On February 26, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the fourth quarter and year ended Dec. 31, 2025.

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"We closed out an outstanding year with a strong fourth quarter, reflecting the strength of our innovative test portfolio, disciplined execution and the dedication of the entire Castle team who continue to deliver meaningful impact for patients and clinicians every day," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We exited 2025 with clear leadership across our core dermatologic and gastrointestinal franchises, highlighted by continued momentum in TissueCypher, which achieved 86% test report growth over 2024.

"In 2025, we also delivered an important milestone with the limited access launch of AdvanceAD-Tx, which materially expanded our total addressable market and reinforced our commitment to providing clinical answers to dermatology clinicians and their patients. As we look ahead to 2026 and beyond, we believe we are well positioned to continue delivering stockholder value and capitalize on our near- and long-term opportunities, supported by continued test adoption growth for our core tests, a robust pipeline and a strong balance sheet."

Twelve Months Ended Dec. 31, 2025, Financial and Operational Highlights

Revenues were $344.2 million, compared to $332.1 million in 2024, growth of 4% over 2024. Excluding DecisionDx-SCC and IDgenetix revenue, growth of 34% over 2024. Affecting year ended Dec. 31, 2025, revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
Revenues for our non-dermatologic tests were $127.9 million, compared to $75.1 million in 2024.
Core revenue drivers:

2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 37% over 2024:
DecisionDx-Melanoma test reports delivered in 2025 were 39,083, compared to 36,008 in 2024.
TissueCypher Barrett’s Esophagus test reports delivered in 2025 were 39,014, compared to 20,956 in 2024.
Additional tests:

DecisionDx-SCC test reports delivered in 2025 were 17,294, compared to 16,348 in 2024. Affecting twelve-month test report volume was the change in Medicare coverage effective April 24, 2025, and the re-focus of our commercial efforts.
MyPath Melanoma test reports delivered in 2025 were 4,288, compared to 3,909 in 2024.
DecisionDx-UM test reports delivered in 2025 were 1,769, compared to 1,699 in 2024.
Discontinued tests:

IDgenetix test reports delivered in 2025 were 3,605, compared to 17,151 in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
Gross margin for 2025 was 69%, and Adjusted Gross Margin was 80%, compared to 79% and 82%, respectively, for the same periods in 2024. Affecting 2025 gross margin was the loss of revenues from DecisionDx-SCC and the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million during the three months ended March 31, 2025.
Net cash provided by operations was $64.3 million, compared to $64.9 million in 2024.
Net loss for 2025, which includes non-cash stock-based compensation expense of $45.9 million, was $24.2 million, compared to net income of $18.2 million in 2024.
Net loss per share, Basic and Diluted, was $0.83 and Adjusted Net Loss per Share, Basic and Diluted, was $0.14, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.66 and $0.62, respectively, for 2024.
Adjusted EBITDA for 2025 was $44.0 million, compared to $75.0 million in 2024.
Cash, Cash Equivalents and Marketable Investment Securities

As of Dec. 31, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $299.5 million.

Fourth Quarter Ended Dec. 31, 2025, Financial and Operational Highlights

Revenues were $87.0 million, compared to $86.3 million during the same period in 2024, growth of 1% over the fourth quarter of 2024. Excluding DecisionDx-SCC and IDgenetix, revenue growth was 43% over the fourth quarter of 2024. Affecting fourth quarter 2025 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
Revenues for our non-dermatologic tests were $38.4 million, compared to $22.5 million during the same period in 2024.
Core revenue drivers:

Fourth quarter 2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 42% over the fourth quarter of 2024:
DecisionDx-Melanoma test reports delivered in the quarter were 10,022, compared to 8,672 in the fourth quarter of 2024.
TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 11,803, compared to 6,672 in the fourth quarter of 2024.
Additional tests:

