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Summary of Natera FY Conference Call - September 23, 2025 Company Overview - **Company**: Natera (NasdaqGS:NTRA) - **Industry**: Life Sciences Tools and Diagnostics Key Points Market Opportunity - The addressable market for Minimal Residual Disease (MRD) testing is significant, with approximately 2 million cancer diagnoses annually in the U.S. [9] - It is estimated that 1.5 million of these diagnoses are relevant for MRD and recurrence monitoring, leading to a potential total addressable market (TAM) of around $30 billion based on an average selling price (ASP) of $2,000 per test [12] - Current revenue from Signatera is projected to be around $1 billion, indicating substantial growth potential [12] Product and Technology - Natera's Signatera test is positioned as a leader in MRD testing, with a focus on identifying cancer recurrences earlier than traditional methods [22] - The company is developing a tumor-naive test, Latitude, to address patients without viable tissue samples, which represents an unmet need in the market [51] - The blended cost of goods sold (COGS) for Signatera is competitive, allowing for sustainable growth and investment in clinical trials [14][60] Clinical Trials and Evidence Generation - Natera is conducting multiple clinical trials to build evidence for the clinical utility of Signatera, including a Phase III trial in muscle invasive bladder cancer [24] - The company emphasizes the importance of prospective clinical trials to demonstrate the effectiveness of their tests, which is crucial for adoption by physicians [42][43] Competitive Landscape - The company acknowledges the presence of competition in the MRD testing space but believes that their focus on solving unmet patient needs will differentiate them [36] - Natera's strategy involves leveraging their existing relationships in oncology and primary care to enhance market penetration [68] Future Outlook - Natera anticipates that the adoption of MRD testing will increase as more data becomes available, and they expect to see a rise in ASP as reimbursement becomes more consistent [57] - The company is optimistic about the future of their products and believes that the market has not fully priced in the potential of Signatera [79] Additional Insights - The company is aware of the challenges in the blood-based early cancer detection market, particularly for colorectal cancer, and is focused on addressing these challenges through innovative solutions [67] - Natera's leadership emphasizes the importance of transparency and data sharing with investors to build trust and confidence in their products [70] Conclusion Natera is positioned for significant growth in the MRD testing market, with a strong focus on clinical evidence, competitive differentiation, and addressing unmet patient needs. The company is optimistic about future adoption and market potential, despite existing competition.

Core Insights - Mainz Biomed has launched its flagship product, ColoAlert®, in Switzerland, marking a significant milestone for the company [1] - The launch follows a strategic partnership with labor team w ag, a leading diagnostic laboratory in Switzerland, which will facilitate the distribution of ColoAlert® [2] - Swissmedic has granted official registration and marketing approval for ColoAlert®, allowing its distribution in Switzerland and enhancing patient access to colorectal cancer screening [3] Company Developments - Mainz Biomed completed a technology transfer with labor team, enabling local processing and analysis of ColoAlert® samples in Switzerland, ensuring operational efficiency and high-quality diagnostics [4] - The company is progressing with its eAArly DETECT clinical study, aiming to enroll 2,000 patients from the average risk population by the end of 2025, without pausing for interim readouts [5] - Mainz Biomed is also preparing for a pivotal FDA study for US regulatory approval, indicating its commitment to expanding its market presence [6]

Core Insights - Cancer is the leading cause of death for individuals under 85, with 600,000 deaths and 2 million diagnoses annually [1][2] - Current screening methods only cover four types of cancer, while there are 50 types that could potentially be screened [2][4] - The goal of new testing methods is to detect cancer at early stages when it is most treatable, as early-stage cancer is generally asymptomatic and localized [3][4] Company Insights - The new cancer test aims to detect 70% of cancers that currently lack screening methods, with a detection rate of approximately 64% [4][5] - The test is designed to complement existing screening methods rather than replace them, focusing on early detection [4][5] - The company has set a lower price point of $689 for the test to increase accessibility and aims for Medicare coverage in the future [8][9] Industry Insights - Early detection combined with advanced therapies represents a new paradigm in cancer treatment, potentially improving patient outcomes [7] - The competitive landscape includes other companies like GRAIL, which offers similar testing at different price points [7][8] - There is ongoing legislative support for Medicare to evaluate and potentially cover this class of testing, indicating a favorable regulatory environment [9]

Core Insights - Mainz Biomed N.V. has received official registration for its ColoAlert® test from the Medicines and Healthcare products Regulatory Agency (MHRA), allowing it to be marketed in the UK [1][4] - The approval follows a technology partnership with EDX Medical Group plc, aimed at increasing accessibility of the DNA-based colorectal cancer screening test [2] - Colorectal cancer is the fourth most common cancer in the UK, with around 44,000 new cases diagnosed each year, and ColoAlert offers a non-invasive screening option [3] Company Developments - The approval of ColoAlert enables the UK laboratory partner to provide a reliable and user-friendly test, supporting the goal of increasing participation in preventive screening [4] - Mainz Biomed is committed to expanding access to innovative diagnostic solutions for early cancer detection, addressing a leading cause of cancer-related mortality [4] - The company is also running a pivotal FDA clinical study for US regulatory approval and has other product candidates like PancAlert for pancreatic cancer screening [5]

