AcelRx Pharmaceuticals(ACRX) - 2024 Q3 - Quarterly Results

Financial Performance - Net loss from continuing operations for Q3 2024 was $3.4 million, compared to a net loss of $1.4 million in Q3 2023[7]. - Net loss attributable to common shareholders for Q3 2024 was $3.4 million, or $0.13 per share, compared to a net loss of $1.4 million, or $0.08 per share, in Q3 2023[8]. - Talphera's total operating costs and expenses for Q3 2024 were $3.7 million, compared to $3.4 million in Q3 2023[6]. - Total operating expenses for the three months ended September 30, 2024, were $3,749,000, slightly up from $3,426,000 in the same period last year[21]. - The company reported a total of $12,256,000 in operating expenses for the nine months ended September 30, 2024, compared to $12,976,000 for the same period in 2023[21]. Research and Development - Combined R&D and SG&A expenses for Q3 2024 were $3.7 million, up from $3.4 million in Q3 2023, primarily due to NEPHRO study costs[6]. - Research and development expenses for the three months ended September 30, 2024, were $2,053,000, up from $1,178,000 for the same period in 2023, representing a 74% increase[21]. - The NEPHRO CRRT study aims to enroll 166 patients across up to 14 clinical sites in the U.S.[4]. - The first patient was enrolled in the NEPHRO CRRT study in August 2024[3]. - The study's primary endpoint is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours[4]. - Talphera anticipates completing the NEPHRO study by the end of 2025 with improved enrollment rates[2]. Financial Position - Cash and investments totaled $11.1 million as of September 30, 2024[5]. - Cash, cash equivalents, and investments increased to $11,117,000 as of September 30, 2024, up from $9,381,000 at December 31, 2023[20]. - Total assets rose to $21,014,000, compared to $20,395,000 at the end of 2023[20]. - Total liabilities increased significantly to $11,373,000 from $6,290,000[20]. - Total stockholders' equity decreased to $9,641,000, down from $14,105,000[20]. Operating Expenses - Selling, general, and administrative expenses decreased to $1,696,000 for the three months ended September 30, 2024, from $2,248,000 in the prior year[21]. - Non-GAAP operating expenses for the three months ended September 30, 2024, were $3,515,000, compared to $3,048,000 in the prior year[21]. - Stock-based compensation expense for the three months ended September 30, 2024, was $234,000, down from $378,000 in the same period last year[21]. Regulatory Status - The company has received Breakthrough Device Designation status from the FDA for its lead product candidate, Niyad™[11].