Julie Rubinstein
Analyst · Goldman Sachs. Your line is open
Thank you. As Chad mentioned, we developed our immune medicine platform to decode and translate the information held within our adaptive immune systems with the scale, precision and speed necessary to develop clinical products. We are leveraging this platform across three key areas, life sciences research, clinical diagnostics, and drug discovery. Starting first with life sciences research, this is at the core of everything we do at Adaptive. Our research product is called immunoSEQ and it is the key component of our platform that enables us to sequence immune receptors at high throughput. Its primary purpose is to generate data to inform the development of future clinical products. That said immunoSEQ is also a revenue generating product with a $1 billion market opportunity. Since its launch in 2010. immunoSEQ has been used by over 2000 academic researchers and 125 biopharma companies in over 480 clinical trials to empower the discovery of new prognostic and diagnostic biomarkers in cancer and other immune mediated diseases.We are also on track to launch a new RUO kit later this year, which will enable even more quantitative results for any sample type that a researcher is using in their lab. We also plan to further increase utilization of immunoSEQ among our biopharma partners by moving into later stage clinical trials and expanding beyond oncology. Turning next to clinical diagnostics, our first clinical diagnostic product, clonoSEQ is for monitoring MRD in most blood cancers. MRD refers to the amount of cancer cells remaining in a patient on end or after treatment. We are focused on select blood cancers called lymphoid malignancies, in which the cancer cell is in mature T or B cell. ClonoSEQ leverages our proprietary immuno-sequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows clinicians to predict patient outcomes, assess responsive therapy over time, monitor patients during remission and detect potential relapse.There are an estimated 4.6 million patients globally who are newly diagnosed or living with these blood cancers. As patients are living longer than ever before due to new therapies clinicians need a better tool to monitor disease burden and treatment response on a regular basis. We believe clonoSEQ is uniquely positioned to measure MRD in all patients with lymphoid malignancies, translating to a $4.5 billion market opportunity. In 2018, clonoSEQ was granted De Novo Designation and Marketing authorization by the FDA for the detection and monitoring of MRD in patients with multiple myeloma and B cell acute lymphoblastic leukemia using DNA from bone marrow samples.ClonoSEQ is the first and only FDA authorized invitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immuno-sequencing to receive FDA clearance. In late July, the state of New York Clinical Laboratory Evaluation Program, or CLEP approved clonoSEQ for the detection and monitoring of MRD. CLEP approval makes clonoSEQ testing accessible to patients in New York, who have been diagnosed with B cell cancers, a subset of lymphoid malignancies, that includes ALL, multiple myeloma, CLL and non-Hodgkins lymphoma, or NHL. In January of this year, we received CMS coverage for longitudinal monitoring in multiple myeloma and ALL. Following Medicare coverage private insurer access has rapidly increased over the first half of 2019. To-date, we secured contractual agreements or positive medical policies with several of the largest national private health insurance insurers as well as significant regional coverage, bringing the total private payer coverage in the United States to more than 165 million covered lives. On a national basis the current medical policies for Aetna, Anthem Blue Cross and Blue Shield and Cigna along with United Healthcare is updated medical policy effective September 1 are closely aligned with the clonoSEQ FDA cleared indications for use with patients with ALL or multiple myeloma.Additionally, several regional payers such as Kaiser have new or existing medical policies, also deeming the use of next generation sequencing for detecting MRD as medically necessary. While we are encouraged about securing coverage with these private payers in just six months, we expect it to take a quarter or two for these policies and contracts to be implemented, and to see a corresponding increase in how we recognize related clonoSEQ testing revenue.Following our FDA clearance and progress with CMS and private payer coverage, we are now focused on executing against a well-defined path towards market leadership for clonoSEQ seek. To accelerate this commercial opportunity for the ALL and multiple myeloma markets we are expanding our commercial and medical teams, investing in medical education, and accelerating patient advocacy to ramp clinical adoption. With regards to Lifecycle Management, we are gearing up for our first label expansion with submission on track to the FDA by the end of 2019 for clonoSEQ to be used to monitor patients with CLL from blood samples. Work is also underway to expand our current