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MAINZ BIOMED N.V.

MAINZ BIOMED N.V.MYNZ決算レポート

Nasdaq · ヘルスケア · 医薬製剤

Mainz Biomed N.V. is a molecular diagnostics company specializing in the development and commercialization of non-invasive early detection tests for gastrointestinal cancers, primarily colorectal cancer. Its flagship product ColoAlert is approved and available across European markets, with active expansion initiatives targeting North America and other global regions.

What changed in MAINZ BIOMED N.V.'s 20-F — 2023 vs 2024

Top changes in MAINZ BIOMED N.V.'s 2024 20-F

269 paragraphs added · 287 removed · 199 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

51 edited+14 added−5 removed154 unchanged
The value of our ordinary shares could decline due to the impact of any of the following factors upon the market price of our ordinary shares: ● sales or potential sales of substantial amounts of our ordinary shares; ● announcements about us or about our competitors; ● litigation and other developments relating to our intellectual property or other proprietary rights or those of our competitors; ● conditions in the diagnostic test industry; ● governmental regulation and legislation; ● variations in our anticipated or actual operating results; ● change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations; ● change in general economic trends; and ● investor perception of our industry or our prospects.
The value of our ordinary shares could decline due to the impact of any of the following factors upon the market price of our ordinary shares: ● sales or potential sales of substantial amounts of our ordinary shares; ● announcements about us or about our competitors; ● litigation and other developments relating to our intellectual property or other proprietary rights or those of our competitors; 12 ● conditions in the diagnostic test industry; ● governmental regulation and legislation; ● variations in our anticipated or actual operating results; ● change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations; ● change in general economic trends; and ● investor perception of our industry or our prospects.
Any judgment or settlement for personal injury or wrongful death claims could be more than our assets and, even if not justified, could prove expensive to contest. Although we maintain product and general liability insurance of the types and in the amounts that we believe are customary for the industry, we are not fully insured against all such potential claims.
Any judgment or settlement for personal injury or wrongful death claims could be more than our assets and, even if not justified, could prove expensive to contest. 6 Although we maintain product and general liability insurance of the types and in the amounts that we believe are customary for the industry, we are not fully insured against all such potential claims.
The imposition of new laws or regulations, including potential trade barriers, may increase our operating costs, impose restrictions on our operations or require us to spend additional funds to gain compliance with the new rules, if possible, which could have an adverse impact on our financial condition. Our business is subject to various complex laws and regulations.
The imposition of new laws or regulations, including potential trade barriers, may increase our operating costs, impose restrictions on our operations or require us to spend additional funds to gain compliance with the new rules, if possible, which could have an adverse impact on our financial condition. 9 Our business is subject to various complex laws and regulations.
We have primarily funded our operations through in common equity, debt, or preferred stock financing and intend to engage in such financings in the future. Your rights and the value of your investment in our securities could be reduced as a result of any such future financing. Interest on debt securities could increase costs and negatively impact operating results.
We have primarily funded our operations through sales of common equity, debt, or preferred stock financing and intend to engage in such financings in the future. Your rights and the value of your investment in our securities could be reduced as a result of any such future financing. Interest on debt securities could increase costs and negatively impact operating results.
Thus, FINRA requirements may make it more difficult for broker-dealers to recommend that their customers buy our ordinary shares, which may limit your ability to buy and sell our shares, have an adverse effect on the market for our shares and, thereby, depress their market prices. Volatility in our ordinary shares price may subject us to securities litigation.
Thus, FINRA requirements may make it more difficult for broker-dealers to recommend that their customers buy our ordinary shares, which may limit your ability to buy and sell our shares, have an adverse effect on the market for our shares and, thereby, depress their market prices. 13 Volatility in our ordinary shares price may subject us to securities litigation.
If our products do not achieve an adequate level of acceptance, we may not generate enough revenues to become profitable or profitability may occur much later. Competing tests for the initial diagnosis, reoccurrence diagnosis and optimal treatment of cancer are being manufactured and marketed by other companies.
If our products do not achieve an adequate level of acceptance, we may not generate enough revenues to become profitable or profitability may occur much later. 5 Competing tests for the initial diagnosis, reoccurrence diagnosis and optimal treatment of cancer are being manufactured and marketed by other companies.
A broad or active public trading market for our ordinary shares may not develop or be sustained. 9 You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares. In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our present shareholders.
A broad or active public trading market for our ordinary shares may not develop or be sustained. You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares. In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our present shareholders.
Although U.S. tax rules also permit a U.S. investor to make a “qualified electing fund” election with respect to the shares of a non-U.S. corporation that is a PFIC if the non-U.S. corporation provides certain information to its investors, we do not currently intend to provide the information that would be necessary for a U.S. investor to make a valid “qualified electing fund” election with respect to our ordinary shares. 11 Nasdaq maintains certain standards which Nasdaq requires listed companies meet for their respective securities to continue to be listed and traded on its exchange, and if we are unable to continue to meet such continued listing requirements, Nasdaq may choose to delist our ordinary shares from its exchange, which may adversely affect the liquidity and trading price of our ordinary shares.
Although U.S. tax rules also permit a U.S. investor to make a “qualified electing fund” election with respect to the shares of a non-U.S. corporation that is a PFIC if the non-U.S. corporation provides certain information to its investors, we do not currently intend to provide the information that would be necessary for a U.S. investor to make a valid “qualified electing fund” election with respect to our ordinary shares. 15 Nasdaq maintains certain standards which Nasdaq requires listed companies meet for their respective securities to continue to be listed and traded on its exchange, and if we are unable to continue to meet such continued listing requirements, Nasdaq may choose to delist our ordinary shares from its exchange, which may adversely affect the liquidity and trading price of our ordinary shares.
Our shareholders may not have access to certain information they may deem important and are accustomed to receiving from U.S. reporting companies. 10 We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.
Our shareholders may not have access to certain information they may deem important and are accustomed to receiving from U.S. reporting companies. We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.
If we are unable to raise additional capital through debt and equity financings, we could be forced to curtail or cease our operations, including in the near term. Terms of subsequent financings may adversely impact your investment.
If we are unable to raise additional capital through debt and equity financings, we could be forced to curtail or cease our operations, including in the near term. 1 Terms of subsequent financings may adversely impact your investment.
If we are delisted and are unable to have our ordinary share quoted on the OTCQB or “pink sheets” or similar bulletin board, our shareholders would not be able to resell their securities in a public market.
If we are delisted and are unable to have our ordinary share quoted on the OTCQB or “pink sheets” or similar bulletin board, our shareholders would not be able to resell their securities in a public market. 16
If these systems do not operate as we expect them to, we may be required to expend significant resources to make corrections or find alternative sources for performing these functions. 8 A significant cyber incident could impact production or laboratory capability, harm our reputation, cause us to breach our contracts with other parties or subject us to regulatory actions or litigation, any of which could materially affect our business, prospects, financial condition and operating results.
If these systems do not operate as we expect them to, we may be required to expend significant resources to make corrections or find alternative sources for performing these functions. 11 A significant cyber incident could impact production or laboratory capability, harm our reputation, cause us to breach our contracts with other parties or subject us to regulatory actions or litigation, any of which could materially affect our business, prospects, financial condition and operating results.
Given the volatility of exchange rates, we might not be able to effectively manage our currency transaction risks, and volatility in currency exchange rates might have a material adverse effect on our business, financial condition or results of operations. 3 Risks Related to Our Technology and Business Strategy We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.
Given the volatility of exchange rates, we might not be able to effectively manage our currency transaction risks, and volatility in currency exchange rates might have a material adverse effect on our business, financial condition or results of operations. 4 Risks Related to Our Technology and Business Strategy We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.
If we cannot convince general practitioners in Europe that our products are the superior choice, we cannot grow there as quickly as we need, if at all. 5 We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.
If we cannot convince general practitioners in Europe that our products are the superior choice, we cannot grow there as quickly as we need, if at all. 7 We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.
The future issuance of any such additional ordinary shares or other securities, including those underlying the warrants and options we have issued and granted, would dilute the voting power of our current stockholders, could dilute the net tangible book value per share at the time of such future issuance and may create downward pressure on the trading price of our ordinary shares.
The future issuance of any such additional ordinary shares or other securities, including those underlying the warrants and options we have issued and granted, would dilute the voting power of our current shareholders, could dilute the net tangible book value per share at the time of such future issuance and may create downward pressure on the trading price of our ordinary shares.
In addition, the auditor’s opinion accompanying our audited financial statements for the year ended December 31, 2023 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern as a result of recurring losses from operations and negative cash flows.
In addition, the auditor’s opinion accompanying our audited financial statements for the year ended December 31, 2024 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern as a result of recurring losses from operations and negative cash flows.
While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually based on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, our next determination will be made based on information as of June 30, 2023.
While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually based on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, our next determination will be made based on information as of June 30, 2025.
The commercial success and our ability to generate revenues depends on a variety of factors, including the following: ● patient acceptance of and demand for our tests; ● acceptance of our test in the medical community; ● successful sales, marketing, and educational programs; ● the amount and nature of competition from other colon cancer screening products and procedures; ● the ease of use of our ordering process for physicians; ● maintaining and defending intellectual property and trade secrets, and our ability to establish and maintain adequate commercial manufacturing, distribution, sales and laboratory testing capabilities; and ● The potential of being sued by competitors to avoid or delay market entry in certain geographic markets.
The commercial success and our ability to generate revenues depends on a variety of factors, including the following: ● regulatory approval for the use and sale of our test in new markets, particularly the United States; ● patient acceptance of and demand for our tests; ● acceptance of our test in the medical community; ● successful sales, marketing, and educational programs; ● the amount and nature of competition from other colon cancer screening products and procedures; ● the ease of use of our ordering process for physicians; ● maintaining and defending intellectual property and trade secrets, and our ability to establish and maintain adequate commercial manufacturing, distribution, sales and laboratory testing capabilities; and ● The potential of being sued by competitors to avoid or delay market entry in certain geographic markets.
If we intend to register securities for sale that are equal to more than one-third of our public float in any 12-month period, we would have to do so through a registration statement on Form F-1, and any such financing could require less favorable terms or have a lesser chance of success. 1 Our inability to manage growth could harm our business.
If we intend to register securities for sale that are equal to more than one-third of our public float in any 12-month period, we would have to do so through a registration statement on Form F-1, and any such financing could require less favorable terms or have a lesser chance of success.
Fluctuations in currency exchange rates may significantly impact our results of operations. A substantial percentage of our operations are conducted in Europe. As a result, we are exposed to an exchange rate risk between the U.S. and the Euro. The exchange rates between these currencies in recent years have fluctuated significantly and may continue to do so in the future.
A substantial percentage of our operations are conducted in Europe. As a result, we are exposed to an exchange rate risk between the U.S. and the Euro. The exchange rates between these currencies in recent years have fluctuated significantly and may continue to do so in the future.
Risks that we face in undertaking this expansion include: ● training new personnel; ● forecasting production and revenue; ● expanding our marketing efforts; ● controlling expenses and investments in anticipation of expanded operations; ● establishing and maintaining relationships with new customers and partners; ● implementing and enhancing administrative infrastructure, systems and processes; ● unforeseen delays in the development of new products; ● unforeseen delays in regulatory approvals; ● unforeseen test performance that we may experience performing FDA studies; and ● addressing new markets.
Risks that we face in undertaking this expansion include: ● training new personnel; ● forecasting production and revenue; ● expanding our marketing efforts; ● controlling expenses and investments in anticipation of expanded operations; ● establishing and maintaining relationships with new customers and partners; ● implementing and enhancing administrative infrastructure, systems and processes; ● unforeseen delays in the development of new products; ● unforeseen delays in regulatory approvals; ● unforeseen test performance that we may experience performing FDA studies; and ● addressing new markets. 2 We intend to continue to hire additional personnel.
We substantially depend upon our management. Our success depends largely on the skills, experience and performance of key members of our management who are critical to directing and managing our growth and development in the future.
Our success depends largely on the skills, experience and performance of key members of our management who are critical to directing and managing our growth and development in the future.
We intend to continue to hire additional personnel. Competition for individuals with relevant experience can be intense, and we may not be able to attract, assimilate, train or retain additional highly qualified personnel in the future. The failure to attract, integrate, train, motivate and retain these additional employees could seriously harm our business and prospects.
Competition for individuals with relevant experience can be intense, and we may not be able to attract, assimilate, train or retain additional highly qualified personnel in the future. The failure to attract, integrate, train, motivate and retain these additional employees could seriously harm our business and prospects. We substantially depend upon our management.
We believe that it is possible that when we analyze whether we are a foreign private issuer as of June 30, 2024 we will conclude that we are not. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly higher.
We anticipate that when we analyze whether we are a foreign private issuer as of June 30, 2025 we will conclude that we are not. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly higher.
Our products and product candidates may not be cleared or approved on a timely basis, if at all. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and filing a pre-market approval application (PMA) with the FDA. Similar review and approval processes may be applicable for corresponding foreign regulatory authorities.
Our products and product candidates may not be cleared or approved on a timely basis, if at all. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and filing a pre-market approval application (PMA) with the FDA.
We are an early-stage company. Since inception, we have incurred operating losses and negative cash flow, and we expect to continue to incur losses and negative cash flow in the future. Our net losses for the years ended December 31, 2023 and December 31, 2022 were approximately $26,295,727 and $26,387,336, respectively.
We are an early-stage company. Since inception, we have incurred operating losses and negative cash flow, and we expect to continue to incur losses and negative cash flow in the future. Our net losses for the years ended December 31, 2024 and December 31, 2023 were $21,650,663 and $26,295,727, respectively.
In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges (including the Nasdaq Capital Market) that are available to foreign private issuers such as the ones described above and exemptions from procedural requirements related to the solicitation of proxies.
In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges (including the Nasdaq Capital Market) that are available to foreign private issuers such as the ones described above and exemptions from procedural requirements related to the solicitation of proxies. 14 If we cease to be a foreign private issuer, we might consider whether to redomicile to a U.S jurisdiction.
If the intellectual property that is the subject of our patent application is not granted a patent or we are otherwise unsuccessful in obtaining or maintaining such intellectual property protection and our trade secrets and know-how are revealed to our competitors, they could use our intellectual property and create diagnostic tests that compete with our diagnostic tests, without paying license fees or royalties to us.
If the intellectual property that is the subject of our patent application is not granted a patent or we are otherwise unsuccessful in obtaining or maintaining such intellectual property protection and our trade secrets and know-how are revealed to our competitors, they could use our intellectual property and create diagnostic tests that compete with our diagnostic tests, without paying license fees or royalties to us. 8 Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
Global financial conditions continue to be subject to volatility arising from international geopolitical developments, such as the ongoing wars in Ukraine and the Middle East, and global economic phenomenon, as well as general financial market turbulence and natural phenomena, such as the COVID-19 pandemic.
Global financial conditions continue to be subject to volatility arising from international geopolitical developments, such as the ongoing wars in Ukraine and the Middle East, potential and global economic phenomenon (including uncertainty about tariffs and retaliatory responses thereto), general financial market turbulence and natural phenomena, such as the COVID-19 pandemic.
