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Odyssey Health, Inc.

For the period ended Jul 31, 2026. Filed Oct 28, 2026.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2026 · Filed Oct 28, 2026

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What changed in Risk Factors?

Read the current filing

Previous report: 10-K

Period ended 2025-07-31; filed 2025-10-29.

0001683168-25-007842

Item 1A. Risk Factors

Current report: 10-K

Period ended 2026-07-31; filed 2026-10-28.

0001683168-26-008124

Item 1A. Risk Factors

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 179 previous paragraphs and 185 current paragraphs.

158 unchanged; 13 reworded; 14 added; 6 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 10 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (14)

Current report

We have substantial convertible note obligations maturing on January 31, 2027 that we do not have the funds to repay, and the waivers we have received from our principal noteholder are limited.

Current report

As of July 31, 2026, we had $4,876,282 in aggregate principal amount of convertible notes outstanding, plus accrued interest, of which $3,835,282 was owed to Mast Hill Fund, L.P. (“Mast Hill”). Our note issued to Mast Hill in August 2025 matured on August 27, 2026 and was not repaid. In addition, we have not reserved the number of shares of common stock required under our notes with Mast Hill (the “Reserved Amount”), and we do not have sufficient authorized shares to do so. Each of these constituted an event of default.

Current report

On October 23, 2026, we entered into a Global Amendment with Mast Hill (the “Global Amendment”) covering all four of our promissory notes held by Mast Hill, including each tranche funded under the Master Note. Under the Global Amendment, (i) the maturity date of each of the notes was extended to January 31, 2027; (ii) Mast Hill agreed to a one-time waiver of any event of default under Section 3.1 or Section 3.2 of the notes that occurred on or before October 23, 2026, which includes our nonpayment of the August 2025 note at maturity and our failure to maintain the Reserved Amount; and (iii) Mast Hill agreed to a one-time waiver of any event of default under Section 3.2 of the notes that may occur from October 23, 2026 through January 31, 2027 as a result of our failure to satisfy the Reserved Amount.

Current report

The waivers are limited to the events of default described above. They do not apply to any other event of default under the notes, to any payment default occurring after October 23, 2026, including a failure to repay the notes at their extended maturity date, or to any failure to maintain the Reserved Amount after January 31, 2027. We do not currently have sufficient funds to repay the Mast Hill notes at January 31, 2027, and unless we obtain additional financing, further extend the maturity date, increase our authorized shares, or otherwise restructure these obligations before that date, we expect to be in default.

Current report

Upon an event of default that is not waived, our noteholders may declare all amounts immediately due and payable, apply default interest and increased default amounts (which, under certain of the Mast Hill notes, include a default amount equal to 150% of outstanding principal and accrued interest and default interest at 16% per annum), terminate the Maintenance Agreement, and pursue collection and other remedies available under the notes and related agreements. If our noteholders accelerate our indebtedness or enforce their rights, we may be forced to seek protection under the U.S. Bankruptcy Code, and our stockholders could lose their entire investment.

Current report

We may pursue a restructuring of our indebtedness or seek relief under the U.S. Bankruptcy Code, either of which could result in substantial dilution to our existing stockholder’s or the loss of their entire investment.

Current report

We are evaluating alternatives to address our indebtedness, including potential exchanges of outstanding notes for equity securities, extensions of maturity dates, and settlements with creditors. Any restructuring would likely involve the issuance of a substantial number of shares of common stock or securities convertible into common stock, which would significantly dilute existing stockholders, and may include the issuance of preferred stock with rights and preferences senior to our common stock. There can be no assurance that our creditors will agree to any restructuring. If we are unable to restructure our obligations, we may file, or our creditors may file against us, a petition under the U.S. Bankruptcy Code. In a liquidation under Chapter 7, our assets would be distributed to creditors in accordance with applicable priority rules, and our common stock would likely become worthless. In a reorganization under Chapter 11, holders of our common stock would likely receive little or no recovery and could lose their entire investment.

Current report

Our common stock no longer trades on the OTCQB and is now quoted on the OTCID Basic Market, which may reduce liquidity and adversely affect our stock price. Our common stock could also be moved to a lower market tier or to the Expert Market.

Current report

Until September 30, 2026, our common stock was quoted on the OTCQB. On July 21, 2026, we received notice from OTC Markets Group that our common stock was not in compliance with the OTCQB minimum closing bid price requirement of $0.01 per share. To remain eligible for quotation on the OTCQB, our closing bid price needed to be $0.01 or higher for ten consecutive trading days by October 19, 2026. Because we did not expect to regain compliance by that date, we paid a fee of $8,040 to OTC Markets Group and transitioned our common stock to the OTCID Basic Market effective October 1, 2026.

