What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-31 · 33 added, 110 removed, 666 unchanged (18% of the section changed)

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under development.

We continue to incur research and development and

selling, marketing and general and administrative expenses related to our operations, development and commercialization of our first

Our operating losses for the years ended December 31, 2021 and 2020 were approximately $4.0 million and $3.1 million,

respectively, and we had an accumulated deficit of approximately $97.5 million as of December 31, 2021.

We expect to continue

to incur losses for the foreseeable future, and these losses will likely increase as we develop and prepare to commercialize GlucoTrack®

If we are not successful in developing, manufacturing and distributing GlucoTrack® 2.0, or if GlucoTrack® 2.0 does not achieve

market acceptance, we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability

in subsequent periods.

We continue to incur research and development and selling, marketing and general and administrative expenses related

to our operations, development and commercialization of our first product.

Our operating losses for the years ended December 31, 2022

and 2021 were approximately $4.4 million and $4.0 million, respectively, and we had an accumulated deficit of approximately $101.9 million

as of December 31, 2022.

We expect to continue to incur losses for the foreseeable future, and these losses will likely increase as we

develop and prepare to commercialize GlucoTrack® 2.0.

If we are not successful in developing, manufacturing and distributing GlucoTrack®

2.0, or if GlucoTrack® 2.0 does not achieve market acceptance, we may never become profitable.

Even if we achieve profitability in

the future, we may not be able to sustain profitability in subsequent periods.

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

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on acceptable terms in a timely manner, or at all.

are dependent on third-party distributors to market and sell our products.

have limited internal marketing, sales or distribution capabilities and currently we do not intend to develop extensive internal marketing,

sales or distribution capabilities in the future.

Rather, we intend to utilize third-party distributors to market our products, and have

entered into exclusive distribution agreements with respect to certain territories.

There is no assurance that third party distributors

will achieve acceptable levels of sales or that, if any of our existing arrangements expire or terminate, we will be able to replace

any distributors on terms advantageous to us, or at all.

Further, there is no assurance that we will be able to expand our distribution

network by adding additional distributors.

If third party distributors cease to promote our products, or if we are unable to make acceptable

arrangements with distributors or sales personnel in other markets, our business prospects, operating results or financial condition

could be materially adversely affected.

clinical investigators and contract research organizations that we engage to conduct our clinical trials may not be diligent, careful

clinical investigators and contract research organizations that we may engage to conduct our clinical trials may not be diligent,

careful or timely.

will depend on independent clinical investigators to conduct our clinical trials.

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to sustain operations.

to obtain additional regulatory approvals outside the United States will prevent or limit us from marketing our product candidates abroad.

intend to market our product candidates in non-U.S.

In order to market product candidates in the EU and many other non-U.S.

jurisdictions, we must obtain separate regulatory approvals.

In December 2012, we submitted our technical file to the Notified Body in

connection with our application to obtain CE Mark approval for GlucoTrack® 1.0.

On June 4, 2013, we received CE Mark approval for

the GlucoTrack® 1.0 from the Notified Body.

Receipt of the CE Mark allows us to market and sell the GlucoTrack® 1.0 in EU member

countries that have adopted the MDD without being subject to additional national regulations with regard to demonstration of performance

The CE Mark also permits the sale in countries that have an MDD Mutual Recognition Agreement with the EU.

However, member

countries may apply and enforce the MDD’s terms differently, and certain EU member countries may request or require that we provide

performance and/or safety data additional to the MDD’s requirements from time to time, on a case-by-case basis, in order to be

cleared to market and sale GlucoTrack® in such countries.

Receipt of FDA approval does not ensure approval by regulatory authorities

in countries, and approval by one or more non-U.S.

regulatory authorities (including receipt of the CE Mark) does not ensure approval

by regulatory authorities in other countries or by the FDA.

regulatory approval process may include all of the risks associated

with obtaining FDA approval or clearance.

We may not obtain additional non-U.S.

regulatory approvals on a timely basis, if at all.

may not be able to file for additional non-U.S.

regulatory approvals and may not receive necessary approvals to commercialize our product

candidates in any market.

governments often impose strict price controls, which may adversely affect our future profitability.

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against such employee.

funding that we received through the Israeli Innovation Authority (IIA) for research and development activities restricts our

ability to manufacture products or to transfer technology outside of Israel.

funding that we received through the Israeli Innovation Authority (IIA) for research and development activities restricts our ability

to manufacture products or to transfer technology outside of Israel.

March 4, 2004, the OCS agreed to provide us with a grant of 420 thousand New Israeli Shekels (“NIS”), or approximately $93

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balance sheet.

may be at risk for delay in product development and other economic repercussions as a result of the COVID-19 pandemic.

may be at risk as a result of the current COVID-19 pandemic.

