Item 2. Management’s Discussion and Analysis
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains forward-looking
statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this
report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and
objectives of management are forward-looking statements. The words “anticipates,” “believes,” “estimates,”
“expects,” “intends,” “may,” “plans,” “projects,” “will,” “would”
and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words.
We have based these forward-looking statements
on our current expectations and projections about future events. Although we believe that the expectations underlying our forward-looking
statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject to risks and uncertainties.
Therefore, you should not place undue reliance on our forward-looking statements.
Many possible
events or factors could affect our future financial results and performance and could cause actual results or performance to differ materially
from those expressed, including those risks and uncertainties described in Part I, Item 1A. “Risk Factors” in our Annual Report
on Form 10-K for the year ended July 31, 2024 (“2024 Annual Report”) and those described from time to time in our future reports
filed with the Securities and Exchange Commission (the “SEC”). We believe these risks and uncertainties could cause
actual results or events to differ materially from the forward-looking statements that we make. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions, projections or expectations prove incorrect, actual results, performance
or financial condition may vary materially and adversely from those anticipated, estimated or expected. Our forward-looking statements
do not reflect the potential impact of future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We
do not assume any obligation to update any of the forward-looking statements contained herein, whether as a result of new information,
future events or otherwise, except as required by law. In the light of these risks and uncertainties, the forward-looking events and circumstances
discussed in this report may not occur, and actual results could differ materially from those anticipated or implied in the forward-looking
statements.
Overview
Our business model is to develop or acquire unique
medical related products, engage third parties to develop and manufacture such products and then distribute the products through various
distribution channels, including third parties. We have two different technologies in research and development stage; the CardioMap®
heart monitoring and screening device, and the Save a Life choking rescue device. To date, none of our product candidates have received
regulatory clearance or approval for commercial sale.
We plan to license, improve, and develop our products
and identify and select distribution channels. We intend to establish agreements with distributors to get products to market quickly and
undertake and engage in direct marketing efforts as we move closer to regulatory approvals. We will determine the most effective distribution
method for each unique product we include in our portfolio. We will engage third-party research and development firms that specialize
in creating products to assist us in developing our own products, and we will apply for trademarks and patents once we have developed
proprietary products.
Recent Funding
Accredited Investor
Promissory Note
On August 14, 2024, we entered into a $300,000
promissory note (the “Note”) with an accredited investor. The $300,000 was received on August 22, 2024. The Note has a one-year
maturity, becoming due on August 22, 2025, and bears interest at the rate of 18% per annum. In addition, we issued the investor a warrant
to purchase 300,000 shares of our common stock at $0.10 per share that expires August 14, 2029, with a fair value of $13,343. At October
31, 2024, $300,000 in principal and $11,539 in accrued interest remained outstanding.
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Going Concern
See Note 1 of Notes to Consolidated Financial Statements.
Significant Accounting Policies and Use of
Estimates
During the three months ended October 31, 2024,
there were no significant changes to our significant accounting policies and estimates as described in Note 2. Summary of Significant
Accounting Policies included in Part II, Item 8. of our Annual Report on Form 10-K for the year ended July 31, 2024, which was filed
with the SEC on November 13, 2024.
Results of Operations
We do not currently sell or market any products
and we did not have any revenue in the three-month periods ended October 31, 2024 or 2023. We will commence actively marketing products
after the products and drugs in development have been FDA cleared or approved, but there can be no assurance, however, that we will be
successful in obtaining FDA clearance or approval for our products.
Three Months Ended
October 31,
$
%
2024
2023
Change
Change
Research and development
$
–
$
23,001
$
(23,001
)
100%
Stock-based compensation
60,487
322,798
(262,311
)
81%
General and administrative
519,841
501,440
18,401
4%
Gain on sale of asset
–
(500,000
)
500,0000
-100%
Loss from operations
(580,328
)
(347,239
)
(233,089
)
-67%
Unrealized losses on investment
(370,698
)
–
(370,698
)
-100%
Interest expense
(68,781
)
(190,861
)
122,080
64%
Other income, net
901
65
836
nm
Net loss
$
(1,018,906
)
$
(538,035
)
$
(480,871
)
-89%
Basic and diluted net loss per share
$
(0.01
)
$
(0.01
)
$
(0.00
)
nm
Research and Development
Research and development relates to our current
projects and includes expenses for clinical research, design and manufacturing, formulation, regulatory and consultants.
