Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2014)
38 slides from Starpharma's shareholder meeting presentation, Nov 20, 2014
Slide 1: AGM – Chair address and CEO presentation
For personal use only AGM – Chair address and CEO presentation Melbourne, Australia; 20 November 2014: 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 4.00pm today. Starpharma H
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
Chairman’s Address Starpharma Holdings Limited Annual General Meeting For personal use only 20 November 2014 Good afternoon and welcome to the annual general meeting of Starpharma. It is with pleasure that I present my first Annual General Meeting as chairman of Starpharma, a position I took up in J
Slide 4: Chairman's Address (continued)
cancer patients gaining access to this potentially enhanced cancer therapy. A key differentiator of Starpharma’s drug delivery platform, as demonstrated in preclinical testing, has been both an improvement of efficacy and a reduction in side effects. These side effects can be incredibly debilitating
Slide 5: CEO Presentation – 2014 AGM
20 November 2014 Dr. Jackie Fairley CEO For personal use only STARPHARMA HOLDINGS LIMITED ASX:SPL; OTCQX:SPHRY CEO Presentation – 2014 AGM
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: Starpharma's Dendrimer Platform
A global leader in nanoscale polymers (dendrimers) For personal use only Potential for multiple and parallel revenue streams Starpharma’s Dendrimer Platform ~100 granted patents VivaGel® Portfolio Drug Delivery Agrochemicals Bacterial DEP™ Partner Improved Partner VivaGel® vaginosis docetaxel Delive
Slide 8: 2013-2014: A year of substantial progress
2013-2014: A year of substantial progress For personal use only DEP™ oxaliplatin Cancer DEP™ VivaGel® shows Priostar® DEP™ Australia docetaxel condom Expanded ARC Grant for better anti- Agrochemical docetaxel funding for phase 1 Receipt of Regulatory agreement Clinical trial Rob Thomas targeted drug
Slide 9: Pharmaceutical Development Portfolio – Recent Progress and Plans
Pharmaceutical Development Portfolio – Recent Progress and Plans For personal use only Res PC PhI PhII PhIII Reg. Mkt BV Symptomatic VivaGel® Relief Antimicrobial BV Prevention of VivaGel® / Antiviral Recurrence (SPL7013)* VivaGel® VivaGel® Coated Condom DEP™ Docetaxel Drug Delivery (various cancers
Slide 10: VivaGel® Portfolio
For personal use only VivaGel® Portfolio
Slide 11: VivaGel® condom: A compelling and differentiated product
VivaGel® condom: A compelling and differentiated product For personal use only • Condom coated with SPL’s patented antiviral lubricant (VivaGel®) • VivaGel® shown in laboratory studies to inactivate up to 99.9% HIV, HPV & Herpes • Licensed to Ansell and Okamoto (SPL receives royalties on sales) • Re
Slide 12: VivaGel® Condom – World's first antiviral condom
VivaGel® Condom – World’s first antiviral condom Lifestyles® DUAL PROTECT ™ - Available in Woolworths For personal use only IFL Science posted a story on Dual Protect™- >83,000 Likes; shared > 18,000 times DUAL PROTECT™ with VivaGel® : lubricated with VivaGel® which has been shown to >2,000 Tweets;
Slide 13: VivaGel® condom: consumer research and partner feedback
VivaGel® condom: A compelling and differentiated product Extensive consumer research of the VivaGel® condom^: For personal use only • Confirms strong interest and purchase intent (~90%) “ Our partnership with • Strong consumer interest across genders, ages and relationship Starpharma is a great exam
Slide 14: VivaGel® - Bacterial Vaginosis (BV)
VivaGel®- Bacterial Vaginosis (BV) Two attractive commercial opportunities For personal use only Bacterial Vaginosis: “It was like gone almost the most common vaginal infection worldwide overnight” “I would definitely use it again.” “The next day I noticed a huge • ~29% women infected in US; u
