Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 3 highly experienced directors. Independent Director Katey Owen was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. 공시 • Apr 27
Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 05, 2026 Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 05, 2026. 공시 • Apr 16
Adaptive Biotechnologies Corporation to Report Q1, 2026 Results on May 05, 2026 Adaptive Biotechnologies Corporation announced that they will report Q1, 2026 results After-Market on May 05, 2026 공시 • Feb 06
Adaptive Biotechnologies Corporation Provides Earnings Guidance for 2026 Adaptive Biotechnologies Corporation provided earnings guidance for 2026. For the period, Adaptive Biotechnologies expects full year revenue for the MRD business to be between $255 millionand $265 million. No revenue guidance is provided for the Immune Medicine business. 공시 • Jan 23
Adaptive Biotechnologies Corporation to Report Q4, 2025 Results on Feb 05, 2026 Adaptive Biotechnologies Corporation announced that they will report Q4, 2025 results at 4:00 PM, US Eastern Standard Time on Feb 05, 2026 공시 • Dec 06
Adaptive Biotechnologies Corporation Showcases Leadership in Hematology-Oncology MRD with New clonoSEQ Data Driving Treatment Interventions at 2025 ASH Annual Meeting Adaptive Biotechnologies Corporation announced growing interventional use of its clonoSEQ test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6-9, 2025, in Orlando. Notably, 17 abstracts utilizing Adaptive's clonoSEQ test exemplify how next-generation sequencing-based measurable residual disease (MRD) status is guiding clinical actions to improve blood cancer patient care. The presentations below show how investigators are applying clonoSEQ MRD results to tailor treatment intensity or duration with greater precision. Multiple Myeloma (MM). A total of 32 abstracts will be presented (31 MM, one smoldering MM), with a focus on MRD assessment of treatment response, real-world data demonstrating the link between MRD status and clinical outcomes, and several studies describing how clonoSEQ MRD Results are being used to guide treatment decisions. A presentation focused on MRD dynamics in the phase III AURIGA study of 200 newly diagnosed MM patients demonstrated that deep MRD responses and sustained MRD negativity correlated with improved progression free survival. The study shows that use of intensified maintenance in MRD-positive patients post-transplant doubled MRD negativity rates (oral presentation, abstract 97). Non-Hodgkin Lymphoma (NHL). Fifteen abstracts in NHL will be presented, focusing on use of MRD to better understand depth of response and to guide therapy. 공시 • Nov 06
Adaptive Biotechnologies Corporation Updates Earnings Guidance for the Full Year 2025 Adaptive Biotechnologies Corporation updates earnings guidance for the full year 2025. The company expected full year revenue for the MRD business to be between $202 million and $207 million, updated from the previous range between $190 million and $200 million. No revenue guidance is provided for the Immune Medicine business. 공시 • Oct 16
Adaptive Biotechnologies Corporation to Report Q3, 2025 Results on Nov 05, 2025 Adaptive Biotechnologies Corporation announced that they will report Q3, 2025 results After-Market on Nov 05, 2025 공시 • Aug 06
Adaptive Biotechnologies Corporation Updates Financial Guidance for the Full Year 2025 Adaptive Biotechnologies Corporation updated financial guidance for the full year 2025. For the year, the company expects full year revenue for the MRD business to be between $190 million and $200 million, updated from the previous range between $180 million and $190 million. No revenue guidance is provided for the Immune Medicine busine. 공시 • Jul 16
Adaptive Biotechnologies Corporation to Report Q2, 2025 Results on Aug 05, 2025 Adaptive Biotechnologies Corporation announced that they will report Q2, 2025 results After-Market on Aug 05, 2025 공시 • May 30
Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers Adaptive Biotechnologies Corporation announced that its next-generation sequencing (NGS)-based clonoSEQ®? test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. Data to be presented at ASCO: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia. Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, Sunday, June 1, 6540 cyclophosphamide, and doxorubicin (DA-EPOCH) + rituximab (R) + tafasitamab (tafa) for adults 9 a.m.-12 p.m. CDT with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL). Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute Sunday, June 1, 6543 lymphoblastic leukemia 9 a.m.-12p.m. CDT Multiple Myeloma: Multiple Myeloma: Primary endpoints of Tuesday, June 3, 7501 lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple. 공시 • May 02
Adaptive Biotechnologies Corporation Revises Earnings Guidance for 2025 Adaptive Biotechnologies Corporation revised earnings guidance for 2025. For the period, the company expects full year revenue for the MRD business to be between $180 million and $190 million, updated from the previous range between $175 million and $185 million. No revenue guidance is provided for the Immune Medicine business. 공시 • Apr 30
Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 10, 2025 Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 10, 2025. Location: entirely via the internet, United States 공시 • Apr 11
Adaptive Biotechnologies Corporation to Report Q1, 2025 Results on May 01, 2025 Adaptive Biotechnologies Corporation announced that they will report Q1, 2025 results After-Market on May 01, 2025 공시 • Mar 11
Adaptive Biotechnologies Corporation Launches Assay Enhancements to Increase clonoSEQ Sensitivity for Clinical MRD Detection in Diffuse Large B-Cell Lymphoma Adaptive Biotechnologies Corporation announced that it has launched an upgraded version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL) using circulating tumor DNA (ctDNA). The enhanced clonoSEQ assay, which incorporates an optimized DNA extraction methodology and maximizes sample input, delivers a 7-fold increase in sensitivity. The assay leverages the same powerful technology as prior versions, detecting MRD by reading the full immune receptor sequence of the malignant B cells rather than relying on individual point mutations. Maintaining this proprietary approach enables improvements in sensitivity while preserving the exquisite specificity that minimizes risk of overtreatment due to false positives. The enhanced assay was previously made available for research use in November 2023 and is already being incorporated into both biopharma-sponsored and investigator-initiated prospective trials. Data generated using this assay and presented at ASH 2024 by Bond and colleagues demonstrated that in patients for which MRD was assessed by clonoSEQ, MRD negativity post-cycle six was highly prognostic of progression-free survival. clonoSEQ is the first and only DLBCL MRD test available for clinical use. Having secured Medicare coverage for clonoSEQ in DLBCL in July of 2022, Adaptive has since provided MRD testing for more than 2,800 DLBCL patients and was used to manage and inform patient care by over 640 providers in 2024 alone. The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) recently approved the enhanced version of the clonoSEQ ctDNA assay for the detection and monitoring of MRD in patients with DLBCL. This comes on the heels of the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas, which included language recommending ctDNA testing for MRD assessment for patients with PET-positive DLBCL at end of first-line treatment. Because DLBCL outcomes can vary widely following frontline treatment, the ability of MRD results to accurately risk stratify patients in this setting is critical, as an MRD test can help clinicians differentiate a likely cure from an impending relapse. As the number of clinical trials in DLBCL exploring novel MRD-directed treatment consolidation strategies to reduce relapse rates grows, the role for clonoSEQ as a highly sensitive and specific ctDNA-based test will continue to expand. 공시 • Jan 23
