MBOT 10-K & 10-Q changes, risk factors and insider trading
Microbot Medical Inc. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 883975 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Microbot’s business depends heavily on the success of its sole product, the LIBERTY® Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.”
New heading “If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving the LIBERTY® Endovascular Robotic Surgical System or any other of its product candidates after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.”
New heading “Our profitability may be negatively impacted by inflation in the cost of labor, materials, and services.”
Removed heading “Microbot’s business depends heavily on the success of its sole lead product candidate, the LIBERTY® Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.”
Removed heading “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.”
Removed heading “Clinical outcome studies for the LIBERTY® Endovascular Robotic Surgical System may not provide sufficient data to make such product candidate the attractive.”
Largest changes
“Our profitability may be negatively impacted by inflation in the cost of labor, materials, and services.”see in full comparison
“Although inflation in the United States has declined since 2023, prices have continued to be significantly impacted by inflation relative to historical levels. This continued inflation has raised our costs for plastic products and other components of our LIBERTY device, thereby increasing our operating costs and capital expenditures. Additionally, the Trump administration has increased tariffs on many imports. …”see in full comparison
“If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving the LIBERTY® Endovascular Robotic Surgical System or any other of its product candidates after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.”see in full comparison
“Microbot’s business depends heavily on the success of its sole lead product candidate, the LIBERTY® Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.”see in full comparison
“Microbot’s business depends heavily on the success of its sole product, the LIBERTY® Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (68)
Through December 31, 2025, Microbot
has hadnot norecognized revenueany revenues, and hascannot incurredmake any assurances of generating
significant operatingrevenues lossesin sincethe inceptionfuture. andIt 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 Microbot
continuesconducts its preclinicalsales and clinicalmarketing development programsoperations for its existing product candidates, primarily the LIBERTY®
Endovascular Robotic Surgical System; and continues
its research and development of any other future product candidates; and all other work necessary
to obtain regulatory clearances or
approvals for its products or 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 the LIBERTY® Endovascular Robotic Surgical System or other future product
candidates are approved or cleared for commercial distribution,and engaging in appropriate sales and marketing activities that, together
with anticipated sales, general and
administrative expenses, will likely result in Microbot incurring further significant losses for the foreseeable
future.
Microbot
ishas anot development-stagerecognized medicalany device company and currently generates no revenuerevenues from product sales,sales through December 31, 2025, and maydoes nevernot beanticipate ablegenerating tosignificant
revenues until it can successfully commercialize
and sell the LIBERTY® Endovascular Robotic Surgical System or other future product candidates. Microbot does not currently have
the required approvals or clearances to market or test in humans the LIBERTY® Endovascular Robotic Surgical System 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,candidates, of
which Microbot can give no assurance.
Even if Microbot or any of its future development partnerspartners, if any, succeed in commercializing anythe
LIBERTY® ofEndovascular itsRobotic productSurgical candidates,System, Microbot may never
generate revenues significant enough to achieve
profitability.
Because of the numerous risks and uncertainties associated with the LIBERTY® Endovascular Robotic Surgical System or 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 ongoing 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 outsideas ofa commercial-stage company since it ceased primarily being a research and development-stage
company, which may make it difficult to evaluate the
prospects for the Company’s future viability.
Microbot has a limited operating history as a commercial-stage company 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’sMicrobot
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 preclinical and clinical trials of product candidates from time to time and, most recently, commencing pre-commercialization
planning for the LIBERTY® Endovascular Robotic Surgical System. 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.
Microbot
willexpects to need additional funding.funding to continue to transition to a profitable commercial enterprise and build a sustainable business model.
If Microbot is unable to raise capital when needed,capital, it could be forced to delay, reduce or eliminate its
product development programs or commercialization
efforts efforts.or future product development programs.
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 generatebe 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.profitable. 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,of the manufacturing, sales and seeksmarketing regulatoryinfrastructure necessary
review of, its product candidates, and begins to commercialize any approved or cleared products following a successful regulatory review.LIBERTY®.
Microbot
also expects the research and development expenses of the Company to continue to increase substantially in future periods as it
potentially conducts clinical trials
for additional research programs for the LIBERTY® Endovascular Robotic Surgical System, and especially if it
initiates additional
research programs for future applications and product candidates. This is the case even with the
Company’s past suspension or termination of the research and development programs relating to the SCS device, the technology
we originally acquired from CardioSert, and other programs. 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. Furthermore, Microbot incurs substantial costs associated with operating as a public
company in the United
States. Accordingly, the Company will likely need to obtain substantial additional funding in connection with its
continuing continuing
operations through its projected profitability, of which it can give no assurance of success. If the Company is unable to
raise 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, in which case it may be unable to meet its obligations or fully implement its business plan,
plan, if at all.
The
Company intends to continue to opportunistically strengthen its balance sheet by raising additional funds through equity offerings or
otherwise in order to meet expected future liquidity needs, including the commercial introduction of the LIBERTY® Endovascular
Robotic Surgical System.needs. The Company’s future capital requirements, generally, will depend on
many factors, including:
Risks
Relating to the Development and Commercialization of Microbot’s Product CandidatesProducts
Microbot’s business depends heavily on the success of its sole product, the LIBERTY® Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.
