBERTY or any
other product candidate, depending on their nature, scope and applicability. Microbot and its business, financial condition and operating results could be
materially and adversely affected as a result of any such costs, delays or uncertainty.
Microbot’s One & Done technology is subject to a buy-back clause which, if triggered, could cause us to lose rights to the technology and delay or
curtail the development of our products.
Pursuant to the agreement we entered into in January 2018 to acquire the One & Done technology, we are required to meet certain commercialization
deadlines or CardioSert may terminate the agreement and buy back the technology for $1.00, subject to certain limited exceptions. One of the exceptions in
the agreement is if “The First Commercial Sale does not occur within 50 months of the Effective Date” of the contract. 50 months have expired in 2022 and
Microbot did not meet the commercialization deadlines.
Our failure to meet the applicable commercialization deadline could therefore result in the sale back of the technology to CardioSert. Although we have not
yet been notified of any such election, any such sale could materially adversely affect our ability to develop and commercialize, or materially delay the
development and commercialization of, our planned One & Done technology.
Microbot will depend upon the ability of third parties, including contract research organizations, collaborative academic groups, future clinical trial
sites and investigators, to conduct or to assist the Company in conducting clinical trials for its product candidates, if such trials become necessary.
As a development-stage, pre-clinical company, Microbot has no prior experience in designing, initiating, conducting and monitoring human clinical trials.
Microbot will depend upon its ability and/or the ability of future collaborators, contract research organizations, clinical trial sites and investigators to
successfully design, initiate, conduct and monitor such clinical trials.
Failure by Microbot or by any of these future collaborating parties to timely and effectively initiate, conduct and monitor a future clinical trial could
significantly delay or materially impair Microbot’s ability to complete those clinical trials and/or obtain regulatory clearance or approval of its product
candidates and, consequently, could delay or materially impair its ability to generate revenues from the commercialization of those products.
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If the commercial opportunity for LIBERTY and any other commercial products that may be developed by Microbot is smaller than Microbot
anticipates, Microbot’s future revenue from LIBERTY and such other products will be adversely affected and Microbot’s business will suffer.
If the size of the commercial opportunities in any of Microbot’s target markets is smaller than it anticipates, Microbot may not be able to achieve
profitability and growth. It is difficult to predict the penetration, future growth rate or size of the market for Microbot’s product candidate.
The commercial success of LIBERTY or any other product candidates will require broad acceptance of the devices by the doctors and other medical
professionals who specialize in the procedures targeted by each device, a limited number of whom may be able to influence device selection and
purchasing decisions. If Microbot’s technologies are not broadly accepted and perceived as having significant advantages over existing medical devices,
then it will not meet its business objectives. Such perceptions are likely to be based on a determination by medical facilities and physicians that Microbot’s
product candidates are safe and effective, are cost-effective in comparison to existing devices, and represent acceptable methods of treatment. Microbot
cannot assure that it will be able to establish the relationships and arrangements with medical facilities and physicians necessary to support the market
uptake of its product candidates. In addition, its competitors may develop new technologies for the same markets Microbot is targeting that are more
attractive to medical facilities and physicians. If doctors and other medical professionals do not consider Microbot product candidates to be suitable for
application in the procedures we are targeting and an improvement over the use of existing or competing products, Microbot’s business goals will not be
realized.
Customers will be unlikely to buy the LIBERTY or any other product candidates unless Microbot can demonstrate that they can be produced for sale to
consumers at attractive prices.
To date, Microbot has focused primarily on research and development of the LIBERTY device and first generation versions of other current and former
product candidates. Consequently, Microbot has no experience in manufacturing its product candidates, and intends to manufacture its product candidates
through third-party manufacturers. Microbot can offer no assurance that either it or its manufacturing partners will develop efficient, automated, low-cost
manufacturing capabilities and processes to meet the quality, price, engineering, design and production standards or production volumes required to
successfully mass produce its commercial products. Even if its manufacturing partners are successful in developing such manufacturing capability and
quality processes, including the assurance of GMP-compliant device manufacturing, there can be no assurance that Microbot can timely meet its product
commercialization schedule or the production and delivery requirements of potential customers. A failure to develop such manufacturing processes and
capabilities could have a material adverse effect on Microbot’s business and financial results.
The proposed price of Microbot’s product candidates, once approved for sale, will be dependent on material and other manufacturing costs. Microbot
cannot offer any assurances that its manufacturing partner will be able manufacture its product candidates at a competitive price or that achieving cost
reductions will not cause a reduction in the performance, reliability and longevity of its product candidates.
Microbot will rely on third party design houses for the redesign of the One & Done guidewire to other specific indications.
Since the One & Done guidewire was originally designed for treating chronic total occlusions, the design will need to be modified to treat other indications.
As we do not specialize in the design of guidewires and microcatheters, Microbot worked with two design houses that specialize in design and high volume
production of guidewires and microcatheters to define the guidewire conceptual design. We are now exploring the option to progress with one of the two
design houses to resume the next phases of the project. Such designs may require several design and regulatory iterations prolonging the product release
and certification, which could delay the commercialization of our One & Done technology and possibly the LIBERTY device.
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Microbot has relied on, and intends to continue to rely on, third-party manufacturers to produce its product candidates.
Microbot currently relies, and expects to rely for the foreseeable future, on third-party manufacturers to produce and supply its product candidates, and it
expects to rely on third parties to manufacture the commercialized products as well, should they receive the necessary regulatory clearance or approval.
Reliance on third-party manufacturers entails risks to which Microbot would not be subject if Microbot manufactured its product candidates or future
commercial products itself, including:
● limitations on supply availability resulting from capacity, internal operational problems or scheduling constraints of third parties;
● potential regulatory non-compliance or other violations by the third-party manufacturer that could result in quality assurance;
● the possible breach of manufacturing agreements by third parties because of various factors beyond Microbot’s control; and
● the possible termination or non-renewal of manufacturing agreements by third parties for various reasons beyond Microbot’s control, at a time that
is costly or inconvenient to Microbot.
If Microbot is not able to maintain its key manufacturing relationships, Microbot may fail to find replacement manufacturers or develop its own
manufacturing capabilities, which could delay or impair Microbot’s ability to obtain regulatory clearance or approval for its product candidates and could
substantially increase its costs or deplete profit margins, if any. If Microbot does find replacement manufacturers, Microbot may not be able to enter into
agreements with them on terms and conditions favorable to it and there could be a substantial delay before new facilities could be qualified and registered
with the FDA and other foreign regulatory authorities.
Additionally, the existing design of the CardioSert device was produced in very low quantities by the seller of the technology. Accordingly, the scaling-up
to high volume production may require significant changes to the existing design and production methods. Microbot worked with two leading third party
companies that specialize in design and high-volume production of guidewires and microcatheters to conceptually define the required changes and
modifications, and we are considering to progress with one of these two design houses to define the next phases of the project. These design
changes/modifications may have significant negative implications in price and time to market of the CardioSert system.
If Microbot’s product candidates are not considered to be a safe and effective alternative to existing technologies, Microbot will not be commercially
successful.
The LIBERTY and our other product candidates rely on new technologies, and Microbot’s success will depend on acceptance of these technologies by the
medical community as safe, clinically effective, cost effective and a preferred device as compared to products of its competitors. Microbot does not have
long-term data regarding efficacy, safety and clinical outcomes associated with the use of LIBERTY or our other product candidates. Any data that is
generated in the future may not be positive or may not support the product candidates’ regulatory dossiers, which would negatively affect market
acceptance and the rate at which its product candidates are adopted. Equally important will be physicians’ perceptions of the safety of Microbot’s product
candidates because Microbot’s technologies are relatively new. If, over the long term, Microbot’s product candidates do not meet surgeons’ expectations as
to safety, efficacy and ease of use, they may not become widely adopted.
Market acceptance of Microbot’s product candidates will also be affected by other factors, including Microbot’s ability to convince key opinion leaders to
provide recommendations regarding its product candidates; convince distributors that its technologies are attractive alternatives to existing and competing
technologies; supply and service sufficient quantities of products directly or through marketing alliances; and price products competitively in light of the
current macroeconomic environment, which is increasingly price sensitive.
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Microbot may be subject to penalties and may be precluded from marketing its product candidates if Microbot fails to comply with extensive
governmental regulations.
Microbot believes that its medical device product candidates will be categorized as Class II devices, which typically require a 510(k) or 510(k) de-novo
premarket submission to the FDA. However, the FDA has not made any determination about whether Microbot’s medical product candidates are Class II
medical devices and may disagree with that classification. If the FDA determines that Microbot’s product candidates should be reclassified as Class III
medical devices, Microbot could be precluded from marketing the devices for clinical use within the United States for months, years or longer, depending
on the specifics of the change in classification. Reclassification of any of Microbot’s product candidates as Class III medical devices could significantly
increase Microbot’s regulatory costs, including the timing and expense associated with required clinical trials and other costs.
The FDA and non-U.S. regulatory authorities require that Microbot product candidates be manufactured according to rigorous standards. These regulatory
requirements significantly increase Microbot’s production costs, which may prevent Microbot from offering products within the price range and in
quantities necessary to meet market demands. If Microbot or one of its third-party manufacturers changes an approved manufacturing process, the FDA
may need to review the process before it may be used. Failure to comply with applicable pre-market and post-market regulatory requirements could subject
Microbot to enforcement actions, including warning letters, fines, injunctions and civil penalties, recall or seizure of its products, operating restrictions,
partial suspension or total shutdown of its production, and criminal prosecution.
If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving its product candidates after
they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.
Healthcare providers and related facilities are generally reimbursed for their services through payment systems managed by various governmental agencies
worldwide, private insurance companies, and managed care organizations. The manner and level of reimbursement in any given case may depend on the
site of care, the procedure(s) performed, the final patient diagnosis, the device(s) utilized, available budget, or a combination of these factors, and coverage
and payment levels are determined at each payor’s discretion. The coverage policies and reimbursement levels of these third-party payors may impact the
decisions of healthcare providers and facilities regarding which medical products they purchase and the prices they are willing to pay for those products.
Microbot cannot assure you that its sales will not be impeded and its business harmed if third-party payors fail to provide reimbursement for Microbot
products that healthcare providers view as adequate.
In the United States, Microbot expects that its product candidates, once approved, will be purchased primarily by medical institutions, which then bill
various third-party payors, such as the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program through Medicare
Administrative Contractors, and other government health care programs and private insurance plans, for the healthcare products and services provided to
their patients. The process involved in applying for coverage and incremental reimbursement from CMS is lengthy and expensive. Moreover, many private
payors look to CMS in setting their reimbursement policies and amounts. If CMS or other agencies limit coverage for procedures utilizing Microbot’s
products or decrease or limit reimbursement payments for doctors and hospitals utilizing Microbot’s products, this may affect coverage and reimbursement
determinations by many private payors.
If a procedure involving a medical device is not reimbursed separately by a government or private insurer, then a medical institution would have to absorb
the cost of Microbot’s products as part of the cost of the procedure in which the products are used. At this time, Microbot does not know the extent to
which medical institutions would consider insurers’ payment levels adequate to cover the cost of its products. Failure by hospitals and surgeons to receive
an amount that they consider to be adequate reimbursement for procedures in which Microbot products are used could deter them from purchasing
Microbot products and limit sales growth for those products.
Microbot has no control over payor decision-making with respect to coverage and payment levels for its medical device product candidates, once they are
approved. Additionally, Microbot expects many payors to continue to explore cost-containment strategies (e.g., comparative and cost-effectiveness
analyses, so-called “pay-for-performance” programs implemented by various public government health care programs and private third-party payors, and
expansion of payment bundling initiatives, and other such methods that shift medical cost risk to providers) that may potentially impact coverage and/or
payment levels for Microbot’s current product candidates or products Microbot develops in the future.
As Microbot’s product offerings are used across diverse healthcare settings, they will be affected to varying degrees by the different payment systems.
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Clinical outcome studies for the LIBERTY may not provide sufficient data to make such product candidates the standard of care.
Microbot’s business plan with respect to the LIBERTY relies on the broad adoption by surgeons of the products for their respective planned applications.
Clinical studies may not show an advantage in LIBERTY based procedures in a timely manner, or at all, and outcome studies have not been designed at this
time, and may be too large and too costly for Microbot to conduct. Both situations could prevent broad adoption of the LIBERTY and materially impact
Microbot’s business.
Microbot products may in the future be subject to mandatory product recalls that could harm its reputation, business and financial results.
The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material
deficiencies or defects in design or manufacture that could pose a risk of injury to patients. In the case of the FDA, the authority to require a recall must be
based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death, although in most cases this mandatory
recall authority is not used because manufacturers typically initiate a voluntary recall when a device violation is discovered. In addition, foreign
governmental bodies have the authority to require the recall of Microbot products in the event of material deficiencies or defects in design or manufacture.
Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall
by Microbot or one of its distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or other deficiencies
and issues. Recalls of any Microbot products would divert managerial and financial resources and have an adverse effect on Microbot’s financial condition
and results of operations, and any future recall announcements could harm Microbot’s reputation with customers and negatively affect its sales. In addition,
the FDA could take enforcement action, including any of the following sanctions for failing to timely report a recall to the FDA:
● untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
● detention or seizure of Microbot products;
● operating restrictions or partial suspension or total shutdown of production;
● refusing or delaying requests for 510(k) clearance or premarket approval of new products or modified products;
● withdrawing 510(k) clearances or other types of regulatory authorizations -that have already been granted;
● refusing to grant export approval for Microbot products; or
● criminal prosecution.
If Microbot’s future commercialized products cause or contribute to a death or a serious injury, Microbot will be subject to Medical Device Reporting
regulations, which can result in voluntary corrective actions or agency enforcement actions.
Under FDA regulations, Microbot will be required to report to the FDA any incident in which a marketed medical device product may have caused or
contributed to a death or serious injury or in which a medical device malfunctioned and, if the malfunction were to recur, would likely cause or contribute
to death or serious injury. In addition, all manufacturers placing medical devices in European Union markets are legally bound to report any serious or
potentially serious incidents involving devices they produce or sell to the relevant authority in whose jurisdiction the incident occurred.
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Microbot anticipates that in the future it is likely that we may experience events that would require reporting to the FDA pursuant to the Medical Device
Reporting (MDR) regulations. Any adverse event involving a Microbot product could result in future voluntary corrective actions, such as product actions
or customer notifications, or agency actions, such as inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or
involuntary, as well as defending Microbot in a lawsuit, will require the dedication of our time and capital, distract management from operating our
business, and may harm our reputation and financial results.
Microbot could be exposed to significant liability claims if Microbot is unable to obtain insurance at acceptable costs and adequate levels or otherwise
protect itself against potential product liability claims.
The testing, manufacture, marketing and sale of medical devices entail the inherent risk of liability claims or product recalls. Product liability insurance is
expensive and may not be available on acceptable terms, if at all. A successful product liability claim or product recall could inhibit or prevent the
successful commercialization of Microbot’s products, cause a significant financial burden on Microbot, or both, which in any case could have a material
adverse effect on Microbot’s business and financial condition.
If Microbot fails to retain certain of its key personnel and attract and retain additional qualified personnel, Microbot might not be able to pursue its
growth strategy effectively.
Microbot is dependent on its senior management, in particular Harel Gadot, Microbot’s Chairman, President and Chief Executive Officer, and Simon
Sharon, its General Manager and Chief Technology Officer. Although Microbot believes that its relationship with members of its senior management is
positive, there can be no assurance that the services of any of these individuals will continue to be available to Microbot in the future. Microbot’s future
success will depend in part on its ability to retain its management and scientific teams, to identify, hire and retain additional qualified personnel with
expertise in research and development and sales and marketing, and to effectively provide for the succession of senior management, when necessary.
Competition for qualified personnel in the medical device industry is intense and finding and retaining qualified personnel with experience in the industry
is very difficult. Microbot believes that there are only a limited number of individuals with the requisite skills to serve in key positions at Microbot,
particularly in Israel, and it competes for key personnel with other medical equipment and technology companies, as well as research institutions.
Microbot does not carry, and does not intend to carry, any key man life insurance policies on any of its existing executive officers.
Risks Relating to International Business
If Microbot fails to obtain regulatory clearances in other countries for its product candidates under development, Microbot will not be able to
commercialize these product candidates in those countries.
In order for Microbot to market its product candidates in countries other than the United States, it must comply with the safety and quality regulations in
such countries.
In Europe, these regulations, including the requirements for approvals, clearance or grant of Conformité Européenne, or CE, Certificates of Conformity and
the time required for regulatory review, vary from country to country. Failure to obtain regulatory approval, clearance or CE Certificates of Conformity (or
equivalent) in any foreign country in which Microbot plans to market its product candidates may harm its ability to generate revenue and harm its business.
Approval and CE marking procedures vary among countries and can involve additional product testing and additional administrative review periods. The
time required to obtain approval or CE Certificate of Conformity in other countries might differ from that required to obtain FDA clearance. The regulatory
approval or CE marking process in other countries may include all of the risks detailed above regarding FDA clearance in the United States. Regulatory
approval or the CE marking of a product candidate in one country does not ensure regulatory approval in another, but a failure or delay in obtaining
regulatory approval or a CE Certificate of Conformity in one country may negatively impact the regulatory process in others. Failure to obtain regulatory
approval or a CE Certificate of Conformity in other countries or any delay or setback in obtaining such approval could have the same adverse effects
described above regarding FDA clearance in the United States.
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Microbot cannot be certain that it will be successful in complying with the requirements of the CE Certificate of Conformity and receiving a CE Mark for
its product candidates or in continuing to meet the requirements of the Medical Devices Directive in the European Economic Area (EEA).
Israel’s Medical Devices Law generally requires the registration of all medical products with the Ministry of Health, or MOH, Registrar through the
submission of an application to the Ministry of Health Medical Institutions and Devices Licensing Department, or AMAR. If the application includes a
certificate issued by a competent authority of a “recognized” country, which includes Australia, Canada, the European Community Member States, Japan or
the United States, the registration process is expedited, but is generally still expected to take 6 to 9 months for approval. If certification from a recognized
country is not available, the registration process takes significantly longer and a license is rarely issued under such circumstances, as the MOH may require
the presentation of significant additional clinical data. Once granted, a license (marketing authorization) for a medical device is valid for five years from the
date of registration of the device, except for implants with a life-supporting function, for which the validity is for only two years from the date of
registration. Furthermore, the holder of the license must meet several additional requirements to maintain the license. Microbot cannot be certain that it will
be successful in applying for a license from the MOH for its product candidates.
Risks Relating to Microbot’s Intellectual Property
Microbot’s right to develop and commercialize the SCS and TipCAT product candidates are subject to the terms and condition of a license granted to
Microbot by Technion Research and Development Foundation Ltd. and termination of the license with respect to one or both of the technology
platforms underlying the product candidates would result in Microbot ceasing its development efforts for the applicable product candidate(s).
Microbot entered into a license agreement with Technion Research and Development Foundation Ltd., or TRDF, in 2012 pursuant to which Microbot
obtained an exclusive, worldwide, royalty-bearing, sub-licensable license to certain patents and inventions relating to the SCS and TipCAT technology
platforms. Pursuant to the terms of the license agreement, in order to maintain the license with respect to each platform, Microbot must use commercially
reasonable efforts to develop products covered by the license, including meeting certain agreed upon development milestones. TRDF has the option to
terminate a license granted with respect a particular technology in the event Microbot fails to meet a development milestone associated with such
technology. Therefore, the failure to meet development milestones may lead to a complete termination of the applicable license agreement and result in
Microbot ceasing its development efforts for the applicable product candidate. The milestone for the TipCAT include commencing first in human clinical
trials in December 2023. The milestones for the SCS include commencing first in human clinical trials by December 2024, and commencing a pivotal study
by June 2027. Failure to meet any development milestone will give TRDF the right to terminate the license with respect to the technology underlying the
missed milestone. TRDF has previously demonstrated flexibility with respect to amending the terms of the license to extend the milestone dates, although
we can give no assurance at this time that TRDF will continue to be so flexible with respect to amending the terms of the license. We have informed TRDF
of our suspension of our SCS research and development program and our plans exploring strategic alternatives for such product and technology. To-date,
TRDF has not taken any action to so terminate the license, although we can give no assurance they will not do so.
Under the license agreement, Microbot is also subject to various other obligations, including obligations with respect to payment upon the achievement of
certain milestones and royalties on product sales. TRDF may terminate the license agreement under certain circumstances, including material breaches by
Microbot or under certain bankruptcy or insolvency events. In the case of termination of the license by Microbot without cause or by TRDF for cause,
TRDF has the right to receive a non-exclusive license from Microbot with respect to improvements to the licensed technologies made by Microbot.
If TRDF were to terminate the license agreement or if Microbot was to otherwise lose the ability to exploit the licensed patents, Microbot’s competitive
advantage with respect to its SCS and TipCAT technology platforms could be reduced or terminated, and Microbot will likely not be able to find a source to
replace the licensed technology.
