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Forward-looking statements Certain statements included in this presentation (this "Presentation") that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United S

Key Takeaway: Nuvation Bio has released forward-looking statements regarding its clinical programs and drug developments, particularly focusing on IBTROZI and safusidenib. IBTROZI, a ROS1 inhibitor, was approved for advanced ROS1+ NSCLC, with an encouraging start marked by 204 new patient starts in Q3 2025. The company also has robust cash reserves that may lead to profitability without additional funding. However, the outlook also brings attention to inherent risks associated with clinical studies and drug commercialization.

Market Sentiment Analysis

POSITIVE FACTORS

  • IBTROZI shows promising clinical results and commercial potential.
  • Nuvation Bio maintains a strong cash position of $549 million.
  • The launch of IBTROZI has been successful with 204 new patient starts in Q3 2025.

CONCERNS & RISKS

  • Forward-looking statements involve risks and uncertainties that may affect actual results.
  • Challenges in drug discovery and commercialization could impede progress.
  • Regulatory process might introduce difficulties in the development timeline.

Full Press Release Details

DRIVEN BY SCIENCE FOCUSED ON LIFE
November 2025 Exhibit 99.1
Forward-looking statements Certain
statements included in this presentation (this "Presentation") that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of
1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend,"
"expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that
predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding IBTROZI's and safusidenib's best-in-class therapeutic
potential, IBTROZI's commercial potential including its theoretical maximum ROS1+ NSCLC market opportunity based on IBTROZI's mPFS, our expectations that updated median duration of response results from taletrectinib TRUST-I and TRUST-II
studies can support a supplemental NDA for IBTROZI, our plans for safusidenib G203 study protocol amendment and patient enrollment, our expectations that such amended G203 study may support approval of safusidenib for the maintenance treatment of
high-grade IDH1-mutant glioma, our plans to share new data and updates from our clinical programs including taletrectinib, the potential of the DDC platform, our expectations regarding regulatory and reimbursement developments, and strength of pro
forma cash position providing a path to profitability without need to raise additional capital. These statements are based on various assumptions, whether or not identified in this Presentation, and on the current expectations of the management team
of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements,
including but not limited to the challenges associated with conducting drug discovery and commercialization and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data;
physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on November 3, 2025 under the heading "Risk Factors," and other
documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Presentation. Nuvation Bio disclaims any obligation or
undertaking to update, supplement or revise any forward-looking statements contained in this Presentation.
Nuvation Bio is focused on tackling
the greatest challenges in cancer treatment IBTROZITM (taletrectinib) is a next generation, potentially best-in-class ROS1 inhibitor approved in June 2025 for advanced ROS1+ NSCLC in the U.S., Japan, and China; 204 new patient starts in Q3 2025
Global, commercial-stage oncology company focused on innovating and developing first- or best-in-class medicines for diseases that represent particularly large unmet patient needs Safusidenib1 is a potentially best-in-class, brain penetrant,
