Phylogica Harnessing biodiversity for biologics discovery

Transcription

1 Phylogica Harnessing biodiversity for biologics discovery AGM November 2010

2 Introductions to Speakers Dr Douglas Wilson - Executive Chairman Former Senior Vice-President, Medicine for Boehringer Ingelheim Overseen multiple drugs at all phases of development including bringing many drugs successfully to the market in the USA Dr Paul Watt CEO Commonwealth overseas scholarship recipient Doctorate at the University of Oxford, 42 publications, including several high-impact and well-cited papers Post Doctoral appointments at Oxford and Harvard Universities Over 10 years commercial biotech experience Inventor on 19 patent families, including multiple issued in US/Europe Mr Nick Woolf CFO, VP Corporate Development 18 years experience in biotech industry, equity research & investment banking Previously Chief Business Officer of Oxford BioMedica plc in the UK Former Head of European Biotech Equity Research at ABN Amro Extensive knowledge of international capital markets and investor relations Qualified accountant and MA in Chemistry from the University of Oxford 3

3 Highlights of the year Successfully entered 2 discovery partnerships with some of the worlds top pharmaceutical companies (Roche, MedImmune/AZ) Appointed Nick Woolf as Chief Financial Officer Completed $2.3 Million Capital Raising Generating new revenue 5 Successfully completed transition to Drug Discovery Model

4 Roche & MedImmune Partnerships Roche Signed in December 2009 Discovery of new cell penetrating peptides Project completed and review of milestone achievements in progress Option structure 18 MedImmune (biologics unit of AstraZeneca) Signed in August 2010 Discovery of novel antibiotic candidates against the hospital-acquired infection Upfront payment of US$750k; additional US$750k in committed funding Development and commercial milestone payments of up to US$98M Royalties on worldwide sales

5 Background Spin-out from collaboration between Telethon Institute for Child Health Research in Western Australia and Fox Chase Cancer Centre in Philadelphia Based in Perth, Western Australia, and Oxford, UK; ~20 staff Listed on Australian Stock Exchange (ASX:PYC) in 2005 Market capitalization of ~AU$14M Tightly held: Top 12 shareholders hold more than 50% 5

6 Financials Capital structure 283M Ordinary shares, 64M options 1.3M convertible notes - convert to 27M shares Net cash burn in FY2010 of approximately AU$3.8M* Cash at hand November 30th of AU$2.6M Objective to achieve cash sustainability in 18 Months 6

7 Low-Risk Business Model Contract Drug Discovery for Pharma Nick Woolf 7

8 Traditional Drug Development Model in Australia Discovery Humans Development Humans Humans Discovery Lead Optimisation Toxicity IND Phase I Phase II Phase III Standard Biotech Drug Development Model Co-development Humans Typically aim to partner (co-develop) after phase I/II Normally not enough funding for even one program High risk of failure challenging for investors

9 Phylogica s focus on Drug Discovery reduces risk Discovery Humans Phylogica Co-development/Partner Humans Co-development path Model requires an exclusive source of new drug leads Phylogica now geared for multiple discovery projects Business model now gaining commercial traction

10 Model provides access to short and long-term revenue streams Discovery Humans Upfront fees, FTEs provide immediate revenue stream Build long-term value through milestones and royalties Secure increasing share of down-stream value through codevelopment, funded by surplus cash flow

11 Structure of our discovery alliances Structure of Discovery Partnerships (eg: MedImmune/AstraZeneca deal) Upfront license fee Value Per Drug Target (US$) $750-$1M Contract revenue for screening (1 yr) $750K- $1M Cumulative milestone payments Up to $100M Royalties single digit %

12 Scaleability of Revenue Streams Revenue Streams Upfront License Fees, FTE s Milestones, Royalties Costs $1.5 Million $98.5 Million

13 Scaleability of Revenue Streams Revenue Streams Upfront License Fees, FTE s Milestones, Royalties Costs $1.5 Million $98.5 Million $1.5 Million $98.5 Million $1.5 Million $98.5 Million $1.5 Million $98.5 Million

14 Big Pharma are increasingly outsourcing drug discovery

15 The discovery-alliance model works Company Platform Market Value 2009 Revenues Listed Morphosys Evolva Evotec Galapagos Antibody Library Screening Library Screening/Small Molecule Genetic Library Screening/Small Molecule Genetic Library Screening/Small Molecule > $357M 81M Frankfurt > $286M CHF19M Swiss > $307M > 40M Frankfurt/ Nasdaq > $402M 100M EuroNext Model also allows for internally funded clinical development pipeline as companies grow

