Groundbreaking topline results demonstrated sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%690 subjects analyzed including previously unexamined and reported patients from Company's ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI AlgorithmThe power to determine advanced adenoma, lesions in a pre-cancerous stage, can change the entire CRC diagnostic field, by treating the patient befo ...

PART I [Key Information](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section details significant investment risks, highlighting the company's early-stage, loss-making status and substantial doubt about its going concern ability, covering operational, technological, regulatory, and share-related factors [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) The company faces risks from operating losses, financing dependence, growth management, reliance on ColoAlert, market competition, regulatory hurdles including FDA approval, cybersecurity, and share price volatility with delisting potential - The company is an early-stage entity with a history of operating losses, reporting net losses of approximately **$26.3 million** in both 2023 and 2022. Its ability to achieve profitability is uncertain and depends on successfully marketing its diagnostic tests[36](index=36&type=chunk)[37](index=37&type=chunk) - The auditor's report for the fiscal year ended December 31, 2023, includes an explanatory paragraph indicating **substantial doubt about the company's ability to continue as a going concern** due to recurring losses and negative cash flows[46](index=46&type=chunk) - The company's future revenue is almost entirely dependent on the commercial success of its ColoAlert colon cancer screening test. Success hinges on factors like patient and physician acceptance, competition, and intellectual property protection[57](index=57&type=chunk) - The company must navigate complex and conflicting legal and regulatory requirements globally, including obtaining **FDA market authorization** to enter the U.S. market, which will require a large and costly clinical study (reconAAsense)[81](index=81&type=chunk)[90](index=90&type=chunk)[165](index=165&type=chunk) - The company's ordinary shares are subject to **significant price volatility** and the **risk of delisting from Nasdaq** if the minimum bid price remains below **$1.00** for an extended period. As of March 26, 2024, the closing price was **$1.01**[99](index=99&type=chunk)[118](index=118&type=chunk) [Information on the Company](index=29&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) Mainz Biomed develops and sells IVD tests for early cancer detection, primarily ColoAlert for colorectal cancer in Europe, while pursuing U.S. market entry and outlining its business, products, strategy, competition, and regulatory landscape [History and Development of the Company](index=29&type=section&id=A.%20History%20and%20development%20of%20the%20Company) Mainz Biomed N.V. was incorporated on March 8, 2021, acquired PharmGenomics GmbH on September 20, 2021, and converted to a Dutch public company on November 9, 2021 - The company was incorporated on March 8, 2021, and acquired PharmGenomics GmbH on September 20, 2021, before converting to a public company on November 9, 2021[121](index=121&type=chunk) [Business Overview](index=29&type=section&id=B.%20Business%20Overview) The company focuses on early cancer detection with ColoAlert for CRC in Europe, developing an enhanced version with mRNA biomarkers for improved sensitivity and planning a pivotal FDA study for U.S. market entry, while also developing PancAlert and facing competition - The company's flagship product is ColoAlert, a CE-IVD certified diagnostic test for colorectal cancer (CRC) being marketed in Europe. It is also developing PancAlert, a screening test for pancreatic cancer[124](index=124&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The company is enhancing ColoAlert by integrating novel mRNA biomarkers (UdeS Biomarkers) to improve detection of advanced adenomas. Clinical studies (ColoFuture and eAArly DETECT) have shown promising results, with the eAArly DETECT study reporting **97% sensitivity for CRC** and **82% for advanced adenomas**[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - The company's U.S. market entry strategy involves a pivotal FDA study named reconAAsense, a prospective clinical study planned to include approximately **15,000 subjects** from **150 sites** across the United States[165](index=165&type=chunk) - Mainz Biomed competes with traditional CRC screening methods like colonoscopy and FIT tests, as well as other diagnostic companies including Exact Sciences (Cologuard), Freenome, Guardant Health (Shield), and GRAIL (Galleri)[194](index=194&type=chunk)[208](index=208&type=chunk) - For the year ended December 31, 2023, one customer accounted for approximately **21% of revenue**. This is a decrease in concentration from 2022 (two customers, **38%**) and 2021 (four customers, **56%**)[204](index=204&type=chunk) [Organizational Structure](index=48&type=section&id=C.%20Organizational%20structure) Mainz Biomed N.V. operates through three wholly-owned subsidiaries: Mainz Biomed Germany GmbH, Mainz Biomed USA, Inc., and European Oncology Lab GmbH - The company has three wholly-owned subsidiaries: Mainz Biomed Germany GmbH, Mainz Biomed USA, Inc., and European Oncology Lab GmbH[209](index=209&type=chunk) [Property, Plant, and Equipment](index=50&type=section&id=D.%20Property,%20plant%20and%20equipment) The company leases approximately **22,400 sq. ft.** of office and lab space at its principal location in Mainz, Germany, with a total monthly rent and ancillary costs of approximately **€31,300** - The company leases approximately **22,400 sq. ft.** of office and lab space at its principal location in Mainz, Germany, with a total monthly rent and ancillary costs of approximately **€31,300**[210](index=210&type=chunk) [Operating and Financial Review and Prospects](index=50&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) This section analyzes the company's financial condition and operations, noting significant revenue growth in FY2023 offset by increased R&D expenses, resulting in continued net losses and a 'going concern' warning, with liquidity dependent on cash and future financing, and detailing key accounting policies [Results of Operations](index=50&type=section&id=Results%20of%20Operations) In 2023, revenue increased **69%** to **$895,479** and gross profit grew **180%** to **$509,659**, but R&D expenses rose **91%** to **$9.6 million**, leading to a net loss of **$26.3 million**, similar to 2022 Financial Performance Comparison (2023 vs. 2022) | Metric | 2023 | 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $895,479 | $529,877 | $365,602 | 69% | | **Gross Profit** | $509,659 | $182,151 | $327,508 | 180% | | **Gross Margin** | 57% | 34% | - | - | | **Research and Development** | $9,590,393 | $5,019,366 | $4,571,027 | 91% | | **Sales and Marketing** | $6,158,477 | $6,396,906 | ($238,429) | (4)% | | **General and Administrative** | $11,405,471 | $15,209,919 | ($3,804,448) | (25)% | | **Loss from Operations** | $(26,644,682) | $(26,444,040) | $91,609 | 1% | | **Net Loss** | $(26,295,727) | $(26,387,336) | $91,609 | 0% | - The **91% increase in R&D expenses** in 2023 was primarily due to a **$1.5 million increase in compensation costs** from higher headcount and a **$3.0 million increase** related to the ColoFuture and eAArly DETECT clinical studies[223](index=223&type=chunk) - The **25% decrease in G&A expenses** was mainly attributable to a **$5.6 million decrease in non-cash stock option expense**, partially offset by a **$1.7 million increase in consulting and professional fees**[225](index=225&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern ability due to recurring losses and negative operating cash flow, with cash on hand at **$7.1 million** as of December 31, 2023, and relies on future financing to fund operations - The company has an accumulated deficit of **$69.3 million** and negative operating cash flow of **$21.9 million** for the year ended Dec 31, 2023, raising **substantial doubt about its ability to continue as a going concern**[229](index=229&type=chunk) Cash Flow Summary (2023 vs. 2022) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | **Cash used in operating activities** | $(21,938,845) | $(14,769,590) | | **Cash (used in) investing activities** | $(1,898,841) | $(658,483) | | **Cash provided by financing activities** | $14,226,692 | $23,943,418 | - In 2023, the company raised **$16.5 million** through a combination of share and warrant sales and the issuance of convertible debt. Management believes current cash and future financing will be sufficient for at least the next year[231](index=231&type=chunk)[544](index=544&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=54&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The company's IFRS financial statements involve significant judgments, with critical policies covering revenue recognition based on delivery or test results, share-based compensation valuation using Black-Scholes or Monte Carlo models, and other areas like impairment and financial instrument valuation - Revenue from sales of testing kits to laboratory partners is recognized upon delivery. Revenue from sales to patients (end users) is deferred until the sample is returned and testing results have been delivered[239](index=239&type=chunk)[240](index=240&type=chunk) - Stock options with time-based vesting are valued using the Black-Scholes model, while those with market-based vesting conditions are valued using a Monte Carlo simulation[250](index=250&type=chunk) - The company continually evaluates long-lived assets for impairment when events indicate their carrying balance may not be recoverable, using undiscounted cash flow estimates[254](index=254&type=chunk) [Directors, Senior Management, and Employees](index=60&type=section&id=ITEM%206.%20DIRECTORS,%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section details the company's leadership, compensation, board structure, and employee base, including biographies of key executives and directors, compensation agreements, board committees, and employee count [Directors and Senior Management](index=60&type=section&id=A.%20Directors%20and%20Senior%20Management) The company is led by CEO Guido Baechler and a management team with extensive life sciences and diagnostics experience, complemented by an experienced board of directors Key Directors and Executive Officers | Name | Age | Position | | :--- | :--- | :--- | | Guido Baechler | 58 | Chief Executive Officer, Executive Director | | William Caragol | 57 | Chief Financial Officer | | Dr. Moritz Eidens | 41 | Chief Scientific Officer, Executive Director | | Dr. Heiner Dreismann | 70 | Non-Executive Director | | Darin Leigh | 56 | Chief Commercial Officer | [Compensation](index=68&type=section&id=B.%20Compensation) Executive compensation includes base salary and stock options, totaling **$2.435 million** in cash for **seven executives** in FY2023, with a new Carve-Out Plan approved in February 2024 for change of control payments and independent directors receiving **$228,000** in fees Aggregate Executive Compensation (FY 2023) | (U.S. dollars in thousands) | All executive officers | | :--- | :--- | | Base compensation | $1,859 | | Bonuses | $452 | | Additional benefit payments | $124 | | **Total cash compensation** | **$2,435** | - CEO Guido Baechler's agreement includes a base salary of **$450,000**, an annual bonus target of **50% of base salary**, and severance provisions[311](index=311&type=chunk) - In February 2024, the company approved a Carve-Out Plan (COP) for its US subsidiary. The plan creates a payment pool equal to **13% of the consideration** in a Change of Control event, to be distributed to key service providers[337](index=337&type=chunk)[338](index=338&type=chunk) - As of March 26, 2024, **2,727,150 stock options** have been granted under the company's Omnibus Incentive Plans[335](index=335&type=chunk) [Board Practices](index=76&type=section&id=C.%20Board%20Practices) The company operates with a one-tier board of **seven directors**, **five** of whom are independent, and has established Audit, Compensation, and Nominating Committees, with Nicole Holden as the audit committee financial expert - The board consists of **seven directors**, with **five deemed independent**: Dr. Alberto Libanori, Nicole Holden, Hans Hekland, Dr. Heiner Driesmann, and Gregory Tibbits[295](index=295&type=chunk)[344](index=344&type=chunk) - The board has three primary committees: Audit, Compensation, and Nominating, all comprised of independent directors[346](index=346&type=chunk) Board Diversity Matrix (As of March 26, 2024) | Gender Identity | Count | | :--- | :--- | | Female | 1 | | Male | 6 | | Non-Binary | 0 | | **Total Directors** | **7** | [Employees](index=80&type=section&id=D.%20Employees) As of March 26, 2024, the company had **71 employees**, primarily in Research & Development and Manufacturing/Clinical Laboratory, with no collective bargaining agreements Employee Breakdown by Activity (As of March 26, 2024) | Activity | Full-Time | Part-Time | Total | | :--- | :--- | :--- | :--- | | Manufacturing and Clinical Laboratory | 16 | 1 | 17 | | Research & Development | 26 | 2 | 28 | | Sales & Marketing | 10 | 2 | 12 | | Finance & Administration | 11 | 1 | 12 | | Executives | 2 | 0 | 2 | | **Total** | **65** | **6** | **71** | [Major Shareholders and Related Party Transactions](index=81&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section discloses beneficial ownership, with directors and executive officers holding **14.9%** and KfW **5.7%** of ordinary shares, and details related party transactions primarily limited to executive compensation and a historical licensing agreement Beneficial Ownership of Key Shareholders (as of March 26, 2024) | Name | Percentage of Ordinary Shares Beneficially Owned | | :--- | :--- | | Directors and Executive Officers as a Group (10 persons) | 14.9% | | Dr. Moritz Eidens (CSO, Executive Director) | 5.1% | | Kreditanstalt für Wiederaufbau (KfW) | 5.7% | - As of April 8, 2024, approximately **80% of ordinary shares** were held by **8 holders** with registered addresses in the United States, though this number is skewed by Cede & Co. holding **17.1 million shares** as a nominee[364](index=364&type=chunk) - Apart from executive employment agreements, the company has not entered into material transactions with related parties, except for historical agreements with ColoAlert AS, which is affiliated with director Hans Hekland[366](index=366&type=chunk) [Financial Information](index=82&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section references the company's IFRS consolidated financial statements, audited by Reliant CPA PC, and notes no material legal proceedings or dividend payments since incorporation - The company's financial statements for the year ended December 31, 2023, are prepared in accordance with IFRS and audited by Reliant CPA PC[368](index=368&type=chunk) - The company has never paid dividends and does not intend to pay any in the foreseeable future, retaining earnings for business operations and development[370](index=370&type=chunk) [The Offer and Listing](index=83&type=section&id=ITEM%209.%20THE%20OFFER%20AND%20LISTING) The company's ordinary shares are traded on the Nasdaq Capital Market under the symbol 'MYNZ' - The company's ordinary shares are listed on the Nasdaq Capital Market with the ticker symbol 'MYNZ'[372](index=372&type=chunk) [Additional Information](index=83&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) This section details the company's corporate structure and governance under Dutch law, summarizing articles of association, material contracts like the PharmGenomics and ColoAlert IP acquisitions, Dutch exchange controls, and tax considerations for shareholders [Memorandum and Articles of Association](index=83&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) The company is a Dutch public limited liability company with a one-tier board, authorized share capital of **45 million ordinary shares** and **5 million preferred shares**, and the Board is authorized to issue and repurchase shares and limit pre-emptive rights - The company has a one-tier board structure consisting of executive and non-executive directors[383](index=383&type=chunk) - Authorized share capital consists of **45,000,000 ordinary shares** and **5,000,000 preferred shares**, with no preferred shares currently outstanding[388](index=388&type=chunk) - The Board of Directors has been authorized by the general meeting until November 9, 2026, to issue shares up to the authorized capital and to limit or exclude pre-emptive rights[393](index=393&type=chunk)[396](index=396&type=chunk) [Material Contracts](index=90&type=section&id=C.%20Material%20Contracts) The company has key agreements including the September 2021 Contribution Agreement for PharmGenomics GmbH acquisition, the February 2023 Intellectual Property Asset Purchase Agreement for ColoAlert, and a Technology Rights Agreement for UdeS Biomarkers - On September 20, 2021, the company acquired PharmGenomics GmbH in exchange for **6,000,000 of its ordinary shares**[427](index=427&type=chunk) - On February 15, 2023, the company acquired the intellectual property for the ColoAlert test for **$2 million in cash** (paid over **four years**), **300,000 restricted shares**, and a revenue share of **$1 per test for 10 years**[433](index=433&type=chunk) - The company acquired the rights to the UdeS Biomarkers on February 15, 2023, in exchange for **€25,000 cash** and a **2% profit share** on net sales of any products using the biomarkers[437](index=437&type=chunk) [Taxation](index=92&type=section&id=E.