ODYY 10-K & 10-Q changes, risk factors and insider trading

We have been incurring operating losses and cash flow flow deficits since the inception of such operations. Our lack of operating history, and the lack of historical pro forma combinedconsolidated financial financial information, makes it difficult for investors to evaluate our prospects for success. Prospective investors should consider the risks and difficulties we might encounter, especially given our lack of an operating history or historical pro forma combinedconsolidated financial information. information. There is no assurance that we will be successful, and the likelihood of success must be considered in light of our relatively early stage of operations. As we have not begun to generate revenue, it is extremely difficult to make accurate predictions and forecasts of our finances. There is no guarantee that our products or services will be attractive to potential consumers.

We have not generated any revenue or profit from operations operations since our inception. Based on our average monthly expenses and current burn rate, we estimate that our cash on hand will not be ablesufficient to support our operations through the balance of this calendar year. This amount could increase if we encounter difficulties that we cannot anticipate at this time or if we acquire other businesses. Should this amount not be sufficient to support our continuing operations, operations, we do not expect to be able to raise any additional capital through debt financing from traditional lending sources since we are not currently generating a profit from operations. Therefore, we only expect to raise money through equity financing via the sale of our common stock or equity-linked securities such as convertible debt. We are currently in discussions with a number of institutional and private investors who could provide the capital required for our ongoing operations. If we cannot raise the money that we need in order to continue to operate our business beyond the period indicated above, we will be forced to delay, scale back or eliminate some or all of our proposed operations. If any of these were to occur, there is a substantial risk that our business would fail. If we are unsuccessful in raising additional financing, we may need to curtail, discontinue, or cease operations.

If adequate funds are not available or are not available available on acceptable terms, our ability to fund our expansion,expansion and take advantage of potential opportunities, would be limited significantly. We We will also scale back or delay implementation of research and development of new products. Thus, the unavailability of capital could substantially substantially harm our business, results of operations and financial condition.

Our independent registered public accounting firm has issued its audit opinion on our consolidated financial statements appearing in our Annual Report on Form 10-K for the fiscal year ended July 31, 2024, 2025, including an explanatory paragraph as to substantial doubt with respect to our ability to continue as a going concern. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. For the fiscal year ended July 31, 2024,2025, our net loss allocable to common stockholders was $905,771, $1,742,691, and we had an accumulated deficit of $61,003,146$62,745,837 at July 31, 2024.2025. As of July 31, 2024,2025, we had current liabilities of $5,919,895, $7,004,421, current assets of $56,943,$49,723, and a working capital deficit of $5,862,952.$6,954,698. These factors raise substantial doubt about our ability to continue as a going concern which is dependent on our ability to raise the required additional capital or debt financing to meet short-short and long-term operating requirements. We may also encounter business endeavors that require significant cash commitments or unanticipated problems or expenses that could result in a need for additional cash. Our ability to continue as a going concern is dependent upon raising capital from financing transactions. To stay in business, we will need to raise additional capital through public or private sales of our securities or debt financing. In the past, we have financed our operations by issuing secured and unsecured convertible debt and equity securities in private placements, in some cases with equity incentives for the investor in the form of warrants to purchase our common stock, and we have borrowed from related parties. We have sought, and will continue to seek, various sources of financing. If we raise additional funds through the issuance of equity or convertible debt securities, the percentage ownership of our current stockholders could be reduced, and such securities might have rights, preferences, or privileges senior to our common stock. Additional financing may not be available upon acceptable terms, or available at all. If adequate funds are not available on acceptable terms, we may not be able to take advantage of prospective business endeavors or opportunities, which could significantly and materially restrict our operations. If we are unable to obtain necessary capital, we may have to cease operations. There are no additional commitments from anyone to provide us with financing. We can provide no assurance as to whether our capital raising efforts will be successful or as to when, or if, we will be profitable in the future. Even if we achieve profitability, we may not be able to sustain such profitability. If we are unable to obtain financing or achieve and sustain profitability, we may have to suspend operations or sell assets, making us unable to execute our business plan. Failure to become and remain profitable may adversely affect the market price of our common stock and our ability to raise capital and continue operations. For additional information, see Management’s Discussion and Analysis of Financial Condition and Results of Operations – “Going Concern.”

