6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the nine months ended September 30, 2023

Commission File No. 001-41010

MAINZ BIOMED N.V.

(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 November 16, 2023, Mainz Biomed N.V. made available its Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and nine months ended September 30, 2023. A copy of the report is attached hereto as Exhibit 99.1.

On November 16, 2023, Mainz Biomed N.V. made available its unaudited Financial Statements for the three and nine months ended September 30, 2023. A copy of the report is attached hereto as Exhibit 99.2.

Furnished as Exhibit 99.3 to this Report on Form 6-K is a press release of Mainz Biomed N.V. (the “Company”) dated November 16, 2023, announcing the Company’s results for the three and nine months ended September 30, 2023.

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) as is the Company’s Current Report on Form 6-K filed on November 15, 2023 and the exhibits included therein.

Exhibit No.	Exhibit
99.1	Management’s Discussion and Analysis of Financial Condition and Results of Operations of Mainz Biomed N.V. for the three and nine months ended September 30, 2023
99.2	Unaudited Financial Statements of Mainz Biomed N.V. as of and for the three and nine months ended September 30, 2023
99.3	Press Release dated November 16, 2023
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).

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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: November 16, 2023	By:	/s/ William J. Caragol
	Name:	William J. Caragol
	Title	Chief Financial Officer

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EX-99.1

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 contain 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, 2022 on Form 20-F, filed with the U.S. Securities and Exchange Commission on April 7, 2023. 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 in-vitro diagnostic (“IVD”) tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. Our flagship product is a colorectal cancer screening product sold under the brand name ColoAlert™. We develop and distribute our IVD kits to third-party laboratories, who in turn provide diagnostic analysis for their patients. Additionally, we operate a clinical diagnostic laboratory for testing patient samples. Substantially all of our revenues in 2023 and 2022 were generated from the sale of our ColoAlert kits and the analytics and delivery of results from testing patient samples.

In addition, we conduct research and development in order to increase and diversify our product portfolio. During 2022 and 2023, we are managing two government funded research and development projects, which provide us non-refundable grant income that covers a portion of the individual project related costs. Our PancAlert product candidate research is partially funded with government programming and Company funds.

On November 9, 2021, we completed our initial public offering whereby we sold 2,300,000 ordinary shares for gross proceeds of $11,500,000. On January 28, 2022, we completed a follow-on public offering whereby we sold 1,725,000 ordinary shares for gross proceeds of $25,875,000.

Results of Operations

Comparison of the Three Months Ended September 30, 2023 and 2022

The following table provides certain selected financial information for the periods presented:

	Three Months Ended September 30,									%
	2023			2022			Change			Change
Revenue	$	181,669		$	96,791		$	84,878			88	%
Cost of revenue	$	94,483		$	78,178		$	16,305			21	%
Gross profit	$	87,186		$	18,613		$	68,573			368	%
Gross margin		48	%		19	%
Research and development	$	1,854,795		$	909,003		$	945,792			104	%
Sales and marketing	$	1,122,134		$	605,844		$	516,290			85	%
General and administrative	$	2,750,895		$	3,979,359		$	(1,228,464	)		(31	)%
Total operating expenses	$	5,727,824		$	5,494,206		$	(233,618	)		4	)%
Loss from operations	$	(5,640,638	)	$	(5,475,593	)	$	(165,045	)		(3	)%
Other expense	$	659,119		$	120,634		$	538,485			446	%
Net loss	$	(6,299,757	)	$	(5,596,227	)	$	(703,530	)		(13	)%
Total comprehensive loss	$	(5,818,294	)	$	(5,532,128	)	$	(286,166	)		(5	)%
Basic and dilutive loss per common share	$	(0.39	)	$	(0.39	)	$	0.00			0	%
Weighted average number of common shares outstanding – basic and diluted		15,967,714			14,286,157

Revenue

Revenue for the three months ended September 30, 2023 was $181,669 as compared to $96,791 for the three months ended September 30, 2022, an increase of 88%. This increase was attributable to an increase in ColoAlert sales, primarily in Germany. We intend to continue our efforts to grow the market for ColoAlert, both in Germany and extending to other countries in Europe and the rest of world.

Cost of Revenue

Cost of Revenue for the three months ended September 30, 2023 was $94,483 as compared to $78,178 for the three months ended September 30, 2022, a 21% increase. This increase was the result of increased ColoAlert sales volume.

Gross profit

Gross profit increased to $87,186 in the three months ended September 30, 2023 compared to $18,613, for the three months ended September 30, 2022. This gross profit increase, resulting in an improvement of gross margin from 19% to 48%, was attributable to improved profits resulting from lowered unit cost of goods sold which in turn was attributable to economies of scale from increased volumes.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2023, were $1,854,795 compared to $909,003 for the three months ended September 30, 2022, an increase of $945,792. This increase was driven by increased payroll expenses of $504,110 to support our ColoFuture and eAArly Detect feasibility studies in the U.S. and in Europe. Additionally, direct costs for our studies increased by $76,363 for the three months ended September 30, 2023, compared to the same period in 2022. Further, amortization of intangible assets related to our intellectual property increased by $131,200 and lab overhead increased by $185,302 for the three months ended September 30, 2023 compared to the comparable period of 2022.

Sales and Marketing Expenses

Sales and marketing expenses for the three months ended September 30, 2023, were $1,122,134 compared to $605,844 for the three months ended September 30, 2022, an increase of $516,290. This net increase was the result of an increase in labor costs (salary and consulting) of $848,559 to support the sale of our ColoAlert product and a decrease in advertising expenses of $374,831 in the three months ended September 30, 2023 compared to the comparable period in 2022.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2023 were $2,750,895 compared to $3,979,359 for the three months ended September 30, 2022, a decrease of $1,228,464. The decreased expenses were primarily the result of a decrease of $1,821,042 of non-cash stock option expenses, and increased overhead to support both a larger employee base, as well as support of our clinical studies and European commercial efforts.

Other Expense

Other expenses, net for the three months ended September 30, 2023 was $659,119 compared to $120,634 for the three months ended September 30, 2022, resulting in increased other expenses (net) of $538,485. This increase was primarily the result of foreign currency transaction losses and increased interest expenses related to our equipment financing program of approximately $86,000. Foreign currency transaction losses result from the translation of net liabilities from Euro to U.S. Dollars.

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Comparison of the Nine Months Ended September 30, 2023 and 2022

The following table provides certain selected financial information for the periods presented:

	Nine Months Ended September 30,									%
	2023			2022			Change			Change
Revenue	$	680,718		$	336,596		$	344,122			102	%
Cost of revenue	$	305,793		$	190,741		$	115,052			60	%
Gross profit	$	374,925		$	145,855		$	229,070			157	%
Gross margin		55	%		43	%
Research and development	$	7,591,168		$	1,702,491		$	5,888,677			346	%
Sales and marketing	$	5,207,795		$	3,393,858		$	1,813,937			53	%
General and administrative	$	7,630,246		$	13,104,566		$	(5,474,320	)		(42	)%
Total operating expenses	$	20,429,209		$	18,200,915		$	2,228,294			12	%
Loss from operations	$	(20,054,284	)	$	(18,055,060	)	$	(1,999,224	)		(11	)%
Other expense	$	1,058,116		$	143,614		$	914,502			637	%
Net loss	$	(21,112,400	)	$	(18,198,674	)	$	(2,913,726	)		(16	)%
Total comprehensive loss	$	(20,781,533	)	$	(18,051,932	)	$	(2,729,601	)		(15	)%
Basic and dilutive loss per common share	$	(1.38	)	$	(1.32	)	$	(0.06	)		(5	)%
Weighted average number of common shares outstanding – basic and diluted		15,924,040			13,821,914

Revenue

Revenue for the nine months ended September 30, 2023 was $680,718 as compared to $336,596 for the nine months ended September 30, 2022, an increase of 102%. This increase was primarily attributable to an increase in ColoAlert sales, which were primarily in Germany. We intend to continue our efforts to grow the market for ColoAlert, both in Germany and extending to other countries in Europe and the rest of world.

Cost of Revenue

Cost of Revenue for the nine months ended September 30, 2023 was $305,793 as compared to $190,741 for the nine months ended September 30, 2022, a 60% increase. This increase was the result of increased ColoAlert sales volume.

Gross profit

Gross profit increased to $374,925 in the nine months ended September 30, 2023 compared to $145,855, for the nine months ended September 30, 2022. This gross profit increase, resulting in an improvement of gross margin from 43% to 55%, was attributable to improved profits resulting from lowered unit cost of goods sold attributable to economies of scale with increased volumes.

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2023 were $7,591,168 compared to $1,702,491 for the nine months ended September 30, 2022, an increase of $5,888,677. This increase was driven by increased payroll expenses of $1,975,576 to support our ColoFuture and eAArly Detect feasibility studies in the U.S. and in Europe. Additionally, direct costs for our studies increased by $2,724,812 for the nine months ended September 30, 2023, compared to the same period in 2022. Further, amortization of intangible assets related to our intellectual property increased by $342,075 and lab overhead increased by $675,028 for the nine months ended September 30, 2023 compared to the comparable period of 2022.

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Sales and Marketing Expenses

Sales and marketing expenses for the nine months ended September 30, 2023, were $5,207,795 compared to $3,393,858 for the nine months ended September 30, 2022, an increase of $1,813,937. This increase was related to labor costs (salary and consulting) to support the sale of our ColoAlert product, which increased by $2,205,539 and a decrease in advertising expenses of $445,165 for the nine months ended September 30, 2023 compared to the comparable period in 2022.

General and Administrative Expenses

General and administrative expenses for the nine months ended September 30, 2023 were $7,630,246 compared to $13,104,566 for the nine months ended September 30, 2022, a decrease of $5,474,320. The decreased expenses were primarily the result of a decrease of $5,046,819 of non-cash stock option expense, and decreased salary and consulting costs of $1,156,776, related to legal, banking, and accounting fees primarily related to our capital raising efforts in the first nine months of 2022.

Other Expense

Other expenses, net for the nine months ended September 30, 2023 was $1,058,116 compared to $143,614 for the nine months ended September 30, 2022, resulting in increased other expenses (net) of $914,502. This increase was the result of commitment fees and expenses related to our June 28, 2023 financing of $280,000, foreign currency transaction losses and increased interest expenses related to our equipment financing program of approximately $230,000. Foreign currency transaction losses result from the translation of net liabilities from Euro to U.S. Dollars.

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 September 30, 2023, we had $9,320,381 of cash and cash equivalents, with $17,141,775 as of December 31, 2022.

The following table summarizes our cash flows from operating, investing and financing activities:

	Nine Months Ended September 30,
	2023			2022			Change
Cash used in operating activities	$	(17,283,658	)	$	(10,057,242	)	$	(7,226,416	)
Cash used in investing activities	$	(1,637,033	)	$	(643,637	)	$	(933,396	)
Cash provided by financing activities	$	10,760,886		$	24,052,931		$	(13,292,045	)

Cash Flow from Operating Activities

For the nine months ended September 30, 2023, cash flows used in operating activities was $17,283,658 compared to $10,057,242 used during the nine months ended September 30, 2022. The increase in cash flows used in operating activities of $7,226,416 was primarily the result of our operating loss for the nine months ended September 30, 2023, net of non-cash stock-based compensation, depreciation and amortization, and timing differences for the settlement of assets and liabilities. A primary driver of this increased loss was the increase in clinical study expenses which increased $2,724,812 in the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022.

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Cash Flows from Investing Activities

During the nine months ended September 30, 2023, we used $1,637,033 in investing activities compared to $643,637 used during the nine months ended September 30, 2022. The increase in cash flows used in investing activities of $933,396 was the result of increased capital expenditures of $393,396 related to the expansion of our office and lab space, and payment of $600,000 for the purchase of our ColoAlert intellectual property in February of 2023.

Cash Flows from Financing Activities

During the nine months ended September 30, 2023, we had cash flow provided by financing activities of $10,760,886 compared to cash flow provided by financing activities of $24,052,931 for the nine months ended September 30, 2022, a decrease of $13,292,045. This decrease was primarily the result of our sale of 1,725,000 ordinary shares on January 28, 2022, for net proceeds of $23,865, 890, and the issuance of two convertible notes during the nine months ended September 30, 2023, for net proceeds of $10,120,000.

Working Capital Discussion

We had recurring losses, accumulated deficit totaling $64,144,694 and negative cash flows used in operating activities of $17,283,658 as of and for the nine months ended September 30, 2023. We also had $9,320,381 of cash on hand on September 30, 2023, and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,921,813.

These conditions are indicators that impact the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. If the Company is unable to obtain funding, the Company could be forced to further delay, reduce or eliminate its research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and its ability to continue as a going concern. We plan to fund our cash flow and working capital needs through current cash on hand and future debt and/or equity financings which we may obtain through one or more public or private equity offerings, debt financings, government or other third-party funding, strategic alliances or collaboration agreements. In December 2022, we entered into a $50,000,000 Controlled Equity Offering; we raised $1.9 million of net cash from this facility during the nine months ended September 30, 2023. Additionally, on June 28, 2023, we entered into a Pre-Paid Advance Agreement have issued $11 million of convertible promissory notes, for net proceeds of $10.1 million during the nine months ended September 30, 2023.

Management believes that our expense reduction plans, coupled with the availability of our Controlled Equity Offering and/or Pre-Paid Advance Agreement, and ability to execute a financing after the reporting of results from our clinical studies, will provide the financing necessary to fund our working capital needs for the foreseeable future.

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

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● Stock Option Compensation

● Impairment of Long-Lived Assets Including Intangibles

● Lease Accounting

● Financial Instruments

Revenue Recognition

Our revenue is primarily derived through providing our ColoAlert genetic diagnostic test kits to customers. We recognize revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.

In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration we expect to be entitled to receive for those goods and services.

We provide a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as we use the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, we have one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.

We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed. This income is included in the Statements of 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 currency, as determined by our management, is the Euro (EUR).

Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. 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 on 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).

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Stock Option Compensation

We have adopted our 2021 Omnibus Incentive Plan and 2022 Omnibus Incentive Plan (the (“Plans”). Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 2,800,000 ordinary shares.

On November 4, 2021, we awarded 1,484,650 stock options under the Plans, with a strike price of $5.00, the per share price in our November 2021 initial public offering. Such stock options were granted to all of our current employees, directors, advisors and senior management team. Such stock options for our non-senior management team, independent directors and advisors will begin vesting on November 4, 2022, and stop vesting on November 4, 2025, at the latest. Such stock options for the four members of our senior management team began vesting in portions equal to 25% of such options granted if, prior to November 4, 2025, the four-year anniversary of our initial public offering, for ten consecutive trading days (with at least 100,000 shares traded per trading day) the volume-weighted average price of the ordinary shares on the principal market is at least:

● $7.50;

● $10.00;

● $12.50, provided that such options cannot vest until the twelve-month anniversary of our initial public offering at the earliest; and

● $15.00, provided that such options cannot vest until the twelve-month anniversary of our initial public offering at the earliest.

100% of these options were fully vested on November 5, 2022.

We have valued these stock options as follows: (a) for those options that have time-based vesting, we will use the Black-Scholes method to value the stock options at the time of award and record the compensation expense in our Statement of Operations over the vesting period, and (b) for options issued with milestone based vesting criteria, we will use a Monte Carlo simulation to value the options at the time of issuance and each subsequent reporting date until fully vested or expired, with any change in compensation expense measured by such method to be recorded in our Statement of Operations.

The Black-Scholes option pricing model considers, among other factors, the expected term of the award and the expected volatility of our stock price. Due to the lack of an adequate history of a public market for the trading of our ordinary shares, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded with historical share price information sufficient to meet the expected life of the stock-based awards. The Monte Carlo simulation approach is a class of computational algorithms that rely on repeated random sampling to compute their results. This approach allows the calculation of the value of such stock options based on a large number of possible stock price path scenarios. Expense for the market-condition stock options will be recognized over the derived service period as determined through the Monte Carlo simulation model.

Impairment of Long-Lived Assets Including Intangibles

We continually evaluate whether events or circumstances have occurred that indicate the remaining estimated useful lives of our long-lived assets including intangible assets may warrant revision or that the remaining balance of such assets may not be recoverable. We use an estimate of the related undiscounted cash flows over the remaining life of the asset in measuring whether the asset is recoverable.

Lease Accounting

We assess at contract inception whether a contract is, or contains, a lease. 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.

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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 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 its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. We determine the classification of financial assets at initial recognition. The classification of debt instruments is driven by our business model for managing 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.

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.

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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.

Capitalization and Indebtedness

 The following table sets forth our capitalization. Such information is set forth on the following basis:

● on an actual basis as of September 30, 2023; and

● on a pro forma basis, giving effect to the sale by us of 4,166,667 Ordinary Shares and Pre-Funded Warrants, at an offering price of $1.20 per Ordinary Share and Pre-Funded Warrant (which include the nominal exercise price to be paid upon the exercise of the Pre-Funded Warrants), after deducting placement agent fees and estimated offering expenses.

You should read this table together with our unaudited financial statements and the related notes appearing as an exhibit to the current report on Form 6-K to which this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” is attached as an exhibit. The pro forma information provided below does not take into account any other changes to our financial information (including any expenses) other than as set out above.

	September 30, 2023
	Actual			Pro Forma
Cash	$	9,320,381		$	13,785,381
Debt:
Convertible notes		7,281,158		$	7,281,158
Silent Partnerships		971,916			971,916
Total Debt	$	8,253,074		$	8,253,074
Stockholders’ Equity:
Share capital	$	187,890			226,867
Share premium		46,525,899			50,951,922
Reserve		20,497,224			20,497,224
Accumulated deficit		(64,144,694	)		(64,144,694	)
Accumulated other comprehensive income		383,049			383,049
Total Stockholders’ Equity		3,449,368		$	7,914,368
Total Capitalization	$	11,702,442		$	16,167,442

9

EX-99.2

Exhibit 99.2

Mainz Biomed N.V.

Condensed Consolidated Statements of Financial Position

(Unaudited)

(Expressed in US Dollars, except share data).

