On November 4, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its third quarter 2025 financial results and highlighted recent corporate achievements.

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"Our third quarter results reflect acceleration across every key dimension of OJEMDA’s performance and growing confidence among prescribers as we continue to build the case for second-line standard-of-care through execution and additional data readouts," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Combined with steady pipeline progress, we are well positioned to deliver sustainable growth for shareholders while we continue our mission to bring meaningful therapies to patients."

OJEMDA Commercial Performance

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OJEMDA net product revenue was $38.5 million in the third quarter of 2025, an increase of 15% from the second quarter of 2025.

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Achieved $102.6 million in U.S. OJEMDA net product revenue for 2025 year-to-date through the third quarter of 2025, representing an 89% increase over fiscal year 2024.

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Quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, representing an 18% increase compared to the second quarter of 2025.

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Third quarter new patient starts grew 19% compared to the second quarter of 2025, driven by the FIREFLY-1 clinical trial 2-year follow-up data.

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The Company is raising the OJEMDA full-year 2025 net product revenue guidance to $145 to $150 million, reflecting continued strength in underlying demand.

Program Highlights

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Progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pediatric low-grade glioma (pLGG), with enrollment completion anticipated in the first half of 2026.

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Advancing dose escalation in the Phase 1a clinical trial of DAY301, a PTK7-targeted antibody drug conjugate (ADC).

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Tovorafenib added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.

Corporate Highlights

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Seasoned biopharmaceutical executive Heather Adkins Huet, PhD, joined Day One in September 2025 as Chief Scientific Officer. Dr. Huet brings over two decades of experience leading and managing the full life cycle of oncology therapeutics, from discovery through life-cycle management of approved products, in biotech startup, mid-cap and large-cap companies including ImmunoGen, Takeda Pharmaceuticals, and Unum Therapeutics.

Third Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $38.5 million for the third quarter of 2025 compared to $20.1 million for the third quarter of 2024 driven by higher patient demand.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $1.3 million for the third quarter of 2025 compared to $73.7 million for the third quarter of 2024 during which period the upfront consideration received from Ipsen for the pLGG license rights of $73.5 million was recognized.

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R&D Expenses: Research and development expenses were $31.4 million for the third quarter of 2025 compared to $33.6 million for the third quarter of 2024.

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SG&A Expenses: Selling, general and administrative expenses were $28.1 million for the third quarter of 2025 compared to $29.0 million for the third quarter of 2024.

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Net Loss: Net loss totaled $19.7 million for the third quarter of 2025 with non-cash stock-based compensation expense of $9.6 million, compared to a net income of $37.0 million for the third quarter of 2024, with non-cash stock-based compensation expense of $11.6 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $451.6 million as of September 30, 2025.

Upcoming Events

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Three-year data from the pivotal FIREFLY-1 trial will be presented in an oral presentation titled ‘Clinical stability following tovorafenib treatment in relapsed/refractory pediatric low-grade glioma:

updated results from the phase 2 FIREFLY-1 trial’ on Sunday, Nov. 23 at 11:49 a.m. HST during the 2025 Society for Neuro Oncology Annual Meeting.

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Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025.

Conference Call

Day One will host a conference call and webcast today, Nov. 4 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

(Press release, Day One, NOV 4, 2025, View Source [SID1234659351])

On November 4, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2025 and reaffirmed its 2025 Revenue guidance(1) while raising and narrowing guidance for Adjusted(2) diluted EPS.

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Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the third quarter and first nine months of 2025 and 2024(6) are summarized below.
($ in millions, except per share amounts)
Third-Quarter Nine Months
2025 2024
% Change
2025 2024
% Change
Revenues $ 16,654 $ 17,702 (6%) $ 45,022 $ 45,864 (2%)
Reported(3) Net Income
3,541 4,465 (21%) 9,419 7,621 24%
Reported(3) Diluted EPS
0.62 0.78 (21%) 1.65 1.34 23%
Adjusted(2) Income
4,949 6,050 (18%) 14,620 14,124 4%
Adjusted(2) Diluted EPS
0.87 1.06 (18%) 2.56 2.48 3%

REVENUES
($ in millions) Third-Quarter Nine Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 16,310 $ 17,392 (6%) (7%) $ 44,056 $ 44,987 (2%) (2%)
Pfizer CentreOne (PC1) 344 285 21% 18% 929 820 13% 13%
Pfizer Ignite — 25 (99%) (99%) 37 56 (34%) (34%)
TOTAL REVENUES $ 16,654 $ 17,702 (6%) (7%) $ 45,022 $ 45,864 (2%) (2%)