%20Taxation) This subsection outlines Dutch tax consequences for shareholders, noting that dividends are generally subject to a **15% Dutch withholding tax** but are exempt if the company's effective management remains in Germany under the German-Dutch tax treaty, with potential Alternative Dividend Withholding Tax for low-tax jurisdictions - Dividends are generally subject to a **15% Dutch dividend withholding tax**. However, as long as the company's place of effective management remains in Germany, it is considered a German tax resident under the German-Dutch tax treaty and is generally exempt from this withholding requirement[442](index=442&type=chunk) - An Alternative Dividend Withholding Tax at the highest corporate rate (currently **25.8%**) may apply to dividends paid to related entities in designated low-tax jurisdictions, effective January 1, 2024, though the German tax residency provides a likely exemption[447](index=447&type=chunk)[448](index=448&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=97&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company faces foreign currency risk from non-Euro transactions, managed by holding cash in multiple currencies without hedging, and anticipates future interest rate risk from variable-rate debt, which would be managed dynamically - The company is exposed to foreign currency risk as its operations are conducted in Europe (functional currency Euro) while it holds cash and incurs expenses in U.S. dollars. It manages this by holding cash in both currencies but does not currently use hedging instruments[466](index=466&type=chunk)[54](index=54&type=chunk) - The company may be exposed to interest rate risk in the future if it takes on variable-rate debt. It plans to manage this risk through a dynamic hedging approach, potentially using interest rate swaps[468](index=468&type=chunk) PART II [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=98&type=section&id=ITEM%2014.%20MATERIAL%20MODIFICATIONS%20TO%20THE%20RIGHTS%20OF%20SECURITY%20HOLDERS%20AND%20USE%20OF%20PROCEEDS) A December 2022 amendment to the Articles of Association eliminated the right for shareholders with over **20% ownership** to nominate a director, and offering proceeds have been used for clinical studies, R&D, and general corporate purposes - A December 2022 amendment to the Articles of Association eliminated the right of shareholders holding over **20% of shares** to nominate a director[474](index=474&type=chunk) - Proceeds from offerings have been used for clinical studies for its next-gen CRC screening product, R&D, and general corporate purposes[478](index=478&type=chunk) [Controls and Procedures](index=98&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes during the fiscal year - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[480](index=480&type=chunk) - Based on the COSO 2013 framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[483](index=483&type=chunk) [Corporate Governance and Other Disclosures](index=99&type=section&id=ITEM%2016.%20Corporate%20Governance%20and%20Other%20Disclosures) This section covers governance and disclosures, identifying Nicole Holden as the audit committee financial expert, detailing the company's code of ethics and insider trading policy, outlining differences in Dutch versus Nasdaq governance practices, and describing its cybersecurity risk management framework [Audit Committee Financial Expert](index=99&type=section&id=ITEM%2016A.%20AUDIT%20COMMITTEE%20FINANCIAL%20EXPERT) The Board has determined that Nicole Holden, Chair of the Audit Committee, qualifies as an audit committee financial expert - The Board has identified Nicole Holden as the audit committee financial expert[488](index=488&type=chunk) [Principal Accountant Fees and Services](index=100&type=section&id=ITEM%2016C.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) In fiscal year 2023, the company was billed **$140,000** by its independent auditor, Reliant CPA PC, for audit and audit-related fees, an increase from **$105,000** in 2022 Auditor Fees (Reliant CPA PC) | Fee Type | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | $80,000 | $60,000 | | Audit-Related Fees | $50,000 | $45,000 | | Tax Fees | $0 | $0 | | **Total** | **$140,000** | **$105,000** | [Corporate Governance](index=101&type=section&id=ITEM%2016G.%20CORPORATE%20GOVERNANCE.) As a foreign private issuer, the company adheres to Dutch corporate governance practices, which differ from Nasdaq rules regarding quorum, proxy solicitation, and shareholder approval for security issuances - The company follows its home country (Dutch) governance practices, which differ from Nasdaq rules regarding quorum requirements, proxy solicitations, and shareholder approvals for certain security issuances[499](index=499&type=chunk)[502](index=502&type=chunk) [Cybersecurity](index=102&type=section&id=ITEM%2016K.%20CYBERSECURITY) The company manages cybersecurity risks through established policies and systems, overseen by the board and audit committee, with the VP of IT responsible for assessments, safeguards, training, and third-party vendor management - The company's board and audit committee oversee cybersecurity risk management[510](index=510&type=chunk) - The VP of Information Technology leads the cybersecurity program, which includes risk assessments, technical safeguards, employee training, and management of third-party vendor risks[511](index=511&type=chunk)[512](index=512&type=chunk) PART III [Financial Statements](index=104&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) This section presents the company's audited consolidated financial statements for 2023 and 2022, prepared under IFRS and audited by Reliant CPA PC, highlighting a **'Going Concern' issue** due to **significant operating losses** and detailing financial position, performance, and cash flows [Report of Independent Registered Public Accounting Firm](index=106&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Reliant CPA PC issued an opinion that the financial statements are fairly presented under IFRS, but included a **'Going Concern' paragraph** due to **significant operating losses** raising **substantial doubt about continued operations** - The auditor's report contains a **'Going Concern' paragraph**, citing the company's **significant operating losses** as a factor that raises **substantial doubt about its ability to continue operations**[522](index=522&type=chunk) [Consolidated Statements of Financial Position](index=107&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) As of December 31, 2023, total assets decreased to **$15.4 million** from **$20.2 million** in 2022, primarily due to reduced cash, while total liabilities increased to **$12.2 million**, and shareholders' equity decreased to **$3.2 million** Consolidated Statements of Financial Position (Expressed in US Dollars) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | $8,979,788 | $18,378,341 | | **Total Assets** | **$15,409,028** | **$20,241,003** | | **Total Current Liabilities** | $9,236,936 | $4,242,606 | | **Total Liabilities** | **$12,159,802** | **$6,144,936** | | **Total Shareholders' Equity** | **$3,249,226** | **$14,096,067** | [Consolidated Statements of Comprehensive Loss](index=108&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) For 2023, the company reported a net loss of **$26.3 million** on **$0.9 million** revenue, similar to the **$26.4 million** loss in 2022, with basic and diluted loss per share improving to **$(1.62)** Consolidated Statements of Comprehensive Loss (Expressed in US Dollars) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Revenue** | $895,479 | $529,877 | $577,348 | | **Loss from operations** | $(26,644,682) | $(26,444,040) | $(9,724,606) | | **Net loss** | **$(26,295,727)** | **$(26,387,336)** | **$(11,690,098)** | | **Basic and diluted loss per ordinary share** | $(1.62) | $(1.86) | $(1.62) | [Notes to the Consolidated Financial Statements](index=112&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) The notes detail the **'going concern' issue**, the February 2023 ColoAlert IP acquisition for **$2 million cash** and shares, the 2023 issuance of **$11 million** in convertible promissory notes, equity transactions including a **$5 million** offering, and related party transactions - **(Note 1)** The company has recurring losses, an accumulated deficit of **$69.3M**, and negative operating cash flow of **$21.9M** for FY2023, raising **substantial doubt about its ability to continue as a going concern**[543](index=543&type=chunk) - **(Note 9)** On Feb 15, 2023, the company acquired the IP for the ColoAlert test. The consideration included **$2M cash** (paid over **4 years**), **300,000 restricted shares**, and a revenue share of **$1 per test for 10 years**. An intangible asset was recognized with a **10-year useful life**[609](index=609&type=chunk) - **(Note 13)** In 2023, the company entered into a Pre-Paid Advance Agreement and sold two Promissory Notes with a total principal of **$11 million**. The notes are convertible at a variable price with a **$2.00 floor**. As of Dec 31, 2023, **$6.4 million in principal** was outstanding[625](index=625&type=chunk)[627](index=627&type=chunk)[633](index=633&type=chunk) - **(Note 16)** In November 2023, the company raised approximately **$5.0 million** in a registered direct offering, selling **4,166,667 units** (share and warrant) at a price of **$1.20 per unit**[647](index=647&type=chunk) - **(Note 23)** Subsequent to year-end, the company made payments on its convertible notes totaling **$858,415 in cash** and issued **721,093 ordinary shares** to reduce the outstanding principal and settle interest/premiums[678](index=678&type=chunk)

PART I This section details company identity, key information, business operations, and financial performance [ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS](index=7&type=section&id=ITEM%201.%20IDENTITY%20OF%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20ADVISERS) This section states that the information is not applicable [ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE](index=7&type=section&id=ITEM%202.%20OFFER%20STATISTICS%20AND%20EXPECTED%20TIMETABLE) This section states that the information is not applicable [ITEM 3. KEY INFORMATION](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section includes reserved items, capitalization, offer details, and critical risk factors [3.A. [Reserved]](index=7&type=section&id=3.A.%20%5BReserved%5D) This section is reserved and contains no information [3.B. Capitalization and Indebtedness](index=7&type=section&id=3.B.%20Capitalization%20and%20Indebtedness) This section states that the information is not applicable [3.C. Reasons for the offer and use of proceeds](index=7&type=section&id=3.C.%20Reasons%20for%20the%20offer%20and%20use%20of%20proceeds) This section states that the information is not applicable [3.D. Risk Factors](index=7&type=section&id=3.D.%20Risk%20Factors) This section details significant risks including operating losses, financing dependence, competition, and regulatory hurdles - The company is an early revenue stage company with recurring operating losses and negative cash flow since inception, reporting net losses of **$26,387,336 in 2022** and **$11,690,098 in 2021**[34](index=34&type=chunk)[35](index=35&type=chunk) - The auditor's opinion for the fiscal year ended December 31, 2022, includes an explanatory paragraph indicating substantial doubt about the company's ability to continue as a going concern due to recurring losses from operations and negative cash flows[41](index=41&type=chunk) - The company's success is heavily dependent on the commercial success of its ColoAlert screening test, which faces challenges from physician reluctance, competing diagnostic tests, and the need to establish and strengthen its brand[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) - The company is incorporated under Dutch law, and a substantial portion of its assets, officers, and directors reside outside the United States, which may limit the ability of U.S. investors to protect their interests through U.S. federal courts[42](index=42&type=chunk)[43](index=43&type=chunk) - The company expects to incur significant expenses and devote substantial management effort to comply with Section 404 of the Sarbanes-Oxley Act once it ceases to qualify as an 'emerging growth company'[100](index=100&type=chunk) [ITEM 4. INFORMATION ON THE COMPANY](index=22&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) This section outlines the company's history, business operations, organizational structure, and assets [4.A. History and development of the Company](index=22&type=section&id=4.A.%20History%20and%20development%20of%20the%20Company) Mainz Biomed N.V. was incorporated in the Netherlands on March 8, 2021, to acquire PharmGenomics GmbH, which it completed on September 20, 2021 - Mainz Biomed N.V. was incorporated on March 8, 2021, and acquired PharmGenomics GmbH on September 20, 2021[103](index=103&type=chunk) - The company converted into a Dutch public company on November 9, 2021, and its ordinary shares are registered under the Exchange Act[103](index=103&type=chunk)[104](index=104&type=chunk) [4.B. Business Overview](index=22&type=section&id=4.B.%20Business%20Overview) Mainz Biomed commercializes IVD tests, notably ColoAlert for CRC screening, and is developing PancAlert, with a strategy for market expansion and FDA approval - Mainz Biomed is a molecular genetic diagnostic company commercializing IVD tests, with its flagship product ColoAlert (CRC screening test) sold in Europe, and PancAlert (pancreatic cancer screening test) in early research[106](index=106&type=chunk)[109](index=109&type=chunk) - The company acquired the ColoAlert test and related intellectual property in February 2023 for **$2 million cash** (to be paid over four years), **300,000 ordinary restricted shares**, and a revenue share limited to **$1 per test sold** for a period of 10 years[119](index=119&type=chunk)[391](index=391&type=chunk) - In February 2023, the company acquired the UdeS Biomarkers for **€25,000 in cash** and a profit share of **2% of the net sales** of any products using these biomarkers, aiming to integrate them into ColoAlert to enhance sensitivity and specificity[121](index=121&type=chunk)[395](index=395&type=chunk) - Ongoing clinical studies include ColoFuture (international multi-center, 662 subjects, evaluating UdeS biomarkers for ColoAlert enhancement, enrollment by late 2023) and eAArly DETECT (U.S. multi-center, 450 subjects, feasibility and stability of UdeS biomarkers, enrollment H1 2023, topline results H1 2023)[123](index=123&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk] - ColoAlert has demonstrated a sensitivity of **85%** and a specificity of **92%** in an independent clinical test, with **98% patient satisfaction**, and the occult blood test component has since been updated to further increase accuracy[117](index=117&type=chunk)[128](index=128&type=chunk) - The addressable market for CRC screening in Europe is around **126 million individuals** (based on a 65% participation rate for 194 million people over 50), and in the United States, it is projected to increase from **$3.7 billion to over $5.2 billion annually** with new guidelines recommending screening from age 45[111](index=111&type=chunk)[112](index=112&type=chunk) - The company's strategy focuses on expanding the commercial opportunity of ColoAlert in Europe through commercial teams and partnerships, preparing for FDA market authorization in the U.S., and continuing research and development of PancAlert[129](index=129&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk)[138](index=138&type=chunk) - Research and development efforts are centered on developing PancAlert and initiating the ColoFuture study (expanded to eAArly DETECT in the U.S.) to evaluate UdeS biomarkers for ColoAlert enhancement[143](index=143&type=chunk)[144](index=144&type=chunk] - The company's global operations are subject to numerous and complex legal and regulatory requirements in Europe (IVDR) and the U.S. (FDA PMA for Class III IVD, CLIA, HIPAA, anti-fraud laws), which are costly and time-consuming to comply with[74](index=74&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk)[84](index=84&type=chunk)[147](index=147&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[166](index=166&type=chunk] [4.C. Organizational structure](index=35&type=section&id=4.C.%20Organizational%20structure) Mainz Biomed N.V. operates with two wholly-owned subsidiaries: Mainz Biomed Germany GmbH and Mainz Biomed USA, Inc - The company has two wholly-owned subsidiaries: Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH) and Mainz Biomed USA, Inc[178](index=178&type=chunk)[419](index=419&type=chunk] [4.D. Property, plant and equipment](index=35&type=section&id=4.D.%20Property%2C%20plant%20and%20equipment) The company's principal premises are located in Mainz, Germany, under a fifteen-year lease agreement from 2013, with additional leases added in 2022 - The company's principal premises are located in Mainz, Germany, under a fifteen-year lease agreement from 2013, with additional lease agreements entered into during 2022[179](index=179&type=chunk) - These facilities are used for administrative purposes, research and development, manufacturing of products, and analysis by laboratories, and are believed to satisfy the company's needs for the next 12 months[180](index=180&type=chunk) [ITEM 4A. UNRESOLVED STAFF COMMENTS](index=36&type=section&id=ITEM%204A.