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 three months ended June 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 August 15, 2023, Mainz Biomed N.V. made available its Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and six months ended June 30, 2023. A copy of the report is attached hereto as Exhibit 99.1.

On August 15, 2023, Mainz Biomed N.V. made available its unaudited Financial Statements for the three and six months ended June 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 August 15, 2023, announcing the Company’s results for the three and six months ended June 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).

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 six months ended June 30, 2023
99.2	Unaudited Financial Statements of Mainz Biomed N.V. as of and for the three and six months ended June 30, 2023
99.3	Press Release dated August 15, 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).

1

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 15, 2023	By:	/s/ William J. Caragol
	Name:	William J. Caragol
	Title	Chief Financial Officer

2

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 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 June 30, 2023 and 2022

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

	Three Months Ended June 30,
	2023			2022			Change			% Change
Revenue	$	248,945		$	139,240		$	109,705			79	%
Cost of revenue	$	100,147		$	58,427		$	41,720			71	%
Gross profit	$	148,798		$	80,813		$	67,985			84	%
Gross margin		60	%		58	%
Research and development	$	3,478,595		$	229,916		$	3,248,679			1,413	%
Sales and marketing	$	1,799,569		$	1,866,384		$	(66,815	)		(4	)%
General and administrative	$	2,796,724		$	4,932,422		$	(2,135,698	)		(43	)%
Total operating expenses	$	8,074,888		$	7,028,722		$	1,046,166			15	%
Loss from operations	$	(7,926,090	)	$	(6,947,909	)	$	(978,181	)		(14	)%
Other income (expense)	$	(325,637	)	$	9,198		$	(334,835	)		(3,640	)%
Net loss	$	(8,251,727	)	$	(6,938,711	)	$	(1,313,016	)		(19	)%
Total comprehensive loss	$	(8,341,751	)	$	(6,892,507	)	$	(1,449,244	)		(21	)%
Basic and dilutive loss per common share	$	(0.56	)	$	(0.48	)	$	(0.08	)		(17	)%
Weighted average number of common shares outstanding – basic and diluted		14,915,905			14,286,157

Revenue

Revenue for the three months ended June 30, 2023 was $248,945 as compared to $139,240 for the three months ended June 30, 2022, an increase of 79%. This increase was attributable to 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 June 30, 2023 was $100,147 as compared to $58,427 for the three months ended June 30, 2022, a 71% increase. This increase was the result of increased ColoAlert sales volume.

Gross profit

Gross profit increased to $148,798 in the three months ended June 30, 2023 compared to $80,813, for the three months ended June 30, 2022. This gross profit increase, resulting in an improvement of gross margin from 58% to 60%, was attributable to improved profits resulting from lowered unit cost of goods sold with attributable to economies of scale from increased volumes.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2023, were $3,478,595 compared to $229,916 for the three months ended June 30, 2022, an increase of $3,248,679. This increase was driven by the cost of our ColoFuture and eAArlyDetect feasibility studies in the U.S. and in Europe. During the three months ended June 30, 2023, clinical study expenses increased $1,831,286 from the comparable period in 2022. Additionally, our increased staffing resulted in higher labor costs, which increased by $668,020 for the three months ended June 30, 2023, compared to the same period in 2022. Increased labor expenses are the result of our continued development of our ColoAlert product and research related to our PancAlert product candidate. As a result of our increased lab capacity and overhead, our lab expenses increased by $495,050 for the three months ended June 20, 2023 compared to the comparable period of 2022.

Sales and Marketing Expenses

Sales and marketing expenses for the three months ended June 30, 2023, were $1,799,569 compared to $1,866,384 for the three months ended June 30, 2022, a decrease of $66,815. This net decrease was the result of an increase in labor costs (salary and consulting) to support the sale of our ColoAlert product of $709,191 and a decrease in advertising expenses of $812,238 in the three months ended June 30, 2023 compared to the comparable period in 2022.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2023 were $2,796,724 compared to $4,932,422 for the three months ended June 30, 2022, a decrease of $2,135,698. The decreased expenses were primarily the result of a decrease of $1,266,730 of non-cash stock option expense, and decreased salary and consulting costs of $854,651, related to legal, banking, and accounting fees primarily related to our capital raising efforts in the first half of 2022.

Other Expense

Other expense, net for the three months ended June 30, 2023 was $325,637 compared to income of $9,198 for the three months ended June 30, 2022, resulting in increased other expenses (net) of $334,835. This increase was primarily the result of commitment fees and expenses related to our June 28, 2023 financing of $280,000.

Comparison of the Six Months Ended June 30, 2023 and 2022

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

	Six Months Ended June 30,
	2023			2022			Change			% Change
Revenue	$	499,049		$	239,805		$	259,244			108	%
Cost of revenue	$	211,310		$	112,563		$	98,747			88	%
Gross profit	$	287,739		$	127,242		$	160,497			126	%
Gross margin		58	%		53	%
Research and development	$	5,736,373		$	793,488		$	4,942,885			623	%
Sales and marketing	$	4,085,661		$	2,788,014		$	1,297,647			47	%
General and administrative	$	4,879,351		$	9,125,207		$	(4,245,856	)		(47	)%
Total operating expenses	$	14,701,385		$	12,706,709		$	1,994,676			16	%
Loss from operations	$	(14,413,646	)	$	(12,579,467	)	$	(1,834,179	)		(15	)%
Other expense	$	(398,997	)	$	(22,980	)	$	(376,017	)		(1,636	)%
Net loss	$	(14,812,643	)	$	(12,602,447	)	$	(2,210,196	)		(18	)%
Total comprehensive loss	$	(14,963,239	)	$	(12,519,804	)	$	(2,443,435	)		(20	)%
Basic and dilutive loss per common share	$	(1.01	)	$	(0.91	)	$	(0.09	)		(10	)%
Weighted average number of common shares outstanding – basic and diluted		14,803,243			13,821,914

2

Revenue

Revenue for the six months ended June 30, 2023 was $499,049 as compared to $239,805 for the six months ended June 30, 2022, an increase of 108%. This increase was primarily attributable to 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 six months ended June 30, 2023 was $211,310 as compared to $112,563 for the six months ended June 30, 2022, an 88% increase. This increase was the result of increased ColoAlert sales volume.

Gross profit

Gross profit increased to $287,739 in the six months ended June 30, 2023 compared to $127,242, for the six months ended June 30, 2022. This gross profit increase, resulting in an improvement of gross margin from 53% to 58%, 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 six months ended June 30, 2023 were $5,736,373 compared to $793,488 for the six months ended June 30, 2022, an increase of $4,942,885. This increase was driven by the cost of our ColoFuture and eAArly Detect feasibility studies in the U.S. and in Europe. During the six months ended June 30, 2023, clinical study expenses increased $2,648,449 from the comparable period in 2022. Additionally, our increased staffing resulted in higher labor costs, which increased by $1,471,466 for the six months ended June 30, 2023, compared to the same period in 2022. Increased labor expenses are the result of our continued development of our ColoAlert product and research related to our PancAlert product candidate. As a result of our increased lab capacity and overhead, our lab expenses increased by $463,078 for the six months ended June 30, 2023 compared to the comparable period of 2022.

Sales and Marketing Expenses

Sales and marketing expenses for the six months ended June 30, 2023, were $4,085,661 compared to $2,788,014 for the six months ended June 30, 2022, an increase of $1,297,647. This increase was related to labor costs (salary and consulting) to support the sale of our ColoAlert product, which increased by $1,356,980 for the six months ended June 30, 2023 compared to the comparable period of 2022.

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2023 were $4,879,351 compared to $9,125,207 for the six months ended June 30, 2022, a decrease of $4,245,856. The decreased expenses were primarily the result of a decrease of $3,225,777 of non-cash stock option expense, and decreased salary and consulting costs of $1,068,694, related to legal, banking, and accounting fees primarily related to our capital raising efforts in the first half of 2022.

Other Expense

Other expense, net for the six months ended June 30, 2023 was $398,997 compared to $22,980 for the six months ended June 30, 2022, resulting in increased other expenses (net) of $376,017. This increase was primarily the result of commitment fees and expenses related to our June 28, 2023 financing of $280,000, and other income from a government grant program under which we earned $36,288 in the six months ended June 30, 2022, which program ended during 2022.

3

Liquidity and Capital Resources

Our principal liquidity requirements are for working capital and operating losses. We fund our liquidity requirements primarily through cash on hand, cash flows from operations and, debt and equity financing. As of June 30, 2023, we had $10,911,087 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:

	Six Months Ended June 30,
	2023			2022			Change
Cash used in operating activities	$	(10,778,125	)	$	(6,456,904	)	$	(4,321,221	)
Cash used in investing activities	$	(1,524,555	)	$	(252,446	)	$	(1,272,109	)
Cash provided by financing activities	$	6,192,507		$	24,091,651		$	(17,899,144	)

Cash Flow from Operating Activities

For the six months ended June 30, 2023, cash flows used in operating activities was $10,778,126 compared to $6,456,904 used during the six months ended June 30, 2022. The increase in cash flows used in operating activities of $4,321,221 was primarily the result of our operating loss for the six months ended June 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 $2,648,449 in the six months ended June 30, 2023 compared to the six months ended June 30, 2022.

Cash Flows from Investing Activities

During the six months ended June 30, 2023, we used $1,524,555 in investing activities compared to $252,446 used during the six months ended June 30, 2022. The increase in cash flows used in investing activities of $1,272,109 was the result of increased capital expenditures of $772,109 related to the expansion of our office and lab space, and the payment of $500,000 for the first installment related to the purchase of our ColoAlert intellectual property in February of 2023.

Cash Flows from Financing Activities

During the six months ended June 30, 2023, we had cash flow provided by financing activities of $6,192,507 compared to cash flow provided by financing activities of $24,091,651 for the six months ended June 30, 2022, a decrease of $17,899,144. This decrease was primarily the result of our sale of 1,725,000 ordinary shares on January 28, 2022, for net proceeds of $23,865,6,890, and the issuance of a convertible note on June 28, 2023, for net proceeds of $5,060,000.

Working Capital Discussion

We had recurring losses, accumulated deficit totaling $57,844,937 and negative cash flows used in operating activities of $10,778,125 as of and for the six months ended June 30, 2023. We also had $10,911,087 of cash on hand on June 30, 2023, and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,431,978.

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 six months ended June 30, 2023. Additionally, on June 28, 2023, we entered into a Pre-Paid Advance Agreement and issued a $5.5 million convertible promissory note, for net proceeds of $5.1 million.

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.

4

Critical Accounting Policies and Significant Judgments and Estimates

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

We believe our most critical accounting policies and estimates relate to the following:

● Revenue Recognition

● Foreign Currency Translation

● Stock Option Compensation

● Lease Accounting

● 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, as determined by our management, is the Euro (EUR).

Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.

Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.

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

Our reporting currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.

Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).

5

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.

Lease Accounting

We assess at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. We apply a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.

At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by us and payments of penalties for terminating the lease, if the lease term reflects us exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, we use our incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.

We recognize right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.

6

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 the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition we can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if we have opted to measure them at FVTPL.

