effective
      communications

                            selling your story

Wayne Schnarr                             ...
always remember


what are YOU selling

to whom are YOU selling

what is the sales process

never stop selling




       ...
you are selling

or you are on the receiving
end of sales pitches

every day




giving lectures

what are you selling

  ...
writing grant proposals

what are you selling

      your intellectual capabilities

to whom are you selling

      granti...
the financial community

why do people invest in biotechnology companies?
      to make money!

how do VCs make money from...
biotech investors balance risk and reward

reward
   multi-billion dollar market
   first-in-class
   best-in-class
   cur...
effective
     presentations:
    PowerPoint 101




 PowerPoint is on your
     computer –

  which does not mean
that yo...
powerpoint 101
the presentation should:
   • be there for the audience, not for the presenter
   • be useful for multiple ...
need expressed
            what is the hunger?
              • what is the specific disease or medical condition
         ...
Real-time Vascular Imaging System
Opportunity and Unmet Need

   • US Market
      – 300,000 plastic and reconstructive su...
There are
     54 million with
          Americans
        low HDL


World’s Largest Drug Market
Top 3 drug categories 200...
The Old Ophthalmic World Order



      Allergan & Alcon



      Nothing disruptive


      No blockbusters

            ...
Lucentis is a big success, but it is not over




Only                         Requires
targets                       mont...
wAMD vs DME


                                                                     DME
                          wAMD
    ...
DME: Disease State



              Normal Retina                                                    Retina with DME




 ...
Multiple Sclerosis (MS)                              TSX:MS




                 Inappropriate immune attack
             ...
TSX:MS




                                                                   33




MS has Two Major Populations         ...
MS has Two Major Markets                                         TSX:MS




Relapsing                                     ...
BREAKING THROUGH



AF Incidence
             arrhythmias            1 in 4 adults will get AF (age 40+)




      6 milli...
BREAKING THROUGH



Healthcare ramifications and risks

             leading cause of stroke                       >15%
  ...
need addressed:
             solution to
           the hunger -
             the value
            proposition




need a...
Neuradiab Survival Data

Clinically compelling difference

                                                   42%
        ...
iCo-007: Method of Action (MOA) - VEGF Plus

 Growth factors

            initiate
            signal


                  ...
iCo-007: MOA - VEGF Plus

      The production of c-Raf             The inhibition of c-Raf
      Signal pathway          ...
Preclinical Evidence: Inhibition of new
blood vessel growth in mouse eye


         Saline                 14μg ISIS 15770...
MBP8298: Overview                                                          TSX:MS




            Only novel agent for SPM...
MBP8298: Drug discovery/
 development for progressive MS                                                 TSX:MS




Analys...
MBP8298 Treatment Induces Tolerization                                       TSX:MS




                                  ...
Published Efficacy Results                                                    TSX:MS




“Long-term follow-up treatment an...
Insulin - Exploding Demand
     Who is going to fill the gap?




                              16,000 kg
     2012



   ...
Supplying World Insulin Demand


 15,000 acres or                  Supply
 3 commercial farms               for the entire...
Insulin - Chemical Equivalence
                          Electrospray Mass Spectrometry
                                  ...
creating value:
            the action plan




action plan
you have already sold them:
   • the unmet medical need
   • t...
Regulatory Path
                                 Conclusions from the meeting:
                                 • Insulin ...
iCo-007: Achievements and Milestones

                                                                    Phase 1
In-licen...
Ongoing Clinical Development                                                          TSX:MS




 MAESTRO-03
 Pivotal Phas...
Target Clinical Timelines                                                                                                 ...
Milestones



SPY System                                         Q3 2005   Q4 2005   Q1 2006

U.S. sales partner          ...
Real-time Image Guidance in the Operating Room
Pipeline Product Strategy
                                            Trial...
Real-time Image Guidance in the Operating Room

                                                                          ...
Trial Design Recent Events

     FDA consultation                           CRO selection


FDA approved Bradmer’s        ...
Neuradiab Pivotal Trial Timeline


                                                                           Full Data
  ...
PAC-113




Uncontrolled Infectious Disease

     Healthy State                 Immune Compromised
     Candida albicans  ...
Current Treatments Deficient


Nystatin                      Azoles                   Amphotericin B
  Topical            ...
Safety Established Clinically

      Four safety and efficacy trials completed
      Indication: gingivitis (gum disease)
...
Significant Market Potential


         Treatment of                           Treatment of
        oral candidiasis      ...
Uncontrolled Immune Response

         Healthy State                Diseased State

1. Pathogens induce                   ...
PAC-G31P Effective in Animal Models
                   30
Neutrophil count




                                           ...
Markets

                                     Asthma
    ARDS                                                             ...
don’t stop selling


                         What is left to sell?
                           management
                ...
Corporate Overview

Established:               1994: Spin out –
                           University of Calgary
Stock Mar...
Patents

Protecting the platform
11 U.S. patents and applications

                                                       ...
Corporate Data



      Founded                                                                                   2005

  ...
Hot Therapeutic Arena


                                                                   Novartis
 Pfizer               ...
An example




Investor Presentation
                    June 2007




                                55
Forward-looking statement

Certain information included in this document is forward-looking and is
subject to important ri...
Hitting a target doesn’t guarantee success

1000’s of high affinity
Antibodies have been identified




                  ...
ARIUS focuses on FunctionFIRST™
   “Does the antibody kill cancer cells
   while leaving normal cells alone?”


          ...
FunctionFIRST™ yields results

                               A pipeline of


                             400
           ...
Genentech exclusive antibody license

                                                    Prevents tumor growth and enhanc...
Our Products

CD44 Cancer Stem Cell Program
Antibody AR001




CD44 cancer stem cell program

                            ...
CD44 – cancer stem cell marker

           Cancer stem cells          Targeting cancer
           are the factory of      ...
Trop-2 Signal Transduction Program
 Antibody AR002




Trop-2 signal transduction program

                               ...
Novel target in key cancer pathway
                           Tarceva, Iressa
                           Tarceva, Iressa
 ...
CD59 immune modulator program
                                                    Shrinks tumors in breast cancer
        ...
Arius antibody pipeline




Robust and growing intellectual property estate


16 issued and allowed patents
    - Composit...
Opportunities




9 licensing deals in 90 days!

