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Adaptive Biotechnologies Corporation (Nasdaq: ADPT) is a commercial-stage biotechnology company dedicated to leveraging the intricate biology of the adaptive immune system to innovate in the diagnosis and treatment of diseases. The company's proprietary immune medicine platform combines high-throughput sequencing with cutting-edge computational infrastructure to offer detailed analyses of T- and B-cell repertoires, critical elements in the body's immune response. Adaptive focuses on two primary business areas: Minimal Residual Disease (MRD) and Immune Medicine.
One of Adaptive's flagship products is clonoSEQ®, a highly sensitive and standardized test authorized by the FDA for detecting minimal residual disease (MRD) in patients with multiple myeloma (MM), B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL). The clonoSEQ test is also available as a CLIA-validated laboratory developed test (LDT) for other lymphoid cancers, such as diffuse large B-cell lymphoma (DLBCL). The MRD status measured by clonoSEQ serves as a powerful predictor of patient outcomes, aiding in personalized treatment and monitoring strategies.
Adaptive Biotechnologies has formed strategic partnerships with leading biopharmaceutical companies. For instance, it collaborates with Genentech on T-cell receptor (TCR) based therapeutic products, providing a neoantigen-specific T-cell receptor identified using Adaptive's TCR discovery platform. The company also signed a multi-year collaboration with BeiGene to use clonoSEQ technology in developing novel therapies for lymphoid malignancies.
In terms of financial achievements, for the year ended December 31, 2023, Adaptive reported a total revenue of $170.3 million, with the MRD revenue contributing significantly to this growth. The company achieved substantial progress in clonoSEQ test volume and introduced strategic updates to maximize the value of its MRD and Immune Medicine businesses.
Adaptive Biotechnologies operates from biotech hubs in Seattle, Washington, and South San Francisco, California. Their team of world-class scientists and open, collaborative culture drive continuous innovation. The company's clinical diagnostics and pipeline developments aim to transform the clinical landscape, offering new hope for treating cancers, autoimmune disorders, and infectious diseases.
Recently, Adaptive Biotechnologies announced significant progress and strategic decisions to enhance its business operations. They integrated clonoSEQ into Epic’s specialty diagnostics suite, easing MRD monitoring accessibility for healthcare providers. The company continues to focus on driving operational efficiencies, as reflected by a decrease in operating expenses while maintaining sustainable growth.
Adaptive Biotechnologies remains committed to leveraging the adaptive immune system's potent capabilities to develop and commercialize immune-driven clinical products tailored to individual patient needs. With a robust cash position, Adaptive aims for profitability in its MRD business while making targeted investments in Immune Medicine.
Adaptive Biotechnologies (ADPT) reported Q4 and full year 2024 financial results, showing mixed performance. Q4 revenue reached $47.5 million (+4% YoY), with MRD business contributing 85% of revenue and growing 31% YoY to $40.1 million. Full-year revenue was $179.0 million (+5% YoY), with MRD revenue up 42% to $145.5 million.
The company's clonoSEQ test volume increased 34% to 20,945 tests in Q4 2024, with 76,105 tests delivered in 2024 (+35% YoY). Medicare increased the Clinical Laboratory Fee Schedule rate for clonoSEQ by 17% to $2,007 per test.
Q4 net loss improved to $33.7 million from $69.5 million in Q4 2023. Full-year 2024 net loss was $159.6 million, compared to $225.3 million in 2023. Cash position stood at $256.0 million as of December 31, 2024.
For 2025, ADPT expects MRD business revenue between $175-185 million and total operating expenses of $340-350 million, with projected cash burn of $60-70 million.
Adaptive Biotechnologies (Nasdaq: ADPT) has announced its participation in two upcoming investor conferences. The company, which specializes in translating adaptive immune system genetics into clinical products, will attend the BTIG 12th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, UT on February 12, 2025, and the TD Cowen 45th Annual Health Care Conference in Boston, MA on March 3, 2025.
At the TD Cowen conference, the company will participate in a fireside chat scheduled for 11:10 a.m. Eastern Time. Investors and interested parties can access live and archived webcasts of the sessions through the 'Investors' section of Adaptive Biotechnologies' website at www.adaptivebiotech.com.
Adaptive Biotechnologies (Nasdaq: ADPT) has announced it will release its fourth quarter and full year 2024 financial results after market close on Tuesday, February 11, 2025. The company will host a conference call and webcast at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day to discuss the results. Investors can access the live audio webcast through the company's website, and a replay will be available within 24 hours after the event.