DecisionDx-SCC test reports delivered in the quarter were 3,971, compared to 4,299 in the fourth quarter of 2024. Affecting fourth quarter test report volume was the change in Medicare coverage effective April 24, 2025, and the re-focus of our commercial efforts.
MyPath Melanoma test reports delivered in the quarter were 1,045, compared to 879 in the fourth quarter of 2024.
DecisionDx-UM test reports delivered in the quarter were 395, compared to 424 in the fourth quarter of 2024.
Gross margin was 76%, and Adjusted Gross Margin was 78%, compared to 76% and 81%, respectively, for the same periods in 2024.
Net cash provided by operations was $26.9 million, compared to $24.4 million for the same period in 2024.
Net loss, which includes non-cash stock-based compensation expense of $11.4 million, was $2.3 million, compared to net income of $9.6 million for the same period in 2024.
Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.08, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.34 and $0.32, respectively, for the same period in 2024.
Adjusted EBITDA was $11.5 million, compared to $21.3 million for the same period in 2024.
2026 Outlook

The Company anticipates generating between $340-350 million in total revenue in 2026.

Fourth Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer

The Company announced the publication of an independent expert consensus paper titled "31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel," which endorsed the Company’s DecisionDx-Melanoma test. Authored by a panel of ten melanoma experts from leading academic and clinical institutions, the paper presented evidence-based recommendations supporting DecisionDx-Melanoma as a best-practice tool for guiding management decisions in patients with cutaneous melanoma (CM). The panel concluded that the test provides prognostic information independent of traditional clinicopathologic factors and can be integrated with existing staging systems to improve patient risk assessment and help optimize clinical decision-making. Drawing on a comprehensive review of 26 published studies encompassing more than 7,500 patients, the panel used a modified Delphi process to reach unanimous agreement on nine consensus statements defining the test’s role in risk stratification, sentinel lymph node biopsy (SLNB) decision making and long-term patient management. See the Company’s news release from Dec. 9, 2025, for more information.
The Company also announced new data demonstrating the clinical value of its DecisionDx-Melanoma test in improving SLNB decision making and enhancing recurrence risk prediction in patients with CM. The data was featured in two oral presentations at the 2nd European Congress on Dermato-Oncology. By combining the biologic information of a patient’s tumor with traditional staging, DecisionDx-Melanoma is designed to enhance five-year prognostic accuracy in SLN-negative patients and potentially provide additional clarity for identifying those at higher risk of recurrence. These findings support the test’s potential to help clinicians make more risk-aligned therapeutic decisions and tailor follow-up care according to a patient’s individual risk. See the Company’s news release from Nov. 14, 2025, for more information.
Gastroenterology

The Company announced the publication of a new systematic review and meta-analysis (SRMA) demonstrating that the TissueCypher Barrett’s Esophagus test provides clinically validated risk stratification for patients with Barrett’s esophagus (BE). The findings confirm that TissueCypher can outperform traditional pathology or clinical factors alone to identify patients at increased risk of developing esophageal cancer. The paper, titled "The Tissue Systems Pathology Test Predicts Risk of Progression in Patients With Barrett’s Esophagus: Systematic Review and Meta-Analysis," was published in the Journal of Clinical Gastroenterology. The analysis consolidated data from six previously published studies and found that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC), a key step toward enabling personalized, risk-aligned patient management aimed at preventing cancer. See the Company’s news release from Dec. 12, 2025, for more information.
Dermatology – Atopic Dermatitis

The Company announced the limited access launch of AdvanceAD-Tx, a 487-gene expression profile test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis, following a presentation of the prospective, multicenter development and validation study at the 25th Annual Fall Clinical Dermatology Conference (news release), which was recently published in the Journal of the American Academy of Dermatology (JAAD) (news release). AdvanceAD-Tx is designed to identify patients with a Janus kinase inhibitor (JAKi) responder profile who are more likely to achieve an Eczema Area and Severity Index improvement of 90% (EASI-90), more quickly and with reduced flares and itch by three months, when treated with a JAKi compared to a T helper type 2 (Th2)-targeted therapy. See the Company’s news release from Nov. 11, 2025, for more information.
Uveal Melanoma

