UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________________
Form
_________________________________
(Mark One)
For the quarterly period ended
or
For the transition period from to .
Commission File No.
____________________________________
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
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Securities registered pursuant to Section 12(b) of the Act: None
| Title of each Class | Trading Symbol | Name of each exchange on which registered |
| N/A | N/A | N/A |
Securities registered pursuant to Section 12(g) of the Act:
| Title of each Class | Trading Symbol | Name of each exchange on which registered |
| OTC |
Indicate by check mark whether
the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
| Large accelerated filer ☐ | Accelerated filer ☐ | |
| Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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shares of common stock, par value $.001 per share, outstanding as of December 14, 2022
ODYSSEY HEALTH, INC.
FORM 10-Q
For the Quarter Ended October 31, 2022
INDEX
| 2 |
Part I - FINANCIAL INFORMATION
| Item 1. | Financial Statements |
Odyssey Health, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
| October 31, | July 31, | |||||||
| 2022 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Research and development rebate due from Australian government | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Intangible assets, net of accumulated amortization of $ | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued wages | ||||||||
| Accrued interest | ||||||||
| Asset purchase liability | ||||||||
| Notes payable, officers and directors | ||||||||
| Notes payable, net of unamortized beneficial conversion
feature, debt discount and closing costs of $ | ||||||||
| Total current liabilities | ||||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders' deficit: | ||||||||
| Preferred stock, $ par value, shares authorized, shares issued or outstanding | ||||||||
| Common stock, $ par value, shares authorized, and shares issued and outstanding | ||||||||
| Additional paid-in-capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders' deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders' deficit | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 3 |
Odyssey Health, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
| For the Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Research and development expense | $ | $ | ||||||
| General and administrative expense | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Interest expense | ( | ) | ( | ) | ||||
| Other expense, net | ( | ) | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Basic net loss per share | $ | ( | ) | $ | ( | ) | ||
| Diluted net loss per share | $ | ( | ) | $ | ( | ) | ||
| Shares used for basic net loss per share | ||||||||
| Shares used for diluted net loss per share | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 4 |
Odyssey Health, Inc. and Subsidiaries
Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited)
| Shares | Dollars | Additional Paid-In Capital | Accumulated Deficit | Total Equity (Deficit) | ||||||||||||||||
| Balances, July 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Stock-based compensation | ||||||||||||||||||||
| Common stock issued in debt financing | – | |||||||||||||||||||
| Common stock issued in equity financings | ||||||||||||||||||||
| Return of reserved shares | ( | ) | ( | ) | ||||||||||||||||
| Net loss | – | ( | ) | ( | ) | |||||||||||||||
| Balances, October 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Shares | Dollars | Additional Paid-In Capital | Accumulated Deficit | Total Equity (Deficit) | ||||||||||||||||
| Balances, July 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Stock-based compensation | – | |||||||||||||||||||
| Common stock issued in debt financing | ||||||||||||||||||||
| Common stock issued in equity financings | ||||||||||||||||||||
| Return of reserved shares | ( | ) | ( | ) | ||||||||||||||||
| Net loss | – | ( | ) | ( | ) | |||||||||||||||
| Balances, October 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 5 |
Odyssey Health, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited)
| For the Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||
| Amortization | ||||||||
| Stock-based compensation | ||||||||
| Common stock issued for debt financing commitment shares | ||||||||
| Amortization of beneficial conversion feature, debt discount and closing costs | ||||||||
| Asset purchase liability | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Increase in research and development rebate due | ( | ) | ( | ) | ||||
| Increase in accounts payable | ||||||||
| Increase (decrease) in accrued wages | ( | ) | ||||||
| Increase in accrued interest | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of intellectual property | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from notes payable | ||||||||
| Principal payments made on notes payable | ( | ) | ||||||
| Proceeds from equity financing | ||||||||
| Net cash provided by financing activities | ||||||||
| Decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents: | ||||||||
| Beginning of period | ||||||||
| End of period | $ | $ | ||||||
| Supplemental disclosure of non-cash information: | ||||||||
| Increase in principal of notes payable | $ | $ | ||||||
| Shares returned to treasury | ||||||||
| Common stock issued for debt financing commitment shares | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 6 |
Odyssey Health, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
(Unaudited)
Note 1. Basis of Presentation and Nature of Operations
Basis of Presentation
The accompanying financial information of Odyssey Health, Inc, formerly known as Odyssey Group International, Inc. (“Odyssey”) and our wholly-owned subsidiary Odyssey Group International Australia, Pty Ltd, is unaudited and has been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). All intercompany balances and transactions have been eliminated. However, such information reflects all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods. The financial information as of July 31, 2022 is derived from our 2022 Annual Report on Form 10-K. The financial statements included herein should be read in conjunction with the financial statements and the notes thereto included in our 2022 Annual Report on Form 10-K filed with the SEC on October 31, 2022. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the full year.
