Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
27 slides from Nuvation Bio's conference presentation, Jan 13, 2025
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE, FOCUSED ON LIFE David Hung, M.D. Founder, President, & CEO J.P. Morgan Healthcare Conference January 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 tackling some of the greatest unmet needs in oncology
Nuvation Bio is tackling some of the greatest unmet needs in oncology Global oncology company aimed at making best-in-class drugs by improving validated mechanisms that have encountered safety liabilities or limitations in efficacy Taletrectinib is a 3rd generation, potentially best-in-class ROS1 in
Slide 4: Nuvation Bio has four differentiated oncology programs
Nuvation Bio has four differentiated oncology programs ranging from China approval / U.S. NDA under review, to Phase 1 ongoing Current Stage of Development Program Potential Indication(s) Anticipated Milestones & Recent Updates Preclinical Phase 1 Phase 2 Pivotal NDA Review • NDA accepted by U.S. FD
Slide 5: Taletrectinib | ROS1i
Taletrectinib | ROS1i NDA accepted by U.S. Advanced ROS1+ FDA for priority review NSCLC in December 2024 5
Slide 6: Taletrectinib has the highest ORR and mPFS of any ROS1 inhibitor in first line
Taletrectinib has the highest overall response rate and median progression- free survival of any ROS1 inhibitor in the first line (TKI-naïve) setting Taletrectinib2 Repotrectinib3 Entrectinib4 Crizotinib5 ALKA-372-001, Study Pooled TRUST-I & TRUST-II TRIDENT-1 STARTRK-1, STARTRK-2 PROFILE 1001 n 160
Slide 7: Few drugs in oncology have matched the 89% ORR and 46-month mPFS
Few drugs in oncology have matched the 89% ORR and 46-month mPFS seen with taletrectinib in the first line (TKI-naïve) setting Program ORR mPFS mDOR Taletrectinib1 89% 46 months 44 months RETEVMO (selpercatinib)2 84% 22 months 20 months AUGTYRO (repotrectinib)3 79% 36 months 34 months ALECENSA (alec
Slide 8: The mPFS of patients given 1st and then 2nd gen. ROS1 inhibitors
The mPFS of patients given 1st and then 2nd gen. ROS1 inhibitors is still 18-21 months shorter than the mPFS of taletrectinib in the 1st line setting Current patient journey Taletrectinib6 First Crizotinib3 Entrectinib4 line1 mPFS: 19 mos. – mPFS: 16 mos. Taletrectinib Second Repotrectinib5 mPFS: 46
Slide 9: Taletrectinib has the highest ORR and mPFS of any ROS1 inhibitor in second line
Taletrectinib has the highest overall response rate and median progression- free survival of any ROS1 inhibitor in the second line (TKI-pretreated) setting Taletrectinib2 Repotrectinib3 Zidesamtinib4 Study Pooled TRUST-I & TRUST-II TRIDENT-1 ARROS-1 Crizotinib & entrectinib Repotrectinib n 113 56 17
Slide 10: Taletrectinib data show an encouraging safety profile relative to approved ROS1 TKIs
Taletrectinib data show an encouraging safety profile relative to approved ROS1 TKIs, including fewer dose modifications and low rates of neuro AEs Dose Modification Neurological AEs 80% 80% 65% 60% 60% 54% 50% 46% 44% 41% 40% 38% 40% 38% 29% 29% 26% 21% 20% 22% 19% 18% 20% 20% 15% 11% 12% 10% 9% 7%
Slide 11: ROS1+ NSCLC market represents a sizeable commercial opportunity
ROS1+ NSCLC market represents a sizeable commercial opportunity; 1st generation ROS1 TKIs with ~1.5-year mPFS still sold ~$500 million in 2023 Key takeaways Estimated newly diagnosed patient population • NSCLC accounts for ~80-85%1 of all lung cancers • ROS1+ lung cancer represents ~2%2 of new NSCLC
Slide 12: Taletrectinib's median progression-free survival generates a potentially substantial market opportunity
Taletrectinib’s median progression-free survival of almost four years generates a potentially substantial market opportunity 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 • Pricin
Slide 13: New NCCN Guidelines now contraindicate IO/chemo and recommend ROS1 TKIs
New NCCN Guidelines (as of January 7, 2025) now 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 Line Therapy PD-L1 Positive
Slide 14: Taletrectinib has greater numerical benefits over its competitors than EGFR and ALK leaders
Taletrectinib has greater numerical benefits over its competitors than the leaders of the EGFR and ALK markets over their nearest competitors Precedent NSCLC markets (1L)1 ROS1+ NSCLC (1L)2 mPFS ORR mPFS (2nd gen.) mPFS (1st gen.) Taletrectinib Taletrectinib ALK+ 10 mo. 26 mo. 72% 79% NSCLC 36 mo. 4
