Quantum Cyber N.V 6-K, filed Sep 26, 2025
Quantum Cyber N.V. (QUCY)
About this 6-K
Quantum Cyber N.V filed this 6-K on September 26, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For
the six months ended June 30,
Commission
File No.
(Translation of registrant’s name into English)
Robert
Koch Strasse 50
55129 Mainz
Germany
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F ☒ Form 40-F ☐
Other Events
On September 26, 2025, Mainz Biomed N.V. made available its Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2025. A copy of the report is attached hereto as Exhibit 99.1.
On September 26, 2025, Mainz Biomed N.V. made available its unaudited Financial Statements for the six months ended June 30, 2025. A copy of the report is attached hereto as Exhibit 99.2.
This current report on Form 6-K and exhibits 99.1 and 99.2 hereto are hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (File No. 333-269091) and its registration statement on Form S-8 (File No. 333-273203).
| Exhibit No. | Exhibit | |
| 99.1 | Management’s Discussion and Analysis of Financial Condition and Results of Operations of Mainz Biomed N.V. for the six months ended June 30, 2025 | |
| 99.2 | Unaudited Financial Statements of Mainz Biomed N.V. as of, and for the six months ended, June 30, 2025 | |
| 101.INS | Inline XBRL Instance Document. | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 26, 2025 | By: | /s/ William J. Caragol |
| Name: | William J. Caragol | |
| Title | Chief Financial Officer |
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Exhibit 99.1
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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 in Exhibit 99.2 to this Form 6-K. 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 our Annual Report for the Year ended December 31, 2024 on Form 20-F, filed with the U.S. Securities and Exchange Commission on March 31, 2025. 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.
Organization and Overview of Operations
We develop and sell in-vitro diagnostic (“IVD”) 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. In addition, we conduct research and development to increase and diversify our product portfolio. Since 2020 we have also been developing a IVD test for the early detection of pancreatic cancer.
During July 2024 and October 2024, we restructured our operations to focus on our ColoAlert business in Europe, the development of our next generation product, the development of PancAlert, and the Early Detect 2 clinical study in the U.S. In line with that focus, we implemented cost reduction efforts which included the reduction of our operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale of our European Oncology Lab (“EOL”) business in St. Ingbert, Germany to a related party. Additionally, we amended the employment contracts of our CEO and CFO, reducing the salaries of those officers to 60% and 50% of their then current salaries, respectively, effective November 1, 2024. During the six months ended June 30, 2025 and 2024, we recorded expenses of $113,113 and $186,601, respectively, for the cost of royalties and other associated costs owed to ColoAlert AS (and its successor, Uni Targeting Research AS, collectively “ColoAlert AS”), the company from which we exclusively licensed the ColoAlert product. A non-executive director of the Company is also an owner of ColoAlert AS. During the six months ended June 30, 2025 and 2024, we paid ColoAlert AS $113,113 and $155,450, respectively.
On December 3, 2024, we effectuated a 1:40 reverse stock split of our ordinary shares. All share and per share amounts in this discussion and analysis account for this reverse stock split.
Results of Operations
Comparison of the Six Months Ended June 30, 2025 and 2024
The following table provides certain selected financial information for the periods presented:
| Six Months Ended June 30, | % | |||||||||||||||
| 2025 | 2024 | Change | Change | |||||||||||||
| Total Revenue | $ | 286,717 | $ | 520,773 | $ | (234,056 | ) | (45 | )% | |||||||
| Cost of revenue | $ | 97,128 | $ | 201,735 | $ | (104,607 | ) | (52 | )% | |||||||
| Gross profit | $ | 189,589 | $ | 319,038 | $ | (129,449 | ) | (41 | )% | |||||||
| Gross margin | 66 | % | 61 | % | ||||||||||||
| Research and development | $ | 3,055,088 | $ | 3,242,622 | $ | (187,534 | ) | (6 | )% | |||||||
| Sales and marketing | $ | 2,349,005 | $ | 2,361,105 | $ | (12,100 | ) | (1 | )% | |||||||
| General and administrative | $ | 2,876,845 | $ | 4,522,639 | $ | (1,645,794 | ) | (36 | )% | |||||||
| Total operating expenses | $ | 8,280,938 | $ | 10,126,366 | $ | (1,845,428 | ) | (18 | )% | |||||||
| Loss from operations | $ | (8,091,349 | ) | $ | (9,807,328 | ) | $ | (1,715,979 | ) | (17 | )% | |||||
| Other expense | $ | (252,862 | ) | $ | (1,216,434 | ) | $ | 963,572 | 79 | % | ||||||
| Net loss | $ | (8,344,211 | ) | $ | (11,023,762 | ) | $ | (2,679,551 | ) | (24 | )% | |||||
| Total comprehensive loss | $ | (8,403,064 | ) | $ | (11,086,128 | ) | $ | (2,683,064 | ) | (24 | )% | |||||
| Basic and dilutive loss per common share | $ | (2.65 | ) | $ | (19.73 | ) | $ | 17.08 | 87 | % | ||||||
| Weighted average number of common shares outstanding – basic and diluted | 3,144,409 | 558,751 | ||||||||||||||
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Total Revenue
Total revenue for the six months ended June 30, 2025 was $286,717 as compared to $520,773 for the six months ended June 30, 2024, a decrease of 45%. This decrease was attributable to our strategic decisions to cease direct to consumer sales and to sell our EOL business in 2024. The result of these decisions decreased revenue by approximately $234,000. During the six months ended June 30, 2025 sales to lab partners increased by approximately $60 thousand, or 30%, compared to the six month period ended June 30, 2024.
Cost of Revenue
Cost of revenue for the six months ended June 30, 2025 was $97,128 as compared to $201,735 for the six months ended June 30, 2024, a 52% decrease. This decrease was the result of decreased ColoAlert sales volume stemming from our decision to cease selling online direct to consumer, which drove efficiencies across our fixed costs, lowering overall unit costs.
Gross profit
Gross profit decreased by $129,449 to $189,589 in the six months ended June 30, 2025 compared to $319,038, for the six months ended June 30, 2024. This gross profit decrease, resulting in an improvement of gross margin from 61% to 66%, was attributable to improved profits resulting from lowered unit cost of goods sold attributable to economies of scale with increased sales volumes and the improved margin profile generated in our sales to lab partners.
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2025 were $3,055,088 compared to $3,242,622 for the six months ended June 30, 2024, a decrease of $187,534. This decrease was driven by the reduction of staffing levels from our 2024 restructuring efforts, which reduced payroll and related expenses of $1.4 million. Additionally, our costs related to clinical studies increased by $1.2 million for the six months ended June 30, 2025 compared to the same period 2024 as the result of our eAArly Detect 2 study in the U.S. which began in January 2025.
Sales and Marketing Expenses
Sales and marketing expenses for the six months ended June 30, 2025, were $2,349,005 compared to $2,361,105 for the six months ended June 30, 2024, a decrease of $12,100. This small change was the result of an increase in our marketing and advertising expense of $1.0 million as the result of non-cash equity expenses related to marketing campaigns in 2025, mitigated by a $0.9 million decrease in labor costs (salary and consulting) in line with our shift in focus away from consumer sales.
General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2025 were $2,876,845 compared to $4,522,639 for the six months ended June 30, 2024, a decrease of $1,645,794. The decreased expenses were primarily the result of a decrease of $1.1 million in payroll and consulting fees driven by the reduction of staffing levels from our 2024 restructuring efforts. Additionally, non-cash stock option expense for the six months ended June 30, 2025 decreased $0.4 million compared to the same period in 2024.