The Company announced new data from the largest prospective, multicenter study to date comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and Preferentially Expressed Antigen in Melanoma (PRAME) gene expression for predicting outcomes in patients with uveal melanoma (UM). The study, titled "Early Genetic Evolution of Driver Mutations in Uveal Melanoma," was conducted by the Collaborative Ocular Oncology Group (COOG) and recently published in Nature Communications. See the Company’s news release from Dec. 17, 2025, for more information.
Corporate

The Company announced that it was recognized by the Houston Chronicle as a Houston Top Workplace, which celebrates people-focused, standout workplace cultures. This marked the fifth consecutive year the Company had been ranked among the Houston metro area’s esteemed workplaces. Castle also earned three Culture Excellence awards in the areas of Employee Appreciation, Employee Well-Being and Professional Development. See the Company’s news release from Nov. 17, 2025, for more information.
Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Thursday, Feb. 26, 2026, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2025 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 19, 2026.

To access the live conference call via phone, please dial 833-470-1428 from the United States, or global dial-in numbers are available here: View Source, at least 10 minutes prior to the start of the call, using the conference ID 695618.

(Press release, Castle Biosciences, FEB 26, 2026, View Source [SID1234663102])

On February 26, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported fourth quarter and full year 2025 financial results and 2026 guidance.

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"Our focus on disciplined execution to date has strengthened the foundation of Relay, aligning our organization to support long-term success. In 2026, Relay is entering a pivotal period defined by multiple upcoming clinical milestones across our zovegalisib program, which recently received Breakthrough Therapy designation from the FDA," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "We anticipate presenting Phase 1/2 breast cancer data at the upcoming ESMO (Free ESMO Whitepaper) TAT Congress, reporting initial data in PIK3CA-driven vascular anomalies, and providing updates on our breast cancer triplet data and frontline Phase 3 development plans. These milestones position us to deliver meaningful updates in areas with significant unmet need for patients, while continuing to build momentum toward potential commercialization."

Anticipated 2026 Milestones

Breast Cancer
Abstract accepted to European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2026 for initial data from the Phase 1/2 ReDiscover trial of zovegalisib (RLY-2608) + fulvestrant at the Phase 3 dose
The abstract is focused on 57 patients treated at the recommended Phase 3 dose of 400mg twice daily (BID) fed that have HR+/HER2-, PI3Kα-mutated metastatic breast cancer and have previously been treated with a CDK4/6 inhibitor
Oral Proffered Paper Session: Dose optimization of zovegalisib, a novel PI3Kα inhibitor, in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer: results from the first-in-human study to support the recommended Phase 3 dose
Location/Date/Time: Paris, France; Monday, March 16, 2026; 4:00 p.m. CET/11:00 a.m. ET
Triplet clinical data and frontline Phase 3 study design plan anticipated in 2026
Vascular Anomalies
Initial clinical data disclosure from the Phase 1 ReInspire trial in PIK3CA-driven vascular anomalies planned for 1H 2026
The pediatric cohort in the trial recently opened ahead of schedule due to faster than expected enrollment and the company anticipates reporting on approximately 20 patients at time of disclosure
Zovegalisib 2025 Highlights