Generally, if a company falls afoul of a Nasdaq continued listing requirement, there is an automatic grace period to regain compliance and Nasdaq may, upon request, grant additional periods for the company to regain compliance.
If a company falls afoul of a Nasdaq continued listing requirement, it may be able to take advantage of an automatic grace period to regain compliance and Nasdaq may, upon request, grant additional periods for the company to regain compliance.
We have recurring losses, accumulated deficit totaling $69,328,021 and negative cash flows used in operating activities of $21,938,845 as of and for the year ended December 31, 2023, and we expect to continue to have recurring losses and negative cash flows in operating activities in the near future as we seek to gain regulatory approval for our principal product in certain jurisdictions.
We have recurring losses, accumulated deficit totaling $91.0 million and negative cash flows used in operating activities of $17.1 million as of and for the year ended December 31, 2024, and we expect to continue to have recurring losses and negative cash flows in operating activities in the near future as we seek to gain regulatory approval for our principal product in certain jurisdictions.
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information. We rely on trade secrets, know-how and technology, which are not protected by patents and do not have any patent applications pending (apart from our patent application related to the UdeS Biomarkers), to protect the intellectual property behind our diagnostic tests.
We rely on trade secrets, know-how and technology, which are not protected by patents and do not have any patent applications pending (apart from our patent application related to the UdeS Biomarkers), to protect the intellectual property behind our diagnostic tests.
The clinical performance of the ColoAlert test for the FDA study might not meet the current product performance. As a result, we may need to undertake additional studies or abandon the study altogether.
The clinical performance of the ColoAlert test for the FDA study might not meet the current product performance. As a result, we may need to undertake additional studies or abandon the study altogether. Additional studies would be costly and delay or prevent our rollout of ColoAlert in the United States.
We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.
Similar review and approval processes may be applicable for corresponding foreign regulatory authorities. 10 We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.
Ordinary shares which we sell could be sold into the public market for our ordinary shares which could adversely affect the market price of our ordinary shares.
If we sell additional ordinary shares, they could be sold into the public market at the time of issuance or thereafter which could adversely affect the market price of our ordinary shares.
As a result of recent and future policy changes, there may be greater restrictions and economic disincentives on international trade. Such changes have the potential to adversely impact the global and local economies, our industry and global demand for our products and, as a result, could have a material adverse effect on our business, financial condition and results of operations.
Such changes have the potential to adversely impact the global and local economies, our industry and global demand for our products and, as a result, could have a material adverse effect on our business, financial condition and results of operations. Fluctuations in currency exchange rates may significantly impact our results of operations.
To further promote our brand, we may be required to change our marketing practices, which could result in substantially increased advertising expenses, including the need to use traditional media such as television, radio and print.
To further promote our brand, we may be required to change our marketing practices, which could result in substantially increased advertising expenses, including the need to use traditional media such as television, radio and print. If we do not develop and maintain strong brands, our business, prospects, financial condition and operating results will be materially and adversely impacted.
If we or our partners, including independent sales representatives, fail to comply with these laws and regulations, we could incur significant fines and penalties and our reputation and prospects could suffer.
If we or our partners, including independent sales representatives, fail to comply with these laws and regulations, we could incur significant fines and penalties and our reputation and prospects could suffer. Additionally, our partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business.
You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and substantial portion of our directors and executive officers reside outside the United States.
If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate our research and development, regulatory, and commercial efforts which could adversely affect our future business prospects and our ability to continue as a going concern. 3 You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and substantial portion of our directors and executive officers reside outside the United States.
We expect to continue to add additional personnel in the areas of sales and marketing, research & development, laboratory operations, finance, quality assurance and compliance. As we build our commercialization efforts and expand research and development activities, our operating expenses and capital requirements have also increased, and we expect that they will continue to increase, significantly.
As we build our commercialization efforts and expand research and development activities, our operating expenses and capital requirements have increased, and we expect that they will continue to increase, significantly.
If we conclude the eAArly DETECT study and decide not to integrate the UdeS Biomarkers, we will have expended significant time and funds in connection with the acquisition and the study without improving our ColoAlert product. Product liability, warranty, personal injury, property damage and recall claims may materially affect our financial condition and damage our reputation.
If we conclude the eAArly DETECT v2 study and decide not to integrate the UdeS Biomarkers, we will have expended significant time and funds in connection with the acquisition and the study without improving our next generation product.
Additional studies would be costly and delay or prevent our rollout of ColoAlert in the United States. 6 Risks Related to Regulations Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violations of these requirements could harm our business.
Risks Related to Regulations Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violations of these requirements could harm our business.
We are authorized to issue an aggregate of 45,000,000 ordinary shares. As of March 26, 2024, we had 21,886,575 ordinary shares outstanding, approximately 45% of the ordinary shares that we are authorized to issue.
We are authorized to issue an aggregate of up to 20,250,000 ordinary shares. As of March 21, 2025, we had 3,038,853 ordinary shares outstanding, approximately 15% of the ordinary shares that we are authorized to issue.
In the future, we may cease to be compliant with Nasdaq’s continued listing requirement, and if that occurs we may not be able to regain compliance within the periods allotted to us.
In the future, we may cease to be compliant with Nasdaq’s continued listing requirement, and if that occurs we may not be able to regain compliance within the periods allotted to us, which periods may be reduced if we fail to comply with the minimum bid price requirement with twelve months of our recent reverse stock split, December 3, 2024.
Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.
We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests. Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.
Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud. 2 Our financial statements for the fiscal year ended December 31, 2023 include an explanatory paragraph from our auditor indicating that there is substantial doubt about our ability to continue as a going concern.
Our financial statements for the fiscal year ended December 31, 2024 include an explanatory paragraph from our auditor indicating that there is substantial doubt about our ability to continue as a going concern.
The public market for our ordinary shares has a limited history. Our ordinary shares began trading on the Nasdaq Capital Market on November 5, 2021, and since that date they have had a high closing price of $27.76 per share and a low closing price of $0.875 per share.
Our ordinary shares began trading on the Nasdaq Capital Market in November 2021, and since that date there has been volatility in the market price of our ordinary shares. For example, in the 2024 calendar year, the high closing price of our ordinary shares was $47.80 per share and the low closing price was $3.78 per share.
An appreciation of the Euro against the U.S. dollar could increase the relative cost of our products outside of Europe, which could lead to decreased sales.
For example, for 2024 the European Central Bank reported a low exchange rate of EUR1.00:US$1.0632 on April 22, 2024 and a high of EUR1.00:US$1.1196 on September 30, 2024. An appreciation of the Euro against the U.S. dollar could increase the relative cost of our products outside of Europe, which could lead to decreased sales.
On February 15, 2023 we acquired a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (the “UdeS Biomarkers”). We are in the process conducting an international multi-center clinical study in the United States and Europe (such study called “eAArly DETECT”) to assess the potential to integrate the UdeS Biomarkers into ColoAlert.
We are in the process conducting an international multi-center clinical study in the United States (such study called “eAArly DETECT v 2”) to assess the potential to integrate the UdeS Biomarkers into our next generation product.
As an “emerging growth company” under applicable law, we will be subject to lessened disclosure requirements. Such reduced disclosure may make our ordinary shares less attractive to investors.
Such reduced disclosure may make our ordinary shares less attractive to investors.
In addition as of March 26, 2024, we had 6,957,500 warrants exercisable into ordinary shares outstanding, 2,749,650 options exercisable into ordinary shares outstanding and $5,185,772 of convertible debt outstanding, which is convertible into 2,576,776 ordinary shares using the lowest permitted conversion price.
In addition as of March 21, 2024, we had 2,839,208 warrants exercisable into ordinary shares outstanding, 472,677 options exercisable into ordinary shares outstanding, and 401,000 prefunded warrants that are convertible into ordinary shares at $0.001.
Removed
We have added, and expect to continue to add, additional personnel in the area of research and development (where the approximate $4.6 million increase in our research and development expenses between our 2023 and 2022 fiscal years was primarily attributable to the increase in headcount in our employees working on research and development) and elsewhere in our company.
Added
We are not currently able to sell any securities through our shelf registration statement on Form F-3.
Removed
If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate our research and development, regulatory, and commercial efforts which could adversely affect our future business prospects and our ability to continue as a going concern.
Added
Our inability to manage growth could harm our business. The successful implementation of our strategies depends upon how we manage our growth. Failure to properly manage our growth could result in our requiring more funds and/or time to obtain our objectives, if ever obtained.
Removed
If we do not develop and maintain strong brands, our business, prospects, financial condition and operating results will be materially and adversely impacted. 4 We might decide not to incorporate the UdeS Biomarkers after we conclude additional studies on such biomarkers.
Added
For example, in 2024, we made the strategic decision to focus our sales effort on distributing our IVD kits to third-party laboratories in Europe and ceased our direct to consumer sales, and we could have utilized the resources we expended on direct consumer sales on distribution efforts to third-parties had we made this decision earlier.
Removed
Additionally, our partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business. 7 We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests.
Added
Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud.
Removed
As of March 26, 2024, the closing price of our common stock was $1.01, and we recently had a six-consecutive day trading day period where the minimum bid price was below $1.00 shortly followed by a 13-consecutive day trading day period where the minimum bid price was below $1.00.
Added
As a result of recent and future policy changes, there may be greater restrictions and economic disincentives on international trade. These could include tariffs of up to 25% on all goods coming from the European Union to the United States as discussed by the current U.S. administration.
Added
In addition to pursuing the development of our ColoAlert screening test, we are pursuing the research and development of a diagnostic test for pancreatic cancer, and such research and development efforts may divert resources from the development of ColoAlert. Such diversion of resources delay or prevent our ability to generate significant revenue from ColoAlert.
Added
We might decide not to incorporate biomarkers that we have acquired after we conclude additional studies on such biomarkers. On February 15, 2023 we acquired a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (the “UdeS Biomarkers”).
Added
Likewise, in March 2024, we acquired a license from Liquid Bioscience, Inc. to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. We have exclusive license to develop such a test using these biomarkers with the unilateral option to acquire them.
Added
If we research these biomarkers but ultimately decide not to incorporated them into a product candidate for a pancreatic cancer diagnostic test, we may expended significant resources without any financial return. Product liability, warranty, personal injury, property damage and recall claims may materially affect our financial condition and damage our reputation.
Added
Even if we do not face any judgments or settlements for personal injury or wrongful death claims, maintaining product and general liability insurance is significant expense. The cost of such insurance will increase if we are able to grow our business and offer our ColoAlert more broadly or offer new products.
Added
If we cease to be a foreign private issuer, we will assess whether it is more beneficial for corporate purposes to redomicile to a U.S. jurisdiction that to remain as a public company under Dutch law.
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Such a redomicile could entail significant cost and time for us to undertake, could affect certain rights that you have as a shareholder and could impose additional disclosure and compliance requirements from both the SEC and Nasdaq. As an “emerging growth company” under applicable law, we will be subject to lessened disclosure requirements.
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In 2024, we ceased to be in compliance with this minimum bid price requirement and only were able to regain compliance after enacting a 1:40 reverse stock split on December 3, 2024.
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However, such automatic grace period is not available to companies that have enacted a reverse stock split within the past twelve months in connection with a failure to maintain compliance with the minimum bid price requirement.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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According to a 2023 report from the American Cancer Society, patients in the United States diagnosed with CRC between 2012 and 2018 had approximate 5-year survival rates for colon and rectal cancer as set out below: Colon Cancer Rectal Cancer Localized 91 % 90 % Regional 72 % 74 % Distant 13 % 17 % According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer and the third leading cause of cancer death in men and women in the United States.
According to a 2023 report from the American Cancer Society, patients in the United States diagnosed with CRC between 2012 and 2018 had approximate 5-year survival rates for colon and rectal cancer as set out below: Colon Cancer Rectal Cancer Localized 91 % 90 % Regional 72 % 74 % Distant 13 % 17 % 17 According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer and the third leading cause of cancer death in men and women in the United States.
Exact Sciences is actively expanding its U.S. market share, strengthening healthcare provider relationships, and diversifying its oncology screening portfolio through strategic acquisitions. ● Freenome Holdings, Inc.: Aiming to enhance early cancer detection, Freenome Holdings is pioneering a blood-based CRC screening test that employs a multimodal data approach, with pivotal FDA study results and clearance anticipated in the next 12 months. ● Geneoscopy Inc.: Focusing on gastrointestinal health, Geneoscopy’s stool RNA test “ColoSense” has shown promising sensitivity and specificity rates in detecting CRC and advanced adenomas during clinical trials.
Exact Sciences is actively expanding its U.S. market share, strengthening healthcare provider relationships, and diversifying its oncology screening portfolio through strategic acquisitions. 29 ● Freenome Holdings, Inc.: Aiming to enhance early cancer detection, Freenome Holdings is pioneering a blood-based CRC screening test that employs a multimodal data approach, with pivotal FDA study results and clearance anticipated in the next 12 months. ● Geneoscopy Inc.: Focusing on gastrointestinal health, Geneoscopy’s stool RNA test “ColoSense” has shown promising sensitivity and specificity rates in detecting CRC and advanced adenomas during clinical trials.
We recognize the importance of catering to markets with a predisposition towards out-of-pocket payments for health services, which presents a favorable environment for ColoAlert’s integration and acceptance in the near term, while pursuing statutory reimbursement for our next generation product. Entry into the U.S.
We recognize the importance of catering to markets with a predisposition towards out-of-pocket payments for health services, which presents a favorable environment for ColoAlert’s integration and acceptance in the near term, while pursuing statutory reimbursement for our next generation product. 23 Entry into the U.S.
Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs, and do not contain identical safe harbors. 20 Self-Referral law.
Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs, and do not contain identical safe harbors. Self-Referral law.
Since the independent clinical study, we have updated the occult blood test component of ColoAlert to what we believe is a more accurate occult blood test in terms of sensitivity and specificity. We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50.
Since the independent clinical study, we have updated the occult blood test component of ColoAlert to what we believe is a more accurate occult blood test in terms of sensitivity and specificity. 18 We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50.
Organizational structure We have three wholly-owned subsidiaries, Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH), Mainz Biomed USA, Inc. and European Oncology Lab GmbH (which is a wholly owned subsidiary of Mainz Biomed Germany GmbH). 22 D. Property, plant and equipment Our principal premises are located at Robert Koch Strasse 50, Mainz, Germany.
Organizational structure We have three wholly-owned subsidiaries, Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH), Mainz Biomed USA, Inc. and European Oncology Lab GmbH (which is a wholly owned subsidiary of Mainz Biomed Germany GmbH). D. Property, plant and equipment Our principal premises are located at Robert Koch Strasse 50, Mainz, Germany.
The studies required in connection with our seeking FDA approval of our technologies will be costly and lengthy. FDA might not ultimately approve any PMA submitted by us in a timely manner or at all. Clinical Trials Clinical trials are usually required to achieve PMA approval.
The studies required in connection with our seeking FDA approval of our technologies will be costly and lengthy. FDA might not ultimately approve any PMA submitted by us in a timely manner or at all. 26 Clinical Trials Clinical trials are usually required to achieve PMA approval.
Each subject outcome was compared to the results from the ColoAlert® test incorporating the novel biomarkers. 14 Above is a typical process flow for the use of ColoAlert for Germany. Typical process flow: 1. The patient is informed about the risk of CRC. 2. The physician discusses with the patient the need for a CRC test. 3.