mIDH1 inhibitor entering a pivotal study for high-grade IDH1-mutant glioma; potential to extend study into high-risk, low-grade patients Robust cash balance of $549 million2 as of 9/30/25 is expected to provide path to profitability without need for
additional funding 1. Protocol amendment to upsize to a pivotal trial and include patients with grade 2 high-risk IDH1-mutant glioma are forthcoming. 2. An additional $50 million under a term loan with Sagard Healthcare Partners is available to the
Company until June 30, 2026. NUV-868 is a BD2-selective BET inhibitor that has completed Phase 1 and Phase 1b studies; Company is also evaluating preclinical candidates from its proprietary Drug-drug conjugate (DDC) platform
Nuvation Bio is a commercial-stage
company with a clinical-stage program entering a pivotal study Program Target Indication(s) Current Stage of Development Anticipated Milestones & Recent Updates Program Potential Indication(s) Preclinical Phase 1 Phase 2 Pivotal Approved
Anticipated Milestones Advanced ROS1+ NSCLC (treatment line agnostic) Approved by the U.S. FDA, Japan's MHLW, and China's NMPA Enrolling TRUST-IV study for early-stage ROS1+ NSCLC Safusidenib2 (mIDH1) Diffuse IDH1-mutant glioma Entering
pivotal study in high-grade IDH1-mutant glioma2 NUV-868 (BET) Currently under internal evaluation Completed Phase 1 monotherapy and Phase 1b combination studies in advanced solid tumors Drug-drug conjugate (DDC) platform Solid tumors Currently
evaluating preclinical candidates BET: Bromodomain and Extra-Terminal motif; ESMO: European Society of Medical Oncology Congress; MHLW: Ministry of Health, Labour and Welfare; mIDH1: mutant isocitrate dehydrogenase 1; NSCLC: Non-small cell lung
cancer; ROS1+: c-ros oncogene 1-positive. 1. Worldwide development and commercial rights in-licensed from Daiichi Sankyo; rights to IBTROZI have been out-licensed in China (Innovent Biologics) and Japan (Nippon Kayaku). 2. Worldwide development and
commercial rights in-licensed from Daiichi Sankyo, excluding Japan where Daiichi Sankyo retains development and commercial rights. Protocol amendment to upsize to a pivotal trial and include patients with grade 2 high-risk IDH1-mutant glioma are
forthcoming. Approved for advanced ROS1+ NSCLC in the U.S., Japan, and China 1
IBTROZI | ROS1i Advanced ROS1+ NSCLC
Approved by U.S. FDA in June 2025
Approved by U.S. FDA on June 11, 2025
Launch of IBTROZI is off to a positive
start, reinforcing its compelling clinical profile and Nuvation Bio's commercial expertise 204 patients started on IBTROZI in Q3 2025 (~15/week) Multiple repeat prescribers across the United States Face-to-face engagement with nearly all Tier
1-2 target accounts Scripts from 100% of 6 sales regions and 98% of 47 sales territories Confirmed payor coverage representing 80% of lives covered to label Source: Nuvation Bio data on file. As of September 30,
IBTROZI is a next generation,
potentially best-in-class ROS1 TKI obtained from the April 2024 acquisition of AnHeart Therapeutics NDA: New Drug Application. FDA: Food and Drug Administration. 1. IBTROZI prescribing information; Perol et al., Journal of Clinical Oncology, 2025.
2. Worldwide development and commercial rights in-licensed from Daiichi Sankyo; rights to IBTROZI have been out-licensed in China (Innovent Biologics) and Japan (Nippon Kayaku). Approved in the U.S., Japan, and China for advanced ROS1+ NSCLC (line
agnostic) NDA received Priority Review from the U.S. FDA following Breakthrough Therapy Designations in 1L & 2L AnHeart in-licensed IBTROZI from Daiichi Sankyo in 2018 Maintain global rights except in Japan and China where rights have been
out-licensed2 Discussions to partner in EU and other ex-US territories ongoing Commercial opportunity Potentially best-in-class efficacy and safety profile Durable responses and prolonged progression-free survival Highly brain penetrant and active
against common mutations Differentiated profile1 Strong partnerships
Note: These data are derived from
different clinical studies, with differences in study design and patient populations. No head-to-head studies have been conducted. Comparisons in a head-to-head study may yield different results. ORR: confirmed Overall response rate; DOR: Duration
of response; IC-ORR: Intracranial overall response rate; PFS: Progression free survival. 1. AUGTYRO prescribing information and Drilon et al., New England Journal of Medicine, 2024. 2. Drilon et al., JTO Clinical Research Reports, 2022. 3. XALKORI
prescribing information and Shaw et al., Annals of Oncology, 2019. While ROS1+ NSCLC treatment has evolved since IO/chemo, there remains an opportunity to improve upon the current landscape of approved therapies n ORR Median DOR Median PFS IC-ORR1
Study First-line (TKI-na ve) 1 prior ROS1 TKI G2032R ORR Repotrectinib1 Entrectinib2 Crizotinib3 TRIDENT-1 ALKA-372-001, STARTRK-1, STARTRK-2 PROFILE 1001 71 79% 34 months 36 months 89% (8/9) 168 68% 21 months 16 months 80% (20/25) 53 72% 25
months 19 months N/A Repotrectinib1 TRIDENT-1 56 38% 15 months 9 months 38% (5/13) 59% (10/17) -- -- --
Dose modification rates of
previously approved TKIs are elevated, while neurological AEs remain a significant issue for patients in the real-world setting Repotrectinib Entrectinib Crizotinib Note: These data are derived from different clinical studies, with differences in
study design and patient populations. No head-to-head studies have been conducted. Comparisons in a head-to-head study may yield different results. AE: Adverse Event. Sources: AUGTYRO prescribing information (includes patients with NTRK+ solid
tumor), ROZLYTREK prescribing information (includes patients with NTRK+ solid tumor), and XALKORI prescribing information (combined analysis of Study 1 & 2 of patients with ALK+ NSCLC patients; Headache adverse event rate from Study 1 only).
Dose Modification Neurological Adverse Events Interruption Reduction Discontinuation Dizziness Dysgeusia Headache
IBTROZI demonstrated high and
durable responses in TKI-na ve patients - Median DOR increased to 50 months in new August 2025 data cutoff to support planned sNDA cORR: confirmed Overall response rate; DOR: Duration of response; IC-cORR: Intracranial confirmed overall
response rate; JCO: Journal of Clinical Oncology; PFS: Progression free survival; sNDA: supplemental New Drug Application. 1. Perol et al., Journal of Clinical Oncology, 2024; Median duration of follow-up of 20.7 months for the pooled data set. 2.
IBTROZI prescribing information, excluding median PFS; IC-cORR is not broken out by TRUST-I and TRUST-II study in the IBTROZI prescribing information and includes patients who had measurable CNS metastases at baseline as assessed by BICR and had not
received radiation therapy to the brain within 2 months prior to study entry; Median duration of follow-up of 40.9 and 20.5 months in TRUST-I and TRUST-II, respectively. 3. Supplemental NDA (sNDA) based on August 2025 data cutoff to be filed by year
end 2025. Pooled (JCO)1 TRUST-I (label)2 TRUST-II (label)2 n cORR Median DOR Median PFS IC-cORR 160 89% 44 months 46 months 77% (13/17) 103 90% Not Reached 45 months 88% (7/8) 54 85% Not Reached Not Reached 57% (4/7) June 2024 data cutoff October
2024 data cutoff Aug. 2025 data cutoff Pooled (planned sNDA)3 Median DOR: 50 months Additional updates from August 2025 data cutoff to be presented at Medical conference in 2026
No drugs in solid tumor oncology
have demonstrated the combined efficacy profile seen with IBTROZI in the first line (TKI-na ve) setting RETEVMO (selpercatinib)1 84% 22 months 20 months AUGTYRO (repotrectinib)2 79% 36 months 34 months ALECENSA (alectinib)3 79% 26 months <
18 months TAGRISSO (osimertinib)4 77% 19 months 17 months LORBRENA (lorlatinib)5 76% > 60 months NE VITRAKVI (larotrectinib)6 75% -- 33 months XTANDI (enzalutamide)7 59% 20 months -- Program ORR Note: Sorted by ORR; Each product is approved for
use in their respective indications and the data shown are derived from different clinical studies with differences in cancer types, study design and patient populations. mDOR: median Duration of response; ORR: Overall response rate; mPFS: median
Progression-free survival. Source: 1. RETEVMO prescribing information; Drilon et al., Journal of Clinical Oncology, 2022. 2. AUGTYRO prescribing information; Drilon et al., New England Journal of Medicine, 2024. 3. ALECENSA prescribing information.
4. TAGRISSO prescribing information; Soria et al., New England Journal of Medicine, 2018. 5. LORBRENA prescribing information; Solomon et al., Journal of Clinical Oncology, 2024. 6. VITRAKVI prescribing information. 7. Beer et al., New England
Journal of Medicine, 2014; Beer et al., European Urology (Final Analysis of PREVAIL study), 2016. mPFS mDOR
IBTROZI also demonstrated notable
results in the TKI-pretreated setting, especially in the majority western TRUST-II study which is still maturing cORR: confirmed Overall response rate; DOR: Duration of response; IC-cORR: Intracranial confirmed overall response rate; PFS:
Progression free survival. 1. Perol et al., Journal of Clinical Oncology, 2024; Median duration of follow-up of 21.0 months for the pooled data set. 2. IBTROZI prescribing information, excluding median PFS and median DOR (median DOR excluded from
the label due to immature follow-up); prescribing information includes response after resistance mutations in addition to G2032R (n=15); IC-cORR is not broken out by TRUST-I and TRUST-II study in the IBTROZI prescribing information and includes
patients who had measurable CNS metastases at baseline as assessed by BICR and had not received radiation therapy to the brain within 2 months prior to study entry; Median duration of follow-up of 35.1 and 20.4 months in TRUST-I and TRUST-II,
respectively. n cORR Median DOR Median PFS IC-cORR 113 56% 17 months 10 months 66% (21/32) 66 52% 13 months 8 months 75% (9/12) 47 62% 19 months 12 months 50% (6/12) G2032R cORR 62% (8/13) 62% (8/13) Pooled (JCO publication)1 TRUST-I (label)2
TRUST-II (label)2 June 2024 data cutoff October 2024 data cutoff
IBTROZI's safety profile
remained favorable and only 6.5% of 337 patients with ROS1+ NSCLC had a TEAE leading to drug discontinuation Adverse Reaction: n (%) Any grade Grade 1 Grade 2 Grade 3 Diarrhea 214 (64) 169 (50) 38 (11) 7 (2) Nausea 159 (47) 123 (36) 31 (9) 5
(1) Vomiting 146 (43) 114 (34) 27 (8) 5 (1) Dizziness 75 (22) 67 (20) 7 (2) 1 (0) Rash 75 (22) 43 (13) 26 (8) 6 (2) Constipation 71 (21) 61 (18) 10 (3) 0 (0) Fatigue 67 (20) 49 (15) 15 (4) 3 (1) Key takeaways from IBTROZI's safety profile
Source: IBTROZI prescribing information. ALT: alanine aminotransferase; AST: aspartate aminotransferase; CPK: creatinine phosphokinase; TEAE: treatment-emergent adverse event. Note: IBTROZI safety population includes 337 patients with ROS1+ NSCLC
who received > 1 dose of IBTROZI (600mg). 1. The denominator used to calculate the rate varied from 149 to 336 based on the number of patients with a baseline value and at least one post-treatment value. Discontinuation rate is lowest of approved
ROS1 TKIs 6.5% of patients discontinued at 11 months of treatment exposure 1 patient (0.3%) discontinued for top 6 adverse events Adverse event profile does not include persistent clinical issues that will impact uptake of IBTROZI 1/337 patients
discontinued due to increased AST/ALT ~80% of diarrhea was grade 1, occurred within ~2 days of starting therapy, and resolved in ~1 day >90% of dizziness was grade 1 and transient, lasting ~3 days, and label does not include CNS warning Lab
Abnormality: n (%) Any grade Grade 1 Grade 2 Grade 31 AST increased 293 (87) 191 (57) 68 (20) 34 (10) ALT increased 284 (85) 170 (51) 70 (21) 44 (13) CPK increased 179 (53) 55 (37) 16 (11) 8 (5) Neutrophils decreased 81 (25) 37 (11) 26 (8) 18