Breast Cancer
Continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
Presented data from Phase 1/2 ReDiscover trial of zovegalisib + fulvestrant at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting and the 2025 San Antonio Breast Cancer Symposium (SABCS). SABCS summary with a data cut-off date of October 15, 2025:
The median progression free survival (PFS) was 10.3 months for all patients (n=52).
Among the total of 31 patients with measurable disease, objective response rate (ORR) was 39%. For second line (2L) patients, median PFS was 11.4 months and ORR was 47%. Median follow-up was 20.2 months.
Efficacy was generally consistent across other subsets of patients. For patients who received prior SERD, median PFS was 11.4 months and ORR was 44% (7/16), and for patients who had a detectable ESR1 mutation at baseline, median PFS was 8.8 months and ORR was 60% (6/10).
The overall tolerability profile remained consistent with mutant-selective PI3Kα inhibition, with treatment-related adverse events that were mostly low-grade, manageable and reversible.
Triplet cohorts of zovegalisib in combination with atirmociclib, ribociclib, or palbociclib are ongoing to inform frontline Phase 3 preferred regimen and plans
Vascular Anomalies
Continued execution of Phase 1 ReInspire trial of zovegalisib in PIK3CA-driven vascular anomalies
Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2025, cash, cash equivalents, and investments totaled $554.5 million compared to approximately $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

Revenue: Revenue was $7.0 million for the fourth quarter of 2025, as compared to $0 for the fourth quarter of 2024. Revenue was $15.4 million for the full year 2025, as compared to $10.0 million for the full year 2024. The revenue recognized in the current year periods was under our Exclusive License Agreement with Elevar Therapeutics, Inc. The revenue recognized in the prior year periods was under our Collaboration and License Agreement with Genentech, Inc.

R&D Expenses: Research and development expenses were $55.4 million for the fourth quarter of 2025, as compared to $68.1 million for the fourth quarter of 2024. Research and development expenses were $261.4 million for the full year 2025, as compared to $319.1 million for the full year 2024. The decreases were primarily due to the series of strategic choices to streamline the research organization throughout 2024 and 2025, as well as decreases in costs incurred on continued development of lirafugratinib after execution of the Exclusive License Agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs related to the ReDiscover-2 trial and ReInspire trial.

G&A Expenses: General and administrative expenses were $12.2 million for the fourth quarter of 2025, as compared to $16.9 million for the fourth quarter of 2024. General and administrative expenses were $56.7 million for the full year 2025, as compared to $76.6 million for the full year 2024. The decreases were primarily due to decreases in stock compensation expense and other employee costs.

Net Loss: Net loss was $54.9 million for the fourth quarter of 2025, or a net loss per share of $0.32, as compared to a net loss of $76.0 million for the fourth quarter of 2024, or a net loss per share of $0.45. Net loss was $276.5 million for the full year 2025, or a net loss per share of $1.61, as compared to a net loss of $337.7 million for the full year 2024, or a net loss per share of $2.36.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies.

(Press release, Relay Therapeutics, FEB 26, 2026, View Source [SID1234663101])

On February 26, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported the first patient dosed with A2B543, initiating the second arm of the Phase 1/2 EVEREST-2 study (NCT06051695).

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A2B543 is an autologous CAR T cell therapy that builds upon A2 Bio’s proprietary Tmod platform. A2B543 adds an inducible, membrane-tethered IL-12 booster, augmenting the platform’s core ability to selectively kill tumor cells while protecting normal tissue. Designed to activate only when the Tmod cell engages a tumor antigen, the booster aims to enhance the potency and persistence of Tmod cells within the immunosuppressive solid tumor microenvironment while avoiding systemic toxicity.

"Dosing the first patient with A2B543 is a significant step forward in the evolution of the Tmod platform," said John Welch, M.D., Ph.D., chief medical officer of A2 Bio. "While systemic IL-12 induces a potent antitumor immune response, its use has been limited by severe toxicity. With A2B543, we are arming our Tmod cells with a membrane-tethered, inducible IL-12 component. This design allows us to localize the impact of IL-12 to the tumor microenvironment, boosting the persistence and potency of Tmod without the systemic side effects."

Enabling Efficient Patient Identification for A2 Bio Precision Medicine Studies

The A2 Bio clinical programs include A2B543, A2B694, A2B395, and the BASECAMP-1 prescreening study, as well as several preclinical programs exploring additional pipeline expansion opportunities using the proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and other grievous diseases.