Other Expense
Other expense, net for the six months ended June 30, 2025 was $252,862 compared to $1,216,434 for the six months ended June 30, 2024, resulting in decreased other expenses (net) of $963,572. This decrease was primarily the result of decreased interest expense of $0.4 million from our lower convertible debt balances and the decrease in the fair value adjustment of $0.5 million.
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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 June 30, 2025, we had $1,911,069 of cash and cash equivalents, with $6,235,670 as of December 31, 2024.
The following table summarizes our cash flows from operating, investing and financing activities:
| Six Months Ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Cash used in operating activities | $ | (6,531,975 | ) | $ | (8,144,745 | ) | $ | 1,612,770 | ||||
| Cash used in investing activities | $ | (451,123 | ) | $ | (420,660 | ) | $ | (30,463 | ) | |||
| Cash provided by financing activities | $ | 2,675,458 | $ | 2,551,325 | $ | 124,133 | ||||||
Cash Flow from Operating Activities
For the six months ended June 30, 2025, cash flows used in operating activities was $6,531,975 compared to $8,144,745 used during the six months ended June 30, 2024. The improvement in cash flows used in operating activities of $1,612,770 was primarily the result of our smaller operating loss for the six months ended June 30, 2025, net of non-cash stock-based compensation, depreciation and amortization, and timing differences for the settlement of assets and liabilities, as compared to the six months ended June 30, 2024.
Cash Flows from Investing Activities
During the six months ended June 30, 2025, we used $451,123 in investing activities compared to $420,660 used during the six months ended June 30, 2024. The cash flows used in investing activities were primarily related to payments for the acquisition of intellectual property for our PancAlert product under development and the acquisition of the ColoAlert intellectual property.
Cash Flows from Financing Activities
During the six months ended June 30, 2025, we had cash flow provided by financing activities of $2,675,458 compared to cash flow provided by financing activities of $2,551,325 for the six months ended June 30, 2024, an increase of $124,133. During the six months ended June 30, 2025 the cash flows from the sale of ordinary shares and warrants increased by approximately $3.0 million compared to the same period in the prior year while cash flows (net) from the issuance and repayments of convertible debt decreased by approximately $2.8 million.
Working Capital Discussion
We had recurring losses, accumulated deficit totaling approximately $99.3 million and negative cash flows used in operating activities of approximately $6.5 million as of and for the six months ended June 30, 2025. We also had approximately $1.9 million of cash on hand on June 30, 2025, and a working capital deficit, of approximately $2.5 million.
These conditions are indicators that impact our ability to continue as a going concern for a period of one year from the date of these financial statements. If we are unable to obtain funding, we could be forced to further 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.
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 2022, we raised $24.2 million of net proceeds from common stock sales and warrant proceeds. 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 2024, we raised $18.2 million from a combination of sale of shares and warrants as well as the issuance of convertible debt. During the first half of 2025, we raised $4 million through the sale of units including ordinary shares and warrants. In August 2025, we raised an additional $3 million through the sale of units including ordinary shares and warrants.
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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 and our Pre-Paid Advance Agreement. We also have the ability to defer certain costs, especially those related to clinical studies, to match financing inflows. During July 2024 and October 2024, we restructured our operations to focus on our ColoAlert business in Europe, the development of our next generation product, the development of PancAlert and planning for the Early Detect 2 clinical study in the U.S. in 2025. In line with that focus, we implemented cost reduction efforts which included the reduction of our operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale/closure of our EOL business in St. Ingbert, Germany. Additionally, we amended the employment contracts of our CEO and CFO, reducing the salaries of those officers to 60% and 50% of their original salaries, respectively, effective November 1, 2024. We believe that these cost reductions will best position our business for 2025 and beyond. We believe that our currently available cash on hand, including additional financing described above, will be sufficient to meet our planned expenditures and to meet our obligations for at least the one-year period following our consolidated financial statement date.
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 we were unable to realize our assets and settle our liabilities as a going concern in the normal course of operations. Such adjustments could be material.
Subsequent Events
Subsequent to June 30, 2025 the Company issued 1,186,000 shares of its ordinary stock for a nominal remaining exercise price for the conversion of prefunded warrants pursuant to the SPA entered into in May 2025. Additionally, 135,000 shares were issued to service providers as compensation pursuant to consulting agreements at a value of $194,700.
On August 4, 2025, we entered into a securities purchase agreement with an institutional investor (the “Purchaser”) pursuant to which we sold to the Purchaser 2,222,222 pre-funded units with each pre-funded unit consisting of one pre-funded warrant to purchase one ordinary share and one and one-half ordinary warrants (the “Offering”). Each pre-funded unit was sold at an offering price of $1.35 less the nominal remaining exercise price of $0.001. The Offering resulted in gross proceeds to us of approximately $3,000,000 before deducting placement agent fees and other estimated offering expenses. The offering closed on August 5, 2025.
Subsequent to June 30, 2025, the Company repaid $300,000 for the fourth promissory note.
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. |
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Revenue Recognition
The Company’s revenue is primarily derived through providing genetic diagnostic tests to customers. The Company recognizes revenue in accordance with 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 the Company expects to be entitled to receive for those goods and services.
The Company sells its genetic diagnostic testing kits to laboratory partners . Upon the delivery of our products to laboratory partners the Company has completed its performance obligations and as such revenue is recorded upon delivery.
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.
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 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, 2022 Omnibus Incentive Plan, and 2025 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, 15% of the total number of shares of ordinary shares outstanding on the last day of the immediately preceding fiscal quarter.
We value issued 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.
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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. 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. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by us and payments of penalties for terminating the lease, if the lease term reflects us exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, we use our incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.
We recognize right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. 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.
Financial Instruments
(a) Classification
We classify our 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. 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. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if we have opted to measure them at FVTPL.
(b) Measurement
Financial assets and liabilities at amortized cost
Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.
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Financial assets and liabilities at FVTPL
Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.
Debt investments at FVTOCI
These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.
Equity investments at FVTOCI
These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.
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Exhibit 99.2
Mainz Biomed N.V.
Consolidated Statements of Financial Position
(Unaudited)
(Expressed in US Dollars)
| June 30, | December 31, | |||||||||
| Note | 2025 | 2024 | ||||||||
| ASSETS | ||||||||||
| Current Assets | ||||||||||
| Cash | $ | $ | ||||||||
| Trade receivables, net | 4 | |||||||||
| Trade receivables - related party | 14 | |||||||||
| Inventories | 5 | |||||||||
| Prepaid expenses and other current assets | 6 | |||||||||
| Total current assets | ||||||||||
| Property and equipment, net | 7 | |||||||||
| Intangible assets | 8 | |||||||||
| Right-of-use assets, net | 9 | |||||||||
| Total assets | $ | $ | ||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
| Current Liabilities | ||||||||||
| Accounts payable and accrued liabilities | 10 | $ | $ | |||||||
| Accounts payable and accrued expense - related party | 14 | |||||||||
| Convertible debt | 11 | |||||||||
| Silent partnership | 12 | |||||||||
| Silent partnership - related party | 14 | |||||||||
| Intellectual property acquisition liability | 8 | |||||||||
| Intellectual property acquisition liability - related party | 8 | |||||||||
| Lease liabilities | 9 | |||||||||
| Total current liabilities | ||||||||||
| Lease liabilities | 9 | |||||||||
| Intellectual property acquisition liability - related party | 8 | |||||||||
| Total liabilities | ||||||||||
| Shareholders’ equity | ||||||||||
| Share capital | 13 | |||||||||
| Share premium | 13 | |||||||||
| Reserve | 13 | |||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||||
| Total shareholders’ equity | ||||||||||
| Total liabilities and shareholders’ equity | $ | $ | ||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Mainz Biomed N.V.
Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
(Expressed in US Dollars)
| Six months ended | ||||||||||
| June 30, | ||||||||||
| Note | 2025 | 2024 | ||||||||
| Revenue | $ | $ | ||||||||
| Revenue - related party | ||||||||||
| Total revenue | ||||||||||
| Cost of revenue | ||||||||||
| Gross profit | ||||||||||
| Operating expenses: | ||||||||||
| Sales and marketing | 19 | |||||||||
| Research and development | 19 | |||||||||
| General and administrative | 19 | |||||||||
| Total operating expenses | ||||||||||
| Loss from operations | ( | ) | ( | ) | ||||||
| Other income (expense) | ||||||||||
| Other income | ||||||||||
| Change in fair value of convertible debt | 11 | ( | ) | |||||||
| Interest expense | ( | ) | ( | ) | ||||||
| Interest expense - related parties | ( | ) | ( | ) | ||||||
| Other expense | ( | ) | ( | ) | ||||||
| Total other expense | ( | ) | ( | ) | ||||||
| Loss before income tax | ( | ) | ( | ) | ||||||
| Income taxes provision | ||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||||
| Foreign currency translation loss | ( | ) | ( | ) | ||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | ||||
| Basic and diluted loss per ordinary share | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of ordinary shares outstanding | ||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Mainz Biomed N.V.
Consolidated Statements of Changes in Shareholders’ Equity
(Unaudited)
(Expressed in US Dollars)
| Number of | Accumulated Other | Total | ||||||||||||||||||||||||||||
| Ordinary | Share | Share | Accumulated | comprehensive | Shareholders ’ | |||||||||||||||||||||||||
| Note | shares | Capital | Premium | Reserve | Deficit | Loss | Equity | |||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||
| Sale of ordinary shares and warrants and exercise of pre funded warrants | 13 | ( | ) | |||||||||||||||||||||||||||
| Share based expense | 13 | |||||||||||||||||||||||||||||
| Stock option expense | 13 | - | ||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||
| Accumulated | Total | |||||||||||||||||||||||||||||
| Number of | Other | Shareholders’ | ||||||||||||||||||||||||||||
| Ordinary | Share | Share | Accumulated | comprehensive | Equity | |||||||||||||||||||||||||
| Note | shares | Capital | Premium | Reserve | Deficit | Loss | (Deficit) | |||||||||||||||||||||||
| Balance, December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||
| Sale of ordinary shares | 13 | |||||||||||||||||||||||||||||
| Issuance of ordinary shares for conversion of debt | 11, 13 | |||||||||||||||||||||||||||||
| Stock option expense | 13 | - | ||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Mainz Biomed N.V.
Consolidated Statements of Cash Flows
(Unaudited)
(Expressed in US Dollars)
| Six months ended | ||||||||||||
| June 30, | ||||||||||||
| Note | 2025 | 2024 | ||||||||||
| Cash Flows From Operating Activities | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Share based compensation | 13 | |||||||||||
| Depreciation and amortization | 7, 8, 9 | |||||||||||
| Bad debt expense | 4, 6 | |||||||||||
| Inventory write down | 5 | |||||||||||
| Accretion expense | 8, 12 | |||||||||||
| Change in fair value of convertible debt | 11 | ( | ) | |||||||||
| Gain on sale of assets | 7 | ( | ) | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Trade receivables, net | ( | ) | ( | ) | ||||||||
| Inventories | ( | ) | ||||||||||
| Prepaid expenses and other current assets | ||||||||||||
| Accounts payable and accrued liabilities | ( | ) | ||||||||||
| Deferred revenue | ( | ) | ||||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||||||
| Cash Flows From Investing Activities | ||||||||||||
| Payment for intangible asset | 8 | ( | ) | |||||||||
| Payment for intangible asset - related party | 8 | ( | ) | ( | ) | |||||||
| Purchase of property and equipment | 7 | ( | ) | ( | ) | |||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||||||
| Cash Flows From Financing Activities | ||||||||||||
| Sale of ordinary shares and warrants | 13 | |||||||||||
| Proceeds from convertible debt | 11 | |||||||||||
| Repayments of convertible debt | 11 | ( | ) | ( | ) | |||||||
| Payments on silent partnerships | 12 | ( | ) | |||||||||
| Payments of lease obligations | 9 | ( | ) | ( | ) | |||||||
| Net cash provided by financing activities | ||||||||||||
| Effect of changes in exchange rates | ( | ) | ( | ) | ||||||||
| Net change in cash | ( | ) | ( | ) | ||||||||
| Cash at beginning of period | ||||||||||||
| Cash at end of period | $ | $ | ||||||||||
| Cash Paid For: | ||||||||||||
| Interest expense | $ | $ | ||||||||||
| Income tax | $ | $ | ||||||||||
| Non-Cash Investing and Financing Activities | ||||||||||||
| Right of use asset additions | 9 | $ | $ | |||||||||
| Acquisition of intangible asset for structured payments | 8 | $ | $ | |||||||||
| Issuance of ordinary shares for conversion of debt | 11, 13 | $ | $ | |||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Mainz Biomed N.V.
Notes to the Consolidated Financial Statements
(Unaudited)
(Expressed in US dollars)
June 30, 2025
1. NATURE OF OPERATIONS AND GOING CONCERN
Mainz Biomed N.V. (the “Company”) is domiciled in Netherlands. The Company’s registered office is at Robert-Koch Strasse 50, 55129 Mainz, Germany with substantially all of its operations in Germany. The Company was formed to acquire the business of Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH (“PharmaGenomics”, “PG”)) in 2021.
We develop and sell in-vitro diagnostic (“IVD”) 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. We have operated a clinical diagnostic laboratory but primarily distribute our IVD kits to third-party laboratories in Europe and through our on-line store in Germany. Since 2020 we have also been developing a IVD test for the early detection of pancreatic cancer. On March 12, 2025, the Company closed a License and Option Agreement with Liquid Bioscience, Inc. (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. 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.
Throughout these consolidated financial statements, Mainz Biomed N.V. and its directly and indirectly wholly owned subsidiaries, Mainz Biomed USA, Inc., Mainz Biomed GmbH (f/k/a PharmGenomics GmbH) and European Oncology Lab GmbH are referred to, collectively and individually as “Mainz”, “Mainz Biomed”, or the “Company”).
Going Concern
The
Company has recurring losses, accumulated deficit totaling $
Management
plans to fund its 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 the Company raised $
5
These 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.
2. BASIS OF PRESENTATION
Basis of Presentation and Statement of Compliance
These condensed interim financial statements have been prepared in accordance with International Accounting Standards (“IAS”) 34, “Interim Financial Reporting” using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and International Financial Reporting Interpretations Committee (“IFRIC”). These condensed interim financial statements do not include all of the information required of a full set of annual financial statements and are intended to provide users with an update in relation to events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since the end of the last annual reporting period. It is therefore recommended that these condensed interim financial statements be read in conjunction with the annual financial statements of the Company for the year ended December 31, 2024 and notes thereto contained in the Company’s annual report filed on Form 20-F.
These condensed interim financial statements have been prepared on a historical cost basis, modified where applicable. In addition, these condensed interim financial statements have been prepared using the accrual basis of accounting except for cash flow information.
The condensed unaudited interim financial statements were authorized for issuance by the Audit Committee of the Board of Directors on September 26, 2025.