Each subject outcome was compared to the results from the ColoAlert® test incorporating the novel biomarkers. Above is a typical process flow for the use of ColoAlert for Germany. Typical process flow: 1. The patient is informed about the risk of CRC. 2. The physician discusses with the patient the need for a CRC test. 3.
As of the date of this annual report, no director, officer or affiliate is a party adverse to us in any legal proceeding or has an adverse interest to us in any legal proceeding. C.
As of the date of this annual report, no director, officer or affiliate is a party adverse to us in any legal proceeding or has an adverse interest to us in any legal proceeding. 30 C.
We believe that we have structured our business operations to comply with applicable legal requirements. 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. 18 United States U.S.
We believe that we have structured our business operations to comply with applicable legal requirements. 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. 25 United States U.S.
The assumed assessment time needed for a Technical Documentation assessment of a Class C device currently is expected to be quite lengthy due to the limited number of Notified bodies and the major increase of submissions requiring NB review/approval. We have already begun discussions with the TÜV SÜD in order to ensure compliance with the IVDR as soon as possible.
The assumed assessment time needed for a Technical Documentation assessment of a Class C device currently is expected to be quite lengthy due to the limited number of Notified Bodies and the major increase of submissions requiring NB review/approval. We have already begun discussions with the TÜV Rheinland in order to ensure compliance with the IVDR as soon as possible.
Market We plan to employ decentralized product and marketing strategy in the United States ; we will seek to sell the ColoAlert test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization.
Market We plan to employ decentralized product and marketing strategy in the United States; we will seek to sell the next generation test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization.
Under the IVDD, developers and manufacturers were required to operate according to a Quality System and validate medical devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance criteria. We have implemented an International Organization for Standardization standard — ISO 13485 — quality management system for the design and manufacture of medical devices.
Under the IVDD, developers and manufacturers were required to operate according to a Quality Management System and validate medical devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance criteria. We have implemented an ISO standard 13485 quality management system for the design and manufacture of medical devices.
The top five laboratory chains in the United States had revenues of nearly $38 billion in 2020. Alternatively or in addition, we could offer ColoAlert, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”).
The top five laboratory chains in the United States had revenues of nearly $38 billion in 2020. Alternatively or in addition, we could offer our next generation test, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”).
In December 2022, we received approval from an independent Institutional Review Board (IRB) for the protocol reconAAsense, our U.S. pivotal study to evaluate the clinical performance of ColoAlert. We plan to initiate the study, which will form the basis of the data package to be submitted for review by the U.S.
In December 2022, we received approval from an independent Institutional Review Board (IRB) for the protocol reconAAsense, our U.S. pivotal study to evaluate the clinical performance of our next generation product. We plan to initiate the study, which will form the basis of the data package to be submitted for review by the U.S.
Strategy We intend to make the next generation ColoAlert the global CRC screening market leader by providing the best performance at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains.
Strategy We intend to make our next generation colorectal cancer screening product the global CRC screening market leader by providing the best performance at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains.
By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients. To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required. We are actively exploring the required regulatory path for the United States.
By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients. To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required.
We additionally operate a clinical diagnostic laboratory and distribute our IVD kits to third-party laboratories in Europe and through our on-line store in Germany. In addition, we conduct research and development to increase and diversify our product portfolio.
We additionally operate a clinical diagnostic laboratory and distribute our IVD kits to third-party laboratories in Europe and during 2023 and a portion of 2024 through our on-line store in Germany. In addition, we conduct research and development to increase and diversify our product portfolio.
For the year ended December 31, 2023, 2022 and 2021, we had revenue from one, two and four customers that accounted for approximately 21%, 38% and 56% of revenue, respectively.
For the year ended December 31, 2024, 2023 and 2022, we had revenue from one, two and four customers that accounted for approximately 57%, 21% and 38% of revenue, respectively.
We are focused on the diagnostic aspect of the cancer industry. For most cancer, early detection can be lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving.
For most cancer, early detection can be lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving.
Studies have shown that the prognosis in asymptomatic patients, when who were diagnosed by chance during other examinations, is significantly better than in patients with characteristic symptoms such as rapid weight loss or back pain. The mean age of onset is 71 years for men and 75 years for women. Similar to other cancers, age is an essential risk factor.
Studies have shown that the prognosis in asymptomatic patients, when who were diagnosed by chance during other examinations, is significantly better than in patients with characteristic symptoms such as rapid weight loss or back pain. 20 The mean age of onset is 71 years for men and 75 years for women.
We are exploring the required clinical and regulatory path to submit ColoAlert to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.
We are exploring the required clinical and regulatory path to submit our next generation product to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.
In addition, private insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring fraud suits on behalf of the government against providers and are entitled to receive a portion of any final recovery.
Numerous federal and state agencies enforce the antifraud and abuse laws. In addition, private insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring fraud suits on behalf of the government against providers and are entitled to receive a portion of any final recovery.
Most patients are over 50, with most diagnoses occurring between the ages of 60 and 80. The fact that pancreatic cancer is the European Union’s third biggest cancer killer, despite being the seventh most common cancer, highlights the extremely poor outlook for patients.
Similar to other cancers, age is an essential risk factor. Most patients are over 50, with most diagnoses occurring between the ages of 60 and 80. The fact that pancreatic cancer is the European Union’s third biggest cancer killer, despite being the seventh most common cancer, highlights the extremely poor outlook for patients.
The ordering physician informs patient about the results and decides on next steps. PancAlert We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.
The ordering physician informs patient about the results and decides on next steps. Pancreatic Cancer We are exploring a stool-based test for the diagnosis of pancreatic cancer, PancAlert, as well as a blood-based test. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.
If our research and development efforts are successful for our next generation colorectal cancer screening test or PancAlert, we intend to file patent applications to protect the intellectual property derived from such research and development.
We have patent applications pending relating to the UdeS Biomarkers, as well as trade secrets. If our research and development efforts are successful for our next generation colorectal cancer screening test or PancAlert, we intend to file patent applications to protect the intellectual property derived from such research and development.
The analysis of the results will be additionally facilitated by a specialized artificial intelligence solution. Based on the research progress in this project, we plan to initiate an initial pilot study with one or more selected clinical sites. We do not expect to conclude such studies prior to 2024.
The analysis of the results will be additionally facilitated by a specialized artificial intelligence solution. Based on the research progress in this project, we may initiate an initial pilot study with one or more selected clinical sites.
There is no need for patients to prepare prior to sample collection, which leads to a higher patient acceptance. According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.
Unfortunately, occult blood is often only present in the later stages of the disease. There is no need for patients to prepare prior to sample collection, which leads to a higher patient acceptance. According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.
Using state-of-the-art genetic diagnostic methods, such as PCR analysis (a process used to rapidly make millions to billions of copies of a specific DNA sample, allowing for the amplification of a small sample of DNA to a large enough amount to study in detail), these shed cells can be isolated and examined for genetic changes. 13 ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, often called occult blood.
Using state-of-the-art genetic diagnostic methods, such as PCR analysis (a process used to rapidly make millions to billions of copies of a specific DNA sample, allowing for the amplification of a small sample of DNA to a large enough amount to study in detail), these shed cells can be isolated and examined for genetic changes.
In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests. Colonoscopy The colonoscopy was established over 50 years ago and is used by countless physicians worldwide. The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope.
In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests. 28 Colonoscopy The colonoscopy was established over 50 years ago and is used by countless physicians worldwide.
Notified Bodies began auditing to the IVDR once they were designated as a Notified Body under the IVDR by their Competent Authority. Mainz has selected TÜV SÜD as the designated Notified Body under the IVDR. For Class C devices (such as ColoAlert), the conformity assessment procedure will be a combination of the Quality Management System audits and Technical Documentation assessments.
Mainz has selected TÜV Rheinland as the designated Notified Body under the IVDR. For Class C devices (such as ColoAlert), the conformity assessment procedure will be a combination of the Quality Management System audits and Technical Documentation assessments.
We believe that the most challenging areas under the IVDR regard the classification of products, which brings the majority of IVDs under the direct review and approval of Notified Bodies, and the performance evaluation of IVDs, which will not only include the classic clinical performance and analytical performance but also scientific validity, the role and responsibilities of the economic actors of the supply chain, the traceability and the transparency of the devices with, in particular, the introduction of the UDI-system and an expanded EUDAMED database.
We believe that the most challenging areas under the IVDR regard the classification of products, which brings the majority of IVDs under the direct review and approval of Notified Bodies, and the performance evaluation of IVDs, which will not only include the classic clinical performance and analytical performance but also scientific validity, the role and responsibilities of the economic actors of the supply chain, the traceability and the transparency of the devices with, in particular, the introduction of the UDI-system and a new EUDAMED database specifically built for this purpose Notified Bodies began auditing to the IVDR once they were designated as a Notified Body under the IVDR by their Competent Authority.
ISO 13485 addresses managerial awareness of regulatory requirements, control systems, inspection and traceability, device design, risk and performance criteria as well as verification for corrective and preventative measures for device failure.
ISO 13485 addresses managerial awareness of regulatory requirements, control systems, inspection and traceability, device design, risk and performance criteria as well as verification for corrective and preventative measures for device failure. ISO 13485 certification establishes conformity to specific European Union directives related to medical devices.
We may consider manufacturing our next generation ColoAlert test kits as private label products to be sold to labs. In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.
In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.
These studies are intended to evaluate the optimal combination of biomarkers, both which may include DNA and mRNA and DNA biomarkers and a FIT test, to be included our next generation of product, to be evaluated in our pivotal FDA PMA study, labeled “reconAAsense”.
These studies are intended to evaluate the optimal combination of biomarkers, both which may include DNA and mRNA and DNA biomarkers and a FIT test, to be included our next generation of product, to be evaluated in our pivotal FDA PMA study, labeled “reconAAsense”. 19 In October 2023, we announced results from the ColoFuture study which included a sensitivity for CRC of 94% with a specificity of 97% and a sensitivity for advanced adenoma (AA) of 80%.
Research and Development Our research and development strategy has been centered on ● developing our product candidate PancAlert, a proposed stool-based screening test for pancreatic cancer that is in the early stages of development and might never become a product, and ● running our ColoFuture study, an international multi-center clinical study to evaluate the effectiveness of the UdeS biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing our next generation prodcut’s rates of diagnostic sensitivity and specificity.
Research and Development Our research and development strategy has been centered on ● running our ColoFuture study, an international multi-center clinical study to evaluate the effectiveness of the UdeS biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing our next generation product’s rates of diagnostic sensitivity and specificity.
ColoAlert is directly offered to medical professionals overseeing colorectal cancer (CRC) screening in Germany. This group is not limited to the 1,800 gastroenterologists who primarily conduct colonoscopies but extends to 55,000 general practitioners and over 7,000 specialized practices in gynecology and urology, who customarily initiate CRC screening, predominantly through the FIT stool test.
This group is not limited to the 1,800 gastroenterologists who primarily conduct colonoscopies but extends to 55,000 general practitioners and over 7,000 specialized practices in gynecology and urology, who customarily initiate CRC screening, predominantly through the FIT stool test. For individuals covered by statutory health insurance, ColoAlert is a supplementary expense, whereas it is reimbursable for those with private insurance.
This access point is particularly beneficial for individuals below the typical screening age, in light of the rising incidence of CRC among the under-50 demographic. We are not currently seeking statutory reimbursement for ColoAlert, as we believe our next-generation test, currently under development, is more attuned to the stringent criteria set by German regulatory and reimbursement agencies.
We are not currently seeking statutory reimbursement for ColoAlert, as we believe our next-generation test, currently under development, is more attuned to the stringent criteria set by German regulatory and reimbursement agencies.
Therefore, we intend to focus much of near-term efforts on: ● expanding the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships; ● preparing and executing a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use ColoAlert as a screening test for CRC in the United States; and ● continuing research and development of PancAlert. 16 Expansion of ColoAlert in Europe and Other Select European Markets We have advanced ColoAlert’s commercial presence in Germany, leveraging our proximity to Frankfurt where our headquarters are located.
We are actively exploring the required regulatory path for the United States. 22 Therefore, we intend to focus much of near-term efforts on: ● expanding the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships; ● preparing and executing a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use our next generation colorectal cancer product as a screening test for CRC in the United States; and ● continuing research and development of PancAlert and our recently licensed blood-based biomarkers for the detection of pancreatic cancer.
We are planning to establish a safety stock from the primary suppliers to allow enough time for the necessary valuation to be performed if a secondary supplier is required. Legal Proceedings We are not involved in, or aware of, any legal or administrative proceedings contemplated or threatened by any governmental authority or any other party.
We are planning to establish a safety stock from the primary suppliers to allow enough time for the necessary valuation to be performed if a secondary supplier is required.
Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient to obtain approval of our product. 19 Laboratory Certification, Accreditation and Licensing If we operate clinical laboratories in the United States, we will also be subject to U.S. and state laws and regulations regarding the operation of clinical laboratories.
Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient to obtain approval of our product.
We could be subject to substantial penalties for violations of these laws, including denial of payment and refunds, suspension of payments from Medicare, Medicaid or other federal healthcare programs and exclusion from participation in the federal healthcare programs, as well as civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the antifraud and abuse laws.
Prohibitions under some of these laws include: ● the submission of false claims or false information to government programs; ● deceptive or fraudulent conduct; ● excessive or unnecessary services or services at excessive prices; and ● prohibitions in defrauding private sector health insurers. 27 We could be subject to substantial penalties for violations of these laws, including denial of payment and refunds, suspension of payments from Medicare, Medicaid or other federal healthcare programs and exclusion from participation in the federal healthcare programs, as well as civil monetary and criminal penalties and imprisonment.
We have received government grants as part of our research and development programs, including approximately $28,000 in our fiscal year ended December 31, 2023 and $151,000 in our fiscal year ended December 31, 2022.
We have received government grants as part of our research and development programs, including approximately $46,000 in our fiscal year ended December 31, 2024 and $28,000 in our fiscal year ended December 31, 2023. Government Regulation In vitro diagnostic medical devices (IVDs) are regulated by government agencies in countries where such products are sold.
The biomarkers associated with pancreatic cancer reach the stool, amongst other ways by the pancreatic juice, which enables a user-friendly sample collection.
Because the initiation of pancreatic cancer occurs on a molecular level, genetic diagnostic methods can be a promising approach for early detection. The biomarkers associated with pancreatic cancer reach the stool, amongst other ways by the pancreatic juice, which enables a user-friendly sample collection.
The compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%. The occurrence of false-positive results is not possible due to the nature of the method. Usually, national screening programs suggest a screening interval of 10 years for this method.
An experienced scopeist will perform the process with less pain and a higher detection rate. The average detection rate of colonoscopy is approximately 95%. The compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%. The occurrence of false-positive results is not possible due to the nature of the method.
These organizations often enjoy more comprehensive customer networks, deeper industry connections, and greater brand recognition, with a history that may enable them to adapt more swiftly to emergent technologies and market shifts. 21 We are in competition with several key players in the CRC screening landscape: ● Exact Sciences: This leading molecular diagnostics firm specializes in the early detection of various cancers, producing Cologuard, a fecal DNA-based CRC screening test.
