Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2017)
45 slides from Starpharma's shareholder meeting presentation, Nov 29, 2017
Slide 1: AGM Chairman's address and CEO presentation
For personal use only AGM Chairman’s address and CEO presentation Melbourne, Australia; 29 November 2017: 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 3.00pm today. About S
Slide 2: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting 29 November 2017 For personal use only Good afternoon, On behalf of the Starpharma Board, it is with great pleasure that I welcome you to the 2017 Annual General Meeting. This past year has been a transformative period for Starpha
Slide 3: Chairman's Address (continued)
In the US, as many as one in three women suffer from BV, and approximately two thirds of these patients encounter recurring episodes of the condition. There is desperate need for safe and effective alternatives to current therapies and importantly, a need for a product that stops BV from recurring.
Slide 4: Chairman's Address (continued)
The phase 1 trial successfully achieved the key objective of determining a Recommended Phase 2 Dose with no reports of protocol-defined dose limiting toxicities. Remarkably, no patients in the phase 1 trial experienced neutropenia, a life-threatening side effect seen in more than 90% of patients who
Slide 5: Chairman's Address (continued)
What’s particularly satisfying is that with every milestone reached we move closer to improving the health of patients worldwide. Women suffering from BV are finally on the cusp of being able to access a safe and effective non-antibiotic solution for this very troubling condition, and we’ve already
Slide 6: 2017 AGM CEO Presentation
For personal use only 2017 AGM CEO PRESENTATION DR JACKIE FAIRLEY 29 NOVEMBER 2017 STARPHARMA HOLDINGS LIMITED ASX:SPL; OTCQX:SPHRY
Slide 7: Important notice and disclaimer
Important notice and disclaimer 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”,
Slide 8: Year in review: VivaGel
Year in review For personal use only VivaGel® US FDA granted Fast Track status & QIDP designation to VivaGel® BV for both Treatment and Prevention of rBV Leading US healthcare investment bank appointed to support global licensing process for VivaGel® BV VivaGel® condom launched in Canada and two new
Slide 9: Year in review: DEP
Year in review DEP® For personal use only Two new targeted DEP® partnerships with world-leading antibody drug conjugate companies US$2M payment triggered by AZD0466 achieving final preclinical milestone DEP® irinotecan outperformed Camptosar® in multiple human colon cancer models DEP® cabazitaxel ac
Slide 10: Starpharma Agrochemicals sold to Agrium Inc.
Starpharma Agrochemicals sold to Agrium Inc. - a leading global agricultural product marketer For personal use only Agrochemicals sold for A$35m cash (June 2017) Execution of Starpharma’s deliberate strategy to maximise the value of, and monetise, Priostar® IP/technology Leading global Sale was more
Slide 11: Global leader in dendrimer products
Global leader in dendrimer products – multiple commercial partnerships with leading companies For personal use only Starpharma’s Dendrimer Platform VivaGel® BV APPROVED GRANTED VIVAGEL® GLOBAL LICENSING SUBMISSION APPROVED DEP® PROCESS UNDERWAY VivaGel® Condom World-leading Antibody Drug Conjugate C
Slide 12: Deep pipeline of VivaGel and DEP products
Starpharma’s deep pipeline of VivaGel® and DEP® products provides exceptional optionality only Product Preclinical Clinical/Regulatory VIVAGEL® BV – BV Treatment and Prevention of rBV ® VIVAGEL VIVAGEL® CONDOM – Anti-viral condom use VIVAGEL® – Viral conjunctivitis DEP® DOCETAXEL – Oncology personal
Slide 13: Strong financial position
Strong financial position FY 2017 FY 20161 Key Financial Data For personal use only A$M A$M Total revenue and income 3.6 4.6 Loss from continuing operations (15.2) (21.3) Profit/(loss) from discontinued operation 23.4 (1.4) Profit/(loss) for the period 8.2 (22.7) Net operating & investing cash inflo
Slide 14: Share price performance
Share price performance 22 Nov ’17: SPL MARKET price target For personal use only CAP >$500M upgraded $1.50 “FY18 to be a SPL AstraZeneca identifies DEP® transformational candidate as AZD0466 year for SPL” Share price (A$) $1.30 ASX200 DEP® docetaxel - Tanushree Jain Analyst, Healthcare & ASX300 pha
Slide 15: VivaGel Portfolio
For personal use only VIVAGEL® PORTFOLIO
Slide 16: VivaGel portfolio overview
VivaGel® portfolio overview – late stage / commercial assets VivaGel® BV: A breakthrough product for Bacterial Vaginosis (BV) For personal use only Treatment & Prevention of Recurrent BV (rBV) • Approved in AUS and expected to be available in pharmacies in 2018 under the FleurstatTM brand • Approved
Slide 17: BV has serious health consequences and significant impact