Slide 15: VivaGel® for Bacterial Vaginosis: Two product opportunities
VivaGel® for Bacterial Vaginosis: Two product opportunities For personal use only Drivers of Value Significant Competitive Development and Market Size Advantages Commercial Progress • Unmet need • No Approved Prevention of • Phase 3 Trials Underway (SPA) • Products BV Recurrence >US$1B • Late stage
Slide 16: BV Prevention of Recurrence Phase 3 Program
BV Prevention of Recurrence Phase 3 Program Two double-blind, multi-centre, randomised trials For personal use only ~600 p per trial ~100 sites across USA, EU, Asia, Mexico “Enriched” R-BV PERIODIC STUDY VISITS population: Nugent Primary Endpoint: Recurrence of BV at or by week 16 visit Score 4-10 1
Slide 17: VivaGel®: Symptomatic Relief of BV
VivaGel®: Symptomatic Relief of BV For personal use only VivaGel® (once a day for 7 days): • Two double-blind trials under IND (250p/trial) demonstrated statistically significant Clinical Cure at the end of treatment (EOT) • VivaGel® resulted in rapid and sustained relief from symptoms • Very positi
Slide 18: VivaGel® - Symptomatic Relief
VivaGel® - Symptomatic Relief For personal use only Odour Resolution – % resolved and time to resolution 80% ** 8.00 ** 70% 7.00 Time to Resolution (Days) 60% 6.00 * % resolution 50% 5.00 86% Placebo 40% Placebo 4.00 VivaGel® VivaGel® 30% 3.00 *p<0.05 20% 2.00 ** p<0.001 10% 1.00 0% - SPL7013-013 SP
Slide 19: Drug Delivery
For personal use only Drug Delivery
Slide 20: Starpharma's DEP™ docetaxel: Multiple benefits
Starpharma’s DEP™ docetaxel: Multiple benefits For personal use only • Docetaxel (Taxotere®) is a blockbuster chemotherapeutic • Docetaxel sales US$3.1B(2012) DEP™ docetaxel vs. Taxotere® • Docetaxel is used in major cancer types including breast, prostate 1. Elimination of major dose-limiting and l
Slide 21: DEP™ docetaxel preclinical: Multiple Benefits
DEP™ docetaxel preclinical: Multiple Benefits For personal use only Better efficacy and less toxicity Enhanced Safety Enhanced Efficacy & Less toxicity Complete lack of neutropenia with DEP™ docetaxel cf. severe neutropenia for Taxotere® Docetaxel + water Tumour Targeting: DEP™ docetaxel > 40 fold g
Slide 22: DEP™ docetaxel: Phase 1 Clinical Trial
DEP™ docetaxel: Phase 1 Clinical Trial Encouraging clinical data For personal use only • Underway at 3 Australian sites* ; Open label study - allowing progressive results • Estimated sample: 25-30 cancer patients (various solid tumours) • DEP™ docetaxel administered every 3 weeks; no steroid pre-tre
Slide 23: DEP docetaxel Pharmacokinetics in humans cf. Taxotere
DEP docetaxel® Pharmacokinetics (PK) in humans cf. Taxotere®^ For personal use only 1. Extended duration of exposure with DEP™ docetaxel – DEP™ docetaxel plasma half-life substantially longer (~8 x) than Taxotere® (~150x longer in the initial, rapid phases of plasma clearance) 2. Increased extent of
Slide 24: DEP™ docetaxel compared with BIND's docetaxel
DEP™ docetaxel compared with BIND’s docetaxel Compelling product benefits for DEP™ For personal use only Aspect BIND DEP™ docetaxel Starpharma Benefit complex, self assembled SPL dendrimer manufacture is readily particles; potential Manufacture inconsistency b/w batches; Standard chemistry scalable
Slide 25: Starpharma's DEP™ oxaliplatin: Multiple benefits
Starpharma’s DEP™ oxaliplatin: Multiple benefits For personal use only • Dendrimer Enhanced (DEP™) oxaliplatin is a proprietary dendrimer version of blockbuster cancer drug, oxaliplatin (ELOXATIN®, Sanofi) • Oxaliplatin sales ~ US$2B (2012) • Neuropathy is reported in ~90% patients and Neutropenia i
Slide 26: Additional DEP™ candidates
Additional DEP™ candidates For personal use only SPL’s dendrimer enhanced product (DEP™) nanoparticle technology -broad applicability, especially in oncology -allows for new patent filings creating proprietary products Proof of DEP™ concept for docetaxel, doxorubicin, oxaliplatin, methotrexate, ge
