Core Insights - Myriad Genetics, Inc. announced the presentation of 11 new research studies focused on advancements in oncology and reproductive genetic testing at the NSGC 44 Annual Conference [1][2] - The studies will feature products such as MyRisk Hereditary Cancer Test, FirstGene™ Multiple Prenatal Screen, Prequel Prenatal Screen, and Foresight Carrier Screen [1] Company Commitment - The company emphasizes its commitment to advancing scientific research to improve patient outcomes and provide innovative, data-driven insights for personalized patient care [2] - Myriad Genetics aims to enhance accessibility to genetic testing through collaboration with the genetic counseling community [2] Conference Participation - Myriad Genetics will showcase its latest innovations and support services at booth 317 and through poster presentations during the conference [2] - The presentation schedule includes sessions on November 7 and November 8, 2025 [3] Research Highlights - Key research topics include RNA analysis for interpreting Variants of Uncertain Significance (VUS), fetal fraction amplification for cfDNA screening, and prenatal cell-free DNA screening for maternal colorectal cancer [6] - Additional studies focus on the evolution of genetic screening reports, the spectrum of germline hereditary cancer mutations, and professional development for genetic counselors [6] Company Overview - Myriad Genetics is a leader in molecular diagnostic testing and precision medicine, dedicated to improving health and well-being through molecular tests that assess disease risk and guide treatment decisions [4]

Financial Data and Key Metrics Changes - Total revenues increased 113% year-over-year to $216.8 million, marking a record-breaking quarter for the company [7][22] - Gross margins improved significantly to 68%, up from 43.7% in the same quarter last year [9][26] - Positive adjusted EBITDA of $51.2 million and net income of $24.3 million were reported, along with positive free cash flow of $55.3 million [10][29] - Cash on hand grew to nearly $760 million, an increase of 4.7% sequentially [10] Business Line Data and Key Metrics Changes - Elective profiling services revenues increased to $207.6 million, representing over 121% year-over-year growth [7][22] - Pharma R&D services revenues increased to $9.2 million, an increase of 18.3% year-over-year [7][22] - Clinical case volumes were slightly less than 51,000 individual profiles, reflecting an 18.2% year-over-year growth [8][11] - Average Selling Price (ASP) increased to $4,089 per profile, representing an 87% year-over-year growth [8][9] Market Data and Key Metrics Changes - The company has reached approximately 6,000 oncologists across the country, with 40% of blood cases also having a tissue case performed, up from the mid-30% range [12][70] - The penetration rate for comprehensive genomic profiling remains relatively low at about 30%, indicating significant growth opportunities [11] Company Strategy and Development Direction - The company aims to incorporate whole genome sequencing into its early detection tests, moving towards personalized disease prevention [5][6] - The focus remains on expanding the technology platform and developing new products, particularly in multi-cancer early detection [10][30] - The company is strategically assessing opportunities for expansion within marketing and sales, as well as external opportunities [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of precision medicine and the potential for significant advancements in early detection and MRD solutions [20][21] - The company anticipates continued improvement in commercial reimbursement and expects to see a positive trend in collections from commercial payers [23][24] - Management is optimistic about achieving a full-year gross margin of 62% for 2025, up from 43.4% in 2024 [28] Other Important Information - The company has generated a cumulative total of over 1,150 peer-reviewed publications through its Precision Oncology Alliance [14] - The Achieve program remains a cornerstone of the early detection platform, with strong representation across normal and pre-malignant populations [20] Q&A Session Summary Question: What is the implied Q4 revenue and underlying gross margins excluding true-ups? - The implied Q4 revenue is expected to be in the $200 million-$210 million range, with underlying gross margins around 61% excluding true-ups [33] Question: Is the colorectal MRD data sufficient for submission to CMS? - The data is sufficient for submission, but the company is cautious about the response from CMS and has additional data ready [34][35] Question: What is the pricing strategy for early detection tests? - The company plans to adopt a premium pricing strategy for its early detection tests, reflecting the unique capabilities of its technology [81] Question: How does the company view the growth of blood-based therapy selection volumes? - The company has seen an acceleration in blood-based therapy selection volumes, with expectations for continued growth as more physicians become comfortable with the offerings [70] Question: What are the expectations for pharma R&D services in Q4? - The company expects pharma R&D services to contribute $20 million-$30 million in Q4, driven by ongoing contracts and partnerships [72][74]

