Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007

Transcription

1 Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007 Peter Thompson, M.D., FACP President, CEO and Chairman Trubion Pharmaceuticals, Inc.

2 Safe Harbor Statement Certain matters discussed today or answers that may be given to questions asked could constitute forward-looking statements that are subject to risks and uncertainties relating to Trubion s future financial or business performance. The words believe, anticipate, expect, intend, plan, may, will and other similar expressions generally identify forward-looking statements. Trubion s actual results could differ materially from those anticipated in these forward-looking statements. The factors that might affect our results are found in the sections entitled Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations in our quarterly report on Form 10-Q for the second quarter of 2007 and other filings we make with the SEC from time to time. You can access these filings in the SEC s EDGAR database found at Please note that Trubion does not intend to and is under no obligation to update any of the forward-looking statements discussed today. 2

3 A Biopharmaceutical Company Focused on the Discovery, Development and Commercialization of Protein Therapeutics to Treat Autoimmune Diseases and Cancer

4 Investment Highlights Product Pipeline Targeting Safer, More Effective Therapies Large Markets and Lower Development Risk with Validated Targets Proprietary, Rapid Custom Drug Assembly Engine Strategic Alliance with Wyeth Strong, Proven Management Team 4

5 Our Lead Product Pipeline Development Stage Target Product Candidate Disease Indication Design Pre- Clinical Phase I Phase II Phase III Market CD20 CD20 TRU-015 TRU-015 Rheumatoid Arthritis (RA) Systemic Lupus Erythematosus (SLE) Wyeth & Trubion Alliance CD20 TRU-015 B-cell Malignancies Additional Alliance Compounds and Indications CD37 TRU-016 Non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) 5

6 Current Focus: Targeting B Cells Good B Cells Produce Antibodies to Attack and Kill Bacteria / Viruses Bad B Cells Mistakenly Identify Healthy Cells as Pathogens and Initiate an Immune Response Autoimmune Diseases Rheumatoid Arthritis Systemic Lupus Erythematosus Multiple Sclerosis Graves Disease Type 1 Diabetes Help Coordinate Other Immune System Cells Become Malignant and Can Result in Cancers Cancers Lymphomas Leukemias Myelomas The Solution: B Cell Depletion to Reboot the System 6

7 Affecting Large Patient Populations US Affected 2005 Protein Therapeutics RA 2.5M $7.6B SLE 236K None Currently Available Autoimmune Diseases Rheumatoid Arthritis Systemic Lupus Erythematosus Multiple Sclerosis Graves Disease Type 1 Diabetes TRU-015 NHL 350K $3.2B CLL 70K Cancers Lymphomas Leukemias Myelomas TRU-016 7

8 Today s Protein Therapeutics Monoclonal Antibodies (mabs) E.g., Rituxan, Erbitux Highly Specific Binding to Target Antigens Predictable Biological Activity Reliable Manufacturing 8

9 Our SMIP Designer Drugs: The Next Generation of Protein Therapeutics Monoclonal Antibodies (mabs) E.g., Rituxan, Erbitux Highly Specific Binding to Target Antigens Predictable Biological Activity Small Modular Immunopharmaceutical (SMIP ) All the Benefits of mabs Reliable Manufacturing PLUS: Customizable Biologic Activity Customizable Half Life Improved Biodistribution ½ the Particle Size of mabs CH2 CH3 Target Simple Structure and Known Targets = Rapid Deployment and Risk Reduction 9

10 Our Rapid Custom Drug Assembly Engine Hinge Domain Library Hinge / Effector Domain Library Effector Domain Library Binding Domain Selection SMIP Product Candidates Final SMIP Product Candidate 10 Binding Domain Selection Trubion Product Specification Hinge/ Effector Domain Library Selection CH2 Preclinical Testing & Development CH3 Target Binding Domain Hinge Domain Effector Domain TRU-015 Concept to IND in Less Than 24 Months

11 Current Product Candidates CD20 TRU-015 Rheumatoid Arthritis Systemic Lupus Erythematosus B-cell Malignancies Target Product Candidate Disease Indication CD37 TRU-016 Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia 11