(b) Measurement

Financial assets and liabilities at amortized cost

Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.

Financial assets and liabilities at FVTPL

Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.

Debt investments at FVTOCI

These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.

Equity investments at FVTOCI

These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.

7

EX-99.2

Exhibit 99.2

Mainz Biomed N.V.

Condensed Interim Consolidated Statements of Financial Position

(Unaudited)

(Expressed in US Dollars).

			June 30,			December 31,
	Note		2023			2022
ASSETS
Current Assets
Cash			$	10,911,087		$	17,141,775
Trade and other receivables, net		4		370,931			259,138
Inventories				387,178			175,469
Prepaid expenses		5		455,934			801,959
Total current assets				12,125,130			18,378,341
Property and equipment, net		6		1,617,228			661,692
Intangible assets		7		3,630,384			-
Right-of-use assets		8		1,932,258			1,177,695
Other assets				106			23,275
Total assets			$	19,305,106		$	20,241,003
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued liabilities		9	$	4,326,662		$	2,916,679
Convertible loan		11		43,637			43,057
Convertible promissory note at fair value		11		5,015,000			-
Convertible debt - related party		10		32,615			32,181
Silent partnership		12		211,994			759,168
Silent partnership - related party		12		211,994			206,167
Payable for acquisition of intangible asset current portion – related party		7		393,483			-
Lease liabilities		8		472,767			285,354
Total current liabilities				10,708,152			4,242,606
Silent partnerships		12		721,137			687,128
Silent partnerships - related party		12		263,324			256,086
Lease liabilities		8		1,560,408			959,116
Intellectual property acquisition liability - related party		7		874,698			-
Total liabilities				14,127,719			6,144,936
Shareholders’ equity
Share capital		13		175,785			164,896
Share premium		13		43,212,004			38,831,542
Reserve		13		19,732,949			18,079,741
Accumulated deficit				(57,844,937	)		(43,032,294	)
Accumulated other comprehensive income (loss)				(98,414	)		52,182
Total shareholders’ equity				5,177,387			14,096,067
Total liabilities and shareholders’ equity			$	19,305,106		$	20,241,003

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

Mainz Biomed N.V.

Condensed Interim Consolidated Statements of Profit and Loss and Comprehensive Loss

(Unaudited)

(Expressed in US Dollars)

			Three months ended						Six months ended
			June 30,						June 30,
	Note		2023			2022			2023			2022
Revenue			$	248,945		$	139,240		$	499,049		$	239,805
Cost of revenue		14		100,147			58,427			211,310			112,563
Gross profit				148,798			80,813			287,739			127,242
Operating expenses:
Sales and marketing		19		1,799,569			1,866,384			4,085,661			2,788,014
Research and development		19		3,478,595			229,916			5,736,373			793,488
General and administrative		19		2,796,724			4,932,422			4,879,351			9,125,207
Total operating expenses				8,074,888			7,028,722			14,701,385			12,706,709
Loss from operations				(7,926,090	)		(6,947,909	)		(14,413,646	)		(12,579,467	)
Other income (expense)
Other income		16		107,143			17,601			170,968			92,932
Other expense				(432,780	)		(8,403	)		(569,965	)		(115,912	)
Total other income (expense)				(325,637	)		9,198			(398,997	)		(22,980	)
Loss before income tax				(8,251,727	)		(6,938,711	)		(14,812,643	)		(12,602,447	)
Income taxes provision				-			-			-			-
Net loss			$	(8,251,727	)	$	(6,938,711	)	$	(14,812,643	)	$	(12,602,447	)
Foreign currency translation gain (loss)				(90,024	)		46,204			(150,596	)		82,643
Comprehensive loss			$	(8,341,751	)	$	(6,892,507	)	$	(14,963,239	)	$	(12,519,804	)
Basic and dilutive loss per ordinary share			$	(0.56	)	$	(0.48	)	$	(1.01	)	$	(0.91	)
Weighted average number of ordinary shares outstanding				14,915,905			14,286,157			14,803,243			13,821,914

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

2

Mainz Biomed N.V.

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

(Unaudited)

(Expressed in US Dollars)

For the Three and Six months ended June 30, 2023

															Accumulated			Total
			Number of		Share		Share					Accumulated			Other Comprehensive			Shareholders’ Equity
	Note		Shares		Capital		Premium		Reserve			Deficit			Income (loss)			(Deficit)
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		13		195,044		2,094		1,281,291		-			-			-			1,283,385
Share based expenses		13		2,112		22		14,741		-			-			-			14,763
Stock option expense		13		-		-		-		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		13		112,321		1,224		608,587		-			-			-			609,811
Share based expenses		13		32,388		353		162,574		-			-			-			162,927
Ordinary shares issued for acquisition of intangible asset		7, 13		300,000		3,270		2,051,730		-			-			-			2,055,000
Ordinary shares issued for commission of issuance of convertible debt		11, 13		54,428		593		249,407		-			-			-			250,000
Ordinary shares issued for cashless exercise of warrants		13		305,771		3,333		12,132		(15,465	)		-			-			-
Stock option expense		13		-		-		-		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

3

Mainz Biomed N.V.

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

(Unaudited)

(Expressed in US Dollars)

For the Three and Six months ended June 30, 2022

													Accumulated		Total
	Number of		Share		Share					Accumulated			Other Comprehensive		Shareholders’ Equity
	Shares		Capital		Premium		Reserve			Deficit			Income (loss)		(Deficit)
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
Share based expense		-		-		-		2,469,549			-			-		2,469,549
Stock option expense		-		-		-		-			-			-		-
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

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

4

Mainz Biomed N.V.

Condensed Interim Consolidated Statements of Cash Flows

(Unaudited)

(Expressed in US Dollars)

			Six months ended
			June 30,
	Note		2023			2022
Cash Flows From Operating Activities
Net loss			$	(14,812,643	)	$	(12,602,447	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Share based compensation		13		2,096,363			5,682,070
Depreciation and amortization				458,368			62,369
Bad debt expense				53,295			470
Accretion expense		7,12		88,759			40,697
Change in fair value of convertible debt				(45,000	)		-
Changes in operating assets and liabilities:
Trade and other receivables				58,898			(47,371	)
Inventory				(208,367	)		(38,269	)
Prepaid expenses and other assets				372,018			332,078
Accounts payable and accrued liabilities				1,161,515			113,499
Deferred revenue				(1,331	)		-
Net cash used in operating activities				(10,778,125	)		(6,456,904	)
Cash Flows From Investing Activities
Purchase of intangible asset				(500,000	)		-
Purchase of property and equipment		6		(1,024,555	)		(252,446	)
Net cash used in investing activities				(1,524,555	)		(252,446	)
Cash Flows From Financing Activities
Sale of ordinary shares		13		1,894,742			23,865,890
Warrant exercise proceeds				-			382,500
Proceeds from issuance of convertible debt				5,060,000			-
Repayment of loans payable				(560,755	)		(111,049	)
Payment of lease obligations		8		(201,480	)		(45,690	)
Net cash provided by financing activities				6,192,507			24,091,651
Effect of changes in exchange rates				(120,515	)		(103,234	)
Net change in cash				(6,230,688	)		17,279,067
Cash at beginning of period				17,141,775			8,727,542
Cash at end of period			$	10,911,087		$	26,006,609
Non-Cash Investing And Financing Activities
Right of use asset additions		8	$	969,813		$	-
Acquisition of intangible asset for payable and stock payable		7	$	3,271,828		$	-
Interest expense paid			$	104,822		$	-

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

5

Mainz Biomed N.V.

Notes to the Condensed Interim Consolidated Financial Statements

(Unaudited)

(Expressed in US dollars)

June 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”, “PG”)). 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 consolidated financial statements, Mainz Biomed N.V. and its wholly owned subsidiaries, Mainz Biomed USA, Inc. and Mainz Biomed GmbH (f/k/a PharmGenomics 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 $57,844,937 and negative cash flows used in operating activities of $10,778,125 as of and for the six months ended June 30, 2023. The Company also had $10,911,087 of cash on hand on June 30, 2023 and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,431,978. 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 13); the Company raised $1.9 million of net cash from this facility during the six months ended June 30, 2023. Additionally, on June 28, 2023, the Company entered into a Pre Paid Advance Agreement and issued a $5.5 million convertible promissory note (see Note 11) for net proceeds of $5.1 million.

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.

COVID-19 Impact

On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions and the severity and frequency of new strains of the coronavirus. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.

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 August 11, 2023.

NOTE 3. ACCOUNTING POLICIES, ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS

Inventories

Inventories are measured at the lower of cost and net realizable value. The cost of inventories is based on a weighted average cost and includes expenditure incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses.

7

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

Estimates of the useful lives of property and equipment 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 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 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.

8

Estimating the fair value of financial instruments

When the Company recognizes a financial instrument, where there is no active market for such 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;

● 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 AND OTHER RECEIVABLES

	June 30,			December 31,
	2023			2022
Accounts receivable	$	145,681		$	130,588
Less: allowance for doubtful accounts		(50,241	)		(66,852	)
Accounts receivable, net		95,440			63,736
VAT receivable, net		275,491			192,154
Other		-			3,248
	$	370,931		$	259,138

For the six months ended June 30, 2023, the Company recorded bad debt reserve of $53,295 for VAT receivable.

NOTE 5. PREPAID AND OTHER CURRENT ASSETS

	June 30,		December 31,
	2023		2022
Prepaid insurance	$	213,045	$	624,033
Other prepaid expense		109,879		55,356
Security deposit		133,010		122,570
	$	455,934	$	801,959

9

NOTE 6. PROPERTY AND EQUIPMENT

	Laboratory equipment		Office equipment		Construction in progress		Total
Cost
Balance at December 31, 2022	$	579,261	$	176,347	$	-	$	755,608
Additions		837,200		172,594		45,338		1,055,132
Disposal		-		-		-		-
Effects of currency translation		11,736		3,186		212		15,134
Balance at June 30, 2023	$	1,428,197	$	352,127	$	45,550	$	1,825,874
Accumulated depreciation
Balance at December 31, 2022	$	75,650	$	18,266	$	-	$	93,916
Depreciation		53,681		59,252		-		112,933
Disposal		-		-		-		-
Effects of currency translation		1,228		569		-		1,797
Balance at June 30, 2023	$	130,559	$	78,087	$	-	$	208,646
Net book value at June 30, 2022	$	503,611	$	158,081	$	-	$	661,692
Net book value at June 30, 2023	$	1,297,638	$	274,040	$	45,550	$	1,617,228

NOTE 7. 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 six months ended June 30, 2023 the Company paid $500,000 to the seller. The Company recorded amortization of $141,444 and interest expense of $51,354 for the six months ended June 30, 2023.

NOTE 8. LEASES

Right-of-Use Assets

The Company leases certain assets under lease agreements.

