#United States #San Mateo #Talphera #Niyad #Nafamostat

Talphera Inc. 2025 Financial Results and Updates on Clinical Trials

On March 23, 2026, Talphera, Inc. (Nasdaq: TLPH), a company specializing in the development and commercialization of innovative pharmacological therapies, revealed their financial results for the fourth quarter and full year of 2025, alongside a corporate update.

Key Achievements in Clinical Trials
This announcement follows the significant milestone of reaching 50% enrollment in the clinical study named NEPHRO CRRT, designed to evaluate the efficacy of nafamostat in continuous renal replacement therapy (CRRT). The company has successfully enrolled 35 patients in the trial, marking a quarter where all 12 clinical study sites are now active for patient recruitment. CEO Vince Angotti expressed optimism about the study's progress, stating that the company is on course to meet the completion deadline expected later this year.

Considering the feedback from principal investigators, the excitement surrounding nafamostat's potential approval as a powerful anticoagulant, especially given the limitations of current options used during CRRT, has fueled interest among the selected clinical sites.

Financial Overview
As of December 31, 2025, Talphera reported a total of $20.4 million in cash and investments. Research and development (R&D) costs and selling, general, and administrative (SGA) expenses increased to $3.5 million for the fourth quarter, comparatively higher than $3.0 million during the prior year. The surge in operating expenses can be attributed to expenses related to Niyad’s development and various general administrative costs. The net loss for the fourth quarter of 2025 stood at $3.8 million or $0.06 per diluted share, reflecting an increase from the previous year.

Looking ahead, Talphera anticipates cash operating expenses for 2026 to be between $17 million to $18 million. This expected hike is associated with finalizing the NEPHRO CRRT registration trial and additional costs related to manufacturing and validating batches prior to filing for Premarket Approval (PMA) with the FDA.

Upcoming Investor Engagement
In conjunction with the financial updates, Talphera is set to hold a Virtual Investor and Analyst Day webcast, presenting details regarding ongoing clinical studies and key business trajectories. During this event, investors will hear firsthand from two principal investigators about their experiences with the trial and insights into the unmet medical needs in the anticoagulant domain for CRRT. Interested parties are encouraged to register for this event and access further information through the company’s official website.

About Talphera and Niyad
Talphera is committed to producing innovative therapies for medically supervised scenarios, particularly through products like Niyad®, which is a lyophilized formulation of nafamostat being evaluated as an anticoagulant in extracorporeal circuits and has received FDA Breakthrough Device Designation. Nafamostat itself acts as a synthetic serine protease inhibitor with several potential applications, including anticoagulation and anti-inflammatory properties.

The NEPHRO CRRT study, now fully underway, aims to enroll 70 adult patients who are unable to tolerate conventional anticoagulants. This pivotal clinical trial underscores the imperative need for more effective therapeutic options, particularly in critical care settings where patient safety and treatment efficacy are crucial.

In conclusion, with significant milestones achieved in both financial performance and clinical research, Talphera is confidently moving toward what it hopes will be a landmark year in pharmaceutical innovation and patient care solutions.