Talphera (TLPH) Corporate presentation summary

Product portfolio and pipeline

• Lead product candidate Niyad is a nafamostat-based regional anticoagulant for extracorporeal circuits, regulated as a device, with a registrational study expected to complete in 2026.

• LTX-608 is another nafamostat candidate targeting various indications, with phase 2 development expected post-toxicology studies.

• Pre-filled syringe products include Fedsyra (ephedrine hydrochloride) and phenylephrine hydrochloride, both in NDA submission evaluation.

• DSUVIA (sufentanil) was divested, generating royalties and milestone payments.

Niyad clinical and regulatory progress

• Niyad is the only regional anticoagulant candidate for CRRT and IHD with FDA Breakthrough Device Designation.

• A single registrational study, with endpoints agreed by FDA, is underway and expected to complete in 2026.

• Enrollment has accelerated, with 35 patients enrolled by March 2026 and final sites activated in Q1 2026.

• The study targets 70 patients, focusing on those unable to tolerate heparin or at high bleeding risk.

Market landscape and opportunity

• Niyad addresses a significant unmet need, as no FDA-approved regional anticoagulants exist for extracorporeal circuits.

• Estimated peak sales for Niyad in CRRT and IHD exceed $200 million.

• Market share projections: 19.5% of ICU CRRT patients (32K) and 6% of IHD patients (26K) could use Niyad.

• Acute kidney injury and ESRD rates are rising, expanding the addressable market.