Full Press Release Details
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 and NUV-1511, 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. 2
Nuvation Bio is focused on tackling the greatest challenges in cancer
treatment 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 TM IBTROZI (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 1 Safusidenib 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 NUV-1511, the Company's first clinical-stage drug-drug conjugate (DDC), is being evaluated in a Phase 1/2 study; NUV-868 is a
BD2-selective BET inhibitor that has completed Phase 1 and Phase 1b studies 2 Robust cash balance of $549 million as of 9/30/25 is expected to provide path to profitability without need for additional funding 3 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.
Nuvation Bio has four differentiated oncology programs ranging from
approved in the U.S., Japan, and China to Phase 1 ongoing Current Stage of Development Program Target Indication(s) Anticipated Milestones & Recent Updates Preclinical Phase 1 Phase 2 Pivotal Approved 1 Advanced ROS1+ NSCLC Approved by
the U.S. FDA, Japan's MHLW, and China's NMPA Approved Approved f fo or advanced r advanced ROS1+ ROS1+ NSCL NSCLC in C in the U the U. .S., S., Japan, Japan, and and China China (treatment line agnostic) Enrolling TRUST-IV study
for early-stage ROS1+ NSCLC 2 Safusidenib 2 Diffuse IDH1-mutant glioma Entering pivotal study in high-grade IDH1-mutant glioma (mIDH1) NUV-1511 3 Advanced solid tumors Phase 1/2 dose escalation study ongoing (DDC) NUV-868 Currently
under internal Completed Phase 1 monotherapy and Phase 1b combination (BET) evaluation studies in advanced solid tumors 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. 4 3. Includes patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu and/or
Trodelvy per approved U.S. FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), advanced pancreatic cancer, and platinum-resistant ovarian
IBTROZI | ROS1i Approved by U.S. FDA Advanced ROS1+ NSCLC in June 2025
Approved by U.S. FDA on June 11, 2025 6
Launch of IBTROZI is off to a positive start, reinforcing its compelling
clinical profile and Nuvation Bio's commercial expertise As of September 30, 2025: 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 7 Source: Nuvation Bio data on file.
IBTROZI is a next generation, potentially best-in-class ROS1 TKI
obtained from the April 2024 acquisition of AnHeart Therapeutics 1 Differentiated profile Strong partnerships Commercial opportunity Approved in the U.S., Japan, and Potentially best-in-class efficacy AnHeart in-licensed
IBTROZI from China for advanced ROS1+ NSCLC and safety profile Daiichi Sankyo in 2018 (line agnostic) Durable responses and prolonged Maintain global rights except in Previously received Breakthrough progression-free survival
Japan and China where rights have 2 Therapy Designations in 1L & 2L been out-licensed Highly brain penetrant and active (U.S. and China) against common mutations Discussions to partner in EU and other ex-US territories ongoing 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 8 Biologics) and Japan
While ROS1+ NSCLC treatment has evolved since IO/chemo, there remains an
opportunity to improve upon the current landscape of approved therapies First-line (TKI-na ve) 1 prior ROS1 TKI 1 2 3 1 Repotrectinib Entrectinib Crizotinib Repotrectinib ALKA-372-001, TRIDENT-1 PROFILE 1001 TRIDENT-1 Study STARTRK-1, STARTRK-2
71 168 53 56 n ORR 79% 68% 72% 38% Median 34 months 21 months 25 months 15 months DOR Median 36 months 16 months 19 months 9 months PFS G2032R -- -- -- 59% (10/17) ORR 1 IC-ORR 89% (8/9) 80% (20/25) N/A 38% (5/13) 9 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.
Dose modification rates of previously approved TKIs are elevated, while
neurological AEs remain a significant issue for patients in the real-world setting Dose Modification Neurological Adverse Events 80% 80% 65% 60% 60% 54% 50% 46% 44% 38% 38% 40% 40% 29% 26% 22% 20% 19% 18% 20% 20% 12% 11% 9% 7% N/A 0% 0% Interruption
Reduction Discontinuation Dizziness Dysgeusia Headache Interruption Reduction Discontinuation Dizziness Dysgeusia Headache Repotrectinib Entrectinib Crizotinib 10 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
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 June 2024 data cutoff October 2024 data cutoff Aug. 2025 data cutoff 1 2 2 3 Pooled (JCO) TRUST-I (label) TRUST-II (label) Pooled (planned
sNDA) n 160 103 54 Median DOR: cORR 89% 90% 85% 50 months Median Additional updates 44 months Not Reached Not Reached DOR from August 2025 data cutoff to be Median presented at Medical 46 months 45 months Not Reached PFS conference in 2026 IC-cORR
77% (13/17) 88% (7/8) 57% (4/7) 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. 11 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.
No drugs in solid tumor oncology have demonstrated the combined
efficacy profile seen with IBTROZI in the first line (TKI-na ve) setting Program ORR mPFS mDOR 1 RETEVMO (selpercatinib) 84% 22 months 20 months 2 AUGTYRO (repotrectinib) 79% 36 months 34 months 3 ALECENSA (alectinib) 79% 26 months < 18
months 4 TAGRISSO (osimertinib) 77% 19 months 17 months 5 LORBRENA (lorlatinib) 76% > 60 months NE 6 VITRAKVI (larotrectinib) 75% -- 33 months 7 XTANDI (enzalutamide) 59% 20 months -- 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., 12 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.
