Sunesis Pharmaceuticals — Investor Presentation (September 2006)
31 slides from Sunesis Pharmaceuticals's investor presentation, September 2006
Slide 1: Innovative Medicines
Innovative Medicines September 2006
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: Creating New Standards in Cancer Care
Creating New Standards in Cancer Care Sunesis aims to change cancer care by discovering, developing and marketing unique small molecule therapeutics that improve the lives of patients 3
Slide 4: Accomplishments Since IPO in 2005
Accomplishments Since IPO in 2005 Completed Phase 1 clinical trials of SNS-595 Initiated Phase 2 clinical trials of SNS-595 Advanced second program, SNS-032, into clinic Continued progress on preclinical program for SNS-314 Received over $5 million in milestones in partnered programs with Merck and
Slide 5: Cancer Care is Changing
Cancer Care is Changing ● Significantly expanding market – New agents extend survival by weeks, sometimes months • Gleevec, Tarceva, Nexavar, Sutent – $26B in 2005 growing to $50B in 2010 ● Clinicians want drugs with unique MOAs targeting cancer-dependent pathways – Improve anticancer activity and t
Slide 6: Growing Oncology Franchise
Growing Oncology Franchise Cell Cycle Provides Many Opportunities for Targeted Therapeutic Intervention G0 ● Sunesis has built a portfolio of (Non-Dividing) targeted cell cycle inhibitors – Biologically selective inhibitors – Broadly active molecules M ● Informed development programs (Mitosis) – Int
Slide 7: Sunesis' Broad Oncology Portfolio
Sunesis’ Broad Oncology Portfolio Distinct Points of Intervention and Multiple Tumor Types Programs Discovery Preclinical Phase 1 Phase 2 SNS-595 (DNA-PK) Acute Leukemias Single Agent Solid Tumors NSCLC SCLC Ovarian SNS-032 (CDK) Single Agent Solid Tumors B-Cell Malignancies SNS-314 (Aurora) Single
Slide 8: Numerous Upcoming Milestones
Numerous Upcoming Milestones SNS-595 SNS-032 SNS-314 Raf Kinase Program Initiated Start Phase ● Complete GLP ● Select Safety Phase 2 Solid 1/2 Solid Tox Studies Assessment Tumor Trials Tumor Trial Candidate 2006 Present Phase 1 Solid Tumor Data • Present AML Phase 1 Data ● Initiate AML • Present ● F
Slide 9: SNS-595 Exploits a Novel Pathway
SNS-595 Exploits a Novel Pathway ● First-in-class therapeutic G0 (Non- ● Promising Phase 1 trial Dividing) results in solid tumors M (Mitosis) support ongoing Phase 2 trials G2 G1 (Gap 2) (Gap 1) – Well tolerated – Evidence of activity S (Synthesis) ● Opportunity for accelerated approvals: – AML – L
Slide 10: SNS-595 Unique Mechanism of Action
Unique Mechanism of Action SNS-595 Double-Strand Break Induced at Replication Fork ● Damage signaled only during active replication Damage Only Rapid Apoptosis of Cell Repaired by NHEJ ● No dependence on ATM, ATR, p53 ● Rapid caspase-3 activation ● Strong dependence on DNA-PK, p73 10
Slide 11: Phase 1 Solid Tumor Experience
Phase 1 Solid Tumor Experience Dose Activity Study Schedule Patients (mg/m2) (SD/PR) 3-75 SPO-0001 q3wk, iv 41 29% MTD: 48 3-24 SPO-0002 qwk, iv 21 33% MTD: 15 ● DLT: Grade 3/4 non-cumulative neutropenia ● No study-drug related SAEs observed ● Minimal PK variability 11