Through December 31, 2025, Microbot has not recognized any revenues from its operations, and might not generate significant revenues in the foreseeable future, if at all, and depends heavily on the successful commercialization of the LIBERTY® Endovascular Robotic Surgical System. The success of commercializing the LIBERTY® Endovascular Robotic Surgical System, will depend on a number of factors, including the following:
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® Endovascular Robotic Surgical System or any other product candidate, which would materially harm its business.
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 the LIBERTY® Endovascular Robotic Surgical System or any other of Microbot’s future product candidate.
The commercial success of the LIBERTY® Endovascular Robotic Surgical System 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 products 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 products. 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’s products 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.
Microbot only recently, in 2025, shifted its focus primarily from research and development of the LIBERTY® Endovascular Robotic Surgical System to its commercialization. Consequently, Microbot has limited experience in manufacturing, and intends to manufacture its products 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 good manufacturing practice (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 products will be dependent on material and other manufacturing costs. Microbot cannot offer any assurances that its manufacturing partner will be able manufacture its products at a competitive price or that achieving cost reductions will not cause a reduction in the performance, reliability and longevity of its products.
If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving the LIBERTY® Endovascular Robotic Surgical System or any other of its product candidates after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.
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 products or products Microbot develops in the future.
Microbot’s
business depends heavily on the success of its sole lead product candidate, the LIBERTY® Endovascular Robotic
Surgical System. If Microbot is unable to commercialize the LIBERTY® Endovascular Robotic Surgical System,
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® Endovascular
Robotic Surgical System, or any other product candidate, are collected, Microbot must still obtain FDA clearance or approval to market
the system 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® Endovascular Robotic Surgical System, or any of our other product candidates from time to time. The success
of commercializing any of our product candidates, include the LIBERTY® Endovascular Robotic Surgical System, will depend
on a number of factors, including the following:
We
previously suspended our research and development programs for all of our product candidates and platforms other than the LIBERTY®
Endovascular Robotic Surgical System 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® Endovascular Robotic Surgical System.
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® Endovascular Robotic Surgical System 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 future product applications or candidates.
Microbot
believes that its success will depend in part on its ability to expand its product offerings and continue to improve its existing productproducts
candidates in response to changing technologies, customer demands and competitive pressures. As such, Microbot expects to continue dedicating significant
significant resources in research and development. The product candidates and services being developed by Microbot may not be technologically successful.
successful. In addition, the length of Microbot’s product candidates and service development cycle may be greater than Microbot originally
originally expected.
Microbot
has established internal goals, based upon expectations with respect to its technologies, which Microbot has used to assess its progress
towardtowards, developingmost recently, commercializing the LIBERTY® Endovascular Robotic Surgical System. These goals relate to technology
and design improvements
as well as to dates for achieving specific development, commercialization and results. If the LIBERTY®
Endovascular Robotic
Surgical System exhibits technical defects or are unable to meet cost or performance goals, among other things,
Microbot’s commercialization schedule
could be delayed and potential purchasers may decline to purchase such products or may opt
to pursue alternative products, which would
materially harm its business.
AtMicrobot
this time, Microbot does not know whether theany data submitted with itsany future 510(k) application will satisfy all FDA requirements to support
clearance of
any thefuture LIBERTY®product Endovascularcandidate Roboticof Surgical System,Microbot, which createswould create uncertainty for Microbot as
well as the possibility of increased product
development costs and time to market.market for any such product candidate.
In
the event Microbot
has identifiedpursues a future product candidate that requires FDA approval or clearance, it would have to identify a predicate
device for thethat LIBERTY®product Endovascular Robotic Surgical System,candidate which it usedwould then 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 submitted in itsany such 510(k).
Furthermore, even though Microbot intends to commence its human trials based on protocols
agreed to with the FDA as part of its IDE submission, 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 requireswill require clinical data to be submitted as part of theany LIBERTY®future Endovascularproduct Robotic Surgical Systemcandidate’s marketing submission,
and 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.
investigation. In addition, the sponsor of the investigation must also submit and obtain FDA approval of an Investigational Device Exemption,
or IDE,
application, which we have submitted and are continuing the submission process with the FDA while we commence the approved human trials.
trials. 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
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
participating clinicians and clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility criteria, failure
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,
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® Endovascular Robotic
Surgical System or any otherfuture product candidate would significantly
increase the costs associated with developing and commercializing
the product and delay the timing of U.S. regulatory authorization.
Additionally, The current uncertainty regarding near-termany medical device regulatory
changes by the FDA could further affect our development plans for the LIBERTY® Endovascular Robotic Surgical System 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
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 itsany future product applications
and candidates, if such
trials become necessary.
AsAlthough
a development-stage, clinical-stage company, Microbot has no prior experience in designing, initiating, conducting and monitoring human
clinical trials.trials, Microbotit willexpects to continue to depend
in part 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 itsany future product candidates and, consequently, could delay or materially impair its ability to generate revenues
from the commercialization of any of those future products.
Our research and development program is dependent on the availability of certain components from suppliers, the delay in delivery of which could materially adversely affect our ongoing development and ability to manufacture and package devices in the timeframes currently expected.
As
a result of the Israel-Hamas war and related conflicts, we arehave currentlyexperienced experiencingfrom time to time delays in the supply for certain components
from from
Israeli-based vendors. We cannot determine with any certainty as to whether these shortagesthere will continuebe future shortages, especially if the recently commenced U.S.-Israeli war against Iran escalates and spreads, and if so, for how long.