Current report

The OTCID Basic Market is a lower market tier than the OTCQB. Quotation on the OTCID may reduce liquidity in our common stock, cause some broker-dealers to restrict or decline trading in it, limit our ability to raise capital, and adversely affect our stock price. To remain on the OTCID, we must continue to satisfy its eligibility requirements, including remaining current in our public disclosure. If we fail to do so, our common stock may be moved to the Pink Limited market or to the Expert Market, where quotations are not publicly available and investors may be unable to sell their shares. In addition, if we fail to remain current in our SEC periodic reports, the SEC could revoke the registration of our common stock under Section 12(j) of the Exchange Act.

Current report

Our variable-price convertible notes could cause substantial dilution and a decline in our stock price, and we do not have sufficient authorized shares to satisfy all potential conversions.

Current report

A majority of the aggregate principal amount of our convertible notes is convertible into shares of our common stock at a discount to the lowest trading prices of our common stock during specified periods preceding the applicable conversion. Asthe market price of our common stock declines, the number of shares issuable upon conversion increases. As of October 27, 2026, we had 110,218,663 shares of common stock outstanding and 500,000,000 shares authorized. Based on recent trading prices, the conversion of all outstanding notes and accrued interest would requirethe issuance of substantially more shares of common stock than are currently authorized and available for issuance. The resale of shares issued upon conversion could exert additional downward pressure on the market price of our common stock, which could further increase the number of shares issuable. Increasing our authorized shares would require stockholder approval, which we may not obtain in a timely manner or at all.

Current report

We may be unable to fund the cost of remaining an SEC reporting company, and we may cease filing reports or deregister our common stock.

Current report

Remaining an SEC reporting company requires us toincur significant expenses for audit and legal services and SEC filing obligations. We have limited cash and no committed source of additional financing. If we are unable to fund these costs, we may fail to file our periodic reports when due, or we may seek to terminate the registration of our common stock under the Exchange Act if we are eligible to do so. If we cease filing reports, investors would have access to substantially less information about us, our common stock would likely be moved to the Expert Market, our stockholders may be unable to rely on Rule 144 to resell their shares, and our failure to file could constitute an event of default under our convertible notes.
Removed paragraphs (6)

Previous report

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 (“IRB”), for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the 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 organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, with respect to the foregoing, such as an inadequate demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

Previous report

We currently do not maintain product liability insurance as we do not have marketed products. At the time we require it, we may be unable to maintain sufficient product liability insurance.

Previous report

We may incur product liability for products sold through our distribution chain. Consumers may sue if products sold through our distribution chain or purchased through our websites are defective or injure the user. This type of claim could require us to spend significant time and money in litigation or to pay significant damages. At this time, we carry no product liability insurance. As a result, any legal claims, whether or not successful, could seriously damage our reputation and business.

Previous report

Our common stock may never be listed on a national exchange and is subject to being removed from the OTC Marketplace.

Previous report

Our common stock is quoted for trading on the OTCQB Marketplace. Should we fail to satisfy the fully reporting eligibility standards of OTC Markets, the trading price of our common stock could continue to suffer, and the trading market for our common stock may become less liquid and our common stock price may be subject to increased volatility.

Previous report

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. If any of the analysts who may cover us, adversely change their recommendation regarding our stock, or provide more favorable relative recommendations about our competitors, our stock price would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Reworded paragraphs (13)

Previous wording

We have been incurring operating losses and cash flow deficits since the inception of such operations. Our lack of operating history, and the lack of historical pro forma consolidated 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 consolidated financial 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.

Current wording

We have been incurring operating losses and cash flow deficits since the inception of such operations. Our lack of operating history, and the lack of historical pro forma consolidated financial information make 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 consolidated financial 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.

Previous wording

We have not generated any revenue or profit from operations since our inception. Based on our average monthly expenses and current burn rate, we estimate that our cash on hand will not be sufficient 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, 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.

Current wording

We have not generated any revenue or profit from operations since our inception. Based on our average monthly expenses and current burn rate, we estimate that our cash on hand will not be sufficient 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, 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 currently have no commitments for additional financing, and we have not identified any source of 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.

Previous wording

Our ability to raise additional financing depends on many factors beyond our control, including the state of capital markets, the market price of our common stock and the development or prospects for development of competitive products by others. Because our common stock is not listed on a major stock market, many investors may not be willing or allowed to purchase it or may demand steep discounts. If additional funds are raised through the issuance of equity, convertible debt or similar securities of our company, the percentage of ownership of our company by our company’s stockholders will be reduced, our company’s stockholders may experience additional dilution upon conversion, and such securities may have rights or preferences senior to those of our common stock. The preferential rights granted to the providers of such additional financing may include preferential rights to payments of dividends, super voting rights, a liquidation preference, protective provisions preventing certain corporate actions without the consent of the fund providers, or a combination thereof. We are unable to provide any assurance that additional financing will be available on terms favorable to us or at all.

