Board Change • Jun 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. No highly experienced directors. Member of Strategic Advisory Board Soren Thestrup-Nielsen is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • May 25
Quantum Cyber N.V., Annual General Meeting, Jun 29, 2026 Quantum Cyber N.V., Annual General Meeting, Jun 29, 2026. Location: cms, atrium, parnassusweg 737, 1077 dg amsterdam., Netherlands Announcement • May 23
Quantum Cyber N.V. Files Provisional Patent with USPTO for Quantum Drone Autonomous System Quantum Cyber N.V. had announced the filing of a provisional patent application with the United States Patent and Trademark Office (USPTO) for its Quantum Drone Autonomous System (QDAS). The application, assigned USPTO Application No. 64/069,586 and filed May 19, 2026, covers a novel multi-layer architecture combining quantum-sensor-fused GPS-denied navigation, sentinel drone rotation protocols, aerial LIDAR pathfinding, and an integrated 12-drone swarm interceptor defense system deployed from an autonomous amphibious ground vehicle platform. The patented architecture centers on a Quantum Sensing Navigation Core (QSNC) aboard a sentinel UAV, incorporating a miniaturized quantum magnetometer and quantum inertial navigation unit (QINU) to generate GPS-independent position, navigation, and timing (PNT) data with accuracy exceeding conventional inertial navigation by more than one order of magnitude. A Quantum Reference Beacon Protocol (QRBP) then transmits that quantum-derived PNT solution as an encrypted position reference to the host autonomous ground vehicle and to a swarm of up to 12 subordinate interceptor micro-drones simultaneously, enabling quantum-accurate coordinated navigation of an entire unmanned fleet from a single airborne quantum sensor platform. The QDAS patent further claims a Two-Sentinel Continuous Coverage System (TSCS), a rotation handoff algorithm ensuring zero temporal gap in airborne quantum PNT beacon coverage as sentinel drones alternate between active deployment and fast-charge docking aboard the host ground vehicle. The system also incorporates a Sentinel LIDAR Pathfinding Loop that transmits real-time 3D terrain mesh from the airborne sentinel to the ground vehicle navigation stack for AI-computed optimal path planning. The Integrated Swarm Interceptor Defense Architecture (ISIDA) deploys 12 dual-role micro-drones from hull-embedded launch cells: six anti-air kinetic interceptors and six anti-ground loiter munitions, coordinated via QRBP quantum navigation under autonomous threat classification and intercept assignment. An Adaptive Hydrodynamic CTIS System rounds out the architecture with closed-loop tire pressure optimization for amphibious operations. The filing of a provisional patent application does not guarantee issuance of a patent. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) inability to successfully pursue our new initiatives; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the "SEC") by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025, its mid-year report on Form 6-K filed on September 26, 2025, and its subsequent filings with the SEC. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. Announcement • May 22
Quantum Cyber N.V. Files Provisional Patent For Quantum-Navigated Amphibious Autonomous Ground Vehicle Platform Quantum Cyber N.V. assembled an AI-powered System-of-Systems platform and filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for its SCOUT-AX6 GUARDIAN: a quantum-navigated, amphibious, remote-controlled autonomous ground vehicle designed for multi-domain defense operations across land and water in GPS-denied environments. The provisional application, docket number QDI-2026-QDAS-001, was filed in May 2026. The sole inventor is Jacob Gitman, with Quantum Drone Inc. named as assignee. The Company has 12 months from the filing date to file a corresponding non-provisional application to establish full patent rights. The SCOUT-AX6 GUARDIAN is a 6x6 all-wheel in-hub electric amphibious remote-controlled platform engineered for autonomous multi-domain military operations. The vehicle carries a 200 kg payload, achieves 80 km/h on land and 6-8 km/h in water via wheel-paddle amphibious propulsion, and operates for up to 200 km per mission. Its hull is constructed from 6061-T6 aluminium with UHMWPE belly armor and is rated IP68 for full amphibious operations with no external jets or watercraft modifications required. The platform's defining innovation is its Quantum Sensing Navigation Core (QSNC): a miniaturized quantum magnetometer and quantum inertial navigation unit (QINU) mounted aboard an airborne sentinel UAV that operates as a persistent overhead navigation beacon for the ground vehicle. The sentinel continuously broadcasts a quantum-derived, GPS-independent position reference to the SCOUT-AX6 via the Quantum Reference Beacon Protocol (QRBP), achieving navigation accuracy below 10 meters RMS in fully GPS-denied environments — more than an order of magnitude better than conventional inertial navigation systems. All data links use post-quantum encryption standardized by NIST (CRYSTALS-Kyber), making the communications architecture resistant to both classical and quantum-based cyber attack. A novel Two-Sentinel Continuous Coverage System (TSCS) ensures zero-gap navigation availability: one sentinel UAV is always airborne as the active quantum beacon while a second charges aboard the vehicle's docking port, with an automated handoff algorithm maintaining uninterrupted position reference during transitions. The airborne sentinel additionally provides real-time aerial LIDAR terrain mapping, transmitting 3D path data to the vehicle's autonomous navigation stack for AI-computed route optimization in complex and obstacle-dense environments. The platform also incorporates a patented Adaptive Hydrodynamic Central Tire Inflation System (AH-CTIS), which uses in-wheel motor torque telemetry as a real-time proxy for paddle hydrodynamic efficiency, automatically optimizing tire pressure during amphibious operations to maximize swim speed per unit of power. The SCOUT-AX6 GUARDIAN directly addresses priority areas established by the Trump Administration across defense and homeland security policy. The U.S. Department of Defense Fiscal year 2027 Budget Request allocates approximately $55 billion toward drone and autonomous warfare capabilities, with GPS-resilient navigation identified as a critical operational requirement following documented GPS jamming and spoofing in active theaters in Ukraine and the Middle East. The SCOUT-AX6 GUARDIAN's quantum navigation architecture operates entirely passively, relying on no external radio frequency signals, making it immune to jamming, spoofing, and signal denial in contested environments. The platform's post-quantum encrypted communications align with the Trump Administration's National Cybersecurity Strategy directive to accelerate adoption of post-quantum cryptographic standards across national security systems. The U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Homeland Security (DHS) have further identified GPS signal integrity and resilient autonomous navigation as critical infrastructure protection priorities -- requirements the SCOUT-AX6 GUARDIAN is engineered to meet. The vehicle's amphibious capability addresses a documented gap in U.S. autonomous defense platforms, which have historically been limited to single-domain (land or maritime) operations. The SCOUT-AX6 GUARDIAN operates across both domains without reconfiguration, enabling applications in border security, port defense, littoral zone operations, and rapid logistics resupply to forward positions -- all operational contexts prioritized under current DHS and DoD homeland security frameworks. Announcement • May 21
Quantum Cyber N.V. Files Non-Provisional Patent Application For Emp-Shielding 3D-Printable Composite Filament For Drone And Defense Electronics Quantum Cyber N.V. filed a non-provisional utility patent application with the United States Patent and Trademark Office (USPTO) for an Electromagnetic Pulse Shielding Composite Filament for Fused Deposition Modeling and Method of Manufacture Thereof. The patent application describes a multi-component composite thermoplastic filament formulated for use in standard fused deposition modeling (FDM) three-dimensional printers. The filament, composed of a PETG polymer matrix combined with aluminum flake, carbonyl iron powder, carbon black, and milled carbon fiber, produces 3D-printed drone enclosures that achieve broadband shielding effectiveness of 35 to 55 dB across the full frequency range of 10 kHz to 10 GHz, as measured per ASTM D4935. Unlike metallic Faraday enclosures or conductive gaskets that impose weight and manufacturing complexity penalties incompatible with modern UAV size, weight, and power constraints, the Company's filament is designed for use with commercially available desktop FDM printers, enabling on-demand production of EMP-hardened drone enclosures and electronics housings at the unit level. Electromagnetic pulse attacks represent one of the most consequential unsolved problems in autonomous drone warfare. A single EMP event -- whether generated by a high-altitude nuclear detonation, a non-nuclear electromagnetic device, or a high-power microwave weapon -- can simultaneously destroy the semiconductor components and flight control systems of an entire drone swarm. No publicly listed drone defense company, including platforms the Company monitors as market comparables, currently offers a fielded EMP-hardening solution at the drone enclosure level. Quantum Cyber believes this patent application establishes its first-mover position in EMP hardening for autonomous systems, a capability layer that management views as essential infrastructure for any serious drone defense platform. The Company intends to integrate this technology across its developing System-of-Systems portfolio. Announcement • May 20