%20UNRESOLVED%20STAFF%20COMMENTS) This section states that the information is not applicable [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=36&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) This section analyzes financial condition and operations, highlighting increased net loss, expense growth, and going concern status [Organization and Overview of Operations](index=36&type=section&id=Organization%20and%20Overview%20of%20Operations) Mainz Biomed N.V. was incorporated in 2021 to acquire Mainz Biomed Germany GmbH, which became a wholly-owned subsidiary - Mainz Biomed N.V. acquired Mainz Biomed Germany GmbH in September 2021, which was treated as a reverse acquisition for accounting purposes[185](index=185&type=chunk)[186](index=186&type=chunk] - The company's primary revenue source is expected to be the sale of its ColoAlert product, having terminated its COVID-19 testing revenue stream prior to the start of 2022[187](index=187&type=chunk) - The company completed an initial public offering in November 2021, raising **$11,500,000 in gross proceeds**, and a follow-on public offering in January 2022, raising **$25,875,000 in gross proceeds**[189](index=189&type=chunk)[207](index=207&type=chunk] [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Revenue decreased by 8% in 2022, while operating expenses surged 170%, resulting in a 126% higher net loss Selected Financial Information (Year Ended December 31, 2022 vs. 2021) | Metric | 2022 (USD) | 2021 (USD) | Change (USD) | % Change | | :-------------------------- | :----------- | :----------- | :----------- | :------- | | Revenue | 529,877 | 577,348 | (47,471) | (8)% | | Cost of revenue | 347,726 | 399,726 | (52,000) | (13)% | | Gross profit | 182,151 | 177,622 | 4,529 | 3% | | Gross profit percentage | 34.4% | 30.8% | | | | Research and Development | 3,660,495 | 466,689 | 3,193,806 | 684% | | Sales and Marketing | 5,702,143 | 957,522 | 4,744,621 | 496% | | General and Administrative | 17,328,942 | 8,478,017 | 8,850,925 | 104% | | Total operating expenses | 26,691,580 | 9,902,228 | 16,789,352 | 170% | | Loss from operations | (26,509,429) | (9,724,606) | (16,784,823) | 173% | | Net loss | (26,387,336) | (11,690,098) | (14,697,238) | 126% | | Basic and dilutive loss per common share | (1.86) | (1.62) | (0.24) | (15)% | | Weighted average number of common shares outstanding | 14,157,492 | 7,210,889 | 6,946,603 | 96% | Revenue by Product and Service Category (Year Ended December 31, 2022 vs. 2021) | Category | 2022 (USD) | 2021 (USD) | | :-------------------------- | :----------- | :----------- | | ColoAlert | 519,728 | 226,438 | | Covid-19 Testing | - | 233,662 | | Research use only product sales | - | 48,886 | | Other revenue | 10,149 | 68,362 | | **Total Revenue** | **529,877** | **577,348** | - Research and development expenses increased by **$3,193,806 (684%)** in 2022, primarily due to an increase in headcount from three to 29 employees, leading to higher compensation, lab and office expenses, and materials for clinical studies[195](index=195&type=chunk)[196](index=196&type=chunk] - Sales and marketing expenses increased by **$4,744,621 (496%)** in 2022, mainly attributable to a **$4.3 million increase** in advertising and marketing for ColoAlert in Germany and Europe, and a **$0.4 million increase** in compensation due to headcount growth from two to seven employees[197](index=197&type=chunk) - General and administrative expenses increased by **$8,850,925 (104%)** in 2022, driven by a **$2.5 million increase** in stock option expense, a **$2.9 million increase** in salaries and benefits from senior management expansion, and **$2.4 million** in consulting and professional fees related to capital raising[198](index=198&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) Operating cash outflow increased to $14.77 million in 2022, funded by $23.94 million from financing, addressing going concern - Net cash flows used in operating activities increased by **$11,459,266** to **$14,769,590** for the year ended December 31, 2022, primarily due to the increase in net loss[204](index=204&type=chunk)[205](index=205&type=chunk] - Cash provided by financing activities was **$23,943,418** in 2022, primarily attributable to a follow-on public offering in January 2022 for **$25.9 million** and proceeds of **$0.4 million** from warrant exercises[204](index=204&type=chunk)[207](index=207&type=chunk] - The company had **$17,141,775 of cash on hand** at December 31, 2022, and believes this, combined with its ability to raise additional capital, will sufficiently fund its planned expenditures and obligations for at least one year, despite recurring losses and negative operating cash flows[202](index=202&type=chunk)[490](index=490&type=chunk] Cash Flow Summary (Year Ended December 31, 2022 vs. 2021) | Activity | 2022 (USD) | 2021 (USD) | Change (USD) | | :----------------------------------- | :----------- | :----------- | :----------- | | Cash used in operating activities | (14,769,590) | (3,220,324) | (11,549,266) | | Cash provided by (used in) investing activities | (658,483) | 1,203,151 | 1,861,634 | | Cash provided by financing activities | 23,943,418 | 10,610,534 | 13,332,884 | [Critical Accounting Policies and Significant Judgments and Estimates](index=40&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section details critical accounting policies and estimates for revenue, currency, stock options, leases, and financial instruments - The company's most critical accounting policies and estimates relate to Revenue Recognition (IFRS 15), Foreign Currency Translation (Euro functional, USD presentation), Stock Option Compensation (Black-Scholes, Monte Carlo), Lease Accounting (IFRS 16, using incremental borrowing rate), and Financial Instruments[209](index=209&type=chunk)[210](index=210&type=chunk)[214](index=214&type=chunk)[222](index=222&type=chunk)[224](index=224&type=chunk)[227](index=227&type=chunk)[506](index=506&type=chunk)[514](index=514&type=chunk)[522](index=522&type=chunk)[534](index=534&type=chunk)[544](index=544&type=chunk] - Revenue from sales to laboratory partners is recognized upon delivery, while sales to patients (end users) are recognized when samples are delivered to the lab, tested, and results are delivered to the end user[212](index=212&type=chunk)[508](index=508&type=chunk] - Stock options with time-based vesting are valued using the Black-Scholes method, and those with milestone-based vesting criteria are valued using a Monte Carlo simulation, with compensation expense recorded over the vesting period[222](index=222&type=chunk)[223](index=223&type=chunk)[535](index=535&type=chunk] Contractual Obligations (as of December 31, 2022) | Contractual Obligation | Less than One Year (USD) | 1 – 3 Years (USD) | 3 – 5 Years (USD) | Over 5 Years (USD) | | :--------------------- | :----------------------- | :---------------- | :---------------- | :----------------- | | Office Rent | 164,053 | 401,852 | 314,412 | 174,941 | | Laboratory Equipment | 124,560 | 176,731 | 740 | - | | Automobiles | 35,341 | 46,580 | 6,359 | - | | Office Equipment | 14,800 | 27,004 | 11,733 | - | | **TOTAL** | **338,754** | **652,167** | **333,244** | **174,941** | [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=44&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section outlines the company's directors, senior management, compensation, board structure, and employee details [6.A. Directors and Senior Management](index=44&type=section&id=6.A.%20Directors%20and%20Senior%20Management) The company's leadership includes Guido Baechler (CEO), William Caragol (CFO), Dr. Moritz Eidens (CSO), Philipp Freese (COO), and Darin Leigh (CCO), along with five independent non-executive directors - Key management personnel include Guido Baechler (Chief Executive Officer), William Caragol (Chief Financial Officer), Dr. Moritz Eidens (Chief Scientific Officer), Philipp Freese (Chief Operating Officer), and Darin Leigh (Chief Commercial Officer)[234](index=234&type=chunk) - The Board of Directors consists of seven directors, five of whom qualify as 'independent' according to Nasdaq Stock Market rules[258](index=258&type=chunk)[301](index=301&type=chunk] [6.B. Compensation](index=48&type=section&id=6.B.%20Compensation) Executive compensation aligns with shareholder interests, comprising base salary and stock options, with total cash compensation of $1.51 million in FY2022 - Executive compensation policies and practices are designed to align management incentives with long-term shareholder interests, consisting of base salary and long-term incentives in the form of stock options[264](index=264&type=chunk)[265](index=265&type=chunk)[267](index=267&type=chunk] Summary Compensation for All Executive Officers (FY2022) | Component | Amount (USD in thousands) | | :-------------------------- | :------------------------ | | Base compensation | 1,229,400 | | Bonuses | 170,002 | | Additional benefit payments | 111,314 | | **Total cash compensation** | **1,510,716** | - As of April 4, 2023, **2,399,150 stock options** were awarded under the Plans, with strike prices ranging from **$5.00 to $20.87** and a weighted average strike price of **$7.20**[295](index=295&type=chunk)[296](index=296&type=chunk] - Independent directors received an aggregate of **$130,250** for their services in fiscal year 2022, with a quarterly fee of **$10,500** for directors and **$15,000** for the Board Chairman[298](index=298&type=chunk) [6.C. Board Practices](index=54&type=section&id=6.C.%20Board%20Practices) The company has a one-tier board structure with two executive and five non-executive directors, elected by the general meeting - The company has a one-tier board structure consisting of two executive directors and five non-executive directors, who are elected by the general meeting upon a binding nomination[338](index=338&type=chunk)[340](index=340&type=chunk] - Three committees have been established under the board of directors: an Audit Committee (Chair: Nicole Holden, financial expert), a Compensation Committee (Chair: Dr. Heiner Dreismann), and a Nominating Committee (Chair: Gregory Tibbitts), each comprised of independent directors[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk)[441](index=441&type=chunk] - An informal Strategic Advisory Board, currently with three members, assists the Board of Directors in setting strategies, achieving goals, and analyzing opportunities[303](index=303&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk] [6.D. Employees](index=56&type=section&id=6.D.%20Employees) As of April 4, 2023, the company had 58 full-time and 6 part-time employees across manufacturing, R&D, sales & marketing, finance & administration, and executives Employee Breakdown by Activity (as of April 4, 2023) | Activity | Number of Full-Time Employees | Number of Part-Time Employees | | :-------------------------- | :---------------------------- | :---------------------------- | | Manufacturing and Clinical Laboratory | 12 | 1 | | Research & Development | 29 | 3 | | Sales & Marketing | 7 | 2 | | Finance & Administration | 5 | 1 | | Executives | 5 | 0 | | **Total** | **58** | **6** | [6.E. Share Ownership](index=56&type=section&id=6.E.%20Share%20Ownership) This section refers to Item 7 for shareholdings of officers and directors and states that officers and directors do not hold any other convertible securities besides stock options - The shareholdings of officers and directors are set out in Item 7[314](index=314&type=chunk) - Officers and directors do not hold any other securities convertible into ordinary shares, apart from stock options[315](index=315&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=57&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section identifies major shareholders and details transactions involving related parties [7.A. Major Shareholders](index=57&type=section&id=7.A.%20Major%20Shareholders) Major shareholders include institutional and individual investors, with directors and officers owning 23.2% of shares Beneficial Ownership of Ordinary Shares (as of April 4, 2023) | Name | Ordinary Shares Beneficially Owned | Percentage of Ordinary Shares Beneficially Owned | | :------------------------------------------------- | :------------------------------- | :--------------------------------------------- | | Guido Baechler, CEO, Executive Director | 722,357 | 4.7% | | William Caragol, CFO | 175,950 | 1.2% | | Dr. Moritz Eidens, CSO, Executive Director | 1,124,577 | 7.5% | | Philipp Freese, COO | 360,201 | 2.4% | | Darin Leigh, CCO | 57,500 | 0.4% | | Dr. Heiner Dreismann, Non-Executive Director | 78,000 | 0.5% | | Dr. Alberto Libanori, Non-Executive Director | 25,000 | 0.2% | | Hans Hekland, Non-Executive Director | 1,147,885 | 7.7% | | Nicole Holden, Non-Executive Director | 25,000 | 0.2% | | Gregory Tibbits, Non-Executive Director | - | -% | | **Directors and Executive Officers as a Group (Ten Persons)** | **3,716,470** | **23.2%** | | Kreditanstalt für Wiederaufbau | 1,237,501 | 8.4% | | Coloalert AS | 1,121,427 | 7.6% | - Approximately **7,821,777 ordinary shares**, accounting for about **52.8% of outstanding shares** as of April 4, 2023, are held by eight record holders in the United States, including Cede & Co. as nominee for The Depository Trust Company[318](index=318&type=chunk) [7.B. Related Party Transactions](index=58&type=section&id=7.B.%20Related%20Party%20Transactions) Beyond employment/consulting agreements and the ColoAlert IP acquisition, the company has immaterial, arms'-length service arrangements with immediate family members of its COO and CSO - The company has immaterial, arms'-length service arrangements with the wife of its Chief Operating Officer (approximately **€5,400 per year**, ended June 2022) and the wife of its Chief Scientific Officer (approximately **€42,000 per year**)[320](index=320&type=chunk) [7.C. Interests of Experts and Counsel](index=58&type=section&id=7.C.%20Interests%20of%20Experts%20and%20Counsel) This section states that the information is not applicable [ITEM 8. FINANCIAL INFORMATION](index=58&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section presents consolidated financial statements, other financial data, and reports significant changes [8.A. Consolidated Statements and Other Financial Information](index=58&type=section&id=8.A.%20Consolidated%20Statements%20and%20Other%20Financial%20Information) FY2022 IFRS financial statements are audited, with no material legal proceedings or planned dividends - The company's financial statements for the year ended December 31, 2022, have been prepared in accordance with IFRS and are included under Item 18, audited by Reliant CPA PC[322](index=322&type=chunk) - The company is not currently a party to any material litigation or legal proceedings[323](index=323&type=chunk) - The company has not paid any dividends and does not intend to declare or pay any cash dividends in the foreseeable future, planning to retain all future earnings for business operation and development[324](index=324&type=chunk) [8.B. Significant Changes](index=59&type=section&id=8.B.%20Significant%20Changes) This section states that no significant changes have occurred since the date of the consolidated financial statements, except as disclosed in the Form 20-F [ITEM 9. THE OFFER AND LISTING](index=59&type=section&id=ITEM%209.%20THE%20OFFER%20AND%20LISTING) This section details the company's offer, listing on Nasdaq, market information, and related expenses [9.A. Offer and Listing](index=59&type=section&id=9.A.%20Offer%20and%20Listing) The company's ordinary shares are traded on the Nasdaq Capital Market under the symbol "MYNZ" - The company's ordinary shares are traded on the Nasdaq Capital Market under the symbol "MYNZ"[327](index=327&type=chunk) [9.B. Plan of Distribution](index=59&type=section&id=9.B.%20Plan%20of%20Distribution) This section states that the information is not applicable [9.C. Markets](index=59&type=section&id=9.C.%20Markets) This section refers to Section 9.A for market information [9.D. Selling Shareholders](index=59&type=section&id=9.D.%20Selling%20Shareholders) This section states that the information is not applicable [9.E. Dilution](index=59&type=section&id=9.E.%20Dilution) This section states that the information is not applicable [9.F. Expenses of the Issue](index=59&type=section&id=9.F.%20Expenses%20of%20the%20Issue) This section states that the information is not applicable [ITEM 10. ADDITIONAL INFORMATION](index=59&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) This section provides additional details on share capital, corporate governance, material contracts, and tax implications [10.A. Share Capital](index=59&type=section&id=10.A.%20Share%20Capital) This section states that the information is not applicable [10.B. Memorandum and Articles of Association](index=59&type=section&id=10.B.%20Memorandum%20and%20Articles%20of%20Association) The company is a Dutch public company with a one-tier board, 45 million authorized ordinary shares, and shareholder pre-emptive rights - The company was incorporated on March 8, 2021, as a private limited liability company under Dutch law and converted into a Dutch public company with limited liability on November 9, 2021[335](index=335&type=chunk) - The authorized share capital consists of **45,000,000 ordinary shares** with a nominal value of **EUR 0.01 per share** and **5,000,000 preferred shares** with a nominal value of **EUR 0.01 per share**, with no preferred shares currently outstanding[343](index=343&type=chunk) - Holders of ordinary shares have pre-emptive rights in relation to newly issued ordinary shares under Dutch law, which can be restricted or excluded by a resolution of the general meeting (requiring a two-thirds majority if less than half of the issued share capital is present) or by the Board of Directors if authorized[349](index=349&type=chunk)[350](index=350&type=chunk] - The general meeting, based on a proposal from the Board of Directors, may resolve to amend the articles of association (requiring an absolute majority of votes cast) or dissolve the company (requiring an absolute majority of votes cast)[379](index=379&type=chunk)[380](index=380&type=chunk] [10.C. Material Contracts](index=66&type=section&id=10.C.%20Material%20Contracts) Material contracts include the PharmGenomics acquisition, ColoAlert IP purchase, UdeS Biomarkers IP acquisition, and various silent partnership loans - On September 20, 2021, the company acquired PharmGenomics GmbH pursuant to a Contribution Agreement, issuing **6,000,000 ordinary shares** in exchange for all outstanding shares of PharmGenomics[385](index=385&type=chunk) - On February 15, 2023, the company acquired the intellectual property for the ColoAlert test through an Intellectual Property Asset Purchase Agreement, for **$2 million cash** (paid over four years), **300,000 ordinary restricted shares**, and a revenue share limited to **$1 per test sold** for 10 years, superseding previous licensing and option agreements[391](index=391&type=chunk)[612](index=612&type=chunk] - On February 15, 2023, the company acquired the intellectual property rights associated with the UdeS Biomarkers for **€25,000 in cash** and a profit share of **2% of the net sales** of any products using these biomarkers[395](index=395&type=chunk)[614](index=614&type=chunk] - The company has entered into various silent partnership (loan) agreements with different investors, featuring varying interest rates, maturity dates, and profit-sharing clauses, some with options for additional payments at maturity[396](index=396&type=chunk) [10.D. Exchange Controls](index=68&type=section&id=10.D.%20Exchange%20Controls) There are no Dutch laws restricting capital export/import or dividend remittances to non-resident holders, other than withholding tax requirements - There are no Dutch laws or governmental decrees restricting the export or import of capital, or affecting the remittance of dividends, interest, or other payments to a non-resident holder of ordinary shares, other than withholding tax requirements[396](index=396&type=chunk) [10.E. Taxation](index=69&type=section&id=10.E.%20Taxation) This section details Dutch tax implications for ordinary shares, including dividend withholding, income, capital gains, gift, and inheritance taxes - Dividends distributed by the company are generally subject to a **15% Dutch dividend withholding tax**, but the company is in principle not required to withhold this tax as long as its place of effective management remains in Germany, according to the German-Dutch tax treaty[399](index=399&type=chunk) - Dutch Resident Individuals are subject to income tax on benefits derived from shares at progressive rates if attributable to an enterprise, or an annual income tax on a deemed return on the net value of investment assets (up to **6.17% in 2023**, taxed at a flat rate of **32%**)[407](index=407&type=chunk)[408](index=408&type=chunk] - Dutch Resident Entities are subject to Dutch corporate income tax on benefits and capital gains from shares at a rate of **19%** for taxable profits up to **€200,000** and **25.8%** for amounts exceeding that (2023 rates)[409](index=409&type=chunk) - Non-residents of the Netherlands are generally not subject to Dutch taxes on income or capital gains in respect of shares, provided they do not have a Dutch enterprise or derive benefits from activities in the Netherlands that go beyond ordinary asset management[410](index=410&type=chunk) [10.F. Dividends and Paying Agents](index=73&type=section&id=10.F.