Additionally, if there is any future dispute between Microbot and TRDF regarding the respective parties’ rights under the license agreement, Microbot’s
ability to develop and commercialize the SCS and TipCAT may be materially harmed, although at this time no material development or commercialization
of either platform is in effect.
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Microbot may not meet its product candidates’ development and commercialization objectives in a timely manner or at all.
Microbot has established internal goals, based upon expectations with respect to its technologies, which Microbot has used to assess its progress toward
developing its product candidates. These goals relate to technology and design improvements as well as to dates for achieving specific development results.
If the product candidates exhibit technical defects or are unable to meet cost or performance goals, Microbot’s commercialization schedule could be
delayed and potential purchasers of its initial commercialized products may decline to purchase such products or may opt to pursue alternative products,
which would materially harm its business.
Intellectual property litigation and infringement claims could cause Microbot to incur significant expenses or prevent Microbot from selling certain of
its product candidates.
The medical device industry is characterized by extensive intellectual property litigation. From time to time, Microbot might be the subject of claims by
third parties of potential infringement or misappropriation. Regardless of outcome, such claims are expensive to defend and divert the time and effort of
Microbot’s management and operating personnel from other business issues. A successful claim or claims of patent or other intellectual property
infringement against Microbot could result in its payment of significant monetary damages and/or royalty payments or negatively impact its ability to sell
current or future products in the affected category and could have a material adverse effect on its business, cash flows, financial condition or results of
operations.
If Microbot or TRDF are unable to protect the patents or other proprietary rights relating to Microbot’s product candidates, or if Microbot infringes on
the patents or other proprietary rights of others, Microbot’s competitiveness and business prospects may be materially damaged.
Microbot’s success depends on its ability to protect its intellectual property (including its licensed intellectual property) and its proprietary technologies.
Microbot’s commercial success depends in part on its ability to obtain and maintain patent protection and trade secret protection for its product candidates,
proprietary technologies, and their uses, as well as its ability to operate without infringing upon the proprietary rights of others.
Microbot currently holds, through licenses or otherwise, an intellectual property portfolio that includes U.S. and international patents and pending patents,
and other patents under development. Microbot intends to continue to seek legal protection, primarily through patents, including the TRDF licensed
patents, for its proprietary technology. Seeking patent protection is a lengthy and costly process, and there can be no assurance that patents will be issued
from any pending applications, or that any claims allowed from existing or pending patents will be sufficiently broad or strong to protect its proprietary
technology. There is also no guarantee that any patents Microbot holds, through licenses or otherwise, will not be challenged, invalidated or circumvented,
or that the patent rights granted will provide competitive advantages to Microbot. Microbot’s competitors have developed and may continue to develop and
obtain patents for technologies that are similar or superior to Microbot’s technologies. In addition, the laws of foreign jurisdictions in which Microbot
develops, manufactures or sells its product candidates may not protect Microbot’s intellectual property rights to the same extent as do the laws of the
United States.
Adverse outcomes in current or future legal disputes regarding patent and other intellectual property rights could result in the loss of Microbot’s intellectual
property rights, subject Microbot to significant liabilities to third parties, require Microbot to seek licenses from third parties on terms that may not be
reasonable or favorable to Microbot, prevent Microbot from manufacturing, importing or selling its product candidates, or compel Microbot to redesign its
product candidates to avoid infringing third parties’ intellectual property. As a result, Microbot may be required to incur substantial costs to prosecute,
enforce or defend its intellectual property rights if they are challenged. Any of these circumstances could have a material adverse effect on Microbot’s
business, financial condition and resources or results of operations.
Microbot has the first right, but not the obligation, to control the prosecution, maintenance or enforcement of the licensed patents from TRDF. However,
there may be situations in which Microbot will not have control over the prosecution, maintenance or enforcement of the patents that Microbot licenses, or
may not have sufficient ability to consult and input into the patent prosecution and maintenance process with respect to such patents. If Microbot does not
control the patent prosecution and maintenance process with respect to the TRDF licensed patents, TRDF may elect to do so but may fail to take the steps
that are necessary or desirable in order to obtain, maintain and enforce the licensed patents.
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Microbot’s ability to develop intellectual property depends in large part on hiring, retaining and motivating highly qualified design and engineering staff
and consultants with the knowledge and technical competence to advance its technology and productivity goals. To protect Microbot’s trade secrets and
proprietary information, Microbot has entered into confidentiality agreements with its employees, as well as with consultants and other parties. If these
agreements prove inadequate or are breached, Microbot’s remedies may not be sufficient to cover its losses.
Dependence on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may result in
Microbot’s payment of significant monetary damages or impact offerings in its product portfolios.
Microbot’s long-term success largely depends on its ability to market technologically competitive product candidates. If Microbot fails to obtain or
maintain adequate intellectual property protection, it may not be able to prevent third parties from using its proprietary technologies or may lose access to
technologies critical to our product candidates. Also, Microbot currently pending or future patent applications may not result in issued patents, and issued
patents are subject to claims concerning priority, scope and other issues.
Furthermore, Microbot has not filed applications for all of our patents internationally and it may not be able to prevent third parties from using its
proprietary technologies or may lose access to technologies critical to its product candidates in other countries.
Risks Relating to Operations in Israel
Microbot has facilities located in Israel, and therefore, political conditions in Israel may affect Microbot’s operations and results.
Microbot has facilities located in Israel. In addition, one of its seven directors, its General Manager and Chief Technology Officer, Chief Medical Officer
and its Chief Financial Officer, as well as substantially all of its research and development team and non-management employees, are residents of Israel.
Accordingly, political, economic and military conditions in Israel will directly or indirectly affect Microbot’s operations and results. Most recently, for
example, the current political situation in Israel where the ruling parties are attempting to implement laws that essentially allow the parliament to enact laws
that are preemptively immune to judicial review could adversely affect our business and results of operations. In addition, since the establishment of the
State of Israel, a number of armed conflicts have taken place between Israel and its Arab neighbors. An ongoing state of hostility, varying in degree and
intensity has led to security and economic problems for Israel. For a number of years there have been continuing hostilities between Israel and the
Palestinians. This includes hostilities with the Islamic movement Hamas in the Gaza Strip, which have adversely affected the peace process and at times
resulted in armed conflicts. Such hostilities have negatively influenced Israel’s economy as well as impaired Israel’s relationships with several other
countries. Israel also faces threats from Hezbollah militants in Lebanon, from ISIS and rebel forces in Syria, from the government of Iran and other
potential threats from additional countries in the region. Moreover, some of Israel’s neighboring countries have recently undergone or are undergoing
significant political changes. These political, economic and military conditions in Israel could have a material adverse effect on Microbot’s business,
financial condition, results of operations and future growth.
Political relations could limit Microbot’s ability to sell or buy internationally.
Microbot could be adversely affected by the interruption or reduction of trade between Israel and its trading partners. Some countries, companies and
organizations continue to participate in a boycott of Israeli firms and others doing business with Israel, with Israeli companies or with Israeli-owned
companies operating in other countries. Foreign government defense export policies towards Israel could also make it more difficult for us to obtain the
export authorizations necessary for Microbot’s activities. Also, over the past several years there have been calls in the United States, Europe and elsewhere
to reduce trade with Israel. There can be no assurance that restrictive laws, policies or practices directed towards Israel or Israeli businesses will not have an
adverse impact on Microbot’s business.
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Israel’s economy may become unstable.
From time to time, Israel’s economy may experience inflation or deflation, low foreign exchange reserves, fluctuations in world commodity prices, military
conflicts and civil unrest. For these and other reasons, the government of Israel has intervened in the economy employing fiscal and monetary policies,
import duties, foreign currency restrictions, controls of wages, prices and foreign currency exchange rates and regulations regarding the lending limits of
Israeli banks to companies considered to be in an affiliated group. The Israeli government has periodically changed its policies in these areas. Reoccurrence
of previous destabilizing factors could make it more difficult for Microbot to operate its business and could adversely affect its business.
Exchange rate fluctuations between the U.S. dollar and the NIS currencies may negatively affect Microbot’s operating costs.
A significant portion of Microbot’s expenses are paid in New Israeli Shekels, or NIS, but its financial statements are denominated in U.S. dollars. As a
result, Microbot is exposed to the risks that the NIS may appreciate relative to the U.S. dollar, or the NIS instead devalues relative to the U.S. dollar, and
the inflation rate in Israel may exceed such rate of devaluation of the NIS, or that the timing of such devaluation may lag behind inflation in Israel. In any
such event, the U.S. dollar cost of Microbot’s operations in Israel would increase and Microbot’s U.S. dollar-denominated results of operations would be
adversely affected. Microbot cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation (if any) of the NIS against the U.S.
dollar.
Microbot’s primary expenses paid in NIS that are not linked to the U.S. dollar are employee expenses in Israel and lease payments on its Israeli facility. If
Microbot is unsuccessful in hedging against its position in NIS, a change in the value of the NIS compared to the U.S. dollar could increase Microbot’s
research and development expenses, labor costs and general and administrative expenses, and as a result, have a negative impact on Microbot’s profits.
Funding and other benefits provided by Israeli government programs may be terminated or reduced in the future and the terms of such funding may
have a significant impact on future corporate decisions.
Microbot participates in programs under the auspices of the Israeli Innovation Authority, for which it receives funding for the development of its
technologies and product candidates. If Microbot fails to comply with the conditions applicable to this program, it may be required to pay additional
penalties or make refunds and may be denied future benefits. From time to time, the government of Israel has discussed reducing or eliminating the benefits
available under this program, and therefore these benefits may not be available in the future at their current levels or at all.
Microbot’s research and development efforts from inception until now have been financed in part through such Israeli Innovation Authority royalty bearing
grants in an aggregate amount of approximately $1,500,000 through December 31, 2022, In addition, as a result of our 2018 agreement with CardioSert and
our 2022 agreement with Nitiloop, we took over the liability to repay CardioSert’s and Nitiloop’s IIA grants in the aggregate amount of approximately
$530,000 and $925,000, respectively.
With respect to such grants Microbot is committed to pay royalties at a rate of between 3% to 3.5% on sales proceeds up to the total amount of grants
received, linked to the dollar, plus interest at an annual rate of USD LIBOR. In addition, as a recipient of Israeli Innovation Authority grants, Microbot
must comply with the requirements of the Israeli Encouragement of Industrial Research and Development Law, 1984, or the R&D Law, and related
regulations. Under the terms of the grants and the R&D Law, Microbot is restricted from transferring any technologies, know-how, manufacturing or
manufacturing rights developed using Israeli Innovation Authority grants outside of Israel without the prior approval of Israeli Innovation Authority.
Therefore, if aspects of its technologies are deemed to have been developed with Israeli Innovation Authority funding, the discretionary approval of an
Israeli Innovation Authority committee would be required for any transfer to third parties outside of Israel of the technologies, know-how, manufacturing or
manufacturing rights related to such aspects. Furthermore, the Israeli Innovation Authority may impose certain conditions on any arrangement under which
it permits Microbot to transfer technology or development outside of Israel or may not grant such approvals at all.
If approved, the transfer of Israeli Innovation Authority-supported technology or know-how outside of Israel may involve the payment of significant fees,
which will depend on the value of the transferred technology or know-how, the total amount Israeli Innovation Authority funding received by Microbot, the
number of years since the funding and other factors. These restrictions and requirements for payment may impair Microbot’s ability to sell its technology
assets outside of Israel or to outsource or transfer development or manufacturing activities with respect to any product or technology outside of Israel.
Furthermore, the amount of consideration available to Microbot’s shareholders in a transaction involving the transfer of technology or know-how
developed with Israeli Innovation Authority funding outside of Israel (such as through a merger or other similar transaction) may be reduced by any
amounts that Microbot is required to pay to the Israeli Innovation Authority.
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Some of Microbot’s employees and officers are obligated to perform military reserve duty in Israel.
Generally, Israeli adult male citizens and permanent residents are obligated to perform annual military reserve duty up to a specified age. They also may be
called to active duty at any time under emergency circumstances, which could have a disruptive impact on Microbot’s workforce.
It may be difficult to enforce a non-Israeli judgment against Microbot or its officers and directors.
The operating subsidiary of the Company is incorporated in Israel. Some of Microbot’s executive officers and directors are not residents of the United
States, and a substantial portion of Microbot’s assets and the assets of its executive officers and directors are located outside the United States. Therefore, a
judgment obtained against Microbot, or any of these persons, including a judgment based on the civil liability provisions of the U.S. federal securities laws,
may not be collectible in the United States and may not necessarily be enforced by an Israeli court. It also may be difficult to affect service of process on
these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel. Additionally, it may be difficult for an
investor, or any other person or entity, to initiate an action with respect to U.S. securities laws in Israel. Israeli courts may refuse to hear a claim based on
an alleged violation of U.S. securities laws reasoning that Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an
Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the
content of applicable U.S. law often involves the testimony of expert witnesses, which can be a time consuming and costly process. Certain matters of
procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters described above. As a result of the
difficulty associated with enforcing a judgment against Microbot in Israel, it may be impossible to collect any damages awarded by either a U.S. or foreign
court.
Risks Relating to Microbot’s Securities, Governance and Other Matters
If we fail to comply with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted and the price of our
common stock and our ability to access the capital markets could be negatively impacted.
Our common stock is currently listed on the Nasdaq Capital Market. In order to maintain that listing, we must satisfy minimum financial and other
continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum
stockholders’ equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to comply with
the applicable listing standards. In 2018, we effected a 1:15 reverse stock split to address our stock price falling below the minimum share price required by
Nasdaq. Failure to again meet applicable Nasdaq continued listing standards could result in a delisting of our common stock. A delisting of our common
stock from The Nasdaq Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the
price of our common stock. In addition, delisting could harm our ability to raise capital on terms acceptable to us, or at all, and may result in the potential
loss of confidence by investors, employees and fewer business opportunities. Additionally, if we are not eligible for quotation or listing on another
exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted
securities such as the OTC Marketplace. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common
stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common
stock to decline further.
We do not expect to pay cash dividends on our common stock.
We anticipate that we will retain our earnings, if any, for future growth and therefore do not anticipate paying cash dividends on our Common Stock in the
future. Investors seeking cash dividends should not invest in our Common Stock for that purpose.
33
Anti-takeover provisions in the Company’s charter and bylaws under Delaware law may prevent or frustrate attempts by stockholders to change the
board of directors or current management and could make a third-party acquisition of the Company difficult.
Provisions in the Company’s certificate of incorporation and bylaws may delay or prevent an acquisition or a change in management. These provisions
include a classified board of directors. In addition, because the Company is incorporated in Delaware, it is governed by the provisions of Section 203 of the
DGCL, which prohibits stockholders owning in excess of 15% of outstanding voting stock from merging or combining with the Company. Although the
Company believes these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with the
Company’s board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may
frustrate or prevent any attempts by the Company’s stockholders to replace or remove then current management by making it more difficult for
stockholders to replace members of the board of directors, which is responsible for appointing members of management.
General Risks
Raising additional capital may cause dilution to the Company’s investors, restrict its operations or require it to relinquish rights to its technologies or
product candidates.
Until such time, if ever, as the Company can generate substantial product revenues, it expects to finance its cash needs through a combination of equity
offerings, including possibly through its existing At-the-Market offering, licensing, collaboration or similar arrangements, grants and debt financings. The
Company does not have any committed external source of funds. To the extent that the Company raises additional capital through the sale of equity or
convertible debt securities, the ownership interest of its stockholders will be diluted, and the terms of these securities may include liquidation or other
preferences that adversely affect the rights of holder of the Company’s common stock. Debt financing, if available, may involve agreements that include
covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring
dividends or other distributions, selling or licensing intellectual property rights, and other operating restrictions that could adversely affect the Company’s
ability to conduct its business.
If the Company raises additional funds through licensing, collaboration or similar arrangements, it may have to relinquish valuable rights to its
technologies, future revenue streams, research and development programs or product candidates or to grant licenses on terms that may not be favorable to
the Company. If the Company is unable to raise additional funds through equity or debt financings or other arrangements when needed, it may be required
to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market product candidates
that it would otherwise prefer to develop and market itself.
34
Microbot operates in a competitive industry and if its competitors have products that are marketed more effectively or develop products, treatments or
procedures that are similar, more advanced, safer or more effective, its commercial opportunities will be reduced or eliminated, which would materially
harm its business.
Our competitors may develop products, treatments or procedures that directly compete with our products and potential products and which are similar,
more advanced, safer or more effective than ours. The medical device industry is very competitive and subject to significant technological and practice
changes. Microbot expects to face competition from many different sources with respect to the LIBERTY and other products that it is seeking to develop or
commercialize with respect to its other product candidates in the future.
Competing against large established competitors with significant resources may make establishing a market for any products that it develops difficult which
would have a material adverse effect on Microbot’s business. Microbot’s commercial opportunities could also be reduced or eliminated if its competitors
develop and commercialize products, treatments or procedures quicker, that are safer, more effective, are more convenient or are less expensive than the
LIBERTY or any product that Microbot may develop. Many of Microbot’s potential competitors have significantly greater financial resources and expertise
in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products
than Microbot may have. Mergers and acquisitions in the medical device industry market may result in even more resources being concentrated among a
smaller number of Microbot’s potential competitors.
Our business strategy in part relies on identifying, acquiring and developing complementary technologies and products, which entails risks which could
negatively affect our business, operations and financial condition.
We have in the past and may again in the future pursue other acquisitions of businesses and technologies. Acquisitions entail numerous risks, including:
● difficulties in the integration of acquired operations, services and products;
● failure to achieve expected synergies;
● diversion of management’s attention from other business concerns;
● assumption of unknown material liabilities of acquired companies;
● amortization of acquired intangible assets, which could reduce future reported earnings;
● potential loss of clients or key employees of acquired companies; and
● dilution to existing stockholders.
As part of our growth strategy, we may consider, and from time to time may engage in, discussions and negotiations regarding transactions, such as
acquisitions, mergers and combinations within our industry. The purchase price for possible acquisitions could be paid in cash, through the issuance of
common stock or other securities, borrowings or a combination of these methods.
We cannot be certain that we will be able to identify, consummate and successfully integrate acquisitions, and no assurance can be given with respect to the
timing, likelihood or business effect of any possible transaction. For example, we could begin negotiations that we subsequently decide to suspend or
terminate for a variety of reasons. However, opportunities may arise from time to time that we will evaluate. Any transactions that we consummate would
involve risks and uncertainties to us. These risks could cause the failure of any anticipated benefits of an acquisition to be realized, which could have a
material adverse effect on our business, financial condition, results of operations and prospects.
35
Microbot operations in international markets involve inherent risks that Microbot may not be able to control.
Microbot’s business plan includes the marketing and sale of its proposed product candidates internationally, and specifically in Europe and Israel.
Accordingly, Microbot’s results could be materially and adversely affected by a variety of factors relating to international business operations that it may or
may not be able to control, including:
● adverse macroeconomic conditions affecting geographies where Microbot intends to do business;
● closing of international borders, including as a result of biohazards or pandemics;
● foreign currency exchange rates;
● political or social unrest or economic instability in a specific country or region;
● higher costs of doing business in certain foreign countries;
● infringement claims on foreign patents, copyrights or trademark rights;
● difficulties in staffing and managing operations across disparate geographic areas;
● difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems;
● trade protection measures and other regulatory requirements, which affect Microbot’s ability to import or export its product candidates from or to
various countries;
● adverse tax consequences;
● unexpected changes in legal and regulatory requirements;
● military conflict, terrorist activities, natural disasters and medical epidemics; and
● Microbot’s ability to recruit and retain channel partners in foreign jurisdictions.
Microbot’s financial results may be affected by fluctuations in exchange rates and Microbot’s current currency hedging strategy may not be sufficient
to counter such fluctuations.
Microbot’s financial statements are denominated in U.S. dollars and the financial results of the Company are denominated in U.S. dollars, while a
significant portion of Microbot’s business is conducted, and a substantial portion of its operating expenses are payable, in currencies other than the U.S.
dollar. Exchange rate fluctuations may have an adverse impact on Microbot’s future revenues or expenses as presented in the financial statements. Microbot
may in the future use financial instruments, such as forward foreign currency contracts, in its management of foreign currency exposure. These contracts
would primarily require Microbot to purchase and sell certain foreign currencies with or for U.S. dollars at contracted rates. Microbot may be exposed to a
credit loss in the event of non-performance by the counterparties of these contracts. In addition, these financial instruments may not adequately manage
Microbot’s foreign currency exposure. Microbot’s results of operations could be adversely affected if Microbot is unable to successfully manage currency
fluctuations in the future.
The market price for our Common Stock may be volatile.
