Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2018)
40 slides from Starpharma's shareholder meeting presentation, Nov 29, 2018
Slide 1: AGM Chairman's address and CEO's presentation
For personal use only AGM Chairman’s address and CEO’s presentation Melbourne, Australia; 29 November 2018: 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
Slide 2: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting 29 November 2018 For personal use only Good afternoon, On behalf of the Starpharma Board, it is with great pleasure that I welcome you to the 2018 Annual General Meeting. This was another very positive year for Starpharma in which
Slide 3: Chairman's Address: VivaGel BV licensing
In regard to licensing VivaGel® BV, a critical factor in Starpharma’s partner selection involves an assessment of each potential partner’s sales and marketing expertise and resources to successfully market a novel, specialty women’s health product, as For personal use only well as obtaining the best
Slide 4: Chairman's Address: DEP portfolio progress
In our internal DEP® portfolio, we reported excellent clinical trial results for DEP® docetaxel, which transitioned seamlessly into phase 2, and in parallel we advanced the clinical development of two other lead products – DEP® cabazitaxel and DEP® irinotecan. With the phase 1 data for DEP® docetaxe
Slide 5: Chairman's Address: the year ahead
Turning to the year ahead, this is a really exciting and rewarding time for Starpharma. We look forward to the market launch of VivaGel® BV in multiple regions, signing a US licence and FDA approval of VivaGel® BV as well as multiple value-adding milestones for the DEP® portfolio. With the achieveme
Slide 6: 2018 AGM CEO Presentation, Dr Jackie Fairley
For personal use only 2018 AGM CEO PRESENTATION, DR JACKIE FAIRLEY 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: Agenda
Agenda For personal use only 1 Overview 2 Internal DEP® 3 Partnered DEP® 4 VivaGel® 5 Outlook Please note: This presentation focuses on recent achievements and upcoming milestones, and is not intended to provide a comprehensive overview of the Company 3
Slide 9: Deep portfolio of high-value global products
Starpharma has a deep portfolio of high- value global products with the potential For personal use only to significantly improve patient outcomes Starpharma is an ASX300 company with Market capitalisation ~A$550M (as at 28 Nov) a proven record of Issued shares 371.3M successful development & commerc
Slide 10: Deep portfolio of global products
Starpharma has a deep portfolio of global products with the potential to significantly improve patient outcomes For personal use only VIVAGEL® DEP® VivaGel® BV US - ADVANCED NEGOTIATION Starpharma’s SUBMISSION APPROVED APPROVED GRANTED proprietary dendrimer platform World-leading VivaGel® Condom Ant
Slide 11: Starpharma's pipeline
Starpharma’s pipeline Product Indication Preclinical Clinical/Regulatory Commercial For personal use only VIVAGEL® BV Bacterial Vaginosis VIVAGEL® VIVAGEL® CONDOM Anti-viral condom SPL7013 OPHTHALMIC Viral conjunctivitis DEP® DOCETAXEL Oncology INTERNAL DEP® DEP® CABAZITAXEL Oncology DEP® IRINOTECAN
Slide 12: Strategy provides exceptional optionality
Starpharma’s strategy provides exceptional optionality underpinned by valuable, late-stage products For personal use only CREATE VALUE through: • commercialising or monetising products at the right stage • developing new IP for Starpharma & for partners BUILD PORTFOLIO through: LEVERAGE platform: •
Slide 13: Strong financial position to expand and accelerate programs
Starpharma is in a strong financial position to expand & accelerate multiple high-value programs For personal use only FY 2018 FY 2017 Key Financial Data A$M A$M Total revenue and income 5.0 3.6 39% Loss from continuing operations (10.3) (15.2) 32% Profit/(loss) from discontinued operation - 23.
