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 January 31, 2025,
$300,000 in principal and $26,149 in accrued interest remained outstanding.
17
Going Concern
See Note 1 of Notes to Condensed Consolidated Financial
Statements.
Significant Accounting Policies and Use of Estimates
During the six months ended January 31, 2025, 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 or six-month periods ended January 31, 2025 or 2024. 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 January 31,
$
%
2025
2024
Change
Change
Research and development expense
$ –
$ 42,765
$ (42,765 )
-100%
Stock-based compensation
36,131
677,391
(641,260 )
-95%
General and administrative expense
120,462
437,274
(316,812 )
-72%
Loss from operations
(156,593 )
(1,157,430 )
1,000,837
-86%
Gain on sale of asset
–
15,900,687
(15,900,687 )
100%
Investment revaluation
–
(1,332,980 )
1,332,980
100%
Interest expense
(63,431 )
(141,601 )
78,170
55%
Other income (loss), net
(102 )
8,890
(8,992 )
-101%
Net income (loss)
(220,126 )
13,277,566
(13,497,692 )
102%
Deemed dividend
–
(63,455 )
63,455
100%
Net income (loss) attributable to common stockholders
$ (220,126 )
$ 13,214,111
$ (13,434,237 )
-102%
Basic net income (loss) per share
$ 0.00
$ 0.14
$ (0.14 )
-100%
Diluted net income (loss) per share
$ 0.00
$ 0.12
$ (0.12 )
-100%
Six Months Ended January 31,
$
%
2025
2024
Change
Change
Research and development expense
$ –
$ 65,766
$ (65,766 )
-100%
Stock-based compensation
96,618
1,000,188
(903,570 )
-90%
General and administrative expense
639,402
938,716
(299,314 )
-32%
Loss from operations
(736,020 )
(2,004,670 )
(1,268,650 )
-64%
Gain on sale of asset
–
16,400,687
(16,400,687 )
-100%
Investment revaluation
(370,698 )
(1,332,980 )
962,282
72%
Interest expense
(132,217 )
(332,462 )
200,245
60%
Other income, net
(97 )
8,956
(9,053 )
-101%
Net income (loss)
(1,239,032 )
12,739,531
(13,978,563 )
-110%
Deemed dividend
–
(63,455 )
63,455
-100%
Net income (loss) attributable to common stockholders
$ (1,239,032 )
$ 12,676,076
$ (13,915,108 )
-110%
Basic net income (loss) per share
$ (0.01 )
$ 0.14
$ (0.15 )
-108%
Diluted net income (loss) per share
$ (0.01 )
$ 0.12
$ (0.13 )
-108%
18
Research and Development Expense
Our Research and development expense includes expenses
related to our current projects and include clinical research, design and manufacturing, formulation, regulatory and consultants.
We are not currently working on any projects and,
therefore, we did not have any Research and development expense in the three or six months ended January 31, 2025.
Stock-Based Compensation
The decreases in Stock-based compensation for the
three and six month periods ended January 31, 2025 compared to the same periods of 2024 were due to no options granted in the three and
six month periods ended January 31, 2025 and fewer unvested awards outstanding.
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.
The decreases in General and administrative expense
were due to the following:
Three months ended
January 31, 2025 compared to three months ended
Six months ended
January 31, 2025 compared to six months ended
January 31, 2024
January 31, 2024
Increase (decrease) in:
Business development and investor relations
$ (41,385 )
$ (96,756 )
Consulting fees
(10,000 )
(25,000 )
Insurance expense
(6,249 )
(11,451 )
Legal and professional fees
(91,247 )
(120,179 )
Public Company Expense
(29,628 )
154,536
Wages
(126,503 )
(198,549 )
Other
(11,800 )
(1,915 )
$ (316,812 )
$ (299,314 )
The decreases in wages and business development and
investor relations were due to fewer employees and lower activity throughout the company. The decrease in legal and professional fees
was due to lower legal fees incurred.
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.
19
Interest Expense
Interest expense includes interest on debt outstanding,
as well as the amortization of beneficial conversion feature, debt discount and debt issuance costs. Certain information regarding debt
outstanding was as follows:
Three Months Ended January 31,
Six Months Ended January 31,
2025
2024
2025
2024
Weighted average debt outstanding
$ 1,902,147
$ 1,724,492
$ 1,829,421
$ 1,836,816
Weighted average interest rate
10.4%
8.8%
10.8%
8.2%
The decreases in interest expense in the three and
six month periods ended January 31, 2025, compared to the same periods of 2024 were due to lower amortization of beneficial conversion
feature, debt discount and debt issuance costs, partially offset by higher average debt outstanding and higher average interest rates.
Liquidity and Capital Resources
See Recent Funding above for a discussion of our recent
financings.
The following table sets forth the primary sources and uses of cash:
Six Months Ended January 31,
2025
2024
Net cash used in operating activities
$ (295,192 )
$ (967,442 )
Net cash provided by investing activities
–
1,000,000
Net cash provided by financing activities
300,000
96,717
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:
January 31, 2025
July 31, 2024
Convertible note issued to LGH due July 31, 2025, 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 July 31, 2025, 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 July 31, 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
(19,646 )
(38,134 )
$ 1, 965,021
$ 1,646,533
20
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.
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.