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])

On February 19, 2026 Daiichi Sankyo reported that European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

"Patients who have residual invasive disease despite neoadjuvant therapy face a heightened risk of recurrence and are in need of better options following neoadjuvant treatment and surgery," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "This validation in the EU is an important step toward bringing ENHERTU to eligible patients earlier in the treatment journey to help reduce the risk of disease recurrence and progression to metastatic disease."

Additional regulatory submissions for ENHERTU also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from DESTINY-Breast09 and for previously treated HER2 positive unresectable or metastatic solid tumors based on data from DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01.

About DESTINY-Breast05
DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Post Neoadjuvant Treatment for HER2 Positive Early Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer is considered HER2 positive.3

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.5,6,7,8,9

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence.10 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.11

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.12,13

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, FEB 19, 2026, View Source [SID1234662809])

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 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])

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])