(5) Select Adverse Reactions 20% Select Laboratory Abnormalities1 (Grade 3/4 5%)
selectivity for ROS1 over TRKb in enzymatic assays and cell growth inhibition assays IC50 nM Fold selectivity CD74-ROS1 SLC34A-ROS1 GOPC-ROS1 ROS1 average ETV6-NTRK2 (TRKb) IBTROZI 1.7 11.1 3.8 5.5 103 19x Repotrectinib 0.8 6.5 2.2 3.2 3.3 1x IC50
nM Fold selectivity ROS1 TRKb IBTROZI1 0.207 2.28 11x IBTROZI2 0.073 1.47 20x Repotrectinib3 1.1 1.2 1x Kinase selectivity In vitro cell growth inhibition in ROS1 and TRKb-fusion driven cell lines Source: Nuvation Bio internal preclinical research
data on file; Katayama et al, Nature Communications, 2019. 1. ATP concentration at Km. 2. ATP concentration at 10 uM. 3. ATP concentration at 1 mM.
ROS1+ NSCLC market represents a
sizeable global commercial opportunity - IBTROZI now approved in U.S., Japan, and China mPFS: median progression-free survival; TKI: tyrosine kinase inhibitor. 1. American Cancer Society (2025). 2. National Center for Biotechnology
Information: Gendarme et al., Curr Oncol (2022). 3. Initially approved by U.S. FDA in 2011 for the treatment of patients with advanced or metastatic ALK-positive NSCLC; later approved in 2016 for the treatment of patients with metastatic ROS1+
NSCLC. 4. Approved by U.S. FDA in 2019 for the treatment of patients with metastatic ROS1+ NSCLC and the treatment of patients with neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation. 5. Approved by
U.S. FDA in 2023 for the treatment of patients with advanced or metastatic ROS1+ NSCLC. 6. National Cancer Center Japan (2019). 7. European Cancer Information Systems (2021). 8. Gao et al., J Thorac Oncol (2020). 9. Zhang et al., Thorac Cancer
(2019). ~2,000-4,0001,2 ~2,600-5,2002,7 ~16,5008,9 ~1,000-2,0002,6 NSCLC accounts for ~87%1 of all lung cancers ROS1+ lung cancer represents ~2%2 of new NSCLC cases each year There are three therapies other than IBTROZI approved in the U.S. to treat
ROS1+ NSCLC: Crizotinib (Pfizer, approved 20163) Entrectinib (Roche, approved 20194) Repotrectinib (Bristol Myers Squibb, approved 20235) 1st gen. 2nd gen Key takeaways Estimated new cases per year
IBTROZI's strong clinical
profile turns the commercial opportunity from an incidence story to a prevalence story NSCLC: Non-small cell lung cancer. Note: Based on median progression-free survival demonstrated by IBTROZI in the first line setting (Pooled TRUST-I and TRUST-II
data: Perol et al., Journal of Clinical Oncology, 2024). 1. Reflects midpoint of epidemiology assumptions based on ROS1+ lung cancer representing approximately 2% of new NSCLC cases annually; American Cancer Society (2025), National Center for
Biotechnology Information: Gendarme et al., Curr Oncol (2022). 2. Nuvation Bio pricing information. 3. Reflects full market potential for 10 of 12 months in final year given median progression-free survival of 46 months in the pooled TKI-na ve
dataset. Theoretical maximum U.S. ROS1+ NSCLC market opportunity Year 1 Year 2 Year 3 Year 4 ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$800 million3 3,000
patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1 billion 3,000 patients X $350k per year ~$1

Frequently Asked Questions

What are forward-looking statements in Nuvation Bio's presentation?

Forward-looking statements predict future events and trends, often using terms like 'anticipate' or 'expect'.

What is IBTROZI approved for?

IBTROZI is approved for advanced ROS1+ NSCLC in the U.S., Japan, and China.

What is the status of safusidenib?

Safusidenib is entering a pivotal study for high-grade IDH1-mutant glioma.

What is Nuvation Bio's cash position?

Nuvation Bio has a robust cash balance of $549 million, supporting growth without extra funding.

What is the potential of NUV-868?

NUV-868 is a BD2-selective BET inhibitor that is currently in evaluation after Phase 1 studies.

Last updated: Nov 26, 2025