Sunesis Pharmaceuticals — Viracta Therapeutics — Investor Presentation (October 2023)
47 slides from Sunesis Pharmaceuticals's investor presentation, Oct 4, 2023
Slide 1: Viracta Therapeutics, Inc. October 2023
Exhibit 99.2 Viracta Therapeutics, Inc. October 2023
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 of Viracta Therapeut
Slide 3: Experienced Leadership Team
Experienced Leadership Team Mark Rothera Daniel Chevallard, CPA Darrel P. Cohen, MD, PhD Chief Operating Officer & Chief Financial President and Chief Executive Chief Medical Officer Officer Officer Patric Nelson, MBA Ayman Elguindy, PhD Senior VP, Business Dev. & Chief Scientific Officer Corporate
Slide 4: A Clinical-Stage Precision Oncology Company Focused on Virus-Associated Cancers
A Clinical-Stage Precision Oncology Company Focused on the Treatment and Prevention of Virus-Associated Cancers that Impact Patients Worldwide Adverse survival outcomes are seen with most Epstein-Barr virus (EBV)-associated cancers; need for targeted therapies EBV-associated cancer incidence >300,00
Slide 5: Epstein-Barr Virus (EBV): A High Global Cancer Priority
Epstein-Barr Virus (EBV): A High Global Cancer Priority + EBV malignancies account for ~2% of all new cancer cases globally 1, 2,3 EBV positivity, by lymphoma subtype 4 EBV positivity, by solid tumor subtype * Peripheral T-cell lymphoma (PTCL) 40-65% Nasopharyngeal carcinoma (NPC) 75-95% Diffuse lar
Slide 6: Developing a Precision Medicine to Treat Unique Subsets of EBV+ Lymphoma
Viracta is Developing a Precision Medicine to Treat Unique Subsets of + EBV Lymphoma with Adverse Survival Outcomes Currently limited or no targeted therapy options for EBV-associated cancers 2 1 Diffuse Large B-cell Lymphoma Peripheral T-cell Lymphoma (Progression-Free Survival) (Overall Survival)
Slide 7: Nana-val: a Unique Approach to Targeting and Killing EBV Cancer Cells
+ Nana-val: a Unique Approach to Targeting and Killing EBV Cancer Cells + Nanatinostat sensitizes EBV tumors to the cytotoxic effects of ganciclovir LATENCY THE KICK THE KILL EBV is latent in cancer cells. Nanatinostat potently induces Activated GCV inhibits DNA Valganciclovir, antiviral & cytotoxic
Slide 8: Nana-val + R/R EBV Lymphoma Program
Nana-val + R/R EBV Lymphoma Program
Slide 9: Nana-val Study 201: Phase 1b/2 Trial in R/R EBV Lymphoma
+ Nana-val Study “201”: Phase 1b/2 Trial in R/R EBV Lymphoma + § Open-label, dose escalation study of Nana-val in patients with R/R EBV lymphoma + § Eligibility: R/R EBV lymphoma (any histology), ≥1 prior therapy with no curative options per Investigator § Endpoints: Response rate (ORR by PET-CT; Lu
Slide 10: Extended Follow-up and Additional Patients Build Upon Published Clinical Outcomes Data
Extended Follow-up and Additional Patients Continues to Build Upon Previously Published Clinical Outcomes Data Heavily pretreated patient population with all major subtypes of aggressive lymphomas represented Key Subtype Data All Subtypes* PTCL DLBCL PTLD Study 201 Capsule + Study 201 Capsule + Stud
Slide 11: Expanded and Extended Safety Data Show Nana-val Generally Well-Tolerated
Expanded and Extended Safety Data Demonstrated Nana-val Regimen was Generally Well-Tolerated Treatment-Emergent Adverse Events Treatment-Emergent Serious Adverse Events Occurred in 23 of 64 (36%) Patients Reported in >16 (>25%) Patients Study 201 Capsule + Tablet (N=64) § Treatment-emergent serious
