TALPHERA, INC.

TALPHERA, INC. is a specialty pharmaceutical company that develops and commercializes innovative therapies for use in medically supervised settings. The company's portfolio primarily focuses on its lead product candidate, Niyad (nafamostat mesylate), which is intended for use as a regional anticoagulant during continuous renal replacement therapy (CRRT). TALPHERA may also develop LTX-608, a nafamostat formulation designed for direct intravenous (IV) infusion. This formulation is being considered for one or more indications, including disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), acute pancreatitis, or as an anti-viral treatment. The company has two pre-filled syringe product candidates that are currently being evaluated for discontinuation. In January 2022, TALPHERA acquired Lowell Therapeutics, Inc. for approximately $32.5 million plus net cash acquired and certain other adjustments. This acquisition also included up to approximately $26.0 million of contingent consideration, payable in cash or stock at TALPHERA's option, upon achieving regulatory and sales-based milestones. Through this merger, TALPHERA acquired Niyad and LTX-608 (lyophilized vials of nafamostat for infusion into the extracorporeal circuit or direct IV infusion to the patient, respectively), which are considered in-process research and development (IPR&D) assets. Niyad, a lyophilized vial containing nafamostat for infusion, is intended as a regional anticoagulant for infusion into the extracorporeal circuit. It has received an investigational device exemption (IDE) and Breakthrough Device Designation from the United States Food and Drug Administration (FDA), and its registrational trial is ongoing with completion expected in 2026. LTX-608, also a lyophilized vial containing nafamostat for infusion, is being considered for IV infusion for DIC, ARDS, acute pancreatitis, or as an anti-viral treatment. An Investigational New Drug (IND) application for LTX-608 will be evaluated for submission following toxicology evaluation to enable a Phase 2 study.