2025 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2025 Revenue guidance of $61.0 to $64.0 billion.
■Raises and narrows Adjusted(2) diluted EPS guidance(1) to a range of $3.00 to $3.15 from $2.90 to $3.10 previously.
■The updated 2025 Adjusted(2) diluted EPS guidance takes into consideration our solid year-to-date performance, continued confidence in our business, progress with ongoing cost improvement initiatives, and improvement in our effective tax rate.
–Includes a one-time $1.35 billion Acquired In-Process R&D charge related to the in-licensing agreement with 3SBio, Inc. recorded in the third quarter of 2025 with an unfavorable impact of approximately $0.20.
■The company’s guidance absorbs the impact of the currently imposed tariffs from China, Canada, and Mexico.
Revenues
$61.0 to $64.0 billion
Adjusted(2) SI&A Expenses
$13.1 to $14.1 billion
Adjusted(2) R&D Expenses
$10.0 to $11.0 billion
(previously $10.4 to $11.4 billion)
Effective Tax Rate on Adjusted(2) Income
Approximately 11.0%
(previously approximately 13.0%)
Adjusted(2) Diluted EPS
$3.00 to $3.15
(previously $2.90 to $3.10)

CAPITAL ALLOCATION
During the first nine months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$7.2 billion invested in internal research and development projects, and
•Approximately $1.6 billion invested in business development transactions, primarily reflecting the 3SBio in-licensing deal.
▪Returning capital directly to shareholders through $7.3 billion of cash dividends, or $1.29 per share of common stock.
No share repurchases have been completed to date in 2025. As of November 4, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,714 million and 5,705 million were used to calculate Reported(3) and Adjusted(2) diluted EPS for third-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2025 vs. Third-Quarter 2024)
Third-quarter 2025 revenues totaled $16.7 billion, a decrease of $1.0 billion, or 6%, compared to the prior-year quarter, reflecting an operational decrease of $1.3 billion, or 7%, and a favorable impact of foreign exchange of $203 million. The operational decrease was primarily driven by a year-over-year decline in COVID-19 product revenues largely due to lower infection rates impacting Paxlovid demand as well as a narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population for Comirnaty.
Third-quarter 2025 operational revenue reflected higher revenues primarily for:
▪Eliquis globally, up 22% operationally, driven primarily by higher demand globally and favorable net price in the U.S. as a result of the expected favorable year-over-year impact of the elimination of the coverage gap as part of the IRA Medicare Part D Redesign, partially offset by generic entry and price erosion in certain international markets;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 7% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, as well as improved patient affordability in the U.S.; partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as new payer contracts; and
▪Nurtec ODT/Vydura globally, up 22% operationally, driven primarily by strong demand in the U.S. and recent launches in certain international markets, partially offset by lower net price in the U.S. mainly due to unfavorable changes in channel mix;
more than offset primarily by lower revenues for:
▪Paxlovid, down 55% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower international government purchases, as well as the non-recurrence of a $442 million favorable U.S. government stockpile purchase in the third quarter of 2024; partially offset by favorable adjustments of rebate accruals related to prior periods, as well as higher net price in the U.S. following transition from the U.S. government agreement; and
▪Comirnaty, down 20% operationally, mainly due to a narrower recommendation for vaccination in the U.S. as well as delayed approval of the new variant vaccine; partially offset by a lower returns provision and higher market share in the U.S., as well as higher contractual deliveries in certain international markets.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and CEO of Pfizer:
"I am proud of Pfizer’s leadership as the first in our industry to reach an agreement with the U.S. Government, which we believe provides greater clarity for our business. Additionally, our recent strategic actions have strengthened opportunities to advance innovation that could address significant medical needs in high growth markets, helping us deliver value for patients and shareholders."
David Denton, CFO and EVP of Pfizer:
"Our third-quarter performance demonstrates our continued focus on execution and financial discipline. We raised and narrowed our full-year 2025 Adjusted diluted EPS guidance, underscoring confidence in our ability to deliver strong results for our shareholders."
OVERALL RESULTS
■Third-Quarter 2025 Revenues of $16.7 Billion, Representing a 7% Year-over-Year Operational Decline
–Strengthened Commercial Execution Drives 4% Operational Revenue Growth of Non-COVID Portfolio
■Third-Quarter 2025 Reported(3) Diluted EPS of $0.62, and Adjusted(2) Diluted EPS of $0.87
■Reaffirms Full-Year 2025 Revenue Guidance(1) in a Range of $61.0 to $64.0 Billion
■Raises and narrows Full-Year 2025 Adjusted(2) Diluted EPS Guidance(1) to a Range of $3.00 to $3.15
■On Track to Deliver Approximately $7.2 Billion in Overall Anticipated Net Cost Savings from Previously Announced Cost Improvement Initiatives(4) by End of 2027, Driving Productivity Gains and Operating Margin Expansion