The market price for our Common Stock may be volatile and subject to wide fluctuations in response to factors including the following:
● actual or anticipated fluctuations in our quarterly or annual operating results;
● changes in financial or operational estimates or projections;
● conditions in markets generally;
● changes in the economic performance or market valuations of companies similar to ours;
● announcements by us or our competitors of new products, acquisitions, strategic partnerships, joint ventures or capital commitments;
● our intellectual property position; and
● general economic or political conditions in the United States, Israel or elsewhere.
In addition, the securities market has from time to time experienced significant price and volume fluctuations that are not related to the operating
performance of particular companies. These market fluctuations may also materially and adversely affect the market price of shares of our Common Stock.
36
The issuance of shares upon exercise of outstanding warrants and options could cause immediate and substantial dilution to existing stockholders.
The issuance of shares upon exercise of warrants and options could result in substantial dilution to the interests of other stockholders since the holders of
such securities may ultimately convert and sell the full amount issuable on conversion.
Item 1B. Unresolved Staff Comments
Not Applicable.
Item 2. Description of Property.
Microbot’s principal executive office is located at 25 Recreation Drive, Unit 108, Hingham, MA 02043. Microbot also occupies facilities in premises of
approximately 6,975 square feet at 6 Hayozma St., Yokneam, P.O.B. 242, Israel. This facility is expected to provide the space and infrastructure necessary
to accommodate its development work based on its current operating plan. Microbot does not own any real property.
Item 3. Legal Proceedings.
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. However, litigation
is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm business.
Litigation Resulting from 2017 Financing
We were named as the defendant in a lawsuit captioned Empery Asset Master Ltd., Empery Tax Efficient, LP, Empery Tax Efficient II, LP, Hudson Bay
Master Fund Ltd., Plaintiffs, against Microbot Medical Inc., Defendant, in the Supreme Court of the State of New York, County of New York (Index No.
651182/2020). The complaint alleges, among other things, that we breached multiple representations and warranties contained in the SPA, of which the
Plaintiffs participated, and fraudulently induced Plaintiffs into signing the Securities Purchase Agreement (the “SPA”) related to our June 8, 2017 equity
financing (the “Financing”). The complaint seeks rescission of the SPA and return of the Plaintiffs’ $6.75 million purchase price with respect to the
Financing. We are currently in the discovery phase. Management is unable to assess the likelihood that we will succeed at trial with respect to the SPA or
the Financing, having previously lost another lawsuit with respect to the Financing.
Alliance Litigation
On April 28, 2019, we brought an action against Alliance Investment Management, Ltd. (“Alliance”), later amended to include Joseph Mona (“Mona”) as a
defendant, in the Southern District of New York under Section 16(b) of the Securities Exchange Act of 1934, 15 U.S.C. 78p(b), to compel Alliance and
Mona to disgorge short swing profits realized from purchases and sales of our securities within a period of less than six months. The case is Microbot
Medical Inc. v. Alliance Investment Management, Ltd., No. 19-cv-3782-GBD (SDNY). The amount of profits was estimated in the complaint to be
approximately $468,000.
On October 28, 2019, Alliance filed a motion for summary judgment requesting that the Court dismiss the claims against Alliance. On February 4, 2020,
Mona answered the 16(b) claim we asserted against him by claiming various equitable defenses, and filed a counterclaim against Microbot under Section
10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, claiming a net loss on trading Microbot stock of $150,954.
On September 17, 2020, the Court issued a Memorandum Decision & Order that, among other things, granted Alliance’s summary judgment motion.
37
On March 30, 2021, the Court issued an Order; and on March 31, 2021, the Clerk entered Judgement against Joseph Mona and in favor of Microbot in the
amount of $484,614.30. On April 27, 2021, Mona filed an appeal of the Court’s Judgment, which is pending before the U.S. Court of Appeals for the
Second Circuit.
In June 2021, the Magistrate issued an order permitting Mona to file an Amended Counterclaim Complaint, and rejected our request to execute on the
Judgment. We filed a response to Mona’s amended counterclaim on July 21, 2021, and in February 2023 filed a motion for summary judgment on Mona’s
fraud claim on the basis of inability to demonstrate reliance or loss causation. The motion is scheduled to be fully briefed and submitted on May 1, 2023.
Other than the foregoing, we are not currently a party in any legal proceeding or governmental regulatory proceeding nor are we currently aware of any
pending or potential legal proceeding or governmental regulatory proceeding proposed to be initiated against us that would have a material adverse effect
on us or our business.
Item 4. Mine Safety Disclosures.
Not applicable.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Our common stock is listed on the NASDAQ Capital Market under the symbol “MBOT” since November 29, 2016. Prior to that, our common stock was
traded under the symbol “STEM.”
As of March 28, 2023, there were approximately 102 holders of record of our common stock, and the closing price of our common stock as reported on the
NASDAQ Capital Market was $2.25.
Dividend Policy
We have never paid cash dividends on our common stock and we do not anticipate paying cash dividends on common stock in the foreseeable future. The
payment of dividends on our common stock will depend on earnings, financial condition, debt covenants in place, and other business and economic factors
affecting us at such time as our Board of Directors may consider relevant. If we do not pay dividends, our common stock may be less valuable because a
return on a stockholders’ investment will only occur if our stock price appreciates.
Equity Compensation Plan Information Table
The following table provides information about shares of our common stock that may be issued upon the exercise of options under all of our existing
compensation plans as of December 31, 2022.
Plan Category
Equity compensation plans approved by security holders:
2017 Equity Incentive Plan
2020 Omnibus Performance Award Plan
Equity compensation plans not approved by security holders:
Microbot Israel Employee Stock Option Plan(1)
Stock Options (2)
Total
Number of
securities to be
issued upon
exercise of
outstanding
options, warrants
and rights
Weighted-
average exercise
price of
outstanding
options, warrants
and rights
Number of
securities
remaining
available for
future issuance
520,466
847,248
61,577
77, 846
1,507,137
$
$
$
$
10.45
6.17
0.01
4.20
103,252
573,404
-
-
676,656
(1) Such options were originally issued by Microbot Israel under its Employee Stock Option Plan, and represented the right to purchase an aggregate of
500,000 of Microbot Israel’s ordinary shares. As of the effective time of the Merger, such options were retroactively adjusted to reflect the Merger and
now represent the right to purchase shares of our common stock.
(2) Such options were originally issued by Microbot Israel to MEDX Ventures Group LLC, of which Mr. Gadot is the Chief Executive Officer, Company
Group Chairman and majority equity owner, and represented the right to purchase an aggregate of 486,263 of Microbot Israel’s ordinary shares. As of
the effective time of the Merger, such options were retroactively adjusted to reflect the Merger and now represent the right to purchase shares of our
common stock.
38
Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Forward Looking Statements
Certain information contained in this MD&A includes “forward-looking statements.” Statements which are not historical reflect our current expectations
and projections about our future results, performance, liquidity, financial condition and results of operations, prospects and opportunities and are based
upon information currently available to us and our management and their interpretation of what is believed to be significant factors affecting our existing
and proposed business, including many assumptions regarding future events. Actual results, performance, liquidity, financial condition and results of
operations, prospects and opportunities could differ materially and perhaps substantially from those expressed in, or implied by, these forward-looking
statements as a result of various risks, uncertainties and other factors, including those risks described in detail in the section of this Annual Report on Form
10-K entitled “Risk Factors” as well as elsewhere in this Annual Report.
Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the
words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “seek,” or “project” or the negative
of these words or other variations on these words or comparable terminology.
In light of these risks and uncertainties, and especially given the nature of our existing and proposed business, there can be no assurance that the forward-
looking statements contained in this section and elsewhere in this Annual Report on Form 10-K will in fact occur. Potential investors should not place
undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or
revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.
Overview
Microbot is a pre-clinical medical device company specializing in the research, design and development of next generation robotic endoluminal surgery
devices targeting the minimally invasive surgery space. Microbot is primarily focused on leveraging its medical-robotic technologies with the goal of
redefining surgical robotics while improving surgical outcomes for patients.
Microbot’s current technological platforms, LIBERTY®, One & DoneTM, NovaCross™, ViRobTM and TipCATTM, and, are comprised of proprietary
innovative technologies. Utilizing the LIBERTY and One & DoneTM platforms, Microbot is developing the first ever fully disposable robotic system for
various endovascular interventional procedures. In addition, the Company is focused on the development of a Multi Generation Pipeline Portfolio utilizing
all of its proprietary technologies.
Microbot has a patent portfolio of 58 issued/allowed patents and 51 patent applications pending worldwide, of which 6 issued/allowed patents and 34
patent applications relate to the LIBERTY device.
39
Financial Operations Overview
Research and Development Expenses
Research and development expenses consist primarily of salaries and related expenses and overhead for Microbot’s research, development and engineering
personnel, prototype materials and research studies, obtaining and maintaining Microbot’s patent portfolio. Microbot expenses its research and
development costs as incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of the costs associated with management salaries and benefits, professional fees for accounting,
auditing, consulting, legal services, and insurance expenses.
Microbot expects that its general and administrative expenses will increase over the long-term, even if a period-to-period comparison may show a decrease,
as it expands its operating activities, maintains compliance with exchange listing and SEC requirements. Microbot expects these potential increases will
likely include management costs, legal fees, accounting fees, directors’ and officers’ liability insurance premiums and expenses associated with investor
relations.
Income Taxes
Microbot has incurred net losses and has not recorded any income tax benefits for the losses. It is still in its development stage and has not yet generated
revenues, therefore, it is more likely than not that sufficient taxable income will not be available for the tax losses to be fully utilized in the future.
Critical Accounting Policies and Significant Judgments and Estimates
Management’s discussion and analysis of Microbot’s financial condition and results of operations are based on its consolidated financial statements, which
have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these consolidated financial statements
requires Microbot to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent
assets and liabilities at the date of the consolidated financial statements. Microbot bases its estimates on historical experience, known trends and events, and
various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under
different assumptions or conditions.
While Microbot’s significant accounting policies are described in more detail in the notes to its consolidated financial statements, Microbot believes the
following accounting policies are the most critical for fully understanding and evaluating its consolidated financial condition and results of operations.
Contingencies
Management records and discloses legal contingencies in accordance with ASC Topic 450 Contingencies. A provision is recorded when it is both probable
that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company monitors the stage of progress of its litigation
matters to determine if any adjustments are required.
Fair Value of Financial Instruments
The Company measures the fair value of certain of its financial instruments on a recurring basis.
40
A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at
fair value will be classified and disclosed in one of the following three categories:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.
Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities,
unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Results of Operations
Comparison of Years Ended December 31, 2022 and 2021
The following table sets forth the key components of Microbot’s results of operations for the years ended December 31, 2022 and 2021 (in thousands):
Research and development expenses
General and administrative expenses
Financing income, net
Capital loss
For the Years Ended
December 31,
$
2022
2021
Change
(7,736) $
(5,545)
118
(5)
(6,153) $
(5,204)
44
-
(1,583)
(341)
74
(5)
Research and Development Expenses. Microbot’s research and development expenses were approximately $7,736,000 for the year ended December 31,
2022, compared to approximately $6,153,000 for the same period in 2021. The increase in research and development expenses of approximately
$1,583,000 in 2022 as compared to 2021 was primarily due to increased salaries and recruitment of employees, professional services and material expenses
relating to the LIBERTY project, minimally offset by savings resulting from the suspension of our SCS research program. Microbot expects its research
and development expenses to continue to increase over time as Microbot advances its development programs and begins pre-clinical and preparations for
clinical trials for the LIBERTY.
General and Administrative Expenses. General and administrative expenses were approximately $5,545,000 for the year ended December 31, 2022,
compared to approximately $5,204,000 for the same period in 2021. The increase in general and administrative expenses of approximately $341,000 in
2022 as compared to 2021 was primarily due to increased salaries, share-based compensation, and travel of $777,000, partially offset by a decrease of
$436,000 in government fees and professional services. Microbot believes its general and administrative expenses may increase over time as it advances its
programs, requiring additional investments in headcount, facilities and other general and administrative operating activities to support its growth, and as it
continues to incur expenses associated with public-company compliance.
Financing Income. Financing income was approximately $118,000 for the year ended December 31, 2022, consisting of, income from interest, net totaling
$54,000 and an exchange rate gain of $64,000, compared to approximately $44,000 for the year ended December 31, 2021, which consisted mainly of the
reversal of $131,000 of other liability stemming from our 2016 merger with StemCells, offset by exchange rate expenses of $87,000.
Capital loss was approximately $5,000 for the year ended December 31, 2022, relating to assets disposal related to SCS suspension, compared to $0 of
capital loss for the year ended December 31, 2021.
41
Liquidity and Capital Resources
Microbot has incurred losses since inception and negative cash flows from operating activities for the years ended December 31, 2022 and 2021. As of
December 31, 2022 and 2021, Microbot had a net working capital of approximately $6,745,000 and $13,895,000, respectively, consisting primarily of cash,
cash equivalents and marketable securities. Microbot anticipates that it will continue to incur net losses for the foreseeable future as it continues research
and development efforts of its product candidates, hires additional staff, including clinical, scientific, operational, financial and management personnel, and
continues to incur costs associated with being a public company.
Microbot has funded its operations through the issuance of capital stock, grants from the Israeli Innovation Authority, and convertible debt. Since inception
(November 2010) through December 31, 2022, Microbot has raised net cash proceeds of approximately $59,094,000, and incurred a total cumulative loss
of approximately $68,761,000. Microbot returned $3,375,000 (before interest) of such proceeds to an investor as a result of an adverse outcome in a
litigation that concluded in the first quarter of 2020 and is still subject to an additional lawsuit seeking the return of an additional $6,750,000 of such
proceeds. This litigation is in its discovery stages, and we cannot project what the eventual outcome will be, though management is vigorously defending
its position that no return of capital is warranted.
Microbot Israel obtained from the Israeli Innovation Authority (“IIA”) grants for participation in research and development for the years 2013 through
December 31, 2022 in the total amount of approximately $1,500,000 and, in return, Microbot Israel is obligated to pay royalties amounting to 3%-3.5% of
its future sales up to the amount of the grant. The grant is linked to the exchange rate of the dollar to the New Israeli Shekel and bears interest at an annual
rate of USD LIBOR. Under the terms of the grant and applicable law, Microbot is restricted from transferring any technologies, know-how, manufacturing
or manufacturing rights developed using the grant outside of Israel without the prior approval of the Israel Innovation Authority. Microbot has no
obligation to repay the grant, if the SCS project fails, is unsuccessful or aborted before any sales are generated. The financial risk is assumed completely by
the IIA. In addition, in February 2023, Microbot Israel was awarded an NIS 300,000 grant from Israel’s Ministry of Economy to encourage the Company’s
marketing activities and enhance the commercialization of the LIBERTY Robotic System in the US market, within the scope of its “Smart Money”
program.
To date, we have not generated revenues from our operations. As of December 31, 2022, we had unrestricted cash, cash equivalents and marketable
securities of approximately $8,202,000, excluding encumbered cash, which management believes is sufficient to fund our operations for less than four
months from the date of this Annual Report on Form 10-K. However, in the event we are unsuccessful in our current litigation discussed above, pursuant to
which certain investors are seeking the return of $6,750,000 in proceeds we received from them in a 2017 stock offering, we will not have funds to
continue our operation. As a result of the foregoing and our current cash position, these conditions raise substantial doubt about Microbot’s ability to
continue as a going concern beyond approximately the next 4 months, which could adversely affect our ability to raise capital, expand our business and
develop our planned products.
Microbot plans to continue to fund its research and development and other operating expenses, other development activities relating to additional product
candidates, and the associated losses from operations, through its existing cash and possibly additional grants. Microbot intends to also raise capital through
future issuances of debt and/or equity securities including registered offerings under its existing Registration Statement on Form S-3 for up to $75 million
of securities, which it may draw down from time to time subject to limitations on our use of Registration Statements on Form S-3 as a result of our public
float. The capital raises from issuances of convertible debt and equity securities could result in additional dilution to Microbot’s shareholders. In addition,
to the extent Microbot determines to incur additional indebtedness, Microbot’s incurrence of additional debt could result in debt service obligations and
operating and financing covenants that would restrict its operations. Microbot can provide no assurance that financing will be available in the amounts it
needs or on terms acceptable to it, if at all. If Microbot is not able to secure adequate additional working capital when it becomes needed, it may be
required to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned research
programs. Any of these actions could materially harm Microbot’s business.
42
Cash Flows
The following table provides a summary of the net cash flow activity for each of the periods presented (in thousands):
Net cash flows from operating activities
Net cash flows from investing activities
Net cash flows from financing activities
Net decrease in cash and cash equivalents
Comparison of the Years Ended December 31, 2022 and 2021
For the Years Ended
December 31,
2022
2021
$
$
(11,549) $
(3,836)
4,324
(11,061) $
(9,354)
3,200
-
(6,154)
Cash used in operating activities for the year ended December 31, 2022 was approximately $11,549,000, compared to $9,354,000 in 2021. The increase
was primarily from higher net losses in 2022, mostly related to increase in research and development relating to LIBERTY.
Net cash flows from investing activities increased in 2022 compared to 2021 primarily from the net purchases of marketable securities in 2022.
Net cash flows from financing activities increased in 2022 to approximately $4,324,000 due to the issuance of common stock and warrants to an
institutional investor in October 2022. The Company did not raise capital in 2021.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Microbot’s cash and cash equivalents as of December 31, 2022 consisted of readily available checking and money market funds. Microbot’s primary
exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-
term nature of the instruments in Microbot’s portfolio, a sudden change in market interest rates would not be expected to have a material impact on
Microbot’s financial condition and/or results of operations. Microbot does not believe that its cash or cash equivalents have significant risk of default or
illiquidity. While Microbot believes its cash and cash equivalents do not contain excessive risk, Microbot cannot provide absolute assurance that in the
future its investments will not be subject to adverse changes in market value. In addition, Microbot maintains significant amounts of cash and cash
equivalents at one or more financial institutions that are in excess of federally insured limits.
Foreign Exchange Risks
Our financial statements are denominated in U.S. dollars and financial results are denominated in U.S. dollars, while a significant portion of our business is
conducted, and a substantial portion of our operating expenses are payable, in currencies other than the U.S. dollar.
Exchange rate fluctuations may have an adverse impact on our future revenues, if any, or expenses as presented in the financial statements. We may in the
future use financial instruments, such as forward foreign currency contracts, in its management of foreign currency exposure. These contracts would
primarily require us to purchase and sell certain foreign currencies with or for U.S. dollars at contracted rates. We may be exposed to a credit loss in the
event of non-performance by the counterparties of these contracts. In addition, these financial instruments may not adequately manage our foreign currency
exposure. Our results of operations could be adversely affected if we are unable to successfully manage currency fluctuations in the future.
Effects of Inflation
Inflation generally affects Microbot by increasing its research and development expenses. Microbot does not believe that inflation and changing prices had
a significant impact on its results of operations for any periods presented herein, but may have a significant, adverse impact in 2023.
43
Item 8. Financial Statements and Supplementary Data.
The consolidated financial statements and supplementary data required by this item are included in this Annual Report on Form 10-K immediately
following Part IV and are incorporated herein by reference.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Disclosure Controls and Procedures. We maintain a system of disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act).
As required by Rule 13a-15(b) under the Exchange Act, management of the Company, under the direction of our Chief Executive Officer and Chief
Financial Officer, reviewed and performed an evaluation of the effectiveness of design and operation of our disclosure controls and procedures (as defined
in Rule 13a-15(e) under the Exchange Act) as of December 31, 2022. Based on that review and evaluation, the Chief Executive Officer and Chief Financial
Officer, along with the management of the Company, have determined that as of December 31, 2022, the disclosure controls and procedures were effective
to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms and were effective to provide reasonable assurance that
such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as
appropriate to allow timely decisions regarding required disclosures.
Management’s Annual Report on Internal Control Over Financial Reporting. Our management is responsible for establishing and maintaining effective
internal control over financial reporting (as defined in Rule 13a – 15(f) of the Exchange Act). There are inherent limitations to the effectiveness of any
internal control, including the possibility of human error and the circumvention or overriding of controls. Accordingly, even effective internal controls can
provide only reasonable assurance with respect to financial statement preparation. Further, because of changes in conditions, the effectiveness of internal
control may vary over time. We have assessed the effectiveness of our internal controls over financial reporting (as defined in Rule 13a -15(f) of the
Exchange Act) as of December 31, 2022, and have concluded that, as of December 31, 2022, our internal control over financial reporting was effective.
This annual report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by our registered public accounting firm pursuant to the rules of the Securities and Exchange
Commission that permit us to provide only management’s report in this annual report.
Changes in Internal Control Over Financial Reporting. There were no changes in our internal control over financial reporting, identified in connection with
the evaluation of such internal control that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
44
Item 10. Directors, Executive Officers, and Corporate Governance.