Current wording

Our ability to raise additional financing depends on many factors beyond our control, including the state of capital markets, the market price of our common stock and the development or prospects for development of competitive products by others. Because our common stock is not listed on a major stock market, many investors may not be willing or allowed to purchase it or may demand steep discounts. If additional funds are raised through the issuance of equity, convertible debt or similar securities of our company, the percentage of ownership of our company by our company’s stockholders will be reduced, our company’s stockholders may experience additional dilution upon conversion, and such securities may have rights or preferences senior to those of our common stock. The preferential rights granted to the providers of such additional financing may include preferential rights to payments of dividends, supervoting rights, a liquidation preference, protective provisions preventing certain corporate actions without the consent of the fund providers, or a combination thereof. We are unable to provide any assurance that additional financing will be available on terms favorable to us or at all.

Previous wording

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, 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, 2025, our net loss allocable to common stockholders was $1,742,691, and we had an accumulated deficit of $62,745,837 at July 31, 2025. As of July 31, 2025, we had current liabilities of $7,004,421, current assets of $49,723, and a working capital deficit of $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 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 operat…

Excerpt shortened here; the source contains the full paragraph.

Current wording

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, 2026, 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, 2026, our net loss allocable to common stockholders was $5,729,693, and we had an accumulated deficit of $68,475,530 at July 31, 2026. As of July 31, 2026, we had current liabilities of $12,277,546, current assets of $147,859, and a working capital deficit of $12,129,687. 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 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 ope…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

Under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, substantial changes in a corporation’s ownership may limit the amount of net operating losses, or NOLs, that can be utilized annually in the future to offset the corporation’s (and the corporation’s affiliates’) U.S. federal and state taxable income. Specifically, this limitation may arise in the event of a cumulative change in ownership of more than 50% within any three-year period. The amount of the annual limitation is determined based on the value of the corporation that underwent the ownership change, immediately before the ownership change. Subsequent ownership changes may further affect any limitation in future years (including by way of exercising of warrants).

Current wording

Under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, substantial changes in a corporation’s ownership may limit the amount of net operating losses, or NOLs, that can be utilized annually in the future to offset the corporation’s (and the corporation’s affiliates’) U.S. federal and state taxable income. Specifically, this limitation may arise in the event of a cumulative change in ownership of more than 50% within any three-year period. The amount of the annual limitation is determined based on the value of the corporation that underwent the ownership change, immediately before the ownership change. Subsequent ownership changes may further affect any limitation in future years (including by way of exercising of warrants). Conversions of our convertible notes and any restructuring of our indebtedness, including exchanges of debt for equity, could cause an ownership change. In addition, any cancellation of indebtedness income arising from any restructuring would reduce our NOLs.

Previous wording

In addition to the penny stock rules promulgated 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 their customers’ ability to buy and sell our common stock and have an adverse effect on the market value for our shares of common stock.

Current wording

In addition to the penny stock rules promulgated by the SEC, 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 their customers’ ability to buy and sell our common stock and have an adverse effect on the market value for our shares of common stock.

Previous wording

A limited number of stockholders, including our founders and members of the Board of Directors and our management, currently own a significant portion of our outstanding common shares. Accordingly, these stockholders may, if they act together, exercise significant influence over all matters requiring stockholder approval, including the election of a majority of our directors and the determination of significant corporate actions. This concentration could also have the effect of delaying or preventing a change in control that could otherwise be beneficial to our stockholders.

Current wording

A limited number of stockholders, including members of the Board of Directors and our management, currently own a significant portion of our outstanding common shares. Accordingly, these stockholders may, if they act together, exercise significant influence over all matters requiring stockholder approval, including the election of a majority of our directors and the determination of significant corporate actions. This concentration could also have the effect of delaying or preventing a change in control that could otherwise be beneficial to our stockholders.

Previous wording

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; and as a result of any of these factors, the market price of our common stock at any given point in time 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 common stock. Any of these factors may materially adversely affect the prices of our common shares regardless of our operating performance.

Current wording

Our common stock is quoted on the OTC Markets. 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; and the size of our public float may limit the ability of some institutions to invest in our common stock. As a result of any of these factors, the market price of our common stock at any given point in time 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 common stock. Any of these factors may materially adversely affect the prices of our common shares regardless of our operating performance.

Previous wording

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

Current wording

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

Previous wording

We currently have a limited number of employees and resources available to perform the research and development necessary to commercialize our product candidates and potential future product candidates. We therefore rely, and will continue to rely, on third-party research institutions, collaborators and consultants for this capability.

