Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — Q2 2025 Earnings Presentation
38 slides from Nuvation Bio's earnings presentation, Aug 7, 2025
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE FOCUSED ON LIFE August 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 IBTROZITM (taletrectinib) is a next gen
Slide 4: Nuvation Bio has four differentiated oncology programs ranging 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 Current Stage of Development Program Target Indication(s) Anticipated Milestones & Recent Updates Preclinical Phase 1 Phase 2 Pivotal Approved 1 Advanced ROS1+ NSCLC • Approved by th
Slide 5: IBTROZI | ROS1i
IBTROZI | ROS1i Advanced ROS1+ Approved by U.S. FDA 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 July 31, 2025: ✓ 70 patients started on IBTROZI ✓ Over 50 different prescribers across the United States ✓ 80% of top 10 target accounts have prescribed IBTROZI ✓ S
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 Commercial opportunity Differentiated profile1 Strong partnerships • Approved in the U.S. and in China • Potentially best-in-class efficacy • AnHeart in-licensed IBTROZI
Slide 9: Opportunity to improve upon the current ROS1+ NSCLC landscape
While ROS1+ NSCLC treatment has evolved since IO/chemo, there remains an opportunity to improve upon the current landscape First-line (TKI-naïve) Second-line (TKI-pretreated) Repotrectinib1 Entrectinib2 Crizotinib3 Repotrectinib1 Zidesamtinib4 ALKA-372-001, Study TRIDENT-1 PROFILE 1001 TRIDENT-1 ARR
Slide 10: 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 11: IBTROZI demonstrated 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 June 2024 data cutoff October 2024 data cutoff Pooled (JCO publication)1 TRUST-I (label)2 TRUST-II (label)2 n 160 103 54 cORR 89% 90% 85% Med
Slide 12: No solid tumor drugs show the combined efficacy profile of IBTROZI in 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 RETEVMO (selpercatinib)1 84% 22 months 20 months AUGTYRO (repotrectinib)2 79% 36 months 34 months ALECENSA (alectinib)3 79% 26 months < 18 mo
Slide 13: IBTROZI 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 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
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 Diarrhea 214 (64) 169 (50) 38 (11
Slide 15: 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 cell
Slide 16: ROS1+ NSCLC market represents a sizeable global commercial opportunity
ROS1+ NSCLC market represents a sizeable global commercial opportunity 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 ~1,000-2,0002,6 • There are currently three therapies appr
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 • Incidence: ~3,0001 newly diagnosed ROS1+ NSCLC patients in the U.S. each year based on current DNA
Slide 18: New NCCN Guidelines include taletrectinib as a 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 2025 ROS1 Rearrangement: First Line Therapy ROS1 Rearrangement: First Line Therapy PD-L1 Positive (>1%): First Li
Slide 19: IBTROZI has the 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 Precedent NSCLC markets (First line)1 ROS1+ NSCLC (First line)2 mPFS ORR mPFS (2nd gen.) mPFS (1st gen.) ALK+ 10 mo. 26 mo. 72% 79% NSCLC 45 mo. –
Slide 20: Osimertinib captured >90% market share; U.S. EGFR market has grown >3x
Osimertinib captured >90% 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 | mIDH1i
Safusidenib | mIDH1i Diffuse Entering pivotal IDH1-mutant glioma studies in 2025 21
Slide 22: 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 Therapeutics Unmet need Validated target Differentiated profile Global rights • People diagnosed with • Vorasidenib approved to • Encouraging early data
Slide 23: The diffuse IDH1-mutant glioma market represents a sizeable commercial 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 24: Vorasidenib is the only IDH1 inhibitor approved for IDH1-mutant glioma
Vorasidenib is the only IDH1 inhibitor approved for the treatment of IDH1-mutant glioma Transaction Overview • 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 u
Slide 25: Safusidenib's response rate in low grade glioma
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 Low grade mutant IDH1 glioma (vorasidenib vs. safusidenib) 60% Vorasidenib n=22 Safusidenib n=12 40% 33% 20% 18% (phase 1 study) 11% (pivotal study)
Slide 26: Two CRs 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 mutant IDH1 glioma (vorasidenib vs. safusidenib) Vorasidenib n=30 Safusidenib n=35 40% 20% ORR: 17% 2 out of 6 high grade PRs: 11%
Slide 27: Safusidenib's anti-tumor effects appear to result from enhancement of 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 Intracranial glioma model in immune competent mice Survival 27 Source: Nuvation Bio internal preclinical research data on file.
Slide 28: Adverse events in a Phase 1 study of safusidenib
Five of the top eight adverse events seen in a Phase 1 study of safusidenib are consistent with an 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) N/A Arthralgia 13 (28) 1 (2) Nausea 12
Slide 29: NUV-1511 | DDC
NUV-1511 | DDC Advanced solid Phase 1/2 study ongoing tumors 29
Slide 30: Drug-drug conjugate platform is a potential advance beyond ADCs
Nuvation Bio’s drug-drug conjugate (DDC) platform is a potentially revolutionary advance beyond ADCs Antibody-drug conjugates Drug-drug conjugates ✓ Improves therapeutic index vs. untargeted ✓ Tissue-selective targeting improves warhead therapeutic index vs. untargeted warhead IV delivery ✓ Oral o
Slide 31: 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 31
Slide 32: 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 Tumor Volume (mm3) Tumor Volume (mm3) 1500 500 1000 250 500 0 0 0 7 14 21 28 35 0 7 14 21 28 35 Day D
Slide 33: 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 Tumor Volume (mm3) 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 33 Source: Nuvation Bio internal precli
Slide 34: NUV-1511 is initially being 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 35: NUV-868 | BETi
NUV-868 | BETi Advanced solid Completed Phase 1 tumors and Phase 1b studies Currently evaluating Future indications next steps for program 35
Slide 36: 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, incl
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. and China for • Founded by Dr. David Hung, the founder advanced ROS1+ NSCLC (line agnostic) and CEO of Medivation, who successfully • Approved by the U.S.
Slide 38: $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