Significant Accounting Policies
Our significant accounting policies have not changed during the three months ended October 31, 2022 from those disclosed in our Annual Report on Form 10-K for the year ended July 31, 2022.
Nature of Operations
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 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, 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.
We are not currently selling or marketing any products, as our products are in development and Food and Drug Administration ("FDA") clearance or approval to market our products will be required in order to sell in the United States.
Going Concern
We did not recognize any revenues for the year ended
July 31, 2022, or the three months ended October 31, 2022, and we had an accumulated deficit of $
The operating deficit indicates substantial doubt about our ability to continue as a going concern. 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 the additional financing on a timely basis, we may be required to further scale down or perhaps even cease operations.
| 7 |
The issuance of additional equity securities could result in a significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, would increase our liabilities and future cash commitments. Our financial statements do not include adjustments that might result from the outcome of this uncertainty.
If we are unable to raise additional capital by December 14, 2023, we will adjust our 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. 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
As the COVID-19 pandemic continues to severely impact the U.S. and global economy, our business may be impacted in a variety of ways. Political, legal or regulatory actions as a result of the COVID-19 pandemic in jurisdictions where we may plan to manufacture, source or distribute products have created supply disruptions which could affect our plans, and may cause additional supply disruptions or shortages in the future. We cannot currently predict the frequency, duration or scope of these governmental actions and supply disruptions.
Note 2. New Accounting Pronouncements
ASU 2020-06
In August 2020, the FASB issued ASU 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40),” which simplifies the accounting for convertible instruments, reduces complexity for preparers and practitioners and improves the decision usefulness and relevance of the information provided to financial statement users. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. We have not yet determined the impact of adopting this standard on our financial position, results of operations or cash flows.
Note 3. Intangible Assets
Intangible assets consisted of costs related to a patent for our concussion drug device combination.
Amortization expense was as follows:
| Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Amortization expense | $ | $ | ||||||
Future amortization of intangible assets is as follows:
| Remainder of fiscal 2023 | $ | |||
| Fiscal 2024 | ||||
| Fiscal 2025 | ||||
| Fiscal 2026 | ||||
| Fiscal 2027 | ||||
| Thereafter | ||||
| Total amortization expense | $ |
| 8 |
Note 4. Fair Value
The fair value of financial assets and liabilities are determined utilizing a three-level framework as follows:
Level 1 – Observable inputs, such as unadjusted quoted prices in active markets, for substantially identical assets and liabilities.
Level 2 – Observable inputs other than quoted prices within Level 1 for similar assets and liabilities. These include quoted prices for similar assets and liabilities in active markets, quoted prices for identical assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. If the asset or liability has a specified or contractual term, the input must be observable for substantially the full term of the asset or liability.
Level 3 – Unobservable inputs that are supported by little or no market activity, generally requiring a significant amount of judgment by management.
The methods described above may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Further, although we believe our valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.
We did not have any transfers of assets or liabilities measured at fair value on a recurring basis to or from Level 1, Level 2, or Level 3 during the three months ended October 31, 2022, or the year ended July 31, 2022.
The carrying values of cash, prepaid expenses, accounts payable and accrued wages approximate their fair value due to their short maturities.
No changes were made to our valuation techniques during the quarter ended October 31, 2022.
Contingent Liabilities
At October 31, 2022 and July 31, 2022, we had contingent consideration related to the acquisition of intellectual property, know-how and patents for an anti-choking, life-saving medical device in fiscal 2019. According to the agreement, we will make a one-time cash payment totaling $250,000 upon FDA clearance of the device. The fair value of the contingent consideration is reviewed quarterly and determined based on the current status of the project (Level 3). We determined the value was zero at both periods since it is not yet probable that we will file for FDA clearance.
