Bio-Techne Advances Spatial Biology with Modular Expansion of COMETâ"¢ Suite Accessibility StatementSkip Navigation MINNEAPOLIS, March 25, 2026 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents and diagnostic products, today announced the expansion of its COMETâ"¢ solution portfolio with the addition of the new SPYREâ"¢ Focus Panelsand SPYREâ"¢ Amplification Kits. Together, these strengthen the COMET technology modular, automated spatial biology workflo ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $43.9 million, representing a 25% increase year-over-year and a 7% sequential increase [11] - Organic revenue declined by 22% [11] - Adjusted EBITDA loss was $7.9 million, an improvement of $4 million from a loss of $11.9 million in Q3 [16] - Cash equivalents, marketable securities, and restricted cash at the end of the quarter totaled $122 million [16] Business Line Data and Key Metrics Changes - Simoa contributed $27 million, reflecting a 22% organic revenue decline [11] - Spatial reported $17 million, down 23% year-over-year, with a 16% decline when excluding a terminated diagnostics development agreement [11] - Instrument revenue was $6.1 million, with 21 Simoa and 17 Spatial instruments placed in the quarter [12] - Consumables revenue was $23 million, up $3.8 million sequentially [12] Market Data and Key Metrics Changes - Academic customers represented approximately 55% of the business in Q4 [12] - Pharma revenue declined by 21% year-over-year due to lower large Accelerator projects [13] - Diagnostics partnerships generated $9.6 million in revenue during 2025, up from $6 million in the prior year [13] Company Strategy and Development Direction - The company aims to achieve break-even profitability in 2026, with a focus on operational rigor and steady growth [8][16] - The strategy includes expanding the diagnostics market, particularly in Alzheimer's disease, leveraging its ultrasensitive platforms [8] - The company has completed major integration activities and is focusing on profitable growth [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the base business and the plan for break-even profitability [19] - The company is focused on generating clinical utility data for the LucentAD Complete test to support payer conversations [14][34] - The FDA submission for the LucentAD test is expected to take 6 to 9 months, with anticipated approval by Q4 2026 [38] Other Important Information - The company launched 13 new assays in 2025 and plans for a continuous stream of assay launches throughout 2026 [27] - The terminated diagnostics development agreement had a minimal impact on the core business for 2026 [18] Q&A Session Summary Question: Assessment of Quanterix's core high sensitivity proteomics and Spatial Biology businesses - Management is assessing the diversified strategy and is pleased with the increased diversification in the Spatial business post-Akoya acquisition [23][24] Question: New assay or product launches planned for 2026 - The company expects a regular cadence of assay launches every quarter, with several already in the pipeline for Q1 [27] Question: Prioritization of diagnostics versus Simoa proteomics versus Spatial business - Management is excited about the diagnostics opportunity, particularly in Alzheimer's, and is focusing on payer engagement and reimbursement strategies [34] Question: Update on FDA submission and potential timeline - The FDA approval for the LucentAD test is expected within 6 to 9 months, with a focus on establishing a good payer strategy [38]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $43.9 million, a 25% increase year-over-year and a 7% increase sequentially [11] - Organic revenue declined by 22% [11] - Adjusted EBITDA was a loss of $7.9 million, an improvement from a loss of $11.9 million in Q3 [16] - The company ended the quarter with $122 million in cash equivalents and marketable securities [16] Business Line Data and Key Metrics Changes - Revenue from diagnostics partners was $3.1 million in the quarter [11] - Simoa contributed $27 million, reflecting a 22% organic revenue decline [11] - Spatial reported $17 million, down 23% year-over-year, with a 16% decline when excluding a terminated diagnostics development agreement [11] - Instrument revenue was $6.1 million, with 21 Simoa and 17 Spatial instruments placed in the quarter [12] Market Data and Key Metrics Changes - Academic customers represented approximately 55% of the business in Q4 [12] - Pharma revenue declined by 21% year-over-year due to lower large Accelerator projects [13] - The company has 25 partnerships generating $9.6 million in revenue during 2025, up from $6 million in the prior year [13] Company Strategy and Development Direction - The company aims for break-even profitability in 2026, with a focus on operational rigor and steady growth [8][16] - The management is prioritizing the diagnostics market, particularly in Alzheimer's disease, leveraging its ultrasensitive platforms [8] - The company plans to continue launching new assays and expanding its product offerings [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving break-even profitability and scaling the business into profitable growth areas [19] - The company is focused on generating clinical utility data for its LucentAD Complete test to support payer conversations [14][36] - The management anticipates a minimal impact from the terminated diagnostics development agreement on core business in 2026 [18] Other Important Information - The company has implemented $74 million of its $85 million cost synergy target and is on track to meet this by the end of Q1 [16] - The company launched 13 new assays in 2025 and plans for a continuous stream of assay launches throughout 2026 [28] Q&A Session Summary Question: Assessment of Quanterix's core high sensitivity proteomics and Spatial Biology businesses - Management highlighted effective execution in diversifying the business and achieving synergy targets, with a focus on growth in both Simoa and Akoya spatial spaces [24][25] Question: New assay or product launches planned for 2026 - Management confirmed a continuous stream of assay launches is expected throughout 2026, with several already in the pipeline for Q1 [28] Question: Prioritization of diagnostics versus Simoa proteomics and Spatial business - Management emphasized the importance of the Alzheimer's diagnostics opportunity and ongoing clinical utility studies to guide payer engagement [35][36] Question: Update on FDA submission and potential timeline for approval - Management expects FDA approval for the 510(k) submission within 6 to 9 months, anticipating approval by Q4 [40]