Slide 14: DEP highlights
DEP® highlights For personal use only First patent published for Starpharma’s DEP® dendrimer with AstraZeneca’s Bcl2/xL inhibitors Commenced DEP® docetaxel phase 2 trial following successful phase 1 results Commenced DEP® cabazitaxel phase 1 / 2 trial DEP® irinotecan outperformed standard irinotecan
Slide 15: VivaGel BV highlights
VivaGel® BV highlights For personal use only VivaGel® BV licensed to Mundipharma for Europe, Russia, CIS and Latin America for an attractive revenue share, in addition to milestones of up to US$15.5M (A$20.9M) VivaGel® BV licensed to Mundipharma for Asia, Middle East, Africa and the majority of Lati
Slide 16: DEP platform enhances commercial and therapeutic value
Starpharma’s DEP® platform enhances the commercial and therapeutic value of a wide range of drugs For personal use only Improved Reduced efficacy1: DEP® side-effects1: DEP® reduces improves anti-cancer important side effects such as efficacy through better bone marrow toxicity / low white drug targe
Slide 17: DEP platform benefits
Starpharma’s DEP® platform enhances the commercial and therapeutic value of a wide range of drugs For personal use only DEP® BENEFITS Improved Efficacy Reproducible results with many candidates & tumour types Improved Safety Reduced neutropenia/bone marrow toxicities Targeting Tumour Tissue 45-70 x
Slide 18: DEP platform has enabled a deep pipeline
Starpharma’s DEP® platform has enabled the creation of a deep pipeline of high-value products For personal use only DEP® docetaxel: Improved Efficacy Starpharma’s most Benefit in combination with marketed anti-cancer therapies advanced DEP® product - a Improved Safety detergent-free, enhanced
Slide 19: DEP docetaxel enhanced version of Taxotere
DEP® docetaxel is an enhanced version of widely used cancer drug, Taxotere® For personal use only Enhanced version of docetaxel PHASE 1 RESULTS (Taxotere®) - one of the most • No steroid pre-treatment required due to DEP® widely used cancer drugs for a docetaxel’s detergent-free formulation - unlike
Slide 20: DEP docetaxel phase 2 program underway
DEP® docetaxel phase 2 program underway For personal use only PHASE 2 TRIAL UPDATE (currently recruiting) Monotherapy arm • Positive interim trial results for the Multi-site trial – 4 sites monotherapy arm show continued lack Commercial of neutropenia and encouraging currently recruiting (Guy’s Obje
Slide 21: DEP cabazitaxel enhanced version of Jevtana
DEP® cabazitaxel is an enhanced version of leading prostate cancer drug, Jevtana® For personal use only Starpharma’s patented DEP® cabazitaxel is an enhanced version of cabazitaxel (Jevtana®) – primarily used for prostate cancer and in clinical development for other cancers including breast, bladder
Slide 22: DEP cabazitaxel phase 1/2 trial program
DEP® cabazitaxel phase 1 / 2 trial program underway Phase 1: Open-label, sequential For personal use only PHASE 1 / 2 dose-escalation (accelerated) to (currently recruiting) establish the MTD (Maximum Tolerated Dose) and Dose Limiting Toxicities, RP2D Multi-site trial – currently (Recommended Phase
Slide 23: DEP docetaxel and cabazitaxel outperformed gemcitabine and Abraxane
DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane® in human pancreatic cancer model For personal use only L e a d in g p a n c r e a tic c a n c e r th e r a p ie s s h o w m in im a l a c tiv ity ) 1400 3 M e a n T u m o u r V o lu m e (m m V e h ic le 1200 G e m c ita b in
Slide 24: DEP irinotecan enhanced version of Camptosar
DEP® irinotecan is an enhanced version of widely used cancer drug, Camptosar® For personal use only An improved DEP® irinotecan demonstrated significantly better anti-tumour activity version of and increased survival compared with irinotecan (Camptosar®) in irinotecan multiple human colon cancer mod
Slide 25: DEP irinotecan outperformed standard treatments
DEP® irinotecan outperformed standard treatments in human pancreatic cancer model For personal use only DEP® irinotecan is currently in DEP® irinotecan alone showed complete tumour advanced preparations for regression and 100% survival in a human phase 1 / 2 trial, expected to pancreatic cancer mode
Slide 26: AstraZeneca's DEP programs illustrate potential returns
DEP® AstraZeneca’s DEP® programs illustrate the potential returns from DEP® partnered programs For personal use only Partnered-DEP® AstraZeneca has three active DEP® programs Starpharma produces DEP® candidates under research collaboration Partner selects candidate – either novel or existing drug (f