Raising additional capital by issuing securities or through debt financings or licensing arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidatecandidates on terms unfavorable to us.

To the extent that we raise additional capital through through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital capital expenditures or declaring dividends. If we raise additional funds through strategic partnerships with third parties, we may have to relinquish valuable rights to our technologies or product candidate,candidates, future revenue streams, or research programs or product candidate,programs, or otherwise grant grant licenses on terms that are not favorable to us. If we are unable to raise additional capital when needed, we may be required to delay, delay, limit, reduce or terminate our product development or commercialization efforts for our product candidatecandidates or our preclinical product candidates, or grant rights to develop and market potential future product candidates that we would otherwise prefer to develop and market ourselves. Any of these events could adversely affect our ability to achieve our product development and commercialization goals and have a material adverse effect on our business, financial condition and results of operations.

Our revenue and income potential are unproven, andunproven. the business model of Odyssey is new. Our new business model is based on a variety of assumptions based on a growing trend in the healthcare systems in the United States and many other countries, where we are seeing a movement towards preventative medicine that is directly decreasing general healthcare costs.

The CardioMap®,CardioMap, through its screening and predictive values, is a tool, that if approved or cleared, might be implemented in this preventative approach. Considering heart disease-caused deaths are still the number one cause of death and one of the most important healthcare costs factors, the CardioMap® device has potential value value in any medical practice. If approved or cleared for marketing, it could be an ideal device, allowing insurance companies to potentially cut costs through early diagnostic and preventative care. These assumptions may not reflect the current business and market conditions we actuallyconditions. face. As a result, our operating results could differ materially from those projected under our business model, and our business model may prove to be unprofitable. There is no guarantee that the device will be approved or cleared for commercial use.

The Save-a- Life®Save-A-Life choking rescue device is in the the development stage and has not been approved or cleared for commercial use. Further development is required, and the final product will will require FDA approval or clearance. There is no guarantee that the device will be approved or cleared for commercial use.

We currently have no products authorized for commercial distribution in either the United States, Europe or any other country. We are developing the devices and pharmaceutical drugs which require regulatory clearance or approvals,approvals. weWe cannot begin marketing and selling our product candidates until we obtain applicable authorizations from the respective regulatory agency. The process of obtaining regulatory authorization is expensive and time-consuming and can vary substantially based upon, among other things, the type, complexity and novelty of a product candidate. Changes in regulatory policy, changes in, or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application may cause delays in the authorization of a product candidate or rejection of a regulatory application altogether.

We face significant competition in an environment of rapid technological change, and our competitors may develop products that are more advanced or more effective than ours ,ours, which may adversely affect our financial condition and our ability to successfully market our products.

Our competitors in the industry are predominantly large companies with longer operating histories,histories than us, along with significantly easier access to capital and other resources and an established product pipeline than us.pipeline. There can be no assurance that we will be able to establish ourselves in our target markets, or, if established, that that we will be able to maintain our market position, if any. Our commercial opportunity may be reduced if our competitors develop new or improved products that are more convenient, more effective or less expensive than our product candidates are. Competitors also may obtain FDA or other regulatory marketing authorization for their products more rapidly or earlier than we may obtain marketing authorization for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

We are, and will continue to be, significantly dependent, in-part, on outside scientists and third-party research institutions for our research and development in order to be able to commercialize commercialize our product candidates.

We may not be able to protect our trade names and domain names against all infringers, which could decrease the value of our brand name and proprietary rights. We currently hold the Internet domain name Odyssey Health, Inc. Domain names are generally regulated by Internet regulatory bodies, are subject to change, and, in some cases, may be superseded, in some cases by by-laws,bylaws, rules and regulations governing the registration of trade names and trademarks with the United States Patent and Trademark Office as well as other common law rights. If the domain registrars are changed, if new ones are created, or if we are deemed to be infringing upon another’s trade name or trademark, we may be unable to prevent third parties from acquiring or using, as the case may be, our domain name, trade names or trademarks, which could adversely affect our brand name and other proprietary rights.