%20Dividends%20and%20Paying%20Agents) This section states that the information is not applicable [10.G. Statements by Experts](index=73&type=section&id=10.G.%20Statements%20by%20Experts) This section states that the information is not applicable [10.H. Documents on Display](index=73&type=section&id=10.H.%20Documents%20on%20Display) Documents referred to in the annual report can be inspected at the company's offices in Mainz, Germany, and at the SEC's public reference facility or website (www.sec.gov) - Documents referred to in this annual report may be inspected at the company's offices in Mainz, Germany, and at the SEC's public reference facility or website (www.sec.gov)[417](index=417&type=chunk) [10.I. Subsidiary Information](index=74&type=section&id=10.I.%20Subsidiary%20Information) The company has two wholly-owned subsidiaries: Mainz Biomed Germany GmbH and Mainz Biomed USA, Inc - The company has two wholly-owned subsidiaries: Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH) and Mainz Biomed USA, Inc[419](index=419&type=chunk) [ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=74&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company faces foreign currency risk (USD, Euro) and potential interest rate risk, managed through cash holdings and dynamic hedging - The company is exposed to foreign currency risk on borrowings, investments, sales, purchases, royalties, licenses, management fees, and interest expense/income denominated in currencies other than the functional currency (Euro), managed by holding cash deposits in both U.S. dollars and Euro[421](index=421&type=chunk) - In the future, the company may be exposed to interest rate risk on variable-rate interest-bearing financial liabilities and plans to apply a dynamic interest rate hedging approach, potentially entering into interest rate swap agreements[423](index=423&type=chunk) [ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES](index=74&type=section&id=ITEM%2012.%20DESCRIPTION%20OF%20SECURITIES%20OTHER%20THAN%20EQUITY%20SECURITIES) This section states that the information is not applicable PART II This section addresses defaults, security holder rights, internal controls, audit committee, ethics, and corporate governance [ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES](index=75&type=section&id=ITEM%2013.%20DEFAULTS%2C%20DIVIDEND%20ARREARAGES%20AND%20DELINQUENCIES) This section states that there have been no defaults with respect to dividends, arrearages, or delinquencies since incorporation [ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS](index=75&type=section&id=ITEM%2014.%20MATERIAL%20MODIFICATIONS%20TO%20THE%20RIGHTS%20OF%20SECURITY%20HOLDERS%20AND%20USE%20OF%20PROCEEDS) Articles of Association were amended, and $33.89 million net proceeds from offerings were used for clinical studies and R&D - On December 15, 2022, the Articles of Association were amended, eliminating the right of shareholders holding more than **20% of outstanding shares** from nominating a director[430](index=430&type=chunk) - The company received approximately **$10,358,750 in net proceeds** from its November 2021 initial public offering and approximately **$23,529,700 in net proceeds** from its January 2022 public offering[431](index=431&type=chunk)[432](index=432&type=chunk] - As of the date of this annual report, approximately **$10 million of net proceeds** remained from these offerings, primarily used for the design and structure of European and U.S. clinical studies for ColoAlert, research and development, recruitment of commercial personnel, and general corporate purposes[433](index=433&type=chunk) [ITEM 15. CONTROLS AND PROCEDURES](index=75&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) This section details the effectiveness of disclosure controls and management's report on internal control over financial reporting [15.A. Disclosure Controls and Procedures](index=75&type=section&id=15.A.%20Disclosure%20Controls%20and%20Procedures) As of December 31, 2022, the CEO and CFO concluded that the company's disclosure controls and procedures were effective, designed to ensure timely and accurate reporting of required information - As of December 31, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[435](index=435&type=chunk) [15.B. Management's Annual Report On Internal Control Over Financial Reporting](index=75&type=section&id=15.B.%20Management%27s%20Annual%20Report%20On%20Internal%20Control%20Over%20Financial%20Reporting) Management, under CEO and CFO supervision, assessed the effectiveness of internal control over financial reporting as of December 31, 2022, based on the COSO 2013 framework, and concluded it was effective - Management, under the supervision of the CEO and CFO, assessed the effectiveness of internal control over financial reporting as of December 31, 2022, based on the COSO (2013) framework, and concluded it was effective[438](index=438&type=chunk) [15.C. Attestation report of the registered public accounting firm](index=76&type=section&id=15.C.%20Attestation%20report%20of%20the%20registered%20public%20accounting%20firm) This section states that the information is not applicable [15.D. Changes In Internal Control Over Financial Reporting](index=76&type=section&id=15.D.%20Changes%20In%20Internal%20Control%20Over%20Financial%20Reporting) No changes to internal controls over financial reporting occurred during FY2022 that materially affected or are reasonably likely to materially affect them - No changes were made to the company's internal controls over financial reporting during the fiscal year ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, them[440](index=440&type=chunk) [ITEM 16. [RESERVED]](index=76&type=section&id=ITEM%2016.%20%5BRESERVED%5D) This section is reserved and contains no information [ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT](index=76&type=section&id=ITEM%2016A.%20AUDIT%20COMMITTEE%20FINANCIAL%20EXPERT) The Audit Committee consists of three independent non-executive directors: Nicole Holden (Chair), Gregory Tibbits, and Dr. Alberto Libanori - Nicole Holden, an independent non-executive director, qualifies as an "audit committee financial expert" within the meaning of SEC rules and chairs the Audit Committee[441](index=441&type=chunk) [ITEM 16B. CODE OF ETHICS](index=76&type=section&id=ITEM%2016B.%20CODE%20OF%20ETHICS) The company adopted a Code of Ethics and Business Conduct on October 26, 2021, applicable to directors, officers, and employees - The company adopted a Code of Ethics and Business Conduct on October 26, 2021, which applies to its directors, officers, and other employees[442](index=442&type=chunk) [ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES](index=76&type=section&id=ITEM%2016C.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Reliant CPA PC replaced BF Borgers CPA P.C. as auditor, with BF Borgers billing $86,000 in fees for FY2022 - Reliant CPA PC was appointed as the independent registered public accounting firm on January 17, 2023, replacing BF Borgers CPA P.C[443](index=443&type=chunk)[451](index=451&type=chunk] Principal Accountant Fees and Services (FY2022 vs. FY2021) | Firm | Category | 2022 (USD) | 2021 (USD) | | :----------------- | :----------------- | :--------- | :--------- | | BF Borgers CPA P.C. | Audit Fees | 60,000 | 45,000 | | | Audit Related Fees | 26,000 | 8,600 | | | Tax Fees | 0 | 0 | | | **Total** | **86,000** | **53,600** | | Reliant CPA PC | Audit Fees | 0 | 0 | | | Audit Related Fees | 0 | 0 | | | Tax Fees | 0 | 0 | | | **Total** | **0** | **0** | - The Audit Committee's policy is to pre-approve all audit and permissible non-audit services to be performed by the independent auditors[448](index=448&type=chunk) [ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES](index=77&type=section&id=ITEM%2016D.%20EXEMPTIONS%20FROM%20THE%20LISTING%20STANDARDS%20FOR%20AUDIT%20COMMITTEES) This section states that the information is not applicable [ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS](index=77&type=section&id=ITEM%2016E.%20PURCHASES%20OF%20EQUITY%20SECURITIES%20BY%20THE%20ISSUER%20AND%20AFFILIATED%20PURCHASERS) This section states that there were no purchases of equity securities by the issuer and affiliated purchasers [ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT.](index=77&type=section&id=ITEM%2016F.%20CHANGE%20IN%20REGISTRANT%27S%20CERTIFYING%20ACCOUNTANT.) Reliant CPA PC replaced BF Borgers CPA P.C. as the independent registered public accounting firm on January 17, 2023, as previously disclosed - Reliant CPA PC replaced BF Borgers CPA P.C. as the independent registered public accounting firm on January 17, 2023, a change previously disclosed in a Form 6-K filing[451](index=451&type=chunk) [ITEM 16G. CORPORATE GOVERNANCE.](index=78&type=section&id=ITEM%2016G.%20CORPORATE%20GOVERNANCE.) As a foreign private issuer, the company follows Dutch corporate governance, differing from Nasdaq rules on quorum and shareholder approvals - As a "foreign private issuer," the company follows Dutch corporate governance practices, which differ from Nasdaq standards regarding quorum requirements for general meetings, solicitation of proxies, and shareholder approval for certain security issuances[452](index=452&type=chunk)[454](index=454&type=chunk] [ITEM 16H. MINE SAFETY DISCLOSURE.](index=78&type=section&id=ITEM%2016H.%20MINE%20SAFETY%20DISCLOSURE.) This section states that the information is not applicable [ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS](index=78&type=section&id=ITEM%2016I.%20DISCLOSURE%20REGARDING%20FOREIGN%20JURISDICTIONS%20THAT%20PREVENT%20INSPECTIONS) This section states that the information is not applicable PART III This section presents the company's audited financial statements and a list of all filed exhibits [ITEM 17. FINANCIAL STATEMENTS](index=79&type=section&id=ITEM%2017.%20FINANCIAL%20STATEMENTS) This section states that the information is not applicable [ITEM 18. FINANCIAL STATEMENTS](index=79&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) This section presents audited IFRS financial statements for 2020-2022, including auditor's going concern warning and detailed notes [Report of Independent Registered Public Accounting Firm (Reliant CPA PC)](index=81&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm%20(PCAOB%20ID%3A%206906)) Reliant CPA PC issued an unmodified opinion on FY2022/2021 IFRS financials, noting going concern doubt - Reliant CPA PC issued an unmodified opinion on the consolidated financial statements for December 31, 2022, and 2021, stating they present fairly in all material respects, in conformity with International Financial Reporting Standards (IFRS)[463](index=463&type=chunk) - The auditor's opinion includes an explanatory paragraph indicating substantial doubt about the company's ability to continue as a going concern due to recurring losses from operations and net operating cash outflows during 2022 and 2021[464](index=464&type=chunk) [Report of Independent Registered Public Accounting Firm (BF Borgers CPA PC)](index=82&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm%20(PCAOB%20ID%3A%205041)) BF Borgers CPA PC audited the consolidated financial statements for FY2020, expressing an unmodified opinion that they present fairly in all material respects, in conformity with IFRS - BF Borgers CPA PC issued an unmodified opinion on the consolidated financial statements for the year ended December 31, 2020, stating they present fairly in all material respects, in conformity with International Financial Reporting Standards (IFRS)[471](index=471&type=chunk) [Consolidated Statements of Financial Position](index=83&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) Total assets increased to $20.24 million in 2022, with shareholders' equity rising to $14.10 million despite a $43.03 million accumulated deficit Consolidated Statements of Financial Position (as of December 31, 2022 vs. 2021) | Metric | December 31, 2022 (USD) | December 31, 2021 (USD) | | :--------------------------------- | :------------------------ | :------------------------ | | Cash | 17,141,775 | 8,727,542 | | Total Current Assets | 18,378,341 | 9,609,209 | | Property and equipment, net | 661,692 | 37,884 | | Right-of-use asset | 1,177,695 | 393,702 | | **Total assets** | **20,241,003** | **10,040,795** | | Total current liabilities | 4,242,606 | 1,351,755 | | Total Liabilities | 6,144,936 | 3,679,640 | | Share capital | 164,896 | 141,075 | | Share premium | 38,831,542 | 13,126,493 | | Reserve | 18,079,741 | 9,736,066 | | Accumulated deficit | (43,032,294) | (16,644,958) | | **Total shareholders' equity** | **14,096,067** | **6,361,155** | [Consolidated Statements of Comprehensive Loss](index=84&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) Net loss increased to $26.39 million in 2022, driven by a 170% rise in operating expenses, despite stable revenue Consolidated Statements of Comprehensive Loss (Year Ended December 31, 2022 vs. 2021 vs. 2020) | Metric | 2022 (USD) | 2021 (USD) | 2020 (USD) | | :-------------------------- | :----------- | :----------- | :----------- | | Revenue | 529,877 | 577,348 | 493,565 | | Cost of revenue | 347,726 | 399,726 | 370,480 | | Gross profit | 182,151 | 177,622 | 123,085 | | Total operating expenses | 26,691,580 | 9,902,228 | 796,800 | | Loss from operations | (26,509,429) | (9,724,606) | (673,715) | | Net loss | (26,387,336) | (11,690,098) | (586,895) | | Comprehensive loss | (26,337,633) | (11,485,129) | (811,551) | | Basic and dilutive loss per ordinary share | (1.86) | (1.62) | (0.10) | | Weighted average number of ordinary shares outstanding | 14,157,492 | 7,210,889 | 5,607,243 | [Consolidated Statement of Changes in Shareholders' Equity (Deficit)](index=85&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Shareholders%27%20Equity%20(Deficit)) Shareholders' equity rose to $14.10 million in 2022, driven by share premiums and stock option expense, despite a $26.39 million net loss Consolidated Statement of Changes in Shareholders' Equity (Deficit) (as of December 31, 2022 vs. 2021 vs. 2020) | Metric | December 31, 2022 (USD) | December 31, 2021 (USD) | December 31, 2020 (USD) | | :--------------------------------- | :------------------------ | :------------------------ | :------------------------ | | Share Capital | 164,896 | 141,075 | 64,265 | | Share Premium | 38,831,542 | 13,126,493 | 41,846 | | Reserve | 18,079,741 | 9,736,066 | 2,309,684 | | Accumulated Deficit | (43,032,294) | (16,644,958) | (4,954,860) | | Accumulated other comprehensive income (loss) | 52,182 | 2,479 | (202,490) | | **Total Shareholders' Equity (Deficit)** | **14,096,067** | **6,361,155** | **(2,741,555)** | [Consolidated Statements of Cash Flows](index=86&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating cash outflow increased to $14.77 million in 2022, offset by $23.94 million from financing, raising cash to $17.14 million Consolidated Statements of Cash Flows (Year Ended December 31, 2022 vs. 2021 vs. 2020) | Activity | 2022 (USD) | 2021 (USD) | 2020 (USD) | | :----------------------------------- | :----------- | :----------- | :----------- | | Net cash used in operating activities | (14,769,590) | (3,220,324) | (468,737) | | Net cash used in investing activities | (658,483) | 1,203,151 | (9,685) | | Net cash provided by financing activities | 23,943,418 | 10,610,534 | 396,681 | | Effect of changes in exchange rates | (101,112) | 11,613 | 721 | | Net change in cash | 8,414,233 | 8,604,974 | (81,020) | | Cash at end of period | 17,141,775 | 8,727,542 | 122,568 | [Notes to the Consolidated Financial Statements](index=87&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) These notes detail operations, going concern, accounting policies, financial statement components, related parties, and subsequent events [1. Nature of Operations and Going Concern](index=87&type=section&id=1.%20Nature%20of%20Operations%20and%20Going%20Concern) Mainz Biomed, an IVD test developer, faces going concern doubt due to recurring losses, but expects sufficient funding from cash and financing - Mainz Biomed N.V. acquired PharmGenomics GmbH in September 2021 and develops and sells in-vitro diagnostic (IVD) tests, primarily its flagship ColoAlert product, in European markets[486](index=486&type=chunk)[487](index=487&type=chunk)[489](index=489&type=chunk] - The company has recurring losses, an accumulated deficit totaling **$43,032,294**, and negative cash flows used in operating activities of **$14,769,590** as of and for the year ended December 31, 2022, raising substantial doubt about its ability to continue as a going concern[490](index=490&type=chunk) - Despite the substantial doubt, the company believes its currently available cash on hand (**$17,141,775** at December 31, 2022) plus additional sources of funding (e.g., Controlled Equity Offering) will sufficiently fund its planned expenditures and obligations for at least one year[490](index=490&type=chunk) [2. Basis of Presentation](index=88&type=section&id=2.