Slide 12: NAVAL-1: Pivotal Phase Trial in R/R EBV Lymphomas
+ NAVAL-1: Pivotal Phase 2 Trial in R/R EBV Lymphomas Global study, with an adaptive Simon 2-stage design, focused on the largest EBV-positive lymphoma patient populations, with high unmet medical need and positive Study 201 clinical data + EBV PTCL cohort achieved ORR threshold in Q2 2023 to advanc
Slide 13: R/R EBV PTCL: T-cell lymphoma with high unmet medical need
+ R/R EBV PTCL: T-cell lymphoma with high unmet medical need
Slide 14: PTCL: Patient Journey and Treatment Options are Suboptimal
* PTCL: Patient Journey and Treatment Options are Suboptimal No established second-line treatment for PTCL 1 1L Patients R/R PTCL Patients Key Considerations § PTCL is highly aggressive with limited No Current SoC treatment options • 5-year survival rate: Nana-val o PTCL, NOS ~25% overall (2L Initia
Slide 15: EBV PTCL: Initial Data from NAVAL-1 is Consistent with Study 201
+ EBV PTCL: Initial Data from NAVAL-1 is Consistent with Study 201 Complete responses achieved ORR threshold to advance PTCL indication into Stage 2 New New Study 201 Capsule NAVAL-1 1 + Tablet Data (n=5*) (n=13) 2 Evaluable Patients ITT (n=8) (n=5) Response ORR 4 (50%) 2 (40%) CR 3 (38%) 2 (40%) PR
Slide 16: Nana-val Well Positioned for Potential Accelerated Approval in R/R EBV PTCL
+ Nana-val is Well Positioned for Potential Accelerated Approval in R/R EBV PTCL Anticipate engagement with FDA in 2024 to align on accelerated registration pathway + Accelerated Approval Criteria Nana-val: R/R EBV PTCL Program + Unmet medical need population No approved therapies for R/R EBV PTCL R
Slide 17: EBV DLBCL: A distinct and unique subtype
+ EBV DLBCL: A distinct and unique subtype
Slide 18: EBV DLBCL Has a Significantly Worse Prognosis
+ - EBV DLBCL Has a Significantly Worse Prognosis Compared to EBV DLBCL Recognized as a unique subtype of DLBCL with its own classification by the World Health Organization § DLBCL is the most common lymphoma (~25% of all NHLs) • ~5-15% of DLBCL cases are associated with EBV • 5-year relative surviv
Slide 19: R/R EBV DLBCL Lymphoma: Expanded Clinical Response Data
+ R/R EBV DLBCL Lymphoma: Expanded Clinical Response Data Early data suggests Nana-val delivers a compelling combination of ORR and DoR New New Study 201 Capsule 1 + Tablet Data (n=10) 2 Evaluable Patients (n=9) Response ORR 6 (67%) CR 3 (33%) PR 3 SD 1 PD 2 Clinical Benefit Rate 7 (78%) Data Cutoff
Slide 20: DLBCL Treatment Landscape
DLBCL Treatment Landscape Emerging data and high unmet medical need could enable earlier-line positioning 1L Patients 2L R/R DLBCL Patients 3L R/R DLBCL Patients Antibody-based therapy Nana-val (3L Initial positioning) Chemotherapy Diagnosis Chemotherapy +/- Gemcitabine-based regimen Antibody-based
Slide 21: EBV PTLD: Post-transplant complication highly associated with EBV
+ EBV PTLD: Post-transplant complication highly associated with EBV
Slide 22: Main Risk Factors for Developing PTLD: EBV Status and Immunosuppression
2 Main Risk Factors for Developing PTLD: EBV Status and Immunosuppression Patients with these risk factors are the most likely to receive regular EBV monitoring EBV Status Immunosuppression (IS) § EBV-negative patients are at the highest risk § Patients with higher levels of IS are at higher risk of
Slide 23: R/R EBV PTLD Lymphoma: Initial Clinical Response Data