			September 30,			December 31,
	Note		2023			2022
ASSETS
Current Assets
Cash			$	9,320,381		$	17,141,775
Trade receivables, net		4		108,630			66,984
Inventories		5		493,588			175,469
Prepaid expenses and other current assets		6		1,052,693			994,113
Total Current Assets				10,975,292			18,378,341
Property and equipment, net		7		1,606,333			661,692
Intangible assets		8		3,536,089			-
Right-of-use assets		9		1,788,977			1,177,695
Other assets				104			23,275
Total assets			$	17,906,795		$	20,241,003
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued liabilities		10	$	3,104,456		$	2,916,679
Convertible debt		12		7,249,439			43,057
Convertible debt - related party		11		31,719			32,181
Silent partnerships, current portion		13		-			759,168
Silent partnerships, current portion - related party		13		-			206,167
Intellectual property acquisition liability, current portion - related party		8		400,854			-
Lease liabilities, current		9		474,011			285,354
Total current liabilities				11,260,479			4,242,606
Silent partnerships, non-current		13		713,928			687,128
Silent partnerships, non-current - related party		13		257,988			256,086
Lease liabilities, non-current		9		1,428,368			959,116
Intellectual property acquisition liability, non-current - related party		8		796,664			-
Total Liabilities				14,457,427			6,144,936
Shareholders’ equity
Share capital		14		187,890			164,896
Share premium		14		46,525,899			38,831,542
Reserve		14		20,497,224			18,079,741
Accumulated deficit				(64,144,694	)		(43,032,294	)
Accumulated other comprehensive income				383,049			52,182
Total shareholders’ equity				3,449,368			14,096,067
Total liabilities and shareholders’ equity			$	17,906,795		$	20,241,003

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

1

Mainz Biomed N.V.

Condensed Consolidated Statements of Profit and Loss and Comprehensive Loss

(Unaudited)

(Expressed in US Dollars, except share data)

			Three months ended						Nine months ended
			September 30,						September 30,
	Note		2023			2022			2023			2022
Revenue			$	181,669		$	96,791		$	680,718		$	336,596
Cost of sales		15		94,483			78,178			305,793			190,741
Product margin				87,186			18,613			374,925			145,855
Operating expenses:
Sales and marketing		20		1,122,134			605,844			5,207,795			3,393,858
Research and development		20		1,854,795			909,003			7,591,168			1,702,491
General and administrative		20		2,750,895			3,979,359			7,630,246			13,104,566
Total operating expenses				5,727,824			5,494,206			20,429,209			18,200,915
Loss from operations				(5,640,638	)		(5,475,593	)		(20,054,284	)		(18,055,060	)
Other income (expense)
Other income		17		38,652			78,081			209,620			171,013
Other expense				(697,771	)		(198,715	)		(1,267,736	)		(314,627	)
Total other expense				(659,119	)		(120,634	)		(1,058,116	)		(143,614	)
Loss before income tax				(6,299,757	)		(5,596,227	)		(21,112,400	)		(18,198,674	)
Income taxes provision				-			-			-			-
Net loss			$	(6,299,757	)	$	(5,596,227	)	$	(21,112,400	)	$	(18,198,674	)
Foreign currency translation gain				481,463			64,099			330,867			146,742
Comprehensive loss			$	(5,818,294	)	$	(5,532,128	)	$	(20,781,533	)	$	(18,051,932	)
Basic and dilutive loss per ordinary share			$	(0.39	)	$	(0.39	)	$	(1.38	)	$	(1.32	)
Weighted average number of ordinary shares outstanding				15,967,714			14,286,157			15,294,040			13,821,914

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 

2

Mainz Biomed N.V.

Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit)

(Unaudited)

(Expressed in US Dollars, except share data)

														Accumulated
		Number of		Share		Share					Accumulated			Other comprehensive			Total Shareholders’
	Note	shares		Capital		Premium		Reserve			Deficit			Income (loss)			Equity
Balance, December 31, 2022			14,629,457	$	164,896	$	38,831,542	$	18,079,741		$	(43,032,294	)	$	52,182		$	14,096,067
Sale of ordinary shares	14		195,044		2,094		1,281,291		-			-			-			1,283,385
Share based expense	14		2,112		22		14,741		-			-			-			14,763
Stock option expense	14		-		-		-		904,664			-			-			904,664
Net loss			-		-		-		-			(6,560,916	)		-			(6,560,916	)
Foreign currency translation			-		-		-		-			-			(60,572	)		(60,572	)
Balance, March 31, 2023			14,826,613	$	167,012	$	40,127,574	$	18,984,405		$	(49,593,210	)	$	(8,390	)	$	9,677,391
Sale of ordinary shares	14		112,321		1,224		608,587		-			-			-			609,811
Share based expense	14		32,388		353		162,574		-			-			-			162,927
Ordinary shares issued for acquisition of intangible asset	8, 14		300,000		3,270		2,051,730		-			-			-			2,055,000
Ordinary shares issued for commission of issuance of convertible debt	12, 14		54,428		593		249,407		-			-			-			250,000
Ordinary shares issued for cashless exercise of warrant	14		305,771		3,333		12,132		(15,465	)		-			-			-
Stock option expense	14		-		-		-		764,009			-			-			764,009
Net loss			-		-		-		-			(8,251,727	)		-			(8,251,727	)
Foreign currency translation			-		-		-		-			-			(90,024	)		(90,024	)
Balance, June 30, 2023			15,631,521	$	175,785	$	43,212,004	$	19,732,949		$	(57,844,937	)	$	(98,414	)	$	5,177,387
Share based expense	14		100,000		1,085		324,915		-			-			-			326,000
Issuance of ordinary shares for conversion of debt	12, 14		1,015,939		11,020		2,988,980		-			-			-			3,000,000
Stock option expense	14		-		-		-		764,275			-			-			764,275
Net loss			-		-		-		-			(6,299,757	)		-			(6,299,757	)
Foreign currency translation			-		-		-		-			-			481,463			481,463
Balance, September 30, 2023			16,747,460	$	187,890	$	46,525,899	$	20,497,224		$	(64,144,694	)	$	383,049		$	3,449,368

3

												Accumulated
	Number of	Share		Share					Accumulated			Other comprehensive		Total Shareholders’
	shares	Capital		Premium		Reserve			Deficit			Income		Equity
Balance, December 31, 2021	12,010,001	$	141,075	$	13,126,493	$	9,736,066		$	(16,644,958	)	$	2,479	$	6,361,155
Sale of ordinary shares	1,725,000		15,525		23,850,364		-			-			-		23,865,889
Issuance of ordinary shares for exercise of warrants	107,500		968		321,533		(64,156	)		-			-		258,344
Share based expense	58,000		522		787,098		-			-			-		787,620
Stock option expense	-		-		-		2,424,901			-			-		2,424,901
Net loss	-		-		-		-			(5,663,736	)		-		(5,663,736	)
Foreign currency translation	-		-		-		-			-			36,439		36,439
Balance, March 31, 2022	13,900,501	$	158,090	$	38,085,488	$	12,096,811		$	(22,308,694	)	$	38,918	$	28,070,612
Issuance of ordinary shares for exercise of warrants	582,473		5,243		171,172		(52,258	)		-			-		124,156
Stock option expense	-		-		-		2,469,549			-			-		2,469,549
Net loss	-		-		-		-			(6,938,711	)		-		(6,938,711	)
Foreign currency translation	-		-		-		-			-			46,204		46,204
Balance, June 30, 2022	14,482,974	$	163,332	$	38,256,659	$	14,514,102		$	(29,247,405	)	$	85,122	$	23,771,810
Stock option expense	-		-		-		2,585,317			-			-		2,585,317
Net loss	-		-		-		-			(5,596,227	)		-		(5,596,227	)
Foreign currency translation	-		-		-		-			-			64,099		64,099
Balance, September 30, 2022	14,482,974	$	163,332	$	38,256,659	$	17,099,419		$	(34,843,632	)	$	149,221	$	20,824,999

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4

Mainz Biomed N.V.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(Expressed in US Dollars, except share data)

			Nine months ended
			September 30,
	Note		2023			2022
Cash Flows From Operating Activities
Net loss			$	(21,112,400	)	$	(18,198,674	)
Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation		14		3,186,638			8,267,387
Depreciation and amortization				661,942			135,276
Bad debt expense				95,340			-
Inventory write down				13,301			-
Accretion expense		8, 12		132,963			59,792
Government grant		17		-			(88,674	)
Change in fair value of convertible debt				87,000			-
Debt forgiveness				(48,735	)		-
Changes in operating assets and liabilities:
Trade receivables. net				(85,689	)		(148,110	)
Inventories				(342,056	)		(7,155	)
Prepaid expenses and other assets				(107,528	)		151,743
Accounts payable and accrued liabilities				235,566			(228,827	)
Net cash used in operating activities				(17,283,658	)		(10,057,242	)
Cash Flows From Investing Activities
Purchase of intangible asset		8		(600,000	)		-
Purchase of property and equipment		7		(1,037,033	)		(643,637	)
Net cash used in investing activities				(1,637,033	)		(643,637	)
Cash Flows From Financing Activities
Sale of ordinary shares		14		1,893,196			23,865,890
Warrant exercise proceeds				-			382,500
Proceeds from convertible debt		12		10,120,000			-
Payments on silent partnerships		13		(772,423	)		(107,027	)
Payments on silent partnerships - related party		13		(162,450	)		-
Payment of lease obligations		9		(317,437	)		(88,432	)
Net cash provided by financing activities				10,760,886			24,052,931
Effect of changes in exchange rates				338,411			(72,976	)
Net change in cash				(7,821,394	)		13,279,076
Cash at beginning of period				17,141,775			8,727,542
Cash at end of period			$	9,320,381		$	22,006,618
Non-Cash Investing and Financing Activities
Right of use asset additions		9	$	1,009,638		$	949,277
Ordinary shares issued for acquisition of intangible asset		8	$	3,271,828		$	-
Issuance of ordinary shares for cashless exercise of warrants		14	$	15,465		$	52,258
Issuance of ordinary shares for conversion of debt		12, 14	$	3,000,000		$	-
Supplemental Cash Flow Information
Interest expense paid			$	153,580		$	67,989
Income tax paid			$	-		$	-

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

Mainz Biomed N.V.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

(Expressed in US dollars, except share data)

September 30, 2023

NOTE 1. NATURE OF OPERATIONS AND GOING CONCERN

Mainz Biomed N.V. (the “Company”) is domiciled in the Netherlands. The Company’s registered office is at Keizersgracht 391A, EJ Amsterdam and its headquarters are in Mainz, Germany. The Company was formed to acquire the business of Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH (“PharmaGenomics”)). In September 2021, the Company completed such acquisition.

We develop in-vitro diagnostic (“IVD”) tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine, led by our flagship ColoAlert™ product in European markets. We additionally operate a clinical diagnostic laboratory. We develop and distribute our IVD kits to third-party laboratories and through our on-line store.

Throughout these condensed consolidated financial statements, Mainz Biomed N.V. and its 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”.

Share Exchange

On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) between Mainz Biomed B.V. (“Mainz”), which was a private company with limited liability under Dutch law incorporated for the purpose of acquiring PharmGenomics. Under the Contribution Agreement, 100% of the shares of PharmGenomics were acquired in exchange for 6,000,000 shares of the Company. Upon the closing of the Contribution Agreement, PharmGenomics became a wholly owned subsidiary of the Company and the former shareholders of PharmGenomics held approximately 62% of the outstanding shares of the Company prior to the Company’s initial public offering. On September 20, 2021, PharmGenomics and the Company closed the Contribution Agreement.

IPO and Follow-on Equity Offering

In November 2021, the Company completed its initial public offering (“IPO”) of its ordinary shares on the Nasdaq Capital Market, selling 2,300,000 shares at $5.00 per share. Upon its IPO, Mainz Biomed B.V. became Mainz Biomed N.V. In January 2022, the Company completed a follow on offering of its ordinary shares, selling 1,725,000 ordinary shares for gross proceeds of approximately $25.9 million (proceeds net of offering expenses was $23.9 million).

Going Concern

The Company has recurring losses, accumulated deficit totaling $64,144,694 and negative cash flows used in operating activities of $17,283,658 as of and for the nine months ended September 30, 2023. The Company also had $9,320,381 of cash on hand on September 30, 2023 and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,921,813. These conditions are indicators that impact the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. If the Company is unable to obtain funding, the Company could be forced to further delay, reduce or eliminate its research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and its ability to continue as a going concern.

The Company plans to fund its cash flow and working capital 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. In December 2022, the Company entered into a $50,000,000 Controlled Equity Offering (see Note 14); the Company raised $1.9 million of net cash from this facility during the nine months ended September 30, 2023. Additionally, on June 28, 2023, the Company entered into a Pre-Paid Advance Agreement and issued $11.0 million in convertible promissory notes (see Note 12) for net proceeds of $10.1 million during the nine months ended September 30, 2023.

6

Management believes that the availability of its Controlled Equity Offering and/or Pre-Paid Advance Agreement, combined with the potential to execute a financing after the reporting of results from its clinical studies, will provide the financing necessary to fund the Company’s working capital needs for the foreseeable future.

These 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 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.

NOTE 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, 2022 and notes thereto contained in the Company’s 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 November 14, 2023.

NOTE 3. ACCOUNTING POLICIES, ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS

Inventories

Inventories are measured at the lower of cost or 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.

Reclassifications

Certain prior year amounts have been reclassified for consistency with the current period presentation.

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.

7

Useful lives of property and equipment and intangible assets

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.

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.

8

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.

NOTE 4. TRADE RECEIVABLES

	September 30,
	2023 (unaudited)			December 31, 2022
Accounts receivable	$	133,347		$	130,588
Less: allowance for doubtful accounts		(24,717	)		(66,852	)
Accounts receivable, net		108,630			63,736
Other		-			3,248
	$	108,630		$	66,984

For the nine months ended September 30, 2023, the Company recorded bad debt expense of $42,045 for trade receivables.

NOTE 5. INVENTORIES

	September 30,
	2023 (unaudited)			December 31, 2022
Raw materials	$	331,090		$	175,469
Finished goods		175,799			-
		506,889			175,469
Less: write down		(13,301	)		-
	$	493,588		$	175,469

For the nine months ended September 30, 2023, the Company recorded inventory write down of $13,301.

9

NOTE 6. PREPAID EXPENSES AND OTHER CURRENT ASSETS

	September 30, 2023 (unaudited)		December 31, 2022
Prepaid insurance	$	85,153	$	624,033
Prepaid stock compensation		302,714		-
Other prepaid expenses		131,483		55,356
Security deposit		129,358		122,570
VAT receivable		403,985		192,154
	$	1,052,693	$	994,113

For the nine months ended September 30, 2023, the Company recorded bad debt reserve of $53,295 for VAT receivables.

NOTE 7. PROPERTY AND EQUIPMENT

	Laboratory equipment			Office equipment			Construction in progress			Total
Cost
Balances at December 31, 2022	$	579,171		$	176,347		$	-		$	755,518
Additions		933,246			160,708			49,390			1,143,344
Disposals		(16,810	)		-			-			(16,810	)
Effects of currency translation		(30,055	)		(22,240	)		(1,174	)		(53,470	)
Balances at September 30, 2023 (unaudited)	$	1,465,551		$	314,815		$	48,216		$	1,828,582
Accumulated depreciation
Balances at December 31, 2022	$	77,833		$	15,993		$	-		$	93,826
Depreciation		92,068			43,404			-			135,472
Disposals		(2,335	)		-			-			(2,335	)
Effects of currency translation		(3,255	)		(1,459	)		-			(4,714	)
Balances at September 30, 2023 (unaudited)	$	164,311		$	57,938		$	-		$	222,249
Net book value at December 31, 2022	$	501,338		$	160,354		$	-		$	661,692
Net book value at September 30, 2023 (unaudited)	$	1,301,240		$	256,877		$	48,216		$	1,606,333

For the nine months ended September 30, 2023 and 2022, the Company recorded deprecation of $135,472 and $32,767, respectively.

During the first nine months of 2023 we have begun the expansion of our clinical laboratory in our headquarters facility. Expenditures related to that lab expansion are included in Construction in progress.

NOTE 8. INTANGIBLE ASSET

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 €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €5 per ColoAlert test sold (the “Option”). Subsequent to February 11, 2021, ColoAlert AS assigned their interest in ColoAlert and in the Licensing Agreement and the Option to Uni Targeting Research AS.

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) $2 million cash, to be paid out over the next four years, (ii) 300,000 ordinary restricted shares and (iii) a revenue share limited to $1 per test sold for a period of 10 years. The Company recognized an intangible asset from this purchase and assigned a 10-year useful life. The intangible assets were valued: (a) for the portion to be settled in stock of the Company at the value on the day of closing, or $6.85 per share, and (b) for the cash portion, at the present value of the future payments using a 10% discount. During the nine months ended September 30, 2023 the Company paid $600,000 to the seller. The Company recorded amortization of $235,739 and interest expense of $80,690 for the nine months ended September 30, 2023. As of September 30, 2023, the liability for remaining required payments of $1,197,518 is recorded on the statement of financial position.

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NOTE 9. LEASES

Right-of-Use Assets

The Company leases certain assets under lease agreements.

	Office			Laboratory
	Equipment			Equipment			Vehicle			Office			Total
Cost
Balances as of December 31, 2022	$	64,226		$	362,970		$	94,008		$	1,035,200		$	1,556,404
Additions		-			370,011			51,675			587,951			1,009,637
Effects of currency translation		(922	)		(13,992	)		(2,575	)		(28,814	)		(46,303	)
Balances at September 30, 2023	$	63,304		$	718,989		$	143,108		$	1,594,337		$	2,519,738
Accumulated amortization
Balances as of December 31, 2022	$	20,707		$	77,838		$	22,109		$	258,055		$	378,709
Amortization		9,060			152,755			37,878			166,486			366,179
Effects of currency translation		(512	)		(4,742	)		(1,216	)		(7,657	)		(14,127	)
Balances at September 30, 2023	$	29,255		$	225,851		$	58,771		$	416,884		$	730,761
Net book value
December 31, 2022	$	43,519		$	285,132		$	71,899		$	777,145		$	1,177,695
September 30, 2023	$	34,049		$	493,138		$	84,337		$	1,177,453		$	1,788,977

As of September 30, 2023, management assessed that there were no events or changes in circumstances that would require impairment testing.

