Sunesis Pharmaceuticals — Investor Presentation (June 2007)
31 slides from Sunesis Pharmaceuticals's investor presentation, June 2007
Slide 1: Demonstrating the Sunesis Difference
Demonstrating the Sunesis Difference Sunesis Pharmaceuticals, Inc. June 2007
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements concerning Sunesis Pharmaceuticals, Inc. Such forward- looking statements are not historical facts and involve risks and uncertainties. A number of important factors could cause actual results to differ materially from those
Slide 3: Building a Top-Tier Oncology Company
Building a Top-Tier Oncology Company Improving the Standard of Care for Cancer Patients ● Three clinical-stage anticancer products in multiple trials – SNS-595 (DNA replication) has near-term clinical data readouts from Phase 1 and 2 studies – SNS-032 (CDK) and SNS-314 (Aurora) in Phase 1 studies ●
Slide 4: Multiple Clinical Readouts in 2007
Multiple Clinical Readouts in 2007 Robust Small-Molecule Oncology Pipeline Programs Discovery Preclinical Phase 1 Phase 2 SNS-595 (DNA Replication) Acute Leukemia Acute Leukemia w/ Cytarabine Small Cell Lung Ovarian Solid Tumor Combination SNS-032 (CDKs) B-Cell Malignancies SNS-314 (Aurora) Single A
Slide 5: Collaborating with Leading Investigators
Collaborating with Leading Investigators ● AML – Judith E. Karp, M.D. – Johns Hopkins – Jeffrey E. Lancet, Ph.D. – H. Lee Moffitt ● B-Cell – Ashraf Z. Badros, M.D., Ch.B. – University of Maryland – William G. Wierda, M.D., Ph.D. – MD Anderson ● Ovarian – Carol Aghajanian, M.D. – Memorial Sloan-Kette
Slide 6: SNS-595
SNS-595
Slide 7: SNS-595: Lead Cancer Program
SNS-595: Lead Cancer Program ● Novel cell cycle agent ● Pursuing multiple single-agent indications – Small Cell Lung Cancer in Phase 2 – Ovarian Cancer in Phase 2 – AML in Phase 1 ● Promising clinical activity and safety profile ● Multiple near-term clinical readouts 7
Slide 8: SNS-595 Targets DNA Replication
SNS-595 Targets DNA Replication SNS-595 Binds SNS-595 Binds to to Replication Replication Fork Fork Protein, Protein, ● Novel napthyridine Causing aa dsDNA Causing dsDNA Break Break analog DNA Damage Sensor ● Causes DNA damage proteins during S-phase of cell Site of dsDNA break cycle ● DNA repair me
Slide 9: Phase 1 Solid Tumor Experience
Phase 1 Solid Tumor Experience Dose Activity Study Schedule Patients (mg/m2) (SD/PR) SPO-0001 q3wk, iv 41 MTD: 48 29% SPO-0002 qwk, iv 21 MTD: 15 33% ● Dose escalation trials in patients with progressive disease ● 2 PRs (ovarian, mesothelioma), 17 SD (>16 weeks) ● Multiple tumor types including lung
Slide 10: Small-Cell Lung Cancer Phase 2 Trial
Small-Cell Lung Cancer Phase 2 Trial ● Single-agent, two-stage trial in 40 patients – Second-line, treatment-sensitive (PF > 90 days) – Dosing q3w at 48 mg/m2 ● Clinical endpoints – Primary: Objective Response Rate (ORR) – Secondary: PFS, TTP, Survival ● Market opportunity – 15,000 U.S. patient popu
Slide 11: Ovarian Cancer Phase 2 Trial
Ovarian Cancer Phase 2 Trial ● Single-agent, two-stage trial in 55 patients – Second-line, platinum resistant (PF < 180 days) – Dosing q3w at 48 mg/m2 ● Clinical endpoints – Primary: Objective Response Rate (ORR) – Secondary: CA 125, PFS, TTP, Survival ● Market opportunity – 8,000 U.S. patient popul
Slide 12: Acute Leukemia Phase 1 Trial
Acute Leukemia Phase 1 Trial ● Phase 1 dose-escalation trial underway with 44 patients treated – Schedule A: Once-weekly x3 per cycle – Schedule B: Twice-weekly x2 per cycle ● Clinical endpoints – Safety, bone marrow ablation, objective responses ● Reported activity to date: 1CR, 1CRp, 1CRi, 1PR – C
Slide 13: Upcoming AML Trials
Upcoming AML Trials ● Initiate Phase 1b combination dose escalation trial with cytarabine in Q3 2007 – Evidence of significant preclinical synergy (ASH 2006) ● Initiate Phase 2 single-agent trial in untreated elderly patients who are “unfit” for standard therapy in Q4 2007 13
Slide 14: SNS-032
SNS-032
Slide 15: SNS-032: Second Cancer Program
SNS-032: Second Cancer Program ● Potent CDK inhibitor ● Pursuing a B-Cell Malignancies Phase 1 trial – Chronic Lymphocytic Leukemia – Multiple Myeloma ● Compelling rationale supported by promising preclinical activity in multiple myeloma cells 15
Slide 16: SNS-032 Has Dual Mechanism of Action
SNS-032 Has Dual Mechanism of Action SNS-032 Inhibits CDK2 CDK7 CDK9 • Cell-Cycle Progression • Transcriptional Initiation • DNA Repair • Transcriptional Repair Cell-Cycle Progression Transcription of Into S Phase Survival Proteins 16
Slide 17: SNS-032 Kills Multiple Myeloma Cells