We also had contingent consideration at October 31, 2022 and July 31, 2022 related to milestones in our Asset Purchase Agreement with Prevacus, Inc. The fair value of the contingent consideration is reviewed quarterly and determined based on the current status of the project (Level 3). Based on these reviews, the fair value of the contingent consideration was determined to be zero at both periods as it is not yet probable that any of the milestones will be met.
Fixed-Rate Debt
We have fixed-rate debt that is reported on our consolidated balance sheets at carrying value less unamortized debt discount and closing costs. The fair value of our fixed-rate debt was calculated using a discounted cash flow methodology with estimated current interest rates based on similar risk profile and duration (Level 2). The carrying value, excluding unamortized debt discount and debt issuance costs, and the fair value of our fixed-rate long-term debt were as follows:
| October 31, 2022 | July 31, 2022 | |||||||
| Carrying value | $ | $ | ||||||
| Fair value | $ | $ | ||||||
| 9 |
Note 5. Debt
Promissory Note
On September 21, 2022, we entered into a promissory
note for $
LGH Investments, LLC
On September 29, 2022, we entered into Amendment No.
3 to the Convertible Promissory Note to the Securities Purchase Agreement dated April 5, 2021, with LGH Investments, LLC. Pursuant to
the Amendment, the parties have agreed to extend the maturity date of the note to December 31, 2022. As consideration, $
Directors and Officers Promissory Note Amendments
On September 30, 2022, we entered into five Promissory Note Amendments, to the Promissory Notes entered into December 21, 2021 and December 22, 2021 and as amended April 20, 2022, and June 3, 2022, with three directors and two officers. Pursuant to the Amendments, the parties have agreed to extend the maturity date of the Promissory Notes to December 31, 2022. All other terms and conditions remain the same.
Notes Payable
The following notes payable were outstanding:
| October 31, 2022 | July 31, 2022 | |||||||
| Convertible note issued to LGH due December 31, 2022 with a flat interest rate of 8.0% of the original principal of $1,050,000 and convertible at $0.20 per share | $ | $ | ||||||
| Promissory notes issued to officers and directors due December 31, 2022 with a fixed interest rate of 8.0% per annum (see Note 10) | ||||||||
| Promissory note with an interest rate of 8% per annum due December 31, 2022 | ||||||||
| Tysadco convertible promissory note payable due March 1, 2022 with a flat interest rate of 8.0% of the original principal of $250,000 and convertible at $0.30 per share | ||||||||
| Unamortized debt discount and closing costs | ( | ) | ( | ) | ||||
| $ | $ | |||||||
2021 Omnibus Stock Incentive Plan
At October 31, 2022, shares of our common stock were reserved for issuance pursuant to the 2021 Plan and shares remained available for future awards.
Stock Options
Stock option activity during the quarter ended October 31, 2022 was as follows:
Number of Options | Weighted Average Exercise Price | |||||||
| Options outstanding at July 31, 2022 | $ | |||||||
| Options granted | ||||||||
| Options expired or cancelled | ( | ) | ||||||
| Options outstanding at October 31, 2022 | ||||||||
| 10 |
Criteria used for determining the Black-Scholes value of options granted were as follows:
| October 31, 2022 | ||||
| Expected stock price volatility | % - % | |||
| Risk free interest rate | % - % | |||
| Expected life of options (years) | – | |||
| Expected dividend yield | ||||
Restricted Stock Units (“RSUs”)
RSU activity during the quarter ended October 31, 2022 was as follows:
| RSUs outstanding at July 31, 2022 | ||||
| RSUs vested | ( | ) | ||
| RSUs outstanding at October 31, 2022 | ||||
Warrants
There was warrant activity during the quarter ended October 31, 2022.
Unrecognized Compensation Costs
At October 31, 2022, we had unrecognized stock-based compensation of $, which will be recognized as a component of general and administrative expenses over the weighted average remaining vesting period of years.
Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Potentially dilutive common stock and common stock equivalents, including stock options, RSUs and warrants are excluded as they would be antidilutive.