Core Insights - HydroGraph Inc. is collaborating with Hawkeye Bio and Ease Healthcare to commercialize a new lung cancer screening product called LEAP, which utilizes HydroGraph's patented fractal graphene technology [1][2][4] - The LEAP test is a non-invasive blood test with a 99.8% negative predictive value, aimed at early detection of lung cancer in high-risk populations [2][5] - The partnership highlights the medical potential of high-purity graphene in diagnostics, with HydroGraph's technology supporting innovative solutions for cancer detection [4][5] Company Overview - HydroGraph is a leading producer of ultra-pure graphene using an "explosion synthesis" process, ensuring exceptional purity and consistency [8] - Hawkeye Bio specializes in developing low-cost diagnostic tests for early detection of cancer and other diseases, with a focus on using nanoscale graphene biosensors [7][8] - Ease Healthcare is responsible for marketing the LEAP test, which is designed to be a cost-effective diagnostic solution for primary care physicians [5][10] Market Context - Lung cancer is the leading cause of cancer deaths in the U.S., with an estimated 125,000 deaths and 227,000 new cases expected in 2025 [4] - Current screening compliance is low, with only 2% to 6% of at-risk individuals undergoing recommended screenings, despite the benefits of early detection [4] - The eligible population for lung cancer screening in the U.S. is currently estimated at 15-19.3 million, with expectations for growth as screening guidelines evolve [6]

Core Insights - BioMark Diagnostics has established a strategic partnership with SAMA CONSULTING to explore the clinical application of its liquid biopsy technology for lung cancer detection in Tunisia and North Africa, targeting a population of over 90 million [1][5][6] - The collaboration aims to address the urgent need for innovative early detection solutions for lung cancer, which is a leading cause of cancer-related mortality in Tunisia [2][5] - A proof-of-concept trial is set to begin in October 2025 to evaluate the performance and clinical utility of BioMark's technology within the Tunisian healthcare system [3][7] Strategic Expansion - This partnership marks BioMark's entry into the North African market, demonstrating its commitment to expanding access to advanced cancer diagnostics in emerging healthcare markets [4][6] - The collaboration leverages SAMA CONSULTING's local expertise to facilitate rapid implementation and regulatory compliance [4][9] Clinical Objectives - Key objectives include assessing the technology's effectiveness in the target population, advancing the publication of clinical data to support broader adoption, and evaluating integration potential with national screening programs [5][6] Regulatory Compliance - Both organizations are committed to ensuring compliance with Tunisian healthcare regulations and international clinical trial standards, operating under comprehensive Non-Disclosure Agreements to protect proprietary information [8][9] Company Background - BioMark Diagnostics is a leading developer of liquid biopsy tests for early cancer detection, utilizing metabolomics and machine learning algorithms to enable earlier diagnosis and improved patient outcomes [10] - SAMA CONSULTING SARL specializes in healthcare innovation and clinical research facilitation, providing expertise in regulatory compliance and clinical trial management across North Africa and Francophone Africa [9]

Core Insights - Mainz Biomed N.V. has secured public funding for its pancreatic cancer project from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), which will cover up to 50% of the project's total costs, highlighting the project's scientific and societal value [1][2] - The funding is a significant endorsement of Mainz Biomed's non-invasive, blood-based screening test aimed at early detection of pancreatic cancer, which is crucial for improving treatment outcomes [2][3] - The project is currently in the feasibility phase, focusing on evaluating mRNA biomarkers and a machine learning-driven algorithm using real clinical blood samples, as part of a broader strategy to enhance non-invasive diagnostics for various cancers [4] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product, ColoAlert®, being a non-invasive early-detection test for colorectal cancer, marketed in Europe and the UAE [5] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [5]

Core Insights - Mainz Biomed is advancing its PancAlert project, focusing on a non-invasive blood test for early pancreatic cancer detection, aiming to confirm previous findings of 95% sensitivity and 98% specificity [1][5] Group 1: Project Development - The feasibility phase will verify candidate mRNA biomarkers and an accompanying machine learning algorithm in clinical blood samples to assess diagnostic performance [2][3] - The company plans to collaborate with Crown Bioscience, a CRO specializing in oncology, to support the verification process [2] Group 2: Objectives and Future Plans - The primary goal of the feasibility stage is to evaluate the robustness, reproducibility, and diagnostic performance of the assay, including sensitivity and specificity [3] - Following the feasibility phase, Mainz Biomed intends to conduct a validation study with a larger cohort, which is crucial for optimizing the test for clinical use and potential FDA submission [5] Group 3: Market Context - Early detection of pancreatic cancer is a significant unmet need in oncology, and the company is committed to improving patient outcomes through its diagnostic solutions [4] - The PancAlert project is part of Mainz Biomed's broader strategy to develop accessible molecular diagnostics for early cancer detection in areas with limited screening tools [5][7]

Core Insights - Mainz Biomed N.V. plans to provide an interim readout of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025 [1][2] - The study aims to validate a next-generation colorectal cancer screening test that combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test on approximately 2,000 average-risk patients [1][3] - The company is on track to initiate its U.S. pivotal trial, ReconAAsense, in 2026 based on the outcomes of the eAArly DETECT 2 study [2][3] Study Details - The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, targeting the reporting of top-line results by Q4 2025 [2] - The study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown the ability to identify advanced adenomas and early-stage colorectal cancer [3] Company Mission - The company aims to advance its mission of eliminating colorectal cancer and reducing global cancer mortality rates through precise detection of advanced precancerous lesions and early-stage colorectal cancer [3]