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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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])

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])

On November 4, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the third quarter ended September 30, 2025.

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Third Quarter 2025 Financial Results

Total revenue of $20.6 million, compared with $11.2 million in the third quarter of 2024
HEPZATO KIT revenue of $19.3 million, compared to $10.0 million in the third quarter of 2024
CHEMOSAT revenue of $1.3 million, compared to $1.2 million in the third quarter of 2024
Gross margins of 87%, compared to 85% in the third quarter of 2024
Net income of $0.8 million, compared to a net income of $1.9 million in the third quarter of 2024
Non-GAAP positive adjusted EBITDA in the third quarter of $5.3 million, compared to a positive adjusted EBITDA of $1.0 million in the third quarter of 2024
Cash provided by operations of $4.8 million in the quarter; compared to $3.6 million used by operations in the third quarter of 2024
Cash and investments of $88.9 million as of September 30, 2025
Business Highlights

There are currently 25 active centers across the U.S.
In August, the first patient was dosed at City of Hope National Medical Center in the global Phase 2 trial of HEPZATO in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer. The study will enroll approximately 90 patients across 20+ sites in the U.S. and Europe, with topline data expected in 2028
Announced that results from the investigator-initiated Phase 2 CHOPIN trial at Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma were presented at the October 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress by Principal Investigator Ellen Kapiteijn, MD, showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
"In the third quarter, we made strong progress with our clinical programs, reporting compelling positive CHOPIN results and first-patient dosing in our global Phase 2 trial in liver-dominant metastatic colorectal cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems. "While revenue results in the quarter reflected the impact of NDRA discounts and seasonal factors, our fundamentals remain strong. We are confident that the growing clinical validation of HEPZATO positions us well to drive continued progress and long-term value for patients and shareholders."

2025 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2025:

Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $83 to $85 million, an increase in volume of approximately 150% over 2024
Gross margins in the range of 85% to 87%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Third Quarter 2025 Results

Total revenue for the quarter ending September 30, 2025 was $20.6 million compared to $11.2 million for the same period in the prior year. Revenue in the quarter includes sales of $19.3 million of HEPZATO in the U.S. and $1.3 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending September 30, 2025, were $8.0 million compared to $3.9 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer and Phase 2 clinical trial in metastatic breast cancer. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ended September 30, 2025, were $10.3 million compared to $7.0 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net income for the quarter ended September 30, 2025 was $0.8 million compared to net income of $1.9 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended September 30, 2025 was $5.3 million compared to adjusted EBITDA of $1.0 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of September 30, 2025, the Company had $88.9 million in cash and investments, and no debt.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, November 6, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=a3bb91787b

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, NOV 4, 2025, View Source [SID1234659352])

On November 4, 2025 Prelude Therapeutics Incorporated (Nasdaq:PRLD), a clinical-stage precision oncology company, reported an exclusive option agreement with Incyte (Nasdaq:INCY) focused on Prelude’s previously undisclosed mutant selective JAK2V617F JH2 inhibitor program in development for patients with myeloproliferative neoplasms (MPNs). Per the agreement, Incyte secures an exclusive option to acquire the JAK2V617F program in exchange for an upfront payment and a strategic equity investment in Prelude, plus potential downstream milestones and royalties.

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Kris Vaddi, Ph.D., Chief Executive Officer of Prelude stated, "We’re pleased to put this agreement in place with Incyte, recognized global leaders in the MPN field. Prelude and Incyte both aim to deliver transformational treatments to improve upon the standard of care established with first generation JAK2 JH1 inhibitors like Jakafi (ruxolitinib). Our research team made significant progress discovering the first known inhibitors that bind into the JAK2 JH2 ‘deep pocket’ where the V617F mutation resides. These potent and orally bioavailable compounds demonstrate mutant specific inhibition and the potential for disease modification in multiple preclinical models of MPNs. Today’s agreement with Incyte provides us with the capital needed to advance further our JAK2V617F program, while also allowing us to advance the development of our other pipeline programs."

"The agreement with Prelude provides an opportunity to enhance our robust portfolio of clinical and preclinical JAK2V617F candidates for patients with MPNs," said Bill Meury, President and Chief Executive Officer of Incyte. "This transaction aligns with our strategy to develop new and innovative therapies poised to make a meaningful difference for patients."

Terms of the Agreement
Under the terms of the Transaction Agreement, Incyte secures an exclusive option to acquire Prelude’s mutant selective JAK2V617F JH2 inhibitor program, including Prelude’s library of preclinical candidates. Prelude will receive $60 million in capital, comprised of an upfront payment of $35 million, plus a $25 million equity investment by Incyte in Prelude. Incyte will purchase 6.25 million shares of Prelude non-voting common stock at a price of $4.00 per share at deal close. Prelude intends to apply the upfront payment and net proceeds from the sale of the purchased shares to advance the JAK2V617F program and other pipeline assets, and for working capital and general corporate purposes.

Prelude expects to advance the JAK2V617F program to pre-defined milestones. Incyte may elect to exercise its exclusive option during the option period to acquire the program and associated assets from Prelude for $100 million. As the JAK2V617F program candidates advance in the clinic, Prelude would be eligible to receive up to $775 million in additional clinical and regulatory milestones, and single digit royalties on global net sales. Combined, total potential cash payments from the transaction, excluding royalties, could reach up to $910 million.

If Incyte elects to not exercise its option to acquire the program, all JAK2V617F global program rights and interests would remain in the sole ownership and control of Prelude.

Prelude Therapeutics was advised on the transaction by Morgan Lewis & Bockius LLP as legal counsel.

Mutant selective JAK2V617F JH2 inhibitor program
JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been a shared goal and challenge for industry. If successful, this approach has potential to reduce mutant allele burden, modify disease progression, and transform treatment outcomes for MPN patients. Prelude has discovered novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. The first disclosure of program data was accepted for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting taking place in Orlando, FL December 6-9, 2025. The abstract can be found on the ASH (Free ASH Whitepaper) 2025 website ASH (Free ASH Whitepaper) Annual Meeting & Exposition – Hematology.org.

(Press release, Prelude Therapeutics, NOV 4, 2025, View Source [SID1234659368])