Quantum Cyber N.V. Files Patent Application for Autonomous Naval Mine Countermeasure System Quantum Cyber N.V. filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for an Autonomous Distributed Naval Mine Countermeasure System. The filing, numbered 64/066-872, establishes a priority date for the Company's proprietary technology for autonomous detection and neutralization of underwater naval mines using unmanned aerial vehicle-deployed sensor and neutralization platforms. The technology is directly relevant to an active and publicly documented military crisis. U.S. Central Command has confirmed that Iran has laid naval mines in the Strait of Hormuz following the outbreak of the 2026 Iran war. The Pentagon has issued navigational warnings describing the strait as "extremely hazardous due to the presence of mines that have not been fully surveyed and mitigated," and has directed commercial vessels to alternate routing through Omani territorial waters. The U.S. Navy's legacy mine countermeasure assets, including Avenger-class minesweepers and Littoral Combat Ships with MCM mission packages, are currently stretched across the theater, with several units having departed the U.S. Central Command area of responsibility for scheduled maintenance. Quantum Cyber's patented system addresses this documented capability gap through a fully autonomous, UAV-based architecture requiring no personnel in the water. The system deploys semi-submerged survey pods from an unmanned aerial vehicle into the target area. Each survey pod conducts multibeam sonar scanning, magnetometer sensing, and hydrophone acoustic array analysis to detect and classify underwater mines with a probability of identification exceeding 85% in testing. A tethered UAV communications relay maintains persistent command and control connectivity between the survey pods and the ground control station throughout the operation. Upon target confirmation, the deployment UAV retrieves survey pods and deploys expendable influence-neutralization pods near confirmed mine locations. Each neutralization pod generates programmable acoustic signatures, three-axis magnetic field waveforms, and optional pressure impulse charges calibrated to trigger the influence fuzes of the targeted mines, achieving selective neutralization without collateral damage to surrounding infrastructure or vessels. The filing advances Quantum Cyber's growing patent portfolio, which now includes a provisional application for the autonomous naval mine countermeasure system and a non-provisional utility patent application for an EMP-shielding composite filament for UAV and UAS electronics protection. The Company's broader technology pipeline encompasses autonomous drone warfare platforms, counter-UAS perimeter defense systems, portable drone command and control systems, and quantum antenna communications technology currently in development, all assembled under a single System-of-Systems platform architecture. The Strait of Hormuz carries approximately 20% of global oil supply and one-third of the world's liquefied natural gas trade. The Iranian mining of the strait has contributed to significant disruption to global energy markets and maritime commerce. The Trump administration is separately seeking approximately $55 billion for drone and autonomous warfare programs in the fiscal 2027 defense budget, the largest single-year autonomous warfare allocation in U.S. history, as military doctrine shifts toward AI-enabled unmanned systems for precisely these types of maritime and asymmetric threat environments. Announcement • May 19
Quantum Cyber N.V. Announces Executive Appointments for Quantum Drones Corporation Quantum Drones Corporation announced appointment of executives. Peter O'Rourkehas been appointed President and Director of Quantum Drones Corporation. Mr. O'Rourke is a former Acting Secretary of the U.S. Department of Veterans Affairs under President Trump and previously served as a U.S. Air Force commissioned officer and U.S. Navy enlisted servicemember aboard the USS Abraham Lincoln. He brings extensive experience in federal government administration, SPAC leadership (as Chairman of NVAC on Nasdaq), and board service across multiple Nasdaq-listed companies, including ProFusa. Robert Liscouskihas been appointed Director of Quantum Drones Corporation. Mr. Liscouski brings senior-level experience in defense, intelligence, and critical infrastructure security, with deep relationships across U.S. government defense and national security agencies, as well as being co-founder, CEO, and Chairman of a NASDAQ-listed start-up quantum computing company. Reported Earnings • May 18
First quarter 2026 earnings released: US$0.21 loss per share (vs US$1.33 loss in 1Q 2025) First quarter 2026 results: US$0.21 loss per share (improved from US$1.33 loss in 1Q 2025). Net loss: US$2.49m (loss narrowed 40% from 1Q 2025). Revenue is expected to decline by 67% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 22%. Announcement • May 16
Quantum Cyber N.V. Appoints Peter M. O'rourke Sr. as Independent Member of Board of Directors, Effective May 14, 2026 Quantum Cyber N.V. announced the appointment of Peter M. O'Rourke Sr. as an independent member of its Board of Directors, effective May 14, 2026. Mr. O'Rourke served as Acting Secretary of the U.S. Department of Veterans Affairs under the Trump administration in 2018, where he led over 380,000 employees and helped oversee one of the largest federal healthcare and benefits systems in the country, with an annual budget exceeding $180 billion at the time. Before his role as Acting Secretary, he served as Chief of Staff and Senior Advisor to the Secretary, where he championed the bipartisan VA Mission Act and guided strategic alignment with White House defense and veterans initiatives, and played a key leadership role in standing up the VA Office of Accountability and Whistleblower Protection to strengthen oversight, transparency, and accountability across the Department. Mr. O'Rourke is a U.S. military veteran, having served as a Commissioned Officer in the U.S. Air Force from 1998 to 2006 and as an Enlisted Airman in the U.S. Navy aboard the USS Abraham Lincoln from 1990 to 1994. He holds a Master of Science degree from the Air Force Institute of Technology and a Department of Defense Top Secret SCI Security Clearance (inactive). Mr. O'Rourke brings significant Nasdaq board experience to Quantum Cyber, having served as Chairman of Northview Acquisition Corporation and Lead Independent Director of ProFusa. He is the Founder and Managing Partner of TCI Partners LLC, a consulting firm focused on defense, healthcare, and government engagement, and serves as President and Founder of the National Association for Veterans Rights. Board Change • Apr 26
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Non-Executive Director Greg Tibbitts was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. New Risk • Apr 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 4.9% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (312% increase in shares outstanding). Revenue is less than US$1m (US$537k revenue). Market cap is less than US$10m (US$6.33m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$16m net loss in 3 years). Reported Earnings • Apr 04
Full year 2025 earnings released: US$2.70 loss per share (vs US$22.36 loss in FY 2024) Full year 2025 results: US$2.70 loss per share (improved from US$22.36 loss in FY 2024). Revenue: US$1.07m (up 20% from FY 2024). Net loss: US$16.2m (loss narrowed 25% from FY 2024). Revenue is expected to decline by 70% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Announcement • Mar 14