%20Basis%20of%20Presentation) The financial statements are prepared in accordance with IFRS as issued by the IASB, on a historical cost and accrual basis - The financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB), on a historical cost basis and using the accrual basis of accounting[493](index=493&type=chunk)[494](index=494&type=chunk] - Amendments to IAS 1, 'Classification of Liabilities as Current or Non-current,' are effective for reporting periods beginning on or after January 1, 2023, and the company is evaluating their impact on its consolidated financial statements[495](index=495&type=chunk) [3. Summary of Significant Accounting Policies and Use of Estimates and Judgments](index=88&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Use%20of%20Estimates%20and%20Judgments) This section outlines accounting policies for inventories, property, leases, revenue, R&D, financial instruments, and share-based compensation - Inventories are measured at the lower of cost (based on weighted average) and net realizable value[497](index=497&type=chunk) - Property and equipment are recorded at cost less accumulated depreciation, using the straight-line method over estimated useful lives of 5-10 years for laboratory equipment, 3-10 years for office equipment, and lease terms for right-of-use assets[498](index=498&type=chunk)[499](index=499&type=chunk] - Leases are accounted for under IFRS 16, recognizing right-of-use assets and lease liabilities, with the latter measured at the present value of lease payments using the incremental borrowing rate (IBR) when the interest rate implicit in the lease is not readily determinable[502](index=502&type=chunk)[503](index=503&type=chunk] - Revenue is recognized in accordance with IFRS 15 upon the satisfaction of performance obligations, which occurs upon delivery of products to laboratory partners or when testing results are delivered to end-user patients[506](index=506&type=chunk)[508](index=508&type=chunk] - Expenditure on research activities is recognized in profit or loss as incurred, while development expenditure is capitalized only if specific criteria (e.g., technical/commercial feasibility, probable future economic benefits) are met[510](index=510&type=chunk)[511](index=511&type=chunk] - Financial instruments are classified as at fair value through profit and loss (FVTPL), at fair value through other comprehensive income (FVTOCI), or at amortized cost, with initial recognition at fair value[514](index=514&type=chunk) - Government grants are recognized as income when there is reasonable assurance of receipt and compliance with conditions; loans received from government grants are recognized at fair value, with the difference between fair value and amount received recorded as government grant gain[532](index=532&type=chunk)[533](index=533&type=chunk] - Share-based compensation for time-based stock options is estimated using the Black-Scholes-Merton pricing model, and for market-based options using Monte Carlo simulation techniques, expensed on a straight-line basis over the vesting/derived service period[534](index=534&type=chunk)[535](index=535&type=chunk] [4. Contribution Agreement](index=95&type=section&id=4.%20Contribution%20Agreement) The acquisition of PharmGenomics GmbH by Mainz Biomed N.V. in September 2021 was accounted for as a reverse acquisition under IFRS 3 but treated as a share-based payment transaction under IFRS 2 because Mainz Biomed N.V. was not a business - The acquisition of PharmGenomics GmbH by Mainz Biomed N.V. in September 2021 was considered a reverse acquisition under IFRS 3 but accounted for as a share-based payment transaction in accordance with IFRS 2, as Mainz Biomed N.V. did not meet the definition of a business[546](index=546&type=chunk)[547](index=547&type=chunk)[549](index=549&type=chunk] - An acquisition expense of **$2,019,739** was recognized in the consolidated statement of loss and comprehensive loss, representing the value in excess of the net identifiable assets acquired from Mainz Biomed N.V[549](index=549&type=chunk)[550](index=550&type=chunk] [5. Trade and Other Receivables](index=96&type=section&id=5.%20Trade%20and%20Other%20Receivables) As of December 31, 2022, net trade and other receivables were $259,138, up from $111,842 in 2021 Trade and Other Receivables, Net (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Accounts receivable, net | 63,736 | 17,199 | | VAT receivable | 192,154 | 94,085 | | Other | 3,248 | 558 | | **Total** | **259,138** | **111,842** | [6. Prepaid and Other Current Assets](index=96&type=section&id=6.%20Prepaid%20and%20Other%20Current%20Assets) Prepaid and other current assets totaled $801,959 as of December 31, 2022, a slight increase from $769,825 in 2021, primarily consisting of prepaid insurance, other prepaid expenses, and security deposits Prepaid and Other Current Assets (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Prepaid insurance | 624,033 | 743,750 | | Other prepaid expense | 55,356 | 12,590 | | Security deposit | 122,570 | 13,485 | | **Total** | **801,959** | **769,825** | [7. Property and Equipment](index=96&type=section&id=7.%20Property%20and%20Equipment) Net property and equipment increased significantly to $661,692 as of December 31, 2022, from $37,884 in 2021, primarily due to $658,482 in additions (mainly laboratory and office equipment) Property and Equipment, Net (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Cost | 755,518 | 90,388 | | Accumulated depreciation | (93,826) | (52,504) | | **Net Property and equipment** | **661,692** | **37,884** | - Additions to property and equipment totaled **$658,482** in 2022, primarily comprising laboratory equipment (**$496,077**) and office equipment (**$162,405**)[553](index=553&type=chunk) [8. Leases](index=98&type=section&id=8.%20Leases) Right-of-use assets increased to $1,177,695 as of December 31, 2022, from $393,702 in 2021, with additions of $1,010,300 in 2022 Right-of-Use Assets (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Cost | 1,556,404 | 559,973 | | Accumulated amortization | (378,709) | (166,271) | | **Net Right-of-Use Assets** | **1,177,695** | **393,702** | Lease Liabilities (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Current portion | 285,354 | 55,076 | | Long-term portion | 959,116 | 387,766 | | **Total Lease Liabilities** | **1,244,470** | **442,842** | - The company uses an incremental borrowing rate of **10% per annum** to measure the present value of future lease payments[558](index=558&type=chunk) [9. Accounts Payable and Accrued Expenses](index=99&type=section&id=9.%20Accounts%20Payable%20and%20Accrued%20Expenses) Accounts payable and accrued expenses significantly increased to $2,656,679 as of December 31, 2022, from $784,786 in 2021, primarily due to increases in accounts payable and accrued liabilities Accounts Payable and Accrued Expenses (as of December 31, 2022 vs. 2021) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------------------ | :------------------------ | | Accounts payable | 1,333,044 | 747,768 | | Accrued liabilities | 1,236,942 | 26,989 | | Payroll liabilities | 86,693 | 6,812 | | Value added taxes payable | - | 3,217 | | **Total** | **2,656,679** | **784,786** | [10. Convertible Debt – Related Party](index=99&type=section&id=10.%20Convertible%20Debt%20%E2%80%93%20Related%20Party) Convertible debt, including related party loans, decreased to $75,238 as of December 31, 2022, from $77,887 in 2021 Convertible Debt Continuity (as of December 31, 2022 vs. 2021 vs. 2020) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | December 31, 2020 (USD) | | :-------------------------- | :------------------------ | :------------------------ | :------------------------ | | 2019 and 2020 Convertible Loans – Related party | 32,181 | 32,221 | 447,181 | | 2017 Convertible Loans | 43,057 | 45,666 | 86,189 | | **Total** | **75,238** | **77,887** | **533,370** | - During the year ended December 31, 2021, loan amounts totaling **$508,237** were converted into **392,757 shares** of share capital[565](index=565&type=chunk) [11. Loans Payable](index=100&type=section&id=11.%20Loans%20Payable) Loans payable decreased to $0 as of December 31, 2022, from $115,546 in 2021, as all loans were extinguished during the year Loans Payable Continuity (as of December 31, 2022 vs. 2021 vs. 2020) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | December 31, 2020 (USD) | | :-------------------------- | :------------------------ | :------------------------ | :------------------------ | | 0.1% Loan | - | 22,754 | 24,528 | | Related party 6% Loans | - | 39,819 | 41,326 | | LOC | - | 52,973 | 66,979 | | **Total** | **-** | **115,546** | **132,833** | - All loans payable, including the 0.1% Loan, Related Party 6% Loans, and the Line of Credit (LOC), were extinguished during the year ended December 31, 2022[570](index=570&type=chunk) [12. Silent Partnerships](index=100&type=section&id=12.%20Silent%20Partnerships) Silent partnership liabilities decreased to $1.91 million in 2022, comprising various agreements with differing interest and profit-sharing terms Silent Partnerships Continuity (as of December 31, 2022 vs. 2021 vs. 2020) | Category | December 31, 2022 (USD) | December 31, 2021 (USD) | December 31, 2020 (USD) | | :-------------------------- | :------------------------ | :------------------------ | :------------------------ | | 3% SPAs | 537,359 | 528,849 | 288,558 | | 3.5% SPAs | 43,938 | 43,271 | 43,313 | | 8.5% SPAs | 909,703 | 935,081 | 1,030,167 | | 8% SPAs | 417,549 | 432,918 | 456,212 | | **Total** | **1,908,549** | **1,940,119** | **1,818,250** | - The **EUR300,000** (approximately **$343,830**) 8% SPA loan was repaid in January 2022[396](index=396&type=chunk)[575](index=575&type=chunk] - Some silent partnership agreements were received at below market interest rates, with the difference between the face value and fair value recognized as government grant income (e.g., **$92,774** for 3% SPAs in 2020 and **$51,410** for 3% SPAs in 2021)[571](index=571&type=chunk)[572](index=572&type=chunk] [13. Equity](index=103&type=section&id=13.%20Equity) Authorized share capital is 45 million ordinary shares; 2022 saw $25.9 million from share issuance and increased stock options - The company has **45 million ordinary shares** authorized, with a par value of **EUR0.01 per share**[577](index=577&type=chunk) - During 2022, the company issued **1,725,000 ordinary shares** for gross proceeds of approximately **$25.9 million**, **821,456 ordinary shares** from warrant exercises (generating **$382,500 in cash proceeds**), and **73,000 ordinary shares** for services valued at **$906,920**[578](index=578&type=chunk) - During 2021, the company issued **6,000,000 common shares** for the PharmGenomics acquisition, sold **3,510,000 shares** for **$2.2 million gross proceeds**, sold **2,300,000 shares** in its IPO for **$10.43 million net proceeds**, and issued **392,757 ordinary shares** for the conversion of debt[580](index=580&type=chunk) Warrants Activity (as of December 31, 2022 vs. 2021) | Metric | 2022 | 2021 | | :-------------------------- | :----------- | :----------- | | Balance as of Jan 1 | 3,916,000 | - | | Grants | - | 3,916,000 | | Exercised | (668,500) | - | | Expired | - | - | | **Balance as of Dec 31** | **3,247,500** | **3,916,000** | | Weighted Average Exercise Price (Dec 31) | $3.00 | $3.08 | | Weighted Average Life (years) (Dec 31) | 0.44 | 1.60 | Stock Options Activity (as of December 31, 2022 vs. 2021) | Metric | 2022 | 2021 | | :-------------------------- | :----------- | :----------- | | Balance as of Jan 1 | 1,504,650 | - | | Grants | 894,500 | 1,504,650 | | Exercised | - | - | | Forfeited | (5,000) | - | | Expiry | - | - | | **Balance as of Dec 31** | **2,394,150** | **1,504,650** | | Weighted Average Exercise Price (Dec 31) | $7.18 | $5.10 | | Weighted Average Life (years) (Dec 31) | 9.11 | 9.85 | | Exercisable as of Dec 31 | 1,398,179 | - | - The company recorded share-based compensation expenses of **$8,917,237 in 2022** and **$6,430,158 in 2021**[585](index=585&type=chunk) [14. Related Party Transactions](index=106&type=section&id=14.%20Related%20Party%20Transactions) Key management personnel compensation (salaries and benefits) was $1,291,058 in 2022, up from $673,464 in 2021 Key Management Personnel Compensation (Salaries and Benefits) | Year | Amount (USD) | | :--- | :----------- | | 2022 | 1,291,058 | | 2021 | 673,464 | | 2020 | 202,442 | - The company incurred interest expense of **$32,457** and accretion expense of **$14,847** on balances owing to related parties during 2022[589](index=589&type=chunk)[590](index=590&type=chunk] - Expenses for royalties and other associated costs owed to ColoAlert AS (a related party) were **$97,924 in 2022**, with no unpaid liabilities recorded as of December 31, 2022[591](index=591&type=chunk) [15. Government Grants](index=106&type=section&id=15.%20Government%20Grants) The company received government grants for R&D activities, totaling $151,054 in 2022 and $298,997 in 2021 Government Grants Received for R&D Projects | Project | 2022 (USD) | 2021 (USD) | 2020 (USD) | | :------------------------------------------------- | :----------- | :----------- | :----------- | | Rapid detection of antibody-based pathogens | 42,055 | 102,780 | 91,461 | | Multi-marker test for the early detection of pancreatic cancer | 108,999 | 196,217 | 100,591 | | Microarray based on nucleic acid detection for respiratory pathogens | - | - | 5,995 | | Genetically based rapid detection of respiratory tract infections | - | - | 26,087 | | **Total** | **151,054** | **298,997** | **224,134** | [16. Financial Instrument Risk Management](index=107&type=section&id=16.%20Financial%20Instrument%20Risk%20Management) The company manages foreign currency, credit, and liquidity risks, with $17.14 million cash covering current liabilities, and no interest rate risk - The company is exposed to foreign currency risk (primarily U.S. dollars and Euro) and manages this risk by holding cash deposits in both currencies to match budgeted expenditures[601](index=601&type=chunk) - As of December 31, 2022, the company had an unrestricted cash balance of **$17,141,775** to settle current liabilities of **$3,889,340**, indicating strong liquidity[597](index=597&type=chunk) - The company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates[602](index=602&type=chunk) Contractual Maturities of Financial Liabilities (as of December 31, 2022) | Category | Within one year (USD) | Between one and five years (USD) | More than five years (USD) | | :-------------------------- | :-------------------- | :----------------------------- | :------------------------- | | Accounts payable and accrued liabilities | 2,656,679 | - | - | | Accrued payroll | 260,000 | - | - | | Convertible debt | 75,238 | - | - | | Silent partnerships | 965,335 | 943,214 | - | | Lease liabilities | 285,354 | 771,457 | 187,659 | | **Total** | **4,242,606** | **1,714,671** | **187,659** | [17. Concentrations](index=109&type=section&id=17.%20Concentrations) In 2022, three major customers accounted for approximately 77% of the company's annual revenue, indicating a high customer concentration - For the year ended December 31, 2022, three major customers accounted for approximately **77% of the company's annual revenues**, indicating a high customer concentration, up from **56% in 2021** and **46% in 2020**[605](index=605&type=chunk) [18. Income Taxes](index=109&type=section&id=18.%20Income%20Taxes) The company reported an expected income tax recovery of $0 for 2022, 2021, and 2020, despite significant net losses Income Tax Provision Reconciliation (Year Ended December 31, 2022 vs. 2021 vs. 2020) | Metric | 2022 (USD) | 2021 (USD) | 2020 (USD) | | :------------------------------------------------- | :----------- | :----------- | :---------

Colorectal Cancer (CRC) & Market Opportunity - Colorectal cancer is the 2nd most lethal cancer in the US, but early detection provides over 90% 5-year survival rates[8] - The U S market potential is over 52 million tests per year for individuals over 45, based on recent FDA guidance[8] - The estimated market opportunity in the U S is $3 7 billion[15] - Approximately 38 8% of Americans aged 50 to 75 have never been screened for CRC[14] ColoAlert & Pancreatic Cancer (PANCAlert) - ColoAlert is a non-invasive, at-home test with 92% specificity and 85% sensitivity, designed to be easier to administer than Exact Science's ColoGuard and more accurate than FIT[8] - ColoAlert demonstrated up to 60% fewer missed cases compared to the fecal immunochemical test (FIT)[17] - Mainz BioMed is developing proprietary genetic testing methods for pancreatic cancer, with a potential for over 50 million tests per year in Europe alone[31] Company & Financials - Mainz BioMed is aiming to become a leading provider of easy-to-use diagnostic solutions[5] - The company had $29 0 million in cash on hand as of April 30, 2022[38] - The company's market capitalization (basic) was $173 7 million as of April 30, 2022[38]

[FORM 20-F Filing Information](index=1&type=section&id=FORM%2020-F%20Filing%20Information) This section details the company's Form 20-F annual report filing for fiscal year 2021, its registrant status, and forward-looking statement disclaimers [Filing Details](index=1&type=section&id=Filing%20Details) This is an Annual Report on Form 20-F for fiscal year 2021 by Mainz Biomed N.V., a Dutch company with shares on Nasdaq - The filing is an Annual Report on Form 20-F for the fiscal year ended December 31, 2021[2](index=2&type=chunk) - Mainz Biomed N.V. is incorporated in The Netherlands with principal executive offices in Mainz, Germany[3](index=3&type=chunk) **Title of Each Class and Exchange Registered** | Title of Each Class | Name of each exchange on which registered | | :------------------ | :---------------------------------------- | | Ordinary Shares | The Nasdaq Stock Market LLC | [Registrant Status](index=3&type=section&id=Registrant%20Status) The company is a Non-Accelerated Filer and Emerging Growth Company, adhering to IFRS and fulfilling all Exchange Act reporting requirements - The Registrant is not a well-known seasoned issuer (No)[9](index=9&type=chunk) - The Registrant is required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (No)[10](index=10&type=chunk) - The Registrant has filed all required reports during the preceding 12 months and has been subject to filing requirements for the past 90 days (Yes)[12](index=12&type=chunk) - The Registrant is a **Non-Accelerated Filer** and an **Emerging Growth Company**[15](index=15&type=chunk) - The Registrant has used **International Financial Reporting Standards (IFRS)** to prepare its financial statements[15](index=15&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements subject to significant risks and uncertainties, which the company does not undertake to update unless legally required - The report contains forward-looking statements identifiable by words such as 'anticipates', 'estimates', 'projects', 'expects', 'contemplates', 'intends', 'believes', 'plans', 'may', 'will'[22](index=22&type=chunk) - Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different[24](index=24&type=chunk) - The company does not undertake to update any forward-looking statements to reflect actual results, changes in assumptions, or changes in other factors, except as required by applicable securities laws[25](index=25&type=chunk) [PART I](index=7&type=section&id=PART%20I) This part covers key information about the company, including its business overview, risk factors, financial performance, and corporate governance details [ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS](index=7&type=section&id=ITEM%201.%20IDENTITY%20OF%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20ADVISERS) This item is not applicable to the current report - This item is marked 'Not Applicable'[30](index=30&type=chunk) [ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE](index=7&type=section&id=ITEM%202.