On February 19, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported new translational and clinical biomarker data from its Phase 1b C-800-01 trial (NCT03860272) evaluating botensilimab (BOT), an Fc-enhanced anti–CTLA-4 antibody, in combination with balstilimab (BAL), an anti–PD-1 antibody. The data were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) Conference in Los Angeles.

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The retrospective analyses demonstrate that survival with BOT+BAL is associated with the balance of two opposing biological factors: systemic inflammation in the blood (associated with poorer outcomes) and tumor immune activity within the tumor microenvironment (TME) (associated with more favorable outcomes). Notably, BOT+BAL enabled clinical benefit even at levels of immune infiltration typically considered insufficient for conventional checkpoint inhibitors, suggesting the Fc-enhanced mechanism lowers the threshold of baseline immunity required for activity. Integrating blood-based inflammatory markers with tumor immune features improved overall survival stratification in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to conventional checkpoint inhibitors.

Traditional biomarkers such as PD-L1 expression and tumor mutational burden have shown limited predictive value in MSS mCRC. These findings suggest that a broader view of inflammatory and immune biology may better define patients most likely to benefit from next-generation immunotherapy.

Durable Clinical Activity Across Historically "Cold" Tumor Types

In 341 efficacy-evaluable patients with advanced, treatment-refractory cancers and available biomarker data (data cutoff December 13, 2025):

Objective response rate (ORR): 17%
Clinical benefit rate (CBR): 26%
Median overall survival (OS): 17.2 months
24-month overall survival rate: 38%
Clinical activity was observed across tumor types commonly considered immunologically "cold," including MSS mCRC, ovarian cancer, sarcoma, and PD-1 relapsed or refractory non-small cell lung cancer. Notably, durable benefit was observed in patients both naïve to and resistant/refractory to prior anti–PD-(L)1/CTLA-4 therapies.

To better understand the biological drivers of these outcomes, integrated translational analyses evaluated both systemic inflammation and tumor microenvironment immune features.

Biomarker Insights Identify Patient Subgroups in Immunologically "Cold" Cancers

Systemic Inflammation Negatively Impacts Survival
Baseline indicators of systemic inflammation were significantly associated with shorter OS, including elevated neutrophil-to-lymphocyte ratio, C-reactive protein and other markers reflective of inflammatory and organ stress.

Even Low Immune-Infiltration of TME Associated with Longer Survival
Survival benefit was observed across immunologically "cold" tumors, including at low levels of tumor-infiltrating lymphocytes (≥34 cells/mm²), demonstrating activity beyond conventional checkpoint biomarker thresholds.

Integrated Blood and Tumor Biomarkers Improve Survival Stratification in MSS mCRC
Combining blood and tumor features distinguished biologically distinct MSS mCRC subgroups with markedly different survival outcomes (C-index up to 0.73).

Early Immune Activation Correlates with Benefit
Patients who experienced immune-mediated adverse events (imAEs) within the first 12 weeks of treatment demonstrated longer median OS (22.4 months vs. 13.7 months), consistent with distinct baseline immune features.
"These data show that outcomes with BOT+BAL are shaped by the interplay between systemic inflammation and tumor immune biology," said Dhan Chand, PhD, Vice President of Research and Development at Agenus. "By integrating blood- and tumor-based features, we are establishing a biologically grounded approach to patient stratification in immunologically ‘cold’ cancers such as MSS colorectal cancer, where conventional biomarkers provide limited guidance. Notably, the activity observed at low levels of immune infiltration further underscores the differentiated immune-modulating profile of botensilimab."

The poster (No. B036), titled "Systemic and Tumor-Microenvironment Inflammation Shape Outcomes in Patients with Immunologically Cold, Treatment-Refractory Tumors Treated with Fc-Enhanced Anti–CTLA-4 Botensilimab," was presented during the General Poster Session and is available in the Publications section of the Company’s website at www.agenusbio.com/publications

(Press release, Agenus, FEB 19, 2026, View Source [SID1234662797])

On February 19, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter and full year ended December 31, 2025.