SNS-032 Kills Multiple Myeloma Cells Apoptotic Apoptotic Cells Cells 12% 3.0% 300nM SNS-032 15% 6 h exposure 87% PI PI 71% washout 3.5% 2% 6.3% 0 1 2 3 4 0 1 2 3 4 10 10 10 10 10 10 10 10 10 10 Viable Annexin VV Viable Annexin Annexin V cells Control: DMSO-treated cells SNS-032 treated RPMI-8226 Cel
Slide 18: B-Cell Malignancies Phase 1 Trial
B-Cell Malignancies Phase 1 Trial ● Phase 1 dose-escalation trial underway in patients with advanced B-Cell malignancies – Weekly schedule: 15-minute loading dose, followed by a 6-hour infusion ● Clinical endpoints – Safety/tolerability, disease control, objective responses ● Proof of principle from
Slide 19: SNS-314
SNS-314
Slide 20: SNS-314: Third Cancer Program
SNS-314: Third Cancer Program Anti-Mitotic Target ● Potent pan-Aurora inhibitor – Discovered by Sunesis ● Favorable preclinical profile with broad activity and therapeutic window ● Filed IND in February 2007 ● Initiate Phase 1 solid tumor trial in Q3 2007 ● Active partnering discussions ongoing 20
Slide 21: Extended Tumor Retention
Extended Tumor Retention 100000 10000 Tumor ● SNS-314 is retained Conc (ng/mL) 1000 in tumor relative to 100 plasma 10 Plasma 1 0 6 12 18 24 pHH3 Suppression (%) 100 80 100 mg/kg ● Histone H3 60 phosphorylation is suppressed for 40 50 mg/kg ~12 hours 20 0 0 6 12 18 24 Time Post-Single Dose (h) 21
Slide 22: Goal: Best-in-Class Aurora Inhibitor
Goal: “Best-in-Class” Aurora Inhibitor Less Frequent Dosing May Enhance Therapeutic Profile HCT-116 Colorectal Model 2000 Tumor Volume (mm3) Vehicles 1500 VX-680/MK-457 (bid x 14) 1000 Irinotecan (qw x 3) * 500 MLN8054 (bid x 20) SNS-314 (biw x 3) 0 0 10 20 30 40 50 Days 22
Slide 23: Solid Tumor Phase 1 Trial
Solid Tumor Phase 1 Trial ● Phase 1 dose-escalation trial to be initiated in Q3 2007 – Weekly schedule: 3-hour IV infusion – Advanced solid tumor malignancies ● Clinical endpoints – Safety/tolerability, disease control, objective responses ● Status – Submitted protocol to study sites – Evaluating op
Slide 24: Partnered Programs Making Progress
Partnered Programs Making Progress Partnered Programs Disease Discovery Preclinical Phase I Phase II Merck BACE Alzheimer’s Anti-Viral Anti-viral Current Status Biogen Idec Planned Activities Raf* Oncology Other Kinases* Onc & Inflamm J&J PRD (Cathepsin-S) Inflammation SARcode (LFA-1) Inflammation *
Slide 25: BACE Program
BACE Program α ● Collaboration with Merck Golgi addressing promising β α Membrane γ Amyloid Alzheimer's disease target Precursor Protein ● Inhibition of BACE reduces amyloid plaque BACE, γ --Secretase ● Status Аβ Peptide – In May, earned $1M preclinical milestone – Goal: initiate Phase 1 by Amyloid
Slide 26: Raf Kinase Program
Raf Kinase Program ● Collaboration with Biogen Idec – Up to 6 kinase targets RTK – Funded FTEs P P Shc SOS Ras ● Raf inhibits key cell P P GTP proliferation signaling pathway GRB2 ● Status B-RAF V600E RAF-A/B/C 65% Melanoma – Robust xenograft activity 30% Ovarian 10% Colon – Next milestone is select
Slide 27: Cathepsin S Program
Cathepsin S Program ● Collaboration with J&J PRD for oral inhibitors ● Cat-S enzyme plays key Antigen role in activation of T- Antigen Presentation proteolysis cells Ii CLIP CLIP – $10.8 billion in 2006 Cat S Peptide sales of TNF inhibitors MHCII exchange for inflammatory conditions • Cat S is requi
Slide 28: LFA-1 Program
LFA-1 Program SARcode ● Collaboration with SARcode, Inc. normal flow rolling adhesion extravasation ● LFA-1 plays key role in activation of T-cells ● SARcode is pursuing T- LFA-1 cell mediated ophthalmic ICAM-1 indications ● Status cytokine – Next milestone is filing Induced inflammation of an IND 2
Slide 29: Financial Highlights
Financial Highlights ● Cash at March 31, 2007* $72.6M ● Debt at March 31, 2007 $1.8M ● Expected cash burn rate 2007 ~$40M (assuming no new partnerships) ● Shares outstanding 34.3M * Pro forma with net proceeds from May 30, 2007 offering 29
Slide 30: Key Milestones in 2007
Key Milestones in 2007 SNS-595 9 Advance to Stage 2 for SCLC Phase 2 trial ● Reach MTD in Phase 1 AML trial ● Initiate additional AML trials ● Present SCLC Phase 2 data ● Complete Stage 1 of Ovarian Phase 2 trial ● Present final AML Phase 1 data SNS-032 9 Present preclinical data supporting dosing f
Slide 31: Building a Top-Tier Oncology Company
Building a Top-Tier Oncology Company Improving the Standard of Care for Cancer Patients ● Three clinical-stage anticancer products in multiple trials – SNS-595 (DNA replication) has near-term clinical data readouts from Phase 1 and 2 studies – SNS-032 (CDK) and SNS-314 (Aurora) in Phase 1 studies ●
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