SAN MATEO, Calif., March 18, 2026 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will host a virtual investor and analyst event on Monday, March 23, 2026 at 11:00 AM ET featuring Blaithin McMahon, PhD, MBBChr (Medical University of South Carolina) and Joao Teixeira, MD (University of New Mexico), principal investigators in Talphera's NEPHRO CRRT study evaluating Niyad for continuous renal replacement therapy (CRRT). To register, click here.
The experts will discuss their experience with CRRT, the anticoagulants being used during CRRT today, and how they see Talphera's nafamostat filling a need. Nafamostat is a broad spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral properties with a variety of applications in medically supervised settings and has been the standard of care for CRRT anticoagulation in Japan and South Korea for over three decades. The Company's lead product candidate, Niyad, a lyophilized form of nafamostat, leverages the ultrashort half-life of nafamostat and its potent anticoagulant effects for potential use as a regional anticoagulant during CRRT in patients who cannot tolerate heparin or who have an increased risk of bleeding. Heparin is the only FDA approved anticoagulant for use in CRRT but it is not safe for patients with a high risk of bleeding or heparin intolerance. Citrate, the only other anticoagulant being used for CRRT, is used off-label, is complex to administer, cannot be used in liver impaired patients, and is principally only used by large academic institutions with the resources to monitor administration.
A live question and answer session will follow the formal presentations.
About Blaithin McMahon, PhD, MBBChr
Blaithin McMahon, PhD, MBBChr is an Associate Professor of Medicine at the Medical University of South Carolina. She did her medical residency and nephrology fellowship training at the Johns Hopkins Hospital, Baltimore, from 2011-2016. In July 2016, she joined the nephrology faculty at the Johns Hopkins Hospital prior to moving to MUSC in September 2018. Dr. McMahon's key research is in the field of Acute Kidney Injury (AKI). She has published over 50 papers in leading peer reviewed international nephrology medical journals and penned numerous editorials, commentaries, case reports, expert opinions, review papers, book chapters and has more than 1000 citations in this area of interest. She is the director of nephrology clinical trials at MUSC and is involved in several prospective national and international ICU studies ongoing in the area of Acute Kidney Injury and continuous kidney replacement therapy. Dr. McMahon is also the Director of CRRT at MUSC and is responsible for managing prescription protocols related to dialysis in the intensive care unit. She has been awarded multiple teaching awards at Johns Hopkins Hospital MUSC and University College Dublin.
About Joao Teixeira, MD
Joao Teixeira, MD is an Associate Professor in Divisions of Nephrology and Pulmonary, Critical Care, and Sleep Medicine in the Department of Internal Medicine (DOIM) at the University of New Mexico (UNM). He staffs the inpatient nephrology consult service and medical intensive care unit (ICU) at UNM Hospital (UNMH), works as medical co-director of a local outpatient hemodialysis unit, and serves as the director of the acute dialysis and continuous kidney replacement therapy (CRRT) programs at UNMH. He was previously the Training Program Director of UNM's Nephrology Fellowship and has served as Core Faculty in the Critical Care Medicine Fellowship and the Internal Medicine Residency. As a critical care nephrologist, his scholarly interests lie in all areas of overlap between the two fields, centering on AKI. He developed a critical care research program focused on diagnostics and therapeutics for AKI, CRRT, septic shock, vasopressor therapy, extracorporeal membrane oxygenation (ECMO), hepatorenal syndrome (HRS), COVID-19, and acute respiratory distress syndrome (ARDS). As an investigator, he has enrolled approximately 300 critically ill or hospitalized patients into more than a dozen investigator-initiated or industry-sponsored clinical trials. He has coauthored over 100 peer-reviewed publications, book chapters, and conference abstracts; he is on the editorial boards of three journals and has served as an ad hoc reviewer for several dozen other journals. He has served as invited faculty at over a dozen national and international conferences, including the National Kidney Foundation Spring Clinical Meeting, American Society of Nephrology Kidney Week, and European Society of Intensive Care Medicine.
About the NEPHRO CRRT Study
The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk of bleeding. The primary endpoint of the study is the mean post-filter activated clotting time on Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
About Niyad and Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or anti-viral treatment, amongst other potential targets.
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).
This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com
Forward-looking statements
This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: nafamostat's potential use as regional anticoagulant for CRRT. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
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