IBTROZI also demonstrated notable results in the TKI-pretreated
setting, especially in the majority western TRUST-II study which is still maturing June 2024 data cutoff October 2024 data cutoff 1 2 2 Pooled (JCO publication) TRUST-I (label) TRUST-II (label) n 113 66 47 cORR 56% 52% 62% Median 17 months 13 months
19 months DOR Median 10 months 8 months 12 months PFS G2032R 62% (8/13) 62% (8/13) cORR IC-cORR 66% (21/32) 75% (9/12) 50% (6/12) 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 13 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.
IBTROZI's safety profile remained favorable and only 6.5% of 337
patients with ROS1+ NSCLC had a TEAE leading to drug discontinuation Select Adverse Reactions 20% Key takeaways from IBTROZI's safety profile Adverse Reaction: n (%) Any grade Grade 1 Grade 2 Grade 3 Discontinuation rate
is lowest of approved ROS1 TKIs Diarrhea 214 (64) 169 (50) 38 (11) 7 (2) Nausea 159 (47) 123 (36) 31 (9) 5 (1) 6.5% of patients discontinued at 11 months of Vomiting 146 (43) 114 (34) 27 (8) 5 (1) treatment exposure Dizziness 75 (22) 67 (20)
7 (2) 1 (0) 1 patient (0.3%) discontinued for top 6 adverse Rash 75 (22) 43 (13) 26 (8) 6 (2) events Constipation 71 (21) 61 (18) 10 (3) 0 (0) Adverse event profile does not include persistent Fatigue 67 (20) 49 (15) 15 (4) 3 (1)
clinical issues that will impact uptake of IBTROZI 1 Select Laboratory Abnormalities (Grade 3/4 5%) 1/337 patients discontinued due to increased AST/ALT 1 Lab Abnormality: n (%) Any grade Grade 1 Grade 2 Grade 3 AST increased
293 (87) 191 (57) 68 (20) 34 (10) ~80% of diarrhea was grade 1, occurred within ~2 ALT increased 284 (85) 170 (51) 70 (21) 44 (13) days of starting therapy, and resolved in ~1 day CPK increased 179 (53) 55 (37) 16 (11) 8 (5) >90%
of dizziness was grade 1 and transient, lasting Neutrophils decreased 81 (25) 37 (11) 26 (8) 18 (5) ~3 days, and label does not include CNS warning 14 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.
IBTROZI has 11-20x selectivity for ROS1 over TRKb in enzymatic
assays and cell growth inhibition assays Kinase selectivity IC50 nM Fold selectivity ROS1 TRKb 1 IBTROZI 0.207 2.28 11x 2 IBTROZI 0.073 1.47 20x 3 Repotrectinib 1.1 1.2 1x In vitro cell growth inhibition in ROS1 and TRKb-fusion driven cell lines
IC50 nM Fold selectivity ROS1 ETV6-NTRK2 CD74-ROS1 SLC34A-ROS1 GOPC-ROS1 average (TRKb) IBTROZI 1.7 11.1 3.8 5.5 103 19x Repotrectinib 0.8 6.5 2.2 3.2 3.3 1x 15 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 Key takeaways Estimated new cases per year 1 NSCLC accounts for ~87% of all lung cancers 2 ROS1+ lung cancer represents ~2% of new NSCLC cases each year 1,2 2,6 ~2,000-4,000
~1,000-2,000 There are three therapies other than IBTROZI approved in the U.S. to treat ROS1+ NSCLC: 3 Crizotinib (Pfizer, approved 2016 ) st 1 gen. 4 Entrectinib (Roche, approved 2019 ) nd 2 Repotrectinib (Bristol
Myers Squibb, 2,7 8,9 ~2,600-5,200 ~16,500 gen 5 approved 2023 ) 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 16 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).
IBTROZI's strong clinical profile turns the commercial
opportunity from an incidence story to a prevalence story Theoretical maximum U.S. ROS1+ NSCLC market opportunity Key assumptions and commentary 1 Incidence: ~3,000 newly diagnosed ROS1+ NSCLC patients in the U.S. each year based on current
DNA testing (RNA testing will detect ~30% more ROS1 fusions) 2 Pricing: ~$350,000 per year, based on gross IBTROZI annual price Total: ~$3.8 billion Does not incorporate product market share or other factors impacting potential
revenue including product adoption, access and reimbursement, and persistency ~$1 billion 3,000 patients X $350k per year Total: ~$3 billion ~$1 billion ~$1 billion 3,000 patients X 3,000 patients X $350k per year $350k per year Total: ~$2 billion
~$1 billion ~$1 billion ~$1 billion 3,000 patients X 3,000 patients X 3,000 patients X $350k per year $350k per year $350k per year Total: ~$1 billion 3 ~$1 billion ~$1 billion ~$1 billion ~$800 million 3,000 patients X 3,000 patients X 3,000
patients X 3,000 patients X $350k per year $350k per year $350k per year $350k per year Year 1Year 2Year 3Year 4 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 17 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