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the patients may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1,2

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2B543

A2B543 is designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. A2B543 is comprised of autologous Tmod cells transduced with two lentiviral vectors: one expressing both the HLA-A*02-targeted blocker and the MSLN-targeted CAR activator; and a second expressing an inducible, membrane-tethered IL-12 (mem-IL-12) booster. The inducible mem-IL-12 booster, which activates only upon engagement with tumor antigens, is designed to reduce toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of Tmod.

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is recruiting patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

Invented at A2 Bio, the TmodTM platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

(Press release, A2 Biotherapeutics, FEB 26, 2026, View Source [SID1234663100])

On February 26, 2026 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada). STK-012, a first-in-class α/β-IL-2 receptor biased partial agonist, will be evaluated in combination with standard of care chemotherapy and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed cell death receptor-1) therapy, in the ongoing SYNERGY-101 randomized Phase 2 study in first-line, PD-L1 negative nonsquamous (NSQ) non-small cell lung cancer (NSCLC).

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"In our Phase 1b study, STK-012 in combination with pembrolizumab and chemotherapy has shown promising efficacy in first-line PD-L1 negative NSQ NSCLC patients, with a 50% response rate in this population presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025," said Debanjan Ray, Chief Executive Officer of Synthekine. "We are excited to collaborate with Merck on our randomized Phase 2 study to further demonstrate the potential of this combination to deliver improved clinical outcomes for these patients, who receive limited benefit from current standard of care therapies."

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity.

Under the terms of the agreement, Merck will provide its anti-PD-1 therapy, Keytruda, to be used in combination with STK-012 and standard of care chemotherapy in the SYNERGY-101 trial. SYNERGY-101 is a global, randomized Phase 2 study that has already begun enrollment, with the first patient dosed in November 2025. This study will investigate the safety and efficacy of STK-012 in combination with standard dose pembrolizumab and chemotherapy vs. the safety and efficacy of standard dose pembrolizumab and chemotherapy in patients with first-line, PD-L1 negative NSQ NSCLC. Synthekine and Merck will each retain all commercial rights to their respective compounds for use as monotherapies or in combination regimens.

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

(Press release, Synthekine, FEB 26, 2026, View Source [SID1234663099])

On February 26, 2026 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"In 2025, a record number of patients received treatment with Novocure’s Tumor Treating Fields therapy, a milestone that reflects our growth and commitment to advancing the treatment of cancer with our technology," said Frank Leonard, CEO, Novocure. "This momentum continues in 2026 with the U.S. FDA approval of Optune Pax for pancreatic cancer, an achievement we are incredibly proud of given the exceptional challenge of developing treatment for this disease. We are well-positioned to continue to drive our patient-forward mission while prioritizing our goal of achieving profitability."

Financial updates for the year and fourth quarter ended December 31, 2025:

Total net revenues for the year were $655.4 million, an increase of 8% year-over-year.
Total net revenues for the fourth quarter were $174.4 million, an increase of 8% year-over-year, primarily driven by an increase in active patients on therapy.
The U.S., Germany, France and Japan contributed $101.6 million, $21.3 million, $20.3 million and $10.2 million in quarterly net revenues, respectively, with our other active markets contributing $16.3 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the fourth quarter was $3.5 million, including $2.4 million from non-small cell lung cancer (NSCLC) and $1.1 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 76%, compared to 79% in the same period in 2024. The reduction was primarily driven by the continued roll out of our Head Flexible Electrode (HFE) array for use with Optune Gio, costs associated with treating NSCLC patients prior to establishing reimbursement and increased tariffs.
Research, development and clinical studies expenses for the quarter were $60.9 million, an increase of 19% from the same period in 2024, primarily driven by higher clinical trial costs associated with the KEYNOTE D58 and LUNAR-2 trials, as well as higher regulatory affairs expenses.
Sales and marketing expenses for the quarter were $68.7 million, an increase of 2% from the same period in 2024, primarily driven by higher marketing expenses in preparation for the U.S. launch of Optune Pax.
General and administrative expenses for the quarter were $43.0 million, a decrease of 41% from the same period in 2024. This was primarily driven by a decrease in share-based compensation expenses.
Net loss for the quarter was $24.5 million with loss per share of $0.22.
Adjusted EBITDA* for the quarter was $(16.4) million.
Cash, cash equivalents and short-term investments were $447.7 million as of December 31, 2025.
Operational updates for the year and fourth quarter ended December 31, 2025:

As of December 31, 2025, there were 4,620 total active patients on TTFields therapy globally.
Optune Gio
1,609 Optune Gio prescriptions for the treatment of glioblastoma (GBM) were received in the quarter, an increase of 6% from the same period in 2024. The U.S., Germany, France and Japan contributed 950; 178; 197 and 139 prescriptions, respectively, with the remaining 145 prescriptions contributed by other active markets.
As of December 31, 2025, there were 4,464 active Optune Gio patients on therapy. The U.S., Germany, France and Japan contributed 2,251; 623; 509 and 542 Optune Gio active patients, respectively, with the remaining 539 active patients contributed by other active markets.
Optune Lua
145 total prescriptions for Optune Lua were received in the quarter.
118 Optune Lua prescriptions were received for the treatment of NSCLC. The U.S., Germany and France contributed 87; 29 and 1 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
27 Optune Lua prescriptions were received for the treatment of MPM. The U.S. and Germany contributed 10 and 16 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
As of December 31, 2025, there were 122 active Optune Lua patients on therapy for the treatment of NSCLC. The U.S. and Germany contributed 102 and 19 active patients, respectively, with the remaining 1 active patient contributed by other active markets.
As of December 31, 2025, there were 34 active Optune Lua patients on therapy for the treatment of MPM. The U.S. and Germany contributed 8 and 24 active patients, respectively, with the remaining 2 active patients contributed by other active markets.
In its Q1 2026 financial reporting, Novocure intends to stop reporting new prescriptions received in indications which have been commercially available for more than one year (GBM, MPM and NSCLC). Prescriptions received for the treatment of pancreatic cancer will be provided for a one-year period following launch. Novocure will continue to report active patients on therapy separated by product (Optune Gio, Optune Lua, Optune Pax) and material market.
Fourth quarter and recent updates:

December 2025
Novocure announced the appointment of Frank Leonard as Chief Executive Officer. Mr. Leonard previously served as Novocure’s President.
Novocure submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for TTFields therapy use for the treatment of brain metastases from NSCLC.
January 2026
Public health insurers in Czechia announced coverage for Optune Gio for the treatment of adult patients with newly diagnosed GBM.
February 2026
The U.S. FDA approved Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.
British Columbia (BC) Cancer announced coverage for Optune Gio for adult patients with newly diagnosed GBM.
Chief Medical Officer Nicolas Leupin, M.D., Ph.D., resigned effective February 25, 2026. Chief Innovation Officer Uri Weinberg, M.D., Ph.D. will lead the organization that reported to Dr. Leupin.
In January 2026, Novocure’s billing privileges for its products with the U.S. Centers for Medicare & Medicaid Services (CMS) were revoked retroactive to December 17, 2025 due to an administrative process issue identified during Novocure’s DME supplier re-validation. On February 24, 2026, Novocure received notification from CMS rescinding the revocation of billing privileges and reinstating Novocure’s billing privileges retroactively to December 17, 2025. Novocure does not believe there will be any impact to its ability to recognize revenue for services provided during the period of ineligibility.
William Vernon stepped down as Lead Independent Director and Chairperson of Novocure’s Compensation Committee, effective February 25, 2026. Martin Madden, current member of the board, assumed the roles of Lead Independent Director and Chairperson of the Compensation Committee. Mr. Vernon continues to serve as a director of Novocure’s board.

(Press release, NovoCure, FEB 26, 2026, View Source [SID1234663098])