Mainz Biomed N.V. Announces Appointment of Robert P. Liscouski as Chairman of the Board of Directors Mainz Biomed N.V. announced that Robert P. Liscouski has been appointed Chairman of its Board of Directors. Mr. Liscouski is a frequent contributor to CNBC, CNN, BBC, Fox News, and other business and security media on Homeland Security, Terrorism and Cyber Security issues and has appeared before Congress on Homeland Security Issues. Mr. Liscouski received his Master of Public Administration from the John F. Kennedy School of Government, Harvard University. Mr. Liscouski was appointed by President George W. Bush as the first Assistant Secretary for Infrastructure Protection when the U.S. Department of Homeland Security was founded in 2003 in the wake of the 911 attacks. During his tenure, Mr. Liscouski was responsible for the design, development, implementation and management of the Office of Infrastructure Protection, including integrating various units from other government agencies including; FBI, DoD, General Services Administration, the Department of Energy and the Depart of Commerce and the creation of the National Cyber Security Division. Mr. Liscouski’s foundational efforts led to the creation of today’s Critical Infrastructure and Security Agency (CISA). Mr. Liscouski most recently was co-founder, CEO and Chairman of Quantum Computing Inc. an innovative, integrated photonics company that manufactures accessible and affordable quantum machines. His technological leadership extends to the realm of artificial intelligence and high-performance computing. As the co-founder of Fog Data Sciences, LLC, he has been instrumental in developing geo-location intelligence solutions that leverage AI and advanced computing capabilities. These solutions serve critical needs in law enforcement and the US Security and Intelligence Community, applying cutting-edge technology to complex security challenges. At The Coca-Cola Company, Mr. Liscouski served as the Director of Information Assurance, where he was responsible for evaluating, designing, and implementing the company’s Information Security Program. New Risk • Mar 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (220% increase in shares outstanding). Revenue is less than US$1m (US$660k revenue). Market cap is less than US$10m (US$8.96m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Board Change • Jan 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Independent Non-Executive Director Greg Tibbitts was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Dec 30
Mainz Biomed N.V. has filed a Follow-on Equity Offering in the amount of $2.152823 million. Mainz Biomed N.V. has filed a Follow-on Equity Offering in the amount of $2.152823 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Dec 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (155% increase in shares outstanding). Revenue is less than US$1m (US$660k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$16m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$10.6m market cap). Announcement • Oct 10
Mainz Biomed N.V. Reports Topline Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Mainz Biomed N.V. announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier this year. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors. These findings are consistent with the strong performance previously demonstrated in discovery and validation datasets, which achieved 95% sensitivity and 98% specificity earlier this year. The reproducibility of these results further strengthens confidence in the robustness of the biomarker panel and its potential as the foundation of a reliable, non-invasive screening test. Importantly, the algorithm developed by Liquid Biosciences not only distinguished pancreatic cancer from healthy controls but also successfully detected precancerous lesions that have the potential to develop into pancreatic cancer if left untreated. The ability to identify these lesions through a blood test opens the door to monitoring at-risk individuals, intervening earlier in the disease process, and ultimately reducing the incidence and mortality associated with pancreatic cancer. Having confirmed the validity of a panel of candidate mRNA biomarkers with strong potential clinical relevance, Mainz Biomed will begin planning a larger clinical study to finalize biomarker selection using banked prospective samples. This upcoming study will evaluate the biomarkers' performance across different stages of cancer and further investigate the ability to identify early various stages of cancer and pre-cancer, leveraging next-generation sequencing technologies. Subject to the outcome of the larger confirmatory study, Mainz Biomed intends to proceed with a validation study using a larger cohort of blood samples using Polymerase Chain Reaction technology (PCR). This would be a critical step toward optimizing the test for potential clinical utility and preparing it for future regulatory consideration, including a possible submission to the U.S. Food and Drug Administration (FDA). The pancreatic cancer project is part of the Company's broader strategy to develop accessible molecular diagnostics for early cancer detection, particularly in indications where current screening tools are limited or non-existent. Reported Earnings • Sep 30
First half 2025 earnings released: US$2.65 loss per share (vs US$19.73 loss in 1H 2024) First half 2025 results: US$2.65 loss per share (improved from US$19.73 loss in 1H 2024). Net loss: US$8.34m (loss narrowed 24% from 1H 2024). Revenue is forecast to grow 79% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Announcement • Sep 25
Mainz Biomed N.V. Announces Commercial Launch of ColoAlert in Switzerland Mainz Biomed N.V. announced the commercial launch of its product, ColoAlert®?, in Switzerland. This milestone comes as the result of several key achievements. Earlier this year, Mainz Biomed signed a strategic partnership with labor team w ag ("labor team"), one of the country's leading diagnostic laboratories. This collaboration provides a strong foundation for ColoAlert's successful introduction, ensuring that patients and physicians across Switzerland will have access to the test through an established and trusted network. Following this, Swissmedic, the Swiss authority responsible for therapeutic product regulation, granted official registration and marketing approval for ColoAlert®?. This authorization enables the test to be distributed in Switzerland and marks an important regulatory step toward expanding patient access to innovative colorectal cancer screening solutions. In addition, Mainz Biomed successfully completed a comprehensive technology transfer with labor team, enabling the laboratory to process and analyze ColoAlert®? samples directly at its facility in Goldach, Switzerland. This local implementation not only ensures operational efficiency but also guarantees that Swiss patients benefit from high-quality diagnostics performed within their own healthcare system. Together, these accomplishments have paved the way for the commercial launch of ColoAlert®?, making the test available to patients and healthcare providers throughout Switzerland. The Company continues to make progress on recruitment for its 2,000 patient, average risk population study. With its goal of completing enrollment by the end of 2025, management has decided not to pause the study for an interim readout, but instead completing enrollment, analysis, and read out on the completed study. Announcement • Sep 04
Mainz Biomed N.V. Announces Registration of ColoAlert in the United Kingdom Mainz Biomed N.V. announced that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom. This milestone follows the technology partnership announced earlier this year with EDX Medical Group plc and represents an important step toward making Mainz Biomed’s DNA-based colorectal cancer (CRC) screening test, ColoAlert, broadly accessible to patients across the country. Colorectal cancer is the fourth most common cancer in the UK, with approximately 44,000 new cases diagnosed annually. ColoAlert provides a non-invasive approach to CRC screening by detecting DNA biomarkers in stool samples. The test aims to complement the existing Bowel Cancer Screening Program, which currently invites around 4 million people aged 50 to 74 to complete a FIT test annually, by providing an additional, accessible option that could help increase participation. The approval of ColoAlert in the UK underscores Mainz Biomed’s commitment to expanding access to innovative diagnostic solutions for early cancer detection. By equipping healthcare providers and patients with an additional tool for colorectal cancer prevention, the Company continues to advance its mission of addressing one of the leading causes of cancer-related mortality worldwide. Announcement • Aug 14
Mainz Biomed N.V. Receives Swiss Regulatory Approval to Market ColoAlert Mainz Biomed N.V. announced that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices. In Switzerland, CRC screening programs primarily focus on individuals between the ages of 50 and 74, with options for a biennial Fecal Immunochemical Test (FIT) or a colonoscopy every 10 years. The population in the 50 to 74 age group is estimated at around 2.8 million, accounting for approximately 31.4% of Switzerland's total inhabitants. Despite the presence of over 13 screening programs nationwide, current participation rates fall below 50%. The introduction of innovative early detection test for colorectal cancer, such as ColoAlert, could significantly contribute to improving participation rates, supporting national health goals, and addressing a critical gap in prevention efforts. The regulatory approval by Swissmedic follows the Company’s previously announced partnership with a local laboratory in Switzerland, labor team w ag, earlier this year. With this milestone, ColoAlert® is now authorized for use in the Swiss market and will be made available through the partner laboratory’s diagnostic service offering, with no remaining obstacles to the upcoming launch. ColoAlert® is a non-invasive screening test which is currently marketed in select countries across Europe and is designed to detect CRC tumor DNA and other biomarkers with high sensitivity in stool samples. Mainz Biomed continues to focus on expanding ColoAlert®'s reach through decentralized partnerships with laboratories and regional healthcare providers—ensuring broad access and localized implementation of its advanced molecular diagnostics. Announcement • Aug 06
Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $2.997777 million. Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $2.997777 million.
