Study Overview - Mainz Biomed NV launches eAArly DETECT 2, a U S feasibility study to evaluate its next-generation colorectal cancer (CRC) test, integrating mRNA biomarkers, AI algorithms, and FIT test, targeting a population of approximately 2,000 average-risk patients [1] - The study aims to validate previous feasibility study results, which included both average-risk and identified-risk patients, and is expected to complete enrollment in the second half of 2025 with topline results reported by Q4 2025 [1][2] Study Objectives and Impact - The eAArly DETECT 2 study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown unique ability to identify advanced adenomas and early-stage CRC [3] - The study aims to enhance product specifications by combining these biomarkers with Mainz Biomed's proprietary AI algorithm, potentially increasing diagnostic sensitivity and specificity for early-stage CRC [3] - Successful outcomes from the study will enable Mainz Biomed to finalize protocols for ReconAAsense, its U S pivotal study, scheduled to initiate in 2026 [2] Company Strategy and Vision - The launch of eAArly DETECT 2 is a significant milestone for Mainz Biomed, accelerating the timeline to evaluate biomarkers for inclusion in the U S pivotal study [3] - The company's next-generation CRC test aims to transform colorectal cancer screening by detecting cancerous polyps with high accuracy and potentially preventing the disease through early detection of precancerous adenomas [2][3] - Mainz Biomed's mission is to transform CRC screening practices and reduce global cancer mortality rates by enabling precise detection of advanced adenomas and early-stage CRC [3] Company Background - Mainz Biomed specializes in molecular genetics diagnostics for life-threatening conditions, with ColoAlert® as its flagship product, marketed in Europe and the UAE [4] - The company is conducting a pivotal FDA clinical study for U S regulatory approval of ColoAlert® and is developing PancAlert, an early-stage pancreatic cancer screening test [4]

Core Insights - Mainz Biomed has entered into an agreement with Quest Diagnostics to support the commercialization of its NextGen colorectal cancer screening test, ColoAlert, pending FDA approval [1][3] - The ColoAlert test utilizes PCR technology to detect colorectal cancer tumor DNA from stool samples, demonstrating promising sensitivity and specificity in preliminary studies [2] - The collaboration includes Quest providing clinical trial laboratory services for Mainz Biomed's ReconAAsense study, which will involve approximately 15,000 subjects across 150 sites in the U.S. to gather data for FDA validation [3] Industry Context - Colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020, highlighting a significant public health concern [4] - The U.S. Preventive Services Task Force recommends screening for colorectal cancer starting at age 45, yet about one-third of U.S. residents aged 50-75 have never been screened, representing a market opportunity exceeding $4 billion [4] - The introduction of alternative screening methods like stool DNA-FIT tests could help address the screening gap in the population [4]

Core Points - Mainz Biomed N.V. has successfully closed a follow-on offering of 1,367,521 units, generating approximately $8.0 million in gross proceeds [1] - Each unit was sold at an effective price of $5.85, which includes one ordinary share and two types of warrants [1] - The Class A and Class B warrants are both immediately exercisable at the same price and have different expiration conditions [1] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection [3] - The flagship product, ColoAlert®, is a non-invasive test for colorectal cancer, currently marketed in Europe [3] - The company is conducting a pivotal FDA clinical study for regulatory approval in the U.S. and is developing PancAlert, a pancreatic cancer screening test [3]

Core Viewpoint - Mainz Biomed N.V. announced a 1-for-40 reverse stock split effective December 3, focusing on early cancer detection, particularly colorectal cancer [1] Group 1: Collaboration and Product Development - Mainz Biomed entered a collaborative agreement with Thermo Fisher Scientific to jointly develop and commercialize a next-generation colorectal cancer screening product [1][2] - The collaboration will utilize Thermo Fisher's technologies to create proprietary assays for mRNA-based colorectal cancer screening tests [2] - The goal is to develop a home collection colorectal screening tool that effectively detects adenomas [3] Group 2: Financial Performance - In October, Mainz Biomed reported a 4% increase in revenue and a 32% decrease in operational losses for the first half of 2024, attributed to cost-reduction efforts [3] Group 3: Product Enhancements - Significant improvements were made to the ColoAlert product, which is available in Europe and select international markets [4] - The new proprietary buffer in ColoAlert reduces the need for additional sample submissions, speeding up result delivery [4] - ColoAlert now boasts the industry's lowest retesting rates, with screening outcomes delivered within two to three days of laboratory arrival [5] Group 4: Stock Performance - As of the publication date, MYNZ stock is down 13.09%, trading at $6.93 [6]

BERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a 1-for-40 reverse stock split of its issued and outstanding shares. The reverse stock split was authorized by the Board of Directors of the Company pursuant to shareholder approval granted at its Extraordinary Shareholders Meeting on November 20, 2024. The reverse stock ...

Revenue increases 4% year over year while loss from operations decreases by 32% Pooled Results of ColoFuture and eAArly DETECT studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia Company highlights its path to success for 2025 BERKELEY, Calif. and MAINZ, Germany, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diag ...

Consolidated Financial Statements [Consolidated Statements of Financial Position](index=1&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) The company's financial position weakened significantly by June 30, 2024, as total assets fell 45% and shareholders' equity turned into a $4.14 million deficit Consolidated Statements of Financial Position (Unaudited) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Current Assets** | $2,389,703 | $8,979,896 | | **Total Assets** | **$8,454,030** | **$15,409,028** | | **Total Current Liabilities** | $10,013,944 | $9,236,936 | | **Total Liabilities** | **$12,592,730** | **$12,159,802** | | **Total Shareholders' Equity (Deficit)** | **($4,138,700)** | **$3,249,226** | | **Total Liabilities and Shareholders' Equity (Deficit)** | **$8,454,030** | **$15,409,028** | - Cash decreased drastically from **$7,070,925** at the end of 2023 to **$977,764** at June 30, 2024[2](index=2&type=chunk) - The accumulated deficit increased from **$(69,328,021)** to **$(80,351,783)** during the first six months of 2024[2](index=2&type=chunk) [Consolidated Statements of Comprehensive Loss](index=2&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported an improved net loss of $11.02 million for H1 2024, down from $14.81 million YoY, driven by a 31.1% reduction in operating expenses Six Months Ended June 30, Performance Comparison | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $520,773 | $499,049 | +4.4% | | **Gross Margin** | $319,038 | $287,739 | +10.9% | | **Total Operating Expenses** | $10,126,366 | $14,701,385 | -31.1% | | **Loss from Operations** | ($9,807,328) | ($14,413,646) | +32.0% | | **Net Loss** | **($11,023,762)** | **($14,812,643)** | **+25.6%** | | **Basic and Diluted Loss per Share** | **($0.49)** | **($1.00)** | **+51.0%** | - The reduction in operating expenses was driven by decreases in **Sales and Marketing** ($2.36M vs $3.99M YoY), **Research and Development** ($3.24M vs $5.48M YoY), and **General and Administrative** ($4.52M vs $5.23M YoY) costs[4](index=4&type=chunk) [Consolidated Statement of Changes in Shareholders' Equity (Deficit)](index=3&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Shareholders%27%20Equity%20(Deficit)) Shareholders' equity shifted from a $3.25 million surplus to a $4.14 million deficit, primarily due to the period's $11.02 million net loss Changes in Shareholders' Equity (Deficit) for the Six Months Ended June 30, 2024 | Description | Amount (USD) | | :--- | :--- | | **Balance, December 31, 2023** | **$3,249,226** | | Sale of ordinary shares | $515,262 | | Issuance of ordinary shares for conversion of debt | $2,154,557 | | Stock option expense | $1,028,383 | | Net loss | ($11,023,762) | | Foreign currency translation | ($62,366) | | **Balance, June 30, 2024** | **($4,138,700)** | [Consolidated Statements of Cash Flows](index=4&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a net cash decrease of $6.09 million in H1 2024, driven by an $8.14 million operating cash burn not fully offset by financing activities Cash Flow Summary (Six Months Ended June 30) | Cash Flow Category | 2024 | 2023 | | :--- | :--- | :--- | | **Net cash used in operating activities** | **($8,144,745)** | **($10,778,125)** | | Net cash used in investing activities | ($420,660) | ($1,524,555) | | **Net cash provided by financing activities** | **$2,551,325** | **$6,192,507** | | Net change in cash | ($6,093,161) | ($6,230,688) | | **Cash at end of period** | **$977,764** | **$10,911,087** | - Non-cash financing activities included the issuance of **$2,154,557 in ordinary shares** for the conversion of debt[9](index=9&type=chunk) Notes to the Condensed