Accessibility StatementSkip Navigation BOSTON, Nov. 11, 2025 /PRNewswire/ -- Complete Genomics, a leading innovator in genomic sequencing, today announced a collaboration with SOPHiA GENETICS (NASDAQ: SOPH), a global leader in AI-driven precision medicine, to launch and co-market MSK-ACCESS® and MSK-IMPACT® powered with SOPHiA DDMâ"¢ on Complete Genomics' DNBSEQ-T1+ sequencing platform. The companies aim to broaden access to precision oncology testing by offering the best-in-class liquid biopsy and solid tu ...

Core Insights - SOPHiA GENETICS and Element Biosciences announced a partnership to integrate sequencing and AI analytics, aiming to enhance genomic workflows and support precision medicine research [1][2][4] Company Overview - SOPHiA GENETICS is a leader in AI-driven precision medicine, focusing on expanding access to data-driven healthcare through its SOPHiA DDM™ platform [8] - Element Biosciences is transforming scientific discovery with advanced technologies that enhance the pace and accessibility of genomics [9] Partnership Details - The collaboration combines SOPHiA DDM™ with Element's AVITI24™ 5D multiomic and AVITI sequencing systems, creating a streamlined end-to-end workflow for next-generation sequencing (NGS) [2] - This integration is expected to provide speed, scalability, and flexibility, allowing clinical researchers to derive actionable insights from NGS data efficiently [2][4] Expected Impact - The partnership aims to democratize access to genomic research, enabling healthcare organizations of all sizes to adopt innovative, AI-driven technologies [4] - The collaboration is anticipated to enhance the accuracy and consistency of genomic testing, ultimately accelerating the delivery of precision medicine to more patients [3][4]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $19.5 million, a 23% increase from $15.9 million in Q3 2024, continuing a trend of accelerating growth [26][32] - Adjusted gross margin remained flat at 73.1% year-over-year, despite a 40% increase in data processed by the platform [12][28] - Adjusted EBITDA loss was $10.2 million, an 8% increase from the prior year loss of $9.4 million, indicating improved operating leverage when excluding certain charges [31][33] Business Line Data and Key Metrics Changes - The company signed 31 new customers in Q3, bringing the total for 2025 to 94, surpassing the 92 customers signed in all of 2024 [5][18] - Revenue from the US market grew 30% year-over-year, contributing significantly to overall growth [7][15] - HMONK analysis volumes grew 18% year-over-year, while liquid biopsy testing saw over 2,000 analyses conducted in Q3, marking a 300% increase year-over-year [16][26] Market Data and Key Metrics Changes - EMEA region experienced a 24% revenue growth, with the UK and Belgium growing 120% and 70% respectively [15] - Asia-Pacific saw a 35% increase in analysis volume, with Japan beginning to contribute revenue as partnerships ramp up [16][19] - Latin America showed softness, but recent booking momentum suggests potential for recovery [16] Company Strategy and Development Direction - The company is focused on expanding its customer base and increasing the adoption of its applications, particularly in the US and liquid biopsy markets [5][10] - Strategic partnerships, such as with AstraZeneca for liquid biopsy testing, are expected to enhance market access and drive future growth [10][20] - The introduction of SOPHiA DDM Digital Twins aims to leverage multimodal data for better treatment decisions, indicating a shift towards more advanced AI-driven solutions [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum, citing strong customer signings and a healthy pipeline for future growth [36] - The company raised its 2025 revenue guidance to $75 million-$77 million, reflecting optimism about continued growth [32][33] - Management acknowledged challenges such as elevated social charges and foreign exchange impacts but emphasized ongoing efforts to optimize costs and maintain growth [30][33] Other Important Information - The company analyzed over 99,000 patients across 70 countries in Q3, showcasing the extensive use of its platform [12] - Total cash burn for Q3 was $13.1 million, a 36.5% increase year-over-year, but the company maintains a strong cash position of $81.6 million [31][32] Q&A Session Summary Question: Why is the Q4 growth guidance lower than Q3? - Management indicated a conservative approach to guidance, emphasizing strong momentum but wanting to ensure continued overachievement [39][41] Question: How many liquid biopsy customers are generating revenue? - Approximately 20% of the 60 liquid biopsy customers have started routine analyses, with expectations for significant ramp-up in the coming quarters [42][45] Question: What is the outlook for biopharma R&D spending in 2026? - Management expressed optimism about biopharma spending, noting a favorable position for SOPHiA in the market and strong pipeline activity [50][53] Question: How did customer onboarding times trend in Q3? - Implementation activities remained healthy, with a substantial backlog still present, indicating strong future revenue potential [74] Question: What is the expected contribution from AstraZeneca in Q4? - AstraZeneca's contributions are expected to ramp up in Q4, with revenue recognized upon hitting project milestones [60][62]

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 ...

