Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Investor Presentation (January 2026)
37 slides from Nuvation Bio's investor presentation, January 2026
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE January 2026
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 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 IBTROZI® (taletrectinib) is a next gene
Slide 4: Nuvation Bio is a commercial-stage company following approval of IBTROZI in the U.S.
Nuvation Bio is a commercial-stage company following approval of IBTROZI in the U.S., and is also enrolling a pivotal study for safusidenib Current Stage of Development Target Program Anticipated Milestones & Recent Updates Commercial Partners Indication(s) Preclinical Phase 1 Phase 2 Pivotal Approv
Slide 5: Recently announced partnership with Eisai validates IBTROZI's global potential
Recently announced partnership with Eisai further validates the global commercial potential and differentiated clinical profile of IBTROZI Transaction overview Strategic rationale • Exclusive licensing agreement for IBTROZI in Europe and • Strategic collaboration with leading oncology partner additi
Slide 6: IBTROZI | ROS1i
IBTROZI | ROS1i Advanced ROS1+ Approved by U.S. FDA NSCLC in June 2025 6
Slide 7: 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 Global approvals Differentiated profile1 Robust commercial opportunity • Line agnostic approved in the U.S. • Potentially best-in-class efficacy • ~3,000 newly diagnosed
Slide 8: New patient starts for ROS1 TKIs typically decline in the fourth quarter
New patient starts for ROS1 TKIs have typically declined in the fourth quarter due to the impact of the holiday season Estimated ROS1 TKI new patient starts per quarter per IQVIA 200 100 0 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024
Slide 9: U.S. launch of IBTROZI continued to grow despite seasonality
U.S. launch of IBTROZI continued to grow despite seasonality, reinforcing its compelling clinical profile and Nuvation Bio’s commercial expertise Key metrics Recent launches in ROS1+ NSCLC As of December 31, 2025 Meaningful increase in new patient ✓ 432 new patient starts since launch – a rate of st
Slide 10: There was an opportunity to improve upon approved ROS1 TKIs
There was an opportunity to improve upon the landscape of approved ROS1 TKIs prior to the launch of IBTROZI First-line (TKI-naïve) 1 prior ROS1 TKI Repotrectinib1 Entrectinib2 Crizotinib3 Repotrectinib1 ALKA-372-001, Study TRIDENT-1 PROFILE 1001 TRIDENT-1 STARTRK-1, STARTRK-2 n 71 168 53 56 ORR 79%
Slide 11: IBTROZI demonstrated high and durable responses in TKI-naïve patients
IBTROZI demonstrated high and durable responses in TKI-naïve patients – median DOR is now 50 months June 2024 data cutoff October 2024 data cutoff Aug. 2025 data cutoff Pooled (JCO)1 TRUST-I (label)2 TRUST-II (label)2 Pooled n 160 103 54 Median DOR: cORR 89% 90% 85% 50 months Median Additional updat
Slide 12: No solid tumor drugs match IBTROZI's combined ORR and mDOR in first line
No drugs in solid tumor oncology have demonstrated the combined ORR and mDOR seen with IBTROZI in the first line (TKI-naïve) setting Program ORR mPFS mDOR RETEVMO (selpercatinib)1 84% 22 months 20 months AUGTYRO (repotrectinib)2 79% 36 months 34 months ALECENSA (alectinib)3 79% 26 months < 18 months
Slide 13: IBTROZI's cORR and IC-cORR in the second-line setting are unmatched
IBTROZI’s cORR and IC-cORR in the second- line setting are unmatched June 2024 data cutoff October 2024 data cutoff Pooled (JCO publication)1 TRUST-I (label)2 TRUST-II (label)2 n 113 66 47 cORR 56% 52% 62% Median DOR 17 months 13 months 19 months Median PFS 10 months 8 months 12 months G2032R cORR 6