BV has serious health consequences and significant impact for patients For personal use only Bacterial Vaginosis (BV) BV – Major Impact for Patients • Most common vaginal infection • >2/3 of women reported BV had worldwide a major impact on their lives • ~30% women infected in US; up to 51% in some
Slide 18: VivaGel BV: Two Attractive Commercial Opportunities
VivaGel® BV: Two Attractive Commercial Opportunities For personal use only 1 in 3 women Significant unmet will get BV medical need for BV TREATMENT Est. market valued at US$750M p.a. 6 in 10 have recurrent BV No approved therapies for rBV PREVENTION (RECURRENT BV) Est. market valued at US$1B p.a. 14
Slide 19: VivaGel BV: A breakthrough therapy for BV
VivaGel® BV: A breakthrough therapy for BV - a significant unmet medical need For personal use only “VivaGel® BV is a wonderful product which specifically targets BV bacteria. My patients have called it a ‘life-changing and miraculous treatment’.” Dr Belvia Carter, Ob-Gyn, Memphis, Tennessee. Princi
Slide 20: US FDA regulatory milestones
US FDA regulatory milestones: Fast Track, QIDP & New Drug Application (NDA) For personal use only “Guidance reviews are one of several FDA initiatives under • Fast Track status and QIDP the US GAIN Act aimed at encouraging and expediting new designation granted - designed to antimicrobial developmen
Slide 21: Successful VivaGel rBV phase 3 trial results
Successful VivaGel® rBV phase 3 trial results (Aug 2017) For personal use only VivaGel® BV demonstrated statistically significant efficacy in 2 pivotal phase 3 trials Two randomised, double-blinded, placebo-controlled trials enrolled 1,223 women across more than 100 trial sites conducted under SPA V
Slide 22: Statistically significant efficacy in prevention of rBV
VivaGel® BV phase 3: Statistically significant efficacy in prevention of rBV For personal use only 1o endpoint : Imputed Recurrence Rate1 was met • Rate of BV recurrence at or by week 16 with drop-outs treated as failures HRR of 63.9% • VivaGel® BV: Imputed Recurrence Rate1 was 44.2% vs Placebo 54.3
Slide 23: Efficacy in five secondary endpoints
VivaGel® BV also demonstrated efficacy in five secondary endpoints For personal use only 1. Time to recurrence of BV 2. Reduced recurrence of patient reported symptoms of odour and/or discharge 3. Reduced recurrence of BV by Nugent score 4. Reduced recurrence of individual Amsel criteria (clinical f
Slide 24: Significant and sustained benefits in odour
VivaGel® BV: Significant and sustained benefits in the symptom that matters most to patients – Odour For personal use only Odour is the most distressing symptom women with BV describe “It is absolutely horrible…the most embarrassing thing ever.” “I feel like I’m not normal.” Verbatims from BV suffer
Slide 25: Independent US Market Research for VivaGel BV
Independent US Market Research for VivaGel® BV Starpharma commissioned independent market research for VivaGel® BV in the For personal use only US to inform marketing plans and its licensing discussions for the product Qualitative Research Quantitative Research Detailed Interviews Online Surveys 11
Slide 26: Positive market research findings from physicians and payers
Positive market research findings for VivaGel® BV - from US physicians and payers alike For personal use only “I would love to try it [VivaGel® BV] “it [VivaGel® BV] is certainly simple enough because it is not an antibiotic.” and the side effect profile is minimal” -US GYN #1 -US GYN #6 “The good n
Slide 27: Product profile appealing to patients
US Physicians conclude that VivaGel® BV’s Product Profile will be very appealing to patients For personal use only >70% of BV Patients are interested in Top VivaGel® BV attributes to patients a non-antibiotic BV therapy Time TimetoTo Resolution of Resolution Of Odour 74% Odor Efficacy Cure Rate 73%
Slide 28: Physicians predict increased preventative therapy usage
US Physicians predict significant increases in usage of preventative BV therapy following VivaGel® BV launch For personal use only Number of BV episodes per year Following VivaGel® BV launch, physicians estimate: • Twice as many Physicians will prescribe a 31% 55% of preventative therapy to 2 episod
Slide 29: Extensive global licensing negotiations for VivaGel BV
Extensive global licensing negotiations for VivaGel® BV VivaGel® BV Licensing strategy and negotiations Global and regional negotiations covering all the large For personal use only positively impacted by: markets, including in North America, Europe and Asia • Revised FDA BV guidance • Multiple term
Slide 30: VivaGel condom
VivaGel® condom • VivaGel® condoms carry the VivaGel® brand and For personal use only Starpharma receives royalties based on sales THE • VivaGel® condom recently launched in Canada under WORLD’S LifeStyles® Dual Protect™ brand FIRST ANTI-VIRAL CONDOM • Ansell sold its sexual wellness division to Chi
