Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Investor Presentation (November 2025)
36 slides from Nuvation Bio's investor presentation, Nov 26, 2025
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE November 2025 Exhibit 99.1
Slide 2: Forward-looking statements
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 statemen
Slide 3: Nuvation Bio is focused on tackling the greatest challenges in cancer treatment
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-
Slide 4: Commercial-stage company with a clinical-stage program entering a pivotal study
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 Adva
Slide 5: IBTROZI | ROS1i Advanced ROS1+ NSCLC
IBTROZI | ROS1i Advanced ROS1+ NSCLC Approved by U.S. FDA in June 2025
Slide 6: Approved by U.S. FDA on June 11, 2025
Approved by U.S. FDA on June 11, 2025
Slide 7: Launch of IBTROZI is off to a positive start
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 account
Slide 8: IBTROZI is a next generation, potentially best-in-class ROS1 TKI
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 developme
Slide 9: Opportunity to improve upon the current landscape of approved ROS1 therapies
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-OR
Slide 10: Dose modification rates of previously approved TKIs are elevated
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 p
Slide 11: IBTROZI demonstrated high and durable responses in TKI-naïve patients
IBTROZI demonstrated high and durable responses in TKI-naïve 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 Cl
Slide 12: No solid tumor drugs have shown IBTROZI's combined efficacy profile
No drugs in solid tumor oncology have demonstrated the combined efficacy profile seen with IBTROZI in the first line (TKI-naïve) 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 (osimert
Slide 13: Notable results in the TKI-pretreated setting
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.
Slide 14: IBTROZI's safety profile remained favorable
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) 2
Slide 15: IBTROZI has 11–20x selectivity for ROS1 over TRKb
IBTROZI has 11–20x 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 IBT
Slide 16: ROS1+ NSCLC market is a sizeable global commercial opportunity
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 O
Slide 17: From an incidence story to a prevalence story
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., Journ
Slide 18: New NCCN Guidelines include taletrectinib as a preferred therapy
New NCCN Guidelines now include taletrectinib as a preferred therapy and specifically contraindicate IO/chemo and recommend ROS1 TKIs for ROS1+ NSCLC Source: National Comprehensive Cancer Network 2026 and 2024. NCCN Guidelines 2024 NCCN Guidelines 2026 ROS1 Rearrangement: First Line Therapy ROS1 Rea
Slide 19: IBTROZI has the potential to multiply the size of the ROS1+ NSCLC market
Based on its clinical profile, IBTROZI has the potential to multiply the size of the ROS1+ NSCLC market, similar to precedent growth seen in ALK and EGFR Precedent NSCLC markets (First line)1 ROS1+ NSCLC (First line)2 ALK+ NSCLC Note: These data are derived from different clinical studies, with diff
Slide 20: Osimertinib captured >95% market share; U.S. EGFR market grew >3x
Osimertinib captured >95% market share after incremental, but meaningful improvements over 1st gen. TKIs; U.S. EGFR market has grown >3x since launch Source: Evaluate Pharma, Earning Reports from AstraZeneca (osimertinib, erlotinib) and Roche (gefitinib) from 2013 to 2024. Note: Net revenue of afati
Slide 21: Safusidenib | mIDH1i Diffuse IDH1-mutant glioma
Safusidenib | mIDH1i Diffuse IDH1-mutant glioma Entering pivotal study in high-grade IDH1-mutant glioma
Slide 22: Safusidenib is a potentially best-in-class mIDH1 inhibitor
Safusidenib is a potentially best-in-class mIDH1 inhibitor for diffuse IDH1-mutant glioma, which was also obtained from the acquisition of AnHeart Therapeutics BID: Twice-a-day dosing; CR: Complete response; mIDH1: mutant IDH1; RP2D: Recommended Phase 2 dose. 1. In August 2024, the U.S. FDA approved
Slide 23: Vorasidenib is the only approved IDH1 inhibitor for IDH-mutant glioma