New Accounting Standards
Standards, interpretations and amendments to standards and interpretations in the reporting period not yet effective and not yet applied:
| ● | In April 2024, the International Accounting Standards Board issued IFRS 18, Presentation and Disclosure in the Financial Statements, which sets out the overall requirements for presentation and disclosures in the financial statements. The new standard will replace IAS 1, Presentation of Financial Statements. Although much of the substance of IAS 1, Presentation of Financial Statements, will carry over into the new standard, the new standard incrementally will: |
| o | With a view to improving comparability amongst entities, require presentation in the statement of operations of a subtotal for operating profit and a subtotal for profit before financing and income taxes (both subtotals as defined in the new standard); |
6
| o | Require disclosure and reconciliation, within a single financial statement note, of management-defined performance measures that are used in public communications to share management’s views of various aspects of an entity’s performance and which are derived from the statements of income and other comprehensive income; |
| o | Enhance the requirements for aggregation and disaggregation of financial statement amounts; and |
| o | Require limited changes to the statement of cash flows, including elimination of options for the classification of interest and dividend cash flows. |
The new standard is effective for annual reporting periods beginning on or after January 1, 2027, with earlier adoption permitted. We are currently assessing the impacts of the new standard; while there will be shifts of where a number of our management-defined performance measures are disclosed and reconciled (primarily a shift from management’s discussion and analysis to the financial statements) and where certain cash flows will be categorized in our statements of cash flows (primarily a shift of interest paid from operating activities to financing activities), we do not expect that the totality of our financial disclosure will be materially affected by the application of the new standard.
| o | In May 2024, the International Accounting Standards Board issued Amendments to the Classification and Measurement of Financial Instruments (Amendments to IFRS 9 and IFRS 7). The narrow-scope amendments are to address diversity in accounting practice in respect of the classification of financial assets with environmental, social and corporate governance and similar features; and to clarify the date on which a financial asset or financial liability is derecognized when using electronic payment systems. The new standard is effective for annual reporting periods beginning on or after January 1, 2026, with earlier adoption permitted. We are currently assessing the impacts of the new standard but do not expect to be materially affected by the application of the amendments. |
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS
Inventories
Inventories are measured at the lower of cost and net realizable value. The cost of inventories is based on a weighted average cost and includes expenditure incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses.
Property and Equipment
Property and equipment are recorded at cost less accumulated depreciation. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets. Management evaluates the useful lives and method of depreciation at least annually and accounts for any changes to the useful life or method prospectively. Maintenance and repairs are charged to expense as incurred; cost of major additions and betterments are capitalized.
7
The estimated useful lives are:
| Laboratory equipment | ||
| Office equipment | ||
| Right-of-use assets |
Impairment of Non-Financial Assets
The Company performs impairment tests on its long-lived assets, including property and equipment and intangible assets when new events or circumstances occur, or when new information becomes available relating to their recoverability. When the recoverable amount of each separately identifiable asset or cash generating unit (“CGU”) is less than its carrying value, the asset or CGU’s assets are written down to their recoverable amount with the impairment loss charged against profit or loss. A reversal of the impairment loss in a subsequent period will be charged against profit or loss if there is a significant reversal of the circumstances that caused the original impairment. The impairment will be reversed up to the amount of depreciated carrying value that would have otherwise occurred if the impairment loss had not occurred.
The CGU’s recoverable amount is evaluated using fair value less costs to sell calculations. In calculating the recoverable amount, the Company utilizes discounted cash flow techniques to determine fair value when it is not possible to determine fair value from active markets or a written offer to purchase. Management calculates the discounted cash flows based upon its best estimate of a number of economic, operating, engineering, environmental, political and social assumptions. Any changes in the assumptions due to changing circumstances may affect the calculation of the recoverable amount. There was no impairment recognized in the consolidated financial statements for the six months ended June 30, 2025 and 2024.
Leases
The Company assesses 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, the Company has the right to obtain substantially all of the economic benefits from the use of the asset through the specified period, and the Company has the right to direct the use of the specified assets, which involves the right to make the decisions that are most relevant to its use. The Company applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets, which are recognized in profit or loss as the expense is incurred.
At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating the lease, if the lease term reflects the Company exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, the Company uses the rate implicit in the lease, or if not readily determinable, its incremental borrowing rate (“IBR”). After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset. Upon a remeasurement of a lease liability, the Company records a proportionate adjustment to the corresponding right-of-use asset. If the remeasurement results in a reduction of the right-of-use asset to nil, the difference is recorded in the statements of profit or loss in the period of occurrence.
8
The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. 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.
Revenue Recognition
The Company’s revenue is primarily derived through providing genetic diagnostic tests to customers. The Company recognizes revenue in accordance with 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 the Company expects to be entitled to receive for those goods and services.
The Company sells its genetic diagnostic testing kits to laboratory partners. Upon the delivery of our products to laboratory partners the Company has completed its performance obligations and as such revenue is recorded upon delivery.
Cost of revenue
Cost of revenue consists of patient test kits and laboratory kits sold to laboratory partners and patients, and labor and overhead expenses related to the performance of those tests.
For the six months ended June 30, 2025 and 2024, cost of revenue consisted of as follows;
| Six months ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Test kits | $ | $ | ||||||
| Labor | ||||||||
| $ | $ | |||||||
Research and Development
Expenditure on research activities, undertaken with the prospect of gaining new technical knowledge and understanding, is recognized in profit or loss as incurred.
Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditure is capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. The expenditure capitalized includes the cost of materials, direct labor, overhead costs that are directly attributable to preparing the asset for its intended use, and borrowing costs on qualifying assets. Other development expenditures are recognized in profit or loss as incurred.
9
Financial Instruments
| a) | Classification |
The Company classifies 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. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s 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 the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as of FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if the Company has opted to measure them at FVTPL.
| b) | Measurement |
Financial assets and liabilities at amortized cost
Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment. The Company’s financial assets measured at amortized cost are comprised of its cash and trade and other receivables, net. The Company’s financial liabilities measured at amortized cost are comprised of its accounts payable and accrued liabilities, loans payable, loans payable – related party, convertible debt, convertible debt – related parties, silent partnerships, silent partnerships – related party and lease liabilities.
Financial assets and liabilities at FVTPL
Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.
Debt instruments at FVTOCI
These assets are initially measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses associated with changes in fair value are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss. The Company does not hold any debt instruments at FVTOCI.
Equity instruments at FVTOCI
These assets are initially measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses associated with changes in fair value are recognized in OCI and are never reclassified to profit or loss. The Company does not hold any equity instruments at FVTOCI.
10
| c) | Impairment of financial assets at amortized cost |
The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost. At each reporting date, the Company measures the loss allowance for the financial asset at an amount equal to the lifetime expected credit losses if the credit risk on the financial asset has increased significantly since initial recognition. If at the reporting date, the financial asset has not increased significantly since initial recognition, the Company measures the loss allowance for the financial asset at an amount equal to the twelve month expected credit losses. The Company shall recognize in the statements of loss and comprehensive loss, as an impairment gain or loss, the amount of expected credit losses (or reversal) that is required to adjust the loss allowance at the reporting date to the amount that is required to be recognized.
| d) | Derecognition |
Financial assets
The Company derecognizes financial assets only when the contractual rights to cash flows from the financial assets expire, or when it transfers the financial assets and substantially all of the associated risks and rewards of ownership to another entity.
Financial liabilities
The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled or expire. The Company also derecognizes a financial liability when the terms of the liability are modified such that the terms and/or cash flows of the modified instrument are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value.
Gains and losses on derecognition are generally recognized in profit or loss.