%20OFFER%20STATISTICS%20AND%20EXPECTED%20TIMETABLE) This item is not applicable to the current report - This item is marked 'Not Applicable'[31](index=31&type=chunk) [ITEM 3. KEY INFORMATION](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section details the company's capitalization, indebtedness, and comprehensive risk factors, including operating losses, growth challenges, regulatory hurdles for ColoAlert, and share price volatility [3.A. [Reserved]](index=7&type=section&id=3.A.%20%5BReserved%5D) This section is reserved - This section is reserved[32](index=32&type=chunk) [3.B. Capitalization and Indebtedness](index=7&type=section&id=3.B.%20Capitalization%20and%20Indebtedness) This section is not applicable to the current report - This section is marked 'Not applicable'[32](index=32&type=chunk) [3.C. Reasons for the offer and use of proceeds](index=7&type=section&id=3.C.%20Reasons%20for%20the%20offer%20and%20use%20of%20proceeds) This section is not applicable to the current report - This section is marked 'Not applicable'[33](index=33&type=chunk) [3.D. Risk Factors](index=7&type=section&id=3.D.%20Risk%20Factors) This section details various risks related to the company's business, technology, regulations, and ordinary shares, including financial losses and market competition [Risks Related to Our Business Generally](index=7&type=section&id=Risks%20Related%20to%20Our%20Business%20Generally) The company faces risks from operating losses, growth management, personnel retention, acquisition integration, and global economic and currency fluctuations - The company is an early revenue stage company and has incurred operating losses and negative cash flow since inception, expecting to continue incurring losses[37](index=37&type=chunk)[38](index=38&type=chunk) **Net Losses (2020-2021)** | Year Ended December 31, | Net Loss | | :---------------------- | :------------ | | 2021 | $(11,690,098) | | 2020 | $(586,895) | - Inability to manage growth effectively, attract and retain personnel, and successfully integrate the PharmGenomics acquisition (September 2021) pose significant risks[40](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk) - Global economic conditions, changes to trade policy, tariffs, and fluctuations in currency exchange rates (U.S. dollar and Euro) could materially adversely impact demand, production costs, and financial results[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) [Risks Related to Our Technology and Business Strategy](index=11&type=section&id=Risks%20Related%20to%20Our%20Technology%20and%20Business%20Strategy) Commercial success hinges on ColoAlert's adoption and regulatory approval, facing competition, product liability, and limited intellectual property protection - Commercial success depends almost entirely on the **ColoAlert screening test**, which requires patient and medical community acceptance, effective marketing, and competitive advantages[55](index=55&type=chunk)[56](index=56&type=chunk) - Physicians may be reluctant to adopt new diagnostic tests like ColoAlert, and competing tests could render the company's products obsolete or non-competitive[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - The company currently relies on **trade secrets, know-how, and technology** to protect its intellectual property, with no patents or pending patent applications, increasing the risk of competitors using their technology[74](index=74&type=chunk)[75](index=75&type=chunk) - Failure to obtain **third-party payor reimbursement**, particularly for specific reimbursement codes in different countries, could compromise commercial success and harm reputation[66](index=66&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk) - Results of FDA required studies for ColoAlert may not create desired clinical performance, potentially leading to follow-on studies and delaying product launch in the US[76](index=76&type=chunk) [Risks Related to Regulations](index=16&type=section&id=Risks%20Related%20to%20Regulations) Global operations are subject to complex and conflicting regulations, including health, safety, marketing, data privacy, and anti-fraud laws, with U.S. market entry requiring rigorous FDA approvals - Global operations expose the company to numerous and conflicting legal and regulatory requirements, including health and safety, marketing, anticorruption, and data privacy, with violations potentially leading to significant fines and sanctions[78](index=78&type=chunk)[79](index=79&type=chunk) - The clinical laboratory industry is subject to extensive governmental certification and licensing regulations, as well as federal and state laws regarding test ordering, billing, marketing, health information privacy (HIPAA), and anti-markup legislation[80](index=80&type=chunk)[84](index=84&type=chunk) - Entry into new markets, particularly the U.S., will require obtaining regulatory approval (e.g., **FDA market authorization** through pre-market review for Class III IVDs like ColoAlert), which involves costly and time-intensive clinical trials[85](index=85&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - The company is subject to national and regional healthcare fraud and abuse laws and regulations (e.g., federal Anti-Kickback Statute, Stark Law), with potential for substantial penalties for non-compliance[88](index=88&type=chunk)[89](index=89&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) [Risks Related to Our Ordinary Shares and this Offering](index=19&type=section&id=Risks%20Related%20to%20Our%20Ordinary%20Shares%20and%20this%20Offering) The company's ordinary shares face market price volatility, dilution from future issuances, and no dividend payments, while benefiting from lessened disclosure as an emerging growth company - The market price of ordinary shares may be **volatile** and fluctuate disproportionately to operating performance due to factors like sales of substantial amounts of shares, competitor announcements, industry conditions, and regulatory changes[91](index=91&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Future issuance of additional ordinary shares or preferred shares (authorized up to **48,550,000 ordinary shares**) could dilute the ownership interests and voting power of current shareholders[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The company does not intend to pay dividends, meaning any gain on investment will depend on appreciation in the price of ordinary shares[96](index=96&type=chunk) - As a foreign private issuer and an '**emerging growth company**,' the company is subject to lessened disclosure requirements, which may make its ordinary shares less attractive to investors and result in a less active or more volatile trading market[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [ITEM 4. INFORMATION ON THE COMPANY](index=25&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) Mainz Biomed, incorporated in March 2021, is a molecular genetic diagnostic company focused on commercializing IVD tests, primarily ColoAlert for colorectal cancer screening, and developing new product candidates [4.A. History and development of the Company](index=25&type=section&id=4.A.%20History%20and%20development%20of%20the%20Company) Mainz Biomed N.V. was incorporated in March 2021, acquired PharmGenomics GmbH in September 2021, and converted to a Dutch public company in November 2021 - Mainz Biomed N.V. was incorporated on March 8, 2021, and acquired PharmGenomics GmbH on September 20, 2021[106](index=106&type=chunk) - The company converted into a Dutch public company with limited liability on November 9, 2021[106](index=106&type=chunk) - The principal place of business is Robert Koch Strasse 50, 55129 Mainz, Germany[106](index=106&type=chunk) [4.B. Business Overview](index=25&type=section&id=4.B.%20Business%20Overview) This section provides an overview of Mainz Biomed's business, including its industry focus, product portfolio, competitive advantages, strategic goals, regulatory environment, and customer base [General](index=25&type=section&id=General) Mainz Biomed is a molecular genetic diagnostic company commercializing IVD tests globally, with its subsidiary Mainz Biomed Germany GmbH being an ISO 13485-certified manufacturer - Mainz Biomed is a molecular genetic diagnostic company focused on commercializing its product portfolio in Europe, the United States, and globally[109](index=109&type=chunk) - Its subsidiary, Mainz Biomed Germany GmbH (f/k/a PharmGenomics), is a German **DIN EN ISO 13485-certified manufacturer** of in-vitro diagnostic (IVD) tests with its own molecular genetic laboratory[109](index=109&type=chunk) [About the Industry](index=26&type=section&id=About%20the%20Industry) The company operates in the cancer diagnostics market, focusing on early detection of colorectal cancer (CRC), a leading cause of cancer death with a global market projected to exceed $2 billion by 2022 - The company focuses on the diagnostic aspect of the cancer industry, particularly early detection of **colorectal cancer (CRC)**[110](index=110&type=chunk)[111](index=111&type=chunk) - CRC is the third most-commonly diagnosed cancer and the second leading cause of cancer death globally, with a 5-year survival rate over **90%** if diagnosed at Dukes' Stage A, but only **8%** at Stage D[112](index=112&type=chunk)[113](index=113&type=chunk) - Global CRC cases are expected to increase by **60%** to over **2.2 million** new cases and **1.1 million** deaths by 2030[113](index=113&type=chunk) **CRC Diagnostics Market Projections** | Metric | Value | | :----------------------------------- | :---------------------------------- | | Global CRC diagnostics market (2022) | > $2 billion | | European market volume (2023) | 50 million screening tests annually | | U.S. addressable market (current) | $3.7 billion annually | | U.S. addressable market (next 10 yrs)| > $5.2 billion annually | [Products and Product Candidates](index=26&type=section&id=Products%20and%20Product%20Candidates) Mainz Biomed's portfolio includes ColoAlert, a CE-IVD certified CRC screening test, and early-stage candidates PancAlert for pancreatic cancer and GenoStrip, a rapid molecular lateral-flow test platform - The company's portfolio includes **ColoAlert** (CRC screening test), **PancAlert** (pancreatic cancer screening candidate), and **GenoStrip** (platform technology candidate)[116](index=116&type=chunk) - ColoAlert is a **CE-IVD certified multitarget stool-based DNA test** for CRC, analyzing genetic anomalies (KRAS, BRAF mutations) and occult blood[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) **ColoAlert Clinical Performance (Independent Study)** | Metric | Result | | :----------------- | :----- | | Sensitivity | 85% | | Specificity | 92% | | Patient Satisfaction | 98% | - The company licenses ColoAlert from ColoAlert AS, paying a fee per sample and a **50% net profit split**, with an option to acquire the intellectual property[121](index=121&type=chunk) - In January 2022, the company acquired an exclusive unilateral option to license UdeS Biomarkers, which showed **75% sensitivity** for advanced adenomas and **95% for CRC** with **96% specificity**, for future integration into ColoAlert[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) - PancAlert is in early development as a stool-based screening test for pancreatic cancer, aiming for Real-Time PCR-based multiplex detection of molecular-genetic biomarkers, with pilot studies not expected before 2024[127](index=127&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk) - GenoStrip is an early-stage rapid molecular lateral-flow test platform designed for qualitative evaluations in short timeframes, potentially for COVID-19, other respiratory viruses, STDs, or mutated genes[131](index=131&type=chunk)[132](index=132&type=chunk) [Competitive Advantages & Operational Strengths](index=31&type=section&id=Competitive%20Advantages%20%26%20Operational%20Strengths) Mainz Biomed's competitive advantages include ColoAlert's high accuracy, rapid results, and ease of use, supported by an experienced executive team and government-backed R&D - ColoAlert boasts high accuracy with **85% sensitivity** and **92% specificity**, exceeding European CRC screening guidelines, and efforts are underway to further increase these metrics with UdeS Biomarkers[133](index=133&type=chunk) - The test offers a rapid time-to-result, as low as **three days** in Germany, and is easy to use, being a non-invasive, at-home stool test that does not require prior preparation or clinic visits[133](index=133&type=chunk) - Operational strengths include an executive team with extensive experience in diagnostic product development and commercialization, strong relationships with European government organizations and universities, and government grants supporting R&D for PancAlert and GenoStrip[133](index=133&type=chunk) [Strategy](index=32&type=section&id=Strategy) The company aims to make ColoAlert a global CRC screening leader through large laboratory collaborations, European expansion, U.S. FDA market authorization, and continued R&D for new biomarkers - The strategy is to make ColoAlert the global CRC screening market leader by providing the best performance at an affordable cost, primarily through collaborations with large laboratory chains[134](index=134&type=chunk) - The company plans to expand ColoAlert in Europe, starting with German-speaking countries and then other Western European markets like the UK, Italy, Spain, or Scandinavia, by securing additional partner laboratories and expanding its sales team[135](index=135&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk) - For the U.S. market, the company intends to pursue **FDA market authorization** for ColoAlert as a screening test for asymptomatic patients aged 45-80, potentially selling test kits to CLIA-certified laboratories or offering it as a laboratory developed test[140](index=140&type=chunk)[141](index=141&type=chunk) - Research and development efforts will continue for PancAlert and GenoStrip, and clinical trials on UdeS biomarkers will be conducted to potentially integrate them into ColoAlert[143](index=143&type=chunk) - Government grants have supported R&D programs, with approximately **$299,000 in 2021** and **$224,000 in 2020**[145](index=145&type=chunk) [Government Regulation](index=33&type=section&id=Government%20Regulation) The company's IVD products are subject to stringent European IVD-R and U.S. FDA regulations, requiring costly approvals and compliance with clinical laboratory, privacy, and anti-fraud laws - In Europe, ColoAlert is CE-IVD registered under the IVD-D but must comply with the new, more stringent **IVD-R by May 26, 2022**, which will bring almost all IVDs under direct control of Notified Bodies and require extensive performance evaluation[122](index=122&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - For the U.S. market, the company intends to seek **FDA premarket approval (PMA)** for ColoAlert, likely as a Class III IVD, which requires submission of 'valid scientific evidence' from extensive clinical trials and compliance with Quality System Regulation (QSR)[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - U.S. clinical laboratory operations would be subject to federal **CLIA requirements** and state laws, with sanctions for non-compliance including civil monetary penalties and prohibition from running tests[160](index=160&type=chunk) - The company is subject to **HIPAA** for health information privacy and federal/state anti-fraud and abuse laws (e.g., Anti-Kickback Statute, Stark Law), with potential for substantial penalties, fines, and exclusion from healthcare programs for violations[161](index=161&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) [Competition](index=38&type=section&id=Competition) ColoAlert competes with traditional CRC screening methods like colonoscopies and FITs, as well as other non-invasive tests from companies with significantly greater resources - ColoAlert competes with traditional CRC screening methods such as **colonoscopies** and **Fecal Immunochemical Tests (FITs)**[169](index=169&type=chunk) - Colonoscopies have a high detection rate (approx. **95%**) but low patient acceptance (<**20%**) due to invasiveness and preparation requirements[170](index=170&type=chunk)[171](index=171&type=chunk) - FITs are non-invasive with high patient acceptance but lower sensitivity (around **65%**), often detecting occult blood only in later disease stages[173](index=173&type=chunk) - Key competitors in non-invasive screening include Exact Sciences (**Cologuard**, **92% sensitivity**, **87% specificity**), Epigenomics AG (**Epi proColon** blood test, **68% sensitivity**, **80% specificity**), Novigenix SA (**Colox** blood test, **78% sensitivity**, **92% specificity**), and others developing liquid biopsy tests[174](index=174&type=chunk)[175](index=175&type=chunk) - Many competitors have significantly greater financial, technical, manufacturing, and marketing resources, posing a challenge for Mainz Biomed's market entry and commercialization[174](index=174&type=chunk)[175](index=175&type=chunk) [Customers](index=40&type=section&id=Customers) The company's primary customers are clinical laboratories in Germany, with a significant portion of revenue concentrated among a few major clients - Current customers are primarily laboratories in Germany, including some of the largest chains, that offer the ColoAlert test to physicians[176](index=176&type=chunk) **Revenue Concentration by Customers** | Year | Number of Customers > 10% Revenue | % of Total Revenue | | :--- | :-------------------------------- | :----------------- | | 2021 | 4 | 56% | | 2020 | 3 | 46% | | 2019 | 4 | 59% | [Suppliers and Raw Material](index=40&type=section&id=Suppliers%20and%20Raw%20Material) The company sources most supplies off-the-shelf and plans to maintain safety stock and second-source suppliers to ensure supply chain resilience - Most supplies are purchased 'off-the-shelf' at market rates, with second-source suppliers available for contingency[177](index=177&type=chunk) - The company plans to establish a safety stock from primary suppliers to allow for necessary validation if a secondary supplier is required[177](index=177&type=chunk) [Legal Proceedings](index=40&type=section&id=Legal%20Proceedings) The company is not currently involved in any legal or administrative proceedings, nor is it aware of any contemplated or threatened by governmental authorities or other parties - The company is not involved in, or aware of, any legal or administrative proceedings contemplated or threatened by any governmental authority or any other party[178](index=178&type=chunk) [4.C. Organizational structure](index=40&type=section&id=4.C.