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ALGORAE PHARMACEUTICALS LIMITED — AGM Information 2012
Nov 15, 2012
64249_rns_2012-11-15_20c334ab-9a09-4c53-8888-1cfe780425f2.pdf
AGM Information
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ASX: LCT - OTCQX: LVCLY
Diabetes – Neurodegenerative Diseases – Cell Encapsulation
Consolidation & Acceleration CEO REPORT AGM 2012
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
SAFE HARBOR STATEMENT
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This document contains certain forward-looking statements, relating to LCT’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. LCT is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
A company on a mission
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Cell based therapies to improve the lives of people with serious disease
Null virus pig herd
GMP manufacture
Encapsulation
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Comprehensive IP portfolio - US, EU, world
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Lead products advancing in the clinic
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NTCELL[® ]
DIABECELL[ ®]
NEW HOPE IN PARKINSON’S DISEASE
BREAKTHROUGH IN TYPE 1 DIABETES
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Type 1 Diabetes
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Destruction of insulin-producing cells insulin
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Lifetime complications
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Daily insulin regime restricts life activities
– Increased risk of kidney, eye and vascular co-morbidities
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Daily risks
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Dangerously high (hyper) or low (hypo) blood glucose levels
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Insulin therapy & hypoglycaemia
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Standard of care for T1DM is intensive insulin therapy
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Artificial insulin lacks feedback mechanisms of natural pancreas
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Strict glucose control = 3x increased risk of hypoglycaemia
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Long term intensive insulin treatment may lead to increased unaware hypoglycaemia
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Sudden & unexpected loss of consciousness
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Significant loss of quality of life
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
DIABECELL – changing lives
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Patients with “unstable Type I diabetes” despite intensive insulin therapy
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Wide fluctuations in blood glucose levels
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Increased Hba1c
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Frequent episodes of unaware hypoglycaemia
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DIABECELL offers replacement of β-cell function without the need for immunosuppressants
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
NZ Phase I/IIa – reduction in hypoglycaemic events
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10,000 IEQ/Kg Dose
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Arg Phase I/IIa - improved clinical outcomes
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HbA1c Unaware Hypo
9 25
8.5
8 20
7.5
7 15
6.5
6 10
5.5
5 5
4.5
4 0
Pre-Tx 12 weeks Pre-Tx 12 weeks
Single implant - 10,000 IEQ/Kg Dose
ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
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Arg Phase I/IIa – DIABECELL retrieval
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Day of the first implant Three months after first implant
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Glucagon
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Insulin
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
DIABECELL – The path to patients
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Manufacturing in a commercial environment
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Yield (IEQ/pancreas)
• Treat more patients
200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 2010 2011 2012
• Reduced COGs
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Improve profit
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Yield (IEQ/pancreas)
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Lead products advancing in the clinic
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NTCELL
DIABECELL[ ®]
NEW HOPE IN PARKINSON’S DISEASE
BREAKTHROUGH IN TYPE 1 DIABETES
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Significant unmet clinical need in Parkinson’s disease
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Loss of dopamine producing cells in the brain
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movement, emotion, motivation, memory, problem solving and attention
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4 – 6 million sufferers worldwide
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Current treatment = dopamine replacement
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Effectiveness declines as disease progresses
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Symptomatic only – does not stop disease
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$2bn market for these small molecule treatments
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
NTCELL
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Choroid plexus (CP) cells naturally produce factors that protect brain and nerve cells from degeneration or injury and enhance repair
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NTCELL: Porcine-derived CP cells encapsulated with IMMUPEL™
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Phase I clinical trial in Parkinson’s
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MEDSAFE authorisation Oct 2012 – ACHIEVED
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Ethics approval Nov 2012 - ACHIEVED
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Phase I clinical trial design
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4 patients
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Safety study
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Safety is primary endpoint
– efficacy measures as secondary
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
World class clinical investigator team
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Dr Barry Snow, MB ChB; FRACP, Neurologist, Auckland Hospital Dr Arnold Bok, MB ChB (SA); FCS (SA); MMed (SA); FRACS , Neurosurgeon, Auckland Hospital
Dr Jon Stoessl, MD Neurologist, PET Studies, Vancouver Hospital and Health
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Second product entering clinic in 2013
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NTCELL™ for the treatment of Parkinson’s
Feature Product Enca sulated orcine choroid lexus cells p p p Target market Patients with mid-stage Parkinson’s disease - 1.6m atients p Product Restoration of normal function by regeneration of differentiator appropriate neural pathways Stage of Phase I planned in NZ 2013 development Expected date of 2018 filin for re istration g g
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
GOALS 2012/2013
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Commence Phase III DIABECELL in Type I diabetes
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Argentina, NZ and Germany
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Complete all implants during 2013
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Commence Phase I NTCELL in Parkinson’s – Complete all implants during 2013
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Commence clinical program in second indictation for NTCELL
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Finalise & communicate commercialisation plan for DIABECELL
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Secure additional partnerships
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On going funding of current products
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Strengthen product pipeline with new products
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Sound finances & safe hands
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Fundamental
Details
Shares outstanding 357m 5day VWAP (29/10/12) 0.051 52 wk Hi/Low 0.13-0.04 Cash on hand (AUD) (30/9/12) 2.9m Current burn/annum (AUD) 1.7m Estimate first product 2016 revenues
Board
Roy Austin (Chair) Professor Bernie Tuch Robert Wilcox Laurie Hunter Professor Bob Elliott
Management
Dr Andrea Grant (CEO) Professor Bob Elliott (acting CSMO) John Cowan (Finance) Peter Hosking (Operations) Isobel Cooper (Animal welfare)
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
A big thank you – staff & management
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
Equally big thank you
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- Board and partners, in particular Otsuka Pharmaceutical Factory
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ANDREA GRANT | CEO | +64 210 785 421 | [email protected]
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ASX: LCT - OTCQX: LVCLY
Diabetes – Neurodegenerative Diseases – Cell Encapsulation
Thank you to our shareholders for your continued commitment and support
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