Adaptive Biotechnologies Corporation to Report Q4, 2024 Results on Feb 11, 2025 Adaptive Biotechnologies Corporation announced that they will report Q4, 2024 results After-Market on Feb 11, 2025 Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. Independent Director Katey Owen was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. 공시 • Dec 09
Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in Mrd Testing with Clonoseq and Its Impact on Blood Cancer Treatment Decisions Adaptive Biotechnologies Corporation announced new data demonstrating the impact of measurable residual disease assessment using Adaptive’s next-generation sequencing-based clonoSEQ test in blood cancer clinical care and drug development. The data are featured in more than 65 abstracts being presented at the 66th Annual Meeting of the American Society of Hematology, taking place December 6-10 in San Diego. Phase 3 data from the ECOG-ACRIN EA4151 trial indicate that autologous hematopoietic cell transplantation (auto-HCT) may not provide additional benefit for mantle cell lymphoma patients in first complete remission who have undetectable minimal residual disease at a sensitivity of 10?6. The findings will be presented in a late-breaking abstract titled, Lack of Benefit of Autologous Hematopoietic Cell Transplantation (auto-HCT) in Mantle Cell Lymphoma Patients (pts) in First Complete Remission with Undetectable Minimal Residual Disease (uMRD): Initial Report from the ECOG-ACRIN EA4151 Phase 3 Randomized Trial (Abstract LBA6). Patients in CR with uMRD at 10?6 sensitivity from peripheral blood were randomized to receive either auto-HCT plus three years of maintenance rituximab or MR alone. Interim analysis, with a median follow-up of 2.7 years, showed no significant difference in overall survival between the two groups, suggesting that auto-HCT may be unnecessary for patients achieving deep remission as measured by highly sensitive MRD assessment. Data from the FELIX study indicate that achieving deep molecular remission, defined as MRD levels below 10?6, correlates with improved outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel. These findings were presented in an oral session titled Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes (Abstract 963). The study found that 84% of treatment responders who had a clonoSEQ MRD test, achieved MRD <10?6. This result was associated with more durable responses, and higher event-free survival and OS rates than those observed in patients with MRD =10-4 and between 10-4 and 10-6. Additional Key clonoSEQ Data Presented at the Meeting: Blinatumomab Added to Chemotherapy Improves Disease-Free Survival in Newly Diagnosed NCI Standard Risk Pediatric B-Acute Lymphoblastic Leukemia: Results from the Randomized Children’s Oncology Group Study AALL1731 (Abstract1). This Phase 3 randomized trial evaluated the addition of blinatumomab to standard chemotherapy in pediatric patients with newly diagnosed standard-risk B-ALL with average or higher risk of relapse. In the SR average cohort, patients that were MRD positive by clonoSEQ were randomized to receive standard chemotherapy with or without blinatumomab. The study found that incorporating blinatumomab significantly improved disease-free survival compared to chemotherapy alone, establishing a new treatment standard for this patient population. Implications of MRD Progression in Newly Diagnosed Multiple Myeloma (NDMM) Treated with Quadruplet Therapy and Autologous Stem Cell Transplantation (Abstract 363). This study identified 49 newly diagnosed multiple myeloma patients treated with a quadruplet regimen followed by autologous stem cell transplantation who experienced MRD progression as assessed by clonoSEQ, or disease progression as defined by the International Myeloma Working Group. The median time from MRD progression to IMWG-defined disease progression was 10.1 months, supporting that rising MRD levels are an early indicator of impending clinical relapse in MM patients. Minimal Residual Disease-Adapted Duration of Front-Line Venetoclax and Obinutuzumab Treatment for Fit Patients with Chronic Lymphocytic Leukemia (Abstract 1010). This Phase 2 study evaluating the use of venetoclax and obinutuzumab in treatment-naïve CLL patients found that those achieving undetectable MRD (<10?6) after nine cycles could discontinue therapy early. These patients had progression-free survival comparable to those who completed the standard 12 cycles, demonstrating the feasibility of MRD-guided treatment duration to minimize therapy exposure without compromising efficacy. Reported Earnings • Nov 09
Third quarter 2024 earnings released: US$0.22 loss per share (vs US$0.35 loss in 3Q 2023) Third quarter 2024 results: US$0.22 loss per share (improved from US$0.35 loss in 3Q 2023). Revenue: US$46.4m (up 23% from 3Q 2023). Net loss: US$32.1m (loss narrowed 36% from 3Q 2023). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. 공시 • Oct 10
Adaptive Biotechnologies Corporation to Report Q3, 2024 Results on Nov 07, 2024 Adaptive Biotechnologies Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 공시 • Aug 29
Adaptive Announces IVDR Certification for clonoSEQ® in European Union Adaptive Biotechnologies Corporation announced that clonoSEQ® has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). The medical diagnostics field has experienced significant technological advancement in recent years, leading the EU to replace its previous regulatory framework, the In Vitro Diagnostics Directive (IVDD), with a more stringent set of standards for quality and safety, known as IVDR. Adaptive worked with EU notified body BSI to complete the certification process and transition the company’s IVDD CE-marked product, the clonoSEQ Assay B-Cell Reagent Set, to this new regulation. clonoSEQ is now the first and only test to receive IVDR certification for the detection of minimal residual disease (MRD) in lymphoid malignancies. clonoSEQ’s intended use under IVDR is broad in scope, allowing for assessment of MRD status and changes in disease burden during and after treatment in patients diagnosed with B-cell malignancies. As MRD testing becomes increasingly adopted in patient care, clonoSEQ provides a powerful and dynamic way to measure risk status for patients with lymphoid malignancies and yields real-time insights into disease progression that can help oncologists provide a more personalized treatment approach. In addition to clinical use, clonoSEQ is the test of choice for MRD assessment among drug developers performing clinical research in hematologic malignancies. The assay