Slide 14: 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 Dose Modification Neurological Adverse Events 80% 80% 65% 60% 60% 54% 50% 46% 44% 40% 38% 40% 38% 29% 26% 20% 22% 19% 18% 20% 20% 11% 12% 7% 9% N
Slide 15: IBTROZI's safety profile is favorable
IBTROZI’s safety profile is favorable as only 6.5% of 337 patients with ROS1+ NSCLC had a TEAE leading to drug discontinuation in pivotal studies Select Adverse Reactions ≥20% Key takeaways from IBTROZI’s safety profile Adverse Reaction: n (%) Any grade Grade 1 Grade 2 Grade ≥3 Diarrhea 214 (64) 169
Slide 16: IBTROZI is well-tolerated with few discontinuations
IBTROZI is well-tolerated with only 1 of 337 patients (0.3%) discontinuing treatment due to the 6 most common adverse events seen in pivotal studies Median Time Median Time Dose Treatment Dose Interruption, TEAE to Onset to Resolution, Reduction, Discontinuation, n (%) (Days) (Days) n (%) n (%) Incr
Slide 17: 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 Kinase selectivity IC50 nM Fold selectivity ROS1 TRKb IBTROZI1 0.207 2.28 11x IBTROZI2 0.073 1.47 20x Repotrectinib3 1.1 1.2 1x In vitro cell growth inhibition in ROS1 and TRKb-fusion driven cel
Slide 18: ROS1+ NSCLC market represents a sizeable global commercial opportunity
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 • NSCLC accounts for ~87%1 of all lung cancers • ROS1+ lung cancer represents ~2%2 of new NSCLC cases each year ~2,000-4,0001,2 ~1,000-2,
Slide 19: 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 Theoretical maximum U.S. ROS1+ NSCLC market opportunity Key assumptions and commentary • Incidence: ~3,0001 newly diagnosed ROS1+ NSCLC patients in the U.S. each year based on current DNA
Slide 20: New NCCN Guidelines include taletrectinib as a preferred therapy
New NCCN Guidelines now include taletrectinib as a preferred therapy, while also contraindicating IO/chemo and recommending ROS1 TKIs for ROS1+ NSCLC NCCN Guidelines 2024 NCCN Guidelines 2026 ROS1 Rearrangement: First Line Therapy ROS1 Rearrangement: First Line Therapy PD-L1 Positive (>1%): First Li
Slide 21: IBTROZI has potential to multiply the ROS1+ NSCLC market size
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 mPFS ORR mPFS ALK+ 10 mo. 26 mo. 72% 79% NSCLC 45 mo. – Not Reached 26 mo. NR @ 5-
Slide 22: Osimertinib captured >95% market share; EGFR market has grown >3x
Osimertinib captured >95% market share after incremental, but meaningful improvements over 1st gen. TKIs; U.S. EGFR market has grown >3x since launch Total Net U.S. Revenue (EGFR+ NSCLC TKIs) $ in millions Osimertinib TKI Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Market Share: 1% 21% 32% 61% 83% 92% 95% 95% 95-100
Slide 23: Safusidenib | mIDH1i
Safusidenib | mIDH1i Diffuse Enrolling pivotal study IDH1-mutant glioma 23
Slide 24: Safusidenib is a potentially best-in-class mIDH1 inhibitor for glioma
Safusidenib is a potentially best-in-class mIDH1 inhibitor for diffuse IDH1- mutant glioma, which was also obtained from the acquisition of AnHeart Unmet need Validated target Differentiated profile Global rights • People diagnosed with • 15% royalty on U.S. sales of • 24-month PFS rate of 88% in •
Slide 25: The diffuse IDH1-mutant glioma market represents a sizeable opportunity
The diffuse IDH1-mutant glioma market represents a sizeable commercial opportunity, particularly because patients can remain on drug for years IDH-mutant glioma epidemiology overview Annual Incidence: IDH-mutant glioma IDH-mutant glioma classification Low-grade: Grade 2 High-grade: Grades 3 – 4 • Ne
Slide 26: Vorasidenib is the only approved IDH inhibitor; early launch suggests >$1B potential
