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Item 1A. Risk Factors

2024-08-13 compared with 2024-05-15 · 66 added, 61 removed, 25 unchanged (84% of the section changed)

9 unchanged sentences

filings with the SEC.

The risk factors set forth below supplements and updates the risk factors previously disclosed and should be read

The risk factor set forth below supplements and updates the risk factors previously disclosed and should be read

together with the risk factors described in our Annual Report for the fiscal year ended December 31, 2023 and with any risk factors we

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may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.

the current momentum for continuous blood glucose monitoring (“CBGM”) in the diabetes market, we have announced our

decision to reset our priorities, improve our commercial outlook and refine our business strategy to focus on our implantable CBGM

Should our efforts to focus on this CBGM technology not be successful, we will need to further evaluate our business

strategy and, as a result, our Board of Directors may decide that it is in the best interest of our stockholders to dissolve our

Company and liquidate our assets or otherwise modify our strategy in the future.

In this regard, we may, from time to time, focus

our product development efforts on different product candidates or may delay, suspend or terminate the future development of a

product candidate at any time for strategic, business, financial or other reasons.

As a result of changes in our strategy, we have

and may in the future change or refocus our existing product development, commercialization and manufacturing activities.

require changes in our facilities and our personnel.

Any product development changes that we implement may not be successful.

particular, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable

product candidates.

Our decisions to allocate our research and development, management and financial resources toward particular

product candidates may not lead to the development of viable commercial products and may divert resources from better opportunities.

Similarly, our decisions to delay or terminate product development programs may also prove to be incorrect and could cause us to

miss valuable opportunities.

the current momentum for continuous glucose monitoring (“CGM”) in the diabetes market, we have announced our decision to

reset our priorities, improve our commercial outlook and refine our business strategy to focus on our implantable CGM technology.

our efforts to focus on CGM not be successful, we will need to further evaluate our business strategy and, as a result, our Board of

Directors may decide that it is in the best interest of our stockholders to dissolve our Company and liquidate our assets or otherwise

modify our strategy in the future.

In this regard, we may, from time to time, focus our product development efforts on different product

candidates or may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial

or other reasons.

As a result of changes in our strategy, we have and may in the future change or refocus our existing product development,

commercialization and manufacturing activities.

This could require changes in our facilities and our personnel.

Any product development

changes that we implement may not be successful.

In particular, we may fail to select or capitalize on the most scientifically, clinically

or commercially promising or profitable product candidates.

Our decisions to allocate our research and development, management and financial

resources toward particular product candidates may not lead to the development of viable commercial products and may divert resources

from better opportunities.

Similarly, our decisions to delay or terminate product development programs may also prove to be incorrect

and could cause us to miss valuable opportunities.

failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.

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to maintain the listing of our common stock on The Nasdaq Stock Market LLC.

As previously disclosed, on

May 26, 2023, we received notice from the Staff indicating that, based upon the closing bid price of our common stock for the prior 30

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

initially had 180 days from May 26, 2023, or through November 22, 2023, to regain compliance with the Bid Price Rule.

However, on November

24, 2023, we received a notice from Nasdaq stating that we were granted an additional 180 calendar days, or until May 20, 2024, to regain

compliance with the Bid Price Rule (the “Extended Compliance Period”).

If at any time during the Extended Compliance Period,

the closing bid price of our Common Stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide

written confirmation that we have regained compliance with the Bid Price Rule.

If we cannot demonstrate compliance during the Extended

Compliance Period, then Nasdaq will provide notice that our Common Stock will be subject to delisting.

At that time, the Company may

appeal the Staff’s determination to a hearings panel.

the Company’s annual meeting of stockholders held on April 26, 2024, the stockholders of the Company approved a proposal to authorize

the Company’s Board of Directors (the “Board”) to file a Certificate of Amendment to the Company’s Certificate

of Incorporation, as amended, to effect a reverse stock split of the Company’s common stock, par value $0.001 per share at a ratio

between 1-for-5 and 1-for-30, to be effected at such time and date, if at all, as determined by the Board in its sole discretion (the

“Reverse Stock Split”).

On April 30, 2024, the Board approved the Reverse Stock Split.

Among other considerations, the Company

plans to implement the Reverse Stock Split to satisfy the Bid Price Rule for continued listing on Nasdaq.

can be no assurance that we will be able to regain and sustain compliance with all applicable requirements for continued listing on Nasdaq.

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

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

days, or until May 20, 2024 (the “Extended Compliance Period”), to regain compliance with the Minimum Bid Price Requirement

in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

May 21, 2024, we received a third letter from Nasdaq (the “Letter”) notifying us that it had not regained compliance with

the Minimum Bid Price Requirement during the Extended Compliance Period.

The Letter also notified us that our Form 10-Q for the period

ended March 31, 2024, indicates that we no longer meet the $2,500,000 minimum stockholders’ equity requirement for continued listing

set forth under Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”).

Pursuant to Listing Rule

5810(d)(2), the failure to comply with the Minimum Stockholders’ Equity Requirement has become an additional and separate basis

for delisting.

we were under review for failure to meet the Minimum Bid Price Requirement, we were not eligible to submit a plan to regain compliance.

Accordingly, unless we would request an appeal of this determination by May 28, 2024, trading of our common stock would be suspended

at the opening of business on May 30, 2024, and a Form 25-NSE would be filed with the Securities and Exchange Commission (the “SEC”).

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.

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

Certificate of Incorporation with the Secretary of State of the State of Delaware which effected, as of 4:30 p.m.

Eastern Time, on May

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.

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

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

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.

(a) During the quarter ended March 31, 2024, there were no unregistered sales of our securities that were not reported

in a Current Report on Form 8-K.

(b) Not applicable.

Defaults Upon Senior Securities

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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