12 TRU-015 in a Nutshell Markets Proven, Growing, Multi-Billion Dollar Markets in B-Cell Malignancies Huge Upside in Inflammatory Diseases Product Advantages Potent B-Cell Depletion Differentiated Design for Enhanced Safety and Efficacy Biodistribution Advantage Development Status Completed Phase IIb Trial in Rheumatoid Arthritis Trubion and Wyeth Analyzing Data 12

13 Our Unique Ability to Customize the Mechanism of Action 1 Apoptosis Cellular Suicide 2 ADCC Activity Flagging for Destruction by Another Cell 3 CDC Activity Membrane Attack from the Blood Stream s Complement System CD20 CD20 CD20 TRU-015 B Cell TRU-015 B Cell TRU-015 B Cell Instruction To Self Destruct Binds and Destroys Target Cell NK Cell Complement Components Assemble Membrane Attack Complex That Destroys Target Cell C1 Complex 13

14 TRU-015: Differentiated by Design 1 Apoptosis 2 ADCC Activity 3 CDC Activity % Apoptosis hr 48 hr Media TRU-015 Rituxan TM % Specific Lysis Concentration (ug/ml) % Specific Lysis TRU-015 Rituxan x Concentration (ug/ml) 0.01 Lowered CDC for Safety and Enhanced Efficacy 14

15 TRU-015: Preclinical Studies Show Potency and Differentiation Potent Depletion of Normal B-Cells B in Non-Human Primate Studies Superior Efficacy in Bulky Tumors vs. Rituxan Effective in Rituxan Resistant Tumors 15

16 Potent B-Cell Depletion Non-Human Primates Control 140% 120% Rituxan TRU % % of Baseline B-Cells 80% 60% 40% 20% 0% 0-20% Days Post-Treatment 16

17 Increased Efficacy in Large Tumors Survival Rate Tumor-Free Percentage 100% 100% 75% 75% 50% 50% 25% 25% 0% 0% Trx. Day TRU-015 Rituxan HulgG Trx. Day 17

18 Efficacy in Rituxan -Resistant Tumors Survival Rate Tumor-Free Percentage 100% 100% 75% 75% 50% 50% 25% 25% 0% Trx. Day 0% Trx. Day TRU-015 (100) TRU-015 (1000) Rituxan (100) Rituxan (1000) HulgG 18

19 Rheumatoid Arthritis: TRU-015 Potential Limitations 2/3rds Treated Patients Still Experience Daily Pain, Stiffness and Fatigue Current Therapies 30% Biologics e.g. TNF Antagonists DMARDs, Non-Steroidal Anti-Inflammatories 20% Patients Fail to Respond to TNF Inhibition 20% and 20% Patients Have Diminishing Response Opportunity Better Safety Profile with Reduced Complement Activation Single-Dose Treatment Course for Optimal Efficacy with Shorter Duration of B-Cell Depletion 19

20 Dose Dependent Response Phase I Trial 120% 100% mg/kg % Of Baseline B-cells 80% 60% 0.05 mg/kg 0.15 mg/kg 40% 0.5 mg/kg 1.5 mg/kg 5.0 mg/kg 20% 15.0 mg/kg 0% 15.0 mg/kg x Days Potent Drug in Humans Long Half-Life, No Observed Immunogenicity Predictable, Dose-Dependent Pharmacodynamics Enables Optimization of Dose & Schedule 20

21 Improving RA Signs and Symptoms Phase IIa Trial Percentage of Patients Showing Improvement (n = 29, Within 24 Weeks After TRU-015 Infusion) 72% 85% All Subjects RF+ Subjects 28% 35% 14% 20% ACR20 ACR50 ACR70 American College of Rheumatology (ACR) Criteria for Improvement 21

22 TRU-015 Phase IIb Trial for RA Patients Design Randomized, double-blind, placebo-controlled 24 week period 280 RA patients Single infusion, ranging from 200 mg to 1,600 mg per patient Evaluating improvement in disease activity» Improvement in DAS-28 scale at 12 weeks» Composite measurements as defined by ACR Status: Trial completed Trubion and Wyeth analyzing the data Intend to report TRU-015 RA Phase IIb results in Q

