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Agendia to Present Five Posters Demonstrating the Expanding Clinical Utility of MammaPrint + BluePrint at the 2025 San Antonio Breast Cancer Symposium

On November 4, 2025 Agendia, Inc., a leader in precision oncology for breast cancer, reported it will present new results from the ongoing real-world FLEX Study (NCT03053193) at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12 in San Antonio, Texas.

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The company will present five posters, led by Agendia investigators and independent academic collaborators, that collectively highlight the broad clinical impact of MammaPrint + BluePrint genomic profiling in optimizing treatment decisions and improving outcomes for patients with hormone receptor positive, HER2-negative (HR+/HER2–) early breast cancer (EBC).

"We look forward to sharing these new findings from the FLEX Study, which spans more than 20,000 participants across 100 global sites, making it the largest and most diverse real-world evidence cohort for early-stage breast cancer," said William Audeh, M.D., Chief Medical Officer at Agendia. "These results underscore our commitment to generating robust clinical evidence in settings beyond traditional clinical trials, ensuring the results can inform personalized treatment decisions across diverse patient populations and everyday clinical practice."

The full list of abstracts & poster presentations is as follows:

3.2yr Updated Outcome Analysis of ACT-T Benefit by MammaPrint Risk Result
Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC
Poster #PS2-07-03 | Dec. 10, 5:00 PM – 6:30 PM | Presenter: Joyce O’Shaughnessy

MammaPrint Provides Stronger Prognostic Value Than Histologic Grade
70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC
Poster # PS5-04-19 | Dec. 12, 12:30-2:00 PM | Presenter: Erin Cobain

Older Patients with Aggressive Breast Cancer May Benefit from Chemotherapy
HR+HER2– Patients Aged ≥70 with High Risk MammaPrint Benefit from Chemotherapy
Poster #PS3-08-17 | Dec. 11, 12.30 PM – 2 PM | Presenter: Reshma Mahtani

Understanding Breast Cancer in Overweight Latin American Patients
Distinct Immune and Metabolic Profiles in Latin American Breast Cancer Patients with Obesity
Poster #PS4-09-09 | Dec. 11, 5:00 PM – 6:30 PM | Presenter: Marcela Mazo Canola

30,000-Patient Study Expanding to Improve Breast Cancer Outcomes
FLEX: From Genomic Profiling to Real-World Insights in 30,000 Patients with Early-Stage Breast Cancer
Poster #PS5-09-19 | Dec. 12 12:30-2:00 PM | Presenter: Linsey P. Gold

(Press release, Agendia, NOV 4, 2025, View Source [SID1234659403])

Opna Bio Announces 2025 ASH Presentations Highlighting Preclinical Data from Novel Protein Degrader Program and Updated Interim Data from Phase 1 Combination Study of OPN-2853 with Ruxolitinib in Advanced Myelofibrosis

On November 4, 2025 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that it will have an oral and a poster presentation at the upcoming 67th Annual American Society for Hematology (ASH) (Free ASH Whitepaper) conference, taking place December 6-9, 2025, in Orlando, FL. The presentations will focus on the company’s novel, multi-functional protein degrader program and OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor currently being tested in a Phase 1 combination study with ruxolitinib in patients with advanced myelofibrosis. Presentation details are included below.

The oral presentation will feature preclinical data from Opna’s protein degrader program, which is focused on creating novel therapeutics designed to block multiple oncogenic targets – EP300, CBP, IKZF1 and IKZF3 – concurrently in the same cancer cell. The data highlights the preclinical compound’s potential for activity as a single agent in hematological malignancies such as multiple myeloma and lymphoma.

"Our protein degrader program builds on compelling preclinical data presented at ASH (Free ASH Whitepaper) in 2024 showing strong synergy when combining immunomodulatory (IMiD) drugs and OPN-6602," said Gideon Bollag, PhD, chief scientific officer of Opna Bio. "OPN-6602, an oral, small molecule EP300/CBP inhibitor, is currently being tested in a Phase 1 study in patients with relapsed or refractory multiple myeloma at multiple sites in the U.S."

