On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067) performed at the University of British Columbia evaluating ZetaMet (Zeta-BC-003) for safety and efficacy for the treatment of MBC lytic bone lesions in Stage 4 breast cancer patients. Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) and many demonstrated a reconstitution of trabecular bone, which further underscores the potential of ZetaMet to not only halt disease progression but restore skeletal integrity.

The findings build on prior compassionate use cases published in peer-reviewed journals with two-year follow-up, reinforcing ZetaMet’s potential to prevent SREs and improve overall survival. The abstract will be published in SABCS 2025 Proceedings and featured in Clinical Cancer Research.

With the trial now complete and comprehensive analyses underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions.

Presentation Details:

Abstract Number: 3549
Presentation Number: PS1-13-18
Presentation Title: Single Intratumoral Drug Injection Yields Complete Response in Metastatic Breast Cancer Bone Lesions: Results from Phase 2a Trial
Poster Presentation: Wednesday, December 10, 2025, 12:30-2:00pm CST
"The promising Phase 2a findings for ZetaMet mirror our earlier peer-reviewed results, reinforcing the strength of our clinically validated strategy in treating metastatic breast cancer." said Joe C. Loy, CEO of Zetagen Therapeutics. "We observed that both treated and adjacent non-treated lesions within the same vertebral body achieved complete response, with no signs of tumor activity and no skeletal-related events—all using the same drug concentration validated in our preclinical studies—strongly affirming the scientific foundation of our approach".

About ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule, administered intratumorally to minimize off target toxicity, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet.

Zetagen with FDA and Health Canada (HC) approval via the Expanded Access (Compassionate Use) program has treated eight (8) patients with ZetaMet (Zeta-BC-003) with results published multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of seven (7) lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659381])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In a head-to-head comparison with standard-of-care therapies Tamoxifen and Abemaciclib (i.e., Verzenio), a single intratumoral injection of Zeta-BC-007 significantly outperformed both agents. Mice treated with Zeta-BC-007 containing NME + NaN + ABE showed a 66% reduction in tumor volume and complete absence of tumor activity by day 60, while all mice in the TAM and ABE groups succumbed to disease.

"Zeta-BC-007 represents a significant leap forward in intratumoral cancer therapy. By combining a novel molecular entity with synergistic therapeutics in a lipid-based hydrogel, we’ve demonstrated not only superior tumoricidal activity but also extended survival in preclinical models. These results reinforce our commitment to developing localized, non-systemic treatments that challenge the limitations of conventional cancer care."

— Bryan S. Margulies, PhD, Co-founder and CSO, Zetagen Therapeutics

"These results mark a pivotal moment in our journey to redefine primary breast cancer treatment," said Joe C. Loy, CEO of Zetagen Therapeutics. "the ability of Zeta-BC-007 to deliver potent tumoricidal effects through a single localized injection — without systemic toxicity — represents a new frontier in oncology. We believe this platform has the potential to transform how solid tumors are treated."

Presentation Details:

Abstract Number: 3638
Presentation Number: PSA-06-30
Presentation Title: Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)
Poster Presentation: Thursday, December 11, 2025, 5:00-6:30pm CST
About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, the novel formulation enables controlled release of multiple small molecules — with one being our novel molecular entity coupled with any other fat-soluble drugs; including other companies CDK4 or CDK4/6 protein inhibitors or any anticancer therapeutic. Designed for solubility within adipose tissue, ZetaPrime is a paradigm-shifting intratumoral approach to adjuvant therapy that targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659380])

On November 4, 2025 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies in an animal model of Acute Myeloid Leukemia (AML), in which Cantrixil was combined with drugs used in standard of care treatments. Vivesto also announced that a new international patent application covering the treatment of hematological cancer with Cantrixil in combination with other treatments has been filed, with the potential to significantly strengthen the IP position.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The drug candidate Cantrixil has been evaluated in vivo in combination with other anti-cancer drugs in an animal model involving difficult to treat human AML cancer. The results demonstrate clear positive effects of Cantrixil alone and even stronger effects when Cantrixil was combined with other anti-cancer drugs. These positive results confirm previous preclinical in vitro and in vivo efficacy data that have shown strong effects of Cantrixil alone and synergistic effects when combined with standard of care treatments, and support continued development of Cantrixil in hematological cancer, especially in AML.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting further development of the Cantrixil program. The next steps involve further pre-clinical studies ahead of moving the program into clinical development," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new international patent application for the treatment of hematological cancer with Cantrixil that may further increase the value of the program."

Vivesto is continuing the planning of activities needed to bring Cantrixil into clinical trials, and in parallel will investigate opportunities to partner the project to optimize the development program.