Adaptive Biotechnologies (ADPT) and NeoGenomics (NEO) announced a multi-year exclusive strategic commercial collaboration to enhance minimal residual disease (MRD) monitoring for blood cancer patients. The partnership integrates Adaptive's FDA-cleared clonoSEQ test with NeoGenomics' COMPASS and CHART assessment services.
The collaboration enables clinicians using NeoGenomics' COMPASS for initial blood cancer diagnosis to simultaneously identify DNA sequences for patient tracking. The service covers multiple myeloma, B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, and diffuse large B-cell lymphoma. Subsequent CHART assessments can include clonoSEQ MRD testing throughout treatment.
Testing will be performed at Adaptive's CLIA-certified, CAP-accredited laboratory in Seattle. The companies will begin implementing the necessary infrastructure with cross-promotional efforts expected later this year. Financial terms were not disclosed.
Adaptive Biotechnologies (ADPT) announced that its clonoSEQ® test for minimal residual disease (MRD) assessment has received a new Medicare Clinical Laboratory Fee Schedule (CLFS) rate of $2,007, effective January 1, 2025. Additionally, MolDX has updated the clonoSEQ episode pricing to $8,029 across all covered indications.
The CLFS rate was established through a gapfill determination process, where Medicare evaluates the test's value based on factors including required resources, other payer rates, and similar technology costs. The clonoSEQ test provides MRD measurement in lymphoid malignancies and is widely covered by Medicare and commercial payers.
With this finalized rate, Adaptive plans to leverage it for establishing new payer agreements, updating existing agreements to include the clonoSEQ PLA code, and expanding coverage to additional indications.
Adaptive Biotechnologies (Nasdaq: ADPT), a commercial stage biotechnology company focused on adaptive immune system genetics and clinical products, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco.
The company's management will deliver their presentation on Tuesday, January 14th at 5:15 p.m. Pacific Time / 8:15 p.m. Eastern Time. Investors and interested parties can access both live and archived versions of the presentation through the 'Investors' section on the company's website at www.adaptivebiotech.com.
Adaptive Biotechnologies (ADPT) presented new data at the 66th ASH Annual Meeting showcasing the effectiveness of their clonoSEQ® test in measuring residual disease (MRD) for blood cancer treatment. Key findings from multiple studies demonstrate that achieving MRD levels below 10⁻⁶ correlates with improved patient outcomes.
The Phase 3 ECOG-ACRIN EA4151 trial revealed that mantle cell lymphoma patients with undetectable MRD may not need autologous transplantation. The FELIX study showed 84% of treatment responders achieved MRD <10⁻⁶, associated with better survival rates. Additional studies in multiple myeloma, chronic lymphocytic leukemia, and pediatric B-ALL further validated clonoSEQ's utility in guiding treatment decisions and monitoring disease progression.
Adaptive Biotechnologies (Nasdaq: ADPT) announced that its clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in over 65 abstracts at the 66th ASH Annual Meeting. The presentations span eight different types of blood cancer and include a plenary session, a late-breaking abstract, and 25 oral presentations. The studies demonstrate clonoSEQ's role as a standard for efficacy measurement in pivotal clinical trials and highlight its advantages in both clinical trials and real-world practice. Several practice-changing studies use MRD as a primary endpoint in multiple myeloma, mantle cell lymphoma, and chronic lymphocytic leukemia.
Adaptive Biotechnologies reported its Q3 2024 financial results, highlighting a 22% revenue increase to $46.4 million compared to Q3 2023. The MRD business contributed 81% of revenue, growing 52% year-over-year, with clonoSEQ test volume rising 30% to 19,600 tests. The company achieved an updated Medicare CLFS Gapfill rate for clonoSEQ at $2,007 per test, a 17% increase, and expanded Medicare coverage for Mantle Cell Lymphoma.
Operating expenses decreased 11% to $79.1 million, with a net loss of $32.1 million, down from $50.3 million in Q3 2023. Adjusted EBITDA loss improved to $14.3 million from $29.8 million. Cash reserves stood at $267.2 million.
Updated 2024 guidance projects MRD revenue between $143 million and $145 million and total operating expenses between $335 million and $340 million.
Adaptive Biotechnologies (NASDAQ: ADPT) announced expanded Medicare coverage for its clonoSEQ test to include measurable residual disease (MRD) assessment in mantle cell lymphoma (MCL) patients. The coverage follows Medicare's episode pricing structure with an updated rate of $8,029. MCL, affecting approximately 4,000 new cases annually in the US, is an aggressive form of non-Hodgkin lymphoma where most patients experience multiple relapses. clonoSEQ offers a minimally invasive, blood-based MRD testing option to assess treatment response and monitor disease progression. This expansion adds to existing Medicare coverage for multiple myeloma, chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, and diffuse large B-cell lymphoma.
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