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If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations.
+Added: The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors.
We have incurred significant losses, and we may never achieve profitability.
It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
+Added: Servicing our existing and future debt, including the Lind Notes, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness.
The diagnostics market is highly competitive and subject to rapid technological change;
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If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business.
−Removed: Our business is dependent on our ability to successfully develop and commercialize diagnostic products.
−Removed: If we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations.
+Added: Our business is dependent not only on our ability to successfully develop and commercialize diagnostic products but also the ability of our licensing partners.
+Added: If we/they fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations.
Failure to successfully develop, manufacture, market, and sell our future products will have a material adverse effect on our business, financial condition, and results of operations.
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We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage third party providers for such services, could have a material adverse effect on our business.
−Removed: We rely on third parties to manufacture and supply our intended products.
+Added: We rely on third parties to clinically validate, manufacture and supply our intended products.
Any problems experienced by these third parties could result in a delay or interruption in the supply of our intended products to our customers, which could have a material negative effect on our business.
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We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate.
−Removed: If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
+Added: If we fail to regain compliance with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
+Added: Lind has conversion rights under each of the Lind Notes, the exercise of which could result in the issuance of a substantial amount of our common stock at a significant discount to the trading price of our common stock.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
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adverse changes in the healthcare industry (human and canine).
+Added: Servicing our existing and future debt, including the Lind Notes, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness.
+Added: On May 20, 2025, we issued a secured convertible note to Lind Global Asset Management XII LLC, a Delaware limited liability company (“Lind”), which has a principal amount of $7,500,000 (the “2025 Lind Note”) and an accompanying common stock purchase warrant.
+Added: On January 15, 2026, we issued an additional secured convertible note to Lind which has a principal amount of $2,400,000 (the “2026 Lind Note”) and an accompanying common stock purchase warrant.
+Added: The 2025 Lind Note and the 2026 Lind Note are collectively referred to as the “Lind Notes”.
+Added: Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, including the Lind Notes (which Notes permit us to elect to use shares of common stock for repayments in lieu of cash under certain circumstances), depends on our future performance, which is subject to economic, financial, competitive, and other factors beyond our control.
+Added: We may not generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures.
+Added: If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt, or obtaining additional debt financing or equity capital on terms that may be onerous or highly dilutive.
+Added: Our ability to refinance any future indebtedness will depend on the capital markets and our financial condition at such time.
+Added: We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.
+Added: In addition, the Amended and Restated Securities Purchase Agreement, dated January 7, 2026, by and between the Company and Lind (the “Lind Securities Purchase Agreement”), and the Lind Notes contain, and any of our future debt agreements may contain, restrictive covenants that may prohibit us from adopting any of these alternatives.
+Added: Our failure to comply with these covenants could result in an event of default which, if not cured or waived, could result in the acceleration of our debt.
The diagnostics market is highly competitive and subject to rapid technological change;
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These activities require significant capital commitments and investment.
−Removed: There can be no assurance that our intended products or proprietary technologies will remain competitive following the introduction of new products and technologies by competing companies within the industry.
+Added: There can be no assurance that our intended products or proprietary technologies will remain competitive following the introduction of new products and technologies by competing companies within the industry, including competitors’ use of artificial intelligence (“AI”).
+Added: AI is increasingly being used across the diagnostics market, including by our competitors, which presents risks to our competitive position.
Furthermore, there can be no assurance that our competitors will not develop products that render our future products obsolete or that are more effective, accurate or can be produced at lower costs.
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Our competitors include large multinational corporations and their operating units, including Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, Roche Diagnostics, Cytovale Inc.
−Removed: and Immunexpress Inc., and from companies such as One Health Company (Fidocure) focused on the veterinary space.
+Added: and Immunexpress Inc., and from companies such as One Health Company (Fidocure) and focused on the veterinary space.
There may also be other companies developing products competitive with ours of which we are unaware.
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If the market for our future products does not develop sufficiently or the products are not accepted, our revenue potential will be harmed.
−Removed: Our business is dependent on our ability to successfully develop and commercialize diagnostic products.
−Removed: If we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations.
+Added: Our business is dependent not only on our ability to successfully develop and commercialize diagnostic products but also the ability of our licensing partners.
+Added: If we/they fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations.
Our current business strategy focuses on discovering, developing and commercializing diagnostic products.
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However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise, which could have a material adverse impact on our business.
−Removed: We rely on third parties to manufacture and supply our intended products.
+Added: We rely on third parties to clinically validate manufacture and supply our intended products.
Any problems experienced by these third parties could result in a delay or interruption in the supply of our intended products to our customers, which could have a material negative effect on our business.
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Our test is also available in Japan through Fujifilm Vet Systems Co.
−Removed: Ltd, a leading provider of veterinary testing services in Japan.
+Added: Ltd, a leading provider veterinary testing services in Japan.
