Phio Pharmaceuticals Aligns Leadership Team to Support Next Stage Development of PH-762 and Advancement of PH-894

On February 19, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio Pharmaceuticals Corp. reported leadership appointments as the Company prepares for upcoming regulatory discussions and key clinical milestones for PH-762, while continuing work on PH-894.

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The Company promoted Lisa Carson to Chief Financial Officer and Jennifer Phillips, Pharm.D., to Senior Vice President, Regulatory and Corporate Affairs. In addition, Kimberly Man joined Phio as Vice President of Program Development and Strategic Planning, reporting to Robert Bitterman, President and Chief Executive Officer.

"Upcoming regulatory discussions and clinical milestones demand a team built for follow-through," said Robert Bitterman. "These appointments strengthen finance and regulatory leadership to support PH-762 as it moves into its next stage, while we continue work on PH-894. Our focus is delivering the next set of milestones with discipline and consistency."

In her role as Chief Financial Officer, Ms. Carson will oversee financial operations, capital planning and financial reporting to support Phio’s clinical programs. She joined Phio in May 2025 and brings more than 20 years of finance and accounting leadership experience. Prior to Phio, she served as Vice President, Finance and Controller at Prelude Therapeutics, where she supported the company’s IPO and subsequent expansion, and previously held finance leadership roles at TELA Bio and PhaseBio Pharmaceuticals.

In her expanded role, Dr. Phillips will lead regulatory strategy and agency engagement as Phio prepares for upcoming regulatory interactions and clinical milestones. She joined Phio in February 2023 and has more than 25 years of regulatory affairs experience, including senior roles spanning major pharmaceutical organizations such as Aventis and Wyeth and regulatory leadership at Cutanea Life Sciences.

Ms. Man will lead day-to-day program coordination for PH-762 and support longer-term program work on PH-894. She has over 20 years of experience in program and portfolio leadership, product development, and clinical and regulatory operations, including roles at Sandoz and Cutanea Life Sciences.

These appointments support near-term regulatory priorities while strengthening the foundation for the next phase of clinical development.

(Press release, Phio Pharmaceuticals, FEB 19, 2026, View Source [SID1234662799])

Moderna to Present at Upcoming Conferences in March 2026

On February 19, 2026 Moderna, Inc. (Nasdaq:MRNA), reported its participation in the following upcoming investor conferences:

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TD Cowen 46th Annual Healthcare Conference, on Tuesday, March 3rd at 1:50pm ET

Barclays 28th Annual Global Healthcare Conference, on Tuesday, March 10th at 9:30am ET

A live webcast of each of these presentations will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com.

A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.

(Press release, Moderna Therapeutics, FEB 19, 2026, View Source [SID1234662798])

Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BAL

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])

Guardant Health Reports Fourth Quarter and Full Year 2025 Financial Results and Provides 2026 Outlook

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])

Veracyte to Participate in Upcoming Investor Conferences

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])