Slide 12: Evidence of Activity in Phase 1
Evidence of Activity in Phase 1 Evidence of Activity (patients receiving >4 cycles) Studies 001 and 002 Dose Tumor Weeks on Best Weekly Dose Tumor Weeks on Best (mg/m2) Type Therapy Response (mg/m2) Type Therapy Response 3 Lung 18 SD 6 Renal 16 SD 6 Renal 18 SD 12 Leiomyosarcoma 16 SD 12 75* SD Mela
Slide 13: NSCLC Case Study
NSCLC Case Study ● 64-year-old female with progressing stage IIIB with metastasis to the adrenal gland ● Prior treatments with cisplatin, etoposide, radiation therapy, docetaxel and gefitinib SNS-595 stopped her disease progression, twice! SPO-0001 SPO-0003 Pt ID Dose Dose Status Duration Duration (
Slide 14: Advancing Broad Solid Tumor Plan
Advancing Broad Solid Tumor Plan Non-Small Cell Lung Cancer Small Cell Lung Cancer ● Phase 2 in second-line setting ● Phase 2 in second-line setting ● Opportunity: displace current ● Opportunity: displace Topotecan, standards, pursue combinations 1st to market for refractory 2nd line ● 50 patient st
Slide 15: SNS-595 in Acute Leukemias
SNS-595 in Acute Leukemias Opportunity ● Meet unmet need in relapsed refractory AML Rationale ● Myelosuppression was dose-limiting toxicity in solid tumor Phase 1 trials ● Strong anti-tumor effect in preclinical leukemia models Status ● Phase 1 trial underway – Weekly and twice-weekly dosing – At do
Slide 16: SNS-595 Ablates Murine Bone Marrow
SNS-595 Ablates Murine Bone Marrow Vehicle SNS-595 20 mg/kg (48hr post 2nd dose) 100% cellularity 10% cellularity 16
Slide 17: Favorable Profile vs. First-Line Standard
Favorable Profile vs. First-Line Standard The Combination of SNS-595 + Ara-C More Effective than Either Agent Alone 100 SNS-595 75 Bone Marrow (d6) % Cellularity 50 100 25 75 %Cellularity 0 e /k /k /k /k cl m m m m hi 5 10 15 20 50 Ve 5@ 5@ 5@ 5@ 59 59 59 59 25 Ara-C 100 0 le /k /k /k 75 m m m ic %
Slide 18: SNS-032 is a Potent CDK Inhibitor
SNS-032 is a Potent CDK Inhibitor ● Inhibitor of CDK 2, 7 and 9 G0 – Dual mechanism: proliferation (Non- and apoptosis pathways Dividing) M ● Clear therapeutic hypothesis (Mitosis) based on frequent dosing G2 G1 (Gap 2) (Gap 1) ● Initiated broad-based development plans: S – Solid tumors (Synthesis)
Slide 19: Single Agent Active on Daily Dosing
Single Agent Active on Daily Dosing A2780 Ovarian Cancer Model Week 1 Week 2 Day: 30 m/k IPqdx8 60 m/k IPq4dx2 60 m/k IPq4dx3 1750 60 m/k IPqwx3 1500 Tumor Volume (mm3) 1250 1000 750 500 250 0 0 2 4 6 8 10 12 14 16 18 20 Days Post-Dosing 19
Slide 20: Phase 1/2 Study Exploring Safety and Biologic Activity
Phase 1/2 Study Exploring Safety and Biologic Activity ● Single-agent Phase 1/2 ongoing: – I.V. 1-hour daily x 5 every 3 weeks – Starting dose: 3 mg/m2 – Several dose-escalations without reaching MTD ● At MTD, explore activity in 24 patients – Lung – Breast – Melanoma } Dependent on CDK-2 pathways ●
Slide 21: Future Plans: B-Cell and Combinations
Future Plans: B-Cell and Combinations ● Initiate Phase 1 B-cell malignancies trial in 2006 – MCL-1 is a key B-cell survival protein that is rapidly lost following inhibition of CDK-9 – Flavopiridol showed significant effect in CLL patients with significant toxicities ● Initiate Phase 1b solid tumor
