What changed in MAINZ BIOMED N.V.'s 10-K — 2024 vs 2025

ITEM 3. KEY INFORMATION A. [Reserved] B. Capitalization and Indebtedness Not applicable. C. Reasons for the offer and use of proceeds Not applicable. D. Risk Factors An investment in our ordinary shares carries a significant degree of risk.

You should carefully consider the following risks, as well as the other information contained in this annual report, including our historical financial statements and related notes included elsewhere in this annual report, before you decide to purchase our ordinary shares.

Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our ordinary shares. Refer to “Special Note Regarding Forward-Looking Statements”.

We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us.

There may be additional risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion of your investment due to any of these risks and uncertainties.

Risks Related to Our Business Generally We are an early revenue stage company and have incurred operating losses since inception, and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.

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.

Ultimately, our ability to generate sufficient operating revenue to earn a profit depends upon our success in developing and marketing or licensing our diagnostic tests and technology.

Any failure to do so could result in the possible closure of our business or force us to seek additional capital through loans or additional sales of our equity securities to continue business operations, which could dilute the value of any securities you hold or could result in the loss of your entire investment.

Until we earn a profit (and even if we earn a profit, until we earn a sufficient profit), our ability to continue and grow our operations depend on our ability to raise additional capital through debt and equity financings.

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.

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.

Preferred shares could be issued in series from time to time with such designation, rights, preferences, and limitations as needed to raise capital. The terms of preferred shares could be more advantageous to those investors than to the holders of ordinary shares.

In addition, if we need to raise more equity capital from the sale of ordinary shares, institutional or other investors may negotiate terms at least as, and possibly more, favorable than the terms of your investment.

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 of the date of this annual report, we are subject to the “baby shelf” restrictions for the use of a shelf registration statement, meaning that we can only offer one-third of our public float through a shelf registration statement in any 12-month period.

We are not currently able to sell any securities through our shelf registration statement on Form F-3.

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.

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.

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.

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.

Our ability to manage our growth effectively requires us to forecast expenses accurately, and to properly forecast and expand operational and testing facilities, if necessary, to expend funds to improve our operational, financial and management controls, reporting systems and procedures.

As we move forward in commercializing our tests and developing our test portfolio, we will also need to effectively manage our growing manufacturing, laboratory operations and sales and marketing needs. If we are unable to manage our anticipated growth effectively, our business could be harmed.

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.

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.

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 substantially depends upon our senior management’s ability to lead our company, implement successful corporate strategies and initiatives, develop key relationships, including relationships with collaborators and business partners, and successfully commercialize products and services. While our management has significant experience developing diagnostic products, we have considerably less experience in commercializing these products or services.

The efforts of our management will be critical as we develop our technologies and seek to commercialize our tests and other products and services. Failure of our internal controls over financial reporting could harm our business and financial results. Our management is responsible for establishing and maintaining adequate internal control over financial reporting.

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting for external purposes in accordance with accounting principles generally accepted in the United States.

Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures of our assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements would be prevented or detected on a timely basis.

Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected. Our growth and entry into new diagnostic tests, technologies and markets will place significant additional pressure on our system of internal control over financial reporting.

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.

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.

Since inception, we have devoted substantially all of our resources to developing our in-vitro diagnostic tests, establishing partnerships and sales channels to distribute such tests and operating a clinical diagnostic laboratory.

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.

These factors led management to conclude that there is a substantial doubt as to our ability to continue as a going concern for a period that is one year from the date of our financial statements, and we prepared out financial statements on that basis.

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.

We expect our financial condition and operating results to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.

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 are constituted under the laws of the Netherlands. A substantial portion of our officers, and directors, reside outside the United States. In addition, a substantial portion of their assets and our assets are located outside of the United States.

As a result, you may have difficulty serving legal process within the United States upon us or any of these persons. You may also have difficulty enforcing, both in and outside of the United States, judgments you may obtain in U.S. courts against us or these persons in any action, including actions based upon the civil liability provisions of U.S.

Furthermore, there is substantial doubt as to the enforceability in the Netherlands against us or against any of our directors, officers and the expert named in this annual report who are not residents of the United States, in original actions or in actions for enforcement of judgments of U.S. courts, of liabilities based solely upon the civil liability provisions of the U.S. federal securities laws.

In addition, shareholders in Dutch corporations may not have standing to initiate a shareholder derivative action in U.S. federal courts. As a result, our public shareholders may have more difficulty in protecting their interests through actions against us, our management, our directors or our major shareholders than would shareholders of a corporation incorporated in a jurisdiction in the United States.

Global economic conditions could materially adversely impact demand for our products and services. Our operations and performance depend significantly on economic conditions.

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.

Uncertainty about global economic conditions could result in: ● customers postponing purchases of our products and services in response to tighter credit, unemployment, negative financial news and/or declines in income or asset values and other macroeconomic factors, which could have a material negative effect on demand for our products and services; and ● third-party suppliers being unable to produce components for our products in the same quantity or on the same timeline or being unable to deliver such parts and components as quickly as before or subject to price fluctuations, which could have a material adverse effect on our production or the cost of such production; and accordingly, on our business, results of operations or financial condition.

Access to public financing and credit can be negatively affected by the effect of these events on German, Dutch, European, U.S. and global credit markets. The health of the global financing and credit markets may affect our ability to obtain equity or debt financing in the future and the terms at which financing or credit is available to us.

These instances of volatility and market turmoil could adversely affect our operations and the trading price of our ordinary shares. Changes to trade policy, tariffs, and import/export regulations may have a material adverse effect on our business, financial condition, and results of operations. Changes in laws and policies governing foreign trade could adversely affect our business.

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.

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.

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.

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.

Conversely, to the extent that we are required to pay for goods or services in U.S. dollars, the depreciation of the Euro dollar against the U.S. dollar would increase the cost of such goods and services.

We do not hedge our currency exposure and, therefore, we incur currency transaction risk whenever we enter into either a purchase or sale transaction using a currency other than the Euro.

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.

We believe our commercial success depends upon our ability to successfully market and sell our products and solutions, to continue to expand our current relationships and to develop new relationships with customers, physicians, and laboratories.

The demand for our existing and future services may decrease for a number of reasons, including, but is not limited to, the development by competitors of new products, and increased competition from companies that offer similar products and solutions.

In addition to reducing our revenue, if our laboratory partners or clients decide to decrease or discontinue their partnerships or relationships with us, and their use of our knowledge and interpretation-based solutions, this may reduce our access to research and patient data that facilitates the incorporation of newly developed information about rare diseases into our data repository.

Our success depends heavily on our ColoAlert screening tests. For the foreseeable future, our ability to generate revenues depends almost entirely on the commercial success of ColoAlert, our colon cancer screening test.

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.

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.

If we are unable to develop and maintain substantial sales of our tests or if we are significantly delayed or limited in doing so, our business prospects, financial condition and results of operation would be adversely affected.

Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.

Physicians and hospitals may be reluctant to try a new diagnostic test due to the high degree of risk associated with the application of new technologies and diagnostic test in the field of human medicine, especially if the new test differs from the current standard of care for detecting cancer in patients.

For example, CRC prevention strategies, such as FIT and colonoscopies, are well known in the patient group aged over 50 years, while ColoAlert and similar diagnostic tests are not vastly known by physicians or patients. We will need to expend significant sums of money to market our products to increase the public’s awareness.

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.

To compete with other diagnostic tests, particularly any that sell at lower prices, our tests will have to provide medically significant advantages or be more cost effective.

Even if we can overcome physician reluctance and compete with products that are currently on the market, our competitors may succeed in developing new, safer, more accurate or more cost-effective diagnostic tests that could render our diagnostic tests and technologies obsolete or non-competitive.

We may not succeed in establishing, maintaining and strengthening ColoAlert and other brands associated with our products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects. Our business and prospects heavily depend on our ability to develop, maintain and strengthen the ColoAlert brand and the brands of our future products.

Any failure to develop, maintain and strengthen these brands may materially and adversely affect our ability to sell our products. Most of our sales are to clinical reference laboratories or routine diagnostic laboratories. Those laboratories are generally more focused on taking orders than on marketing the products that they sell.

We need to educate these reference laboratories and the general public as to why we believe our products are superior. If we are not able to establish, maintain and strengthen our brands, we may lose the opportunity to build our customer base.

We expect that our ability to develop, maintain and strengthen our brands will depend heavily on the success of our marketing efforts. We intend to use current cash assets to market our products, but we might not be successful in such expanded marketing.

Due to the specifics of the market in which we operate, the investment in customer acquisition will be high and the uptake is likely slow until a critical mass is reached.

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes to those statements included elsewhere in this annual report on Form 20-F.

This discussion and analysis contains forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections.

Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the section titled “Risk Factors” and elsewhere in this annual report on Form 20-F.

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.

Our flagship ColoAlert product is being marketed and sold in European markets. We are currently developing our next generation colorectal cancer screening product and intend to launch that product in the future in the United States and in Europe.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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, 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.

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.

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.

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.

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.

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.

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.

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.

The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods.

Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

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.

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 recognize revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”. In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations.

Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration we expect to be entitled to receive for those goods and services.

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.

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.

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).

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.

Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.

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.

Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.

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 2022 Omnibus Incentive Plan (the (“Plans”).

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.

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.

The Black-Scholes option pricing model considers, among other factors, the expected term of the award and the expected volatility of our stock price.

Due to the lack of an adequate history of a public market for the trading of our ordinary shares, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded with historical share price information sufficient to meet the expected life of the stock-based awards.

The Monte Carlo simulation approach is a class of computational algorithms that rely on repeated random sampling to compute their results. This approach allows the calculation of the value of such stock options based on a large number of possible stock price path scenarios.

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.

That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. We apply a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets.

ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management The following table sets forth the names and ages of all of our directors and executive officers.

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.

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.

Mr. Baechler founded Berkeley Life Science Advisors, a diagnostic and life science start-up consulting business, in 2019. He was the Chief Executive Officer of SummerBio, a leading COVID testing CLIA laboratory in California, from July 2020 to February 2021 and Chief Executive Officer and Chief Operating Officer of Singulex, Inc. from November 2008 to June 2019. 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.

Baechler is the chairman of the board of Telo Genomics, a publicly traded Canadian biotech company and an advisor to other life science companies. Mr.

Baechler holds a Bachelor’s Degree in Electrical Engineering and completed a series of executive finance and management classes at the London School of Business and at the Haas Business School at the University of California, Berkeley. William Caragol , our Chief Financial Officer, has over thirty years of experience working with growth stage technology companies.

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.

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.

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.

Heiner Dreismann , Ph.D., a non-executive director, had a successful career at the Roche Group from 1985 to 2006 where he held several senior positions, including President and CEO of Roche Molecular Systems, Head of Global Business Development for Roche Diagnostics and as a member of Roche’s Global Diagnostic Executive Committee. During the past five years, Dr.

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.

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.

Before his position at Mainz Biomed, Dr. von Toerne has held program management and functional leadership positions at Siemens (2009-2013), Novartis and Grifols (2013-2019) in the United States, and more recently at Eppendorf SE where he co-led the OEM business through the COVID pandemic (2019-2022).

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.

He has had several executive positions in international Banking and Industry until 2001 when he established Sarsia Innovation as the tech-transfer-office for University of Bergen. He has during his career developed Sarsia into a venture fund management company, established three venture funds.

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.

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.

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.

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.

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.

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.

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.

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.

A material relationship is a relationship which could, in the view of our Board of Directors, be reasonably expected to interfere with the exercise of a director’s independent judgment. Code of Ethics and Business Conduct We have adopted a Code of Ethics and Business Conduct that applies to our directors, officers and other employees. B.

Compensation Compensation Discussion and Analysis This section sets out the objectives of our company’s executive compensation arrangements, our company’s executive compensation philosophy and the application of this philosophy to our company’s executive compensation arrangements. It also provides an analysis of the compensation design, and the decisions that the Board intends to make with respect to our executive officers.

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.

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.

Rather, in determining the compensation level for each executive, the Compensation Committee will look at factors such as the relative complexity of the executive’s role within the organization, the executive’s performance and potential for future advancement and pay equity considerations.

Elements of Compensation The compensation paid to executive officers in any year consists of two primary components: (a) base salary; and (b) long-term incentives in the form of stock options.

The key features of these two primary components of compensation are discussed below: Base Salary Base salary recognizes the value of an individual to our company based on his or her role, skill, performance, contributions, leadership and potential. It is critical in attracting and retaining executive talent in the markets in which we compete for talent.

Base salaries for the Named Executive Officers are intended to be reviewed annually.

Any change in base salary of a Named Executive Officer is generally determined by an assessment of such executive’s performance, a consideration of competitive compensation levels in companies similar to our company and a review of our performance as a whole and the role such executive officer played in such corporate performance.

Stock Option Awards We provide long-term incentives to executive officers in the form of stock options as part of our overall executive compensation strategy.

Our Compensation Committee believes that stock option grants serve our executive compensation philosophy in several ways: firstly, it helps attract, retain, and motivate talent; secondly, it aligns the interests of the executive officers with those of the shareholders by linking a specific portion of the officer’s total pay opportunity to the share price; and finally, it provides long-term accountability for executive officers.

Risks Associated with Compensation Policies and Practices The oversight and administration of our executive compensation program requires the Compensation Committee to consider risks associated with our compensation policies and practices. Potential risks associated with compensation policies and compensation awards are considered at annual reviews and also whenever it is deemed necessary by the Compensation Committee.

Our executive compensation policies and practices are intended to align management incentives with the long-term interests of the Corporation and its shareholders. In each case, the Corporation seeks an appropriate balance of risk and reward.

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.

Director compensation is currently limited to the grant of stock options pursuant to the Stock Option Plan. It is anticipated that the Chief Executive Officer will review the compensation of our executive officers for the prior year and in comparison to industry standards via information disclosed publicly and obtained through copies of surveys.