The poster presentation will highlight updated interim data from the ongoing Phase 1 study of OPN-2853 in patients with myelofibrosis who are no longer responding to ruxolitinib. This investigator-initiated study is led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK) and is run through the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

ASH Presentation Details:

Title: Novel multifunctional degraders of EP300/CBP and IKZF1/3 with potent anti-myeloma activity
Publication Number: 573
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Emerging Myeloma Disease Mechanisms and Therapeutic Strategies
Date and Session Time : December 7, 2025, 12:00 PM – 1:30 PM ET
Presentation Time: 12:30 PM – 12:45 PM ET
Presenter: Pan-Yu Chen, PhD, Associate Director, Translational Medicine, Opna Bio

Title: Interim analysis of PROMise, a clinical study combining the BET inhibitor OPN-2853 with ruxolitinib in patients with advanced myelofibrosis experiencing an inadequate response to ruxolitinib
Publication Number: 3794
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Date and Session Time: December 7, 2025, 6:00 PM – 8:00 PM ET
Presentation Time: 6:00 PM – 8:00 PM ET
Presenter: Adam Mead, PhD, Professor of Haematology, Radcliffe Department of Medicine, CRUK Senior Cancer Research Fellow

(Press release, Opna Bio, NOV 4, 2025, View Source [SID1234659402])

Flatiron Health Announces Research to Be Presented at the 2025 American Society of Hematology’s Annual Meeting & Exposition

On November 4, 2025 Flatiron Health reported its presence at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition happening from December 6-9, 2025, in Orlando, Florida. Flatiron’s real-world data and research capabilities are featured across multiple presentations, including 12 research acceptances spanning hematologic malignancies—from CAR T cell therapy delivery and outcomes to measurable residual disease (MRD) testing patterns and treatment equity across blood cancers.

Flatiron’s presence at ASH (Free ASH Whitepaper) 2025 closely follows their announcement of six new hematology Panoramic datasets, including five B-cell lymphomas and multiple myeloma, which draw from over 505,000 relevant longitudinal patient records in Flatiron’s network. The datasets represent a six-fold increase in cohort sizes when compared to the company’s previously available datasets and lay the evidence foundation that will guide better treatment decisions, accelerate new development, and ultimately improve outcomes for patients with blood cancers.

"The rapid advancements in the treatment of hematologic malignancies have required an incredibly thoughtful approach to research, one that captures the clinical nuance of disease subtypes, rare patient cohorts, novel endpoints, and evolving biomarkers at scale," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Our presence at ASH (Free ASH Whitepaper) unlocks answers to questions that are shaping hematology care right now and our six newly launched hematology Panoramic datasets represent a clinical breakthrough, enabling researchers to study the real-world complexity of blood cancer care—from MRD testing patterns to CAR T therapy utilization—with a level of depth and rigor that was previously impossible."

Research highlights include:

Research examining real-world CAR T cell therapy delivery patterns across US oncology practices, including analysis of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and healthcare burden—addressing critical gaps in understanding how this transformative therapy is implemented across care settings.
Multiple studies evaluating measurable residual disease testing patterns and their association with clinical outcomes in Philadelphia-negative B-cell acute lymphoblastic leukemia and multiple myeloma, providing insights into the real-world impact of this precision monitoring approach.
EHR-derived datasets from Germany and the United Kingdom providing comprehensive analysis of diffuse large B-cell lymphoma and multiple myeloma management, demonstrating Flatiron’s ability to generate high-quality, multinational real-world evidence.
Join Flatiron Health at booth # Follow Flatiron Health on X and LinkedIn for more updates from #ASH25.