Convertible Debt
The Company evaluates at initial recognition of a convertible debt the different components and features of the hybrid instruments and determines whether these elements are equity instruments or embedded derivatives which require bifurcation. In subsequent periods, the liability component is accounted for using (i) the fair value method, or (ii) the effective interest method, based on the expected maturity of the debt. The equity component is not remeasured, while embedded derivatives unless closely related to the host instruments, are recorded at fair value through the Consolidated Statement of Operations unless the convertible debt falls under FVTPL.
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 management, of the Company 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.
11
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.
The Company’s 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.
Exchange gains and losses arising from translation to the Company’s presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).
Income Taxes
Current income tax:
Current income tax assets and liabilities for the current period are measured at the amount expected to be recovered from or paid to taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted, at the reporting date, in the countries where the Company operates and generates taxable income.
Current income tax relating to items recognized directly in other comprehensive income or equity is recognized in other comprehensive income or equity and not in profit or loss. Management periodically evaluates positions taken in the tax returns with respect to situations in which applicable tax regulations are subject to interpretation and establishes provisions where appropriate.
Deferred tax:
Deferred tax is recognized on temporary differences at the reporting date arising between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.
The carrying amount of deferred tax assets is reviewed at the end of each reporting period and recognized only to the extent that it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted and are expected to apply by the end of the reporting period. Deferred tax assets and deferred income tax liabilities are offset if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred taxes relate to the same taxable entity and the same taxation authority.
12
Government Grants
Government grants are recognized when there is reasonable assurance that the grant will be received and that the Company will comply with the conditions attached to them. When the grant relates to an expense item, it is recognized as income on a systematic basis over the periods that the related costs, for which it is intended to compensate, are expensed. When the grant relates to an asset, it is recognized as income in equal amounts over the expected useful life of the related asset.
Loans received with better than market terms from government programs are recognized initially at fair value, with the difference between the fair value of the loan based on prevailing market interest rates and the amount received recorded as a gain in the statements of loss and comprehensive loss.
Share-Based Compensation
Our stock option grants may contain time based or market-based vesting provisions. Time based options are expensed on a straight-line basis over the vesting period. Market based options (“MBOs”) are expensed when the related service and market performance conditions are expected to be met, such that the expenses ultimately recognized is based on the number of awards that meet the related service and market performance conditions at the vesting date.
The fair value of the stock options is determined on the grant date and is affected by our stock price and other assumptions regarding a number of complex and subjective variables. These variables include our expected stock price volatility over the term of the awards, risk free interest rates, expected dividends, and the expected option exercise term. The Company estimates the fair value of time-based stock options using the Black-Scholes-Merton pricing model. The simplified method is used to estimate the expected term of stock options due to a lack of related historical data regarding exercise, cancellation, and forfeiture. For MBOs, the fair value is estimated using Monte Carlo simulation techniques.
Where an equity-settled award is cancelled, it is treated as if it vested on the date of the cancellation and any expense not yet recognized for the award (being the total expense as calculated at the grant date) is recognized immediately. This includes any awards where vesting conditions within the control of either the Company or the employee are not met. However, if a new award is substituted for the cancelled award and designated as a replacement award on the date that it is granted, the cancelled award and new awards are treated as if they were a modification of the original awards.
Loss per Share
Basic loss per share is calculated by dividing the loss attributable
to common shareholders by the weighted average number of common shares outstanding in the period. For all periods presented, the loss
attributable to common shareholders equals the reported loss attributable to owners of the Company. When calculating the diluted earnings
(loss) per share, the Company adds to the average number of ordinary shares outstanding, that was used to calculate the basic earnings
per share, the weighted average of the number of shares to be issued assuming that all shares that have a potentially dilutive effect
would be converted into shares. Potential ordinary shares are only taken into account in cases where their effect is dilutive (reducing
the earnings per share or increasing the loss per share).
| June 30, | June 30, | |||||||
| 2025 | 2024 | |||||||
| Weighted average number of ordinary shares outstanding - basic | ||||||||
| Effect of potentially dilutive ordinary shares | ||||||||
| Weighted average number of ordinary shares outstanding - diluted | ||||||||
13
Segment Report
The
Company operates in
Reclassifications
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no impact on previously reported total assets, liabilities, equity, net income (loss), or cash flows for any periods presented.
Critical Accounting Estimates and Significant Management Judgments
The preparation of financial statements in accordance with IFRS requires the Company to use judgment in applying its accounting policies and make estimates and assumptions about reported amounts at the date of the financial statements and in the future. The Company’s management reviews these estimates and underlying assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted for prospectively in the period in which the estimates are revised.
Useful lives of property and equipment
Estimates of the useful lives of property and equipment and intangible assets are based on the period over which the assets are expected to be available for use. The estimated useful lives are reviewed annually and are updated if expectations differ from previous estimates due to physical wear and tear, technical or commercial obsolescence, not electing to exercise renewal options on Leases, and legal or other limits on the use of the relevant assets. In addition, the estimation of the useful lives of the relevant assets may be based on internal technical evaluation and experience with similar assets. It is possible, however, that future results of operations could be materially affected by changes in the estimates brought about by changes in the factors mentioned above. The amounts and timing of recorded expenses for any period would be affected by changes in these factors and circumstances. A reduction in the estimated useful lives of the property and equipment and intangible assets would increase the recorded expenses and decrease the non-current assets.
Provision for expected credit losses on trade receivables
The provision for expected credit losses on trade receivables are estimated based on historical information, customer concentrations, customer solvency, current economic and geographical trends, and changes in customer payment terms and practices. The Company will calibrate its provision matrix to adjust the historical credit loss experience with forward-looking information. The assessment of the correlation between historical observed default rates, forecast economic conditions and expected credit losses is a significant estimate. The amount of expected credit losses is sensitive to changes in circumstances and of forecast economic conditions. The Company’s historical credit loss experience and forecast of economic conditions may also not be representative of the customer’s actual default in the future.
Estimating the incremental borrowing rate on leases
The Company cannot readily determine the interest rate implicit in leases where it is the lessee. As such, it uses its incremental borrowing rate (“IBR”) to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of comparable value to the right-of-use asset in a similar economic environment. IBR therefore reflects what the Company “would have to pay”, which requires estimation when no observable rates are available or where the applicable rates need to be adjusted to reflect the terms and conditions of the lease. The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates.
14
Estimating the fair value of share-based payment transactions
The Company utilizes a Black-Scholes model, or where appropriate, a Monte-Carlo Simulation to estimate the fair value of its share-based payments. In applying these models, management must estimate the expected future volatility of the Company’s estimated share price and makes such assumptions based on a proxy of publicly listed entities under an expectation that historical volatility is representative of the expected future volatility. Additionally, estimates have been made by management, in respect of the performance warrants, regarding the length of the vesting period as well as the number of performance warrants that are likely to vest.
Estimating the fair value of financial instruments
When the Company recognizes a financial instrument, where there is no active market for such an instrument, the Company utilizes alternative valuation methods. The Company utilizes inputs from observable markets to the extent that an appropriate market can be identified, but when there is a lack of such a market, the Company applies judgment to determine a fair value. Such judgments require those such as risk and volatility, of which changes in such assumptions may impact the fair value of the financial instrument.
