Talphera(NASDAQ:TLPH) reported second quarter 2025 results on August 14, 2025, highlighting accelerated clinical trial enrollment and a reduction in annual cash operating expense guidance to $16 million–$17 million for 2025. The company ended the quarter with $6.8 million in cash and reaffirmed its plan to complete the pivotal Niyad (nafamostat) study by year-end 2025. The following insights detail the operational turnaround, financing structure, and market entry strategy discussed on the call.
New site strategy accelerates Talphera enrollment
After appointing Dr. Shakil Aslam as Chief Medical Officer, Talphera reduced the nephro CRRT (continuous renal replacement therapy) trial size to 70 patients and implemented new site and investigator selection criteria. Over the last six weeks, more than 90% of enrolled patients have come from three new target profile sites, a significant improvement over legacy site performance.
"We have seen a strong acceleration of the enrollment rate over the last six weeks from the first three sites with our new target profile. This target profile includes a nephrologist principal investigator and the institution screening patients at medical ICUs. As a result, the number of total enrolled patients has more than doubled since May."
-- Vincent Angotti, Chief Executive Officer
This operational shift demonstrates management’s ability to identify and address bottlenecks, increasing confidence in timely trial completion and reducing the risk of enrollment-driven delays.
Financing structure aligns with Talphera milestones
Talphera’s cash balance was $6.8 million as of June 30, 2025, supported by the first of three financing tranches. Additional tranches are contingent on reaching 17 and 35 enrolled patients, as well as the stock being priced above 73¢ per share at each milestone. Year-to-date 2025 operating expenses were $3.7 million, down from $4.3 million in 2024, primarily due to personnel and general and administrative reductions.
"the financing was structured in three equal tranches, with the first tranche received at the initial closing and the two additional tranches committed upon achieving an enrollment of 17 patients and 35 patients, and with the stock priced above 73¢ per share following the announcement of each milestone. Expected proceeds from the closing of the two additional tranches, combined with the $6.8 million in cash at 06/30/2025, should support the company through the completion of the study anticipated by the end of the year."
-- Raffi Asadorian, Chief Financial Officer
This financing approach ties capital access directly to clinical progress, but the share price clause introduces execution risk if equity performance does not keep pace with operational milestones.
Compassionate use IDE targets unmet CRRT need
In addition to the registrational trial, Talphera is submitting a compassionate use Investigational Device Exemption (IDE) for nafamostat at a major institution treating patients ineligible for heparin or citrate, the main anticoagulants for CRRT. Ongoing shortages of both heparin and citrate, driven by manufacturing and supply constraints, highlight the urgency for an FDA-approved regional anticoagulant.
"Physicians at this institution see an immediate and compelling need for a subset of patients with contraindications to currently available anticoagulants and need an alternative. We are in the process of submitting a compassionate use IDE to the FDA. This is an opportunity to provide an alternative to these patients who cannot receive the currently available anticoagulants and, as a result, clot their CRRT circuits frequently."
-- Dr. Shakil Aslam, Chief Medical Officer
This initiative could foster early prescriber familiarity and generate supportive safety data for future regulatory filings, while also underscoring the inadequacy of current CRRT anticoagulant options for critical patient subgroups.
Looking Ahead
Management reiterated guidance to complete enrollment of the 70-patient Niyad registrational trial by year-end 2025, with three new target profile sites activated and six more expected during the third quarter. Full-year 2025 cash operating expense guidance was reduced to $16 million–$17 million, and management expects available cash and committed follow-on financing to be sufficient through study completion. No additional quantitative guidance for 2026 was provided.