Abstracts and Poster Presentations

Use and Outcomes Following Blinatumomab Rechallenge in Adolescents and Young Adults (AYA) and Adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Michaela Liedtke, Nikesh N. Shah, Jessica T. Leonard, Anthony Proli, Yazan K. Barqawi, Hui-Han Chen, Alan Yong, Vikram Shetty, Elias Jabbour, Mark B. Geyer
Author Affiliations: Stanford Cancer Institute, Tampa General Hospital Cancer Institute, Knight Cancer Institute, AstraZeneca, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Flatiron Health
Session Name: 612. Acute Lymphoblastic Leukemias: Clinical and Epidemiological: Poster I
Publication Number: 1555
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

What Remains Matters: Real-World Impact of Measurable Residual Disease Testing in Multiple Myeloma
Ahmed Sawas, Farhad Khan, Jingru Wang, Evan Vietorisz, Yulia Kuznetsova, Amy Pierre, Siobhan Halloran
Session Name: 907. Outcomes Research: Plasma Cell Disorders: Poster I
Publication Number: 2789
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Biallelic TP53 Alterations Predict Poorer Survival in Mantle Cell Lymphoma: Insights from a National Real-World Cohort
Patrick Bliven, Xiaoyan Wang, Morgan Lael, Anosheh Afghahi, Mayur Narkhede
University of Alabama Birmingham, Flatiron Health
Session Name: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Publication Number: 1830
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Mediators of Racial and Ethnic Inequities in Access to Front-Line Therapies for Chronic Lymphocytic Leukemia in the United States: A Real-World Evidence Study
Joanna M. Rhodes, Adam S. Kittai, Paul J. Hampel, Xiaoliang Wang, Qianhong Fu, Danni Zhao, Smriti Karwa, Olive Mbah, Ahmed Sawas, Benji Wagner, Rachel Myers, Derrick van Beuge, Gregory A. Maglinte, Erlene K. Seymour, Jacqueline C. Barrientos
Author Affiliations: Rutgers Cancer Institute, Icahn School of Medicine at Mount Sinai, Mayo Clinic, BeOne Medicines, Mount Sinai Comprehensive Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I
Publication Number: 2720
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Real-World Insights into Diffuse Large B-Cell Lymphoma from EHR-Derived Data in Germany and the United Kingdom
Christoph Buhl, Ahmed Sawas, Arun Sujenthiran, Mohamed S Ali, Blythe Adamson
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4487
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Measurable Residual Disease (MRD) Testing Patterns and Associated Outcomes in Patients with Philadelphia-Negative B-Cell Acute Lymphoblastic Leukemia
Anthony Proli, Jason Sharpe, Jingru Wang, Jenna Collins, Ahmed Sawas
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4484
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Treatment Patterns and Survival Outcomes in Second and Third Line Settings in Large B-Cell Lymphoma (LBCL)
Joseph P. McGuirk, Miguel-Angel Perales, Mark R. Fesen, Jeremy Snider, Matt Bye, Anthony J. Proli, Blythe Adamson, Samuel Hong, Babatunde Adedokun, Hil Hsu
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4503
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Treatment Patterns and Clinical Outcomes in High-Risk Mantle Cell Lymphoma: A Retrospective Analysis
Preetesh Jain, Anna Teschemaker, Essam Ibrahim, Taavy Miller, Danni Zhao, Ayush Kris, Ahmed Sawas, Debbie Adkins, Anouchka Chelles, Victoria Otero, Tycel Phillips
Author Affiliations: The University of Texas MD Anderson Cancer Center, AstraZeneca, City of Hope Comprehensive Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4482
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Beyond the Trial: Real-World CRS, ICANS, and Healthcare Burden of CAR T-Cell Therapy Across US Oncology Practices
Taiga Nishihori, Li Chen, Benjamin Wagner, Niquelle Wadé, Selina Radlein, Spencer Langerman, Trong Le, Ahmed Sawas, Christina Fullerton
Author Affiliations: Moffitt Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III
Publication Number: 6263
Poster Session Date/Time: December 8, 2025, 6:00 PM – 8:00 PM

Barriers and Bridges: Real-World CAR T Delivery Across US Oncology Practices
Taiga Nishihori, Maneet Kaur, Spencer Langerman, Christina Fullerton, Ahmed Sawas
Author Affiliations: Moffitt Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III
Publication Number: 6262
Poster Session Date/Time: December 8, 2025, 6:00 PM – 8:00 PM

