Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
iCo Therapeutics
Andrew Rae, President & CEO
604-602-9414
www.icotherapeutics.com / TSX-V: ICO
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
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
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
*
iCo – 007 Novel 2nd generation
antisense candidate
for the treatment of
Diabetic
Macular Edema Partner: Isis Pharmaceuticals
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
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
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.
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
“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)
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
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
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)
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
iCo – 008 Human monoclonal
antibody treating
both the back and
front of the eye
Partners: AstraZeneca/MedImmune & Immune Pharmaceuticals
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)
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
Oral Amphotericin B
Delivery System
Partner: The University of British Columbia
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
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
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
Financials &
Corporate Review
iCo Pipeline
23
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
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
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
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
iCo Therapeutics TSX-V: ICO
604-602-9414
www.icotherapeutics.com