Core Viewpoint - The initiative led by PharosAI aims to create one of the world's largest multimodal cancer datasets using 10x Genomics' Xenium spatial platform, enhancing precision medicine through advanced AI models and analytical tools [1][3]. Group 1: Initiative Overview - PharosAI is a research consortium formed by four leading UK institutions, including King's College London and Queen Mary University of London, to leverage clinical expertise and advanced technologies for cancer research [2][3]. - The project is supported by £18.9 million from the UK Government's Research Ventures Catalyst, along with contributions from charities and industry partners, to develop AI-ready datasets for earlier diagnosis and new treatment discoveries [1][5]. Group 2: Technological Framework - The Xenium spatial platform will transform decades of archived NHS cancer samples into high-resolution, multimodal datasets, facilitating the development of AI models for diagnosis and drug discovery [2][4]. - The initiative will initially focus on breast cancer, with plans to expand to lung and pancreatic cancer, utilizing thousands of clinical tissue samples to uncover previously hidden patterns [3][5]. Group 3: Expected Outcomes - By combining genomic, transcriptomic, imaging, and spatial biology data, PharosAI aims to produce datasets that enable researchers to ask broader questions and accelerate the discovery of new diagnostics and therapies [3][5]. - The program is designed to democratize access to these datasets, ensuring they are available to a wide community of researchers and innovators, positioning the UK as a leader in AI-driven cancer research [5].

Bio-Techne FY Conference Summary Company Overview - **Company Name**: Bio-Techne (NasdaqGS: TECH) - **Headquarters**: Minneapolis - **Employee Count**: 3,100 across 34 global locations - **Revenue**: $1.2 billion in 2025 - **Segments**: - Protein Sciences (73% of revenue) - Diagnostics and Spatial Biology (27% of revenue) [3][4] Core Business Insights - **Product Portfolio**: - 6,000 proteins and 400,000 antibodies - Focus on consumables (81% of revenue), instruments (9%), services (7%), and royalties (2%) [4] - **Revenue Breakdown**: - 41% from core reagents - 12% from diagnostic controls - 51% from biopharma, 20% from academia, 16% from diagnostics, 13% from distributors [5][6] Market Position and Strategy - **Total Addressable Market (TAM)**: $27 billion with significant growth potential [18][22] - **Growth Factors**: - Discovery of biological insights - Development of advanced therapeutics - Enablement of precision diagnostics [9][10] - **Key Applications**: - Cell therapies (7% of revenue) - Proteomic applications in drug development - Spatial interrogation [10][13] Financial Performance - **Revenue Growth**: 10% CAGR over the last five years despite market headwinds [19] - **Organic Revenue Growth**: 5% in fiscal 2025 [20] - **Profitability**: Targeting 35%-40% operating margins [23] Industry Trends - **Biotech Industry**: Experienced a decline in Q1 but showed signs of recovery with a 90% increase in funding in Q4 [24][25] - **Academic Sector**: Stabilizing with a shift in research focus from infectious diseases to chronic diseases [25][26] - **China Market**: Contributing 8% of revenue, showing potential for growth due to favorable government policies and funding [28][29] Cell Therapy Insights - **Growth in Cell Therapy**: Revenue reached $80 million, with $60 million from GMP proteins [30] - **Fast-Track Designation**: Two major customers received fast-track designation, potentially leading to significant future revenue [30][31] - **Clinical Trials**: 57% increase in cell therapy trials year-over-year [32] Diagnostics and Spatial Biology - **Market Size**: $5 billion for spatial biology, with 75% in translational and clinical markets [35] - **Innovations**: Introduction of RNAscope for RNA detection and COMET for multi-omic analysis [36][37] Future Outlook - **Growth Projections**: Anticipating low single-digit growth for fiscal 2026 due to current market conditions [41] - **Innovation Focus**: Continued investment in R&D (8% of revenues) and new product launches, including AI-designed proteins and ultra-sensitive immunoassays [38][39] - **M&A Strategy**: Plans to pursue acquisitions to enhance cell therapy and proteomic analytical capabilities [42] Conclusion - Bio-Techne is positioned for sustained growth through its differentiated product portfolio, strategic market focus, and commitment to innovation, despite facing short-term challenges in the biotech and academic sectors. The company aims to leverage its strengths to navigate market fluctuations and capitalize on emerging opportunities.