	Office		Laboratory				Lab and
	Equipment		Equipment		Vehicle		Office Space		Total
Cost
Balance as of December 31, 2022	$	64,226	$	362,970	$	94,008	$	1,035,200	$	1,556,404
Additions		-		331,544		51,757		588,881		972,182
Effects of currency translation		865		5,634		1,383		15,268		23,150
Balance as of June 30, 2023	$	65,091	$	700,148	$	147,148	$	1,639,349	$	2,551,736
Accumulated amortization
Balance as of December 31, 2022	$	20,707	$	77,838	$	22,109	$	258,055	$	378,709
Depreciation		6,050		93,569		26,421		109,100		235,140
Effects of currency translation		293		1,260		358		3,718		5,629
Balance as of June 30, 2023	$	27,050	$	172,667	$	48,888	$	370,873	$	619,478
Net book value at June 30, 2022	$	43,519	$	285,132	$	71,899	$	777,145	$	1,177,695
Net book value at June 30, 2023	$	38,041	$	527,481	$	98,260	$	1,268,476	$	1,932,258

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

10

The carrying amount of the right-of-use assets is amortized on a straight-line basis over the life of the leases, which at June 30, 2023, had an average expected life of 5 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		972,183
Interest expenses		92,575
Lease payments		(294,549	)
Effects of currency translation		18,496
Balance as of June 30, 2023	$	2,033,175

Lease liabilities	June 30, 2023		December 31, 2022
Current portion	$	472,767	$	285,354
Long-term portion		1,560,408		959,116
Total lease liabilities	$	2,033,175	$	1,244,470

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

Maturity analysis	June 30, 2023
Less than one year	$	317,745
One to two years		632,966
Two to three years		537,593
Three to four years		356,609
Four to five years		224,224
More than five years		501,319
Total undiscounted lease liabilities	$	2,570,456
Amount representing implicit interest		(537,281	)
Lease obligations	$	2,033,175

11

NOTE 9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

	June 30,		December 31,
	2023		2022
Accounts payable	$	2,743,514	$	1,333,044
Accrued liabilities		1,493,632		1,236,942
Payroll liabilities		89,516		346,693
	$	4,326,662	$	2,916,679

NOTE 10. 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. 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 June 30, 2023 and December 31, 2022, the Company’s Convertible Debt – Related Party is $32,615 (EUR30,000) and $32,181 (EUR30,000), respectively.

NOTE 11. 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. During the year ended December 31, 2019, principal in the amount of EUR5,000 ($5,597) was exchanged for the 2019 and 2020 Convertible Loans and EUR5,000 ($5,597) was extinguished as the lender elected to offset the debt amount against amounts in trade receivables due to the Company. 

Convertible Promissory Note

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. The Holder is not obligated to purchase any additional Promissory Notes from us under the PPA.

12

Each Promissory Notes 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 Note at fair value as of the June 28, 2023 issuance date. 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 has 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. For the period ended June 30, 2023, the Company recorded a change in fair value of $45,000, resulting in a balance of $5,015,000 as of June 30, 2023.

We classified this fair value as a Level 3 fair value measurement and used a fair value pricing model to calculate the fair value as of June 28, 2023 and June 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 Initial Promissory Note is as follows:

	June 28,			June 30,
	2023			2023
Stock price	$	4.82		$	4.78
Expected life in years		1			1
Risk free rate		5.32	%		5.40	%
Expected volatility		74.65	%		74.66	%
Discount rate		79.27	%		78.54	%

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NOTE 12. 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%.

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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		-		-		(138,747	)		(422,008	)		(560,755	)
Discount		-		-		-			-			-
Accretion		20,592		1,659		14,341			812			37,404
Interest expense		-		-		-			-			-
Effects of currency translation		7,335		599		11,670			3,647			23,251
Balance, June 30, 2023	$	565,286	$	46,196	$	796,967		$	-		$	1,408,449

NOTE 13. 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 six months ended June 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 six months ended June 30, 2023, the Company issued ordinary shares as follows:

● 34,500 ordinary shares issued for services rendered which were valued at $177,690

● 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

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 expire in November 2023.

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	%

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A summary of activity during the six months ended June 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 June 30, 2023		2,430,833		$	3.00		0.35

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 six months ended June 30, 2023, the Company granted 312,500 stock options valued at $1,072,612. Stock options with time-based vesting were valued using the Black-Scholes pricing model.

During the six months ended June 30, 2023, the Company recorded stock based compensation of $1,668,673 and had unamortized expense of $4,519,283 as of June 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 six months ended June 30, 2023, the estimated fair values of the stock options are as follows:

		June 30,
		2023
Exercise price	$	4.78 - 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 six months ended June 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		312,500			5.06		10.00
Exercised		-			-		-
Forfeited		(27,592	)		6.88		-
Expired		-			-		-
Balance as of June 30, 2023		2,679,058		$	6.97		8.80
Exercisable as of June 30, 2023		1,567,950		$	5.95		8.40

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NOTE 14. COST OF REVENUE

For the six months ended June 30, 2023 and 2022, cost of revenue consisted of test kit materials, both patient collection kits and lab based PCR kits.

NOTE 15. RELATED PARTY TRANSACTIONS

Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board, its Chief Executive Officer, Chief Financial Officer, Chief Operating Officer, Chief Commercial Officer and Chief Scientific Officer. The remuneration of directors and key management personnel during the six months ended June 30, 2023 and 2022 was as follows:

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	921,492	$	1,264,187

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

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	14,956	$	61,116

During the six months ended June 30, 2023 and 2022, the Company incurred interest expense of $16,664 and $16,838 on balances owing to related parties, respectively.

During the six months ended June 30, 2023 and 2022, the Company incurred accretion expense of $6,807 and $7,885 on balances owing to related parties, respectively.

During the six months ended June 30, 2023 and 2022, we recorded expenses of $52,264 and $126,173, 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 16. GOVERNMENT GRANTS

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

	Six months ended
	June 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	19,072
Multi-marker test for the early detection of pancreatic cancer		28,117		50,037
	$	28,117	$	69,109

As of June 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 $35,852 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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NOTE 17. FINANCIAL INSTRUMENT RISK MANAGEMENT

Basis of Fair Value

Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:

● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;

● Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and

● Level 3 — Inputs that are not based on observable market data.

The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.

The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.

Credit Risk

The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. 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 six months ended June 30, 2023, the Company incurred $53,295 (related to VAT receivables) 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 June 30, 2023, the Company had an unrestricted cash balance of $10,911,087 to settle current liabilities, excluding the Initial Promissory Note, which is expected to be settled in ordinary shares, of $6,475,516.

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.

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

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	4,326,662	$	-	$	-
Convertible promissory note to be settled with ordinary shares		5,015,000		-		-
Convertible loans		76,252		-		-
Silent partnerships		423,988		984,461		-
Lease liabilities		472,767		1,059,089		501,319
Payable for acquisition of intangible asset - related party		393,483		874,698		-
	$	10,708,152	$	2,918,248	$	501,319

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.

NOTE 18. CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the six months ended June 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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NOTE 19. OPERATING EXPENSES

For the six months ended June 30, 2023 and 2022, operating expenses consisted of the following:

	Six months Ended
	June 30,
Research and development	2023		2022
Payroll expenses	$	2,010,670	$	539,204
Clinical study expenses		2,827,894		179,445
Depreciation and amortization		210,875		-
Travel expenses		100,383		13,138
Lab consumables		35,221		97
Other expenses		551,330		61,604
	$	5,736,373	$	793,488

	Six months Ended
	June 30,
Sales and marketing	2023		2022
Payroll	$	707,833	$	370,597
Consulting services		1,143,077		123,333
Product and brand advertising		2,176,808		2,247,142
Other expenses		57,943		46,942
	$	4,085,661	$	2,788,014

	Six months Ended
	June 30,
General and administrative	2023		2022
Payroll	$	923,351	$	1,132,948
Stock option expense		1,668,673		4,894,450
Depreciation and amortization		246,710		62,369
Travel and car expenses		69,924		146,861
Consulting services		1,146,792		2,005,889
IT expense		107,101		-
Training		1,050		3,755
Insurance and taxes		478,149		529,120
Rent and Premises		77,672		83,732
Other expenses		159,929		266,083
	$	4,879,351	$	9,125,207

NOTE 20. SUBSEQUENT EVENTS

Subsequent to June 30, 2023, pursuant to the PPA (see Note 11), the Holder converted $500,000 in principal value on the Initial Promissory Note, resulting in the issuance of 134,458 ordinary shares.

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EX-99.3

Exhibit 99.3

Mainz Biomed Announces Financial Half Year Results 2023 and Provides Corporate Update

ColoAlert® Revenue Increases 108% Year Over Year in the First Six Months of 2023

ColoFuture and eAArly Detect Studies on Track to Report Results in September and in Q4, 2023

BERKELEY, US – MAINZ, Germany – August 15, 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 the results of the first six months and second quarter ending June 30, 2023 and provided a corporate update.

Key Highlights During Q2 2023

● ColoAlert® revenues for the first six months of 2023 were USD $499,049, representing an increase of 108% compared to the first half of 2022.

● Expanded international commercialization for ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (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.

● Launched ColoAlert®’s commercial activities in Poland, Portugal, and Romania while growing its network of laboratory partnerships in established markets across Europe in Q2 as well as post-period.

● Grew 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.

● U.S. Pivotal Clinical Trial (ReconAAsense) remains on track to commence patient enrollment – Opportunity to achieve gold-standard status for self-administered CRC screening.

● Continued executing European and U.S. clinical studies (ColoFuture/eAArly DETECT) evaluating portfolio of novel gene expression (mRNA) biomarkers for potential inclusion in ReconAAsense – Company plans to report results from its ColoFuture and eAArly DETECT feasibility studies in September and in the fourth quarter of 2023.

● Established partnership with Microba Life Sciences to explore the discovery and potential integration of novel microbiome biomarkers into pipeline asset PancAlert, a potential first-in-class screening test for pancreatic cancer.

“I’m extremely pleased with the progress achieved during the second quarter as we execute our ambitious corporate growth strategy anchored by ColoAlert®’s commercial franchise and our product development pipeline,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of 2023 with a great deal of momentum as ColoAlert® continues to gain commercial traction across Europe and in select international territories, we ramp-up enrollment planning for the ReconAAsense U.S. pivotal CRC study, execute our clinical trials evaluating a portfolio of proprietary novel gene expression (mRNA) biomarkers for potential inclusion into ReconAAsense, and advance PancAlert, a next-generation pancreatic cancer detection test.”

Commercial Update: Launched ColoAlert® in three European markets, expanded network of laboratory partners in existing territories & grew corporate health program in Germany

During the quarter, Mainz Biomed continued ColoAlert®’s European commercial roll-out by entering the Polish, Portuguese, and Romanian markets. In Poland, the Company established its footprint by partnering with TESTDNA Sp. z o.o. Sp. k. Katowice, one of the Country’s leading independent laboratories. The total addressable market in Poland is estimated to be 21 million patients and, according to Digestive Cancers Europe, Poland shows a particularly high need for reliable non-invasive screening methods, with only about one in five patients willing to use colonoscopy for screening. Furthermore, the incidence in Poland of 19,000 new cases diagnosed annually with approximately 12,000 colorectal cancer-related deaths, confirms the need for at-home screening tests with good early-stage detection.