Board of Directors
PART III
We currently have seven directors serving on our Board. The following table lists the names, ages and positions of the individuals who serve as directors of
the Company, as of March 30, 2023:
Name
Harel Gadot
Yoseph Bornstein(1)(3)
Scott Burell(1)(2)
Martin Madden(1)(3)
Prattipati Laxminarain(2)
Aileen Stockburger(3)
Tal Wenderow(2)
Position
Age
51 President, Chief Executive Officer and Chairman of the Board of Directors
65 Director
58 Director
62 Director
65 Director
60 Director
48 Director
(1) Member of Audit Committee.
(2) Member of Corporate Governance Committee.
(3) Member of Compensation Committee.
We have a classified Board, with each of our directors serving a staggered three-year term. The following table shows the current composition of the three
classes of our Board:
Class I Directors (terms scheduled to expire in 2025):
Harel Gadot
Martin Madden
Tal Wenderow
Class II Directors (term scheduled to expire in 2023):
Scott Burell
Aileen Stockburger
Class III Directors (term scheduled to expire in 2024):
Yoseph Bornstein
Prattipati Laxminarain
Harel Gadot, became President, Chief Executive Officer and Chairman of the Company’s Board following the consummation of the merger of C&RD
Israel Ltd, a wholly owned subsidiary of the Company, with and into Microbot Medical Ltd. (“Microbot Israel”), with Microbot Israel surviving as a
wholly owned subsidiary of the Company (the “Merger”). Mr. Gadot is a co-founder of Microbot Israel and has served as Microbot Israel’s Chief Executive
Officer since Microbot Israel was founded in November 2010. He has been the Chairman of Microbot Israel’s board of directors since July 2014. He also
serves as the Chairman of XACT Robotics Ltd., an Israel-based private company seeking to develop a novel platform technology for robotic needle
steering in minimally invasive interventional procedures such as biopsies and ablations, since August 2013 and MEDX Xelerator L.P., a medical device and
digital health Israeli incubator, since July 2016. From December 2007 to April 2010 Mr. Gadot was a Worldwide Group Marketing Director at Ethicon Inc.,
a Johnson and Johnson Company, where he was responsible for the global strategic marketing of the Company. Mr. Gadot also held management positions,
as well as leading regional strategic position for Europe, Middle-East and Africa, as well as In Israel, while at Johnson and Johnson. Mr. Gadot served as
director for ConTIPI Ltd. from August 2010 until November 2013 when ConTIPI Ltd. was acquired by Kimberly-Clark Corporation. Mr. Gadot holds a
B.Sc. in Business from Siena College, Loudonville NY, and an M.B.A. from the University of Manchester, UK. The Company believes that Mr. Gadot is
qualified to serve as Chairman of the Board and as President and Chief Executive Officer of the Company due to his extensive experience in strategic
marketing and general management in the medical device industry.
45
Yoseph Bornstein, became a director of the Company following the Merger. Mr. Bornstein is a co-founder of Microbot Israel and has been a member of the
Board of Directors since Microbot Israel was founded in November 2010. Mr. Bornstein founded Shizim Ltd., a life science holding group in October 2000
and has served as its CEO and director since then. Mr. Bornstein is the Chairman of, and through Shizim owns a stake in: GCP Clinical Studies Ltd., a
provider of clinical research services and educational programs in Israel since January 2002; Biotis Ltd., a service company for the bio-pharmaceutical
industry, since June 2000; Dolphin Medical Ltd., which supplies the medical device industry, since April 2012, and LSA – Life Science Accelerator Ltd.,
since 2000. He is the Chairman of ASIS Enterprises B.B.G. Ltd., a business development company focusing on creating business ties between Israeli and
Japanese entities, since August 2007. Mr. Bornstein is a co-founder and director of XACT Robotics, which is developing a novel platform technology for
robotic needle steering in minimally invasive interventional procedures. In October 1992, Mr. Bornstein founded Pharmateam Ltd., an Israeli company that
specialized in representing international pharmaceutical companies which was sold in 2000. Mr. Bornstein is also a founder of a number of other privately
held life-science companies. Mr. Bornstein served as the Biotechnology Committee Chairman of the United States-Israel Science & Technology
Commission (the “USISTC”) from September 2002 to February 2005 as well as a consultant for USISTC from September 2002 to February 2005. He is
also the founder of ILSI-Israel Life Science Industry Organization (who was integrated into IATI) and ITTN-Israel Tech Transfer Organization. He founded
in July 2014 ShizimXL Ltd., an international medical device innovation center, and founded in January 2020 ShizimVS Ltd., a digital health innovation
center. Mr. Bornstein is an external director in Can-fit BioPharma Ltd. (Nasdaq:CANF). The Company believes that Mr. Bornstein is qualified to serve as a
member of the Board due to his extensive experience in, and knowledge of, the life sciences industry and international business.
Scott R. Burell, became a director of the Company following the Merger. Since August 1, 2018, Mr. Burell has been the Chief Financial Officer and
Secretary of AIVITA Biomedical, Inc., an Irvine California-based immuno-oncology company focused on the advancement of commercial and clinical-
stage programs utilizing curative and regenerative medicines. From November 2006 until its sale to Invitae Corp. (NASDAQ: NVTA) in November 2017,
he was the Chief Financial Officer, Secretary and Treasurer of CombiMatrix Corporation (NASDAQ: CBMX), a family health-focused clinical molecular
diagnostic laboratory specializing in pre-implantation genetic screening, prenatal diagnosis, miscarriage analysis, and pediatric developmental disorders.
He successfully led the split-off of CombiMatrix in 2007 from its former parent, has led several successful public and private debt and equity financing
transactions as well as CombiMatrix’s reorganization in 2010. Prior to this, Mr. Burell had served as CombiMatrix’s Vice President of Finance since
November 2001 and as its Controller from February 2001 to November 2001. From May 1999 to first joining CombiMatrix in February 2001, Mr. Burell
was the Controller for Network Commerce, Inc. (NASDAQ: SPNW), a publicly traded technology and information infrastructure company located in
Seattle. Prior to this, Mr. Burell spent nine years with Arthur Andersen’s Audit and Business Advisory practice in Seattle. During his tenure in public
accounting, Mr. Burell worked with many clients, both public and private, in the high-tech and healthcare markets, and was involved in numerous public
offerings, spin-offs, mergers and acquisitions. Mr. Burell obtained his Washington state CPA license in 1992 and is a certified public accountant (currently
inactive). He holds Bachelor of Science degrees in Accounting and Business Finance from Central Washington University. The Company believes Mr.
Burell’s qualifications to serve on the Board include his experience as an executive of a public life sciences company and knowledge of financial
accounting in the medical technology field.
Martin Madden, has been a director of the Company since February 6, 2017. Mr. Madden has held various positions at Johnson & Johnson and its affiliates
from 1986 to January 2017, most recently as Vice President, Research & Development of DePuy Synthes, a Johnson & Johnson Company, from February
2016 to January 2017. Prior to that, from July 2015 to February 2016, Mr. Madden was the Vice President, New Product Development of Johnson &
Johnson Medical Devices. From January 2012 to July 2015, Mr. Madden was the Vice President, Research & Development of Johnson & Johnson’s Global
Surgery Group. During his thirty-year tenure with Johnson & Johnson’s Medical Device organization, he was an innovator and research leader for nearly
every medical device business including Cardiology, Electrophysiology, Peripheral Vascular Surgery, General and Colorectal Surgery, Aesthetics,
Orthopaedics, Sports Medicine, Spine, and Trauma. As an executive of Johnson & Johnson, Mr. Madden served on the management boards of Johnson &
Johnson’s Global Surgery Group, Ethicon, Ethicon Endo-Surgery, DePuy-Synthes, and Cordis, with responsibility for research and development – inclusive
of organic and licensed/acquired technology. He was also Chairman of J&J’s Medical Device Research Council, with responsibility for talent strategy and
technology acceleration. Mr. Madden serves on the Board of Directors of Novocure (NASDAQ: NVCR), a global oncology company, and is an advisor to
numerous medical device start-ups. Mr. Madden holds a MBA from Columbia University, a M.S. from Carnegie Mellon University in Mechanical
Engineering, and a B.S. from the University of Dayton in Mechanical Engineering. The Company believes that Mr. Madden is qualified to serve as a
member of the Board due to his extensive experience in research and development, portfolio planning, technology assessment and assimilation, and project
management and budgeting.
46
Prattipati Laxminarain, has been a director of the Company since December 6, 2017. From April 2006 through October 2017, Mr. Laxminarain served as
Worldwide President at Codman Neuro, a global neurosurgery and neurovascular company that offers a portfolio of devices for hydrocephalus
management, neuro intensive care and cranial surgery and other technologies, and which was part of DePuy Synthes Companies of Johnson & Johnson. Mr.
Laxminarain is currently the CEO of Deinde Medical Corporation, and is a Board Member of Oculogica Inc., Millar Inc., and GT Medical Inc. He has a
degree in Mechanical Engineering from Osmania University, Hyderabad, India and an MBA from Indian Institute of Management. The Company believes
that Mr. Laxminarain is qualified as a Board member of the Company because of his extensive experience working with medical device companies and
knowledge of the industries in which the Company intends to compete.
Aileen Stockburger was appointed by the Board on March 26, 2020 to fill a vacancy on the Board and to serve as a Class II director of the Company, with a
term commencing on April 1, 2020. Since February 2018, Ms. Stockburger has provided M&A consulting and advisory services through Aileen
Stockburger LLC. Prior to that, from 1989 through January 2018, Ms. Stockburger held various positions in Johnson & Johnson, most recently as Vice
President, Worldwide Business Development & Strategic Planning for the DePuy Synthes Group of Johnson & Johnson, and as a member of its Worldwide
Board and Group Operating Committee, from 2010-2018. In that role, she oversaw the group’s merger and acquisition activities, including deal structuring,
negotiations, contract design and review, and deal terms. Before joining Johnson & Johnson, Ms. Stockburger spent several years at
PriceWaterhouseCoopers, and earned her CPA certification. She is also a Non-Executive Director of Next Science Limited (ASX: NXS), a medical
technology company headquartered in Sydney, Australia, with a primary focus in the development and continued commercialization of its proprietary
technology to reduce the impact of biofilm based infections in human health. She also serve on the Audit Committee and the People, Culture and
Remuneration Committee of the Board of Directors of Next Science Limited. Ms. Stockburger received her MBA and BS from The Wharton School,
University of Pennsylvania. The Company believes that Ms. Stockburger is qualified as a Board member of the Company because of her extensive
experience in strategizing, managing and closing sizable, complex worldwide mergers and acquisitions, licensing agreements and divestitures, as well as
her expertise in business development, strategic planning and finance.
Tal Wenderow was appointed by the Board on July 29, 2020 to fill a vacancy on the Board and to serve as a Class I director of the Company, with a term
commencing on August 1, 2020. Since September 2021, Mr. Wenderow serves as the Venture Partner at Genesis MedTech, a global medical device
company. Previously, from February 2019, Mr. Wenderow served as the President and CEO of Vocalis Health Inc., an AI healthtech company pioneering
the development of vocal biomarkers. Previously, Mr. Wenderow co-founded Corindus Vascular Robotics in 2002, which was a New York Stock Exchange-
listed company upon its acquisition by Siemens Healthineers in 2019. Mr. Wenderow held various positions at Corindus from founder, Chief Executive
Officer and director at inception, Executive Vice President Product & Business Development to his most recent role as Executive Vice President of
International & Business Development. Mr. Wenderow received a B.Sc. in Mechanical Engineering at the Technion – Israel Institute of Technology, Haifa,
Israel. The Company believes that Mr. Wenderow is qualified as a Board member of the Company because of his extensive knowledge of the medical
robotics space with specific focus on interventional procedures, as well as his medical devices start up experience.
47
Executive Officers
Following are the name, age and other information for our executive officers, as of March 31, 2023. All company officers have been appointed to serve
until their successors are elected and qualified or until their earlier resignation or removal. Information regarding Harel Gadot, our Chairman, President and
Chief Executive Officer, is set forth above under “Board of Directors.”
Name
Harel Gadot
Rachel Vaknin
Simon Sharon
Eyal Morag
Age
51
44
63
58
President, Chief Executive Officer and Chairman of the Board of Directors
Chief Financial Officer
Chief Technology Officer and General Manager, Microbot Israel
Chief Medical Officer
Position
Rachel Vaknin, has served as the Company’s Chief Financial Officer since April 2022 and before that was its VP Finance since January 2022. From
September 2017 to December 2021, Ms. Vaknin served as the Chief Financial Officer at Imagry, an Israeli-American autonomous technologies software
provider. From April 2004 through December 2016, Ms. Vaknin was the FP&A Department Manager at Mellanox Technologies Ltd., an Israeli-American
multinational supplier of computer networking products acquired by Nvidia in 2020, where she was responsible, among other things, for budget planning,
budget control, building and maintaining business intelligence key performance indicators, leading teams with respect to preparing quarterly financial
statements, obtaining and managing grant monies, and Sarbanes-Oxley controls.
Simon Sharon, has served as the Company’s Chief Technology Officer since April 2018 and as the General Manager of Microbot Israel since April 2021.
From August 2016 to March 2018, Mr. Sharon served as the Chief Technology Officer at MEDX Xelerator, an Israel-based medical device and digital
health incubator. He is also a director of XACT Robotics Ltd., a private Israeli company developing a novel platform robotic technology for needle steering
in minimally invasive interventional procedures. Mr. Harel Gadot, the Company’s President, CEO and Chairman, is the Chairman of each of XACT and
MEDX Xelerator. Prior to this, Mr. Sharon held the position of Chief Operating Officer at Microbot Israel before it became a publicly traded company from
February 2013 to August 2016. Prior to joining Microbot Israel, Mr. Sharon was the Vice President of Research & Development with IceCure Medical, a
TASE traded company developing a portfolio of cryogenic ablation systems. Prior to IceCure, he held roles of increasing responsibility at Rockwell
Automation–Anorad Israel Ltd., a leading linear motor-based, precision positioning equipment manufacturer. Prior to Rockwell, Mr. Sharon was the
Research & Development Manager at Disc-O-Tech Medical Technologies Ltd., a private orthopedic venture that was acquired by Kyphon (currently part of
Medtronic), and before this was the Research & Development Manager at CI Systems, a worldwide supplier of a wide range of electro-optical test and
measurement equipment.
Eyal Morag, has served as the Company’s Chief Medical Officer (“CMO”) since May 2020. As CMO, Dr. Morag leads the development and execution of
the clinical strategy of the Company, including its current development of the SCS and LIBERTY products as well as its future pipeline. Dr. Morag is a
member of the Company’s Scientific Advisory Board since November 1, 2017. Dr. Morag is certified by the American Board of Radiology, and from
March 2017 through May 2020 has been the Chairman of Radiology at Assuta Ashdod Medical Center, Ashdod, Israel. Previously, from July 2014 through
March 2017, he was the senior Radiologist at URG Teleradiology LLC, the largest provider of subspecialty radiology and teleradiology services in New
Jersey. He is a graduate of Boston University School of Medicine and completed both his Radiology residency and Fellowship in Cardiovascular &
Interventional Radiology at the Beth Israel Deaconess Medical Center & Harvard Medical School. Following his clinical training, Dr. Morag then joined a
private practice in western Massachusetts, where he served as Chief of Radiology at Holyoke Medical Center for several years. He has also served as the
Regional Radiology Director at Mercy Health Partners Hospitals in Toledo, Ohio, and was a member of the University Radiology Group where he headed
the International Investment efforts for the Ventures division. Dr. Morag’s international experience developing and establishing radiology-related
businesses includes teleradiology, interventional Radiology services, and free-standing imaging centers. During his fellowship, Dr. Morag co-founded
InTek Technology, a medical device startup company. Later he founded Global Versa Radiology (“GVR”), an Israeli and U.S. based teleradiology company.
GVR has established imaging centers in Russia and Ukraine and provided teleradiology services in countries outside the U.S. and Israel. Dr. Morag served
as GVR’s Chief Medical Officer and Vice-President. He continues to be involved in several startup companies ranging from AI to medical devices. Dr.
Morag is also a member of the Advisory Board of MEDX Xelerator, a medical device and digital health incubator, of which Mr. Gadot is Chairman.
Committees of the Board of Directors
Presently, the Board has three standing committees — the Audit Committee, the Compensation and Stock Option Committee (the “Compensation
Committee”), and the Corporate Governance and Nominating Committee (the “Corporate Governance Committee”). All members of the Audit Committee,
the Compensation Committee, and the Corporate Governance Committee are, and are required by the charters of the respective committees to be,
independent as determined under Nasdaq Listing rules.
48
Audit Committee
The Audit Committee is composed of Messrs. Burell, Madden and Bornstein. Each of the members of the Audit Committee is independent, and the Board
has determined that Mr. Burell is an “audit committee financial expert,” as defined in SEC rules. The Audit Committee acts pursuant to a written charter
which is available through our website at www.microbotmedical.com. The Audit Committee held four meetings during the fiscal year ended December 31,
2022.
The primary function of the Audit Committee is to assist the Board of Directors in fulfilling its oversight responsibilities. The Audit Committee does this
primarily by reviewing the Company’s financial reports and other financial information as well as the Company’s systems of internal controls regarding
finance, accounting, legal compliance, and ethics that management and the Board of Directors have established. The Audit Committee also assesses the
Company’s auditing, accounting and financial processes more generally. The Audit Committee recommends to the Board of Directors the appointment of a
firm of independent auditors to audit the financial statements of the Company and meets with such personnel of the Company to review the scope and the
results of the annual audit, the amount of audit fees, the company’s internal accounting controls, the Company’s financial statements contained in this proxy
statement, and other related matters.
Compensation Committee
The Compensation Committee is composed of Messrs. Madden (Chairman), Bornstein and Stockburger. Each of the members of the Compensation
Committee is independent. The Compensation Committee acts pursuant to a written charter which is available through our website at
www.microbotmedical.com. The Compensation Committee held two meetings during the fiscal year ended December 31, 2022 and acted by unanimous
written consent two times.
The Compensation Committee acts pursuant to a written charter. The Compensation Committee makes recommendations to the Board of Directors and
management concerning salaries in general, determines executive compensation and approves incentive compensation for employees and consultants.
Corporate Governance Committee
The Corporate Governance Committee is composed of Messrs. Laxminarain, Burell and Wenderow. Each of the members of the Corporate Governance
Committee is independent. The Corporate Governance Committee acts pursuant to a written charter which is available through our website at
www.microbotmedical.com. The Corporate Governance Committee acted by unanimous written consent one time during the fiscal year ended December
31, 2022.
The Corporate Governance Committee oversees nominations to the Board and considers the experience, ability and character of potential nominees to serve
as directors, as well as particular skills or knowledge that may be desirable in light of the Company’s position at any time. From time to time, the Corporate
Governance Committee may engage the services of a paid search firm to help the Corporate Governance Committee identify potential nominees to the
Board. The Corporate Governance Committee and Board seek to nominate and appoint candidates to the Board who have significant business experience,
technical expertise or personal attributes, or a combination of these, sufficient to suggest, in the Board’s judgment, that the candidate would have the ability
to help direct the affairs of the Company and enhance the Board as a whole. The Corporate Governance Committee may identify potential candidates
through any reliable means available, including recommendations of past or current members of the Board from their knowledge of the industry and of the
Company. The Corporate Governance Committee also considers past service on the Board or on the board of directors of other publicly traded or
technology focused companies. The Corporate Governance Committee has not adopted a formulaic approach to evaluating potential nominees to the Board;
it does not have a formal policy concerning diversity, for example. Rather, the Corporate Governance Committee weighs and considers the experience,
expertise, intellect, and judgment of potential nominees irrespective of their race, gender, age, religion, or other personal characteristics. The Corporate
Governance Committee may look for nominees that can bring new skill sets or diverse business perspectives. Potential candidates recommended by
security holders will be considered as provided in the company’s “Policy Regarding Shareholder Candidates for Nomination as a Director,” which sets
forth the procedures and conditions for such recommendations. This policy is available through our website at www.microbotmedical.com.
49
Director Oversight and Qualifications
While management is responsible for the day-to-day management of the risks the company faces, the Board, as a whole and through its committees, has
responsibility for the oversight of risk management. An important part of risk management is not only understanding the risks facing the company and what
steps management is taking to manage those risks, but also understanding what level of risk is appropriate for the company. In support of this oversight
function, the Board receives regular reports from our Chief Executive Officer and members of senior management on operational, financial, legal, and
regulatory issues and risks. The Audit Committee additionally is charged under its charter with oversight of financial risk, including the company’s internal
controls, and it receives regular reports from management, the company’s internal auditors and the company’s independent auditors. The chairman of the
Board and independent members of the Board work together to provide strong, independent oversight of the company’s management and affairs through its
standing committees and, when necessary, special meetings of directors.
Code of Business Conduct and Ethics
We have adopted a Code of Ethics and Conduct that applies to all of our directors, officers, employees, and consultants. A copy of our code of ethics is
posted on our website at www.microbotmedical.com. We intend to disclose any substantive amendment or waivers to this code on our website. There were
no substantive amendments or waivers to this code in 2022.
