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, 2021 (“2021 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 manufacture such products and then distribute the products through various distribution
channels, including third parties. We are developing potentially life-saving technologies: the CardioMap® heart monitoring and screening
device; the Save A Life choking rescue device, a unique neurosteroid drug compound intended to treat concussions and a unique drug compound
to treat rare brain disorders in partnership with Prevacus, Inc. To date, none of our product candidates has 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,
as well as to undertake and engage in our own direct marketing efforts. We will determine the most effective method of distribution for
each unique product that we include in our portfolio. We will engage third-party research and development firms who specialize in the
creation of our products to assist us in the development of our own products, and we will apply for trademarks and patents once we have
developed proprietary products.
Recent Funding
LPC Securities Purchase Agreement
On October 22, 2021, we entered into a Securities
Purchase Agreement (the “SPA”) with Lincoln Park Capital Fund, LLC (“LPC”) pursuant to which we received $250,000
in cash from LPC and LPC received (i) 1,500,000 restricted shares of our common stock, and (ii) 833,333 warrants exercisable at $0.50
per common share expiring in five years.
13
LPC Purchase Agreement Draws
During the first quarter of Fiscal 2022, we sold
974,482 shares of our common stock to LPC for total proceeds of $367,035. As of December 10, 2021, LPC purchased a total of 3,127,808
shares of our common stock pursuant to the agreement and remaining purchase availability is $8,411,489 and remaining shares available
are 16,143,556.
Tysadco
On August 29, 2021, we entered into a Securities
Purchase Agreement (the “SPA”) with Tysadco Partners (“Tysadco”) pursuant to which we entered into a $250,000
face value convertible promissory note which bears interest at a one-time rate of 8.0% applied to the face value and is due March 1, 2022.
We received $250,000 net cash from the issuance of the promissory note and issued 200,000 shares of common stock with a fair value of
$17,718 which is being expensed over the life of the note as a component of interest expense. The conversion rate of the note is $0.30
for a total of 900,000 shares of our common stock if converted in full, including interest.
On October 18, 2021, we entered into a Securities
Purchase Agreement (the “SPA”) with Tysadco pursuant to which we received $250,000 in cash from Tysadco and Tysadco received
(i) 1,500,000 restricted shares of our common stock, and (ii) 833,333 warrants exercisable at $0.50 per common share expiring in five
years.
Going Concern
Substantial doubt exists as to our ability to
continue as a going concern based on the facts that we may not have adequate working capital to finance our day-to-day operations and
we do not have any sources of revenue. We had an accumulated deficit of $47,380,097 as of October 31, 2021 and cash of $471,140. Management’s
plans include engaging in further research and development and raising additional capital in the short term to fund such activities through
sales of its common stock. Our continued existence depends on the success of our efforts to raise additional capital necessary to meet
our obligations as they come due and to obtain sufficient capital to execute our business plan.
We may obtain capital primarily through issuances
of debt or equity or entering into collaborative arrangements with corporate partners. There can be no assurance that we will be successful
in completing additional financing or collaboration transactions or, if financing is available, that it can be obtained on commercially
reasonable terms. If we are not able to obtain additional financing on a timely basis, we may be required to further scale down or cease
the operation of our business. The issuance of additional equity securities by us could result in a significant dilution in the equity
interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities
and future cash commitments. Our financial statements do not include adjustments that might result from the outcome of this uncertainty.
For the foreseeable future, we expect to experience
continuing operating losses and negative cash flows from operations as our management executes our current business plan. The cash of
$471,140 available at October 31, 2021, may not provide enough working capital to meet our current operating expenses through December
10, 2022.
If we are unable to raise additional capital
by December 10, 2022, we will adjust our current business plan. Due to the unknown and volatile nature of the stock price and
trading volume of our common stock, is it is difficult to predict the timing and amount of availability pursuant to our equity line
of credit with LPC (see Note 7 of Notes to Financial Statements). Given our recurring losses, negative cash flow, accumulated
deficit, and the impact of COVID-19, there is substantial doubt about our ability to continue as a going concern.