Core Insights - The company reported solid business fundamentals despite a challenging funding environment, with key positive drivers of performance continuing into Q2 [1][2] - Total revenue for Q2 was $173 million, with a notable settlement payment of $68 million from patent litigation contributing to the financial results [4][21] - The company is focused on advancing technology leadership in single-cell and spatial biology, with new product launches expected to enhance capabilities and drive growth [10][12] Financial Performance - Total revenue for Q2 was $172.9 million, representing a 13% increase year-over-year, while excluding the settlement revenue, it was $145.6 million, down 5% [21] - Consumables revenue was $122.2 million, down 1%, with spatial consumables revenue increasing by 24% to $36.4 million, driven by Xenium products [21] - Operating income for Q2 was $30.1 million compared to an operating loss of $41.7 million in the previous year, indicating a significant turnaround [24][25] Market Dynamics - The funding environment remains uncertain, particularly in the academic sector, leading to cautious customer spending and extended project timelines [2][7] - Despite these challenges, there is a strong demand for single-cell and spatial biology tools, with researchers increasingly investing in these technologies [8][9] - The company noted a temporary increase in purchasing activity in China, driven by customers accelerating orders ahead of potential tariff changes, estimating a $4 million revenue impact from this pull forward [23][51] Product Development and Innovation - The company launched several new products, including Visium HD 3 Prime and Flex v2, aimed at increasing throughput and lowering costs for researchers [10][11] - The acquisition of Scale Biosciences is expected to enhance the company's capabilities in single-cell analysis, making it more powerful and accessible [16][17][18] - The company is prioritizing the integration of new technologies to support larger-scale applications and maintain high-quality data standards [17][18] Customer Engagement and Sentiment - The company is closely monitoring customer sentiment and remains aligned with them to navigate the uncertain funding landscape [2][7] - Conversations with customers indicate that clarity on future budgets and the actual disbursement of funds are critical for unlocking spending [8][64] - The company is optimistic about the long-term potential of its products, as customer feedback remains positive regarding the quality and utility of its offerings [6][48]

