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 ...

Core Insights - Mainz Biomed N.V. has announced significant improvements to its ColoAlert product aimed at enhancing customer satisfaction and streamlining laboratory operations [9][10] - The updated ColoAlert product features a novel DNA stabilizing buffer that accommodates varying sample volumes, reducing the need for retesting and expediting result delivery to patients [3][10] - Colorectal cancer (CRC) represents a substantial market opportunity, with over 1.9 million new cases reported globally in 2020 and a $4.0 billion+ market opportunity in the US due to screening gaps [11][12] Company Developments - The ColoAlert product is now accessible to existing laboratory partners and available for prospective collaborators, indicating a focus on expanding market reach [4] - Enhancements to the ColoAlert kit include improved usability features such as a new collection device and tube holder, aimed at providing a more straightforward user experience [10] - Mainz Biomed is planning to conduct a pivotal FDA clinical study for US regulatory approval of ColoAlert, indicating a strategic move to enter the US market [12] Industry Context - CRC is the third most common cancer worldwide, with significant screening recommendations from health authorities, highlighting the importance of early detection tests like ColoAlert [11] - The US Preventive Services Task Force recommends stool DNA tests every three years starting at age 45, emphasizing the need for effective screening solutions [11] - Approximately one-third of US residents aged 50-75 have never been screened for colon cancer, representing a critical gap in healthcare that Mainz Biomed aims to address [11]

On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with specificity of 93% BERKELEY, Calif. and MAINZ, Germany, July 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnos ...

BERKELEY, Calif. and MAINZ, Germany, July 02, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024. Key Highlights During First Half 2024 "I'm extremely pleased with the progress achieved during the first half of 2024 ...

BERKELEY, Calif. and MAINZ, Germany, July 02, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024. Key Highlights During First Half 2024 Mainz Biomed presented industry leading results of its pooled study at ASCO 2024 ...

New study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia Results from pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed's mRNA biomarkers to detect CRC and precancerous lesions BERKELEY, Calif. and MAINZ, Germany, June 03, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic ...

New study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia Results from pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed's mRNA biomarkers to detect CRC and precancerous lesions BERKELEY, Calif. and MAINZ, Germany, June 03, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic ...