Microbot Medical Inc S-1/A, filed Jan 22, 2024

Microbot Medical Inc. (MBOT)

S-1/A 2024-01-22

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Delaware	2836	94-3078125
(State or other jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
incorporation or organization)	Classification Code Number)	Identification Number)

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

	Page

ABOUT THIS PROSPECTUS	1
RISK FACTOR SUMMARY	2
PROSPECTUS SUMMARY	5
THE OFFERING	10
RISK FACTORS	11
USE OF PROCEEDS	31
MARKET FOR COMMON STOCK	31
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	32
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	33
BUSINESS	39
BOARD OF DIRECTORS AND MANAGEMENT	53
EXECUTIVE COMPENSATION	58
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS	63
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	64
DILUTION	65
SELLING STOCKHOLDERS	65
PLAN OF DISTRIBUTION	66
DESCRIPTION OF CAPITAL STOCK	67
LEGAL MATTERS	70
EXPERTS	70
WHERE YOU CAN FIND MORE INFORMATION	70
FINANCIAL STATEMENTS	F-1

	●	There is substantial doubt regarding on our ability to continue as a going concern.

	●	We are subject to litigation, which may divert management’s attention and, in the event of an adverse judgment or settlement for some or all of the $6,750,000 being litigated, will have a material adverse effect on our financial condition and our ability to continue our operations.

	●	Microbot has had no revenue and has incurred significant operating losses since inception and is expected to continue to incur significant operating losses for the foreseeable future. The Company may never become profitable or, if achieved, be able to sustain profitability.

	●	Microbot has a limited operating history outside of being a research and development-stage company, which may make it difficult to evaluate the prospects for the Company’s future viability.

	●	Microbot will need additional funding. If Microbot is unable to raise capital when needed, it could be forced to delay, reduce or eliminate its product development programs or commercialization efforts.

	●	At this time, Microbot does not know the extent of the clinical trial that the FDA will require it to submit in support of its future marketing applications for its LIBERTY^®Endovascular Robotic Surgical System product candidate, which creates uncertainty for Microbot as well as the possibility of increased product development costs and time to market.

	●	Microbot’s technology acquired from CardioSert and part of its One & Done^TM feature is subject to a buy-back clause which, if triggered, could cause us to lose rights to the technology.

	●	If Microbot or TRDF are unable to protect the patents or other proprietary rights relating to Microbot’s product candidates, or if Microbot infringes on the patents or other proprietary rights of others, Microbot’s competitiveness and business prospects may be materially damaged.

	●	Dependence on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may result in Microbot’s payment of significant monetary damages or impact offerings in its product portfolios.

	●	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 with the surprise attack on the State of Israel on October 7, 2023.

	●	Microbot has facilities located in Israel, and therefore, political conditions in Israel may affect Microbot’s operations and results.

	●	Political relations could limit Microbot’s ability to sell or buy internationally.

	●	Israel’s economy may become unstable.

	●	Exchange rate fluctuations between the U.S. dollar and the NIS currencies may negatively affect Microbot’s operating costs.

	●	Funding and other benefits provided by Israeli government programs may be terminated or reduced in the future and the terms of such funding may have a significant impact on future corporate decisions.

	●	Some of Microbot’s employees are obligated to perform military reserve duty in Israel.

Common stock offered by the selling stockholders			1,769,966 shares
Common stock outstanding before the offering (1)			13,392,999 shares
Common stock to be outstanding after the offering (2)			15,162,965 shares
Nasdaq Capital Market Symbol			MBOT

(1)	Based on the number of shares outstanding as of January 19, 2024.
(2)	Assumes the exercise of all of the 1,769,966 options held by the selling stockholders, the underlying shares of which are being registered pursuant to the registration statement of which this prospectus forms a part. Does not include the exercise of any other options or warrants that may be outstanding or issuable.

	●	the timing and outcomes of the product candidates’ regulatory reviews, subsequent approvals or clearances, or other regulatory actions;

	●	the final outcome of the Company’s existing lawsuit with Empery and Hudson Bay;

	●	the costs, design, duration and any potential delays of the clinical trials that could be conducted at the FDA’s request using Microbot’s product candidates;

	●	the costs of acquiring, licensing or investing in new and existing businesses, product candidates and technologies;

	●	the costs to maintain, expand and defend the scope of Microbot’s intellectual property portfolio;

	●	the costs to secure or establish sales, marketing and commercial manufacturing capabilities or arrangements with third parties regarding same;

	●	the Company’s need and ability to hire additional management and scientific and medical personnel; and

	●	the costs to operate as a public company in the United States.