Section 16(a) Reports
Section 16(a) of the Exchange Act requires our executive officers, directors, and persons who own more than 10% of a registered class of our equity
securities, to file with the SEC reports of ownership of our securities and changes in reported ownership. Executive officers, directors and greater than 10%
beneficial owners are required by SEC rules to furnish us with copies of all Section 16(a) reports they file. Based solely on a review of the copies of such
forms furnished to us, or written representations from the reporting persons that no Form 5 was required, we believe that, during the fiscal year ended
December 31, 2022, with the exception of one untimely Form 3 for Ms. Vaknin, all Section 16(a) filing requirements applicable to our officers, directors
and greater than 10% beneficial owners have been met.
50
Item 11. Executive Compensation.
The following table sets forth information regarding each element of compensation that was paid or awarded to the named executive officers of the
Company for the periods indicated.
Name and Principal Position
Year
Salary
($)
Bonus ($)
Stock
Awards
($)
Option
Awards
($) (1)
Non-Equity
Incentive Plan
Compensation
($)
All Other
Compensation
($)
Total
($)
Harel Gadot
CEO, President & Chairman
2022
2021
542,000
534,000
386,000(2)
300,000(4)
–
–
971,217
959,618
Simon Sharon
CTO and General Manager
2022
2021
348,197
365,472
89,721
110,293
Eyal Morag
Chief Medical Officer
Rachel Vaknin
Chief Financial Officer
2022
2021
401,517
453,000
89,164
91,000
2022
2021
189,384
-
–
–
–
–
–
–
–
–
65,114
58,142
90,836
46,000
45,263
-
–
–
–
–
–
–
–
–
13,800(3)
13,800(3)
1,913,017
1,807,418
23,298(5)
26,106(5)
19,752(5)
23,059(5)
–
–
526,330
560,013
601,269
613,059
234,647
-
(1) Amounts shown do not reflect cash compensation actually received by the named executive officer. Instead, the amounts shown are the non-cash
aggregate grant date fair values of stock option awards made during the periods presented as determined pursuant to ASC Topic 718 and excludes the
effect of forfeiture assumptions. The assumptions used to calculate the fair value of stock option awards are set forth under Note 9 to the Consolidated
Financial Statements of the Company included in this Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
(2) Represents Mr. Gadot’s bonus for the 2022 fiscal year, which amount was actually paid in 2023.
(3) All Other Compensation includes Mr. Gadot’s monthly automobile allowance and tax gross-up.
(4) Represents Mr. Gadot’s bonus for the 2021 fiscal year, which amount was actually paid in 2022.
(5) All Other Compensation includes the executive’s yearly automobile allowance.
51
Outstanding Equity Awards at Fiscal Year-End
The following table presents the outstanding equity awards held by each of the named executive officers as of the end of the fiscal year ended December
31, 2022.
Option Awards
Stock Awards
Number of
Securities
Underlying
Unexercised
Options
Name
Exercisable
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
Option
Exercise
Price
Option
Expiration
Date
Number of
Shares
or Units of
Stock That
Have
Not Vested
Market
value of
Shares
of Units of
Stock That
Have
Not Vested
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Equity
Incentive
Plan
Awards:
Market
or Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
Vested
Harel Gadot
Simon Sharon
Eyal Morag
Rachel Vaknin
77,846
120,847
166,666
166,250
32,500
-
10,000
14,170
8,125
21,250
8,125
6,500
-
-
– $
-
–
23,750
67,500
160,000
–
-
16,875
3,750
16,875
13,500
10,000
13,000
4.20
15.75
9.64
8.48
6.48
3.73
9.00
5.95
6.48
6.16
6.48
6.48
4.80
3.73
1/01/2025
9/14/2027
2/25/2030
02/01/2031
01/26/2032
12/21/2032
08/13/2028
08/12/2029
01/26/2032
7/14/2030
01/26/2032
01/26/2032
07/18/2032
12/21/2032
Executive Employment Agreements
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
The Company entered into an employment agreement (the “Gadot Agreement”) with Harel Gadot on November 28, 2016, to serve as the Company’s
Chairman of the Board of Directors and Chief Executive Officer, on an indefinite basis subject to the termination provisions described in the Agreement.
The Gadot Agreement was amended most recently on January 26, 2022, with a subsequent annual salary increase on December 21, 2022. Mr. Gadot’s
annual base salary for 2022 was $515,000, and has been increased to $530,450 for 2023. The salary is reviewed on an annual basis by the Compensation
Committee of the Company to determine potential increases taking into account such performance metrics and criteria as established by Mr. Gadot and the
Company.
Effective as of January 26, 2022, Mr. Gadot shall also be entitled to receive a target annual cash bonus of up to a maximum amount of 75% of base salary,
which maximum amount was paid for the 2022 fiscal year.
Mr. Gadot shall be further entitled to a monthly automobile allowance and tax gross up on such allowance of $1,150. Upon execution of the Gadot
Agreement, he was granted options to purchase shares of common stock of the Company representing 5% of the issued and outstanding shares of the
Company. Since then, the Compensation Committee of the Board of Directors considers the granting to Mr. Gadot of additional compensatory options on
an annual basis. Most recently, in December 2022, the Company granted Mr. Gadot 160,000 options.
In the event Mr. Gadot’s employment is terminated as a result of death, Mr. Gadot’s estate would be entitled to receive any earned annual salary, bonus,
reimbursement of business expenses and accrued vacation, if any, that is unpaid up to the date of Mr. Gadot’s death.
In the event Mr. Gadot’s employment is terminated as a result of disability, Mr. Gadot would be entitled to receive any earned annual salary, bonus,
reimbursement of business expenses and accrued vacation, if any, incurred up to the date of termination.
In the event Mr. Gadot’s employment is terminated by the Company for cause, Mr. Gadot would be entitled to receive any compensation then due and
payable incurred up to the date of termination.
In the event Mr. Gadot’s employment is terminated by the Company without cause, he would be entitled to receive (i) any earned annual salary; (ii) 12
months’ pay and full benefits, (iii) a pro rata bonus equal to the maximum target bonus for that calendar year; (iv) the dollar value of unused and accrued
vacation days; and (v) applicable premiums (inclusive of premiums for Mr. Gadot’s dependents) pursuant to the Consolidated Omnibus Budget
Reconciliation Act of 1986, as amended, for twelve (12) months from the date of termination for any benefits plan sponsored by the Company. In addition,
100% of any unvested portion of his stock options shall immediately vest and become exercisable.
The agreement contains customary non-competition and non-solicitation provisions pursuant to which Mr. Gadot agrees not to compete and solicit with the
Company. Mr. Gadot also agreed to customary terms regarding confidentiality and ownership of intellectual property.
52
Rachel Vaknin Employment Agreement
We entered into an employment agreement (the “Vaknin Agreement”), as of January 2, 2022, with Ms. Vaknin, to serve as the Company’s Chief Financial
Officer, on an indefinite basis subject to the termination provisions described in the Vaknin Agreement. The salary is reviewed on an annual basis by the
Compensation Committee of the Company to determine potential increases taking into account such performance metrics and criteria as established by the
Company. Pursuant to the terms of the Vaknin Agreement, Ms. Vaknin shall receive a base salary in 2022 of NIS 32,000 per month plus Global Overtime
(as defined in the Vaknin Agreement) of NIS 8,000 per month. In January 2023, her annual base salary was increased to $170,000.
Ms. Vaknin shall also be entitled to receive a target annual cash bonus, based on certain milestones, of up to a maximum amount of 25% (increased from
20% in January 2023) of her annual salary.
Ms. Vaknin shall be further entitled to a monthly automobile allowance not to exceed NIS 1,000 per month plus expenses and applicable taxes, and
originally was granted options to purchase 20,000 shares of common stock of the Company based on vesting and other terms set forth in the Vaknin
Agreement. Since then, the Compensation Committee of the Board of Directors considers the granting to Ms. Vaknin of additional compensatory options
on an annual basis. Most recently, in January 2023, the Company granted Ms. Vaknin 10,000 options.
Pursuant to the Vaknin Agreement, the Company shall pay an amount equal to 8.33% of Ms. Vaknin’s salary to be allocated for severance pay, 6.5% of Ms.
Vaknin’s salary to be allocated for pension savings and 7.5% to be allocated to an educational fund. The Company may have additional payment
obligations for disability insurance as specified in the Vaknin Agreement.
Either the Company or Ms. Vaknin may terminate the Vaknin Agreement at its discretion at any time by providing the other party with two months prior
written notice of termination (the “Advance Notice Period”).
The Company may terminate the Vaknin Agreement “For Cause” (as defined in the Vaknin Agreement) at any time by written notice without the Advance
Notice Period.
The Vaknin Agreement contains customary non-competition and non-solicit provisions pursuant to which Ms. Vaknin agrees not to compete and solicit
with the Company. Ms. Vaknin also agreed to customary terms regarding confidentiality and ownership of intellectual property.
Simon Sharon Employment Agreement
The Company entered into an employment agreement, dated as of March 31, 2018 and amended pursuant to a First Amendment to Employment Agreement
dated as of April 19, 2021 (as so amended, the “Sharon Agreement”), with Mr. Sharon, to serve as the Company’s Chief Technology Officer and the
General Manager of Microbot Israel, on an indefinite basis subject to the termination provisions described in the Sharon Agreement.
The salary is reviewed on an annual basis by the Compensation Committee of the Company to determine potential increases taking into account such
performance metrics and criteria as established by the Company.
Pursuant to the terms of the Sharon Agreement, Mr. Sharon received in 2022 a combined base salary and overtime payment of NIS72,000 per month. Mr.
Sharon is also entitled to receive an annual cash bonus of up to 35% of the annual combined salary and overtime payment, based on certain performance
factors established and assessed by the Compensation Committee of the Board of Directors of the Company, which he received in full for the 2022 fiscal
year. For 2023, his annual base salary increased to NIS74,160 per month.
Mr. Sharon shall be further entitled to a monthly automobile allowance plus a tax gross up to cover taxes relating to the grant of such motor vehicle, and
pursuant to the Sharon Agreement was initially granted options in 2018 to purchase 150,000 shares (pre-stock split) of common stock of the Company.
53
Pursuant to the Sharon Agreement, the Company pays to (unless agreed otherwise by the parties) an insurance company or a pension fund, for Mr. Sharon,
an amount equal to 8.33% of the base salary and overtime payments, which shall be allocated to a fund for severance pay, and an additional amount equal
to 6.5% of the base salary and overtime payments, which shall be allocated to a provident fund or pension plan. The Company also pays an additional sum
for disability insurance to insure Mr. Sharon for up to 75% of base salary and overtime payments, and 7.5% of each monthly payment to be allocated to an
educational fund.
Either the Company or Mr. Sharon may terminate the Sharon Agreement without cause (as defined in the Sharon Agreement) by providing the other party
with ninety days prior written notice.
The Company may terminate the Sharon Agreement for cause at any time by written notice without any advance notice.
The Sharon Agreement contains customary non-competition and non-solicit provisions pursuant to which Mr. Sharon agrees not to compete and solicit with
the Company. Mr. Sharon also agreed to customary terms regarding confidentiality and ownership of intellectual property.
Eyal Morag Employment Agreement
We entered into an employment agreement (the “Morag Agreement”), as of February 18, 2020, with Dr. Morag, to serve as the Company’s Chief Medical
Officer, on an indefinite basis subject to the termination provisions described in the Morag Agreement. The salary is reviewed on an annual basis by the
Compensation Committee of the Company to determine potential increases taking into account such performance metrics and criteria as established by the
Company. Pursuant to the terms of the Morag Agreement, Dr. Morag shall receive a base salary in 2022 of NIS64,000 per month plus Global Overtime (as
defined in the Morag Agreement) of NIS16,000 per month. For 2023, his annual base salary increased to NIS82,408 per month.
Dr. Morag shall also be entitled to receive a target annual cash bonus, based on certain milestones, of up to a maximum amount of 30% of his annual salary,
which he received in full for the 2022 fiscal year.
Dr. Morag shall be further entitled to a monthly automobile allowance not to exceed NIS 4,800 per month plus expenses and applicable taxes, and shall be
granted options to purchase 25,000 shares of common stock of the Company based on vesting and other terms set forth in the Morag Agreement.
Pursuant to the Morag Agreement, the Company shall pay an amount equal to 8.33% of Dr. Morag’s salary to be allocated for severance pay, 6.5% of Dr.
Morag’s salary to be allocated for pension savings and 7.5% to be allocated to an educational fund. The Company may have additional payment obligations
for disability insurance as specified in the Morag Agreement.
Either the Company or Dr. Morag may terminate the Morag Agreement at its discretion at any time by providing the other party with six months prior
written notice of termination (the “Advance Notice Period”).
The Company may terminate the Morag Agreement “For Cause” (as defined in the Morag Agreement) at any time by written notice without the Advance
Notice Period.
The Morag Agreement contains customary non-competition and non-solicit provisions pursuant to which Dr. Morag agrees not to compete and solicit with
the Company. Dr. Morag also agreed to customary terms regarding confidentiality and ownership of intellectual property.
54
Indemnification Agreements
The Company generally enters into indemnification agreements with each of its directors and executive officers. Pursuant to the indemnification
agreements, the Company has agreed to indemnify and hold harmless these current and former directors and officers to the fullest extent permitted by the
Delaware General Corporation Law. The agreements generally cover expenses that a director or officer incurs or amounts that a director or officer becomes
obligated to pay because of any proceeding to which he is made or threatened to be made a party or participant by reason of his service as a current or
former director, officer, employee or agent of the Company, provided that he acted in good faith and in a manner he reasonably believed to be in or not
opposed to the best interests of the Company. The agreements also provide for the advancement of expenses to the directors and officers subject to
specified conditions. There are certain exceptions to the Company’s obligation to indemnify the directors and officers, and, with certain exceptions, with
respect to proceedings that he initiates.
Limits on Liability and Indemnification
We provide directors and officers insurance for our current directors and officers.
Our certificate of incorporation eliminate the personal liability of our directors to the fullest extent permitted by law. The certificate of incorporation further
provide that the Company will indemnify its officers and directors to the fullest extent permitted by law. We believe that this indemnification covers at least
negligence on the part of the indemnified parties. Insofar as indemnification for liabilities under the Securities Act may be permitted to our directors,
officers, and controlling persons under the foregoing provisions or otherwise, we have been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is therefore unenforceable.
Director Compensation
The Company adopted in January 2021 an amended compensation package for the non-management members of its Board, pursuant to which each such
Board member would receive for his or her services $35,000 per annum. Furthermore, each member of the Audit Committee of the Board receives an
additional $10,000 per annum ($20,000 if Chairman), each member of the Compensation Committee of the Board receives an additional $7,500 per annum
($15,000 if Chairman) and each member of the Corporate Governance and Nominating Committee of the Board receives an additional $5,000 per annum
($10,000 if Chairman). Board members are also entitled to receive equity awards. Upon joining the Board, a member would receive an initial grant of
$190,000 of stock options (calculated as the product of the exercise price on the date of grant multiplied by the number of shares underlying the stock
option award required to equal $190,000), with an additional grant of stock options each year thereafter, to purchase such number of shares of the
Company’s common stock equal to $95,000, computed on a similar basis.
The following table summarizes cash and equity-based compensation information for our outside directors, for the year ended December 31, 2022:
Name
Yoseph Bornstein
Scott Burell
Martin Madden
Prattipati Laxminarain
Aileen Stockburger
Tal Wenderow
Fees
earned
or paid
in cash
$ 52,500
$ 60,000
$ 60,000
$ 45,000
$ 42,500
$ 40,000
Stock
Awards
Option
Awards
(1)
Non-Equity
Incentive Plan
Compensation
Nonqualified
Deferred
Compensation
Earnings
All Other
Compensation
Total
– $ 49,787
– $ 49,787
– $ 49,787
– $ 49,787
– $ 50,305
– $ 50,313
–
–
–
–
–
–
–
–
–
–
–
–
– $ 102,287
– $ 109,787
– $ 109,787
– $ 94,787
– $ 92,805
– $ 90,313
(1) Amounts shown do not reflect cash compensation actually received by the director. Instead, the amounts shown are the non-cash aggregate grant date
fair values of stock option awards made during the period presented as determined pursuant to U.S. GAAP. The assumptions used to calculate the fair
value of stock option awards are described in Note 9 to the Consolidated Financial Statements of the Company included in this Annual Report on Form
10-K for the fiscal year ended December 31, 2022.
Mr. Gadot received compensation for his services to the Company as set forth under the summary compensation table above.
55
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table shows the number of shares of our common stock beneficially owned, as of March 30, 2023, by (i) each of our directors and director
nominees, (ii) each of our named executive officers, (iii) all of our current directors and executive officers as a group, and (iv) all those known by us to be
to a beneficial owner of more than 5% of the Company’s common stock. In general, “beneficial ownership” refers to shares that an individual or entity has
the power to vote or dispose of, and any rights to acquire common stock that are currently exercisable or will become exercisable within 60 days of March
30, 2023. We calculated percentage ownership in accordance with the rules of the SEC. The percentage of common stock beneficially owned is based on
8,130,628 shares outstanding as of March 30, 2023. In addition, shares issuable pursuant to options or other convertible securities that may be acquired
within 60 days of March 30, 2023 are deemed to be issued and outstanding and have been treated as outstanding in calculating and determining the
beneficial ownership and percentage ownership of those persons possessing those securities, but not for any other persons.
This table is based on information supplied by each director, officer and principal stockholder of the Company. Except as indicated in footnotes to this
table, the Company believes that the stockholders named in this table have sole voting and investment power with respect to all shares of Common Stock
shown to be beneficially owned by them, based on information provided by such stockholders. Unless otherwise indicated, the address for each director,
executive officer and 5% or greater stockholders of the Company listed is: c/o Microbot Medical Inc., 25 Recreation Park Drive, Unit 108, Hingham, MA
02043.
Beneficial Owner
Armistice Capital, LLC(1)
Chasing Value Asset Management Inc.(2)
Harel Gadot(3)
Yoseph Bornstein(4)
Scott Burell(5)
Martin Madden(5)
Prattipati Laxminarain(5)
Aileen Stockburger(5)
Simon Sharon(5)
Eyal Morag(5)
Tal Wenderow(5)
Rachel Vaknin(5)
All current directors and executive officers as a group (10 persons)(5)
Number of Shares
Beneficially Owned
Percentage of Common
Stock Beneficially
Owned
799,180
610,657
700,956
259,231
17,203
17,203
17,203
11,478
32,295
29,375
10,245
6,500
1,101,689
9.83%
8.59%
8.88%
3.29%
*
*
*
*
*
*
*
*
13.96%
Less than 1%.
*
(1) Based on a Schedule 13G filed on February 14, 2023, Armistice Capital, LLC (“Armistice Capital”) and Steven Boyd share voting and dispositive
power over 799,180 shares. Armistice Capital is the investment manager of Armistice Capital Master Fund Ltd. (the “Master Fund”), the direct holder
of the Shares, and pursuant to an Investment Management Agreement, Armistice Capital exercises voting and investment power over the securities of
the Company held by the Master Fund and thus may be deemed to beneficially own the securities of the Company held by the Master Fund. Mr. Boyd,
as the managing member of Armistice Capital, may be deemed to beneficially own the securities of the Company held by the Master Fund. The Master
Fund specifically disclaims beneficial ownership of the securities of the Company directly held by it by virtue of its inability to vote or dispose of such
securities as a result of its Investment Management Agreement with Armistice Capital. The address of the principal business office of the reporting
persons is 510 Madison Avenue, 7th Floor, New York, New York 10022.
(2) Based on a Schedule 13G filed by the reporting person on January 20, 2021, the reporting person has sole voting power over 207,000 shares and sole
dispositive power over 610,657 shares. Sheldon D. Liber is the Chief Executive Officer of the reporting person. The address of the principal business
office of the reporting person is 2444 Wilshire Boulevard, Suite 300, Santa Monica, California 90403.
56
(3) Includes (i) 136,847 shares of our common stock owned by MEDX Ventures Group LLC, (ii) 77,846 shares of our common stock issuable upon the
exercise of options granted to MEDX Ventures Group LLC, and (iii) 486,263 shares of our common stock issuable upon the exercise of options
granted to Mr. Gadot. Mr. Gadot is the Chief Executive Officer, Company Group Chairman and majority equity owner of MEDX Venture Group, LLC
and thus may be deemed to share voting and investment power over the shares and options beneficially owned by this entity.
(4) Represents (i) 242,028 shares of our common stock owned by LSA - Life Science Accelerator Ltd. and (ii) 17,203 shares of our common stock
issuable to Mr. Bornstein upon exercise of options. Based on representations and other information made or provided to the Company by Mr.