Other significant judgments
The preparation of these financial statements in accordance with IFRS requires the Company to make judgments, apart from those involving estimates, in applying accounting policies. The most significant judgments in applying the Company’s financial statements include:
| ● | The assessment of the Company’s ability to continue as a going concern and whether there are events or conditions that may give rise to significant uncertainty; |
| ● | The determination of the lease term of contracts with renewal and termination options; |
| ● | Determination of the extent to which it is probable that future taxable income will be available to allow all or part of the temporary differences and net operating losses to be utilized; |
| ● | Whether there are indicators of impairment of the Company’s long-lived assets, including its intangible assets; |
| ● | Development costs do not meet the conditions for capitalization in accordance with IAS 38 and therefore all research and development costs have been expensed as incurred. |
4. TRADE RECEIVABLES
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Trade receivables | $ | $ | ||||||
| Less: allowance for doubtful accounts | ( | ) | ||||||
| $ | $ | |||||||
As
of June 30, 2025 and December 31, 2024, the Company recorded allowance for doubtful accounts of $
Allowance for doubtful accounts
| 2025 | ||||
| Beginning Balance | $ | |||
| Addition | ||||
| Effects of currency translation | ||||
| Ending balance | $ | |||
15
5. INVENTORIES
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Finished goods | ||||||||
| Less: Reserve | ( | ) | ( | ) | ||||
| $ | $ | |||||||
For the six months ended June 30, 2025 and 2024,
the Company recorded an inventory write down under cost of revenue of $
Reserve
| 2025 | ||||
| Beginning Balance | $ | |||
| Addition | ||||
| Effects of currency translation | ||||
| Ending balance | $ | |||
6. PREPAID AND OTHER CURRENT ASSETS
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Prepaid insurance | $ | $ | ||||||
| Other prepaid expense | ||||||||
| Prepaid stock-based payments | ||||||||
| Security deposit | ||||||||
| VAT receivable | ||||||||
| $ | $ | |||||||
7. PROPERTY AND EQUIPMENT
Property and equipment and the changes in property, equipment and accumulated depreciation for the six months ended June 30, 2025 are provided as follows:
| Laboratory equipment | Office equipment | Total | ||||||||||
| Cost | ||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | |||||||||
| Additions | ||||||||||||
| Disposal/reclasses/Sale | ( | ) | ( | ) | ||||||||
| Effects of currency translation | ||||||||||||
| Balance at June 30, 2025 | ||||||||||||
| Accumulated depreciation | ||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | |||||||||
| Depreciation | ||||||||||||
| Disposal/reclasses/Sale | ( | ) | ( | ) | ||||||||
| Effects of currency translation | ||||||||||||
| Balance at June 30, 2025 | ||||||||||||
| Net book value at December 31, 2024 | $ | $ | $ | |||||||||
| Net book value at June, 2025 | $ | $ | $ | |||||||||
16
For
the six months ended June 30, 2025 and 2024, the Company recorded depreciation expense of $
As of June 30, 2025 and December 31, 2024, management assessed that there were no events or changes in circumstances that would require impairment testing of its fixed assets.
8. INTANGIBLE ASSET
ColoAlert IP
Our
flagship product is ColoAlert, a colorectal cancer (“CRC”) screening test. On January 1, 2019, we entered into an exclusive
licensing agreement (the “Licensing Agreement”) with ColoAlert AS to license the intellectual property related to the ColoAlert
test. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for the ColoAlert
test for (i) either a one-time cash payment of €
On
February 15, 2023, we entered into an Intellectual Property Asset Purchase Agreement (“IPA”), which supersedes the Licensing
and Options Agreements. Pursuant to the IPA, we acquired the intellectual property underlying the ColoAlert test. Pursuant to the IPA,
we were able to reduce the price paid for the intellectual property to (i) $
In
January 2022 the Company licensed the right to a novel set of mRNA biomarkers, including the exclusive license under a patent pending.
Upon completion of the Company’s evaluation of those biomarkers it exercised its right to acquire the rights to those biomarkers
including the rights under the patent pending on February 15, 2023. The Company plans to use several of these biomarkers in its next
generation product. Pursuant to the technology assignment agreement with SOCPRA Sciences Sante et Humaines S.E.C., operating under
the name Transfertech Sherbrooke (“Sherbrooke”), the Company will owe Sherbrooke a royalty payment of
17
Pancreatic Cancer IP
On
March 12, 2025, the Company closed a License and Option Agreement with Liquid Bioscience, Inc. (“Liquid”) to access a portfolio
of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. 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. Total
license payments will total $
The activity in the Intangible Assets account for the six months ended June 30, 2025 is as follows:
| Intangible assets | ||||
| Net book amount at December 31, 2024 | $ | |||
| Additions | ||||
| Disposal | ||||
| Amortization | ( | ) | ||
| Net book amount at June 30, 2025 | $ | |||
Cost of and amortization methods and useful life
The Company’s intangible assets consist of Intellectual properties and are initially measured at cost and are subsequently carried at cost less accumulated amortization and any provision for impairment. Amortization is calculated using the straight-line method over the estimated useful lives, which is 10 years.
The
Company recorded amortization of $
The Company has considered the carrying amount of intangible assets as of June 30, 2025, and concluded that, as there are no indicators of impairment, an impairment test is not required.
Contingent Consideration
In the event that the Company exercises the Liquid
option and makes commercial sales of products utilizing the underlying intellectual property, it will owe Liquid a profit share payment
of
18
9. LEASES
Right-of-Use Assets
The Company leases certain assets under lease agreements.
| Office | Laboratory | |||||||||||||||||||
| Equipment | Equipment | Vehicle | Office | Total | ||||||||||||||||
| Cost | ||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | |||||||||||||||
| Additions | ||||||||||||||||||||
| Deletions | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Effects of currency translation | ||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | |||||||||||||||
| Accumulated amortization | ||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | |||||||||||||||
| Amortization | ||||||||||||||||||||
| Deletions | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Effects of currency translation | ||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | |||||||||||||||
| Net book value | ||||||||||||||||||||
| December 31, 2024 | ||||||||||||||||||||
| June 30, 2025 | $ | $ | $ | $ | $ | |||||||||||||||
As of June 30, 2025 and December 31, 2024, management assessed that there were no events or changes in circumstances that would require impairment testing of our right of use assets.
The
carrying amount of the right-of-use assets is amortized on a straight-line basis over the life of the leases, which at June 30, 2025,
had an average expected life of
19
Lease Liabilities
The
Company’s lease liabilities consist of office and laboratory equipment, vehicle and office space. The present value of future lease
payments were measured using an weighted average incremental borrowing rate of
| Total | ||||
| As of December 31, 2024 | $ | |||
| Additions | ||||
| Deletion | ( | ) | ||
| Interest expenses | ||||
| Lease payments | ( | ) | ||
| Effects of currency translation | ||||
| As of June 30, 2025 | $ | |||
| Lease liabilities | June 30, 2025 | |||
| Current portion | $ | |||
| Long-term portion | ||||
| Total lease liabilities | $ | |||
As of June 30, 2025, the Company is committed to minimum lease payments as follows:
| Maturity analysis | June 30, 2025 | |||
| Less than one year | $ | |||
| One to two years | ||||
| Two to three years | ||||
| Three to four years | ||||
| Four to five years | ||||
| More than five years | ||||
| Total undiscounted lease liabilities | $ | |||
| Amount representing implicit interest | ( | ) | ||
| Lease obligations | $ | |||
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Payroll liabilities | ||||||||
| $ | $ | |||||||
20
11. CONVERTIBLE DEBT
The Company’s Convertible Debt includes Convertible Loans entered into in 2017, 2019 and 2020 and a series of Convertible Promissory Notes entered into during 2023 and 2024. Both the Loans and Notes are further detailed as follows:
| Juen 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Convertible loans | $ | $ | ||||||
| Convertible promissory notes | ||||||||
| $ | $ | |||||||
Convertible Loan
2017 Convertible Loans
In
November 2017, the Company entered into loan agreements with two former shareholders of the Company for loans totaling EUR
2019 and 2020 Convertible Loans
During
the years ended December 31, 2019 and 2020, the Company entered into loan agreements with related parties totaling EUR
A continuity of the Company’s Convertible loan is as follows:
| 2019 and 2020 Convertible Loans | 2017 Convertible Loans | |||||||
| Balance, Dec 31, 2024 | $ | $ | ||||||
| Effects of currency translation | ||||||||
| Balance, Jun 30, 2025 | $ | $ | ||||||
Convertible Promissory Notes
On
June 28, 2023, we entered into a Pre-Paid Advance Agreement (the “PPA”) with YA II PN, Ltd. (“Holder”). Pursuant
to the PPA, we may (a) request that the Holder purchase from us up to $
21
On
June 28, 2023, we sold the Holder a Promissory Note (the “Initial Promissory Note”) in the principal amount of $
On
April 18, 2024, we sold the Holder a Promissory Note under the PPA (the “Third Promissory Note”) in the principal amount
of $
On
October 8, 2024, we issued a fourth promissory note under our PPA in the original principal amount of $
The
Promissory Notes are convertible at the Holder’s discretion into our ordinary shares at a conversion price (the “Conversion
Price”) equal to the lower of (a) (I) $
Under
the Promissory Notes, a “Trigger Event” occurs if the trading price of an ordinary share is lower than the applicable Floor
Price for any
In
connection with the execution of the PPA, we agreed to pay a commitment fee of $
22
Initial Promissory Note, Second Promissory Note and Third Promissory Note were all paid off as of December 31, 2024 and Fourth Promissory Note is outstanding as of June 30, 2025.