(Press release, Pfizer, NOV 4, 2025, View Source [SID1234659367])

On November 4, 2025 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $8.3 million during the third quarter of 2025. Year-to-date revenues for the first nine months of the year totaled $30.8 million, representing an increase of 12% over the first nine months of 2024.
Cumberland ended the quarter with approximately $66 million in total assets, $40 million in liabilities and $26 million of shareholders’ equity.
"We are very pleased to add an established, FDA approved brand to our commercial portfolio," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "We are also encouraged by the continued progress with our development programs designed to address a series of unmet medical needs in orphan patient populations. As we move into the final quarter of 2025, we remain focused on our mission of working together to provide unique products that improve the quality of patient care."

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RECENT COMPANY DEVELOPMENTS INCLUDE:
New Product Added to Commercial Product Portfolio
Cumberland recently announced arrangements with RedHill Biopharma Ltd. ("RedHill") to jointly commercialize Talicia, marking the latest addition to its commercial product portfolio. The FDA-approved oral capsule is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection and leading risk factor for gastric cancer.
Cumberland has formed a new company with RedHill, named Talicia Holdings, Inc. RedHill has assigned all its Talicia-related assets to the new company for a 70% ownership position. Cumberland will provide $4 million in investment capital over a two-year period and receive ownership of the 30% remaining shares. Cumberland and RedHill have equal board seats and voting rights in the new company, and these arrangements will enable Cumberland to participate in the value it helps create in the brand.
Through a co-commercialization agreement, Cumberland will assume responsibility for the distribution and sale of Talicia in the U.S. Cumberland will record Talicia product sales and equally share Talicia’s net revenues. Cumberland will also provide an annual investment to cover certain distribution, marketing and sales costs, and will lead the sales promotion for Talicia by leveraging its established field national sales division.

Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin, and is now recommended as a first-line therapy in the American College of Gastroenterology (ACG) clinical guidelines. Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.
International Agreements
During the third quarter, Cumberland announced the launch of Vibativ in Saudi Arabia. The product launch follows an agreement with Tabuk Pharmaceutical Manufacturing Company to introduce Vibativ into the Middle East. The arrangement provided Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk has obtained the final approvals needed to commercialize Vibativ in Saudi Arabia.
In October 2025, Cumberland’s ibuprofen injection product received regulatory approval in Mexico. The Company previously announced its partnership with PiSA Farmaceutica, a well-established Mexican pharmaceutical firm. Under the agreement, PiSA is responsible for the registration and commercialization of the product for the Mexican market, while Cumberland provides regulatory support and the product supply.
Additionally, Cumberland previously announced that its Vibativ product received approval from the regulatory authorities in China, the world’s second-largest pharmaceutical market.
Vibativ 4-Vial Starter Pak Now Available for Vizient Providers
Cumberland recently announced the availability of the Vibativ (telavancin) 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their healthcare providers nationwide.
As the country’s largest provider-driven healthcare performance improvement company, Vizient serves more than 65% of the nation’s acute care providers, including 97% of academic medical centers and 35% of the non-acute market. Through this agreement, Vizient members now have access to Vibativ’s new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings for this potentially life-saving therapy.
Vibativ Added to Premier National Group Purchasing Agreement
In October 2025, Cumberland announced that Vibativ was added to a national group purchasing agreement with Premier, Inc. The product additional allows Premier members to purchase Vibativ, in the 12-vial carton and 4-vial Starter Pak. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,350 U.S. hospitals and 325,000 other providers and organizations. With expanded access, Premier member healthcare providers now have greater flexibility in ordering Vibativ for both inpatient and outpatient settings.