Financial Performance - Total revenue increased to $216.8 million, a 113% year-over-year increase[10] - Molecular Profiling Services revenue increased to $207.6 million, a 121% year-over-year increase[10] - Pharma R&D Services revenue increased to $9.2 million, an 18% year-over-year increase[10] - Clinical ASP improved by 87%, from $2,184 to $4,089[13] - Achieved Positive Adjusted EBITDA of $51.2 million and GAAP Net Income of $24.3 million[13] - Achieved Positive Free Cash Flow of $55.3 million[13] - Q3 2025 gross margin was 68%, a ~2,432 bps improvement[13] Clinical Volume and Data - Clinical volume grew by 18%, completing 50,763 clinical cases[13] - The dataset surpassed 959,000+ genomic profiles and 660,000+ matched profiles including over 577,000 WES and 628,000 WTS[13] Guidance - Updated CY 2025 total revenue guidance to $720 - $730 million, representing 75-77% year-over-year growth[50] - Updated CY 2025 clinical therapy selection volume growth to 21-22% year-over-year[50] Partnership - 97 POA sites with now over 1,150 publications[13]

Core Insights - The report "Biomarker Deals: Terms Value and Trends 2019-2025" indicates a shift in investment priorities and an increase in biomarker innovation through partnerships to enhance development and market reach [1][2] Market Dynamics - The global biomarkers industry is experiencing a surge in strategic transactions, including licensing, acquisitions, and collaborations, with various deal structures such as upfront payments and milestone-based compensation [2] - The demand for precision medicine, early disease detection, and targeted therapies is driving new biomarker-related partnerships and acquisitions [3] Growth Drivers - The rising incidence of chronic and infectious diseases, such as cancer and diabetes, is increasing the need for early diagnosis and effective treatment, thereby driving demand for biomarkers [4] - Advances in omics and imaging technologies are revolutionizing biomarker discovery and validation, making development more efficient and precise [5] - The shift towards personalized medicine is increasing the need for reliable biomarkers, leading to more partnerships and licensing deals focused on targeted diagnostics and therapies [6] Market Segmentation - The report segments the market based on deal type, including licensing, acquisitions, and collaborations, with partnerships expected to dominate through 2025 [13][14] Challenges and Opportunities - Key challenges in the biomarkers market include high development costs and the need for skilled labor, while opportunities lie in emerging markets and the growth of personalized medicine [15] Emerging Startups - Notable emerging startups in the biomarker space include Grail, Nucleix, Biodesix, and SomaLogic [10][19] Market Leaders - Major players in the biomarkers industry include Abbott, Agilent Technologies, Bayer AG, and Thermo Fisher Scientific, among others [20]

Financial Performance - Q3 2025 revenue increased by 84.7% year-over-year to $334.2 million, compared to $180.9 million in Q3 2024[47] - Genomics revenue totaled $252.9 million in Q3 2025, a 117.2% increase compared to Q3 2024[51] - Data and Services revenue reached $81.3 million in Q3 2025, a 26.1% increase compared to Q3 2024[51] - Gross profit improved by 98.4% year-over-year, reaching $209.9 million in Q3 2025, compared to $105.8 million in Q3 2024[47] - Adjusted EBITDA was $1.5 million in Q3 2025, a $23.3 million improvement from $(21.8) million in Q3 2024[47] Genomics Business - Oncology testing (Tempus Genomics) revenue was $139.5 million in Q3 2025, a 31.7% year-over-year increase[51] - Hereditary testing (Ambry Genetics) revenue was $102.6 million in Q3 2025, a 32.8% increase on a pro forma basis[51] - Hereditary tests delivered in Q3 2025 were approximately 129,500, with an average reimbursement per test of $790[24] Data and Services - Total Remaining Contract Value (TCV) for Data and Services was over $940 million at the end of 2024[34] - Data Licensing Retention was approximately 140% at the end of 2024[34] Guidance - Full year 2025 revenue guidance increased to approximately $1.265 billion, representing approximately 80% annual growth[60]