                               AstraZeneca and
                          ...
Multiple acquisitions in last 12 months

                                                   August 2006
    May 2006      ...
About ARIUS

Headquarters:                 Toronto, Canada

Symbol:                       TSX:ARI

Employees:             ...
Investor Presentation
                    June 2007




        closing thoughts




                                70
if you had only one slide


 need expressed:             hunger

 market opportunity: greed

 need addressed:             ...
Upcoming SlideShare
Loading in …5
×

BioEntrepreneurship: Effective Communications - Selling your story

2,975 views
2,865 views

Published on

MaRS BioEntrepreneurship Series Event, June 12, 2007
Speaker: Wayne Schnarr, Senior VP, Life Sciences, The EquicomGroup
More information including a video: http://www.marsdd.com/bioent/june12

Published in: Business, Health & Medicine
1 Comment
0 Likes
Statistics
Notes
  • Love This!
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Be the first to like this

No Downloads
Views
Total views
2,975
On SlideShare
0
From Embeds
0
Number of Embeds
43
Actions
Shares
0
Downloads
220
Comments
1
Likes
0
Embeds 0
No embeds

No notes for slide

BioEntrepreneurship: Effective Communications - Selling your story

  1. 1. effective communications selling your story Wayne Schnarr MaRS Senior VP, Life Sciences BioEntrepreneurship The Equicom Group June 12, 2007 Forward-looking statement Certain information included in this document is forward-looking and is subject to important risks and uncertainties. The results or events predicted in these statements may differ materially from actual results or events. For additional information with respect to certain of these and other factors, see the reports filed by the various companies mentioned in this presentation with the Securities Commissions of Ontario, Alberta and British Columbia. These companies disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This document does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States. No securities have been registered under the United States Securities Act of 1933, as amended or any state securities laws. 1
  2. 2. always remember what are YOU selling to whom are YOU selling what is the sales process never stop selling 2
  3. 3. you are selling or you are on the receiving end of sales pitches every day giving lectures what are you selling information, passion, ability to think to whom are you selling the students in the chairs what is the sales process lectures plus never stop selling or they fall asleep or don’t attend 3
  4. 4. writing grant proposals what are you selling your intellectual capabilities to whom are you selling granting agencies what is the sales process annual submissions selling never stops unfortunately not selling your story to the financial community & the health care industry 4
  5. 5. the financial community why do people invest in biotechnology companies? to make money! how do VCs make money from investing in biotechnology companies? through an IPO through sale of the company nobody invests in early stage biotechnology companies for a 10% ROI “you have to show them the 10-bagger” - Michael Denny biotech investors buy growth based on the current and future sales of products and services approved products growth of sales and earnings no approved products progress in preclinical and clinical development independent product validation by partners 5
  6. 6. biotech investors balance risk and reward reward multi-billion dollar market first-in-class best-in-class cure risk market risk clinical risk scientific risk biotech investors balance risk and reward reward what are you selling? • a potential reward that justifies the current valuation • a potential reward that is large enough to allow an IPO or M&A transaction risk what are you selling? • you are NOT selling a risk-free opportunity • that you clearly understand the scientific risk • that you can mitigate the clinical risk • that you understand the market risk 6
  7. 7. effective presentations: PowerPoint 101 PowerPoint is on your computer – which does not mean that you are an expert at creating presentations. 7
  8. 8. powerpoint 101 the presentation should: • be there for the audience, not for the presenter • be useful for multiple audiences • be useful both on the screen and as a handout • not contain every piece of information that is in your business plan • be about 30 slides for a general audience or introductory meeting • have a consistent format, colour scheme and font • be talked to or about, not read • use appropriate animal and human pictures • some slides transmit information – critical slides SELL need expressed: what is the hunger? how big is the hunger? no big hunger … no one cares 8
  9. 9. need expressed what is the hunger? • what is the specific disease or medical condition • is there a specific subgroup that is being targeted • what are the currently approved drugs, if any, and what are their deficiencies • what is the unmet medical need how big is the hunger? • be realistic • not every potential patient gets diagnosed or treated • use patient numbers from independent sources • use sales of currently approved drugs where applicable Real-time Cardiac Imaging System Opportunity and Unmet Need • 400,000 CABG procedures annually • 10 to 20% complications: expensive and life threatening Stent Graft • 7,000 TMR procedures • Potentially 30,000 with SPY System JAMA report on graft failure • Up to 30% of vein grafts used in heart bypass surgery fail at one year or less 100% <10% validation 12 peer-reviewed journals - 2000 patient data validation • Improves clinical outcome: 5 - 8% revisions • Equivalent to X-Ray angiography in real-time 9
