Item 1A. Risk Factors
ITEM
1A. RISK FACTORS.
As
of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors disclosed in our Annual Report
on Form 10-K filed with the SEC on September 22, 2022 except for the risks described below. Any of those risk factors could result in a significant or material adverse
effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem
immaterial may also impair our business or 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.
We
may not be able to satisfy the continued listing requirements of the Nasdaq Capital Market in order to maintain the listing of our common
stock.
On
March 17, 2022, the Company received a letter (the “Notice”) from the Listing
Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the minimum closing bid price
per share for its common stock was below $1.00 for 30 consecutive business days preceding the date of the Notice, and that the Company
did not meet the $1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1).
The
Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days, or until September 13, 2022 (the “Compliance
Period”), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period,
the closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days,
Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.
On
September 8, 2022, the Company filed a request for a second 180-day period within which to evidence compliance with the $1.00 bid
price requirement following the expiration of the current compliance period on September 13, 2022. No further communication has been
received from by Nasdaq as at the date of this Quarterly Report on Form 10-Q.
26
As
part of its review process, Nasdaq will make a determination of whether it believes the Company will be able to cure the deficiency.
If Nasdaq concludes that the Company will not be able to cure the deficiency, or if the Company determine not to submit a transfer application
or make the required representation, Nasdaq will provide notice that the Company’s securities will be subject to delisting. If
the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the expiration
of the second compliance period.
Our
Licensor is undergoing equity recapitalization the outcome with which could materially and adversely affect our business, financial condition
and operating results.
We
are party to a Technology License Agreement (the “Technology License Agreement”) with Life Science Biosensor Diagnostics
Pty Ltd. (“LSBD”), pursuant to which, among other things, the Company licenses certain products from LSBD (the “Licensed
Products”), and an option agreement with LSBD and BiosensX (North America) Inc., pursuant to which, among other things, LSBD granted
to the Company an exclusive option (the “Option”) to purchase an exclusive license to use, make, sell and offer to sell products
under the intellectual property rights in connection with the Biosensor technology the glucose/diabetes management field in the United
States, Mexico and Canada. See exhibits 10.2, exhibits 10.3, exhibits 9, 5– Technology License Agreements of the 10-K filed on
September 22, 2022 for a description of the Technology License Agreement, the Licensed Products, and the Option. According to the Australian
Securities and Investment Commission’s (ASIC’s), Companies and Organizations Register, on May 10, 2022, LSBD filed a Notice
of Appointment of External Administrator, followed by a filing of a Deed of Company Arrangement on the August 2, 2022. Pursuant this
filing we understand that LSBD is proposing to undergo a recapitalization of its equity structure on or before December 5, 2022. We understand,
the Deed Administrators granted a further extension from October 2, 2022 to December 5, 2022 to the Deed Proponents to complete their
due diligence. The terms of such recapitalization or other outcome of such administration of LSBD could result in, among other things,
change in control of the Licensor or more parties other than LSBD becoming the owner of the Intellectual Property (IP) rights. Accordingly,
this has an inherent risk of the possibility of modifications to, or the Company’s ability to use, the Licensed Products, which
could materially and adversely affect the Company’s business, financial condition and operating results.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Other than any sales previously reported in the Company’s Current
Reports on Form 8-K, the Company did not sell any unregistered securities during the period covered by this report.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
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