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, 2021 on Form 20-F, filed with the Securities and Exchange Commission on May 3, 2022. 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

Mainz Biomed N.V. was incorporated for the purpose of acquiring Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH). On August 3, 2021, we entered into a contribution agreement (the “Contribution Agreement”) with PharmGenomics GmbH. Under the Contribution Agreement, 100% of the shares of the PharmGenomics GmbH were acquired in exchange for 6,000,000 shares of Mainz Biomed N.V. Upon the closing of the Contribution Agreement on September 20, 2021, PharmGenomics GmbH became a wholly owned subsidiary of Mainz Biomed N.V., with the former shareholders of the PharmGenomics GmbH holding approximately 62% of the outstanding shares of Mainz Biomed N.V. at the closing of the Contribution Agreement.

Pursuant to the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13, we have determined that for accounting purposes the merger of Mainz BioMed N.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed N.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values. Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we refer to Mainz Biomed N.V. and its wholly owned subsidiaries, Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH) and Mainz Biomed USA, Inc., as “Mainz Biomed” or the “Company”.

We develop in-vitro diagnostic (“IVD”) tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. We additionally operate a clinical diagnostic laboratory. We develop and distribute our IVD kits to third party laboratories, who in turn provide diagnostic analysis for their patients. The majority of our revenues in 2022 comes from the sale of our IVD kits under the brand name ColoAlert™.

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

Revenue

Revenue for the six months ended June 30, 2022 was $239,805 as compared to $417,311 for the six months ended June 30, 2021, a decrease of $177,506. This decrease was the result of our ceasing third-party laboratory testing and lab support related to support of COVID-19 diagnostic testing during the pandemic, and other non-core sales. Our revenue attributable to ColoAlert was $238,255 for the six-month ended June 30, 2022, compared to $104,851 during the comparable period last year, an increase of 127%. Our ColoAlert revenue in both six-month periods 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.

Our revenue by product and service category is as follows:

Cost of Revenue

Cost of Revenue for the six months ended June 30, 2022 was $119,005 as compared to $64,772 for the six months ended June 30, 2021, an 84% increase. This increase was the result of increased ColoAlert sales volume.

Gross profit

Gross profit decreased to $120,800 from $352,539, for the six months ended June 30, 2022, as compared to the six months ended June 30, 2021. This gross profit decrease was due to the decrease in total revenue as the result of our ceasing third-party laboratory testing and lab support related to support of COVID-19 diagnostic testing during the pandemic.

Research and Development Expenses

Research and development expenses for the six months ended June 30, 2022 were $911,716 compared to $206,146 for the six months ended June 30, 2021, an increase of $705,570. This increase was driven by increases in labor costs and office and lab lease expenses to support our increased staffing. Labor costs (salary and consulting costs) increased by $506,781 for the six months ended June 30, 2022, compared to the same period in 2021. Lab and office expenses increased by $116,007 for the six months ended June 30, 2022, compared to the same period in 2021; and material used in our research programs was $71,503 in the six months ended June 30, 2022, and nil in the same period of 2021. Our increases in research and development expenses are the result of our continued development of our ColoAlert product and research related to our PancAlert product candidate.

Sales and Marketing Expenses

Sales and marketing expenses for the six months ended June 30, 2022, were $2,520,496 compared to $150,335 for the six months ended June 30, 2021, an increase of $2,370,161. This increase was the result of an increase in marketing and advertising expenses of approximately $2.2 million and an increase of $170,943 related to labor costs (salary and consulting) to support the sale of our ColoAlert product.

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2022 were $9,268,054 compared to $250,692 for the six months ended June 30, 2021, an increase of $9,017,362. The increased expenses were primarily the result of $4.9 million of non-cash stock option expense, , increases of $2.1 million related to labor costs (salary and consulting), and $1.6 million related to legal, banking, and accounting fees primarily related to our capital raising efforts.

Other Income (expense)

Other income (expense) for the six months ended June 30, 2022 was $22,981 compared to $7,087 for the six months ended June 30, 2021, resulting in increased other expenses (net) of $15,894.

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 equity financing. As of June 30, 2022, we had $26,006,609 of cash and cash equivalents, with $8,727,542 as of December 31, 2021.

