Talphera, Inc. reported a net loss of $13.0 million for the fiscal year ending December 31, 2024, a decrease from the $18.4 million loss recorded in 2023. The company's total revenue for 2024 was $0, compared to $0.7 million in 2023, primarily due to the divestment of its DSUVIA product line. As of December 31, 2024, Talphera's accumulated deficit stood at $457.2 million, with cash and cash equivalents totaling $8.9 million, a slight decrease from $9.4 million at the end of 2023. The company continues to face significant financial challenges, raising substantial doubt about its ability to continue as a going concern without additional capital.
In terms of operational developments, Talphera's research and development expenses increased by 21% to $6.7 million in 2024, driven by costs associated with the development of its lead product candidate, Niyad. Selling, general, and administrative expenses decreased by 29% to $8.5 million, attributed to the divestment of DSUVIA and a reduction in headcount. The company employed 13 full-time employees as of December 31, 2024, down from previous levels, reflecting its ongoing efforts to streamline operations.
Strategically, Talphera has focused on the development of Niyad, a regional anticoagulant for use in dialysis circuits, which has received Breakthrough Device Designation from the FDA. The company is currently conducting a registrational trial for Niyad, with plans to submit a Premarket Approval (PMA) application upon completion. In January 2024, Talphera entered into a Purchase Agreement with XOMA, selling rights to future payments related to DSUVIA for $8.0 million, which will help fund the development of Niyad. However, the discontinuation of DSUVIA sales efforts to non-Department of Defense customers by Alora Pharmaceuticals raises uncertainties regarding future revenue streams.
Looking ahead, Talphera anticipates needing additional capital to fund its operations and development activities, particularly for Niyad. The company has indicated that it may seek to raise funds through public or private equity offerings, debt securities, or strategic partnerships. The ongoing clinical trials and regulatory processes for Niyad are critical to its future success, and any delays or failures in these areas could significantly impact the company's financial condition and operational viability.
About TALPHERA, INC.
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