Sunesis Pharmaceuticals — Viracta Therapeutics — Investor Presentation (April 2021)
24 slides from Sunesis Pharmaceuticals's investor presentation, Apr 14, 2021
Slide 1: Viracta Corporate Overview
Exhibit 99.1 VIRACTA CORPORATE OVERVIEW NASDAQ: VIRX I WWW.VIRACTA.COM
Slide 2: Forward Looking Statements
Forward Looking Statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on current expectations, estimates and projections based on information currently available to management, including, without
Slide 3: Viracta Therapeutics: Introduction
Viracta Therapeutics: Introduction Viracta is a precision oncology company focused on the treatment of virus-associated malignancies Novel “kick and kill” oral therapy with a combination of nanatinostat (Nstat) and valganciclovir (VGCV) selectively + targets EBV cancer cells EBV associated with >265
Slide 4: Epstein-Barr Virus (EBV): A High Global Cancer Priority
Epstein-Barr Virus (EBV): A High Global Cancer Priority + There are currently no approved therapies for EBV malignancies EBV: A Herpes family virus affecting a majority of the population • Persists as a life-long latent infection, remaining dormant within cell nuclei • Latency confers resistance to
Slide 5: Viracta's Oral Kick and Kill Approach Selectively Targets EBV Cancer Cells
+ Viracta’s Oral “Kick and Kill” Approach Selectively Targets EBV Cancer Cells LATENCY THE KICK THE KILL Nanatinostat selectively EBV is latent in cancer cells and The cytotoxic GCV then viral kinase genes are silenced and potently induces inhibits DNA replication, epigenetically. Valganciclovir, ex
Slide 6: Pipeline: Innovative approaches to virus-associated cancers
Pipeline Innovative approaches to virus-associated cancers INDICATION PRECLINICAL EARLY-STAGE CLINICAL LATE-STAGE CLINICAL REGULATORY SUBMISSION Nanatinostat + Initiation of NAVAL-1 Pivotal Valganciclovir Trial Expected 1H 2021 + EBV Lymphoma Nanatinostat + Initiation of Phase 1b/2 Valganciclovir Tr
Slide 7: EBV Lymphoma Program
viracta EBV* Lymphoma Program
Slide 8: EBV: Prognostic Significance and Detection
EBV: Prognostic Significance and Detection PERIPHERAL T CELL LYMPHOMA DLBCL EBV positivity correlates with shortened survival in DLBCL, PTCL and HL: Standard of care can extend survival in EBV-negative lymphomas, but is not as + effective in those that are EBV DLBCL Plasmablastic NK/T EBV encoded RN
Slide 9: VT3996-201 Phase 1b/2 Trial of Nstat/VGCV in R/R EBV Lymphoma
+ VT3996-201 Phase 1b/2 Trial of Nstat/VGCV in R/R EBV Lymphoma + Open-label, dose escalation/expansion study of oral Nstat +VGCV combination in patients with recurrent EBV lymphoma Dose-ranging Phase 1b (N=25) identified Recommended Phase 2 Dose (RP2D) RP2D = Nstat 20mg PO days 1-4/wk + VGCV 900mg
Slide 10: VT3996-201 Phase 1b/2 Study: Key Findings
VT3996-201 Phase 1b/2 Study: Key Findings + Nstat/VGCV at the RP2D has promising activity and is well tolerated in refractory EBV lymphomas • ORR: + − 80% in EBV T cell lymphomas (n=10) + − 44% in EBV B cell lymphomas (n=9) (including 4 of 6 responses in DLBCL patients) − Multiple complete responses
Slide 11: Promising Activity in Heavily Pre-treated, Refractory EBV Lymphomas
+ Promising Activity in Heavily Pre-treated, Refractory EBV Lymphomas Subtype Enrolled (n) Evaluable (n) B cell B-NHL 10 (22%) 9 ORR 4/9 (44%) DLBCL 7 CR (2), PR (2), SD (2) CR 2/9 (22%) Other B Cell 3 PD (3) T-NHL 15 (33%) 10 T cell ENKTL 6 CR, PR (3), PD PTCL, NOS 3 CR, PR ORR 8/10 (80%) AITL 5 CR
Slide 12: Response Duration for All Evaluable Patients
Response Duration for All Evaluable Patients (N=35) By lymphoma subtype B-NHL T/NK-NHL Withdrawn for autoSCT ENKTL Withdrawn for autoSCT T-NHL IA-LPD Withdrawn for CAR-T cell therapy Hodgkin 2 4 6 8 10 12 14 16 18 Time, months 12 As of October 27, 2020
Slide 13: RP2D has a Favorable Safety Profile