We are in competition with several key players in the CRC screening landscape: ● Exact Sciences: This leading molecular diagnostics firm specializes in the early detection of various cancers, producing Cologuard, a fecal DNA-based CRC screening test.
Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with the risk of punctuating the colon. An experienced scopeist will perform the process with less pain and a higher detection rate. The average detection rate of colonoscopy is approximately 95%.
The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope. Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with the risk of punctuating the colon.
Our ColoFuture Study has been expanded into the United States under the label “eAArly DETECT”. Our research and development team is located at our facilities in Mainz, Germany, and consisted of 26 employees and independent contractors as of December 31, 2023. We have patent applications pending relating to the UdeS Biomarkers, as well as trade secrets.
Our ColoFuture Study has been expanded into the United States under the label “eAArly DETECT” and ● developing our product candidate PancAlert, a proposed stool-based screening test for pancreatic cancer that is in the early stages of development and might never become a product. 24 Our research and development team is located at our facilities in Mainz, Germany, and consisted of 26 employees and independent contractors as of December 31, 2023.
The genetic analysis consists of the quantification of human DNA, the analysis of somatic point mutations in the KRAS (codon 12/13) and BRAF (codon 600) genes.
ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, often called occult blood. The genetic analysis consists of the quantification of human DNA, the analysis of somatic point mutations in the KRAS (codon 12/13) and BRAF (codon 600) genes.
Occult blood tests With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC. Unfortunately, occult blood is often only present in the later stages of the disease.
Any developments that result in the reduction of the cost of colonoscopies, the accuracy of their results or the ease of use may not be transferable to IVD tests. Occult blood tests With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC.
ISO 13485 certification establishes conformity to specific European Union directives related to medical devices and allows CE Marking and sale of the device. The European In Vitro Diagnostic Regulation (EU 2017/746), or the IVDR, became effective as of May 25, 2017, marking the beginning of a five-year transition period for manufacturers selling IVD devices into Europe.
The Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) became effective as of May 25, 2017, marking the beginning of a transition period for manufacturers selling IVD devices into Europe. The IVDR, which replaced the IVDD, has been fully implemented since May 26, 2022.
For individuals covered by statutory health insurance, ColoAlert is a supplementary expense, whereas it is reimbursable for those with private insurance. Out of Germany’s 84 million populace, approximately 10 million have private health coverage. To facilitate sales, we are developing targeted marketing resources and planning to engage physicians and healthcare providers at medical conferences.
Out of Germany’s 84 million populace, approximately 10 million have private health coverage. To facilitate sales, we are developing targeted marketing resources and planning to engage physicians and healthcare providers at medical conferences. Our strategy also includes partnering with laboratories that have a stronghold in CRC screening. These partnerships enable us to reach broader physician networks affiliated with these labs.
If the clinical pilot studies show promising results, we intend to start developing an IVD-R and FDA approvable product for the European and U.S. markets. 15 Competitive Advantages & Operational Strengths We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests.
If such a clinical pilot studies show promising results, we would intend to start developing an IVD-R and FDA approvable product for the European and U.S. markets.
Although, the survival rate of pancreatic cancer patients has improved in the last few decades, there is still the urgent need for early diagnostic optimization. A definitive diagnosis is currently made through a series of investigations, including imaging scans, blood tests and biopsy, which are usually only performed in symptomatic patients.
Although, the survival rate of pancreatic cancer patients has improved in the last few decades, there is still the urgent need for early diagnostic optimization. PancAlert We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer.
In 2024, Germany will remain our focal market, as we aim to enlarge our footprint through a combination of direct sales, channel partnerships, and heightened product visibility. We are implementing a dual distribution model: a centralized system via our laboratory and a decentralized approach through associated lab partners.
Expansion of ColoAlert in Europe and Other Select European Markets We have advanced ColoAlert’s commercial presence in Germany, leveraging our proximity to Frankfurt where our headquarters are located. In 2024, Germany will remain our focal market, as we aim to enlarge our footprint through a combination of direct sales, channel partnerships, and heightened product visibility.
In December 2023, we announced topline results from our eAArly DETECT U.S. clinical study which reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. 17 During this market preparation period market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product.
During this market preparation period market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product. We may consider manufacturing our next generation ColoAlert test kits as private label products to be sold to labs.
Based on the study’s outcome, we will decide whether to integrate the biomarkers evaluated in ColoFuture’s eAArly DETECT into the reconAAsense study.
Based on the study’s outcome, we will decide whether to integrate the biomarkers evaluated in ColoFuture’s eAArly DETECT into the reconAAsense study. In December 2023, we announced topline results from our eAArly DETECT U.S. clinical study which reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%.
Currently, we are managing our government funded research and development project called PancAlert, which provide us non-refundable grant income that covers a percentage of the individual project-related costs. 12 About the Industry The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them.
Currently, we are managing our government funded research and development project called PancAlert, which provide us non-refundable grant income that covers a percentage of the individual project-related costs. In March 2024, we acquired a license from Liquid Bioscience, Inc. to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test.
Europe Until May 26, 2022, medical devices such as ColoAlert were regulated by the IVD Directive (IVDD) (98/79/EC), requiring CE-Mark through self-certification process due to the lowest risk classification.
There is no uniform set of regulations governing our product portfolio. Following is a summary of governmental regulations in Europe (EU), our principal market. Europe Until May 26, 2022, IVDs were regulated by the European Directive 98/79/EC (IVDD). Due to the lowest risk classification, IVDs such as ColoAlert have been approved and CE marked as part of a self-certification process.
Our strategy also includes partnering with laboratories that have a stronghold in CRC screening. These partnerships enable us to reach broader physician networks affiliated with these labs. Approximately 12 lab chains in Germany process about 64% of the FIT tests, amounting to roughly 3 million tests annually.
Approximately 12 lab chains in Germany process about 64% of the FIT tests, amounting to roughly 3 million tests annually. By partnering with significant lab chains and independent laboratories, we aim to amplify ColoAlert’s market penetration.
However, recent research suggests that the disease can persist for a longer period of time without patients becoming symptomatic; providing an important opportunity for early detection. Because the initiation of pancreatic cancer occurs on a molecular level, genetic diagnostic methods can be a promising approach for early detection.
A definitive diagnosis is currently made through a series of investigations, including imaging scans, blood tests and biopsy, which are usually only performed in symptomatic patients. However, recent research suggests that the disease can persist for a longer period of time without patients becoming symptomatic; providing an important opportunity for early detection.
By partnering with significant lab chains and independent laboratories, we aim to amplify ColoAlert’s market penetration. Furthermore, we have pioneered a direct-to-consumer channel allowing patients to acquire ColoAlert via an online portal, bypassing the need for a doctor to prescribe the test.
Furthermore, we have pioneered a direct-to-consumer channel allowing patients to acquire ColoAlert via an online portal, bypassing the need for a doctor to prescribe the test. This access point is particularly beneficial for individuals below the typical screening age, in light of the rising incidence of CRC among the under-50 demographic.
Because of the invasive procedure and the prior bowel cleansing, this method has a patient acceptance rate of less than 20%.. Any developments that result in the reduction of the cost of colonoscopies, the accuracy of their results or the ease of use may not be transferable to IVD tests.
Usually, national screening programs suggest a screening interval of 10 years for this method. Because of the invasive procedure and the prior bowel cleansing, this method has a patient acceptance rate of less than 20%.
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In October 2023, we announced results from the ColoFuture study which included a sensitivity for CRC of 94% with a specificity of 97% and a sensitivity for advanced adenoma (AA) of 80%.
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We have an exclusive license to develop such a test using these biomarkers with the unilateral option to acquire them. About the Industry The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them. We are focused on the diagnostic aspect of the cancer industry.
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Government Regulation In-vitro diagnostic (IVD) devices are regulated by government agencies in countries where such products are sold there is no uniform set of regulations governing our product portfolio. Following is a summary of governmental regulations in Europe (EU), our principal market, and the United States, the next country that we seek to market.
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Blood-Based Test In March 2025, we entered into a License and Option Agreement with Liquid Bioscience, Inc. to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test.
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Medical device companies such as ours are subject to pre-market compliance assessments from Notified Bodies, a certification organization which the national authority (the competent authority) of a European Union member state designates to conduct one or more of the conformity assessment procedures.
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Under the terms of the agreement, we have an exclusive license to develop a test using Liquid’s biomarkers with the unilateral option to acquire the exclusive global rights to the gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting pancreatic cancer. The discovery process included multiple independent pancreatic cancer study cohorts.
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The IVDR, which replaced the IVDD, has been fully implemented, and new IVDD applications will not be accepted by notified bodies. During the transition period manufacturers had to update their technical documentation and processes to fulfill the new, more stringent EU regulatory requirements.
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Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. Liquid further confirmed the biomarkers with two additional, independent cohorts, validating the strong clinical contribution of each biomarker shown in the initial discovery phase.
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Prohibitions under some of these laws include: ● the submission of false claims or false information to government programs; ● deceptive or fraudulent conduct; ● excessive or unnecessary services or services at excessive prices; and ● prohibitions in defrauding private sector health insurers.
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In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid, achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer.
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The terms of the agreement include both a license fee and a royalty on future revenues in the event of the exercise of the option. 21 Competitive Advantages & Operational Strengths We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests.
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We are implementing a dual distribution model: a centralized system via our laboratory and a decentralized approach through associated lab partners. ColoAlert is directly offered to medical professionals overseeing colorectal cancer (CRC) screening in Germany.
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This means that all new IVDs have to fulfill the new and more stringent EU regulatory requirements. Legacy IVDD products can be sold on the EU market until the end of a transition period, which is defined by the risk class of the respective future IVDR product.
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In order to be able to sell the product under IVDR, manufacturers had to update their technical documentation and processes to fulfill the EU regulation.
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Laboratory Certification, Accreditation and Licensing If we operate clinical laboratories in the United States, we will also be subject to U.S. and state laws and regulations regarding the operation of clinical laboratories.
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These organizations often enjoy more comprehensive customer networks, deeper industry connections, and greater brand recognition, with a history that may enable them to adapt more swiftly to emergent technologies and market shifts.
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Legal Proceedings On March 22, 2024, we filed a complaint in the Supreme Court of the State of New York against a former underwriter for breach of contract, unjust enrichment, and a declaratory judgment.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

32 edited+29 added−21 removed25 unchanged
Our presentation currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.
Our reporting currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.
Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss). Stock Option Compensation We have adopted our 2021 Omnibus Incentive Plan and the 2022 Omnibus Incentive Plan (the “Plans”).
Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss). Stock Option Compensation We have adopted our 2021 Omnibus Incentive Plan and 2022 Omnibus Incentive Plan (the (“Plans”).
You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Organization and Overview of Operations We develop and sell in-vitro diagnostic (“IVD”) tests for the early detection of cancer.
You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Organization and Overview of Operations We develop and sell in-vitro diagnostic tests for the early detection of cancer.
Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.
Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of loss and comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.
Financial Instruments (a) Classification We classify our financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. We determine the classification of financial assets at initial recognition.
Financial Instruments (a) Classification We classify our its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. We determine the classification of financial assets at initial recognition.
We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets. At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term.
We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets. 36 At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term.
The classification of debt instruments is driven by our business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day we acquire them, we can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI.
The classification of debt instruments is driven by our business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition we can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI.
Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 2,300,000 ordinary shares.
Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed, 2,800,000 ordinary shares.
The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.
The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are amortized on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.
We value our stock options as follows: (a) for those options that have time-based vesting, we use the Black Scholes method to value the stock options at the time of award and record the compensation expense in our Statement of Operations over the vesting period, and (b) for options issued with milestone based vesting criteria, we use a Monte Carlo simulation to value the options at the time of issuance and each subsequent reporting date until fully vested or expired, with any change in compensation expense measured by such method to be recorded in our Statement of Operations.
We have valued these stock options as follows: (a) for those options that have time-based vesting, we will use the Black-Scholes method to value the stock options at the time of award and record the compensation expense in our Statement of Operations over the vesting period, and (b) for options issued with milestone based vesting criteria, we will use a Monte Carlo simulation to value the options at the time of issuance and each subsequent reporting date until fully vested or expired, with any change in compensation expense measured by such method to be recorded in our Statement of Operations.
While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this annual report, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Critical Accounting Policies and Significant Judgments and Estimates This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board.
Such adjustments could be material. Critical Accounting Policies and Significant Judgments and Estimates This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board.
If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate our research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and our ability to continue as a going concern.
If the Company is unable to obtain funding, the Company could be forced to further delay, reduce or eliminate its research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and its ability to continue as a going concern.
We believe our most critical accounting policies and estimates relate to the following: ● Revenue Recognition, ● Foreign Currency Translation, ● Stock Option Compensation, ● Impairment of Long-Lived Assets Including Intangibles, ● Lease Accounting, and ● Financial Instruments. Revenue Recognition Our revenue is primarily derived through providing genetic diagnostic tests to customers.
We believe our most critical accounting policies and estimates relate to the following: ● Revenue Recognition; ● Foreign Currency Translation; ● Stock Option Compensation; ● Lease Accounting; and ● Financial Instruments. Revenue Recognition Our revenue is primarily derived through providing our ColoAlert genetic diagnostic test kits to customers.
We plan to fund our cash flow needs through current cash on hand and future debt and/or equity financings which it may obtain through one or more public or private equity offerings, debt financings, government or other third-party funding, strategic alliances, or collaboration agreements. During 2022 we raised $24.2 million of net proceeds from common stock sales and warrant proceeds.
We plan to fund our cash flow and working capital needs through current cash on hand and future debt and/or equity financings which we may obtain through one or more public or private equity offerings, debt financings, government or other third-party funding, strategic alliances or collaboration agreements.
During 2023 we raised $16.5 million from a combination of sale of shares and warrants as well as the issuance of convertible debt.
During 2023, the Company raised $16.5 million from a combination of sale of shares and warrants as well as the issuance of convertible debt. During 2024, the Company raised $16.9 million of net proceeds from the issuance of a convertible note and through the sales of ordinary shares.
During 2024 and beyond we believe that we will be able to raise additional funds through a combination of the sale of ordinary shares, the sale and/or conversion of warrants, and use of our access to capital through our Controlled Equity Offering (see Note 16) and our Pre-Paid Advance Agreement (see Note 13).
The Company believes that it will be able to raise additional funds through a combination of the sale of ordinary shares, the sale and/or conversion of warrants, and use of the Company’s access to capital through its Controlled Equity Offering and its Pre-Paid Advance Agreement.
Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.
Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction.
These factors raise a substantial doubt as to the Company’s ability to continue as a going concern for a period that is one year from the date these financial statements are published.
These conditions are indicators that impact the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.
Currently, we are managing our government funded research and development project called PancAlert, which provide us non-refundable grant income that covers a percentage of the individual project-related costs.
In addition, we conducted research and development to increase and diversify our product portfolio. During 2023 and 2024, we also performed government funded research and development project called PancAlert, which provided us non-refundable grant income that covers a percentage of the individual project-related costs.
Foreign Currency Translation The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional currency, as determined by our management, is the Euro (EUR). Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction.
This income is included in the Statements of Loss and Comprehensive Loss as Other Income. 35 Foreign Currency Translation The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by our management, is the Euro (EUR).