(Press release, Vivesto, NOV 4, 2025, View Source [SID1234659379])

On November 4, 2025 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the third quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Werewolf is delivering on the promise of its proprietary PREDATOR platform of conditionally activated immune therapeutics, marked by significant progress for our lead INDUKINETM clinical programs, WTX-124 and WTX-330, and our first INDUCER T-cell engager candidate, WTX-1011," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "For WTX-124, which received Fast Track Designation last month, we plan to provide an update later in the fourth quarter of 2025 on the path to a registration-enabling trial based on interim Phase 1/1b clinical trial data and feedback from an End of Phase 1 meeting with the FDA. At the same time, we plan to provide an update on the current Phase 1b/2 clinical trial of WTX-330 and a potential development plan for this program. Finally, we continue to make progress in IND-enabling studies for WTX-1011, our first INDUCER T cell Engager development candidate, and plan to nominate a differentiated target candidate by year-end."

Recent Highlights and Upcoming Milestones
Clinical-Stage INDUKINE Molecules:
•WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
◦Fast Track Designation received from the US FDA for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. Fast Track Designation is intended to expedite the development of drugs to address a serious unmet medical need and provide opportunities for frequent FDA interactions.
◦All expansion arms are either actively enrolling patients or fully enrolled in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks (IV Q2W). Enrollment is expected to be completed in all arms by the first quarter of 2026.
◦In the fourth quarter of 2025, Werewolf plans to release interim data from the monotherapy and combination expansion arms and to provide feedback from the Company’s End of Phase 1 meeting with the FDA. These inputs are expected to provide insight into potential registrational pathways for WTX-124 in advanced or metastatic cutaneous melanoma.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Pharmacokinetic insight into the IL-2 INDUKINE prodrug WTX-124: real-time assessment of tumor-specific activation and immune modulation."

•WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
◦Actively enrolling in a Phase 1b/2 clinical trial (WTX-330×2102) in locally advanced or metastatic solid tumors. An update on the clinical trial is expected to be released in the fourth quarter of 2025, with guidance on potential further development plans.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Sequential administration of WTX-124 and mWTX-330, IL-2 and IL-12 INDUKINE molecules, enhanced anti-tumor activity in mice bearing poorly immunogenic EMT6 tumors without systemic toxicity."
Preclinical-Stage INDUCER Molecules:
•WTX-1011: a potential first-in-class conditionally activated anti-STEAP1 T-cell engager to provide an improved therapeutic index.
◦STEAP1 is a promising prostate cancer target with limited expression in normal tissues, but notable toxicities are associated with existing anti-STEAP1 T-cell engager therapy.
◦Preclinical data demonstrated that PREDATOR masking technology successfully silenced peripheral activity and prevented cytokine release.
•Utilizing a novel and highly effective anti-CD3 masking strategy, Werewolf expects to nominate a differentiated target candidate in the fourth quarter of 2025.
•At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Development of conditional T cell engagers (INDUCERTM molecules) with a highly effective masking approach to reduce dose-limiting cytokine release and off-target peripheral toxicity."
Preclinical-Stage INDUKINE Partnering Opportunities:
•Werewolf’s previously announced development candidates available for partnering include: WTX-712, its Interleukin-21 (IL-21) INDUKINE molecule, and WTX-518, its binding protein resistant Interleukin-18 (IL-18) INDUKINE molecule, each for the treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases.
Financial Results for the Third Quarter of 2025:
•Cash position: As of September 30, 2025, cash and cash equivalents were $65.7 million, compared to $77.6 million as of June 30, 2025. The Company believes its cash and cash equivalents as of September 30, 2025, will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $11.6 million for the third quarter of 2025, compared to $12.5 million for the same period in 2024.
•General and administrative expenses: General and administrative expenses were $4.1 million for the third quarter of 2025, compared to $4.6 million for the same period in 2024.
•Net loss: Net loss was $16.4 million for the third quarter of 2025, compared to $16.7 million for the same period in 2024.