The carrying amount of the right-of-use assets is amortized on a straight-line basis over the life of the leases, which at September 30, 2023, had a weighted average expected life of 4.24 years.

Lease Liabilities

The Company’s lease liabilities consist of office and laboratory equipment and office space. The present value of future lease payments was measured using an incremental borrowing rate of 10% per annum as of January 1, 2022 and January 1, 2023.

	Total
Balance as of December 31, 2022	$	1,244,470
Additions		1,009,637
Interest expenses		141,097
Lease payments		(458,534	)
Effects of currency translation		(34,291	)
As of September 30, 2023	$	1,902,379

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Lease liabilities	September 30, 2023		December 31, 2022
Current portion	$	474,011	$	285,354
Long-term portion		1,428,368		959,116
Total lease liabilities	$	1,902,379	$	1,244,470

On September 30, 2023, the Company was committed to minimum lease payments as follows:

Maturity analysis	September 30, 2023
Remaining of 2023	$	174,452
2024		622,666
2025		529,912
2026		353,897
2027		225,147
Thereafter		504,663
Total undiscounted lease liabilities	$	2,410,737
Amount representing implicit interest		(508,358	)
Lease obligations	$	1,902,379

NOTE 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

	September 30,
	2023 (unaudited)		December 31, 2022
Accounts payable	$	1,504,273	$	1,333,044
Accrued liabilities		1,463,834		1,236,942
Payroll liabilities		136,349		346,693
	$	3,104,456	$	2,916,679

NOTE 11. CONVERTIBLE DEBT – RELATED PARTY

During the years ended December 31, 2019 and 2020, the Company entered into loan agreements with related parties totaling EUR417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. One of those loans was not converted and is payable on demand (balance of $31,719 as of September 30, 2023). While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. As the Company incurred losses during 2021, 2020 and 2019, no expense has been recorded in any period for profit sharing. At maturity, the 2019 and 2020 Convertible Loans are convertible into ordinary shares of the Company at EUR1 per share.

The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature. The Company recognized debt discounts totaling EUR13,064 on issuance of the 2019 and 2020 Convertible Loans.

As of September 30, 2023 and December 31, 2022, the Company’s Convertible Debt – Related Party is $31,719 (EUR30,000) and $32,181 (EUR30,000), respectively.

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NOTE 12. CONVERTIBLE DEBT

Convertible Loans

In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totaling EUR80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totaling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand.

As of September 30, 2023 and December 31, 2022, the Company’s Convertible loan was $42,439 (EUR40,139) and $40,057 (EUR40,139), respectively.

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 request that the Holder purchase from us up to $50,000,000 (the “Commitment Amount”) of promissory notes (each, a “Promissory Note”). The Holder will purchase each Promissory Note at 92% of the principal amount of that Promissory Note. On June 28, 2023, we sold the Holder a Promissory Note (the “Initial Promissory Note”) in the principal amount of $5,500,000 and received $5,060,000, net of discount. The Holder is not obligated to purchase any additional Promissory Notes from us under the PPA. On September 26, 2023, the Company issued 2^nd Promissory Note of $5,500,000 and received $5,060,000, net of discount.

Each Promissory Note matures one year from the date of its issuance. The Promissory Notes do not carry any interest, except if there is an event of default in which case the interest will increase to 15% per annum. We may prepay a Promissory Note with at an 8% premium with advance written notice ranging between five business days and thirty calendar days prior to such prepayment, depending on the market price of our ordinary shares at the time of the notice.

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) $4.9986 in respect of the Initial Promissory Note and (II) with respect to each subsequent Promissory Note, if any, 110% of the volume weighted average price (“VWAP”) of our ordinary shares on the trading day immediately preceding the issuance of such Promissory Note (the “Fixed Price”) or (b) 92% of the average of the two lowest daily VWAPs of the shares during the eight trading days immediately prior to such conversion. In no event, however, shall the conversion price be less than a floor price of $2.00, as may be adjusted for stock splits and other similar transactions (the “Floor Price”).

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 five of seven consecutive trading days. Within five trading days of a Trigger Event, we must make a monthly cash payment to the Holder in connection with the Promissory Notes (the “Monthly Payment”) equal to the lesser of (i) $550,000, plus an 8% redemption premium on any principal being repaid plus any accrued and unpaid interest and (ii) all principal outstanding under all outstanding Promissory Notes, plus an 8% redemption premium on any principal being repaid plus any accrued and unpaid interest. Thereafter, we must pay the Holder a Monthly Payment every 30 calendar days after the due date of the initial Monthly Payment; provided that our monthly obligation hereunder will end with respect to a particular Trigger Event if (i) the daily VWAP of the ordinary shares for seven consecutive trading days immediately prior to the due date of the next Monthly Payment is 10% or greater than the Floor Price or (ii) we reduce the Floor Price for all outstanding Promissory Notes by 50%, unless a new Trigger Event occurs.

In connection with the execution of the PPA, we agreed to pay a commitment fee of $250,000. Such commitment fee was paid on the date of the PPA in the form of 54,428 ordinary shares, which was derived using a per ordinary share price equal to the average of the daily VWAPs of the Ordinary Shares during the three trading days prior to the PPA.

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The Company elected to account for the Promissory Notes at fair value. Management believes that the fair value option appropriately reflects the underlying economics of the Promissory Notes. Under the fair value election, changes in fair value 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 Initial Promissory Note had a face value of $5,500,000 and had an original issue discount of $440,000. The Company recorded the Initial Promissory Note at its fair value of $5,060,000, which was also the cash received and the 2^nd Promissory Note at its fair value of $5,008,000.

During the period ended September 30, 2023, principal amounts of the Initial Promissory Note of $3,000,000 was converted into 1,015,939 ordinary shares, at conversion prices ranging from $2.70 to $4.17.

For the period ended September 30, 2023, the Company recorded a change in fair value of $87,000, resulting in a balance of $7,207,000 as of September 30, 2023.

Changes in the balance of the convertible notes are as follows:

				Carrying
	Face			Amount at
	Value			Fair Value
Balance at December 31, 2022	$	-		$	-
Issuance of convertible promissory notes		11,000,000			10,120,000
Repayments of debt		-			-
Conversion of notes with ordinary shares		(3,000,000	)		(3,000,000	)
Change in fair value of convertible promissory notes		-			87,000
Balance at September 30, 2023	$	8,000,000		$	7,207,000

We classified this fair value as a Level 3 fair value measurement and used a fair value pricing model to calculate the fair value for the period ended September 30, 2023. Key inputs for the fair value model are summarized below.

A summary of the Company’s significant inputs into the fair value of the Promissory Notes is as follows:

		September 30,
		2023
Stock price	$	2.92 - 4.82
Expected life in years		0.74 - 1.00
Risk free rate		5.32% - 5.57	%
Expected volatility		74.65% - 75.00	%
Discount rate		78.54% - 82.88	%

NOTE 13. SILENT PARTNERSHIPS

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR299,400 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs has the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs was determined to be EUR218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs of EUR81,280 ($92,774) has been recognized as government grant income during the period. During the year ended December 31, 2021 the Company received the remaining EUR200,000 ($236,640). The initial fair value of the 3.0% SPAs received was determined to be EUR230,000 (approximately $272,136), determined using an estimated effective interest rate of 11.5%. The initial fair value of the 3.0% SPAs received in 2021 was determined to be EUR156,549 (approximately $185,229), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3.0% SPAs received in 2021 of EUR43,451 (approximately $51,410) has been recognized as government grant income during the period.

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. Pursuant to the silent partnership agreement, the Company notified the holder, at which point the holder declined the opportunity to convert their loan into common shares. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

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Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totaling EUR798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR398,634 (approximately $408,496) of the loans by June 30, 2023 (such amounts were paid between the end of June and the beginning of July 2023) and EUR400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366 (approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration, and the Company recognized a gain on the extinguishment of $8,214.

In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR300,000 (approximately $343,830) (the “8% SPA”). The Company repaid this loan in January 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%.

Certain of the Silent Partnership agreements are with a German based bank, which also owns ordinary shares of the Company. Those debts are classified as “related party” in the statement of financial position. A continuity of the Company’s silent partnerships is as follows:

	3% SPAs			3.5% SPAs			8.5% SPAs			8% SPAs			Total
Balance, December 31, 2022	$	537,359		$	43,938		$	909,703		$	417,549		$	1,908,549
Issued during the year		-			-			-			-			-
Extinguished during the year		-			-			(512,502	)		(422,370	)		(934,872	)
Debt forgiveness		-			-			(48,735	)		-			(48,735	)
Accretion		31,412			2,528			17,521			813			52,274
Effects of currency translation		(8,460	)		(691	)		(157	)		4,008			(5,300	)
Balance, September 30, 2023	$	560,311		$	45,775		$	365,830		$	-		$	971,916

NOTE 14. EQUITY

Ordinary shares

The Company has 45 million ordinary shares authorized. Holders of ordinary shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. The par value of share capital is EUR0.01 per share.

Controlled Equity Offering

In December 2022, the Company entered into a Controlled Equity Offering, known as an “ATM” facility. Pursuant to the ATM, the Company at its discretion and subject to an effective registration statement with the U.S. Securities and Exchange Commission, may sell through its agent ordinary shares at market prices, for a fee of 3%. During the nine months ended September 30, 2023 the Company issued 307,365 ordinary shares pursuant to the ATM for net proceeds of $1,894,742, at an average price of $6.16.

15

In addition, during the nine months ended September 30, 2023, the Company issued ordinary shares as follows:

● 134,500 ordinary shares issued for services rendered which were valued at $503,690

● 305,771 ordinary shares issued for cashless exercise of warrants

● 54,428 ordinary shares issued for a commitment fee on a convertible promissory note valued at $250,000

● 300,000 ordinary shares issued for acquisition of intangible assets valued at $2,055,000

● 1,015,939 ordinary shares issued for conversion of debt of $3,000,000

Warrants

During the year ended December 31, 2021, in conjunction with private sales units, which included ordinary shares and warrants, the Company issued 3,755,000 warrants and issued 161,000 underwriter warrants with its IPO, cumulatively valued at $754,286, which was recorded to Reserve in the Statement of Financial Position. The warrants were valued using the Black-Scholes pricing model. The Black-Scholes model requires six basic data inputs: the exercise or strike price, time to expiration, the risk-free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Changes to these inputs could produce a significantly higher or lower fair value measurement.  Unexercised warrants were to expire in November 2023. On September 8, 2023 the Board of Directors approved an amendment to the outstanding warrant agreements, which all warrant holders accepted. The amendment extended the remaining life of the warrants to November 9, 2024 and removed the option for cashless exercise. No other terms were changed.

During the year ended December 31, 2021, the estimated fair value of the warrants as follows:

Stock price at time of issuance	$	0.283 - 1.602
Exercise price	$	3.00
Expected term		2 - 5 years
Expected average volatility		75 - 95	%
Expected dividend yield		0
Risk-free interest rate		0.16 - 1.08	%

A summary of activity during the nine months ended September 30, 2023 is as follows:

	Warrant			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		3,247,500		$	3.00		0.44
Grants		-			-		-
Exercised		(816,667	)		3.00		-
Expired		-			-		-
Balance as of September 30, 2023		2,430,833		$	3.00		1.11

Stock options

During 2021, we adopted our 2021 Omnibus Incentive Plan, and on June 28, 2022 we adopted our 2022 Omnibus Incentive Plan (the “Plans”). Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 3,100,000 ordinary shares.

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During the nine months ended September 30, 2023, the Company granted 332,500 stock options valued at $1,174,201. Stock options with time-based vesting were valued using the Black-Scholes pricing model.

During the nine months ended September 30, 2023, the Company recorded stock-based compensation of $2,432,948 and had unamortized expense of $3,856,598 as of September 30, 2023. Forfeitures are estimated at the time of grant and adjusted, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

For the nine months ended September 30, 2023, the estimated fair values of the stock options are as follows:

		September 30,
		2023
Exercise price	$	4.09 – 7.02
Expected term		5.25 – 7.00 years
Expected average volatility		70% - 76	%
Expected dividend yield		-
Risk-free interest rate		3.48% - 4.27	%

A summary of activity during the nine months ended September 30, 2023 follows:

	Stock options			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		2,394,150		$	7.18		9.11
Grants		332,500			4.93		10.00
Exercised		-			-		-
Forfeited		(47,092	)		6.48		-
Expiry		-			-		-
Balance as of September 30, 2023		2,679,558		$	6.96		8.59
Exercisable as of September 30, 2023		1,626,816		$	6.12		8.17

NOTE 15. COST OF REVENUE

For the nine months ended September 30, 2023 and 2022, cost of revenue consisted of test kit materials, both patient collection kits and lab-based PCR kits and the cost of performing those tests for ColoAlert tests run in our analytical laboratory.

NOTE 16. RELATED PARTY TRANSACTIONS

Key management personnel include those people who have 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, Chief Financial Officer, Chief Operating Officer, Chief Commercial Officer and Chief Scientific Officer. The remuneration of directors and key management personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	627,988	$	468,050

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Remuneration paid to related parties other than key personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	14,902	$	64,055

During the nine months ended September 30, 2023 and 2022, the Company incurred interest expense of $25,017 and $24,426 on balances owing to related parties, respectively.

During the nine months ended September 30, 2023 and 2022, the Company incurred accretion expense of $8,752 and $11,553 on balances owing to related parties, respectively.

During the nine months ended September 30, 2023 and 2022, we recorded expenses of $52,731 and $97,924, 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 until we purchased the intellectual property on February 15, 2023 (see Note 7). A member of our Board of Directors is also a significant equity holder of ColoAlert AS.

NOTE 17. GOVERNMENT GRANTS

The Company receives government grants related to its research and development activities. The amount of government grants received during the nine months ended September 30, 2023 and 2022 and recognized as research grant revenue were as follows:

	Nine months ended
	September 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	42,055
Multi-marker test for the early detection of pancreatic cancer		27,696		108,999
	$	27,696	$	151,054

As of September 30, 2023 and December 31, 2022, 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 $6,604 and $81,706, respectively. Grant income is included as Other Income in the condensed interim consolidated statements of profit and loss.

NOTE 18. 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 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.

18

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. The Company carries cash balances at US financial institutions that exceed the federally insured limit of $250,000 per institution and in German financial institutions that exceed €100,000 limit per institution. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.

Management believes that the Company is not exposed to any significant credit risk with respect to its cash.

The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. During the nine months ended September 30, 2023, the Company incurred $95,340 (related to Trade receivable and VAT receivable) and in bad debt expense (2022 - $0). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.

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 September 30, 2023, the Company had an unrestricted cash balance of $9,320,381 to settle current liabilities, excluding the Initial Promissory Note, which is expected to be settled in ordinary shares, of $6,921,813.

Historically, the Company’s primary source of funding has been the issuance of ordinary shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to equity or debt financing.

The following is an analysis of the contractual maturities of the Company’s financial liabilities as of September 30, 2023:

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	3,104,456	$	-	$	-
Convertible promissory note to be settled with ordinary shares		7,207,000		-		-
Convertible loans		74,158		-		-
Silent partnerships		-		971,916		-
Lease liabilities		474,011		923,705		504,663
Intellectual property acquisition liability - related party		400,854		796,664		-
	$	11,260,479	$	2,692,285	$	504,663

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. As the Company operates in Germany it holds a portion of its cash balances in Euro to approximate its estimated short term operating needs. The remainder of the Company’s cash is held in U.S. Dollars, the Company’s reporting currency, which we also expect to be the currency of the Company’s largest cash outlays over the next twenty-four months.

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

In the management of capital, the Company includes components of stockholders’ equity. 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 a young growth company, issuance of equity 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.

19

NOTE 19. CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the nine months ended September 30, 2023 and 2022, the Company had revenue from one and four customers that accounted for approximately 18% and 81% of revenue, respectively.

NOTE 20. OPERATING EXPENSES

For the nine months ended September 30, 2023 and 2022, operating expenses consisted of the following:

	Nine months ended
	September 30,
Research and development	2023		2022
Payroll expenses	$	2,969,663	$	994,087
Clinical study expenses		3,322,251		597,439
Amortization of intangibles		342,075		-
Travel expenses		140,839		29,795
Lab consumables		73,238		13,096
Lab overhead and other expenses		743,102		68,074
	$	7,591,168	$	1,702,491

	Nine months ended
	September 30,
Sales and marketing	2023		2022
Payroll expenses	$	1,021,828	$	248,263
Consulting services		1,630,346		198,372
Product and brand advertising		2,478,919		2,924,084
Other expenses		76,702		23,139
	$	5,207,795	$	3,393,858

	Nine months ended
	September 30,
General and administrative	2023		2022
Payroll expenses	$	1,560,706	$	1,531,427
Stock option expense		2,432,948		7,479,767
Depreciation and amortization		395,087		-
Travel expenses		87,947		189,130
Consulting services		1,998,633		2,884,688
IT expense		171,560		-
Training		17,052		6,365
Insurance and taxes		640,530		751,805
Rent and premises		115,124		129,203
Other expenses		210,659		132,181
	$	7,630,246	$	13,104,566

NOTE 21. SUBSEQUENT EVENTS

Subsequent to September 30, 2023, pursuant to the PPA (see Note 12), the Holder converted $500,000 in principal value on the Initial Promissory Note, resulting in the issuance of 243,080 ordinary shares.

On November 13, 2023, we entered into a securities purchase agreement with several institutional investors to purchase approximately $5.0 million of our ordinary shares (or pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase ordinary shares in a registered direct offering. The combined effective purchase price for each ordinary share (or pre-funded warrant) and associated warrant to purchase one ordinary share will be $1.20. Under the terms of the securities purchase agreement, we have agreed to issue 4,166,667 ordinary shares (or pre-funded warrant in lieu thereof) and warrants (the “Warrants”) to purchase up to an aggregate of 4,166,667 shares. The Warrants will be exercisable immediately on the date of issuance until the fifth anniversary of the issuance date at a price of $1.20 per share.

20

EX-99.3

Exhibit 99.3

 

Mainz Biomed Reports Third Quarter 2023 Financial Results and Provides Corporate Update

ColoAlert® Revenue Increases 102% Year Over Year for the Nine Months Ended September 30, 2023

ColoFuture Study Reported Groundbreaking Results Demonstrating Sensitivity for Colorectal Cancer of
94% with Specificity of 97% and Advanced Adenoma Sensitivity of 80%

BERKELEY, US – MAINZ, Germany – November 16, 2023 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results of the third quarter ending September 30, 2023 and provided a corporate update.