Core Insights - TG4050 demonstrates the ability to induce neoantigen-specific cytotoxic CD8+ T cell responses, which can target and eliminate tumor cells, potentially reducing the risk of cancer relapse [1][3][4] Company Overview - Transgene is a biotech company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset [9][12] - TG4050 is an individualized therapeutic vaccine based on the myvac® platform, designed to stimulate the immune system to recognize and destroy tumor cells [10][12] Clinical Development - TG4050 is currently being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers, with the first immunogenicity data from the Phase II part expected in the second half of 2026 [14] - The trial includes a randomized study design, assessing the treatment benefits of TG4050 in patients at risk of relapse [14] Immunological Data - New immunological data presented at the SITC Annual Meeting confirm TG4050's mechanism of action and its potential for sustained prevention of cancer relapses [4][5] - CD8+ T cells induced by TG4050 exhibit an effector phenotype and persist for up to two years post-treatment, indicating long-term immune response capabilities [8][5] Collaboration and Technology - Transgene collaborates with NEC Corporation, leveraging NEC's AI-driven platform to enhance the development of individualized neoantigen therapeutic vaccines [5][12] - NEC's Neoantigen Prediction System utilizes advanced AI to identify and select the most immunogenic sequences for the vaccine [15][12]

Financial Data and Key Metrics Changes - Novanta reported record revenue of $248 million for Q3 2025, surpassing guidance, with a reported revenue growth of +1% and organic revenue declines of 4% [5][6] - Adjusted gross margins were 46.5%, up 30 basis points year over year, and adjusted EBITDA margins were above 23% [5][17] - Non-GAAP adjusted earnings per share was $0.87, up 2% year over year and up 14% sequentially [18] Business Line Data and Key Metrics Changes - Medical markets accounted for 53% of year-to-date revenue, intelligent subsystems contributed nearly 30%, and medical consumables represented about 15% of sales, with the latter growing at a high teens rate [8][10] - Advanced surgery business revenue grew 17% year over year, while precision medicine business sales declined 4% year over year but grew sequentially by 3% [24][25] - Robotics and automation applications saw revenue growth driven by demand for products supporting physical AI applications [12] Market Data and Key Metrics Changes - Customer bookings grew 17% year over year and 4% sequentially, indicating a stronger backlog and positive outlook [20] - Sales to China increased by 11% sequentially, with strong design win activity and new product revenue growth [25][26] - The advanced industrial markets showed continued improvement, with normalized order patterns leading to sequential growth in precision manufacturing [13] Company Strategy and Development Direction - Novanta's long-term growth strategy focuses on markets with secular tailwinds such as AI-driven robotics, advanced minimally invasive surgery, and precision medicine [6][9] - The company is investing in regionalized manufacturing and a new ERP system to build a strong foundation for growth and resilience [10] - Novanta aims to deliver sustainable mid-to-high single-digit organic revenue growth with less cyclicality [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to positive organic growth and double-digit profit growth in Q4 2025, with expectations for mid-single-digit organic growth for the full year of 2026 [6][31] - The company noted strong momentum in growth platforms, design wins, and new product launches, positioning it well for future performance [15][31] - Management highlighted the importance of customer partnerships and proprietary technology solutions in driving growth [8][10] Other Important Information - Novanta's adjusted gross profit for Q3 2025 was $115 million, with R&D expenses at $24 million and SG&A expenses at $44 million [17] - The company ended Q3 with gross debt of $457 million and a net leverage ratio of approximately 1.7 times [19] - An additional $200 million share buyback program was authorized by the board of directors [19] Q&A Session Summary Question: Update on robotics retail customer contracts - Management confirmed ongoing excitement about a major design win with a large e-commerce player, with deployment expected to start in 2026 [32][33] Question: Potential for revenue and scaling in humanoid robotics - The combined physical AI market opportunity is estimated at $1 billion by 2030, with current deployments still in early stages [34] Question: Progress on regional manufacturing footprint - Management indicated that the transition to regional manufacturing is expected to be completed by the end of Q1 2026, with potential for 100 basis points of margin expansion [36][37] Question: Growth expectations for 2026 across business units - Advanced surgery and robotics are expected to be the higher growth categories, while precision manufacturing is anticipated to return to growth [38][40] Question: Update on tariff-related revenue dynamics - Management noted that solid growth in China and strong design win activity are contributing to the recovery of revenue previously impacted by tariffs [44][45] Question: Outlook for DNA sequencing and EUV business - The DNA sequencing business is not expected to grow, while the EUV business is anticipated to gain momentum in 2026 [46][47] Question: Recognition of the $50 million warehouse automation opportunity - Management confirmed that bookings and revenue from the warehouse automation opportunity are expected to materialize in 2026 [49][50]