	●	our ability to obtain additional capital;

	●	successful completion of animal studies and, if necessary, human clinical trials and the collection of sufficient data to demonstrate that the device is safe and effective for its intended use;

	●	receipt of marketing approvals or clearances from the FDA and other applicable regulatory authorities;

	●	establishing commercial manufacturing arrangements with one or more third parties;

	●	obtaining and maintaining patent and trade secret protections;

	●	protecting Microbot’s rights in its intellectual property portfolio;

	●	establishing sales, marketing and distribution capabilities;

	●	generating commercial sales, if and when approved, whether alone or in collaboration with other entities;

	●	acceptance of our product candidates, if and when commercially launched, by the medical community, patients and third-party payors;

	●	effectively competing with existing and competitive products on the market and any new competing products that may enter the market; and

	●	maintaining quality and an acceptable safety profile of our products following clearance or approval.

	●	potential regulatory non-compliance or other violations by the third-party manufacturer that could result in quality assurance;
	●	the possible breach of manufacturing agreements by third parties because of various factors beyond Microbot’s control; and
	●	the possible termination or non-renewal of manufacturing agreements by third parties for various reasons beyond Microbot’s control, at a time that is costly or inconvenient to Microbot.

	●	untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

	●	detention or seizure of Microbot products;

	●	operating restrictions or partial suspension or total shutdown of production;

	●	refusing or delaying requests for 510(k) clearance or premarket approval of new products or modified products;

	●	withdrawing 510(k) clearances or other types of regulatory authorizations -that have already been granted;

	●	refusing to grant export approval for Microbot products; or

	●	criminal prosecution.

	●	adverse macroeconomic conditions affecting geographies where Microbot intends to do business;

	●	closing of international borders, including as a result of biohazards or pandemics;

	●	foreign currency exchange rates;

	●	political or social unrest or economic instability in a specific country or region;

	●	higher costs of doing business in certain foreign countries;

	●	infringement claims on foreign patents, copyrights or trademark rights;

	●	difficulties in staffing and managing operations across disparate geographic areas;

	●	difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems;

	●	trade protection measures and other regulatory requirements, which affect Microbot’s ability to import or export its product candidates from or to various countries;

	●	adverse tax consequences;

	●	unexpected changes in legal and regulatory requirements;

	●	military conflict, terrorist activities, natural disasters and medical epidemics; and

	●	Microbot’s ability to recruit and retain channel partners in foreign jurisdictions.

	●	That some of the Company’s Israeli subcontractors, vendors, suppliers and other companies in which the Company relies, are currently only partially active, as instructed by the relevant authorities; and

	●	A slowdown in the number of international flights in and out of Israel.

	Three Months Ended September 30,								Nine Months Ended September 30,
	2023			2022			Change		2023			2022			Change
Research and development expenses, net	$	(1,612	)	$	(1,953	)	$	341	$	(4,594	)	$	(5,852	)	$	1,258
General and administrative expenses		(932	)		(1,521	)		589		(3,193	)		(4,361	)		1,168
Financing income, net		98			6			92		201			43			158

	For the Years Ended December 31,
	2022			2021			Change
Research and development expenses	$	(7,736	)	$	(6,153	)	$	(1,583	)
General and administrative expenses		(5,545	)		(5,204	)		(341	)
Financing income, net		118			44			74
Capital loss		(5	)		-			(5	)

	Years Ended December 31,						Nine Months Ended September 30,
	2022			2021			2023			2022
Net cash flows used in operating activities	$	(11,549	)	$	(9,354	)	$	(6,712	)	$	(9,086	)
Net cash flows (used in) provided by investing activities		(3,836	)		3,200			(984	)		(83	)
Net cash flows provided by financing activities		4,324			-			6,558			-
Decrease in cash, cash equivalents and restricted cash	$	(11,061	)	$	(6,154	)	$	(1,138	)	$	(9,169	)