Key Highlights:

● ColoAlert® revenues were USD 681,000, representing an increase of 102% compared to the first nine months of 2022.

● Reported groundbreaking clinical trial results from ColoFuture, an international study evaluating the Company’s portfolio of novel gene expression (mRNA) biomarkers for potential inclusion into pivotal FDA PMA clinical trial (ReconAAsense) for next generation colorectal cancer (CRC) screening test.

● Advanced eAArly DETECT feasibility study (U.S. ColoFuture clinical trial) scheduled to report results in Q4 of 2023.

● Expanded network of international commercial partners for ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for CRC being sold via the Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility.

● Continued to grow corporate health program within Germany’s “BGM” system which provides health services to employees – Germany’s total BGM market represents a €1 billion per annum opportunity.

● Ramped-up preparations for ReconAAsense clinical study which remains on track to commence patient enrollment in mid-2024. Presents an opportunity to achieve gold-standard status for self-administered CRC screening.

● Presented at leading healthcare investment forums including the Cantor Fitzgerald Global Healthcare Conference, H.C. Wainwright Global Investment Conference and JonesTrading 2023 Healthcare Summit.

“This past quarter was an important period of progress for the Company highlighted by ColoFuture’s spectacular readout of results. Multiple novel mRNA biomarkers were identified for potential integration into our pivotal clinical trial being designed to potentially bring to market the gold-standard CRC self-administered screening test,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This fantastic milestone coupled with ColoAlert®’s commercial momentum, and our product development initiatives, have us well positioned to meet our corporate growth objectives for the foreseeable future.”

Commercial Update: Expanded network of laboratory partners, commenced commercial launches in multiple markets and grew corporate health program and insurance access across Germany

During the quarter, Mainz Biomed continued to execute its unique business model of partnering with third-party laboratories and experienced distribution partners as opposed to the traditional methodology of operating a single facility for test processing. The Company expanded its network of European and international commercial partnerships with the addition of Israel to its coverage via a collaboration with Fugene Genetics (FG). Founded in 2008, FG is a renowned genetic testing service provider offering a wide range of advanced genetic testing services to private clients, health organizations, hospitals, and genetic institutes throughout the country. Israel has one of the highest screening compliance rates in the world with over one million people being screened each year. It is expected that over 3.5 million adults could benefit from the availability of ColoAlert® in Israel. Under the terms of the agreement, Mainz Biomed is providing ColoAlert® to FG under its standard partnership structure and the two companies will collaborate on co-marketing activities to ensure a successful commercial launch in Israel.

In addition to expanding the Company’s international commercial footprint, a key highlight during the quarter was launching ColoAlert®’s sales activities with its partners in the United Kingdom and Poland. For the UK, Mainz Biomed is collaborating with Marylebone Laboratory, which recently expanded its presence in London, under the Marylebone Diagnostic Centre brand where it provides a comprehensive range of screening and diagnostic testing services. Across the UK, CRC remains a critical health concern, with approximately 43,000 diagnoses and 16,800 deaths occurring each year in the UK alone. This equates to an average of 46 lives lost every day. With a population of 67 million people, the UK, presents a substantial market for CRC screening. Specifically, within the age groups of 40 to 49 years and 50 to 75 years, there are approximately 8.4 million and 20 million individuals respectively. Additionally, there are 6.2 million individuals aged over 75. With a recommended frequency of CRC screening once every two years for patients aged 50 to 74, ColoAlert® represents a pivotal tool in the fight against this devastating disease. Considering these figures, the addressable UK market for ColoAlert® amounts to a staggering 34.6 million potential users.

In Poland, Mainz Biomed is partnered with testDNA Sp. z o. o. Sp. K (“testDNA”), one of the country’s leading DNA-based testing services. Its laboratory, headquartered in Katowice, Poland, boasts an expansive network of over 300 collection points throughout the country. Poland is a particularly important market as the need for alternative CRC screening options is underscored by data from the World Cancer Research Fund International which ranked Poland 7th (seventh) in the world for the highest mortality rate. With over 21 million people aged over 40, the market opportunity for ColoAlert® is significant, especially as there has been a low level of national participation in CRC screening which traditionally has been colonoscopies. In the recently published NordICC study in the New England Journal of Medicine, only 33% of those invited to participate in colonoscopy screening actually took part. This highlights the need to have alternative screening options that are less invasive and easier to perform at home.

2

A key initiative during the quarter was the Company’s continued effort to make ColoAlert® accessible and affordable in Germany, its flagship market. The Company continued to execute its two-prong strategy, the first being the expansion of its corporate health offering via integration into Germany’s BGM system (“betriebliches Gesundheitsmanagement”), an established corporate health program providing services to employees at 48 of the 50 largest companies in the country. Through corporate health management programs such as BGM, best-in-class companies in Germany offer employees healthcare services ranging from gym memberships to diabetes management to counseling, all to better their health. The second component of the patient access strategy is to increase ColoAlert®’s awareness in Germany’s private health insurance segment. During the quarter, Mainz Biomed established a strategic partnership with Ärztliches Labor Dr. Buhlmann, a respected player in PCR-based analysis. The Company’s comprehensive services include molecular diagnostics, genetics, HLA testing, and infectious disease assessments, catering to a diverse clientele spanning statutory and private insurance segments. Approximately 10.5% of Germany’s population, or roughly 8.7 million individuals, are covered by private health insurance (PHI), as estimated by the Association of Substitute Health Insurance Funds (vdek) in 2022. A substantial portion of these PHI beneficiaries fall within the critical 50-74 age range, the target demographic for CRC screening in Germany.

Product Development Highlights: Reported groundbreaking ColoFuture results, eAArly DETECT on track to report results in Q4 2023, continued preparations to commence patient enrollment in ReconAAsense U.S. pivotal clinical trial

During the quarter, Mainz Biomed achieved a significant growth milestone by reporting groundbreaking results from its ColoFuture study, a multi-center international clinical trial assessing the potential to integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers into its pivotal FDA PMA clinical trial (ReconAAsense) which is evaluating a next generation CRC at-home screening test. The outstanding results included demonstrated sensitivity for CRC of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80%. This proprietary family of mRNA biomarkers represents a potentially game-changing innovation in CRC screening as the portfolio has previously demonstrated the ability to detect CRC lesions, including AA, a type of pre-cancerous polyp often attributed to this deadly disease. In concert with ColoFuture, the Company continued to advance its U.S. clinical study of the same design and purpose (eAArly DETECT). The eAArly DETECT clinical trial is a multi-center feasibility study enrolling 266 subjects across 25 sites and remains on track to report results in Q4 2023.

Throughout the third quarter, Mainz Biomed continued to prepare for commencing patient enrollment in the ReconAAsense clinical trial (ClinicalTrials.gov Identifier: NCT05636085). This U.S. pivotal clinical trial assessing Mainz Biomed’s CRC test will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It will include approximately 15,000 subjects from 150 sites across the U.S. The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. If any of the biomarkers are integrated into the ReconAAsense trial and the study produces positive results, this next iteration of Mainz Biomed’s CRC test will be positioned as one of the most robust and accurate at-home diagnostic screening solutions on the market as it will not only detect cancerous polyps with a high degree of accuracy, but has the potential to prevent CRC through early detection of precancerous adenomas.

CONDENSED CONSOLIDATED FINANCIAL INFORMATION

During the nine months ended September 30, 2023, the Company saw its revenue from ColoAlert® grow 102% compared to the same period of 2022. During the reporting period, the Company’s operating loss grew from USD 18.1 million to USD 20.1 million, when compared to the first nine months of 2022. This increased loss was attributable to the growth of sales and marketing and research and development (R&D) costs, mitigated by a decrease in general and administrative costs. Sales and marketing expenses increased as planned due to the expansion of the Company’s commercial activities in Europe. The increased research and development expenses are attributable to the continued development of Mainz Biomed’s next generation colorectal cancer screening test and increased R&D costs related to the peak enrollment in its eAArly Detect and ColoFuture studies.

The Company has filed a current report on Form 6-K on November 16, 2023, with the U.S. Securities and Exchange Commission, which includes both consolidated financial statements and management’s discussion and analysis of its financial results for the third quarter of 2023. Summary financial tables are included below.

3

Mainz Biomed N.V.

Condensed Consolidated Statements of Financial Position (Unaudited)

(in U.S. Dollars)

	September 30,			December 31,
	2023			2022
ASSETS
Current Assets
Cash	$	9,320,381		$	17,141,775
Trade receivables, net		108,630			66,984
Inventories		493,588			175,469
Prepaid expenses and other current assets		1,052,693			994,113
Total Current Assets		10,975,292			18,378,341
Property and equipment, net		1,606,333			661,692
Intangible asset		3,536,089			-
Right-of-use asset		1,788,977			1,177,695
Other asset		104			23,275
Total assets	$	17,906,795		$	20,241,003
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued liabilities	$	3,104,456		$	2,916,679
Current maturities of long term debt		7,281,158			1,040,573
Intellectual property acquisition liability		400,854			-
Lease liabilities		474,011			285,354
Total current liabilities		11,260,479			4,242,606
Long term debt		971,916			943,214
Lease liabilities		1,428,368			959,116
Intellectual property acquisition liability		796,664			-
Total Liabilities		14,457,427			6,144,936
Shareholders’ equity
Share capital		187,890			164,896
Share premium		46,525,899			38,831,542
Reserve		20,497,224			18,079,741
Accumulated deficit		(64,144,694	)		(43,032,294	)
Accumulated other comprehensive income		383,049			52,182
Total shareholders’ equity		3,449,368			14,096,067
Total liabilities and shareholders’ equity	$	17,906,795		$	20,241,003

4

Mainz Biomed N.V.

Condensed Consolidated Statements of Profit and Loss and Comprehensive Loss (Unaudited)

(in U.S. Dollars)

	Three months ended						Nine months ended
	September 30,						September 30,
	2023			2022			2023			2022
Revenue	$	181,669		$	96,791		$	680,718		$	336,596
Cost of revenue		94,483			78,178			305,793			190,741
Gross profit		87,186			18,613			374,925			145,855
Gross margin		48	%		19	%		55	%		43	%
Operating expenses:
Sales and marketing		1,122,134			605,844			5,207,795			3,393,858
Research and development		1,854,795			909,003			7,591,168			1,702,491
General and administrative		2,750,895			3,979,359			7,630,246			13,104,566
Total operating expenses		5,727,824			5,494,206			20,429,209			18,200,915
Loss from operations		(5,640,638	)		(5,475,593	)		(20,054,284	)		(18,055,060	)
Other expense		(659,119	)		(120,634	)		(1,058,116	)		(143,614	)
Loss before income tax		(6,299,757	)		(5,596,227	)		(21,112,400	)		(18,198,674	)
Income tax provision		-			-			-			-
Net loss	$	(6,299,757	)	$	(5,596,227	)	$	(21,112,400	)	$	(18,198,674	)
Foreign currency translation gain (loss)		481,463			64,099			330,867			146,742
Comprehensive loss	$	(5,818,294	)	$	(5,532,128	)	$	(20,781,533	)	$	(18,051,932	)
Basic and dilutive loss per ordinary share	$	(0.39	)	$	(0.39	)	$	(1.38	)	$	(1.32	)
Weighted average number of ordinary shares outstanding		15,967,714			14,286,157			15,294,040			13,821,914

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.

5

For media inquiries -

In Europe:

MC Services AG

Anne Hennecke/Caroline Bergmann

+49 211 529252 20

mainzbiomed@mc-services.eu

In the U.S.:

Josh Stanbury
+1 416 628 7441
josh@sjspr.co

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

6

XML

Document And Entity Information	9 Months Ended
	Sep. 30, 2023
Document Information Line Items
Entity Registrant Name	MAINZ BIOMED N.V.
Document Type	6-K
Current Fiscal Year End Date	--12-31
Amendment Flag	false
Entity Central Index Key	0001874252
Document Period End Date	Sep. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Entity File Number	001-41010

XML

Condensed Consolidated Statements of Financial Position (Unaudited) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current Assets
Cash	$ 9,320,381	$ 17,141,775
Trade receivables, net	108,630	66,984
Inventories	493,588	175,469
Prepaid expenses and other current assets	1,052,693	994,113
Total Current Assets	10,975,292	18,378,341
Property and equipment, net	1,606,333	661,692
Intangible assets	3,536,089
Right-of-use assets	1,788,977	1,177,695
Other assets	104	23,275
Total assets	17,906,795	20,241,003
Current Liabilities
Accounts payable and accrued liabilities	3,104,456	2,916,679
Convertible debt	7,249,439	43,057
Convertible debt - related party	31,719	32,181
Silent partnerships, current portion		759,168
Silent partnerships, current portion - related party		206,167
Intellectual property acquisition liability, current portion - related party	400,854
Lease liabilities, current	474,011	285,354
Total current liabilities	11,260,479	4,242,606
Silent partnerships, non-current	713,928	687,128
Silent partnerships, non-current - related party	257,988	256,086
Lease liabilities, non-current	1,428,368	959,116
Intellectual property acquisition liability, non-current - related party	796,664
Total Liabilities	14,457,427	6,144,936
Shareholders’ equity
Share capital	187,890	164,896
Share premium	46,525,899	38,831,542
Reserve	20,497,224	18,079,741
Accumulated deficit	(64,144,694)	(43,032,294)
Accumulated other comprehensive income	383,049	52,182
Total shareholders’ equity	3,449,368	14,096,067
Total liabilities and shareholders’ equity	$ 17,906,795	$ 20,241,003

XML

Condensed Interim Consolidated Statements of Profit and Loss and Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Profit or loss [abstract]
Revenue	$ 181,669	$ 96,791	$ 680,718	$ 336,596
Cost of sales	94,483	78,178	305,793	190,741
Product margin	87,186	18,613	374,925	145,855
Operating expenses:
Sales and marketing	1,122,134	605,844	5,207,795	3,393,858
Research and development	1,854,795	909,003	7,591,168	1,702,491
General and administrative	2,750,895	3,979,359	7,630,246	13,104,566
Total operating expenses	5,727,824	5,494,206	20,429,209	18,200,915
Loss from operations	(5,640,638)	(5,475,593)	(20,054,284)	(18,055,060)
Other income (expense)
Other income	38,652	78,081	209,620	171,013
Other expense	(697,771)	(198,715)	(1,267,736)	(314,627)
Total other expense	(659,119)	(120,634)	(1,058,116)	(143,614)
Loss before income tax	(6,299,757)	(5,596,227)	(21,112,400)	(18,198,674)
Income taxes provision
Net loss	(6,299,757)	(5,596,227)	(21,112,400)	(18,198,674)
Foreign currency translation gain	481,463	64,099	330,867	146,742
Comprehensive loss	$ (5,818,294)	$ (5,532,128)	$ (20,781,533)	$ (18,051,932)
Basic and loss per ordinary share (in Dollars per share)	$ (0.39)	$ (0.39)	$ (1.38)	$ (1.32)
Weighted average number of ordinary shares outstanding (in Shares)	15,967,714	14,286,157	15,294,040	13,821,914

XML

Condensed Interim Consolidated Statements of Profit and Loss and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Profit or loss [abstract]
Dilutive loss per ordinary share	$ (0.39)	$ (0.39)	$ (1.38)	$ (1.32)