We have recurring losses, accumulated deficit totaling $69,328,021 and negative cash flows used in operating activities of $21,938,845 as of and for the year ended December 31, 2023. We also had $7,070,925 of cash on hand at December 31, 2023.
Working Capital Discussion We have incurred recurring losses, have an accumulated deficit totaling $91.0 million and negative cash flows used in operating activities of $17.1million as of and for the year ended December 31, 2024. We also had $ 6.2 million of cash on hand on December 31, 2024, and working capital of $1.9 million.
Revenue from these sales is deferred on our Statement of Financial Position until recognition. 25 We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed. This income is included in the Statements of Comprehensive Loss as Other Income.
Accordingly, we have one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time. We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed.
General and Administrative Expenses General and administrative expenses for the year ended December 31, 2023 were $11,405,471 compared to $15,209,919 for the year ended December 31, 2022, a decrease of $3,804,448.
General and Administrative Expenses General and administrative expenses for the year ended December 31, 2024 were $6,572,765 compared to $11,405,471 for the year ended December 31, 2023, a decrease of $4,832,706 The decreased expenses were primarily the result of a decrease of $3.1 million of non-cash stock option expense for the year ended December 31, 2024 compared to the same period in 2023.
Cash Flows from Investing Activities During the year ended December 31, 2023, cash used in investing activities was $1,898,841, including $1.2 million for the capital expenditure and $700 thousand for the purchase of intellectual property to support our ColoAlert product. For the year ended December 31, 2022 we had capital expenditures of $0.7 million.
The improvement in cash flows used in investing activities of $1,700,024 was the primarily the result of higher capital expenditures during the year ended December 31, 2023 related to the expansion of our office and lab space.
Other net gains and losses are recognized in OCI and are never reclassified to profit or loss. 27 Disclosure of Contractual Arrangements On December 31, 2023, we were committed to minimum lease payments as follows: Contractual Obligation Less than One Year 1 – 3 Years 3 – 5 Years Over 5 Years Office Rent $ 278,563 $ 633,018 $ 453,050 $ 358,513 Laboratory Equipment $ 27,317 $ 37,558 $ 14,784 $ 9,856 Automobiles $ 54,794 $ 39,531 $ - $ - Office Equipment $ 6,359 $ 6,840 $ 788 $ - TOTAL $ 367,033 $ 716,947 $ 468,622 $ 368,369 The amounts above are undiscounted and include the total amounts due, including the interest component.
Disclosure of Contractual Arrangements On December 31, 2024, we were committed to minimum lease payments as follows: Contractual Obligation Less than One Year 1 – 3 Years 3 – 5 Years Over 5 Years Office Rent $ 321,250 $ 554,947 $ 322,434 $ 103,336 Laboratory Equipment $ 20,317 $ 29,228 $ 13,934 $ 2,322 Automobiles $ 35,060 $ 9,462 $ - $ - Office Equipment $ 3,727 $ 3,714 $ $ - TOTAL $ 380,354 $ 597,351 $ 336,368 105,658 The amounts above are undiscounted and include the total amounts due, including the interest component.
Expense for the market-condition stock options will be recognized over the derived service period as determined through the Monte Carlo simulation model. 26 Impairment of Long-Lived Assets Including Intangibles We continually evaluate whether events or circumstances have occurred that indicate the remaining estimated useful lives of our long-lived assets including intangible assets may warrant revision or that the remaining balance of such assets may not be recoverable.
Expense for the market-condition stock options will be recognized over the derived service period as determined through the Monte Carlo simulation model. Lease Accounting We assess at contract inception whether a contract is, or contains, a lease.
We additionally operate a clinical diagnostic laboratory and distribute our IVD kits to third-party laboratories in Europe and through our on-line store in Germany. In addition, we conduct research and development to increase and diversify our product portfolio.
During 2023 and 2024 we operated a clinical diagnostic laboratory to support sales through our on-line store in Germany and a limited number of lab partners. During 2024, we made the strategic decision to focus our sales effort on distributing our IVD kits to third-party laboratories in Europe and ceased our direct to consumer sales.
Other income (expense) Other income for the year ended December 31, 2023 was $348,955 compared to $56,704 for the year ended December 31, 2022. This increase in other income was primary related to a fair value adjustment (income) of $0.6 million related to our convertible debt financing in November 2023, net of increased financing fees and foreign currency translation losses.
The biggest driver of this change was the result in an increased non-cash expense of $2.7 million for the adjustment of fair value on convertible debt in the year ended December 31, 2024 compared to the year ended December 31, 2023.
Results of Operations Comparison of the Year Ended December 31, 2023 and 2022 The following table provides certain selected financial information for the periods presented: Year Ended December 31, 2023 2022 Change % Change Revenue $ 895,479 $ 529,877 $ 365,602 69 % Cost of revenue $ 385,820 $ 347,726 $ 38,094 11 % Gross profit $ 509,659 $ 182,151 $ 327,508 180 % Gross profit percentage 57 % 34 % Research and Development $ 9,590,393 $ 5,019,366 $ 4,571,027 91 % Sales and Marketing $ 6,158,477 $ 6,396,906 $ (238,429 ) (4 )% General and Administrative $ 11,405,471 $ 15,209,919 $ (3,804,448 ) (25 )% Total operating expenses $ 27,154,341 $ 26,626,191 $ 528,150 2 % Loss from operations $ (26,644,682 ) $ (26,444,040 ) $ 91,609 1 % Other income (expense) $ 348,955 $ 56,094 $ 292,251 515 % Net loss $ (26,295,727 ) $ (26,387,336 ) $ 91,609 0 % Total Comprehensive Loss $ (26,800,221 ) $ (26,337,633 ) $ (462,588 ) (2 )% Basic and dilutive loss per common share $ (1.62 ) $ (1.86 ) $ 0.24 13 % Weighted average number of common shares outstanding – basic and diluted 16,242,334 14,157,492 2,084,842 15 % 23 Revenue Revenue for the year ended December 31, 2023 was $895,479 compared to $529,877 in the prior year, which represented a 69% year over year increase compared to the prior year.
Our program to explore screening or diagnostic solutions for pancreatic cancer continues through internally funded research and development. 31 Results of Operations Comparison of the Year Ended December 31, 2024 and 2023 The following table provides certain selected financial information for the periods presented: Year Ended December 31, % 2024 2023 Change Change Revenue $ 832,422 $ 895,479 $ (63,057 ) (7 )% Revenue – related party $ 61,569 $ - $ 61,569 - Total Revenue $ 893,991 $ 895,479 $ (1,488 ) 0 % Cost of revenue $ 319,108 $ 385,820 $ (66,712 ) (17 )% Gross profit $ 574,883 $ 509,659 $ 65,224 13 % Gross margin 64 % 57 % Research and development $ 5,839,033 $ 9,590,393 $ (3,751,360 ) (39 )% Sales and marketing $ 6,581,333 $ 6,158,477 $ 422,856 7 % General and administrative $ 6,572,765 $ 11,450,471 $ (4,832,706 ) (42 )% Restructuring expense $ 277,160 $ - $ 277,160 - % Total operating expenses $ 19,270,291 $ 27,154,341 $ (7,884,050 ) (29 )% Loss from operations $ (18,695,408 ) $ (26,644,682 ) $ (7,949,274 ) (30 )% Other (income) expense $ 2,955,255 $ (348,955 ) $ 3,304,210 (947 )% Net loss $ (21,650,663 ) $ (26,295,727 ) $ (4,645,064 ) (18 )% Total comprehensive loss $ (21,755,223 ) $ (26,800,221 ) $ (5,044,998 ) (19 )% Basic and dilutive loss per common share $ (22.36 ) $ (64.76 ) $ 42.40 65 % Weighted average number of common shares outstanding – basic and diluted 968,234 406,058 Revenue Revenue for the year ended December 31, 2024 was $893,991 as compared to $895,479 for the year ended December 31, 2023.
Sales and Marketing Expenses Sales and marketing expenses for the year ended December 31, 2023, were $6,158,477 compared to $6,396,906 for the year ended December 31, 2022, a decrease of $238,429.
Sales and Marketing Expenses Sales and marketing expenses for the year ended December 31, 2024, were $6,581,333 compared to $6,158,477 for the year ended December 31, 2023, an increase of $422,856. This increase was related to an increase in our marketing and advertising expense of $0.9 million as we continued to invest in our brand and market awareness programs.
Securities and Exchange Commission on April 7, 2023 and incorporated herein by reference. Liquidity and Capital Resources Our principal liquidity requirements are for working capital and capital expenditures. Historically, we have funded our liquidity requirements primarily through cash on hand, cash flows from operations, and equity and debt financing.
We fund our liquidity requirements primarily through cash on hand, cash flows from operations and, debt and equity financing. As of December 31, 2024, we had $6,235,670 of cash and cash equivalents, with $7,070,925 as of December 31, 2023.
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This increase was the result of an increase in the sale of our ColoAlert product, primarily in Germany.
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During 2024, we made the decision to cease our direct to consumer and other business lines to focus on expanding our lab network and sales of IVDR kits to those lab partners.
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We sell our ColoAlert directly to lab partners, who in turn provide the tests to patients and perform the tests and deliver results to those patients; we also market directly to patients through our online platform, where we deliver and perform the test, and provide reports directly to those patients.
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For the year ended December 31, 2024, ColoAlert sales through our lab network increased by 33% from $423,676 in the year ended December 31, 2023 compared to $562,507 during the year ended December 31, 2024. During those same periods revenue from direct to consumer sales decreased by 34% from $414,899 to $272,813 as we exited that business.
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As we gain access to reimbursed markets in Europe, we expect our revenue to grow, led by our lab partner channel. We plan to launch our FDA pivotal study in the next twelve months for our next generation product; that product, if approved by the FDA, will be launched in the United States and in Europe.
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Cost of Revenue Cost of revenue for the year ended December 31, 2024 was $319,108 as compared to $385,820 for the year ended December 31, 2023, a 17% decrease. This decrease was the result of the decrease in direct to consumer sales, which resulted in the reduction of labor and overhead expenses in our commercial lab.
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Cost of Revenue Cost of Revenue for the year ended December 31, 2023 increased by $38,094, or 11%, compared to the year ended December 31, 2022, as the result of increased costs associated with the increase in ColoAlert sales.
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Gross profit Gross profit increased to $574,883 in the year ended December 31, 2024 compared to $509,659, for the year ended December 31, 2023.
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Gross profit Gross profit increased from $182,151 for the year ended December 31, 2022, to $509,659for the year ended December 31, 2023, with gross margins increasing from 34% to 57%. The increased gross margins were the result of revenue growth from sales performed in our diagnostic lab, where our margins are higher than in sales to lab partners.
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This gross profit increase, resulting in an improvement of gross margin from 57% to 64%, was attributable to increased sales through our lab network which have a higher gross margin. 32 Research and Development Expenses Research and development expenses for the year ended December 31, 2024 were $5,839,033 compared to $9,590,393 for the year ended December 31, 2023, a decrease of $3,751,360.
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Research and Development Expenses Research and development expenses for the year ended December 31, 2023 were $9,590,393 compared to $5,019,366 for the year ended December 31, 2022.
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This decrease was driven by the cost of our ColoFuture and eAArly Detect feasibility studies in the U.S. and in Europe, which drove significant expenses in 2023 compared to 2024.
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This increase of $4,571,027 was primarily attributable to the increase in headcount in our employees working on research and development, resulting in an increase in compensation (salary, benefits and consulting related to our clinical studies) costs of $1.5 million and an increase of $3.0 million related to our ColoFuture and eAArly DETECT clinical studies in Europe and the United States, respectively.
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During the year ended December 31, 2023, clinical study expenses and professional fees related to those studies were $4.3 million compared to $1.0 million in the year ended December 31, 2024.
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This decrease was attributable to a $1.2 million decrease in advertising and marketing expenses after our initial marketing launch expenses in 2022, net of a $0.9 million increase in salaries and benefits resulting from increased headcount in our sales and marketing department.
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This increase was mitigated by reduced labor costs (salary and consulting) of $0.5 million as the result of our shift in focus away from consumer sales.
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This decrease was attributable to a $5.6 million decrease in stock option expense (a non-cash expense), net of an increase of $1.7 million for consulting and professional fees primarily related to costs associated with raising capital and increasing brand and company awareness.
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In addition, our professional and consulting fees were reduced by $1.5 million in line with our cost reduction efforts in 2024. Restructuring Expenses Restructuring expenses for the year ended December 31, 2024 were $277,160 compared to nil for the year ended December 31, 2023, an increase of $277,160.
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Comparison of the Year Ended December 31, 2022 and 2021 For a discussion of our results for the year ended December 31, 2022 compared to the year ended December 31, 2021, please see “Operating and Financial Review and Prospects – Results of Operations – Comparison of the Year Ended December 31, 2022 and 2021” contained in our annual report on Form 20-F filed with the U.S.
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During July 2024 and October 2024, the Company restructured its operations to focus on its ColoAlert business in Europe, the development of its next generation product, and planning for the Early Detect 2 clinical study in the U.S. in 2025.
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We also have the ability to defer certain costs, especially those related to clinical studies, to match financing inflows.
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In line with that focus, the Company implemented cost reduction efforts which included the reduction of its operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale of its European Oncology Lab (“EOL”) business in St. Ingbert, Germany to a related party.
Removed
We believe that with currently available cash on hand, including additional financing described above, will be sufficient to meet our planned expenditures and to meet the our obligations for at least the one-year period following its consolidated financial statement issuance date. 24 The following table summarizes our cash flows from operating, investing and financing activities: Year Ended December 31, 2023 2022 Change Cash used in operating activities $ (21,938,845 ) $ (14,769,590 ) $ (7,169,255 ) Cash provided by (used in) investing activities $ (1,898,841 ) $ (658,483 ) $ (1,240,358 ) Cash provided by financing activities $ 14,226,692 $ 23,943,418 $ (9,716,726 ) Cash Flow from Operating Activities For the year ended December 31, 2023, net cash flows used in operating activities was $21,938,845, an increase of $7,169,255 from the year ended December 31, 2022.
Added
The sale of the EOL business included a payment to the Company of €31,511 ($32,785). Additionally, the Company amended the employment contracts of its CEO and CFO, reducing the salaries of those officers to 60% and 50% of their then current salaries, respectively, effective November 1, 2024.
Removed
This increase was primarily from the increase of our net loss, net of stock-based compensation, depreciation, amortization and change in fair value of convertible debt. Operating activities also included $500,187 of increased expenditures related to inventories in support of our commercial efforts.
Added
For the year ended December 31, 2024, the Company recorded severance expenses and impairment loss from this transaction of $277,160 as restructuring expense and gain on sale of EOL of $28,328.
Removed
Cash Flows from Financing Activities During the year ended December 31, 2023, we raised $6.4 million from the sale of ordinary shares and warrants and $9.0 million (net) from our Pre-Paid Advance agreement, in the form of convertible debt. During 2023 we also made principal payments of $1.2 million for silent partnerships and lease obligations.
Added
In conjunction with its restructuring program, for the year ended December 31, 2024, the Company recorded an impairment on construction in progress of $47,449 as the construction project was on hold and there is not a plan for future use.
