The following discussion should be read in conjunction with our unaudited financial statements and related notes included in Item 1, "Financial Statements," of this Quarterly Report on Form 10-Q, as well as our Annual Report on Form 10-K for the fiscal year ended
December 31, 2021. 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 entitled "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2021. 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 Quarterly Report on Form 10-Q 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. 15 Overview
We are 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. We are developing the first ever fully disposable robot for various endovascular interventional procedures, and our primary mission is to enable accessibility to robotic solutions to all stakeholders by removing barriers for adoption such as capital expense and enabling remote access to patients and users. Our current technological platforms are comprised of the proprietary LIBERTY® and One & Done™ (the instrument platform which currently includes assets acquired from Cardiosert) innovative technological platforms, as well as other assets and intellectual property. In addition, we are focused on the development of a Multi Generation Product Portfolio utilizing our proprietary technologies, which together is expected to redefine surgical robotics while improving surgical outcomes for patients. Recent Developments
October 2022Financing On October 21, 2022, we entered into a Securities Purchase Agreement with an institutional investor, pursuant to which we issued and sold, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market, (i) an aggregate of 782,495 shares of Common Stock, at an offering price of $4.89per 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 $4.8899per Pre-Funded Warrant, for aggregate gross proceeds from the Offerings (as defined below) of approximately $5.0 millionbefore deducting the placement agent fee (as described in greater detail below) and related offering expenses. Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of $0.0001per 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, we 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 $4.64per 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 $4.64per 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. On October 3, 2022we 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 above-referenced Securities Purchase Agreement. As compensation for such placement agent services, the Company paid Wainwright aggregate cash fees and reimbursed Wainwright for its expenses aggregating approximately $565,000. We also issued to Wainwright or its designees warrants to purchase 51,125 shares of our common stock (the "Wainwright Warrants"). The Wainwright Warrants have a term of five years, and have an exercise price of $6.1125per share. Suspension of ATM
October 21, 2022, we delivered written notice to Wainwright that we were suspending and terminating the prospectus supplement (the "ATM Prospectus Supplement") related to our common stock issuable pursuant to the At The Market Offering Agreement, dated June 10, 2021, by and between us and Wainwright (the "ATM Agreement"). We will not make any sales of our securities pursuant to the ATM Agreement, unless and until a new prospectus supplement is filed. Other than the termination and suspension of the ATM Prospectus Supplement, the ATM Agreement remains in full force and effect. 16 LIBERTY Milestones
October 11, 2022, we announced that we have made the strategic decision to suspend the continued research and development of our Self-Cleaning Shunt (SCS) project, effective immediately. We further announced that we are planning to focus our strategic efforts on the growing endovascular space and advancing the LIBERTY® Robotic System to achieve our regulatory and commercial milestones, as well as expanding the LIBERTY® ecosystem. We plan to explore opportunities with the SCS assets with the focus on maximizing shareholders value, which may include 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. We have been in discussions with the licensor of the original SCS and ViRob intellectual property with respect to the suspension of the SCS project, and we expect that if we are unsuccessful in entering into alternative arrangements for the SCS assets, we will return such licensed assets to the licensor pursuant to the terms of the license agreement. Any such return or other alternative with respect to the SCS assets will not affect any other licensed or owned assets of Microbot.
Acquisition of the assets of Nitiloop
October 6, 2022, our wholly-owned subsidiary 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 such technology owned by Nitiloop and designated by Nitiloop as "NovaCross", "NovaCross Xtreme" and "NovaCross BTK" and any enhancements, modifications and improvements thereof ("Devices"). We 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 Nitiloop assets, Microbot Israel shall pay royalties to Nitiloop, which shall not, in the aggregate, exceed $8,000,000, as follows:
? Royalties at the rate of 3% of the net turnover generated as a result of sales,
license or other use of the Devices; and
? Royalties at the rate of 1.5% of the net revenue generated by the sale, license or
other exploitation of commercialization of the technology as part of an integrated product. Technological Platforms 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 the CardioSert platform or possibly other guidewire/microcatheter technologies. 17
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 CardioSert technology or possibly other guidewire/microcatheter technologies, it may be designed to streamline cath-lab procedures with our proprietary "One & Done" tool 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. 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.
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. On March 31, 2022, the Company filed its pre-submission package for the LIBERTY Robotic System with the U.S. Food and Drug Administration("FDA"), addressing the regulatory pathway for the LIBERTY Robotic System. The Company expects to meet with the FDA following a normal review process to discuss the pre-submission and ensure the testing protocols and regulatory pathway are aligned with the FDA to obtain clearance for LIBERTY. On July 22, 2022, the Company completed a pre-submission process with the FDA regarding the LIBERTY device. Formal feedback from the FDA included a recommendation to perform a clinical study and a human factors validation study, to support clearance through the 510(k) notification process. In September 2022the company conducted a GLP Animal study at an FDA accredited laboratory. The study was performed by a team of seasoned Key Opinion Leaders (KOLs) in the endovascular space at a world-class MedTechresearch laboratory with FDA-required levels of planning, controlling, monitoring, and reporting (GLP standards), using porcine model. During the GLP animal study, the physicians conducted pre-determined 63 navigations to the targeted sites using the investigational 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 3 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 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.
We are continuously exploring and evaluating other innovative guidewire/microcatheter technologies to integrate and combine with the LIBERTY robotic platform.
We are continuing our animal feasibility trials for the LIBERTY device.
One & Done™ technology (CardioSert)
April 8, 2018, Microbot acquired a patent-protected technology from CardioSert Ltd., a privately-held medical device company based in Israelthat 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 CardioSert 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". Nitiloop
As stated above, on
October 6, 2022, our wholly-owned subsidiary purchased substantially all of the assets of Nitiloop. Nitiloop's assets are composed of the NovaCross family of microcatheters, including NovaCross CTO, NovaCross Xtreme and NovaCross BTK. These devices enable the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), before percutaneous transluminal coronary angioplasty (PTCA) or stent intervention. The NovaCross microcatheter family can be used as standalone devices and are expected to be able to be incorporated into our One & Done technology. They can also potentially form a collection of customized procedure-related kits for the LIBERTY Robotic System.
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. 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. Financial Operations Overview
Research and development costs
Research and development expenses primarily include salaries and related expenses and overhead of Microbot’s research, development and engineering personnel, prototype materials and research studies, procurement and maintenance of the Microbot patents. Microbot accrues its research and development costs as they are incurred.
General and administrative expenses
General and administrative expenses primarily include costs associated with executive salaries and benefits, professional fees for accounting, auditing, consulting and legal services, and allocated overhead.
Microbot expects that its general and administrative expenses may increase in the future as it expands its operating activities, maintains and expands its patent portfolio and maintains compliance with exchange listing and
SECrequirements. 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.
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 some of its financial instruments on a recurring basis.
A fair value hierarchy is used to rank the quality and reliability of 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 rely on little or no market activity and that are significant to the fair value of assets or liabilities.
Results of Operations
Comparison of the three and nine month periods ended
The following table sets forth the key components of Microbot's results of operations for the three and nine month periods ended
September 30, 2022and 2021 (in thousands): Three months ended Nine months ended September 30, September 30, 2022 2021 Change 2022 2021 Change
Research and development costs
$ (5,852 ) $ (3,897 ) $ (1,955 )General and administrative expenses (1,521 ) (1,163 ) (358 ) (4,361 ) (3,523 ) (838 ) Financing income (expenses), net 6 (3 ) 9
43 (34 ) 77 Research and Development Expenses. Microbot's research and development expenses were approximately
$1,953,000and $5,852,000for the three and nine months ended September 30, 2022, respectively, compared to approximately $1,389,000and $3,897,000for the comparable periods in 2021. The increase in research and development expenses for the periods presented was primarily due to increases in payroll due to new hires and salary increases, as well as increases relating to the initial preparations to transfer the LIBERTY device from R&D to low volume and controlled production (to be used for bench, animal and clinical trials). Microbot expects its research and development expenses to continue to increase over time as Microbot advances its development programs and begins pre-clinical and clinical trials for its LIBERTY device and possibly other product candidates, which increase is expected to be somewhat offset by the decrease in R&D expenses relating to the SCS device due to its suspension in October 2022. 20 General and Administrative Expenses. General and administrative expenses were approximately $1,521,000and $4,361,000for the three and nine months ended September 30, 2022, respectively, compared to approximately $1,163,000and $3,523,000for the comparable periods in 2021. The increase in general and administrative expenses for the periods presented was primarily due to increases in payroll due to new hires and salary increases, increases in share-based compensation expense, D&O insurance premiums and travel expenses, which have resumed as Covid-related lockdowns have been lifted. These increases were partially offset by decreases in legal and consultant fees and expenses. Microbot believes its general and administrative expenses may increase over time as it advances its programs, increases its headcount and operating activities and incurs increasing expenses associated with being a public company. Financing Income (Expenses), net. Financing income was approximately $6,000and $43,000for the three and nine months ended September 30, 2022, respectively, compared to financing expenses of approximately $3,000and $34,000for the comparable periods in 2021. The increase in financial income for the periods presented was primarily due to an increase in the exchange rate between the U.S.Dollar and NIS offset by a reduction of financial expenses related to leasing liabilities.