XML

Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) (Unaudited) - USD ($)	Share Capital	Share Premium	Reserve	Accumulated Deficit	Accumulated Other comprehensive Income (loss)	Total
Balance at Dec. 31, 2021	$ 141,075	$ 13,126,493	$ 9,736,066	$ (16,644,958)	$ 2,479	$ 6,361,155
Balance (in Shares) at Dec. 31, 2021	12,010,001
Sale of ordinary shares	$ 15,525	23,850,364				23,865,889
Sale of ordinary shares (in Shares)	1,725,000
Issuance of ordinary shares for exercise of warrants	$ 968	321,533	(64,156)			258,344
Issuance of ordinary shares for exercise of warrants (in Shares)	107,500
Share based expenses	$ 522	787,098				787,620
Share based expenses (in Shares)	58,000
Stock option expense			2,424,901			2,424,901
Net loss				(5,663,736)		(5,663,736)
Foreign currency translation					36,439	36,439
Balance at Mar. 31, 2022	$ 158,090	38,085,488	12,096,811	(22,308,694)	38,918	28,070,612
Balance (in Shares) at Mar. 31, 2022	13,900,501
Balance at Dec. 31, 2021	$ 141,075	13,126,493	9,736,066	(16,644,958)	2,479	6,361,155
Balance (in Shares) at Dec. 31, 2021	12,010,001
Issuance of ordinary shares for conversion of debt
Ordinary shares issued for acquisition of intangible asset
Net loss						(18,198,674)
Balance at Sep. 30, 2022	$ 163,332	38,256,659	17,099,419	(34,843,632)	149,221	20,824,999
Balance (in Shares) at Sep. 30, 2022	14,482,974
Balance at Mar. 31, 2022	$ 158,090	38,085,488	12,096,811	(22,308,694)	38,918	28,070,612
Balance (in Shares) at Mar. 31, 2022	13,900,501
Issuance of ordinary shares for exercise of warrants	$ 5,243	171,172	(52,258)			124,156
Issuance of ordinary shares for exercise of warrants (in Shares)	582,473
Stock option expense			2,469,549			2,469,549
Net loss				(6,938,711)		(6,938,711)
Foreign currency translation					46,204	46,204
Balance at Jun. 30, 2022	$ 163,332	38,256,659	14,514,102	(29,247,405)	85,122	23,771,810
Balance (in Shares) at Jun. 30, 2022	14,482,974
Stock option expense			2,585,317			2,585,317
Net loss				(5,596,227)		(5,596,227)
Foreign currency translation					64,099	64,099
Balance at Sep. 30, 2022	$ 163,332	38,256,659	17,099,419	(34,843,632)	149,221	20,824,999
Balance (in Shares) at Sep. 30, 2022	14,482,974
Balance at Dec. 31, 2022	$ 164,896	38,831,542	18,079,741	(43,032,294)	52,182	14,096,067
Balance (in Shares) at Dec. 31, 2022	14,629,457
Sale of ordinary shares	$ 2,094	1,281,291				1,283,385
Sale of ordinary shares (in Shares)	195,044
Share based expenses	$ 22	14,741				14,763
Share based expenses (in Shares)	2,112
Stock option expense			904,664			904,664
Net loss				(6,560,916)		(6,560,916)
Foreign currency translation					(60,572)	(60,572)
Balance at Mar. 31, 2023	$ 167,012	40,127,574	18,984,405	(49,593,210)	(8,390)	9,677,391
Balance (in Shares) at Mar. 31, 2023	14,826,613
Balance at Dec. 31, 2022	$ 164,896	38,831,542	18,079,741	(43,032,294)	52,182	14,096,067
Balance (in Shares) at Dec. 31, 2022	14,629,457
Issuance of ordinary shares for conversion of debt						3,000,000
Ordinary shares issued for acquisition of intangible asset						3,271,828
Net loss						(21,112,400)
Balance at Sep. 30, 2023	$ 187,890	46,525,899	20,497,224	(64,144,694)	383,049	3,449,368
Balance (in Shares) at Sep. 30, 2023	16,747,460
Balance at Mar. 31, 2023	$ 167,012	40,127,574	18,984,405	(49,593,210)	(8,390)	9,677,391
Balance (in Shares) at Mar. 31, 2023	14,826,613
Sale of ordinary shares	$ 1,224	608,587				609,811
Sale of ordinary shares (in Shares)	112,321
Share based expenses	$ 353	162,574				162,927
Share based expenses (in Shares)	32,388
Ordinary shares issued for acquisition of intangible asset	$ 3,270	2,051,730				2,055,000
Ordinary shares issued for acquisition of intangible asset (in Shares)	300,000
Ordinary shares issued for commission of issuance of convertible debt	$ 593	249,407				250,000
Ordinary shares issued for commission of issuance of convertible debt (in Shares)	54,428
Ordinary shares issued for cashless exercise of warrants	$ 3,333	12,132	(15,465)
Ordinary shares issued for cashless exercise of warrants (in Shares)	305,771
Stock option expense			764,009			764,009
Net loss				(8,251,727)		(8,251,727)
Foreign currency translation					(90,024)	(90,024)
Balance at Jun. 30, 2023	$ 175,785	43,212,004	19,732,949	(57,844,937)	(98,414)	5,177,387
Balance (in Shares) at Jun. 30, 2023	15,631,521
Share based expenses	$ 1,085	324,915				326,000
Share based expenses (in Shares)	100,000
Issuance of ordinary shares for conversion of debt	$ 11,020	2,988,980				3,000,000
Issuance of ordinary shares for conversion of debt (in Shares)	1,015,939
Stock option expense			764,275			764,275
Net loss				(6,299,757)		(6,299,757)
Foreign currency translation					481,463	481,463
Balance at Sep. 30, 2023	$ 187,890	$ 46,525,899	$ 20,497,224	$ (64,144,694)	$ 383,049	$ 3,449,368
Balance (in Shares) at Sep. 30, 2023	16,747,460

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Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash Flows From Operating Activities
Net loss	$ (21,112,400)	$ (18,198,674)
Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation	3,186,638	8,267,387
Depreciation and amortization	661,942	135,276
Bad debt expense	95,340
Inventory write down	13,301
Accretion expense	132,963	59,792
Government grant		(88,674)
Change in fair value of convertible debt	87,000
Debt forgiveness	(48,735)
Changes in operating assets and liabilities:
Trade receivables. net	(85,689)	(148,110)
Inventories	(342,056)	(7,155)
Prepaid expenses and other assets	(107,528)	151,743
Accounts payable and accrued liabilities	235,566	(228,827)
Net cash used in operating activities	(17,283,658)	(10,057,242)
Cash Flows From Investing Activities
Purchase of intangible asset	(600,000)
Purchase of property and equipment	(1,037,033)	(643,637)
Net cash used in investing activities	(1,637,033)	(643,637)
Cash Flows From Financing Activities
Sale of ordinary shares	1,893,196	23,865,890
Warrant exercise proceeds		382,500
Proceeds from convertible debt	10,120,000
Payments on silent partnerships	(772,423)	(107,027)
Payments on silent partnerships - related party	(162,450)
Payment of lease obligations	(317,437)	(88,432)
Net cash provided by financing activities	10,760,886	24,052,931
Effect of changes in exchange rates	338,411	(72,976)
Net change in cash	(7,821,394)	13,279,076
Cash at beginning of period	17,141,775	8,727,542
Cash at end of period	9,320,381	22,006,618
Non-Cash Investing and Financing Activities
Right of use asset additions	1,009,638	949,277
Ordinary shares issued for acquisition of intangible asset	3,271,828
Issuance of ordinary shares for cashless exercise of warrants	15,465	52,258
Issuance of ordinary shares for conversion of debt	3,000,000
Supplemental Cash Flow Information
Interest expense paid	153,580	67,989
Income tax paid

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Nature of Operations and Going Concern

9 Months Ended

Sep. 30, 2023

Nature of Operations and Going Concern [Abstract]

NATURE OF OPERATIONS AND GOING CONCERN

NOTE 1. NATURE OF OPERATIONS AND GOING CONCERN

Mainz Biomed N.V. (the “Company”) is domiciled in the Netherlands. The Company’s registered office is at Keizersgracht 391A, EJ Amsterdam and its headquarters are in Mainz, Germany. The Company was formed to acquire the business of Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH (“PharmaGenomics”)). In September 2021, the Company completed such acquisition.

We develop in-vitro diagnostic (“IVD”) tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine, led by our flagship ColoAlert™ product in European markets. We additionally operate a clinical diagnostic laboratory. We develop and distribute our IVD kits to third-party laboratories and through our on-line store.

Throughout these condensed consolidated financial statements, Mainz Biomed N.V. and its 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”.

Share Exchange

On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) between Mainz Biomed B.V. (“Mainz”), which was a private company with limited liability under Dutch law incorporated for the purpose of acquiring PharmGenomics. Under the Contribution Agreement, 100% of the shares of PharmGenomics were acquired in exchange for 6,000,000 shares of the Company. Upon the closing of the Contribution Agreement, PharmGenomics became a wholly owned subsidiary of the Company and the former shareholders of PharmGenomics held approximately 62% of the outstanding shares of the Company prior to the Company’s initial public offering. On September 20, 2021, PharmGenomics and the Company closed the Contribution Agreement.

IPO and Follow-on Equity Offering

In November 2021, the Company completed its initial public offering (“IPO”) of its ordinary shares on the Nasdaq Capital Market, selling 2,300,000 shares at $5.00 per share. Upon its IPO, Mainz Biomed B.V. became Mainz Biomed N.V. In January 2022, the Company completed a follow on offering of its ordinary shares, selling 1,725,000 ordinary shares for gross proceeds of approximately $25.9 million (proceeds net of offering expenses was $23.9 million).

Going Concern

The Company has recurring losses, accumulated deficit totaling $64,144,694 and negative cash flows used in operating activities of $17,283,658 as of and for the nine months ended September 30, 2023. The Company also had $9,320,381 of cash on hand on September 30, 2023 and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,921,813. These conditions are indicators that impact the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. If the Company is unable to obtain funding, the Company could be forced to further delay, reduce or eliminate its research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and its ability to continue as a going concern.

The Company plans to fund its cash flow and working capital 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. In December 2022, the Company entered into a $50,000,000 Controlled Equity Offering (see Note 14); the Company raised $1.9 million of net cash from this facility during the nine months ended September 30, 2023. Additionally, on June 28, 2023, the Company entered into a Pre-Paid Advance Agreement and issued $11.0 million in convertible promissory notes (see Note 12) for net proceeds of $10.1 million during the nine months ended September 30, 2023.

Management believes that the availability of its Controlled Equity Offering and/or Pre-Paid Advance Agreement, combined with the potential to execute a financing after the reporting of results from its clinical studies, will provide the financing necessary to fund the Company’s working capital needs for the foreseeable future.

These 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 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.

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Basis of Presentation

9 Months Ended

Sep. 30, 2023

Basis of Presentation [Abstract]

BASIS OF PRESENTATION

NOTE 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, 2022 and notes thereto contained in the Company’s 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 November 14, 2023.

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Accounting Policies, Estimates and Significant Management Judgments

9 Months Ended

Sep. 30, 2023

Accounting Policies, Estimates and Significant Management Judgments [Abstract]

ACCOUNTING POLICIES, ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS

NOTE 3. ACCOUNTING POLICIES, ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS

Inventories

Inventories are measured at the lower of cost or 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.

Reclassifications

Certain prior year amounts have been reclassified for consistency with the current period presentation.

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 and intangible assets

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.

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.

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Trade Receivables

9 Months Ended

Sep. 30, 2023

Trade Receivables [abstract]

TRADE RECEIVABLES

NOTE 4. TRADE RECEIVABLES

	September 30,
	2023 (unaudited)			December 31, 2022
Accounts receivable	$	133,347		$	130,588
Less: allowance for doubtful accounts		(24,717	)		(66,852	)
Accounts receivable, net		108,630			63,736
Other		-			3,248
	$	108,630		$	66,984

For the nine months ended September 30, 2023, the Company recorded bad debt expense of $42,045 for trade receivables.

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Inventories

9 Months Ended

Sep. 30, 2023

Inventories [Abstract]

INVENTORIES

NOTE 5. INVENTORIES

	September 30,
	2023 (unaudited)			December 31, 2022
Raw materials	$	331,090		$	175,469
Finished goods		175,799			-
		506,889			175,469
Less: write down		(13,301	)		-
	$	493,588		$	175,469

For the nine months ended September 30, 2023, the Company recorded inventory write down of $13,301.

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Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2023

Prepaid Expenses and Other Current Assets [Abstract]

PREPAID EXPENSES AND OTHER CURRENT ASSETS

NOTE 6. PREPAID EXPENSES AND OTHER CURRENT ASSETS

	September 30, 2023 (unaudited)		December 31, 2022
Prepaid insurance	$	85,153	$	624,033
Prepaid stock compensation		302,714		-
Other prepaid expenses		131,483		55,356
Security deposit		129,358		122,570
VAT receivable		403,985		192,154
	$	1,052,693	$	994,113

For the nine months ended September 30, 2023, the Company recorded bad debt reserve of $53,295 for VAT receivables.

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Property and Equipment

9 Months Ended

Sep. 30, 2023

Property and Equipment [abstract]

PROPERTY AND EQUIPMENT

NOTE 7. PROPERTY AND EQUIPMENT

	Laboratory equipment			Office equipment			Construction in progress			Total
Cost
Balances at December 31, 2022	$	579,171		$	176,347		$	-		$	755,518
Additions		933,246			160,708			49,390			1,143,344
Disposals		(16,810	)		-			-			(16,810	)
Effects of currency translation		(30,055	)		(22,240	)		(1,174	)		(53,470	)
Balances at September 30, 2023 (unaudited)	$	1,465,551		$	314,815		$	48,216		$	1,828,582
Accumulated depreciation
Balances at December 31, 2022	$	77,833		$	15,993		$	-		$	93,826
Depreciation		92,068			43,404			-			135,472
Disposals		(2,335	)		-			-			(2,335	)
Effects of currency translation		(3,255	)		(1,459	)		-			(4,714	)
Balances at September 30, 2023 (unaudited)	$	164,311		$	57,938		$	-		$	222,249
Net book value at December 31, 2022	$	501,338		$	160,354		$	-		$	661,692
Net book value at September 30, 2023 (unaudited)	$	1,301,240		$	256,877		$	48,216		$	1,606,333

For the nine months ended September 30, 2023 and 2022, the Company recorded deprecation of $135,472 and $32,767, respectively.

During the first nine months of 2023 we have begun the expansion of our clinical laboratory in our headquarters facility. Expenditures related to that lab expansion are included in Construction in progress.

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Intangible asset

9 Months Ended

Sep. 30, 2023

Intangible assets [abstract]

INTANGIBLE ASSET

NOTE 8. INTANGIBLE ASSET

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 €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €5 per ColoAlert test sold (the “Option”). Subsequent to February 11, 2021, ColoAlert AS assigned their interest in ColoAlert and in the Licensing Agreement and the Option to Uni Targeting Research AS.

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) $2 million cash, to be paid out over the next four years, (ii) 300,000 ordinary restricted shares and (iii) a revenue share limited to $1 per test sold for a period of 10 years. The Company recognized an intangible asset from this purchase and assigned a 10-year useful life. The intangible assets were valued: (a) for the portion to be settled in stock of the Company at the value on the day of closing, or $6.85 per share, and (b) for the cash portion, at the present value of the future payments using a 10% discount. During the nine months ended September 30, 2023 the Company paid $600,000 to the seller. The Company recorded amortization of $235,739 and interest expense of $80,690 for the nine months ended September 30, 2023. As of September 30, 2023, the liability for remaining required payments of $1,197,518 is recorded on the statement of financial position.

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Leases

9 Months Ended

Sep. 30, 2023

Leases [Abstract]

LEASES

NOTE 9. LEASES

Right-of-Use Assets

The Company leases certain assets under lease agreements.

	Office			Laboratory
	Equipment			Equipment			Vehicle			Office			Total
Cost
Balances as of December 31, 2022	$	64,226		$	362,970		$	94,008		$	1,035,200		$	1,556,404
Additions		-			370,011			51,675			587,951			1,009,637
Effects of currency translation		(922	)		(13,992	)		(2,575	)		(28,814	)		(46,303	)
Balances at September 30, 2023	$	63,304		$	718,989		$	143,108		$	1,594,337		$	2,519,738
Accumulated amortization
Balances as of December 31, 2022	$	20,707		$	77,838		$	22,109		$	258,055		$	378,709
Amortization		9,060			152,755			37,878			166,486			366,179
Effects of currency translation		(512	)		(4,742	)		(1,216	)		(7,657	)		(14,127	)
Balances at September 30, 2023	$	29,255		$	225,851		$	58,771		$	416,884		$	730,761
Net book value
December 31, 2022	$	43,519		$	285,132		$	71,899		$	777,145		$	1,177,695
September 30, 2023	$	34,049		$	493,138		$	84,337		$	1,177,453		$	1,788,977

As of September 30, 2023, management assessed that there were no events or changes in circumstances that would require impairment testing.

The carrying amount of the right-of-use assets is amortized on a straight-line basis over the life of the leases, which at September 30, 2023, had a weighted average expected life of 4.24 years.

Lease Liabilities

The Company’s lease liabilities consist of office and laboratory equipment and office space. The present value of future lease payments was measured using an incremental borrowing rate of 10% per annum as of January 1, 2022 and January 1, 2023.

	Total
Balance as of December 31, 2022	$	1,244,470
Additions		1,009,637
Interest expenses		141,097
Lease payments		(458,534	)
Effects of currency translation		(34,291	)
As of September 30, 2023	$	1,902,379

Lease liabilities	September 30, 2023		December 31, 2022
Current portion	$	474,011	$	285,354
Long-term portion		1,428,368		959,116
Total lease liabilities	$	1,902,379	$	1,244,470

On September 30, 2023, the Company was committed to minimum lease payments as follows:

Maturity analysis	September 30, 2023
Remaining of 2023	$	174,452
2024		622,666
2025		529,912
2026		353,897
2027		225,147
Thereafter		504,663
Total undiscounted lease liabilities	$	2,410,737
Amount representing implicit interest		(508,358	)
Lease obligations	$	1,902,379

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Accounts Payable and Accrued Expenses

9 Months Ended

Sep. 30, 2023

Accounts Payable And Accrued Expenses [abstract]

ACCOUNTS PAYABLE AND ACCRUED EXPENSES

NOTE 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

	September 30,
	2023 (unaudited)		December 31, 2022
Accounts payable	$	1,504,273	$	1,333,044
Accrued liabilities		1,463,834		1,236,942
Payroll liabilities		136,349		346,693
	$	3,104,456	$	2,916,679

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Convertible Debt - Related Party

9 Months Ended

Sep. 30, 2023

Convertible Debt - Related Party [Abstract]

CONVERTIBLE DEBT - RELATED PARTY

NOTE 11. CONVERTIBLE DEBT – RELATED PARTY

During the years ended December 31, 2019 and 2020, the Company entered into loan agreements with related parties totaling EUR417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. One of those loans was not converted and is payable on demand (balance of $31,719 as of September 30, 2023). While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. As the Company incurred losses during 2021, 2020 and 2019, no expense has been recorded in any period for profit sharing. At maturity, the 2019 and 2020 Convertible Loans are convertible into ordinary shares of the Company at EUR1 per share.

The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature. The Company recognized debt discounts totaling EUR13,064 on issuance of the 2019 and 2020 Convertible Loans.

As of September 30, 2023 and December 31, 2022, the Company’s Convertible Debt – Related Party is $31,719 (EUR30,000) and $32,181 (EUR30,000), respectively.

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Convertible Debt

9 Months Ended

Sep. 30, 2023

Convertible Debt [Abstract]

CONVERTIBLE DEBT

NOTE 12. CONVERTIBLE DEBT

Convertible Loans

In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totaling EUR80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totaling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand.

As of September 30, 2023 and December 31, 2022, the Company’s Convertible loan was $42,439 (EUR40,139) and $40,057 (EUR40,139), respectively.

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 request that the Holder purchase from us up to $50,000,000 (the “Commitment Amount”) of promissory notes (each, a “Promissory Note”). The Holder will purchase each Promissory Note at 92% of the principal amount of that Promissory Note. On June 28, 2023, we sold the Holder a Promissory Note (the “Initial Promissory Note”) in the principal amount of $5,500,000 and received $5,060,000, net of discount. The Holder is not obligated to purchase any additional Promissory Notes from us under the PPA. On September 26, 2023, the Company issued 2^nd Promissory Note of $5,500,000 and received $5,060,000, net of discount.

Each Promissory Note matures one year from the date of its issuance. The Promissory Notes do not carry any interest, except if there is an event of default in which case the interest will increase to 15% per annum. We may prepay a Promissory Note with at an 8% premium with advance written notice ranging between five business days and thirty calendar days prior to such prepayment, depending on the market price of our ordinary shares at the time of the notice.