Consequently, Consequently,
our operational and development timeline could be adversely affected if we were unable to obtain these components from
our suppliers
in the quantities or based on the timeline we require. Although we believe in most cases that we could identify alternative
suppliers, suppliers,
we can give no assurance that our research and development timelines will not be delayed while we identify and retain replacement suppliers. Accordingly,
Accordingly, any material delay in delivery of any component parts or packaging could materially adversely affect our ability to obtain
FDA approval and otherwise meet our expected
timeframes.
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 the LIBERTY® Endovascular Robotic Surgical System 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.
To
date, Microbot has focused primarily on research and development of the LIBERTY® Endovascular Robotic Surgical System
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 good manufacturing practice (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 has relied on, and intends to continue to rely on, third-party manufacturers to produce its products and product candidates.
Microbot
currently relies, and expects to rely for the foreseeable future, on third-party manufacturers to produce and supply its productproducts, candidates,and
and it expects to rely on third parties to manufacture the commercialized products as well, should they receive the necessary regulatory
clearance or approval.well. 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:
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 obtainsupply regulatory clearance or approvalproducts for
its product candidatescustomers 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.
If Microbot’s products and 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 products and product candidates if Microbot fails to comply with extensive governmental regulations.
MicrobotMicrobot’s
believes that its medical device productproducts candidates will beare categorized as Class II devices, which typically requirerequired a 510(k) or 510(k)
de-novo premarket submission to the FDA.
In addition, Microbot believes that any future medical device products it may develop would also likely be categorized as Class II devices.
However, the FDA has not made any determination about whether Microbot’s contemplated future medical product
candidates are Class
II medical devices and may disagree with that classification. If the FDA determines that Microbot’s future 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.
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.
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.
Clinical
outcome studies for the LIBERTY® Endovascular Robotic Surgical System may not provide sufficient data to
make such product candidate the attractive.
Microbot’s
business plan with respect to the LIBERTY® Endovascular Robotic Surgical System relies on the broad adoption by doctors
of the product for its planned applications.
Clinical
studies may not show an advantage in the LIBERTY® Endovascular Robotic Surgical System 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® Endovascular Robotic Surgical System and materially impact Microbot’s
business.
If LIBERTY® or other of 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
anticipates that in the future it is likely that weit 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
is dependent on its senior management, in particular Harel Gadot, Microbot’s Chairman, President and Chief Executive Officer, and
Simonthe Sharon,other itssenior General Manager and Chief Technology Officer.executive. 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. In particular, as part of our May 2023 cost reduction program, we reduced all executive officers’ salariesMicrobot’s
by between 30%-50%. Although the salaries of all executives have since been reinstated, we can give no assurance that any of our executives
will remain with our company in light of such reductions. 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.
Our profitability may be negatively impacted by inflation in the cost of labor, materials, and services.
Although inflation in the United States has declined since 2023, prices have continued to be significantly impacted by inflation relative to historical levels. This continued inflation has raised our costs for plastic products and other components of our LIBERTY device, thereby increasing our operating costs and capital expenditures. Additionally, the Trump administration has increased tariffs on many imports. The Trump administration has also imposed and expanded so called ‘reciprocal’ tariffs on a wide range of United States trading partners with which the United States has sizable trade imbalances and has announced or threatened additional increases on imports from Canada, Mexico, and other key partners. These and other import tariffs could substantially increase our operating and capital costs as we ramp up production and manufacturing of the LIBERTY device. Although we cannot predict any future inflation trends or the impact of current or future import tariffs, higher operating and capital costs would negatively impact our future profitability to the extent we are unable to recover such higher costs through passing them along to our customers.
If
Microbot fails to obtain regulatory clearances in other countries for itsLIBERTY® or any other future product candidates under development,
candidates, Microbot will not be
able to commercialize these products or product candidates in those countries.
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. IfMicrobot thehas
submitted an application
includes ato certificateAMAR issuedbased byon aits competent510(k) authorityclearance of a “recognized” country, which includes Australia, Canada, the European
Community Member States, Japan orin the United States,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.
Existing
and historical risks relating to our operations in Israel are being exacerbated by the current military actions and operations, and related
activities, that commenced withfollowing the surpriseU.S.-Israel attackjoint attach on the State of Israel on October 7, 2023.Iran.
The
ongoing risks of operating in Israel arehave beingbeen exacerbated as a result of the October 7, 2023 surprise attack by hostile forces from
Gaza, which led to Israeli military operation at first in Gaza andGaza, then in Lebanon.Lebanon, Syria, Yemen and Iran. These include security and economic
risks, risks
relating to our ability to sell or buy internationally, risk of economic instability, risk of exchange rate fluctuation
negatively negatively
affecting operating costs, and the risk of employees leaving to perform military service. These military operations and related
activities, such as the recent collapse of the Assad regime in Syria and Israel’s subsequent military operations in Syria, and
the recent escalation of military operations by and against the Houthis in Yemen,activities are on-going as of the filing date of this Annual
Report on Form 10-K, although there have been temporary cease fires in such military operations from time to time.10-K.
Management's Discussion & Analysis (MD&A)
Removed heading “Research and Development Expenses, net.”
