Investor Presentation May 2011

Copyright 2011, Oncothyreon
Investor Presentation May 2011

Robert Kirkman, MD President & CEO Julie Eastland CFO
Forward-looking Statement
This presentation contains forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the commencement, duration and timing or availability of clinical trials and analyses of the trial results; efficacy, safety and clinical benefit of products; ability to secure and timing of regulatory clearances; impact of the clinical hold on the results of trials of Stimuvax; timing of product launches; ability to retain or secure collaborative partners; retention and performance of contractual third parties, including key personnel; use and adequacy of cash reserves; ability to obtain suitable financing to support our operations; the achievement and value of contract milestones; the potential market for our product candidates; and the ability of partners to effectively market our products. Although the Company believes that the forward-looking statements contained herein are reasonable, we can give no assurance that the Companys expectations are correct. A full discussion of the Companys operations and financial condition, including factors that may affect business and future prospects, is contained in the Companys most recent regulatory filings. All forward-looking statements are expressly qualified in their entirety by this Cautionary Statement. For a complete account of our official corporate documents, you are encouraged to review documents filed with the securities regulators in the U.S. and Canada.
Oncothyreon Multiple Assets Driving Value

Stimuvax Two Phase 3 trials for Non-Small Cell Lung Cancer START data expected mid-2012 or sooner Phase 2 showed median survival advantage of 17 months Broad applicability, not patient-specific Fully funded by Merck KGaA, significant milestones & royalties PX-866 Irreversible PI-3 Kinase Inhibitor Pan-isoform inhibition important for solid tumors Only irreversible inhibitor in clinical development potential dosing and scheduling advantages Phase 2 in several indications, initial data in 2011 ONT-10 Proprietary follow-on vaccine to Stimuvax Induces robust antibody and T-cell response Phase 1 trial initiation expected late 2011
Strong Pipeline with 2011 Milestones
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
2011 MILESTONES
MUC1-based Cancer Vaccines STIMUVAX

NON-SMALL CELL LUNG CANCER
ONT-10 PI-3 Kinase Inhibitor PX-866 + DOCETAXEL

HEAD & NECK, NSCLC
PX-866 + CETUXIMAB
HEAD & NECK, COLORECTAL

Q2 11
PX-866
CHEMOTHERAPY NAVE PROSTATE
PX-866
GLIOBLASTOMA
PX-866
IDIOPATHIC PULMONARY FIBROSIS
Stimuvax Off-the-Shelf Vaccine Targeting Large Market

Current non-small cell lung cancer market exceeds $4B* Not a patient-specific immunotherapy Other MUC1 positive cancers include breast, colon, ovarian, prostate Partner Merck KGaA highly committed Conducting 1,450+ patient pivotal trial Up to $90 M in remaining milestone payments
Stage IIIIa 50%
Non-Small Cell Lung Cancer Annual incidence of 1 million worldwide*

Stage IIIb 20% Stage IV 30%
*Global Cancer Statistics, CA Cancer J Clin 2011 Feb 4
Royalty on net sales ranging from mid-teens to high single digits, depending on territory
*Global Data : NSCLC - Pipeline Assessment & Market Forecast to 2017
Stage III Lung Cancer Current Treatment Paradigm

Stage III lung cancer characteristics: Confined to chest cavity Lymph node involvement Generally unresectable No distant metastases
Standard of care: Concurrent or sequential radiochemotherapy Chemo is platinum-based doublet

Outcome: Average five year survival of 15% Median survival approximately 12-18 months No approved immunotherapies Stimuvax would be maintenance after induction chemoradiation
Stimuvax: Advanced Clinical Program Nearing Pivotal Data

Liposomal vaccine designed to generate a cellular immune response against the tumor associated antigen MUC1
MUC1 expressed by most carcinomas (lung, breast, colon, ovarian, prostate) Positive Phase 2 data in Stage IIIb non-small cell lung cancer 17+ month survival advantage Strong long-term follow up survival data Two ongoing Phase 3 trials, START and INSPIRE, in non-small cell lung cancer
8
Phase 2b Study 17.3 Month Median Survival Advantage
17.3 month median survival advantage (30.6 month vs. 13.3 months) (n = 22) Stage IIIb patients were a pre-stratified subset of Phase 2 trial design Long term survivors in both trials
(n = 35)
(n = 30)
Pivotal Phase 3 START Trial (Merck KGaA)

START (Stimulating Targeted Antigenic Response to NSCLC Trial) Placebo-controlled, randomized design; SPA in place Targeted to enroll 1476 patients in 30 countries worldwide Two planned event-driven interim looks
First look Q4 2010 Independent DMC recommended trial continue Second look anticipated H2 2011
Patient Population Stage III unresectable locoregional disease, responded or stable after firstline chemo-rad Stimuvax + Best Supportive Care
RANDOMIZE 2:1
Primary endpoint: overall survival

Placebo + Best Supportive Care
10
Phase 3 INSPIRE Trial (Merck KGaA)
INSPIRE (Stimuvax Trial In Asian NSCLC Patients: Stimulating Immune Reponse) Similar design to START Targeted to enroll 420 patients in Asian countries
Patient Population
Stage III unresectable locoregional disease, responded or stable after firstline chemo-rad
Stimuvax + Best Supportive Care

RANDOMIZE 2:1
Primary endpoint: overall survival

Placebo + Best Supportive Care
11
Stimuvax Summary
Tremendous clinical need with Stage III average survival today of approximately one year 17 month survival advantage in Phase 2 No immunotherapies approved for NSCLC Attractive milestones and royalties from Merck KGaA 1476 patient pivotal trial top-line data expected by mid-2012
12
ONT-10 Proprietary Follow-on Vaccine

