Nuvation Bio Inc. · NYSE:NUVB
Nuvation Bio — TD Cowen 45th Annual Health Care Conference 2025
40 slides from Nuvation Bio's conference presentation, Mar 3, 2025
Slide 1: Driven by Science, Focused on Life
DRIVEN BY SCIENCE, FOCUSED ON LIFE David Hung, M.D. Founder, President, & CEO TD Cowen Health Care Conference March 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: $250 million non-dilutive financing with Sagard validates taletrectinib's commercial potential
$250 million non-dilutive financing with Sagard validates taletrectinib’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 funded upon U.S. FDA approval
Slide 6: Taletrectinib | ROS1i
Taletrectinib | ROS1i NDA accepted by U.S. Advanced ROS1+ FDA for priority review NSCLC in December 2024 6
Slide 7: Taletrectinib is a 3rd generation, potentially best-in-class ROS1 TKI
Taletrectinib is a 3rd generation, potentially best-in-class ROS1 TKI obtained from the acquisition of AnHeart Therapeutics, which closed in April 2024 Commercial opportunity Differentiated profile Strong partnerships • NDA accepted by U.S. FDA (line • Potentially best-in-class efficacy • AnHeart in
Slide 8: 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 9: 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 10: The mPFS of patients given 1st and then 2nd gen. ROS1 inhibitors is still shorter
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 11: PFS is considered the most important factor in making treatment decisions
PFS is considered the most important factor in making treatment decisions, followed by other efficacy parameters and then safety-related attributes Nuvation Bio’s market research suggests the highest patient risk is disease progression Relative Importance of Product Attributes When Making Favorable
Slide 12: Taletrectinib has the highest ORR and mPFS in the second line setting
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 13: Taletrectinib data show an encouraging safety profile
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 14: 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 15: Taletrectinib's mPFS 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 16: New NCCN Guidelines now 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 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 17: Taletrectinib has greater numerical benefits over 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 18: 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 19: Osimertinib captured >90% market share after modest mPFS increase
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 20: Nuvation Bio has hired a commercial team with blockbuster experience
Nuvation Bio has hired a commercial team with blockbuster experience primed to launch taletrectinib into favorable market dynamics Commercial launch dynamics XTANDI vs. ZYTIGA sales • Chief Commercial Officer and team comprised of Medivation alumni $350 • XTANDI sales surpassed ZYTIGA with a fractio
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: 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 24: Safusidenib crosses the blood-brain-barrier, inhibits mIDH1, and suppresses 2-HG
Safusidenib crosses the blood-brain-barrier, inhibits mIDH1, and suppresses 2-HG levels 24 Source: Whittle et al., Neuro-Oncology, 2024. *Asterix denotes normal brain sample for patient A-04.
Slide 25: 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% 25 Source: CBTRUS Statistical Report: U.S. Cancer Statis
Slide 26: Royalty Pharma's acquisition of 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 27: 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 28: Two complete responses observed with patients still on treatment
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 29: Another IDH1 inhibitor (ivosidenib) increases tumor infiltrating 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 30: 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 31: Five of the top eight adverse events 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 32: NUV-1511 | DDC
NUV-1511 | DDC Advanced solid Phase 1/2 study ongoing tumors 32
Slide 33: Nuvation Bio's 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 34: 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 34
Slide 35: 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 36: 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 36 CDX: Cell-line derived xenograft.
Slide 37: 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 38: NUV-868 | BETi
NUV-868 | BETi Advanced solid Completed Phase 1 tumors and Phase 1b studies Currently evaluating Future indications next steps for program 38
Slide 39: 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 40: 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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