Largest changes
“The increase in research and development expenses of approximately $0.9 million in 2024 as compared to 2023 was primarily due to increases in headcount, employees’ salaries and bonuses. Additionally, there were increased regulatory expenses in 2024 due to the Investigational Device Exemption and 510K submission, as well as higher costs associated with clinical studies conducted in 2024 compared to 2023.”see in full comparison
“We routinely evaluate the quantity and value of our inventories in light of current market conditions, and based on expiration of sterilization dates or defective inventory, and record write-downs when NRV is below cost. As of December 31, 2025, no reserve for excess or obsolete inventory was recognized.”see in full comparison
Microbot Israel obtained from the Israeli Innovation Authority (“IIA”) grants for participation in research and development for the years 2013 through December 31,see in full comparison20242025 in the total amount of approximately$1.9$2.5 million. This amount includes amounts received of approximately$378,000,$518,000, which are a portion of an additional grant from the IIA in the amount of approximately NIS1.62.2 million (approximately$447,000$673,000) approved onJuneJuly1,15,2023,2025, to further finance the development of the manufacturing process of the LIBERTY® Endovascular Robotic Surgical System.On January 4, 2018, Microbot Israel entered into an agreement with CardioSert to acquire certain of its patent-protected technology as well as to assume CardioSert’s grants from the IIA in the aggregate amount of approximately $530,000. During the 3rd quarter of 2024, Microbot Israel transferred such technology back to CardioSert, for nominal consideration and, as a result, Microbot Israel’s liability to repay CardioSert’s IIA grants in the aggregate amount of approximately $530,000 was also transferred back to CardioSert.On October 6, 2022, Microbot Israel entered into an agreement with Nitiloop Ltd. to acquire substantially all of its assets. Nitiloop received grants from the IIA in the aggregate amount of approximately $925,000 and Microbot Israel took over the liability to repay such grants.
“Loss on legal settlement, net. Loss on legal settlement, net for the year ended December 31, 2023 is related to the issuance of restricted shares of our common stock to settle the Lawsuit pursuant to the Settlement Agreement.”see in full comparison
see in full comparisonOn MarchAs2,of2023,Decemberthe31,Company2025,announced that itMicrobot receivedapproval for a grantgrants from the Ministry of Economy of the State of Israel in the amount of approximatelyNIS300,000, which based on an exchange rate on such date of NIS 1.00 = $0.2923, would be approximately $88,000,$50,000, to further finance the marketing activities of the LIBERTY® Endovascular Robotic Surgical System in the U.S. market. In relation to the Ministry of Economy grant, the Company is obligated to pay royalties amounting to 3% of future sales of the LIBERTY® Endovascular Robotic Surgical System up to the grant amount plus interest.
Full comparison: every changed paragraph (30)
Microbot
is a clinical-stage medical device company specializing in the research, design and development of next generation robotic endoluminal
surgery devices
targeting the minimally invasive surgery space. We are primarily focused on leveraging our robotic technologies with
the goal of redefining
surgical robotics while improving surgical outcomes for patients.
Using
our LIBERTY® technological platform, we arehave developingdeveloped the first everfirst-ever fully disposable robot for various endovascular
interventional procedures. The LIBERTY® Endovascular Robotic Surgical System is designed to maneuver guidewires and over-the-wire
devices (such as microcatheters) within the body’s vasculature. It is intended for the remote delivery and manipulation of guidewires
and catheters, and remote manipulation of guide catheters to facilitate navigation to anatomical targetstargets, inwith the current intention
to focus on the peripheral vasculature.
vasculature market. It is designed to eliminate the need for extensive capital equipment requiring dedicated
Cath-lab rooms as well as dedicated staff.
Research
and Development ExpensesExpenses, net
Research
and development expenses consist primarily of salaries, benefits 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, net
of government grants and NRE payments.grants. Microbot expenses its research and development costs as incurred.
Sales, General and Administrative Expenses
GeneralSales,
general and administrative expenses consist primarily of the costs associated with management salaries, benefits and related expenses, sales
and marketing activities, business development expenses, professional
fees for accounting, auditing, consulting, legal services, and
insurance expenses, net of insurance loss recoveries.expenses.
Microbot
expects that its sales, general and administrative expenses will increase over the long-term, as it expands its operating and
commercialization activities, maintains
compliance with exchange listing and SEC requirements. Microbot expects these potential
increases will likely include management costs, the costs of building out marketing and sales teams for the LIBERTY®
product, legal fees, accounting fees, directors’ and officers’ liability insurance premiums and expenses associated with
investor investor
relations.
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,losses, 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.
Inventory
Inventories are stated at the lower of actual cost, determined using the first-in, first-out method, or net realizable value (“NRV”).
Inventories primarily consist of raw materials ordered by us or in advance by our third-party contract manufacturer. Work in process and finished goods are produced by our third-party contract manufacturer and include direct labor and allocable overhead.
We routinely evaluate the quantity and value of our inventories in light of current market conditions, and based on expiration of sterilization dates or defective inventory, and record write-downs when NRV is below cost. As of December 31, 2025, no reserve for excess or obsolete inventory was recognized.
The Company began ramping up inventory manufacturing for units intended for sale after receiving FDA clearance on September 4, 2025.
The Company accounts for warrants issued to investors as either equity-classified or liability-classified instruments, based on an assessment of the warrant’s specific terms and the applicable authoritative guidance in Financial Accounting Standards Board (“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, or meet all of the requirements for equity classification under FASB ASC 815, including whether the warrants are indexed to the Company’s own shares of common stock 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.
