Philippe Menu
Analyst · JPMorgan. Please go ahead with your question
Thank you, Jurgi, and good morning to all of you. My name is Philippe Menu. I'm the Chief Medical Officer at SOPHiA GENETICS. On today's call, I will be discussing our menu expansion efforts and the progress we saw in this area in the third quarter. At SOPHiA, our teams are laser focused on driving innovation across our menu of offerings by providing users with frequent updates incorporating new features, new applications, new data modalities and new services. We feel great excitement around the pace of our product development as we accelerate towards the future generation of our solutions and technology. There are three specific efforts that I would like to highlight today with respect to our recent progress on the expansion of our menu of offerings. First, SOPHiA's HRD solution, which you heard Jurgi speak about earlier on the call; second, our groundbreaking new collaboration with Memorial Sloan Kettering Cancer Center; and third, SOPHiA CarePath, our latest module deployed on the SOPHiA DDM platform. Let's start with SOPHiA's HRD solution. Two weeks ago, we presented the first data set on the clinical validation of our CE-IVD HRD solution at the European Society of Gynaecological Oncology Congress. We shared robust data demonstrating that our decentralized solution is highly concordant with the centralized method, also highlighting the higher producibility of results generated by our technology in a decentralized setting. In addition, clinical validation of nearly 200 samples from the PAOLA-1 confirmatory clinical trial of olaparib in advanced ovarian cancer is very much in line on the progression-free survival navigation metric. This update provides clinical guidance for practitioners in Europe by demonstrating the ability to identify HRD positive ovarian cancer patients that could potentially benefit from first-line maintenance treatment with PARP inhibitors. These results are validating the high performance of our assay and further demonstrate our algorithmic capabilities to pick the signal from the noise, even when applied to a complex biomarker such as HRD and in a decentralized setting. As Jurgi mentioned earlier, we are very pleased with our HRD market traction to date and see a long runway ahead of us. Beyond ovarian cancer, we also see potential for HRD to be relevant going forward in other tumor types, such as breast cancer, prostate cancer or pancreatic cancer as well as in other areas of synthetic lethality at large. We view HRD's total addressable market to be approximately $800 million. Shifting to the next effort. At SOPHiA, we don't work alone. We partner with other likeminded, mission-driven institutions with a shared objective to advance the practice of data driven medicine to improve patient outcomes. As announced at our Investor Day, we are incredibly excited to be working on a strategic collaboration with Memorial Sloan Kettering, which is among the most prestigious cancer centers in the United States and across the world. Our collaboration will initially focus on two main areas; one, work with MSK to bring their proprietary NGS assays to the world by decentralizing assays such as MSK-IMPACT for comprehensive genomic profiling and potentially other similar technologies for liquid biopsy testing. Second, collaborate on MSK's longitudinal clinical genomic database to generate novel insights and potentially fuel new applications on the SOPHiA CarePath module. We see this partnership with MSK as highly synergistic, whereby we can leverage our technological infrastructure, global decentralized network of healthcare institutions and algorithmic capabilities, together with MSK's deep clinical expertise in oncology and proprietary assays and data sets. Our shared vision with MSK is to expand access to world class data, including to our current network and further expand the collective intelligence of our SOPHiA DDM platform. As mentioned, the collaboration also intends to combine MSK's rich precision oncology data from their extensive database of over 65,000 patient profiles with our SOPHiA CarePath module, which we intend to jointly leverage to support R&D efforts in the biopharma space. Jurgi will further expand upon this later on the call. Overall, we are thrilled to work with MSK and believe it will help drive further penetration in the clinical and biopharma end markets. This is a new type of partnership with SOPHiA, and we intend to replicate similar collaborations with other leading academic medical centers across the world. This type of relationship enables open innovation where we leverage on the content already developed by the academic clinical centers to add applications and further innovate our platform without reinventing the wheel. In this context, we are very excited about the opportunity to continue partnering with organizations and in the transformation of healthcare as we leverage our combined capabilities to spark innovation. The third effort I would like to highlight is SOPHiA CarePath, which is a new module on the SOPHiA DDM platform that enables the analysis of multimodal longitudinal healthcare data. You have heard us speak about this new module on past earnings calls and more recently at our Investor Day, where I performed the demo of its core capabilities. As a reminder, SOPHiA CarePath offers advanced capabilities around data visualization, cohorting and eventually prediction through a single comprehensive lens across an oncology patient journey. We anticipate that this module will be of high interest in the biopharma community as it helps life sciences customers generate new insights leveraging on our real-world data sets and next-generation patient certification strategies. We feel great excitement about this new module and believe it will uniquely position SOPHiA as a big player in the healthcare space. SOPHiA CarePath is currently in beta testing in select healthcare institutions in the U.S. and in Europe. This initial deployment of SOPHiA CarePath is taking place in the context of our ongoing international DEEP-Lung-IV initiative, which aims to predict response to immunotherapy at the individual patient level in the context of metastatic non-small cell lung cancer. We are very pleased with the continued strong traction and enthusiasm around the platform. We continue onboarding top tier sites, such as Mayo Clinic, who recently joined the initiative, and we are proud to announce today that we have just reached 1,000 patients enrolled, which is a fantastic milestone in our journey. Coming back to SOPHiA CarePath, our risk efforts have been focused on getting this new module into the hands of users to actively collect feedback before its official launch expected in 2023. In this context, we were very happy to have UMass Memorial Medical Center recently become the first such users in the U.S. To date, we have had great response from both clinical and biopharma stakeholders. They see SOPHiA CarePath as one of their key missing technological links to bring precision medicine to scale. We believe that we are only scratching the surface here, and we see this opportunity extending well beyond lung cancer into other cancer types in the near future. On that note, it is important to note that there have been recent updates in the U.S. regulatory environment, which we view as a positive for SOPHiA CarePath over the long term. Indeed, last month, the FDA issued new guidance concerning clinical decision support software that will impact our space. We welcome the increase in regulatory requirements, which we see as a net positive as we believe that higher quality standards may contribute to increased adoption once in the market. Taking a step back, we want to remind you that continuously expanding our menu of offerings is one of our core strategic pillars at SOPHiA. The three highlighted examples of the HRD solution, the collaboration with MSK as well as progress on our SOPHiA CarePath module, all demonstrate our steadfast commitment to constantly invest in this effort. We look forward to updating you more on this front in the future. And with that, I will now pass it back over to Jurgi to continue on with the rest of the Q3 business highlights. Thank you.