In Romania, Mainz Biomed launched ColoAlert®’s commercialization through a partnership with Bioclinica, a state-of-the art diagnostics company and supplier of healthcare products. Bioclinica manages 15 laboratories and 146 collection points across the country. Summarizing from data contained in the United Nations, Department of Economic and Social Affairs population statistics, ColoAlert® screening has the potential to benefit over six million individuals aged between 50 and 74 years in Romania where the CRC incidence rates are among the highest in Europe.

In Portugal, Mainz BioMed commenced commercialization by expanding its partnership with Instituto de Microecologia which initially launched ColoAlert® in Spain (February 2023). For more than 60 years, the Instituto de Microecologia has been a pioneer in microbiota studies and food sensitivity, focused on disseminating the importance of intestinal health through microbiological analysis and diagnosis of microbiota profiles and specific health parameters. According to the World Cancer Research Fund International, CRC is the third most common cancer worldwide and Portugal ranks seventh in total global CRC rates with 10,501 cases reported in 2020.

Mainz Biomed is providing ColoAlert® to TESTDNA, Bioclinica and Instituto de Microecologia under the standard terms of the Company’s partnership agreements.

In addition to commercial launches of ColoAlert® in new European markets, a key highlight during the second quarter was the continued expansion of Mainz Biomed’s network of independent laboratories in countries where the Company has already established a commercial foothold. In its home market, the Company announced a partnership with Eurofins GeLaMed which manages four locations throughout Germany and is part of Eurofins Scientific, an international laboratory group with more than 61,000 employees in 61 countries, conducting more than 450 million tests annually. According to GeLaMed, in the German market, it processes over 15,000 orders each working day covering more than 2,000 different analytical methods from its laboratory medicine and microbiology portfolios under the direction of medical specialists.

2

Throughout the second quarter, the Company continued to ramp-up its corporate health program through its flagship initiative in Germany via integration of its test into BGM (“betriebliches Gesundheitsmanagement”), an established corporate health initiative 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. Key highlights during the quarter included adding three new companies to the program and commencing patient processing from a CRC screening campaign being conducted in partnership with Zöller-Kipper GmbH, part of the Kirchhoff group with more than 2,500 employees. Using Mainz Biomed’s online portal which was built to serve participants in the Company’s corporate health program, Zöller-Kipper employees registered to be mailed the ColoAlert® test. Once the sample was received and processed, confidential test results were sent back to the employee through the portal, along with an explanation of the results. If an employee had approved for a physician to be notified of test results, then the doctor could directly follow-up with the patient. As part of its commitment to the BGM program, Mainz Biomed provided education to employees and physicians on CRC and recommendations for next steps.

Product Development Update: ReconAAsense U.S. pivotal clinical trial, ColoFuture/eAArly DETECT clinical studies & pancreatic test development

Throughout the second quarter, Mainz Biomed continued to prepare for commencing patient enrollment in the ReconAAsense study (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.

Additionally, Mainz Biomed continued executing its ColoFuture (Europe) and eAArly DETECT (U.S.) studies evaluating the Company’s proprietary portfolio of novel gene expression (mRNA) biomarkers for possible inclusion in the ReconAAsense trial because they have previously demonstrated ability to detect CRC lesions, including Advanced Adenoma, a type of pre-cancerous polyp often attributed to this deadly disease.

The eAArly DETECT clinical trial, remains on track to report results during Q4, 2023. The multi-center feasibility study is enrolling 250 subjects across 25 sites in the U.S. The international multi-center ColoFuture study continued enrolling patients in Europe (recruiting over 600 patients in the age range of 40-85) with results expected during Q3, 2023. 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 solution 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. To this end, a promising research milestone was achieved during the first quarter when Mainz Biomed announced positive results from an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the same portfolio of gene expression biomarkers. Key findings included Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effective, and two of the mRNA biomarkers were found to be particularly valuable in detecting disease signals in advanced adenoma samples.

3

During the quarter, Mainz Biomed continued to conduct pre-clinical work on PancAlert, the Company’s novel and potential first-in-class early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. An important highlight, in the context of optimizing the technical profile of the test, was the establishment of a research partnership with Microba Life Sciences (ASX: MAP), a precision microbiome company that is built around a unique metag platform technology with the ability to produce comprehensive and accurate species profiles of human gastrointestinal samples. The collaboration is focusing on leveraging this sequencing technology and bioinformatic tool to potentially discover novel microbiome biomarkers for pancreatic cancer detection for integration into PancAlert’s technical configuration.

CONDENSED CONSOLIDATED FINANCIAL INFORMATION

During the six months ended June 30, 2023, the Company saw its revenue from ColoAlert® grow 108% compared to the same period of 2022, with gross margins expanding from 53% to 58%. During the reporting period, the Company’s operating loss grew from USD 12.6 million to USD 14.7 million, when compared to the first six months of 2022. This increased loss was attributable to 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 August 15, 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 second quarter of 2023. Summary financial tables are included below.

4

Mainz Biomed N.V.

Condensed Interim Consolidated Statements of Financial Position (Unaudited)

(in U.S. Dollars)

	June 30,			December 31,
	2023			2022
ASSETS
Current Assets
Cash	$	10,911,087		$	17,141,775
Trade and other receivables, net		370,931			259,138
Inventories		387,178			175,469
Prepaid expenses		455,934			801,959
Total Current Assets		12,125,130			18,378,341
Property and equipment, net		1,617,228			661,692
Intangible asset		3,630,384			—
Right-of-use asset		1,932,258			1,177,695
Other asset		106			23,275
Total assets	$	19,305,106		$	20,241,003
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued liabilities	$	4,720,145		$	2,916,679
Current maturities of long term debt		5,515,240			1,040,573
Lease liabilities		472,767			285,354
Total current liabilities		10,708,152			4,242,606
Long term debt		984,461			943,214
Lease liabilities		1,560,408			959,116
Intellectual property acquisition liability - related party		874,698			—
Total Liabilities		14,127,719			6,144,936
Shareholders’ equity
Share capital		175,785			164,896
Share premium		43,212,004			38,831,542
Reserve		19,732,949			18,079,741
Accumulated deficit		(57,844,937	)		(43,032,294	)
Accumulated other comprehensive income		(98,414	)		52,182
Total shareholders’ equity		5,177,387			14,096,067
Total liabilities and shareholders’ equity	$	19,305,106		$	20,241,003

5

Mainz Biomed N.V.

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

(in U.S. Dollars)

	Three months ended June 30,						Six months ended June 30,
	2023			2022			2023			2022
Revenue	$	248,945		$	139,240		$	499,049		$	239,805
Cost of revenue		100,147			58,427			211,310			112,563
Gross Profit		148,798			80,813			287,739			127,242
		60	%		58	%		58	%		53	%
Operating expenses:
Sales and marketing		1,799,569			1,866,384			4,085,661			2,788,014
Research and development		3,478,595			229,916			5,736,373			793,488
General and administrative		2,796,724			4,932,422			4,879,351			9,125,207
Total operating expenses		8,074,888			7,028,722			14,701,385			12,706,709
Loss from operations		(7,926,090	)		(6,947,909	)		(14,413,646	)		(12,579,467	)
Other income (expense)		(325,637	)		9,198			(398,997	)		(22,980	)
Income (loss) before income tax		(8,251,727	)		(6,938,711	)		(14,812,643	)		(12,602,447	)
Income taxes provision		—			—			—			—
Net loss	$	(8,251,727	)	$	(6,938,711	)	$	(14,812,643	)	$	(12,602,447	)
Foreign currency translation gain (loss)		(90,024	)		46,204			(150,596	)		82,643
Comprehensive loss	$	(8,341,751	)	$	(6,892,507	)	$	(14,963,239	)	$	(12,519,804	)
Basic and dilutive loss per ordinary share	$	(0.56	)	$	(0.48	)	$	(1.01	)	$	(0.91	)
Weighted average number of ordinary shares outstanding		14,915,905			14,286,157			14,803,243			13,821,914

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 or follow us on LinkedIn, Twitter/X and Facebook. 

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

6

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.

7

XML

Document And Entity Information	6 Months Ended
	Jun. 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	Jun. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Entity File Number	001-41010

XML

Condensed Interim Consolidated Statements of Financial Position (Unaudited) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current Assets
Cash	$ 10,911,087	$ 17,141,775
Trade and other receivables, net	370,931	259,138
Inventories	387,178	175,469
Prepaid expenses	455,934	801,959
Total current assets	12,125,130	18,378,341
Property and equipment, net	1,617,228	661,692
Intangible assets	3,630,384
Right-of-use assets	1,932,258	1,177,695
Other assets	106	23,275
Total assets	19,305,106	20,241,003
Current Liabilities
Accounts payable and accrued liabilities	4,326,662	2,916,679
Convertible loan	43,637	43,057
Convertible promissory note at fair value	5,015,000
Convertible debt - related party	32,615	32,181
Silent partnership	211,994	759,168
Silent partnership - related party	211,994	206,167
Payable for acquisition of intangible asset current portion – related party	393,483
Lease liabilities	472,767	285,354
Total current liabilities	10,708,152	4,242,606
Silent partnerships	721,137	687,128
Silent partnerships - related party	263,324	256,086
Lease liabilities	1,560,408	959,116
Intellectual property acquisition liability - related party	874,698
Total liabilities	14,127,719	6,144,936
Shareholders’ equity
Share capital	175,785	164,896
Share premium	43,212,004	38,831,542
Reserve	19,732,949	18,079,741
Accumulated deficit	(57,844,937)	(43,032,294)
Accumulated other comprehensive income (loss)	(98,414)	52,182
Total shareholders’ equity	5,177,387	14,096,067
Total liabilities and shareholders’ equity	$ 19,305,106	$ 20,241,003

XML

Condensed Interim Consolidated Statements of Profit and Loss and Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Profit or loss [abstract]
Revenue	$ 248,945	$ 139,240	$ 499,049	$ 239,805
Cost of revenue	100,147	58,427	211,310	112,563
Gross profit	148,798	80,813	287,739	127,242
Operating expenses:
Sales and marketing	1,799,569	1,866,384	4,085,661	2,788,014
Research and development	3,478,595	229,916	5,736,373	793,488
General and administrative	2,796,724	4,932,422	4,879,351	9,125,207
Total operating expenses	8,074,888	7,028,722	14,701,385	12,706,709
Loss from operations	(7,926,090)	(6,947,909)	(14,413,646)	(12,579,467)
Other income (expense)
Other income	107,143	17,601	170,968	92,932
Other expense	(432,780)	(8,403)	(569,965)	(115,912)
Total other income (expense)	(325,637)	9,198	(398,997)	(22,980)
Loss before income tax	(8,251,727)	(6,938,711)	(14,812,643)	(12,602,447)
Income taxes provision
Net loss	(8,251,727)	(6,938,711)	(14,812,643)	(12,602,447)
Foreign currency translation gain (loss)	(90,024)	46,204	(150,596)	82,643
Comprehensive loss	$ (8,341,751)	$ (6,892,507)	$ (14,963,239)	$ (12,519,804)
Basic loss per ordinary share (in Dollars per share)	$ (0.56)	$ (0.48)	$ (1.01)	$ (0.91)
Weighted average number of ordinary shares outstanding (in Shares)	14,915,905	14,286,157	14,803,243	13,821,914

