Financial Performance - The net loss from continuing operations for Q4 2024 was $1.9 million, compared to a net loss of $4.5 million in Q4 2023, reflecting improved financial performance[10] - The net loss attributable to common shareholders for Q4 2024 was $1.9 million, or $0.07 per share, compared to a net loss of $4.5 million, or $0.25 per share, in Q4 2023[10] - Talphera reported cash and investments of $8.9 million as of December 31, 2024, and announced a private placement financing of up to $14.8 million[10] - The company recognized no revenue for Q4 2024, consistent with Q4 2023, while total revenue for the year was $0 compared to $651,000 in 2023[18] Expenses and Cost Management - Combined R&D and SG&A expenses for Q4 2024 totaled $3.0 million, down from $4.6 million in Q4 2023, primarily due to reductions in personnel and administrative expenses[10] - Talphera expects cash operating expenses in 2025 to be between $18 million and $19 million, including costs related to the NEPHRO CRRT trial[7] - Research and development expenses for Q4 2024 were $1.323 billion, a decrease from $1.769 billion in Q4 2023, representing a decline of about 25.2%[21] - Selling, general and administrative expenses for Q4 2024 were $1.673 billion, down from $2.795 billion in Q4 2023, reflecting a decrease of approximately 40.2%[21] - Total operating expenses for Q4 2024 were $2.996 billion, a decrease from $4.564 billion in Q4 2023, indicating a decline of about 34.4%[21] - Non-GAAP operating expenses for the year ended December 31, 2024, were $14.263 billion, down from $15.830 billion in 2023, representing a decrease of approximately 9.9%[21] - Stock-based compensation expense for the year ended December 31, 2024, was $989 million, down from $1.710 billion in 2023, indicating a decrease of about 42.0%[21] - The company is focusing on cost reduction strategies, as evidenced by the significant decrease in both operating expenses and stock-based compensation[21] Assets and Liabilities - Cash, cash equivalents, and investments decreased to $8.863 billion in 2024 from $9.381 billion in 2023, representing a decline of approximately 5.5%[20] - Total assets decreased to $18.236 billion in 2024, down from $20.395 billion in 2023, reflecting a decrease of about 10.6%[20] - Total liabilities increased significantly to $10.235 billion in 2024, compared to $6.290 billion in 2023, marking an increase of approximately 62.5%[20] - Total stockholders' equity fell to $8.001 billion in 2024, down from $14.105 billion in 2023, indicating a decrease of around 43.4%[20] Clinical Trials and Product Development - The FDA approved a reduction in the NEPHRO CRRT study size from 166 to 70 patients, with a primary endpoint powered at 90%[4] - The company plans to complete the NEPHRO CRRT study by the end of 2025, supported by new site additions and increased enrollment potential[3] - Talphera's lead product candidate, Niyad™, is being studied as an anticoagulant and has received Breakthrough Device Designation from the FDA[11]
Talphera(TLPH) - 2024 Q4 - Annual Results