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ALGORAE PHARMACEUTICALS LIMITED — AGM Information 2013
Nov 18, 2013
64249_rns_2013-11-18_9b8f1a67-732f-4d20-b4c3-3be6572de48d.pdf
AGM Information
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Annual General Meeting 2013 Andrea Grant PhD, Managing Director
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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.
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Company snapshot
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Origins Listed on ASX 2004 First clinical trial DIABECELL started 2007 First clinical trial NTCELL started 2013 Key strategic relationships Otsuka Pharmaceutical factory Callaghan Innovation (NZ government) Operations NZ main operating centre Two products in clinical development R&D group generating new IP
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Technology foundation
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Null virus pig herd GMP manufacture
Encapsulation
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Comprehensive IP portfolio - US, EU, world
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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Therapeutic products in clinical development DIABECELL[® ]
DIABECELL: Phase I/IIa trials to date
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| Trial | Endpoint | Country | # patients | Status |
|---|---|---|---|---|
| DIA-07(R) | Safety | Russia | 10 | Complete |
| DIA-06 | Safety & dose finding |
NZ | 16 | Complete |
| DIA-09 | Safety & dose finding |
Argentina | 8 | Complete |
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | @LCTglobal
Reduction HbA1c: 1.5-2% with 20K dose DIA-09 (Argentina, 8 patients)
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20K/IEQ per Kg
10K/IEQ per Kg
Baseline
Tx1 Tx2 16wks 52 wks
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | @LCTglobal
57% reduction unaware hypoglycaemia with 20K dose DIA-09 (Argentina, 8 patients)
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20K/IEQ per Kg
10K/IEQ per Kg
Baseline
Tx1 Tx2 16wks 52 wks
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | @LCTglobal
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Safety assessments DIA-09 (Argentina, 8 patients)
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Minor adverse events abdominal pain & fever One major SAE bowel, required IV meds. Otherwise, well tolerated.
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
DIABECELL – clinical summary to date
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Three Phase I/IIa clinical trials Safe Optimum dose: two implants of 10K/IEQ, 3 months between implants Significant reduction unaware hypoglycaemia without increasing in HbA1c
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
DIABECELL – next steps clinical development
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Strategy prior to August 2013 30 patient study designed to enable registration in New Zealand by 2016
Strategy post August 2013 Modified formulation improved efficacy in in-vivo animal studies
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Re-design clinical development pathway to enable registration in New Zealand, Australia and Singapore Clinical studies in EU and USA also being explored
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
DIABECELL – commercialisation strategy
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DOL is responsible for commercialisation of DIABECELL Local treatment centres in NZ and Australia to service local markets
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Treatment centres in Singapore (SG) to service international markets via established medical tourism industry
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๏ Discussions underway with hospital partners with existing medical tourism infra-structure Regulatory strategy for EU and US registration in development Explore additional pig herds to determine suitability as tissue source for xenotransplantation
๏ Reduces capital required for pig facility scale up
๏ Discussions underway with multiple parties
๏ Will seek exclusive access for purposes of live cell therapeutics
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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Therapeutic products in clinical development NTCELL[ ®]
Loss of dopamine neurons
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Normal No
Parkinson’s
Parkinson’s Parkinson’s
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Parkinson’s disease
“The saddest of all diseases”
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
NTCELL: a regenerative therapy
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100’s of growth factors
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Nerve regeneration Stem cell differentiation Protection from cell death
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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>50% improvement in primate models
Motor function (turning)
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Neurological function
3.0
NT
Empty
2.5
Sham
2.0
***
1.5
1.0
0 2 4 6 8 10 12 14 16 18 20 22 24
Weeks post implant
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NT
100 Empty
Sham
75
***
50
25
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Weeks post implant
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Control
NT
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
NTCELL for Parkinson’s Phase I underway
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4 patients – SAFETY study First implant safely completed Sept 2013
Provided safety demonstrated – we will aim for fast track/breakthrough designation with FDA
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | @LCTglobal
The Otsuka partnership significantly reduces LCT’s cash needs for clinical programmes
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LCT shareholders retain 50% share profits $25m invested to date for clinical development of DIABECELL Potential for additional $20m on exercise of NTCELL option Up to $5m option fee direct to LCT Enhanced R&D and commercialisation capabilities
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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New therapeutic candidates in pre-clinical development
Examples of programs in pre-clinical development
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NTCELL • Neurological conditions: Huntington’s, Alzheimer’s, hearing loss
Encapsulated cells • Musculoskeletal
NTCELL • Wound healing Secreted growth • Respiratory factors Other cell types • Non-liver cells for Factor VIII
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Strategy
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Current therapeutic candidates Adopt expanded regulatory strategy for DIABECELL Demonstrate safety of NTCELL in Parkinson’s and initiate efficacy studies
Strategy for new therapeutic development Significant unmet need Powerful justification for cell replacement or regenerative approach
Exploit key competencies, whilst diversifying product portfolio Opportunities for new therapeutic development NTCELL in other neurodegenerative conditions NTCELL secreted products for degenerative & inflammatory conditions Non-pig cell based products exploiting know-how
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
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Shareholding & financial position
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58%
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Shares outstanding 357m Options outstanding 12m Last close (11 Nov 13) $0.09 52 wk range $0.04-0.10 Mkt Cap $30.2m Current cash (30 Sep 13) $4.8m Cash utilisation/annum $1.2m
1% Substantial (>5%) Major (1%<>5%) Directors (>1% Retail/Other
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
LCT:ASX 12mth chart
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Investment summary
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Global pharmaceutical partner substantially invested Two breakthrough products in clinical development for diseases of high unmet need & substantial target populations IP protected technology platform with freedom to operate and develop new technologies Solid cash position with low per annum cash utilisation De-novo R&D identifying new therapeutic candidates Experienced management and governance
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Future news flow
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DSMB decision NTCELL Phase I trial Dec 2013 Complete implants NTCELL Phase I trial 1H 2014 Interim analysis efficacy NTCELL Phase I 2H 2014 Commence new clinical development DIABECELL 2H2014 Identification new clinical candidates 2H2014
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
Thank you to our partners, staff, management, shareholders and BOD
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ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | @LCTglobal