+ R/R EBV PTLD Lymphoma: Initial Clinical Response Data Promising early signal from Phase 1b/2 study Study 201 Capsule Study 201 Capsule + 1 Data Tablet Data (n=4) (n=5) 2 2 Evaluable Patients Evaluable Patients (n=3) (n=3) Response ORR 1 (33%) 1 (33%) CR 1 (33%) 1 (33%) PR 0 0 SD 0 1* PD 2 1 Clinic
Slide 24: R/R PTLD Patients Generally Enrolled in Trials or Receive Intensive Chemotherapy
R/R PTLD Patients Generally Enrolled in Clinical Trials or Receive Intensive Chemotherapy Regimens PTLD Treatment Algorithm (R/R, transplant ineligible) Insights Reduce immunosuppression § Initial approach to treating PTLD is EBV PCR remains elevated lowering the dose of immunosuppression Rituximab
Slide 25: Nana-val: Lymphoma Market Opportunity
Nana-val: Lymphoma Market Opportunity
Slide 26: US Incidence Estimates for EBV Hematological Malignancies
+ US Incidence Estimates for EBV Hematological Malignancies Incidence and % EBV Positivity by Lymphoma Subtype Annual EBV Subtype R/R Total (newly diagnosed) Positivity Peripheral T-cell ~1,100 ~3,600 40%-65% ~2,600 lymphoma (PTCL)* Diffuse large B-cell ~13,800 ~41,500 5%-15% ~27,700 lymphoma (DLBCL
Slide 27: Global Incidence Estimates for Priority EBV Hematological Malignancies
+ Global Incidence Estimates for Priority EBV Hematological Malignancies + Nana-val has the potential to address other EBV hematological malignancies Incidence and % EBV Positivity by Lymphoma Subtype Annual EBV Subtype R/R Total (newly diagnosed) Positivity Peripheral T-cell ~15,200 ~6,300 ~21,500
Slide 28: Summary of Key Growth Drivers for Nana-val in Lymphoma
Summary of Key Growth Drivers for Nana-val in Lymphoma High unmet need, targeted treatment, compelling efficacy and duration data will drive strong value PTCL DLBCL PTLD + No standard of care for second line Separate EBV WHO classification Pricing Considerations Low 5-year survival (11%) Low 5-year
Slide 29: Nana-val: EBV Solid Tumor Program
Nana-val: + EBV Solid Tumor Program
Slide 30: Nana-val Study 301: Phase 1b/2 Trial in Advanced EBV Solid Tumors
+ Nana-val Study “301”: Phase 1b/2 Trial in Advanced EBV Solid Tumors Open-label, multicenter study to evaluate the safety, tolerability, PK, and preliminary antitumor activity + of Nana-val in patients with advanced EBV solid tumors Endpoints: Phase 1b dose escalation + EBV Recurrent/Metastatic NPC
Slide 31: R/M EBV NPC Responses to Date and Phase 1b Dose Escalation Schedule
+ R/M EBV NPC Responses to Date and Phase 1b Dose Escalation Schedule Emerging evidence of dose response at higher doses suggesting promise of split dosing approach New Dose Nstat Oral Dose Best VGCV Oral Dose N Level (Days 1-4/wk) Additional Response responses at 30 mg split dose of Nstat 5 20 mg /
Slide 32: Nana-val has been Generally Well-Tolerated at all Dose Levels
Nana-val has been Generally Well-Tolerated at all Dose Levels Preliminary safety data support continued dose escalation to determine RP2D New Treatment-Related Adverse Events in ≥3 Patients Dose Level 1 = RP2D for R/R Lymphoma Safety: Dose Level Dose Level Dose Level Dose Level Dose Level 1 2 3 4 5
Slide 33: Eight Hours Exposure to Nanatinostat Required for EBV Lytic Reactivation
New Eight Hours Exposure to Nanatinostat Required for EBV Lytic Reactivation in Solid Tumors Expression of EBV protein kinase (BGLF4) was markedly higher in animals treated with split dose Nstat Single Dose e.g., 40 mg Vehicle Split Dose e.g., 20+20 mg Single Threshold for EBV lytic Dose reactivatio
Slide 34: Split Dosing Augments Anti-Tumor Activity of Nana-val in Xenograft Model
