New Case Study Highlights Ability of bioAffinity Technologies’ CyPath® Lung to Reduce Diagnostic Burden for Patients At Risk for Lung Cancer

On February 19, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported a new clinical case study in which its CyPath Lung noninvasive diagnostic test for lung cancer helped determine the appropriate treatment for a 79-year-old female with a suspicious lung finding on a low-dose computed tomography (LDCT) scan.

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The patient, a current smoker with a medical history significant for chronic obstructive pulmonary disease (COPD) and coronary heart disease, underwent LDCT screening in June 2025. Imaging revealed a spiculated, or irregularly shaped, nodule about half an inch in size at the bottom of the right lung, near the lining of the lung. Spiculated nodules raise concerns about malignancy due to their uneven, irregular appearance.

"Spiculated findings on CT scans often trigger concern and can lead to invasive procedures, particularly in older high-risk patients," said Daya Nadarajah, MD, the patient’s pulmonologist. "Given this patient’s age, smoking history and comorbidities, we were not comfortable proceeding directly to an invasive procedure. CyPath Lung gives us objective data to better stratify risk and avoid putting our patients through unnecessary and potentially risky procedures."

The CyPath Lung test result was negative, indicating an unlikely malignancy in the lung and supporting a conservative management approach that includes annual CT screening. A repeat scan in October 2025 showed that the suspicious finding from the June scan had resolved, and there were no pulmonary nodules in the lungs.

"Every suspicious finding is concerning. Even when the probability of malignancy is low, the consequences of missing a cancer are significant," said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. "Physicians now have a tool in CyPath Lung that further refines risk and provides valuable reassurance when deciding whether to monitor or escalate care."

Supporting Confident, Noninvasive Management

Based on the reassuring imaging and negative CyPath Lung result, the patient and her care team agreed to continue with serial annual CT scans as follow-up care. In this case, CyPath Lung:

Provided the confidence to defer invasive procedures
Prevented an unnecessary biopsy
Put the patient at ease with ongoing surveillance
Complemented imaging findings in a high-risk individual
About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.

(Press release, BioAffinity Technologies, FEB 19, 2026, View Source [SID1234662810])

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])

Havah Therapeutics to Present at the RiseUp For Breast Cancer and Women’s Health Conference

On February 19, 2026 Havah Therapeutics, a clinical-stage biopharmaceutical company pioneering androgen receptor (AR) agonist therapies for hormone receptor positive breast cancer, reported that Professor Stephen Birrell MD, PhD, will deliver a presentation titled "HAV-088: Bending Evolution to the Will of Medicine" at the upcoming RiseUp for Breast Cancer and Women’s Health Conference in San Francisco.

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Key highlights of the presentation include:

A translational framework for "endocrine steering" of hormonally active breast tissue using HAV-088, an androgen receptor (AR) agonist
An overview of Havah’s prospectively registered pilot, randomized controlled trial comparing HAV-088 with tamoxifen in high-risk premenopausal women with dense breasts and marked MRI background parenchymal enhancement (BPE)
An integrated evidence chain linking drug exposure, spatial tissue biology, intracrine hormone metabolism, and imaging biomarkers
Details for the presentation are as follows:

RiseUp For Breast Cancer and Women’s Health Conference
February 19-21, 2026
Hotel Nikko, San Francisco, CA

Presentation Title: HAV-088: Bending Evolution to the Will of Medicine
Presenter: Professor Stephen Birrell, MD, PhD
Date/Time: Friday, February 20, 12:10 Pacific Time

(Press release, HavaH Therapeutics, FEB 19, 2026, View Source [SID1234662811])

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])

ALX Oncology to Present at Upcoming Investor Conferences in Q1 2026

On February 19, 2026 ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that ALX Oncology leadership will participate in the Wells Fargo Executive Biotech Summit, TD Cowen 46th Annual Health Care Conference, and UBS Biotech Summit.

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The details of the meetings are as follows:

Wells Fargo Executive Biotech Summit

Format: One-on-one meetings
Date: February 24-25, 2026
Location: Lake Tahoe, CA

TD Cowen 46th Annual Health Care Conference

Format: Presentation
Date: March 3, 2026
Time: 9:10 AM EST
Location: Boston, MA
Webcast link: Available here

UBS Biotech Summit

Format: One-on-one meetings
Date: March 10, 2026
Location: Miami, FL

The webcast of the TD Cowen 46th Annual Health Care Conference presentation can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. Replay of the webcast will be archived for up to 90 days following the presentation date.

(Press release, ALX Oncology, FEB 19, 2026, View Source [SID1234662779])