Talphera (NASDAQ:TLPH) today reported financial results for the fourth quarter and full year ended December 31, 2025, detailing the fiscal costs of its ongoing transition into a specialized developer of hospital-based therapies.
The San Mateo, California-based company reported a net loss of $3.8 million for the fourth quarter, or $0.06 per share.
For the full year, the net loss widened to $14.3 million, equivalent to $0.34 per share.
Revenue for the 2025 fiscal year was reported at $28,000, reflecting the company’s current stage as a clinical-development entity focused on future commercialization rather than immediate product sales.
The elevated net loss is primarily attributed to sustained research and development spending as Talphera advances its lead candidate, Niyad™, a lyophilized formulation of nafamostat.
Niyad is currently being developed as an anticoagulant for use in the extracorporeal circuit for patients undergoing continuous renal replacement therapy (CRRT).
Management’s strategy for 2026 centers on the execution of the NEPTUNE pivotal study.
The company recently confirmed that enrollment is progressing in line with expectations, with top-line data anticipated in the second half of 2026.
If successful, the trial will support a Premarket Approval (PMA) submission to the FDA, potentially positioning Niyad as the first heparin alternative for CRRT in the United States—a market segment with significant unmet needs due to the risks of heparin-induced thrombocytopenia.
Despite the annual loss, Talphera has maintained a disciplined capital allocation strategy, ending the year with a cash position intended to bridge the company toward its primary clinical catalysts.