Core Insights - SOPHiA GENETICS reported a strong third quarter for 2025, with revenue growth accelerating to 23% year-over-year, marking the third consecutive quarter of growth [3][6] - The company signed 31 new customers in Q3 2025, with an average contract value increase of 180% year-over-year, indicating robust business momentum [3][7] - The adjusted EBITDA loss improved by 13% year-over-year when excluding elevated Swiss social charges on equity-based compensation, reflecting strong operational leverage [3][12] Financial Performance - Revenue for Q3 2025 was $19.5 million, up from $15.9 million in Q3 2024, representing a 23% increase [6][32] - Gross margin was reported at 66.3% and adjusted gross margin at 73.1%, compared to 67.2% and 73.1% respectively in the prior year [6][33] - The net IFRS loss was $20.0 million, a 9% increase from the previous year, while the adjusted EBITDA loss was $10.2 million, up 8% year-over-year [6][30] Business Highlights - The company performed a record 99,000 analyses on its SOPHiA DDM platform, achieving a 9% year-over-year volume growth [7] - Significant growth was noted in the U.S. market, with a 30% year-over-year revenue increase [12] - SOPHiA DDM was adopted by major institutions, including Nice University Hospital in France and Baylor Scott & White Health in Texas, expanding its application areas [7][12] Future Outlook - Full-year revenue is now expected to be between $75 million and $77 million, reflecting a year-over-year growth of 15% to 18% [6][12] - The adjusted EBITDA loss is projected to be between $39 million and $41 million for the full year, factoring in the impact of Swiss social charges and currency fluctuations [6][12] - The company aims to approach adjusted EBITDA breakeven by the end of 2026 and achieve positive adjusted EBITDA in the second half of 2027 [12][30]

Core Insights - A.D.A.M. Innovations and SOPHiA GENETICS have formed a strategic partnership to introduce advanced liquid biopsy genomic testing in Japan, aiming to enhance personalized cancer care [1][4][5] - The collaboration will leverage SOPHiA's AI-powered DDM Platform to improve cancer testing efficiency and accuracy, with a focus on local testing and research [2][3][5] Company Overview - A.D.A.M. Innovations has been a leader in genetic testing in Japan for over 20 years, having conducted more than 2.8 million genomic tests [2][9] - SOPHiA GENETICS is a cloud-native healthcare technology company specializing in AI-driven data analysis for cancer and rare disorders [6] Partnership Details - The initial focus will be on launching the MSK-ACCESS® liquid biopsy application, which detects genomic alterations from a single blood draw using AI to analyze circulating tumor DNA [3][4] - The companies plan to develop a liquid biopsy companion diagnostic test to enhance access to tumor profiling and support drug development in Japan [4][5] Strategic Goals - The partnership aims to make precision oncology more accessible in Japan, combining local expertise with global technology to drive the adoption of data-driven medicine [5] - A.D.A.M. Innovations will utilize its clinical and regulatory knowledge to facilitate the development and approval processes for new diagnostic tools [4][5]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - rYojbaba Co., Ltd. (RYOJ) increased by 134% to $5.09 - Linkage Global Inc (LGCB) rose by 101% to $3.33 - MIRA Pharmaceuticals, Inc. (MIRA) gained 87% to $2.46 - Auddia Inc. (AUUD) went up by 23% to $2.54 - SOPHiA GENETICS SA (SOPH) increased by 16% to $4.99 - J.B. Hunt Transport Services, Inc. (JBHT) rose by 13% to $157.44 - AlphaVest Acquisition Corp (ATMV) increased by 11% to $13.09 - New Era Energy & Digital, Inc. (NUAI) went up by 10% to $3.71 - Critical Metals Corp. (CRML) rose by 9% to $24.80 - Blaize Holdings, Inc. (BZAI) increased by 9% to $6.90 [3] Premarket Losers - Fossil Group, Inc. (FOSL) decreased by 40% to $2.23 - Pinnacle Food Group Limited (PFAI) fell by 25% to $3.41 - American Battery Technology Company (ABAT) declined by 22% to $6.91 - Sadot Group Inc. (SDOT) dropped by 20% to $6.15 - TechCreate Group Ltd. (TCGL) decreased by 14% to $4.14 - PMGC Holdings Inc. (ELAB) fell by 13% to $6.43 - Arcadia Biosciences, Inc. (RKDA) decreased by 13% to $4.73 - ATIF Holdings Limited (ZBAI) dropped by 11% to $9.28 - Roma Green Finance Limited (ROMA) fell by 7% to $2.62 - Australian Oilseeds Holdings Limited (COOT) decreased by 6% to $2.46 [4]