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) $4.9986 in respect of the Initial Promissory Note and (II) with respect to each subsequent Promissory Note, if any, 110% of the volume weighted average price (“VWAP”) of our ordinary shares on the trading day immediately preceding the issuance of such Promissory Note (the “Fixed Price”) or (b) 92% of the average of the two lowest daily VWAPs of the shares during the eight trading days immediately prior to such conversion. In no event, however, shall the conversion price be less than a floor price of $2.00, as may be adjusted for stock splits and other similar transactions (the “Floor Price”).

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 five of seven consecutive trading days. Within five trading days of a Trigger Event, we must make a monthly cash payment to the Holder in connection with the Promissory Notes (the “Monthly Payment”) equal to the lesser of (i) $550,000, plus an 8% redemption premium on any principal being repaid plus any accrued and unpaid interest and (ii) all principal outstanding under all outstanding Promissory Notes, plus an 8% redemption premium on any principal being repaid plus any accrued and unpaid interest. Thereafter, we must pay the Holder a Monthly Payment every 30 calendar days after the due date of the initial Monthly Payment; provided that our monthly obligation hereunder will end with respect to a particular Trigger Event if (i) the daily VWAP of the ordinary shares for seven consecutive trading days immediately prior to the due date of the next Monthly Payment is 10% or greater than the Floor Price or (ii) we reduce the Floor Price for all outstanding Promissory Notes by 50%, unless a new Trigger Event occurs.

In connection with the execution of the PPA, we agreed to pay a commitment fee of $250,000. Such commitment fee was paid on the date of the PPA in the form of 54,428 ordinary shares, which was derived using a per ordinary share price equal to the average of the daily VWAPs of the Ordinary Shares during the three trading days prior to the PPA.

The Company elected to account for the Promissory Notes at fair value. Management believes that the fair value option appropriately reflects the underlying economics of the Promissory Notes. Under the fair value election, changes in fair value 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 Initial Promissory Note had a face value of $5,500,000 and had an original issue discount of $440,000. The Company recorded the Initial Promissory Note at its fair value of $5,060,000, which was also the cash received and the 2^nd Promissory Note at its fair value of $5,008,000.

During the period ended September 30, 2023, principal amounts of the Initial Promissory Note of $3,000,000 was converted into 1,015,939 ordinary shares, at conversion prices ranging from $2.70 to $4.17.

For the period ended September 30, 2023, the Company recorded a change in fair value of $87,000, resulting in a balance of $7,207,000 as of September 30, 2023.

Changes in the balance of the convertible notes are as follows:

				Carrying
	Face			Amount at
	Value			Fair Value
Balance at December 31, 2022	$	-		$	-
Issuance of convertible promissory notes		11,000,000			10,120,000
Repayments of debt		-			-
Conversion of notes with ordinary shares		(3,000,000	)		(3,000,000	)
Change in fair value of convertible promissory notes		-			87,000
Balance at September 30, 2023	$	8,000,000		$	7,207,000

We classified this fair value as a Level 3 fair value measurement and used a fair value pricing model to calculate the fair value for the period ended September 30, 2023. Key inputs for the fair value model are summarized below.

A summary of the Company’s significant inputs into the fair value of the Promissory Notes is as follows:

		September 30,
		2023
Stock price	$	2.92 - 4.82
Expected life in years		0.74 - 1.00
Risk free rate		5.32% - 5.57	%
Expected volatility		74.65% - 75.00	%
Discount rate		78.54% - 82.88	%

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Silent Partnerships

9 Months Ended

Sep. 30, 2023

Silent Partnerships [Abstract]

SILENT PARTNERSHIPS

NOTE 13. SILENT PARTNERSHIPS

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR299,400 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs has the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs was determined to be EUR218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs of EUR81,280 ($92,774) has been recognized as government grant income during the period. During the year ended December 31, 2021 the Company received the remaining EUR200,000 ($236,640). The initial fair value of the 3.0% SPAs received was determined to be EUR230,000 (approximately $272,136), determined using an estimated effective interest rate of 11.5%. The initial fair value of the 3.0% SPAs received in 2021 was determined to be EUR156,549 (approximately $185,229), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3.0% SPAs received in 2021 of EUR43,451 (approximately $51,410) has been recognized as government grant income during the period.

During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. Pursuant to the silent partnership agreement, the Company notified the holder, at which point the holder declined the opportunity to convert their loan into common shares. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.

Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totaling EUR798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR398,634 (approximately $408,496) of the loans by June 30, 2023 (such amounts were paid between the end of June and the beginning of July 2023) and EUR400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366 (approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration, and the Company recognized a gain on the extinguishment of $8,214.

In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR300,000 (approximately $343,830) (the “8% SPA”). The Company repaid this loan in January 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%.

Certain of the Silent Partnership agreements are with a German based bank, which also owns ordinary shares of the Company. Those debts are classified as “related party” in the statement of financial position. A continuity of the Company’s silent partnerships is as follows:

	3% SPAs			3.5% SPAs			8.5% SPAs			8% SPAs			Total
Balance, December 31, 2022	$	537,359		$	43,938		$	909,703		$	417,549		$	1,908,549
Issued during the year		-			-			-			-			-
Extinguished during the year		-			-			(512,502	)		(422,370	)		(934,872	)
Debt forgiveness		-			-			(48,735	)		-			(48,735	)
Accretion		31,412			2,528			17,521			813			52,274
Effects of currency translation		(8,460	)		(691	)		(157	)		4,008			(5,300	)
Balance, September 30, 2023	$	560,311		$	45,775		$	365,830		$	-		$	971,916

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Equity

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

EQUITY

NOTE 14. EQUITY

Ordinary shares

The Company has 45 million ordinary shares authorized. Holders of ordinary shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. The par value of share capital is EUR0.01 per share.

Controlled Equity Offering

In December 2022, the Company entered into a Controlled Equity Offering, known as an “ATM” facility. Pursuant to the ATM, the Company at its discretion and subject to an effective registration statement with the U.S. Securities and Exchange Commission, may sell through its agent ordinary shares at market prices, for a fee of 3%. During the nine months ended September 30, 2023 the Company issued 307,365 ordinary shares pursuant to the ATM for net proceeds of $1,894,742, at an average price of $6.16.

In addition, during the nine months ended September 30, 2023, the Company issued ordinary shares as follows:

● 134,500 ordinary shares issued for services rendered which were valued at $503,690

● 305,771 ordinary shares issued for cashless exercise of warrants

● 54,428 ordinary shares issued for a commitment fee on a convertible promissory note valued at $250,000

● 300,000 ordinary shares issued for acquisition of intangible assets valued at $2,055,000

● 1,015,939 ordinary shares issued for conversion of debt of $3,000,000

Warrants

During the year ended December 31, 2021, in conjunction with private sales units, which included ordinary shares and warrants, the Company issued 3,755,000 warrants and issued 161,000 underwriter warrants with its IPO, cumulatively valued at $754,286, which was recorded to Reserve in the Statement of Financial Position. The warrants were valued using the Black-Scholes pricing model. The Black-Scholes model requires six basic data inputs: the exercise or strike price, time to expiration, the risk-free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Changes to these inputs could produce a significantly higher or lower fair value measurement.  Unexercised warrants were to expire in November 2023. On September 8, 2023 the Board of Directors approved an amendment to the outstanding warrant agreements, which all warrant holders accepted. The amendment extended the remaining life of the warrants to November 9, 2024 and removed the option for cashless exercise. No other terms were changed.

During the year ended December 31, 2021, the estimated fair value of the warrants as follows:

Stock price at time of issuance	$	0.283 - 1.602
Exercise price	$	3.00
Expected term		2 - 5 years
Expected average volatility		75 - 95	%
Expected dividend yield		0
Risk-free interest rate		0.16 - 1.08	%

A summary of activity during the nine months ended September 30, 2023 is as follows:

	Warrant			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		3,247,500		$	3.00		0.44
Grants		-			-		-
Exercised		(816,667	)		3.00		-
Expired		-			-		-
Balance as of September 30, 2023		2,430,833		$	3.00		1.11

Stock options

During 2021, we adopted our 2021 Omnibus Incentive Plan, and on June 28, 2022 we adopted our 2022 Omnibus Incentive Plan (the “Plans”). Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed 3,100,000 ordinary shares.

During the nine months ended September 30, 2023, the Company granted 332,500 stock options valued at $1,174,201. Stock options with time-based vesting were valued using the Black-Scholes pricing model.

During the nine months ended September 30, 2023, the Company recorded stock-based compensation of $2,432,948 and had unamortized expense of $3,856,598 as of September 30, 2023. Forfeitures are estimated at the time of grant and adjusted, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

For the nine months ended September 30, 2023, the estimated fair values of the stock options are as follows:

		September 30,
		2023
Exercise price	$	4.09 – 7.02
Expected term		5.25 – 7.00 years
Expected average volatility		70% - 76	%
Expected dividend yield		-
Risk-free interest rate		3.48% - 4.27	%

A summary of activity during the nine months ended September 30, 2023 follows:

	Stock options			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		2,394,150		$	7.18		9.11
Grants		332,500			4.93		10.00
Exercised		-			-		-
Forfeited		(47,092	)		6.48		-
Expiry		-			-		-
Balance as of September 30, 2023		2,679,558		$	6.96		8.59
Exercisable as of September 30, 2023		1,626,816		$	6.12		8.17

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Cost of Revenue

9 Months Ended

Sep. 30, 2023

Cost of Revenue [Abstract]

COST OF REVENUE

NOTE 15. COST OF REVENUE

For the nine months ended September 30, 2023 and 2022, cost of revenue consisted of test kit materials, both patient collection kits and lab-based PCR kits and the cost of performing those tests for ColoAlert tests run in our analytical laboratory.

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Related Party Transactions

9 Months Ended

Sep. 30, 2023

Related Party Transactions [Abstract]

RELATED PARTY TRANSACTIONS

NOTE 16. RELATED PARTY TRANSACTIONS

Key management personnel include those people who have 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, Chief Financial Officer, Chief Operating Officer, Chief Commercial Officer and Chief Scientific Officer. The remuneration of directors and key management personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	627,988	$	468,050

Remuneration paid to related parties other than key personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	14,902	$	64,055

During the nine months ended September 30, 2023 and 2022, the Company incurred interest expense of $25,017 and $24,426 on balances owing to related parties, respectively.

During the nine months ended September 30, 2023 and 2022, the Company incurred accretion expense of $8,752 and $11,553 on balances owing to related parties, respectively.

During the nine months ended September 30, 2023 and 2022, we recorded expenses of $52,731 and $97,924, 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 until we purchased the intellectual property on February 15, 2023 (see Note 7). A member of our Board of Directors is also a significant equity holder of ColoAlert AS.

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Government Grants

9 Months Ended

Sep. 30, 2023

Government Grants [Abstract]

GOVERNMENT GRANTS

NOTE 17. GOVERNMENT GRANTS

The Company receives government grants related to its research and development activities. The amount of government grants received during the nine months ended September 30, 2023 and 2022 and recognized as research grant revenue were as follows:

	Nine months ended
	September 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	42,055
Multi-marker test for the early detection of pancreatic cancer		27,696		108,999
	$	27,696	$	151,054

As of September 30, 2023 and December 31, 2022, 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 $6,604 and $81,706, respectively. Grant income is included as Other Income in the condensed interim consolidated statements of profit and loss.

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Financial Instrument Risk Management

9 Months Ended

Sep. 30, 2023

Financial Instrument Risk Management [Abstract]

FINANCIAL INSTRUMENT RISK MANAGEMENT

NOTE 18. 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 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. The Company carries cash balances at US financial institutions that exceed the federally insured limit of $250,000 per institution and in German financial institutions that exceed €100,000 limit per institution. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.

Management believes that the Company is not exposed to any significant credit risk with respect to its cash.

The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. During the nine months ended September 30, 2023, the Company incurred $95,340 (related to Trade receivable and VAT receivable) and in bad debt expense (2022 - $0). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.

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 September 30, 2023, the Company had an unrestricted cash balance of $9,320,381 to settle current liabilities, excluding the Initial Promissory Note, which is expected to be settled in ordinary shares, of $6,921,813.

Historically, the Company’s primary source of funding has been the issuance of ordinary shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to equity or debt financing.

The following is an analysis of the contractual maturities of the Company’s financial liabilities as of September 30, 2023:

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	3,104,456	$	-	$	-
Convertible promissory note to be settled with ordinary shares		7,207,000		-		-
Convertible loans		74,158		-		-
Silent partnerships		-		971,916		-
Lease liabilities		474,011		923,705		504,663
Intellectual property acquisition liability - related party		400,854		796,664		-
	$	11,260,479	$	2,692,285	$	504,663

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. As the Company operates in Germany it holds a portion of its cash balances in Euro to approximate its estimated short term operating needs. The remainder of the Company’s cash is held in U.S. Dollars, the Company’s reporting currency, which we also expect to be the currency of the Company’s largest cash outlays over the next twenty-four months.

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

In the management of capital, the Company includes components of stockholders’ equity. 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 a young growth company, issuance of equity 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.

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Concentrations

9 Months Ended

Sep. 30, 2023

Concentrations [Abstract]

CONCENTRATIONS

NOTE 19. CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the nine months ended September 30, 2023 and 2022, the Company had revenue from one and four customers that accounted for approximately 18% and 81% of revenue, respectively.

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Operating Expenses

9 Months Ended

Sep. 30, 2023

Operating Expenses [Abstract]

OPERATING EXPENSES

NOTE 20. OPERATING EXPENSES

For the nine months ended September 30, 2023 and 2022, operating expenses consisted of the following:

	Nine months ended
	September 30,
Research and development	2023		2022
Payroll expenses	$	2,969,663	$	994,087
Clinical study expenses		3,322,251		597,439
Amortization of intangibles		342,075		-
Travel expenses		140,839		29,795
Lab consumables		73,238		13,096
Lab overhead and other expenses		743,102		68,074
	$	7,591,168	$	1,702,491

	Nine months ended
	September 30,
Sales and marketing	2023		2022
Payroll expenses	$	1,021,828	$	248,263
Consulting services		1,630,346		198,372
Product and brand advertising		2,478,919		2,924,084
Other expenses		76,702		23,139
	$	5,207,795	$	3,393,858

	Nine months ended
	September 30,
General and administrative	2023		2022
Payroll expenses	$	1,560,706	$	1,531,427
Stock option expense		2,432,948		7,479,767
Depreciation and amortization		395,087		-
Travel expenses		87,947		189,130
Consulting services		1,998,633		2,884,688
IT expense		171,560		-
Training		17,052		6,365
Insurance and taxes		640,530		751,805
Rent and premises		115,124		129,203
Other expenses		210,659		132,181
	$	7,630,246	$	13,104,566

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Subsequent Events

9 Months Ended

Sep. 30, 2023

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 21. SUBSEQUENT EVENTS

Subsequent to September 30, 2023, pursuant to the PPA (see Note 12), the Holder converted $500,000 in principal value on the Initial Promissory Note, resulting in the issuance of 243,080 ordinary shares.

On November 13, 2023, we entered into a securities purchase agreement with several institutional investors to purchase approximately $5.0 million of our ordinary shares (or pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase ordinary shares in a registered direct offering. The combined effective purchase price for each ordinary share (or pre-funded warrant) and associated warrant to purchase one ordinary share will be $1.20. Under the terms of the securities purchase agreement, we have agreed to issue 4,166,667 ordinary shares (or pre-funded warrant in lieu thereof) and warrants (the “Warrants”) to purchase up to an aggregate of 4,166,667 shares. The Warrants will be exercisable immediately on the date of issuance until the fifth anniversary of the issuance date at a price of $1.20 per share.

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Accounting Policies, by Policy (Policies)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Inventories

Inventories

Inventories are measured at the lower of cost or 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.

Reclassifications

Reclassifications

Certain prior year amounts have been reclassified for consistency with the current period presentation.

Critical Accounting Estimates and Significant Management Judgments

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 and intangible assets

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.

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.

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Trade Receivables (Tables)

9 Months Ended

Sep. 30, 2023

Trade Receivables [abstract]

Schedule of Trade Receivables

	September 30,
	2023 (unaudited)			December 31, 2022
Accounts receivable	$	133,347		$	130,588
Less: allowance for doubtful accounts		(24,717	)		(66,852	)
Accounts receivable, net		108,630			63,736
Other		-			3,248
	$	108,630		$	66,984

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Inventories (Tables)

9 Months Ended

Sep. 30, 2023

Inventories [Abstract]

Schedule of Inventories

	September 30,
	2023 (unaudited)			December 31, 2022
Raw materials	$	331,090		$	175,469
Finished goods		175,799			-
		506,889			175,469
Less: write down		(13,301	)		-
	$	493,588		$	175,469

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Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2023

Prepaid Expenses and Other Current Assets [Abstract]

Schedule of Prepaid and Other Current Assets

	September 30, 2023 (unaudited)		December 31, 2022
Prepaid insurance	$	85,153	$	624,033
Prepaid stock compensation		302,714		-
Other prepaid expenses		131,483		55,356
Security deposit		129,358		122,570
VAT receivable		403,985		192,154
	$	1,052,693	$	994,113

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Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2023

Property and Equipment [abstract]

Schedule of Property and Equipment

	Laboratory equipment			Office equipment			Construction in progress			Total
Cost
Balances at December 31, 2022	$	579,171		$	176,347		$	-		$	755,518
Additions		933,246			160,708			49,390			1,143,344
Disposals		(16,810	)		-			-			(16,810	)
Effects of currency translation		(30,055	)		(22,240	)		(1,174	)		(53,470	)
Balances at September 30, 2023 (unaudited)	$	1,465,551		$	314,815		$	48,216		$	1,828,582
Accumulated depreciation
Balances at December 31, 2022	$	77,833		$	15,993		$	-		$	93,826
Depreciation		92,068			43,404			-			135,472
Disposals		(2,335	)		-			-			(2,335	)
Effects of currency translation		(3,255	)		(1,459	)		-			(4,714	)
Balances at September 30, 2023 (unaudited)	$	164,311		$	57,938		$	-		$	222,249
Net book value at December 31, 2022	$	501,338		$	160,354		$	-		$	661,692
Net book value at September 30, 2023 (unaudited)	$	1,301,240		$	256,877		$	48,216		$	1,606,333

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Leases (Tables)

9 Months Ended

Sep. 30, 2023

Leases [Abstract]

Schedule of Leases Certain Assets Under Lease Agreements

The Company leases certain assets under lease agreements.