has been included in global, label-enabling studies for a multitude of therapies approved by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) over the past several years. IVDR certification allows Adaptive to meet the clinical trial regulations for testing EU subjects’ samples, and sponsors can seamlessly send clinical trial subjects’ samples from the EU to Adaptive’s Seattle, Washington laboratory. clonoSEQ is well-established as a leading tool in blood cancer MRD assessment, supported by more than 150 peer-reviewed publications and used clinically by more than 3,700 clinicians over the past year. Furthermore, clonoSEQ MRD is currently being utilized in more than 160 active biopharma-sponsored trials. clonoSEQ is available locally in the EU to oncologists through technology transfer partnerships with major academic laboratories. clonoSEQ testing can currently be performed in France by Centre Hospitalier Universitaire (CHU) Toulouse, in Italy by Hospital of Bologna, in Spain by Hospital 12 du Octubre, and in Germany by HPH laboratory. Additional technology transfer partnerships are expected to launch in the EU and surrounding markets later in
2024. Reported Earnings • Aug 02
Second quarter 2024 earnings released: US$0.31 loss per share (vs US$0.33 loss in 2Q 2023) Second quarter 2024 results: US$0.31 loss per share (improved from US$0.33 loss in 2Q 2023). Revenue: US$43.2m (down 12% from 2Q 2023). Net loss: US$46.2m (loss narrowed 3.3% from 2Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings. 공시 • Jul 12
Adaptive Biotechnologies Corporation to Report Q2, 2024 Results on Aug 01, 2024 Adaptive Biotechnologies Corporation announced that they will report Q2, 2024 results After-Market on Aug 01, 2024 Reported Earnings • May 08
First quarter 2024 earnings released: US$0.33 loss per share (vs US$0.40 loss in 1Q 2023) First quarter 2024 results: US$0.33 loss per share (improved from US$0.40 loss in 1Q 2023). Revenue: US$41.9m (up 11% from 1Q 2023). Net loss: US$47.5m (loss narrowed 18% from 1Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 52% per year, which means it is performing significantly worse than earnings. 공시 • Apr 28
Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 07, 2024 Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 07, 2024, at 09:00 Pacific Standard Time. Agenda: To elect two Class II director nominees to serve on the board of directors of Adaptive Biotechnologies Corporation for a three-year term expiring at the 2027 annual meeting of shareholders. The two nominees for election to the board of directors are Peter Neupert and Michelle Griffin; to approve, on a non-binding advisory basis, the compensation of our named executive officers as described in the proxy statement; to ratify the appointment of Ernst & Young LLP as our independent registered public accounting firm for the year ending December 31, 2024; and to conduct any other business properly brought before the meeting or any adjournments thereof. New Risk • Apr 28
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$114m net loss in 3 years). Shareholders have been diluted in the past year (2.1% increase in shares outstanding). Significant insider selling over the past 3 months (€575k sold). 공시 • Apr 19
Adaptive Biotechnologies Corporation to Report Q1, 2024 Results on May 07, 2024 Adaptive Biotechnologies Corporation announced that they will report Q1, 2024 results After-Market on May 07, 2024 공시 • Apr 04
Adaptive Biotechnologies Corporation Announces CFO Changes Adaptive Biotechnologies Corporation announced that Tycho Peterson will depart the company as CFO. Kyle Piskel, the company's Principal Accounting Officer, will succeed Peterson as full-time CFO. Piskel served as the company's interim CFO from February to June 2022. 공시 • Apr 03
Adaptive Biotechnologies Corporation Provides Revenue Guidance for the First Quarter Ended March 31, 2024 Adaptive Biotechnologies Corporation provided revenue guidance for the first quarter ended March 31, 2024. For the period, total revenue of approximately $41 to $43 million for the first quarter of 2024, an increase of approximately 12% compared to the first quarter of 2023. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. Independent Director Katey Owen was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Mar 07
Co-Founder recently sold €154k worth of stock On the 5th of March, Chad Robins sold around 49k shares on-market at roughly €3.16 per share. This transaction amounted to 1.9% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Chad's only on-market trade for the last 12 months. Reported Earnings • Mar 03
Full year 2023 earnings released: US$1.56 loss per share (vs US$1.41 loss in FY 2022) Full year 2023 results: US$1.56 loss per share (further deteriorated from US$1.41 loss in FY 2022). Revenue: US$170.3m (down 8.1% from FY 2022). Net loss: US$225.3m (loss widened 13% from FY 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 52% per year, which means it is performing significantly worse than earnings. Reported Earnings • Feb 15
Full year 2023 earnings released: US$1.56 loss per share (vs US$1.41 loss in FY 2022) Full year 2023 results: US$1.56 loss per share (further deteriorated from US$1.41 loss in FY 2022). Revenue: US$170.3m (down 8.1% from FY 2022). Net loss: US$225.3m (loss widened 13% from FY 2022). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 9.8% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. 공시 • Jan 30
Adaptive Biotechnologies Corporation to Report Q4, 2023 Results on Feb 14, 2024 Adaptive Biotechnologies Corporation announced that they will report Q4, 2023 results After-Market on Feb 14, 2024 공시 • Dec 05
Adaptive Biotechnologies Corporation and Collaborators to Present More Than 30 Abstracts Demonstrating the Actionability of ClonoSEQ MRD Testing in Blood Cancer Patient Care and Drug Development at the 65th Annual Meeting Adaptive Biotechnologies Corporation together with its collaborators will present data from more than 30 abstracts demonstrating the actionability of Adaptive's next-generation sequencing (NGS)-based clonoSEQ test in assessing minimal residual disease (MRD) in blood cancer patients at the 65th Annual Meeting of the American Society of Hematology (ASH), December 9-12 in San Diego, California. clonoSEQ is the only U.S. Food and Drug Administration (FDA)-cleared test to detect MRD in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for other lymphoid malignancies, includingdiffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and follicular lymphoma (FL) is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, Washington. Minimal residual disease – also referred to as measurable residual disease – is one of the strongest predictors of outcomes in blood cancers and routine testing provides a personalized way to track a patient’s individual response to treatment and inform shared decision-making to optimize care. In addition to clinical use, MRD testing is widely used in drug development to get an early read on efficacy to inform patient stratification and increasingly as a trial endpoint. Data supporting clonoSEQ’s clinical and research utility, as well as insights based on analysis of real-world experience, will be featured in a late-breaking presentation, eight oral presentations and 24 posters across lymphoid malignancies. Studies will be presented demonstrating the clinical actionability of MRD testing across disease states. Notably, data illustrating the prognostic value of clonoSEQ MRD assessment using peripheral blood in MM and from circulating tumor DNA (ctDNA) in DLBCL will also be presented. Additionally, biopharmaceutical companies and other investigators will share data from 13 studies using clonoSEQ as an endpoint to measure deep responses during or after therapy, including novel treatment regimens such as CAR T-cell therapies and bispecifics. To advance biopharmaceutical partner research, Adaptive recently made available a new version of the ctDNA-based assay to assess MRD in DLBCL clinical trials. The research use only (RUO) assay has increased sensitivity to enable MRD assessment in clinical trials at the end of treatment timepoint (EOT) when disease burden is lowest as well as in post-treatment surveillance and later lines of therapy. 공시 • Nov 12