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

Cash Flow from Operating Activities

For the six months ended June 30, 2022, cash flows used in operating activities was $6,456,904 compared to $132,530 used during the six months ended June 30, 2021. The increase in cash flows used in operating activities of $6,324,374 was primarily the result of our operating loss for the six months ended June 30, 2022, net of non-cash stock-based compensation, and timing differences for the settlement of assets and liabilities.

Cash Flows from Investing Activities

During the six months ended June 30, 2022, we used $252,446 in investing activities compared to $4,580 used during the year ended six months ended June 30, 2021. Cash used for investing activities in both periods was for the purchase of fixed assets and the build out of new lab and office space.

Cash Flows from Financing Activities

During the six months ended June 30, 2022, we had cash flow provided by financing activities of $24,091,651 compared to cash flow provided by financing activities of $217,029 for the six months ended June 30, 2021, an increase of $23,874,622. This increase was primarily the result of our sale of 1,725,000 ordinary shares on January 28, 2022, for net proceeds of $23,865,890.

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

Our revenue is primarily derived through providing selling 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).

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:

As of June 30, 2022, all of these criteria had been met, resulting in 100% of these options being 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.

Of the 1,484,650 stock options granted prior to this offering, 393,000 were granted with simple time-based vesting. Using the Black-Scholes method, we have estimated the compensation costs related to these options to be approximately $1.3 million, which will be recognized over the vesting period in our Condensed Interim Consolidated Statements of Profit and loss and Comprehensive Loss. The remaining options for our senior management team vest, as described above, based on milestones tied to increased shareholder value as measured by increases in our stock price. The accounting for the 1,091,650 options issued to our senior management team, were measured at the time of issuance ($10,861,918). During the six months ended June 30, 2022, $2,996,852 of this amount was expensed, and during the six months ended December 31, 2022, the remaining unamortized balance of $1,817,597 will be expensed. All expenses are or will be recorded in the Company’s Consolidated Statements of Profit and loss and Comprehensive Loss.

Lease Accounting

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

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

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

Financial Instruments

(a) Classification

The Company classifies its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as 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 the Company has opted to measure them at FVTPL.

(b) Measurement

Financial assets and liabilities at amortized cost

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

Financial assets and liabilities at FVTPL

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

Debt investments at FVTOCI

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

Equity investments at FVTOCI

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

Off-Balance Sheet Arrangements

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

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Exhibit 99.3

Mainz Biomed Reports First Half 2022 Financial Results

BERKELEY, US – MAINZ, Germany – September 7, 2022 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the first half of the fiscal year ended June 30, 2022.

Key Corporate & Product Development Highlights

“At the outset of 2022, we established ambitious commercial and product development objectives for the year, mostly around our flagship product ColoAlert. I’m pleased to report that we achieved all of our corporate growth goals for the first half period,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The Company is financially well positioned to maintain momentum as ColoAlert continues to gain impressive commercial traction across Europe and select international territories, and as we ramp up to launch its U.S. pivotal clinical trial by the end of the year.”

Commercial Update: ColoAlert continues to grow market presence via a unique business model

Throughout the first half of 2022, Mainz executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.

The Company hired former Abbott and Luminex executive Darin Leigh as its Chief Commercial Officer (April) to drive growth. Mr. Leigh brings over 30 years of In Vitro Diagnostic (IVD) and life science experience to Mainz and is currently responsible for driving ColoAlert’s market expansion in Europe and international territories.

The Company is pleased to report key commercial highlights during the first half of 2022, including announcing high-profile partnerships with leading laboratories such as Labor MVZ Dr. Stein + Kollegen, commonly referred to as “Laboratory Mönchengladbach” (February), covering the North Rhine-Westphalia region (NRW) of Germany, and Dante Labs (May) for Italy and the United Arab Emirates (UAE). Laboratory Mönchengladbach is one of the largest diagnostics laboratories in Germany, servicing over 2,500 physicians, processing over five million samples annually and screening approximately 1,000 patients per week specifically for CRC. Dante Labs is a global leader in genome sequencing with a product development and commercial franchise focused on providing preventive healthcare solutions to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions and operating a robust e-commerce platform. With the addition of Laboratory Mönchengladbach and Dante Labs, Mainz now has five core partnerships, including GANZIMMUN Diagnostics AG, one of Europe’s leading laboratories for preventive and complementary medicine which processes approximately 5,500 laboratory orders daily.

