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Talphera Announces Agreement with the FDA to Reduce the NEPHRO CRRT Study Size to 70 Patients From 166 and a Private Placement Financing Priced At-the Market of up to $14.8 Million
TLPHTalphera(TLPH) Prnewswire·2025-03-31 12:30

Core Viewpoint - The FDA has approved a reduction in the NEPHRO CRRT study size from 166 to 70 patients, which is expected to facilitate timely completion by the end of 2025, supported by a capital raise of up to 14.8millionthroughaprivateplacement[1][2][11]Group1:NEPHROCRRTStudy−TheNEPHROCRRTstudywillnowenroll70adultpatientsundergoingrenalreplacementtherapy,focusingonthosewhocannottolerateheparinorareatriskforbleeding[11]−Theprimaryendpointofthestudyisthemeanpost−filteractivatedclottingtimeusingNiyadversusplacebooverthefirst24hours,withkeysecondaryendpointsincludingfilterlifespananddialysisefficacy[11]Group2:FinancingandCapital−TalpherahasenteredintosecuritiespurchaseagreementsforaprivateplacementledbyNantahalaCapitalandRosalindAdvisors,aimingtoraiseupto14.8 million through a private placement [1][2][11] Group 1: NEPHRO CRRT Study - The NEPHRO CRRT study will now enroll 70 adult patients undergoing renal replacement therapy, focusing on those who cannot tolerate heparin or are at risk for bleeding [11] - The primary endpoint of the study is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan and dialysis efficacy [11] Group 2: Financing and Capital - Talphera has entered into securities purchase agreements for a private placement led by Nantahala Capital and Rosalind Advisors, aiming to raise up to 14.8 million [1][3] - The first closing is expected to yield 4.925million,withadditionaltranchescontingentonpatientenrollmentmilestones[3][4]−CashandinvestmentsasofDecember31,2024,areprojectedtobe4.925 million, with additional tranches contingent on patient enrollment milestones [3][4] - Cash and investments as of December 31, 2024, are projected to be 8.9 million, which, along with the financing proceeds, should support the completion of the NEPHRO CRRT study [1][2] Group 3: Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings, with its lead product candidate, Niyad™, currently under investigation [8][10] - Niyad™ has received Breakthrough Device Designation from the FDA and is being studied as an anticoagulant for the extracorporeal circuit [10]