Nuvation Bio (US:NUVB)2025-11-03 21:15Product Performance - In Q3 2025, 204 new patients started treatment with IBTROZI, marking the company's first full quarter as a commercial-stage entity[1]. - IBTROZI's median Duration of Response (DOR) has increased to 50 months as of August 2025, demonstrating its durability in treating advanced ROS1-positive non-small cell lung cancer (NSCLC)[1][4]. - Net product revenue from U.S. sales of IBTROZI was approximately $7.7 million for the three months ended September 30, 2025[8]. - Product revenue for Q3 2025 was $7.72 million, compared to $0 in Q3 2024, indicating a strong market entry[39]. Revenue and Financial Performance - Total revenues for Q3 2025 reached $13.12 million, a significant increase from $727,000 in Q3 2024[39]. - Collaboration and license agreements revenue increased to $5.4 million in Q3 2025, up from $0.7 million in the same period in 2024, driven by a $3.8 million increase in research and development service revenue[10]. - Collaboration and license agreements revenue increased to $5.40 million in Q3 2025 from $727,000 in Q3 2024[39]. - Gross profit for Q3 2025 was $9.77 million, compared to a gross deficit of $788,000 in Q3 2024[39]. Expenses - Research and development expenses for Q3 2025 were $28.8 million, compared to $27.7 million in Q3 2024, reflecting increased clinical study costs[11]. - Research and development expenses for Q3 2025 totaled $28.85 million, slightly up from $27.73 million in Q3 2024[39]. - Selling, general, and administrative expenses rose to $37.4 million in Q3 2025, up from $19.6 million in Q3 2024, primarily due to increased personnel and marketing costs[12]. - Selling, general and administrative expenses rose to $37.36 million in Q3 2025 from $19.58 million in Q3 2024[39]. Net Loss and Financial Position - The company reported a net loss of $55.8 million, or $(0.16) per share, for Q3 2025, compared to a net loss of $41.2 million, or $(0.15) per share, in the same period in 2024[13]. - The net loss for Q3 2025 was $55.79 million, compared to a net loss of $41.21 million in Q3 2024[39]. - As of September 30, 2025, the company had a strong balance sheet with cash, cash equivalents, and marketable securities totaling $549.0 million[7]. - Cash and cash equivalents increased to $98.90 million as of September 30, 2025, up from $35.72 million at the end of 2024[38]. - Total assets as of September 30, 2025, were $601.56 million, compared to $540.63 million at the end of 2024[38]. Future Plans and Developments - The company plans to prepare a supplemental New Drug Application (sNDA) to include updated data in the IBTROZI label, with additional data expected to be presented at a medical conference in 2026[9]. - The first patient was enrolled in the TRUST-IV phase 3 study of IBTROZI for the adjuvant treatment of ROS1+ early-stage NSCLC in September 2025[9]. - The company expects to receive a $25 million milestone payment from Nippon Kayaku, which will support future growth initiatives[36].