On November 4, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the third quarter ended September 30, 2025.

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"We delivered another outstanding quarter of testing revenue growth and adjusted EBITDA margin expansion, enabling us to raise both our revenue and profitability guidance," said Marc Stapley, Veracyte’s chief executive officer. "We continue to advance our mission of transforming cancer care by generating high-quality evidence and clinical insights that reinforce the value of our tests and our market leadership. The strong momentum we have seen this year, combined with our upcoming TrueMRD and Prosigna LDT launches, gives us confidence in delivering durable, long-term growth from our broad portfolio of tests covering the care continuum in multiple indications."

Key Financial Highlights

For the three-month period ended September 30, 2025, as compared to the same period in 2024:

Increased total revenue by 14% to $131.9 million and testing revenue by 17% to $127.8 million.
Increased total volume by 18% to 45,888 tests and testing volume by 19% to 43,679 tests.
Grew Decipher revenue by 26% to $82.2 million and Afirma revenue by 7% to $43.2 million.
Grew Decipher volume by 26% to approximately 26,700 tests and Afirma volume by 13% to approximately 17,000 tests.
Recorded GAAP net income of $19.1 million, or 15% of revenue, including $6.7 million of loss related to the deconsolidation of the SAS entity.
Delivered adjusted EBITDA of $39.7 million, or 30% of revenue.
Generated $44.8 million of cash from operations to end the quarter with $366.4 million of cash, cash equivalents, and short-term investments as of September 30, 2025.
Raised full year revenue guidance to $506 million to $510 million, including raising testing revenue guidance to $484 million to $487 million or 16% year-over-year growth.
Key Business Highlights

Presented at ASTRO 2025 nine Decipher-focused abstracts, including the first validation data from the BALANCE trial that demonstrated the PAM50 molecular signature predicts hormone therapy benefit in men with recurrent prostate cancer using Decipher GRID.
Announced data published online in Cell from the STAMPEDE trial showing that the Decipher Prostate Genomic Classifier predicts chemotherapy benefit in patients with metastatic prostate cancer in an effort to help patients avoid unnecessary toxicity.
Launched the Afirma v2 transcriptome to improve the efficiency of the Afirma testing business, while providing a platform for future product launches, such as Prosigna LDT.
Supported the presentation of twelve abstracts covering clinical Afirma GSC data and research with Afirma GRID at the 2025 American Thyroid Association Annual Meeting.
Completed NIGHTINGALE clinical utility trial enrollment for the Percepta Nasal Swab test.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Third Quarter 2025 Financial Results

Total revenue for the third quarter of 2025 was $131.9 million, an increase of 14% compared to $115.9 million reported in the third quarter of 2024. Testing revenue was $127.8 million, an increase of 17% compared to $109.5 million in the third quarter of 2024, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.3 million, an increase of 4% compared to $3.2 million in the third quarter of 2024. Biopharmaceutical and other revenue was $0.8 million, a decrease compared to $3.1 million in the third quarter of 2024 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the third quarter of 2025 was 69%, compared to 68% in the third quarter of 2024. Non-GAAP gross margin was 73%, compared to 71% in the third quarter of 2024.

Operating expenses were $68.3 million for the third quarter of 2025. Non-GAAP operating expenses grew 2% to $58.6 million compared to $57.6 million in the third quarter of 2024.

Net income for the third quarter of 2025 was $19.1 million, an improvement of 26% compared to the third quarter of 2024, including a $6.7 million loss from the deconsolidation of the Veracyte SAS entity. Diluted net earnings per common share was $0.24, an improvement of $0.05 compared to the third quarter of 2024. Non-GAAP diluted net earnings per common share was $0.51, an increase of $0.18 compared to the third quarter of 2024. Net cash provided by operating activities in the first nine months of 2025 was $83.7 million, an improvement of $33.2 million compared to the same period in 2024.

Adjusted EBITDA for the third quarter of 2025 was $39.7 million, an improvement of 45% compared to the third quarter of 2024, representing 30.1% of revenue compared to 23.6% of revenue in the same period of 2024.

2025 Financial Outlook

The company is raising full-year 2025 testing revenue guidance to $484 million to $487 million, or 16% year-over-year growth, from prior guidance of $477 million to $483 million. Adjusting for the impact of the paused Envisia test, the guidance implies 17% to 18% year-over-year testing revenue growth. The company is also raising full-year 2025 total revenue guidance to $506 million to $510 million, or 14% year-over-year growth, from prior guidance of $496 million to $504 million.

Additionally, the company is raising guidance for 2025 adjusted EBITDA as a percentage of revenue to over 25% from the 23.5% prior guidance.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA as a percentage of revenue to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering via the following link: View Source

(Press release, Veracyte, NOV 4, 2025, View Source [SID1234659376])

On November 4, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the first presentation of patient-reported outcomes data from the Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1 inhibitor, as well as encore pivotal efficacy and safety data from the ARROS-1 trial, during two poster presentations at the 2025 IASLC ASCO (Free ASCO Whitepaper) North America Conference on Lung Cancer being held December 5-7, 2025 in Chicago.