Impact of COVID-19
The COVID-19 global pandemic has had an unfavorable
impact on our business operations. The pandemic has impacted our ability to get financing, engage third-party vendors and timing of clinical
trials. In addition, the COVID-19 outbreak has adversely affected the U.S. and global economies and financial markets, which may result
in a long-term economic downturn that could negatively affect future performance and our ability to secure additional debt or equity funding.
Significant Accounting Policies and Use of
Estimates
During the three months ended October 31, 2021,
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, 2021, which was filed
with the Securities and Exchange Commission on October 29, 2021.
14
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, 2021 or 2020. 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,
$
%
2021
2020
Change
Change
Research and development expense
$ 322,504
$ –
$ 322,504
100%
General and administrative expense
1,106,884
525,269
581,615
111%
Loss from operations
(1,429,388 )
(525,269 )
904,119
172%
Interest expense
216,886
186,245
30,641
16%
Net loss
$ (1,646,274 )
$ (711,514 )
$ 934,760
131%
Basic and diluted net loss per share
$ (0.02 )
$ (0.01 )
$ 0.01
137%
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.
Research and development expense is expensed as incurred and totaled $322,504 and zero for the three months ended October 31, 2021 and
2020, respectively.
General and Administrative Expense
Our General and administrative expense includes
salaries and related benefits for employees in finance, accounting, sales, and administrative activities, as well as stock-based compensation,
costs related to maintaining compliance as a public company and legal and professional fees.
The increase in General and administrative expense
in the three months ended October 31, 2021 as compared to the same period of 2021 was due to the following:
Three
months ended
October 31, 2021
compared to
three months
ended
October 31, 2020
Increase (decrease) in:
Board and stock
expense
$ 400,325
Business development and investor
relations
87,398
Consulting fees
26,077
Financing fees
10,113
Insurance expense
24,939
Legal and professional fees
(108,063 )
Wages
165,324
Other
(24,498 )
$ 581,615
The increase in Board and stock expense of $400,325
for the quarter ended October 31, 2021 compared to the quarter ended October 31, 2020, was due to board grants in the current year quarter,
option and restricted stock unit expense for the employees, consultants and the scientific and sports advisory boards. The increase in
wages of $165,324 was a result of increased headcount for the quarter ended October 31, 2021, as compared to the quarter ended October
31, 2020. The increases were partially offset by a decrease in legal and professional fees of $108,063 in the quarter ended October 31,
2021, as compared to the quarter ended October 31, 2020.
15
Interest Expense
Interest expense includes interest on debt outstanding,
as well as the amortization of unamortized debt issuance costs and debt closing costs. Certain information regarding debt outstanding
was as follows:
Three Months Ended October 31,
2021
2020
Weighted average debt outstanding
$ 1,221,196
$ 656,957
Weighted average interest rate
8.0%
9.5%
The increase in interest expense for the three-month
period ended October 31, 2021 compared to the same period of 2020 was due to LGH and Tysadco investments in April 2021 and October 2021,
respectively.
Net Loss
Net loss increased in the three-month period ended
October 31, 2021 compared to the same period of 2020 due to increased board and stock expense, research and development and wages, as
well increased interest expense, partially offset by the lower weighted average interest rate.
Liquidity and Capital Resources
See Recent Funding above for a discussion of our recent debt and equity
financings.
The following table sets forth the primary sources and uses of cash:
Three Months Ended October 31,
2021
2020
Net cash used in operating activities
$ (1,165,210 )
$ (303,496 )
Net cash provided by financing activities
1,079,766
533,300
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 may need to suspend the creation of new products until market conditions improve.
Debt
The following notes payable were outstanding:
October 31, 2021
Convertible note issued to LGH due February 5,
2022 with an interest rate of 8.0% and convertible at $1.00 per share
$ 1,050,000
Tysadco convertible promissory note payable due March 1, 2022 with an interest rate of 8.0% and convertible at $0.30 per share
250,000
1,300,000
Unamortized debt discount and closing costs
(184,089 )
$ 1,115,911
16
Australian Research and Development Rebate
On November 2, 2021, we received a research and
development rebate from the government of Australia in the amount of $284,981 AUD ($214,120 USD) for clinical work performed in Australia
related to our Phase 1 human trial for safety and efficacy for the treatment of concussed individuals. The $214,120 is accounted for as
an offset to research and development expense, which is a component of General and administrative on our Statements of Operations.
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.