Nuvation Bio (US:NUVB)2025-03-06 22:12Financial Position - Nuvation Bio reported a strong balance sheet with cash, cash equivalents, and marketable securities totaling $502.7 million as of December 31, 2024[1]. - Nuvation Bio's total assets decreased to $540.6 million as of December 31, 2024, down from $621.5 million in 2023[17]. - The accumulated deficit increased to $910.7 million as of December 31, 2024, compared to $342.8 million in 2023[17]. Revenue and Profitability - Revenue for Q4 2024 was $5,711,000 compared to $0 in Q4 2023, indicating a significant increase[18]. - Gross profit for the year ended December 31, 2024, was $795,000, up from $0 in 2023[18]. - Comprehensive loss for the year ended December 31, 2024, was $567,547,000, compared to $70,095,000 in 2023[18]. Expenses - Research and development expenses for Q4 2024 were $29.3 million, a significant increase from $15.4 million in Q4 2023, primarily due to personnel-related costs from the acquisition of AnHeart Therapeutics[7]. - Selling, general, and administrative expenses rose to $26.1 million in Q4 2024, compared to $5.5 million in Q4 2023, driven by increased personnel and marketing expenses[9]. - Total operating expenses for Q4 2024 were $55,437,000, a substantial increase from $20,831,000 in Q4 2023[18]. - The company reported a significant increase in total operating expenses for the year, totaling $593,422,000 compared to $99,822,000 in 2023[18]. Net Loss - Nuvation Bio reported a net loss of $49.4 million, or $(0.15) per share, for Q4 2024, compared to a net loss of $13.8 million, or $(0.06) per share, in the same period of 2023[10]. - Net loss for Q4 2024 was $49,445,000, compared to a net loss of $13,787,000 in Q4 2023[18]. - Net loss per share attributable to common stockholders for Q4 2024 was $(0.15), compared to $(0.06) in Q4 2023[18]. Financing and Funding - The company secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners, which includes $150 million in royalty interest financing and $50 million in debt upon FDA approval of taletrectinib by September 30, 2025[5]. - Interest income for the year ended December 31, 2024, was $27,062,000, up from $24,611,000 in 2023[18]. Product Development and Regulatory Updates - The FDA accepted and granted Priority Review to the NDA for taletrectinib for advanced ROS1-positive NSCLC, with a PDUFA goal date set for June 23, 2025[3]. - Taletrectinib has been approved by China's NMPA for adult patients with locally advanced or metastatic ROS1+ NSCLC, with Innovent Biologics commercializing the drug in Greater China[8]. - The company launched an Expanded Access Program in the U.S. for taletrectinib in February 2025, allowing eligible patients to access the drug outside of clinical trials[8]. Shareholder Information - The weighted average common shares outstanding increased to 336,934 in Q4 2024 from 218,993 in Q4 2023[18].