Bornstein, Mr. Bornstein is the CEO and Director of LSA - Life Science Accelerator Ltd. and of Shizim Ltd., and Mr. Bornstein is the majority equity
owner of Shizim Ltd. Shizim Ltd. is the majority equity owner of LSA - Life Science Accelerator Ltd. Accordingly, Mr. Bornstein may be deemed to
share voting and investment power over the shares beneficially owned by these entities and has an address of 16 Irus Street, Rosh-Ha’Ayin Israel
4858022.
(5) Represents options to acquire shares of our common stock.
(6) Includes shares of our common stock issuable upon the exercise of options as set forth in footnotes (3), (4) and (5).
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Related parties can include any of our directors or executive officers, certain of our stockholders and their immediate family members. Each year, we
prepare and require our directors and executive officers to complete Director and Officer Questionnaires identifying any transactions with us in which the
officer or director or their family members have an interest. This helps us identify potential conflicts of interest. A conflict of interest occurs when an
individual’s private interest interferes, or appears to interfere, in any way with the interests of the company as a whole. Our code of ethics requires all
directors, officers and employees who may have a potential or apparent conflict of interest to immediately notify our general counsel, who serves as our
compliance officer. In addition, the Corporate Governance Committee is responsible for considering and reporting to the Board any questions of possible
conflicts of interest of Board members. Our code of ethics further requires pre-clearance before any employee, officer or director engages in any personal
or business activity that may raise concerns about conflict, potential conflict or apparent conflict of interest. Copies of our code of ethics and the Corporate
Governance Committee charter are posted on the corporate governance section of our website at www.microbotmedical.com.
There have been no related party transactions or any other transactions or relationships required to be disclosed pursuant to Item 404 of Regulation S-K.
Director Independence
NASDAQ’s listing standards and the Company’s Corporate Governance Guidelines require that the Company’s Board of Directors consist of a majority of
independent directors, as determined under the applicable NASDAQ listing rules.
The independent members of our Board are Messrs. Bornstein, Burell, Madden, Laxminarain and Wenderow, and Ms. Stockburger.
Item 14. Principal Accountant Fees and Services.
Audit and Tax Fees
The Board, upon the recommendation of the Audit Committee, has selected the independent accounting firm of Brightman Almagor Zohar & Co., a Firm in
the Deloitte Global Network, to audit the accounts of the Company for the year ending December 31, 2022.
The Audit Committee considered the tax compliance services provided by Brightman Almagor Zohar & Co. and Deloitte Israel & Co., concluded that
provision of such services is compatible with maintaining the independence of the independent accountants, and approved the provision by Brightman
Almagor Zohar & Co. of tax compliance services with respect to the year ending December 31, 2022.
57
The Audit Committee received the following information concerning the fees of the independent accountants for the years ended December 31, 2022 and
2021, has considered whether the provision of these services is compatible with independence of the independent accountants, and concluded that it is:
Audit Fees (1)
Tax Fees
All Other Fees (2)
For the Years Ended
December 31,
2022
2021
$
105,000 $
11,250
15,000
85,000
10,250
12,500
(1) Audit fees represents fees for the audit of our annual consolidated financial statements and reviews of the interim consolidated financial statements,
and review of audit-related SEC filings.
(2) Includes fees related to issuing a comfort letter and Auditor consents.
Audit and tax fees include administrative overhead charges and reimbursement for out-of-pocket expenses.
Pre-Approval Policies and Procedures
The Audit Committee has adopted policies and procedures for pre-approving all services (audit and non-audit) performed by our independent auditors. In
accordance with such policies and procedures, the Audit Committee is required to pre-approve all audit and non-audit services to be performed by the
independent auditors in order to assure that the provision of such services is in accordance with the rules and regulations of the SEC and does not impair
the auditors’ independence. Under the policy, pre-approval is generally provided up to one year and any pre-approval is detailed as to the particular service
or category of services and is subject to a specific budget. In addition, the Audit Committee may pre-approve additional services on a case-by-case basis.
Item 15. Exhibits and Financial Statement Schedules
(a) The following documents are filed as part of this Annual Report on Form 10-K:
(1) Financial Statements:
PART IV
The financial statements are filed as part of this Annual Report on Form 10-K commencing on page F-1 and are hereby incorporated by reference.
(2) Financial Statement Schedules:
The financial statement schedules are omitted as they are either not applicable or the information required is presented in the financial statements and notes
thereto.
58
(3) Exhibits:
The documents set forth below are filed herewith or incorporated by reference to the location indicated.
Exhibit
Number
2.1
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
Description of Document
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. (incorporated by reference to the Company’s Current Report on Form 8-K filed on August 15, 2016).
Restated Certificate of Incorporation of the Company (incorporated by reference to the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2006 and filed on March 15, 2007).
Certificate of Amendment to the Restated Certificate of Incorporation of the Company (incorporated by reference to the Company’s Current
Report on Form 8-K filed on November 29, 2016).
Certificate of Amendment to the Restated Certificate of Incorporation (incorporated by reference to the Company’s Current Report on Form
8-K filed on September 4, 2018).
Amended and Restated By-Laws of the Company (incorporated by reference to the Company’s Current Report on Form 8-K filed on May 3,
2016).
Certificate of Elimination (incorporated by reference to the Company’s Current Report on Form 8-K filed on December 12, 2018).
Certificate of Amendment to the Restated Certificate of Incorporation (incorporated by reference to the Company’s Current Report on Form
8-K filed on September 11, 2019).
Amendment to Section 5 of the Amended and Restated By-Laws of the Company (incorporated by reference to the Company’s Current
Report on Form 8-K filed on May 3, 2021).
Form of Series A Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 16, 2016).
Form of Series B Warrant (incorporated by reference to the Company’s Current Report on Form 8-K filed on December 16, 2016).
Form of Wainwright Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 16, 2019)
Form of Wainwright Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 17, 2019).
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 25, 2019).
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 27, 2019).
Form of Wainwright Warrants (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 25, 2019).
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 30, 2019).
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 31, 2019).
Description of the Company’s Securities (incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2019).
Form of Pre-Funded Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 25, 2022)
Form of Series A Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 25, 2022)
Form of Series B Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 25, 2022)
Form of Wainwright Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 25, 2022)
Form of Securities Purchase Agreement, dated as of October 21, 2022, by and among Microbot Medical Inc. and the purchaser party thereto
(incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 25, 2022)
10.1
Form of Indemnification Agreement, between the Company and each of its Directors and Officers (incorporated by reference to the
Company’s Current Report on Form 8-K filed on November 29, 2016).
10.2*
Employment Agreement with Harel Gadot (incorporated by reference to the Company’s Current Report on Form 8-K filed on November 29,
2016).
10.3
License Agreement, dated June 20, 2012, by and between Technion Research and Development Foundation, and Microbot Medical Ltd.
(incorporated by reference to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and filed on March
21, 2017).
10.4*
Form of Stock Option Agreement under the Microbot Medical Inc. 2017 Equity Incentive Plan (incorporated by reference to the Company’s
Quarterly Report on Form 10-Q for the Quarter ended September 30, 2017, filed on November 14, 2017).
10.5
Agreement, dated January 4, 2018, by and between CardioSert Ltd. and Microbot Medical Ltd. (incorporated by reference to the Company’s
Current Report on Form 8-K filed on January 8, 2018).
59
10.6*
Employment Agreement with Dr. Eyal Morag (incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2019 filed on April 14, 2020).
10.7*
Microbot Medical Inc. 2017 Equity Incentive Plan (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement on
Schedule 14A filed on August 11, 2017).
10.8*
Microbot Medical Inc. 2020 Omnibus Performance Award Plan (incorporated by reference to Exhibit A of the Company’s definitive Proxy
Statement on Schedule 14A filed on July 31, 2020)
10.9*
Form of Restricted Stock Unit Award Agreement under the Microbot Medical Inc. 2020 Omnibus Performance Award Plan (incorporated by
reference to Exhibit 4.2 of the registration Statement on Form S-8 of the Company filed on November 25, 2020)
10.10*
Form of NQO Award Agreement under the Microbot Medical Ltd. 2020 Omnibus Performance Award Plan (incorporated by reference to
Exhibit 4.3 of the registration Statement on Form S-8 of the Company filed on November 25, 2020)
10.11*
Form of Restricted Stock Award Agreement under the Microbot Medical Ltd. 2020 Omnibus Performance Award Plan (incorporated by
reference to Exhibit 4.4 of the registration Statement on Form S-8 of the Company filed on November 25, 2020)
10.12*
Form of SAR Award Agreement under the Microbot Medical Ltd. 2020 Omnibus Performance Award Plan (incorporated by reference to
Exhibit 4.5 of the registration Statement on Form S-8 of the Company filed on November 25, 2020)
10.13*
Form of ISO Award Agreement under the Microbot Medical Ltd. 2020 Omnibus Performance Award Plan (incorporated by reference to
Exhibit 4.6 of the registration Statement on Form S-8 of the Company filed on November 25, 2020)
10.14*
Employment Agreement, as of March 31, 2018, with Simon Sharon (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K
filed on April 7, 2021)
10.15*
First Amendment to Employment Agreement, dated as of April 19, 2021, with Simon Sharon (incorporated by reference to Exhibit 10.1 of
the Company’s Form 8-K filed on April 22, 2021)
10.16
At the Market Offering Agreement, dated June 10, 2021, by and between Microbot Medical Inc. and H.C. Wainwright & Co., LLC
(incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on June 10, 2021)
10.17**
Strategic Collaboration Agreement for Technology Co-Development with Stryker Corporation, acting through its Neurovascular Division
(incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on December 27, 2021)
10.18
Asset Purchase Agreement with Nitiloop, Ltd. dated October 6, 2022 (incorporated by reference to the Registrant’s Current Report on Form
8-K filed on October 7, 2022)
10.19*
Employment Agreement with Rachel Vaknin (incorporated by reference to the Company’s Current Report on Form 8-K filed on April 5,
2022)
10.20*
Second Amendment to Employment Agreement with Harel Gadot (incorporated by reference to the Company’s Current Report on Form 8-
K filed on February 1, 2022)
10.21
21.1
Letter Agreements dated March 18, 2021 between Microbot Medical Ltd. and Technion Research and Development Foundation Ltd.
Subsidiaries of the Company (incorporated by reference to the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2016 and filed on March 21, 2017).
23.1
31.1
Consent of Independent Registered Public Accounting Firm
Certification Pursuant to Securities Exchange Act Rule 13(a)-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
(Harel Gadot, Chief Executive Officer)
31.2
Certification Pursuant to Securities Exchange Act Rule 13(a)-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
(Rachel Vaknin, Chief Financial Officer)
32.1
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Harel Gadot,
Chief Executive Officer)
32.2
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Rachel Vaknin,
Chief Financial Officer)
101.INS Inline XBRL Instance - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the
Inline XBRL document.
101.SCH Inline XBRL Taxonomy Extension Schema.
101.CAL Inline XBRL Taxonomy Extension Calculation.
101.DEF Inline XBRL Taxonomy Extension Definition.
101.LAB Inline XBRL Taxonomy Extension Labels.
101.PRE Inline XBRL Taxonomy Extension Presentation.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
Indicates Management contract or compensatory plan or arrangement
*
** Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly
disclosed.
Item 16. Form 10-K Summary
The Company has elected not to provide summary information.
60
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
SIGNATURES
MICROBOT MEDICAL INC.
/s/ Harel Gadot
Harel Gadot
President, Chief Executive Officer and Chairman
Dated: March 31, 2023
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Harel Gadot
Harel Gadot
/s/ Rachel Vaknin
Rachel Vaknin
/s/ Yoseph Bornstein
Yoseph Bornstein
/s/ Prattipati Laxminarain
Prattipati Laxminarain
/s/ Scott Burell
Scott Burell
/s/ Martin Madden
Martin Madden
/s/ Aileen Stockburger
Aileen Stockburger
/s/ Tal Wenderow
Tal Wenderow
Chairman, President and Chief Executive Officer
March 31, 2023
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial and Accounting Officer)
Director
Director
Director
Director
Director
Director
61
March 31, 2023
March 31, 2023
March 31, 2023
March 31, 2023
March 31, 2023
March 31, 2023
March 31, 2023
MICROBOT MEDICAL INC.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 1197)
Consolidated Balance Sheets as of December 31, 2022, and 2021
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2022 and 2021
Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2022 and 2021
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
Notes to the Consolidated Financial Statements
F-1
Page
F-2 - F-3
F-4
F-5
F-6
F-7
F-8 – F-24
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Microbot Medical Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Microbot Medical Inc. and its subsidiary (the “Company”) as of December 31, 2022 and
2021 and the related consolidated statements of comprehensive loss, shareholders’ equity and cash flows, for each of the two years in the period ended
December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021,
and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting
principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1B to the
financial statements, the Company’s financial statements include a net loss of $ 13,168 thousand for the year ended December 31, 2022 and accumulated
deficit of $ 68,761 thousand as of December 31, 2022. The Company is dependent on its ability to obtain additional debt or equity in order to continue its
operations. These conditions raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules
and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over
financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and
performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in
the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or
required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2)
involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical
audit matter or on the accounts or disclosures to which it relates.
F-2
Commitments and Contingencies: Litigation — Refer to Note 2P and 9 to the financial statements
Critical Audit Matter Description
The Company is involved in a litigation as the defendant resulting from the 2017 financing Litigation from third parties may result in a substantial loss. An
estimated loss from a loss contingency is accrued by a charge to expenses or shareholders’ equity if it is probable that a liability has been incurred and the
amount of the loss can be reasonably estimated.
The Company concluded that the loss from the case is not probable and it cannot be reasonably estimable at this stage and no provision was recorded as of
December 31, 2022.
The determination of litigation contingency accruals is subject to significant management judgement in assessing the likelihood of a loss being incurred and
when determining whether a reasonable estimate of the loss or range of loss can be made
Given the inherent uncertainty of the outcome of identified litigation, auditing the valuation assertion of litigation contingency required a high degree of
auditor judgment and an increased extent of effort when performing audit procedures to evaluate management’s assessment on the likelihood and
magnitude of the contingent loss and whether this litigation is reasonably estimable as of December 31, 2022.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the potential loss contingency liability and disclosure of the litigation included the following, among others:
● We made inquiries with management to obtain an understanding of litigation matter and status that the Company is currently undergoing.
● We obtained legal letters from the external legal counsel.
● We inquired of the external and internal legal counsels to determine the status of the case and to understand the basis for management’s conclusion
that the loss from the case is not probable and it cannot be reasonably estimable at this stage.
● We evaluated the assumptions used by management to estimate the litigation contingency likelihood and magnitude, including corroborating these
assumptions with internal and external legal counsel.
● We evaluated the Company’s litigation contingencies disclosure for consistency with our evidence obtained on the litigation matter.
/s/ Brightman Almagor Zohar & Co.
Brightman Almagor Zohar & Co.
Certified Public Accountants
A firm in the Deloitte Global Network
Tel Aviv, Israel
March 31, 2023
We have served as the Company’s auditor since 2013
F-3
MICROBOT MEDICAL INC.
Consolidated Balance Sheets
U.S. dollars in thousands
(Except share and per share data)
Notes
2022
2021
As of December 31,
ASSETS
Current assets:
Cash and cash equivalents
Marketable securities
Short-term deposit
Restricted cash
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Operating right-of-use assets
Total assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payables
Lease liabilities
Accrued liabilities
Total current liabilities
Non-current liabilities:
Long-term lease liabilities
Total liabilities
Commitments and contingencies
Stockholders’ equity:
Common stock; $0.01 par value; 60,000,000 shares authorized as of
December 31, 2022 and 2021; 7,890,628 and 7,108,133 shares issued and
outstanding as of December 31, 2022 and 2021, respectively.
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
3
3,4
5
7
6
6
8
6
9
10
$
$
$
$
2,442 $
5,760
3
77
532
8,814
221
502
9,537 $
116 $
283
1,670
2,069
179
2,248
13,493
1,999
-
87
300
15,879
244
644
16,767
279
278
1,427
1,984
402
2,386
80
75,970
(68,761)
7,289
9,537 $
72
69,902
(55,593)
14,381
16,767
The accompanying notes are an integral part of these consolidated financial statements.
F-4
MICROBOT MEDICAL INC.
Consolidated Statements of Comprehensive Loss
U.S. dollars in thousands
(Except share and per share data)
For the Years Ended
December 31,
2022
2021
(7,736) $
(5,545)
(13,281)
118
(5)
(13,168) $
(1.81) $
(6,153)
(5,204)
(11,357)
44
-
(11,313)
(1.59)
$
$
$
Research and development
General and administrative
Operating loss
Financing income, net
Capital loss
Net loss
Basic and diluted net loss per share
Basic and diluted weighted average common shares outstanding
7,260,344
7,108,133
The accompanying notes are an integral part of these consolidated financial statements.
F-5
MICROBOT MEDICAL INC.
Consolidated Statements of Shareholders’ Equity
U.S. dollars in thousands
(Except share and per share data)
Balances, December 31, 2021
Issuance of common stock and warrants net of
issuance costs
Share-based compensation
Net loss
Balances, December 31, 2022
Balances, December 31, 2020
Share-based compensation
Net loss
Balances, December 31, 2021
Common Stock
Shares
Amount
Additional
Paid-In
Capital
Amount
Accumulated
Deficit
Total
Stockholders’
Equity
Amount
Amount
7,108,133
$
72
$
69,902 $
(55,593) $
14,381
782,495
-
-
7,890,628
7,108,133
-
-
7,108,133
$
$
$
8
-
-
80
72
-
-
72
$
$
$
4,316
1,752
-
75,970 $
68,516 $
1,386
-
69,902 $
-
-
(13,168)
(68,761) $
(44,280) $
-
(11,313)
(55,593) $
4,324
1,752
(13,168)
7,289
24,308
1,386
(11,313)
14,381
The accompanying notes are an integral part of these consolidated financial statements.
F-6
MICROBOT MEDICAL INC.
Consolidated Statements of Cash Flows
U.S. dollars in thousands
Operating activities:
Net loss
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation and amortization
Unrealized gain from marketable securities
Loss on disposal of property and equipment
Share-based compensation expense
Changes in assets and liabilities:
Prepaid expenses and other assets
Other payables and accrued liabilities
Net cash flows used in operating activities
Investing activities:
Short-term deposit
Purchase of property and equipment
Proceeds from sale of investment
Purchase of marketable securities
Proceeds from sales of marketable security
Net cash flows provided by (used in) investing activities
Financing activities:
Issuance of common stock and warrants net of issuance costs
Net cash flows provided by financing activities
Decrease in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
Cash, cash equivalents and restricted cash at ending of period
Supplemental disclosure of cash flow information:
Cash received from interest
Right-of-use assets and lease liability
For the Years Ended December 31,
2022
2021
$
(13,168) $
(11,313)
102
(12)
5
1,752
13
(241)
(11,549)
(3)
(84)
-
(3,749)
-
(3,836)
4,324
4,324
(11,061)
13,580
2,519 $
51 $
103 $
76
-
-
1,386
177
320
(9,354)
-
(69)
270
-
2,999
3,200
-
-
(6,154)
19,734
13,580
1
69
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-7
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 1 - GENERAL
A. Description of business:
Microbot Medical Inc. (the “Company”) is a pre-clinical medical device company specializing in the research, design and development of
next generation micro-robotics assisted medical technologies targeting the minimally invasive surgery space. The Company is primarily
focused on leveraging its micro-robotic technologies with the goal of redefining surgical robotics while improving surgical outcomes for
patients.
The Company incorporated on August 2, 1988 in the State of Delaware under the name Cellular Transplants, Inc. The original Certificate of
Incorporation was restated on February 14, 1992 to change the name of the Company to Cyto Therapeutics, Inc. On May 24, 2000, the
Certificate of Incorporation as restated was further amended to change the name of the Company to StemCells, Inc.
On November 28, 2016, the Company consummated a transaction pursuant to an Agreement and Plan of Merger, dated August 15, 2016, with
Microbot Medical Ltd., a private medical device company organized under the laws of the State of Israel (“Microbot Israel”). On the same
day and in connection with the Merger, the Company changed its name from StemCells, Inc. to Microbot Medical Inc. On November 29,
2016, the Company’s common stock began trading on the Nasdaq Capital Market under the symbol “MBOT”.
The Company and its subsidiary are sometimes collectively referred to as the “Company” as the context may require.
B. Risk Factors:
To date, the Company has not generated revenues from its operations. As of December 31, 2022, the Company had cash equivalents and
marketable securities balance of approximately $8,202 excluding encumbered cash, which management believes is sufficient to fund its
operations for additional 4 months form the date of this annual report. As of the issuance date, there is a substantial doubt as to the Company’s
ability to continue as a going concern.
F-8
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
Due to continuing research and development activities, the Company expects to continue to incur additional losses for the foreseeable future.
While management of the Company believes that it has sufficient funds until August 2023, the Company will seek to raise additional funds
through future issuances of either debt and/or equity securities and possibly additional grants from the Israeli Innovation Authority and other
government institutions. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors,
including, but not limited to, the market demand for the Company’s stock, which itself is subject to a number of development and business
risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that
are favorable to the Company.