Security Name: Pre-Funded Units
Security Type: Equity/Derivative Unit
Securities Offered: 2,222,222
Price\Range: $1.349
Discount Per Security: $0.094
Transaction Features: Registered Direct Offering Announcement • Jun 11
Mainz Biomed N.V. Initiates Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Mainz Biomed N.V. announced the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of 95% with specificity of 98% for the detection of pancreatic cancer in blood samples. Having previously identified a panel of candidate mRNA biomarkers with potential clinical relevance, Mainz Biomed will now begin the verification process in collaboration with Crown Bioscience, a global contract research organization (CRO) known for its expertise in translational platforms that support drug discovery and development. The company provides preclinical and clinical research services to support biomarker development, enabling more accurate, predictive, and personalized medicine. The feasibility stage involves testing the selected biomarkers and the accompanying ML-based algorithm in real clinical blood samples. The primary aim of this step is to evaluate the robustness, reproducibility, and diagnostic performance of the assay under controlled laboratory conditions using a predefined sample set. Feasibility will include assessing the assay's sensitivity, specificity, and consistency, alongside evaluating the algorithm's ability to accurately stratify samples based on risk. The data obtained will help determine the suitability of the current panel and algorithm for further development. Subject to the outcome of the feasibility phase, Mainz Biomed intends to proceed with a validation study using a larger cohort of blood samples. This would be a critical step toward optimizing the test for potential clinical utility and preparing it for future regulatory considerations, including a possible submission to the U.S. Food and Drug Administration (FDA). The pancreatic cancer project is part of the company's broader strategy to develop accessible molecular diagnostics for early cancer detection, particularly in indications where current screening tools are limited or non-existent. Announcement • May 20
Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $4 million. Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $4 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 375,000
Price\Range: $2
Discount Per Security: $0.14
Security Name: Pre-Funded Units
Security Type: Equity/Derivative Unit
Securities Offered: 1,625,000
Price\Range: $1.9999
Discount Per Security: $0.14 Announcement • May 06
Mainz Biomed N.V., Annual General Meeting, Jun 02, 2025 Mainz Biomed N.V., Annual General Meeting, Jun 02, 2025. Location: offices of cms, atrium, parnassusweg 737, 1077 dg amsterdam, Netherlands Reported Earnings • Apr 01
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: US$22.36 loss per share (improved from US$64.76 loss in FY 2023). Net loss: US$21.7m (loss narrowed 18% from FY 2023). Revenue missed analyst estimates by 16%. Earnings per share (EPS) also missed analyst estimates by 30%. Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Announcement • Mar 28
Mainz Biomed N.V. Enrolls First Patient in Its eAArly DETECT 2 Clinical Study Mainz Biomed N.V. announced the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company's next-generation colorectal cancer (CRC) test. The test integrates its proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the results of previous feasibility studies and support the transition of CRC screening to CRC prevention. The eAArly DETECT2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study's outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company's U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC and APL test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas. The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas - curable precancerous colonic polyps - as well as treatable early-stage CRC. The eAArlydetECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed's proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC. Announcement • Mar 14
Mainz Biomed N.V. and Liquid Biosciences Make Groundbreaking Discovery of Mrna Biomarkers for Blood Based Detection of Pancreatic Cancer Mainz Biomed N.V. announced it has entered into a License and Option Agreement with Liquid Biosciences to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. Under the terms of the Agreement, the Company has the rights to develop a test using Liquid's biomarkers through an exclusive license with the unilateral option to acquire the exclusive global rights to the gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting pancreatic cancer. The financial terms of the Agreement include both a license fee and a royalty on future revenues in the event of the exercise of the option. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. Liquid further confirmed the biomarkers with two additional, independent cohorts, confirming the strong clinical contribution of each biomarker shown in the initial discovery phase. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid, achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position the Company's test to be the most robust and accurate screening test for pancreatic cancer on the market. The parties plan to jointly develop this pancreatic cancer screening test, which will include enhancement of commercial assays, refinement of algorithms, and preparation for potential FDA application and approval. New Risk • Mar 05
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.91m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Negative equity (-US$4.1m). Shareholders have been substantially diluted in the past year (293% increase in shares outstanding). Revenue is less than US$1m (US$917k revenue). Market cap is less than US$10m (US$9.91m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Announcement • Jan 22
Mainz Biomed Initiates U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population Mainz Biomed NV announced the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company's next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients. The eAArly DETECT2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline results by the fourth quarter of 2025. Based on the study's outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company's U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas. The five novel gene expression (mRNA) biomarkers, which the Company acquired from the Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas, i.e. curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArlydetECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed's proprietary AI algorithm to enhance product specifications to extend its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC. New Risk • Jan 06
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 229% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Negative equity (-US$4.1m). Shareholders have been substantially diluted in the past year (229% increase in shares outstanding). Revenue is less than US$1m (US$917k revenue). Market cap is less than US$10m (US$7.33m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$17m net loss next year). Announcement • Dec 18
Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $7.999998 million. Mainz Biomed N.V. has completed a Composite Units Offering in the amount of $7.999998 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 1,367,521
Price\Range: $5.85
Discount Per Security: $0.4095 New Risk • Oct 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 53% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$20m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-US$4.1m). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Revenue is less than US$1m (US$917k revenue). Market cap is less than US$10m (US$7.43m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$30m net loss in 2 years). Reported Earnings • Oct 20
First half 2024 earnings released: US$0.49 loss per share (vs US$1.00 loss in 1H 2023) First half 2024 results: US$0.49 loss per share (improved from US$1.00 loss in 1H 2023). Revenue: US$520.8k (up 4.4% from 1H 2023). Net loss: US$11.0m (loss narrowed 26% from 1H 2023). Revenue is forecast to grow 88% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in the US. Announcement • Oct 08
