Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2012)
28 slides from Starpharma's shareholder meeting presentation, Nov 30, 2012
Slide 1: AGM – Chair address and CEO's presentation
For personal use only AGM – Chair address and CEO’s presentation Melbourne, Australia; Friday 30 November 2012: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), to be held at 10.00am today. St
Slide 2: Forward Looking Statements
Forward Looking Statements This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “
Slide 3: Chairman's Address – Peter Bartels
Chairman’s Address – Peter Bartels Annual General Meeting of For personal use only Starpharma Holdings Limited, 30 November 2012 It is with pleasure that I again welcome you to our Annual General Meeting. As I’m sure you can appreciate, before the activities of the last few days I was expecting to d
Slide 4: Chairman's Address (continued)
The additional capital gave us additional capacity to further advance the various opportunities for VivaGel® as well as our drug delivery and agrochemicals development programs. Our agrochemical and crop protection program continues to produce impressive data in the improvement of major products inc
Slide 5: Starpharma Holdings Limited Annual General Meeting November 2012
For personal use only Starpharma Holdings Limited ASX:SPL Annual General Meeting 30 November 2012 Dr. Jackie Fairley CEO
Slide 6: Forward-looking statements
For personal use only This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targe
Slide 7: 2011/2012 Key Highlights
For personal use only 2011/2012 Key Highlights VivaGel® 2 Pivotal Phase 3 BV treatment trials commenced, fully recruited and completed. FDA Special Protocol Assessment for BV Trials Phase 2 BV prevention of recurrence trial commenced Phase 2 BV prevention of recurrence trial fully recruited. D
Slide 8: Shareholding, Performance, and Financial Position
For personal use only Shareholding, Performance, and Financial Position SPL growth year‐on‐year (as at 29/11/12): • CAGR (5 years) 26% • CAGR (3 years) 27% Institutional Shareholding increasingly global • 29% ‐ up from 5% in 2005 • Substantial holders include Acorn, M&G and Allan Gray Strong c
Slide 9: A platform technology with broad optionality and applicability
For personal use only A platform technology with broad optionality and applicability Starpharma’s strategy: commercially exploit its platform to generate multiple, parallel revenue streams Drug Delivery VivaGel® Lead internal program: Lead internal dendrimer-docetaxel program: (Taxotere) VivaGel for
Slide 10: VivaGel® Portfolio
For personal use only VivaGel® Portfolio VivaGel® active (SPL7013) is a potent antiviral and antibacterial VivaGel®-Coated Condom VivaGel® Condom coated with patented antiviral 1. Bacterial Vaginosis (BV) Gel VivaGel® Kills ≥99.99% viral STIs 2. Topical Microbicide Gel: for Product ( HIV & Herpes) v
Slide 11: Clinical Trial Summary
For personal use only Clinical Trial Summary PHASE 3 BV TREATMENT TRIAL DESIGN 1% SPL7013 Gel END OF TEST OF CURE TREATMENT BV Patients (TOC) (EOT) (2‐3 weeks post Rx) (2‐5 days post Rx) Placebo Gel Day 1‐7 2˚endpoints PRIMARY Product Admin ENDPOINT 1xd at bedtime Assessment of Clinical Cure Assessm
Slide 12: Clinical Cure of BV – Phase 3
For personal use only Clinical Trial Summary CLINICAL CURE OF BV – PHASE 3 Clinical Cure: SPL7013-015 SPL7013-016 1% SPL7013 Gel Placebo Gel 1% SPL7013 Gel Placebo Gel EOT 50%** 17% 57%** 21% (2-5 days post Rx) TOC 27% 21% 28% 28% (2-3 weeks post Rx) ** Statistically significant result compared with
Slide 13: Resolution of Clinical Signs – Amsel Criteria – Phase 3
For personal use only Clinical Trial Summary RESOLUTION OF CLINICAL SIGNS – AMSEL CRITERIA – PHASE 3 Resolution of Amsel Criteria at EOT 80 SPL7013-015 SPL7013-016 ** ** ** 1.0% SPL7013 Gel - 015 ** ** ** HEC Placebo Gel - 015 60 % with Resolution 1.0% SPL7013 Gel - 016 HEC Placebo Gel - 016 40 ** *
Slide 14: Clinical Cure of BV – Phase 2 & Phase 3 Comparison
For personal use only Clinical Trial Summary CLINICAL CURE OF BV – PHASE 2 & PHASE 3 COMPARISON Clinical Cure in Phase 2 (013) and Phase 3 (015 and 016) 80 5 1.0% SPL7013 Gel - 015 (1) HEC Placebo Gel - 015 (2) 60 1.0% SPL7013 Gel - 016 (3) % Clinical Cure 3 1 HEC Placebo Gel - 016 (4) 40 1.0% SPL70
Slide 15: Symptomatic Relief: Resolution of BV Symptoms – Phase 3
For personal use only Clinical Trial Summary Symptomatic Relief: RESOLUTION OF BV SYMPTOMS – PHASE 3 Resolution of Symptoms at EOT SPL7013-015 SPL7013-016 100 1.0% SPL7013 Gel - 015 80 HEC Placebo Gel - 015 ** ** % with Resolution ** 1.0% SPL7013 Gel - 016 60 ** HEC Placebo Gel - 016 40 ** = p < 0.0
Slide 16: High level of Patient Acceptability and Experience of VivaGel
