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Talphera (Nasdaq: TLPH) announced two abstracts accepted for presentation at AKI & CRRT 2026 (March 29–April 2, 2026) describing nafamostat as a regional anticoagulant for CRRT. One poster details the ongoing registrational NEPHRO-CRRT trial now enrolling patients; the other reports porcine PK/PD data showing >95% pre-filter removal and minimal systemic ACT effect.
The company says a target post-filter ACT of 175–225 seconds may provide extracorporeal anticoagulation while limiting systemic effects; if approved, nafamostat would be the first FDA-approved regional anticoagulant for CRRT.
Talphera (Nasdaq: TLPH) reported Q4 and full‑year 2025 results and a corporate update on March 23, 2026. Key items: 50% enrollment (35 of 70) in the NEPHRO CRRT registrational study, closing of a $4.1M financing tranche, and $20.4M cash and investments at December 31, 2025.
Q4 combined R&D and SG&A were $3.5M, net loss attributable to common shareholders was $3.8M (or $0.06 per share). 2026 cash operating expenses are guided to $17–18M. A virtual investor day was held March 23, 2026.
Talphera (Nasdaq: TLPH) will host a virtual investor and analyst event on March 23, 2026 at 11:00 AM ET to discuss Niyad for use in continuous renal replacement therapy (CRRT).
Presenters Blaithin McMahon, PhD, MBBChr, and Joao Teixeira, MD, principal investigators in the NEPHRO CRRT study, will review CRRT anticoagulation practices, nafamostat's profile, and a live Q&A will follow.
Talphera (Nasdaq: TLPH) announced it has enrolled 35 of 70 patients (50%) in the NEPHRO-CRRT registrational trial as of March 2, 2026. The company said it reduced total enrollment by nearly 60%, refocused sites on medical ICUs with nephrologist PIs, and achieved >90% enrollment from new sites.
Talphera will host a virtual investor and analyst event on March 23, 2026 at 11:00 am ET featuring nephrologists Dr. Blaithin McMahon and Dr. Joao Teixeira; a replay will be available for 90 days.
Talphera (Nasdaq: TLPH) reported third quarter 2025 results and a corporate update on November 12, 2025. Key items: Talphera closed a $17.0 million first tranche of a potential $29.0 million private placement led by CorMedix (Nasdaq: CRMD); cash and investments were $21.3 million at September 30, 2025. Five of nine target NEPHRO CRRT study sites are active and study completion is expected in H1 2026. Q3 combined R&D and SG&A were $3.4 million (ex-stock comp $3.3M). Q3 net loss from continuing operations was $4.4 million ($0.11 per share). 2025 cash operating expense guidance was reduced to $14–15 million.
Talphera (Nasdaq: TLPH) will release third quarter 2025 financial results after market close on Wednesday, November 12, 2025.
The company will host a live webcast and conference call on Nov 12, 2025 at 4:30 p.m. ET / 1:30 p.m. PT to discuss results and provide a corporate update. The webcast includes a slide presentation and a replay that will be available on the Talphera investor website for 90 days after the event.
Investors can join the conference call via 1-800-836-8184 (North America) or 1-646-357-8785 (international); conference ID 08207. Webcast links are posted in Investors > News & Events > Upcoming Events at www.talphera.com.
Talphera (Nasdaq: TLPH) appointed Joe Todisco, CEO of CorMedix (Nasdaq: CRMD), to its Board of Directors effective Oct 21, 2025.
CorMedix made a strategic investment in Talphera in Sept 2025 and, under that transaction, gained the right to nominate a board representative and a 60-day exclusive negotiation period triggered by the announcement of primary endpoint and topline results from the NEPHRO CRRT clinical study. Talphera and CorMedix cite potential regulatory progress for Niyad with management referencing a possible approval in 2026.
Talphera (NASDAQ:TLPH) has secured a private placement financing of up to $29 million led by CorMedix Inc. as the strategic investor, along with institutional investors including Nantahala Capital, Rosalind Advisors, and Rock Springs Capital. The financing includes $17 million in the first closing (expected September 10, 2025) and potential $12 million in a second tranche upon achieving the primary endpoint in the NEPHRO CRRT study.
The first closing involves issuing 25,036,363 shares at $0.55 per share and 5,845,455 pre-funded warrants at $0.549. CorMedix receives a 60-day exclusivity period to negotiate Talphera's acquisition following NEPHRO study results and gains board nomination rights. The funding is expected to support Talphera through the planned Niyad PMA approval in H2 2026.
Talphera (NASDAQ:TLPH) has reached a significant milestone in its pivotal NEPHRO CRRT clinical trial, enrolling 17 patients, representing approximately 25% of the targeted 70-patient enrollment. This achievement fulfills a requirement for the second tranche of their March 2025 three-tranche financing agreement.
The company reports an accelerated recruitment rate from new profile clinical sites, with over 90% of enrolled patients coming from these new locations. With six additional sites expected to begin enrollment in Q3, Talphera remains confident in completing the study by the end of 2025.
Talphera (Nasdaq: TLPH) reported Q2 2025 financial results and provided updates on its NEPHRO clinical study. The company has enrolled 15 patients in the registrational study, which remains on track for completion by year-end. Cash position stood at $6.8 million as of June 30, 2025.
Key financial metrics include a net loss of $3.5 million ($0.10 per share) in Q2 2025, improved from $3.8 million loss in Q2 2024. Operating expenses decreased to $3.7 million from $4.3 million year-over-year. The company secured a three-tranche financing of up to $14.8 million, with the first tranche of $4.9 million closed in April 2025.
Talphera revised its 2025 cash operating expense guidance to $16-17 million, down from the previous $17-19 million range.