Core Insights - The Sequel II CNDx system has received Class III Medical Device Registration approval from the National Medical Products Administration (NMPA) in China, enabling the use of PacBio HiFi sequencing for complex genetic conditions, starting with thalassemia [1][2] - This approval represents the world's first regulatory clearance for a clinical-grade long-read sequencer, marking a significant advancement in precision medicine and genomic testing in China [2] - The Sequel II CNDx system allows clinicians to obtain a comprehensive view of the genome in a single test, accurately capturing various genetic variants [3] Company Developments - The approval of the Sequel II CNDx system, in conjunction with Berry Genomics' clinical thalassemia assay, establishes the first end-to-end long-read sequencing workflow for hospitals and diagnostic labs in China [4] - PacBio's technology utilizes Single Molecule, Real-Time (SMRT) technology, which is capable of delivering high accuracy and long read lengths of 20 kb and greater, enhancing the analysis of DNA molecules [5] - Berry Genomics plans to expand its capabilities to include additional clinical assays for various genetic disorders, demonstrating a commitment to improving diagnostic accuracy [6] Industry Impact - The NMPA approval signifies a major advancement for China's clinical genomics ecosystem, allowing for in-country testing with reduced turnaround times and improved diagnostic yield compared to existing technologies [6] - As demand for comprehensive genomic testing increases, PacBio aims to enhance the clinical utility of HiFi sequencing through partnerships and investments in AI-powered analysis [6] - The collaboration between PacBio and Berry Genomics reflects a shared vision to provide clinicians with accurate and comprehensive genomic insights, potentially transforming patient care [6]

Core Insights - Bio-Techne Corporation and Nucleai presented pivotal data from the SECOMBIT clinical trial at the SITC 2025 Annual Meeting, highlighting the importance of spatial biology in immuno-oncology research [1][2] Study Overview - The SECOMBIT trial combined an immuno-oncology multiplex immunofluorescence panel with AI-driven multimodal biomarker analysis, profiling 42 pre-treatment biopsies from metastatic melanoma patients [2][5] - The study utilized Bio-Techne's COMET platform and Nucleai's multimodal spatial operating system to correlate immune cell interactions with clinical outcomes such as progression-free survival (PFS) and overall survival (OS) [2][5] Key Findings - The location and interaction of immune cells within tumors significantly influence treatment success, enabling better predictions of patient responses to therapies [4] - Specific immune activation markers were linked to improved outcomes across different treatment arms, indicating the potential of spatial biomarkers in clinical decision-making [6][4] Clinical Trial Data - The trial data demonstrated that Bio-Techne's and Nucleai's technologies can identify predictive biomarkers in melanoma patients treated with immunotherapy and targeted therapy [5] - The study was recognized as one of the top 150 abstracts from over 1,200 submissions at the SITC 2025 [5] Availability at SITC 2025 - Bio-Techne's spatial biology portfolio, including the new ProximityScope assay, will be showcased at Booth 603, with visual data from the SECOMBIT study presented in Poster 528 [7] Company Background - Bio-Techne Corporation is a global life sciences company with over $1.2 billion in net sales for fiscal 2025, providing tools and reagents for research and clinical diagnostics [8] - Nucleai specializes in AI-powered multimodal spatial biology, integrating high-plex spatial proteomics and clinical data to develop precision medicine products [9]

Company Overview The AI Platform for Precision Medicine November 4, 2025 Cautionary notices This presentation contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, products and technology, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking ...