Starpharma Holdings Limited · ASX:SPL
Starpharma — Investor Presentation (September 2020)
44 slides from Starpharma's investor presentation, Sep 30, 2020
Slide 1: Investor Presentation
For personal use only Investor Presentation 30 SEPTEMBER 2020 ASX:SPL OTC:SPHRY Not for release to US wire services or distribution in the United States DR JACKIE FAIRLEY CEO 1
Slide 2: Important notice and disclaimer
Important notice and disclaimer . This presentation is dated 30 September 2020 and has been prepared by Starpharma Holdings Limited (ACN 078 532 180) (Starpharma or the Company) in connection with (a) an institutional placement of new fully paid ordinary shares (New Shares) in the Company (Placement
Slide 3: Important notice and disclaimer
Important notice and disclaimer . Future performance and forward-looking statements This presentation may contain forward-looking statements and comments about future events, including statements regarding Starpharma’s current intentions, objectives, plans, expectations, assumptions and beliefs abou
Slide 4: Overview
For personal use only 1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 4
Slide 5: Dendrimer platform delivers significant optionality with multiple revenue streams
Starpharma’s dendrimer platform delivers significant optionality with multiple potential revenue streams, valuable products & clinical-stage assets For personal use only Key Investment Data Through innovative research and development, Starpharma is creating therapies which have the potential to impr
Slide 6: Starpharma's portfolio: VivaGel products, SPL7013 antivirals and DEP clinical assets
Starpharma’s portfolio: High-value assets including VivaGel® products on market, SPL7013 antivirals and multiple DEP® clinical assets For personal use only Extensive & growing pipeline Multiple approved of proprietary assets Multiple clinical stage assets products APPROVED PRODUCTS INTERNAL LICENSED
Slide 7: SPL7013 COVID-19 nasal spray is virucidal, inactivating >99.9% of SARS-CoV-2
SPL7013 COVID-19 nasal spray is virucidal, inactivating >99.9% of SARS-CoV-2 (coronavirus) For personal use only SPL7013 has antiviral activity when applied before, or after, exposure of cells to virus BROAD SPECTRUM ANTIVIRAL MECHANISM SPL7013: POSITIVE FEATURES ANTIVIRAL SPRAY • SPL7013 COVID-19 n
Slide 8: Expediting development of SPL7013 COVID-19 nasal spray for 1H CY2021
Starpharma is expediting the development of the SPL7013 COVID-19 nasal spray; expected to be ready for market 1H CY2021 For personal use only SPL7013 is the active included in marketed VivaGel® products; In addition to coronavirus (SARS-CoV-2), SPL7013 has also demonstrated activity in HIV, HSV, HPV
Slide 9: DEP remdesivir: slow release and soluble version of remdesivir
DEP® remdesivir: slow release (long-acting) & soluble version of Gilead’s remdesivir Gilead’s antiviral drug, remdesivir, is being utilised for the treatment of COVID-19 under emergency use For personal use only authorisation from the US Food and Drug Administration for patients with severe disease
Slide 10: Key highlights
Key highlights ►► DEP® irinotecan ►► DEP® ►► DEP® docetaxel For personal use only ►► AstraZeneca’s first DEP® product, AZD0466, phase 1/2 trial cabazitaxel trial + gemcitabine commenced phase 1, commenced advanced into combination study triggering US$3M and advanced into phase 2 on commenced milesto
Slide 11: Financial summary
Financial summary FY20 FY19 Key Financial Data For personal use only A$M A$M Revenue and other income 7.1 162% 2.7 Loss for the period (14.7) (14.3) Net operating cash outflows (10.8) (10.3) Net cash burn1 (11.2) (10.1) Cash as at 30 June $30.1M $41.3M FY20 Result: • Total revenue and other income o
Slide 12: DEP overview
For personal use only 1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 12
Slide 13: DEP platform strategy creates significant optionality and upside
Starpharma’s DEP® platform strategy creates significant optionality and upside For personal use only DEP® platform strategy provides technical, IP and financial leverage, as well as increasing commercial opportunities, improving ROI and de-risking development INTERNAL DEP® PARTNERED DEP® • Applicati