Core Insights - SOPHiA GENETICS has launched SOPHiA DDM™ Digital Twins, a technology that creates virtual representations of individual patients to aid oncologists in treatment decision-making [1][7] - The Digital Twins utilize a patient's unique clinical, biological, imaging, and genomic data to simulate treatment responses and disease trajectories in real time [1][4] - This technology aims to enhance personalized treatment insights, reduce unnecessary side effects and costs, and leverage a global dataset for improved clinical decisions [6][7] Technology Overview - SOPHiA DDM™ Digital Twins enables integrative visualization of multimodal oncologic data, revealing correlations across different data types [2] - The technology supports in silico experimentation, allowing for anticipatory and individualized clinical decision-making [2][4] - It continuously evolves with new data, improving accuracy and research capabilities over time [5][6] Clinical Implications - The Digital Twins concept is seen as transformative for oncology, particularly in managing complex cancers and pre-surgical immunotherapy for non-small cell lung cancer [3][5] - Clinicians can simulate potential outcomes before treatment, which may significantly change future care delivery [3][4] - The tool provides insights derived from a broad network of global patient cases, breaking down institutional and geographic barriers [3][6] Future Directions - The launch of Digital Twins marks a shift towards AI-powered decision support in precision oncology, moving beyond retrospective evidence [7] - Initially available for lung cancer, the technology will expand to include more cancer types in the coming months [7] - SOPHiA GENETICS aims to make data-driven medicine the global standard of care through this innovative approach [6]

Core Insights - Biotech stocks experienced a significant after-hours rally, with SOPHiA GENETICS and SELLAS Life Sciences leading the gains due to positive announcements regarding upcoming data presentations [1][2]. Company Highlights - SOPHiA GENETICS (SOPH) saw its shares increase by nearly 10%, closing at $4.44 [3]. - SELLAS Life Sciences Group Inc. (SLS) shares rose by 3.5% to $2.07 after announcing the presentation of preclinical efficacy data for its CDK9 inhibitor, SLS009, at the ESMO Congress 2025 [2]. - Other notable biotech companies that experienced stock price increases include Ironwood Pharmaceuticals (up 6.76% at $1.58), Spectral AI (up 8.60% at $2.40), and Adverum Biotechnologies (up 7.21% at $4.46) [3].

Core Insights - Two health-tech stocks are experiencing a significant surge in their Momentum scores, indicating strong performance relative to other stocks [1][2] Group 1: Sophia Genetics SA - Sophia Genetics SA's Momentum score increased from 32.45 to 81.80 over the past week [3] - The stock has surged by 30% in the past month due to an expanded collaboration with AstraZeneca PLC to develop an AI-powered next-generation sequencing solution for breast and prostate cancer [4] - The stock shows a favorable price trend across short, medium, and long-term time frames [4] Group 2: DarioHealth Corp - DarioHealth Corp's Momentum score rose from 7.69 to 59.45 within a week [5] - The stock has increased by over 83% in the past month, driven by the announcement of a committee exploring a potential sale, merger, or business combination [5] - Similar to Sophia Genetics, DarioHealth Corp also exhibits a favorable price trend in the short, medium, and long terms [6]