Vorasidenib is the only IDH1 inhibitor approved for the treatment of IDH-mutant glioma – early launch suggests >$1 billion peak sales potential Servier acquired vorasidenib through its 2021 acquisition of Agios’ oncology business In May ‘24, Royalty Pharma acquired Agios’ 15% royalty1 on U.S. net sa
Slide 24: IDH1-mutant glioma market is a sizeable commercial opportunity
The diffuse IDH1-mutant glioma market represents a sizeable commercial opportunity, particularly because patients can remain on drug for years Source: 2025 CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2017–2021; UpToDate – a Wolte
Slide 25: Ongoing study will become pivotal once protocol amendment is complete
Ongoing study for maintenance treatment of high-grade IDH1-mutant glioma will officially become pivotal once protocol amendment to upsize trial is complete BID: Twice-a-day dosing; BICR: Blinded Independent Central Review; IDH1: isocitrate dehydrogenase 1; KPS: Karnofsky Performance Status; RANO, Re
Slide 26: Safusidenib 24-month landmark PFS rate of 88% in phase 2 study
BID: Twice-a-day dosing; PFS: Progression-free survival; 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. 1. Cloughesy,
Slide 27: Safusidenib response rate is 4x vorasidenib in low-grade glioma
Safusidenib’s response rate in a phase 2 study of low-grade glioma is 4x the response rate demonstrated by vorasidenib in its pivotal INDIGO study BID: Twice-a-day dosing; ORR: Overall response rate. Response was assessed by Response Assessment in Neuro-Oncology (RANO) – LGG. These data are derived
Slide 28: Two CRs observed in high-grade glioma
In high-grade glioma, two CRs were observed lasting 174 weeks (glioblastoma) and 95 weeks (oligodendroglioma), with patients still on treatment at data cutoff CR: Complete Response; ORR: Overall response rate. Note: All data shown are for the enhancing populations, the majority of which are high-gra
Slide 29: Treatment-emergent adverse events
TEAEs All Grades ≥ Grade 3 All Grades ≥ Grade 3 All TEAEs 45 (96) 20 (43) 26 (96) 10 (37) Alopecia 13 (28) 0 (0) 16 (59) 0 (0) Arthralgia 13 (28) 1 (2) 15 (56) 1 (4) Skin hyperpigmentation 25 (53) 0 (0) 13 (48) 0 (0) ALT increased 4 (9) 3 (6) 11 (41) 2 (7) Rash 11 (23) 0 (0) 10 (37) 0 (0) AST increa
Slide 30: NUV-868 | BETi Advanced solid tumors
NUV-868 | BETi Advanced solid tumors Completed Phase 1 and Phase 1b studies Future indications Currently evaluating next steps for program
Slide 31: NUV-868 is the most BD2-selective BET inhibitor in development
First generation BET inhibitors have been toxic and poorly effective; NUV-868 is the most BD2-selective BET inhibitor in development BET proteins regulate the expression of many oncogenes, including cMYC – an oncogene that has not been targetable directly with a drug Non-selective BD1/2-inhibitors h
Slide 32: DDC Platform Advanced solid tumors
DDC Platform Advanced solid tumors Evaluating preclinical candidates
Slide 33: Drug-drug conjugate platform vs. antibody-drug conjugates
Oral or IV delivery Improves therapeutic index vs. untargeted warhead IV delivery Limited to cell-surface targets Complex and expensive CMC Antibody-drug conjugate Nuvation Bio is developing a new type of targeted oncology candidate through its Drug-drug conjugate (DDC) platform Drug-drug conjugates
Slide 34: DDCs are designed to bind two different targets simultaneously
DDCs are designed to bind TWO different targets simultaneously Two separate drugs with two separate targets Drug Target X Drug Target Y Drug X Drug Y Fuse Binding Domains Drug Target X Drug Target Y Drug X Drug Y
Slide 35: Nuvation Bio is focused on tackling the greatest challenges in cancer treatment
Nuvation Bio is focused on tackling the greatest challenges in cancer treatment Nuvation bio pipeline is led by safusidenib Safusidenib | mIDH1 inhibitor: Entering high-grade pivotal2 study supported by Phase 2 and Phase 1 results NUV-868 | BD2-selective BET inhibitor: Completed Phase 1 and Phase 1b
Slide 36: $250 million non-dilutive financing with Sagard
$250 million non-dilutive financing with Sagard validates IBTROZI’s commercial potential and provides Nuvation Bio with path to profitability Source: Nuvation Bio press release and financing agreements. 1. $50 million in debt is available at the company’s option for 12 months following first commerc