Real-World Insights into Multiple Myeloma Management: An Analysis of EHR-Derived Data in the UK and Germany
Christoph Buhl, Harlan Pittell, Arun Sujenthiran, Ahmed Sawas, Golnessa Mojtahedi, Blythe Adamson
Online only

The Bispecific Blind Spot: Uncovering Real-World Inequities in Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Multiple Myeloma Therapy Access
Gene G. Ho, Olive M. Mbah, Cleo A. Ryals, Amy E. Pierre
Online only

(Press release, Flatiron Health, NOV 4, 2025, View Source [SID1234659401])

Ankyra Announces Publication of Phase 1 Clinical Data, and Will Present at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 4, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported the publication online of Part 1 results from its Phase 1 first-in-human study of tolododekin alfa in Nature Communications in the September 29, 2025, issue. Ankyra recently completed dose escalation of a phase 1 first-in-human study of monotherapy tolododekin alfa, the first anchored IL-12 designed for local tumor retention. The study was conducted at several centers in the United States and Canada in patients with progressive solid tumors. Data from Part 1 of the study focused on patients with superficially accessible tumors. "Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of cancers", said Howard L. Kaufman, MD. "This data opens the door for realizing the therapeutic potential of interleukin-12 for patients with cancer."

"The emerging data supports the proposed mechanism action for tolododekin alfa", stated Joe Elassal, MD, chief medical officer at Ankyra Therapeutics, "and provides initial proof of concept for the anchored drug conjugate platform". The company has an emerging pipeline and will be presenting initial data with their ANK-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 7, 2025.

Ankyra Therapeutics Announces Multiple Scientific Presentations at SITC (Free SITC Whitepaper) Meeting

Highlights include:

NKT Cells as Predictive Biomarkers of Response to IL-12 Conjugate Immunotherapy Abstract# 189 (oral presentation)
Exploratory analysis of phase 1 solid tumor patients treated demonstrates baseline levels of circulating natural killer T (NKT) cells may serve as predictive biomarkers of response to anchored IL-12 treatment.
First-in-Class ANK-201 Data Abstract # 999
Preclinical results from Ankyra’s next-generation candidate, ANK-201, will be presented for the first time, highlighting the expansion of the company’s pipeline beyond cytokines.
Combination anchored IL-12 and HDAC inhibitor therapy improves therapeutic responses Abstract #631
Results from an ongoing collaboration with the National Cancer Institute Center for Immuno-Oncology will report on anchored murine IL-12 in combination with a histone deacetylase (HDAC) inhibitor in checkpoint-refractory tumor models.
Pharmacologic evaluation of a canine anchored IL-12 (JEN-101) in dogs with melanoma Abstract #1195
In collaboration with Timothy M. Fan, DVM, PhD from the Department of Veterinary Clinical Medicine and Cancer Center at Illinois, University of Illinois at Urbana-Champaign and Jenga Biosciences, new data will be presented from a clinical trial of weight-based versus volume-based dosing of JEN-101, a canine anchored IL-12 conjugate, in dogs with melanoma.
"We are pleased with the data to be presented at the SITC (Free SITC Whitepaper) meeting showing the therapeutic potential of anchored immunotherapy", stated Howard Kaufman, MD.

About Tolododekin alfa (ANK-101)
Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 4, 2025, View Source [SID1234659400])

Tempus Reports Third Quarter 2025 Results

On November 4, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended September 30, 2025.

Revenue grew 84.7% year-over-year to $334.2 million in the third quarter of 2025
Gross profit reached $209.9 million in the third quarter of 2025, an improvement of 98.4% year-over-year
217,000 clinical tests delivered in the quarter, representing 33% year-over-year volume growth, with Oncology volume growth accelerating to 27% and Hereditary at 37%
Insights bookings of $150 million across multiple new contracts with year-over-year revenue growth of 37.6% in the quarter
Increasing full year 2025 revenue guidance to $1.265 billion, representing approximately 80% growth year-over-year
Ended the quarter with $764.3 million of cash and marketable securities
"Not only are we growing at an incredible rate, reaching positive adjusted EBITDA marks an important milestone and reflects the strength of our underlying business," said Eric Lefkofsky, Founder and CEO of Tempus. "One of the hardest things to do, and a sign of business model endurance, is being able to slow down the rate of reinvesting back into the business and still maintain growth, which is exactly what we achieved this quarter."

