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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
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 its agreement with the FDA to reduce the size of the NEPHRO CRRT study to 70 patients from the 166 previously included in the study protocol. The Company also announced it has entered into securities purchase agreements with certain institutional investors and a member of management for the
About this update from Talphera, Inc.
[{"type":"text","content":"The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 patients, of which 6 patients are already enrolled","length":174,"tagName":"p","attribs":{}},{"type":"text","content":"Talphera believes the NEPHRO CRRT study should be completed by the end of 2025","length":78,"tagName":"p","attribs":{}},{"type":"text","content":"Existing investors, Nantahala Capital and Rosalind Advisors led the capital commitment priced at-the-market as defined by Nasdaq rules","length":134,"tagName":"p","attribs":{}},{"type":"text","content":"$4.925 million in gross proceeds at first closing with the potential to receive an additional $9.85 million across two $4.925 million tranches upon achieving certain patient enrollment milestones","length":195,"tagName":"p","attribs":{}},{"type":"text","content":"Cash and investments at December 31, 2024 of $8.9 million, together with the expected proceeds from the financing of up to $14.8 million should provide capital through targeted completion of the NEPHRO CRRT study by the end of 2025","length":231,"tagName":"p","attribs":{}},{"type":"text","content":"SAN MATEO, Calif., March 31, 2025 /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 its agreement with the FDA to reduce the size of the NEPHRO CRRT study to 70 patients from the 166 previously included in the study protocol. The Company also announced it has entered into securities purchase agreements with certain institutional investors and a member of management for the sale and issuance of shares of common stock and pre-funded warrants in lieu of shares to purchase common stock in a three-tranche private placement for potential gross proceeds of up to $14.8 million.","length":756,"tagName":"p"},{"type":"text","content":""We are pleased that the FDA agreed with our assessment to reduce the study size to 70 patients, which still keeps the study's primary endpoint powered at 90%," stated Vince Angotti, Talphera CEO. "This change, along with the other protocol changes to the study inclusion criteria and the addition of new sites with higher enrollment potential will support a timely completion of the...