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Fourth Quarter 2025 Financial Highlights
For the three-month period ended December 31, 2025, as compared to the same period of 2024:
•Reported total revenue of $281.3 million, an increase of 39%, driven by:
◦Oncology revenue of $189.9 million, an increase of 30%, and approximately 79,000 oncology tests, an increase of 38%
◦Biopharma & Data revenue of $54.0 million, an increase of 9%
◦Screening revenue of $35.1 million, and approximately 38,000 Shield screening tests, compared to 6,400 tests in the prior year period
•Generated non-GAAP gross margin of 66%, compared to 63% for the fourth quarter of 2024
Full Year 2025 Financial Highlights
For the twelve months ended December 31, 2025, as compared to the same period of 2024:
•Reported total revenue of $982.0 million, an increase of 33%, driven by:
◦Oncology revenue of $683.6 million, an increase of 26%, and approximately 276,000 oncology tests, an increase of 34%
◦Biopharma & Data revenue of $210.1 million, an increase of 18%
◦Screening revenue of $79.7 million, and approximately 87,000 Shield screening tests
•Generated non-GAAP gross margin of 66%, compared to 62% for the full year 2024
•Improved full year 2025 free cash flow burn to $(233) million, compared to $(275) million for the full year 2024
Recent Operating Highlights
Oncology
•Received the first Guardant360 CDx companion diagnostic approval in colorectal cancer
•Launched in-house testing service in Italy at Policlinico Gemelli based on Guardant360 CDx technology
•Expanded tissue-free Guardant Reveal to include late-stage therapy response monitoring
•Submitted Guardant Reveal chemotherapy monitoring data package to MolDx for Medicare reimbursement
Biopharma & Data
•Established a strategic collaboration with Merck to develop companion diagnostics and commercialize new cancer therapies using Guardant Infinity Smart Platform
Screening
•Launched dedicated health systems team for Shield and deployed our first enterprise integrations with large health systems in West Virginia and Georgia
•Shield CRC received coverage for active-duty service members and their families through TRICARE, the U.S. military’s health insurance coverage, with no copay for average-risk individuals ages 45+
•Completed the acquisition of MetaSight Diagnostics, expanding technology capabilities with potential to enhance testing performance across the portfolio
"We delivered an outstanding end to a great year, with fourth quarter revenue growth of 39% year-over-year," said Helmy Eltoukhy, co-founder and co-CEO. "Our progress in 2025 is a testament to our breakthrough innovation and best-in-class execution across our portfolio. We are uniquely positioned with scaled offerings spanning both therapy selection and monitoring, and the recent launch of Reveal for therapy response monitoring further strengthens our competitive moat. We look forward to another strong year ahead, supported by a diverse set of growth catalysts across our business."

