SWEDISH-AMERICAN LIFE SCIENCE SUMMIT August 19-21, 2009

An Introduction to Affibody

Corporate Background Privately held (HealthCap 43%, Investor 25%)

Founded in 1998 by scientists from KTH and KI

Based in Stockholm, Sweden

25 FTEs

Technology Platforms Affibody® platform - high affinity binders

AlbumodTM platform - extending the half life of biotherapeutics

Business Model Balanced business model generating SEK 28m (~USD 3.5m) in revenue 2008

10 deals with partners such as GE, Merck, Biovitrum, and Finnzymes

4 industrial products marketed by partners

Second generation antibody mimetics company

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Affibody® Technology – Proprietary Triple Helical Platforms

Affibody® Platform AlbumodTM Platform

5 kDa 6 kDa

Two proprietary platforms – versatile business model

The Antibody Opportunity

More than 20 approved therapeutic mAbs

Blockbusters such as Rituxan®, Remicade®, Herceptin®, Avastin®, Humira®, Erbitux®, and Synagis®

Therapeutic mAb revenue projected at above USD 30bn in ’09

Expected 5-yr Sales CAGR >10%

Large pipeline of products in late-stage development

Monoclonal Antibody (mAb)

Monoclonal antibodies are reshaping the industry

Therapeutic mAbs

Affibody® molecule 6 kDa

Monoclonal Antibody (mAb)150 kDa

Affibody® Molecules – Next Generation Antibody

A fraction of the size packed with the same power

Small size (1/25th the size of a mAb)

High selectivity and affinity (high potency)

Rapid and reversibly folding (extreme stability)

Flexible low cost production (peptide synthesis or recombinant production)

Flexible engineering and formatting (modified properties and formats)

Anti-HER2 Affibody® Molecule vs. Trastuzumab

When you can see it you can treat it

mAb

High background

Extended exposure of non-target organs

6 h p.i.

6 h p.i.

124I-Trastuzumab, N87 Xenografted mice

124I-Anti-HER2 Affibody® Molecule, N87 Xenografted mice

24 h p.i.

24 h p.i.

Affibody® Molecule

Rapid high tumor uptake

Improved potency / side-effect ratio

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Affibody® Technology – Proprietary Triple Helical Platforms

Affibody® Platform AlbumodTM Platform

5 kDa 6 kDa

Two proprietary platforms – versatile business model

AlbumodTM Platform – Extending Half-Life

Potency – sustained efficacy

Economy – reduced dosage

Safety – avoid high peak blood concentrations

Life cycle management / Biosuperiors

Half Life from Minutes to Days (primate)

5-fold Higher Dose on Tumor (mouse)

Half-life: from hours to days increased potency

Therapeutics and Imaging Portfolio Overview

Program Preclinical Research

Anti-HER2Affibody® Molecule

Clinical Development

TargetSelection

LeadIdentification

LeadOptimization

Preclinical

Breast Cancer, Phase I/IIa study approved, exploratory clinical data

Bladder Cancer, Phase I study approved

Breast and Bladder Cancer, pre-clinical efficacy

Phase I Phase II Phase III

Therapeutics

Imaging

Oncology

Anti-EGFRAffibody® Molecule

Head and Neck Cancer, ready for development

Anti-PDGFRβAffibody® Molecule

Anti-PSMAAffibody® Molecule

Cancer, ready for development

Prostate Cancer

Inflammation and autoimmune

Undisclosed Undisclosed

Hematology

Long-acting G-CSF Neutropenia,PK data

HER2 Program(Imaging and Therapy)

Anti-HER2 Affibody® Molecule Imaging Opportunity

Breast Cancer

Exploratory clinical data available

Phase I dose finding study approved

Bladder Cancer Imaging

Exploratory application approved

Safety and Immunology

Repeated dose tox demonstrated the molecule to be safe and well tolerated

Non-immunogenic after repeated dosing in rat

Clinical Development Plan

Phase I dose finding study (27 patients, 6 months)

Phase III confirmatory study (150-200 patients, 9 months)Breast Cancer patient with brain metastasis

Short time to market – limited number of patients

Orlova, A., et al. (2007) Cancer Research, 67: 2178-86.

HER2 Imaging – Novel Diagnostic Applications

Use cases demonstrated not possible with current standard (biopsy)

CORONAL TRANSVERSAL

Global HER2 status (2 h p.i., PET/CT)

Tumor

Tumor

17-AAGtreated

Monitoring therapy response (4 h p.i., SPECT)

Trends in Oncology mAb Therapy

Antibody-drug conjugation (payloads)

– T-DM1 (Herceptin + payload), Ph III, Genentech/ImmunoGen

Genentech plans to file 1-2 INDs on payload drugs annually

– SGN-35 (CD30 + payload), Ph III, Seattle Genetics

Focus on effector functions

– e.g. Xencor, Macrogenics, Glycart, Micromet – BiTE, Merrimack – HER2/HER3

The Affibody® molecule is an optimal payload carrier

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Toxin fusion 250 g/kg

Tumor volumeBT474 Xenografts

PE38 toxin

Anti-HER2 Affibody® Molecule – Payload Therapeutics

Therapeutic Efficacy - HER2 Affibody® Toxin Fusion Protein

HER2 Affibody® Toxin Fusion shrinks solid tumors

Long-acting G-CSF(Therapy)

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G-CSF-ABD035

G-CSF

Long-acting G-CSF – A Biosuperior Opportunity

A single i.v. injection of equimolar amounts of G-CSF-ABD0 fusion (n=5) or G-CSF (Neupogen®) (n=2) to rats

10-Fold Increased Circulation Time Retained Specific Activity

10x increased circulation time and fully retained activity

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Standard (Neupogen)

G-CSF Albumod

NFS-60 proliferation assay

Achievements During 2009

Therapeutics

– Preclinical efficacy demonstrated in collaboration with NCI (HER2)

– Prolonged circulation time with retained activity demonstrated (G-CSF)

Medical Imaging

– Approved Swedish Bladder Cancer Imaging Study

– Approved German Breast Cancer Imaging Study

Business Development

– Collaboration with Biovitrum

– New deals currently negotiated

Considerable achievements during 2009

The Value of Antibody Mimetics – Example of Deals

Amgen acquired Avidia for $290m (2006)

Amgen bought Avidia to get access to a small scaffold protein, based on only early preclinical data.

Pfizer bought BioRexis for an unknown amount (2006)

The acquisition gave Pfizer proprietary rights to transferin as a scaffold, and for halflife extension of peptides. Only preclinical data were available at the time of purchase.

GSK acquired Domantis for $455m (2006)

Domantis was a domain antibody scaffold company. Only preclinical data were available at the time of purchase.

BMS bought Adnexus for $430 million (2007)

Adnexus had proprietary rights to fibronectin as a scaffold, and for halflife extension of peptides. Only preclinical data were available at the time of purchase.

Significant values have been realized by similar technologies

Investment Case

Balanced portfolio – therapeutics and diagnostics

– From imaging to therapy in oncology

– Excellent payload carrier

Growing revenue stream

– Primarily driven by royalty revenue

Validating collaborations

Positioned to capitalize on the next wave of antibody therapeutics