●	Continue to refine existing product candidates and develop additional surgical robotic solutions. As Microbot prepares to bring its initial product through the support of pre-clinical and clinical trials, it continues gathering patients, patient and clinical data, and patient and physician feedback post-market. Microbot also expects to continue to innovate in the surgical robotics field by continuing to find ways of using its core technology to solve unmet needs, with the overarching goal of providing a safer, more effective and more efficient surgical environment for patients and physicians.
●	Establish and leverage relationships with key institutions and leading clinicians. Microbot’s objective will be to maintain clinical focus with leading hospitals and clinics so as to establish LIBERTY, as well as possibly other future products, as the standard of care in such institutions for their respective procedures. Microbot also expects to identify Key Opinion Leaders (KOLs) with the relevant specialties (for instance interventional radiology) with the expectation that such clinical focus will accelerate the adoption of its candidate products.
●	Continuously invest in research and development. Microbot’s most significant expense has historically been research and development, and Microbot expects to continue investing in research and development activities, including expenses it expects to incur to improve on its prototype products in order to respond to clinical data, to develop additional applications using its technologies and to develop future product candidates.
●	Explore partnerships for the introduction of Microbot’s products. In parallel to its efforts to establish direct sales and marketing capabilities, Microbot intends to continue its efforts on pursuing collaborations with global medical device companies that have established sales and distribution networks. Microbot will seek to enter collaborations and partnerships with strategic players that offer synergies with Microbot’s product candidates and expertise.
●	Seek additional IP and technologies to complement and strengthen Microbot’s current IP portfolio. Microbot intends to continue exploring new technologies, IP and know-how to add to its current portfolio through licensing, mergers and/or acquisitions and to allow Microbot to enter new spaces and strengthen its overall product portfolio.

●	product design, and development;
●	product safety, testing, labeling and storage;
●	record keeping procedures; and
●	product marketing.

●	the timely submission of product listing and establishment registration information, along with associated establishment user fees;
●	continued compliance with the Quality System Regulation, or QSR, which require specification developers and manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
●	labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
●	clearance or approval of product modifications that could significantly affect the safety or effectiveness of the device or that would constitute a major change in intended use;
●	Medical Device Reporting regulations (MDR), which require that manufacturers keep detailed records of investigations or complaints against their devices and to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;
●	adequate use of the Corrective and Preventive Actions process to identify and correct or prevent significant systemic failures of products or processes or in trends which suggest same;
●	post-approval restrictions or conditions, including post-approval study commitments;
●	post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; and
●	notices of correction or removal and recall regulations.

●	Class I devices, which are low risk and subject to only general controls (e.g., registration and listing, medical device labeling compliance, MDRs, Quality System Regulations, and prohibitions against adulteration and misbranding) and, in some cases, to the 510(k) premarket clearance requirements;
●	Class II devices, which are moderate risk and generally require 510(k) or 510(k) de-novo premarket clearance before they may be commercially marketed in the United States as well as general controls and potentially special controls like performance standards or specific labeling requirements; and
●	Class III devices, which are devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a predicate device. Class III devices generally require the submission and approval of a PMA supported by clinical trial data.

●	Development of comprehensive product description and indications for use;
●	Comprehensive review of predicate devices and development of data supporting the new product’s substantial equivalence to one or more predicate devices; and
●	If appropriate and required, certain types of clinical trials (IDE submission and approval may be required for conducting a clinical trial in the US).

●	Assuming successful completion of all required testing, a detailed 510(k) premarket notification or 510(k) de-novo is submitted to the FDA requesting clearance to market the product. The notification includes all relevant data from pertinent preclinical and clinical trials, together with detailed information relating to the product’s manufacturing controls and proposed labeling, and other relevant documentation.
●	A 510(k) clearance letter from the FDA will authorize commercial marketing of the device for one or more specific indications for use.
●	After 510(k) clearance, Microbot will be required to comply with a number of post-clearance requirements, including, but not limited to, Medical Device Reporting and complaint handling, and, if applicable, reporting of corrective actions. Also, quality control and manufacturing procedures must continue to conform to QSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QSRs, which impose extensive procedural, substantive, and record keeping requirements on medical device manufacturers. In addition, changes to the manufacturing process are strictly regulated, and, depending on the change, validation activities may need to be performed. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with QSRs and other types of regulatory controls.
●	After a device receives 510(k) clearance from the FDA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use or technological characteristics, requires a new 510(k) clearance or could require a PMA. The FDA requires each manufacturer to make the determination of whether a modification requires a new 510(k) notification or PMA in the first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance or PMA for a particular change, the FDA may retroactively require the manufacturer to seek 510(k) clearance or PMA. The FDA can also require the manufacturer to cease U.S. marketing and/or recall the modified device until additional 510(k) clearance or PMA approval is obtained.
●	The FDA and the Federal Trade Commission, or FTC, will also regulate the advertising claims of Microbot’s products to ensure that the claims Microbot makes are consistent with its regulatory clearances, that there is scientific data to substantiate the claims and that product advertising is neither false nor misleading.