Slide 15: Good, but not great drugs have still increased the ALK market ~4x
Good, but not great drugs (neither alectinib or lorlatinib have best-in-class efficacy and safety), have still increased the ALK market ~4x Total Net U.S. Revenue (ALK+ NSCLC TKIs) $ in millions Alectinib TKI Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Market Share: 0% 19% 37% 54% 55% 56% 55% 57% Lorlatinib $921 approv
Slide 16: Osimertinib captured >90% market share; US EGFR market has grown ~3x
Osimertinib captured >90% market share after only increasing mPFS by ~9 months and ORR by ~8%; US EGFR market has grown ~3x since its launch Total Net U.S. Revenue (EGFR+ NSCLC TKIs) $ in millions Osimertinib TKI Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Market Share: 1% 21% 32% 61% 83% 92% 95% 95% Osimertinib $2,279
Slide 17: Safusidenib | mIDH1i
Safusidenib | mIDH1i Diffuse Entering pivotal IDH1-mutant glioma studies in 2025 17
Slide 18: IDH mutations in glioma lead to accumulation of oncometabolite 2-HG
IDH mutations in glioma lead to accumulation of oncometabolite 2-HG, which drives cancer growth and creates an immunosuppressive tumor microenvironment Mechanism of Action: IDH mutations • Gain-of-function mutation confers novel enzymatic activity, which convert α-KG to 2-HG • Epigenetic dysregulati
Slide 19: Safusidenib crosses the blood-brain-barrier, inhibits mIDH1, and suppresses 2-HG levels
Safusidenib crosses the blood-brain-barrier, inhibits mIDH1, and suppresses 2-HG levels 19 Source: Whittle et al., Neuro-Oncology, 2024. *Asterix denotes normal brain sample for patient A-04.
Slide 20: 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 Grade 3 ~13.3K – 18.3K ~37% people living with diffuse IDH1- Grade 2: mutant glioma in the U.S. ~63% 20 Source: CBTRUS Statistical Report: U.S. Cancer Statis
Slide 21: Royalty Pharma's acquisition of Agios' vorasidenib royalty validates safusidenib's market potential
Royalty Pharma’s acquisition of rights to Agios Pharmaceuticals’ royalty on U.S. net sales of vorasidenib validates safusidenib’s market potential Transaction Overview • In May 2024, Royalty Pharma announced it acquired an interest in Agios Pharmaceuticals’ royalty on U.S. net sales of Servier’s vor
Slide 22: Safusidenib early-stage data showed higher response rates than vorasidenib
Safusidenib early-stage data showed higher response rates than vorasidenib in low-grade (non-enhancing) and high-grade (enhancing) diffuse mIDH1 glioma Safusidenib1 Vorasidenib2 Enhancing glioma n=35 Enhancing glioma n=30 Non-enhancing glioma n=12 Non-enhancing glioma n=22 40% 40% 33% 20% 17% 20% 18
Slide 23: Two complete responses observed lasting 174 weeks and 95 weeks
Two complete responses observed lasting 174 weeks (grade 4 astrocytoma) and 95 weeks (grade 3 oligodendroglioma), with patients still on treatment at data cutoff Safusidenib1 Vorasidenib3 EnhancingEnhancing glioma n=35 Non-enhancing Enhancing Non-enhancing RANO responses RANO responses Non-enhancing
Slide 24: Another IDH1 inhibitor (ivosidenib) blocks 2-HG synthesis and increases CD8+ T cells
Another IDH1 inhibitor (ivosidenib) blocks 2-HG synthesis and increases tumor infiltrating CD8+ T cells, demonstrating augmentation of immunity Ivosidenib promotes tumor CD8+ T-cell infiltration1 Depletion of CD8+ T-cells blocks anti-tumor activity of ivosidenib2 ivosidenib + anti-CD8 vehicle ivosid
Slide 25: Safusidenib shows far greater activity in mice with an intact immune system
Safusidenib, unlike vorasidenib, shows far greater activity in mice with an intact immune system rather than immunocompromised mice, suggesting immune MOA Xenografts in immunodeficient mice Xenografts in immunocompetent mice 2,500 Tumor Volume Survival vehicle Tumor Volume (mm3) 2,000 Safusidenib 20
Slide 26: Five of the top eight adverse events are consistent with an immune-related MOA
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) 0 Arthralgia 13 (28) 1 (2) Nausea 12 (
Slide 27: Committed team tackling the greatest unmet needs in oncology
Committed team tackling the greatest unmet needs in oncology Experienced biotech leadership team Broad pipeline across multiple stages of • Founded by Dr. David Hung, previously the development founder and CEO of Medivation, who successfully • Taletrectinib | ROS1 inhibitor: developed and commercial
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