Removed
During the year ended December 31, 2022 we raised $23.9 million and the sale of ordinary shares and warrants and made principal payments of $300 thousan for silent partnerships and lease obligations.
Added
Other Expense (net) Other expense (net) for the year ended December 31, 2024 was $2,955,255 compared to other income (net) of $348,955 for the year ended December 31, 2023, resulting in increased other expenses (net) of $3,304,210.
Removed
We sell our genetic diagnostic testing kits to both laboratory partners and directly to patients who are the end users of the product. Upon the delivery of our products to laboratory partners, we have completed our performance obligations and as such revenue is recorded upon delivery.
Added
In addition, interest expense increased by $0.5 million in the year ended December 31, 2024 compared to the year ended December 31, 2023 as the result of higher convertible debt balances. 33 Liquidity and Capital Resources Our principal liquidity requirements are for working capital and operating losses.
Removed
Sales to patients, or end users, where samples are sent to our diagnostic lab for testing and evaluation, are recognized when they are delivered to the end user, returned to our laboratory, and testing results have been delivered.
Added
The following table summarizes our cash flows from operating, investing and financing activities: Years Ended December 31, 2024 2023 Change Cash used in operating activities $ (17,090,011 ) $ (21,938,845 ) $ 4,848,834 Cash used in investing activities $ (198,817 ) $ (1,898,841 ) $ 1,700,024 Cash provided by financing activities $ 16,599,629 $ 14,226,692 $ 2,372,937 Cash Flow from Operating Activities For the year ended December 31, 2024, cash flows used in operating activities was $17,090,011 compared to $21,938,845 used during the year ended December 31, 2023.
Removed
On November 4, 2021, we awarded 1,484,650 stock options under the Plan, with a strike price of $5.00, the per share price in our November 2021 initial public offering. Such stock options were granted to all of our current employees, directors, advisors and senior management team.
Added
The improvement in cash flows used in operating activities of $4,848,834 was primarily the result of a reduction of our net loss of $4.6 million during December 31, 2024 compared to December 31, 2023.
Removed
Such stock options for our non-senior management team, independent directors and advisors will begin vesting on November 4, 2022 and stop vesting on November 4, 2025 at the latest.
Added
Cash Flows from Investing Activities During the year ended December 31, 2024, we used $198,817 in investing activities compared to $1,898,841 used during the year ended December 31, 2023.
Removed
Such stock options for the four members of our senior management team will begin vesting in portions equal to 25% of such options granted if, prior to November 4, 2025, the four-year anniversary of our initial public offering, for ten consecutive trading days (with at least 100,000 shares traded per trading day) the volume-weighted average price of the ordinary shares on the principal market is at least: ● $7.50; ● $10.00; ● $12.50, provided that such options could not vest until the twelve-month anniversary of the initial public offering; and ● $15.00, provided that such options could not vest until the twelve-month anniversary of the initial public offering.
Added
Cash Flows from Financing Activities During the year ended December 31, 2024, we had cash flow provided by financing activities of $16,599,629 compared to cash flow provided by financing activities of $14,226,692 for the year ended December 31, 2023, an increase of $2,372,937.
Removed
We use an estimate of the related undiscounted cash flows over the remaining life of the asset in measuring whether the asset is recoverable. Lease Accounting We assess at contract inception whether a contract is, or contains, a lease.
Added
This increase was primarily the result of the Company raising $13.8 million from the sale of shares and warrants during 2024, compared to $6.4 million in 2023, mitigated by a decrease in issuances of convertible debt of $5.8M between 2023 and 2024.
Added
The Company also has the ability to defer certain costs, especially those related to clinical studies, to match financing inflows. During July 2024 and October 2024, the Company restructured its operations to focus on its ColoAlert business in Europe, the development of its next generation product, and planning for the eAArly DETECT 2 clinical study in the U.S. in 2025.
Added
In line with that focus, the Company implemented cost reduction efforts which included the reduction of its operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale/closure of its European Oncology Lab (“EOL”) business in St. Ingbert, Germany.
Added
Additionally, the Company amended the employment contracts of its CEO and CFO, reducing the salaries of those officers to 60% and 50% of their original salaries, respectively, effective November 1, 2024. The Company believes that these cost reductions will best position our business for 2025 and beyond.
Added
The Company believes that its currently available cash on hand, including additional financing described above, will be sufficient to meet its planned expenditures and to meet the Company’s obligations for at least the one-year period from December 31, 2024. 34 Our consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business.
Added
These consolidated financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations.
Added
We provide a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as we use the testing kits to collect samples in order to deliver the diagnostic test results to the customer.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

46 edited+7 added−54 removed57 unchanged
Such options shall vest in quarterly amounts on each of those dates when for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
Such options shall vest in quarterly amounts on each of those dates when for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
Metzger received his Ph.D. in Biology and a Masters’ Degree in Biology from the University of Heidelberg.
Metzger received his Ph.D. in Biology and a Masters’ Degree in Biology from the University of Heidelberg. D.
The Audit Committee is responsible for, among other things: ● selecting our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm; ● reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response and approving all proposed related-party transactions, as defined in Item 404 of Regulation S-K; ● discussing the annual audited financial statements with management and our independent registered public accounting firm; ● annually reviewing and reassessing the adequacy of our Audit Committee charter; 36 ● meeting separately and periodically with the management and our independent registered public accounting firm; ● reporting regularly to the full board of directors; ● reviewing the adequacy and effectiveness of our accounting and internal control policies and procedures and any steps taken to monitor and control major financial risk exposure; and ● such other matters that are specifically delegated to our Audit Committee by our board of directors from time to time.
The Audit Committee is responsible for, among other things: ● selecting our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm; ● reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response and approving all proposed related-party transactions, as defined in Item 404 of Regulation S-K; 46 ● discussing the annual audited financial statements with management and our independent registered public accounting firm; ● annually reviewing and reassessing the adequacy of our Audit Committee charter; ● meeting separately and periodically with the management and our independent registered public accounting firm; ● reporting regularly to the full board of directors; ● reviewing the adequacy and effectiveness of our accounting and internal control policies and procedures and any steps taken to monitor and control major financial risk exposure; and ● such other matters that are specifically delegated to our Audit Committee by our board of directors from time to time.
Baechler previously held several leadership positions at Roche Molecular Systems, including serving as a member of its executive team. He held various leadership positions at Roche Diagnostics within Research, Development, and Marketing in Switzerland and California during his almost twenty years with the company. 28 Since 2020, Mr.
Baechler previously held several leadership positions at Roche Molecular Systems, including serving as a member of its executive team. He held various leadership positions at Roche Diagnostics within Research, Development, and Marketing in Switzerland and California during his almost twenty years with the company. Since 2020, Mr.
Dreismann served on the Board of Directors of Myriad Genetics, Inc., Med BioGene, Inc. and Ignyta, Inc. He earned a M.S. degree in biology and his Ph.D. in microbiology/molecular biology (summa cum laude) from Westfaelische Wilhelms University (The University of Münster) in Germany.
Dreismann served on the Board of Directors of Myriad Genetics, Inc., Med BioGene, Inc. and Ignyta, Inc. He earned a M.S. degree in biology and his Ph.D. in microbiology/molecular biology (summa cum laude) from Westfaelische Wilhelms University (The University of Münster) in Germany. Dr.
He holds board positions in several healthcare and biotech companies, and since 2021, he has been on the board of Lifecare AS (Euronext Growth: LIFE), a company developing a continuous glucose measurement implant. In 2013 he established ColoAlert AS together with Dr.
He holds board positions in several healthcare and biotech companies, and since 2021, he has been on the board of Lifecare AS (Euronext Growth: LIFE), a company developing a continuous glucose measurement implant. 39 In 2013 he established ColoAlert AS together with Dr.
Practices that are designed to avoid inappropriate or excessive risks include (i) financial controls that provide limits and authorities in areas such as capital and operating expenditures to mitigate risk taking that could affect compensation, (ii) balancing base salary and variable compensation elements and (iii) spreading compensation across short and long-term programs. 32 Compensation Governance The Compensation Committee intends to conduct a yearly review of directors’ compensation having regard to various reports on current trends in directors’ compensation and compensation data for directors of reporting issuers of comparative our size.
Practices that are designed to avoid inappropriate or excessive risks include (i) financial controls that provide limits and authorities in areas such as capital and operating expenditures to mitigate risk taking that could affect compensation, (ii) balancing base salary and variable compensation elements and (iii) spreading compensation across short and long-term programs. 42 Compensation Governance The Compensation Committee intends to conduct a yearly review of directors’ compensation having regard to various reports on current trends in directors’ compensation and compensation data for directors of reporting issuers of comparative our size.
Although the Strategic Advisory Board has no formal powers, our Board of Directors plans to consult it in setting strategies, achieving goals and analyzing opportunities. Our Strategic Advisory Board currently has three members; Dr. Soren Thestrup-Nielsen . Dr.
Although the Strategic Advisory Board has no formal powers, our Board of Directors plans to consult it in setting strategies, achieving goals and analyzing opportunities. Our Strategic Advisory Board currently has three members; 47 Dr. Soren Thestrup-Nielsen . Dr.
Summary Compensation Table We set out below certain disclosure on compensation paid to our seven executives on an aggregate basis for the year ended December 31, 2023, as disclosure of compensation on an individual basis is not required in our home country and is not otherwise publicly disclosed by us.
Summary Compensation Table We set out below certain disclosure on compensation paid to our seven executives on an aggregate basis for the year ended December 31, 2024, as disclosure of compensation on an individual basis is not required in our home country and is not otherwise publicly disclosed by us.
Baechler; and (v) reimbursement for up to $3,500 of the monthly U.S. health insurance premium paid by Mr. Baechler for himself and his dependents until the earliest date set forth by the Baechler Agreement. 33 The Baechler Agreement will terminate upon the death of Mr. Baechler. We may terminate Mr. Bachelor upon disability as defined by the Baechler Agreement.
Baechler; and (v) reimbursement for up to $3,500 of the monthly U.S. health insurance premium paid by Mr. Baechler for himself and his dependents until the earliest date set forth by the Baechler Agreement. The Baechler Agreement will terminate upon the death of Mr. Baechler. We may terminate Mr. Bachelor upon disability as defined by the Baechler Agreement. If Mr.
Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies. 37 Dr. Rainer Metzger. Dr.
Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies. Dr. Rainer Metzger. Dr.
Involvement in Certain Legal Proceedings During the past ten years, none of our directors or executive officers have been the subject of the following events: 1. a petition under the Federal bankruptcy laws or any state insolvency law was filed by or against, or a receiver, fiscal agent or similar officer was appointed by a court for the business or property of such person, or any partnership in which he was a general partner at or within two years before the time of such filing, or any corporation or business association of which he was an executive officer at or within two years before the time of such filing; 2. convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding traffic violations and other minor offenses); 3. the subject of any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from, or otherwise limiting, the following activities; i) acting as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person regulated by the Commodity Futures Trading Commission, or an associated person of any of the foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee of any investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity; ii) engaging in any type of business practice; or iii) engaging in any activity in connection with the purchase or sale of any security or commodity or in connection with any violation of Federal or State securities laws or Federal commodities laws; 4. the subject of any order, judgment or decree, not subsequently reversed, suspended or vacated, of any Federal or State authority barring, suspending or otherwise limiting for more than 60 days the right of such person to engage in any activity described in paragraph 3.i in the preceding paragraph or to be associated with persons engaged in any such activity; 5. was found by a court of competent jurisdiction in a civil action or by the SEC to have violated any Federal or State securities law, and the judgment in such civil action or finding by the SEC has not been subsequently reversed, suspended, or vacated; 6. was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated; 7. was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of: i) any Federal or State securities or commodities law or regulation; or ii) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or iii) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or 8. was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member. 31 Director Independence We have five non-executive directors who qualify as “independent” according to the rules of the Nasdaq Stock Market, LLC.
Involvement in Certain Legal Proceedings During the past ten years, none of our directors or executive officers have been the subject of the following events: 1. a petition under the Federal bankruptcy laws or any state insolvency law was filed by or against, or a receiver, fiscal agent or similar officer was appointed by a court for the business or property of such person, or any partnership in which he was a general partner at or within two years before the time of such filing, or any corporation or business association of which he was an executive officer at or within two years before the time of such filing; 2. convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding traffic violations and other minor offenses); 3. the subject of any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from, or otherwise limiting, the following activities; i) acting as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person regulated by the Commodity Futures Trading Commission, or an associated person of any of the foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee of any investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity; ii) engaging in any type of business practice; or iii) engaging in any activity in connection with the purchase or sale of any security or commodity or in connection with any violation of Federal or State securities laws or Federal commodities laws; 40 4. the subject of any order, judgment or decree, not subsequently reversed, suspended or vacated, of any Federal or State authority barring, suspending or otherwise limiting for more than 60 days the right of such person to engage in any activity described in paragraph 3.i in the preceding paragraph or to be associated with persons engaged in any such activity; 5. was found by a court of competent jurisdiction in a civil action or by the SEC to have violated any Federal or State securities law, and the judgment in such civil action or finding by the SEC has not been subsequently reversed, suspended, or vacated; 6. was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated; 7. was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of: i) any Federal or State securities or commodities law or regulation; or ii) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or iii) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or 8. was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
Caragol is eligible to receive an annual bonus of up to 50% of his salary as determined by the Compensation Committee of the Board of Directors; (c) Mr. Caragol is to have his healthcare expensed paid, and a monthly office allowance, not to exceed $1,500 per month; and (d) Mr.
Caragol has an annual salary of $350,000; (b) Mr. Caragol is eligible to receive an annual bonus of up to 50% of his salary as determined by the Compensation Committee of the Board of Directors; (c) Mr. Caragol is to have his healthcare expensed paid, and a monthly office allowance, not to exceed $1,500 per month; and (d) Mr.
Director Compensation for Fiscal 2023 In addition to salaries and other compensation that we paid to our directors for services that they provided as officers, we paid each of our independent directors a quarterly fee of $10,500 for their services as directors (with the retainer for the Board Chairman at $15,000 per quarter).
Hekland. 45 Director Compensation for Fiscal 2024 In addition to salaries and other compensation that we paid to our directors for services that they provided as officers, we paid each of our independent directors a quarterly fee of $10,500 for their services as directors (with the retainer for the Board Chairman at $15,000 per quarter).
In our fiscal 2023, we paid our directors an aggregate of $228,000 for their services as directors. Pension Benefits We do not have any defined benefit pension plans or any other plans requiring us to make retirement payments or pay comparable benefits.
In our fiscal 2024, we paid our directors an aggregate of $144,000 for their services as directors. Pension Benefits We do not have any defined benefit pension plans or any other plans requiring us to make retirement payments or pay comparable benefits.
Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 3,175,000 ordinary shares.
Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 79,375 ordinary shares.
When determining the compensation arrangements for our executive officers, our Compensation Committee considers the objectives of: (i) retaining an executive critical to our success and the enhancement of shareholder value; (ii) providing fair and competitive compensation; (iii) balancing the interests of management and our shareholders; and (iv) rewarding performance, both on an individual basis and with respect to the business in general.