XML

Condensed Interim Consolidated Statements of Profit and Loss and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Profit or loss [abstract]
Dilutive loss per ordinary share	$ (0.56)	$ (0.48)	$ (1.01)	$ (0.91)

XML

Condensed Interim 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
Net loss						(12,602,447)
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
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
Share based expenses			2,469,549			2,469,549
Stock option expense
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
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
Net loss						(14,812,643)
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
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
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
Share based expenses	$ 353	162,574				162,927
Share based expenses (in Shares)	32,388
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

XML

Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash Flows From Operating Activities
Net loss	$ (14,812,643)	$ (12,602,447)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Share based compensation	2,096,363	5,682,070
Depreciation and amortization	458,368	62,369
Bad debt expense	53,295	470
Accretion expense	88,759	40,697
Change in fair value of convertible debt	(45,000)
Changes in operating assets and liabilities:
Trade and other receivables	58,898	(47,371)
Inventory	(208,367)	(38,269)
Prepaid expenses and other assets	372,018	332,078
Accounts payable and accrued liabilities	1,161,515	113,499
Deferred revenue	(1,331)
Net cash used in operating activities	(10,778,125)	(6,456,904)
Cash Flows From Investing Activities
Purchase of intangible asset	(500,000)
Purchase of property and equipment	(1,024,555)	(252,446)
Net cash used in investing activities	(1,524,555)	(252,446)
Cash Flows From Financing Activities
Sale of ordinary shares	1,894,742	23,865,890
Warrant exercise proceeds		382,500
Proceeds from issuance of convertible debt	5,060,000
Repayment of loans payable	(560,755)	(111,049)
Payment of lease obligations	(201,480)	(45,690)
Net cash provided by financing activities	6,192,507	24,091,651
Effect of changes in exchange rates	(120,515)	(103,234)
Net change in cash	(6,230,688)	17,279,067
Cash at beginning of period	17,141,775	8,727,542
Cash at end of period	10,911,087	26,006,609
Non-Cash Investing And Financing Activities
Right of use asset additions	969,813
Acquisition of intangible asset for payable and stock payable	3,271,828
Interest expense paid	$ 104,822

XML

Nature of Operations and Going Concern

6 Months Ended

Jun. 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”, “PG”)). 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 consolidated financial statements, Mainz Biomed N.V. and its wholly owned subsidiaries, Mainz Biomed USA, Inc. and Mainz Biomed GmbH (f/k/a PharmGenomics 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 $57,844,937 and negative cash flows used in operating activities of $10,778,125 as of and for the six months ended June 30, 2023. The Company also had $10,911,087 of cash on hand on June 30, 2023 and working capital, excluding liabilities expected to be settled with ordinary shares, of $6,431,978. 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 13); the Company raised $1.9 million of net cash from this facility during the six months ended June 30, 2023. Additionally, on June 28, 2023, the Company entered into a Pre Paid Advance Agreement and issued a $5.5 million convertible promissory note (see Note 11) for net proceeds of $5.1 million.

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.

COVID-19 Impact

On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions and the severity and frequency of new strains of the coronavirus. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.

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Basis of Presentation

6 Months Ended

Jun. 30, 2023

Disclosure of 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 August 11, 2023.

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Accounting Policies, Estimates and Significant Management Judgments

6 Months Ended

Jun. 30, 2023

Significant accounting policies [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 and net realizable value. The cost of inventories is based on a weighted average cost and includes expenditure incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses.

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

Estimates of the useful lives of property and equipment 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 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 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 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;

● 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 and Other Receivables

6 Months Ended

Jun. 30, 2023

Trade and other receivables [Abstract]

TRADE AND OTHER RECEIVABLES

NOTE 4. TRADE AND OTHER RECEIVABLES

	June 30,			December 31,
	2023			2022
Accounts receivable	$	145,681		$	130,588
Less: allowance for doubtful accounts		(50,241	)		(66,852	)
Accounts receivable, net		95,440			63,736
VAT receivable, net		275,491			192,154
Other		-			3,248
	$	370,931		$	259,138

For the six months ended June 30, 2023, the Company recorded bad debt reserve of $53,295 for VAT receivable.

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Prepaid and Other Current Assets

6 Months Ended

Jun. 30, 2023

Prepaid and Other Current Assets [Abstract]

PREPAID AND OTHER CURRENT ASSETS

NOTE 5. PREPAID AND OTHER CURRENT ASSETS

	June 30,		December 31,
	2023		2022
Prepaid insurance	$	213,045	$	624,033
Other prepaid expense		109,879		55,356
Security deposit		133,010		122,570
	$	455,934	$	801,959

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Property and Equipment

6 Months Ended

Jun. 30, 2023

Property and Equipment [Abstract]

PROPERTY AND EQUIPMENT

NOTE 6. PROPERTY AND EQUIPMENT

	Laboratory equipment		Office equipment		Construction in progress		Total
Cost
Balance at December 31, 2022	$	579,261	$	176,347	$	-	$	755,608
Additions		837,200		172,594		45,338		1,055,132
Disposal		-		-		-		-
Effects of currency translation		11,736		3,186		212		15,134
Balance at June 30, 2023	$	1,428,197	$	352,127	$	45,550	$	1,825,874
Accumulated depreciation
Balance at December 31, 2022	$	75,650	$	18,266	$	-	$	93,916
Depreciation		53,681		59,252		-		112,933
Disposal		-		-		-		-
Effects of currency translation		1,228		569		-		1,797
Balance at June 30, 2023	$	130,559	$	78,087	$	-	$	208,646
Net book value at June 30, 2022	$	503,611	$	158,081	$	-	$	661,692
Net book value at June 30, 2023	$	1,297,638	$	274,040	$	45,550	$	1,617,228

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Intangible asset

6 Months Ended

Jun. 30, 2023

Intangible assets [Abstract]

INTANGIBLE ASSET

NOTE 7. 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 six months ended June 30, 2023 the Company paid $500,000 to the seller. The Company recorded amortization of $141,444 and interest expense of $51,354 for the six months ended June 30, 2023.

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Leases

6 Months Ended

Jun. 30, 2023

Leases [Abstract]

LEASES

NOTE 8. LEASES

Right-of-Use Assets

The Company leases certain assets under lease agreements.

	Office		Laboratory				Lab and
	Equipment		Equipment		Vehicle		Office Space		Total
Cost
Balance as of December 31, 2022	$	64,226	$	362,970	$	94,008	$	1,035,200	$	1,556,404
Additions		-		331,544		51,757		588,881		972,182
Effects of currency translation		865		5,634		1,383		15,268		23,150
Balance as of June 30, 2023	$	65,091	$	700,148	$	147,148	$	1,639,349	$	2,551,736
Accumulated amortization
Balance as of December 31, 2022	$	20,707	$	77,838	$	22,109	$	258,055	$	378,709
Depreciation		6,050		93,569		26,421		109,100		235,140
Effects of currency translation		293		1,260		358		3,718		5,629
Balance as of June 30, 2023	$	27,050	$	172,667	$	48,888	$	370,873	$	619,478
Net book value at June 30, 2022	$	43,519	$	285,132	$	71,899	$	777,145	$	1,177,695
Net book value at June 30, 2023	$	38,041	$	527,481	$	98,260	$	1,268,476	$	1,932,258

As of June 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 June 30, 2023, had an average expected life of 5 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		972,183
Interest expenses		92,575
Lease payments		(294,549	)
Effects of currency translation		18,496
Balance as of June 30, 2023	$	2,033,175

Lease liabilities	June 30, 2023		December 31, 2022
Current portion	$	472,767	$	285,354
Long-term portion		1,560,408		959,116
Total lease liabilities	$	2,033,175	$	1,244,470

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

Maturity analysis	June 30, 2023
Less than one year	$	317,745
One to two years		632,966
Two to three years		537,593
Three to four years		356,609
Four to five years		224,224
More than five years		501,319
Total undiscounted lease liabilities	$	2,570,456
Amount representing implicit interest		(537,281	)
Lease obligations	$	2,033,175

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Accounts Payable and Accrued Expenses

6 Months Ended

Jun. 30, 2023

Accounts Payable And Accrued Expenses Abstract

ACCOUNTS PAYABLE AND ACCRUED EXPENSES

NOTE 9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

	June 30,		December 31,
	2023		2022
Accounts payable	$	2,743,514	$	1,333,044
Accrued liabilities		1,493,632		1,236,942
Payroll liabilities		89,516		346,693
	$	4,326,662	$	2,916,679

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Convertible Debt - Related Party

6 Months Ended

Jun. 30, 2023

Disclosure of Convertible Debt Related Party Explanatory [Abstract]

CONVERTIBLE DEBT - RELATED PARTY

NOTE 10. 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. 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 June 30, 2023 and December 31, 2022, the Company’s Convertible Debt – Related Party is $32,615 (EUR30,000) and $32,181 (EUR30,000), respectively.

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Convertible Debt

6 Months Ended

Jun. 30, 2023

Disclosure of Convertible Debt Explanatory [Abstract]

CONVERTIBLE DEBT

NOTE 11. 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. During the year ended December 31, 2019, principal in the amount of EUR5,000 ($5,597) was exchanged for the 2019 and 2020 Convertible Loans and EUR5,000 ($5,597) was extinguished as the lender elected to offset the debt amount against amounts in trade receivables due to the Company. 

Convertible Promissory Note

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. The Holder is not obligated to purchase any additional Promissory Notes from us under the PPA.

Each Promissory Notes 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 Note at fair value as of the June 28, 2023 issuance date. 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 has 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. For the period ended June 30, 2023, the Company recorded a change in fair value of $45,000, resulting in a balance of $5,015,000 as of June 30, 2023.

We classified this fair value as a Level 3 fair value measurement and used a fair value pricing model to calculate the fair value as of June 28, 2023 and June 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 Initial Promissory Note is as follows:

	June 28,			June 30,
	2023			2023
Stock price	$	4.82		$	4.78
Expected life in years		1			1
Risk free rate		5.32	%		5.40	%
Expected volatility		74.65	%		74.66	%
Discount rate		79.27	%		78.54	%

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Silent Partnerships

6 Months Ended

Jun. 30, 2023

Silent Partnerships [Abstract]

SILENT PARTNERSHIPS

NOTE 12. 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%.

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		-		-		(138,747	)		(422,008	)		(560,755	)
Discount		-		-		-			-			-
Accretion		20,592		1,659		14,341			812			37,404
Interest expense		-		-		-			-			-
Effects of currency translation		7,335		599		11,670			3,647			23,251
Balance, June 30, 2023	$	565,286	$	46,196	$	796,967		$	-		$	1,408,449

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Equity

6 Months Ended

Jun. 30, 2023

Equity [Abstract]

EQUITY

NOTE 13. 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 six months ended June 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 six months ended June 30, 2023, the Company issued ordinary shares as follows:

● 34,500 ordinary shares issued for services rendered which were valued at $177,690

● 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

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 expire in November 2023.

