On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company has entered into an agreement to receive funds managed by Blackstone Life Sciences ("Blackstone") for the development of sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global Phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers.

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"This agreement positions Merck to harness the potential of sac-TMT, a promising ADC candidate targeting TROP2, while we continue to advance our broad and expansive pipeline," said Caroline Litchfield, chief financial officer, Merck. "We are making important investments to drive patient impact and revenue growth, and to sustain our business for the future while remaining disciplined towards maintaining an appropriate financial profile."

Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs for sac-TMT expected to be incurred throughout 2026. In return, Blackstone is eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT across all approved indications in Merck’s marketing territories contingent upon receipt of regulatory approval in the U.S. for first-line treatment of triple-negative-breast cancer based on findings of the TroFuse-011 clinical trial.

"Sac-TMT is an innovative asset that has the potential to improve patient care across many forms of cancer," said Dr. Nicholas Galakatos, global head, Blackstone Life Sciences. "We are excited to be collaborating with Merck to realize the full value of this high priority product and contribute to our partner’s revenue growth by leveraging our scale capital and expertise."

Sac-TMT is being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Sichuan Kelun Pharmaceutical Co, Ltd. ("Kelun-Biotech"), which is unchanged by this agreement with Blackstone. Merck will retain decision-making authority and control over the development, manufacturing, and commercialization of sac-TMT; Blackstone will not receive any rights to sac-TMT.

About sacituzumab tirumotecan (sac-TMT)

Sac-TMT is an investigational ADC that consists of three components: 1) a TROP2-targeting monoclonal antibody, sacituzumab, 2) a cytotoxic payload from the topoisomerase 1 inhibitor class, and 3) a novel, irreversible but hydrolyzable linker, which joins the monoclonal antibody and the cytotoxic payload leveraging proprietary linker conjugation technology. The average drug-to-antibody ratio of sac-TMT is 7.4. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion and metastasis. TROP2 ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects and have shown encouraging anti-tumor activity in clinical studies.

Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659363])

On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company, through a subsidiary (Prometheus BioSciences), has reached an agreement with Dr. Falk Pharma GmbH (Falk) to discontinue an existing contract concerning co-development and co-commercialization rights in certain territories for MK-8690 (formerly PRA-052), and for Merck to assume full responsibility for the development program going forward. MK-8690 is an investigational anti-CD30 ligand monoclonal antibody being evaluated by Merck in an early-stage clinical trial.

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Under the terms of the agreement, Prometheus BioSciences (Prometheus) and Falk have discontinued their collaboration based on their existing co-development contract resulting in Prometheus having secured global rights to MK-8690. In exchange, Falk will receive a $150 million upfront payment and is eligible to receive a payment associated with a development milestone as well as royalties on sales in certain territories. The original contract between Falk and Prometheus was signed in 2020. Merck subsequently acquired Prometheus in 2023.

As a result of the transaction with Falk, Merck will record a pre-tax charge to research and development expenses of $150 million, or approximately $0.05 per share, in both its GAAP and non-GAAP fourth quarter results.

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659362])

On November 4, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported third quarter 2025 financial results and provided a corporate update.

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"Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer. "With the initiation of the pivotal KOMET-017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best-in-class potential across the continuum of unmet need in AML. Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well positioned to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value across our pipeline for patients and other key stakeholders."

Recent Highlights

In September 2025, we announced the first patient was dosed in the Phase 3 KOMET-017 trial of ziftomenib in frontline AML (NCT07007312). KOMET-017 comprises two global, randomized, double-blind, placebo-controlled trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML.
In October 2025, we announced the first patient was dosed in the FLT3 inhibitor cohort of the KOMET-007 clinical trial (NCT05735184). The cohort evaluates ziftomenib combined with the FDA-approved FLT3 inhibitor, quizartinib, plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD / NPM1 co-mutations.
In September 2025, the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib as a monotherapy in adult patients with R/R NPM1-m AML. (Reprint)
Two abstracts featuring clinical data from ziftomenib in combination with venetoclax / azacitidine (ven/aza) chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML were accepted for oral presentation at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) to be held in December 2025. (Abstract ID 764; Abstract ID 766)
In October 2025, preliminary clinical data were presented at ESMO (Free ESMO Whitepaper) 2025, highlighting the potential of Kura’s farnesyl transferase inhibitors, darlifarnib (KO-2806) and tipifarnib, to enhance the anti-tumor activity of PI3Ka inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors across a range of diverse tumor types by addressing a common resistance pathway.

