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Risks Related to Our Business and Business Strategy
−Removed: We have incurred significant losses, and we may never achieve profitability.
We may need to raise additional capital in the future.
If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations.
+Added: 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.
35 unchanged sentences
We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate.
+Added: 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.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
4 unchanged sentences
If equity research analysts do not publish research or reports about our business, or if they do publish such reports but issue unfavorable commentary or downgrade our common stock, the price and trading volume of our common stock could decline.
−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.
We are a smaller reporting company and a non-accelerated filer, and we cannot be certain if the reduced disclosure requirements applicable to our filing status, as well as the exemption from the requirement to provide an auditor’s attestation report regarding the effectiveness of our internal controls, will make our common stock less attractive to investors.
Risks Related to Our Business and Business Strategy
−Removed: We have incurred significant losses, and we may never achieve profitability.
−Removed: We are a clinical stage company and have incurred losses since our formation.
−Removed: As of December 31, 2023, we have an accumulated total deficit of approximately $202.6 million.
−Removed: As we continue the discovery and development of our future diagnostic products, we expect our expenses to increase significantly.
−Removed: Even as we begin to market and sell our intended products, we expect our losses to continue as a result of ongoing research and development expenses, as well as increased manufacturing, sales and marketing expenses.
−Removed: These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets and stockholders’ equity.
−Removed: Because of the numerous risks and uncertainties associated with our product development and commercialization efforts, we are unable to predict when or if we will become profitable.
−Removed: Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: If we are unable to achieve and then maintain profitability, our business, financial condition and results of operations will be negatively affected, and the market value of our common stock will decline.
We may need to raise additional capital in the future.
8 unchanged sentences
If we are unable to obtain financing on terms favorable to us, we may be unable to execute our plan of operations and we may be required to cease or reduce development or commercialization of any future products, sell some or all of our technology or assets or merge with another entity.
+Added: We have incurred significant losses, and we may never achieve profitability.
+Added: We are a clinical stage company and have incurred losses since our formation.
+Added: As of December 31, 2024, we have an accumulated total deficit of approximately $229.5 million.
+Added: As we continue the discovery and development of our future diagnostic products, we expect our expenses to increase significantly.
+Added: Even as we begin to market and sell our intended products, we expect our losses to continue as a result of ongoing research and development expenses, as well as increased manufacturing, sales and marketing expenses.
+Added: These losses, among other things, have had and will continue to have an adverse effect on our working capital, total assets and stockholders’ deficit.
+Added: Because of the numerous risks and uncertainties associated with our product development and commercialization efforts, we are unable to predict when or if we will become profitable.
+Added: Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
+Added: If we are unable to achieve and then maintain profitability, our business, financial condition and results of operations will be negatively affected, and the market value of our common stock will decline.
It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
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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 PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.
+Added: and Immunexpress Inc., and from companies such as One Health Company (Fidocure) 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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The invasion of Ukraine and the retaliatory measures that have been taken, and could be taken in future, by the U.S., NATO, and other countries have created global security concerns that could result in a regional conflict and otherwise have a lasting impact on regional and global economies, any or all of which could adversely affect our business.
+Added: Separately, proposals to implement new tariffs or other trade restrictions in the U.S.
+Added: could impact the products we import into the U.S.
+Added: and also result in retaliatory measures in international markets where we sell our products.
+Added: Although we cannot predict whether and in what form such measures will be adopted or implemented, these proposals for tariffs or other trade restrictions could increase our cost of goods sold and negatively impact our business and operating results.
+Added: Supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could also negatively impact our cost of materials and production processes.
We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
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As an organization we have limited experience with direct sales however we are building a team of experienced individuals in terms of market intelligence, product management and account management in addition to building relationships with market-leading established distributors as commercial partners.
−Removed: For example, Heska has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians worldwide at the point of care pursuant to our exclusive global supply and licensing agreement.
+Added: For example, Antech has commenced sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians worldwide at the point of care pursuant to our exclusive global supply and licensing agreement.
We have also engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
−Removed: Although we are investing in direct marketing to support these commercial launches, we may rely on third party resources such as Heska’s global network of veterinarians and IDEXX’s reference laboratory network to successfully market this test and generate revenue.
+Added: Although we are investing in direct marketing to support these commercial launches, we may rely on third party resources such as Antech’s global network of veterinarians and IDEXX’s reference laboratory network to successfully market this test and generate revenue.
Any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third-party providers for such services, could have a material adverse effect on our business.
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We depend, and expect to continue to depend, on third-party distributors to market, sell, and service our products in our intended markets.
−Removed: For example, Heska has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians at the point of care and we engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
−Removed: Further, we have engaged with others including DNAtech, Portugal, and, through our agreement with Heska, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe.
+Added: For example, Antech has commenced pre-order sales of our Nu.Q ® Vet Cancer Test for screening of cancer in canines to veterinarians at the point of care and we engaged IDEXX to make our Nu.Q ® Vet Cancer Test available to reference laboratories in the United States.
+Added: Further, we have engaged with others including DNAtech, Portugal, and, through our agreement with Antech, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe.
In November 2023, we launched the Nu.Q ® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories.
+Added: Our test is also available in Japan through Fujifilm Vet Systems Co.
+Added: Ltd, a leading provider of 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 success depends, in large part, on our ability to protect proprietary methods, discoveries and technologies that we develop under the patents and intellectual property laws of the United States, Europe and other countries, so that we can seek to prevent others from unlawfully using our inventions and proprietary information.
−Removed: Our patent portfolio includes 50 patent families (plus two in-licensed families) and a total 79 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 19 patents granted in Europe and a further 48 patents granted worldwide.
+Added: Our patent portfolio includes 52 patent families (plus three in-licensed families) and a total 75 patents granted related to our diagnostic tests (including veterinary applications), with 13 patents granted in the United States, 20 patents granted in Europe and a further 42 patents granted worldwide.
Additionally, we have 128 patent applications pending, worldwide.
65 unchanged sentences
Investors should consider our independent registered public accountant’s comments when deciding whether to invest in the Company.
+Added: 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: Our common stock is listed on the NYSE American.
+Added: 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.
+Added: 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: 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.
+Added: 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.
Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
25 unchanged sentences
If any of these analysts ceases coverage of us, we could lose visibility in the market, which in turn could cause our common stock price or trading volume to decline and our common stock to be less liquid.
−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.
−Removed: Our common stock is listed on the NYSE American.
−Removed: 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.
−Removed: 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.
−Removed: 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.
We are a smaller reporting company and a non-accelerated filer and we cannot be certain if the reduced disclosure requirements applicable to our filing status, as well as the exemption from the requirement to provide an auditor’s attestation report regarding the effectiveness of our internal controls, will make our common stock less attractive to investors.
5 unchanged sentences
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.