For our pharmaceutical product candidates, we are required to submit an Investigational New Drug Application, or IND, the contents of which are subject to discussions with the FDA and include, among other things, results of preclinical studies and other testing, manufacturing information, proposed clinical trial protocols and a general investigational plan. We cannot begin any clinical trials in the United States until 30 days after the IND has been accepted by the FDA. Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with current Good Clinical Practices, or cGCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring the safety and the effectiveness of criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent Investigational Review Board,Board or IRB,(“IRB”), for each site proposing proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the clinical trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts experts organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check check points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or or other grounds, with respect to the foregoing, such as an inadequate demonstration of efficacy. There are also requirements governing the the reporting of ongoing clinical studies and clinical study results to public registries.

Since we may conduct clinical trials to obtain FDA FDA marketing authorization, we will need to rely heavily on third parties over the course of our clinical trials, and as a result will have have limited control over the clinical investigators and limited visibility into their day-to-day activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and the foregoing third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving our marketing applications or may subject them or us to regulatory enforcement actions. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the cGCP regulations. In addition, our clinical trials may be required to be conducted with a large number of test patients. Our failure or any failure by these third parties to comply with these regulations, or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory marketing authorization process. Moreover, our business may be implicated if any of these third parties violatesviolate federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting our clinical trials are are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other development activities, which could affect their performance on our behalf. If these third parties do not successfully carry carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed, or terminated and we may not be able to complete development of, obtain regulatory marketing authorization of or successfully commercialize our product candidate.candidates. As a result, our financial results and the commercial prospects for our product candidatecandidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

We are subject to governmental oversight and associated civil and criminal enforcement relating to advertising, promotion, and marketing, and such enforcement is evolving and intensifying. Communications regarding our products in development and regarding our clinical trials may subject us to enforcement if they do not comply with applicable laws and regulations. In the United States, we are potentially subject to enforcement from the FDA, other divisions of the Department of Health and Human Services, the U.S. Federal Trade Commission (the “FTC”),Commission, the Department of Justice, and state and local governments. Other parties, including private plaintiffs, are also commonly bringing suit against pharmaceutical and medical device companies. We may be subject to liability based on the actions of individual employees and third-party contractors carrying out activities on our behalf.

We currently are not an “accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended. Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”) requires us to include an internal control report with our Annual Report on Form 10-K. That report must include management’s assessment of the effectiveness of our internal control over financial reporting as of the end of the fiscal year. This report must also include disclosure of any material weaknesses in internal control over financial reporting that we have identified. As of July 31, 2024,2025, management assessed the effectiveness of our internal control over financial reporting based on SEC guidance on conducting such assessments and on the criteria for effective internal control over financial reporting established in Internal Control and Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Management concluded, during the year ended July 31, 2024,2025, that our internal controls and procedures were not effective to detect the inappropriate application of U.S.United States Generally Accepted Accounting Principles (“GAAP”) rules. Management realized there were deficiencies in the design or operation of our internal control that adversely affected our internal control, which management considers to be material weaknesses. A material weakness in the effectiveness of our internal control over financial reporting may increase the chance of fraud and the loss of customers, reduce our ability to obtain financing, and require additional expenditures to comply with these requirements. Any of these consequences could have a material adverse effect on our business, results of operations and financial condition. For additional information, see Item 9A – Controls and Procedures.

Our business strategy requires us to raise additional equity capital through the sale of common stock or preferred stock. Your percentage of ownership will become diluted as we issue new shares of stock. Stockholders have no rights to buy additional shares of stock in the event we issue new shares of stock, known as preemptive rights. We may issue common stock, convertible debt or common stock pursuant to a public offering or a private placement, upon exercise of warrants or options, or to sellers of properties we directly or indirectly acquire instead of, or in addition to, cash consideration. Investors purchasing common stock in this Offering who do not participate in any future stock issues will experience dilution in the percentage of the issued and outstanding stock they own.