The
Company elected to account for the Promissory Notes at fair value through FVTPL. Management believes that the fair value option appropriately
reflects the underlying economics of the Promissory Notes. Under the fair value election in IFRS 9, changes in fair value of the Promissory
Notes, will be reported in the Consolidated Statements of Operations, under change in fair value of debt instrument, in each reporting
period subsequent to the issuance of the Promissory Note. The Fourth Promissory Note was recorded at its fair value of $
During
the six months ended June 30, 2025, the Company repaid principal amounts of the Fourth Promissory Note of $
During
the six months ended June 30, 2024, the Company repaid principal amounts of the Second Promissory Note of $
During
the six months ended June 30, 2024, principal amounts of the Second Promissory Note of $
For
the six months ended June 30, 2025 and 2024, the Company recorded a change in fair value of $
Changes in the balance of the convertible notes classified as Level 3 fair value measurement are as follows:
| Carrying | ||||||||
| Amount at | ||||||||
| Face Value | Fair value | |||||||
| Balance at December 31, 2024 | $ | $ | ||||||
| Repayments of convertible promissory notes | ( | ) | ( | ) | ||||
| Change in fair value of convertible promissory notes | ( | ) | ||||||
| Balance at June 30, 2025 | $ | $ | ||||||
As
of June 30, 2025, the Company used a discount cash flow to value the fair value of the Promissory Notes. The discount rate used was
Key inputs for the lattice model used are summarized below.
| December 31, | ||||
| 2024 | ||||
| Stock price | ||||
| Expected life in years | ||||
| Risk free rate | | |||
| Expected volatility |
23
12. SILENT PARTNERSHIPS
Continuity of the Company’s silent partnerships is as follows:
| 3% SPAs | 3.5% SPAs | 8.5% SPAs | Total | |||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | ||||||||||||
| Issued during the year | ||||||||||||||||
| Extinguished during the year | ( | ) | ( | ) | ||||||||||||
| Discount | ||||||||||||||||
| Accretion | ||||||||||||||||
| Interest expense | ||||||||||||||||
| Effects of currency translation | ||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | $ | ||||||||||||
| (*) | see Note 14 – As of June 30, 2025 and December 31, 2024, $ |
13. EQUITY
Authorized shares
Our
authorized share capital amounts to EUR
Preferred shares
The
Company designates the preferred shares with a nominal value of EUR
| ● | a Series A consisting of |
| ● | a Series B consisting of |
| ● | a Series C consisting of |
| ● | a Series D consisting of |
| ● | a Series E consisting of |
24
Ordinary shares
The
Company has
On
May 19, 2025, we entered into a securities purchase agreement (the “SPA”) with an institutional investor (the “Purchaser”),
pursuant to which we sold to the Purchaser (i)
In addition, during the six months ended June 30, 2025, the Company issued ordinary shares as follows:
| ● |
| ● |
During the six months ended June 30, 2024, the Company issued ordinary shares as follows:
| ● |
| ● |
Warrants
On
November 13, 2023, the Company issued
On
December 12, 2024, the Company issued
On
May 21, 2025, the Company issued
A summary of activity during the six months ended June 30, 2025, is as follows:
| Warrant | Weighted-Average | Weighted-Average | ||||||||||
| Outstanding | Exercise Price | Life (years) | ||||||||||
| Balance as of December 31, 2024 | $ | |||||||||||
| Grants | ||||||||||||
| Exercised | ( | ) | ||||||||||
| Expired | ||||||||||||
| Balance as of June 30, 2025 | $ | |||||||||||
As
of June 30, 2025, all outstanding warrants are exercisable and the intrinsic value of the warrants is $
25
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. The purpose of the COP is to promote the interests of Mainz USA by providing a payment opportunity to individuals providing services to Mainz USA upon the consummation of a corporate transaction or series of transactions resulting in a change of control of Mainz USA or our Company (a “Change of Control” and the completion of a Change of Control, the “Closing”).
Payment
under the COP is based principally upon the carve-out pool amount which is equal to
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. Subject to the terms of the COP, payments under the COP will generally be paid in the same form (or forms) as the consideration
received by shareholder of our Company in respect of their Company equity securities due to the change of control. The Compensation Committee
has allocated
Stock options
In
2021, our shareholders adopted our 2021 Omnibus Incentive Plan (the “2021 Plan”). Under the 2021 Plan, 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 2021 Plan, the aggregate
number of shares underlying awards that we could issue cannot exceed
In
2022, our shareholders adopted our 2022 Omnibus Incentive Plan (the (“2022 Plan”). Under the 2022 Plan, 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 2022 Plan, the aggregate
number of shares underlying awards that we could issue cannot exceed
During
the six months ended June 30, 2025, the Company granted
26
During
the six months ended June 30, 2025 and 2024, the Company recorded share-based compensation of $
For the six months ended June 30, 2025, the estimated fair values of the stock options are as follows:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Exercise price | $ | $ | ||||||
| Expected term | ||||||||
| Expected average volatility | % | |||||||
| Expected dividend yield | ||||||||
| Risk-free interest rate | % | |||||||
A summary of activity during the six months ended June 30, 2025 follows:
| Stock options | Weighted-Average | Weighted-Average | ||||||||||
| Outstanding | Exercise Price | Life (years) | ||||||||||
| Balance as of December 31, 2024 | $ | |||||||||||
| Grants | ||||||||||||
| Forfeited | ( | ) | ||||||||||
| Cancelled | ||||||||||||
| Expiry | ||||||||||||
| Balance as of June 30, 2025 | $ | |||||||||||
| Exercisable as of June 30, 2025 | $ | |||||||||||
| Expected to vest | $ | |||||||||||
As
of June 30, 2025, the intrinsic value of the stock options is $
14. RELATED PARTY TRANSACTIONS
Key
management personnel include those persons having authority and responsibility for planning, directing and controlling the activities
of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board,
its Chief Executive Officer, and Chief Financial Officer.
