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iCo Therapeutics Andrew Rae, President & CEO 604-602-9414 www.icotherapeutics.com / TSX-V: ICO

iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

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Page 1: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo Therapeutics

Andrew Rae, President & CEO

604-602-9414

www.icotherapeutics.com / TSX-V: ICO

Page 2: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Forward Looking Statements

Certain of the statements contained in this presentation

are forward-looking statements which involve known and

unknown risks, uncertainties and other factors which may

cause the actual results, performance or achievements of the

Company, or industry results, to be materially different from

any future results, performance or achievements expressed

or implied by such forward-looking statements.

2

Page 3: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

About iCo Therapeutics

• Targeting ocular diseases

• Lead program: Ph 2 for Diabetic Macular Edema (DME)

• Pipeline: - Human Monoclonal Antibody Targeting eotaxin-1

- Oral Amphotericin B Delivery System

• Partnerships: JDRF, ISIS, AstraZeneca MedImmune & Immune Pharmaceuticals

• Efficient use of capital

• Experienced management & board

3

Page 4: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Pfizer Lpath >$500 M

(wAMD)

Novartis Genentech Undisclosed

(wAMD & DME)

Bayer Regeneron >$320 M

(wAMD & DME)

Allergan Molecular Partners $1.4 B

(wAMD)

Sanofi-Aventis Fovea €370 M

(DME & Other Ophthalmic Therapies)

Alcon ThromboGenics €375

(VMA & Other Ophthalmic Therapies)

Alcon ESBATech $589 M

(Ophthalmic Platform)

Santen Macusight $50 M upfront + undisclosed milestones

( wAMD & DME)

Novartis Alcon $12.9 B

(Ocular Drug and Device Pipeline)

Validated Therapeutic Arena

4 DME = diabetic macular edema

wAMD = wet age-related macular degeneration

104.5% return

* Last 12 Months, October 2012, BMO Capital Markets

*

Page 5: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo – 007 Novel 2nd generation

antisense candidate

for the treatment of

Diabetic

Macular Edema Partner: Isis Pharmaceuticals

Page 6: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Leading cause of blindness in

working age adults

Proliferation of new, permeable

blood vessels allows blood to leak

into retinal area, causing swelling

and deformation

Current treatments: • Steroids

• Laser

• Anti-VEGF

Diabetic Macular Edema (DME)

Normal Retina

Abnormal Retina

6

Page 7: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo-007: MOA - VEGF Plus

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

Growth factors

Modulate signal

Retina

7

Page 8: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo-007 & C-Raf Kinase

8

Recent results have shown

that the pathways activated

by Ras/Raf play a crucial role

in diabetes-associated

complications including

retinopathy.

Page 9: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

The number of patients in study is low, statistical significance cannot be inferred

Phase 1: Patient Examples – Single Injection

110ug dose (sample patient)

350ug dose (sample patient)

528 micron

s

379 microns

391 microns

228 microns

9

Delta: 149 microns Delta: 163 microns

Base

line

6 m

onth

s

700ug dose (sample patient)

867 microns

124 microns

Delta: 743 microns

1000ug dose (sample patient)

Delta: 236 microns

423 microns

187 microns

Page 10: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

“iDEAL” Physician-sponsored US Phase 2

• Randomized, multi-center

study

• Up to 208 patients

• 4 Study Groups • Monotherapy dose 1 (350 ug)

• Monotherapy dose 2 (700 ug)

• Combination with Ranibizumab

• Combination Laser Photocoagulation

• 12 month follow up

• Initiated in Q3 2011

10

• Primary endpoint • Change in visual Acuity

• Secondary endpoints • Visual acuity & reduction of

retinal thickness

• Duration of effect

• Safety of repeated injections

• Pharmacokinetic assessments

(PK)

Page 11: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Category Product

Device Laser

Anti-VEGF

Avastin

Macugen

Eylea

Lucentis

(approved)

Steroids

Iluvien, Ozurdex

Triamcinolone, etc.

Competitive Landscape

11

Key Product Profile Issues

• Treatment burden

• Side effects

• Cost

• Biological targets

Page 12: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo-007 Product Differentiation

• Novel c-raf kinase-targeted antisense specific for DME

• Targets more than just VEGF: Existing competitors target VEGF

only, while DME is caused by multiple growth factors

• Longer half life = fewer injections: Competitors require monthly

injections – costly, time consuming and a logistical burden on both

patients and physicians

• Easy to manufacture

• No known side effects comparable to select competitors

12

Page 13: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

U.S. Diabetes

Patients 40 million

2006 2025

21 million

$10,000 per annual treatment (only clinically significant cases)

*Lucentis = $24,000 annually

Market Opportunity

13

10

M

Penetration

500

%

$ 22% of diabetes patients

report visual impairment (5.3 million Diabetic Retinopathy patients today)

(1.6 million DME patients today)

Page 14: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo-007 Next Steps

Received Health Canada Clearance for Phase 2

Completed “fill finish” manufacturing to produce clinical

supply

US FDA Clearance for Phase 2

US Phase 2 trial initiated August 2011

• Interim results year end

• Ongoing regional partnership discussions

14

Page 15: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo – 008 Human monoclonal

antibody treating

both the back and

front of the eye

Partners: AstraZeneca/MedImmune & Immune Pharmaceuticals

Page 16: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo-008

16

Human monoclonal antibody targeting eotaxin-1

• Binds with high affinity to CCR3

Good safety & significant clinical history

• Ph 1 & 2 (n=126)