Data from the FIT-001 Phase 1 trial evaluating darlifarnib and cabozantinib in patients with renal cell carcinoma (RCC) reflect a manageable safety profile across multiple dose levels of each agent, including at the full label dose of cabozantinib. Antitumor activity was observed across all dose combinations tested, including in patients with prior exposure to cabozantinib. The objective response rate (ORR) was 33-50% in ccRCC, and 17-50% in patients with prior cabozantinib exposure. (Poster)
Data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in patients with PIK3CA-dependent HNSCC also reflect a manageable safety profile. An ORR of 47% was observed at a dose of tipifarnib 1200 mg/day and alpelisib 250 mg/day. Robust antitumor activity was observed in a heavily pretreated patient population where clinical benefit is not expected from either alpelisib or tipifarnib as monotherapy. (Poster)

In October and November 2025, Kura received two $30 million milestone payments under its agreement with Kyowa Kirin in connection with first patient dosing in the pivotal KOMET-017 clinical trial of ziftomenib with intensive and non-intensive chemotherapy in patients with frontline AML.

Forecasted Milestones

Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-m AML.
Present preliminary clinical data in newly diagnosed NPM1-m AML and updated clinical data in R/R NPM1-m and KMT2A-r AML from KOMET-007 cohorts evaluating ziftomenib in combination with ven/aza at ASH (Free ASH Whitepaper) Annual Meeting to be held in December 2025.
Present preliminary data from the KOMET-008 cohort evaluating ziftomenib in combination with the FLT3 inhibitor gilteritinib in patients with R/R NPM1-m AML in 2026.
Initiate FIT-001 Phase 1b expansion cohorts of darlifarnib and cabozantinib in patients with advanced RCC in the first half of 2026.
Present updated dose-escalation data from the combination of darlifarnib and cabozantinib in patients with advanced RCC in 2026.
Present preliminary clinical data from the combination of darlifarnib and adagrasib in patients with KRASG12C-mutated solid tumor indications in 2026.

Financial Results

Collaboration revenue from our Kyowa Kirin partnership for the third quarter of 2025 was $20.8 million, compared to no revenue for the third quarter of 2024.
Research and development expenses for the third quarter of 2025 were $67.9 million, compared to $41.7 million for the third quarter of 2024.
General and administrative expenses for the third quarter of 2025 were $32.8 million, compared to $18.2 million for the third quarter of 2024.
Net loss for the third quarter of 2025 was $74.1 million, compared to a net loss of $54.4 million for the third quarter of 2024. Net loss for the third quarter included non-cash share-based compensation expense of $11.0 million, compared to $8.3 million for the same period in 2024.
As adjusted for the two $30 million clinical trial milestone payments earned under our collaboration agreement with Kyowa Kirin, Kura had, on a pro forma basis, cash, cash equivalents and short-term investments of $609.7 million as of September 30, 2025.
Based on our current plans, we believe that our cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to enable us to fund our current operating expenses into 2027, and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, should support our ziftomenib AML program through topline results from KOMET-017.

Conference Call and Webcast – Third Quarter 2025 Financial Results

Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 4, 2025, to discuss the financial results for the third quarter of 2025 and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com.

Conference Call and Webcast – ASH (Free ASH Whitepaper) 2025 Annual Meeting

Kura plans to host a virtual analyst and investor event at 12:30 p.m. ET / 9:30 a.m. PT on Monday, December 8, 2025, to discuss the Company’s presentations from ziftomenib in combination with ven/aza chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). A live webcast and archived replay of the event will be available online from the investor relations section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, NOV 4, 2025, View Source [SID1234659361])

On November 4, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it will host an R&D Day for investors at the Harvard Club (35 West 44th Street) in New York City on November 10, 2025, beginning at 8:00 a.m. ET.

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The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. There will be a live Q&A session and networking opportunities with the speakers and IMUNON management team following the formal presentations.

Featured Presentations and Speakers:

Title: Advancing Ovarian Cancer Care: IMNN-001’s Potential to Transform the Microtumor Environment from Cold to Hot in Phase 3
Presenter: Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Research, Professor in Gynecologic Oncology, Washington University School of Medicine
Title: Unveiling Progress: Safety, Tolerability, and Translational Insights for IMNN-001
Presenter: Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center

Title: OVATION 3 Probability of Success & the Statistical Properties of Phase 3 Trial Design
Presenter: Giorgio Paulon, Ph.D., Director & Senior Statistical Scientist, Berry Consultants, LLC

Title: Phase 3 OVATION 3 Trial Update
Presenter: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON

(Press release, IMUNON, NOV 4, 2025, View Source [SID1234659360])

On November 4, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported its financial results for the fiscal quarter and nine months ended September 30, 2025.

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In the third quarter of 2025, ImmunityBio reported $31.8 million of product revenue, representing a 434% increase from $6.0 million in the third quarter of 2024. This growth reflects continued commercial traction of ANKTIVA in combination with BCG in BCG-unresponsive NMIBC with CIS with or without papillary tumors. The first three quarters of 2025 sales totaling $74.7 million represents a 467% increase in unit volume during the first three quarters of 2025 versus the last three quarters of 2024. The Company ended the quarter with $257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025.

"We are pleased with the continued strong demand for ANKTIVA in NMIBC CIS. Unit sales grew nearly 6X year-to-date compared with full-year 2024, reflecting adoption both at leading research centers and in community urology clinics, including rural areas," said Richard Adcock, President and CEO of ImmunityBio. "ANKTIVA’s total response rate continues to gain momentum with payors as it was recently added as the preferred drug in its indication by a large medication contracting organization covering ~80 million lives. Additionally, enrollment in the rBCG EAP nearly doubled this quarter, underscoring the urgent need to address the BCG shortage. On the clinical side of the business, our BCG-naïve study is enrolling well, and we are optimistic about the potential to expand ANKTIVA’s reach to an even broader population of bladder cancer patients in the near future."

"We continue to achieve compelling results with the core components of our BioShield platform, demonstrated by sustained demand for ANKTIVA in bladder cancer and encouraging data this quarter showing its potential to reverse lymphopenia in non-small cell lung cancer," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer, of ImmunityBio. "ANKTIVA also showed strong data in achieving disease control in glioblastoma, an extremely difficult to treat cancer. We are excited about the growth opportunities for our science and its potential to address many more unmet needs."

Third-Quarter Ended September 30, 2025 Financial Summary and Comparison to Prior Year Quarter

Product Revenue, Net

Product revenue, net increased $25.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense increased $0.8 million to $51.2 million during the three months ended September 30, 2025, as compared to $50.4 million during the three months ended September 30, 2024. The increase was due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $0.4 million to $36.3 million during the three months ended September 30, 2025, as compared to $35.9 million during the three months ended September 30, 2024. The increase was due to higher costs related to headcount, partially offset by lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $67.3 million during the three months ended September 30, 2025, compared to $85.7 million during the three months ended September 30, 2024. The reduction of loss was primarily driven by increased product revenue and lower related-party interest expense, partially offset by an increase in interest expense related to the revenue interest liability, and changes in the fair value of warrant liabilities, a related-party convertible note and derivative liabilities.

Nine Months Ended September 30, 2025 Financial Summary and Comparison to Prior Year Nine Months

Product Revenue, Net

Product revenue, net increased $67.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

R&D expense decreased $0.2 million to $154.7 million during the nine months ended September 30, 2025, as compared to $154.9 million during the nine months ended September 30, 2024. The decrease was mainly due to a reduction in outside service costs, CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs and by higher manufacturing costs driven by increased production activities.

Selling, General and Administrative Expense

SG&A expense decreased $15.8 million to $111.3 million during the nine months ended September 30, 2025, as compared to $127.1 million during the nine months ended September 30, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $289.5 million during the nine months ended September 30, 2025, compared to $354.4 million during the nine months ended September 30, 2024. This reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability, and lower interest and investment income.

(Press release, ImmunityBio, NOV 4, 2025, View Source [SID1234659359])