New Split Dosing Augments the Anti-Tumor Activity of Nana-val in Xenograft Model Anti-tumor activity of SNU-719 subcutaneous xenograft model in B-NDG mice 1400 1200 Vehicle 1000 Group 1 Vehicle 800 Group 2 Ganciclovir Ganciclovir, 600 **** p = 0.0001 50ul/mice Group 5 400 Nanatinostat (20 mg QD) + N
Slide 35: Dosing Schedule Comparison in Xenograft Model
New Dosing Schedule of 4 Days ON/3 Days OFF Allows Solid Tumor Regrowth but Daily Dosing Renders Potent Anti-Tumor Activity in Xenograft Model 4 Days ON/3 Days OFF Daily Dosing 35 Data on file
Slide 36: Rationale for Split Daily Dosing of Nanatinostat with Valganciclovir
Rationale for Split Daily Dosing (SDD) of Nanatinostat in Combination with Valganciclovir Compelling preclinical data provides supporting evidence to evaluate a new dosing regimen Split dose Split dose (2-4 hours apart) increases expression of EBV protein Significantly increased the anti-tumor activ
Slide 37: Planned Implementation of Split Daily Dosing Strategy into Phase 1b
New Planned Implementation of Split Daily Dosing (SDD) Strategy into Phase 1b Up to 3 additional dose levels planned to determine RP2D in the absence of DLTs through Dose Level 5 Dose Best Nstat Oral Dose VGCV Oral Dose N Level Response 8 40 mg / 40 mg SDD 450 mg / 450 mg SDD - 7 30 mg / 30 mg SDD 4
Slide 38: Nana-val: Milestones & IP Portfolio
Nana-val: Milestones & IP Portfolio
Slide 39: Anticipated Program Milestones
* R&D Day** Data Presentation Key Update Anticipated Program Milestones Indication 2023 2024 2025 NAVA L-1 + PTCL Initial Stage 1 Complete Meet with FDA & Initiate Present Registration Phase (EBV ORR DATA enrollment of align on potential Registration Stage 2 DATA LPI Lymph Stage 2 AA pathway Phase o
Slide 40: Nana-val Protected by an Expanding IP Portfolio
Nana-val “Kick & Kill” Approach Protected by an Expanding IP Portfolio Granted patents provide protection into 2041 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 Nanatinostat Composition of Matter Expiration January 2027 US 7,932,246 (Issued) (Including Patent Term Adjustment) Methods of Treatme
Slide 41: Our focus is maximizing the Nana-val opportunity
Adverse survival outcomes are seen with many EBV-associated cancers Need for targeted therapies Well-tolerated, all-oral combination + approach to targeting EBV cancers Potential tumor agnostic MOA; strengthened clinical data Our focus is + Pivotal NAVAL-1 study in multiple R/R EBV maximizing the ly
Slide 42: Thank you
_ viracta & EEN Thank you
Slide 43: Appendix
Appendix
Slide 44: Blood Advances: Supplementary Figure Patient Flowchart
Blood Advances: Supplementary Figure 1 Patient Flowchart 44 Published in Blood Advances, 2023
Slide 45: Study 201: Prior Therapies in Nana-val Responders
Study 201: Prior Therapies in Nana-val Responders NAVAL-1 prioritized indications Time to Response Duration of Response Best Response Histology Prior Therapy for Nana-val for Nana-val to Nana-val (Days) (Days) PTCL (AITL) CHOP; ICE CR 53 1,491 PTCL (AITL) CHOP CR 45 839 PTCL (NOS) CHOP; romidepsin C
Slide 46: NAVAL-1: Enhancing Patient Enrollment
NAVAL-1: Enhancing Patient Enrollment § Global clinical trial footprint established • Clinical trial sites established North America, Europe, Latin America, and Asia-Pacific • >70 sites now open; more study sites expected § Prioritization of PTCL, DLBCL and PTLD cohorts enables more targeted engagem
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