[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