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 six months ended June 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 June 30, 2023		2,430,833		$	3.00		0.35

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 six months ended June 30, 2023, the Company granted 312,500 stock options valued at $1,072,612. Stock options with time-based vesting were valued using the Black-Scholes pricing model.

During the six months ended June 30, 2023, the Company recorded stock based compensation of $1,668,673 and had unamortized expense of $4,519,283 as of June 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 six months ended June 30, 2023, the estimated fair values of the stock options are as follows:

		June 30,
		2023
Exercise price	$	4.78 - 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 six months ended June 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		312,500			5.06		10.00
Exercised		-			-		-
Forfeited		(27,592	)		6.88		-
Expired		-			-		-
Balance as of June 30, 2023		2,679,058		$	6.97		8.80
Exercisable as of June 30, 2023		1,567,950		$	5.95		8.40

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Cost of Revenue

6 Months Ended

Jun. 30, 2023

Cost of Revenue [Abstract]

COST OF REVENUE

NOTE 14. COST OF REVENUE

For the six months ended June 30, 2023 and 2022, cost of revenue consisted of test kit materials, both patient collection kits and lab based PCR kits.

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Related Party Transactions

6 Months Ended

Jun. 30, 2023

Related Party Transactions [Abstract]

RELATED PARTY TRANSACTIONS

NOTE 15. RELATED PARTY TRANSACTIONS

Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board, its Chief Executive Officer, Chief Financial Officer, Chief Operating Officer, Chief Commercial Officer and Chief Scientific Officer. The remuneration of directors and key management personnel during the six months ended June 30, 2023 and 2022 was as follows:

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	921,492	$	1,264,187

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

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	14,956	$	61,116

During the six months ended June 30, 2023 and 2022, the Company incurred interest expense of $16,664 and $16,838 on balances owing to related parties, respectively.

During the six months ended June 30, 2023 and 2022, the Company incurred accretion expense of $6,807 and $7,885 on balances owing to related parties, respectively.

During the six months ended June 30, 2023 and 2022, we recorded expenses of $52,264 and $126,173, 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

6 Months Ended

Jun. 30, 2023

Government Grants [Abstract]

GOVERNMENT GRANTS

NOTE 16. GOVERNMENT GRANTS

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

	Six months ended
	June 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	19,072
Multi-marker test for the early detection of pancreatic cancer		28,117		50,037
	$	28,117	$	69,109

As of June 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 $35,852 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

6 Months Ended

Jun. 30, 2023

Financial Instrument Risk Management [Abstract]

FINANCIAL INSTRUMENT RISK MANAGEMENT

NOTE 17. FINANCIAL INSTRUMENT RISK MANAGEMENT

Basis of Fair Value

Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:

● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;

● Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and

● Level 3 — Inputs that are not based on observable market data.

The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.

The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.

Credit Risk

The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. 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 six months ended June 30, 2023, the Company incurred $53,295 (related to VAT receivables) 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 June 30, 2023, the Company had an unrestricted cash balance of $10,911,087 to settle current liabilities, excluding the Initial Promissory Note, which is expected to be settled in ordinary shares, of $6,475,516.

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 June 30, 2023:

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	4,326,662	$	-	$	-
Convertible promissory note to be settled with ordinary shares		5,015,000		-		-
Convertible loans		76,252		-		-
Silent partnerships		423,988		984,461		-
Lease liabilities		472,767		1,059,089		501,319
Payable for acquisition of intangible asset - related party		393,483		874,698		-
	$	10,708,152	$	2,918,248	$	501,319

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

6 Months Ended

Jun. 30, 2023

Concentrations [Abstract]

CONCENTRATIONS

NOTE 18. CONCENTRATIONS

Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the six months ended June 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

6 Months Ended

Jun. 30, 2023

Operating Expenses [Abstract]

OPERATING EXPENSES

NOTE 19. OPERATING EXPENSES

For the six months ended June 30, 2023 and 2022, operating expenses consisted of the following:

	Six months Ended
	June 30,
Research and development	2023		2022
Payroll expenses	$	2,010,670	$	539,204
Clinical study expenses		2,827,894		179,445
Depreciation and amortization		210,875		-
Travel expenses		100,383		13,138
Lab consumables		35,221		97
Other expenses		551,330		61,604
	$	5,736,373	$	793,488

	Six months Ended
	June 30,
Sales and marketing	2023		2022
Payroll	$	707,833	$	370,597
Consulting services		1,143,077		123,333
Product and brand advertising		2,176,808		2,247,142
Other expenses		57,943		46,942
	$	4,085,661	$	2,788,014

	Six months Ended
	June 30,
General and administrative	2023		2022
Payroll	$	923,351	$	1,132,948
Stock option expense		1,668,673		4,894,450
Depreciation and amortization		246,710		62,369
Travel and car expenses		69,924		146,861
Consulting services		1,146,792		2,005,889
IT expense		107,101		-
Training		1,050		3,755
Insurance and taxes		478,149		529,120
Rent and Premises		77,672		83,732
Other expenses		159,929		266,083
	$	4,879,351	$	9,125,207

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Subsequent Events

6 Months Ended

Jun. 30, 2023

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 20. SUBSEQUENT EVENTS

Subsequent to June 30, 2023, pursuant to the PPA (see Note 11), the Holder converted $500,000 in principal value on the Initial Promissory Note, resulting in the issuance of 134,458 ordinary shares.

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Accounting Policies, by Policy (Policies)

6 Months Ended

Jun. 30, 2023

Accounting Policies [Abstract]

Inventories

Inventories

Inventories are measured at the lower of cost and net realizable value. The cost of inventories is based on a weighted average cost and includes expenditure incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses.

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

Estimates of the useful lives of property and equipment 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 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 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 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;

● 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 and Other Receivables (Tables)

6 Months Ended

Jun. 30, 2023

Trade and other receivables [Abstract]

Schedule of Trade and Other Receivables

	June 30,			December 31,
	2023			2022
Accounts receivable	$	145,681		$	130,588
Less: allowance for doubtful accounts		(50,241	)		(66,852	)
Accounts receivable, net		95,440			63,736
VAT receivable, net		275,491			192,154
Other		-			3,248
	$	370,931		$	259,138

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Prepaid and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2023

Prepaid and Other Current Assets [Abstract]

Schedule of Prepaid and Other Current Assets

	June 30,		December 31,
	2023		2022
Prepaid insurance	$	213,045	$	624,033
Other prepaid expense		109,879		55,356
Security deposit		133,010		122,570
	$	455,934	$	801,959

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Property and Equipment (Tables)

6 Months Ended

Jun. 30, 2023

Property and Equipment [Abstract]

Schedule of Property and Equipment

	Laboratory equipment		Office equipment		Construction in progress		Total
Cost
Balance at December 31, 2022	$	579,261	$	176,347	$	-	$	755,608
Additions		837,200		172,594		45,338		1,055,132
Disposal		-		-		-		-
Effects of currency translation		11,736		3,186		212		15,134
Balance at June 30, 2023	$	1,428,197	$	352,127	$	45,550	$	1,825,874
Accumulated depreciation
Balance at December 31, 2022	$	75,650	$	18,266	$	-	$	93,916
Depreciation		53,681		59,252		-		112,933
Disposal		-		-		-		-
Effects of currency translation		1,228		569		-		1,797
Balance at June 30, 2023	$	130,559	$	78,087	$	-	$	208,646
Net book value at June 30, 2022	$	503,611	$	158,081	$	-	$	661,692
Net book value at June 30, 2023	$	1,297,638	$	274,040	$	45,550	$	1,617,228

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Leases (Tables)

6 Months Ended

Jun. 30, 2023

Leases [Abstract]

Schedule of Leases Certain Assets Under Lease Agreements

The Company leases certain assets under lease agreements.

	Office		Laboratory				Lab and
	Equipment		Equipment		Vehicle		Office Space		Total
Cost
Balance as of December 31, 2022	$	64,226	$	362,970	$	94,008	$	1,035,200	$	1,556,404
Additions		-		331,544		51,757		588,881		972,182
Effects of currency translation		865		5,634		1,383		15,268		23,150
Balance as of June 30, 2023	$	65,091	$	700,148	$	147,148	$	1,639,349	$	2,551,736
Accumulated amortization
Balance as of December 31, 2022	$	20,707	$	77,838	$	22,109	$	258,055	$	378,709
Depreciation		6,050		93,569		26,421		109,100		235,140
Effects of currency translation		293		1,260		358		3,718		5,629
Balance as of June 30, 2023	$	27,050	$	172,667	$	48,888	$	370,873	$	619,478
Net book value at June 30, 2022	$	43,519	$	285,132	$	71,899	$	777,145	$	1,177,695
Net book value at June 30, 2023	$	38,041	$	527,481	$	98,260	$	1,268,476	$	1,932,258

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		972,183
Interest expenses		92,575
Lease payments		(294,549	)
Effects of currency translation		18,496
Balance as of June 30, 2023	$	2,033,175

Schedule of Lease Liabilities

Lease liabilities	June 30, 2023		December 31, 2022
Current portion	$	472,767	$	285,354
Long-term portion		1,560,408		959,116
Total lease liabilities	$	2,033,175	$	1,244,470

Schedule of Committed to Minimum Lease Payments

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

Maturity analysis	June 30, 2023
Less than one year	$	317,745
One to two years		632,966
Two to three years		537,593
Three to four years		356,609
Four to five years		224,224
More than five years		501,319
Total undiscounted lease liabilities	$	2,570,456
Amount representing implicit interest		(537,281	)
Lease obligations	$	2,033,175

XML

Accounts Payable and Accrued Expenses (Tables)

6 Months Ended

Jun. 30, 2023

Accounts Payable And Accrued Expenses Abstract

Schedule of Accounts Payable and Accrued Expenses

	June 30,		December 31,
	2023		2022
Accounts payable	$	2,743,514	$	1,333,044
Accrued liabilities		1,493,632		1,236,942
Payroll liabilities		89,516		346,693
	$	4,326,662	$	2,916,679

XML

Convertible Debt (Tables)

6 Months Ended

Jun. 30, 2023

Disclosure of Convertible Debt Explanatory [Abstract]

Schedule of Convertible Debt

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

	June 28,			June 30,
	2023			2023
Stock price	$	4.82		$	4.78
Expected life in years		1			1
Risk free rate		5.32	%		5.40	%
Expected volatility		74.65	%		74.66	%
Discount rate		79.27	%		78.54	%

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Silent Partnerships (Tables)

6 Months Ended

Jun. 30, 2023

Silent Partnerships [Abstract]

Schedule of Continuity of the Company’s Silent Partnerships

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		-		-		(138,747	)		(422,008	)		(560,755	)
Discount		-		-		-			-			-
Accretion		20,592		1,659		14,341			812			37,404
Interest expense		-		-		-			-			-
Effects of currency translation		7,335		599		11,670			3,647			23,251
Balance, June 30, 2023	$	565,286	$	46,196	$	796,967		$	-		$	1,408,449

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Equity (Tables)