Third Quarter Summary Results

Quarterly revenue increased 84.7% year-over-year to $334.2 million in the third quarter of 2025.
Revenue from Genomics totaled $252.9 million in the third quarter of 2025, growing 117.2% compared to the third quarter of 2024.
Oncology testing (Tempus genomics) contributed $139.5 million, up 31.7% year-over-year in the third quarter of 2025, with approximately 27% volume growth.
Hereditary testing (Ambry genetics) contributed $102.6 million of revenue in the third quarter of 2025, an increase of 32.8% on a pro forma1 basis after giving effect to the Ambry acquisition, with approximately 37% volume growth.
Revenue from Data and services totaled $81.3 million in the third quarter of 2025, delivering 26.1% growth versus the third quarter of 2024, led by Insights (data licensing), which grew 37.6% year-over-year.
Recorded $209.9 million in quarterly gross profit, representing a 98.4% improvement year-over-year.
Reported a net loss of ($80.0 million) in the third quarter of 2025, including $35.0 million in stock compensation expense and related employer payroll taxes, increased amortization expense of intangibles related to the Ambry acquisition, and a one time $12.0 million expense related to the loss on debt extinguishment, compared to a net loss of ($75.8 million) in the third quarter of 2024.
Adjusted EBITDA of $1.5 million in the third quarter of 2025 compared to ($21.8 million) in the third quarter of 2024, an improvement of $23.3 million year-over-year.
1

The pro forma amounts have been calculated after applying the Company’s accounting policies

Third Quarter and Recent Operational Highlights

Acquired Paige, an AI company specializing in digital pathology, to expand our dataset and technical team, and establish a leading footprint in digital pathology.
Selected by Advanced Research Projects Agency for Health (ARPA-H) to provide testing and CRO services in support of the agency’s ADAPT (Advanced Analysis for Precision Cancer Therapy) program.
Obtained 510(k) clearance from the U.S. FDA for xR IVD (RNA NGS in vitro diagnostic device), which will support life sciences’ drug development programs.
Received U.S. FDA 510(k) clearance for updated Tempus Pixel, an AI-powered cardiac imaging platform and for Tempus’ ECG-Low ejection fraction software, which leverages AI to identify patients who may have a low left ventricular ejection fraction.
Expanded collaboration with Northwestern Medicine to integrate David, Tempus’ generative-AI clinical co-pilot within the EHR platform to transform clinical workflows.
Expanded Tempus Next into breast cancer, providing real-time insights to close guideline-based care gaps.
Third Quarter Financial Results

Three Months Ended September 30,

2025

2024

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

334,206

180,929

84.7

Gross profit

209,942

105,839

98.4

Loss from operations

(60,996

)

(53,616

)

13.8

Net loss

(79,982

)

(75,840

)

5.5

Adjusted EBITDA

1,476

(21,843

)

106.8

Net loss per share attributable to common shareholders, basic and diluted

(0.46

)

(0.46

)

—

Non-GAAP net loss per share

(0.11

)

(0.24

)

54.2

Financial Outlook and Guidance

Tempus increased full year 2025 revenue guidance to approximately $1.265 billion, which represents ~80% annual growth. Given the acquisition of Paige, which we expect will increase losses by approximately $5 million per quarter, we expect Q4 Adjusted EBITDA to be ~$20 million, resulting in slightly positive Adjusted EBITDA for the full year.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, November 4, 2025 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 5436492
Domestic Dial-in Number: (800) 715-9871
International Dial-in Number: (646) 307-1963
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, NOV 4, 2025, View Source [SID1234659399])