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(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 85-0862255 ( State or other jurisdiction o ...

Nuvation Bio (NUVB) Q2 2025 Earnings Call August 07, 2025 08:00 AM ET Speaker0Innovation Bio's Second Quarter twenty twenty five Earnings Conference Call. Earlier today, we released financial results for the quarter ending 06/30/2025, and provided a business update. The press release is available on the Investors section of our website at nuvationbio.com. A recording of this conference call can also be found on the Investors section of our website following its completion. I'd like to remind you that today' ...

Exhibit 99.1 Nuvation Bio Reports Second Quarter 2025 Financial Results and Provides Business Update Received U.S. Food and Drug Administration (FDA) approval for IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1- positive (ROS1+) non-small cell lung cancer (NSCLC) on June 11, 2025 Successfully started 70 patients on IBTROZI as of July 31, 2025, approximately seven weeks after U.S. FDA approval National Comprehensive Cancer Network® added taletrectinib (IBTROZI) as a Preferred Opt ...

Core Viewpoint - Nuvation Bio Inc. (NUVB) has been upgraded to a Zacks Rank 2 (Buy), indicating an upward trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in a company's earnings picture, which is a strong predictor of near-term stock price movements [2][4]. - Rising earnings estimates for Nuvation Bio suggest an improvement in the company's underlying business, likely leading to an increase in stock price [5][10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly Zacks Rank 1 stocks averaging a +25% annual return since 1988 [7]. - The upgrade of Nuvation Bio to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a favorable earnings estimate revision trend [10]. Earnings Estimate Revisions - Nuvation Bio is projected to earn -$0.68 per share for the fiscal year ending December 2025, with no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Nuvation Bio has increased by 1.4%, reflecting positive sentiment among analysts [8].

IBTROZI (Taletrectinib) - IBTROZI获美国FDA批准用于治疗ROS1+ NSCLC[5,7,14,101] - IBTROZI还在中国获批用于治疗ROS1+ NSCLC[5,14,101] - IBTROZI对TKI-naive患者显示出高且持久的反应，中位DOR尚未达到[19,20] - IBTROZI在TKI预处理患者中也显示出显著效果，TRUST-II研究中ORR为62%[23,24] - IBTROZI具有良好的安全性，仅7%的患者因TEAEs导致停药[26] - IBTROZI对ROS1的选择性是TRKb的11-20倍[32] - 美国每年约有3000例新诊断的ROS1+ NSCLC患者[42] - IBTROZI的定价约为每年35万美元[42] - 理论上，美国ROS1+ NSCLC市场机会总额约为38亿美元[40] Safusidenib - Safusidenib将于2025年进入关键性研究，用于治疗弥漫性IDH1突变型胶质瘤[5,6,56] - Royalty Pharma以9.05亿美元收购了Vorasidenib未来美国销售额15%的特许权使用费[61,67] - 在低级别胶质瘤的早期研究中，Safusidenib的反应率是Vorasidenib在关键性INDIGO研究中的3倍[68,69] NUV-1511 - NUV-1511是一种DDC，正在进行1/2期研究，用于治疗晚期实体瘤[5,6,79,93] Financial Position - 截至2025年3月31日，Nuvation Bio拥有4.62亿美元的现金储备[5,102] - Nuvation Bio通过与Sagard Healthcare Partners的合作，获得了高达2.5亿美元的非稀释性资本[5,102,103]

Core Insights - Onco360 has been selected as a pharmacy partner by Nuvation Bio Inc. for IBTROZI™ (taletrectinib), a kinase inhibitor for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) [1] - The approval of IBTROZI is based on Phase 2 TRUST-I and TRUST-II studies involving over 300 patients [1][2] - IBTROZI is a next-generation ROS1 inhibitor therapy that is CNS-active and oral, targeting a rare and aggressive form of lung cancer that accounts for approximately 2% of new NSCLC cases in the U.S. [1] Company Overview - Onco360 is the largest independent Oncology Pharmacy in the U.S., founded in 2003 to meet the specialized needs of oncologists, patients, and healthcare facilities [14] - The company is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation [14] Product Information - IBTROZI is indicated for adult patients with ROS1-positive NSCLC, which has a median diagnosis age of around 50 years and is more common in non-smokers [1] - The drug has shown a significant potential in treating patients with advanced or metastatic ROS1-positive NSCLC, with approximately 3,000 new diagnoses annually in the U.S. [1] Safety and Efficacy - Hepatotoxicity is a notable risk, with 88% of patients experiencing increased AST levels and 85% experiencing increased ALT levels [2][3] - The median time to first onset of AST or ALT elevation is 15 days, with fatal liver events occurring in 0.6% of patients [2] - Interstitial Lung Disease (ILD) or pneumonitis occurred in 2.3% of patients, with a median onset time of 3.8 months [3][4] - The most frequently reported adverse reactions (≥20%) include diarrhea (64%), nausea (47%), and vomiting (43%) [12] Drug Interactions and Administration - IBTROZI should be administered on an empty stomach and should avoid concomitant use with strong and moderate CYP3A inhibitors [6][15] - The drug can cause significant QTc interval prolongation, which may increase the risk of serious cardiac events [5][6] Conclusion - The partnership between Onco360 and Nuvation Bio for IBTROZI represents a significant advancement in the treatment options available for patients with ROS1-positive NSCLC, addressing a critical need in oncology [1][14]

Summary of Nuvation Bio's Q1 2025 Financial Results and Business Update Conference Call Company Overview - **Company**: Nuvation Bio - **Product**: Eptrozi (formerly talatrectinib), a next-generation oral tyrosine kinase inhibitor (TKI) for advanced ROS1 positive non-small cell lung cancer (NSCLC) [2][4] Key Points and Arguments FDA Approval and Product Launch - Eptrozi received FDA approval, which is a significant milestone for Nuvation Bio and offers a new treatment option for patients with ROS1 positive NSCLC [2][4] - The approval was granted weeks ahead of the PDUFA date of June 23, indicating a strong regulatory review process [6][4] - Eptrozi is positioned as a best-in-class ROS1 inhibitor, with a focus on addressing the challenges faced by patients, including durability and tolerability [4][9] Clinical Data and Efficacy - Eptrozi's approval is supported by one of the largest global clinical trial programs for ROS1 positive lung cancer, with a safety database of over 400 patients [9][10] - In the TRUST one study, Eptrozi achieved a confirmed overall response rate (ORR) of 90% in TKI naive patients, with a median duration of response (DOR) not yet reached [11][12] - TRUST two study results showed an ORR of 85% in TKI naive patients, reinforcing the drug's efficacy [12][14] - Eptrozi demonstrated significant intracranial activity, with a confirmed intracranial ORR of 63% in patients with CNS metastases [16][17] Safety Profile - Eptrozi was generally well tolerated, with a low rate of treatment discontinuation due to adverse events (7%) [20][19] - Common adverse reactions included diarrhea, nausea, and dizziness, mostly low grade and manageable [18][19] - The drug's safety profile allows for convenient once-daily dosing without the need for dose loading or titration [20][19] Market Strategy and Commercial Infrastructure - Nuvation Bio has built a commercial infrastructure with 47 oncology account managers to facilitate the launch of Eptrozi [21][20] - The company aims to address testing barriers, as ROS1 testing rates lag behind other mutations, impacting patient access to targeted therapies [22][21] - Eptrozi is priced at $29,488 per month, which is competitive compared to existing therapies [25][54] Financial Position and Future Outlook - Following FDA approval, Nuvation Bio is poised to receive up to $250 million in non-dilutive financing, strengthening its balance sheet [27][54] - The company anticipates capturing a significant share of the ROS1 positive lung cancer market, projecting potential sales of $4 billion to $5.2 billion annually by year four [35][57] - Nuvation Bio is committed to expanding access to Eptrozi globally, with ongoing regulatory filings in other markets [26][27] Additional Insights - The company emphasizes the importance of patient impact, aiming to improve the quality of life for those affected by aggressive lung cancer [28][27] - Nuvation Bio is focused on increasing awareness and utilization of RNA-based testing, which is more sensitive than DNA testing for detecting ROS1 fusions [24][55] Conclusion Nuvation Bio's Q1 2025 conference call highlighted the successful FDA approval of Eptrozi, its robust clinical data supporting efficacy and safety, and a well-prepared commercial strategy to capture a significant market share in the ROS1 positive lung cancer space. The company is positioned for strong growth and aims to make a meaningful impact on patient lives.