6 Months Ended

Jun. 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	%

		June 30,
		2023
Exercise price	$	4.78 - 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 six months ended June 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 June 30, 2023		2,430,833		$	3.00		0.35

	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		312,500			5.06		10.00
Exercised		-			-		-
Forfeited		(27,592	)		6.88		-
Expired		-			-		-
Balance as of June 30, 2023		2,679,058		$	6.97		8.80
Exercisable as of June 30, 2023		1,567,950		$	5.95		8.40

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Related Party Transactions (Tables)

6 Months Ended

Jun. 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 six months ended June 30, 2023 and 2022 was as follows:

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	921,492	$	1,264,187

Schedule of Remuneration Paid to Related Parties

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

	Six months ended
	June 30,
	2023		2022
Salaries and benefits	$	14,956	$	61,116

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Government Grants (Tables)

6 Months Ended

Jun. 30, 2023

Government Grants [Abstract]

Schedule of Research and Development

The amount of government grants received during the six months ended June 30, 2023 and 2022 and recognized as research grant revenue were as follows:

	Six months ended
	June 30,
Research and Development Projects	2023		2022
Rapid detection of antibody-based pathogens	$	-	$	19,072
Multi-marker test for the early detection of pancreatic cancer		28,117		50,037
	$	28,117	$	69,109

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Financial Instrument Risk Management (Tables)

6 Months Ended

Jun. 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 June 30, 2023:

	Within		More than		More than
	one year		one year		five years
Accounts payable and accrued liabilities	$	4,326,662	$	-	$	-
Convertible promissory note to be settled with ordinary shares		5,015,000		-		-
Convertible loans		76,252		-		-
Silent partnerships		423,988		984,461		-
Lease liabilities		472,767		1,059,089		501,319
Payable for acquisition of intangible asset - related party		393,483		874,698		-
	$	10,708,152	$	2,918,248	$	501,319

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Operating Expenses (Tables)

6 Months Ended

Jun. 30, 2023

Operating Expenses [Abstract]

Schedule of Operating Expenses

For the six months ended June 30, 2023 and 2022, operating expenses consisted of the following:

	Six months Ended
	June 30,
Research and development	2023		2022
Payroll expenses	$	2,010,670	$	539,204
Clinical study expenses		2,827,894		179,445
Depreciation and amortization		210,875		-
Travel expenses		100,383		13,138
Lab consumables		35,221		97
Other expenses		551,330		61,604
	$	5,736,373	$	793,488

	Six months Ended
	June 30,
Sales and marketing	2023		2022
Payroll	$	707,833	$	370,597
Consulting services		1,143,077		123,333
Product and brand advertising		2,176,808		2,247,142
Other expenses		57,943		46,942
	$	4,085,661	$	2,788,014

	Six months Ended
	June 30,
General and administrative	2023		2022
Payroll	$	923,351	$	1,132,948
Stock option expense		1,668,673		4,894,450
Depreciation and amortization		246,710		62,369
Travel and car expenses		69,924		146,861
Consulting services		1,146,792		2,005,889
IT expense		107,101		-
Training		1,050		3,755
Insurance and taxes		478,149		529,120
Rent and Premises		77,672		83,732
Other expenses		159,929		266,083
	$	4,879,351	$	9,125,207

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Nature of Operations and Going Concern (Details) - USD ($)				1 Months Ended		6 Months Ended
	Jun. 28, 2023	Jan. 31, 2022	Aug. 03, 2021	Jun. 28, 2023	Nov. 30, 2021	Jun. 30, 2023	Dec. 31, 2022
Nature of Operations and Going Concern [Abstract]
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						$ 57,844,937
Operating activities						10,778,125
Cash on hand						10,911,087
Ordinary shares						$ 6,431,978
Period of going concern						1 year
Equity offering							$ 50,000,000
Raised cash						$ 1,900,000
Prepaid advance agreement	$ 50,000,000			$ 5,500,000
Net proceed				$ 5,100,000

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Trade and Other Receivables (Details)	Jun. 30, 2023 USD ($)
Trade and other receivables [Abstract]
Debt reserve	$ 53,295

XML

Trade and Other Receivables (Details) - Schedule of Trade and Other Receivables - USD ($)	6 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Schedule of trade and other receivables [Abstract]
Accounts receivable	$ 145,681	$ 130,588
Less: allowance for doubtful accounts	(50,241)	(66,852)
Accounts receivable, net	95,440	63,736
VAT receivable, net	275,491	192,154
Other		3,248
Total	$ 370,931	$ 259,138

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Prepaid and Other Current Assets (Details) - Schedule of Prepaid and Other Current Assets - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Schedule of Prepaid and Other Current Assets [Abstract]
Prepaid insurance	$ 213,045	$ 624,033
Other prepaid expense	109,879	55,356
Security deposit	133,010	122,570
Total prepaid and other current assets	$ 455,934	$ 801,959

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Property and Equipment (Details) - Schedule of Property and Equipment	6 Months Ended
	Jun. 30, 2023 USD ($)
Cost
Cost Balance	$ 755,608
Additions	1,055,132
Disposal
Effects of currency translation	15,134
Cost Balance	1,825,874
Accumulated depreciation
Accumulated depreciation Balance	93,916
Depreciation	112,933
Disposal
Effects of currency translation	1,797
Accumulated depreciation Balance	208,646
Net book value	661,692
Accumulated depreciation net book value	1,617,228
Laboratory equipment [Member]
Cost
Cost Balance	579,261
Additions	837,200
Disposal
Effects of currency translation	11,736
Cost Balance	1,428,197
Accumulated depreciation
Accumulated depreciation Balance	75,650
Depreciation	53,681
Disposal
Effects of currency translation	1,228
Accumulated depreciation Balance	130,559
Net book value	503,611
Accumulated depreciation net book value	1,297,638
Office equipment [Member]
Cost
Cost Balance	176,347
Additions	172,594
Disposal
Effects of currency translation	3,186
Cost Balance	352,127
Accumulated depreciation
Accumulated depreciation Balance	18,266
Depreciation	59,252
Disposal
Effects of currency translation	569
Accumulated depreciation Balance	78,087
Net book value	158,081
Accumulated depreciation net book value	274,040
Construction in progress [Member]
Cost
Cost Balance
Additions	45,338
Disposal
Effects of currency translation	212
Cost Balance	45,550
Accumulated depreciation
Accumulated depreciation Balance
Depreciation
Disposal
Effects of currency translation
Accumulated depreciation Balance
Net book value
Accumulated depreciation net book value	$ 45,550

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Intangible asset (Details)		1 Months Ended	6 Months Ended
	Feb. 11, 2021 EUR (€) € / shares	Feb. 15, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) $ / shares
Intangible asset (Details) [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			$ 500,000
Amortization cost			141,444
Interest expense			$ 51,354
Bottom of range [member]
Intangible asset (Details) [Line Items]
Cash Payment (in Euro) | €	€ 2,000,000
Top of range [member]
Intangible asset (Details) [Line Items]
Cash Payment (in Euro) | €	€ 4,000,000

XML

Leases (Details)			6 Months Ended
	Jan. 01, 2023	Jan. 01, 2022	Jun. 30, 2023
Leases [Abstract]
Average expected life			5 years
Present value of future lease payments percentage	10.00%	10.00%

XML

Leases (Details) - Schedule of Leases Certain Assets Under Lease Agreements	6 Months Ended
	Jun. 30, 2023 USD ($)
Cost
Balance	$ 1,556,404
Balance	2,551,736
Additions	972,182
Effects of currency translation	23,150
Accumulated amortization
Balance	378,709
Net book value	1,177,695
Accumulated depreciation net book value	1,932,258
Depreciation	235,140
Effects of currency translation	5,629
Balance	619,478
Office Equipment [Member]
Cost
Balance	64,226
Balance	65,091
Additions
Effects of currency translation	865
Accumulated amortization
Balance	20,707
Net book value	43,519
Accumulated depreciation net book value	38,041
Depreciation	6,050
Effects of currency translation	293
Balance	27,050
Laboratory Equipment [Member]
Cost
Balance	362,970
Balance	700,148
Additions	331,544
Effects of currency translation	5,634
Accumulated amortization
Balance	77,838
Net book value	285,132
Accumulated depreciation net book value	527,481
Depreciation	93,569
Effects of currency translation	1,260
Balance	172,667
Vehicle [Member]
Cost
Balance	94,008
Balance	147,148
Additions	51,757
Effects of currency translation	1,383
Accumulated amortization
Balance	22,109
Net book value	71,899
Accumulated depreciation net book value	98,260
Depreciation	26,421
Effects of currency translation	358
Balance	48,888
Lab and Office Space [Member]
Cost
Balance	1,035,200
Balance	1,639,349
Additions	588,881
Effects of currency translation	15,268
Accumulated amortization
Balance	258,055
Net book value	777,145
Accumulated depreciation net book value	1,268,476
Depreciation	109,100
Effects of currency translation	3,718
Balance	$ 370,873

XML

Leases (Details) - Schedule of Future Lease Payments	6 Months Ended
	Jun. 30, 2023 USD ($)
Schedule of Future Lease Payments [Abstract]
Balance	$ 1,244,470
Additions	972,183
Interest expenses	92,575
Lease payments	(294,549)
Effects of currency translation	18,496
Balance	$ 2,033,175

XML

Leases (Details) - Schedule of Lease Liabilities - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Schedule of lease liabilities [Abstract]
Current portion	$ 472,767	$ 285,354
Long-term portion	1,560,408	959,116
Total lease liabilities	$ 2,033,175	$ 1,244,470

XML

Leases (Details) - Schedule of Committed to Minimum Lease Payments	6 Months Ended
	Jun. 30, 2023 USD ($)
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	$ 2,570,456
Amount representing implicit interest	(537,281)
Lease obligations	2,033,175
Less than one year [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	317,745
One to two years [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	632,966
Two to three years [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	537,593
Three to four years [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	356,609
Four to five years [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	224,224
More than five years [Member]
Leases (Details) - Schedule of Committed to Minimum Lease Payments [Line Items]
Total undiscounted lease liabilities	$ 501,319

XML

Accounts Payable and Accrued Expenses (Details) - Schedule of Accounts Payable and Accrued Expenses - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Schedule Of Accounts Payable And Accrued Expenses [Abstract]
Accounts payable	$ 2,743,514	$ 1,333,044
Accrued liabilities	1,493,632	1,236,942
Payroll liabilities	89,516	346,693
Total	$ 4,326,662	$ 2,916,679

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Convertible Debt - Related Party (Details)			6 Months Ended		12 Months Ended
	Nov. 30, 2017 USD ($)	Nov. 30, 2017 EUR (€)	Jun. 30, 2023 USD ($)	Jun. 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 (€)
Disclosure of Convertible Debt Related Party Explanatory [Abstract]
Loan agreements totaling	$ 92,007	€ 80,278					$ 467,154	€ 417,133	$ 467,154	€ 417,133
Bear interest			3.50%	3.50%
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			$ 32,615	€ 30,000	$ 32,181	€ 30,000
Convertible Debt maturity Date			Sep. 30, 2022	Sep. 30, 2022