When determining the compensation arrangements for our executive officers, our Compensation Committee considers the objectives of: (i) retaining an executive critical to our success and the enhancement of shareholder value; (ii) providing fair and competitive compensation; (iii) balancing the interests of management and our shareholders; and (iv) rewarding performance, both on an individual basis and with respect to the business in general. 41 Benchmarking Our Compensation Committee handles matters relating to compensation, including benchmarking.
Board Practices Board of Directors We have seven directors, five of whom satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act.
Board Practices Board of Directors We have four directors, three of whom satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act.
Nicole Holden is the Chair of the Audit Committee and is an “audit committee financial expert” within the meaning of the SEC rules and possesses financial sophistication within the meaning of the Listing Rules of the Nasdaq Stock Market. The Audit Committee oversees our accounting and financial reporting processes and the audits of the financial statements of our company.
Gregory Tibbits is the Chair of the Audit Committee and is an “audit committee financial expert” within the meaning of the SEC rules and possesses financial sophistication within the meaning of the Listing Rules of the Nasdaq Stock Market. The Audit Committee oversees our accounting and financial reporting processes and the audits of the financial statements of our company.
Our officers and directors do not hold any other securities convertible into our ordinary shares. 38
Our officers and directors do not hold any other securities convertible into our ordinary shares. 48
Benchmarking Our Compensation Committee handles matters relating to compensation, including benchmarking. The Compensation Committee considers a variety of factors when designing and establishing, reviewing and making recommendations for executive compensation arrangements for all our executive officers. The Compensation Committee does not intend to position executive pay to reflect a single percentile within the industry for each executive.
The Compensation Committee considers a variety of factors when designing and establishing, reviewing and making recommendations for executive compensation arrangements for all our executive officers. The Compensation Committee does not intend to position executive pay to reflect a single percentile within the industry for each executive.
(U.S. dollars in thousands) All executive officers Base compensation $ 1.859 Bonuses 452 Additional benefit payments 124 Total cash compensation $ 2,435 Executive Compensation Agreements Guido Baechler, Chief Executive Officer On July 1, 2021, we entered into a management services agreement with Guido Baechler (as amended, the “Baechler Agreement”). Pursuant to the Baechler Agreement: (a) Mr.
(U.S. dollars in thousands) All executive officers Base compensation $ 1,088,133 Bonuses - Additional benefit payments - Total cash compensation $ 1,088,133 Executive Compensation Agreements Guido Baechler, Chief Executive Officer On July 1, 2021, we entered into a management services agreement with Guido Baechler (as amended, the “Baechler Agreement”). Pursuant to the Baechler Agreement: (a) Mr.
Term of Office Each director is to serve until his successor is elected and qualified or until his death, resignation or removal. Our Board of Directors appoints our officers and each officer is to serve until his successor is appointed and qualified or until his or her death, resignation or removal.
Our Board of Directors appoints our officers and each officer is to serve until his successor is appointed and qualified or until his or her death, resignation or removal.
If we terminate the Baechler Agreement without good cause or Mr. Baechler resigns with good reason in compliance with the relevant terms and conditions of the Baechler Agreement, we shall be obligated to provide a severance package to Mr.
Baechler resigns with good reason in compliance with the relevant terms and conditions of the Baechler Agreement, we shall be obligated to provide a severance package to Mr.
Audit Committee We appointed to our Audit Committee three non-executive directors, Nicole Holden, Dr. Alberto Libanori, and Gregory Tibbitts, that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act.
Audit Committee We appointed to our Audit Committee three non-executive directors, Gregory Tibbitts, Hans Hekland and Heiner Dreismann, that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act.
Nominating Committee We appointed to our Nominating Committee three non-executive directors, Gregory Tibbitts, Nicole Holden and Dr. Alberto Libanori, that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Gregory Tibbits is the Chair of the Nominating Committee.
Nominating Committee We appointed to our Nominating Committee three non-executive directors, Gregory Tibbitts, Dr. Heiner Dreismann and Hans Hekland, that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Mr. Hekland is the Chair of the Nominating Committee.
During this time, Mr. von Toerne has obtained significant technical experience in various diagnostic technologies (PCR, sequencing, immuno-assays, AST), alliance management, and key account management. Successful registration of several products with the FDA fall into this timeframe.
Chris von Toerne , our Chief Operating Officer, has over 15 years of experience in the development and global commercialization of IVD products. During this time, Mr. von Toerne has obtained significant technical experience in various diagnostic technologies (PCR, sequencing, immuno-assays, AST), alliance management, and key account management. Successful registration of several products with the FDA fall into this timeframe.
Employees As of March 26, 2024, the breakdown of employees by main category of activity is as follows: Activity Number of Full-Time Employees Number of Part-Time Employees Manufacturing and Clinical Laboratory 16 1 Research & Development 26 2 Sales & Marketing 10 2 Finance & Administration 11 1 Executives 2 0 Total: 65 6 None of our employees are covered by a collective bargaining agreement.
Employees As of March 21, 2025, the breakdown of employees by main category of activity is as follows: Activity Number of Full-Time Employees Number of Part-Time Employees Manufacturing and Clinical Laboratory 1 - Research & Development 6 2 Sales & Marketing 3 2 Finance & Administration 8 1 Executives 1 2 Total: 19 7 None of our employees are covered by a collective bargaining agreement.
Baechler; and (iii) such benefits (including equity compensation), if any, to which Mr. Baechler may be entitled under our benefit plans as of termination; provided that, in no event shall Mr. Baechler be entitled to any payments in the nature of severance or termination payments except as specifically provided in the Baechler Agreement (collectively the “Accrued Amounts”).
Baechler; and (iii) such benefits (including equity compensation), if any, to which Mr. Baechler may be entitled under our benefit plans as of termination; provided that, in no event shall Mr.
The carve-out pool will be allocated and paid to participants in the COP based on the product of the participant’s applicable carve-out percentage as defined in the COP. 35 Under the COP, participants may receive transaction carve-out equal to the carve-out pool amount multiplied by each participant’s carve-out percentage specified in such participant’s participation acknowledgment less that participant’s equity offset, as defined under the COP.
Under the COP, participants may receive transaction carve-out equal to the carve-out pool amount multiplied by each participant’s carve-out percentage specified in such participant’s participation acknowledgment less that participant’s equity offset, as defined under the COP.
Alberto Libanori 34 Non-Executive Director November 2021 California, USA Hans Hekland 65 Non-Executive Director November 2021 Bergen, Norway Philipp Freese 42 Chief Business Officer February 2015 Grevenbroich, Germany Nicole Holden 51 Non-Executive Director November 2021 Virginia, USA Gregory Tibbitts 56 Non-Executive Director December 2022 California, USA Business Experience The following summarizes the occupation and business experience for our directors, and executive officers as of the date of this annual report: Guido Baechler , our Chief Executive Officer and an executive director, has global experience in private and public companies specializing in the life science and medical diagnostics fields.
Chris von Toerne 53 Chief Operating Officer June 2022 Mainz, Germany Hans Hekland 66 Non-Executive Director November 2021 Bergen, Norway Gregory Tibbitts 57 Non-Executive Director December 2022 California, USA 38 Business Experience The following summarizes the occupation and business experience for our directors, and executive officers as of the date of this annual report: Guido Baechler , our Chief Executive Officer and an executive director, has global experience in private and public companies specializing in the life science and medical diagnostics fields.
Our Board has determined that the following non-executive directors are “independent” as such directors do not have a direct or indirect material relationship with our company: Dr. Alberto Libanori, Nicole Holden, Hans Hekland, Dr. Heiner Driesmann and Gregory Tibbits.
Director Independence We have three non-executive directors who qualify as “independent” according to the rules of the Nasdaq Stock Market, LLC. Our Board has determined that the following non-executive directors are “independent” as such directors do not have a direct or indirect material relationship with our company: Hans Hekland, Dr. Heiner Driesmann and Gregory Tibbits.
Dr. von Toerne holds a Masters’s Degree and a Doctorate in Applied Mathematics from Bonn University, Germany. He also holds a Project Management Professional (PMP) certificate and has undergone Six Sigma Green Belt training.
Dr. von Toerne holds a Masters’s Degree and a Doctorate in Applied Mathematics from Bonn University, Germany. He also holds a Project Management Professional (PMP) certificate and has undergone Six Sigma Green Belt training. Hans Hekland , a non-executive director, graduated Siviløkonom (MBA) from Norwegian School of Economics and Business Administration in Bergen, Norway in 1983.
Each award was made pursuant to a COP participation acknowledgement form. Future awards of carve-out percentages may be made at the discretion of our Compensation Committee.
Each award was made pursuant to a COP participation acknowledgement form. Future awards of carve-out percentages may be made at the discretion of our Compensation Committee. On March 4, 2025 the Compensation Committee approved the allocation of the entire 100% of the COP. The allocations are 40% for Mr. Baechler, 25% for Mr.
Name, Region/State and Country of Residence Age Position Director/Officer Since Guido Baechler 58 Chief Executive Officer, Executive Director July 2021 California, USA William Caragol 57 Chief Financial Officer July 2021 Florida, USA Dr. Moritz Eidens 41 Chief Scientific Officer, Executive Director June 2008 Ingelheim, Germany Dr.
Name, Region/State and Country of Residence Age Position Director/Officer Since Guido Baechler 59 Chief Executive Officer, Executive Director July 2021 California, USA William Caragol 58 Chief Financial Officer July 2021 Florida, USA Dr. Heiner Dreismann 71 Non-Executive Director December 2022 Florida, USA Dr.
Caragol has served as the Chief Operating Officer for Iron Horse Acquisitions Corp. (NASDAQ: IROH), a special purpose acquisition corporation. Mr. Caragol earned a B.S. in business administration and accounting from Washington & Lee University and is a member of the American Institute of Certified Public Accountants. Dr.
Caragol has been Chairman of the Board of Thermomedics, Inc., a medical diagnostic equipment company. Mr. Caragol earned a B.S. in business administration and accounting from Washington & Lee University and is a member of the American Institute of Certified Public Accountants. Dr.
William Caragol, Chief Financial Officer On April 29, 2022, effective May 1, 2022, we entered into an Employment Contract with Mr. Caragol (the “Caragol Contract”). Pursuant to the Caragol Contract: (a) Mr. Caragol has an annual salary of $350,000; (b) Mr.
As discussed in further detail below, we have also granted Mr. Baechler a carve-out percentage under our Carve-Out Plan equal to 40% of the carve-out pool amount. William Caragol, Chief Financial Officer On April 29, 2022, effective May 1, 2022, we entered into an Employment Contract with Mr. Caragol (the “Caragol Contract”). Pursuant to the Caragol Contract: (a) Mr.
He obtained a B.B.A. at University of San Diego and an M.B.A. at San Diego State University. 30 Family Relationships There are no family relationships among any of our directors and executive officers. Arrangements We are not aware of any arrangement among shareholders regarding the nomination or approval of directors or senior management.
Family Relationships There are no family relationships among any of our directors and executive officers. Arrangements We are not aware of any arrangement among shareholders regarding the nomination or approval of directors or senior management. Term of Office Each director is to serve until his successor is elected and qualified or until his death, resignation or removal.
(“Mainz USA”) and the Board of Directors of Mainz USA approved the COP.
Carve-Out Plan On February 22, 2024, our Compensation Committee approved the carve-out plan (the “COP”) of Mainz Biomed USA, Inc. (“Mainz USA”) and the Board of Directors of Mainz USA approved the COP.
Dagfinn Øgreid and Dr Roger Løvlie and engaged PharmGenomics to develop the ColoAlert test, which led to the current license agreement. Dr. Alberto Libanori , a non-executive director, serves as Managing Director to Boustead Securities, LLC.
Dagfinn Øgreid and Dr Roger Løvlie and engaged PharmGenomics to develop the ColoAlert test, which led to the current license agreement. Gregory Tibbitts , a non-executive director, is a Certified Public Accountant with over 30 years of professional experience as a senior financial executive and as a board member of publicly traded and privately held companies.
Securities and Exchange Commission. He worked as a Chief Financial Officer for both public and private companies, primarily in the medical diagnostics and life sciences sectors. He served as a board member for CoImmune Inc, a biotechnology company, through March 2024, and served as a board member for IDMI Pharma, Inc., a NASDAQ listed biotech company prior to its acquisition.
He served as a board member for CoImmune Inc, a biotechnology company, through March 2024, and served as a board member for IDMI Pharma, Inc., a NASDAQ listed biotech company prior to its acquisition. He obtained a B.B.A. at University of San Diego and an M.B.A. at San Diego State University.
In 2018, he founded and is the Managing Director of Quidem LLC, a corporate strategic and financial advisory firm. Since 2015, Mr. Caragol has been Chairman of the Board of Thermomedics, Inc., a privately held medical diagnostic equipment company. Since February 2021, Mr.
In 2018, he founded and is the Managing Director of Quidem LLC, a corporate strategic and financial advisory firm. Since November 2021, Mr. Caragol has also served as the Chief Operating Officer and Chief Financial Officer of Iron Horse Acquisitions Corp. (NASDAQ: IROH). Since July 2023, Mr.
Gregory Tibbitts , a non-executive director, is a Certified Public Accountant with over 30 years of professional experience as a senior financial executive and as a board member of publicly traded and privately held companies. His expertise includes multiple debt and equity transactions, restructure of complex manufacturing operations, resolution of technical accounting issues and direct interactions with the U.S.
His expertise includes multiple debt and equity transactions, restructure of complex manufacturing operations, resolution of technical accounting issues and direct interactions with the U.S. Securities and Exchange Commission. He worked as a Chief Financial Officer for both public and private companies, primarily in the medical diagnostics and life sciences sectors.
If Mr. Baechler is terminated on account of death or disability, we will provide Mr. Baechler, his estate, or, if applicable, Mr. Baechler’s beneficiaries with the Accrued Amounts. As discussed in further detail below, we have also granted Mr. Baechler a carve-out percentage under our Carve-Out Plan equal to 30% of the carve-out pool amount.
Baechler is terminated on account of death or disability, we will provide Mr. Baechler, his estate, or, if applicable, Mr. Baechler’s beneficiaries with the Accrued Amounts. On November 1, 2024, the Company and Mr. Baechler amended the Baechler Agreement, reducing the salary and commitment level of Mr. Baechler to 60% of his then current salary, effective November 1, 2024.
Freese may resign and terminate the Freese Agreement with written notice until the last day of the sixth month after the change of control has occurred. Stock Option Plans and Stock Options We have adopted our 2021 Omnibus Incentive Plan and our 2022 Omnibus Incentive Plan, as amended (the “Plans”).
Caragol a carve-out percentage under our Carve-Out Plan equal to 25% of the carve-out pool amount. 44 Stock Option Plans and Stock Options We have adopted our 2021 Omnibus Incentive Plan and our 2022 Omnibus Incentive Plan, as amended (the “Plans”).
During 2022 all of these options vested. As discussed in further detail below, we have also granted Mr. Caragol a carve-out percentage under our Carve-Out Plan equal to 15% of the carve-out pool amount. Dr. Moritz Eidens, Chief Scientific Officer On September 20, 2021, we entered into a Management Services Agreement with Dr.
During 2022 all of these options vested. On November 1, 2024, the Company and Mr. Caragol amended the Caragol Agreement, reducing the salary and commitment level of Mr. Caragol to 50% of his then current salary, effective November 1, 2024. As discussed in further detail below, we have also granted Mr.