23 Systemic Lupus Erythematosus: TRU-015 Potential Significant Unmet Needs Current Therapies Acetaminophen NSAID s Immunosuppressants Corticosteroids No Cure Treatments Are Palliative Only Limited Palette of Therapeutics» Safety and Efficacy Issues Persistent Breakthrough of Disease Opportunity B-Cell Depletion-Mediated Relief of Signs and Symptoms 23

24 B-cell Malignancies: TRU-015 Potential Significant Unmet Needs Current Therapies Combination Therapy Rituxan Zevalin / BEXXAR No Cure Many patients unresponsive to current treatments Most responders become refractory Opportunity Provide improved therapeutic options for patients with relapsed and refractory disease Campath 24

25 TRU-015 Summary Design Potent B-Cell Depletion Differentiated Design for Enhanced Safety and Efficacy Biodistribution Advantage Pre-Clinical: Depletes Normal B Cells at Least as Well as Rituxan Superior to Rituxan :» When Diffusion is Limiting» In Depleting Cells Resistant to Rituxan In the Clinic: Generally Safe and Well-Tolerated Pharmacokinetic Half-Life Preserved Despite Smaller Size Predictable, Dose-Dependent B-cell Depletion Clinically Significant Responses in RA Potential opportunities in SLE, MS, B-cell Malignancies 25

26 Current Product Candidates CD20 TRU-015 Rheumatoid Arthritis Rheumatoid Arthritis Systemic Lupus Systemic Erythematosus Lupus Erythematosus B-cell Malignancies Target Product Candidate Disease Indication CD37 TRU-016 Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia 26

27 TRU-016 in a Nutshell Markets $3.2B Market in B-Cell Malignancy Demand Need for Non-CD20 Therapy Product Advantages Targets CD37 Potent Anti-Tumor Activity Differentiated Design for Enhanced Efficacy Biodistribution Advantage Development Status IND Filing Planned 2H 2007 Rights 100% Trubion 27

28 in vivo Efficacy in Tumor Xenografts Survival Rate Tumor-Free Percentage 100% 100% 75% 75% 50% 50% 25% 25% 0% Trx. Day 0% Trx. Day TRU-016 TRU-015 Rituxan HulgG 28

29 Strategic Alliance Development and Worldwide Commercialization of TRU-015, other CD20-Directed Therapies, and Selected Additional Targets Innovation and Development Engine Expertise in Bioprocess Development and Commercialization Significant Transaction $40M Upfront Payment $785M in Potential Milestone Payments Funded SMIP Discovery Program Committed R&D Funding and Royalties IPO Investment: Side-by-Side Common Stock Placement 29

30 Financial Results Q H 2007 Cash Balance (Q1 $98.4) $ 90.3 M $ 90.3 M Revenue $ 5.0 M $ 9.8 M Operating Expenses $ 13.5 M $ 24.4 M Net Loss $ (7.5) M $(.42) $ (12.5) M $(.71) 30

31 2007 Financial Guidance 2007 Operating Cash Requirements (excluding capital expenditures) $ M Revenue Total Operating Expenses (including $2-3M non-cash stock-based comp. exp.) $ M $ M 31

32 Near-Term Milestones Initiated TRU-015 RA Phase IIb Trial Presented TRU-015 RA Phase IIa Results Expanded Organization and Capabilities Completed TRU-015 RA Phase IIb Trial Report TRU-015 RA Phase IIb Results File TRU-016 IND 2H 07 32

33 Trubion: Better Drugs Faster and with Lower Development Risk Product Pipeline Targeting Safer, More Effective Therapies Large Markets and Lower Development Risk with Validated Targets Proprietary, Rapid Custom Drug Assembly Engine Strategic Alliance with Wyeth Strong, Proven Management Team 33

34 Thank You BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007 Peter Thompson, M.D., FACP President, CEO and Chairman Trubion Pharmaceuticals, Inc.