C. Use of estimates:
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions pertaining to
transactions and matters whose ultimate effect on the financial statements cannot precisely be determined at the time of financial statements
preparation. Although these estimates are based on management’s best judgment, actual results may differ from these estimates.
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies applied in the preparation of the financial statements are as follows:
A. Basis of presentation:
The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America
(“US GAAP”).
B. Financial statement in U.S. dollars:
The functional currency of the Company is the U.S. dollar (“dollar”) since the dollar is the currency of the primary economic environment in
which the Company has operated and expects to continue to operate in the foreseeable future.
Transactions and balances denominated in dollars are presented at their original amounts. Transactions and balances denominated in foreign
currencies have been re-measured to dollars in accordance with the provisions of Accounting Standards Codification (“ASC”) 830-10,
“Foreign Currency Translation”.
All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in
the statement of operations as financial income or expenses, as appropriate.
C. Principles of consolidation:
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. Inter-company balances and
transactions have been eliminated in consolidation.
D. Cash and cash equivalents:
Cash and cash equivalents consist of cash and demand deposits in banks, and other short-term liquid investments (primarily interest-bearing
time deposits) with original maturities of three months or less at the date of purchase.
E. Restricted cash:
Restricted cash as of December 31, 2022 and 2021 included an $77 and $87, respectively, collateral account for the Company’s leases
agreements and credit line from the bank.
F-9
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
F. Fair value of financial instruments:
The carrying values of cash and cash equivalents, other receivable and other accounts payable and accrued liabilities approximate their fair
value due to the short-term maturity of these instruments.
The Company measures the fair value of certain of its financial instruments (such as marketable securities) on a recurring basis. The method
of determining the fair value of marketable securities is discussed in Note 4.
A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities
carried at fair value will be classified and disclosed in one of the following three categories:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.
Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and
liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or
liabilities.
G. Concentrations of credit risk
Financial instruments which potentially subject the Company to credit risk consist primarily of cash and cash equivalents and marketable
securities. The Company holds these investments in highly rated financial institutions. These amounts at times may exceed federally insured
limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on
these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option
contracts, or other hedging arrangements.
H. Property and equipment:
Property and equipment are presented at cost less accumulated depreciation. Depreciation is calculated based on the straight-line method over
the estimated useful lives of the assets, at the following annual rates:
Research equipment and software
Furniture and office equipment
Leasehold improvements
%
25-33
7
Over the lease period
I. Liabilities due to termination of employment agreements:
Under Israeli employment laws, employees of Microbot Israel are included under Article 14 of the Severance Compensation Act, 1963
(“Article 14”). According to Article 14, these employees are entitled to monthly deposits made by Microbot Israel on their behalf with
insurance companies. Payments in accordance with Article 14 release Microbot Israel from any future severance payments (under the Israeli
Severance Compensation Act, 1963) with respect of those employees. The aforementioned deposits are not recorded as an asset in the
Company’s balance sheets.
F-10
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
J. Basic and diluted net loss per share:
Basic net loss per share is calculated by dividing net loss attributable to common stock shareholders by the weighted average number of
shares of common stock outstanding during the year without consideration of potentially dilutive securities. Diluted net loss per share is
calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method.
All outstanding stock options and warrants have been excluded from the calculation of the diluted loss per share for the years ended
December 31, 2022 and December 31, 2021, since all such securities have an anti-dilutive effect.
K. Research and development expenses
Research and development expenses are charged to the statement of comprehensive loss as incurred. Grants for funding of approved research
and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred and applied as a
deduction from the research and development expenses.
L. Share-based compensation:
The Company applies ASC 718-10, “Share-Based Payment” (“ASC 718-10”), which requires the measurement and recognition of
compensation expenses for all share-based payment awards made to employees and directors including stock options under the Company’s
stock plans based on estimated fair values.
ASC 718-10 requires companies to estimate the fair value of stock options using an option-pricing model, which is recognized as an expense
over the requisite service periods in the Company’s statement of comprehensive loss, based on a straight-line method. The Company
recognizes compensation cost for an equity classified award with only service conditions that has a graded vesting schedule on a straight-line
basis over the requisite service period for the entire award, provided that the cumulative amount of compensation cost recognized at any date
at least equals the portion of the grant date fair value of such award that is vested at that date.
The Company accounts for shares and warrant grants issued to non-employees using the guidance of ASU No. 2018-07 “Compensation -
Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.” which expand the scope of Topic 718,
Compensation - Stock Compensation (which currently only includes share-based payments to employees) to include share-based payments
issued to nonemployees for goods or services.
The Company estimates the fair value of stock options granted as share-based payment awards using a Black-Scholes options pricing model.
The option-pricing model requires a number of assumptions, of which the most significant are expected volatility and the expected option
term (the time from the grant date until the options are exercised or expire). Expected volatility is estimated based on volatility of similar
companies in the technology sector for equity awards granted prior to the Merger and on the Company’s trading share price for equity awards
granted subsequent to the Merger. The Company has historically not paid dividends and has no foreseeable plans to issue dividends. The risk-
free interest rate is based on the yield from governmental zero-coupon bonds with an equivalent term.
The expected stock option term is calculated for stock options granted to employees and directors using the “simplified” method. Grants to
non-employees are based on the contractual term. Changes in the determination of each of the inputs can affect the fair value of the stock
options granted and the results of operations of the Company.
F-11
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
M. Income Taxes:
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the
differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are
expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely
than not that some or all of the deferred tax assets will not be realized. As of December 31, 2022, and 2021, the Company had a full valuation
allowance against deferred tax assets.
N. Marketable securities:
The Company invests in various debt securities and an equity security. Debt securities consist of U.S. treasury securities. Equity security
consist of a mutual fund. The Company records these investments in the consolidated balance sheet at fair value. For all of the Company’s
debt securities, the Company elected the fair value option and thus all unrealized gains or losses for these securities are included in financing
income, net. Unrealized gains or losses for the equity security are included in financing income, net. The Company classifies its investments
as current based on the nature of the investments and their availability for use in current operations.
O. Leases
The Company implements ASU 2016-02, Leases (“Topic 842”). This ASU requires entities that lease assets to recognize on the balance sheet
the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months.
Arrangements that are determined to be leases at inception are recognized as long-term right-of-use assets (“ROU”) and lease liabilities in the
balance sheet at lease commencement. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of
the future fixed lease payments over the lease term at commencement date. As most of the Company’s leases do not provide an implicit rate,
the Company applies its incremental borrowing rate based on the economic environment at commencement date in determining the present
value of future payments. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company
will exercise that option. Lease expense for operating leases or payments are recognized on a straight-line basis over the lease term.
The Company determines if an arrangement is a lease at inception. Operating lease assets are presented as operating lease ROU assets, and
corresponding as lease liabilities (current portion), and as operating long-term lease liabilities, on the Company’s consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the remaining lease payments over the
lease term at commencement date. The Company’s leases do not provide an implicit interest rate. The Company calculates the incremental
borrowing rate to reflect the interest rate that it would have to pay to borrow on a collateralized basis an amount equal to the lease payments
in a similar economic environment over a similar term and considers the Company’s historical borrowing activities and market data in this
determination. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs
incurred. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise
that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
The Company has lease agreements with lease and non-lease components, which it accounts for as a single lease component. The Company
has elected not to recognize ROU assets and lease liabilities for short-term leases that have a term of 12 months or less. The effect of short-
term leases on the Company’s ROU assets and lease liabilities was not material. The Company’s lease agreements do not contain any material
residual value guarantees or material restrictive covenants. In addition, the Company does not have any related party leases and its sublease
transactions are de minimis.
F-12
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
P. Contingencies
Management records and discloses legal contingencies in accordance with ASC Topic 450 Contingencies. A provision is recorded when it is
both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company monitors the stage of
progress of its litigation matters to determine if any adjustments are required.
Q. Government grants
Government grants which are received from the IIA by way of participation in research and development that is conducted by the Company,
are received in installments as the program progresses based on qualified research spending. Grants received are recognized when the grant
becomes receivable, provided there was reasonable assurance that the Company will comply with the conditions attached to the grant and
there was reasonable assurance the grant will be received.
R. Recently issued accounting pronouncements
From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of
the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a
material impact on our financial position or results of operations upon adoption.
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities About Government
Assistance, which requires entities to provide disclosures on material government assistance transactions for annual reporting periods. The
disclosures include information around the nature of the assistance, the related accounting policies used to account for government assistance,
the effect of government assistance on the entity’s financial statements, and any significant terms and conditions of the agreements, including
commitments and contingencies. The new standard is effective for the Company on January 1, 2022 and only impacts annual financial
statement footnote disclosures. Refer to Note 2Q above.
NOTE 3 – CASH AND CASH EQUIVALENTS AND MARKETABLE SECURITIES
The following table sets forth our cash, cash equivalents and marketable securities as of December 31, 2022 and 2021:
Cash and cash equivalents:
Cash
U.S. treasury securities
Total cash and cash equivalents
Marketable securities:
Money market mutual funds
U.S. treasury securities
Total marketable securities
Total cash and cash equivalents and marketable securities
As of December 31,
2022
2021
1,195 $
1,247
2,442 $
1,999 $
3,761
5,760 $
13,493
-
13,493
1,999
-
1,999
8,202 $
15,492
$
$
$
$
$
The unrealized gains on our marketable securities were $12 and less than $1 for the years ended December 31, 2022 and 2021, respectively.
Treasuries have contractual maturities of less than 12 months.
F-13
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 4 - FAIR VALUE MEASUREMENTS
Fair value measurement
The following table summarizes the Company’s financial assets subject to fair value measurement and the level of inputs used in such
measurements as of December 31, 2022 and 2021:
Cash equivalents:
U.S. treasury securities
Marketable securities:
U.S. treasury securities
Money market mutual funds
Total
As of December 31, 2022
Level 2
Level 1
Level 3
$
1,247 $
1,247 $
- $
$
$
3,761 $
1,999
5,760 $
3,761 $
1,999
5,760 $
- $
-
- $
Total
As of December 31, 2021
Level 2
Level 1
Level 3
Cash equivalents:
Money market funds
Marketable securities:
Money market mutual funds
$
- (*)
$
- (*)
$
- $
$
1,999
$
1,999
$
- $
(*) Reclassified
-
-
-
-
-
-
The Company’s financial assets are measured at fair value on a recurring basis by level within the fair value hierarchy. The Company’s
securities and money market funds are classified as Level 1. Other than that, the Company doesn’t have any other financial assets or financial
liabilities marked to market at fair value as of December 31, 2022 and 2021.
NOTE 5 – PREPAID EXPENSES AND OTHER CURRENT ASSETS
Amounts due from government institutions
Prepaid expenses
F-14
As of December 31,
2022
2021
$
$
103 $
429
532 $
174
126
300
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 6 - LEASES
In November 2019, the Company signed a lease agreement for the period from November 2019 till October 2024. In addition, the Company
received an option to extend the lease agreement for additional 5 years.
The monthly lease payments are approximately $16.
To secure the lease payments the Company had issued a bank guarantee of $54 in favor of the facility’s lessor.
Supplemental cash flow information related to operating leases was as follows:
Cash payments and expenses
For the Years Ended December 31,
2022
2021
$
344 $
330
Undiscounted maturities of operating lease payments as of December 31, 2022 are summarized as follows:
2023
2024
2025
Total future lease payments
Less imputed interest
Total lease liability balance
Operating leases weighted average remaining lease term (in years)
Operating leases weighted average discount rate
NOTE 7 - PROPERTY AND EQUIPMENT, NET
Cost:
Research equipment and software
Leasehold improvement
Furniture and office equipment
Accumulated Depreciation:
Research equipment and software
Leasehold improvement
Furniture and office equipment
NOTE 8 - ACCRUED LIABILITIES
Employee-related liabilities
Other current liabilities
As of December 31,
2022
$
$
As of December 31,
2022
2021
2
9%
312
181
2
495
(33)
462
3
9%
As of December 31,
2022
2021
$
$
71 $
229
308
608
63
135
189
387
221 $
68
229
236
533
54
89
146
289
244
As of December 31,
2022
2021
1,372 $
298
1,670 $
1,031
396
1,427
$
$
F-15
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 9 - COMMITMENTS AND CONTINGENCIES
Government Grants:
Microbot Israel has received grants from the Israeli Innovation Authority (“IIA”) for participation in research and development since 2013
through December 31, 2022 totaling approximately $1,500.
In addition, as a result of the agreement with CardioSert Ltd. (“CardioSert”) on January 4, 2018, Microbot Israel took over the liability to
repay CardioSert’s IIA grants in the aggregate amount of approximately $530.
In addition, as a result of the agreement with Nitiloop, on October 6, 2022, Microbot Israel took over the liability to repay Nitiloop’s IIA
grants in the aggregate amount of approximately $925.
In relation to the IIA grants described above, the Company is obligated to pay royalties amounting to 3.0%-3.5% of its future sales of the
products relating to such grants.
The grants are linked to the exchange rate of the dollar to the New Israeli Shekel and bears interest of Libor per annum.
The repayment of the grants is contingent upon the successful completion of the Company’s research and development programs and
generating sales. The Company has no obligation to repay these grants, if the project fails, is unsuccessful or aborted or if no sales are
generated. The financial risk is assumed completely by the Government of Israel. The grants are received from the Government on a project-
by-project basis.
TRDF Agreement:
Microbot Israel signed an agreement with the Technion Research and Development Foundation (“TRDF”) in June 2012 by which TRDF
transferred to Microbot Israel a global, exclusive, royalty-bearing license (as amended, the License Agreement”). As partial consideration for
the license, Microbot Israel shall pay TRDF royalties on net sales (between 1.5%-3.0%) and on sublicense income as detailed in the
agreement.
Pursuant to the License Agreement, both parties agreed to extend the next development milestone for the Company’s Self Cleaning Shunt
(SCS) project, which includes the First In Human milestone, until December 2024, and to continue to maintain the TipCat assets, which are
still in a discovery phase, until December 2023. The Company in October 2022 suspended the SCS project while it evaluates alternatives for
the SCS assets (mainly related patents), which may include seeking buyers for the assets, entering into joint ventures or licensing
arrangements, spinning off the assets into a new operating company or discontinuing the project altogether. The Company has certain
obligations to seek to develop and commercialize the SCS and the TipCat assets under the License Agreement. At the time of filing of this
Annually Report on Form 10-K, the Company has been in discussions with TRDF with respect to the suspension of the SCS project and the
status of the TipCat assets, and the Company expects that if it is unsuccessful in entering into alternative arrangements for such assets, the
Company will return the licensed assets to TRDF.
Agreement with CardioSert Ltd.:
On January 4, 2018, Microbot Israel entered into an agreement with CardioSert to acquire certain patent-protected technology owned by
CardioSert (the “Technology”). Pursuant to the Agreement, Microbot Israel made an initial payment of $50 to CardioSert and had 90-days to
elect to complete the acquisition. At the end of the 90-day period, at Microbot Israel’s sole option, CardioSert shall assign and transfer the
Technology to Microbot Israel and Microbot Israel shall pay to CardioSert additional amounts and securities as determined in the agreement.
F-16
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
On May 25, 2018, Microbot Israel, delivered an Exercise Notice to CardioSert Ltd., notifying it that Microbot Israel elected to exercise the
option to acquire the Technology owned by CardioSert and therefore made an additional cash payment of $250 and 6,738 shares of common
stock estimated at $74.
The agreement may be terminated by Microbot Israel at any time for convenience upon 90-days’ notice. The agreement may be terminated by
CardioSert in case the first commercial sale does not occur by the third anniversary of the date of signing of the agreement except if Microbot
Israel. has invested more than $2,000 in certain development stages, or the first commercial sale does not occur within 50 months. As of
December 31, 2022, the 50 months period has expired and CardioSert can buy-back the Technology at any time. As of the report date,
CardioSert has not purchased back the Technology.
In each of the above termination events, or in case of breach by Microbot Israel, CardioSert shall have the right to buy back the Technology
from Microbot Israel for $1.00, upon 60 days prior written notice, but only 1 year after such termination. Additionally, the agreement may be
terminated by either party upon breach of the other (subject to cure). CardioSert agreed to assist Microbot Israel in the development of the
Technology for a minimum of one year, for a monthly consultation fee of NIS40 (or approximately US$11.37, based on an exchange rate of
NIS 3.519 to the dollar) covering up to 60 consulting hours per month.
ATM Agreement:
On June 10, 2021, the Company entered into an At-the-Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co.
LLC (“Wainwright”), as sales agent, in connection with an “at the market offering” under which the Company may offer and sell, from time
to time in its sole discretion, shares of its Common Stock having an aggregate offering price of up to $10,000 at market prices or as otherwise
agreed with Wainwright. Any shares sold under the ATM Agreement from time to time will be offered and sold pursuant to the Company’s
Registration Statement on Form S-3, which was initially filed on November 25, 2020 and which was declared effective by the SEC on
December 4, 2020, and the related prospectus as supplemented by a prospectus supplement that the Company filed on June 10, 2021 (the
“June 2021 Prospectus”). To date, we have not sold any shares of Common Stock pursuant to the ATM Agreement, and as of October 13,
2022, the Company suspended the ATM Agreement, which remains in full force and effect, and terminated the June 2021 Prospectus.
Acquisition of Nitiloop’s Assets
On October 6, 2022, Microbot Israel purchased substantially all of the assets, including intellectual property, devices, components and product
related materials (the “Assets”), of Nitiloop Ltd., an Israeli limited liability company (“Nitiloop”). The Assets include intellectual property
and technology in the field of intraluminal revascularization devices with anchoring mechanism and integrated microcatheter (the
“Technology”) and the products or potential products incorporating the Technology owned by Nitiloop and designated by Nitiloop as
“NovaCross”, “NovaCross Xtreme” and “NovaCross BTK” and any enhancements, modifications and improvements thereof (“Devices”).
Microbot Israel did not assume any material liabilities of Nitiloop other than obligations Nitiloop has to the IIA and relating to certain
renewal/maintenance fees for a European patent application.
In consideration for the acquisition of the Assets, Microbot Israel shall pay royalties to Nitiloop, which shall not, in the aggregate, exceed
$8,000, as follows:
●
●
Royalties at a rate of 3% of net revenue generated as a result of sales, license or other exploitation of the
Devices; and
Royalties at a rate of 1.5% of net revenue generated from the sale, license or other exploitation of
commercialization of the technology as part of an integrated product.
F-17
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for
as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross
assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is
accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired
inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in
the application of the screen test to determine whether an acquisition is accounted for as business combination or an acquisition of assets.
Based on the Company’s analysis, the Company concluded that the acquisition of the assets does not meet the definition of a business for the
purpose of applying SEC Rules (S-X Rules of 3-05, 8-04 and 11-01).
Litigation:
Litigation Resulting from 2017 Financing
The Company was named as the defendant in a lawsuit captioned Empery Asset Master Ltd., Empery Tax Efficient, LP, Empery Tax Efficient
II, LP, Hudson Bay Master Fund Ltd., Plaintiffs, against Microbot Medical Inc., Defendant, in the Supreme Court of the State of New York,
County of New York (Index No. 651182/2020). The complaint alleges, among other things, that the Company breached multiple
representations and warranties contained in the Securities Purchase Agreement (the “SPA”) related to the Company’s June 8, 2017 equity
financing (the “Financing”), of which the Plaintiffs participated, and fraudulently induced Plaintiffs into signing the SPA. The complaint seeks
rescission of the SPA and return of the Plaintiffs’ $6,750 purchase price with respect to the Financing. The Company is currently in the
discovery phase. Management is unable to assess the likelihood that the Company will succeed at trial with respect to the SPA or the
Financing, having previously lost another lawsuit with respect to the Financing.
Alliance Litigation
On April 28, 2019, the Company brought an action against Alliance Investment Management, Ltd. (“Alliance”), later amended to include
Joseph Mona (“Mona”) as a defendant, in the Southern District of New York under Section 16(b) of the Securities Exchange Act of 1934, 15
U.S.C. 78p(b), to compel Alliance and Mona to disgorge short swing profits realized from purchases and sales of the Company’s securities
within a period of less than six months. The case is Microbot Medical Inc. v. Alliance Investment Management, Ltd., No. 19-cv-3782-GBD
(SDNY). The amount of profits was estimated in the complaint to be approximately $468.
On October 28, 2019, Alliance filed a motion for summary judgment requesting that the Court dismiss the claims against Alliance. On
February 4, 2020, Mona answered the 16(b) claim the Company asserted against him by claiming various equitable defenses and filed a
counterclaim against the Company under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder,
claiming a net loss on trading the Company’s stock of approximately $151.
On September 17, 2020, the Court issued a Memorandum Decision & Order that, among other things, granted Alliance’s summary judgment
motion.
