Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Q1 2026 Earnings Presentation
34 slides from Nuvation Bio's earnings presentation, May 4, 2026
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE May 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 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 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 March 31, 2026 IBTROZI U.S. net product revenue ($M) ✓ >600 new patient starts since launch Q3 ‘25 $7.7 Q4 ‘25: $15.7 Q1 ‘26 $18.5
Slide 8: Opportunity to improve upon approved ROS1 TKIs prior to IBTROZI launch
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 9: 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 Pooled3 n 160 103 54 157 cORR 89% 90% 85% 90% Median DOR 44 months Not Reached Not
Slide 10: 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 11: 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 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 months 13 months 19 months 17 months Median PFS 10 mont
Slide 12: Dose modification rates of approved TKIs are elevated; neurological AEs remain an issue
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 13: 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 14: 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 15: 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 16: 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 17: 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 18: 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 19: IBTROZI could multiply the ROS1+ NSCLC market, as seen in 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 20: Osimertinib captured >95% market share; U.S. 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 21: Safusidenib | IDH1i
Safusidenib | IDH1i Enrolling pivotal IDH1-mutant glioma SIGMA study 21
Slide 22: 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, which was also obtained from the acquisition of AnHeart 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 di
Slide 23: IDH1-mutant glioma market represents a sizeable commercial opportunity
The 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 • New cases
Slide 24: Ongoing studies evaluate safusidenib where vorasidenib is not approved
Ongoing studies are evaluating safusidenib for classes of IDH1-mutant glioma where vorasidenib is not approved Classification Incidence1 Median Survival2 SoC following surgery3 Approved IDHi4 Safusidenib High Grade 4 ~280 – 300 ~2 – 6+ years Radiation + chemotherapy -- SIGMA astrocytoma Grade 3 SIGM
Slide 25: 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 26: Vorasidenib showed 24-month landmark PFS of 59% in low-grade glioma
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 27: Safusidenib has shown promising efficacy signals in IDH1-mutant glioma
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 28: Pivotal SIGMA study design for IDH1-mutant astrocytoma
Pivotal SIGMA study is evaluating safusidenib as a maintenance therapy for patients with IDH1-mutant astrocytoma with high-risk features Key eligibility criteria Pivotal study design • Patients with grade 2 or grade 3 IDH1-mutant Randomized study design: astrocytoma (both with high-risk features) Sa
Slide 29: New cohort in grade 3 IDH1-mutant oligodendroglioma
New cohort evaluating safusidenib in grade 3 IDH1-mutant oligodendroglioma may provide an earlier data readout than the SIGMA study (2027) Key eligibility criteria Additional cohort design • Patients with grade 3 IDH1-mutant Single arm cohort design: oligodendroglioma with residual / recurrent disea
Slide 30: TEAEs 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