What changed in this filing

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Item 1A. Risk Factors

2024-11-14 compared with 2024-08-13 · 50 added, 31 removed, 60 unchanged (57% of the section changed)

40 unchanged sentences

for continued listing on Nasdaq as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).

We had 180 days

from May 26, 2023, or through November 22, 2023, to regain compliance with the Bid Price Rule.

We had 180 days from

May 26, 2023, or through November 22, 2023, to regain compliance with the Bid Price Rule.

November 24, 2023, we received a second letter from Nasdaq notifying the Company that it had been granted an additional 180 calendar

13 unchanged sentences

We timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”).

The hearing request would result in a stay

of any suspension or delisting action pending the hearing.

On August 5, 2024, we received the decision of the Panel, and they granted us an extension to November 18, 2024 to

regain compliance with the Minimum Stockholders’ Equity Requirement.

The hearing request would result in a stay of

any suspension or delisting action pending the hearing.

On August 5, 2024, we received the decision of the Panel, and they granted us

an extension to November 18, 2024 to regain compliance with the Minimum Stockholders’ Equity Requirement.

May 17, 2024, in order to regain compliance with the Minimum Bid Price Requirement, we filed a Certificate of Amendment to the Company’s

2 unchanged sentences

17, 2024, a one-for-five Reverse Stock Split of our issued and outstanding shares of Common Stock.

the event that we are unable to regain and sustain compliance with all applicable requirements for continued listing on the Nasdaq,

our Common Stock may be delisted from Nasdaq.

If our Common Stock were delisted from Nasdaq, trading of our common stock would most

likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained

by OTC Markets Group Inc.

An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to

buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to

difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national

exchange or other reasons.

In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny

stock,” which impose additional disclosure requirements on broker-dealers.

The regulations relating to penny stocks, coupled

with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally

representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of

investors to trade in our common stock.

In addition, delisting would materially and adversely affect our ability to raise capital on

terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and

employees and fewer business development opportunities.

For these reasons and others, delisting would adversely affect the

liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse

effect on our business, financial condition and results of operations, including our ability to attract and retain qualified

employees and to raise capital.

Unregistered Sales of Equity Securities and Use of Proceeds.

Defaults Upon Senior Securities

Mine Safety Disclosures

the event that we are unable to regain and sustain compliance with all applicable requirements for continued listing on the Nasdaq, our

Common Stock may be delisted from Nasdaq.

If our Common Stock were delisted from Nasdaq, trading of our common stock would most likely

take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC

Markets Group Inc.

An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our

common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing

over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons.

addition, as a delisted security, our common stock would be subject to SEC rules as a “penny stock,” which impose additional

disclosure requirements on broker-dealers.

The regulations relating to penny stocks, coupled with the typically higher cost per trade

to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of

a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock.

delisting would materially and adversely affect our ability to raise capital on terms acceptable to us, or at all, and may result in

the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of

an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including

our ability to attract and retain qualified employees and to raise capital.

rely on third parties to manufacture and supply our product.

do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a prototype lab.

We have no experience in medical device manufacturing and lack the resources and the capability to manufacture the Glucotrack CBGM on

a commercial scale.

our manufacturing partners are unable to produce our products in the amounts, timing or pricing that we require, we may not be able to

establish a contract and obtain a sufficient alternative supply from another supplier on a timely basis and in the quantities or pricing

We expect to depend on third-party contract manufacturers for the foreseeable future.

CBGM does, and our future product candidates, if any, likely will require precise, high quality manufacturing.

Any of our contract manufacturers

will be subject to ongoing periodic unannounced inspections by the FDA and other non-U.S.

regulatory authorities to ensure strict compliance

with quality system regulations, including current good manufacturing practices and other applicable government regulations and corresponding

If our contract manufacturers fail to achieve and maintain high manufacturing standards in compliance with quality system

regulations, we may experience manufacturing errors resulting in patient injury or death, product recalls or withdrawals, delays or interruptions

of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for our

products, cost overruns or other problems that could seriously harm our business.

performance failure on the part of our contract manufacturers could delay clinical development or regulatory clearance or approval of

our product candidates or commercialization of our future product candidates, depriving us of potential product revenue and resulting

in additional losses.

In addition, our dependence on a third-party for manufacturing may adversely affect our future profit margins.

Our ability to replace an existing manufacturer may be difficult because the number of potential manufacturers is limited, and the FDA

must approve any replacement manufacturer before it can begin manufacturing our product candidates.

Such approval would require additional

non-clinical testing and compliance inspections.

It may be difficult or impossible for us to identify and engage a replacement manufacturer

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

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-Q

Item 1A. Risk Factors