Nuvation Bio (NUVB) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update Second Quarter 2025 Highlights Nuvation Bio achieved key Q2 2025 milestones, including FDA approval for IBTROZI™ for ROS1+ NSCLC, successful patient enrollment, NCCN guideline inclusion, and a strong balance sheet - Received U.S. Food and Drug Administration (FDA) approval for IBTROZI™ (taletrectinib) on June 11, 2025, for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)[1] - Successfully started 70 patients on IBTROZI as of July 31, 2025, approximately seven weeks after U.S. FDA approval[1] - National Comprehensive Cancer Network® added taletrectinib (IBTROZI) as a Preferred Option to Clinical Practice Guidelines in Oncology for advanced ROS1+ NSCLC on June 20, 2025[1] Cash, Cash Equivalents, and Marketable Securities | As of Date | Amount (Millions) | | :---------- | :---------------- | | June 30, 2025 | $607.7 | CEO Commentary CEO highlighted IBTROZI's rapid FDA approval, swift patient delivery, efficacy, safety, NCCN preferred status, and pipeline progress - Nuvation Bio swiftly evolved into a commercial-stage company, delivering IBTROZI to 70 patients in seven weeks post-FDA approval[3] - IBTROZI's efficacy, safety, and once-daily dosing led to its rapid designation as a preferred option in NCCN guidelines for advanced ROS1-positive NSCLC across lines of therapy[3] - The company is advancing its broader pipeline, with safusidenib moving towards pivotal trials in IDH1-mutant glioma and NUV-1511 progressing through an early study in advanced solid tumors[3] Recent Corporate Highlights: Product & Pipeline Key product and pipeline advancements include IBTROZI's FDA approval, successful initial patient uptake, NCCN guideline inclusion, new data demonstrating superior outcomes, and updated trial designs for safusidenib and NUV-1511 - IBTROZI (taletrectinib) received U.S. FDA approval in June 2025 for adult patients with locally advanced or metastatic ROS1+ NSCLC[4] - As of July 31, 2025, 70 patients have started treatment with IBTROZI, prescribed by over 50 different prescribers[4] - Taletrectinib (IBTROZI) was added as a Preferred Agent in the NCCN Guidelines® for NSCLC in June 2025, for both first-line and subsequent therapy for ROS1+ NSCLC, including specific recommendations for brain metastases and resistance mutations[9] - New data presented at ISPOR 2025 showed significantly improved outcomes for IBTROZI versus entrectinib in TKI-naïve ROS1+ NSCLC[9] - The randomized Phase 2 study of safusidenib in diffuse IDH1-mutant glioma has an updated trial design to evaluate maintenance treatment against placebo in high-grade IDH1-mutant glioma, with ongoing discussions with the FDA for registration-enabling trials[9] - An update from the Phase 1/2 dose escalation study of NUV-1511 in advanced solid tumors is expected in the second half of 2025[5] Corporate Updates: Financing Nuvation Bio secured $200 million in non-dilutive financing from Sagard Healthcare Partners in June 2025, following IBTROZI's FDA approval - Received $200 million in non-dilutive financing from Sagard Healthcare Partners in June 2025, following U.S. FDA approval of IBTROZI[6] - The financing includes $150 million in royalty interest financing and $50 million under a term loan[6] - The Company has access to an additional $50 million under the term loan at its option until June 30, 2026[6] Second Quarter 2025 Financial Results Overview of Financial Position As of June 30, 2025, Nuvation Bio maintained a strong financial position with substantial cash, cash equivalents, and marketable securities Cash, Cash Equivalents, and Marketable Securities (as of June 30, 2025) | Category | Amount (Millions) | | :------- | :---------------- | | Total | $607.7 | Revenue Analysis Nuvation Bio began generating product revenue from IBTROZI sales in June 2025, totaling $1.2 million for the quarter, with collaboration and license agreements revenue also increasing significantly year-over-year - Product revenue, net from U.S. sales of IBTROZI was approximately $1.2 million for the three months ended June 30, 2025, generated from 13 business days of sales post-FDA approval[8] - Collaboration and license agreements revenue increased to $3.6 million for Q2 2025, up from $1.4 million in Q2 2024, primarily due to increases in product supply, royalty revenue, and R&D service revenue under the Innovent collaboration[10] - The company anticipates taletrectinib will be listed on China's National Reimbursement Drug List in 2026[10] Operating Expenses Research and development expenses decreased year-over-year due to reduced third-party costs and a shift towards commercial drug production, while selling, general, and administrative expenses significantly increased due to sales and marketing efforts and personnel costs Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :--------------------------- | :----------------- | :----------------- | :----------- | | Research and Development | $27.4 | $29.3 | -$1.9 | | Selling, General, and Administrative | $38.5 | $16.2 | +$22.3 | - R&D decrease was due to a $4.3 million decrease in third-party costs (NDA preparation in prior period) and a $1.8 million shift to commercial drug production, partially offset by a $3.2 million increase in salaries and benefits and a $1.0 million increase in stock compensation[11] - SG&A increase was driven by a $10.9 million increase in sales and marketing, a $10.3 million increase in personnel-related costs, a $1.5 million increase in stock compensation, and a $0.9 million increase in other expenses for commercial launch systems[12] Net Loss Nuvation Bio reported a significantly reduced net loss for Q2 2025 compared to the prior year, primarily due to the absence of a large acquisition-related charge Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------- | :----------------- | :----------------- | :----------- | | Net Loss | $(59.0) | $(462.5) | +$403.5 | | EPS | $(0.17) | $(1.89) | +$1.72 | - The substantial decrease in net loss from Q2 2024 was primarily due to the prior period's net loss being driven by the acquisition of AnHeart Therapeutics[13] Conference Call Information Conference Call and Webcast Details Nuvation Bio hosted a conference call and webcast on August 7, 2025, to discuss its Q2 2025 financial results and business updates, with access details provided for investors and the public - Nuvation Bio hosted a conference call and webcast on Thursday, August 7, 2025, at 8:00 a.m. ET[14] - Investors and the public could access the live webcast via the Investor Relations section of Nuvation Bio's website or by dialing +1 833-470-1428 (U.S. toll-free) with access code 926066[15] - An archived recording of the webcast will be available on Nuvation Bio's website for 90 days[15] Product Information: IBTROZI About ROS1+ NSCLC ROS1+ non-small cell lung cancer (NSCLC) affects approximately 2% of NSCLC patients globally, with a significant portion experiencing brain metastases, highlighting a critical need for more effective and tolerable treatments - Approximately 2% of patients with NSCLC have ROS1+ disease[16