Talphera Reports Q2 2025 Financial Results and Highlights Corporate Progress

San Mateo, CA – August 14, 2025
Talphera, Inc. (Nasdaq: TLPH), a specialty pharmaceutical firm concentrating on innovative therapy development, has recently released its financial results for the second quarter of 2025, alongside a significant corporate update. The report indicates substantial progress in their NEPHRO clinical study and a comprehensive analysis of their financial standing.

Clinical Study Enrollment Progress

During this quarter, Talphera has successfully enrolled 15 patients in the NEPHRO study, which is pivotal for assessing the efficacy of its lead product candidate, Niyad®. CEO Vince Angotti expressed optimism regarding the accelerated enrollment rate, attributing it to enhanced strategies that include new clinical sites and adjusted study protocols. The continuous feedback from clinical sites has emphasized a desire for nafamostat as a preferred alternative to current Continuous Renal Replacement Therapy (CRRT) anticoagulation products.

With the anticipated addition of six more clinical sites by the end of Q3 2025, Talphera expects to increase the total number of participating sites to 13, including nine aligned with its target profiles. The goal is to complete the NEPHRO study by the end of this year, pending ongoing enrollment success.

Financial Overview

As of June 30, 2025, Talphera reported a cash and cash equivalents balance of $6.8 million. In comparison to the same quarter in 2024, the combined Research and Development (R&D) and Selling, General and Administrative (SGA) expenses have seen a decrease, registering at $3.7 million compared to $4.3 million from the previous year. This reduction is primarily due to lower personnel and administrative expenses.

The net loss from continuing operations for Q2 2025 was recorded at $3.5 million, a slight improvement from a loss of $3.8 million in Q2 2024. The loss attributable to common shareholders stood at $3.5 million, equating to $0.10 per basic and diluted share, a notable change from the preceding year's loss of $3.8 million, or $0.15 per share.

Revised Expense Guidance

Looking ahead, Talphera has adjusted its projected cash operating expenses for 2025 to an estimated range of $16 million to $17 million, which reflects their focused approach on completing the NEPHRO CRRT registration trial within the designated timeline.

Upcoming Conference Call

Talphera will host a conference call and webcast on August 14, 2025, at 4:30 PM ET, where company officials will dive deeper into these results and outline future strategies. Investors are encouraged to join the call by dialing the provided numbers or accessing the webcast directly through the company’s website.

About Talphera, Inc.

Talphera specializes in developing and commercializing cutting-edge therapeutic solutions tailored for medically supervised environments. Their flagship product, Niyad®, is currently under investigational study for its potential use as an anticoagulant in extracorporeal circuits, having received Breakthrough Device Designation from the FDA.

Conclusion

With a clear trajectory for their NEPHRO study and a solid financial framework, Talphera appears well-positioned for advancements in both clinical efficacy and market readiness. Stakeholders eagerly anticipate the outcomes of the ongoing trials and the potential FDA approval of Niyad® as an innovative solution in the healthcare landscape.