	Office			Laboratory
	Equipment			Equipment			Vehicle			Office			Total
Cost
Balances as of December 31, 2022	$	64,226		$	362,970		$	94,008		$	1,035,200		$	1,556,404
Additions		-			370,011			51,675			587,951			1,009,637
Effects of currency translation		(922	)		(13,992	)		(2,575	)		(28,814	)		(46,303	)
Balances at September 30, 2023	$	63,304		$	718,989		$	143,108		$	1,594,337		$	2,519,738
Accumulated amortization
Balances as of December 31, 2022	$	20,707		$	77,838		$	22,109		$	258,055		$	378,709
Amortization		9,060			152,755			37,878			166,486			366,179
Effects of currency translation		(512	)		(4,742	)		(1,216	)		(7,657	)		(14,127	)
Balances at September 30, 2023	$	29,255		$	225,851		$	58,771		$	416,884		$	730,761
Net book value
December 31, 2022	$	43,519		$	285,132		$	71,899		$	777,145		$	1,177,695
September 30, 2023	$	34,049		$	493,138		$	84,337		$	1,177,453		$	1,788,977

Schedule of Future Lease Payments

The Company’s lease liabilities consist of office and laboratory equipment and office space. The present value of future lease payments was measured using an incremental borrowing rate of 10% per annum as of January 1, 2022 and January 1, 2023.

	Total
Balance as of December 31, 2022	$	1,244,470
Additions		1,009,637
Interest expenses		141,097
Lease payments		(458,534	)
Effects of currency translation		(34,291	)
As of September 30, 2023	$	1,902,379

Schedule of Lease Liabilities

Lease liabilities	September 30, 2023		December 31, 2022
Current portion	$	474,011	$	285,354
Long-term portion		1,428,368		959,116
Total lease liabilities	$	1,902,379	$	1,244,470

Schedule of Committed to Minimum Lease Payments

On September 30, 2023, the Company was committed to minimum lease payments as follows:

Maturity analysis	September 30, 2023
Remaining of 2023	$	174,452
2024		622,666
2025		529,912
2026		353,897
2027		225,147
Thereafter		504,663
Total undiscounted lease liabilities	$	2,410,737
Amount representing implicit interest		(508,358	)
Lease obligations	$	1,902,379

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Accounts Payable and Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2023

Accounts Payable And Accrued Expenses [abstract]

Schedule of Accounts Payable and Accrued Expenses

	September 30,
	2023 (unaudited)		December 31, 2022
Accounts payable	$	1,504,273	$	1,333,044
Accrued liabilities		1,463,834		1,236,942
Payroll liabilities		136,349		346,693
	$	3,104,456	$	2,916,679

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Convertible Debt (Tables)

9 Months Ended

Sep. 30, 2023

Convertible Debt [Abstract]

Schedule of Changes in the Balance of the Convertible Notes

Changes in the balance of the convertible notes are as follows:

				Carrying
	Face			Amount at
	Value			Fair Value
Balance at December 31, 2022	$	-		$	-
Issuance of convertible promissory notes		11,000,000			10,120,000
Repayments of debt		-			-
Conversion of notes with ordinary shares		(3,000,000	)		(3,000,000	)
Change in fair value of convertible promissory notes		-			87,000
Balance at September 30, 2023	$	8,000,000		$	7,207,000

Schedule of Significant Inputs into the Fair Value of the Promissory Notes

A summary of the Company’s significant inputs into the fair value of the Promissory Notes is as follows:

		September 30,
		2023
Stock price	$	2.92 - 4.82
Expected life in years		0.74 - 1.00
Risk free rate		5.32% - 5.57	%
Expected volatility		74.65% - 75.00	%
Discount rate		78.54% - 82.88	%

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Silent Partnerships (Tables)

9 Months Ended

Sep. 30, 2023

Silent Partnerships [Abstract]

Schedule of Continuity of the Company’s Silent Partnerships

Those debts are classified as “related party” in the statement of financial position. A continuity of the Company’s silent partnerships is as follows:

	3% SPAs			3.5% SPAs			8.5% SPAs			8% SPAs			Total
Balance, December 31, 2022	$	537,359		$	43,938		$	909,703		$	417,549		$	1,908,549
Issued during the year		-			-			-			-			-
Extinguished during the year		-			-			(512,502	)		(422,370	)		(934,872	)
Debt forgiveness		-			-			(48,735	)		-			(48,735	)
Accretion		31,412			2,528			17,521			813			52,274
Effects of currency translation		(8,460	)		(691	)		(157	)		4,008			(5,300	)
Balance, September 30, 2023	$	560,311		$	45,775		$	365,830		$	-		$	971,916

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Equity (Tables)

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

Schedule of Estimated Fair Values of the Warrants Measured

During the year ended December 31, 2021, the estimated fair value of the warrants as follows:

Stock price at time of issuance	$	0.283 - 1.602
Exercise price	$	3.00
Expected term		2 - 5 years
Expected average volatility		75 - 95	%
Expected dividend yield		0
Risk-free interest rate		0.16 - 1.08	%

		September 30,
		2023
Exercise price	$	4.09 – 7.02
Expected term		5.25 – 7.00 years
Expected average volatility		70% - 76	%
Expected dividend yield		-
Risk-free interest rate		3.48% - 4.27	%

Schedule of Activity

A summary of activity during the nine months ended September 30, 2023 is as follows:

	Warrant			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		3,247,500		$	3.00		0.44
Grants		-			-		-
Exercised		(816,667	)		3.00		-
Expired		-			-		-
Balance as of September 30, 2023		2,430,833		$	3.00		1.11

	Stock options			Weighted- Average		Weighted- Average
	Outstanding			Exercise Price		Life (years)
Balance as of December 31, 2022		2,394,150		$	7.18		9.11
Grants		332,500			4.93		10.00
Exercised		-			-		-
Forfeited		(47,092	)		6.48		-
Expiry		-			-		-
Balance as of September 30, 2023		2,679,558		$	6.96		8.59
Exercisable as of September 30, 2023		1,626,816		$	6.12		8.17

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Related Party Transactions (Tables)

9 Months Ended

Sep. 30, 2023

Related Party Transactions [Abstract]

Schedule of Remuneration of Directors and Key Management Personnel

The remuneration of directors and key management personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	627,988	$	468,050

Schedule of Remuneration Paid to Related Parties

Remuneration paid to related parties other than key personnel during the nine months ended September 30, 2023 and 2022 was as follows:

	Nine months ended
	September 30,
	2023		2022
Salaries and benefits	$	14,902	$	64,055

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Government Grants (Tables)

9 Months Ended

Sep. 30, 2023

Government Grants [Abstract]

Schedule of Research and Development

The Company receives government grants related to its research and development activities. The amount of government grants received during the nine months ended September 30, 2023 and 2022 and recognized as research grant revenue were as follows:

	Nine months ended
	September 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	42,055
Multi-marker test for the early detection of pancreatic cancer		27,696		108,999
	$	27,696	$	151,054

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Financial Instrument Risk Management (Tables)

9 Months Ended

Sep. 30, 2023

Financial Instrument Risk Management [Abstract]

Schedule of Contractual Maturities Financial Liabilities

The following is an analysis of the contractual maturities of the Company’s financial liabilities as of September 30, 2023:

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	3,104,456	$	-	$	-
Convertible promissory note to be settled with ordinary shares		7,207,000		-		-
Convertible loans		74,158		-		-
Silent partnerships		-		971,916		-
Lease liabilities		474,011		923,705		504,663
Intellectual property acquisition liability - related party		400,854		796,664		-
	$	11,260,479	$	2,692,285	$	504,663

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Operating Expenses (Tables)

9 Months Ended

Sep. 30, 2023

Operating Expenses [Abstract]

Schedule of Operating Expenses

For the nine months ended September 30, 2023 and 2022, operating expenses consisted of the following:

	Nine months ended
	September 30,
Research and development	2023		2022
Payroll expenses	$	2,969,663	$	994,087
Clinical study expenses		3,322,251		597,439
Amortization of intangibles		342,075		-
Travel expenses		140,839		29,795
Lab consumables		73,238		13,096
Lab overhead and other expenses		743,102		68,074
	$	7,591,168	$	1,702,491

	Nine months ended
	September 30,
Sales and marketing	2023		2022
Payroll expenses	$	1,021,828	$	248,263
Consulting services		1,630,346		198,372
Product and brand advertising		2,478,919		2,924,084
Other expenses		76,702		23,139
	$	5,207,795	$	3,393,858

	Nine months ended
	September 30,
General and administrative	2023		2022
Payroll expenses	$	1,560,706	$	1,531,427
Stock option expense		2,432,948		7,479,767
Depreciation and amortization		395,087		-
Travel expenses		87,947		189,130
Consulting services		1,998,633		2,884,688
IT expense		171,560		-
Training		17,052		6,365
Insurance and taxes		640,530		751,805
Rent and premises		115,124		129,203
Other expenses		210,659		132,181
	$	7,630,246	$	13,104,566

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Nature of Operations and Going Concern (Details) - USD ($)			1 Months Ended	9 Months Ended
	Jan. 31, 2022	Aug. 03, 2021	Nov. 30, 2021	Sep. 30, 2023	Dec. 31, 2022
Nature of Operations and Going Concern [Line Items]
Agreement percentage		100.00%
Share exchange (in Shares)		6,000,000
Outstanding shares percentage		62.00%
Shares sold (in Shares)			2,300,000
Shares per share (in Dollars per share)			$ 5
Ordinary shares issued (in Shares)	1,725,000
Gross proceeds	$ 25,900,000
Net of offering expenses	$ 23,900,000
Accumulated deficit total				$ 64,144,694
Operating activities				17,283,658
Cash on hand				9,320,381
Ordinary shares				$ 6,921,813
Period of going concern				1 year
Equity offering					$ 50,000,000
Raised cash				$ 1,900,000
Prepaid advance amount				11,000,000
Net proceed				$ 10,100,000

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Trade Receivables (Details)	Sep. 30, 2023 USD ($)
Trade Receivables [Line Items]
Debt reserve	$ 42,045

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Trade Receivables (Details) - Schedule of Trade Receivables - USD ($)	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Schedule of trade and other receivables [Abstract]
Accounts receivable	$ 133,347	$ 130,588
Less: allowance for doubtful accounts	(24,717)	(66,852)
Accounts receivable, net	108,630	63,736
Other		3,248
Total	$ 108,630	$ 66,984

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Inventories (Details)	9 Months Ended
	Sep. 30, 2023 USD ($)
Inventories [Line Items]
Inventory write down	$ 13,301

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Inventories (Details) - Schedule of Inventories - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Schedule of Inventories [Abstract]
Raw materials	$ 331,090	$ 175,469
Finished goods	175,799
Current inventories	506,889	175,469
Less: write down	(13,301)
Total	$ 493,588	$ 175,469

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Prepaid Expenses and Other Current Assets (Details)	9 Months Ended
	Sep. 30, 2023 USD ($)
Prepaid Expenses and Other Current Assets [Abstract]
VAT receivables	$ 53,295

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Prepaid Expenses and Other Current Assets (Details) - Schedule of Prepaid and Other Current Assets - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Schedule of Prepaid and Other Current Assets [Abstract]
Prepaid insurance	$ 85,153	$ 624,033
Prepaid stock compensation	302,714
Other prepaid expense	131,483	55,356
Total prepaid and other current assets	129,358	122,570
VAT receivable	403,985	192,154
Total	$ 1,052,693	$ 994,113

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Property and Equipment (Details) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Property, plant and equipment [member]
Property, Plant and Equipment [Line Items]
Deprecation	$ 135,472	$ 32,767

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Property and Equipment (Details) - Schedule of Property and Equipment - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Cost
Cost Balance	$ 755,518
Additions	1,143,344
Disposal	(16,810)
Effects of currency translation	(53,470)
Cost Balance	1,828,582
Accumulated depreciation
Accumulated depreciation Balance	93,826
Depreciation	135,472
Disposals	(2,335)
Effects of currency translation	(4,714)
Accumulated depreciation Balance	222,249
Net book value		$ 661,692
Accumulated depreciation net book value		1,606,333
Laboratory equipment [Member]
Cost
Cost Balance	579,171
Additions	933,246
Disposal	(16,810)
Effects of currency translation	(30,055)
Cost Balance	1,465,551
Accumulated depreciation
Accumulated depreciation Balance	77,833
Depreciation	92,068
Disposals	(2,335)
Effects of currency translation	(3,255)
Accumulated depreciation Balance	164,311
Net book value		501,338
Accumulated depreciation net book value		1,301,240
Office equipment [Member]
Cost
Cost Balance	176,347
Additions	160,708
Disposal
Effects of currency translation	(22,240)
Cost Balance	314,815
Accumulated depreciation
Accumulated depreciation Balance	15,993
Depreciation	43,404
Disposals
Effects of currency translation	(1,459)
Accumulated depreciation Balance	57,938
Net book value		160,354
Accumulated depreciation net book value		256,877
Construction in progress [Member]
Cost
Cost Balance
Additions	49,390
Disposal
Effects of currency translation	(1,174)
Cost Balance	48,216
Accumulated depreciation
Accumulated depreciation Balance
Depreciation
Disposals
Effects of currency translation
Accumulated depreciation Balance
Net book value
Accumulated depreciation net book value		$ 48,216

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Intangible asset (Details)		1 Months Ended	9 Months Ended
	Feb. 11, 2021 EUR (€) € / shares	Feb. 15, 2023 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares
Intangible Assets [Line Items]
Royalty payment per share (in Euro per share) | € / shares	€ 5
intellectual property amount		$ 2,000,000
Ordinary restricted shares (in Shares) | shares		300,000
Revenue (in Dollars per share) | $ / shares		$ 1
Estimated useful life			10 years
Closing company stock (in Dollars per share) | $ / shares			$ 6.85
Future payments percentage			10.00%
Amount paid to seller			$ 600,000
Amortization cost			235,739
Interest expense			80,690
Liability on required payment			$ 1,197,518
Bottom of range [member]
Intangible Assets [Line Items]
Cash Payment (in Euro) | €	€ 2,000,000
Top of range [member]
Intangible Assets [Line Items]
Cash Payment (in Euro) | €	€ 4,000,000

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Leases (Details)			9 Months Ended
	Jan. 01, 2023	Jan. 01, 2022	Sep. 30, 2023
Leases [Abstract]
Average expected life			4 years 2 months 26 days
Present value of future lease payments percentage	10.00%	10.00%

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Leases (Details) - Schedule of Leases Certain Assets Under Lease Agreements	9 Months Ended
	Sep. 30, 2023 USD ($)
Cost
Balance	$ 1,556,404
Additions	1,009,637
Effects of currency translation	(46,303)
Balance	2,519,738
Accumulated amortization
Balance	378,709
Depreciation	366,179
Effects of currency translation	(14,127)
Balance	730,761
Net book value
Net book value at December 31, 2022	1,177,695
Net book value at September 30, 2023	1,788,977
Office Equipment [Member]
Cost
Balance	64,226
Additions
Effects of currency translation	(922)
Balance	63,304
Accumulated amortization
Balance	20,707
Depreciation	9,060
Effects of currency translation	(512)
Balance	29,255
Net book value
Net book value at December 31, 2022	43,519
Net book value at September 30, 2023	34,049
Laboratory Equipment [Member]
Cost
Balance	362,970
Additions	370,011
Effects of currency translation	(13,992)
Balance	718,989
Accumulated amortization
Balance	77,838
Depreciation	152,755
Effects of currency translation	(4,742)
Balance	225,851
Net book value
Net book value at December 31, 2022	285,132
Net book value at September 30, 2023	493,138
Vehicle [Member]
Cost
Balance	94,008
Additions	51,675
Effects of currency translation	(2,575)
Balance	143,108
Accumulated amortization
Balance	22,109
Depreciation	37,878
Effects of currency translation	(1,216)
Balance	58,771
Net book value
Net book value at December 31, 2022	71,899
Net book value at September 30, 2023	84,337
Office [Member]
Cost
Balance	1,035,200
Additions	587,951
Effects of currency translation	(28,814)
Balance	1,594,337
Accumulated amortization
Balance	258,055
Depreciation	166,486
Effects of currency translation	(7,657)
Balance	416,884
Net book value
Net book value at December 31, 2022	777,145
Net book value at September 30, 2023	$ 1,177,453

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Leases (Details) - Schedule of Future Lease Payments	9 Months Ended
	Sep. 30, 2023 USD ($)
Schedule of Future Lease Payments [Abstract]
Balance	$ 1,244,470
Additions	1,009,637
Interest expenses	141,097
Lease payments	(458,534)
Effects of currency translation	(34,291)
Balance	$ 1,902,379

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Leases (Details) - Schedule of Lease Liabilities - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Schedule of lease liabilities [Abstract]
Current portion	$ 474,011	$ 285,354
Long-term portion	1,428,368	959,116
Total lease liabilities	$ 1,902,379	$ 1,244,470

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Leases (Details) - Schedule of Committed to Minimum Lease Payments	9 Months Ended
	Sep. 30, 2023 USD ($)
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	$ 2,410,737
Amount representing implicit interest	(508,358)
Lease obligations	1,902,379
Remaining of 2023 [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	174,452
2024 [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	622,666
2025 [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	529,912
2026 [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	353,897
2027 [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	225,147
Thereafter [Member]
Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	$ 504,663

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Accounts Payable and Accrued Expenses (Details) - Schedule of Accounts Payable and Accrued Expenses - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Schedule of Accounts Payable and Accrued Expenses [Abstract]
Accounts payable	$ 1,504,273	$ 1,333,044
Accrued liabilities	1,463,834	1,236,942
Payroll liabilities	136,349	346,693
Total	$ 3,104,456	$ 2,916,679