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Details of the poster presentations are as follows:

Title: Patient-Reported Outcomes and Health-Related Quality of Life of TKI Pre-Treated and TKI-naïve Patients with Advanced ROS1-Positive NSCLC Treated with Zidesamtinib: Examination of ARROS-1 Phase 2 Trial Data
Abstract Number: PP01.41
Presenting Author: Melissa Laurie, Pharm.D., M.S., M.B.A.1
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

Title: Zidesamtinib in Patients With Advanced Metastatic ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Tyrosine Kinase Inhibitors (TKI): Pivotal Efficacy and Safety Data From the Phase 1/2 ARROS-1 Trial
Abstract Number: PP01.32
Presenting Author: Stephen V. Liu, M.D.2
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

1 Nuvalent, Inc., Cambridge, MA, USA; 2Georgetown University, Washington, DC, USA

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC. Nuvalent completed its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC in the third quarter of 2025 and continues to engage with the U.S. Food and Drug Administration (FDA) on potential opportunities for line-agnostic expansion.

(Press release, Nuvalent, NOV 4, 2025, View Source [SID1234659394])

On November 4, 2025 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported third quarter 2025 financial results and provided updates across the company’s hematology and genetic disease franchises.

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"As we near the end of 2025, we see broad-based momentum across our growing portfolio of clinical-stage hematology and liver-targeted genetic disease base editing programs," said John Evans, chief executive officer at Beam. "Our alpha-1 antitrypsin deficiency program, the first clinical program to directly correct a disease-causing mutation in vivo, remains a top priority, and we’re pleased with the continued enrollment and dosing progress in the BEAM-302 Phase 1/2 trial. We look forward to providing a broad update on the program in early 2026 with new clinical data and next steps to advance BEAM-302 to patients. In sickle cell disease, we look forward to sharing updated data from the BEACON trial of BEAM-101 at the ASH (Free ASH Whitepaper) meeting in December, where we aim to continue to demonstrate a differentiated manufacturing and clinical profile in these patients with recurrent severe VOCs. We have also initiated dosing of the BEAM-103 antibody from our ESCAPE platform, which we believe can play an important role in next wave therapies for sickle cell disease."

Mr. Evans continued, "In addition, we are thrilled for the Orbital Therapeutics team following its proposed acquisition by Bristol Myers Squibb, indicating the significant potential of Orbital’s platform and pipeline. Beam contributed capabilities and technology in mRNA and targeted lipid nanoparticles to Orbital, and this outcome further validates our innovative platform strategy to unlock additional shareholder value in non-core areas and accelerate the creation of new medicines for patients."

Third Quarter 2025 and Recent Progress

•
Updated data from the BEACON Phase 1/2 clinical trial of BEAM-101 in patients with sickle cell disease (SCD) were accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, 2025, in Orlando, Fla.
•
The first subject was dosed in a Phase 1 healthy volunteer clinical trial of BEAM-103, an anti-CD117 monoclonal antibody (mAb) developed as part of the company’s ESCAPE (Engineered Stem Cell Antibody Evasion) platform. ESCAPE represents a potential alternative to genotoxic conditioning regimens in stem cell transplantation, potentially avoiding toxicity challenges associated with currently available conditioning regimens for patients with SCD and beta-thalassemia.
•
In the Phase 1/2 study of BEAM-302 in alpha-1 antitrypsin deficiency (AATD), dosing has commenced in the multi-dose cohort evaluating two 60 mg doses administered eight weeks apart in Part A of the trial, designed to evaluate AATD patients with lung disease. In addition, the first patient was dosed in the first cohort in Part B of the trial, designed to evaluate AATD patients with mild to moderate liver disease with or without lung disease.

•
In August, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101 for the treatment of SCD. The designation is designed to support the development and evaluation of regenerative medicines, with the intention of addressing serious or life-threatening diseases that have unmet medical needs.
•
In October, Bristol Myers Squibb announced a definitive agreement under which they will acquire Beam collaborator Orbital Therapeutics for $1.5 billion in cash. As of the announcement, Beam held 75 million shares of Orbital common stock, which represented a fully diluted ownership stake of approximately 17%.1
Key Anticipated Milestones

Liver-targeted Genetic Disease Franchise

•
Beam expects to report data from the dose-escalation portions of Part A and Part B of the BEAM-302 Phase 1/2 trial and provide a clinical development update in early 2026.
•
Beam plans to continue dosing in the Phase 1/2 clinical trial of BEAM-301 in glycogen storage disease Ia (GSDIa).
Hematology Franchise

•
Beam plans to present updated data from the BEACON Phase 1/2 trial at the ASH (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, 2025.
Third Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of September 30, 2025, compared to $850.7 million as of December 31, 2024.
•
Research & Development (R&D) Expenses: R&D expenses were $109.8 million for the third quarter of 20252, compared to $94.3 million for the third quarter of 2024.
•
General & Administrative (G&A) Expenses: G&A expenses were $26.7 million for the third quarter of 2025, compared to $26.5 million for the third quarter of 2024.
•
Net Income (Loss): Net loss was $112.7 million, or $1.10 per share, for the third quarter of 2025, compared to $96.7 million, or $1.17 per share, for the third quarter of 2024.
Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of September 30, 2025, will enable the company to fund its anticipated operating expenses and capital expenditure requirements into 2028. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, ESCAPE, BEAM-301 and BEAM-302 described above.

(Press release, Beam Therapeutics, NOV 4, 2025, View Source [SID1234659345])

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 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.

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"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])