Slide 22: SNS-314: Aurora Kinase Inhibitor
SNS-314: Aurora Kinase Inhibitor ● Targeted mitotic inhibitor G0 – Inhibits both A and B (Non- Dividing) ● Activity in multiple xenograft M models with broad (Mitosis) therapeutic window G2 G1 (Gap 2) (Gap 1) ● Supports flexible dosing schedule S ● Upcoming milestones: (Synthesis) – Complete IND-ena
Slide 23: SNS-314 is as Active as VX-680 and MLN8054
SNS-314 is as Active as VX-680 and MLN8054, but on Less Frequent Schedule ● VX-680 and MLN8054 dosed at published dose and schedule; SNS-314 dosed at MTD HCT-116 Colorectal Model 2000 Tumor Volume (mm3) Vehicles 1500 VX-680 (bid x 14) 1000 Irinotecan (qw x 3) * 500 MLN8054 (bid x 20) SNS-314 (biw x
Slide 24: Sunesis' Partnered Programs
Sunesis’ Partnered Programs Partnered Programs Disease Discovery Preclinical Phase I Phase II Biogen Idec Raf Kinase* Oncology Other Kinases* Oncology Current Status Merck Planned activities Alzheimer’s BACE Anti-Infective Anti-Viral *Co-development and co-promotion rights J&J PRD (Cathepsin-S) Infl
Slide 25: Raf Kinase Inhibitor Program
Raf Kinase Inhibitor Program ● Collaboration with Biogen Idec G0 ● Xenograft activity confirmed (Non- for two lead series Dividing) M – Preliminary tox study planned (Mitosis) for Q3 2006 G2 G1 ● Program on track to select (Gap 2) (Gap 1) safety assessment candidate in 2006 S (Synthesis) ● File IND
Slide 26: BACE Collaboration With Merck
BACE Collaboration With Merck α ● Recently earned $4.25M Golgi pre-clinical milestones β α Membrane γ Amyloid – Next milestone Phase I Precurser Protein ● BACE is seen as promising Alzheimer's target BACE, γ --Secretase ● 4.5M Americans and half Аβ Peptide of elderly 85+ suffer from Alzheimer’s Amyl
Slide 27: Experienced Management Team
Experienced Management Team James Young, Ph.D. Exec. Chairman ALZA, Affymax, Sepracor Daniel Swisher CEO ALZA Daniel Adelman, M.D. SVP, Disc. & Dev. Pharmacyclics, Genentech Eric Bjerkholt SVP & CFO IntraBiotics, JPMorgan Daryl Winter, Ph.D., J.D. SVP & GC Genentech Gradon Knotts VP, Bus. Dev. Xenog
Slide 28: Financial Highlights
Financial Highlights ● Cash at June 30, 2006 $79.1M ● Debt at June 30, 2006 2.0M ● Expected cash burn rate 2006 $8-9M/quarter ● Shares outstanding 29.3M 28
Slide 29: Numerous Upcoming Milestones
Numerous Upcoming Milestones SNS-595 SNS-032 SNS-314 Raf Kinase BACE Program Program Present Start Phase ● Complete ● Select Safety Assessment Achieve SPO-002 1/2 Solid GLP studies $4.25M in Phase 1 data Tumor trial Candidate payable 2006 ● Present milestones Leukemia data at ASH ● Initiate AML regi
Slide 30: First Generation Kinase Inhibitors
First Generation Kinase Inhibitors 30
Slide 31: Tethering Yields Promising Leads
® Tethering Yields Promising Leads R R S S S R S S X S R S SH S SH S S S Link Selected Fragment Target Protein Introduce Screen and with Binding Elements “Extender” Identify from Extender Replace Ligands Disulfide Protein Purine Extender Extended Hit Hit Construct Pocket Generation Fragment Synthesi
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