Slide 14: DEP platform conveys product benefits across a wide range of drugs
Starpharma’s DEP® platform conveys product benefits and enhances the commercial value of a wide range of drugs and therapeutic areas For personal use only DEP® BENEFITS* 3 x w e e k ly in je c t io n s Improved Efficacy Reproducible results with many candidates DEP® platform: ) 3 1400 M e a n T u m
Slide 15: DEP platform creates significant leverage through partnering
DEP® platform creates significant leverage through partnering DEP® can be used by commercial partners to improve novel drugs or existing products for life-cycle management For personal use only Starpharma attaches the partner’s drug DEP® case study: AstraZeneca’s DEP® programs include clinical to th
Slide 16: DEP Internal: Multiple clinical-stage assets with high commercial value potential
DEP® Internal: Multiple clinical-stage assets with high commercial value potential COMMERCIAL Create value through clinical proof-of- License following proof-of-concept Utilise accelerated development / regulatory OBJECTIVE concept in one or more cancer types clinical data; platform validation pathw
Slide 17: DEP docetaxel phase 2 program: positive interim results
DEP® docetaxel phase 2 program – ongoing recruitment and positive interim results MONOTHERAPY ARM COMBINATION ARM (+ VARGATEF) For personal use only 35 patients treated DEP® DOCETAXEL 13 patients treated Open-label, two-stage design to allow for exploration of efficacy Encouraging efficacy signals o
Slide 18: Case study: DEP docetaxel in advanced oesophageal cancer
Case study: DEP® docetaxel in advanced oesophageal cancer • Oesophageal cancer is the seventh most commonly For personal use only occurring cancer in men1 Stage IV metastatic oesophageal patient: • Est. 5-year mortality for stage IV disease > 85% to 90% 1 http://www.wcrf.org/dietandcancer/cancer-tre
Slide 19: Case study: DEP docetaxel in advanced lung cancer
Case study: DEP® docetaxel in advanced lung cancer • Lung cancer is the most common cancer globally For personal use only • Non-Small Cell Lung Cancer (NSCLC) accounting for Stage IV metastatic 84% of all lung cancers lung cancer (NSCLC) patient: • Stage IV lung cancer patients have a 5 year surviva
Slide 20: DEP cabazitaxel: positive phase 1 results and phase 2 underway
DEP® cabazitaxel – positive phase 1 results & phase 2 underway PHASE 1 RESULTS PHASE 2 For personal use only Positive phase 1 results (dose-escalation) First stage will enrol ~20 patients with a • 14 patients enrolled and received DEP ® cabazitaxel at doses variety of cancers, including prostate bet
Slide 21: Clinical case study: DEP cabazitaxel in advanced prostate cancer
Clinical case study: DEP® cabazitaxel in advanced prostate cancer Prostate cancer is the second most commonly occurring cancer in men For personal use only Stage III Prostate Cancer PSA level following DEP® cabazitaxel Patient: • Stable Disease >47 weeks 120 DEP® • 79% decrease in PSA 10 79% cabazit
Slide 22: Clinical case study: DEP cabazitaxel in ovarian cancer
Clinical case study: DEP® cabazitaxel in ovarian cancer Ovarian cancer has the lowest survival rate For personal use only Advanced ovarian of women’s cancer* and is the eighth most commonly occurring cancer in women cancer patient with * https://ovariancancer.net.au/wp-content/uploads/2019/01/Ovaria
Slide 23: DEP irinotecan: positive phase 1 results and phase 2 underway
DEP® irinotecan - positive phase 1 results & phase 2 now underway DEP® irinotecan incorporates POSITIVE PHASE 1 RESULTS (DOSE-ESCALATION) PHASE 2 UNDERWAY For personal use only the irinotecan active moiety • 7 patients were enrolled and received DEP® irinotecan at a range of (SN38) and is an improve
Slide 24: Clinical case study: DEP irinotecan in advanced breast cancer
Clinical case study: DEP® irinotecan in advanced breast cancer Breast cancer is the most common cancer For personal use only affecting women and is the second leading cause Stage IV breast of cancer-related death in Australian women, cancer patient with accounting for 14.9% of all female cancer deat