Mainz Biomed Reports Increased Demand for Enhanced Coloalert, Existing Partners to Transition to New Version Mainz Biomed N.V. announced increasing demand from existing and prospective laboratory partners for its enhanced ColoAlert product that has been launched in July 2024 and is currently being commercialized across Europe and in select international markets. This advanced version of the Company's colorectal cancer (CRC) screening test is set to become the standard offering for all existing partners, reflecting its proven benefits in optimizing screening efficiency and improving user experience. One of the earliest partners to make the transition is GANZIMMUN Diagnostics, one of Germany's premier laboratories, which licensed the ColoAlert test. GANZIMMUN will fully implement the enhanced version of the innovative DNA biomarker-based screening product by the beginning of next year, taking advantage of the significant improvements in sample processing and usability that have set a new industry benchmark. Partners are particularly drawn to the enhanced features, such as the proprietary DNA stabilizing buffer that ensures reliable results despite varying sample volumes, and the streamlined collection devices that simplify at-home testing for users. These innovations have drastically reduced the need for retesting, offering faster turnaround times for patients, with results available in just 2-3 days from sample arrival. GANZIMMun Diagnostics will showcase the enhanced ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress in Germany focusing on complementary medicine, which takes place from October 30 to November 3, 2024. This underscores the increasing role of complementary medicine in cancer prevention and early detection. The event will provide an ideal platform to promote Mainz Biomed's innovative DNA-based CRC screening test to medical professionals, integrative medicine practitioners, and researchers interested in advanced diagnostic solutions. Announcement • Oct 02
Mainz Biomed N.V. Announces FDA Trials in 2025 Mainz Biomed N.V. 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 transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through its innovative diagnostic solutions. Corporate Product: Breakthrough Data and U.S. Expansion: mRNA-based next-generation CRC screening tests are redefining standards in early cancer detection. Mainz Biomed's non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both U.S. and European trials. Presentations at DDW and ASCO this year have highlighted sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development. Mainz Biomed, alongside other companies, emphasizes the use of stool-based samples for CRC and advanced adenoma detection due to their direct connection to cancer cells and adenomas. Recent reports suggesting the ease of blood tests over stool tests must be carefully evaluated, as extensive studies in the U.S. and Europe have shown significantly lower sensitivity of blood tests in identifying advanced adenomas. This limitation arises because early-stage advanced adenomas are not typically connected to the body's blood supply, making them undetectable through blood samples. In early July the Company has announced that based on its robust clinical data package it submitted for FDA Breakthrough Device Designation (BDD) for its next generation CRC screening test. Following encouraging feedback from the FDA, the Company has made the strategic decision to withdraw its BDD application to focus on extending its clinical research program. Mainz Biomed will expand its dataset to include a larger average-risk patient population with its pivotal ReconAAsense trial. The Company plans to submit this comprehensive data in 2025 to FDA. The consistently positive data from the Company’s clinical feasibility studies presented at ASCO 2024 and Digestive Disease Week (DDW), provide a strong foundation as Mainz Biomed prepares for U.S. FDA clinical trials in 2025, a key milestone in its strategy to penetrate the U.S. market. Successful completion of the FDA trial will allow Mainz Biomed’s next generation CRC screening test to be marketed to millions of Americans at risk of colorectal cancer, representing a major revenue growth opportunity for the company. Innovative Diagnostic Pipeline: In addition to its mRNA next-generation CRC screening test, Mainz Biomed is advancing a robust pipeline of cutting-edge diagnostic technologies aimed at detecting multiple cancers, with PancAlert leading the way. Its focus on molecular diagnostics, powered by proprietary biomarkers, positions to address a wide range of cancers early, improving patient outcomes and reducing healthcare costs globally. The success of its upcoming products will help diversify its revenue streams and strengthen its leadership in cancer diagnostics. Current development and expansion of the current ColoAlert screening test: Mainz Biomed has redeveloped and relaunched an expanded version of its first-generation CRC screening test currently commercialized in Germany and selected other countries in Europe. The change implemented in the ColoAlert product significantly simplified the workflow and reduced the retest rates. The feedback from the lab communities has been very positive and the Company expects this new product to further accelerate the growth and lab expansion. Committed on delivering on key milestones for fair Company valuation: Mainz Biomed’s strong clinical results, expanding pipeline, and upcoming FDA trial, it is the management’s position that the Company’s current stock price does not adequately reflect its true value. While the Mainz Biomed cannot directly influence the stock market, the management team is fully focused on delivering on key milestones and executing its strategy to unlock value for shareholders. Looking Ahead: FDA Trials and Major Growth in 2025: 2024 is a year of continued clinical progress and market expansion, but the FDA trials anticipated for 2025 represent a pivotal moment for Mainz Biomed. Successfully navigating the regulatory landscape in the U.S. will unlock significant opportunities to serve millions of patients in the world’s largest healthcare market. Price Target Changed • Aug 06
Price target decreased by 33% to US$2.00 Down from US$3.00, the current price target is provided by 1 analyst. New target price is 453% above last closing price of US$0.36. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$0.88 next year compared to a net loss per share of US$1.62 last year. Announcement • Jul 25
Mainz Biomed N.V. Launches Enhanced Coloalert with Cutting-Edge Features to Optimize Screening Efficiency and User Convenience Mainz Biomed N.V. 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. ColoAlert is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. To increase screening/lab efficiency, Mainz Biomed has introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes. This breakthrough addresses a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. Consequently, patients frequently have to repeat their screening test. The new proprietary buffer used in ColoAlert significantly reduces the necessity for additional sample submissions, thereby reducing the time for the patients to obtain their results. This enhancement has enabled ColoAlert to achieve the industry's lowest retaining rates, ensuring that screening outcomes are delivered within just 2 - 3 days upon arrival at the laboratory. Furthermore, Mainz Biomed has refined the ColoAlert kit for improved usability, including a variety of new features, such as an improved collection device, a new tube and tube holder, etc. These upgrades streamline the sample collection process, offering users a more straightforward and reliable experience. The updated ColoAlert product is now accessible to existing laboratory partners and readily available to prospective collaborators. Announcement • Jul 09
Mainz Biomed N.V. Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test Mainz Biomed N.V. announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company's novel portfolio of mRNA biomarkers. Subject to the FDA's review, a Breakthrough Device Designation could significantly accelerate approval. The regulatory submission follows consistently excellent read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO 2024. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the Company plans to use in its Next Generation product, and the FDA premarket approval study. The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings. The FDA's Breakthrough Devices Designation is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to allow patients and health care providers timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations. Breakthrough Devices must meet the FDA's rigorous standards for device safety and effectiveness in order to be authorized for marketing. Announcement • May 08
Mainz Biomed N.V. Presents an Analysis from Its eAArly Detect Study At Digestive Disease Week Mainz Biomed N.V. will present an analysis from its eAArly DETECT study at Digestive Disease Week (DDW) 2024 in Washington D.C. from May 18th to May 21st. eAArly DETECT is a US multi-site study performed at 21 specialized gastroenterology sites that enrolled 254 clinical patients. The results show compelling performance of its multimodal screening test combining Fecal Immunochemical Test (FIT), DNA and mRNA biomarkers with a unique artificial intelligence (AI) /machine learning algorithm to differentiate between colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas and patient samples with no findings. The presentation will delve into the test's ability to accurately analyze a combination of biomarkers, improving early detection rates for both colorectal cancer and significant precancerous conditions. By leveraging this dual approach, Mainz Biomed aims to accelerate the shift from cancer detection to prevention by advancing current colorectal cancer screening practices, reflecting its commitment to reducing cancer mortality rates worldwide. The eAArly DETECT was performed to identify novel mRNA biomarker for potential integration into the Mainz Biomed's pivotal FDA PMA clinical trial ReconAAsense. The study enrolled 254 evaluable subjects across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation. Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert®? test incorporating the novel biomarkers. Major Estimate Revision • Apr 16