  10. 10. Real-time Vascular Imaging System Opportunity and Unmet Need • US Market – 300,000 plastic and reconstructive surgeries – 60,000 solid organ transplants – 100,000+ tumor margin detection • 30% of breast reconstructive surgeries may experience complications • Poor perfusion: #1 contributor to complications and failed procedures • No other practical method of assessing tissue or organ perfusion Coronary Heart Disease Number one 20% killer! of all deaths 10
  11. 11. There are 54 million with Americans low HDL World’s Largest Drug Market Top 3 drug categories 2004 annual sales $30.2B } $25.5B 5 blockbuster drugs $23.8B Cytostatics Cholesterol & Antiulcerants (Cancer) triglyceride (GI tract) reducers 11
  12. 12. The Old Ophthalmic World Order Allergan & Alcon Nothing disruptive No blockbusters 23 iCo Therapeutics | IPO presentation | Now Lucentis is a Big Success $940 million* 95 Revenue % $380 million* efficacy in treating wAMD F2007 2006 Decimated incumbent therapies 24 iCo Therapeutics | IPO presentation | *Source: Genentech documents and Rodman & Renshaw analyst reports 12
  13. 13. Lucentis is a big success, but it is not over Only Requires targets monthly one growth injections to factor (VEGF) retain efficacy 25 iCo Therapeutics | IPO presentation | wAMD is not DME (diabetic macular edema) Our Focus is DME 26 iCo Therapeutics | IPO presentation | 13
  14. 14. wAMD vs DME DME wAMD Acute event Disease progression Gradual deterioration Working years Elderly Average onset VEGF bFGF IGF-I Predominantly VEGF Pathology EPO HGF integrins 27 iCo Therapeutics | IPO presentation | DME: Leaking Vasculature at Back of Eye Proliferation of new blood vessels in PDR More blood brought to area Vessels are permeable Blood leaks into retina area Causes swelling & deformation of retina 28 iCo Therapeutics | IPO presentation | 14
  15. 15. DME: Disease State Normal Retina Retina with DME 29 iCo Therapeutics | IPO presentation | DME Treatment Options are Currently Limited Laser Photocoagulation Unsuccessful Kenalog or Vitrectomy Recurrent Successful DR DME 5.3 MM pts 1.6 MM pts Kenalog or Vitrectomy • Even well-timed and adequate laser treatment only effectively controls edema in 50% of patients with CSME and repeated laser therapy (more than three or four treatments) is contraindicated due to cumulative destruction of the visual field. Patients with diffuse or cystic macular edema tend to have a poorer response to laser. • Kenalog is gaining usage in these patients, and those with vitreous traction are candidates for vitrectomy. 30 iCo Therapeutics | IPO presentation | DH Insight Briefing – Ophthalmology | November, 2005 pg. 44 15
  16. 16. Multiple Sclerosis (MS) TSX:MS Inappropriate immune attack on the protective coating (myelin) surrounding the nerves of the brain and spinal cord MBP8298 suppresses immune attack at the most common molecular target MS Susceptibility Factors TSX:MS Geography Genetics DR2/ DR2/ DR4 DR4 DR2/ DR4 up to of all MS patients 75% 2.5 million patients have HLA-DR2 or HLA-DR4 genes (our responder group) 32 16
  17. 17. TSX:MS 33 MS has Two Major Populations TSX:MS Market Relapsing 40-45% Remitting MS of MS patients (RRMS) MBP8298 Phase II trial 50% convert 90% convert in 10 yrs in 25 yrs Secondary Market 40-45% Progressive MS of MS patients (SPMS) MBP8298 Phase III trials 17
  18. 18. MS has Two Major Markets TSX:MS Relapsing US$5.8B ~500,000 treated current patients annually of Remitting MS market >1 million patients (RRMS) Secondary Few patients treated of Blockbuster Progressive MS market >1 million patients (SPMS) potential 35 MS has Two Major Markets TSX:MS US$5.8B Approved Products Relapsing Biogen Idec: Avonex® current Remitting MS Bayer Schering Pharma AG: Betaseron® Teva: Copaxone® market (RRMS) Merck Serono S.A: Rebif® Biogen Idec/Elan: Tysabri® Secondary Approved Products Blockbuster Betaseron® (No proven delay in Progressive MS progression, only approved with market relapses) (SPMS) potential Novantrone® (Cardiotoxicity limits use to 2 – 3 years) 36 18
  19. 19. BREAKING THROUGH AF Incidence arrhythmias 1 in 4 adults will get AF (age 40+) 6 million patients in the world Annual incidence: 700,000 * Wang et al. Circulation: Journal of the American Heart Association. August 2004. BREAKING THROUGH Current treatment drawbacks drugs heat ablation used in <3% of cases treats symptoms only only when drugs fail high procedural risks: 30 – 60% effectiveness PV stenosis diminishes over time Thrombosis Esophageal perforation serious side effects 19
  20. 20. BREAKING THROUGH Healthcare ramifications and risks leading cause of stroke >15% 1 leads to chronic heart failure 2 >20% 3 leading cause of hospitalizations 415,000 (U.S.) 4 cost to healthcare US$6.6 billion no practical solution! * Donald M Lloyd-Jones, Md, ScM, FACC. Medscape Cardiology 8 (2). 2004. AF Business Opportunity Untreated Pool New Cases/Year 2.2 million 160,000 >$2 Billion Annual Business Opportunity 2.1 million 145,000 4.3 million 305,000 20
  21. 21. need addressed: solution to the hunger - the value proposition need addressed what is your product? • type of drug, device, diagnostic • what is the mechanism of action what is the value of your product? • the value is in the data • human data is more valuable than animal data • if you have human data, eliminate or minimize the animal data • consider the audience when assessing the complexity and presentation of the data being used 21
  22. 22. Neuradiab Survival Data Clinically compelling difference 42% 91 Surgery + Radiation + Temozolomide + Neuradiab weeks 64 2005 Surgery + Radiation + Temozolomide weeks 1980 53 Surgery + Radiation to weeks 2004 0 15 30 45 60 75 90 105 Survival in weeks 43 iCo–007 for the treatment of DME 22