The following anti-dilutive securities were excluded from the calculations of diluted net loss per share:
| Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Options to purchase common stock | ||||||||
| Shares issuable upon conversion of convertible notes and related accrued interest | ||||||||
| Warrants to purchase common stock | ||||||||
| Restricted stock units | ||||||||
| Total potentially dilutive securities | ||||||||
Note 8. Research and Development Rebate
In the first quarter of fiscal 2023, we incurred $
| 11 |
Note 9. Common Stock
Common Stock for Services
In September and October 2022, in connection with
entering into consulting agreements, we issued consultants restricted shares of our common stock valued at an average price
of $ per share for a total value of $
Returned Shares
In September and October 2022, two shareholders returned at total of common stock shares valued at $ to treasury and all rights, title and interest in the shares were relinquished.
Lincoln Park
Lincoln Park Capital Fund, LLC (“LPC”)
purchased shares at an average price of $ per share for total proceeds to us of $
Note 10. Related Party Transactions
Due to Officers
The following amounts were due to officers for reimbursement of expenses and were included in accounts payable within the accompanying consolidated balance sheets:
| October 31, 2022 | July 31, 2022 | |||||||
| Joseph M. Redmond, CEO | $ | $ | ||||||
| Christine Farrell, CFO | ||||||||
| $ | $ | |||||||
The amount of unpaid salary and bonus due to our officers was included in accrued wages within the accompanying consolidated balance sheets and was as follows:
| October 31, 2022 | July 31, 2022 | |||||||
| Joseph M. Redmond, CEO | $ | $ | ||||||
| Christine Farrell, CFO | ||||||||
| $ | $ | |||||||
Promissory Notes
In December 2021, we entered into a total of five
promissory notes with three of our directors and two officers. Mr. Joseph Michael Redmond, President and Chief Executive Officer, Ms.
Christine M. Farrell, Chief Financial Officer, Mr. Jerome H. Casey, Director, Mr. John P. Gandolfo, Director, and Mr. Ricky W. Richardson,
Director, each loaned us $
| 12 |
Note 11. Subsequent Events
Hiring of Executive Officers of Subsidiary Odyssey NeuroPharma, Inc.
On November 1, 2022, Odyssey NeuroPharma, Inc., a wholly-owned subsidiary of Odyssey Health, Inc. entered into employment agreements with Mr. Erik Emerson and Mr. Gregory Gironda (the “Executives”). The Executives entered into employment agreements for a one year term as Chief Commercial Officer and Chief Operations Officer, respectively. During the employment term, and subject to raising funds, we will pay the Executives a minimum annual base salary of $125,000, which will not begin to be payable until such time that we have raised a cumulative of $5,000,000 in funding. Each Executive was granted 600,000 shares of our common stock, with vesting based upon milestones.
LPC Draws
Subsequent to October 31, 2022 and through December 14, 2022, we sold an additional 1,100,000 shares of our common stock to LPC for total proceeds $200,320. As of December 14, 2022, LPC had purchased a total of 5,982,518 shares of our common stock for total proceeds of $2,461,296 and the remaining purchase availability was $7,788,704 and the remaining shares available were 13,288,846.
LGH Note Payable Conversion
On November 10, 2022, LGH provided notice to convert $300,000 of their outstanding convertible note into 1,500,000 shares of our common stock at $0.20 per share. Subsequent to the conversion, $995,000 remained outstanding on the convertible note.
Research and Development Rebate
On November 18, 2022, we received a research and development rebate from the government of Australia in the amount of $313,709 for clinical work performed in Australia related to our Phase I human clinical trial during the fiscal year ended July 31, 2022.
On December 8, 2022, we received a goods and service tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount of $82,705 related to our Phase I human clinical trial during July, August and September 2022.
Prevacus Option Agreement
On November 21, 2022, we entered into an Option to Purchase Intellectual Property Agreement (the “Option Agreement”) with Prevacus, Inc. Subject to the terms and conditions of the Option Agreement, Prevacus granted us the right to purchase 100% of the intellectual assets at any time within 180 days of the effective date. We have the option to purchase and acquire from Prevacus, free and clear of all encumbrances, 100% of Prevacus’ right, title, and interest in the worldwide and USPTO Patents to PRV-001 and one Enantiomer. If we choose to exercise the option on either of the assets, we will complete the purchase within 90 days of exercising the option. As consideration, we issued Prevacus 1,000,000 shares of our common stock at $0.17 per share for a total value of $170,000 which will be expensed as a component research and development expense in the quarter ending January 31, 2023.