Consolidated Financial Statements [Note 1: Nature of Operations and Going Concern](index=5&type=section&id=1%2E%20NATURE%20OF%20OPERATIONS%20AND%20GOING%20CONCERN) The company's recurring losses and negative cash flow raise substantial doubt about its ability to continue as a going concern, prompting significant cost-cutting measures - The company's flagship product, **ColoAlert**, is marketed in Europe, and a next-generation product is in development for the US and European markets[12](index=12&type=chunk) - Recurring losses, an accumulated deficit of **$80.4 million**, and negative operating cash flow of **$8.1 million** raise substantial doubt about the company's ability to continue as a going concern[14](index=14&type=chunk) - Management plans to fund operations through future financing and has implemented cost reductions, including a **65% reduction in personnel** and the sale of its European Oncology Lab[15](index=15&type=chunk) [Note 2: Basis of Presentation](index=6&type=section&id=2%2E%20BASIS%20OF%20PRESENTATION) The interim financial statements are prepared under IAS 34 and should be read with the 2023 annual report, with the company assessing the future impact of IFRS 18 - The financial statements are prepared in accordance with **IAS 34, "Interim Financial Reporting"** and IFRS[17](index=17&type=chunk) - The company is assessing the impact of the new **IFRS 18** standard, which will require changes to the presentation of the statement of operations and cash flows[19](index=19&type=chunk])[20](index=20&type=chunk]) [Note 3: Summary of Significant Accounting Policies and Use of Estimates and Judgments](index=7&type=section&id=3%2E%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES%20AND%20USE%20OF%20ESTIMATES%20AND%20JUDGMENTS) Key accounting policies include deferring revenue until test results are delivered and expensing all R&D costs, with significant judgments on going concern and asset valuation - Revenue from sales to patients is **deferred** until the test sample is returned to the lab and results have been delivered[31](index=31&type=chunk]) - All research and development costs are **expensed as incurred** as they do not meet capitalization criteria under IAS 38[33](index=33&type=chunk])[69](index=69&type=chunk]) - Critical accounting judgments include the assessment of the company's ability to continue as a **going concern**, determination of lease terms, and impairment testing of long-lived assets[69](index=69&type=chunk]) [Note 12: Convertible Debt](index=20&type=section&id=12%2E%20CONVERTIBLE%20DEBT) The company holds significant convertible debt with a carrying amount of $5.8 million, primarily from a Pre-Paid Advance Agreement with a variable conversion price - On April 18, 2024, the company sold a third Promissory Note for **$3.3 million** in principal, receiving **$2.97 million** in net proceeds[96](index=96&type=chunk]) - The Promissory Notes are convertible at a price equal to the lower of a fixed price or 92% of the average of the two lowest daily VWAPs during the eight trading days prior to conversion, with a **floor price of $2.00**[98](index=98&type=chunk]) Convertible Promissory Notes Activity (H1 2024) | Description | Face Value | Carrying Amount (Fair Value) | | :--- | :--- | :--- | | **Balance at Dec 31, 2023** | **$6,400,000** | **$4,859,000** | | Issuance of notes | $3,300,000 | $2,970,000 | | Repayments | ($787,633) | ($787,633) | | Conversion to shares | ($1,770,577) | ($1,770,577) | | Change in fair value | - | $528,210 | | **Balance at June 30, 2024** | **$7,141,790** | **$5,799,000** | [Note 14: Equity](index=22&type=section&id=14%2E%20EQUITY) The company increased authorized shares and issued new shares for cash and debt conversion, with 6.6 million warrants and 2.7 million stock options outstanding - Shareholders approved an increase of authorized ordinary shares from **45 million up to a potential 225 million**[109](index=109&type=chunk]) - During H1 2024, the company issued **1,055,000 ordinary shares for $515,262** and **3,366,093 ordinary shares for the conversion of debt** valued at $2,154,557[111](index=111&type=chunk]) Warrants and Stock Options Outstanding at June 30, 2024 | Security | Outstanding | Weighted Avg. Exercise Price | Weighted Avg. Life (years) | | :--- | :--- | :--- | :--- | | Warrants | 6,597,500 | $1.86 | 2.90 | | Stock Options | 2,727,150 | $6.89 | 7.89 | [Note 17: Financial Instrument Risk Management](index=26&type=section&id=17%2E%20FINANCIAL%20INSTRUMENT%20RISK%20MANAGEMENT) The company faces significant liquidity risk due to its low cash balance, alongside credit and foreign exchange risks, while focusing on raising capital for growth - The company faces significant **liquidity risk**, with a cash balance of only **$977,764** as of June 30, 2024, and its ability to meet obligations depends on uncertain future capital raises[129](index=129&type=chunk])[131](index=131&type=chunk]) - Capital management strategy relies on raising funds through the **sale of ordinary shares** and other forms of equity and debt financing to fund continued growth[134](index=134&type=chunk]) - The company is exposed to **foreign exchange risk** as it operates in Germany (functional currency is Euro) but its reporting currency is the U.S. Dollar[132](index=132&type=chunk]) [Note 19: Operating Expenses](index=28&type=section&id=19%2E%20OPERATING%20EXPENSES) Total operating expenses decreased significantly to $10.1 million in H1 2024, driven by major reductions in clinical study, marketing, and advertising costs Operating Expenses Breakdown (Six Months Ended June 30) | Expense Category | 2024 | 2023 | | :--- | :--- | :--- | | Sales and marketing | $2,361,105 | $3,992,975 | | Research and development | $3,242,622 | $5,481,229 | | General and administrative | $4,522,639 | $5,227,181 | | **Total Operating Expenses** | **$10,126,366** | **$14,701,385** | - Clinical study costs within R&D dropped significantly from **$2,162,000** in H1 2023 to **$322,000** in H1 2024[136](index=136&type=chunk]) - Marketing and advertising expenses were more than halved, decreasing from **$2,176,808** in H1 2023 to **$885,051** in H1 2024[136](index=136&type=chunk]) [Note 20: Subsequent Events](index=29&type=section&id=20%2E%20SUBSEQUENT%20EVENTS) Post-period, the company initiated a major restructuring including a 65% personnel reduction and continued to raise capital through its PPA and a new promissory note - The company implemented significant cost-reduction efforts, including a **65% reduction of personnel**, reduction of external consulting costs, and the sale/closure of its European Oncology Lab business[139](index=139&type=chunk]) - The salaries of the CEO and CFO were reduced to **60% and 50%** of their original salaries, respectively, effective November 1, 2024[139](index=139&type=chunk]) - On October 8, 2024, the company issued a fourth promissory note under its PPA for a principal amount of **$1,500,000** with a 10% original issue discount[141](index=141&type=chunk])

BERKELEY, Calif. and MAINZ, Germany, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, today released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Management believes 2025 will be a transformat ...

Core Insights - Mainz Biomed N.V. has appointed Petra Smeltzer Starke as a Brand Ambassador to enhance messaging on the importance of early detection of colorectal cancer [1][2] - The company plans to launch a pivotal PMA trial for its next-generation colorectal cancer screening product by the end of 2025 [2] - Mainz Biomed's flagship product, ColoAlert®, is a non-invasive diagnostic test for colorectal cancer, currently marketed in Europe and the UAE, with an ongoing pivotal FDA clinical study for US regulatory approval [6] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, focusing on early cancer detection [6] - The company is developing PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [6] Brand Ambassador Profile - Petra Smeltzer Starke has a distinguished background, having studied international business and law, and served in significant roles during the Obama Administration, including General Counsel to the White House Council of Economic Advisors [3][4][5] - Starke's extensive experience and international network are expected to contribute significantly to Mainz Biomed's mission in cancer detection [2][4]

BERKELEY, Calif. and MAINZ, Germany, July 25, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in early detection of cancer, today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. To increase screening/lab efficiency, Mainz Biomed has introduced a novel DNA stabilizing buf ...