Financial Data and Key Metrics Changes - Organic revenue declined 1% in Q1, primarily due to clinical stage timing from large customers in the cell therapy business and ongoing softness in biotech funding [4][19] - Adjusted EPS for the quarter was $0.42, flat year-over-year, while GAAP EPS increased to $0.24 from $0.21 in the prior year [18][19] - Total revenue for Q1 was $286.6 million, representing a 1% year-over-year decline on both an organic and reported basis [19] - Adjusted gross margin improved to 70.2%, up from 69.5% last year, driven by the exosome diagnostics divestiture and ongoing productivity initiatives [20] - Adjusted operating margin reached 29.9%, up 90 basis points year-over-year [20] Business Line Data and Key Metrics Changes - Protein sciences segment reported sales of $202.2 million, down 1% year-over-year, with organic revenue declining 3% [22] - Diagnostics and spatial biology segment sales were $79.5 million, down 4% year-over-year, but achieved 3% organic growth [22] - The protein analytical tools business showed notable strength from large pharma customers, contributing to organic growth [22] Market Data and Key Metrics Changes - Revenue from large pharma customers increased low double digits, while biotech spending continued to decline, resulting in high single-digit declines in Q1 [5][19] - North America experienced mid-single digit revenue decline, while Europe and Asia posted low single-digit growth [19][22] - China achieved its second consecutive quarter of growth, driven by strong performance in ProteinSimple analytical instruments and spatial biology portfolio [7][19] Company Strategy and Development Direction - The company is focused on productivity and cost management while investing in strategic growth pillars [5][17] - The acquisition of Wilson Wolf is expected to enhance the company's position in the cell therapy market, with plans to complete the acquisition by the end of calendar 2027 [9][10] - The company anticipates a return to positive organic growth in the second half of the fiscal year, driven by improving conditions in the biopharma sector and stabilization in U.S. academic markets [25][39] Management's Comments on Operating Environment and Future Outlook - Management noted that underlying market trends remain constructive, with early signs of stabilization in biotech activity levels [6][18] - The company expects Q2 organic growth to be consistent with Q1, reflecting continued strength in pharma and renewed growth in China [25] - Management expressed optimism about the recovery in biotech funding and the potential for lower interest rates to support investment levels in emerging biotech companies [6][35] Other Important Information - The company achieved an estimated 40% reduction in Scope 1 and 2 emissions during fiscal 2025, transitioning to 100% renewable electricity at its largest site [17] - The diagnostics business grew mid-single digits in Q1, supported by balanced performance across core diagnostic controls and kits [15] Q&A Session Summary Question: How long might the air pocket persist for GMP proteins? - Management indicated that the headwind from two large customers would be approximately 400 basis points in Q2, but they remain positive about the underlying recovery in the biotech markets [28][30] Question: Are growth plans for fiscal 2026 still low single-digit? - Management confirmed that plans remain unchanged, with a commitment to the cell therapy market and expectations for low single-digit growth for the year [30] Question: What is the outlook for the second half of the fiscal year? - Management expects a return to positive organic growth in the second half, driven by easing headwinds and improved market conditions [25][39] Question: Can you provide an update on Wilson Wolf? - Wilson Wolf had a flat quarter, but management remains optimistic about its potential to accelerate growth in the cell therapy market [43][44] Question: What are the assumptions for government shutdown impacts? - Management noted no significant changes in academic customer buying patterns due to the government shutdown, indicating stability in the academic market [52]

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]

Core Insights - Bio-Techne Corporation has launched the ProximityScope assay, a spatial solution that integrates with the BOND RX staining platform from Leica Biosystems, enabling visualization of functional protein-protein interactions on fixed tissue with subcellular resolution [1][2][4] Product Features - The ProximityScope assay provides a visual signal only when two proteins are in close proximity, offering insights into biological mechanisms that were previously inaccessible [2] - It works in conjunction with the BOND RX staining system and ACD's RNAscope Multiomic LS kit, allowing for enhanced detection of RNA and protein on the same tissue section [2] - The assay combines high sensitivity, specificity, and low background, addressing limitations of traditional methods like bulk pull-down assays [3] Applications - Key applications include visualizing cell-cell interactions for immune checkpoint studies, analyzing cell surface interactions that activate signaling pathways, evaluating antibody-based therapeutics, and investigating intracellular interactions related to transcriptional activation [4] Industry Context - The ProximityScope assay represents a significant advancement in spatial biology, providing researchers with a powerful automated solution to decode complex biological systems and accelerate therapeutic innovation [3][4] - Bio-Techne generated over $1.2 billion in net sales in fiscal 2025, indicating strong market presence and demand for innovative life science tools [6]

Core Insights - Bio-Techne Corporation (TECH) announced advancements in its spatial biology portfolio, specifically the RNAscope ISH technology and Lunaphore COMET, which are expected to enhance clinical utility workflows for lymphoid malignancies and B-cell clonality [1][8] - The company will showcase these innovations at the National Society for Histotechnology (NSH) Convention from September 26-30 in Long Beach, CA [1][8] Company Performance - Following the announcement on September 26, Bio-Techne shares increased by 2.7%, closing at $51.85 [2][8] - The company has a market capitalization of $8.07 billion and an earnings yield of 3.9%, which is significantly better than the industry's -21.1% [3] - Over the trailing four quarters, Bio-Techne delivered an average earnings surprise of 9.2% [3] Product Innovations - RNAscope technology allows for the detection of clinically relevant biomarkers within routine anatomic pathology workflows, while COMET provides automated, high-throughput analysis of RNA and protein biomarkers [4] - Scientific studies presented at the NSH highlighted the use of RNAscope for assessing B-cell clonality and COMET for spatial profiling of lymphoid malignancies [5][10] Market Trends - The spatial biology market is projected to grow from $1.64 billion in 2024 to $1.79 billion in 2025, with expectations to reach $2.88 billion by 2030, reflecting a CAGR of 9.85% [11] Recent Developments - In August, Bio-Techne agreed to sell its Exosome Diagnostics business to Mdxhealth SA while retaining rights to the exosome technology for future kit development [12]