Vorasidenib is the only IDH inhibitor approved for the treatment of IDH- mutant glioma – early launch suggests >$1 billion peak sales potential Vorasidenib history Vorasidenib U.S. launch U.S. net sales ($ in millions) • Servier acquired vorasidenib through its 2021 acquisition of Agios’ oncology bu
Slide 27: Vorasidenib showed a 24-month landmark PFS of 59%
Vorasidenib showed a 24-month landmark PFS of 59% in a pivotal study of low- grade lDH-mutant glioma; 0% cORR was reported in a phase 1 high-grade study Progression-free survival (INDIGO study)1 Confirmed objective response rate Vorasidenib n=168; Placebo n=163 Low-grade High-grade (non-enhancing) (
Slide 28: Safusidenib has shown promising efficacy signals
Safusidenib has shown promising efficacy signals, including a 24-month landmark PFS of 88% in low-grade and 17% cORR including 2 CRs in high-grade IDH1-mutant glioma Progression-free survival (J201 study)1 Confirmed objective response rate n= 27 (250mg BID) Low-grade High-grade (non-enhancing) (enha
Slide 29: Ongoing pivotal study is evaluating safusidenib in the maintenance setting
Ongoing pivotal study is evaluating safusidenib for patients with high-grade and high-risk IDH1-mutant gliomas in the maintenance setting Key eligibility criteria Pivotal study design • Patients with IDH1-mutant grade 2 or grade 3 Randomized study design: astrocytoma (both with high-risk features) S
Slide 30: New cohort evaluating safusidenib in grade 3 oligodendroglioma
New cohort evaluating safusidenib in grade 3 oligodendroglioma – a portion of the high-grade population – may provide an earlier data readout (2028) Key eligibility criteria Additional cohort design • Patients with IDH1-mutant grade 3 Single arm cohort design: oligodendroglioma with residual / recur
Slide 31: Treatment emergent adverse events mostly mild to moderate and manageable
Treatment emergent adverse events were mostly mild to moderate, and manageable, and consistent across the Phase 1 and Phase 2 studies ≥20% of pts. in either study Phase 1 (n=47) Phase 2 (n=27) Key Observations TEAEs All Grades ≥ Grade 3 All Grades ≥ Grade 3 Across Phase 1 and Phase 2 studies All TEA
Slide 32: NUV-868 | BETi
NUV-868 | BETi Advanced solid Completed Phase 1 tumors and Phase 1b studies Currently evaluating Future indications next steps for program 32
Slide 33: 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 NUV-868 is the most selective BD2 vs. BD1 BET inhibitor in development BRD4 Affinity2 • BET proteins regulate the expression of many BD2 BD1 Selectivity oncogenes, inc
Slide 34: DDC Platform
DDC Platform Advanced solid Evaluating preclinical tumors candidates 34
Slide 35: Developing a new type of targeted oncology candidate through the DDC platform
Nuvation Bio is developing a new type of targeted oncology candidate through its Drug-drug conjugate (DDC) platform Antibody-drug conjugates Drug-drug conjugates ✓ Improves therapeutic index vs. untargeted ✓ Tissue-selective targeting improves warhead therapeutic index vs. untargeted warhead IV de
Slide 36: 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 Fuse Binding Domains Drug Target X Drug Target Y Drug X Drug Y Drug Target X Drug Target Y Drug X Drug Y 36
Slide 37: Nuvation Bio is focused on tackling the greatest challenges in cancer treatment
Nuvation Bio is focused on tackling the greatest challenges in cancer treatment Experienced biotech leadership team IBTROZI approved in the U.S., Japan, and China • Founded by Dr. David Hung, the founder for advanced ROS1+ NSCLC (line agnostic) and CEO of Medivation, who successfully • Approved by t