"Shield has become one of the most successful diagnostic launches, with meaningful volume and revenue generation in 2025 that exceeded our expectations," said AmirAli Talasaz, co-founder and co-CEO. "We are proud of the level of impact we have had to date, our commercial performance, and the strong operational foundations we’ve built to support the growing demand for Shield. We are excited to deliver another year of significant growth in 2026, fueled by our expanding commercial infrastructure and a pipeline of growth drivers in front of us."
Fourth Quarter 2025 Financial Results
Revenue was $281.3 million for the fourth quarter of 2025, a 39% increase from $201.8 million for the corresponding prior year period. Oncology revenue grew 30% to $189.9 million for the fourth quarter of 2025, from $145.6 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume, which grew 38% over the prior year period. Screening revenue was $35.1 million for the fourth quarter of 2025, primarily generated from approximately 38,000 Shield screening tests. Biopharma and Data revenue grew 9% to $54.0 million for the fourth quarter of 2025, from $49.5 million for the corresponding prior year period. Licensing and other revenue was $2.2 million for the fourth quarter of 2025, compared to $2.6 million for the corresponding prior year period.
Gross profit, or total revenue less cost of revenue, was $181.8 million for the fourth quarter of 2025, an increase of $57.6 million from $124.2 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 62% for the corresponding prior year period.
Non-GAAP gross profit was $185.4 million for the fourth quarter of 2025, an increase of $59.1 million or 47%, from $126.4 million for the corresponding prior year period. Non-GAAP gross margin was 66% for the fourth quarter of 2025, as compared to 63% for the corresponding prior year period.
Operating expenses were $302.6 million for the fourth quarter of 2025, as compared to $250.2 million for the corresponding prior year period. Non-GAAP operating expenses were $260.0 million for the fourth quarter of 2025, as compared to $214.7 million for the corresponding prior year period. The year-over-year increase in both operating expenses and non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support both the Shield product launch and existing product growth.
Net loss was $128.5 million for the fourth quarter of 2025, as compared to $111.0 million for the corresponding prior year period. Net loss per share was $1.00 for the fourth quarter of 2025, as compared to $0.90 for the corresponding prior year period.
Non-GAAP net loss was $63.8 million for the fourth quarter of 2025, as compared to $77.3 million for the corresponding prior year period. Non-GAAP net loss per share was $0.50 for the fourth quarter of 2025, as compared to $0.62 for the corresponding prior year period.
Adjusted EBITDA loss was $64.9 million for the fourth quarter of 2025, as compared to a $78.4 million loss for the corresponding prior year period.
Free cash flow for the fourth quarter of 2025 was $(54.2) million, as compared to $(83.4) million for the corresponding prior year period.
In November 2025, Guardant Health completed a follow-on underwritten public offering, in which it issued and sold 2,856,981 shares of its common stock, and reissued and sold 976,351 shares of its treasury stock, at a price of $90.00 per share, and received net proceeds of $327.3 million. As a result of the reissuance of its treasury stock, Guardant Health recorded a gain of $42.9 million included in its additional paid-in capital on the consolidated balance sheets. In addition, in November 2025, Guardant Health issued $402.5 million principal amount of 0% convertible senior notes due 2033.
In December 2025, Guardant Health purchased all of the outstanding shares of MetaSight Diagnostics Ltd, a health technology company. The transaction consists of $59.0 million in upfront cash consideration paid at closing in December 2025, plus up to $90.0 million in variable contingent consideration tied to future commercial performance and regulatory approvals of the MetaSight technology.
Cash, cash equivalents, restricted cash and marketable debt securities were $1.3 billion as of December 31, 2025.
Full Year 2025 Financial Results
Revenue was $982.0 million for 2025, a 33% increase from $739.0 million for the corresponding prior year period. Oncology revenue grew 26% to $683.6 million for 2025, from $542.8 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume, which grew 34% over the prior year period. Screening revenue was $79.7 million for 2025, primarily generated from approximately 87,000 Shield screening tests. Biopharma and Data revenue grew 18% to $210.1 million for 2025, from $177.6 million for the corresponding prior year period, driven primarily by an increase in volume of our GuardantINFINITY test, as well as an increase in revenue derived from the achievement of certain milestones of our service agreements. Licensing and other revenue was $8.6 million for 2025, compared to $13.5 million for the corresponding prior year period.

Gross profit, or total revenue less cost of revenue, was $633.0 million for 2025, an increase of $183.8 million from $449.2 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 64%, as compared to 61% for the corresponding prior year period.
Non-GAAP gross profit was $644.8 million for 2025, an increase of $185.2 million or 40%, from $459.6 million for the corresponding prior year period. Non-GAAP gross margin was 66% for 2025, as compared to 62% for the corresponding prior year period.
Operating expenses were $1,070.3 million for 2025, as compared to $892.8 million for the corresponding prior year period. The year-over-year increase in operating expenses was primarily related to commercial team expansion and marketing activities to support both the Shield product launch and existing product growth, as well as an increase in stock-based compensation expense and information technology infrastructure costs. Non-GAAP operating expenses were $903.7 million for 2025, as compared to $757.3 million for the corresponding prior year period. The year-over-year increase in non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support both the Shield product launch and existing product growth, as well as an increase in information technology infrastructure costs.
Net loss was $416.3 million for 2025, as compared to $436.4 million for the corresponding prior year period. Net loss per share was $3.32 for 2025, as compared to $3.56 for the corresponding prior year period.
Non-GAAP net loss was $228.1 million for 2025, as compared to $247.2 million for the corresponding prior year period. Non-GAAP net loss per share was $1.82 for 2025, as compared to $2.01 for the corresponding prior year period.
Adjusted EBITDA loss was $220.9 million for 2025, as compared to a $257.5 million loss for the corresponding prior year period.
Free cash flow for 2025 was $(233.1) million, as compared to $(274.9) million for the corresponding prior year period.
2026 Guidance
Guardant Health expects full year 2026 revenue to be in the range of $1.25 to $1.28 billion, representing growth of 27% to 30% compared to full year 2025.
Within this revenue range:
•Oncology revenue is expected to grow in the range of 25% to 27% in 2026 and Oncology volume is expected to grow approximately 30% year-over-year in 2026.
•Biopharma & Data revenue growth is expected to be in the low double-digit range.
•Screening revenue is expected to be in the range of $162 to $174 million in 2026 and Screening volume is expected to be in the range of 210,000 to 225,000 tests in 2026. This compares to Screening revenue of $79.7 million and Screening volume of approximately 87,000 in 2025.
Guardant Health expects full year 2026 non-GAAP gross margin to be in the range of 64% to 65%. Guardant Health expects total non-GAAP operating expenses to be in the range of $1.03 to $1.05 billion, representing a 14% to 16% increase compared to 2025. Guardant Health expects free cash flow burn to be in the range of $185 to $195 million in 2025, an improvement compared to $233 million for the full year 2025.
Webcast Information
Guardant Health will host a conference call to discuss the fourth quarter and full year 2025 financial results after market close on Thursday, February 19, 2026 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Guardant Health, FEB 19, 2026, View Source [SID1234662796])