Ifetroban Clinical Studies
In June 2025, breakthrough findings from Cumberland’s Phase II FIGHT DMD trial, evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy ("DMD"), were presented at the Parent Project Muscular Dystrophy Annual Conference. The findings demonstrated that high-dose ifetroban delivered a 5.4% improvement in cardiac function in patients with DMD. The presentation also included additional biomarker data indicating reduced cardiac damage, which correlated with the clinical findings. These results position ifetroban as a potential treatment for DMD cardiomyopathy – the leading cause of death in these patients and a critical unmet medical need affecting 90% of DMD patients.
The top-line FIGHT DMD study findings were also selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical & Scientific Conference in March 2025. In June 2025, Cumberland completed the comprehensive analysis of the study results, finalized its clinical study report and submitted it to the FDA, along with a request for an end-of-Phase 2 meeting. Cumberland then began interaction with the FDA to determine the remaining development requirements.
Meanwhile, Cumberland has been evaluating its ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis. Enrollment in the study was completed this year, and Cumberland is monitoring the clinical sites in preparation to lock the database and begin evaluating the results.
In addition, Cumberland has a Phase II clinical study, the FIGHTING FIBROSIS trial, underway in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment is now well underway in medical centers across the U.S. The study design includes both an interim safety analysis, as well as an interim efficacy analysis.

FINANCIAL RESULTS:
Net Revenue: For the third quarter of 2025, net revenues were $8.3 million and included $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ and $0.9 million for Caldolor.
Year-to-date 2025 net revenues were $30.8 million. Year-to-date net revenues by product were $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ and $3.8 million for Caldolor.
Operating Expenses: Total operating expenses were $10.3 million for the third quarter of 2025 and $32.3 million for the first nine months of the year.
Net Income (Loss): Year-to-date net loss was approximately $1.4 million and the third quarter net loss was approximately $1.9 million.
Adjusted Earnings: The adjusted loss for the third quarter of 2025 was $0.8 million, or $0.06 per share. Adjusted earnings for the first nine months of 2025 was $1.9 million, or $0.13 per diluted share.
Balance Sheet: On September 30, 2025, Cumberland had approximately $66 million in total assets, including $15 million in cash and cash equivalents. Liabilities totaled $40 million, including $5 million on the Company’s credit facility. Total shareholders’ equity was $26 million on September 30, 2025.

EARNINGS REPORT CALL:
A conference call will be held today, November 4, 2025, at 4:30 p.m. Eastern Time to provide a Company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, NOV 4, 2025, View Source [SID1234659384])

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.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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

On November 4, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported at the World ADC Conference in San Diego, USA, highly encouraging results from its latest preclinical in vivo study evaluating Accum-Kadcyla, a novel version of Genentech/Roche’s marketed ADC Kadcyla (ado-trastuzumab emtansine), in mouse models of HER2-positive breast cancer.

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Study Results: 20-Fold Increased Potency at Equivalent Dose

In the comparative in vivo study, Accum-Kadcyla demonstrated a ~20-fold higher anti-tumor efficacy than Kadcyla alone when administered at the same dose (0.5 mg/kg). Tumor growth was significantly halted in the Accum-Kadcyla-treated group, resulting in a durable and near-complete response in most mice while Kadcyla at the same dose (0.5 mg/kg) had no effect on tumor growth. Importantly, 100% of the animals survived throughout the duration of the study with no signs of toxicity, underscoring the excellent tolerability of the treatment.

Implications for Patients and the Industry

These results confirm that Defence’s Accum platform can dramatically enhance the intracellular delivery and potency of ADCs by overcoming endosomal entrapment—a known bottleneck in ADC performance. By increasing the therapeutic payload’s reach inside cancer cells, Accum enables a more efficient drug release and tumor killing, even at lower doses.

This finding is particularly meaningful for patients: the ability to achieve the same or better efficacy at reduced doses translates into a potential reduction in toxicity and side effects, addressing one of the main limitations of current ADC therapies. Practically, it could potentially bring this current second line of treatment to a first line of treatment for the benefit of the patients.

Dr. Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics, commented:

"These results further validate the power of Accum as a transformative technology for ADCs. By amplifying the potency of a clinically proven ADC like Kadcyla by 20 times at the same dose, we demonstrate that Accum can unlock a new generation of safer and more effective targeted therapies for cancer patients."

Next Steps and Commercial Outlook

Following these promising results, Defence Therapeutics plans to expand its Accum-ADC program to additional HER2-positive and HER2-low tumor models and to advance discussions with potential pharmaceutical partners.

(Press release, Defence Therapeutics, NOV 4, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-demonstrates-strong-preclinical-in-vivo-efficacy-results-evaluating-accum-kadcyla-in-breast-cancer-models [SID1234659633])