  23. 23. iCo-007: Method of Action (MOA) - VEGF Plus Growth factors initiate signal VEGF HGF EPO c-Raf Retina Signal through c-Raf 45 iCo Therapeutics | IPO presentation | iCo-007: MOA - VEGF Plus Growth factors Modulate signal Retina iCo-007 inhibits the production of c-raf, thereby preventing the signaling of growth factors, which in turn prevents the production of new and permeable blood vessels 46 iCo Therapeutics | IPO presentation | 23
  24. 24. iCo-007: MOA - VEGF Plus The production of c-Raf The inhibition of c-Raf Signal pathway Signal pathway interrupted iCo-007 mRNA ribosome Inhibits c-Raf production which prevents cell growth and permeability 47 iCo Therapeutics | IPO presentation | Preclinical Evidence: Inhibition of c-Raf c-Raf immunostaining % Saline Control of porcine eye 120 100 Control 80 60 40 20 107189 Treated 0 D7 D7 D14 Saline 34μg 180μg 180μg 48 iCo Therapeutics | IPO presentation | 24
  25. 25. Preclinical Evidence: Inhibition of new blood vessel growth in mouse eye Saline 14μg ISIS 15770 49 iCo Therapeutics | IPO presentation | Preclinical Evidence: 3 month dosing achievable Half life 44 days Single intravitreal (90 μg) injection 50 iCo Therapeutics | IPO presentation | 25
  26. 26. MBP8298: Overview TSX:MS Only novel agent for SPMS Indications: SPMS & RRMS in Phase III trials Synthetic peptide for Designer drug specific responder group (up to 75% of MS patients) Epitope-specific tolerance, not Unique mechanism general immunosuppressant Convenient administration IV ’push’ every six months Delayed median time to progression Long-term efficacy* for 5 years in responder group Side effect: minor injection site Very safe* irritation * Based on previous clinical trial results TSX:MS MBP8298 slows the progression of MS 52 26
  27. 27. MBP8298: Drug discovery/ development for progressive MS TSX:MS Analysis of CSF autoantibodies guided development • RRMS: Autoantibodies detectable only during relapse events • SPMS/PPMS: Autoantibodies continuously present – useful indicator of drug effect Drug concept: Induction of antigen-specific tolerance • Observed in early vaccine development • High dose intravenous administration of soluble antigen MBP8298 was designed to replicate the most common antibody target • IV administration suppressed CSF autoantibody levels in most patients • HLA-DR2-restricted T-cells target the same sequence HLA-DR genes • Direct the fine specificity of immune responses • HLA-DR2 and -DR4 predispose to MS and make up the majority of patients • Easy genetic test for HLA type MBP8298 Replicates the Myelin Target TSX:MS T-cells & B-cells from immune system attack 82-98 portion of 1 myelin in HLA-DR2 (and other) patients MBP8298 17 amino acid peptide Identical to the natural sequence Blood Brain Nerve Fiber Blood Vessel Barrier 27
  28. 28. MBP8298 Treatment Induces Tolerization TSX:MS “Classic” Tolerization Principle: 2 500mg dose every six “Reverse” of vaccination months Established in vaccine research 50+ years ago Shown to cure or prevent EAE animal models of MS MBP8298 synthetic peptide identical to dominant site of immune attack Blood Vessel Blood Brain Nerve Fiber Barrier Immune System is Tolerized TSX:MS Tolerization Result: Eliminates antibodies to 3 MBP8298 for six+ months Requires dose every six months Clinical delay in disease 4 progression Blood Vessel Blood Brain Nerve Fiber Barrier 28
  29. 29. Published Efficacy Results TSX:MS “Long-term follow-up treatment and assessment of patients in this responder group showed a median time to progression of 78 months for MBP8298 treated patients compared with 18 months for placebo-treatment (Kaplan–Meier analysis, P = 0.004…)” Five Year Delay in Progression TSX:MS 100 Phase II Trial: Kaplan-Meier Analysis of HLA-DR2 and/or DR4 80 % Not Progressed patients at 84 Months 60 40 Endpoint: Time to 1st confirmed Placebo progression on EDSS 20 18 months MBP8298 78 months 0 MBP8298 Placebo 29
  30. 30. Insulin - Exploding Demand Who is going to fill the gap? 16,000 kg 2012 2006 6,000 kg 13 Company estimates Fermentation is One Alternative $ 1.2B 2006: 6,000 kg of insulin (est.) Capital invested in existing manufacturing plants 2.5X 2012: 16,000 kg of insulin More capital required 4 to 6 years Long lead times 14 30
  31. 31. Supplying World Insulin Demand 15,000 acres or Supply 3 commercial farms for the entire planet in 2012 1 commercial farm 1 mile 15 Economics of Plant-Produced Insulin Safflower Enabling technology to meet insulin demand insulin expression of 1.2 % total seed protein ~1.0 acre produces 1 kg of insulin acres to supply 2012 15,000 Seed Floret projected insulin demand est. capital cost for 1,000 kg $80M of plant-produced insulin Capital cost % 70 reduction compared to fermentation 16 31
  32. 32. Insulin - Chemical Equivalence Electrospray Mass Spectrometry Safflower-derived insulin: Commercial • chemically equivalent to pharmaceutical- commercially-available human grade insulin: insulin Molecular mass 5807 Da • folds identically to commercially- available human insulin V8 protease fingerprinting Safflower- derived insulin: Molecular mass 5807 Da 17 Insulin - Functional Equivalence (mouse) Safflower Insulin Tolerance Test 120 % Initial Blood Glucose 100 80 60 40 error bars = +/- SEM 20 0 50 100 150 Minutes Post Injection Saline Insulin (Humulin® R-Eli Lilly) USP Insulin (pharma grade standard) Insulin (SemBioSys) 18 32
  33. 33. creating value: the action plan action plan you have already sold them: • the unmet medical need • the value proposition what is left to sell them? • that you can increase the value of the product by appropriately spending their money 33