16 Why are big Pharma interested in Phylomers Paul Watt 23

17 Traditional drug development pipelines are drying up No. new small molecules drugs/per annum Nature Reviews Drug Discovery, Vol 9, p92, 2010 Numbers of conventional small molecule drugs coming to market are diminishing

18 Traditional drug development pipelines are drying up No. new small molecules drugs/per annum Nature Reviews Drug Discovery, Vol 9, p92, 2010 Numbers of conventional small molecule drugs coming to market are diminishing

19 BIOLOGICS: the new wave in drug development Biologics are a new class of therapeutics including antibodies and peptides Biologics represent fastest growing class of drugs (Herceptin, Humira) More than half of newly approved drugs by 2015 will be biologics Peptides have some key advantages over larger protein-based biologics Antibody Phylomer (15-30X smaller) 12

20 Peptide market growing nearly twice as fast as conventional drugs 45 marketed peptides represent $4 billion market (excluding insulin) 132 peptides in clinical development and hundreds of peptides in advanced preclinical development (tip of the iceberg) Virtually all peptides come from analogues of natural peptides Discovery of peptides against new targets has proved challenging

21 Phylomer peptides come from parts of biodiverse proteins From biodiverse microorganisms, many of which live in extreme environments like volcanic streams, geysers and deep sea volcanic vents Phylomer libraries contain several billion distinct peptides Phylomer structures have evolved to allow survival, such as high thermal stability Watt PM (2006) Nature Biotechnology 24 (2):

22 Harvesting structural diversity for drug discovery Phylomer libraries offer the most structurally diverse set of peptides available 10

23 Addressing a key challenge of peptide drug discovery Phylomer libraries developed to hit new target classes Phylomer libraries provide the most diverse set of peptide structures available Bigger pool of different structures to choose compounds from Best quality and quantity of peptide drug prototypes against new targets available

24 Roche collaboration: getting drugs into cells Most disease-associated drug targets lie within cells Traditional biologics like antibodies can t access targets inside cells Found Phylomers which are able to penetrate inside cells, providing access to intracellular targets Phylomer Extracellular Antibodies Intracellular X Large size prevents access

25 Big pharma wants in Accessing targets inside the cell with peptides represent the next wave of drugs Pharma paying for drugs that can get inside cells BristolMyersSquibb/Kai pharmaceutics (2008) $25 Million upfront, 10 Million in investment at Kai s option Up to $192 Million in Milestone payments Roche/Aileron deal against 5 intracellular targets: (2010) $25 Million in technology access fees and FTE s Up to $1.1 Billion in milestone payments

26 Roche: Encouraging Data Have identified multiple cell penetrating Phylomer peptides Roche are independently evaluating Phylogica s findings Negative Positive!"#$"%&'()"*+,-./0," "!"#$"%&'()89:9"*%2;</0," " =>"#$"=>@A"*%BC62D,57" =>"#$">?@A"*%BC62D,57"

27 MedImmune: Anti-infectives Emergence of resistant bacteria in US hospitals Preliminary success of Phylomers in killing multi-resistant superbugs attracted interest of Medimmune Medimmune has engaged Phylogica to discover new drugs to treat hospital-based infections Multi-billion dollar market which continues to grow

28 Internal Discovery Programs CANCER TARGETS Collaboration to discover new cancer targets Hitting an emerging high value cancer target 23

29 Sonic Hedgehog (intracellular) High value targets. Useful to treat range of diseases including brain tumours and skin cancers Best targets inside cells In certain cancers, hedgehog (Shh) ligand binds to Ptch: relieves Ptch-mediated inhibition of Smo >100 Phylomer hits Shh Smo now active Ptch Cell Membrane Phylogica developing Phylomers against multiple targets in the Shh signalling pathway Smo Gli Gli Smo signals to activate Gli transciption factors Target Genes Gli translocates to nucleus; activates target gene expression Nucleus Leading to tumour survival and growth

30 Discovering new disease targets Collaboration with Cambridge University, Molecular Therapeutics Program Established a new application of Phylomer libraries to discover drug targets Significant interest from Big Pharma Exploring opportunities for commercialisation of this asset

31 Summary Successfully validated Drug Discovery Model with multiple pharma partners On track to achieving goal of >3 deals per year On-track to achieve revenue neutrality within 18 months Building capital growth asset for a high value exit for our shareholders 5

32 Dr. Paul Watt Chief Executive Officer Tel: Fax: Mobile UK: Mobile AUS: paulw@phylogica.com Nick Woolf CFO, VP Corporate Development Tel: Fax: Mobile UK: nwoolf@phylogica.com ASX: PYC; XETRA: PH7