Although our common stock is listed for quotation on the OTC Markets, under the symbol “ODYY,” the trading activity of our common stock is volatile and may not develop or be sustained. As a result, any trading price of our common stock may not be an accurate indicator of the valuation of our common stock. Any trading in our shares could have a significant effect on our stock price. If a more liquid public market for our common stock does not develop, then investors may not be able to resell the shares of our common stock that they have purchased and may lose all of their investment. No assurance can be given that an active market will develop or that a stockholder will ever be able to liquidate its shares of common stock without considerable delay, if at all. Many brokerage firms may not be willing to effect transactions in theour securities. Even if an investor finds a broker willing to affect a transaction in our securities, the combination of brokerage commissions, state transfer taxes, if any, and any other selling costs may exceed the selling price. Furthermore, our stock price may be impacted by factors that are unrelated or disproportionate to our operating performance. These market fluctuations, as well as general economic, political, and market conditions, such as recessions, interest rates, and international currency fluctuations, may adversely affect the market price and liquidity of our common stock.

In addition to the penny stock rules promulgated by by the SEC, as described above, FINRA rules (which would apply to our common stock in the event that our common stock ultimately becomes traded over the counter via the OTC Electronic Bulletin Board) require that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Under these FINRA rules, before recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. If these FINRA rules were to apply to our common stock, such application would make it more difficult for broker-dealers to recommend that their customers buy our common stock, which could limit thetheir customers’ ability to buy and sell our common stock and have an adverse effect on the market value for our shares of common stock.

Our common stock is listed on the OTCQB. Securities of microcap and small-cap companies have experienced substantial volatility in the past, often based on factors unrelated to the companies’ financial performance or prospects. We believe that trading in our stock has been and will likely continue to be subject to significant volatility. These factors include macroeconomic developments in North America and globally and market perceptions of the attractiveness of particular industries. Factors unrelated to our performance that may affect the price of our common stock include the following: the extent of analytical coverage available to investors concerning our business may be limited if investment banks with research capabilities do not follow us, a reduction in trading volume and general market interest in our common stock may affect an investor’s ability to trade significant numbers of shares of our common stock; the size of our public float may limit the ability of some institutions to invest in our common stock.stock; Asand as a result of any of these factors, the market price of our common stock at any given point in time may may not accurately reflect our long-term value. The price of our common shares may increase or decrease in response to a number of events and factors, including: changes in financial estimates; our acquisitions and financings; quarterly variations in our operating results; the operating and share price performance of other companies that investors may deem comparable; and the purchase or sale of blocks of our our common stock. Any of these factors,factors may materially adversely affect the prices of our common shares regardless of our operating performance.

Our business model is to develop or acquire unique medical relatedmedical-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 heart monitoring and screening device, and the Save a LifeSave-A-Life choking rescue device. To date, none of our product candidates have received regulatory regulatory clearance or approval for commercial sale.

See Note 1 of Notes to Consolidated Financial Statements.

We do not currently sell or market any products and and we did not have any revenue for the years ended July 31, 20242025 or 2023.2024. We will commence actively marketing products after the products and drugs in development have been FDA cleared or approved, buthowever, there can be no assurance, however,assurance that we will be successful in obtaining FDA clearance or approval for our products.

Our Research and development relatesexpense includes expenses related to our current projects andprojects, includes expenses forincluding, clinical research, design and manufacturing, formulation, regulatory and consultants.

In fiscal 2024, we earned a research and development rebate from the Australian government of $53,578 related to our Phase I clinical trial of our concussion drug device combination comparedwhich to $330,050 in fiscal 2023. These amounts werewas recorded as offsetsan offset to Research and development expense.

The decreasedecreases in wages and business development,development and investor relations and consulting fees was a result of decreased activities related to business development. Legal and professional fees decreasedwere due to lower expense in the second halfsalaries of fiscalexecutives 2024.and lower business activity. The decrease in wageslegal and professional fees was due to lower employeelegal headcountfees forincurred. theThe seconddecrease halfin ofstock-based 2024.compensation was due to no options granted in fiscal 2025 and fewer unvested awards outstanding. The decreases were offset by an increase in public company expense.

