Talphera, Inc.

What they do

Talphera develops and intends to commercialize therapies for medically supervised settings. Its lead candidate Niyad is a lyophilized vial of nafamostat infused into the extracorporeal circuit during continuous renal replacement therapy (CRRT) for acute kidney injury patients. Niyad is being studied under an FDA Investigational Device Exemption and holds Breakthrough Device Designation. A second candidate, LTX-608, is an intravenous nafamostat formulation targeted at DIC, ARDS, acute pancreatitis and anti-viral uses; two pre-filled syringe candidates are being evaluated for discontinuation.

Revenue drivers

• Niyad (nafamostat) for CRRT — Lead product candidate, not approved or commercialized; intended as the first FDA-approved regional anticoagulant for adult CRRT patients in hospital intensive care units. No product revenue has been generated from it to date.
• LTX-608 (IV nafamostat) — Earlier-stage candidate for DIC, ARDS, acute pancreatitis or anti-viral use; the company says an IND will be evaluated for submission following toxicology evaluation to enable a Phase 2 study.
• Historical product revenue — Reported annual revenue has been negligible and intermittent: $0 in 2022, $651 thousand in 2023, $0 in 2024 and $28 thousand in 2025, with $0 in each of the last three reported quarters.

Recent performance

Second quarter 2026 net loss attributable to common shareholders was $4.3 million, or $0.06 per basic and diluted share, versus a $3.5 million loss, or $0.10 per share, in the second quarter of 2025. Combined R&D and SG&A expenses were $3.9 million in Q2 2026 compared with $3.7 million a year earlier, with the increase attributed to higher Niyad development costs from increased enrollment. Cash and investments were $17.1 million as of June 30, 2026, while the reported balance sheet shows cash and equivalents of $742 thousand and total assets of $26.8 million at that date. Revenue was $0 in the quarters ended March 31, 2026 and June 30, 2026. Full-year 2025 net loss was $14.3 million on revenue of $28 thousand, and operating cash flow was negative $11.4 million.

Strategy

The immediate priority is completing the NEPHRO CRRT registrational study of Niyad and submitting a Premarket Approval application to the FDA. The trial is 75% enrolled and expected to be complete this year; site realignment is finished with all target clinical sites activated. The company cites the draft 2026 KDIGO AKI guideline referencing nafamostat as an acceptable CRRT anticoagulant and updated market research indicating roughly 200,000 annual U.S. CRRT procedures in 2027, a 21% increase over prior estimates. It plans an investor event as enrollment nears completion. Management states it requires additional capital to fund development and commercialization and to continue as a going concern.

Risks

• Going concern and need for capital — The 10-K states that recurring losses and negative operating cash flow raise substantial doubt about the ability to continue as a going concern, and the company says it requires additional capital.
• No approved product or meaningful revenue — Niyad remains investigational with FDA approval not assured, and reported revenue has been negligible and intermittent, with $0 in each of the last three quarters.
• Clinical and regulatory execution — Completion of the NEPHRO CRRT study and submission of a PMA depend on enrolling and evaluating 70 adult patients across up to 14 U.S. hospital intensive care units, with the primary endpoint being mean post-filter activated clotting time versus placebo over 24 hours.
• Third-party supply concentration — The company lists reliance on single sources of supply for Niyad active pharmaceutical ingredient and finished goods located outside the U.S. among the factors that could harm results.

Outlook

Management says the NEPHRO CRRT study is 75% enrolled and on track to complete by year-end 2026, after which it plans to submit a PMA application. It points to the draft 2026 KDIGO guideline and updated market research estimating about 200,000 U.S. CRRT procedures in 2027 as supporting the commercial opportunity if nafamostat is approved. The company also says it expects to incur significant losses in 2026 and the foreseeable future and will need additional financing.