Currently, we are not working on any research
and development projects.
Stock-Based Compensation
The decrease in stock-based compensation was due
to fewer awards issued in recent quarters as well as a lower price for our common stock.
General and Administrative Expense
General and administrative includes expenses related
to salaries and related benefits for employees in finance, accounting, sales, administrative and research and development activities,
as well as stock-based compensation, costs related to maintaining compliance as a public company and legal and professional fees.
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The change in General and administrative expense
was due to the following:
Three months ended October 31, 2024 compared to three months ended October 31, 2023
Increase (decrease) in:
Public company expense
$ 185,914
Wages
(72,046 )
Business development and investor relations
(70,371 )
Legal and professional fees
(28,932 )
Bad debt expense
22,625
Insurance
(5,202 )
Travel
(4,832 )
Other
(8,755 )
$ 18,401
The decreases in wages and business development
and investor relations were due to fewer employees and lower activity throughout the company.
Gain on Sale of Asset
The gain on sale of asset in fiscal 2024 relates
to our sale of our drug candidates for treating mild traumatic brain injury (“mTBI”), also known as concussion, and for treating
Niemann Pick Disease Type C (“NPC”), as well as our proprietary powder formulation and its nasal delivery device to Oragenics
in December 2023.
Unrealized Losses on Investment
Unrealized losses on investment in relates to
the valuation of the common stock of Oragenics held by us as an investment. See Notes 3 and 4 of Notes to Consolidated Financial Statements
for additional information.
Interest Expense
Interest expense includes interest on debt outstanding,
as well as the amortization of debt discount and debt issuance costs. Certain information regarding debt outstanding was as follows:
Three Months Ended October 31,
2024
2023
Weighted average debt outstanding
$ 1,939,015
$ 2,563,270
Weighted average interest rate
10.07%
9.33%
Liquidity and Capital Resources
See Recent Funding above for a discussion of our recent financings.
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The following table sets forth the primary sources and uses of cash:
Three Months Ended October 31,
2024
2023
Net cash used in operating activities
$ (248,514 )
$ (59,907 )
Net cash provided by financing activities
300,000
220,924
To date, we have financed our operations primarily
through debt financing and limited sales of our common stock. Our ability to continue to access capital could be affected adversely by
various factors, including general market and other economic conditions, interest rates, the perception of our potential future earnings
and cash distributions, any unwillingness on the part of lenders to make loans to us and any deterioration in the financial position of
lenders that might make them unable to meet their obligations to us. If these conditions continue and we cannot raise funds through a
public or private debt financing, or an equity offering, our ability to grow our business may be negatively affected. In such case, we
have suspended research and development activities until market conditions improve.
Debt
The following notes payable were outstanding:
October 31, 2024
July 31, 2024
Convertible note issued to LGH due December 31, 2024, with a set interest amount of $84,000 through July 7, 2023, then an interest rate of 8.0% per annum of outstanding principal and convertible at $0.072 per share
$ 1,035,000
$ 1,035,000
Promissory notes issued to officers and directors due December 31, 2024, with an interest rate of 8.0% per annum and convertible at $0.12 per share
100,000
100,000
Accredited investor promissory note due February 13, 2025, with an interest rate of 10% per annum and convertible into 30,000 shares of Oragenics common stock held by us.
50,000
50,000
Mast Hill convertible promissory note due June 13, 2025, with an interest rate of 10% per annum and convertible at $0.072 per share
499,667
499,667
Accredited investor promissory note due August 22, 2025, with an interest rate of 18% per annum
300,000
–
1,984,667
1,684,667
Unamortized debt discount and closing costs
(31,676 )
(38,134 )
$ 1,952,991
$ 1,646,533
Inflation
Inflation did not have a material impact on our
business and results of operations during the periods being reported on.
Off Balance Sheet Arrangements
We do not have any material off balance sheet
arrangements.
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Item 3.
Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company and are not required to provide
information under this item.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.