Gain on Sale of AssetProduct Candidates and Related Assets

The gain on sale of assetproduct candidates and related assets 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.

Impairment of Investment in Preferred Stock of Oragenics, Inc.

Impairment of investment in preferred stock of Oragenics, Inc. in fiscal 2024 relates to the revaluation to zero of the preferred stock of Oragenics held by us as an investment.investment to zero. See Notes 2 and 6 of Notes to Consolidated Financial Statements for additional information.

UnrealizedLoss lossesfrom on investmentchange in fiscalfair 2024value of Oragenics, Inc. common stock relates relatesto tothe value of the common stock of Oragenics that was held by us as an investment. All shares were sold during fiscal 2025. See Notes 2 and 6 of Notes to Consolidated Financial Statements for additional information.

Interest expense includes interest on debt outstanding, as well as the amortization of unamortizedbeneficial conversion feature, debt issuance costsdiscount and debt closingissuance costs. Certain information regarding debt outstanding outstanding was as follows:

The decrease in interest expense was due to lower weightedamortization averageof beneficial conversion feature, debt outstanding,discount and debt issuance costs, partially offset by a higher weighted average interest rate.rates.

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 usus, and any deterioration in the financial position of of lenders that might make them unable to meet their obligations to us. If these conditions continue and we cannot raise funds through a a public or private debt financing, or an equity offering, our ability to grow our business may be negatively affected. In such case, we we havewould suspendedsuspend research and development activities until market conditions improve.

Inflation did not have a material impact on our business business and results of operations during the periods being reported on.reported.

There have been no material changes during the nine six months ended JanuaryApril 31,30, 2026, to the risk factors discussed in our Annual Report on Form 10-K for the year ended July 31, 2025. 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, 2025, 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.

Other than as described in Note 1 of Notes to Condensed Condensed Consolidated Financial Statements, during the sixnine months ended JanuaryApril 31,30, 2026, 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, 2025, which was filed with the SEC on October 29, 2025.

We provide maintenance and and related services for a commercial facility pursuant to our Maintenance Agreement with Mast Hill Fund, L.P. beginning November 13, 2025 2025 and ending on the first business day of February 2034. In exchange, Mast Hill pays us service fees which currently total $245,000approximately $252,450 per year. We do not currently sell or market any products. The service fees are recorded as an offset to the Maintenance note principal and accrued interest. 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.

The changesnet decreases in General and administrative expense expense were due to the following:

The decrease in public company expense for the nine six months ended JanuaryApril 31,30, 2026 was due to lower securities filing activity. The increase in wages for the three months ended JanuaryApril 31,30, 2026 was due to full wages being paid to our officers. The decreaseincrease in wages for the sixnine months ended JanuaryApril 31,30, 2026,2026 was dueoffset toby a voluntary decrease in executive salaries.salaries in the first two quarters of Fiscal 2026. The decreases in stock-based compensation were due to no stock-based compensation in the three and sixnine months of fiscal 2026 due to no equity awards being granted and no unrecognized stock-based compensation. The decreasesincreases were offset by increases in business development and investor relations expense primarily related to our agreement with NeuRX Health, Inc. and associated investor relations outreach. See Note 3 of Notes to Condensed Consolidated Financial Statements.

Financing costs in the fiscal 2026 periodsincluded included the following:

Change in fair value of derivative liabilities in the fiscal Fiscal 2026 periods relates to the value of the variable conversion featurefeatures embedded in our August 27, 2025 SPA and November 13, 2025 2025 SPA with Mast Hill. See Notes 4 and 5 of Notes to Condensed Consolidated Financial Statements for additional information.

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,us and any deterioration in the financial position of of lenders that might make them unable to meet their obligations to us. If these conditions continue and we cannot raise funds through a a public or private debt financing, or an equity offering, our ability to grow our business may be negatively affected. In such case, we wehave would suspendsuspended research and development activities until market conditions improve.