On February 19, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported it will participate in the following investor conferences.

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Raymond James 47th Annual Institutional Investors Conference – Orlando, FL
Presentation on March 3rd at 8:05 a.m. Eastern Time
Leerink Partners Global Health Conference – Miami, FL
Fireside chat on March 9th at 10:40 a.m. Eastern Time

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days after each live presentation broadcast.

(Press release, Veracyte, FEB 19, 2026, View Source [SID1234662793])

On February 19, 2026 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported that it has been awarded a blended finance grant from the European Innovation Council (EIC) under the EIC Accelerator programme. The funding consists of a €2.5 million grant and potentially up to €10 million in equity investment to support the advancement of Step Pharma’s first-in-class, highly selective, orally bioavailable CTPS1 inhibitor, dencatistat, in CTPS2 null ovarian and endometrial cancers.

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All cancers are dependent on a ready supply of CTP for proliferation, the production of which is catalysed by two isoenzymes, CTPS1 and CTPS2. Loss of CTPS2 in cancer cells creates a synthetic lethal dependency on CTPS1; selective CTPS1 inhibition kills CTPS2 null cancer cells whilst sparing normal tissues. Step Pharma’s highly selective CTPS1 inhibitor, dencatistat, has the potential to deliver efficacy without toxicity.

Dencatistat is currently being evaluated in a phase 1a dose escalation study in patients with solid tumours. This will be followed by safety expansion cohorts in patients with CTPS2 null cancers, including ovarian and endometrial where the prevalence of CTPS2 loss is 15-20%. These expansion cohorts are expected to start enrolling in 2026, with an additional cohort in CTPS2 null lung cancer also planned.

Andrew Parker, Chief Executive Officer, Step Pharma, commented:

"Being selected for an EIC Accelerator award is an important validation of our precision oncology approach targeting the synthetic lethal dependency on CTPS1 in CTPS2 null solid tumours. Building on strong momentum across our three clinical programmes, this award will enable us to advance dencatistat into expansion cohorts in ovarian and endometrial cancer, gynaecological indications where initiatives such as the EIC Accelerator can play a key role in improving outcomes. We look forward to working with the EIC as we continue to drive a step change in the way cancer is treated."

The EIC Accelerator award follows a period of significant clinical and corporate progress for Step Pharma, including the completion of a €38 million Series C financing in October 2025 led by V-Bio Ventures, the appointment of Dr Karen Smith as Chief Medical Officer, and the initiation of the Company’s third clinical programme for dencatistat in essential thrombocythaemia (ET). Dencatistat is also being evaluated in a phase 1/2 clinical trial for adult patients with relapsed/refractory T or B cell lymphoma, and received US FDA orphan drug designation for the treatment of T cell lymphoma in May 2025.

The EIC Accelerator supports breakthrough innovations with the potential to create new markets or disrupt existing ones, through combined grant and equity investments. Step Pharma’s blended finance award will fund pivotal activities including:

Expansion of dencatistat phase 1b trial into CTPS2 null ovarian and endometrial cancer cohorts; and
Preparation for phase 2 studies in gynaecological cancers including drug manufacture and pivotal toxicology studies.
The support also includes access to EIC Business Acceleration Services, providing strategic guidance, networking opportunities, and investor connections.

(Press release, Step Pharma, FEB 19, 2026, View Source [SID1234662792])

On February 19, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse technology using proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported business updates and financial results for the fourth quarter and full year ended December 31, 2025.