  34. 34. Regulatory Path Conclusions from the meeting: • Insulin can follow the abbreviated There is a 505(b)(2) rule clear regulatory • First human trial will be a Phase II for pharmacokinetics & pharmacodynamics process for Reverses • 50 subjects, 1 month study safflower- • Second human trial will be a plaque build-up Phase III for longer-term safety derived insulin • 500 subjects, 6 months, 2 arms safflower insulin and Humulin® • 500 subjects, 6 months, 1 arm safflower insulin only Met with the FDA for a pre IND • No special regulations related to plant, consultation in October 2006 QC/OA requirements cover all host related issues 19 Trial Design Dr. Scott Cousins Dr. David Boyer Durham NC Beverly Hills CA Dr. Philip Rosenfeld Miami FL - 15-30 patients - Single administration - 6 month follow-up - Ascending dosage - Open label - 3 planned centres - Secondary efficacy endpoint 68 iCo Therapeutics | IPO presentation | 34
  35. 35. iCo-007: Achievements and Milestones Phase 1 In-license Results P2 P3 NDA - IND Accepted Safety - Manufacturing scale-up H2 H1 H2 H2 2005 2007 2007 2008 - License from ISIS Initiate Phase 1 - World wide rights - 15-30 patient trial Out License - All therapeutic indications - Dose escalation study - Minimal upfront payment - Back-end loaded milestones - Royalty rate doesn’t impede partnering 69 iCo Therapeutics | IPO presentation | Ongoing Clinical Development TSX:MS MAESTRO-01 Pivotal Phase III SPMS trial – Canada and Europe • Powered for HLA DR2 & DR4 responder group • Placebo-controlled, double blind, 2-year treatment period • Recruitment is complete • Includes approximately 550 patients • Interim analysis: mid-2008 MAESTRO-02 Open-Label, Follow-on Portion to MAESTRO-01 • After patients have completed 2 years of treatment in MAESTRO-01, patients may chose to receive MBP8298 • MAESTRO-02 will primarily evaluate long-term safety • Support regulatory submissions 35
  36. 36. Ongoing Clinical Development TSX:MS MAESTRO-03 Pivotal Phase III SPMS trial – United States • Received FDA clearance to proceed with pivotal phase III • Placebo-controlled, double blind, 2-year treatment period • Powered for HLA DR2 & DR4 responder group • Up to 510 patients MINDSET-01 Phase II RRMS trial – Europe • Fifteen month, double-blind, placebo-controlled • Up to 215 patients from 30 sites • Followed by 12-month active treatment open label extension period MAESTRO-01 Phase III SPMS Trial TSX:MS Lead Investigators Dr. Mark Freedman Ottawa General Hospital Canada Dr. Carolyn Young The Walton Centre Clinical Trials Centre Liverpool, UK Dr. Tomas Olsson Karolinska Universitetssjukhuset, Solna Stockholm, Sweden Canada & Europe Professor Hans-Peter Hartung • 48 trial sites Neurologische Klinik • 10 countries Heinrich-Heine-Universität Düsseldorf, Germany 72 Trial sites around the world 36
  37. 37. Target Clinical Timelines TSX:MS MBP8298 Timelines 2007 2008 2009 2010 2011 Phase III Data Analysis & Trial SPMS Trial submission MAESTRO-01 Interim Analysis Phase III SPMS Regulatory Data Analysis & Trial (US Trial) Enrollment Trial Submission submission MAESTRO-03 Interim Analysis Phase II Open Label Data Analysis & Enrollment RRMS Trial Extension Trial Phase III Trial submission MINDSET-01 Trial Completion Near-Term Milestones TSX:MS Interim analysis in MAESTRO-01 trial (mid-2008) Initiate enrolment in Phase III MAESTRO-03 trial in United States (mid-2007) Complete enrolment in Phase II MINDSET-01 RRMS trial in Europe (mid-2007) Completion of MINDSET-01 Phase II trial (mid-2008) Potential Partnerships 37
  38. 38. Milestones SPY System Q3 2005 Q4 2005 Q1 2006 U.S. sales partner X Installed in 25 U.S. hospitals X Initiate studies for expanded indications X OPTTX System Initiate North American multi-centre trial X Initiate combo trial with multi-national partner X File for Canadian and European approval X Pipeline Strategy & Corporate Overview Real-time medical imaging in the operating room 38
  39. 39. Real-time Image Guidance in the Operating Room Pipeline Product Strategy Trials Market FDA Development Launch for FDA Clearance Design / POP Install base in US 70+ devices Cardiac Install base in US 150+ devices TMR Plastic / Launch FDA cleared Q1 2007 Recon / H2-07 Transplant FDA Launch Surgical clearance Health Canada Approved H1-08 Urology Q3-07 Human POP Prostate Launch 2008 Human POP Other Urological H2-07 Procedures Launch Human POP MINI MIS H1-08 H2-07 Real-time Image Guidance in the Operating Room & Marketed products opportunity $900 million $600MM+ $250MM* Recurring $50MM* 860,000 / year 400,000 / year 60,000 / year revenue model $700 Average kit price $200 Cost of goods *Selling Price Country-specific 39
  40. 40. Real-time Image Guidance in the Operating Room & MINI Pipeline product opportunity $1 Billion $700MM $250MM* Recurring $50MM* 1,000,000 / year 400,000 / year 60,000 / year revenue model $700 Average kit price $200 Cost of goods *Selling Price Country-specific Multi-Center Pivotal Trial Design Structure: Newly Diagnosed GBM Endpoints Randomized Primary 1 arm is standard of care Overall Survival 1 arm adds Neuradiab as adjunct Final analysis at 456 events therapy Secondary 1 and 2 year survival Multicenter Progression-free survival 310 patients per arm 30-40 sites Exploratory Analysis Larger than Temodar study Potential to see incremental benefit in non-Temodar responders 11 80 40
  41. 41. Trial Design Recent Events FDA consultation CRO selection FDA approved Bradmer’s CRO selected by Bradmer plan for Phase III trial for Phase III trial Prologue Research International November 2006 End of Phase II meeting Oncology specialist; former oncology clinical op’s team from Q2 2007 Pharmacia-Adria Final protocol and manufacturing data to be submitted Big pharma and biotech clients Experience with radiopharmaceutical trials 111 8 cGMP Manufacturing – Transition to Commercial Laureate Pharma MDS Nordion Antibody Producer Radiolabeling Partner Status Report: Antibody scale-up complete Sufficient supply to complete Phase III cGMP antibody product completed in January > 2 dozen successful equivalence tests Final formulation, optimization of radiolabel process ongoing at Nordion Clinical trial material to be released mid year 112 82 8 41
