Talphera Releases Q1 2024 Financial Results and Corporate Update

Talphera, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for medically supervised settings, has released its financial results for the first quarter of 2024 and provided a corporate update. The company is anticipating the enrollment of the first patients in the NEPHRO CRRT registrational study by the second quarter of 2024. This study is crucial to demonstrating the efficacy and safety of Niyad, Talphera's unique anticoagulant.

CEO Vince Angotti expressed enthusiasm about beginning patient enrollment to expedite the trial process, which measures its primary endpoint within 24 hours. Despite initial activation delays, discussions with principal investigators reflect an optimistic outlook for swift trial completion. Once patient enrollment begins, Talphera will offer an updated projection for the study's completion date. Additionally, the company has bolstered its team with the appointment of Dr. Shakil Aslam as Chief Development Officer, bringing over two decades of experience in renal and vascular diseases to the table.

Highlighting the initial quarter of 2024, Talphera underwent a corporate rebranding from AcelRx Pharmaceuticals, Inc. to Talphera, Inc. This change aligns with the company's strategic shift following the divestment of assets focused on acute pain and a renewed focus on developing products like Niyad. The company began trading under the ticker symbol "TLPH" on the Nasdaq Global Market starting January 10, 2024.

Financially, Talphera announced $26 million in committed capital in January 2024. This includes $8 million from a partial monetization of DSUVIA royalties and milestones with Xoma Royalty, and $18 million from equity investments by two existing investors. The equity investment is structured to release $6 million at the first closing, $10 million upon positive NEPHRO registration trial data, and an additional $2 million if Talphera's stock meets specific price criteria post-announcement.

As of March 31, 2024, Talphera reported cash and investments totaling $18.6 million. The company's combined R&D and SG&A expenses for the first quarter of 2024 were $4.2 million, a decrease from the $5.3 million reported in the same period in 2023. This reduction is attributed to a lower headcount following the divestment of DSUVIA.

The net loss from continuing operations was $4.0 million for the first quarter of 2024, contrasting with a net income of $0.1 million from continuing operations for the same period in 2023. This loss primarily resulted from changes in the fair value of the company's warrant liability. Net loss attributable to common shareholders was $4.0 million, or $0.16 per basic and diluted share, compared to a net loss of $8.2 million, or $0.75 per basic and diluted share, for the first quarter of 2023.

Talphera will host a conference call and webcast on May 14, 2024, at 4:30 p.m. ET to discuss these results and provide a business update. The webcast will feature a slide presentation and will be accessible on the Talphera website for 90 days post-event.

Talphera's lead product candidate, Niyad, is a lyophilized formulation of nafamostat being studied as an anticoagulant for the extracorporeal circuit under an investigational device exemption (IDE). The product has received Breakthrough Device Designation from the FDA. The NEPHRO CRRT study, now with central Institutional Review Board (IRB) approval, will be conducted across up to 10 U.S. hospital ICUs and will involve 166 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk of bleeding.

Dr. Aslam, who will join Talphera on May 20, 2024, brings with him a wealth of experience from roles at BioCryst Pharmaceuticals, Angion Biomedica, Fresenius Medical Care, Amgen, and as an assistant professor at Georgetown University Hospital, specializing in nephrology.

Talphera's strategic outlook involves leveraging its innovative product pipeline to support healthcare providers in optimizing clinical outcomes in medically supervised settings.