Item 1A. Risk Factors
Item
1A. Risk Factors.
You
should carefully consider the factors discussed in Part I, Item 1A., “Risk Factors” in our Annual Report for the fiscal year
ended December 31, 2023, which could materially affect our business, financial position, or future results of operations. The risks described
in our Annual Report for the fiscal year ended December 31, 2023, are not the only risks we face. Additional risks and uncertainties
not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial position,
or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future
filings with the SEC. The risk factors 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
may include in subsequent periodic filings with the SEC.
We
may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.
Given
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
technology. 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. 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.
Our
failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.
Our
common stock is currently listed for trading on The Nasdaq Stock Market LLC. We must satisfy the continued listing requirements of Nasdaq,
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
consecutive business days, we were not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share
for continued listing on Nasdaq as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
We
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.
At
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.
There
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,
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.
Item
2. 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.
(c) None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
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