Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries Posters for Phase 2 and Phase 3 clinical trials available CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immu ...

Core Insights - Burning Rock Biotech Limited reported a total revenue of RMB 131.6 million (US$ 18.5 million) for Q3 2025, marking a 2.3% increase from RMB 128.6 million in Q3 2024 [3] - The company achieved a gross profit of RMB 98.8 million (US$ 13.9 million) for the same period, representing a 7.6% increase from RMB 91.8 million in Q3 2024, with a gross margin of 75.1% [5] - The net loss for Q3 2025 was RMB 16.8 million (US$ 2.4 million), a significant improvement compared to a net loss of RMB 35.7 million in Q3 2024 [10] Financial Performance - Total revenues for Q3 2025 were RMB 131.6 million (US$ 18.5 million), up from RMB 128.6 million in Q3 2024 [3] - Cost of revenues decreased to RMB 32.8 million (US$ 4.6 million) in Q3 2025, down 10.9% from RMB 36.8 million in Q3 2024 [4] - Gross profit increased to RMB 98.8 million (US$ 13.9 million) in Q3 2025, with a gross margin of 75.1%, compared to 71.4% in Q3 2024 [5][7] - Non-GAAP gross profit for Q3 2025 was RMB 100.9 million (US$ 14.2 million), a 3.2% increase from RMB 97.8 million in Q3 2024 [8] Revenue Breakdown - Revenue from the in-hospital business was RMB 52.8 million (US$ 7.4 million) in Q3 2025, a 17.1% decrease from RMB 63.8 million in Q3 2024 [6] - Revenue from the central laboratory business was RMB 36.8 million (US$ 5.2 million), down 7.9% from RMB 40.0 million in Q3 2024 [6] - Revenue from pharma research and development services surged to RMB 42.0 million (US$ 5.9 million), a 68.6% increase from RMB 24.9 million in Q3 2024 [6] Operating Expenses - Total operating expenses for Q3 2025 were RMB 115.0 million (US$ 16.2 million), down 11.9% from RMB 130.4 million in Q3 2024 [9] - Research and development expenses decreased to RMB 41.5 million (US$ 5.8 million), a 15.6% decline from RMB 49.2 million in Q3 2024 [13] - Selling and marketing expenses were RMB 41.8 million (US$ 5.9 million), down 13.6% from RMB 48.4 million in Q3 2024 [13] Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling RMB 467.0 million (US$ 65.6 million) [10]

Core Insights - N2OFF, Inc. has completed the acquisition of MitoCareX Bio Ltd., focusing on the precision oncology market and leveraging MitoCareX's proprietary MITOLINE algorithm for drug discovery [1][2][3] Company Overview - MitoCareX Bio Ltd. is a biotechnology company utilizing MITOLINE, an algorithm for 3D modeling of mitochondrial transport proteins, to develop therapies for difficult-to-treat cancers [2][4] - The company targets mitochondrial SLC25 transport proteins, which are crucial in the metabolic reprogramming of aggressive cancers like lung and pancreatic cancer, with a projected global therapeutic market exceeding $50 billion by 2026 [3][4] Strategic Direction - MitoCareX aims to optimize hit-to-lead medicinal chemistry and pharmacokinetic profiling in 2026, with the goal of nominating a preclinical development candidate [5] - The company is exploring strategic collaborations and licensing agreements to expand MITOLINE's applications, creating non-dilutive revenue opportunities [6][7] Long-Term Vision - The long-term strategy includes preparing for IND-enabling studies to transition MitoCareX toward clinical readiness while establishing MITOLINE as a scalable discovery engine [7][8] - MitoCareX's approach combines mitochondrial biology, computational modeling, and precision oncology, positioning it uniquely in the biotech sector [8][9] Innovation and Value Creation - The MITOLINE algorithm enables high-throughput in silico screening of small molecules, accelerating the drug discovery process [4][10] - The company aims to build a repeatable, data-driven discovery platform that transforms mitochondrial biology into sustained innovation and value creation [10][11]

Prelude Therapeutics (NasdaqGS:PRLD) Q3 2025 Earnings Call November 12, 2025 08:00 AM ET Speaker3Morning, everyone, and welcome everyone to the Prelude Therapeutics Investor Conference Call. Today's call is being recorded and is expected to last up to 45 minutes. At this time, I will now turn the call over to Prelude's Chief Financial Officer and Chief Legal Officer, Bryant Lim. Please go ahead.Speaker0Thank you, Operator. During today's call, we will make forward-looking statements based on current expecta ...