The Board expects that the Chief Executive Officer will make recommendations on compensation to the Compensation Committee. The Compensation Committee will review and make suggestions with respect to compensation proposals, and then make a recommendation to the Board. The Compensation Committee is comprised of independent directors.

The Compensation Committee’s responsibility is to formulate and make recommendations to our directors in respect of compensation issues relating to our directors and executive officers. Its responsibilities are more fully described under the section of this annual report entitled “Item 6.B Compensation — Compensation Governance”.

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.

(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.

Baechler is appointed as our Chief Executive Officer and will undertake and perform the duties and responsibilities normally and reasonably associated with such office; (b) we paid Mr.

Baechler annual base remuneration of $240,000 that increased to $350,000 upon the filing of the Form F-1 for our initial public offering, and to $450,000 in the year after the initial public offering provided we make satisfactory progress in Board-approved goals (the “Base Remuneration”); (c) we shall reimburse Mr.

Baechler for one U.S. health plan and one U.S. dental plan (if not included in the health plan) amounting up to $3,500 per month; (d) we shall provide to Mr.

Baechler any benefits plan, if and when we have adopted such benefits; (e) our Board of Directors shall, in good faith, consider the payment of an annual bonus equal to 50% of that year’s Base Remuneration based upon our performance and upon the achievement of mutually agreed-upon milestones (the “Annual Bonus”); and (e) Mr.

Baechler will be entitled to twenty days paid annual vacation per calendar year as well as the reimbursement of reasonable and necessary business expenses. Furthermore, our Board of Directors granted Mr. Baechler 467,850 stock options exercisable into ordinary shares under the 2021 Omnibus Incentive Plan.

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.

During 2022, all of these options vested. We or Mr.

Baechler may terminate the Baechler Agreement at any time for any reason by providing not less than ten calendar days’ notice in writing, provided that (a) we shall have the option to provide a lump sum payment equal to ten (10) days’ Base Remuneration in lieu of such notice if terminating without cause; and (b) we may waive all or any part of the notice period for no consideration by giving written notice to Mr.

Baechler if terminating with cause. In the event we terminate the Baechler Agreement for cause or if Mr. Baechler’s terminates the Baechler Agreement without good reason, Mr. Baechler is entitled to (i) any accrued but unpaid Base Remuneration and payment for any accrued but unused vacation; (ii) reimbursement for unreimbursed business expenses properly incurred by Mr.

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”). 43 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 that includes: (i) the Accrued Amounts (ii) equal installment payments payable under the our normal payroll practices, but no less frequently than monthly, which are in the aggregate equal to the Mr.

Baechler’s Base Remuneration for the year in which termination occurs; (iii) an amount equal to the Annual Bonus for the year in which the termination takes place; (iv) vesting of an additional 12 months (removing any cliff) under all time-based vesting schedules for equity-based incentives held by Mr.

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.

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.

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.

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.

Caragol will be entitled to receive 80,000 options to purchase our ordinary shares subject to a the 2021 Omnibus Incentive Plan. If we elect to terminate the Caragol Contract without good cause or Mr.

Caragol resigns with good reason in compliance with the relevant terms and conditions of the Caragol Agreement, we shall be obligated to provide a severance package to Mr. Caragol that includes: (i) any amounts due to him under the Caragol Agreement that have not yet been paid, (ii) the amounts due to Mr.

Caragol for a year subsequent to the date when the termination occurs; (iii) an amount equal to Mr.

Caragol’s target annual bonus for the year in which the termination takes place, with all criterion for such annual bonus deemed to have been achieved; and (iv) the vesting of an additional twelve months under all time-based vesting schedules for equity-based incentives held by Mr. Caragol.

Prior to the Employment agreement, effective on July 16, 2021, we entered into a consulting agreement with William Caragol (as amended, the “Caragol Agreement”). Pursuant to the Caragol Agreement: (a) Mr. Caragol was paid a monthly salary of $15,000; and (b) Mr. Caragol received 155,950 options to purchase our ordinary shares subject to our 2021 Omnibus Incentive Plan.

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.

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.

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”).

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.

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.

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.

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.

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A.

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.

Except as otherwise indicated, all persons listed below have (i) sole voting power and investment power with respect to their ordinary shares, except to the extent that authority is shared by spouses under applicable law, and (ii) record and beneficial ownership with respect to their ordinary shares.

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.

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.

(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.

(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.

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.

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.

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.

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.

Related Party Transactions Apart from the employment and consulting agreements described elsewhere in this annual report and the agreements with ColoAlert AS (one of our directors is a director and controlling shareholder of ColoAlert AS) described below under “Material Agreements”, we have not entered into any material transactions with our directors, officers, promoters and shareholders or who beneficially own more than 10% of our ordinary shares (or their immediate family members).

C. Interests of Experts and Counsel Not Applicable.