Summary of Nuvation Bio (NUVB) FY Conference Call - May 28, 2025 Company Overview - **Company**: Nuvation Bio (NUVB) - **Focus**: Oncology, specifically targeting ROS1 positive lung cancer with the drug telotrectinib Key Industry Insights - **Upcoming Events**: Important PDUFA date for telotrectinib on June 23, 2025, and presentation at ASCO meeting regarding TRUST datasets [5][6] - **Market Dynamics**: Changes in NCCN guidelines have shifted treatment recommendations, potentially increasing the use of ROS1 agents [19][20] Core Data and Findings - **TRUST Studies**: TRUST one (China) and TRUST two (global) datasets show consistent efficacy and safety across different ethnic groups, with response rates of 89% in TKI naive patients and 52% in pretreated Asian patients [6][7][10] - **Comparative Efficacy**: Telotrectinib demonstrated a 58% reduction in risk of disease progression and a 52% reduction in risk of death compared to Roslitech, and a 52% reduction in PFS and 66% reduction in risk of death compared to crizotinib [11][12] - **Intracranial Response Rates**: 77% in naive patients and 66% in pretreated patients, highlighting the drug's effectiveness in addressing CNS metastases [16][17] Market Opportunities and Challenges - **Sales Growth**: TKI sales have increased by 20% since the new NCCN guidelines, indicating a growing market for ROS1 agents [20][21] - **Tolerability Issues**: Oktyra has faced challenges due to tolerability, with a 30% dropout rate per quarter, emphasizing the importance of good tolerability for long-term use [21][22] - **Patient Switching Dynamics**: Patients on first-generation TKIs may switch to telotrectinib if they experience intolerable side effects or disease progression [34][36] Regulatory and Approval Insights - **FDA Interactions**: Positive and responsive interactions with the FDA under breakthrough designation, with expectations for approval by the PDUFA date [37][38] - **Labeling Discussions**: Ongoing discussions regarding labeling, with no advisory committee required for approval [39][40] Future Plans and Partnerships - **European Market**: Actively seeking partnerships in Europe, with existing partnerships in Japan and China for telotrectinib [50][51] - **Pricing Strategy**: Anticipated pricing to be similar to existing competitors, with a monthly cost around $30,000 [53] Additional Research and Development - **IDH1 Mutant Product**: Ongoing phase two study for glioma, with plans for a pivotal study based on upcoming data [57][62] - **Response Rates in Glioma**: Previous ORR in low-grade glioma was 33%, significantly higher than the INDIGO study's 11% [59][60] Conclusion - **Commercial Focus**: Nuvation Bio is committed to launching telotrectinib effectively, leveraging experienced teams and focusing on patient therapy metrics as key indicators of success [47][48]

Summary of Nuvation Bio Conference Call Company Overview - **Company**: Nuvation Bio - **Focus**: Development of innovative therapies, particularly in oncology, with a strong emphasis on ROS1 inhibition for non-small cell lung cancer [1][2] Key Points and Arguments Drug Development and FDA Approval - Nuvation Bio is on the verge of receiving FDA approval for its first drug, **telotrectinib**, a ROS1 inhibitor targeting ROS1-driven non-small cell lung cancers [3][4] - The New Drug Application (NDA) was submitted last year and accepted with priority review, with a PDUFA date set for **June 23** [4][9] - Telotrectinib shows an **overall response rate of 89%** and a **progression-free survival (PFS) of 46 months**, significantly outperforming standard care options [5][10] Patient Outcomes - The drug has demonstrated long-term PFS, with some patients remaining progression-free for **up to nine years** [6][10] - The average age of patients with ROS1 lung cancer is around **50 years**, with a significant number developing brain metastases early in the disease [4][5] Competitive Landscape - Nuvation Bio is the only ROS1 agent in development with **breakthrough designation** in both first and second-line settings [8][36] - The company has a robust safety database with over **400 patients** and a follow-up time of up to **nine years** [37] Market Opportunity - The potential market for telotrectinib is estimated at nearly **$4 billion annually** based on current DNA testing, with expectations to exceed **$5 billion** once RNA testing becomes standard [24][25] - The company anticipates commanding a significant share of this market due to its favorable drug profile [25] Launch Preparations - The commercial team is fully prepared for an immediate launch upon FDA approval, leveraging prior experience from successful launches at Medivation [18][20] - The team is confident in the drug's value proposition and market opportunity, despite acknowledging that launches can be challenging [23] Regulatory Changes - Recent updates to NCCN guidelines now contraindicate the use of immunotherapy for patients with ROS1 mutations, which is expected to shift treatment dynamics significantly [14][15] Pipeline and Future Developments - Nuvation Bio is also developing **safacitinib**, a mutant IDH1 inhibitor, which has shown promising response rates in glioma [39][40] - The company is exploring the potential of safacitinib as a new generation oral immuno-oncology agent [42] - The drug-drug conjugate platform, including candidate **1511**, is currently in clinical trials for various difficult-to-treat cancers [45] Financial Position - Nuvation Bio has **$62 million** on its balance sheet and expects to access an additional **$250 million** in non-dilutive capital upon approval [47] - The company is actively seeking new opportunities to bolster its pipeline, with a focus on innovative deals [48] Additional Important Insights - The launch in China has been positively received, with endorsements from medical organizations, indicating strong potential for international markets [32][33] - The company is committed to increasing awareness and testing rates for ROS1 mutations, which could further enhance patient identification and treatment rates [28][29] This summary encapsulates the critical insights from the Nuvation Bio conference call, highlighting the company's strategic positioning, drug development progress, and market opportunities.