Research and Development Expenses, net. The decrease in research and development expenses of approximately $0.3 million in 2025 as compared to 2024 was primarily due to increases in government grants recognized as contra research and development expenses in 2025 and a decrease in professional services in 2025 due to a material, non-recurring clinical study conducted in 2024. This decrease was partially offset by an increase in payroll and related expenses due to new hires, salary increases and bonuses above 2024 levels.
Research
and Development Expenses, net.
The increase in research and development expenses
of approximately $0.9 million in 2024 as compared to 2023 was primarily due to increases in headcount, employees’ salaries and bonuses.
Additionally, there were increased regulatory expenses in 2024 due to the Investigational Device Exemption and 510K submission, as well
as higher costs associated with clinical studies conducted in 2024 compared to 2023.
Sales,
General
and Administrative Expenses, net.Expenses. The increase in sales, general and administrative expenses of approximately $0.9$3.5 million in 2024
2025 as compared
to 20232024 was primarily due to certainan costincrease reductionin plans targeting employee salariessales and bonusesmarketing payroll and related expenses mainly due to
new hiring, commercialization activities, as well as board of director fees that
were implementedincreases in 2023professional services, including legal, audit and laterrecruitment
fees, relaxedand higher travel and office rent expenses. This increase was partially offset by a decrease in 2024.stock-based compensation
expenses.
Financing
Income, net. The decreaseincrease in Financefinancing income in 2024 as2025 compared towith 20232024 iswas dueprimarily todriven aby decrease inhigher market gains offsetearned byon increasemarketable in
interestsecurities, incomefollowing andthe foreigninvestments exchangeof changes.capital raised during 2025.
Other Income. The Company received a judgment in the amount of approximately $316,000, net of legal fees and expenses.
Loss
on legal settlement, net. Loss on legal settlement, net for the year ended December 31, 2023 is related to the issuance of restricted
shares of our common stock to settle the Lawsuit pursuant to the Settlement Agreement.
To
date,Through December 31, 2025, Microbot has not generatedrecognized any revenues, and cannot make any assurances of generating
significant revenues fromin operations.the future. Microbot has incurred losses since inception and negative
cash flows from
operating activities for all periods presented. As of December 31, 2024,2025, Microbot had a net working capital of approximately $3.4
$76.4 million,
consisting primarily of cash and cash equivalents and marketable securities. This compares to net working capital of approximately
$3.4 $4.1
million as of December 31, 2023. This does not include any of the approximately $30.6 million we have raised subsequent
to December 31, 2024, discussed further below.2024. Microbot anticipates that it will continue to incur net losses for the foreseeable future
as it
continues to ramp up manufacturing and commercialization of LIBERTY®, continues research and development efforts with
respect to other uses for LIBERTY® and rampsother uppotential commercializationtechnologies ofand its primary product candidateproducts, and continues to incur
costs associated
with being a public company.
SinceDuring
Januaryour 1,fiscal year ended December 31, 2025, we have raised the following amounts:
Microbot
Israel obtained from the Israeli Innovation Authority (“IIA”) grants for participation in research and development for the
years 2013 through December 31, 20242025 in the total amount of approximately $1.9$2.5 million. This amount includes amounts received of approximately
$378,000,$518,000, which are a portion of an additional grant from the IIA in the amount of approximately NIS 1.62.2 million (approximately $447,000$673,000)
approved on JuneJuly 1,15, 2023,2025, to further finance the development of the manufacturing process of the LIBERTY® Endovascular
Robotic Surgical System. On January 4, 2018, Microbot Israel entered into an agreement with CardioSert to acquire certain of its patent-protected
technology as well as to assume CardioSert’s grants from the IIA in the aggregate amount of approximately $530,000. During the
3rd quarter of 2024, Microbot Israel transferred such technology back to CardioSert, for nominal consideration and, as a result, Microbot
Israel’s liability to repay CardioSert’s IIA grants in the aggregate amount of approximately $530,000 was also transferred
back to CardioSert. On October 6, 2022, Microbot Israel entered into an agreement with Nitiloop Ltd. to acquire substantially all of
its assets. Nitiloop received grants from the IIA in the aggregate amount of approximately $925,000 and Microbot Israel took over the
liability to repay such grants.
Microbot
Israel is obligated to pay royalties amounting to 3%-5% of its future sales up to the amount of the grants. The grants are linked to
the exchange rate of the dollar to the New Israeli Shekel and bears interest at an annual rate of SOFR, a benchmark interest rate which
replaced LIBOR. Under the terms of the grants 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 grants, if the applicable project fails, is unsuccessful or aborted before any sales
are generated; accordingly, as we have discontinued the CardioSert program and are returning the technology to CardioSert, we do not
expect to repay, or have the obligation to repay, the grants relating to that technology. The financial risk is assumed completely by
the IIA.generated.
On
MarchAs 2,of 2023,December the31, Company2025, announced that itMicrobot received approval for a grant grants
from the Ministry of Economy of the State of Israel in the amount of approximately
NIS 300,000, which based on an exchange rate on such date of NIS 1.00 = $0.2923, would be approximately $88,000,$50,000, to further finance the
marketing activities
of the LIBERTY® Endovascular Robotic Surgical System in the U.S. market. In relation to the Ministry
of Economy grant,
the Company is obligated to pay royalties amounting to 3% of future sales of the LIBERTY® Endovascular
Robotic Surgical
System up to the grant amount plus interest.