Ocular:

Vernal & Atopic

Keratoconjunctivitis, Wet Age

Related Macular Degeneration

Systemic:

Inflammatory Bowel Disease,

Severe Asthma (License granted

to Immune Pharmaceuticals)

Page 17: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo 008 Licensing: MedImmune & Immune

17

In-licensing

• $400,000 up front payment

• $7,000,000 milestone payments

• Exclusive rights to entire body

Out-licensing

• $500,000 upfront received

• $32,000,000 incoming milestones

• 600,000 Immune shares

• 200,000 Immune warrants

• 6.14% ownership with dilution provisions

• Royalties on net sales

• Retained WW rights to all ocular applications

Page 18: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Oral Amphotericin B

Delivery System

Partner: The University of British Columbia

Page 19: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Amphotericin B & IV Delivery

IT WORKS …

– Gold standard

– AmBisome®

• >$400M in sales

• Premium pricing for safety

… BUT NOT PRACTICAL IN MANY SITUATIONS

– Variety of Developed World fungal infections

– Lack of resources in Developing World

– Inconvenient

19

unmet need: oral formulation

Page 20: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Proprietary Oral Delivery Platform

Expanding the Amp B market: Safety and convenience, HIV

Oral treatment for : Goal of WHO & Gates Foundation,

Governments & several other global

health organizations

Non-dilutive funding to date: CPDD/Gates and CIHR, NRC

20

Lipid capsule “Candy Wrapper”

• Proprietary platform

• Used for insoluble products including vaccines and proteins

Page 21: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Oral Amphotericin B Delivery System Studies

21

• HIV/AIDS currently managed using a combination of drugs

(HAART)

• HIV often remains hidden in tissue “reservoirs”

• Amphotericin B may be efficient at “flushing” out latent

HIV in reservoirs

• $1.1 million in non-dilutive grant funding from Canadian

government/Gates Foundation • Next steps: feasibility testing, further pre-clinical studies and clinical trials

Page 22: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Financials &

Corporate Review

Page 23: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo Pipeline

23

Page 24: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Biotech Value Inflection: iCo & Peers (as of Nov 1, 2012)

Ph 2 data Ph 1 data IND Ph 3 final data NDA Approval

iCo $39.5 M

Lpath $68.5 M

Medicago $114.1 M Thrombogenics

$1,731.1 M

Just received approval for Symptomatic

Vitreomacular Adhesion (VMA) MethylGene

$57.3 M

Other Biotech

Value Drivers

• Partnerships

• SPA

Other iCo Value

Drivers

• Ph 2 Interim data

• Partnerships

• Immune holdings

24

Page 25: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Upcoming Milestones

25

Milestone Timing Completed

iCo 007: Complete ‘fill finish’ manufacturing for clinical supply

iCo 007: US FDA Clearance for Phase 2

iCo 007: US Phase 2 trial initiated

iCo 008: Licensed systemic rights to Immune Pharma $32+ Million

Amp B: Non-dilutive grant funding

iCo 007: Interim results H2 2012 2012 YE

iCo 007: Regional partnership discussions Ongoing

iCo 008: Pursuing non-dilutive funding of ocular programs Ongoing

Amp B: Phase 1 trial 2013

Page 26: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Andrew Rae, MBA

Co-founder, Director,

President & CEO

Peter Hnik, MD, MHSc.

Chief Medical Officer

John Meekison, BA, CIM, P. Log.

Co-founder & Chief Financial Officer

William Jarosz, JD

Chairman of the Board, iCo

Cartesian Capital Group, LLC

Richard Barker, PhD

Former Director General of the

Association of the British

Pharmaceutical Industry, Celgene

director

Noel Hall

Co-founder of Aspreva

Douglas Janzen

Former President & CEO,

Cardiome

Donald Buell, MD

iCo-009 SAB Chair, Former Senior

Medical Director, Astellas USA

George Lasezkay, JD

Principal, Turning Point Consultants,

LLC, Former VP Corp Development,

Allergan

Non-Executive Directors Strategic Advisory Board

Extensive public company and life science experience | Solid operational and product

development expertise | Ophthalmic specific expertise

Management and Directors

Management

26

Page 27: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

Financials (as of June 30, 2012)

Filings available at www.sedar.com

Invested Capital to Date $22.5 million

Largest Shareholders

Special Situations Funds (11%)

Isis Pharmaceuticals (9.7%)

Management (8.7%)

Cash $2.8 million *not including $1.1M grant

Cash Runway Through Q2 2013 (past interim data)

Share Capital 52.7M (SO)

65.8M (FD)

Head Office Vancouver BC, Canada

27

Page 28: iCo Therapeutics - Toronto Stock Exchange · Cardiome Donald Buell, MD iCo-009 SAB Chair, Former Senior Medical Director, Astellas USA George Lasezkay, JD Principal, Turning Point

iCo Therapeutics TSX-V: ICO

604-602-9414

www.icotherapeutics.com