Risks that could affect our business include the duration and scope of the

COVID-19 pandemic and the impact on the demand for our products;

actions by governments, businesses and individuals taken in response

to the pandemic;

the length of time of the COVID-19 pandemic and the possibility of its reoccurrence;

the timing required to develop

effective treatments and a vaccine in the event of future outbreaks;

the eventual impact of the pandemic and actions taken in response

to the pandemic on global and regional economies;

and the pace of recovery when the COVID-19 pandemic subsides.

We had identified a material weakness in

our internal control over financial reporting, and we may not be able to successfully implement remedial measures.

Common Stock may be delisted from The Nasdaq Capital Market (“Nasdaq”) if we fail to comply with continued listing standards.

Common Stock is currently traded on Nasdaq under the symbol “MARA”.

If we fail to meet any of the continued listing standards

of Nasdaq, for which we have one or more deficiencies, our Common Stock could be delisted from Nasdaq.

The continued listing standards

include specifically enumerated criteria, such as:

$1.00 minimum closing bid price;

Stockholders’

equity of $2,500 thousand;

shares of publicly held Common Stock with a market value of at least $1,000 thousand;

round-lot stockholders;

with Nasdaq’s corporate governance requirements, as well as additional or more stringent criteria that may be applied in the

exercise of Nasdaq’s discretionary authority.

had identified a material weakness in our internal control over financial reporting, and we may not be able to successfully implement

remedial measures.

identified material weaknesses related to our internal control over financial reporting as of December 31, 2022 and concluded that internal

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over financial reporting was due to identification of material weaknesses related to lack of sufficient internal accounting personnel,

se gregation of duties, and lack of sufficient internal controls

(including IT general controls) that encompass the Company as a whole with respect to entity and transactions level controls in order

to ensure complete documentation of complex and non-routine transactions and adequate financial reporting.

expect to complete our remediation plan within the next 12 months.

However, we have not tested the effectiveness of our internal control

over financial reporting and cannot assure you that we will be able to successfully remediate this material weakness and, even if we

do, we cannot assure you that we will not suffer from other material weaknesses in the future.

Except for additional personnel costs,

the cost of systems and the costs of our third-party service providers, we do not expect to incur any material costs related to our remediation

segregation of duties, and lack of sufficient internal controls (including IT general controls) that encompass the Company as a whole

with respect to entity and transactions level controls in order to ensure complete documentation of complex and non-routine transactions

and adequate financial reporting.

there can be no assurance that we will not suffer from other material weaknesses or significant deficiencies in the future.

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which could cause a decline in the value of the common stock.

our common stock is a “penny stock,” it may be more difficult for investors to sell shares of the common stock, and the market

price of the common stock may be adversely affected.

common stock may be a penny stock if, among other things, the stock price is below $5.00 per share.

Broker-dealers who sell penny

stocks must provide purchasers of these stocks with a standardized risk- disclosure document prepared by the SEC.

This document provides

information about penny stocks and the nature and level of risks involved in investing in the penny-stock market.

A broker must also

give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation, make

a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement

to the purchase.

Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer a monthly

statement containing price and market information relating to the penny stock.

If a penny stock is sold to an investor in violation of

the penny stock rules, the investor may be able to cancel its purchase and get its money back.

applicable, the penny stock rules may make it difficult for investors to sell their shares of common stock.

Because of the rules and

restrictions applicable to a penny stock, there is less trading in penny stocks and the market price of the common stock may be adversely

Also, many brokers choose not to participate in penny stock transactions.

Accordingly, investors may not always be able to

resell their shares of common stock publicly at times and prices that they feel are appropriate.

with changing regulations concerning corporate governance and public disclosure may result in additional expenses.

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These measures, however, may not adequately protect us from material adverse effects.

adoption of the “Conflict Minerals” regulations may adversely affect the manufacturing of our current and future products.

requirements regarding the use of “conflict minerals” could affect the sourcing and availability of the raw materials used

by our third-party manufacturers.

We may be subject to costs associated with the new regulations, including for the diligence pertaining

to the presence of any conflict minerals used in our products and the cost of remediation and other changes to products, processes, or

sources of supply as a consequence of such verification activities.

The impact of the regulations may result in a limited pool of suppliers

who provide conflict free minerals, and we cannot assure that we will be able to obtain products in sufficient quantities or at competitive

We may face reputational challenges with our customers and other stakeholders if we are unable to sufficiently verify the origins

for the metals used in the products we sell.

As a result, we may not be able to obtain the materials necessary to manufacture our products,

which could force us to cease production or search for alternative supply sources, possibly at a higher cost.

Such disruptions may have

a material adverse effect on our business, financial condition, results of operations and cash flows.

Unresolved Staff Comments.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors