Talphera, Inc. reported significant financial challenges in its latest 10-Q filing for the quarter ending September 30, 2024. The company recorded no revenue for both the three and nine months ended September 30, 2024, a stark decline from $117,000 and $370,000 in the same periods of 2023, respectively. This drop is attributed to the divestment of its DSUVIA product line, which has created uncertainty regarding future sales, particularly to the U.S. Department of Defense (DoD).

The company's total operating expenses for the three months ended September 30, 2024, were $3.7 million, slightly up from $3.4 million in the prior year. Research and development expenses surged to $2.1 million for the quarter, compared to $1.2 million in 2023, reflecting increased investment in the development of its key product candidates, Niyad and LTX-608. Despite the rise in expenses, total operating costs for the nine months decreased to $12.3 million from $13.0 million in 2023.

Talphera's net loss for the three months ended September 30, 2024, was $3.4 million, compared to a loss of $1.4 million in the same period last year. For the nine months, the net loss was $11.1 million, a slight improvement from $13.9 million in 2023. The basic and diluted loss per share for the quarter was $(0.13), up from $(0.08) in 2023, while for the nine months, it was $(0.43), down from $(1.08).

The company’s financial position showed a cash and cash equivalents balance of $11.1 million as of September 30, 2024, an increase from $5.7 million at the end of 2023. This increase was bolstered by financing activities, which provided $12.0 million in the nine months, primarily from a private placement and the monetization of future payments related to DSUVIA.

Strategically, Talphera has focused on its product development pipeline, particularly Niyad, which has received Breakthrough Device Designation from the FDA. The company has also entered into significant agreements, including a Purchase Agreement with XOMA for $8.0 million related to future payments from Alora, and a private placement that raised $6.0 million in January 2024.

Despite these efforts, Talphera continues to face substantial doubt about its ability to continue as a going concern, as it has incurred recurring operating losses and negative cash flows since inception. The company anticipates needing additional capital to fund operations within the next twelve months, with plans to explore various capital-raising methods, including public and private equity offerings.