SOPHiA GENETICS SA Ordinary Shares - SOPH STOCK NEWS

SOPHiA GENETICS (Nasdaq: SOPH) will present groundbreaking research at ESMO 2024, showcasing AI-driven patient stratification for non-small cell lung cancer (NSCLC) treatment. The study, conducted with AstraZeneca, analyzed the POSEIDON Phase 3 clinical trial using multimodal machine learning to identify NSCLC patient subgroups most likely to benefit from combination immunotherapy.

The research revealed signatures associated with higher overall survival benefit from adding tremelimumab to durvalumab and chemotherapy in first-line treatment of metastatic NSCLC. Key genetic factors included EGFR wild-type, FGFR3 wild-type, CDKN2A wild-type, KRAS mutation, and STK11 mutation. This approach could significantly impact NSCLC treatment by enabling more personalized care strategies.

SOPHiA GENETICS (Nasdaq: SOPH) will present two posters at the ESMO Congress 2024 in Barcelona. The first poster focuses on the analytical validation of an NGS panel-based ecDNA detection device for Boundless Bio's POTENTIATE clinical study. This innovative tool aims to detect extrachromosomal DNA in cancer patients, potentially improving patient selection for clinical trials.

The second poster presents the TRIDENT study, which uses machine learning to develop multimodal signatures for identifying patients who would benefit most from adding tremelimumab to durvalumab and chemotherapy in first-line treatment of stage IV non-small cell lung cancer. This study is based on a retrospective analysis of the POSEIDON Phase 3 trial.

SOPHiA GENETICS (Nasdaq: SOPH) announced updates on SOPHiA UNITY, its global consortium for precision oncology research, at ESMO 2024. Several world-renowned healthcare organizations have joined the initiative, including Exactis Innovation in Canada, Institut Paoli-Calmettes in France, and potentially Gemelli Hospital in Italy. These institutions join inaugural member Memorial Sloan Kettering Cancer Center, expanding the network to three countries and over 100,000 committed patient profiles with multimodal data.

SOPHiA UNITY aims to accelerate oncology innovation by harmonizing high-quality, diverse data at scale. Members benefit from participating in industry-funded global projects and access to SOPHiA GENETICS' AI-driven technology for efficient data curation and harmonization. The initiative leverages SOPHiA CarePath™, which provides insights from various data modalities including imaging, genomics, pathology, and clinical notes.

SOPHiA GENETICS (Nasdaq: SOPH) and AstraZeneca have announced a partnership to expand global access to liquid biopsy testing. They aim to deploy MSK-ACCESS® powered with SOPHiA DDM™ to 20 locations worldwide over the next 12 months. This liquid biopsy test, developed by Memorial Sloan Kettering Cancer Center, offers a less invasive alternative to solid tumor testing.

The collaboration seeks to understand how liquid biopsy testing can complement or surpass solid tissue testing. A real-world evidence study will evaluate operational benefits, including result speed and data quality. Since April 2024, 14 leading healthcare institutions have adopted the application. The partnership is expected to generate valuable real-world data for advancing cancer research and drug development.

SOPHiA GENETICS (Nasdaq: SOPH) announced an update on its collaboration with Boundless Bio and Precision for Medicine to develop and deploy an extrachromosomal DNA (ecDNA) detection algorithm for clinical trials. The ecDNA Solution (ECS) algorithm, designed as an Investigational Use Only Clinical Trial Assay, identifies patients with ecDNA amplified tumors using routine clinical next-generation sequencing data. This technology is being utilized in Boundless Bio's POTENTIATE Phase 1/2 study of BBI-355, an ecDNA-directed therapy.

The collaboration leverages SOPHiA GENETICS' SOPHiA DDM™ Platform for data analysis and Precision for Medicine's laboratory services. This innovative approach aims to expedite clinical diagnostics and streamline market entry for pharmaceutical companies targeting oncogene amplified cancers, which affect over 14% of cancer patients.

SOPHiA GENETICS (Nasdaq: SOPH) has unveiled the new generation of its SOPHiA DDM™ Platform at the Morgan Stanley Healthcare Conference 2024. This cloud-native platform offers a new web-based architecture designed to compute large amounts of data more efficiently at-scale, while enhancing customer experience with integrated access to multimodal analytics modules.

The platform now processes nearly 30,000 analyses per month, with over 1.8 million genomic profiles analyzed to date. The new generation introduces faster data processing, enabling quicker turnaround times and new capabilities such as whole genome sequencing. It integrates genomic, radiomic, and multimodal analytics in a single workspace, allowing customers to select applications that best suit their needs.

SOPHiA GENETICS (SOPH), a cloud-native software company specializing in data-driven medicine, has announced its participation in two major healthcare conferences in September 2024. Ross Muken, the company's CFO and COO, will present at the 22nd Annual Morgan Stanley Healthcare Conference on September 4 at 1:50 p.m. EDT in New York City.

The following week, Dr. Jurgi Camblong, co-Founder and CEO, will join a panel discussion on AI in Healthcare at the 9th Annual TD Cowen FutureHealth Conference on September 10 at 3:15 p.m. EDT, also in New York City. Both presentations will be webcast live on the SOPHiA GENETICS Investor Relations website, with replays available after the events.

SOPHiA GENETICS (Nasdaq: SOPH) has announced that its SOPHiA DDM™ Platform has received CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR). This certification validates the platform's analytical capabilities and allows its use for patient diagnostics in the EU and other markets recognizing this certification.

The transition from IVDD to IVDR represents a significant advancement in regulatory standards for genetic testing and analysis. The SOPHiA DDM™ Platform's IVDR certification ensures compliance with these new standards, promoting transparency, traceability, and reliability in genomic analysis processes.

The platform offers a 'Dx Mode' to meet IVDR requirements and includes five existing CE-IVD applications. Powered by proprietary deep learning algorithms, it has facilitated the analysis of over 1.7 million genomic profiles to date.

SOPHiA GENETICS (Nasdaq: SOPH) reported Q2 2024 financial results, showing mixed performance. Revenue increased 5% year-over-year to $15.8 million, with constant currency revenue excluding COVID-19 up 7% to $16.0 million. Gross margins improved to 68.2% (reported) and 73.2% (adjusted), up from 66.7% and 70.0% respectively in the prior year.

The company saw strong growth in the U.S. market but faced challenges in BioPharma and EMEA regions. Operating loss improved by 25% to $15.0 million (reported) and 32% to $9.9 million (adjusted). For the full year 2024, SOPHiA GENETICS revised its revenue outlook to $65-$67 million, representing 4-7% growth, and expects adjusted gross margin between 72.0-72.5%.