To
the extent available, Microbot intends to continue to raise capital through future public and private issuances of debt and/or
equity equity
securities, to fund its commercial activities and working capital and general business purposes.purposes, including to continue to
build a commercial and sales team in the U.S. and elsewhere as part of its full market release of LIBERTY® expected
in April 2026. 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 determinesis determined to incur additional indebtedness, Microbot’s
incurrence of additional debt could result in debt service obligations
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, at the times it needs it or
on terms acceptable to it, if at all, and will need additional funds to continue
the commercialization process for the
LIBERTY® Endovascular Robotic Surgical System.
The
increase in net cash flows used in operating activities was primarily from an increase in research and development expensesexpenses, manufacturing
inventory, sales and marketing, and general
and administration expenses discussed above.
The
decreaseincrease of net cash flows providedused byin investing activities was primarily due to aan decreaseincrease in proceeds from maturitiespurchases of marketable
securities in 2024 2025
compared to 2023.2024.
The
increase in net cash flows provided by financing activities was due to increased issuances of common stock and warrants in 20242025 compared
to 2023.2024, also discussed above.
What changed in the latest 10-Q
Risk Factors
Not required for a smaller reporting company.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
“During the first quarter, certain units sold included inventory that had been manufactured prior to FDA clearance, for which those costs were included in R&D expenses in prior periods. Cost of revenues increased during the second quarter primarily due to higher manufacturing labor costs and increased customer concessions.”see in full comparison
The Company entered into an agreement with Emory University, which will allow the parties to evaluate and explore the potential for a future collaboration in connection with autonomous robotics in endovascular procedures. Under the terms of the agreement, Emory University will assume the responsibility of exploring the feasibility of integrating the LIBERTY® Endovascular Robotic System with an imaging system to create an autonomous robotic system for endovascularsee in full comparisonprocedures.InproceduresNovember 2025, we announced that Emory University Hospital adopted LIBERTY® Endovascular Robotic System for patient care, and that we are collaborating with it to establish an Endovascular Robotics Program in interventional radiology..
“Research and Development Expenses. The decrease for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to an increase in government grants recognized as a reduction of research and development expenses in 2026. Additionally, manufacturing costs were capitalized into inventory in 2026, by contrast, during 2025, prior to the Company’s receipt of FDA clearance for the LIBERTY® Endovascular Robotic System in September 2025, such manufacturing costs were expensed as incurred within research and development expense. …”see in full comparison
“Research and Development Expenses. The decrease for the three months ended March 31, 2026, compared to the same periods in 2025, was primarily due to increases government grants recognized as a reduction of research and development expenses in 2026, as well as a decrease in professional services expenses which was primarily due to the capitalization of manufacturing costs into inventory in 2026. …”see in full comparison
“In the third quarter of 2025, the Company launched the limited market release of the LIBERTY® Endovascular Robotic System, where it strategically introduced the product into select high procedure volume regions. This limited market release continued through March 31, 2026, generating $105,000 in revenues during the three-month period then ended. In April 2026, the Company transitioned from the limited market release to the full market release of the LIBERTY® Endovascular Robotic System and is pursuing broader commercial adoption to grow its customer base and revenues. …”see in full comparison
Revenues. During thesee in full comparisonthree-monththree-periodand six-month periods endedMarchJune31,30, 2026, the Company generated revenue exclusively from the sale of the LIBERTY® Endovascular Robotic System in itsLimitedlimitedMarketmarketReleaserelease and full market release to certain hospital customers, compared with no revenue in the corresponding period of 2025 as the Company had not yet commenced commercial operations.In the third quarter of 2025, the Company launched the Limited Market Release of the LIBERTY® Endovascular Robotic System, where it strategically introduced the product into select high procedure volume regions. This Limited Market Release continued through the end of the three-month period ended March 31, 2026.The CompanycommencedtransitioneditsfromFulltheMarketlimited marketRelease subsequentrelease to thethreefullmonthmarketperiod ended March 31, 2026,release in April 2026.
Full comparison: every changed paragraph (35)
The
FDA-cleared LIBERTY® Endovascular Robotic System features a unique compact, single-usesingle use design with the capability
to be
operated remotely, reduce radiation exposure and physical strain to the physician, as well as the potential to eliminate the use
of consumables.
The
LIBERTY® Endovascular Robotic System ishas been designed
to have the following attributes:
On
August 13, 2024, we announced that we received ISO 13485:2016 certification
for our quality management system. Receiving ISO 13485 certification
indicates that a company has developed and implemented robust policies
and procedures for the development and manufacture of regulated
medical products. This is a certification ensuring compliance with the
Quality Management System (QMS) requirements of the EU Medical
Devices Regulation (MDR 2017/745) and supporting our future CE Mark approval,
and to ultimately allowingallow us to market the LIBERTY®
Endovascular Robotic System in Europe as well as other regions who accept
the CE Mark. We anticipate CE Mark approval in the second half
of 2026. However, we can give no assurance that we will meet this or any
other projected milestones, if ever. In addition, in view of
the recent revision published by the FDA regarding the quality system management regulationsregulation and its incorporation by
reference of the
ISO 13485 standard, we believe it will help streamline our transition into this revised FDA regulation.
The
Company entered into an agreement with Emory University, which will
allow the parties to evaluate and explore the potential for a future
collaboration in connection with autonomous robotics in endovascular
procedures. Under the terms of the agreement, Emory University will
assume the responsibility of exploring the feasibility of integrating
the LIBERTY® Endovascular Robotic System with an
imaging system to create an autonomous robotic system for endovascular
procedures. Inprocedures November 2025, we announced that Emory University Hospital adopted LIBERTY® Endovascular Robotic System
for patient care, and that we are collaborating with it to establish an Endovascular Robotics Program in interventional radiology..
The
Company has considered various ongoing risks relating to these and otherthe military operationoperations and related matters, including:
The
Company closely monitors how these and otherthe military operations and
related activities could adversely affect its anticipated milestones and its
Israel-based activities to support future commercial, clinical
and regulatory milestones, including the Company’s ability to import
materials that are required to construct the LIBERTY®
Endovascular Robotic System devices and to ship them outside of
Israel. In addition, the Company is also monitoring how negative international
reaction to the events in Gaza, the West Bank and elsewhere
in the Middle East or any further escalation of hostilities involving Iran
could create a corresponding negative perception of companies
based in Israel, which if broad enough, could negatively impact the Company’s
business.
OurRevenues revenues consistsconsist of selling our LIBERTY® Endovascular
Robotic System to hospitals.
Our costCost of revenues consists primarily of labor expenses, materials, and other related manufacturing costs associated with manufacturing
units of the LIBERTY®
Endovascular Robotic System.
Comparison
of Three and Six Months Ended MarchJune 31,30, 2026 and 2025
The
following table sets forth the key components of Microbot’s results of operations for the three-monththree- and six-month periods ended March 31,June
30, 2026
and 2025 (in thousands):
Revenues.
During the three-monththree- periodand six-month periods ended MarchJune 31,30, 2026, the Company generated
revenue exclusively from the sale of the LIBERTY®
Endovascular Robotic System in its Limitedlimited Marketmarket Releaserelease and full market release to certain
hospital customers, compared with no revenue
in the corresponding period of 2025 as the Company had not yet commenced commercial operations.
In the third quarter of 2025, the Company launched the Limited Market Release of the LIBERTY® Endovascular Robotic System,
where it strategically introduced the product into select high procedure volume regions. This Limited Market Release continued through
the end of the three-month period ended March 31, 2026. The Company commencedtransitioned itsfrom Fullthe Marketlimited
market Release subsequentrelease to the threefull monthmarket period
ended March 31, 2026,release in April 2026.
In the third quarter of 2025, the Company launched the limited market release of the LIBERTY® Endovascular Robotic System, where it strategically introduced the product into select high procedure volume regions. This limited market release continued through March 31, 2026, generating $105,000 in revenues during the three-month period then ended. In April 2026, the Company transitioned from the limited market release to the full market release of the LIBERTY® Endovascular Robotic System and is pursuing broader commercial adoption to grow its customer base and revenues. The Company generated $241,000 in revenues during the three-month period ended on June 30, 2026.
Cost
of revenues. Cost of revenuerevenues consists
primarily of direct and indirect costs related to the manufacturing of units of the
LIBERTY® Endovascular Robotic System
for commercial sale, including personnel costs, third-party manufacturing costs,
packaging services, freight, storage costs, royalties, and write
down of inventories. The Company did not recognize cost of revenues
for the three-monththree- periodand six-month periods ended MarchJune 31,30, 2025 as it had not yet
commenced commercial operations.
Research
and Development Expenses. The decrease for the three months ended March 31, 2026, compared to the
same periods in 2025, was primarily due to increases government grants recognized as a reduction of research and development expenses
in 2026, as well as a decrease in professional services expenses which was primarily due to the capitalization of manufacturing costs
into inventory in 2026. In contrast, during 2025, prior to the Company’s receipt of FDA clearance for the LIBERTY®
Endovascular Robotic System in September 2025, such manufacturing costs were expensed as incurred within research and development expense.
This decrease was partially offset by an increase in payroll and related expenses due to new hires, salary increases and bonuses.
Sales,
General and Administrative Expenses. The increase for the three months ended March 31, 2026, compared to the
same periods in 2025, was primarily due to an increase in payroll and related expenses mainly due to new hiring, salary increases and
bonuses and increase in commercialization activities.
Other
Income. During the three months ended March 31, 2025, the Company received a judgment
in the amount of approximately $316,000 net of legal fees and expenses. This judgment is non-recurring and no similar payments or other
income was paid to the Company during the three months ended March 31, 2026.
FinancingCost
Income.of Therevenues increaseincreased forin the threethree-month monthsperiod ended June 30, 2026 compared to the three-month period ended March 31, 2026 comparedprimarily
due to the samefollowing periods in 2025, was primarily due to
higher interest income from short-term investments resulting from the capital raised in 2025.factors:
During the first quarter, certain units sold included inventory that had been manufactured prior to FDA clearance, for which those costs were included in R&D expenses in prior periods. Cost of revenues increased during the second quarter primarily due to higher manufacturing labor costs and increased customer concessions.
We expect our cost of revenues per system to decrease over time as production volumes grow. In addition, we are implementing several cost-reduction initiatives.
Research and Development Expenses. The decrease for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to an increase in government grants recognized as a reduction of research and development expenses in 2026. Additionally, manufacturing costs were capitalized into inventory in 2026, by contrast, during 2025, prior to the Company’s receipt of FDA clearance for the LIBERTY® Endovascular Robotic System in September 2025, such manufacturing costs were expensed as incurred within research and development expense. This decrease was partially offset by an increase in payroll and related expenses due to new hires, salary increases and bonuses, increase in patent expenses, and increase in allocation expenses due to increase in office maintenance.