RP2D has a Favorable Safety Profile Grade 3/4 AEs in ≥2 patients Phase 1b (n=25) Phase 2 (n=21) • Oral regimen was generally well-tolerated All G3/4 All G3/4 Thrombocytopenia 13 (52%) 8 (32%) 5 (24%) 3 (14%) • The most common G3/4 AEs were reversible Nausea 10 (40%) 0 7 (33%) 2 (10%) cytopenias Neut
Slide 14: Case Studies
Case Studies 01 CASE STUDY CASE STUDY 02 37 y.o. female, extranodal NK/T-cell Lymphoma (ENKTL) 58 y.o. male, peripheral T cell lymphoma (PTCL) nd Refractory to 2 line autologous stem cell transplantation; Durable PR after prior HDACi therapy and autologous stem cell transplantation durable response
Slide 15: Key FDA Regulatory Milestones Achieved
Key FDA Regulatory Milestones Achieved Orphan Drug Designations End of Phase 2 Meeting Fast Track Designation granted for Nstat/VGCV for (November 2020) (November 2019) treatment of: Obtained alignment on the For the treatment of + design of Viracta’s Phase 2 relapsed/refractory EBV • T-cell lymphom
Slide 16: ORR/DoR from Single Arm Studies in R/R Lymphoma Receiving Accelerated Approval
ORR/DoR from Single Arm Studies in R/R Lymphoma Receiving Accelerated Approval Nstat/VGCV comparison to lymphoma drugs receiving accelerated approval + 25 ORR and DoR for Nstat/VGCV in EBV lymphoma tafasitamab/lenalidomide compare favorably with other accelerated zanubrutinib approvals in various R/
Slide 17: NAVAL-1 Pivotal Phase EBV Lymphoma Trial
+ NAVAL-1 Pivotal Phase 2 EBV Lymphoma Trial Expected Initiation in Q2 2021 Stage 1 Global, multicenter basket study with an Stage 2 Multiple lymphoma subtypes adaptive Simon 2-stage design + EBV DLBCL, NOS Patient population: + Peripheral T cell • Relapsed/refractory EBV lymphoma without available
Slide 18: Encouraging Feedback from Physician/KOL and Payor Primary Market Research
Encouraging Feedback from Physician/KOL and Payor Primary Market + Research for Viracta’s Differentiated Approach in EBV Lymphoma Unmet Need EBV Testing Potential NSTAT-VGCV Forecast Utilization + 10%-15% of all lymphomas are EBV- Familiarity with EBV-associated Potential upside in share of EBV asso
Slide 19: EBV Solid Tumor Program
viracta EBV* Solid Tumor Program
Slide 20: Preclinical Proof of Concept for Nstat & VGCV Combination in Solid Tumors
Preclinical Proof of Concept for Nstat & VGCV Combination in Solid Tumors *** *** *** ** Annual incidence of nasopharyngeal 2 carcinoma (NPC) and gastric carcinoma (GC): ~218,000 (global) and >4,000 (U.S.) High unmet need exists, especially for R/R disease 2 Efficacy of combination approach was init
Slide 21: Induction by Nstat of EBV Protein Kinase and Tissue Uptake in Xenograft Tumors
Induction by Nstat of EBV Protein Kinase in Tumor Cells and Tissue Uptake of Nstat in Xenograft tumors in Mice + Phase 1b/2 study in EBV solid tumors planned to start in H2 2021 High Tumor Uptake of Nstat in a Murine Induction by Nstat of EBV Protein Kinase RNA + Xenograft Tumor Model in SNU-719 EBV
Slide 22: Key Upcoming Milestones
Key Upcoming Milestones 03 02 04 01 EXPECTED IN MID-2021 EXPECTED IN H2 2021 + Clearance of EBV solid Initiate global phase tumor IND 1b/2 trial in advanced EXPECTED IN H1 2021 EXPECTED IN H2 2021 + EBV solid tumors Updated data from the Initiation of NAVAL-1, a Phase 1b/2 VT3996-201 global pivotal
Slide 23: Leadership Team
Leadership Team Ivor Royston, MD Daniel Chevallard, CPA Lisa Rojkjaer, MD President and Chief Executive Officer Chief Operating Officer & Chief Financial Officer Chief Medical Officer Hybritech Robert McRae Douglas Faller, MD, PhD Cheryl Madsen VP, Operations & Strategic Alliances Senior VP, Regulat
Slide 24: Viracta Therapeutics: Investment Thesis
Viracta Therapeutics: Investment Thesis Focused on unmet medical need with novel targeted therapeutic approach representing a new MOA for the + Expansion into EBV solid tumors with global phase treatment EBV-associated cancers 1b/2 clinical trial EBV associated with >265,000 cases/year in lymphoma,
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