Talphera 2025 Q3 Earnings Narrowed Losses Amid Extended Study Timelines

Talphera (TLPH) reported mixed results for Q3 2025, with a narrowed per-share loss but a wider overall net loss. The company revised cash expense guidance downward and secured $17 million in financing, though clinical site delays pushed study completion to H1 2026.

Revenue

Talphera generated $1,000 in Q3 2025 revenue, flat year-over-year compared to $0 in Q3 2024. The company reported no segment-specific revenue breakdown.

Earnings/Net Income

Talphera narrowed its per-share loss to $0.11 from $0.13, a 15.4% improvement, but the net loss widened to $4.44 million (from $3.35 million), a 32.3% increase. The company has sustained losses for 12 consecutive years in this quarter. While the EPS improvement is positive, the expanding net loss indicates ongoing financial challenges.

Price Action

Talphera’s stock fell 3.67% in the latest trading day, 9.48% in the past week, and 7.89% month-to-date.

Post-Earnings Price Action Review

A strategy of buying Talphera shares post-earnings following a revenue decline has underperformed over three years, with a cumulative -46.8% return and an average annual loss of -22.4%. Holding periods of 30 days yielded similarly poor results, underscoring the strategy’s ineffectiveness.

CEO Commentary

CEO Vincent Angotti highlighted progress in the NEPHRO study, including a $17 million financing round and a $5 million strategic investment from CorMedix. The study’s patient target was reduced from 166 to 70, accelerating enrollment at high-volume sites. However, delays in activating six new sites pushed study completion to H1 2026. Angotti expressed confidence in Niyad’s market potential, citing its advantages over existing anticoagulants and nafamostat’s 30-year safety record.

Guidance

Talphera cut 2025 cash operating expenses to $14–15 million (from $16–17 million) due to delayed site activations. The company expects to complete the NEPHRO study by H1 2026, with PMA approval targeted for late 2026.

Additional News

Talphera closed a $17 million first tranche of a $29 million financing led by CorMedix, which secured a board seat for CorMedix’s CEO. The company also announced a $5 million strategic investment from CorMedix, including a 60-day exclusive negotiation period for a potential acquisition. Delays in activating six new clinical sites, including a 3–4-month setback at the Veterans Affairs Medical Center due to staff cuts, pushed study completion to H1 2026. Management emphasized submitting revised eligibility criteria to the FDA to accelerate enrollment.