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Recent Business Highlights

Endocardial Catheter AF Ablation

● Highlighted 100% procedural success, or freedom from atrial fibrillation (AF), at 6 months and 96% procedural success at one year, of evaluable patients, following treatments with the nPulse Cardiac Catheter System in the first-in-human feasibility study which was presented as late-breaking data at the 31st Annual AF Symposium Meeting.
● Received FDA approval to commence a pivotal IDE study for the treatment of paroxysmal atrial fibrillation with the nPulse Cardiac Catheter System in Q4 2025. The first patient is expected to be enrolled in the next few months and the last patient is expected to be enrolled in Q4 2026.

Surgical AF Ablation

● Continued enrollment in the nPulse Cardiac Surgery System IDE pivotal study, NANOCLAMP AF, for the treatment of AF, representing the first PFA study approved by the FDA for a surgical cardiac ablation device in concomitant surgical procedures.
● Expanding and accelerating IDE site activation to support patient enrollment completion in 2026.

Soft Tissue Ablation

● Generated $264 thousand of revenue in a highly controlled commercial launch.
● Continued enrollment of the PRECISE-BTN study, for the treatment of benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system, and plan to complete enrollment of 50 patients in the next few months and expand enrollment to 100 patients over the ensuing two quarters.
● Initiated a research collaboration with University of Texas MD Anderson Cancer Center to evaluate the use of nsPFA for the treatment of both benign and malignant thyroid tumors.

"2025 was a highly productive year for Pulse Biosciences as we achieved notable milestones in each of our market development programs. Most importantly, we have advanced our nsPFA platform into late-stage clinical development to treat atrial fibrillation in both electrophysiology and cardiac surgery, receiving FDA IDE approvals to initiate both pivotal studies," said Paul LaViolette, CEO of Pulse Biosciences. "I am thrilled in particular with the compelling clinical evidence being developed by our programs, especially the best-in-class procedural success rates treating paroxysmal AF from our large feasibility study. Our focus in 2026 is on clinical trial execution, including completing pivotal enrollment in both cardiac programs."

Fourth Quarter 2025 Financial Results

Total revenue was $264 thousand for the fourth quarter of 2025, including both nPulse capital and Vybrance disposables sales, compared to $86 thousand in the third quarter of 2025.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general, and administrative expenses, for the three months ended December 31, 2025, were $18.5 million, a decrease of $1.7 million compared to $20.3 million in the prior year period. The decrease was primarily driven by non-recurring legal and severance costs in the prior year period, partially offset by expenses related to the expanding organization to support advancement of nsPFA device clinical trials and commercialization. Non-GAAP costs and expenses for the three months ended December 31, 2025, were $13.3 million, an increase of $2.0 million compared to $11.3 million in the prior year period.

GAAP net loss for the three months ended December 31, 2025 was ($17.4) million compared to ($19.4) million for the three months ended December 31, 2024. Non-GAAP net loss for the three months ended December 31, 2025 was ($12.2) million compared to ($10.4) million for the three months ended December 31, 2024.

Full year 2025 Financial Results

Total revenue was $350 thousand for the full year 2025.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general, and administrative expenses, for the full year ended December 31, 2025, were $77.3 million, an increase of $21.0 million compared to $56.3 million in the prior year. The increase was primarily driven by expenses related to the expanding organization to support advancement of the nsPFA device clinical trials and commercialization. Non-GAAP costs and expenses for the year ended December 31, 2025, were $55.4 million, an increase of $15.8 million compared to $39.6 million in the prior year period.

GAAP net loss for the full year 2025 was ($72.8) million compared to ($53.6) million for the prior year. Non-GAAP net loss for the year ended December 31, 2025 was ($50.8) million compared to ($36.9) million for the year ended December 31, 2024.

Cash and cash equivalents totaled $80.7 million as of December 31, 2025, compared to $118.0 million as of December 31, 2024 and $95.2 million as of September 30, 2025. Cash used in operating activities in the fourth quarter of 2025 totaled $14.8 million, compared to $9.1 million used in the same period in the prior year, and $13.0 million used in the third quarter of 2025.

Reconciliations of GAAP to Non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, February 19, 2025, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 7647402. A live and recorded webcast of the event will be available at View Source

(Press release, Pulse Biosciences, FEB 19, 2026, View Source [SID1234662791])