Consensus revenue estimates fall by 48% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$2.50m to US$1.30m. Forecast losses increased from -US$0.78 to -US$0.875 per share. Biotechs industry in the US expected to see average net income decline 9.3% next year. Consensus price target down from US$3.00 to US$2.00. Share price fell 9.3% to US$0.98 over the past week. Reported Earnings • Apr 09
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2023 results: US$1.62 loss per share (improved from US$1.86 loss in FY 2022). Net loss: US$26.3m (flat on FY 2022). Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 4.1%. Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Announcement • Dec 05
Mainz Biomed N.V. Reports Positive Topline Results from U.S. eAArly DETECT Study Evaluating Novel mRNA Biomarkers Mainz Biomed N.V. announced topline results from its eAArly DETECT U.S. clinical study, a multi-center feasibility study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert®?, the company's highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. The eAArly DETECT topline results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. They confirm the positive results from ColoFuture, its European counterpart which reported data in October 2023. The eAArly DETECT study enrolled 254 evaluable subjects across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation. Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert® test incorporating the novel biomarkers. The results from eAArly DETECT not only confirm but even surpass the good results from ColoFuture earlier this year that reported sensitivity for colorectal cancer of 94% with specificity of 97% and advanced adenoma sensitivity of 80%. Major Estimate Revision • Nov 23
Consensus revenue estimates decrease by 28%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$1.27m to US$920.0k. EPS estimate increased from -US$1.88 to -US$1.69 per share. Biotechs industry in the US expected to see average net income growth of 10% next year. Consensus price target down from US$9.00 to US$5.00. Share price was steady at US$1.14 over the past week. Reported Earnings • Nov 17
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$0.40 loss per share (improved from US$0.48 loss in 3Q 2022). Net loss: US$6.30m (loss narrowed 8.6% from 3Q 2022). Revenue missed analyst estimates by 48%. Earnings per share (EPS) exceeded analyst estimates by 20%. Revenue is forecast to grow 94% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Announcement • Nov 17
Mainz Biomed N.V. has completed a Follow-on Equity Offering. Mainz Biomed N.V. has completed a Follow-on Equity Offering.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,359,655
Price\Range: $1.2
Discount Per Security: $0.084
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 4,166,667
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 807,012
Price\Range: $1.18
Discount Per Security: $0.084
Transaction Features: Registered Direct Offering New Risk • Nov 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Revenue is less than US$1m (US$789k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$41m net loss in 2 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$20.1m market cap). Announcement • Oct 19
Mainz Biomed N.V. Presents Results of Colofuture Study Mainz Biomed N.V. announced that it is presenting its results of its ColoFuture Study. Originally scheduled for presentation by Dr. Moritz Eidens, the Company's Chief Scientific Officer, to assembled academics as part of a poster session at the 4th International Conference on Gastroenterology in Paris, the event has since been rescheduled from October to December. In consultation with the Conference leadership, Mainz Biomed has opted to release the eagerly anticipated ColoFuture results in line with the original conference schedule. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert(R), the Company's highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) which is being commercialized across Europe and in select international territories. The presented results of the study included a sensitivity for CRC of 94% with a specificity of 97% and a sensitivity for advanced adenoma (AA) of 80%. The presented results of the study included a sensitivity forRC of 94% with a specificity the specificity of 97% and a sensitive for advanced adenoma (AAA) of 80%. The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert®? will be evaluated in the FDA-registration trial 'ReconAAsense.' Once approved in the US, the Company's commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. Announcement • Sep 14
Mainz Biomed N.V. Announces Positive Topline Results from its ColoFuture Study Mainz Biomed N.V. announced positive topline results from its ColoFuture study. The ColoFuture study is a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) which is being commercialized across Europe and in select international territories. The results of this study included sensitivity for colorectal cancer of 94% with a specificity of 97% and a sensitivity for advanced adenoma of 81%. The portfolio of mRNA biomarkers evaluated in the ColoFuture study was acquired from the Université de Sherbrooke (January 2022) to potentially enhance ColoAlert’s technical profile to further extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, and to increase the diagnostic sensitivity and specificity rates for CRC. In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional mRNA biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma and identified a subset of mRNA biomarkers that provided the sensitivity and specificity of detection (Herring et al. 2021). Mainz Biomed specifically selected those mRNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with advanced adenomas. The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable. By treating the patient before the polyps can progress to a cancerous stage, CRC can be prevented. COLOFUTURE is an international clinical study evaluating the performance of the Mainz Biomed Colorectal Cancer Screening Test. This test is a combination of the ColoAlert test and novel mRNA markers. COLOFUTURE includes subjects aged 40-85 from participating centers in Germany, Norway and Denmark. Subjects are invited to participate in the study either when referred for colonoscopy (screening or diagnostic) or if already diagnosed with colorectal adenocarcinoma but treatment-naive. To be included, subjects provide informed consent and submit samples from one stool collection prior to colonoscopy or treatment. Completed subjects are placed into one of the following groups based on the colonoscopy results and any applicable pathology report from biopsy: colorectal adenocarcinoma, advanced precancerous lesions in the colon or rectum, non-advanced adenoma, or normal. Each subject’s stool sample is tested with the Mainz Biomed Colorectal Cancer Screening Test. The primary endpoints of the study are to determine sensitivity and specificity for colorectal adenocarcinoma. There are multiple secondary and exploratory endpoints including determining sensitivity and specificity for advanced precancerous lesions in the colon. The interim analysis included 220 subjects. Announcement • Aug 22
Mainz Biomed Announces Live Launch of ColoAlert with testDNA Laboratory in Poland Mainz Biomed NV announces the commercial launch of ColoAlert in Poland, made possible through a strategic collaboration with testDNA Sp. z o. o. Sp. K (“testDNA”). The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer (“CRC”). ColoAlert, Mainz Biomed's product is a user-friendly and highly effective at-home screening test able to help meaningfully address the pressing global challenge of early colorectal cancer detection. The strategic alliance with testDNA aims to extend the reach of this transformative technology, providing improved access to screening tools that come with the potential to save countless lives across Poland. Operating since 2003, testDNA is a national leader in the field of DNA-based testing services. As an accredited research laboratory sanctioned by the Polish Center for Accreditation, the laboratory is headquartered in Katowice, Poland, and boasts an expansive network of over 300 collection points throughout the country. With a comprehensive portfolio, testDNA is renowned for delivering genetic-based testing solutions tailored to individual needs. The urgency for alternative CRC screening options is underscored by data from the World Cancer Research Fund International which ranked Poland 7th (seventh) in the world for the highest mortality rate. With over 21 million people aged over 40, the market opportunity for ColoAlert is significant, especially as there has been a low level of national participation in CRC screening which traditionally has been colonoscopies. In the recently published NordICC study in the New England Journal of Medicine, only 33% of those invited to participate in colonoscopy screening actually took part. This highlights the need to have alternative screening options that are less invasive and easier to perform at home. Major Estimate Revision • Aug 22