Slide 31: DEP Portfolio
For personal use only DEP® PORTFOLIO
Slide 32: Dendrimer Enhanced Products (DEP) Dual Strategy
Dendrimer Enhanced Products (DEP®) Dual Strategy Starpharma’s dual DEP® strategy provides technical, IP and financial leverage, as well as For personal use only increasing commercial opportunities, improving ROI and de-risking development INTERNAL DEP® PARTNERED DEP® • Application to • Application t
Slide 33: AstraZeneca multiproduct licence and further program
AstraZeneca multiproduct licence and further program – Partnered DEP® momentum building For personal use only DEP® multiproduct licence • First DEP® candidate, AZD0466: US$126M + royalties • Subsequent DEP® candidates US$93M + royalties • Tiered royalties on net sales on the resultant AstraZeneca DE
Slide 34: AstraZeneca's first candidate AZD0466
AstraZeneca’s multiproduct licence 1st candidate AZD0466: An exciting novel oncology agent For personal use only “…the DEP® technology has • Bcl2 is an exciting and enabled us to advance a very clinically validated oncology target exciting novel oncology agent towards the clinic” AZD0466 • Venetocla
Slide 35: DEP pipeline – internal products
Starpharma’s DEP® pipeline – internal products The optionality with the DEP® platform enables Starpharma to build a deep For personal use only pipeline of enhanced drugs – a very attractive commercial strategy DEP® docetaxel: Starpharma’s most DEP® irinotecan: DEP® cabazitaxel: advanced DEP® product
Slide 36: DEP docetaxel commenced phase 2
DEP® docetaxel commenced phase 2, multiple benefits observed in phase 1 For personal use only Phase 1: (27 cancer patients - various solid tumours) • Trial completed PHASE 2 STUDY • No protocol-defined DLTs in patients across all dose levels (currently recruiting in the UK) • Recommended Phase 2 Dos
Slide 37: DEP cabazitaxel: Multiple benefits
DEP® cabazitaxel: Multiple benefits For personal use only About cabazitaxel DEP® cabazitaxel (Jevtana®) Significantly enhanced 2016 sales efficacy versus Jevtana® approx.US$400M (cabazitaxel) in human (est. US$500M by 2018) breast and prostate cancer models Primary indication – prostate cancer and i
Slide 38: DEP cabazitaxel phase 1/2 trial
DEP® cabazitaxel phase 1 / 2 trial For personal use only • Final stages of phase 1 / 2 preparation – trial expected to commence shortly (CY17) • Majority of trial preparations substantially complete (product manufacture, site selection, CRO appointment, ethics and regulatory submissions, etc) • To b
Slide 39: DEP irinotecan outperformed Camptosar
Further validation of the DEP® platform – DEP® irinotecan outperformed Camptosar® For personal use only • Irinotecan (Camptosar®) is primarily used for the treatment of advanced colorectal cancer (peak sales DEP® Benefits US$1.1B) • Colorectal cancer is the third most common cancer and Readily scala
Slide 40: DEP irinotecan: Enhanced efficacy and survival in colon cancer model
DEP® irinotecan: Significantly enhanced efficacy and survival in colon cancer model For personal use only HT-29 (colon) Xenograft SW620 (colon) Xenograft • Excellent efficacy demonstrated in two colon cancer models known to be resistant to irinotecan (including HT-29) P<0.0001 P<0.0001 • Significant
Slide 41: DEP: A true platform with reproducible benefits
DEP®: A true platform with highly reproducible benefits creating exceptional optionality For personal use only Improved Efficacy Improved Safety Improved Survival DEP® docetaxel DEP® docetaxel DEP® docetaxel DEP® cabazitaxel DEP® cabazitaxel DEP® cabazitaxel Mouse xenograft models using MBA-231 Lack
Slide 42: GMP scale-up facility for DEP products
Starpharma’s GMP scale-up facility for DEP® products commissioned in early 2017 For personal use only • Rapid manufacture of preclinical and clinical grade DEP® materials • GMP facility used for both internal and partnered DEP® programs • Significant financial benefits and faster turnaround compared
Slide 43: Outlook: VivaGel
Outlook For personal use only VivaGel® Finalise submission of NDA for VivaGel® BV Launch of VivaGel® BV in Australia (under FleurstatTM brand), Europe, US and elsewhere Sign licence agreement(s) for VivaGel® BV (multiple territories/licences) Further regulatory approvals for VivaGel® BV Launch of Vi
Slide 44: Outlook: DEP
Outlook For personal use only DEP® DEP® cabazitaxel phase 1 / 2 trial commencement and recruitment Recruitment and updates on phase 2 for DEP® docetaxel AstraZeneca program developments, including progressing AZD0466 to the clinic and associated milestones Other DEP® candidates developed and advance
Slide 45: www.starpharma.com
41 For personal use only www.starpharma.com
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