label from bone marrow to blood and to extend utility to patients with NHL also from blood samples. We continue to engage KOLs and our biopharma partners to strategically incorporate clonoSEQ in different research and clinical settings to support coverage, label expansion and clinical adoption.While it is still early days, we are confident that clonoSEQ has the potential to become a standardized MRD monitoring tool for clinicians to manage their patients.Turning now to our clinical diagnostics pipeline, we are actively developing our second clinical diagnostic product, immunoSEQ Dx. Our vision is to enable the early and accurate diagnosis of many diseases at the same time by reading the genetics of the adaptive immune system. To do this, we are mapping millions of T cell receptors to thousands of clinically relevant disease specific antigens to create a TCR antigen map leveraging our collaboration with Microsoft. We envision a future where this map will enable a doctor to get a clear picture of what a patient's immune system is seeing from a single blood test. Developing diagnostics from the TCR antigen map has significant advantages. Typically, development of molecular diagnostics for early detection requires massively expensive and lengthy prospective studies because the samples required have to be collected and stored in a very specific way. Our technology can use DNA from samples collected on almost any protocol or stored in any way, including SFPE.This allows us to more rapidly and cost effectively validate early detection tests in multiple diseases simultaneously. Our production lab dedicated to generating data to build the TCR antigen map came online in June, we are continuing to ramp volume, and we expect the lab to be at full capacity by the end of this year. The potential economic model for immunoSEQ Dx of becoming one test with many results is very compelling. As mentioned, signal validation for multiple diseases at the same time can be done quickly and cost effectively using retrospective samples and our existing TCR sequences in our clinical economics database.Each signal is then developed further by running clinical validation studies within our existing lab infrastructure and our core immunoSEQ technology. When multiple tests are ordered, at the same time, the marginal cost for each additional test result is negligible. Our path to commercialization starts with an initial focus on diseases for which there is a high unmet medical needs and antigens are well understood. To begin with, we are focused on ovarian cancer in high risk women as a test case for oncology, Celiac disease as an example for autoimmune disorders, and Lyme disease as a starting point for infectious diseases. We already have two early clinical signals for both Celiac and Lyme disease. We expect to confirm at least one of these clinical signals and initiate a clinical validation study by the end of 2019 with a path towards submission to FDA for our first indication in 2020.Turning now to drug discovery, the same technology that we use to connect TCRs to antigens to make the TCR antigen map is also used to discover TCRs for therapeutic use. Over the last few years, we have built a robust discovery and screening technology called True TCR to identify TCRs that map to cancer related antigens and then funnel them down to the ones that enables strong binding, target killing and may have minimal off target effects. Today we've characterized more than 1200 TCRs against 600 clinically relevant cancer antigens.As Chad mentioned, earlier this year, we announced that Genentech selected our TCR discovery and screening process as their foray into cellular therapy and oncology. First, we are advancing the development of shared cellular therapy products using off the shelf TCRs against prioritized target cancer antigens that are shared between patients. We are currently completing data packages for the first set of TCRs against shared, targeted shared antigens, which will be evaluated by Genentech in the third quarter. One or more of these TCRs will be selected by Genentech for inclusion in the first shared product IND filing plan for submission in 2020. In addition to these shares, cellular therapy products, we are also working in parallel to develop a personalized cellular therapy where we plan to identify in real time the TCRs that are specific to each patient's tumor. The goal is to design and manufacture a unique therapy for each patient that targets that patients unique and individual cancer mutations. We are on track for the product prototype and we are currently working together with Genentech to enable a one month vein to vein time for this personalized prototype to be tested in the clinic. In summary, we are making important progress with our commercialized products and we have a robust clinical pipeline spanning both diagnostic and therapeutic products, all stemming from the same platform, which we believe will lead to a very strong margin profile at scale.With that, I will now turn the call over to Chad Cohen for more details on our financials. Chad?