Slide 27: AstraZeneca's DEP Bcl2/xL inhibitors show efficacy and synergy
DEP® AstraZeneca’s DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination For personal use only R S 4 ;1 1 X e n o g ra ft m o d e l (A L L ) S u D H L -4 (D L B C L X e n o g r a ft M o d e l) 5 x w e e k ly in je c tio n s 4 x w e e k ly in je c tio n s 1500 2000 V e h ic le ) V
Slide 28: VivaGel portfolio - innovative, late-stage global products
VivaGel® portfolio - innovative, late-stage global products For personal use only VivaGel® BV - VivaGel® condom - A breakthrough product for World’s first and BV Treatment & Prevention only anti-viral of Recurrent BV condom – launched in Australia and Approved in Australia and the EU Canada; Licen
Slide 29: VivaGel BV - breakthrough for most common vaginal infection
VivaGel® BV - a breakthrough product for the most common vaginal infection worldwide For personal use only Bacterial Vaginosis (BV): • affects 1 in 3 women in the US, and recurs in Starpharma’s VivaGel® BV is a ~50-60% of women; and patented, non-antibiotic, • is twice as common as thrush. rapidly a
Slide 30: Positive patient experiences with VivaGel BV
Positive patient experiences from women who have already benefited from VivaGel® BV 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, Principal Investigator & O
Slide 31: Positive independent market research from US physicians and payers
Positive independent market research 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 “I think
Slide 32: VivaGel BV licensed to Mundipharma
VivaGel® BV has been licensed in most regions around the world to Mundipharma For personal use only Mundipharma has licensed VivaGel® BV for more than 160 countries throughout Europe, Russia, CIS, Asia, Middle East, Africa & Latin America; to be marketed as part of the popular BETADINE® Feminine Car
Slide 33: Launches for VivaGel BV expected during CY 2019
Launches for VivaGel® BV are expected in most regions during CY 2019 For personal use only US ~ Relative Market Size Reg approval > Finalise Claims & Packaging > Manufacture > Distribution > Launch Launch Process • Advanced launch activities underway by both Mundipharma and Aspen in preparation for
Slide 34: VivaGel BV licensed worldwide; advanced negotiations in US
VivaGel® BV has been licensed in most regions around the world; advanced negotiations in US/North America For personal use only The global market is estimated to be ~US$750M for BV treatment & ~US$1B annually for BV prevention Rest of World (RoW) Europe, Russia, CIS, Asia, Middle East, Africa, Latin
Slide 35: Dendrimer platform yields further product opportunities
Starpharma’s dendrimer platform continues to yield further valuable product opportunities For personal use only Radiopharmaceuticals • Growing category with current sales Leveraging DEP® platform benefits: ~$750M, & est. $12–15B by 20302 • Recent deals incl. Sirtex acquisition • Expand internal pipe
Slide 36: DEP accumulation in glioblastoma model
DEP® shows significant accumulation in glioblastoma (brain tumour) model For personal use only DEP® Radiotherapeutic About Glioblastoma Multiforme (GBM) Highlevel High levelofof DEP® accumulation accumulation of DEP®in • GBM is the most common Glioblastoma in Glioblastoma and aggressive malignant br
Slide 37: SPL7013 ophthalmic drops for adenoviral conjunctivitis
SPL7013 ophthalmic drops – a potential, novel therapy for adenoviral conjunctivitis For personal use only SPL7013 ophthalmic drops: Viral conjunctivitis is the most common showed potent anti-viral cause of infectious conjunctivitis – up to activity against multiple 90% caused by adenoviruses ophth
Slide 38: SPL7013 ophthalmic drops - untapped market
SPL7013 ophthalmic drops – a valuable novel therapeutic for a significant untapped market (viral conjunctivitis) For personal use only “Treating viral conjunctivitis is a “I would probably prescribe this problem. There's no prescribed SPL7013 ophthalmic drops [SPL7013 ophthalmic drops] for the elici
Slide 39: Outlook
Outlook For personal use only VIVAGEL® DEP® PORTFOLIO PORTFOLIO Progress with DEP® docetaxel & VivaGel® BV US / North American licence DEP® cabazitaxel clinical trials and launch VivaGel® BV launch in Australia, Europe DEP® irinotecan trial commencement & other Mundipharma regions Other DEP® program
Slide 40: www.starpharma.com
For personal use only www.starpharma.com
Starpharma Holdings — Shareholder Meeting (November 2018) on 6ix