Adaptive Biotechnologies Corporation Updates Revenue Guidance for the Full Year 2023 Adaptive Biotechnologies Corporation updated revenue guidance for the full year 2023. The company is updating full year 2023 revenue guidance to exclude revenue from the Immune Medicine business. MRD business full year 2023 revenue to be in the range of $100 million to $105 million. Reported Earnings • Nov 10
Third quarter 2023 earnings released: US$0.35 loss per share (vs US$0.32 loss in 3Q 2022) Third quarter 2023 results: US$0.35 loss per share (further deteriorated from US$0.32 loss in 3Q 2022). Revenue: US$37.9m (down 21% from 3Q 2022). Net loss: US$50.3m (loss widened 11% from 3Q 2022). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 53% per year, which means it is performing significantly worse than earnings. 공시 • Nov 03
Adaptive Biotechnologies Corporation to Report Q3, 2023 Results on Nov 09, 2023 Adaptive Biotechnologies Corporation announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 공시 • Sep 14
Adaptive Biotechnologies Corporation Announces Launch of Epic Integration for ClonosEQ Adaptive Biotechnologies Corporation announced that clonoSEQ® is now available to health care providers as a fully integrated test in Aura, Epic’s specialty diagnostics suite. This integration will allow providers to order and review clonoSEQ minimal residual disease (MRD) testing results in Epic as they would for any test performed directly at the site of care. MRD refers to the number of cancer cells that might remain in a patient’s body during and after treatment and that may eventually lead to recurrence of the disease. clonoSEQ is the only FDA-cleared test to detect MRD in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia. clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test. MRD is one of the strongest predictors of outcomes in blood cancers and routine testing provides a personalized way to track a patient’s individual response to treatment and inform clinical decision-making to optimize care. Under the partnership established in September 2022, clonoSEQ is available to healthcare providers through Aura, Epic's specialty diagnostics suite. Integration with Epic EHR provides convenient access to clonoSEQ MRD results along with discrete data directly in patient records, enabling faster, more efficient decision-making for oncologists and equipping patients with real-time insights into their disease status. Reported Earnings • Aug 03
Second quarter 2023 earnings released: US$0.33 loss per share (vs US$0.37 loss in 2Q 2022) Second quarter 2023 results: US$0.33 loss per share (improved from US$0.37 loss in 2Q 2022). Revenue: US$48.9m (up 12% from 2Q 2022). Net loss: US$47.8m (loss narrowed 8.1% from 2Q 2022). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has fallen by 40% per year, which means it is performing significantly worse than earnings. 공시 • Jul 12
Adaptive Biotechnologies Corporation to Report Q2, 2023 Results on Aug 02, 2023 Adaptive Biotechnologies Corporation announced that they will report Q2, 2023 results After-Market on Aug 02, 2023 Board Change • Jun 19
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. Independent Director Kevin Conroy was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Jun 16
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (10% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$135m net loss in 2 years). Significant insider selling over the past 3 months (€260k sold). 공시 • Jun 15
Adaptive Biotechnologies Corporation Announces Resignation of Leslie Trigg from the Board Adaptive Biotechnologies Corporation announced that Leslie Trigg submitted her resignation from the Board at its Annual Meeting held on June 9, 2023. Recent Insider Transactions • Jun 07
Chief Financial Officer recently sold €254k worth of stock On the 2nd of June, Tycho Peterson sold around 38k shares on-market at roughly €6.67 per share. This transaction amounted to 7.7% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Tycho's only on-market trade for the last 12 months. 공시 • Jun 03
Adaptive Biotechnologies Highlights New Data At ASCO 2023 and EHA 2023 Underscoring the Clonoseq® Assay's Impact as A Standard for Minimal Residual Disease Assessment in Patients with Hematologic Cancer Adaptive Biotechnologies Corporation will be included in several oral and poster presentations investigating the clinical significance of minimal residual disease (MRD) assessment at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago, as well as the European Hematology Association (EHA) Hybrid Congress taking place June 8-11 in Frankfurt, Germany. Data will be presented from clinical trials and real-world evidence studies using Adaptive's next-generation sequencing (NGS)-based clonoSEQ® Assay for MRD assessment across a range of hematologic cancers. This assessment is performed as a series of tests in clinical trials and throughout a patient's cancer journey. The clonoSEQ Assay is the first and only NGS-MRD test authorized by the U.S. Food and Drug Administration (FDA) for MRD assessment in certain hematologic malignancies. Presentations will also highlight the value of utilizing NGS-MRD testing in clinical trials to assess the effectiveness of investigational, novel therapeutics. Multiple Myeloma: Oral Abstract 8001: Maintenance therapy with carfilzomib, pomalidomide, and dexamethasone (KPd) in high-risk myeloma (pts): A phase 2 study with a safety run-in: 1:15-4:15 p.m. CDT: Measurable residual disease (MRD) and clonal diversity for multiple myeloma treatment monitoring. 공시 • May 10
Adaptive Biotechnologies Corporation Announces FDA Acceptance of Genentech's Investigational New Drug Application for the First Neoantigen-Directed T-Cell Therapy Product in Oncology Adaptive Biotechnologies Corporation announced that the U.S. Food and Drug Administration has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy. This is the first TCR-based therapeutic product candidate to advance into clinical development based on Adaptive's collaboration with Genentech in oncology. Under the terms of Adaptive and Genentech's collaboration agreement, Genentech has responsibility for clinical, regulatory and commercialization efforts for any T-Cell Therapy product candidate. Adaptive reiterates its full year revenue guidance in the range of $205 to $215 million. 공시 • May 05