Sales, General and Administrative Expenses. The increase for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to an increase in payroll and related expenses mainly due to new hiring of sales and marketing personnel, salary increases and bonuses, as well as increases in legal and other general operating expenses related to commercialization activities.
Other Income. During the six months ended June 30, 2025, the Company received a judgment in the amount of approximately $316,000 net of legal fees and expenses. This judgment is non-recurring and no similar payments or other income was paid to the Company during the three or six months ended June 30, 2026.
Financing Income. The increase for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to interest income from short-term investments resulting from the capital raised in 2025.
AsDuring
the six months ended June 30, 2026, the Company has commenced recognition of Marchrevenues, 31,in 2026,the Microbotamount hasof not$346,000. recognizedThe any significant revenues,
andCompany cannot
make any assurances of continuing to generate revenues, or of generating significant revenuesrevenues, in the future. Microbot has incurred losses
since inception and negative
cash flows from operating activities for all periods presented. As of MarchJune 31,30, 2026, Microbot had a net
working capital of approximately
$73.1 $67.3 million, consisting primarily of cash and cash equivalents and marketable securities. This compares
to net working capital of approximately
$76.4 million as of December 31, 2025. Microbot anticipates that it will continue to incur net
losses for the foreseeable future as it
continues to ramp up manufacturing and commercialization of the LIBERTY® Endovascular
Robotic System, continues research
and development efforts with respect to other uses for it and other potential technologies and products,
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 MarchJune 31,30, 2026, Microbot has raised cash proceeds of approximately $168.3 million.million Since inception
(November 2010) through March 31, 2026, Microbotand incurred
a total cumulative loss of approximately $107.8$113.4 million.
In the third quarter of 2025, the Company launched the Limited Market Release
of the LIBERTY® Endovascular Robotic System, where it strategically introduced the product into select high procedure volume
regions. This Limited Market Release continued through the end of the three-month period ended March 31, 2026, generating $105,000 in
revenues during that period. The Company commenced its Full Market Release subsequent to the three month period ended March 31, 2026,
in April 2026, and is seeking to grow its customer base and its revenues.
During
ourthe fiscal year ended December 31, 2025 and through MarchJune 31,30, 2026, we raised the following amounts:
In addition, on April 10, 2026, the Company filed
with the SEC a prospectus supplement relating to the offer, issuance and sale of up to $39,230,691 of the Company’s shares of common
stock pursuant to the At-the-Market facility.
As of filing date of these interim financial statements,
the Company issued 6,757 shares of its common stock pursuant to the Company’s At the Market facility, for total gross
proceeds of approximately $17,021 before deducting sales agent commissions and other offering expenses of $781.
Microbot
Israel obtained from the Israeli Innovation Authority (“IIA”) grants for participation in research and development for the
years 2013 through MarchJune 31,30, 20262026, in the total amount of approximately $2.5 million. This amount includes amounts received of approximately
$518,000, which are a portion of an additional grant from the IIA in the amount of approximately NIS 2.2 million (approximately $673,000)
approved on July 15, 2025, to further finance the development of the manufacturing process of the LIBERTY® Endovascular
Robotic System. On October 6, 2022, Microbot Israel entered into an agreement with Nitiloop Ltd. to acquire substantially all
of its
assets. Nitiloop received grants from the IIA in the aggregate amount of approximately $925,000 and Microbot Israel took over
the liability
to repay such grants.
As
of MarchJune 31,30, 2026, Microbot received grants from the Ministry of Economy
of the State of Israel in the amount of approximately $50,000,
to further finance the marketing activities of the LIBERTY®
Endovascular Robotic System in the U.S. market. In relation
to the Ministry of Economy grant, the Company is obligated to pay royalties
amounting to 3% of future sales of the LIBERTY®
Endovascular Robotic System up to the grant amount plus interest.
To
the extent available, Microbot intends to continue to raise capital through future public and private issuances of debt and/or equity
securities, including pursuant to our At-the-Market facility described above and upon any cash exercise of its outstanding investment
options by the holders of such options, to fund its commercial activities and working capital and general business purposes, including
to continue to build a commercial and sales team in the U.S. and elsewhere as part of its full market release of the LIBERTY®
Endovascular Robotic System which commenced in April 2026. 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 is determined to incur additional
indebtedness, Microbot’s incurrence of additional debt could result in debt service obligations,
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, at the
times it needs it or on terms acceptable to it, if at all, and will need additional funds to continue
the commercialization process for
the LIBERTY® Endovascular Robotic System.
The
increase in net cash flows used in operating activities during the three
six months ended March 31, 2026 compared with the same periodsperiod in 2025,2025 was
primarily from an increase in themanufacturing costexpenses and sales and marketing expenses relating to manufacturethe inventoryrelease of the
the LIBERTY® Endovascular Robotic System,System salesas we shift to commercialization of the product and marketing,due to an increase in salary
and general and administrationbonus expenses.
The
increase of net cash flows provided by investing activities was primarily due to mostly purchases of marketable securities during the
thesix-month period endingended MarchJune 31,30, 20252025, compared to mostly sales of marketable securities during the samecomparable period in 2026.
The
decrease in net cash flows provided by financing activities was due
to issuanceissuances of common stock and warrants during the first quarter
of 2025, with no similar activity during the comparable period in 2026.
MBOT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding MBOT (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 86,302 | $168.3K | 0.0% | Reduced 81% |