We are subject to a number of risks associated with reliance upon these parties and other third-party distributors, including the following:
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Our failure to obtain necessary regulatory clearances or approvals on a timely basis would significantly impair our ability to distribute and market our future products on the clinical IVD market.
−Removed: We are subject to regulation by the FDA in the United States, the CE in Europe, the CFDA in China, and other regulatory bodies in other countries where we intend to sell our future products.
−Removed: Before we are able to place our intended products in the clinical IVD markets in the United States, China and Europe, we will be required to obtain clearance or approval of our future products from the FDA and the CFDA with respect to the United States and China, respectively, and receive a CE mark with respect to Europe.
+Added: We are subject to regulation by the FDA in the United States, the CE in Europe, the NMPA in China, and other regulatory bodies in other countries where we intend to sell our future products.
+Added: Before we are able to place our intended products in the clinical IVD markets in the United States, China and Europe, we will be required to obtain clearance or approval of our future products from the FDA and the NMPA with respect to the United States and China, respectively, and receive a CE mark with respect to Europe.
In Europe, since May 2022, IVD medical devices are regulated by the new EU IVDR.
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Investors should consider our independent registered public accountant’s comments when deciding whether to invest in the Company.
−Removed: If we fail to comply with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
+Added: If we fail to regain compliance with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
Our common stock is listed on the NYSE American.
The continued listing of our common stock on the NYSE American is subject to our continued compliance with certain listing requirements, including requirements related to corporate governance, our financial condition and operating results, the trading price of our common stock, number of stockholders and our market capitalization.
−Removed: If we fall out of compliance with the NYSE American’s listing standards and fail to regain compliance within the applicable cure periods, our common stock may be delisted from the NYSE American.
+Added: On February 6, 2026, we received a notice of non-compliance from the NYSE American stating that we are not in compliance with continued listing standards of Section 1003(a)(i), Section 1003(a)(ii), and Section 1003(a)(iii).
+Added: To regain compliance, the Company submitted a plan (the “Plan”) advising of actions it has taken or will take to regain compliance with the continued listing standards by August 6, 2027.
+Added: If the NYSE American determines to accept the Plan, the Company will be notified in writing and will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan.
+Added: If the NYSE American rejects the Plan, or accepts the Plan but we fail to regain compliance within the applicable cure periods, our common stock would be subject to delisting from the NYSE American.
The delisting of our common stock could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock.
In addition, delisting could harm our ability to raise capital on terms acceptable to us, or at all, reduce the amount of analyst coverage of our securities, result in the loss of confidence by investors and employees, and could lead to fewer business development opportunities, any of which could adversely affect our business.
+Added: Lind has conversion rights under each of the Lind Notes, the exercise of which could result in the issuance of a substantial amount of our common stock at a significant discount to the trading price of our common stock.
+Added: The 2025 Lind Note and the 2026 Lind Note are convertible at Lind’s option into shares of our common stock at an initial conversion price of $0.72 per share and $0.5714 per share, respectively, subject to any adjustments set forth in the Lind Notes.
+Added: However, upon the occurrence of an Event of Default (as defined in the Lind Notes), the Company will be obligated to pay Lind an amount equal to either 110% or 120% of the then-outstanding principal amount of the applicable Lind Note depending on the nature of the Event of Default, and Lind may declare such Lind Note due and payable, in addition to any other remedies under the Transaction Documents (as defined in the Lind Securities Purchase Agreement).
+Added: Additionally, upon the occurrence of an Event of Default or an event which with the passage of time may result in an Event of Default, Lind may convert all or a portion of the outstanding principal amount of the applicable Lind Note at the lower of (i) the then-current Conversion Price (as defined in the Lind Notes) and (ii) ninety-percent (90%) of the average of the three (3) lowest daily VWAPs during the twenty (20) trading days prior to the delivery of the notice of conversion, which could significantly dilute our stockholders.
+Added: If we experience an Event of Default under either of the Lind Notes, we may experience a material adverse effect on our liquidity, financial condition, and results of operations.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
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Our corporate governance documents, certain corporate laws applicable to us, and share ownership by executive officers and directors, could make a takeover attempt, which may be beneficial to our stockholders, more difficult.
−Removed: Our board of directors has the power, under our charter documents to:
+Added: Our board of directors has the power, under our corporate governance documents to:
issue additional shares of common stock without having to obtain stockholder approval for such action;
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Future sales of our common stock could depress the market price of our common stock.
+Added: In addition to shares of common stock issuable upon conversion and repayment of the Lind Notes, as of February 28, 2026 we also had outstanding warrants to purchase up to an aggregate of 62,137,692 shares of common stock at varying exercise prices.
Sales of a substantial number of shares of our common stock in the public market or the perception that large sales of our shares could occur, could cause the market price of our common stock to decline or limit our future ability to raise capital through an offering of equity securities.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.