Adaptive Biotechnologies Corporation Provides Revenue Guidance for the Full Year 2023 Adaptive Biotechnologies Corporation provides revenue guidance for the full year 2023. The company reiterates full year 2023 revenue to be in the range of $205 million to $215 million. Reported Earnings • May 04
First quarter 2023 earnings released: US$0.40 loss per share (vs US$0.44 loss in 1Q 2022) First quarter 2023 results: US$0.40 loss per share (improved from US$0.44 loss in 1Q 2022). Revenue: US$37.6m (down 2.5% from 1Q 2022). Net loss: US$57.7m (loss narrowed 8.0% from 1Q 2022). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has fallen by 41% per year, which means it is performing significantly worse than earnings. Recent Insider Transactions • Mar 09
President recently sold €182k worth of stock On the 6th of March, Julie Rubinstein sold around 23k shares on-market at roughly €8.02 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Julie's only on-market trade for the last 12 months. 공시 • Feb 16
Adaptive Biotechnologies Corporation Provides Revenue Guidance for Full Year 2023 Adaptive Biotechnologies Corporation provided revenue guidance for full year 2023. For the period, the company expects revenue to be in the range of $205 million to $215 million. Reported Earnings • Feb 16
Full year 2022 earnings released: US$1.41 loss per share (vs US$1.48 loss in FY 2021) Full year 2022 results: US$1.41 loss per share (improved from US$1.48 loss in FY 2021). Revenue: US$185.3m (up 20% from FY 2021). Net loss: US$200.2m (loss narrowed 3.4% from FY 2021). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 22% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. 공시 • Jan 24
Adaptive Biotechnologies Corporation to Report Q4, 2022 Results on Feb 14, 2023 Adaptive Biotechnologies Corporation announced that they will report Q4, 2022 results After-Market on Feb 14, 2023 공시 • Dec 03
Adaptive Biotechnologies Announces Launch of clonoSEQ® to Assess Minimal Residual Disease in Patients with Diffuse Large B-Cell Lymphoma Using Circulating Tumor DNA Adaptive Biotechnologies Corporation announced the launch of its clonoSEQ® Assay to detect minimal residual disease (MRD) in blood for patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma (NHL), affecting more than 100,000 people in the U.S. Because DLBCL is an aggressive but also potentially curable disease for many patients, disease monitoring plays a central role in patient management. clonoSEQ can assess a patient’s MRD status in DLBCL by measuring ctDNA, the fragments of DNA released into the blood from dying cancer cells which can serve as a measure of tumor burden. clonoSEQ is available in DLBCL as a CLIA-validated laboratory developed test (LDT), and beginning this week the company will accept DLBCL blood samples in Streck® tubes, enabling broader access to ctDNA-based MRD testing for clinicians and patients. clonoSEQ MRD testing is covered by Medicare in DLBCL, with coverage extending to all DLBCL patients regardless of line of therapy, treatment regimen, or testing timepoint. clonoSEQ is the first and only MRD test to receive Medicare coverage in DLBCL. Robust peer-reviewed evidence supports the use of clonoSEQ as a powerful blood-based prognostic tool in DLBCL. Data published in the post-frontline surveillance setting, the transplant setting, and post-CART demonstrate the utility of clonoSEQ ctDNA assessment to accurately predict which patients are likely to relapse. When used in conjunction with or as a supplement to imaging-based methods established in clinical practice guidelines, clonoSEQ has the potential to help oncologists optimize DLBCL patient care. In addition to its availability as a CLIA-validated LDT in DLBCL in blood, clonoSEQ is also available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect MRD in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). Reported Earnings • Nov 05
Third quarter 2022 earnings released: US$0.32 loss per share (vs US$0.40 loss in 3Q 2021) Third quarter 2022 results: US$0.32 loss per share (improved from US$0.40 loss in 3Q 2021). Revenue: US$47.8m (up 21% from 3Q 2021). Net loss: US$45.3m (loss narrowed 19% from 3Q 2021). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Life Sciences industry in Europe. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 31% per year, which means it is performing significantly worse than earnings. 공시 • Nov 04
Adaptive Biotechnologies Corporation Provides Revenue Guidance for the Full Year 2022 Adaptive Biotechnologies Corporation provided revenue guidance for the full year 2022. For the year, the company expects revenue to be in the range of $185 million to $190 million compared to the previous expectation of $185 million to $195 million. 공시 • Oct 06
Adaptive Biotechnologies Corporation to Report Q3, 2022 Results on Nov 03, 2022 Adaptive Biotechnologies Corporation announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022 Recent Insider Transactions • Aug 07
Chief Commercial Officer of MRD recently sold €190k worth of stock On the 5th of August, Nitin Sood sold around 18k shares on-market at roughly €10.81 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €522k more than they bought in the last 12 months. Reported Earnings • Aug 04
Second quarter 2022 earnings released: US$0.37 loss per share (vs US$0.35 loss in 2Q 2021) Second quarter 2022 results: US$0.37 loss per share (down from US$0.35 loss in 2Q 2021). Revenue: US$43.7m (up 13% from 2Q 2021). Net loss: US$52.0m (loss widened 5.6% from 2Q 2021). Over the next year, revenue is forecast to grow 32%, compared to a 13% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings. 공시 • Aug 04
Adaptive Biotechnologies Corporation Reiterates Revenue Guidance for the Full Year 2022 Adaptive Biotechnologies Corporation reiterated revenue guidance for the full year 2022. For the year, the company reiterated revenue to be in the range of $185 million to $195 million. 공시 • Jul 09
Adaptive Biotechnologies Corporation to Report Q2, 2022 Results on Aug 03, 2022 Adaptive Biotechnologies Corporation announced that they will report Q2, 2022 results After-Market on Aug 03, 2022 공시 • Jun 16
Adaptive Biotechnologies Launches T-Detect™ Lyme, A New T-Cell Clinical Test for the Detection of Early Lyme Disease Adaptive Biotechnologies Corporation announced the launch of T-Detect™ Lyme. This is the company’s second test to be made available from its growing T-Detect franchise. The T-Detect test detects an immune response by leveraging the body’s unique T-cell response to disease-associated antigens. T-Detect Lyme identifies T cells activated by Borrelia burgdorferi, the bacterium that causes Lyme disease, to help diagnose early Lyme disease. T-Detect Lyme, administered as a simple blood test, is intended to aid in the diagnosis of early Lyme disease in adult patients demonstrating signs and symptoms. These symptoms include, but are not limited to, the presence of an Erythema migrans (EM) rash, fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. In the U.S., Lyme disease is the most common tick-borne illness, with approximately half a million newly infected people per year. An early diagnosis of Lyme disease facilitates treatment initiation to stop disease progression. However, today’s standard antibody tests may miss up to 75% of Lyme disease cases in the acute, or early, phase of infection. In a clinical validation study among