On March 30, 2021, the Court issued an Order; and on March 31, 2021, the Clerk entered judgment against Mona and in favor of the
Company in the amount of approximately $485. On April 27, 2021, Mona filed an appeal of the Court’s judgment, which is pending before
the U.S. Court of Appeals for the Second Circuit.
F-18
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
In June 2021, the Magistrate issued an order permitting Mona to file an Amended Counterclaim Complaint, and rejected the Company’s
request to execute on the judgment. The Company filed a response to Mona’s amended counterclaim in July 2021, and in February 2023 filed
a motion for summary judgment on Mona’s fraud claim on the basis of inability to demonstrate reliance or loss causation. The motion is
scheduled to be fully briefed and submitted on May 1, 2023.
NOTE 10 - SHARE CAPITAL
Share Capital Developments
As of December 31, 2022, and 2021, the Company has 7,890,628 and 7,108,133 shares of common stock issued and outstanding, respectively.
On October 21, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor
(the “Investor”), pursuant to which the Company issued and sold, in a registered direct offering priced at-the-market under the rules of The
Nasdaq Stock Market (the “Registered Offering”), (i) an aggregate of 782,495 shares of Common Stock, at an offering price of $4.89 per
share and (ii) pre-funded warrants exercisable for up to 240,000 shares of Common Stock (the “Pre-Funded Warrants”) to the Investor at an
offering price of $4.8899 per Pre-Funded Warrant, for aggregate gross proceeds from the Offerings (as defined below) of approximately
$5,000 before deducting the placement agent fee (as described below) and related offering expenses.
Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of $0.0001 per share. The Pre-
Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full.
In a concurrent private placement (the “Private Placement” and, together with the Registered Offering, the “Offerings”), the Company issued
to the Investor (i) Series A preferred investment options to purchase up to 1,022,495 shares of Common Stock (the “Series A Warrants”) at an
exercise price of $4.64 per share and (ii) Series B preferred investment options to purchase up to 1,022,495 shares of Common Stock (the
“Series B Warrants”) at an exercise price of $4.64 per share. Each Series A Warrant is exercisable immediately and will expire five years from
the initial exercise date. Each Series B Warrant is exercisable immediately and will expire two years from the initial exercise date.
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance in FASB ASC 480 and FASB ASC 815, “Derivatives and Hedging” (“ASC 815”). The
assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability
pursuant to ASC 480, and meet all of the requirements for equity classification under FASB ASC 815, including whether the warrants are
indexed to the Company’s own ordinary shares and whether the warrant holders could potentially require “net cash settlement” in a
circumstance outside of the Company’s control, among other conditions for equity classification. This assessment is conducted at the time of
warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
The Company analyzed the accounting treatment for the Pre-funded Warrants and for the Common Warrants. The Common Stocks of the
Company are recognized as equity under the requirements of Accounting Standard Codification Topic 505 Equity (ASC 505). Based on the
Company’s analysis the Warrants were classified as equity.
On October 3, 2022 and in connection with the Offerings, the Company entered into an engagement letter with H.C. Wainwright & Co., LLC
(“Wainwright”), pursuant to which Wainwright agreed to serve as the exclusive placement agent for the issuance and sale of securities of the
Company pursuant to the Purchase Agreement. As compensation for such placement agent services, the Company paid Wainwright aggregate
cash fees and reimbursed Wainwright for its expenses aggregating approximately $565. The Company also issued to Wainwright or its
designees warrants to purchase 51,125 shares of Common Stock (the “Wainwright Warrants”). The Wainwright Warrants have a term of five
years from the commencement of sales in the Offerings, and have an exercise price of $6.11 per share. Upon any exercise for cash of any
preferred investment options issued to investors in the offering, the Company obligate to pay 7% percent of the aggregate gross exercise price
of the warrants issued in the Offering and shall issue to Wainwright (or its designees), within five (5) business days of the Company’s receipt
of the exercise price, warrants to purchase that number of shares of common stock of the Company equal to five (5.0%) percent of the
aggregate number of such shares of common stock underlying the preferred investment options that have been so exercised.
F-19
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
The Company analyzed the accounting treatment for the Wainwright Warrants issued to Wainwright. Since the Company did not identify any
features causing liability classification of the Wainwright Warrants according to ASC 718, it concluded that the Wainwright Warrants are
equity-classified awards.
Employee Stock Option Grants
During the year ended December 31, 2021, the Company granted to Mr. Harel Gadot, the Company’s Chairman of the Board, President and
CEO, options to purchase an aggregate of 190,000 shares of the Company’s common stock, at an exercise price per share of $8.48. The stock
options vest over a period of 2 years as outlined in the option agreements evidencing such grants. As a result, the Company recognized
compensation expenses for the year ended December 31, 2021, in the total amount of $646.
During the year ended December 31, 2021, the Company granted to certain employees and consultants and directors, options to purchase an
aggregate of 231,426 shares of the Company’s common stock, at an exercise price per share of $6.72 - $7.26. The stock options vest over a
period of 3 years as outlined in the option agreements evidencing such grants. As a result, the Company recognized compensation expenses
for the year ended December 31, 2021, in the total amount of $740.
During the year ended December 31, 2022, the Company granted to Mr. Harel Gadot, the Company’s Chairman of the Board, President and
CEO, options to purchase an aggregate of 260,000 shares of the Common Stock, at an exercise price per share of $3.73-$6.48. The stock
options vest over a period of three years as outlined in the option agreements evidencing such grants.
During the year ended December 31, 2022, the Company granted to certain employees, consultants and directors, options to purchase an
aggregate of 270,822 shares of the Common Stock, at an exercise price per share of $3.73-$6.48. The stock options vest over a period of three
years as outlined in the option agreements evidencing such grants.
A summary of the Company’s option activity related to options to employees and directors, and related information is as follows:
Outstanding as of December 31, 2021
Granted
Cancelled
Outstanding as of December 31, 2022
Vested as of December 31, 2022
Outstanding as of December 31, 2020
Granted
Outstanding as of December 31, 2021
Vested as of December 31, 2021
For the Year Ended December 31, 2022
Number of stock
options
Weighted average
exercise price
997,148 $
530,822
(20,833)
1,507,137 $
899,609 $
8.48
5.14
8.16
7.31
8.52
For the Year Ended December 31, 2021
Number of stock
options
Weighted average
exercise price
575,722 $
421,426
997,148 $
568,053 $
9.14
7.60
8.48
9.08
F-20
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
The Company recognizes forfeitures of outstanding options as they occur.
The intrinsic value is calculated as the difference between the fair market value of the common stock and the exercise price, multiplied by the
number of in-the-money stock options on those dates that would have been received by the stock option holders had all stock option holders
exercised their stock options on those dates as of December 31, 2022 and December 31, 2021, respectively.
As of December 31, 2022, and 2021, the aggregate intrinsic value of the outstanding options is $185 and $974 respectively, and the aggregate
intrinsic value of the exercisable options is $185 and $815, respectively.
As of December 31, 2022, there were approximately $2,036 of total unrecognized compensation costs related to unvested share-based
compensation awards granted under the Share Incentive Plan. The costs are expected to be recognized over a weighted average period of
2.039 years
The stock options outstanding as of December 31, 2022 and December 31, 2021, summarized by exercise prices, are as follows:
Stock options
outstanding as of
December 31,
2022
Stock options
outstanding as of
December 31,
2021
Weighted
average
remaining
contractual life –
years as of
December 31,
2022
Weighted
average
remaining
contractual life
– years as of
December 31,
2021
Stock options
exercisable as
of December
31, 2022
Stock options
exercisable as
of December
31, 2021
211,000
77,846
32,500
15,808
99,823
17,503
31,492
182,500
117,500
81,426
11,084
20,000
4,902
190,000
9,304
10,000
166,666
35,199
131,007
61,577
1,507,137
-
77,846
-
15,808
-
17,503
31,492
-
125,000
81,426
11,084
25,000
4,902
190,000
9,304
10,000
166,666
38,533
131,007
61,577
997,148
10
2.0
9.6
6.8
9.7
6.6
7.5
9.1
8.4
8.8
7.9
8.8
7.6
8.1
6.1
5.6
7.2
5.0
4.7
3.3
7.6
-
3.0
-
7.8
-
7.6
8.5
-
9.4
9.8
8.9
9.8
8.6
9.1
7.1
6.6
8.2
6.0
5.7
4.3
7.6
-
77,846
-
15,808
-
17,503
26,282
59,312
64,624
38,676
7,756
8,000
3,799
166,250
9,304
10,000
166,666
35,199
131,007
61,577
899,609
-
77,846
-
11,064
-
13,564
16,834
-
31,249
-
4,432
-
2,328
-
9,304
10,000
166,666
38,533
124,656
61,577
568,053
Exercise price $
3.73
4.20
4.80
5.06
5.71
5.95
6.16
6.48
6.72
7.00
7.22
7.26
8.16
8.48
8.60
9.00
9.64
15.30
15.75
(*)
(*) Less than $0.01.
Compensation expense recorded by the Company for its stock-based employee compensation awards in accordance with ASC 718-10 for the
years ended December 31, 2022 and 2021 was $1,752 and $1,386, respectively.
F-21
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
Employee Stock Option Grants
The grant date fair values of stock options granted in the years ended December 31, 2022 and 2021 were estimated using the Black-Scholes
valuation model with the following:
Expected volatility
Risk-free interest
Dividend yield
Expected terms (years)
Warrants
For the Years Ended December 31,
2022
111.2%-161.7%
1.7%- 3.7%
-%
6.2
2021
118.3%-134.3%
0.4%-1.2%
-%
5.3
The remaining outstanding warrants and terms as of December 31, 2022 and 2021 are as follows:
Issuance date
Series A (2013)
Series B (2016)
Warrant to underwriters 1.2019
Warrant to underwriters 1.2019
Warrant to underwriters 12.2019
Warrant to underwriters 12.2019
Warrant to underwriters 12.2019
Series A 10.2022
Series B 10.2022
Warrant to underwriters 10.2022
Outstanding and
exercisable as of
December 31, 2022
183
-
-
-
45,643
47,619
45,045
1,022,495
1,022,495
51,125
Outstanding and
exercisable as of
December 31, 2021
Exercise Price
Exercisable Through
183 $
2,770 $
8,082 $
29,500 $
45,643 $
47,619 $
45,045 $
- $
- $
- $
2,754.00
40.50
8.13
12.50
13.13
13.13
13.88
4.64
4.64
6.11
April 9, 2023
March 14, 2022
July 14, 2022
July 15, 2022
June 25, 2023
June 27, 2023
June 30, 2023
October 25, 2027
October 25, 2024
October 21, 2027
NOTE 11 - BASIC AND DILUTED NET LOSS PER SHARE
The basic and diluted net loss per share and weighted average number of shares of common stock used in the calculation of basic and diluted
net loss per share were presented in the consolidated statements of comprehensive loss for the years ended December 31, 2022 and 2021.
Due to the net loss to common stockholders in each of the periods presented above, diluted loss per share was computed without consideration
to potentially dilutive instruments as their inclusion would have been anti-dilutive. As of December 31, 2022 and 2021, potentially dilutive
securities excluded from the diluted loss per share calculation are as follows:
Series A and B warrants 2013 and 2016
Warrant to underwriters 12.2019
Series A and B warrants 10.2022
Warrant to underwriters 10.2022
Outstanding options to purchase common stock
F-22
For the Years Ended December 31,
2022
2021
183
138,307
2,044,990
51,125
1,507,137
2,953
175,889
-
-
997,148
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 12 - RESEARCH AND DEVELOPMENT EXPENSES, NET
Payroll and related expenses
Share-based compensation
Professional services
Materials
Patents
Rent
Office and maintenance expenses
Depreciation
Other
NOTE 13 - GENERAL AND ADMINISTRATIVE EXPENSES
Payroll and related expenses
Government fees
Share-based compensation
Professional services
Insurance
Public and investor relations
Office and maintenance expenses
Travel
Other
NOTE 14 - TRANSACTIONS AND BALANCES WITH RELATED PARTIES
Transactions:
Payroll and related expenses
ESOP expenses to CEO and executive officers
Board of directors fees
ESOP expenses to directors
Insurance for directors and executives
Balances:
Bonus to CEO and executive offices
Board of directors fees
Payroll and related expenses
F-23
For the Years Ended December 31,
2022
2021
3,558 $
387
2,097
559
341
224
100
102
368
7,736 $
3,030
183
1,532
703
251
206
123
72
53
6,153
For the Years Ended December 31,
2022
2021
1,813 $
35
1,365
998
733
220
120
180
81
5,545 $
1,391
170
1,203
1,298
732
203
108
42
57
5,204
For the Years Ended December 31,
2022
2021
2,067 $
1,172
300
301
722
4,562 $
As of December 31,
2022
2021
581
75
92
748 $
1,912
846
300
91
727
3,876
310
75
28
413
$
$
$
$
$
$
$
MICROBOT MEDICAL INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
(Except share and per share data)
NOTE 15 - TAXES ON INCOME
The Company is subject to income taxes under the Israeli and U.S. tax laws:
Corporate tax rates
The Company is subject to U.S. federal tax rate of 21% for the years ended December 31, 2022 and 2021.
The Company has not been audited by the Internal Revenue Service since its incorporation.
As of December 31, 2022 and 2021, the Company has generated accumulated net operating losses in the U.S. of approximately $502,053 and
$496,950, respectively. Net operating losses in the United States are available through 2035. Utilization of U.S. net operating losses may be
subject to substantial annual limitation due to the “change in ownership” provisions of the Internal Revenue Code of 1986 and similar state
provisions. The annual limitation may result in the expiration of net operating losses before utilization.
Microbot Israel is subject to Israeli corporate tax rate of 23% for the years ended 2022 and 2021. Microbot Israel has not received a final tax
assessment since 2016.
As of December 31, 2022 and 2021, Microbot Israel has generated accumulated net operating losses in Israel of approximately $34,688 and
$26,623, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period.
The Company is still in its development stage and has not yet generated revenues, therefore, it is more likely than not that sufficient taxable
income will not be available for the tax losses to be utilized in the future. Therefore, a valuation allowance was recorded to reduce the
deferred tax assets to its recoverable amounts.
Net operating loss carryforwards
Operation lease liabilities
Accrued vacation pay
Total deferred tax assets
Less: valuation allowance
Net deferred tax assets
Operating leases, right-of-use assets
Total deferred tax liabilities
Total net deferred tax assets
Reconciliation of Income Taxes:
For the Years Ended December 31,
2021
2022
$
$
$
113,393
105
71
113,569
(113,455)
114
(114)
(114)
$
-
109,483
156
45
110,684
(110,536)
148
(148)
(148)
-
The following is a reconciliation of the taxes on income assuming that all income is taxed at the ordinary statutory corporate tax rate in Israel
and the effective income tax rate:
Net loss in Israel
Net loss in U.S.
Statutory tax rate
Income Tax under statutory tax rate
Change in valuation allowance
Actual provision for income tax
NOTE 16 – SUBSEQUENT EVENT
For the Years Ended December 31,
2022
2021
$
$
$
8,065 $
5,103 $
21%-23%
2,922
(2,922)
- $
6,853
4,460
21%-23%
2,513
(2,513)
-
On February 13, 2023, 240,000 pre-funded warrants were exercised to shares of Common Stock (the “Pre-Funded Warrants”) in exercise
price of $0.0001 per share.
F-24
Exhibit 10.21
Technion Research and Development Foundation Ltd.
Technion City, Haifa 32000
Israel
Re: Joint Invention Under License Agreement dated June 20, 2012
We are writing this letter as a follow up to our discussions regarding the invention entitled “Device for Automatically Inserting and Advancing a Medical
Tool into a Bodily Lumen” (as disclosed in US Provisional Patent Application no. 62/941,842, the “Invention”) for which Professor Moshe Shoham, in his
capacity as a consultant to Microbot Medical Ltd. (“Microbot”), and employees of Microbot, who are not required under law, agreement and/or under
TRDF Intellectual Property By-Laws to assign their rights in the Invention to TRDF, are co-inventors. The parties hereby confirm that the Invention is a
Joint Invention in accordance with the terms of that certain License Agreement dated June 20, 2012 between Technion Research and Development
Foundation Ltd. and Microbot (the “License Agreement”).
Without derogating from the above, the Invention will be deemed part of the License Agreement and is subject to its obligations including but not limited
to paragraph 5 (Consideration) and paragraph 11.3 (Effect of Termination) as a Joint Invention.
Please indicate your agreement to the above by signing below.
Sincerely
Microbot Medical Ltd.
/s/ Simon Sharon
By:
Name: Simon Sharon
Title: CTO
March 18, 2021
/s/ Naama
Naama Moav
HR Manager
Agreed to and Accepted:
Technion Research and Development Foundation Ltd.
/s/ Jacob (Koby) Rubinstein
By:
Name: Jacob (Koby) Rubinstein
Title: CEO
24. 3. 2021
Microbot Medical LTD. 6 HaYozma St, Yokneam, 2069204. Israel, P.B 242,
Tel: 972-4-8200710, Fax: 972-4-8200712 www.microbotmedical.com
Technion Research and Development Foundation Ltd.
Technion City, Haifa 32000
Israel
Dear Sirs and Madams,
Microbot Medical Ltd. (“Company”) and Technion Research and Development Foundation Ltd. (“TRDF”) are party to that certain License Agreement
dated June 20, 2012 (the “License Agreement”).
The License Agreement addresses TRDF’s and Company’s agreements with respect to “Shoham Inventions”, “Shoham Patent Rights”, “Joint Inventions”
and “Joint Patent Rights”, as such terms are defined in the License Agreement. The parties acknowledge that Professor Shoham has been providing services
and/or has been a member of the Company’s scientific advisory board, and that in such capacity he was a co-inventor of a Joint Invention referred to in the
confirmation letter executed by the parties on March 18, 2021.
It is our understanding that as of October, 2020, Professor Shoham has ceased being employed by the Technion — Israel Institute of Technology
(“Technion”).
Provided that Professor Shoham has no research activity of any kind at the Technion: (a) inventions and other intellectual property made or generated by
Professor Shoham after the cessation of his employment with the Technion in the provision of services to and/or as a member of the Company’s scientific
advisory board will not be covered by the License Agreement; and (b) TRDF and the Technion will not claim rights in any such inventions or other
intellectual property made or generated by Professor Shoham after the cessation of his employment with the Technion in such capacity by virtue of his
continued affiliation with the Technion.
Please indicate your approval of the above by signing below.
Microbot Medical Ltd.
/s/ Simon Sharon
By:
Name: Simon Sharon
Title: CTO
March 18, 2021
/s/ Naama
Naama Moav
HR Manager
Agreed to and Accepted:
Technion Research and Development Foundation Ltd.
/s/ Jacob (Koby) Rubinstein
By:
Name: Jacob (Koby) Rubinstein
Title: CEO
24. 3. 2021
Microbot Medical LTD. 6 HaYozma St, Yokneam, 2069204. Israel, P.B 242,
Tel: 972-4-8200710, Fax: 972-4-8200712 www.microbotmedical.com
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements on Form S-8 (Registration No. 333-221216 and 333-250963) and the
Registration Statement on Form S-3 (Registration No. 333-250966) of our report dated March 31, 2023 relating to the consolidated financial statements of
Microbot Medical Inc. (the “Company”) appearing in the Annual Report on Form 10-K of the Company for the year ended December 31, 2022.
Exhibit 23.1
/s/ Brightman Almagor Zohar & Co.
Brightman Almagor Zohar & Co.,
Certified Public Accountants
A firm in the Deloitte Global Network
Tel Aviv, Israel
March 31, 2023
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Harel Gadot, certify that:
1.
I have reviewed this annual report on Form 10-K of Microbot Medical Inc.
Exhibit 31.1
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 31, 2023
/S/ HAREL GADOT
Harel Gadot
President and Chief Executive Officer
(principal executive officer)
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Rachel Vaknin, certify that:
1.
I have reviewed this annual report on Form 10-K of Microbot Medical Inc.
Exhibit 31.2
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 31, 2023
/S/ RACHEL VAKNIN
Rachel Vaknin
Chief Financial Officer
(principal financial and accounting officer)
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Microbot Medical Inc. (the “Company”) on Form 10-K for the fiscal year ended December 31, 2022 as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), I, Harel Gadot, President and Chief Executive Officer of the Company,
certify, pursuant to 18 U.S.C. Sec. 1350, as adopted pursuant to Sec. 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the company.
/s/ HAREL GADOT
Harel Gadot
President and Chief Executive Officer
March 31, 2023
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of Microbot Medical Inc. (the “Company”) on Form 10-K for the fiscal year ended December 31, 2022 as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), I, Rachel Vaknin, Chief Financial Officer of the Company, certify,
pursuant to 18 U.S.C. Sec. 1350, as adopted pursuant to Sec. 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the company.
/s/ RACHEL VAKNIN
Rachel Vaknin
Chief Financial Officer
March 31, 2023