Slide 27: Targeted DEP™ Conjugates (TDCs)
Targeted DEP™ Conjugates (TDCs) A new approach to drug conjugate design For personal use only Starpharmas Targeted DEP™ conjugates Can use small molecule, whole antibody, antibody fragments or antibody mimetics Bind with high affinity and specificity Highly efficacious in cancer model in vivo
Slide 28: DEP™ insulin – Improved pharmacokinetics (long acting)
DEP™ insulin – Improved pharmacokinetics (long acting) For personal use only DEP™ insulin – Efficacy and Duration of action^ 600 Blood GLucose mg/dL Diabetes Market 500 $43B 400 Global diabetes market (2013) 300 Marketed 1 day Insulin (Reuters) 200 DEP™ insulin 1 day 100 DEP™ insulin 1 week 0 0 12 2
Slide 29: Agrochemicals
For personal use only Agrochemicals
Slide 30: The Opportunity for Starpharma's Priostar® Dendrimers in Agrochemicals
The Opportunity for Starpharma’s Priostar® Dendrimers in Agrochemicals For personal use only The Challenge for Priostar® benefits for innovative Agrochemical Companies crop protection formulations • The cost and risk of registering new Better in the can: Better in the field: agrochemical actives to
Slide 31: Starpharma's Agrochemical Programs
Starpharma’s Agrochemical Programs For personal use only Partnered Programs Internal Programs • During 2013/2014 seven new agreements have • SPL is also developing a small number of complete been signed with leading agrochemical formulations of selected generic actives with enhanced companies in Eur
Slide 32: Dendrimer Glyphosate Formulation – Field Trial Data
Dendrimer Glyphosate Formulation – Field Trial Data For personal use only More effective in hard-to-kill weeds than comparable marketed formulation • Dendrimer product more effective in a number of 100 hard-to-kill weeds than comparable marketed 90 Dendrimer Glyphosate glyphosate product Product Per
Slide 33: Strong, late-stage portfolio - multiple products and potential revenue streams
Strong, late-stage portfolio - multiple products and potential revenue streams For personal use only Product/ Development and Potential Market SPL Application Partnering Status ($USD) Returns VivaGel® BV Phase 3 underway Prevention Prevention of Recurrence >$1B Royalty/milestones Licence post Phase
Slide 34: Starpharma Holdings – Financials
Starpharma Holdings – Financials For personal use only Key Financial Data FY 2014 FY 2013 FY 2012 (Financial Year to 30 June) AUD $M AUD $M AUD $M Total revenue and income 1.3 2.4 2.9 R&D Tax Incentive 4.2 8.7# 1.3 # incl. $4.1M from FY2012 expenditure Net loss after tax (14.6) (5.2) (13.7) Cash out
Slide 35: Cash Balance and Capital Raising
Cash Balance and Capital Raising For personal use only $M Cash Balance Financing 2014 45 40 Institutional Placement - $18M – Significantly over subscribed with 35 Cash at 30 September - excellent support from existing 30 $37.2M includes holders $18M equity – 6 new local institutions and 7 new 25 rai
Slide 36: SPL Share price and short position: January – October 2014
SPL Share price and short position: January – October 2014 Dendrimer- Docetaxel clinical Share price $ For personal use only 16 trial Commencement VivaGel condom 1 approved in Japan million shares Annual report and full year 0.9 16 financial results Quarterly cashflow 0.8 15 0.7 15 0.6 14 Quarterly
Slide 37: Expected Short-Medium Term News Flow
Expected Short-Medium Term News Flow For personal use only VivaGel® Portfolio: • Regulatory filings for BV Symptomatic Relief product • Commercialisation agreements for BV Symptomatic Relief product • Progress VivaGel® Phase 3 BV Prevention of Recurrence trials • Launches of VivaGel® condom, further
Slide 38: Drug Delivery, VivaGel®, Agrochemicals
Drug Delivery For personal use only VivaGel® Agrochemicals 34
Starpharma Holdings — Shareholder Meeting (November 2014) on 6ix