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Nuvation Bio (NUVB)
NYSE:NUVB
US Market

Nuvation Bio (NUVB) AI Stock Analysis

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Nuvation Bio

(NYSE:NUVB)

Rating:45Neutral
Price Target:
Nuvation Bio's stock is primarily challenged by weak financial performance, characterized by ongoing losses and negative cash flows, despite a strong equity foundation. While there is short-term momentum in the stock price, the lack of sustainable income and negative valuation metrics, such as a negative P/E ratio, weigh heavily on the overall score. The stock's speculative nature and reliance on future growth prospects contribute to its moderate overall score.
Positive Factors
Market Penetration
Nuvation expects higher market penetration than the conservative 30% assumption, mainly due to higher mPFS vs peers, CNS efficacy, and a better safety profile.
Market Position
IBTROZI could rapidly ascend to best-in-disease status relative to competitors, while other agents remain sidelined due to lack of efficacy against CNS metastases.
Regulatory Approval
The FDA granted full approval to IBTROZI (taletrectinib) for the treatment of advanced ROS1+ non-small cell lung cancer on a line-agnostic basis.
Negative Factors
Competitive Pressure
Upcoming catalyst from NUVL puts pressure on NUVB: Investors are also looking at Nuvalent's potentially pivotal data in 2Q25 in late-line ROS1+ NSCLC.
Market Dynamics
The FDA granted priority review status to taletrectinib in ROS1+ NSCLC, indicating a significant market opportunity despite a crowded space.

Nuvation Bio (NUVB) vs. SPDR S&P 500 ETF (SPY)

Nuvation Bio Business Overview & Revenue Model

Company DescriptionNuvation Bio Inc., a clinical-stage biopharmaceutical company, focuses on the development of therapeutic candidates for oncology. The company's lead product candidate is NUV-422, a small molecule inhibitor targeting cyclin-dependent kinase (CDK)2, CDK4, and CDK6. It is also developing NUV-868, a selective oral small molecule BET inhibitor that epigenetically regulates proteins that control tumor growth and differentiation; NUV-569, a differentiated oral small molecule selective inhibitor of the Wee1 kinase for DNA damage repair; NUV-1182, an adenosine receptor inhibitor; and drug-drug conjugate (DDC) platform that focuses on targeting an inhibitor of poly ADP ribose polymerase (PARP) to anti-cancer warheads of existing drugs, as well as PARP inhibitor to address ER+ breast and ovarian cancer. The company was formerly known as RePharmation Inc. and changed its name to Nuvation Bio Inc. in April 2019. Nuvation Bio Inc. was founded in 2018 and is headquartered in New York, New York.
How the Company Makes MoneyNuvation Bio makes money primarily through the development and commercialization of its pharmaceutical products. The company generates revenue from various streams, including partnerships with other biotech and pharmaceutical companies, licensing agreements, and potential future sales of its drug candidates once they receive regulatory approval. Significant partnerships with industry players or research institutions can also provide funding and collaborative opportunities, contributing to the company's financial growth. Additionally, Nuvation Bio may engage in strategic collaborations to enhance its research and development capabilities, which can also lead to milestone payments and royalties that serve as key revenue streams.

Nuvation Bio Earnings Call Summary

Earnings Call Date:May 07, 2025
(Q1-2025)
|
% Change Since: -8.82%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook with strong confidence in the potential approval and market launch of taletrectinib. The company highlighted its robust financial position and pipeline development, although there were concerns about increased expenses and gaps in patient testing and diagnosis.
Q1-2025 Updates
Positive Updates
Potential FDA Approval of Taletrectinib
Taletrectinib, a next-generation ROS1 inhibitor, is under priority review by the FDA with a PDUFA date set for June 23, 2025. It has shown an 89% confirmed overall response rate and a median progression-free survival of 46 months in treatment-naïve patients.
Strong Financial Position
Nuvation Bio ended the quarter with $461.7 million in cash and marketable securities, excluding a $250 million non-dilutive financing agreement with Sagard Healthcare Partners. This positions the company well for the potential launch and further pipeline development without needing additional capital.
Commercial Readiness and Experienced Team
The commercial team is prepared for launch with a strategy focused on early use and long-term persistence, leveraging a team with extensive experience in launching oncology therapies.
Pipeline Development Beyond Taletrectinib
Nuvation Bio is advancing additional pipeline candidates, including safusidenib for IDH1 mutant glioma, NUV-1511 from its drug conjugate platform, and NUV-868, a BD2-selective BET inhibitor.
Negative Updates
Increased Net Loss and SG&A Expenses
Net loss increased due to pre-commercial build-out, with SG&A expenses of $35.4 million driven by commercial hiring and strategic investments.
Challenges with Testing and Diagnosis
Up to 64% of non-small cell lung cancer patients potentially eligible for precision oncology treatments have not yet received a targeted therapy, indicating a significant gap in care delivery that the company needs to address.
Company Guidance
During the Nuvation Bio First Quarter 2025 Financial Results and Business Update Conference Call, the company provided extensive guidance on their upcoming plans and metrics. They are preparing for the potential FDA approval of taletrectinib on June 23, 2025, a ROS1 inhibitor targeting non-small-cell lung cancer, which has shown an 89% overall response rate (ORR) and a median progression-free survival (PFS) of 46 months in clinical trials. The team reported a cash runway of $461.7 million, with an additional $250 million in non-dilutive financing from Sagard Healthcare Partners, ensuring financial stability without needing further capital to achieve profitability. The company is focusing on commercial readiness with a team of 47 oncology account managers and expects to address an estimated U.S. market of 3,000 new ROS1 positive lung cancer patients annually. They emphasized the importance of metrics such as ORR, PFS, duration of response, and safety profile, alongside strategic priorities like educating healthcare providers and enhancing patient testing and identification.

Nuvation Bio Financial Statement Overview

Summary
Nuvation Bio faces significant financial challenges, marked by consistent net losses and negative cash flows, despite a strong equity base and low leverage. The recent revenue increase is a positive sign, yet operational and cash flow improvements are necessary for long-term sustainability. The company's financial health is currently weak, primarily due to its inability to generate positive net income and operating cash flow.
Income Statement
25
Negative
Nuvation Bio has struggled with profitability, exhibiting a negative net profit margin due to substantial net losses over the years. Although there was a notable revenue increase in 2024, margins remain negative, highlighting ongoing operational challenges. The absence of revenue in prior years underscores the lack of stable income streams.
Balance Sheet
40
Negative
The company maintains a strong equity position with a debt-to-equity ratio that indicates low leverage, which is a positive aspect. However, the persistent negative net income has affected the return on equity, which is currently unfavorable. The equity ratio is high, showing that the company is mainly financed through equity, which can be advantageous in managing financial risk.
Cash Flow
30
Negative
Nuvation Bio's cash flow statement reveals a lack of positive operating cash flow, with free cash flow also being negative. This signifies potential issues in cash generation from operations. The company has been relying on financing activities to support cash needs, which may not be sustainable in the long term.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
10.96M7.87M0.000.000.000.00
Gross Profit
1.54M795.00K-222.00K-484.00K-368.00K-103.00K
EBIT
-206.36M-592.63M-99.82M-119.73M-93.32M-43.55M
EBITDA
-611.35M-566.91M-99.60M-119.53M-89.35M-43.45M
Net Income Common Stockholders
-606.38M-567.94M-75.80M-88.66M-79.73M-39.50M
Balance SheetCash, Cash Equivalents and Short-Term Investments
461.68M502.69M611.21M661.01M765.39M215.75M
Total Assets
492.49M540.63M621.48M672.14M776.15M221.79M
Total Debt
11.41M8.91M4.01M4.26M3.06M0.00
Net Debt
-36.56M-26.81M-38.64M-96.84M-129.37M-29.75M
Total Liabilities
73.03M76.84M16.36M17.07M30.15M6.71M
Stockholders Equity
419.46M463.79M605.12M655.08M746.00M215.08M
Cash FlowFree Cash Flow
-114.85M-130.57M-68.07M-96.48M-68.47M-36.67M
Operating Cash Flow
-114.71M-130.41M-68.00M-96.11M-68.19M-36.53M
Investing Cash Flow
169.34M122.70M8.92M63.46M-454.67M-70.32M
Financing Cash Flow
858.00K331.00K628.00K1.33M625.53M133.13M

Nuvation Bio Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.86
Price Trends
50DMA
2.13
Negative
100DMA
2.13
Negative
200DMA
2.40
Negative
Market Momentum
MACD
-0.04
Positive
RSI
38.43
Neutral
STOCH
10.06
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NUVB, the sentiment is Negative. The current price of 1.86 is below the 20-day moving average (MA) of 2.24, below the 50-day MA of 2.13, and below the 200-day MA of 2.40, indicating a bearish trend. The MACD of -0.04 indicates Positive momentum. The RSI at 38.43 is Neutral, neither overbought nor oversold. The STOCH value of 10.06 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NUVB.

Nuvation Bio Risk Analysis

Nuvation Bio disclosed 85 risk factors in its most recent earnings report. Nuvation Bio reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Nuvation Bio Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$892.37M-63.56%270.02%32.69%
54
Neutral
$5.34B3.27-45.10%3.30%16.80%0.02%
52
Neutral
$654.06M-33.48%-25.88%-29.16%
50
Neutral
$676.09M-79.02%-50.69%8.01%
48
Neutral
$545.36M34.94%
45
Neutral
$632.89M-119.66%-551.08%
40
Underperform
$315.67M-60.45%6.99%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
NUVB
Nuvation Bio
1.86
-1.04
-35.86%
ABUS
Arbutus Biopharma
3.58
0.57
18.94%
XNCR
Xencor
9.05
-10.39
-53.45%
RCKT
Rocket Pharmaceuticals
2.88
-17.80
-86.07%
PRAX
Praxis Precision Medicines
43.81
6.12
16.24%
BCAX
Bicara Therapeutics Inc.
10.00
-15.41
-60.65%

Nuvation Bio Corporate Events

Executive/Board ChangesBusiness Operations and Strategy
Nuvation Bio CEO Departs After Achieving Key Goals
Neutral
Feb 12, 2025

On February 12, 2025, Dr. Jerry Wang, CEO of AnHeart Therapeutics, a subsidiary of Nuvation Bio Inc., departed the company after achieving key goals, including regulatory approvals for taletrectinib in China and the U.S., and the integration of AnHeart Therapeutics post-merger. Dr. Wang’s departure was not due to any disagreements, and his role as CEO was deemed unnecessary following these accomplishments.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.