Cash and capital resources
Microbot has incurred losses since inception and negative cash flows from operating activities for all periods presented. As of
September 30, 2022, Microbot had a net working capital of approximately $4,953,000, consisting primarily of cash and cash equivalents and marketable securities. The amount does not include approximately $4.3 millionof net proceeds the Company raised in October 2022. This compares to net working capital of approximately $13,895,000as of December 31, 2021. Microbot anticipates that it will continue to incur net losses for the foreseeable future as it continues research and development efforts of its primary 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 October 31, 2022, Microbot has raised net cash proceeds of approximately $59,000,000and through September 30, 2022incurred a total cumulative loss of approximately $65,763,000. Microbot returned $3,375,000(before interest) of such proceeds as a result of an adverse outcome in a litigation that concluded in the first quarter of 2020 and is now subject to an additional lawsuit seeking the return of an additional $6,750,000of such proceeds. This litigation is in the discovery stage and we cannot project what the eventual outcome will be or if it will be settled prior to trial, though management is currently 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 September 30, 2022in the total amount of approximately $1,500,000. On January 4, 2018, Microbot Israel entered into an agreement with CardioSert to acquire certain of its patent-protected technology. CardioSert received grants from the IIA in the aggregate amount of approximately $530,000and Microbot Israel took over the liability to repay such grants. 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 $925,000and Microbot Israel took over the liability to repay
such grants. Microbot Israel is obligated to pay royalties amounting to 3%-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 USD 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
Israelwithout 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. The financial risk is assumed completely by
We believe that our net cash, taking into account our recent capital raise of approximately
$4.3 millionin net proceeds, will be sufficient to fund operations necessary to continue development activities of LIBERTY for approximately eight months, based on current projected burn rate and milestones. However, in the event we are unsuccessful in our current litigation with Empery and Hudson Bay, pursuant to which they are seeking the return of $6,750,000in proceeds we received from them in a 2017 stock offering, we would have net cash for approximately one month. Outcomes with respect to the regulatory process for our proposed products may further require adjustments to our projections or require the reallocation of funds from one or more existing projects to other projects. For instance, as a result of our recently announced suspension of the SCS project, we reallocated funds budgeted for that program to the LIBERTY
device program. 21 Microbot plans to continue to fund its research and development programs from time to time and other operating expenses, and the associated losses from operations, through its existing cash. Microbot intends to also raise capital through additional, future issuances of debt and/or equity securities, including possibly through its existing
$10 millionregistered At-The-Market offering and other registered offerings under its existing Registration Statement on Form S-3 for up to $75 millionof securities, which it may draw down from time to time. This is regardless that we raised approximately $4.3 millionin net proceeds in a recent capital raise, subject to any limitations we may have agreed to with the investor in that capital raise or pursuant to applicable law. These issuances may be opportunistic and even if the Company has enough funds at such time for operations. 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 and development programs. Any of these actions could materially harm Microbot's business. As a result of the foregoing, we are unable to fully implement our business plan without raising additional capital, if at all, and these conditions raise substantial doubt about Microbot's ability to continue as a going concern. The accompanying consolidated interim financial statements do not include any adjustments to reflect the possible future effects on recoverability and reclassification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
© Edgar Online, source