patients with early Lyme disease, the T-cell test was more accurate than leading antibody tests. T-Detect Lyme has a specificity of approximately 99% and showed more than 1.5 times greater sensitivity than standard two-tiered testing (STTT) in patients who presented with a bullseye rash (54% vs 30%, respectively). In a separate study, T-Detect Lyme showed three times greater sensitivity than STTT in the first four days after symptoms appeared (44% vs 14%, respectively). T-Detect Lyme is the latest application of Adaptive’s immune medicine platform, which uses Adaptive’s TCR sequencing capabilities and Microsoft’s cloud-scale AI to characterize the T-cell repertoire and identify a clinical signal for disease. Adaptive is applying this approach to enable earlier and more accurate diagnosis of many infectious diseases and autoimmune disorders. In early 2021, Adaptive Biotechnologies received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the first diagnostic application of the platform, T-Detect COVID, which has been used by over 30,000 patients to confirm recent or prior SARS-CoV-2 infection. T-Detect Lyme is available to patients with a prescription through a qualified healthcare professional as a Clinical Laboratory Improvement Amendments (CLIA) laboratory-developed test (LDT) service. 공시 • Jun 04
Adaptive Biotechnologies Corporation Includes in Several Abstracts Investigating the Impact of Mrd in Blood Cancers At the American Society of Clinical Oncology Data from Adaptive Biotechnologies Corporation will be included in several abstracts investigating the impact of MRD in blood cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, in Chicago, Illinois. clonoSEQ(R) is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for measuring minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S. MRD is a term used to quantify the number of cancer cells that may remain in a patient's body after treatment, even inthe absence of symptoms. These residual cells can be present at very low levels and require highly sensitive tests like clonoSEQ to identify them. The presence of even a small number of cells offers prognostic value to clinicians as they assess how patients respond to treatment. MRD status may ultimately predict clinical relapse. The clonoSEQ Assay is the first and only FDA-cleared asy for MRD in chronic lymphocytytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples. In August 2020, clonoSEQ received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL. The clonoSEQ Assay leverages Adaptive's proprietary immune medicine 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 physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL. The clonoSEQ Assay is a single-site test performed at Adaptive Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types. Reported Earnings • May 06
First quarter 2022 earnings released: US$0.44 loss per share (vs US$0.29 loss in 1Q 2021) First quarter 2022 results: US$0.44 loss per share (down from US$0.29 loss in 1Q 2021). Revenue: US$38.6m (flat on 1Q 2021). Net loss: US$62.7m (loss widened 54% from 1Q 2021). Over the next year, revenue is forecast to grow 32%, compared to a 12% growth forecast for the industry in Germany. 공시 • May 05
Adaptive Biotechnologies Corporation Reiterates Revenue Guidance for the Full Year 2022 Adaptive Biotechnologies Corporation reiterated revenue guidance for the full year 2022. The company reiterated full year 2022 revenue to be in the range of $185 million to $195 million. 공시 • Apr 23
Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 10, 2022 Adaptive Biotechnologies Corporation, Annual General Meeting, Jun 10, 2022, at 09:00 Pacific Standard Time. Agenda: To consider election of three Class III director nominees to serve on the board of directors of company for a three-year term expiring at the 2025 annual meeting of shareholders; to approve, on a non-binding advisory basis, the compensation of named executive officers as described in the proxy statement; to ratify the appointment of Ernst & Young LLP as independent registered public accounting firm for the year ending December 31, 2022; and to conduct any other business properly brought before the meeting or any adjournments thereof. 공시 • Apr 06
Adaptive Biotechnologies Corporation to Report Q1, 2022 Results on May 04, 2022 Adaptive Biotechnologies Corporation announced that they will report Q1, 2022 results After-Market on May 04, 2022 Recent Insider Transactions • Mar 10
President recently sold €51k worth of stock On the 7th of March, Julie Rubinstein sold around 5k shares on-market at roughly €11.06 per share. This was the largest sale by an insider in the last 3 months. This was Julie's only on-market trade for the last 12 months. 공시 • Feb 19
Adaptive Biotechnologies Corporation Announces New Data Demonstrating ImmunoSEQ® Technology Can Identify T-Cell Receptors Associated with Crohn’s Disease Adaptive Biotechnologies Corporation presented data on T-cell receptor (TCR) sequences associated with Crohn’s disease (CD) during an oral presentation on February 18, 2022 at the 17thCongress of European Crohn’s and Colitis Organisation (ECCO) being held virtually February 16-19. The study identified and characterized TCR sequences associated with CD utilizing Adaptive’s immunoSEQ® technology, providing fundamental insights into the body’s response to CD at the cellular level. The immunoSEQ assay uses sequencing technology to decipher the complexity of the adaptive immune system. Intestinal tissue samples from a subset of 380 cases were also analyzed. Through this analysis, 1,121 CD-associated TCRs were identified in patients’ blood and verified in tissue. The identification of disease-specific TCRs is an important first step in identifying a signal and developing an algorithm to inform development of a diagnostic test for CD. T cells can have a significant impact on inflammation in CD, but until now, disease-associated TCRs have been largely unknown and underleveraged in diagnostics for the disease. These findings show that immunoSEQ can successfully identify TCRs for CD in a blood sample, which is reflective of the TCRs in intestinal tissue. The average length of time from onset of symptoms to diagnosis for a CD patient can be 1-2 years in the US but may be much longer in other countries, so the potential to open a new path to identify the disease earlier is significant. Furthermore, the amount of Crohn’s-related TCRs can provide insights into disease characteristics such as the phenotype and location of the disease, with possible clinical implications. In addition to TCR findings, the analysis also studied the possible association between human leukocyte antigens (HLAs) alleles and CD-associated TCRs, which live on most cells in the body, by leveraging the novel immunoSEQ HLA Classifier. HLA alleles are genetic factors that have been found to contribute to a small portion of risk for CD. In this study, nearly 400 CD-associated TCRs were found to be associated with specific HLA alleles. These TCR associations highlight the importance of studying TCRs in the context of HLA type and potentially point to new risk factors and insights for CD such as the involvement of specific antigens that the immune system may be reacting to in people living with CD. CD is a subtype of inflammatory bowel disease, a group of diseases impacting about 6.8 million adults globally. Early treatment with effective medications can prevent disease progression towards complications, surgery and disability. However, CD is difficult to diagnose and treat, with more than half of patients initially misdiagnosed. No single blood test currently exists for diagnosis of CD. Instead, patients often undergo a series of tests – often invasive – in order to reach a conclusive diagnosis. Based on the results of this study, Adaptive is further investigating specific TCR signatures that are associated with CD related behavior and disease activity to further the development of T-Detect in this indication. Additional research will also focus on signal optimization and clinical validation to explore commercial utility. Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and/or B-cell receptors from a single sample in exquisite detail. The immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures. T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is not FDA-cleared or approved, it has received an EUA from the FDA and is available for prescription use only. Reported Earnings • Feb 16
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$1.48 loss per share (down from US$1.11 loss in FY 2020). Revenue: US$154.3m (up 57% from FY 2020). Net loss: US$207.3m (loss widened 42% from FY 2020). Revenue was in line with analyst estimates. Over the next year, revenue is forecast to grow 24%, compared to a 26% growth forecast for the pharmaceuticals industry in Germany. 공시 • Dec 14
Adaptive Biotechnologies Corporation Announces New Data Demonstrating the Benefit of Serial MRD Testing with the clonoSEQ® Assay in Patients with Blood Cancers at the 63rd ASH Annual Meeting Adaptive Biotechnologies Corporation announced new data highlighting the clinical utility of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay to assess minimal residual disease (MRD) in patients with multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). The data are being presented at the American Society of Hematology (ASH) 63rd Annual Meeting and Exposition, held December 11-14 as a hybrid event, in Atlanta and virtually. MRD refers to the cancer cells that can remain in a patient’s body after treatment. MRD may not cause symptoms, but the presence of even a small number of cells may ultimately predict clinical relapse. These residual cells can be present at very low levels and require highly sensitive tests like clonoSEQ to identify them. Data generated from an analysis of the MASTER trial showed that regularly evaluating the MRD status of patients with newly diagnosed MM (NDMM) allowed confident and successful treatment discontinuation. This data was presented in an oral presentation titled, “Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Transplantation and MRD Response-Adapted Consolidation and Treatment Cessation. Final Primary Endpoint Analysis of the Master Trial” (Abstract 481). The study evaluated 123 patients who were treated with the combination of daratumumab, carfilzomib, lenalidomide and dexamethasone (Dara-KRd) over 30 months. MRD was assessed utilizing clonoSEQ in 118 patients. Of those, 84 patients (71%) achieved two consecutive MRD-negative results <10-5, which facilitated subsequent treatment discontinuation and entry into the MRD surveillance (MRD-SURE) phase of the study. MRD follow-up for MRD-SURE patients occurred at six months after treatment cessation and then on an annual basis. At 12 months post treatment cessation, the risk of MRD resurgence was 4% for patients with standard or high-risk cytogenetic abnormalities (HRCA). 공시 • Dec 03
Adaptive Biotechnologies Corporation Present More than 30 Abstracts on Utility of clonoSEQ® in MRD Testing in Blood Cancer Patients at the 63rd ASH Annual Meeting Adaptive Biotechnologies Corporation together with its collaborators will present data from more than 30 abstracts demonstrating the utility of company’s next-generation sequencing (NGS)-based clonoSEQ® Assay in assessing minimal residual disease (MRD) in blood cancer patients at the 63rd Annual Meeting of the American Society of Hematology (ASH), December 11-14. clonoSEQ is the only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S. MRD assessment is a way to directly detect and quantify remaining disease during and after treatment. With clonoSEQ, clinicians can leverage a precise and reliable technique that can detect as little as one cancer cell among a million healthy cells with sufficient input material. This high sensitivity gives clinicians valuable insight into the dynamics of a patient’s disease, which can help predict outcomes, assess response, monitor remission, and detect potential relapse. Data generated using clonoSEQ in its FDA-cleared indications and beyond will be featured in 9 oral presentations and 25 posters at ASH. The data to be presented demonstrate the utility of clonoSEQ for MRD-directed therapy, the value of sustained, deep MRD negativity, and the use of clonoSEQ to identify circulating tumor cells and circulating tumor DNA (ctDNA) in several lymphoma subtypes. The MRD-related data presented at ASH this year demonstrates how MRD-based decision-making is translating directly to improved patient care in blood cancers. Earlier this month, Palmetto GBA’s Molecular Diagnostics Program (MolDX) finalized a local coverage determination (LCD) which supports Medicare coverage for clonoSEQ to detect and monitor MRD in patients with B-ALL, MM, and CLL. The LCD supports the potential expansion of coverage for additional clonoSEQ indications, providing a clear pathway for Non-Hodgkin Lymphoma (NHL) and other lymphoid cancers. About the clonoSEQ Assay: The clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and ALL using DNA from bone marrow samples. In August 2020, clonoSEQ received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL. The clonoSEQ Assay leverages Adaptive’s proprietary immune medicine 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 physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL. Reported Earnings • Nov 05
Third quarter 2021 earnings released: US$0.40 loss per share (vs US$0.27 loss in 3Q 2020) The company reported a mediocre third quarter result with increased losses and weaker control over costs, although revenues improved. Third quarter 2021 results: Revenue: US$39.5m (up 50% from 3Q 2020). Net loss: US$55.9m (loss widened 52% from 3Q 2020). Director Overboarding • Sep 03
Director Kevin Conroy has joined 4th company board Kevin Conroy has been appointed to the board of SomaLogic, Inc. (NasdaqGM:SLGC). Conroy now sits on a total of 4 company boards. With 4 board positions including the role of CEO at Exact Sciences Corporation (NasdaqCM:EXAS), the director is at risk of having too many board obligations according to the Simply Wall St Risk Model. 공시 • Aug 06
Adaptive Biotechnologies Corporation Provides Earnings Guidance for Full Year 2021 Adaptive Biotechnologies Corporation provided earnings guidance for full year 2021. For the period, the company expects revenue to be in the range of $148 million to $155 million, representing 54% growth at the mid-point of the range over full year 2020 revenue. This compares to Adaptive Biotechnologies’ previous outlook of $145 million to $155 million. Reported Earnings • Aug 05
Second quarter 2021 earnings released: US$0.35 loss per share (vs US$0.26 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$38.5m (up 84% from 2Q 2020). Net loss: US$49.3m (loss widened 47% from 2Q 2020). 공시 • Jun 10
Adaptive Biotechnologies Corporation Announces New Study Published in Nature Provides Further Evidence COVID-19 Vaccine Induced T-Cell Response Targets Known SARS-CoV-2 Variants of Concern Adaptive Biotechnologies Corporation announced that immunoSEQ® T-MAP™ COVID was used in the Nature study to measure the T-cell immune response elicited by the Johnson & Johnson COVID-19 vaccine in the context of multiple variants of SARS-CoV-2, including B 1.351 and B.1.1.7. The study provides further evidence that the T-cell response may contribute to protection from COVID-19. Adaptive’s Technology was used to quantify T-cell expansion across all regions of the virus, demonstrating that the T-cell response is broad and unaltered by mutations that render vaccine-generated antibodies less effective. The study was conducted by Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA. In the multinational phase 3 ENSEMBLE trial, participants given Johnson & Johnson’s vaccine experienced similar efficacy against the B.1.351 variant. To understand the mechanism of protection, the COV1001 phase 1/2 trial analyzed blood samples from 20 vaccinated individuals to measure antibody immune response (humoral immune response) and T-cell response (cellular immune response) against the original SARS-CoV-2 strain WA1/2020 as well as against the B.1.1.7, CAL.20C, P.1., and B.1.351 variants. Post-vaccination, results showed that the levels of neutralizing antibodies were diminished against the variants, but that the T-cell immune response was preserved, suggesting T cells may provide protection against these emerging strains. Results indicate T-cells may be an important correlate of protection and should be considered as an endpoint for vaccine clinical trials. immunoSEQ T-MAP COVID combines the sequencing and mapping capabilities of Adaptive’s immune medicine platform to show how T cells respond to different parts of the virus, including the various parts of the spike protein. Mapping exactly how the variants impact different parts of the virus can indicate if the immune response is likely to be affected. 공시 • May 07
Adaptive Biotechnologies Corporation Provides Financial Guidance for 2021 Adaptive Biotechnologies Corporation provided financial guidance for 2021. For the year, the company expects revenue to be in the range of $145 million to $155 million, representing 52% growth at the mid-point of the range over full year 2020 revenue. Reported Earnings • May 07
First quarter 2021 earnings released: US$0.29 loss per share (vs US$0.25 loss in 1Q 2020) The company reported a solid first quarter result with improved revenues and control over costs, although losses increased. First quarter 2021 results: Revenue: US$38.4m (up 84% from 1Q 2020). Net loss: US$40.6m (loss widened 29% from 1Q 2020). Recent Insider Transactions • Apr 10
Insider recently sold €128k worth of stock On the 7th of April, R. Adams sold around 4k shares on-market at roughly €35.60 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €2.7m more than they bought in the last 12 months. 공시 • Mar 18
Adaptive Biotechnologies Corporation Announces Board Changes On March 16, 2021, David Goel and Eric Dobmeier submitted their resignations to the Board of Directors of Adaptive Biotechnologies Corporation, effective March 17, 2021. On March 17, 2021, the Board, acting upon the recommendation of its Nominating and Corporate Governance Committee, appointed Leslie Trigg and Dr. Katey Einterz Owen as directors of the company, to fill the vacancies created by the departures of Messrs. Goel and Dobmeier. Ms. Trigg will serve as a Class II director for a term expiring at the company's 2021 annual meeting of shareholders or upon her earlier death, resignation or removal. The Board also appointed Ms. Trigg to serve as a member of the Board's Audit Committee. Dr. Owen will serve as a Class I director for a term expiring at the company's 2023 annual meeting of shareholders or upon her earlier death, resignation or removal. Executive Departure • Mar 18
Independent Director has left the company On the 17th of March, David Goel's tenure as Independent Director ended after 4.5 years in the role. We don't have any record of a personal shareholding under David's name. A total of 3 executives have left over the last 12 months. Executive Departure • Mar 18
Independent Director has left the company On the 17th of March, Eric Dobmeier's tenure as Independent Director ended after 4.5 years in the role. We don't have any record of a personal shareholding under Eric's name. A total of 3 executives have left over the last 12 months. 공시 • Mar 06
Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect™ COVID to Confirm Recent or Prior COVID-19 Infection Adaptive Biotechnologies Corporation announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for T-Detect™ COVID to confirm recent or prior COVID-19 infection. This first-in-class T cell- based test is the first indication resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft. EUA was based on a clinical validation study showing that T-Detect COVID demonstrated sensitivity of 97.1% from date of diagnosis using RT-PCR. Sensitivity is the ability of the test to correctly identify a positive case (true positive). T-Detect COVID also showed a specificity of 100%. Specificity is the ability of the test to identify a negative case (true negative). The FDA provides an EUA for medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. Is New 90 Day High Low • Mar 06
New 90-day low: €33.80 The company is down 12% from its price of €38.40 on 04 December 2020. The German market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 7.0% over the same period. 공시 • Mar 04
Adaptive Biotechnologies Corporation and Genentech, Inc. Collaborate the Development of Cellular Therapy Drugs for Treating Cancer by Targeting Immune Cells to Specific Shared and Personalized Cancer-Related Antigen Targets Adaptive Biotechnologies Corporation (the “ Company”) and Genentech, Inc. (“ Genentech”) are collaborating toward the development of cellular therapy drugs for treating cancer by targeting immune cells to specific shared and personalized cancer-related antigen targets. In response to published data relating to the first shared antigen target candidate, the Company was advised by Genentech on March 1, 2021 that, subject to additional review of certain data, it intends to suspend development of a drug against that shared antigen target. The collaboration will continue to move rapidly toward development of potential drugs against other shared and personal antigen targets already under evaluation. Reported Earnings • Feb 26
Full year 2020 earnings released: US$1.11 loss per share (vs US$1.01 loss in FY 2019) The company reported a soft full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: US$98.4m (up 16% from FY 2019). Net loss: US$146.2m (loss widened 110% from FY 2019). Analyst Estimate Surprise Post Earnings • Feb 26
Revenue beats expectations Revenue exceeded analyst estimates by 3.4%. Over the next year, revenue is forecast to grow 52%, compared to a 22% growth forecast for the Life Sciences industry in Germany.