Mast Hill Fund L.P.
On December 13, 2022, we entered into a Securities Purchase Agreement (the “SPA”) with Mast Hill Fund, L.P. (“Mast Hill”). Pursuant to the SPA, we sold Mast Hill (i) an $870,000 face value, one-year, 10% per annum Promissory Note convertible into shares of our common stock at $0.12 per share, (ii) a five-year share purchase warrant entitling Mast Hill to acquire 2,000,000 shares of our common stock at $0.20 per share (the “Warrant”), and (iii) a five-year warrant for 4,000,000 shares of our common stock at $0.20 per share issuable in the event of default. Net proceeds after original discount, fees and expenses, was $723,868.
| 13 |
| 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, 2022 (“2022 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 plan to develop 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 effort as we move closer to regulatory approvals. 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
Mast Hill Fund L.P.
On December 13, 2022, we entered into a Securities Purchase Agreement (the “SPA”) with Mast Hill Fund, L.P. (“Mast Hill”). Pursuant to the SPA, we sold Mast Hill (i) an $870,000 face value, one-year, 10% per annum Promissory Note convertible into shares of our common stock at $0.12 per share, (ii) a five-year share purchase warrant entitling Mast Hill to acquire 2,000,000 shares of our common stock at $0.20 per share (the “Warrant”), and (iii) a five-year warrant for 4,000,000 shares of our common stock at $0.20 per share issuable in the event of default. Net proceeds after original discount, fees and expenses, was $723,868.
| 14 |
LPC Purchase Agreement Draws
During the three months ended October 31, 2022, LPC purchased a total of 1,133,591 shares of our common stock for total proceeds of $240,710 pursuant to the August 14, 2020, LPC Purchase Agreement. Subsequent to October 31, 2022, LPC purchased an additional 1,100,000 shares for total proceeds of $200,320 and, as of December 14, 2022, LPC had purchased a total of 5,982,518 shares of our common stock for total proceeds of $2,461,296 and the remaining purchase availability was $7,788,704 and the remaining shares available were 13,288,846.
Promissory Note
On September 21, 2022, we entered into a promissory note for $30,000 with a consultant for investor relations services with an interest rate of 8% per annum and a due date of December 31, 2022.
Going Concern
We did not recognize any revenues for the year ended July 31, 2022, or the three months ended October 31, 2022, and we had an accumulated deficit of $56,327,534 as of October 31, 2022. For the foreseeable future, we expect to experience continuing operating losses and negative cash flows from operations. Cash available at October 31, 2022, of $50,499 may not provide enough working capital to meet our current operating expenses through December 14, 2023.
The operating deficit indicates substantial doubt about our ability to continue as a going concern. 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 the additional financing on a timely basis, we may be required to further scale down or perhaps even cease operations.
The issuance of additional equity securities could result in a significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, would increase our liabilities and future cash commitments. Our financial statements do not include adjustments that might result from the outcome of this uncertainty.
If we are unable to raise additional capital by December 14, 2023, we will adjust our 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. 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 the timing of our clinical trial in Australia. 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, 2022, 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, 2022, which was filed with the SEC on October 31, 2022.
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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, 2022 or 2021. 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, | $ | % | ||||||||||||||
| 2022 | 2021 | Change | Change | |||||||||||||
| Research and development expense | $ | 354,215 | $ | 322,504 | $ | 31,711 | 9.8% | |||||||||
| General and administrative expense | 1,723,589 | 1,106,884 | 616,705 | 55.7% | ||||||||||||
| Loss from operations | (2,077,804 | ) | (1,429,388 | ) | 648,416 | 45.3% | ||||||||||
| Interest expense | (71,302 | ) | (216,886 | ) | 145,584 | (67.1 | )% | |||||||||
| Other expense, net | (474 | ) | – | 474 | NM | |||||||||||
| Net loss | $ | (2,149,580 | ) | $ | (1,646,274 | ) | $ | 503,306 | 30.6% | |||||||
| Basic and diluted net loss per share | $ | (0.03 | ) | $ | (0.02 | ) | $ | 0.01 | (42.3 | ) | ||||||
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.