1.	To obtain CE Marking certification, comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR).
2.	Appoint a Person Responsible for Regulatory Compliance (PRRC). Determine classification of device - Class I (self-certified); Class I (sterile, measuring or reusable surgical instrument); Class IIa, Class IIb, or Class III.
3.	For all devices, implement a Quality Management System (QMS) in accordance with the MDR. Companies usually apply the EN ISO 13485 standard to achieve compliance. The QMS must include Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plans. Make arrangements with suppliers about unannounced Notified Body audits. For Class I (self-certified), implement a QMS though Notified Body intervention is not required.
4.	Prepare a CE Technical Documentation or Design Dossier (Class III) providing information about the device and its intended use plus testing reports, Clinical Evaluation Report (CER), risk management file, Instruction For Use (IFU), labeling and more. Obtain a Unique Device Identifier (UDI) for the device. All devices, even legacy products in use for decades, will require clinical data. Most of these data should refer to the subject device. Clinical studies are generally required for implantable and Class III devices. Existing clinical data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.
5.	If the company does not have a location in Europe, appoint an Authorized Representative (EC REP) located in the EU who is qualified to handle regulatory issues. Place the EC REP name and address on device label. Obtain a Single Registration Number from the regulators.
6.	For all devices except Class I (self-certified), the QMS and Technical Documentation or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products.
7.	For all devices except Class I (self-certified), the company will be issued a European CE Marking Certificate for the device and an ISO 13485 certificate for the company’s facility following successful completion of the Notified Body audit. ISO 13485 certification must be renewed every year. CE Marking certificates are typically valid for a maximum of 5 years, but are typically reviewed during the annual surveillance audit.
8.	Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable European requirements. At this time, the CE Marking may be affixed.
9.	Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. UDI must be on label and associated with the regulatory documents.
10.	For Class I (self-certified), annual NB audits are not required. However, CER, Technical File, and PMS activities must be kept updated. For all other classes, the company will be audited each year by a Notified Body to ensure ongoing compliance with the MDR. Failure to pass the audit will invalidate the CE Marking certificate. The company must perform Clinical Evaluation, PMS, and PMCF.

●	Name and address of the manufacturer, and of the importer as applicable;
●	Description of the intended use of the medical device and of its medical indications;
●	Technical details of the medical device and of its components, and in the event that the device or the components are not new, information should be provided on the date or renovation;
●	Certificate attesting to the safety of the device, issued by a competent authority of one of the following countries: Australia, Canada, European Community (EC), Member States (MSs), Israel, Japan, or the United States;
●	Information on any risk which may be associated with the use of the device (including precautionary measures to be taken);
●	Instructions for use of the device in Hebrew; the MOH may allow the instructions to be in English for certain devices;
●	Details of the standards to which the device complies;
●	Description of the technical and maintenance services, including periodic checks and inspections; and
●	Declaration, as appropriate: of the local manufacturer/importer, and of the foreign manufacturer.

●	Reside and maintain a place of business in Israel and serve as the regulatory representative.
●	Respond to questions from AMAR concerning the registered products.
●	Report adverse events to AMAR.
●	Renew the registration on time to keep the market approval active.

Name	Age	Position
Harel Gadot	52	President, Chief Executive Officer and Chairman of the Board of Directors
Yoseph Bornstein(1)(3)	65	Director
Scott Burell(1)(2)	58	Director
Martin Madden(1)(3)	63	Director
Prattipati Laxminarain(2)	65	Director
Aileen Stockburger(3)	61	Director
Tal Wenderow(2)	49	Director

(1)	Member of Audit Committee.
(2)	Member of Corporate Governance Committee.
(3)	Member of Compensation Committee.

Board Diversity Matrix (as of January 19, 2024)
Total Number of Directors	7
Gender Identity:	Male	Female	Non-Binary	Gender Undisclosed
Directors	6	1	0	0
Number of Directors who Identify in any of the Categories Below:
African American or Black	0	0	0	0
Alaskan Native or Native American	0	0	0	0
Asian	1	0	0	0
Hispanic or Latinx	0	0	0	0
Native Hawaiian or Pacific Islander	0	0	0	0
White	5	1	0	0
Two or More Races or Ethnicities	0	0	0	0
LGBTQ+	0
Did Not Disclose Demographic Background	0

Name and Principal Position	Year		Salary ($)		Bonus ($)			Stock Awards ($)		Option Awards ($) (1)		Non-Equity Incentive Plan Compensation ($)		All Other Compensation ($)			Total ($)

