Business
Talphera Announces Second Quarter 2024 Financial Results and Provides Corporate Update
NEPHRO CRRT study patient screening has initiated at multiple clinical sites The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT
About this update from Talphera, Inc.
[{"type":"text","content":"NEPHRO CRRT study patient screening has initiated at multiple clinical sites\nThe safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational study in 166 patients at up to 14 clinical sites\nCash and investments at June 30, 2024 of $14.0 million\nConference call and webcast to be held Wednesday, August 14, 2024 at 4:30 pm ET \nSAN MATEO, Calif., Aug. 14, 2024 /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 second quarter 2024 financial results and provided a corporate update.\n\"We're excited to have initiated the screening of patients at multiple clinical sites in the NEPHRO CRRT registrational study. We now have finalized clinical trial agreement terms with eight large academic institutions including our potentially highest enrolling sites. We have also received FDA approval to increase the maximum number of study sites from 10 to 14 which we believe will help expedite completion of the study,\" stated Vince Angotti, CEO of Talphera. \"The NEPHRO study should be enrolled and completed efficiently given the measurement of the primary endpoint is at 24 hours, with patients completing the study after 72 hours. In addition, having Breakthrough Device Designation from the FDA potentially provides an advantage for a timely approval of the product candidate next year. Nafamostat has the potential to address known disadvantages of currently available U.S. products for anticoagulation of the extracorporeal circuit and has been used, as a standard of care, in Japan and South Korea for over 30 years. We're looking forward to making nafamostat available to healthcare providers in the United States, if approved,\" continued Angotti.\nDr. Shakil Aslam, Talphera's Chief Development Officer, has been leading the NEPHRO CRRT study since joining the Company. Dr. Aslam's expertise in nephrology and his 20 years of experience in academia and drug and device development has already proven to be an asset. Oversight of the NEPHRO study transitioned to Dr. Aslam from Dr. Palmer, Talphera's Chief Medical Officer, who, after nearly two decades in this role, will be retiring in October. Upon Dr. Palmer's retirement, Dr. Aslam will succeed her a...