ColoAlert R&D Update: ColoFuture study evaluating acquired mRNA biomarkers

In June 2022, Mainz announced the first patient was enrolled in ColoFuture, an international multi-center clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. The mRNA biomarkers were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and precancerous lesion samples. The results from these studies demonstrated that the mRNA targets chosen by Mainz provided a market-leading combination of sensitivity and specificity of detection (Herring et al. 2021). The ColoFuture study is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to identify advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

The ColoFuture study is enrolling over 600 patients in the age range of 40-85, and the Company is targeting reporting study results in early 2023. If successful, ColoAlert will be positioned as the most robust and accurate at-home diagnostic screening test 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. Additionally, data results from ColoFuture will potentially be incorporated into ColoAlert’s pivotal U.S. clinical study.

ColoAlert’s U.S. Regulatory Approval Update: Pre-submission for pivotal trial design receives feedback from the FDA, and the medical reimbursement process launched with CMS

In March 2022, Mainz announced that it received supportive feedback from the U.S. Food & Drug Administration on its pre-submission package for ColoAlert. The Company will continue working with its clinical team to finalize the study’s protocols and prepare for the multi-center study, which is on track to commence in late 2022. As part of the Company’s activities to prepare for the initiation of the pivotal trial, Mainz also announced the formal commencement of its medical reimbursement process for ColoAlert by scheduling an initial meeting with the Centers for Medicare and Medicaid Services (CMS). CMS is a federal agency in the U.S. Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (CHIP), and health insurance portability standards.

PancAlert R&D Update: Novel screening test for pancreatic cancer achieved multiple preclinical milestones

In May, Mainz announced that PancAlert met multiple preclinical milestones that support the continued development of this potential first-in-class diagnostic for this deadly cancer indication. Multiple predefined milestones for the PancAlert project were accomplished, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of a prototype biomarker test. The Company is continuing PancAlert’s R&D to determine if a clinical trial is warranted.

PancAlert’s technical profile may include functioning as a stool-based test, mirroring the Company’s flagship product ColoAlert. Given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz will evaluate real-time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples and will also evaluate other collection methodologies including saliva, urine and blood.

The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.¹ It has one of the lowest cancer survival rates, with typically late detection and poor outcomes with standard-of-care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.² and 9% globally.³ However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative.

Corporate Update: Successful follow-on offering, key appointments to management team & Strategic Advisory Board of global leaders in molecular diagnostic development and commercialization

In January 2022, the Company announced a $25.8 million public follow-on offering consisting of 1,725,000 of ordinary shares priced at $15.00 per share.

Throughout the first half of 2022, the Company continued to bolster its leadership team highlighted by the appointments of former Abbott Diagnostics executive Steve Quinn as Vice President of Business Development (January) and Jane Edwards (June), as Vice President of Clinical Affairs. Ms. Edwards, who brings over 20 years of senior experience developing clinical trial strategies in diagnostics and medical devices, will lead all of the Company’s clinical trials in the U.S. and Europe including ColoAlert’s forthcoming U.S. pivotal study. An integral part of Mainz’s corporate operational methodology is access to a Strategic Advisory Board (SAB). To this end, Mainz appointed two high profile additions to the SAB in the first quarter of 2022: In January, Dr. Michele Pedrocchi joined, followed by the February appointment of Dr. Rainer Metzger. Dr. Pedrocchi is the former Head of Roche Diagnostics Business Development and brings to the SAB over 25 years of international experience at Roche spanning in vitro diagnostics, digital health, and personalized medicine. Dr. Metzger is a former Danaher, Roche and QIAGE executive with over 25 years of experience within the pharmaceutical and diagnostic industries.

References

Mainz Biomed N.V.

Condensed Consolidated Statements of Profit and Loss and Comprehensive Loss

For the Six Months Ended June 30, 2022 and 2021

(unaudited)

About ColoAlert

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements). The product is commercially available in a selection of countries in the European Union and in the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

About Pancreatic Cancer

Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.¹ It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.² and 9% globally.³ However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative

About Mainz Biomed N.V.

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. ColoAlert is currently marketed across Europe and in the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.

For more information, please visit www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its registration statement on Form F-1 filed on January 21, 2022. 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.

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