Follow-on MUC1 vaccine consisting of: Antigen 43 amino acid glycopeptide Proprietary adjuvant Carrier liposomal lipids Comparison to Stimuvax Designed to produce antibody and T-cell response IND enabling pre-clinical studies in progress Data at AACR April 2011 Phase 1 initiation targeted H2 2011 Fully owned by Oncothyreon Merck KGaA has right of first negotiation
13
ONT-10 Blocks the Growth of Human MUC1 Expressing Tumors
B16 MUC1
1800
Vehicle PET Lipid A (50ug) ONT-10 (5 ug) ONT-25 (5ug)
B16
2200
1600 1400 1200 1000 800 600 400 200 0 0 4
Tumor Volume (mm 3, Mean SEM)
Tumor Volume (mm 3, Mean SEM)
2000 1800 1600 1400 1200 1000 800 600 400 200 0 0
Vehicle PET Lipid A (50ug) ONT-10 (5 ug) ONT-25 (5ug)
12
16
20
24
28
32
36
40
44
12
16
20
24
28
32
Days post Inoculation
Days post Inoculation
14
PX-866 Targets PI-3 Kinase Key Cancer Target
PDK-1
PDK-2
Cell Membrane
PI
PI-3 Kinase
PTEN
PIP3
AKT
AKT
P Thr308 pSer473
PIP2
Inactive AKT
P-AKT
Cell Proliferation
Inhibition of Apoptosis
procaspase 9 Bad Ask-1 p70S6kinase GSK3 mTOR
15
PX-866 Unique Drug Profile
Orally available pan-isoform inhibitor

Potent (nanomolar) and selective PI-3K inhibition Only irreversible inhibitor in development
Covalently binds to target Facilitates sustained blockade of PI-3K pathway signaling Dose and scheduling advantages Potentially fewer off-target effects
Broad activity in preclinical tumor models Active as a single agent and in combination with targeted agents, chemotherapeutics and radiation
16
PX-866 Phase 1 Overview
Schedule Intermittent versus continuous once daily dosing Continuous schedule improved efficacy, similar tolerability
Acceptable safety profile Most common AEs: diarrhea, nausea, vomiting, fatigue and reversible increases in ALT/AST Largely manageable with symptomatic therapy or dose reduction No significant increase in toxicity in patients receiving > 2 cycles Stable disease in 42% of patients on continuous schedule Clinical and pharmacodynamic effects at dose of 8 mg/day Significantly lower doses than competitive products Supports advantages of irreversible mechanism of action
17
PX-866 Broad & Diverse Phase 2 Program

Broad Phase 2 program to maximize Phase 3 opportunities
Multiple indications Combination versus single agent Differentiation from competition
Two combination trials initiated Q4 2010

Phase 1/2 study of PX-866 + Docetaxel (Taxotere) Phase 1/2 study of PX-866 + Cetuximab (Erbitux) Two single agent trials planned for Q2 2011 Phase 2 study in glioblastoma after failure of standard therapy initiated Phase 2 study in castration-resistant prostate cancer after failure of hormone therapy (no prior docetaxel) Collaboration with National Cancer Institute of Canada
Health Canada approval
18
PX-866 Combination Trial Designs

Phase 1/2 Study of PX-866 + Docetaxel (Taxotere)
Phase 1: Dose escalation to determine maximum and/or recommended dose of PX-866 with standard dose docetaxel Phase 2: multinomial 2 stage design Two indications (up to 30 patients each) 2nd/3rd line non-small cell lung cancer 2nd/3rd line squamous cell carcinoma of head and neck Single arm open-label design with pre-specified composite endpoint based on objective response rate and lack of early progression Interim look after 15 patients
Phase 1/2 study of PX-866 + Cetuximab (Erbitux)

Phase 1: Dose escalation to determine maximum and/or recommended dose of PX-866 with standard dose cetuximab Phase 2: Controlled randomized open label design Two indications (up to 72 patients each) Progressive, recurrent, or metastatic SCCHN Progressive or recurrent colorectal carcinoma
19
PX-866 Competitive Positioning
Only irreversible inhibitor in development

Pharmacodynamic and clinical effects at low doses Competitive safety and efficacy in Phase 1 Inhibits isoforms important for solid tumors Differentiated Phase 2 clinical development program
20
2011-2012 Clinical Milestones
Initiate single agent Phase 2 trials for PX-866 Pre-clinical data for ONT-10 Initial PX-866 Phase 2 data Second interim look in START (estimate)
Q2 11 Q2 11 H2 11 H2 11
Initiate Phase 1 trial for ONT-10

Final PX-866 Phase 2 data START completion
H2 11
H1 12 H2 12
21
Oncothyreon Positioned for Success
Stimuvax Phase 3 START data expected mid-2012 or sooner

17+ month survival advantage in Phase 2 Large market opportunity Fully funded by Merck KGaA Oncothyreon retains significant milestones and royalties PX-866 Differentiated PI-3 Kinase inhibitor Broad Phase 2 development program Early data late 2011 ONT-10 Proprietary Follow-on MUC1 Vaccine Strong preclinical data at AACR April 2011 Phase 1 trial initiation expected late 2011
$29.0 million of cash as of March 31, 2011 Additional ~ $43 million from Q2 2011 public offering
22

Investor Presentation May 2011

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Investor Presentation May 2011

Uploaded by

Copyright:

Available Formats

Copyright 2011, Oncothyreon