On February 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that a clinical data abstract submission by cancer experts at Moffitt Cancer Center to the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting has been accepted. The meeting will be held April 11-15, 2026, in Toronto, Ontario.

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The abstract, titled "What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer," was submitted by a multidisciplinary team of cancer experts, including Dr. Mustafa Al-Roubaie, an Interventional Radiologist at Moffitt Cancer Center and member of RenovoRx’s Medical Advisory Board. The abstract explores the hypothesis, based on a review of metabolic response observations, that local, targeted intra-arterial delivery of chemotherapy using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform may help address the poor vascularity commonly associated with locally advanced pancreatic cancer (LAPC). The abstract data further evaluates the potential role of metabolic imaging (FDG (fluorodeoxyglucose) PET/CT)) in evaluating therapeutic activity following targeted intra-arterial treatment in patients with refractory disease.

"Patients diagnosed with LAPC carry a difficult prognosis, partly due to a dense, hypovascular stroma that limits the efficacy of traditional systemic (intravenous) chemotherapy," said Dr. Al-Roubaie. "Regional intra-arterial therapeutic delivery, which is the core attribute of RenovoRx’s TAMP therapy platform, aims to overcome this barrier by delivering high-concentration chemotherapy directly near the tumor. We are excited to present our findings at the upcoming 2026 SIR Meeting."

Abstract Details:
Presentation Date & Time: Monday, April 13, 2026, from 4:45-5:45 PM ET
Title: What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer
Location: Metro Toronto Convention Centre – Toronto, Canada
Abstract Number: 2229370

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, FEB 26, 2026, View Source [SID1234663105])

On February 26, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes.

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In line with the predefined study oversight plan, the IDMC, composed of independent clinical and statistical experts, conducted a comprehensive assessment of patient safety, trial conduct and key efficacy indicators. Based on this review, the IDMC recommended that the study continue without modifications, confirming the robustness of the trial’s conduct to date.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, commented: "We welcome this new positive assessment from the IDMC. A total of 163 patients had been randomized at the time of the meeting, with 152 included in the analysis reviewed by the IDMC. These figures are fully consistent with our recruitment objectives."

Initiated in 2024, ARTEMIA compares Tedopi monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The trial is enrolling across sites in Europe, the UK, the US and Canada and is designed to generate confirmatory data to support potential regulatory filings.

The next IDMC review is scheduled for October 2026. Study enrollment is expected to conclude by year-end 2026. Tedopi NSCLC Pivotal Phase 3 interim futility analysis is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028.

(Press release, OSE Immunotherapeutics, FEB 26, 2026, View Source [SID1234663104])

On February 26, 2026 Boehringer Ingelheim reported that the U.S. Food and Drug Administration (FDA) approved HERNEXEOS (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1

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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Boehringer is currently enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. (NCT06151574).

Accelerated approval is based on data from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion LUNG-1 trial which demonstrated an objective response rate of 76%, including 11% of patients with a complete response and 65% of patients with a partial response.1 Zongertinib demonstrated a duration of response of ≥6 months in 64% of patients.1 This data builds upon the FDA accelerated approval of HERNEXEOS for previously treated patients in August 2025.

"Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy, a manageable safety profile, and once daily oral administration," said coordinating investigator for the Beamion LUNG-1 trial, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "Now these patients finally have a targeted treatment option that they can receive immediately following identification of a HER2 mutation."

"With HERNEXEOS now approved for patients with HER2-mutant advanced NSCLC as an initial treatment option, we are delivering on our promise to transform care for people with this rare and aggressive cancer," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "This approval marks a shift towards personalized care with a targeted treatment option for patients with HER2 mutated lung cancer. It underscores our relentless focus on accelerating innovation to address a significant unmet need."

HER2 (ERBB2) mutations occur in approximately 2-4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.2,3,4 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.2,4

"We first learned about the HER2 genetic mutation as a lung cancer driver in a small subset of patients more than 20 years ago," said Danielle Hicks, Chief Patient Officer of GO2 for Lung Cancer. "Half of these people do not respond to the current standard of care, which is why it is vital to provide them with a treatment option that has been designed specifically for their disease. Understanding your biomarkers is so important because it can unlock more personalized and effective treatment options."

Zongertinib demonstrated a manageable safety profile as an initial treatment that was consistent with that observed and reported in previously treated patients. Adverse events led to dose discontinuations in 6% of patients.1 In a pooled safety population, which included 292 patients with HER2 (ERBB2)-mutant NSCLC, both treatment-naïve and previously treated, the most common (>20%) adverse reactions were diarrhea (54%), rash (28%), hepatotoxicity (27%), fatigue (25%), nausea (23%), musculoskeletal pain (21%), and upper respiratory tract infection (20%).1

The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner’s National Priority Voucher for zongertinib, underscoring its potential to meet critical patient needs for this rare and aggressive cancer.

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.2 The condition is often diagnosed at a late stage, and fewer than 1 in 10 patients are alive five years after diagnosis.6,7 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,9,10 There remains a high unmet need for additional treatment options for people living with advanced NSCLC.

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.2

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).1,11 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.

Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,4

The treatment is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, FEB 26, 2026, View Source [SID1234663103])

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])