  42. 42. Neuradiab Pivotal Trial Timeline Full Data Analysis Enrollment Complete Trial Launch Mid 2007 Trial Preparation Mfg / FDA / Site Prep / Svc Providers License from Duke Q4 2005 2006 2007 2008 2009 2010 2011 “Open Label” Trial NDA submission 83 can you do it all in a few slides? yes! 42
  43. 43. PAC-113 Uncontrolled Infectious Disease Healthy State Immune Compromised Candida albicans Oral Candidiasis 90% of AIDS patients (and up to 43% of HIV patients) present in up to 75% 30% of asthma patients treated with corticosteroids of the population Patients being treated for cancer and diabetes Impaired immune system Immune system permits attack by resident controls growth of resident fungus and bacteria fungus and bacteria High probability of recurrence 43
  44. 44. Current Treatments Deficient Nystatin Azoles Amphotericin B Topical Systemic/Topical Systemic 52% efficacy Potential for resistance Severe side effects Current treatments are ineffective, cause drug resistance, cause severe side effects A novel, safe and effective treatment has the potential to generate US$300 – US$400 million per year worldwide. Fighting Infectious Disease: PAC-113 Based on natural antimicrobial peptide occurring in saliva PAC-113, delivered as mouthwash, binds to fungus surface and kills quickly Highly active against Candida, greater than 95% efficacy in vitro 44
  45. 45. Safety Established Clinically Four safety and efficacy trials completed Indication: gingivitis (gum disease) 300+ patients Conducted in the U.S. by Periodontix Inc. Well tolerated No drug related adverse events Dose related improvement in clinical endpoints PAC-113 Clinical Strategy PAC-113 Nystatin Head to head comparison Randomized, examiner-blinded, parallel design 44 HIV patients per arm 14-day treatment phase 14-day follow-up period day 28 follow-up visit Clinical objectives: Safety and tolerability Efficacy in eliminating or reducing clinical signs and symptoms of infection Microbiological response Initiated Results from Initiate dosing Phase I/II trial Phase I/II trial in Phase II trial Q1-06 Q1-07 Q3-07 45
  46. 46. Significant Market Potential Treatment of Treatment of oral candidiasis topical fungal infections US $300-$400M US $1.6B 90% of all AIDS patients PAC-113 has demonstrated activity against: 30% of asthmatics on steroids – C. albicans patients on chemotherapy / – C. glabrata radiation – C. parapsilosis – C. tropicalis PAC-G31P 46
  47. 47. Uncontrolled Immune Response Healthy State Diseased State 1. Pathogens induce 3. Excess neutrophils an inflammatory can create response by the serious medical immune system complications ARDS 2. One component of Asthma the inflammatory COPD response is neutrophil Pneumonia infiltration Regulating Immune Responses: PAC-G31P cytokine CXCR1 Cytokines bind to PAC-G31P closely CXCR1 and CXCR2 resembles cytokines receptors, attracting and blocks CXCR 1/2 and activating neutrophils CXCR2 neutrophil 47
  48. 48. PAC-G31P Effective in Animal Models 30 Neutrophil count High dose PAC-G31P Endotoxin control 15 Low dose PAC-G31P Normal animal 0 October 2005, The Journal of Leukocyte Biology PAC-G31P Clinical Strategy Manufacturing Toxicity Study Asian Clinical Study North American Ph. I Ongoing H1-07 H1-07 H2-07 Currently manufacturing clinical materials Proceed with preclinical toxicology work for systemic administration Proof-of-concept clinical study in Asia in 2007 in collaboration with a third party Start North American Phase I single dose clinical trial in healthy volunteers by the end of 2007 48
  49. 49. Markets Asthma ARDS COPD 150,000 20.5 million 10.7 million people affected Americans were American adults annually estimated to have were believed to in the U.S. Asthma (2004) have COPD (2003) ARDS: – Mortality is 30% to 40% – No approved drugs for prevention or treatment Asthma: – 1.8 million emergency room visits in 2004 – Total cost to the U.S. in 2004 was $16.1 billion COPD: 4th leading cause of death in the U.S. – – The cost to the U.S. in 2004 was in excess of $37 billion are you finished selling? never! 49
  50. 50. don’t stop selling What is left to sell? management board and other advisors intellectual property manufacturing quality of current shareholders financial situation exit opportunities investment highlights etc. Product Pipeline Class Product Indication Launch Pharmaceutical Diabetes Insulin 2010 Apo AI Atherosclerosis 2014 DermaSphere® Personal care 2005 Non-pharmaceutical StratoDerm™ OTC / Topical Rx 2008 ImmunoSphere™ Animal health 2008 Nutritional supplements 2008 GLA Rich Oil Nutritional supplements DHA Rich Oil 2010 35 50
  51. 51. Corporate Overview Established: 1994: Spin out – University of Calgary Stock Market: TSX: SBS.TO Market cap: $67MM Cash: $28.8MM (31/03/07) Burn rate: - 2006: $1.0 MM per month - Cash to early 2009 Employees: 65 (19 Ph.D.s) 36 Board of Directors Richard Smith (Chairman) Former President & CEO Dow AgroSciences Canada, Inc. Andrew Baum Director, President & CEO SemBioSys Genetics Inc. Alexander R. Giaquinto, Ph.D. Former, Sr. VP, Global Compliance Schering-Plough Douglass Given M.D., Ph.D. Partner, Bay City Capital Nancy Harrison Former Senior VP Ventures West Management Inc. David Howard Chairperson Angiotech Pharmaceuticals, Inc. 37 51