XML

Convertible Debt (Details)					1 Months Ended	6 Months Ended	12 Months Ended
	Jun. 28, 2023 USD ($)	Aug. 03, 2021	Nov. 30, 2017 USD ($)	Nov. 30, 2017 EUR (€)	Jun. 28, 2023 USD ($)	Jun. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2020 USD ($)	Dec. 31, 2020 EUR (€)	Dec. 31, 2019 USD ($)	Dec. 31, 2019 EUR (€)
Convertible Debt (Details) [Line Items]
Loan agreements total			$ 92,007	€ 80,278			$ 467,154	€ 417,133	$ 467,154	€ 417,133
Convertible loan percentage			4.25%	4.25%
Convertible loan amount							$ 5,597	€ 5,000	$ 5,597	€ 5,000
Commitment amount	$ 50,000,000				$ 5,500,000
Principal amount percentage	92.00%				92.00%		3.50%	3.50%
Principal amount	$ 5,500,000
Maturity period						one
Average percentage						92.00%
Floor price per share (in Dollars per share) | $ / shares						$ 2
Redemption premium percentage						8.00%
Floor price percentage		62.00%
Commitment fee						$ 250,000
Ordinary shares issued for commitment fee (in Shares) | shares						54,428
Original issue discount						$ 440,000
Fair value						5,060,000
Balance of fair value						5,015,000
Conversion Price [Member]
Convertible Debt (Details) [Line Items]
Initial promissory note amount						$ 4.9986
Average percentage						110.00%
Initial Promissory Note [Member]
Convertible Debt (Details) [Line Items]
Face value						$ 5,500,000
Fair value						45,000
Monthly Payment [Member]
Convertible Debt (Details) [Line Items]
Redemption premium						$ 550,000
Redemption premium percentage						8.00%
Bottom of range [Member]
Convertible Debt (Details) [Line Items]
Promissory notes interest percentage						15.00%
Bottom of range [Member] | Monthly Payment [Member]
Convertible Debt (Details) [Line Items]
Floor price percentage						10.00%
Top of range [Member]
Convertible Debt (Details) [Line Items]
Promissory notes interest percentage						8.00%
Top of range [Member] | Monthly Payment [Member]
Convertible Debt (Details) [Line Items]
Floor price percentage						50.00%

XML

Convertible Debt (Details) - Schedule of Convertible Debt - $ / shares	1 Months Ended	6 Months Ended
	Jun. 28, 2023	Jun. 30, 2023
Schedule Of Convertible Debt [Abstract]
Stock price (in Dollars per share)	$ 4.82	$ 4.78
Expected life in years	1 year	1 year
Risk free rate	5.32%	5.40%
Expected volatility	74.65%	74.66%
Discount rate	79.27%	78.54%

XML

Silent Partnerships (Details)	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2020 USD ($)	Dec. 31, 2020 EUR (€) € / shares	Dec. 31, 2010 USD ($)	Dec. 31, 2010 EUR (€)	Jun. 28, 2023
Silent Partnerships (Details) [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	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 (Details) [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%

XML

Silent Partnerships (Details) - Schedule of Continuity of the Company’s Silent Partnerships	6 Months Ended
	Jun. 30, 2023 USD ($)
Schedule of continuity of the company’s silent partnerships [Abstract]
Balance beginning	$ 1,908,549
Issued during the year
Extinguished during the year	(560,755)
Discount
Accretion	37,404
Interest expense
Effects of currency translation	23,251
Balance ending	1,408,449
3% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Abstract]
Balance beginning	537,359
Issued during the year
Extinguished during the year
Discount
Accretion	20,592
Interest expense
Effects of currency translation	7,335
Balance ending	565,286
3.5% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Abstract]
Balance beginning	43,938
Issued during the year
Extinguished during the year
Discount
Accretion	1,659
Interest expense
Effects of currency translation	599
Balance ending	46,196
8.5% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Abstract]
Balance beginning	909,703
Issued during the year
Extinguished during the year	(138,747)
Discount
Accretion	14,341
Interest expense
Effects of currency translation	11,670
Balance ending	796,967
8% SPAs [Member]
Schedule of continuity of the company’s silent partnerships [Abstract]
Balance beginning	417,549
Issued during the year
Extinguished during the year	(422,008)
Discount
Accretion	812
Interest expense
Effects of currency translation	3,647
Balance ending

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Equity (Details)	6 Months Ended		12 Months Ended
	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) $ / shares € / shares shares	Dec. 31, 2021 USD ($) shares
Equity (Details) [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	34,500	34,500
Ordinary shares value (in Dollars) | $	$ 177,690	€ 177,690
Exercise of warrants shares	305,771
Ordinary shares issued for commitment fee	54,428
Convertible promissory note value (in Dollars) | $	$ 250,000
Ordinary shares issued for acquisition	300,000
Intangible assets value (in Dollars) | $	$ 2,055,000	2,055,000
Warrants issued			3,755,000
Underwriting warrants			161,000
Underwriting warrant in amount (in Dollars) | $			$ 754,286
Granted shares	312,500
Stock options (in Dollars) | $	$ 1,072,612
Share-based compensation (in Dollars) | $	1,668,673
Unamortized expense (in Dollars) | $	$ 4,519,283	€ 4,519,283
Stock Option [Member]
Equity (Details) [Line Items]
Ordinary shares	3,100,000	3,100,000

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Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured - USD ($)	6 Months Ended	12 Months Ended
	Jun. 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
Bottom of range [Member] | Warrants [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%
Bottom of range [Member] | Stock Options [Member]
Equity (Details) - Schedule of Estimated Fair Values of the Warrants Measured [Line Items]
Exercise price (in Dollars per share)	$ 4.78
Expected term	5 years 3 months
Expected average volatility	70.00%
Risk-free interest rate	3.48%
Top of range [Member] | Warrants [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%
Top of range [Member] | Stock Options [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	6 Months Ended
	Jun. 30, 2023 $ / shares shares
Warrants [Member]
Equity (Details) - 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	4 months 6 days
Stock Option [Member]
Equity (Details) - 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	312,500
Weighted-Average Exercise Price, Grants | $ / shares	$ 5.06
Weighted-Average Life (years), Grants	10 years
Outstanding, Exercised | shares
Weighted-Average Exercise Price, Exercised | $ / shares
Weighted-Average Life (years), Exercised
Outstanding, Forfeited | shares	(27,592)
Weighted-Average Exercise Price, Forfeited | $ / shares	$ 6.88
Weighted-Average Life (years), Forfeited
Outstanding, Expired | shares
Weighted-Average Exercise Price, Expired | $ / shares
Weighted-Average Life (years), Expired
Outstanding, Ending Balance | shares	2,679,058
Weighted-Average Exercise Price, Ending Balance | $ / shares	$ 6.97
Weighted-Average Life (years), Ending Balance	8 years 9 months 18 days
Outstanding, Ending Balance | shares	1,567,950
Weighted-Average Exercise Price, Ending Balance | $ / shares	$ 5.95
Weighted-Average Life (years), Ending Balance	8 years 4 months 24 days

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Related Party Transactions (Details) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Related Party Transactions [Abstract]
Incurred interest expense	$ 16,664	$ 16,838
Incurred accretion expense	6,807	7,885
Recorded expenses	$ 52,264	$ 126,173

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Related Party Transactions (Details) - Schedule of Remuneration of Directors and Key Management Personnel - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Schedule of Remuneration of Directors and Key Management Personnel [Abstract]
Salaries and benefits	$ 921,492	$ 1,264,187

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Related Party Transactions (Details) - Schedule of Remuneration Paid to Related Parties - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Schedule of Remuneration Paid to Related Parties [Abstract]
Salaries and benefits	$ 14,956	$ 61,116

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Government Grants (Details) - USD ($)	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Government Grants [Abstract]
Multi-marker test	$ 35,852
Antibody-based pathogens		$ 81,706

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Government Grants (Details) - Schedule of Research and Development - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Schedule of Research and Development [Abstract]
Rapid detection of antibody-based pathogens		$ 19,072
Multi-marker test for the early detection of pancreatic cancer	28,117	50,037
Total research and development projects	$ 28,117	$ 69,109

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Financial Instrument Risk Management (Details)	6 Months Ended
	Jun. 30, 2023 USD ($)	Jun. 30, 2023 EUR (€)	Jun. 30, 2022 USD ($)
Financial Instrument Risk Management [Abstract]
Federal insured limit	$ 250,000	€ 100,000
Bad debt expense	53,295		$ 0
Unrestricted cash	10,911,087
Current liabilities	$ 6,475,516
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	Dec. 31, 2023 USD ($)
Within one year [Member]
Financial Instrument Risk Management (Details) - Schedule of Contractual Maturities Financial Liabilities [Line Items]
Accounts payable and accrued liabilities	$ 4,326,662
Convertible promissory note to be settled with ordinary shares	5,015,000
Convertible loans	76,252
Silent partnerships	423,988
Lease liabilities	472,767
Payable for acquisition of intangible asset - related party	393,483
Total	10,708,152
More than one year [Member]
Financial Instrument Risk Management (Details) - 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	984,461
Lease liabilities	1,059,089
Payable for acquisition of intangible asset - related party	874,698
Total	2,918,248
More than five years [Member]
Financial Instrument Risk Management (Details) - 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	501,319
Payable for acquisition of intangible asset - related party
Total	$ 501,319

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Concentrations (Details)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Concentrations [Abstract]
Annual revenues percentage	10.00%
Number of customers	1	4
Revenue percentage	18.00%	81.00%

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Operating Expenses (Details) - Schedule of Operating Expenses - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Research and development [Member]
Operating Expenses (Details) - Schedule of Operating Expenses [Line Items]
Payroll expenses	$ 2,010,670	$ 539,204
Clinical study expenses	2,827,894	179,445
Depreciation and amortization	210,875
Travel expenses	100,383	13,138
Lab consumables	35,221	97
Other expenses	551,330	61,604
Research and development total	5,736,373	793,488
Sales and marketing [Member]
Operating Expenses (Details) - Schedule of Operating Expenses [Line Items]
Payroll expenses	707,833	370,597
Consulting services	1,143,077	123,333
Product and brand advertising	2,176,808	2,247,142
Other expenses	57,943	46,942
Sales and marketing total	4,085,661	2,788,014
General and administrative [Member]
Operating Expenses (Details) - Schedule of Operating Expenses [Line Items]
Payroll expenses	923,351	1,132,948
Stock option expense	1,668,673	4,894,450
Depreciation and amortization	246,710	62,369
Travel and car expenses	69,924	146,861
Consulting services	1,146,792	2,005,889
IT expense	107,101
Training	1,050	3,755
Insurance and taxes	478,149	529,120
Rent and Premises	77,672	83,732
Other expenses	159,929	266,083
General and administrative total	$ 4,879,351	$ 9,125,207

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Subsequent Events (Details)	6 Months Ended
	Jun. 30, 2023 USD ($) shares
Subsequent Events [Abstract]
Converted in principal value | $	$ 500,000
Ordinary shares net proceeds | shares	134,458