Consensus revenue estimates fall by 19% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$1.58m to US$1.27m. Forecast losses increased from -US$1.34 to -US$1.88 per share. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target down from US$11.00 to US$8.00. Share price fell 3.4% to US$3.14 over the past week. New Risk • Aug 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 18% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Revenue is less than US$1m (US$789k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$39m net loss in 2 years). Shareholders have been diluted in the past year (12% increase in shares outstanding). Market cap is less than US$100m (US$45.8m market cap). New Risk • Aug 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$21m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Revenue is less than US$1m (US$789k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$21m net loss in 2 years). Shareholders have been diluted in the past year (9.6% increase in shares outstanding). Market cap is less than US$100m (US$46.3m market cap). Reported Earnings • Aug 16
Second quarter 2023 earnings: EPS and revenues miss analyst expectations Second quarter 2023 results: US$0.55 loss per share (further deteriorated from US$0.49 loss in 2Q 2022). Net loss: US$8.25m (loss widened 19% from 2Q 2022). Revenue missed analyst estimates by 9.5%. Earnings per share (EPS) also missed analyst estimates by 62%. Revenue is forecast to grow 88% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Announcement • Aug 02
Mainz Biomed Announces Live Launch of ColoAlert with Marylebone Laboratory in the United Kingdom Mainz Biomed NV announced that Marylebone Laboratory (Marylebone Lab Ltd) has introduced ColoAlert®, Mainz Biomed's product, a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) - to its extensive UK and international customer base. Further strengthening Mainz Biomed's global network of esteemed laboratory partners, the collaboration marks another significant milestone in the Company's mission to combat colorectal cancer (CRC) and save lives through advanced diagnostics. Colorectal cancer remains a critical health concern, with approximately 43,000 diagnoses and 16,800 deaths occurring each year in the UK alone. This equates to an average of 46 lives lost every day. With a population of 67 million people, the UK presents a substantial market for CRC screening. Specifically, within the age groups of 40 to 49 years and 50 to 75 years, there are approximately 8.4 million and 20.0 million individuals respectively. Additionally, there are 6.2 million individuals aged over 75. With a recommended frequency of CRC screening once every two years for patients aged 50 to 74, ColoAlert® represents a pivotal tool in the fight against this devastating disease. Considering these figures, the addressable UK market for ColoAlert® amounts to a staggering 34.6 million potential users. Mainz Biomed is delighted to collaborate with Marylebone Laboratory, which recently expanded its presence in London under the Marylebone Diagnostic Centre brand, where it provides a comprehensive range of screening and diagnostic testing services. Marylebone Laboratory brings extensive expertise in NGS (Next-Generation Sequencing) and PCR (Polymerase Chain Reaction)-based molecular genetic testing. Its focus on innovative methodologies allows for tailored solutions to individual customers as well as larger organizations and ensures the delivery of genetic-based testing services. Announcement • Jun 29
Mainz Biomed N.V. announced that it has received $5.06 million in funding from Yorkville Advisors Global LP Mainz Biomed N.V. announced a private placement and it has issued promissory note for proceeds of $5,060,000 on June 28, 2023. The transaction included participation from new investor, YA II PN, Ltd., a fund managed by Yorkville Advisors Global LP. The note is issued at an 8% original issue discount having a principal value of $5,500,000. The promissory note matures one year from the date of its issuance. The promissory note do not carry any interest, except if there is an event of default in which case the interest will increase to 15% per annum. The promissory note are convertible at investor discretion into our ordinary shares at a conversion price equal to the lower of $4.9986 in respect of the initial promissory note and with respect to each subsequent promissory note, if any, 110% of the volume weighted average price of our ordinary shares on the trading day immediately preceding the issuance of such promissory note or 92% of the average of the two lowest daily volume weighted average prices of the shares during the eight trading days immediately prior to such conversion. In no event, however, shall the conversion price be less than a floor price of $2 as may be adjusted for stock splits and other similar transactions. Announcement • May 26
Mainz Biomed Processes First Patients from Colorectal Cancer Screening Campaign Through its Corporate Health Portal in Partnership with Zöeller-Kipper Mainz Biomed NV announced initial results from its colorectal cancer (CRC) screening campaign through its BGM (“betriebliches Gesundheitsmanagement”) partnership with Zöller-Kipper GmbH, part of the Zöller group with more than 2,500 employees. In April 2023, Zöller-Kipper selected ColoAlert®, Mainz Biomed’s highly efficacious and easy-to-use screening test for CRC, for its corporate health program. Using Mainz Biomed’s online portal, Zöller-Kipper employees registered to be mailed the ColoAlert test. Once the sample was received and processed, confidential test results were sent back to the employee through the portal, along with an explanation of the results. If an employee had approved for a physician to be notified of test results, then the doctor could directly follow-up with the patient. As part of its commitment to the BGM program, Mainz Biomed provided education to employees and physicians on CRC and recommendations for next steps. ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. Announcement • May 20
Mainz Biomed N.V., Annual General Meeting, Jun 28, 2023 Mainz Biomed N.V., Annual General Meeting, Jun 28, 2023, at 14:00 Central European Standard Time. Location: CMS, Atrium, Parnassusweg 737, 1077 DG Amsterdam Netherlands Agenda: To consider the statutory management report for the financial year ended 31 December 2022; to consider adoption of the statutory annual accounts for the financial year ended 31 December 2022; to consider discharge from liability of the directors for their management and supervision during the financial year ended 31 December 2022; to consider approval of amendment of the Mainz Biomed N.V. 2022 Omnibus Incentive Plan; and to consider other matters. Announcement • Jan 19
Mainz Biomed B.V. Launches Corporate Health Program in Germany for ColoAlert Mainz Biomed NV announced launch of a corporate health program in Germany for ColoAlert, its highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. As a start, ColoAlert has been integrated into BGM. Through corporate health management programs such as the BGM network, best-in-class companies offer employees healthcare services ranging from gym memberships to diabetes management to counseling, all to better their health. This investment improves employee satisfaction and performance, which in turn contributes to the organization’s long-term success. Mainz Biomed’s integration into the BGM network includes the launch of an online portal through which employees can register to be sent the ColoAlert test. Once the sample is received and processed, confidential test results are sent back to the employee through the portal, along with an explanation of the results. If an employee has approved for their physician to also be notified, then the doctor can follow up with the patient accordingly. Mainz Biomed provides education for both the employee and physician regarding the ColoAlert results and CRC, as well as recommendations for next steps. Board Change • Nov 16
High number of new and inexperienced directors There are 11 new directors who have joined the board in the last 3 years. The company's board is composed of: 11 new directors. No experienced directors. 1 highly experienced director. Chief Science Officer & Director Moritz Eidens is the most experienced director on the board, commencing their role in 2008. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Aug 02
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. No experienced directors. 1 highly experienced director. Chief Science Officer & Director Moritz Eidens is the most experienced director on the board, commencing their role in 2008. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • May 23
Mainz Biomed B.V., Annual General Meeting, Jun 28, 2022 Mainz Biomed B.V., Annual General Meeting, Jun 28, 2022, at 15:00 Central European Standard Time. Location: at the offices of CMS Netherlands, Atrium, Parnassusweg 737, 1077 DG Amsterdam Amsterdam Netherlands Announcement • May 06