Three months ended October 31, 2022 compared to three months ended October 31, 2021 | ||||
| Increase (decrease) in: | ||||
| Consultants | $ | (73,700 | ) | |
| Drug development | (252,632 | ) | ||
| Phase I clinical trial | 423,943 | |||
| Australian research and development rebate | 46,812 | |||
| Prototype phase | (114,612 | ) | ||
| Regulatory | 1,900 | |||
| $ | 31,711 | |||
The decreases in drug development, consultants and prototype phase were the result of the completion of the development of the concussion drug in the fourth quarter of fiscal 2022. The increase in Phase I clinical trial relates to our concussion drug device trial.
General and Administrative Expense
Our general and administrative expense includes 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 changes in General and administrative expense were due to the following:
| Three months ended October 31, 2022 compared to three months ended October 31, 2021 | ||||
| Increase (decrease) in: | ||||
| Board and stock expense | $ | 81,980 | ||
| Business development and investor relations | 533,523 | |||
| Consulting fees | 4,899 | |||
| Financing fees | (30,113 | ) | ||
| Insurance expense | 8,395 | |||
| Legal and professional fees | 17,578 | |||
| Wages | 6,160 | |||
| Other | (5,717 | ) | ||
| $ | 616,705 | |||
The increase in board and stock expense and business development and investor relations was due to the granting of stock and stock options to the board, officers, employees and consultants.
Interest Expense
Interest expense includes interest on debt outstanding, as well as the amortization of unamortized beneficial conversion feature, debt issuance costs and debt closing costs. Certain information regarding debt outstanding was as follows:
| Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Weighted average debt outstanding | $ | 1,633,043 | $ | 1,221,196 | ||||
| Weighted average interest rate | 6.75% | 8.0% | ||||||
The increase in the weighted average debt outstanding was due to the addition of principal to both the LGH and Tysadco notes in exchange for extending the maturity date of the notes. In addition, we issued a $30,000 promissory note during the first quarter of fiscal 2023.
The decrease in the weighted average interest rate was due to the extension of maturity dates on the LGH and Tysadco notes that have flat interest rates.
Net Loss
Net loss increased in the three-month period ended October 31, 2022 compared to the same period of 2021 primarily due to increased stock-based compensation.
Liquidity and Capital Resources
See Recent Funding above for a discussion of our recent debt and equity financings.
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The following table sets forth the primary sources and uses of cash:
| Three Months Ended October 31, | ||||||||
| 2022 | 2021 | |||||||
| Net cash used in operating activities | $ | (284,707 | ) | $ | (1,165,210 | ) | ||
| Net cash used in investing activities | (8,038 | ) | – | |||||
| Net cash provided by financing activities | 270,710 | 1,079,766 | ||||||
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, 2022 | July 31, 2022 | |||||||
| Convertible note issued to LGH due December 31, 2022 with a flat interest rate of 8.0% of the original principal of $1,050,000 and convertible at $0.20 per share | $ | 1,295,000 | $ | 1,180,000 | ||||
| Promissory notes issued to officers and directors due December 31, 2022 with a fixed interest rate of 8.0% per annum (see Note 10) | 125,000 | 125,000 | ||||||
| Promissory note with an interest rate of 8% per annum due December 31, 2022 | 30,000 | – | ||||||
| Tysadco convertible promissory note payable due March 1, 2022 with a flat interest rate of 8.0% of the original principal of $250,000 and convertible at $0.30 per share | 275,000 | 275,000 | ||||||
| 1,725,000 | 1,580,000 | |||||||
| Unamortized debt discount and closing costs | (95,009 | ) | (48,063 | ) | ||||
| $ | 1,629,991 | $ | 1,531,937 | |||||
Australian Research and Development Rebate
In the first quarter of fiscal 2023, we incurred $663,436 of expenses related to our Phase I clinical trial of our concussion drug device combination that are eligible for the Australian research and development rebate for a rebate due of $322,671, which was recorded as an offset to research and development expense during the quarter ended October 31, 2022.
On November 18, 2022, we received a research and development rebate from the government of Australia in the amount of $313,709 for clinical work performed in Australia related to our Phase I human clinical trial during the fiscal year ended July 31, 2022.
On December 8, 2022, we received a goods and service tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount of $82,705 related to our Phase I human clinical trial during July, August and September 2022.
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.
| Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Management, with the participation of the Company’s Chief Executive Officer and Chief Accounting Officer, evaluated the effectiveness of our disclosure controls and procedures as of October 31, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Based on the evaluation of our disclosure controls and procedures as of October 31, 2021, our Chief Executive Officer and Chief Accounting Officer concluded that, as of such date, as a result of the material weaknesses in internal control over financial reporting that are described below in Management's Report on Internal Control Over Financial Reporting, our disclosure controls and procedures were not effective.
As previously reported in our Annual Report on Form 10-K for the fiscal year ended July 31, 2022 management identified the following material weaknesses in internal control over financial reporting:
Insufficient Resources: We have an inadequate number of personnel with requisite expertise in the key functional areas of finance and accounting.
Inadequate Segregation of Duties: We have an inadequate number of personnel to properly implement control procedures.
We are committed to improving the internal controls and will (1) continue to use third party specialists to address shortfalls in staffing and to assist us with accounting and finance responsibilities, (2) increase the frequency of independent reconciliations of significant accounts, which will mitigate the lack of segregation of duties until there are sufficient personnel, and (3) may consider appointing additional outside directors and audit committee members in the future.
In light of the material weakness described above, prior to the filing of this Form 10-Q for the period ended October 31, 2022, management determined that key quarterly controls were performed timely and also performed additional procedures, including validating the completeness and accuracy of the underlying data used to support the amounts reported in the quarterly financial statements. These control activities and additional procedures have allowed us to conclude that, notwithstanding the material weaknesses, the financial statements in this Form 10-Q fairly present, in all material respects, our financial position, results of operations, and cash flows for the periods presented in conformity with United States GAAP.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
| Item 1. | Legal Proceedings |
We are not currently a party to any legal proceedings.
| Item 1A. | Risk Factors |
There have been no material changes during the three-month period ended October 31, 2022 to the risk factors discussed in our Annual Report on Form 10-K for the year ended July 31, 2022. If any of the identified risks actually occur, our business, financial condition and results of operations could suffer. The trading price of our common stock could decline and you may lose all or part of your investment in our common stock. The risks and uncertainties described in our Annual Report on Form 10-K for the year ended July 31, 2022 are not the only ones we face. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business operations.
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
None.
| Item 3. | Defaults Upon Senior Securities |
Not applicable.
| Item 4. | Mine Safety Disclosures |
Not applicable.
| Item 5. | Other Information |
None.
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| Item 6. | Exhibits |
The following exhibits are filed herewith and this list constitutes the exhibit index.
| Exhibit Number | Exhibit Description | |
| 10.1 | Employment Agreement by and between Odyssey Group International, Inc. and Erik Emerson, dated November 1, 2022 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 4, 2022). | |
| 10.2 | Employment Agreement by and between Odyssey Group International, Inc. and Gregory W. Gironda, dated November 1, 2022 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on November 4, 2022). | |
| 10.3 | Option to Purchase Intellectual Property Agreement by and between Prevacus, Inc. and Odyssey Health, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 23, 2022). | |
| 10.4 | Securities Purchase Agreement, dated December 13, 2022, by and between Odyssey Health, Inc. and Mast Hill Fund, L.P. | |
| 10.5 | Promissory Note issued to Mast Hill Fund, L.P. on December 13, 2022 | |
| 10.6 | First Warrant issued to Mast Hill Fund, L.P. on December 13, 2022 | |
| 10.7 | Second Warrant issued to Mast Hill Fund, L.P. on December 13, 2022 | |
| 31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 | |
| 31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 | |
| 32.1 | Certification of Chief Executive Officer pursuant to Section 1350 | |
| 32.2 | Certification of Chief Financial Officer pursuant to Section 1350 | |
| 101.INS | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted in iXBRL, and included in exhibit 101). |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized, as of December 14, 2022.
| ODYSSEY HEALTH, INC. | ||
| By: | /s/ Joseph Michael Redmond | |
| Joseph Michael Redmond | ||
| Chief Executive Officer, President and Director | ||
| (Principal Executive Officer) | ||
| By: | /s/ Christine M. Farrell | |
| Christine M. Farrell | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
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