| Six months ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Salaries and benefits | $ | $ | ||||||
As
of June 30, 2025 and December 31, 2024, the Company recorded accrued management salaries of $
27
Remuneration paid to related parties other than key personnel during the six months ended June 30, 2025 and 2024 was as follows:
| Six months ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Salaries and benefits | $ | $ | ||||||
During
the six months ended June 30, 2025 and 2024, we recorded expenses of $
On
February 15, 2023, we entered into an Intellectual Property Asset Purchase Agreement (“IPA”), which supersedes the Licensing
and Options Agreements with ColoAlert AS. Pursuant to the IPA, we acquired the intellectual property underlying the ColoAlert test. Pursuant
to the IPA, we were able to reduce the price paid for the intellectual property to (i) $
During
the six months ended June 30, 2025 and 2024, the Company paid $
Related party transactions
As
of June 30, 2025 and December 31, 2024, the Company recorded accounts payable – related party of $
After
the Sale of EOL to a related party effective September 1, 2024, EOL became a regular customer of the Company, generating
revenue – related party in 2025, with an AR balance as of June 30, 2025 and December 31, 2024 of $
Silent partnerships
As
of June 30, 2025 and December 31, 2024, EUR
During
the six months ended June 30, 2025 and 2024, the Company incurred interest expense of $
28
15. GOVERNMENT GRANTS
The Company receives government grants related to its research and development activities. The amount of government grants received during the six months ended June 30, 2025 and 2024 and recognized as other income were as follows:
| Six months ended | ||||||||
| June 30, | ||||||||
| Research and Development Projects | 2025 | 2024 | ||||||
| Multi-marker test for the early detection of pancreatic cancer | $ | $ | ||||||
As
of June 30, 2025 and December 31, 2024, the grants for rapid detection of antibody-based pathogens and a multi-marker test for the early
detection of pancreatic cancer had remaining grant balances of approximately $
16. FINANCIAL INSTRUMENT RISK MANAGEMENT
Basis of Fair Value
Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:
| ● | Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities; |
| ● | Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and |
| ● | Level 3 — Inputs that are not based on observable market data. |
The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.
The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.
Credit Risk
The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. Management believes that the Company is not exposed to any significant credit risk with respect to its cash.
29
The
Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. The Company has been determined
that no credit loss provision is required, as all amounts outstanding are considered collectible. During the six months ended June 30,
2025, the Company incurred $
Liquidity Risk
Liquidity
risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company has a planning and
budgeting process in place to help determine the funds required to support the Company’s normal operating requirements on an ongoing
basis. As of June 30, 2025 and December 31, 2024, the Company had an unrestricted cash balance of $
Historically, the Company’s primary source of funding has been the sale of ordinary shares and borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to significant equity funding.
The following is an analysis of the contractual maturities of the Company’s financial liabilities as of June 30, 2025 and December 31, 2024:
At June 30, 2025:
| Within | More than | More than | ||||||||||
| one year | one year | five years | ||||||||||
| Accounts payable and accrued liabilities | $ | $ | $ | |||||||||
| Accounts payable and accrued expense - related party | ||||||||||||
| Convertible promissory | ||||||||||||
| Convertible loans | ||||||||||||
| Silent partnerships | ||||||||||||
| Lease liabilities | ||||||||||||
| Intellectual property acquisition liability | ||||||||||||
| Intellectual property acquisition liability - related party | ||||||||||||
| $ | $ | $ | ||||||||||
At December 31, 2024:
| Within | More than | More than | ||||||||||
| one year | one year | five years | ||||||||||
| Accounts payable and accrued liabilities | $ | $ | $ | |||||||||
| Accounts payable and accrued expense - related party | ||||||||||||
| Convertible promissory note to be settled with ordinary shares | ||||||||||||
| Convertible loans | ||||||||||||
| Silent partnerships | ||||||||||||
| Lease liabilities | ||||||||||||
| Intellectual property acquisition liability - related party | ||||||||||||
| $ | $ | $ | ||||||||||
30
Foreign Exchange Risk
Foreign
currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated
in currencies that differ from the respective functional currency.
Interest Rate Risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates.
Capital Management
The Company aims to manage its capital resources to ensure financial strength and to maximize its financial flexibility by maintaining strong liquidity and by utilizing alternative sources of capital including equity, debt and bank loans or lines of credit to fund continued growth. The Company sets the amount of capital in proportion to risk and based on the availability of funding sources. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. As an early-stage growth company, the sale of ordinary shares has been the primary source of capital to date. Additional debt and/or equity financing may be pursued in future as deemed appropriate to balance debt and equity. To maintain or adjust the capital structure, the Company may issue new shares, take on additional debt or sell assets to reduce debt.
17. COMMITMENTS AND CONTINGENCIES
From time-to-time, the Company is involved in legal proceedings. The Company records a liability for those legal proceedings when it determines it is probable that a loss has been incurred and the amount of the loss can be reasonably estimated. The Company also discloses when it is reasonably possible that a material loss may be incurred, however, the amount cannot be reasonably estimated. From time to time, the Company may enter into discussions regarding settlement of these matters, and may enter into settlement agreements, if it believes settlement is in the best interest of the Company and its shareholders.
On March 22, 2024, the Company filed a complaint in the Supreme Court of the State of New York against Boustead Securities, LLC, for breach of contract, unjust enrichment, and a declaratory judgment. Several weeks later, Boustead brought an arbitration against Mainz seeking to collect alleged unpaid compensation for financial services plus shares and warrants pursuant to two agreements. Mainz made an application to the Arbitration Panel requesting an order staying the Arbitration proceeding pending final determination by the courts of the issues raised in the Supreme Court case, which was granted on September 12, 2024. There is not a future court conference scheduled, and Mainz is waiting on the Court’s determination of which venue (the Supreme Court or FINRA Dispute Resolution) is proper to hear the dispute. The Company intends to vigorously defend against all claims. Given the preliminary stage of the lawsuit, the uncertainty of litigation, the Company cannot predict the outcome at this time or estimate a reasonably possible loss or range of loss that may result from this action. There has been no change of status to this action since December 31, 2024, through the date of issuance of these financial statements.
31
18. CONCENTRATIONS
Major
customers are defined as customers that each individually account for greater than
19. OPERATING EXPENSES
For the six months ended June 30, 2025 and 2024, operating expenses consisted of the following:
| Six months ended | ||||||||
| June 30, | ||||||||
| Sales and marketing | 2025 | 2024 | ||||||
| Salaries and Benefits | $ | $ | ||||||
| Professional and consulting fees | ||||||||
| Office expenses | ||||||||
| Travel and entertainment | ||||||||
| Depreciation and amortization | ||||||||
| Marketing and advertising | ||||||||
| $ | $ | |||||||
| Six months ended | ||||||||
| June 30, | ||||||||
| Research and development | 2025 | 2024 | ||||||
| Salaries and benefits | $ | $ | ||||||
| Professional fees | ||||||||
| Clinical study expenses | ||||||||
| Office expenses | ||||||||
| Travel and entertainment | ||||||||
| Depreciation and amortization | ||||||||
| Materials for clinical studies | ||||||||
| $ | $ | |||||||
32
| Six months ended | ||||||||
| June 30, | ||||||||
| General and administrative | 2025 | 2024 | ||||||
| Salaries and benefits | $ | $ | ||||||
| Employee stock option expense | ||||||||
| Professional and consulting fees | ||||||||
| Office expenses | ||||||||
| Insurance | ||||||||
| Travel and entertainment | ||||||||
| Depreciation and amortization | ||||||||
| $ | $ | |||||||
20. SUBSEQUENT EVENTS
The
Company issued
On
August 4, 2025, we entered into a securities purchase agreement with an institutional investor (the “Purchaser”) pursuant
to which we sold to the Purchaser
Subsequent
to June 30, 2025, the Company repaid $
33