For personal use only High level of Patient Acceptability and Experience of VivaGel ® Formal market research with trial participants BV is a life impacting, debilitating infection that affects nearly 1in 3 women ““It takes a lot away from your self-esteem, you know, especially when you’re in a rel
Slide 17: Phase 3 BV Treatment Clinical Trial – Conclusions and next steps
For personal use only Phase 3 BV Treatment Clinical Trial – Conclusions and next steps Key Findings: VivaGel® demonstrates statistically significant Clinical Cure and effectiveness in treating symptoms of BV at the end of treatment (EOT) Primary FDA endpoint (Clinical Cure 2-3 weeks after cessat
Slide 18: VivaGel® - Bacterial Vaginosis: Partnering and market opportunity
For personal use only VivaGel® - Bacterial Vaginosis (BV) Partnering and the market opportunity for Prevention of Recurrence Active engagement with ~10 top tier companies in the women’s health field •No approved competitors Potential partners see Prevention of Recurrence (PoR) as a •Off label us
Slide 19: Dendrimer–Docetaxel formulation: significant improvement in solubility
For personal use only Starpharma’s Dendrimer–Docetaxel formulation: significant improvement in solubility Improved Docetaxel (Taxotere ®) Formulation Anti-cancer drug Docetaxel (Taxotere® - Sanofi Aventis) Sales: US$1.2Bi pa. (2011) Docetaxel is insoluble; Taxotere® incorporates a detergent whic
Slide 20: Dendrimer–Docetaxel – Pharmacokinetics and Distribution
For personal use only Starpharma’s Dendrimer–Docetaxel– Pharmacokinetics and Distribution Significant Tumour targeting and extended half-life Pharmacokinetic studies with radiolabelled Dendrimer- Docetaxel plasma half life >60 fold longer than Taxotere® drug demonstrate that the Dendrimer– Plasma
Slide 21: Starpharma's Dendrimer–Docetaxel formulation efficacy
For personal use only Starpharma’s Dendrimer–Docetaxel formulation Starpharma’s Dendrimer–Docetaxel formulation has Efficacy: Breast Cancer Model* significantly* better efficacy than Taxotere® At 94 days 60% dendrimer-docetaxel mice - no evidence of tumour At 94 days Taxotere® 100% mice - tumour
Slide 22: Starpharma's improved docetaxel formulation
For personal use only Starpharma’s improved docetaxel formulation Multiple Advantages shown with Starpharma’s dendrimer formulation Taxotere® (docetaxel) is a blockbuster chemotherapeutic with 2011 sales of US$1.2 billion Docetaxel is used in major cancer types including breast, prostate and lun
Slide 23: Broad potential for dendrimers to improve major drugs
For personal use only Broad potential for dendrimers to improve major drugs, especially anti-cancers Analysis shows dendrimers applicable to > 50% of leading pharmaceuticals • Starpharma’s proprietary dendrimer nanoparticle technology has broad applicability • Dendrimers have significant potential i
Slide 24: Dendrimers for Drug Delivery - Proteins and Peptide Drugs
For personal use only Dendrimers for Drug Delivery - Proteins and Peptide Drugs Longer half life – less frequent dosing In vivo mouse model protein payload conventional insulin dendrimer other function Conjugate protein or peptide to Approach functionalised dendrimer Dendrimer + insulin Control half
Slide 25: Dendrimers in Agrochemicals
For personal use only Dendrimers in Agrochemicals: Apply SPL dendrimers to achieve significant product enhancement Commercial Partnerships with Major Ag. Coys for product enhancement via dendrimers Partnerships with leading global Ag. Dendrimers can enhance the performance of existing Companies agro
Slide 26: Starpharma's internal Agrochemical programs
For personal use only Starpharma’s internal Agrochemical programs: Growing Breadth and Depth Dendrimers: Significant Commercial Opportunities for Improvement of Off-patent Actives Significant opportunity, for both proprietary & generic actives …the value of products >$5B coming off patent 2011‐16 Ph
Slide 27: Programs in Agrochemicals: Multiple Applications in Leading Products
For personal use only Starpharma’s programs in Agrochemicals: Multiple Applications in Leading Products Starpharma’s Dendrimer formulations show significant advantages Enhanced Efficacy Improved Soil Penetration Imidacloprid ($1Bi) Glyphosate ($5Bi) top Sand column 50% 26% middle 42% 34% bottom 8% 4
Slide 28: Summary
For personal use only Summary Strategy: commercially exploit its platform to generate multiple, parallel revenue streams FY 2011 FY 2012 AUD $M AUD $M Total revenue and income 3.3 2.9 Net loss after tax 8.9 13.7 Cash outflow from operations (6.5) (9.8) Net cash inflow from financing 3.5 33.7 Cash at
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