Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Investor Presentation (November 2025)
39 slides from Nuvation Bio's investor presentation, Nov 17, 2025
Slide 1: Driven by Science, Focused on Life
Exhibit 99.1 DRIVEN BY SCIENCE FOCUSED ON LIFE November 2025
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 TM IBTROZI (taletrectinib) is a next ge
Slide 4: Four differentiated oncology programs from approved to Phase 1
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 • Approv
Slide 5: IBTROZI | ROS1i
IBTROZI | ROS1i Approved by U.S. FDA Advanced ROS1+ NSCLC in June 2025 5
Slide 6: Approved by U.S. FDA on June 11, 2025
Approved by U.S. FDA on June 11, 2025 6
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 As of September 30, 2025: 204 patients started on IBTROZI in Q3 2025 (~15/week) ü Multiple repeat prescribers across the United States ü Face-to-face engagement with near
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 1 Differentiated profile Strong partnerships Commercial opportunity • Approved in the U.S., Japan, and • Potentially best-in-class efficacy • AnHeart in-licensed IBTROZI
Slide 9: Opportunity to improve upon current ROS1+ NSCLC therapies
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-naïve) 1 prior ROS1 TKI 1 2 3 1 Repotrectinib Entrectinib Crizotinib Repotrectinib ALKA-372-001, TRIDENT-1 PROFILE 1001 TRIDENT-1 Study STA
Slide 10: Dose modification rates and neurological AEs of previously approved TKIs
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
Slide 11: IBTROZI 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 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
Slide 12: No solid tumor drugs show combined efficacy profile of IBTROZI first line
No drugs in solid tumor oncology have demonstrated the combined efficacy profile seen with IBTROZI in the first line (TKI-naïve) 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
Slide 13: 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 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 mon
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 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
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 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 ce
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 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
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 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 DN
Slide 18: New NCCN Guidelines include taletrectinib as preferred therapy
New NCCN Guidelines now include taletrectinib as a preferred therapy and specifically contraindicate IO/chemo and recommend 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: 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 1 2 Precedent NSCLC markets (First line) ROS1+ NSCLC (First line) mPFS ORR mPFS ALK+ 10 mo. 26 mo. 72% 79% NSCLC 45 mo. – Not Reached 26 mo. NR @
Slide 20: Osimertinib captured >95% market share; EGFR market grew >3x
Osimertinib captured >95% market share after incremental, but meaningful st improvements over 1 gen. TKIs; U.S. EGFR market has grown >3x since launch Total Net U.S. Revenue (EGFR+ NSCLC TKIs) $ in millions Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Osimertinib TKI Market Share: 1% 21% 32% 61% 83% 92% 95% 95% 95-10
Slide 21: Safusidenib | mIDH1i
Safusidenib | mIDH1i Entering pivotal study Diffuse in high-grade IDH1- IDH1-mutant glioma mutant glioma 21
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 Unmet need Validated target Differentiated profile Global rights • 15% royalty on U.S. sales of • 24-month PFS rate of 88% in • AnHeart in-l
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 >$1 billion peak sales potential Vorasidenib history Vorasidenib U.S. launch U.S. net sales ($ in millions) • Servier acquired vorasidenib through its 2021 acquisition of Agios’ oncology b
Slide 24: Diffuse IDH1-mutant glioma market 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 25: Study in high-grade IDH1-mutant glioma to become pivotal
Ongoing study for maintenance treatment of high-grade IDH1-mutant glioma will officially become pivotal once protocol amendment to upsize trial is complete Key eligibility criteria Planned pivotal study design Newly diagnosed grade 3 high-risk and grade 4 IDH1- 1 mutant gliomas Safusidenib 250 mg BI
Slide 26: 24-month landmark PFS rate of 88% in Phase 2 study
Safusidenib demonstrated a 24-month landmark progression free survival rate of 88% in a phase 2 study of IDH1-mutant grade 2 glioma 1 2 Vorasidenib (INDIGO study) Safusidenib (J201 study) Vorasidenib n=168; Placebo n=163 n= 27 (250mg BID) 12 months: 77.3% 12 months: 96.3% 100.0 24 months: 58.8% 80.0
Slide 27: Response rate in low-grade glioma is 4x vorasidenib's
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 Low-grade IDH-mutant glioma (vorasidenib vs. safusidenib) 1 2 Vorasidenib Safusidenib Pivotal INDIGO study Phase 2 study n=168 n=27 (250mg BID) 60% 44% 4
Slide 28: Complete responses 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 High-grade IDH-mutant glioma (vorasidenib vs. safusidenib) 1 2 Vorasidenib Safusidenib Phase 1 study Phase 1 study n=30 n=35 40% ORR: 17% 20%
Slide 29: Treatment emergent adverse events mostly mild to moderate
Treatment emergent adverse events were mostly mild to moderate, and manageable, and consistent across the Phase 1 and Phase 2 studies Phase 1 (n=47) Phase 2 (n=27) Key Observations ≥20% of pts. in either study Across Phase 1 and Phase 2 studies TEAEs All Grades≥ Grade 3 All Grades≥ Grade 3 All TEAEs
Slide 30: NUV-1511 | DDC
NUV-1511 | DDC Advanced solid Phase 1/2 study ongoing tumors 30
Slide 31: DDC platform as an advance beyond ADCs
Nuvation Bio’s drug-drug conjugate (DDC) platform is a potentially revolutionary advance beyond ADCs Antibody-drug conjugates Drug-drug conjugates ü Improves therapeutic index vs. untargeted ü Tissue-selective targeting improves warhead therapeutic index vs. untargeted warhead O IV delivery ü Oral o
Slide 32: 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 Y Drug Target X Drug X Drug Y 32
Slide 33: NUV-1511 suppresses prostate and breast cancer growth in xenografts
NUV-1511, a DDC derivative of a widely used chemotherapy agent, suppresses prostate and breast cancer growth in xenografts Prostate cancer CDX (LNCAP) ER+ breast cancer CDX (T47D) 2500 1000 2000 750 1500 500 1000 250 500 0 0 0 7 14 21 28 35 0 7 14 21 28 35 Day Day 33 Source: Nuvation Bio internal pr
Slide 34: Intermittent dosing of NUV-1511 leads to sustained tumor inhibition
Intermittent dosing of NUV-1511 leads to sustained tumor inhibition for weeks Prostate cancer CDX (LNCAP) 2000 1500 1000 500 0 0 7 14 21 28 Day Vehicle Chemo dose regimen 1 Chemo dose regimen 2 NUV-1511 dose regimen 1 NUV-1511 dose regimen 2 34 Source: Nuvation Bio internal preclinical research data
Slide 35: NUV-1511 initially evaluated in five indications
NUV-1511 is initially being evaluated in five indications for which there is a significant unmet need and large market potential Nuvation Bio initiated a Phase 1/2 study evaluating NUV-1511 for the treatment of patients with: Advanced solid tumors who previously received and progressed on or after t
Slide 36: NUV-868 | BETi
NUV-868 | BETi Advanced solid Completed Phase 1 and Phase 1b studies tumors Currently evaluating Future indications next steps for program 36
Slide 37: 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 2 BRD4 Affinity • BET proteins regulate the expression of many BD2 BD1 Selectivity oncogenes, inc
Slide 38: 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 for advanced ROS1+ NSCLC (line agnostic) • Founded by Dr. David Hung, the founder • Approved by the U.S. FDA on June 11, 2025 and CEO of
Slide 39: $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 $150 million royalty financing $100 million senior term loan • Tiered, declining mid-single-digit royalty on annual • $50M was funded upon U.S. FDA approval o