Talphera reports Q1 EPS (16c), consensus (22c)

The cash and cash equivalents balance was $18.6M as of March 31. “We are eager to have the first patient enrolled in the NEPHRO study so we can complete this pivotal trial and demonstrate the efficacy and safety of this unique anticoagulant. We have finalized clinical trial agreement terms with five large academic institutions and are awaiting these sites to complete their final internal start-up activities before patients are enrolled,” stated Vince Angotti, CEO of Talphera. “While the initial site activation has taken longer than expected, based on our ongoing discussions with the principal investigators, they are eager to get started and expect the trial will complete quickly given the primary endpoint is measured at 24 hours. As a result of the initial delays, we expect that our previous guidance of having top-line data available by September 30 will be revised. Once patients begin enrolling, we plan to provide an updated expected study completion date. Finally, the addition of Aslam to Talphera will provide significant nephrology expertise to the team and further support the development and commercial preparation of Niyad,” continued Angotti.