Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Q2 2026 Earnings Presentation
34 slides from Nuvation Bio's earnings presentation, Aug 6, 2026
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE August 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: Commercial-stage company with a pivotal-stage pipeline program and novel preclinical platform
Nuvation Bio is a commercial-stage company with a pivotal-stage pipeline program and novel preclinical platform Current Stage of Development Target Anticipated Milestones & Program Commercial Partners Indication(s) Preclinical Phase 1 Phase 2 Pivotal Approved Recent Updates • Approved by the U.S. FD
Slide 5: IBTROZI | ROS1i
IBTROZI | ROS1i Advanced ROS1+ Approved by U.S. FDA NSCLC in June 2025 5
Slide 6: IBTROZI is a next generation, potentially best-in-class ROS1 TKI
IBTROZI is a next generation, potentially best-in-class ROS1 TKI Global approvals Differentiated profile1 Robust commercial opportunity • Line agnostic approved in the U.S. • Potentially best-in-class efficacy • Annual Incidence: ~3,000 advanced (June 11, 2025), Japan, and China and safety profile R
Slide 7: Increasing first-line patient starts will support long-term revenue growth
Increasing number of patients starting IBTROZI in the first-line setting will support long-term revenue growth IBTROZI launch highlights IBTROZI launch trajectory As of June 30, 2026 IBTROZI U.S. net product revenue ($M) ✓ ROS1 TKI market leader in first-line and overall new Q3 ‘25 Q4 ‘25: Q1 ‘26 Q2
Slide 8: Efficacy bar with other approved first-line ROS1 therapies
The efficacy bar with other approved first-line ROS1 therapies was 79% ORR and 34-month median DOR prior to the approval of IBTROZI First-line (TKI-naïve) Repotrectinib1 Entrectinib2 Crizotinib3 ALKA-372-001, Study TRIDENT-1 STARTRK-1, STARTRK-2 PROFILE 1001 n 71 168 53 ORR 79% 68% 72% Median DOR 34
Slide 9: IBTROZI's first-line ORR is 90% and median DOR is 50 months
IBTROZI’s first-line ORR is 90% and median DOR is 50 months – unmatched in advanced ROS1 NSCLC June 2024 data cutoff October 2024 data cutoff Aug. 2025 data cutoff Pooled (JCO)1 TRUST-I (label)2 TRUST-II (label)2 Pooled3 n 160 103 54 157 cORR 89% 90% 85% 90% Median DOR 44 months Not Reached Not Reac
Slide 10: No solid tumor drugs have shown the combined ORR and mDOR seen with IBTROZI
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 11: Efficacy bar with other approved second-line ROS1 therapies
The efficacy bar with other approved second-line ROS1 therapies is 49% ORR, 15-month median DOR, and 48% intracranial ORR 1 prior ROS1 TKI Repotrectinib1 Zidesamtinib2 Study TRIDENT-1 ARROS-1 n 56 117 ORR 38% 49% Median DOR 15 months N/A Median PFS 9 months N/A G2032R ORR 59% (10/17) 54% (14/26) IC-
Slide 12: IBTROZI's second-line ORR, median DOR and intracranial ORR
IBTROZI’s second-line ORR is 56%, median DOR is 17 months, and intracranial ORR is 66% – unmatched in advanced ROS1 NSCLC June 2024 data cutoff October 2024 data cutoff Aug. 2025 data cutoff Pooled (JCO)1 TRUST-I (label)2 TRUST-II (label)2 Pooled3 n 113 66 47 113 cORR 56% 52% 62% 56% Median DOR 17 m
Slide 13: Other brain-penetrant ROS1 TKIs have CNS warnings in their labels, except IBTROZI
All other approved brain-penetrant ROS1 TKIs have CNS warnings and precautions in their labels – except IBTROZI Approved ROS1 TKI Brain penetrant CNS label warning CNS-related warning ADRs N/A N/A • Patients experienced one or more events ✓ ✓ of cognitive impairment, including mood disorders, dizzin
Slide 14: 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 15: 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 16: IBTROZI 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 17: 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 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 18: Commercial opportunity turns 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 advanced ROS1+ NSCLC patients in the U.S. each year based on current DNA testin
Slide 19: 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 20: IBTROZI has potential to multiply the ROS1+ NSCLC market, like ALK and EGFR
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 21: 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 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 22: Safusidenib | IDH1i
Safusidenib | IDH1i Enrolling multiple studies across IDH1-mutant glioma IDH1-mutant glioma landscape 22
Slide 23: Safusidenib is a potentially best-in-class IDH1 inhibitor for IDH1-mutant glioma
Safusidenib is a potentially best-in-class IDH1 inhibitor for IDH1-mutant glioma Unmet need in Vorasidenib has validated Safusidenib has shown Nuvation Bio owns IDH1-mutant glioma IDH1 as a target a compelling profile global rights • People diagnosed with IDH1- • 15% royalty on U.S. sales of • 36-mo
Slide 24: IDH1-mutant glioma market is a sizeable commercial opportunity
The IDH1-mutant glioma market represents a sizeable commercial opportunity, particularly because patients can remain on therapy 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 • New cas
Slide 25: IDH1-mutant glioma patients still need additional treatment options
Patients with IDH1-mutant glioma are still in need of additional treatment options, especially those with high-risk and high-grade disease Classification Incidence1 Median Survival2 SoC following surgery3 Approved IDHi4 Safusidenib High Grade 4 ~280 – 300 ~2 – 6+ years Radiation + chemotherapy -- •
Slide 26: Safusidenib development plan addresses all grades and risk groups
Safusidenib development plan now addresses all grades and risk groups across the IDH1-mutant glioma landscape A SIGMA (pivotal): High-risk IDH1-mutant astrocytoma B SIGMA : Grade 3 IDH1-mutant oligodendroglioma Subgroup: High-grade, high-risk & low-grade, high-risk Subgroup: High-grade, low-risk C S
Slide 27: Vorasidenib is the only approved IDH inhibitor for IDH-mutant glioma
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)2 • Servier acquired vorasidenib through its 2021 acquisition of Agios’ oncology b
Slide 28: Vorasidenib 36-month landmark PFS of 52% in low-grade IDH-mutant glioma
Vorasidenib showed a 36-month landmark PFS of 52% 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 Low-grade (non-enhancing) (vorasidenib n=168; placebo n=163) Low-grade
Slide 29: Safusidenib efficacy signals including 36-month landmark PFS of 79%
Safusidenib has shown promising efficacy signals, including a 36-month landmark PFS of 79% in low-grade and 17% cORR including 2 CRs in high-grade IDH1-mutant glioma Progression-free survival (Phase 2 study)1 Confirmed objective response rate Low-grade (non-enhancing) (n= 27; 250mg BID) Low-grade (n
Slide 30: TEAEs were mostly mild to moderate and manageable
TEAEs were mostly mild to moderate and manageable, suggesting a favorable risk-benefit profile that allows for meaningful long-term disease control ≥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 s
Slide 31: DDC Platform
DDC Platform Advanced solid Evaluating preclinical tumors candidates 31
Slide 32: 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 33: 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 33
Slide 34: 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