TALPHERA, INC.

Talphera, Inc. (Nasdaq Capital Market) is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings. The company's website is located at talphera.com.

The company's portfolio is principally centered on Niyad, a nafamostat mesylate product candidate designed for use as a regional anticoagulant during continuous renal replacement therapy, or CRRT, in acute kidney injury patients. Niyad has received an investigational device exemption and Breakthrough Device Designation from the FDA, with a registrational trial ongoing and completion expected in 2026. The company also develops LTX-608, a nafamostat formulation for direct intravenous infusion being explored for indications including disseminated intravascular coagulation, acute respiratory distress syndrome, acute pancreatitis, and as an antiviral treatment. Additionally, Talphera maintains pre-filled syringe product candidates, including Fedsyra, though the company is evaluating whether to discontinue these programs given its focus on nafamostat candidates.

Nafamostat, the active ingredient in both Niyad and LTX-608, has been approved and used in Japan and South Korea for over 30 years as a regional anticoagulant for dialysis circuits, disseminated intravascular coagulation, and acute pancreatitis. The company acquired Niyad and LTX-608 through its January 2022 acquisition of Lowell Therapeutics, Inc. for approximately $32.5 million in upfront consideration plus contingent payments based on regulatory and sales milestones.

Talphera previously commercialized DSUVIA, a sufentanil sublingual product, which the company divested to Alora Pharmaceuticals in April 2023. Under the divestment agreement, Talphera continues to receive royalties and milestone payments while maintaining marketing responsibilities to the Department of Defense.

The company relies on contract manufacturers for production of its product candidates, with single-source suppliers for the nafamostat active ingredient and finished product, though discussions are underway to establish backup manufacturing capacity. The company's commercial strategy focuses on pre-launch activities for Niyad, with evaluation of both internal and partner-based commercialization approaches.