Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Investor Presentation (June 2025)
37 slides from Nuvation Bio's investor presentation, Jun 11, 2025
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE June 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 recently approved for advanced ROS1+ NSCLC in the U.S. and in China Global, commercial-stage oncology company focused on innovating
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. and China to Phase 1 ongoing Program Target Indication(s) Current Stage of Development Anticipated Milestones & Recent Updates Program Potential Indication(s) Preclinical Phase 1 Phase 2 Pivotal Approved Anticip
Slide 5: IBTROZI | ROS1i Advanced ROS1+ NSCLC
IBTROZI | ROS1i Advanced ROS1+ NSCLC Approved by U.S. FDA in June 2025
Slide 6: IBTROZI (taletrectinib)
q BTROZI. faletrectinib x2
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 1. IBTROZI prescribing information; Perol et al., Journal of Clinical Oncology, 2025. 2. Worldwide development and commercial rights in-licensed from Daiichi Sankyo; righ
Slide 8: ROS1 TKI efficacy comparison: ORR, DOR, PFS
Repotrectinib1 Entrectinib2 Crizotinib3 n ORR Median DOR Median PFS IC-ORR1 TRIDENT-1 ALKA-372-001, STARTRK-1, STARTRK-2 PROFILE 1001 71 79% 34 months 36 months 89% (8/9) 168 68% 21 months 16 months 80% (20/25) 53 72% 25 months 19 months N/A Study Note: These data are derived from different clinical
Slide 9: Dose modification rates and neurological AEs of 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 Repotrectinib Entrectinib Crizotinib Note: These data are derived from different clinical studies, with differences in study design and patient p
Slide 10: High and durable responses in TKI-naïve patients
IBTROZI demonstrated high and durable responses in TKI-naïve patients, but latest durability metrics now reflect median not reached with even longer follow-up cORR: confirmed Overall response rate; DOR: Duration of response; IC-cORR: Intracranial confirmed overall response rate; PFS: Progression fre
Slide 11: Combined efficacy profile in first line setting versus other oncology drugs
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 12: Results in the TKI-pretreated setting
IBTROZI demonstrated striking 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. 1. P
Slide 13: Safety profile with low incidence of neuro TEAEs
IBTROZI’s safety profile remained favorable with low incidence of neuro TEAEs; only 7% of patients 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) 11
Slide 14: 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 15: ROS1+ NSCLC market is a sizeable global commercial opportunity
ROS1+ NSCLC market represents a sizeable global commercial opportunity mPFS: median progression-free survival; TKI: tyrosine kinase inhibitor. 1. American Cancer Society (2025). 2. National Center for Biotechnology Information: Gendarme et al., Curr Oncol (2022). 3. Initially approved by U.S. FDA in
Slide 16: 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 17: New NCCN Guidelines recommend ROS1 TKIs for ROS1+ NSCLC
New NCCN Guidelines (as of January 7, 2025) now specifically contraindicate IO/chemo and recommend ROS1 TKIs for ROS1+ NSCLC Source: National Comprehensive Cancer Network 2025 and 2024. NCCN Guidelines 2024 NCCN Guidelines 2025 ROS1 Rearrangement: First Line Therapy ROS1 Rearrangement: First Line Th
Slide 18: 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 (1L)1 ROS1+ NSCLC (1L)2 ALK+ NSCLC Note: These data are derived from different clinical studies, with differences in study
Slide 19: Osimertinib captured >90% share; EGFR market grew ~3x
Osimertinib captured >90% 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 2023. Note: Net revenue of afati
Slide 20: Safusidenib | mIDH1i Diffuse IDH1-mutant glioma
Safusidenib | mIDH1i Diffuse IDH1-mutant glioma Entering pivotal studies in 2025
Slide 21: 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 CR: Complete response. mIDH1: mutant IDH1; 1. In August 2024, the U.S. FDA approved Servier Pharmaceutical’s vorasidenib for the treatment o
Slide 22: Diffuse IDH1-mutant glioma market is a sizeable opportunity
The diffuse IDH1-mutant glioma market represents a sizeable commercial opportunity, particularly because patients can remain on drug for years Source: CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2017–2021 . UpToDate – a Wolters K
Slide 23: Vorasidenib is the only approved mutant IDH1 inhibitor
Vorasidenib is the only mutant IDH1 inhibitor approved for the treatment of mutant IDH1 glioma In May 2024, Royalty Pharma announced it acquired an interest in Agios Pharmaceuticals’ royalty on U.S. net sales of Servier’s vorasidenib Royalty Pharma paid Agios $905 million in cash upon FDA approval o
Slide 24: Safusidenib response rate in low-grade glioma vs vorasidenib
Safusidenib’s response rate in an early-stage study of low-grade glioma is 3x the response rate demonstrated by vorasidenib in its pivotal INDIGO study ORR: Overall response rate. Note: Information depicts response rates with IDH inhibitor in IDH1-mutant gliomas in Phase 1 studies; Low-grade glioma
Slide 25: 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 CR: Complete Response; ORR: Overall response rate. Note: Information depicts response rates with IDH inhibitor in IDH1-mutant gliomas in Phas
Slide 26: Safusidenib anti-tumor effects appear to result from enhanced immunity
Safusidenib’s anti-tumor effects, unlike those of vorasidenib, appear to result from enhancement of immunity, which may drive deep and durable responses like IO Source: Nuvation Bio internal preclinical research data on file. Survival Vehicle Safusidenib (50 mg/kg BID) Safusidenib (150 mg/kg BID) Vo
Slide 27: Safusidenib Phase 1 adverse events consistent with immune-related MOA
TEAE: n (%); Preferred Term1,2 All grades Grade 3 Skin hyperpigmentation 25 (53) N/A Diarrhea 22 (47) 2 (4) Pruritus 14 (30) 0 Alopecia 13 (28) 0 Arthralgia 13 (28) 1 (2) Nausea 12 (26) 0 Rash 11 (23) 0 Headache 11 (23) 1 (2) Source: Natsume et al., Neuro-Oncology, 2023. 1. Safety analysis set (n=47
Slide 28: NUV-1511 | DDC Advanced solid tumors
NUV-1511 | DDC Advanced solid tumors Phase 1/2 study ongoing
Slide 29: DDC platform as an advance beyond ADCs
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’s drug-drug conjugate (DDC) platform is a potentially revolutionary advance beyond ADCs Drug-drug conjugates Tissue-selecti
Slide 30: 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 31: 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 Source: Nuvation Bio internal preclinical research data on file. CDX: Cell-line derived xenograft; ER: Estrogen receptor. Prostate cancer CDX (LNCAP) ER+ breast cancer CDX (T47D
Slide 32: Intermittent dosing leads to sustained tumor inhibition
Intermittent dosing of NUV-1511 leads to sustained tumor inhibition for weeks Prostate cancer CDX (LNCAP) Source: Nuvation Bio internal preclinical research data on file. CDX: Cell-line derived xenograft.
Slide 33: 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: 1 Advanced solid tumors who previously received and progressed on or after
Slide 34: 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 35: 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 36: Broad clinical-stage pipeline provides multiple catalysts in 2025
Nuvation Bio is focused on tackling the greatest challenges in cancer treatment Broad clinical-stage pipeline provides multiple catalysts in 2025 Safusidenib | mIDH1 inhibitor: Update on pivotal study design in 2H 2025; Potential for additional data in 2H 2025 NUV-1511 | Drug-drug conjugate: Update
Slide 37: $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