(Press release, Werewolf Therapeutics, NOV 4, 2025, View Source [SID1234659378])

On November 4, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the third quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our performance in Q3, which was the first full quarter since our accelerated approval and launch of AVMAPKI FAKZYNJA CO-PACK, exceeded expectations with net revenue of over $11 million and demonstrated the strength of our growing commercial business and consistent adoption by both academic and community oncologists for the first treatment approved by the FDA specifically for patients with KRAS- mutated recurrent LGSOC," said Dan Paterson, president and chief executive officer of Verastem Oncology. "As we continue to build on this momentum and the fundamentals we have put into place to guide our commercial business, we’re simultaneously advancing our broader strategic priorities, and are very pleased with the progress of our clinical pipeline programs. Particularly for our KRAS G12D (ON/OFF) inhibitor, VS-7375, preliminary safety, tolerability, and anti-tumor activity are promising, and we believe in line as a potential best-in-class option for patients with pancreatic, lung, and other KRAS G12D-mutated solid tumor cancers. As we move ahead with opening the combination cohort with VS-7375 and cetuximab, we look forward to several important data readouts in the first half of 2026 that we believe will further demonstrate the breadth of our RAS/MAPK pathway-driven approach."

Third Quarter 2025 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib in combination with defactinib) U.S. Launch

· Achieved net product revenue of $11.2 million in the first full quarter of the launch.

· Prescriptions for patients are being received from both academic and community centers, including both repeat prescriptions from physicians prescribing to multiple patients and refills for individual patients.

· There has been broad payer coverage and reimbursement since launch.

Avutometinib and Defactinib Combination in LGSOC

· In the ongoing Phase 3 RAMP 301 confirmatory trial, planned enrollment of the targeted 270 patients was completed a full quarter early.

· A pre-planned Interim Analysis (IA) by an Independent Data Monitoring Committee (IDMC) was conducted for RAMP 301, and the IDMC recommended a modest one-time increase in enrollment. Based on the current total enrollment achieved to date, an additional 29 patients will be added across KRAS mutation status. The Company remains blinded to the IA results.

· Preliminary safety and efficacy data from the Phase 2 RAMP 201J trial in Japan was accepted as an E-Poster (EP228/ #371) at the International Gynecologic Cancer Society (IGCS) 2025 Annual Meeting. In the published abstract, with a data extract date of April 11, 2025, no dose limiting toxicities were observed, and avutometinib and defactinib drug exposure levels were comparable to those observed in the global RAMP-201 study. Additional data, including efficacy (response rates) and updated safety will be available on November 5, 2025, when the embargo lifts.

Key Milestone:

· Expect to complete patient enrollment of the IDMC recommended increase in Q1 2026.

VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Advanced Solid Tumors

· Announced a preliminary update on the Phase 1/2a monotherapy dose escalation trial of VS-7375 in patients with previously treated advanced KRAS G12D mutant solid tumors on Oct. 23, 2025.

o In the study, VS-7375 cleared both the 400 mg daily (QD) and the 600 mg QD monotherapy doses with no dose-limiting toxicities (DLTs) observed. At the two dose levels evaluated in the U.S. cohort, no nausea, vomiting, or diarrhea greater than Grade 1 were reported. In addition, no new safety signals have been observed relative to earlier data presentations in both pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) by our partner, GenFleet Therapeutics, in its ongoing Phase 1/ 2 clinical study in China evaluating VS-7375 (known as GFH375). The Company’s dose escalation study continues with evaluation of the monotherapy 900 mg QD dose level.

o Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction and are still on treatment. The remaining patients receiving either the 400 mg QD or 600 mg QD doses have not yet reached their first response assessment.

· The Company also announced it has initiated patient enrollment for the first dose escalation combination cohort evaluating VS-7375 with cetuximab in patients with advanced solid tumors, including colorectal cancer.

· Announced updated data from partner GenFleet Therapeutics’ Phase 1 /2 study of GFH375 in China that was featured in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 19, 2025.

o Among 59 heavily pre-treated patients with PDAC who received one or more prior lines of therapy, an overall response rate (ORR) of 41% was achieved at the monotherapy recommended Phase 2 dose (RP2D) of 600 mg QD. A disease control rate (DCR) of 96.7% (57/59) was also reported with the majority of patients (91.5%) experiencing a reduction in target lesions.

o Overall survival (OS) observed at month four was 92.2%. The median OS was not reached as of the data cutoff, with a median follow-up time of 5.65 months. The median progression-free survival (mPFS) was 5.52 months with a median follow-up time of 5.65 months and a 4-month PFS rate of 78.2%. At evaluation, 31 (47%) patients were still on treatment with the longest duration of treatment eclipsing one year (367 days). The safety profile in PDAC patients was consistent with the previously reported data at recent medical congresses.

· Announced updated data from GenFleet’s Phase 1 /2 study of GFH375 in China that was featured in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer (WCLC) on September 8, 2025.

o At the RP2D of 600 mg QD, the ORR was 68.8% (11/16) (both confirmed and unconfirmed) and the DCR was 93.8% (15/16). Among the 26 evaluable patients with NSCLC treated across all dose levels, the ORR was 57.7% (15/26) (both confirmed and unconfirmed) and the DCR was 88.5% (23/26).