  52. 52. Patents Protecting the platform 11 U.S. patents and applications 139 Production of recombinant proteins in plants using the oilbody-oleosin technology platform patents issued (19 U.S.) Protecting the tools 8 U.S. patents and applications 139 Tools and techniques to make our products patents pending Protecting the products (16 U.S.) As of January 12, 2007 16 U.S. patents and applications Composition of matter, manufacturing method, and method of use claims directed to formulations comprising oilbodies 38 Upcoming Milestones Insulin Q4 2007 Submit insulin IND to FDA Q1 - Q2 2008 Initiate Phase II trials with completion by Q2, 2008 Q2 - Q4 2008 Partnership Opportunities Apo A1 Q3 2007 Animal Data in Model System – Arabidopsis Q3 2007 Achieve commercial levels of Apo AI expression in safflower Q4 2007 - Q2 2008 Partnership Opportunities Other Initiation of new pharmaceutical product development program Q3 2007 Complete Dermasphere Facility and begin full scale manufacturing Q3 2007 and sales Execute commercialization plan for ImmunoSphere™product and Q2 2007 - Q1 2008 launch in Q1 2008 39 52
  53. 53. Corporate Data Founded 2005 Raised to Date $7.5 million Cash on Hand $2.7 million Burn-rate $600,000 month Head Office Vancouver, BC, Canada 105 iCo Therapeutics | IPO presentation | Management and Directors Strategic Advisory Board Management Non-Executive Directors Richard Glickman Andrew Rae, MBA Sidney Himmel, CA Co-founder, CEO and Chairman, Founder & CEO Chairman Aspreva Pharmaceuticals President and Chief Executive John Clement, PhD Officer, Trigon Uranium Corp. George Lasezkay, JD Principal, Turning Point Consultants, LLC Founder & Chief Technical & William Jarosz, JD Development Officer Julia Levy, PhD Cartesian Capital Group, LLC Co-founder of QLT Santa Jeremy Ono, PhD Alan C. Bird, MD Richard Barker, PhD Chief Scientific Officer Emeritus Professor, UCL Director General of the Association of the British David Boyer, MD Peter Hnik, MD, MHSc. Pharmaceutical Industry Retina-Vitreous Associates Medical Group Chief Medical Officer Philip Rosenfeld, MD, PhD John Meekison, BA, CIM, P. Log. Professor, Bascom Palmer Eye Institute, Founder & Chief Financial Officer University of Miami, School of Medicine Jason Slakter, MD Clinical Professor, NYU School of Medicine Extensive public company and life science experience | Solid operational and product development expertise | Ophthalmic specific expertise 106 iCo Therapeutics | IPO presentation | 53
  54. 54. Hot Therapeutic Arena Novartis Pfizer Allergan Sirna Genentech Eyetech (wAMD + other ophthalmic (wAMD) (wAMD) diseases) Novartis Bayer Alcon QLT Regeneron Amgen (wAMD) (wAMD) (Ophthalmic Therapies) Pfizer OSI Merck Angiosyn Eyetech Sirna (wAMD) (wAMD) (wAMD) 107 iCo Therapeutics | IPO presentation | Investment Highlights iCo-007 has large >$1 billion potential market/blockbuster potential Phase 1 commencing now iCo 008 targets Initial market - $100 million potential multiple indications Phase 2 commencing now Management team / advisory Very attractive valuation board with extensive ocular experience 108 iCo Therapeutics | IPO presentation | 54
  55. 55. An example Investor Presentation June 2007 55
  56. 56. Forward-looking statement Certain information included in this document is forward-looking and is subject to important risks and uncertainties. The results or events predicted in these statements may differ materially from actual results or events. For additional information with respect to certain of these and other factors, see the reports filed by ARIUS Research Inc. with the Securities Commissions of Ontario, Alberta and British Columbia. ARIUS Research Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This document does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States. No securities have been registered under the United States Securities Act of 1933, as amended or any state securities laws. Breakthrough antibody drugs “The mission of ARIUS is to discover and develop the next wave of antibody drugs to address the needs of patients and physicians for safe, effective treatments.” 56
  57. 57. Hitting a target doesn’t guarantee success 1000’s of high affinity Antibodies have been identified In the last decade, only ~20 have been approved and successful There is a target within the target The desired effect (cell death / cell signaling) will only be triggered by specific areas within the targeted antigen 57
  58. 58. ARIUS focuses on FunctionFIRST™ “Does the antibody kill cancer cells while leaving normal cells alone?” If YES, then, we have successfully hit the target within the target Proprietary antibody discovery and selection platform ARIUS Discovery Paradigm Patent Select ARIUS Identify Immunize antibodies antibody target and with for Generate and all eliminate primary function Antibodies epitopes those with human (In vivo on target prior tumor activity) with patents positive efficacy 58
  59. 59. FunctionFIRST™ yields results A pipeline of 400 Three Five antibodies partnerships lead candidates Genentech Oxford bioMedica Takeda PDL BioPharma Medarex $400 Million in potential milestone payments Our Partners 59
  60. 60. Genentech exclusive antibody license Prevents tumor growth and enhances survival in breast cancer models Top oncology antibody company 1500 with blockbuster successes: Tumor Volume (mm3) 1250 1000 • Avastin© Treatment period 750 • Rituxan© 500 • Herceptin© 250 0 0 10 20 30 40 50 60 70 80 120 Isotype control AR7BD-33-11A 100 Partnership signed March 2006 Percent Survival (%) 80 • Upfront licensing fee 60 Treatment period • Milestone payments based 40 on clinical milestones 20 • Royalties 0 0 50 100 150 200 Days Post-Implantation Antibody Dosing: 15 mg/kg i.p. 3x /week x 10 doses Other leaders partnered with ARIUS Takeda PDL BioPharma • Japan’s largest pharma • Leader in antibody humanization • Multi-product collaboration • Partnership to discover and develop antibodies • $1M in cash upfront/$1M equity • Option for in-license antibodies • Fund research activities for life of deal Medarex Oxford BioMedica • Joint research program using • Agreement to jointly develop products Medarex’s UltiMab Human Antibody for cancer therapy Development System • Oxford characterized the antibodies • The combination of technologies and identify cognate antigens eliminates the humanization step in • Liver cancer target identified - 37LRP –(AACR the FunctionFIRST™ platform 2006) and being developed 60