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Convertible Debt - Related Party (Details)	9 Months Ended		12 Months Ended
	Sep. 30, 2023 USD ($)	Sep. 30, 2023 EUR (€) € / shares	Dec. 31, 2022 USD ($)	Dec. 31, 2022 EUR (€)	Dec. 31, 2020 USD ($)	Dec. 31, 2020 EUR (€)	Dec. 31, 2019 USD ($)	Dec. 31, 2019 EUR (€)
Convertible Debt - Related Party [Abstract]
Loan agreements totaling					$ 467,154	€ 417,133	$ 467,154	€ 417,133
Bear interest	3.50%
Convertible Debt maturity Date	Sep. 30, 2022	Sep. 30, 2022
Demand balance (in Dollars) | $	$ 31,719
Loans outstanding, percentage	0.50%	0.50%
Convertible per share (in Euro per share) | € / shares		€ 1
Debt discount | €						€ 13,064		€ 13,064
Convertible debt related party	$ 31,719	€ 30,000	$ 32,181	€ 30,000

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Convertible Debt (Details)					9 Months Ended		12 Months Ended
	Jun. 28, 2023 USD ($)	Aug. 03, 2021	Nov. 30, 2017 USD ($)	Nov. 30, 2017 EUR (€)	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2023 EUR (€) shares	Dec. 31, 2022 USD ($)	Dec. 31, 2022 EUR (€)	Dec. 31, 2020 USD ($)	Dec. 31, 2020 EUR (€)	Dec. 31, 2019 USD ($)	Dec. 31, 2019 EUR (€)	Sep. 26, 2023 USD ($)
Convertible Debt [Line Items]
Loan agreements total									$ 467,154	€ 417,133	$ 467,154	€ 417,133
Convertible loan percentage			4.25%	4.25%
Convertible loan amount					$ 42,439	€ 40,139	$ 40,057	€ 40,139
Commitment amount	$ 50,000,000
Principal amount percentage	92.00%								3.50%	3.50%
Principal amount	$ 5,500,000
Net of discount	$ 5,060,000												$ 5,060,000
Second promissory note amount					$ 5,008,000								$ 5,500,000
Average percentage					92.00%	92.00%
Floor price per share (in Dollars per share) | $ / shares					$ 2
Redemption premium percentage					8.00%	8.00%
Floor price percentage		62.00%
Commitment fee					$ 250,000
Ordinary shares issued for commitment fee (in Shares) | shares					54,428	54,428
Original issue discount					$ 440,000
Loan amount					(1,015,939)	€ 3,000,000
Balance of fair value					$ 7,207,000
Bottom of range [member]
Convertible Debt [Line Items]
Promissory notes interest percentage					15.00%	15.00%
Conversion price (in Dollars per share) | $ / shares					$ 2.7
Top of range [member]
Convertible Debt [Line Items]
Promissory notes interest percentage					8.00%	8.00%
Conversion price (in Dollars per share) | $ / shares					$ 4.17
Monthly Payment [Member]
Convertible Debt [Line Items]
Redemption premium					$ 550,000
Redemption premium percentage					8.00%	8.00%
Monthly Payment [Member] | Bottom of range [member]
Convertible Debt [Line Items]
Floor price percentage					10.00%	10.00%
Monthly Payment [Member] | Top of range [member]
Convertible Debt [Line Items]
Floor price percentage					50.00%	50.00%
Convertible Promissory Notes [Member]
Convertible Debt [Line Items]
Initial promissory note amount					$ 5,060,000
Convertible Loans [Member]
Convertible Debt [Line Items]
Loan agreements total			$ 92,007	€ 80,278
Conversion Price [Member]
Convertible Debt [Line Items]
Initial promissory note amount					$ 4.9986
Average percentage					110.00%	110.00%
Initial Promissory Note [Member]
Convertible Debt [Line Items]
Face value					$ 5,500,000
Fair value					$ 87,000

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Convertible Debt (Details) - Schedule of Changes in the Balance of the Convertible Notes	9 Months Ended
	Sep. 30, 2023 USD ($)
Schedule Of Changes In The Balance Of The Convertible Notes [Abstract]
Balance at December 31, 2022
Balance at December 31, 2022
Balance at September 30, 2023	8,000,000
Balance at September 30, 2023	7,207,000
Issuance of convertible promissory notes	11,000,000
Issuance of convertible promissory notes	10,120,000
Repayments of debt
Repayments of debt
Conversion of notes with ordinary shares	(3,000,000)
Conversion of notes with ordinary shares	(3,000,000)
Change in fair value of convertible promissory notes
Change in fair value of convertible promissory notes	$ 87,000

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Convertible Debt (Details) - Schedule of Significant Inputs into the Fair Value of the Promissory Notes	9 Months Ended
	Sep. 30, 2023 $ / shares
Minimum [Member]
Schedule of Significant Inputs into the Fair Value of the Promissory Notes [Line Items]
Stock price (in Dollars per share)	$ 2.92
Expected life in years	8 months 26 days
Risk free rate	5.32%
Expected volatility	74.65%
Discount rate	78.54%
Maximum [Member]
Schedule of Significant Inputs into the Fair Value of the Promissory Notes [Line Items]
Stock price (in Dollars per share)	$ 4.82
Expected life in years	1 year
Risk free rate	5.57%
Expected volatility	75.00%
Discount rate	82.88%

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Silent Partnerships (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2020 USD ($)	Dec. 31, 2020 EUR (€) € / shares	Dec. 31, 2010 USD ($)	Dec. 31, 2010 EUR (€)	Jun. 28, 2023
Silent Partnerships [Line Items]
Silent partnership agreements description	the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR299,400 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs has the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs was determined to be EUR218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs of EUR81,280 ($92,774) has been recognized as government grant income during the period. During the year ended December 31, 2021 the Company received the remaining EUR200,000 ($236,640). The initial fair value of the 3.0% SPAs received was determined to be EUR230,000 (approximately $272,136), determined using an estimated effective interest rate of 11.5%. The initial fair value of the 3.0% SPAs received in 2021 was determined to be EUR156,549 (approximately $185,229), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3.0% SPAs received in 2021 of EUR43,451 (approximately $51,410) has been recognized as government grant income during the period
Agreed to lend a total		$ 57,071	€ 50,000	$ 343,830	€ 300,000
Convertible to common shares percentage			3.50%	8.00%	8.00%
Interest rate per annum			3.50%	8.00%	8.00%
Net income percent			0.50%
Per share (in Euro per share)			€ 1
Principal amount percentage			3.50%			92.00%
Net income percent				1.95%	1.95%
Additional payment percentage				30.00%	30.00%
Initial fair value rate				8.00%	8.00%
Initial fair value amount				$ 332,254	€ 289,900
SPAs [Member]
Silent Partnerships [Line Items]
Silent partnership agreements description	Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totaling EUR798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR398,634 (approximately $408,496) of the loans by June 30, 2023 (such amounts were paid between the end of June and the beginning of July 2023) and EUR400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366 (approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration, and the Company recognized a gain on the extinguishment of $8,214.
Convertible to common shares percentage			3.50%	8.00%	8.00%
Interest rate per annum			3.50%	11.50%	11.50%

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Silent Partnerships (Details) - Schedule of Continuity of the Company’s Silent Partnerships	9 Months Ended
	Sep. 30, 2023 USD ($)
Schedule of continuity of the company’s silent partnerships [Line Items]
Balance beginning	$ 1,908,549
Issued during the year
Extinguished during the year	(934,872)
Debt forgiveness	(48,735)
Accretion	52,274
Effects of currency translation	(5,300)
Balance ending	971,916
3% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Line Items]
Balance beginning	537,359
Issued during the year
Extinguished during the year
Debt forgiveness
Accretion	31,412
Effects of currency translation	(8,460)
Balance ending	560,311
3.5% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Line Items]
Balance beginning	43,938
Issued during the year
Extinguished during the year
Debt forgiveness
Accretion	2,528
Effects of currency translation	(691)
Balance ending	45,775
8.5% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Line Items]
Balance beginning	909,703
Issued during the year
Extinguished during the year	(512,502)
Debt forgiveness	(48,735)
Accretion	17,521
Effects of currency translation	(157)
Balance ending	365,830
8% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Line Items]
Balance beginning	417,549
Issued during the year
Extinguished during the year	(422,370)
Debt forgiveness
Accretion	813
Effects of currency translation	4,008
Balance ending

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Equity (Details)	9 Months Ended		12 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares € / shares shares	Dec. 31, 2022	Dec. 31, 2021 USD ($) shares
Equity [Line Items]
Ordinary shares authorized	45,000,000	45,000,000
Vote per share	one
Share capital per share. (in Euro per share) | € / shares		€ 0.01
Ordinary shares at market prices			3.00%
Ordinary shares pursuant	307,365
Aggregate proceeds per share (in Dollars per share) | $ / shares	$ 1,894,742	€ 1,894,742
Net of fees and expenses (in Dollars) | $	$ 6.16
Ordinary shares issued for services	134,500	134,500
Exercise of warrants shares	305,771
Ordinary shares issued for commitment fee	54,428
Convertible promissory note (in Dollars) | $	$ 250,000
Ordinary shares issued for acquisition	300,000
Intangible assets value (in Dollars) | $	$ 2,055,000	€ 2,055,000
ordinary shares issued to conversion debt	1,015,939
Conversion of debt (in Dollars) | $	$ 250,000
Warrants issued				3,755,000
Underwriting warrants				161,000
Underwriting warrant in amount (in Dollars) | $				$ 754,286
Granted shares	332,500
Stock options (in Dollars) | $	$ 1,174,201
Share-based compensation (in Dollars) | $	$ 2,432,948
Description of unexercised warrant maturity	Unexercised warrants were to expire in November 2023
Controlled Equity Offering [Member]
Equity [Line Items]
Ordinary shares value (in Dollars) | $	$ 503,690	€ 503,690
Stock Option [Member]
Equity [Line Items]
Ordinary shares	3,100,000	3,100,000
Unamortized expense (in Dollars) | $	$ 3,856,598	€ 3,856,598
Ordinary shares [member]
Equity [Line Items]
Conversion of debt (in Dollars) | $	$ 3,000,000

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Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2021
Warrants [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Exercise price (in Dollars per share)		$ 3
Expected dividend yield (in Dollars)		$ 0
Warrants [Member] | Bottom of range [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Stock price at time of issuance (in Dollars)		$ 0.283
Expected term		2 years
Expected average volatility		75.00%
Risk-free interest rate		0.16%
Warrants [Member] | Top of range [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Stock price at time of issuance (in Dollars)		$ 1.602
Expected term		5 years
Expected average volatility		95.00%
Risk-free interest rate		1.08%
Stock Options [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Expected dividend yield (in Dollars)
Stock Options [Member] | Bottom of range [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Exercise price (in Dollars per share)	$ 4.09
Expected term	5 years 3 months
Expected average volatility	70.00%
Risk-free interest rate	3.48%
Stock Options [Member] | Top of range [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Exercise price (in Dollars per share)	$ 7.02
Expected term	7 years
Expected average volatility	76.00%
Risk-free interest rate	4.27%

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Equity (Details) - Schedule of Activity	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Warrants [Member]
Schedule of Activity [Line Items]
Outstanding, Beginning Balance | shares	3,247,500
Weighted-Average Exercise Price, Beginning Balance | $ / shares	$ 3
Weighted-Average Life (years), Beginning Balance	5 months 8 days
Outstanding, Grants | shares
Weighted-Average Exercise Price, Grants | $ / shares
Weighted-Average Life (years), Grants
Outstanding, Exercised | shares	(816,667)
Weighted-Average Exercise Price, Exercised | $ / shares	$ 3
Weighted-Average Life (years), Exercised
Outstanding, Expired | shares
Weighted-Average Exercise Price, Expired | $ / shares
Weighted-Average Life (years), Expired
Outstanding, Ending Balance | shares	2,430,833
Weighted-Average Exercise Price, Ending Balance | $ / shares	$ 3
Weighted-Average Life (years), Ending Balance	1 year 1 month 9 days
Stock Option [Member]
Schedule of Activity [Line Items]
Outstanding, Beginning Balance | shares	2,394,150
Weighted-Average Exercise Price, Beginning Balance | $ / shares	$ 7.18
Weighted-Average Life (years), Beginning Balance	9 years 1 month 9 days
Outstanding, Grants | shares	332,500
Weighted-Average Exercise Price, Grants | $ / shares	$ 4.93
Weighted-Average Life (years), Grants	10 years
Outstanding, Exercised | shares
Weighted-Average Exercise Price, Exercised | $ / shares
Weighted-Average Life (years), Exercised
Outstanding, Forfeited | shares	(47,092)
Weighted-Average Exercise Price, Forfeited | $ / shares	$ 6.48
Weighted-Average Life (years), Forfeited
Outstanding, Expired | shares
Weighted-Average Exercise Price, Expired | $ / shares
Weighted-Average Life (years), Expired
Outstanding, Ending Balance | shares	2,679,558
Weighted-Average Exercise Price, Ending Balance | $ / shares	$ 6.96
Weighted-Average Life (years), Ending Balance	8 years 7 months 2 days
Outstanding, Ending Balance | shares	1,626,816
Weighted-Average Exercise Price, Ending Balance | $ / shares	$ 6.12
Weighted-Average Life (years), Ending Balance	8 years 2 months 1 day

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Related Party Transactions (Details) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Related Party Transactions [Line Items]
Incurred interest expense	$ 25,017	$ 24,426
Incurred accretion expense	8,752	11,553
Recorded expenses	$ 52,731	$ 97,924

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Related Party Transactions (Details) - Schedule of Remuneration of Directors and Key Management Personnel - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Schedule of Remuneration of Directors and Key Management Personnel [Abstract]
Salaries and benefits	$ 627,988	$ 468,050

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Related Party Transactions (Details) - Schedule of Remuneration Paid to Related Parties - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Schedule of Remuneration Paid to Related Parties [Abstract]
Salaries and benefits	$ 14,902	$ 64,055

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Government Grants (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Government Grants [Abstract]
Antibody-based pathogens	$ 6,604
Multi-marker test		$ 81,706

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Government Grants (Details) - Schedule of Research and Development - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Schedule of Research and Development [Abstract]
Rapid detection of antibody-based pathogens		$ 42,055
Multi-marker test for the early detection of pancreatic cancer	$ 27,696	108,999
Total research and development projects	$ 27,696	$ 151,054

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Financial Instrument Risk Management (Details)	9 Months Ended
	Sep. 30, 2023 USD ($)	Sep. 30, 2023 EUR (€)	Sep. 30, 2022 USD ($)
Financial Instrument Risk Management [Abstract]
Federal insured limit	$ 250,000	€ 100,000
Bad debt expense	95,340		$ 0
Unrestricted cash	9,320,381
Current liabilities	$ 6,921,813
Foreign exchange risk, description	As the Company operates in Germany it holds a portion of its cash balances in Euro to approximate its estimated short term operating needs. The remainder of the Company’s cash is held in U.S. Dollars, the Company’s reporting currency, which we also expect to be the currency of the Company’s largest cash outlays over the next twenty-four months.	As the Company operates in Germany it holds a portion of its cash balances in Euro to approximate its estimated short term operating needs. The remainder of the Company’s cash is held in U.S. Dollars, the Company’s reporting currency, which we also expect to be the currency of the Company’s largest cash outlays over the next twenty-four months.

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Financial Instrument Risk Management (Details) - Schedule of Contractual Maturities Financial Liabilities	Sep. 30, 2023 USD ($)
Within one year [Member]
Schedule of Contractual Maturities Financial Liabilities [Line Items]
Accounts payable and accrued liabilities	$ 3,104,456
Convertible promissory note to be settled with ordinary shares	7,207,000
Convertible loans	74,158
Lease liabilities	474,011
Intellectual property acquisition liability - related party	400,854
Total	11,260,479
More than one year [Member]
Schedule of Contractual Maturities Financial Liabilities [Line Items]
Accounts payable and accrued liabilities
Convertible promissory note to be settled with ordinary shares
Convertible loans
Silent partnerships	971,916
Lease liabilities	923,705
Intellectual property acquisition liability - related party	796,664
Total	2,692,285
More than five years [Member]
Schedule of Contractual Maturities Financial Liabilities [Line Items]
Accounts payable and accrued liabilities
Convertible promissory note to be settled with ordinary shares
Convertible loans
Silent partnerships
Lease liabilities	504,663
Intellectual property acquisition liability - related party
Total	$ 504,663

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Concentrations (Details)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Concentrations [Abstract]
Annual revenues percentage	10.00%
Revenue percentage	18.00%	81.00%

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Operating Expenses (Details) - Schedule of Operating Expenses - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Research and development [Member]
Schedule of Operating Expenses [Line Items]
Payroll expenses	$ 2,969,663	$ 994,087
Clinical study expenses	3,322,251	597,439
Amortization of intangibles	342,075
Travel expenses	140,839	29,795
Lab consumables	73,238	13,096
Lab overhead and other expenses	743,102	68,074
Research and development total	7,591,168	1,702,491
Sales and marketing [Member]
Schedule of Operating Expenses [Line Items]
Payroll expenses	1,021,828	248,263
Consulting services	1,630,346	198,372
Product and brand advertising	2,478,919	2,924,084
Other expenses	76,702	23,139
Sales and marketing total	5,207,795	3,393,858
General and administrative [Member]
Schedule of Operating Expenses [Line Items]
Payroll expenses	1,560,706	1,531,427
Stock option expense	2,432,948	7,479,767
Depreciation and amortization	395,087
Travel expenses	87,947	189,130
Consulting services	1,998,633	2,884,688
IT expense	171,560
Training	17,052	6,365
Insurance and taxes	640,530	751,805
Rent and premises	115,124	129,203
Other expenses	210,659	132,181
General and administrative total	$ 7,630,246	$ 13,104,566

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Subsequent Events (Details) - USD ($)			9 Months Ended
	Jan. 31, 2022	Nov. 13, 2013	Sep. 30, 2023
Subsequent Events [Line Items]
Converted in principal value (in Dollars)			$ 500,000
Issuance of ordinary shares			243,080
Ordinary share issued	1,725,000
Major ordinary share transactions [member]
Subsequent Events [Line Items]
Purchase ordinary shares (in Dollars)		$ 5,000,000
Ordinary share price (in Dollars per share)		$ 1.2
Ordinary share issued		4,166,667
Aggregate shares		4,166,667
Issuance price per share (in Dollars per share)		$ 1.2