Mainz Biomed Provides Product Development Update on Pancalert Mainz Biomed N.V. announced that PancAlert, its screening test candidate for pancreatic cancer has achieved multiple pre-clinical milestones that support the development of this potential first-in-class diagnostic for a deadly cancer indication. The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide. It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S. and 9% globally. However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative. Mainz Biomed reported the achievement of multiple predefined milestones for the PancAlert project, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of prototype biomarker tests. The Company will now allocate resources over the next 12 months to determine if the product candidate warrants clinical evaluation. It's possible that PancAlert’s technical profile will include functioning as a stool-based test, mirroring the Company’s product ColoAlert, a highly efficacious and easy to use at-home detection test for colorectal cancer. However, given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples, and will also evaluate other collection methodologies including saliva, urine and blood. Announcement • May 03
Mainz Biomed B.V. announced delayed 20-F filing On 05/02/2022, Mainz Biomed B.V. announced that they will be unable to file their next 20-F by the deadline required by the SEC. Announcement • Apr 26
Mainz Biomed Appoints Darin Leigh as Chief Commercial Officer Mainz Biomed B.V. announced the appointment of Darin Leigh as Chief Commercial Officer. Darin comes to the role with over 25 years of product lifecycle management and global commercial operations experience across Europe, the United States and Asia. Announcement • Mar 31
Mainz Biomed Completes Successful Pre-Submission Process with the U.S Fda for Coloalert’S Pivotal Clinical Trial Mainz Biomed N.V. announced that it has received supportive feedback from the U.S. Food & Drug Administration (FDA) on the Company’s pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). As Mainz prepares to launch ColoAlert’s pivotal clinical trial, the Company is also pleased to announce the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with The Centers for Medicare and Medicaid Services (CMS) in April 2022. The CMS is a federal agency in the U.S. Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards. An integral part of Mainz’s clinical execution and medical reimbursement strategies is its partnership with Precision for Medicine, a leading global Clinical Research Organization. Precision for Medicine will continue to work with Mainz’s management team to implement the U.S. focused regulatory and market access strategy for ColoAlert by finalizing ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. The Company is planning to integrate CMS guidelines into ColoAlert’s pivotal trial design, utilizing currently marketed CRC screening tests as benchmarks to provide the test with an optimal product profile for regulatory approval and success in the marketplace. Announcement • Feb 24
Mainz Biomed Provides U.S. Regulatory Review Update for Coloalert Mainz Biomed N.V. announced that its pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review. By accepting the pre-submission for review, the FDA will provide feedback to the Company on its proposed pivotal U.S. clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). The FDA feedback is expected in calendar second quarter of 2022, and will offer Mainz the opportunity to gain preliminary insight and guidance on the potential technical parameters and endpoints of the study, which is on track to commence in 2023. A key component of Mainz’s U.S. regulatory strategy for ColoAlert is based on the outcome of the Company’s recently announced (February 4, 2022) launch of ColoFuture, an international clinical study evaluating the potential to integrate a portfolio of in-licensed novel mRNA biomarkers into the product. The rationale behind acquiring the rights to these five biomarkers from the Université de Sherbrooke in December of 2021, was based on their documented, unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC (Herring et al 2021). ColoFuture is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. So, if the study results from ColoFuture prove positive, it will solidify ColoAlert as the gold standard at-home diagnostic tool for CRC currently being marketed across Europe and enable Mainz to incorporate these biomarkers into ColoAlert prior to commencing its U.S. pivotal study for the product. Mainz is currently marketing ColoAlert through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Announcement • Feb 10
Mainz Biomed B.V. Announces the Appointment of Dr. Rainer Metzger to Its Strategic Advisory Board Mainz Biomed N.V. announced the appointment of Dr. Rainer Metzger to its Strategic Advisory Board. Dr. Metzger is a global business executive and operations leader with almost three decades of executive experience within the life science and healthcare sector with global pharmaceutical and diagnostics companies including ROCHE, DANAHER and QIAGEN. During his close-to ten-year career with Roche, Dr. Metzger held several VP roles leading highly-successful global business development and clinical biomarker programs within oncology and corporate and molecular diagnostics. As Roche's VP, Global Head Business and Biomarker Operations and Biosample and Repository Management, his span of influence included the development of the Pharma Biomarker Personalized Healthcare initiative, and the implementation and delivery of a highly-valuable technology/product portfolio with several hundred individual biomarker programs. Announcement • Feb 05
Mainz Biomed Initiates Clinical Study to Evaluate Integrating Novel mRNA Biomarkers Into ColoAlert Mainz Biomed N.V. announced that it has commenced ColoFuture, an international clinical study to evaluate the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer which is being commercialized across Europe. The novel gene expression (mRNA) biomarkers, which the company acquired an exclusive option to in-license from the Université de Sherbrooke in early January 2022, have demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage colorectal cancer (CRC). The ColoFuture study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. The exclusive option to in-license these mRNA biomarkers from the Université de Sherbrooke is the result of the institution’s pioneering work in the field, where researchers tested a battery of novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The results from these studies demonstrated that the five mRNA targets chosen by Mainz Biomed provided the greater sensitivity and specificity of detection. (Herring et al 2021). The ColoFuture study is evaluating over 600 patients including both male and female genders in the age range of 40-85 at two participating centers in Norway and two in Germany. Subjects will be invited to potentially participate in the trial when referred for a colonoscopy (pre-inclusion) to screen for CRC or an overall diagnostic analysis. Those who agree to provide a stool sample in advance of the procedure will be eligible for participation. Inclusion criteria are based on one of the following diagnostic outcomes: CRC, advanced precancerous lesions in colon, or normal colon. Then, each patient outcome will be compared to the observations recorded from the colonoscopy to the results from the ColoAlert test that incorporates the novel biomarkers. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. There are multiple secondary endpoints for evaluating the modified ColoAlert test, including, determining sensitivity for AA lesions in colon, specificity for advanced precancerous lesions in colon and, specificity for no colorectal finding (normal colon). The Company expects to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023. Announcement • Dec 07
Mainz Biomed Launches Ecommerce Store for ColoAlert to Assist Patient Access during Covid-19 Pandemic Mainz Biomed N.V. announced the launch of ColoAlert.de, an ecommerce store providing Germans direct access to its ColoAlert colorectal cancer (CRC) screening test. German residents unable to obtain timely CRC screening via in-person physician visits, will be able to order ColoAlert directly to their home and receive highly accurate results within a maximum of nine working days. This direct-to-patient program will utilize Mainz Biomed’s own, high-throughput, clinical lab based in Mainz, and be administered by in-house physicians. The Company’s clinical team will also be on hand to provide phone-based support to ensure a high level of patient care. In line with Mainz Biomed’s business strategy, it is expected that ColoAlert.de and other Company-owned online points of sale will eventually distribute orders for diagnostic tests to partner labs within the network, both within Germany and globally as further regulatory approvals are secured and member labs integrated. Colorectal cancer is the second deadliest cancer in the European Union (EU), with approximately 170,000 people dying every year, out of a diagnosed population of 370,000. According to Digestive Cancers Europe, if the European Union was able to diagnose more patients in stage 1 from the current 13% to 50%, 130,000 more lives could be saved per year and more than 3 billion €in healthcare budget savings could be generated every year, and possibly the same amount in social and work-related value. Board Change • Nov 05
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. CEO & Director Guido Baechler was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.