Talphera Reports Q2 2024 Financials and Corporate Update

Talphera, Inc., a specialty pharmaceutical company, has begun patient screening for its NEPHRO CRRT registrational study aimed at evaluating the safety and effectiveness of nafamostat. The study will involve 166 patients across up to 14 clinical sites. Vince Angotti, CEO of Talphera, expressed optimism about the study's progress, noting the finalized clinical trial agreements with eight major academic institutions. The FDA has approved expanding the number of study sites from 10 to 14, which is expected to accelerate the study's completion. The primary endpoint is measured at 24 hours, with patients completing the study within 72 hours. Nafamostat, used in Japan and South Korea for over 30 years, could address the shortcomings of current U.S. anticoagulation products.

Chief Development Officer Dr. Shakil Aslam, who joined the company in May 2024, is leading the NEPHRO CRRT study. Dr. Aslam's extensive background in nephrology and drug development is seen as a significant asset to the study. He takes over from Dr. Palmer, Talphera's retiring Chief Medical Officer, who will continue as a consultant until the study's completion. Angotti praised Dr. Palmer for her nearly two decades of service, highlighting her role in achieving U.S. and European drug approvals.

The NEPHRO CRRT study focuses on patients undergoing continuous renal replacement therapy (CRRT) and aims to compare the efficacy of nafamostat against a placebo in terms of post-filter activated clotting time over the first 24 hours. Secondary endpoints include filter lifespan, the number of filter changes, and dialysis efficacy over 72 hours.

Financially, Talphera reported $14.0 million in cash and investments as of June 30, 2024. The second quarter of 2024 saw combined R&D and SG&A expenses of $4.3 million, slightly up from $4.2 million in the same period the previous year. The net loss from continuing operations was $3.8 million, an improvement from the $4.4 million net loss in the second quarter of 2023. The reduction in net loss was attributed to changes in the fair value of the company's warrant liability. The divestment of DSUVIA, now a discontinued operation, did not incur any related expenses in the second quarter of 2024. The net loss attributable to common shareholders was $3.8 million, or $0.15 per share, compared to $4.4 million, or $0.40 per share, in the previous year.

Dr. Aslam's prior experience includes roles at BioCryst Pharmaceuticals, Angion Biomedica, Fresenius Medical Care, and Amgen. He was also an assistant professor at Georgetown University Hospital, specializing in acute and chronic kidney disease, hypertension, and renal transplantation.

Talphera's lead product candidate, Niyad, is a lyophilized formulation of nafamostat, currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit. The product has received Breakthrough Device Designation from the FDA. An ICD-10 procedural code has been issued for the extracorporeal introduction of nafamostat. Talphera is also exploring LTX-608, another nafamostat formulation, for potential treatments including acute respiratory distress syndrome (ARDS) and acute pancreatitis.

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