Harel Gadot		2023		370,552		386,000	(2)		-		470,302		-		13,800	(4)		1,240,654
CEO, President & Chairman		2022		542,000		300,000	(3)		-		971,217		-		13,800	(4)		1,827,017

Simon Sharon		2023		271,662		87,022	(2)		-		88,418				22,828	(5)		469,930
CTO and GM		2022		348,197		89,721	(3)		-		65,114		-		23,298	(5)		526,330

Eyal Morag		2023		314,033		82,878	(2)				101,356				13,605	(5)		511,872
CMO (6)		2022		401,517		89,164	(3)		-		90,836		-		19,752	(5)		601,269

Rachel Vaknin		2023		185,343		27,626	(2)		-		76,533		-		-			289,502
CFO		2022		189,384		-			-		45,263		-		-			234,647

(1)	Amounts shown do not reflect cash compensation actually received by the named executive officer. Instead, the amounts shown are the non-cash aggregate grant date fair values of stock option awards made during the periods presented as determined pursuant to ASC Topic 718 and excludes the effect of forfeiture assumptions. The assumptions used to calculate the fair value of stock option awards are set forth under Note 9 to the Consolidated Financial Statements of the Company for the fiscal year ended December 31, 2022 included in this prospectus.
(2)	Represents bonus for the 2022 fiscal year, which amount was actually paid in 2023.
(3)	Represents bonus for the 2021 fiscal year, which amount was actually paid in 2022.
(4)	All Other Compensation includes Mr. Gadot’s monthly automobile allowance.
(5)	All Other Compensation includes the executive’s yearly automobile allowance.
(6)	On August 29, 2023, Dr. Morag resigned from his position with the Company, effective November 29, 2023.

	Option Awards							Stock Awards
Name	Number of Securities Underlying Unexercised Options Exercisable		Number of Securities Underlying Unexercised Options Unexercisable		Option Exercise Price		Option Expiration Date	Number of Shares or Units of Stock That Have Not Vested		Market value of Shares of Units of Stock That Have Not Vested		Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested		Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

Harel Gadot		77,846		-	$	4.20	1/01/2025		-		-		-		-
		120,847		-		15.75	9/14/2027		-		-		-		-
		166,666		-		9.64	2/25/2030		-		-		-		-
		190,000		-		8.48	02/01/2031		-		-		-		-
		62,500		37,500		6.48	01/26/2032		-		-		-		-
		64,000		96,000		3.73	12/21/2032		-		-		-		-
		-		80,000		2.43	08/01/2033		-		-		-		-
Simon Sharon		10,000		-		9.00	08/13/2028		-		-		-		-
		14,170		-		5.95	08/12/2029		-		-		-		-
		15,625		9,375		6.48	01/26/2032		-		-		-		-
		11,375		23,625		3.48	12/21/2032		-		-		-		-
		-		17,500		2.43	08/01/2033
Rachel Vaknin		12,500		7,500		6.48	01/26/2032		-		-		-		-
		4,750		5,250		4.80	07/18/2032		-		-		-		-
		5,200		7,800		3.73	12/21/2032		-		-		-		-
		-		17500		2.43	08/01/2033


Eyal Morag		25,000		-		6.16	02/29/2024		-		-		-		-
		15,625		-		6.48	02/29/2024		-		-		-		-

Name	Fees earned or paid in cash		Stock Awards		Option Awards (1)		Non-Equity Incentive Plan Compensation		Nonqualified Deferred Compensation Earnings		All Other Compensation		Total

Yoseph Bornstein	$	13,125		-	$	64,116		-		-		-	$	77,241
Scott Burell	$	15,000		-	$	64,116		-		-		-	$	79,116
Martin Madden	$	15,000		-	$	64,116		-		-		-	$	79,116
Prattipati Laxminarain	$	11,250		-	$	64,116		-		-		-	$	75,366
Aileen Stockburger	$	10,625		-	$	67,504		-		-		-	$	78,129
Tal Wenderow	$	10,000		-	$	66,819		-		-		-	$	76,819

	Number of securities to be issued upon exercise of outstanding options, warrants and rights		Weighted-average exercise price of outstanding options, warrants and rights		Number of securities remaining available for future issuance
Plan Category
Equity compensation plans approved by security holders:
2017 Equity Incentive Plan		492,133	$	10.48		131,585
2020 Omnibus Performance Award Plan		1,438,806	$	4.19		581,846
Equity compensation plans not approved by security holders:
Microbot Israel Employee Stock Option Plan(1)		61,577	$	0.01		-
Stock Options (2)		77, 846	$	4.20		-
Total		2,070,362				713,431