%20Organizational%20structure) The company operates with two wholly-owned subsidiaries: Mainz Biomed Germany GmbH and Mainz Biomed USA, Inc - The company has two wholly-owned subsidiaries: Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH) and Mainz Biomed USA, Inc[179](index=179&type=chunk) [4.D. Property, plant and equipment](index=40&type=section&id=4.D.%20Property%2C%20plant%20and%20equipment) The company operates from leased facilities in Mainz, Germany, used for administration, R&D, manufacturing, and laboratory analysis, and does not own any real property - The principal premises are located at Robert Koch Strasse 50, Mainz, Germany, under a fifteen-year lease agreement from 2013 (approx. **€5,730/month**) and an additional seven-year lease from January 2022 (approx. **€2,308/month**)[180](index=180&type=chunk) - These facilities are used for administrative purposes, research and development, manufacturing, and laboratory analysis, and are believed to satisfy needs for the next 12 months[181](index=181&type=chunk) - The company does not own any real property[183](index=183&type=chunk) [ITEM 4A. UNRESOLVED STAFF COMMENTS](index=40&type=section&id=ITEM%204A.%20UNRESOLVED%20STAFF%20COMMENTS) This item is not applicable to the current report - This item is marked 'Not Applicable'[184](index=184&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=40&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) This section reviews the company's financial condition and operations, highlighting the 2021 reverse acquisition, increased net loss, revenue growth, improved liquidity from IPO proceeds, and critical accounting policies [Organization and Overview of Operations](index=41&type=section&id=Organization%20and%20Overview%20of%20Operations) The company, formed in 2021 through a reverse acquisition of Mainz Biomed Germany, focuses on IVD tests like ColoAlert, with significant IPO proceeds enhancing liquidity, though COVID-19 testing revenue is expected to decline - The company was incorporated in 2021 to acquire Mainz Biomed Germany GmbH (f/k/a PharmGenomics GmbH), which was completed on September 20, 2021, and accounted for as a reverse acquisition[186](index=186&type=chunk)[187](index=187&type=chunk) - Operations focus on developing and selling in-vitro diagnostic (IVD) tests, primarily ColoAlert in European markets, and research use only tests in human genetics, with a clinical diagnostic laboratory[188](index=188&type=chunk) - The company performed third-party COVID-19 lab testing in 2020 and 2021, a revenue stream expected to decrease significantly after 2021[188](index=188&type=chunk) - The company completed an initial public offering in November 2021, raising **$11,500,000 gross proceeds**, and a follow-on public offering in January 2022, raising **$25,875,000 gross proceeds**[190](index=190&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in revenue, cost of revenue, gross profit, and operating expenses for the fiscal year 2021 compared to 2020 [Financial Performance Summary (2020 vs 2021)](index=41&type=section&id=Financial%20Performance%20Summary%20(2020%20vs%202021)) Net loss significantly increased in 2021 due to surging general and administrative expenses (stock compensation, merger fees) and sales/marketing costs, despite a 17% revenue growth and 44% gross profit increase **Selected Financial Information (Year Ended December 31, 2021 vs 2020)** | Metric | 2021 ($) | 2020 ($) | Change ($) | % Change | | :-------------------------------------------------------- | :------------ | :----------- | :------------ | :--------- | | Revenue | 577,348 | 493,565 | 83,783 | 17% | | Cost of revenue | 399,726 | 370,480 | 29,246 | 8% | | Gross profit | 177,622 | 123,085 | 54,537 | 44% | | Gross profit percentage | 31% | 25% | | | | Research and Development | 466,689 | 311,851 | 154,838 | 50% | | Sales and Marketing | 957,522 | 110,380 | 847,142 | 767% | | General and Administrative | 8,478,017 | 374,569 | 8,103,448 | 2,163% | | Total operating expenses | 9,902,228 | 796,800 | 9,105,428 | 1,143% | | Loss from operations | (9,724,606) | (673,715) | (9,050,891) | (1,343)% | | Other income (expense) | (1,965,492) | 86,820 | (2,052,312) | (2,364)% | | Net loss | (11,690,098) | (586,985) | (11,103,203) | (1,892)% | | Total Comprehensive Loss | (11,485,129) | (811,551) | (10,673,578) | (1,315)% | | Basic and dilutive loss per common share | (1.62) | (0.10) | (1.52) | (1,449)% | | Weighted average number of common shares outstanding – basic and diluted | 7,210,889 | 5,607,243 | | | [Revenue](index=42&type=section&id=Revenue) Revenue increased by **17% to $577,348** in 2021, mainly from a **36% rise in ColoAlert product revenue** and increased COVID-19 testing, despite declines in other sales - Revenue for 2021 increased by **$83,783 (17%) to $577,348** from $493,565 in 2020[192](index=192&type=chunk) - The increase was primarily due to a **$59,294 (36%) increase in ColoAlert product revenue** and a **$56,973 increase** in third-party lab testing and support (COVID-19 related)[192](index=192&type=chunk) **Revenue by Product and Service Category** | Category | 2021 ($) | 2020 ($) | | :---------------------------- | :------- | :------- | | ColoAlert | 226,438 | 167,074 | | Third party lab testing and support | 233,662 | 176,692 | | Research use only product sales | 48,886 | 93,894 | | Other revenue | 68,362 | 55,905 | | **Total Revenue** | **577,348**| **493,565**| [Cost of Revenue](index=42&type=section&id=Cost%20of%20Revenue) Cost of revenue increased by 8% to $399,726 in 2021, mainly due to higher minimum royalty payments to ColoAlert AS and increased lab equipment maintenance, partially offset by decreases in selling expenses, salaries, and test kit materials - Cost of revenue increased by **8% to $399,726** in 2021 from $370,480 in 2020[194](index=194&type=chunk) - This increase was primarily driven by increased minimum royalty payments to ColoAlert AS and maintenance of lab equipment[194](index=194&type=chunk) [Gross profit](index=42&type=section&id=Gross%20profit) Gross profit increased by 44% to $177,622 in 2021, primarily due to higher ColoAlert sales and testing volume, which have a higher margin profile, despite a larger royalty expense - Gross profit increased to **$177,622** in 2021 from $123,085 in 2020, a **44% increase**[195](index=195&type=chunk) - This increase was attributed to increased ColoAlert sales and testing volume, which have a higher margin profile, mitigated by larger royalty expenses[195](index=195&type=chunk) [Research and Development Expenses](index=42&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses increased by 50% to $466,689 in 2021, driven by increased headcount to support ColoAlert, PancAlert, and GenoStrip product candidates, as well as expanded lab space and equipment - Research and development expenses increased by **$154,838 (50%) to $466,689** in 2021 from $311,851 in 2020[196](index=196&type=chunk) - This increase was due to increased headcount to support ColoAlert, PancAlert, and GenoStrip product candidates, and expanded lab space and equipment[196](index=196&type=chunk) [Sales and Marketing Expenses](index=42&type=section&id=Sales%20and%20Marketing%20Expenses) Sales and marketing expenses surged by 767% to $957,522 in 2021, primarily due to increased headcount in the sales group and higher advertising expenses - Sales and marketing expenses increased by **$847,142 (767%) to $957,522** in 2021 from $110,380 in 2020[197](index=197&type=chunk) - This increase was a result of increased headcount in the sales group and higher advertising expenses[197](index=197&type=chunk) [General and Administrative Expenses](index=42&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses saw a significant increase of 2,163% to $8,478,017 in 2021, largely driven by staffing increases, professional fees related to the merger with Mainz Biomed Germany, and $6,430,158 in employee stock compensation expense from stock options issued during the November 2021 IPO - General and administrative expenses increased by **$8,103,448 (2,163%) to $8,478,017** in 2021 from $374,569 in 2020[198](index=198&type=chunk) - This increase resulted from staffing increases, professional fees related to the merger, and **$6,430,158** in employee stock compensation expense related to stock options issued during the November 2021 IPO[198](index=198&type=chunk) [Other income (expense)](index=42&type=section&id=Other%20income%20(expense)) Other income (expense) shifted from a positive $86,820 in 2020 to a negative $(1,965,492) in 2021, primarily due to a $2,019,739 merger expense from the acquisition of Mainz Biomed Germany - Other income (expense) changed from **$86,820 in 2020 to $(1,965,492) in 2021**[199](index=199&type=chunk) - This increased net expense was primarily related to a **$2,019,739 merger expense** from the acquisition of Mainz Biomed Germany GmbH[199](index=199&type=chunk) [Comparison of the Year Ended December 31, 2020 and 2019](index=43&type=section&id=Comparison%20of%20the%20Year%20Ended%20December%2031%2C%202020%20and%202019) For a discussion of 2020 versus 2019 results, refer to the 'Management's Discussion and Analysis' section in the Form F-1 filed on January 21, 2022 - For a discussion of results for 2020 compared to 2019, refer to 'Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations – Comparison of the Year Ended December 31, 2020 and 2019' in the Form F-1 filed on January 21, 2022[200](index=200&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) This section reviews the company's liquidity and capital resources, including cash flow activities and the impact of the November 2021 IPO on its cash position [Overview of Liquidity and Capital Resources](index=43&type=section&id=Overview%20of%20Liquidity%20and%20Capital%20Resources) The company's liquidity improved significantly after its November 2021 IPO, with cash and cash equivalents increasing to $8,727,542 as of December 31, 2021 - Principal liquidity requirements are for working capital and capital expenditures, historically funded by cash on hand, operations, and debt financing[201](index=201&type=chunk) - The November 2021 IPO raised **$10,432,833** in net proceeds[201](index=201&type=chunk) **Cash and Cash Equivalents** | As of December 31, | Amount ($) | | :----------------- | :--------- | | 2021 | 8,727,542 | | 2020 | 122,568 | [Cash Flow Summary (2020 vs 2021)](index=43&type=section&id=Cash%20Flow%20Summary%20(2020%20vs%202021)) In 2021, operating cash outflow increased to **$3,220,324** due to losses and merger/IPO costs, while investing activities provided **$1,203,151** and financing activities provided **$10,610,534** from the IPO **Cash Flow Activities (Year Ended December 31, 2021 vs 2020)** | Cash Flow Category | 2021 ($) | 2020 ($) | Change ($) | | :---------------------------------------- | :------------ | :----------- | :------------ | | Cash used in operating activities | (3,220,324) | (468,737) | (2,751,587) | | Cash provided by (used in) investing activities | 1,203,151 | (9,685) | 1,212,836 | | Cash provided by financing activities | 10,610,534 | 396,681 | 10,213,853 | [Cash Flow used in Operating Activities](index=43&type=section&id=Cash%20Flow%20used%20in%20Operating%20Activities) Net cash used in operating activities increased to $3,220,324 in 2021 from $468,737 in 2020, primarily due to net losses and the timing of asset and liability settlements, including costs associated with the merger and IPO - Net cash used in operating activities was **$3,220,324** in 2021, compared to $468,737 in 2020[203](index=203&type=chunk) - This increase was primarily due to net losses and timing of settlement of assets and liabilities, including costs of the merger and initial public offering in 2021[203](index=203&type=chunk) [Cash Flows provided by and used in Investing Activities](index=43&type=section&id=Cash%20Flows%20provided%20by%20and%20used%20in%20Investing%20Activities) Cash provided by investing activities in 2021 was $1,203,151, mainly from cash acquired during the merger of Mainz Biomed N.V. In contrast, 2020 saw $9,685 used for fixed asset purchases - Cash provided by investing activities in 2021 was **$1,203,151**, primarily from cash acquired (on hand) of Mainz Biomed N.V. at the closing of the merger[204](index=204&type=chunk) - In 2020, **$9,685** was used in investing activities for the purchase of fixed assets[204](index=204&type=chunk) [Cash Flows provided by Financing Activities](index=43&type=section&id=Cash%20Flows%20provided%20by%20Financing%20Activities) Cash provided by financing activities dramatically increased to $10,610,534 in 2021 from $396,681 in 2020, primarily driven by the $10,432,833 net proceeds from the initial public offering in November 2021 - Cash flow provided by financing activities was **$10,610,534** in 2021, a significant increase from $396,681 in 2020[205](index=205&type=chunk) - This increase was primarily the result of **$10,432,833 net proceeds** from the initial public offering in November 2021[205](index=205&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=43&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines the company's critical accounting policies under IFRS, including revenue recognition, foreign currency translation, stock option compensation, lease accounting, and financial instruments, which involve significant management judgments and estimates [Overview of Critical Accounting Policies](index=43&type=section&id=Overview%20of%20Critical%20Accounting%20Policies) The company's IFRS financial statements rely on critical accounting policies for revenue, foreign currency, stock options, leases, and financial instruments, all requiring significant estimates and assumptions - Financial statements are prepared in accordance with **IFRS**, requiring estimates and assumptions that affect reported amounts[206](index=206&type=chunk) - Critical accounting policies and estimates relate to Revenue Recognition, Foreign Currency Translation, Stock Option Compensation, Lease Accounting, and Financial Instruments[206](index=206&type=chunk)[216](index=216&type=chunk) [Revenue Recognition](index=44&type=section&id=Revenue%20Recognition) Revenue from genetic diagnostic tests is recognized under IFRS 15 upon delivery of test results, while government R&D grant income is recognized when funds are received and performance obligations are completed - Revenue is primarily from genetic diagnostic tests and recognized under **IFRS 15** upon satisfaction of performance obligations[207](index=207&type=chunk)[208](index=208&type=chunk) - The company has one performance obligation, fulfilled upon delivery of test results, as testing services and kits are not separately identifiable[209](index=209&type=chunk) - Income from government-sponsored R&D grants is recognized when funds are received and all performance obligations are completed, included as Other Income[210](index=210&type=chunk) [Foreign Currency Translation](index=44&type=section&id=Foreign%20Currency%20Translation) The functional currency is the Euro, with foreign currency transactions translated at prevailing rates and the U.S. dollar as the presentation currency, where translation gains/losses are recorded in other comprehensive income - The functional currency is the **European dollar (EUR)**[211](index=211&type=chunk) - Foreign currency transactions are translated at transaction date rates, and monetary items at period-end rates[212](index=212&type=chunk) - The presentation currency is the **U.S. dollar**; revenues and expenses are translated using average exchange rates, with translation gains/losses recorded in other comprehensive income (loss)[215](index=215&type=chunk)[216](index=216&type=chunk) [Stock Option Compensation](index=45&type=section&id=Stock%20Option%20Compensation) The 2021 Omnibus Incentive Plan authorizes up to 2,300,000 ordinary shares for equity incentives, with time-based options valued using Black-Scholes and milestone-based options (for senior management) using Monte Carlo simulation - The 2021 Omnibus Incentive Plan authorizes the issuance of up to **2,300,000 ordinary shares** for equity incentives[217](index=217&type=chunk)[286](index=286&type=chunk) - On November 4, 2021, **1,474,650 stock options** were awarded with a strike price of **$5.00**[218](index=218&type=chunk)[287](index=287&type=chunk) - Time-based vesting options are valued using the **Black-Scholes method**, while milestone-based vesting options (for senior management) are valued using a **Monte Carlo simulation**, with compensation expense recorded over the vesting/derived service period[219](index=219&type=chunk)[220](index=220&type=chunk) - Senior management stock options vest in **25% portions** if the volume-weighted average price of ordinary shares reaches **$7.50, $10.00, $12.50, and $15.00** for ten consecutive trading days[218](index=218&type=chunk)[222](index=222&type=chunk)[287](index=287&type=chunk)[292](index=292&type=chunk) [Lease Accounting](index=45&type=section&id=Lease%20Accounting) The company recognizes lease liabilities at the present value of lease payments and corresponding right-of-use assets, depreciating them straight-line over the shorter of the lease term or estimated useful life - The company applies a single recognition and measurement approach for leases, recognizing lease liabilities at the present value of lease payments and right-of-use assets[221](index=221&type=chunk)[222](index=222&type=chunk) - Lease payments include fixed payments, variable payments dependent on an index or rate, and amounts expected under residual value guarantees or purchase/termination options[222](index=222&type=chunk) - The incremental borrowing rate is used to calculate the present value of lease payments when the implicit interest rate is not readily determinable[222](index=222&type=chunk) - 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[223](index=223&type=chunk) [Financial Instruments](index=46&type=section&id=Financial%20Instruments) Financial instruments are classified as fair value through profit and loss (FVTPL), fair value through other comprehensive income (FVTOCI), or amortized cost, with most assets and liabilities carried at amortized cost - Financial instruments are classified as FVTPL, FVTOCI, or amortized cost, with classification determined at initial recognition[224](index=224&type=chunk) - Financial assets and liabilities at amortized cost (e.g., cash, receivables, payables, loans, silent partnerships, lease liabilities) are initially recognized at fair value plus/minus transaction costs and subsequently carried at amortized cost less impairment[225](index=225&type=chunk) - FVTPL instruments are initially recorded at fair value, with realized and unrealized gains/losses recognized in the statements of loss and comprehensive loss[226](index=226&type=chunk) - The company does not hold any debt or equity instruments classified at FVTOCI[227](index=227&type=chunk)[228](index=228&type=chunk) [Disclosure of Contractual Arrangements](index=46&type=section&id=Disclosure%20of%20Contractual%20Arrangements) As of December 31, 2021, the company is committed to minimum undiscounted lease payments totaling $600,293, with $95,663 due within one year, covering office and laboratory equipment and office rent **Contractual Lease Obligations (Undiscounted) as of December 31, 2021** | Contractual Obligation | Less than One Year ($) | 1 – 3 Years ($) | 3 – 5 Years ($) | Over 5 Years ($) | | :--------------------- | :--------------------- | :-------------- | :-------------- | :--------------- | | Office Equipment | 6,553 | 13,106 | 7,049 | 812 | | Laboratory Equipment | 10,896 | 19,151 | 8,264 | - | | Office Rent | 78,214 | 156,428 | 156,428 | 143,392 | | **TOTAL** | **95,663** | **188,685** | **171,741** | **144,204** | [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=48&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section outlines the company's five-member Board of Directors, executive compensation (base salary and stock options), committee structures, and employee breakdown, with 27 full-time and 4 part-time staff as of April 2022 [6.A. Directors and Senior Management](index=48&type=section&id=6.A.%20Directors%20and%20Senior%20Management) This section introduces the company's Board of Directors and executive officers, highlighting their extensive experience in life sciences, medical diagnostics, finance, and corporate governance [Directors and Executive Officers](index=48&type=section&id=Directors%20and%20Executive%20Officers) The company's leadership includes CEO Guido Baechler, CFO William Caragol, CSO Dr. Moritz Eidens, COO Philipp Freese, and independent directors Dr. Alberto Libanori, Hans Hekland, and Nicole Holden, all bringing diverse industry expertise **Directors and Executive Officers** | Name | Age | Position | Director/Officer Since | | :------------------- | :-- | :---------------------------- | :--------------------- | | Guido Baechler | 56 | Chief Executive Officer, Director | July 2021 | | William Caragol | 55 | Chief Financial Officer | July 2021 | | Dr. Moritz Eidens | 39 | Chief Scientific Officer, Director | June 2008 | | Dr. Alberto Libanori | 32 | Director | November 2021 | | Hans Hekland | 63 | Director | November 2021 | | Philipp Freese | 40 | Chief Operating Officer | February 2015 | | Nicole Holden | 49 | Director | November 2021 | - Guido Baechler (CEO) has global experience in life science and medical diagnostics, including founding Berkeley Life Science Advisors and serving as CEO of SummerBio[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) - William Caragol (CFO) has over thirty years of experience with growth stage technology companies, founded Quidem LLC, and serves on multiple boards[236](index=236&type=chunk) - Dr. Moritz Eidens (CSO) founded the company in 2008 and has been instrumental in product development and grant projects[237](index=237&type=chunk)[238](index=238&type=chunk) - Philipp Freese (COO) has a background in business administration and has been a major driver for ColoAlert's product-market-fit and marketing strategies[239](index=239&type=chunk)[240](index=240&type=chunk) - Hans Hekland (Director) has extensive experience in international banking and industry, established Sarsia Innovation, and co-founded ColoAlert AS[241](index=241&type=chunk)[242](index=242&type=chunk) - Dr. Alberto Libanori (Director) is a Managing Director at Boustead Securities, LLC, with 10 years of experience in venture capital, BD&L, M&A, and IPOs in life sciences[243](index=243&type=chunk) - Nicole Holden (Director) is a CPA with over 20 years of accounting advisory, assurance, and regulatory experience, serving as Audit Committee Chair for Nerds On Site, Inc[244](index=244&type=chunk) [Director Independence](index=51&type=section&id=Director%20Independence) Three directors—Alberto Libanori, Nicole Holden, and Hans Hekland—are deemed 'independent' according to Nasdaq rules, indicating no direct or indirect material relationship with the company that could interfere with their independent judgment - Alberto Libanori, Nicole Holden, and Hans Hekland qualify as '**independent**' directors under Nasdaq rules[249](index=249&type=chunk) [6.B. Compensation](index=51&type=section&id=6.B.%20Compensation) This section details the company's executive and director compensation philosophy, including base salaries, long-term stock options, and specific employment agreements with severance provisions [Compensation Discussion and Analysis](index=51&type=section&id=Compensation%20Discussion%20and%20Analysis) Executive compensation aims to retain talent, provide competitive pay, align management and shareholder interests, and reward performance, primarily through base salary and long-term stock options - Executive compensation objectives include retaining critical talent, providing fair and competitive compensation, balancing management and shareholder interests, and rewarding performance[252](index=252&type=chunk) - The Compensation Committee considers factors like role complexity, individual performance, and potential for advancement, rather than a single percentile benchmark[253](index=253&type=chunk) - Compensation consists of two primary components: base salary and long-term incentives in the form of stock options[254](index=254&type=chunk)[259](index=259&type=chunk) [Summary Compensation Table](index=53&type=section&id=Summary%20Compensation%20Table) For the year ended December 31, 2021, the aggregate total cash compensation for all executive officers was $673,464, comprising $647,491 in base compensation and $25,973 in additional benefit payments **Aggregate Executive Compensation (Year Ended December 31, 2021)** | (U.S. dollars in thousands) | All executive officers | | :-------------------------- | :--------------------- | | Base compensation | $647,491 | | Bonuses | — | | Additional benefit payments | 25,973 | | **Total cash compensation** | **$673,464** | [Executive Compensation Agreements](index=53&type=section&id=Executive%20Compensation%20Agreements) Key executives have employment agreements detailing annual base salaries (e.g., CEO $450,000, CFO $350,000, CSO/COO €164,000), annual bonus eligibility, health benefits, and stock option grants with market-condition vesting - Guido Baechler's (CEO) annual base remuneration increased to **$450,000**, with eligibility for a **50% annual bonus** and **467,850 stock options** vesting based on market conditions (**$7.50, $10.00, $12.50, $15.00**)[262](index=262&type=chunk) - William Caragol's (CFO) employment contract (effective May 1, 2022) sets an annual salary of **$350,000**, eligibility for a **50% annual bonus**, healthcare expenses, and **80,000 options**[267](index=267&type=chunk) - Dr. Moritz Eidens (CSO) and Philipp Freese (COO) each receive a fixed gross annual salary of **€164,000** and **233,925 stock options**, also vesting based on market conditions (**$7.50, $10.00, $12.50, $15.00**)[272](index=272&type=chunk)[280](index=280&type=chunk) - Severance provisions for executives include accrued amounts, base remuneration, annual bonus, and accelerated vesting of equity-based incentives upon termination without good cause or resignation with good reason[265](index=265&type=chunk)[268](index=268&type=chunk)[275](index=275&type=chunk)[282](index=282&type=chunk) [Stock Option Plans and Stock Options](index=56&type=section&id=Stock%20Option%20Plans%20and%20Stock%20Options) The 2021 Omnibus Incentive Plan authorizes up to 2,300,000 ordinary shares for equity incentives, with 1,484,650 stock options granted at IPO ($5.00 strike price) vesting based on time or market conditions - The 2021 Omnibus Incentive Plan authorizes up to **2,300,000 ordinary shares** for equity incentives[286](index=286&type=chunk) - At the IPO, **1,484,650 stock options** were granted at a **$5.00 strike price**, with an additional **30,000 options** granted later in 2021[287](index=287&type=chunk) - Options for senior management vest in **25% portions** if the volume-weighted average price of ordinary shares reaches **$7.50, $10.00, $12.50, and $15.00** for ten consecutive trading days[287](index=287&type=chunk)[292](index=292&type=chunk) - Directors and executive officers received **1,166,650** of the 1,484,650 stock options granted prior to the IPO[288](index=288&type=chunk) [Director Compensation for Fiscal 2021](index=56&type=section&id=Director%20Compensation%20for%20Fiscal%202021) In the fourth quarter of 2021, independent directors received a quarterly fee of $10,500, with no compensation paid for director services in fiscal 2020 - Independent directors received a quarterly fee of **$10,500** in the fourth quarter of 2021[289](index=289&type=chunk) - No compensation was paid to directors for their services as directors in fiscal 2020[289](index=289&type=chunk) [Pension Benefits](index=56&type=section&id=Pension%20Benefits) The company does not offer any defined benefit pension plans or other retirement payment plans - The company does not have any defined benefit pension plans or other plans requiring retirement payments or comparable benefits[290](index=290&type=chunk) [Termination of Employment and Change of Control Benefits](index=56&type=section&id=Termination%20of%20Employment%20and%20Change%20of%20Control%20Benefits) Details regarding termination of employment and change of control benefits for directors and executive officers are provided in the 'Executive Compensation Agreements' section - Details on termination of employment and change of control benefits for directors and executive officers are reported under 'Executive Compensation Agreements'[291](index=291&type=chunk) [6.C. Board Practices](index=56&type=section&id=6.C.%20Board%20Practices) This section describes the company's board structure, including its five-member Board of Directors, three independent committees (Audit, Compensation, Nominating), and an informal Strategic Advisory Board [Board of Directors](index=56&type=section&id=Board%20of%20Directors) The Board of Directors comprises five members, with three independent directors, elected annually, and is responsible for appointing officers, with a Nominating Committee eventually assessing candidates - The Board of Directors has **five directors**, three of whom meet Nasdaq's independence requirements[291](index=291&type=chunk) - Directors are elected annually, and the Board is responsible for appointing officers[291](index=291&type=chunk)[292](index=292&type=chunk) [Board Committees](index=57&type=section&id=Board%20Committees) The company has established an Audit Committee, a Compensation Committee, and a Nominating Committee, each with a board-approved charter, and an informal Strategic Advisory Board for strategic guidance - Three committees have been established under the board of directors: an Audit Committee, a Compensation Committee, and a Nominating Committee[293](index=293&type=chunk) - An informal Strategic Advisory Board assists the board in setting strategies, achieving goals, and analyzing opportunities[293](index=293&type=chunk) [Audit Committee](index=57&type=section&id=Audit%20Committee) The Audit Committee, composed of three independent directors including financial expert Nicole Holden, oversees accounting, financial reporting, independent auditor selection, and internal controls - The Audit Committee comprises three independent directors, with **Nicole Holden** identified as an '**audit committee financial expert**'[294](index=294&type=chunk)[423](index=423&type=chunk) - Responsibilities include selecting the independent registered public accounting firm, pre-approving services, reviewing audit problems, discussing financial statements, and assessing internal controls[297](index=297&type=chunk) [Compensation Committee](index=57&type=section&id=Compensation%20Committee) The Compensation Committee, consisting of three independent directors, reviews and approves compensation for senior executives, oversees other executive compensation, and recommends director compensation - The Compensation Committee consists of three independent directors[295](index=295&type=chunk) - Its responsibilities include reviewing and approving compensation for senior executive officers, overseeing other executive compensation, recommending director compensation, and reviewing long-term incentive/equity plans[298](index=298&type=chunk) [Nominating Committee](index=57&type=section&id=Nominating%20Committee) The Nominating Committee, composed of three independent directors, is responsible for overseeing the selection of candidates for the board of directors, considering individuals identified by various sources including management and shareholders - The Nominating Committee comprises three independent directors[296](index=296&type=chunk) - It is responsible for overseeing the selection of persons to be nominated to serve on the board of directors[296](index=296&type=chunk) [Strategic Advisory Board](index=59&type=section&id=Strategic%20Advisory%20Board) The Strategic Advisory Board, with members like Dr. Heiner Dreismann and Dr. Soren Thestrup-Nielsen, assists the Board of Directors in setting strategies and analyzing opportunities, though it holds no formal powers - The Strategic Advisory Board, with members like Dr. Heiner Dreismann, Dr. Soren Thestrup-Nielsen, Dr. Michele Pedrocchi, and Dr. Rainer Metzger, assists the Board of Directors in setting strategies, achieving goals, and analyzing opportunities[300](index=300&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk) - The Strategic Advisory Board has no formal powers[300](index=300&type=chunk) [6.D. Employees](index=59&type=section&id=6.D.%20Employees) As of April 16, 2022, the company has 27 full-time and 4 part-time employees across manufacturing, R&D, sales, and administration, none covered by a collective bargaining agreement **Employee Breakdown by Activity (as of April 16, 2022)** | Activity | Number of Full-Time Employees | Number of Part-Time Employees | | :-------------------------- | :---------------------------- | :---------------------------- | | Manufacturing and Clinical Laboratory | 3 | 2 | | Research & Development | 7 | 0 | | Sales & Marketing | 5 | 2 | | General & Administration | 7 | 0 | | Executives | 5 | 0 | | **Total:** | **27** | **4** | - None of the employees are covered by a collective bargaining agreement[304](index=304&type=chunk) [6.E. Share Ownership](index=60&type=section&id=6.E.%20Share%20Ownership) Shareholdings of officers and directors are detailed in Item 7, while stock options are in Item 6.B, with no other convertible securities held by them - Shareholdings of officers and directors are detailed in Item 7[305](index=305&type=chunk) - Stock options held by officers and directors are detailed in Item 6.B[306](index=306&type=chunk) - Officers and directors do not hold any other securities convertible into ordinary shares[306](index=306&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=60&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section details major shareholders, with directors and executive officers owning **18.2%** of shares, and outlines related party transactions including employment agreements and a loan with the CSO's father [7.A. Major Shareholders](index=60&type=section&id=7.A.%20Major%20Shareholders) As of April 15, 2022, directors and executive officers as a group beneficially owned 18.2% of outstanding ordinary shares, with Kreditanstalt für Wiederaufbau and Coloalert AS as major shareholders **Beneficial Ownership of Ordinary Shares (as of April 15, 2022)** | Name | Ordinary Shares Beneficially Owned | Percentage of Ordinary Shares Beneficially Owned | | :-------------------------------------- | :--------------------------------- | :----------------------------------------------- | | **Directors and Executive Officers:** | | | | Guido Baechler, CEO, Director | 488,432 | 3.4% | | William Caragol, CFO | 77,975 | 0.6% | | Dr. Moritz Eidens, CSO, Director | 1,007,615 | 7.2% | | Alberto Libanori, Director | — | — | | Hans Hekland, Director | 821,427 | 5.9% | | Philipp Freese, COO | 243,239 | 1.7% | | Nicole Holden, Director | — | — | | Directors and Executive Officers as a Group (Seven Persons) | 2,638,688 | 18.2% | | **Other 5% or more Shareholders:** | | | | Kreditanstalt für Wiederaufbau | 1,237,501 | 8.9% | | Coloalert AS | 821,427 | 5.9% | - Based on **13,960,487 ordinary shares** outstanding as of April 15, 2022[308](index=308&type=chunk) - Hans Hekland has dispositive and voting control over shares held by ColoAlert AS[309](index=309&type=chunk) - Ordinary shares are held by approximately **43 total holders of record**, with **7 holders in the United States** accounting for approximately **47% of shares**[310](index=310&type=chunk) [7.B. Related Party Transactions](index=61&type=section&id=7.B.%20Related%20Party%20Transactions) Related party transactions include service arrangements with family members of officers, a loan agreement with the CSO's father, and agreements with ColoAlert AS, where a director is an owner - The company has a services arrangement with the wife of the Chief Operating Officer (approx. **€5,400/year**)[312](index=312&type=chunk) - An employment agreement exists with the wife of the Chief Scientific Officer (approx. **€42,000/year**)[312](index=312&type=chunk) - A loan agreement with the father of the Chief Scientific Officer for **€50,000** at **6% annual interest**, due January 31, 2023[312](index=312&type=chunk) - Agreements with ColoAlert AS are in place, where one of the company's directors is also a director and controlling shareholder[312](index=312&type=chunk) [7.C. Interests of Experts and Counsel](index=61&type=section&id=7.C.%20Interests%20of%20Experts%20and%20Counsel) This section is not applicable to the current report - This section is marked 'Not Applicable'[313](index=313&type=chunk) [ITEM 8. FINANCIAL INFORMATION](index=61&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section confirms the inclusion of IFRS financial statements audited by BF Borgers CPA P.C., notes no material legal proceedings or dividends, and reports no significant changes since the financial statement date [8.A. Consolidated Statements and Other Financial Information](index=61&type=section&id=8.A.%20Consolidated%20Statements%20and%20Other%20Financial%20Information) This section confirms the inclusion of the company's IFRS financial statements, audited by BF Borgers CPA P.C., and states no material legal proceedings or future dividend payments are planned [Financial Statements](index=61&type=section&id=Financial%20Statements) The company's financial statements for the year ended December 31, 2021, prepare