Current wording

We currently have a limited number of employees and resources available to perform the research and development necessary to commercialize our product candidates and potential future product candidates. We therefore rely, and will continue to rely, on third-party clinical research organizations, collaborators and consultants for this capability.

Previous wording

We currently have very few employees and we may either build internal capabilities or rely on distributors to sell our products, if cleared or approved. We cannot assure you that we will succeed in building an internal team or entering into and maintaining productive arrangements with an adequate number of distributors that are sufficiently committed to selling our products, if cleared or approved. The establishment of a distribution network is expensive and time consuming. As we launch new products and increase our marketing effort with respect to existing products, we will need to continue to hire, train, retain and motivate skilled resources with significant technical knowledge. In addition, the commissions we pay for product sales could increase over time, which would result in higher sales and marketing expenses. Furthermore, if we were to rely on distributors, the current and potential distributors may market and sell the products of our competitors. Even if the distributors market and sell our products, our competitors may be able, by offering higher commission payments or other incentives, to persuade these distributors to reduce or terminate their sales and marketing efforts related to our products. The distributors may also help competitors solicit business from our existing customers. Some of our independent distributors may likely account for a significant portion of our sales volume, and, if we were to lose them, our sales could be adversely affected. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expect them to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products.

Current wording

We currently have a limited number of employees and we may either build internal capabilities or rely on distributors to sell our products, if cleared or approved. We cannot assure you that we will succeed in building an internal team or entering into and maintaining productive arrangements with an adequate number of distributors that are sufficiently committed to selling our products, if cleared or approved. The establishment of a distribution network is expensive and time consuming. As we launch new products and increase our marketing effort with respect to existing products, we will need to continue to hire, train, retain and motivate skilled resources with significant technical knowledge. In addition, the commissions we pay for product sales could increase over time, which would result in higher sales and marketing expenses. Furthermore, if we were to rely on distributors, the current and potential distributors may market and sell the products of our competitors. Even if the distributors market and sell our products, our competitors may be able, by offering higher commission payments or other incentives, to persuade these distributors to reduce or terminate their sales and marketing efforts related to our products. The distributors may also help competitors solicit business from our existing customers. Some of our independent distributors may likely account for a significant portion of our sales volume, and, if we were to lose them, our sales could be adversely affected. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expect them to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products.

Previous wording

Additionally, our commercial success will also depend, in part, on not infringing on the patents or proprietary rights of others. There can be no assurance that the technologies and products used or developed by us will not infringe such rights. If such infringement occurs and we are not able to obtain a license from the relevant third party, we will not be able to continue the development, manufacture, use, or sale of any such infringing technology or product. There can be no assurance that necessary licenses to third-party technology will be available at all or on commercially reasonable terms. In some cases, litigation or other proceedings may be necessary to defend against or assert claims of infringement or to determine the scope and validity of the proprietary rights of third parties. Any potential litigation could result in substantial costs to, and diversion of, our resources and could have a material and adverse impact on us.

Current wording

We, as well as our directors and officers, may be subject to claims or lawsuits. These lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources. If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease portions of our business practices or product lines. Any of these outcomes could cause our business, financial performance and cash position to be negatively impacted. Additionally, our commercial success will also depend, in part, on not infringing on the patents or proprietary rights of others. There can be no assurance that the technologies and products used or developed by us will not infringe such rights. If such infringement occurs and we are not able to obtain a license from the relevant third party, we will not be able to continue the development, manufacture, use, or sale of any such infringing technology or product. There can be no assurance that necessary licenses to third-party technology will be available at all or on commercially reasonable terms. In some cases, litigation or other proceedings may be necessary to defend against or assert claims of infringement or to determine the scope and validity of the proprietary rights of third parties. Any potential litigation could result in substantial costs to, and diversion of, our resources and could have a material and adverse impact on us. An adverse outcome in any such litigation or proceeding could subject us to significant liabilities, require us to cease using the subject technology or require us to license the subject technology from the third party, all of which could have a material adverse effect on our business.

Previous wording

If we are unable to obtain a reimbursement code from the U.S. Department of Health and Human Services so that our devices or drugs, following receipt of marketing authorization are covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect on our business, financial condition and operating results.

Current wording

If we are unable to obtain a reimbursement code from the U.S. Department of Health and Human Services so that our devices, following receipt of marketing authorization are covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect on our business, financial condition and operating results.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

We, as well as our directors and officers, may be subject to claims or lawsuits. These lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources. If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease portions of our business practices or product lines. Any of these outcomes could cause our business, financial performance and cash position to be negatively impacted.

Previous report — wording carried elsewhere

An adverse outcome in any such litigation or proceeding could subject us to significant liabilities, require us to cease using the subject technology or require us to license the subject technology from the third party, all of which could have a material adverse effect on our business.