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Business Summary: Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of therapies for use in medically supervised settings. The Company’s portfolio consists of nafamostat product candidates and pre-filled syringe product candidates. The Company’s lead product candidate, Niyad, is a lyophilized formulation of nafamostat and is being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit. Niyad is used in adult patients undergoing continuous renal replacement therapy (CRRT). LTX-608 is its nafamostat formulation for direct IV infusion being explored as an investigational product for one or more indications, including antiviral treatment, or treatment of acute respiratory distress syndrome (ARDS) disseminated intravascular coagulation (DIC), or acute pancreatitis. The Company’s two ready-to-use pre-filled syringe (PFS) product candidates include Fedsyra and phenylephrine.
Financial Summary: BRIEF: For the nine months ended 30 September 2025, Talphera Inc revenues increased from $0K to $28K. Net loss before extraordinary items decreased 5% to $10.6M. Revenues reflect an increase in demand for the Company's products and services due to favorable market conditions. Basic Earnings per Share excluding Extraordinary Items increased from -$0.43 to -$0.31.