  61. 61. Our Products CD44 Cancer Stem Cell Program Antibody AR001 CD44 cancer stem cell program Produces Breast Cancer Regression Buffer Control 800 20mg/kg 700 10mg/kg Treatment Period 600 Tumor Volume (mm3) • Aberrant expression of CD44 2mg/kg 0.2mg/kg 500 occurs in a variety of tumors 400 300 • CD44 implicated as a 200 100 functional cancer stem cell 0 0 10 20 30 40 50 marker in leukemia, breast and Increased Survival in Breast Cancer prostate cancer 120 Treatment period • Arius lead antibody targets the post-treatment period 100 Percent Survival (%) CD44 antigen 80 60 • ARH460-16-2 efficacy shown in 40 breast and prostate tumors 20 Buffer Control Isotype Control 0 ARH460-16-2 0 20 40 60 80 100 120 140 Days Post-Implantation 61
  62. 62. CD44 – cancer stem cell marker Cancer stem cells Targeting cancer are the factory of stem cells may be the tumour more effective Chemotherapy Cancer building shrinks tumour ability is reduced Survival is Tumour returns extended CD44 cancer stem cell program AR001 demonstrates Significant inhibition of tumor growth and metastases in a dose response, human liver cancer model 62
  63. 63. Trop-2 Signal Transduction Program Antibody AR002 Trop-2 signal transduction program Inhibits tumor growth and increases survival in prostate cancer models • Trop-2 identified as a major Buffer AR002 determinant of tumor growth 1400 Treatment Period and metastasis 1200 Tumor Volume (mm ) 3 1000 800 • Over-expression of Trop-2 600 increases growth rates in 400 200 several types of cancer 0 0 10 20 30 Days Post-Implantation • ARIUS Trop-2 antibodies are Buffer Control 120 AR002. the first to demonstrate 100 Percent Survival (%) 80 efficacy 60 40 20 Treatment Period 0 0 20 40 60 80 100 Days Post Implantation 63
  64. 64. Novel target in key cancer pathway Tarceva, Iressa Tarceva, Iressa Tarceva, Lapatinib, Lapatinib, Lapatinib, Gleevac Erbitux, Herceptin, Gleevac Erbitux, Herceptin, Vectibix Vectibix TROP-2 TROP- EGFR PDGFR VEGFR AR47A6.4.2 AR47A6.4.2 Shc SHP-2 Avastin Avastin Grb2 Gleevac Gleevac SOS RAS Antibodies RAF Small molecule inhibitors MEK MAPK Cell Proliferation CD59 Immune Modulator Program Antibody AR003 64
  65. 65. CD59 immune modulator program Shrinks tumors in breast cancer MDA-MB-468 in female athymic nude mice • CD59 widely expressed in No Treatment 400 Vehicle Tumor Volume (mm3) Treatment Period AR003 (20mg/kg) malignant tumors, allowing 350 Taxotere (30mg/kg) 300 cancer cells to evade immune 250 200 system 150 100 50 • AR36A36.11.1 could help 0 30 35 40 45 50 55 60 65 70 75 80 activate immune system in Days Post Implantation Increases survival in lung cancer addition to targeting cells models directly • AR36A36.11.1 has been 120 Treatment Period Buffer Control demonstrated effective in a AR003 100 Survival (%) 80 number of tumor types 60 40 20 0 0 20 40 60 80 100 Days Post-Implantation CD59 immune modulator program Epitope location for Non-function- blocking antibodies Epitope location for function- blocking antibodies Epitope location for ARIUS Antibodies 65
  66. 66. Arius antibody pipeline Robust and growing intellectual property estate 16 issued and allowed patents - Composition of matter of antibodies - Methods of treatment - Antibody discovery technology platform 61 published patent applications 149 patents pending 66
  67. 67. Opportunities 9 licensing deals in 90 days! AstraZeneca and Regeneron Genentech and Genentech and Pharmaceuticals Seattle Genetics BioInvent US$120M US$860M US$190M plus royalties plus royalties plus royalties PDL GSK and Pfizer and Wyeth and Medarex Cambridge BioPharma Antitope Elusys Raven and Antibody and and Trellis Limited Therapeutics Biotechnologies Compugen iCoTherapeutics Bioscience 67
  68. 68. Multiple acquisitions in last 12 months August 2006 May 2006 May 2006 AstraZeneca Merck Merck acquires acquires acquires Cambridge GlycoFi Abmaxis Antibody US$400M US$80M US$1.3B November 2006 December 2006 March 2007 Genentech GSK Eisai acquires acquires acquires Tanox Domantis Morphotek US$919M US$454M US$350M ARIUS Milestones 2007 • Sign additional strategic collaboration/partnering agreements • Advance our programs: – Complete pre-clinical toxicity studies for stem cell program – Pre-IND meeting with the FDA – Develop expression cell lines for other 2 lead programs and transfer to cGMP manufacturer – Advance IND enabling studies for 2 additional programs • Expand intellectual property and library of antibody drug candidates 68
  69. 69. About ARIUS Headquarters: Toronto, Canada Symbol: TSX:ARI Employees: 40 current (18 last year) Cash: $19 million Burn-rate: $2.3 million (Q1, 2007) Management and Board Management Board of Directors David S. Young William T. Bodenhamer Chairman, President Director and Chief Executive Officer Carl L. Gordon Helen Findlay Director Executive Vice President Joe Zakrewzski and Chief Business Officer Director Warren Whitehead Diane Kalina Chief Financial Officer Director Susan Hahn Dan Andersen Director of Development Board Observer Daniel Pereira Chau Q. Khuong Vice President of Research Board Observer Daniel Rubenstein Chief Medical Officer Robert Gundel Chief Scientific Officer 69
  70. 70. Investor Presentation June 2007 closing thoughts 70
  71. 71. if you had only one slide need expressed: hunger market opportunity: greed need addressed: value proposition creating value: the action plan entrepreneurs life sciences 71

×