Removed
Heiner Dreismann 70 Non-Executive Director December 2022 Florida, USA Darin Leigh 56 Chief Commercial Officer March 2022 Florida, USA Dr. Chris von Toerne 52 Chief Operating Officer June 2022 Mainz, Germany Dr. Frank Kreig-Schneider 62 Chief Technology Officer August 2022 Mainz, Germany Dr.
Added
Caragol has also been on the board of directors and has been Chairman of the audit committee of Janover, Inc. (NASDAQ: JNVR), serves on the board of Worksport Ltd. since June 2021, and he served on the board of directors of Greenbox POS (NASDAQ: GBOX) from 2021 to April 2023. Since 2015, Mr.
Removed
Caragol is also on the Board of Directors and is Chairman of the Audit Committee of RYVYL, Inc. (NASDAQ: RVYL) a financial technology company leveraging proprietary blockchain security to build customized payment solutions, and since July 2021 is on the Board of Directors of Worksport Ltd. (Nasdaq: WKSP), an emerging electric vehicle company. Since November 2021, Mr.
Added
Baechler be entitled to any payments in the nature of severance or termination payments except as specifically provided in the Baechler Agreement (collectively the “Accrued Amounts”). 43 If we terminate the Baechler Agreement without good cause or Mr.
Removed
Moritz Eidens , our Chief Scientific Officer and an executive director, received his Masters Degree at the international oriented University of Applied Sciences in Rheinbach near Bonn, Germany in 2006 with a focal point on human genetics and genetic diseases. In 2019, Dr.
Added
As of March 4, 2025, the compensation committee and board of directors approved a 2025 Stock Plan, subject to shareholder approval and granted 416,748 stock options under the 2025 Plans, with a strike of $4.95.
Removed
Eidens graduated from the University-Medicine Hospital of the Johannes Gutenberg University in Mainz, Germany, and was awarded with a Ph.D. from the medical faculty. In 2008, Dr. Eidens founded PharmGenomics and has served since then as an executive of the organization. Dr.
Added
Such stock options have been granted to our current employees, directors, advisors and senior management team, all of which are contingent on shareholder approval of the 2025 Plan.
Removed
Eidens has been involved in PharmGenomics’ development and distribution of several innovative products, managed and coordinated several national and international grant projects with large industrial or academic partners process development, technology transfer, supply chain management as well as internal and external audits. In September 2021, Dr. Eidens was appointed as Chief Scientific Officer at Mainz Biomed N.V.
Added
All of such stock options begin vesting at shareholder approval and will be fully vested subject to shareholder approval two years from the date of grant Of the 416,748 stock options granted as of March 4, 2025, we granted 287,500 to our current directors and executive officers.
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He also serves as Managing Director of Mainz Biomed Germany GmbH and the European Oncology Lab GmbH in St. Ingbert, Germany our wholly-owned subsidiaries. Dr. Eidens heads the Company’s research department, where our product candidate PancAlert, a stool based pancreatic cancer screening tool is under development. Dr.
Added
The carve-out pool will be allocated and paid to participants in the COP based on the product of the participant’s applicable carve-out percentage as defined in the COP.
Removed
Darin Leigh , our Chief Commercial Officer, has over 30 years of global life sciences and in-vitro diagnostics experience. Mr. Leigh founded Simeon Global Consulting LLC in 2017 focused on implementing commercialization strategies for small startup and early-stage diagnostic companies.
Added
Caragol, 10% each for Mr. von Toerne and VP of Commercial Operations Tarrin Khari-Taraki, and 5% each to Dr. Dreismann, Mr. Tibbitts and Mr.
Removed
From December 2020 to April 2022, he was Chief Commercial Officer for CDR Maguire, an emergency management company based in Florida who were responsible for the state’s response to the COVID pandemic including operationalizing testing and vaccination sites across Florida.
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He was Chief Commercial Officer for Chromacode Inc, from July 2019 to December 2020, and Chief Commercial Officer for Singulex, Inc from August 2018 to June 2019. Mr. Leigh previously held leadership positions at Metabolon, Inc, Asuragen, Inc, Luminex Corporation and Abbott Diagnostics.
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During his time at Luminex, he grew the company revenues from $26 million in 2005 to $183 million in 2011 and oversaw significant global commercial growth and formation of international operations in Japan, China and Europe. Mr.
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Leigh holds a Degree in Medical Laboratory Sciences from the University College London and completed several MBA management classes at the University of Chicago Booth School of Business. Dr. Chris von Toerne , our Chief Operating Officer, has over 15 years of experience in the development and global commercialization of IVD products.
Removed
Frank Krieg-Schneider , our Chief Technology Officer, has over 30 years of experience in private, public and startup companies in the life sciences and in-vitro diagnostics field. Dr. Krieg-Schneider founded KS Management Consulting in 2019 focused on connecting startup and IVD companies.
Removed
Prior to joining Mainz Biomed, he was responsible for sales and marketing of the diagnostic products at r-biopharm, a privately owned company and market leader in stool-based diagnostics based in Germany. 29 Dr. Krieg-Schneider previously held leadership positions at Qiagen and r-biopharm. During his time at Qiagen, he developed the QIAamp product line and several automated sample preparation systems.
Removed
Furthermore, he built the company’s OEM business and grew the revenues significantly. At r-biopharm he oversaw the transition of the product portfolio to meet the requirements of the IVDR and positioned the company as one of the leading COVID PCR test providers in several countries in Europe, Latin America and Canada during the pandemic. Dr.
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Krieg-Schneider graduated from Johannes Gutenberg University in Mainz, Germany, and was awarded with a Ph.D. from the faculty of Biology for his thesis conducted at the German Cancer Research Center in Heidelberg, Germany.
Removed
Philipp Freese , our Chief Business Officer, received his Diploma in Business Administration with focus on marketing, business law and production technology at Excellence University RWTH in Aachen/Germany in 2008. Until 2015 he worked in project, product, process, quality and key account management as well as business development for the German Economic Institute.
Removed
In 2014, he successfully finished his postgraduate studies in IT-related business administration. Mr. Freese served as the Interim Head of Marketing at PharmGenomics from 2013 to 2015, and in 2015 he became its Commercial Managing Director responsible for marketing, sales, operations, legal affairs and Finance/IR.
Removed
He was the major driver for ColoAlert’s product-market-fit, brand, customer-facing processes and marketing strategies, established relationships with reference laboratories and assisted in our capital raises. In September 2021, Mr. Freese was appointed as Chief Operating Officer at Mainz Biomed N.V. In July 2023, he transitioned into the commercial role of our Chief Business Officer.
Removed
He also serves as Managing Director of Mainz Biomed Germany GmbH and European Oncology Lab GmbH, our wholly owned subsidiaries. Hans Hekland , a non-executive director, graduated Siviløkonom (MBA) from Norwegian School of Economics and Business Administration in Bergen, Norway in 1983.
Removed
Alberto has 10 years’ work experience at the science-business interface in venture capital, BD&L, M&A and IPOs, focusing in life-sciences, med-tech and cosmeceuticals, having worked with L’Oréal Research and Innovation, M-Ventures, and Novartis Venture Funds (NVF). Previously Alberto founded and helped with the strategic exits of a number of technology start-ups including Atelier Mnemist SAS and Cutech (acquired by Symrise).
Removed
He is currently an Independent Director on the Board of Nasdaq-listed Brera Holdings PLC (BREA), a multi-club ownership company in global football, and The RoyaLand Company Limited, a Bermuda company focused on royal themed multiplayer online role-playing game.
Removed
A prolific scientist, Alberto has published more than 40 peer-reviewed articles in journals including Nature Electronics, Advanced Materials, and ACS Nano, and is the holder of two patents.
Removed
Alberto Libanori holds a PhD and MS in Bioengineering from UCLA, with focus on wearable and implantable bioelectronics and biomaterials for regenerative medicine, an MPhil in Bioscience Enterprise from Cambridge University, and a Bachelor’s in Bimolecular Sciences (Hons) from St Andrews University. Raised internationally, Alberto is fluent in English, French, Spanish, Mandarin Chinese and Portuguese, alongside his native Italian.
Removed
Nicole Holden , CPA, a non-executive director, has more than 20 years of accounting advisory experience for large publicly traded and privately held clients. Ms. Holden advises clients in matters involving SEC reporting, complex financial transactions, initial public offerings, acquisitions and divestiture accounting, restructuring, discontinued operations, and various technical accounting matters. From 2018 to 2023, Ms.
Removed
Holden was the Audit Committee Chair for Nerds On Site, Inc. (CSE: NERD). Prior to joining our Board, Ms. Holden had a broad professional career. She is currently the Vice President, Client Advisory in the Advisory Service practice for The Alliance Group. Ms. Holden was also an Assistant Controller for Enviva LP (NYSE: EVA).
Removed
She was a Director in the Professional practice for the Center for Audit Quality (The CAQ). She also served as a Senior Manager in the Office of Research and Analysis and Assistant Chief Auditor in the Office of the Chief Auditor for the Public Company Accounting Oversight Board (PCAOB).
Removed
She was a Director in the Transaction Services practice at KPMG LLP. She also served as a Senior Manager in the Assurance practice at Stonefield Josephson, Inc. She was a Staff Accountant in the Corporate Finance division of the U.S. Securities and Exchange Commission (SEC). She also worked on the Internal Audit team for Computer Sciences Corp (NYSE: DXC).

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

7 edited+3 added−3 removed3 unchanged
As a result, these numbers may not accurately represent the number of beneficial owners in the United States. 39 Transfer Agent We have appointed Transhare Corporation as the transfer agent for our ordinary shares. Transhare Corporation’s telephone number and address is (303) 662-1112 and 17755 US Hwy 19 N, Clearwater, FL 33764. B.
As a result, these numbers may not accurately represent the number of beneficial owners in the United States. Transfer Agent We have appointed Transhare Corporation as the transfer agent for our ordinary shares. Transhare Corporation’s telephone number and address is (303) 662-1112 and 17755 US Hwy 19 N, Clearwater, FL 33764. 49 B.
Major Shareholders Security Ownership of Certain Beneficial Owners and Management The following table sets forth certain information regarding the beneficial ownership of our ordinary shares as of March 26, 2024 by (a) each shareholder who is known to us to own beneficially 5% or more of our outstanding ordinary shares; (b) all directors; (c) our executive officers and (d) all executive officers and directors as a group.
Major Shareholders Security Ownership of Certain Beneficial Owners and Management The following table sets forth certain information regarding the beneficial ownership of our ordinary shares as of March 21, 2025 by (a) each shareholder who is known to us to own beneficially 5% or more of our outstanding ordinary shares; (b) all directors; (c) our executive officers and (d) all executive officers and directors as a group.
We note that one of these shareholders is Cede & Co. which, as nominee for The Depository Trust Company, is the record holder of 17,115,211 ordinary shares. Accordingly, we believe that the shares held by Cede & Co. include ordinary shares beneficially owned by both holders in the United States and non-United States beneficial owners.
We note that one of these shareholders is Cede & Co. which, as nominee for The Depository Trust Company, is the record holder of 2,837,710 ordinary shares. Accordingly, we believe that the shares held by Cede & Co. include ordinary shares beneficially owned by both holders in the United States and non-United States beneficial owners.
Our ordinary shares are held by 31 holders of record, of which 8 have registered addresses in the United States. Together such shareholders hold approximately 17,557,165 ordinary shares which account for approximately 80% of our ordinary shares outstanding as of April 8, 2024.
Our ordinary shares are held by 21 holders of record, of which 9 have registered addresses in the United States. Together such shareholders hold approximately 2,954,801 ordinary shares which account for approximately 97% of our ordinary shares outstanding as of March 21, 2025.
Name Ordinary Shares Beneficially Owned (1) Percentage of Ordinary Shares Beneficially Owned (1) Directors and Executive Officers: Guido Baechler, Chief Executive Officer, Executive Director 752,357 3.4 % William Caragol, Chief Financial Officer 212,677 1.0 % Dr.
Name Ordinary Shares Beneficially Owned (1) Percentage of Ordinary Shares Beneficially Owned (1) Directors and Executive Officers: Guido Baechler, Chief Executive Officer, Executive Director 20,059 * % William Caragol, Chief Financial Officer 7,899 * % Dr. Chris von Toerne, Chief Operating Officer 2,500 * % Dr.
(2) Hans Hekland has dispositive and voting control over the shares held by Hannibal Invest AS and Unitargeting Research AS.
(2) Hans Hekland has dispositive and voting control over the shares held by Hannibal Invest AS and Unitargeting Research AS. The balance for Hans Hekland includes 208 ordinary shares underlying options that may be exercised within the next 60 days.
Alberto Libanori, Non-Executive Director 35,000 0.2 % Hans Hekland, Non-Executive Director (2) 717,081 3.3 % Nicole Holden, Non-Executive Director 35,000 0.2 % Gregory Tibbits, Non-Executive Director 35,000 0.2 % Directors and Executive Officers as a Group (Ten Persons) 3,497,394 14.9 % Other 5% or more Shareholders: Kreditanstalt für Wiederaufbau (3) 1,237,501 5.7 % (1) Based on 21,886,575 ordinary shares outstanding.
Heiner Dreismann, Non-Executive Director 2,200 * % Hans Hekland, Non-Executive Director (2) 17,979 * % Gregory Tibbits, Non-Executive Director 875 * % Directors and Executive Officers as a Group (Six Persons) 51,512 1.7 % Other 5% or more Shareholders: Armistice Capital LLC (3) 312,915 9.9 % * Less than 1%. (1) Based on 3,038,853 ordinary shares outstanding.
Removed
Moritz Eidens, Chief Scientific Officer, Executive Director 1,126,348 5.1 % Philipp Freese, Chief Business Officer 361,972 1.6 % Darin Leigh, Chief Commercial Officer 115,417 0.5 % Dr. Chris von Toerne, Chief Operating Officer 6,771 0.0 % Dr. Frank Kreig-Schneider, Chief Technology Officer 11,771 0.1 % Dr. Heiner Dreismann, Non-Executive Director 88,000 0.4 % Dr.
Added
(3) Such amount includes shares purchased by Armistice Capital LLC as well as a portion of the ordinary shares underlying pre-funded warrants purchased by Armistice Capital LLC. Such pre-funded warrants are subject to a blocker that prohibits any exercise that would result in the holder owning more than 9.99% of our then outstanding common shares.
Removed
The balance for Hans Hekland includes 208 ordinary shares underlying options that may be exercised within the next 60 days (3) Kreditanstalt für Wiederaufbau (known as KfW) is a public law institution ( Anstalt des öffentlichen Rechts ) serving domestic and international public policy objectives of the Federal Government of the Federal Republic of Germany.
Added
This amount excludes shares underlying such pre-funded warrants that would cause the holder to exceed 9.99% beneficial ownership as well as ordinary shares underlying warrants held by such person that have a blocker preventing exercise that would result in more than 4.99% beneficial ownership.
Removed
We have the following arrangements with immediate family members of related parties that we consider to be arms’-length and immaterial: we have an employment agreement with the wife of our Chief Scientific Officer whereby we pay her approximately €42,000 per year. C. Interests of Experts and Counsel Not Applicable.
Added
C. Interests of Experts and Counsel Not Applicable.

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