Core Insights - QIAGEN has launched QIAsymphony Connect, an advanced automated nucleic acid purification platform, at the AMP 2025 meeting, aimed at enhancing liquid biopsy applications [1][2][3] Product Innovations - QIAsymphony Connect builds on over 3,000 placements of its predecessor and is designed for improved speed, sample traceability, and digital connectivity [2][5] - The platform features superior extraction performance, higher throughput (up to 50% more samples), optimized workflows for high-sensitivity oncology applications, full sample traceability, and seamless connectivity with laboratory information management systems (LIMS) [6][5] Strategic Partnerships - QIAGEN is showcasing its partnerships in precision oncology, including a collaboration with Myriad Genetics to develop a homologous recombination deficiency (HRD) assay for cancer profiling [3][5][12] - The QIAseq xHYB HRD Panel can be combined with the QIAseq xHYB CGP Panel for comprehensive genomic profiling, analyzing 724 cancer-relevant genes and key therapy biomarkers [9][12] Market Positioning - The introduction of QIAsymphony Connect reflects QIAGEN's commitment to advancing sample technologies and supporting laboratories in processing complex samples with greater precision and speed [4][5] - QIAGEN's presence at AMP 2025 emphasizes its leadership in providing Sample to Insight solutions for both research and clinical applications [3][4]

Core Insights - Guardant Health, Inc. has announced new data showing that its Guardant Reveal® blood test enables clinicians to evaluate the effectiveness of chemotherapy in patients with advanced solid tumors significantly earlier than traditional methods [1] Group 1: Clinical Validation - This announcement marks the first robust clinical validation study focused on pan-cancer chemotherapy monitoring [1] - The study results were published in the Journal of Liquid Biopsy, highlighting the credibility of the findings [1] Group 2: Test Characteristics - The Guardant Reveal® test is described as tissue-free and utilizes methylation analysis, which may enhance its applicability and ease of use in clinical settings [1]

Financial Data and Key Metrics Changes - Collaboration revenue from the Kyowa Kirin partnership for Q3 2025 was $20.8 million compared to no revenue in Q3 2024 [16] - Research and development expenses for Q3 2025 were $67.9 million, up from $41.7 million in Q3 2024 [16] - General and administrative expenses for Q3 2025 were $32.8 million, compared to $18.2 million in the same period of 2024 [16] - Net loss for Q3 2025 was $74.1 million, compared to a net loss of $54.4 million in Q3 2024 [16] - Pro forma cash as of September 30, 2025, was $609.7 million, down from $727.4 million as of December 31, 2024 [17] Business Line Data and Key Metrics Changes - The company is advancing its clinical pipeline, particularly with Zifduminib, a menin inhibitor for acute myeloid leukemia (AML) [3][4] - Zifduminib's clinical data from the COMET-001 study showed a favorable benefit-risk profile, with high rates of complete remission and minimal residual disease negativity [5][6] - The company is targeting enrollment at over 150 global sites for its COMET-017 frontline phase 3 trials [7] Market Data and Key Metrics Changes - The company is preparing for the anticipated commercial launch of Zifduminib, with disease awareness campaigns exceeding targets [9] - The commercial organization is fully mobilized and ready to execute upon approval, with a focus on specialty hematologists and large academic institutions [23] Company Strategy and Development Direction - The company aims to position Zifduminib as the menin inhibitor of choice for eligible patients, with a focus on addressing unmet needs beyond the relapsed refractory setting [4] - The dual pipeline strategy includes both menin inhibition and farnesyl transferase inhibitors, which are seen as strategically important for growth [12] - The company plans to submit data for Zifduminib to the NCCN guidelines shortly after FDA approval [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a successful review outcome for Zifduminib, with a PDUFA target action date of November 30, 2025 [3][18] - The company remains in a strong financial position to support its pipeline and commercialization activities, expecting significant milestone payments in the near term [14][17] - Management highlighted the importance of safety and tolerability in differentiating Zifduminib from competitors, especially in the context of the recent black box warning for Torsades [28][30] Other Important Information - The company plans to host a virtual investor and analyst event to discuss ASH presentations on December 8, 2025 [6] - The company has received two $30 million milestone payments for the COMET-017 trials, bringing total milestones received this year to $105 million [14] Q&A Session Summary Question: What account types are being targeted for Zifduminib launch? - The focus is on specialty hematologists, with a mix of large academic institutions and community oncology practices [23][24] Question: What to expect from the ASH update? - The ASH presentations will include more evaluable patients, updated MRD negativity data, and longer follow-up information [25][26] Question: How does the new label impact the NPM1 launch? - The black box warning for Torsades is significant, especially for the NPM1 population, and differentiates Zifduminib based on its favorable safety profile [30][31] Question: What market share is expected relative to competitors? - While specific market share expectations were not provided, the company anticipates capturing a majority share based on Zifduminib's best-in-class profile [39] Question: What are the dynamics with FDA regulatory engagement? - The company has not noticed any changes in cadence with the FDA and remains on track for the November 30 PDUFA date [67]

Core Insights - BullFrog AI Holdings, Inc. announced the acceptance of an abstract for presentation at the 2026 ASCO Gastrointestinal Cancers Symposium, highlighting the company's advancements in AI-driven precision oncology [1][2] - The study focuses on identifying patient subtypes that may respond better to glufosfamide, an investigational drug for pancreatic cancer, utilizing BullFrog AI's proprietary platforms [3][4] Company Overview - BullFrog AI is a technology-enabled drug development company that employs artificial intelligence and machine learning to enhance pharmaceutical and biologic development [1][5] - The company collaborates with leading research institutions to analyze complex biological data, aiming to improve drug discovery and reduce clinical trial failure rates [5] Collaboration and Research - The research was co-authored by experts from Moffitt Cancer Center and Eleison Pharmaceuticals, emphasizing the collaborative nature of the study [3] - The abstract titled "Data-driven subtyping and differential glufosfamide benefit in pancreatic adenocarcinoma" will be presented during the symposium and published in the Journal of Clinical Oncology [2][4] Industry Impact - The acceptance of the abstract by ASCO signifies the increasing recognition of AI's transformative potential in oncology research [4] - The study aims to provide insights that could lead to more precise and effective treatment strategies for challenging cancers like pancreatic adenocarcinoma [4]

Core Insights - Prelude Therapeutics has entered into an exclusive option agreement with Incyte Corporation to advance its JAK2V617F mutant selective inhibitor program, which includes an upfront payment of $35 million and a $25 million equity investment, with potential additional payments of $100 million if the option is exercised [1][2] - The company is prioritizing the development of its KAT6A selective degrader program for ER+ breast cancer, aiming to enter clinical development in 2026 [3][6] - Prelude has decided to pause the clinical development of its SMARCA2 degrader program due to resource allocation considerations [4][6] Financial Overview - Prelude expects its cash runway to extend into 2027 based on preliminary estimates, potentially extending into the third quarter of 2028 if Incyte exercises its option on the JAK2 program [5] - As of October 31, 2025, the company had approximately $52 million in cash, cash equivalents, and marketable securities, with an additional $60 million expected from the Incyte agreement [5] Strategic Developments - The company is focusing on the JAK2V617F and KAT6A programs, believing they present significant opportunities for addressing unmet patient needs and creating value for investors [6] - Prelude's KAT6A program is positioned to potentially offer improved efficacy and safety compared to existing non-selective KAT6A/B inhibitors [8] - The JAK2V617F program targets a mutation present in approximately 95% of patients with polycythemia vera, 60% of patients with essential thrombocythemia, and 55% of patients with myelofibrosis, aiming to transform treatment outcomes for these patients [9] Leadership Changes - The company announced the departure of President and Chief Medical Officer Jane Huang, with Victor Sandor stepping in to provide strategic oversight for clinical development [7][8]

Core Insights - Prelude Therapeutics has entered into an exclusive option agreement with Incyte for the acquisition of its mutant selective JAK2V617F JH2 inhibitor program, which has potential in treating myeloproliferative neoplasms (MPNs) [1][2][3] - The agreement includes a $35 million upfront payment, a $25 million strategic equity investment, and potential future payments totaling up to $910 million, including milestones and royalties [1][4] Agreement Details - Incyte will secure an exclusive option to acquire Prelude's JAK2V617F program for $100 million during the option period [3][4] - Prelude will receive a total of $60 million in capital, which includes the upfront payment and equity investment, to advance its JAK2V617F program and other pipeline assets [3][4] - If Incyte does not exercise its option, Prelude retains full ownership of the JAK2V617F program [5] Program Significance - The JAK2V617F mutation is a key driver in the progression of MPNs, affecting approximately 95% of patients with polycythemia vera, 60% with essential thrombocythemia, and 55% with myelofibrosis [6][7] - Prelude has developed novel allosteric inhibitors that specifically target the JAK2 JH2 'deep pocket' where the V617F mutation resides, showing promise in preclinical models [7] Future Developments - Prelude aims to advance the JAK2V617F program to predefined milestones, with the first program data set to be presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 [7]