· GenFleet shared the following additional analyses on Oct. 27, 2025, from previously presented data at recent medical congresses evaluating GFH375 in both advanced KRAS G12D mutant PDAC and NSCLC:

o In a subgroup analysis, 12 patients with 2L PDAC at 600 mg QD achieved an ORR of 58.3% and a DCR of 100%. In the 3L+ setting, 47 PDAC patients receiving 600 mg QD achieved an ORR of 36.2% and a disease control rate (DCR) of 95.7%. In the 2L subgroup, the mPFS and mOS have not been reached. An additional analysis of gastrointestinal disorders, hematological toxicities, and liver enzyme abnormalities in 2L+ patients with PDAC (n=66) at 600 mg QD showed no adverse events Grade ≥3 occured at rates above 8.0%.

o In an analysis of pre-treated patients with NSCLC at 600 mg QD, the four-month PFS rate was >75% and the mPFS has not been reached. The median follow-up time was 4.2 months.

· GenFleet also shared that the first patient has been dosed in a Phase 1b/2 study of GFH375 combined with cetuximab or chemotherapy for advanced solid tumors on October 22, 2025.

Key Milestones:

· Plan to initiate the dose escalation cohorts in combination with chemotherapy for PDAC and with chemotherapy plus anti-PD-1 for NSCLC in Q4 2025.

· Plan to report an interim safety and efficacy update on the Phase 1/2a trial of VS-7375 in 1H 2026.

· Expect to select the RP2D and plan to initiate monotherapy expansion cohorts in advanced PDAC, NSCLC, and other KRAS G12D-mutated solid tumors in 1H 2026.

· Expect to select the RP2D and plan to initiate combination expansion cohorts in CRC, PDAC, and NSCLC in 1H 2026.

· Plan to engage with the FDA to discuss our development path forward​, including potential registration-directed clinical trials in PDAC and NSCLC in 1H 2026.

RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in First-Line Metastatic PDAC

· Completed enrollment in the RAMP 205 expansion cohort in Q3 2025.

Key Milestone:

· Expect to report an update on the safety and efficacy of the RAMP 205 expansion cohort with 29 patients at the RP2D in 1H26.

RAMP 203: Avutometinib Plus Defactinib in Combination with a KRAS G12C Inhibitor in NSCLC

· Patients continue to be evaluated in both the doublet and triplet combination cohorts of the study.

Key Milestone:

· Report an interim update on the safety and efficacy results in RAMP 203 from both the doublet and triplet combinations in Q4 2025.

Third Quarter 2025 Financial Results

Net product revenue for the three months ended September 30, 2025 (the "2025 Quarter") was $11.2 million, compared to $0.0 million for the three months ended September 30, 2024 (the "2024 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the United States following receipt of FDA approval in May 2025.

Total operating expenses for the 2025 Quarter were $52.0 million, compared to $37.0 million for the 2024 Quarter. Cost of sales associated with product revenue was $1.7 million for the 2025 Quarter, compared to $0.0 for the 2024 Quarter.

Research & development expenses for the 2025 Quarter were $29.0 million, compared to $24.8 million for the 2024 Quarter. The increase of $4.2 million, or 16.9%, was primarily related to increased drug substance and drug product costs, increased contract research organization costs, and increased investigator trial costs.

Selling, general & administrative expenses for the 2025 Quarter were $21.0 million, compared to $12.3 million for the 2024 Quarter. The increase of $8.7 million, or 70.7%, was primarily related to commercialization costs required as part of the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC. This was comprised of increased consulting, personnel costs, and professional fees.

Net loss (GAAP basis) for the 2025 Quarter was $98.5 million, or $1.35 per share (basic and diluted), compared to $24.0 million, or $0.60 per share (basic and diluted) for the 2024 Quarter.

For the 2025 Quarter, non-GAAP adjusted net loss was $39.4 million, or $0.54 per share (diluted) compared to non-GAAP adjusted net loss of $35.3 million, or $0.88 per share (diluted), for the 2024 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Verastem Oncology ended the third quarter of 2025 with cash, cash equivalents and investments of $137.7 million. With existing cash, product revenue, and exercise of cash warrants, Company has expected cash runway into the second half of 2026.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 8:00 a.m. ET to review the third quarter 2025 financial results and recent business updates. To access the conference call, please dial ((888) 596-4144 (U.S.) or (646) 968-2525 (international) and enter the passcode 8194537 at least 10 minutes prior to the event start time. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, NOV 4, 2025, View Source [SID1234659377])