Slide 25: DEP irinotecan with anti PD-1 antibody boosts efficacy in colon cancer models
DEP® irinotecan in combination with immuno-oncology agent (anti PD-1 antibody) boosts efficacy and survival in multiple colon cancer models For personal use only Figure 1: Mean Tumour Volume Over Time MC-38 These results indicate that DEP® irinotecan in combination with an anti PD-1 antibody could b
Slide 26: DEP ADCs further build the value of the DEP platform
DEP® ADCs further build the value of the DEP® platform Interest in clinical and late stage ADC therapeutics heating up For personal use only Mean Tumour Volume Novel DEP® HER-2 ADC Starpharma’s DEP® 1600 Mean Tumour Volume (mm3) conjugate: technology provides • resulted in tumour regression 1200 enh
Slide 27: DEP lutetium shows efficacy in human prostate cancer model
First DEP® radiotherapeutics candidate, DEP® lutetium, shows impressive efficacy in human prostate cancer model For personal use only • Starpharma has developed multiple novel radiotherapeutic DEP® lutetium and radiodiagnostic candidates Starpharma’s first DEP® radiotherapy candidate showed highly s
Slide 28: SPL7013 & VivaGel
For personal use only 1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 28
Slide 29: VivaGel BV: a breakthrough product for the management of BV
VivaGel® BV - a breakthrough product for the management of BV - the most common vaginal infection worldwide For personal use only Management of BV is an area of significant unmet need: 1 in 3 women × Untreated, BV is associated with miscarriage, infertility & PID as well as having a significant impa
Slide 30: VivaGel BV licensed in >160 countries around the world
VivaGel® BV licensed in >160 countries Asia – For personal use only around the launched world On market 1H CY20 Global market for NORTH BV treatment est. to AMERICA EUROPE MIDDLE be US$750M and EAST prevention est. to be US$1B annually ASIA AFRICA Launched in the UK, Europe, Asia, Australia & NZ NZ
Slide 31: Positive patient experiences about VivaGel BV benefits
Positive patient experiences about VivaGel® BV benefits “I spoke to a pharmacist and discovered this new product for BV…called Fleurstat BVgel...I cannot Comments regarding express how impressive this is… It’s been about 2- For personal use only Fleurstat BVgel 3 months now and totally BV free.” BV
Slide 32: Fleurstat BVgel ranks as #1 topical BV treatment in Australia
For personal use only Fleurstat BVgel ranks as #1 topical BV treatment in Australia FLEURSTAT BVGEL (VivaGel® BV) for the treatment of BV and relief of symptoms: Ask your pharmacist – they must decide if this product is right for you. Always read the label. Follow the directions for use. Do not use
Slide 33: VivaGel BV regulatory: approved in countries with further submissions underway
VivaGel® BV regulatory: approved in 40 countries with further submissions underway For personal use only Approved Submitted / Licensed region submissions underway UK Europe Asian countries Australia & New Zealand African & Middle Eastern countries Latin American countries US Progre
Slide 34: VivaGel antiviral condom launched in Japan and approved in Europe
VivaGel® antiviral condom launched in Japan and recently approved in Europe For personal use only • VivaGel® antiviral condom (HIV, Okamoto & Japanese Herpes, HPV) is being marketed Ministry of Health, Labour & under Okamoto’s leading and Welfare have developed a highly successful Zero Zero joint ST
Slide 35: Outlook
For personal use only 1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 35
Slide 36: Outlook
Outlook SPL7013 for Coronavirus • Expedite development and launch of SPL7013 nasal spray LEVERAGE EXISTING APPROVALS For personal use only VIVAGEL® COMMERCIAL OUTCOMES • Commercial roll-out of VivaGel® BV in Europe, Asia & other markets • Further regulatory approvals and launches for VivaGel® BV; bu
Slide 37: Investor relations contact
For personal use only FOR INVESTOR RELATIONS ENQUIRIES CONTACT: Dr Jackie Fairley, CEO Nigel Baade, CFO & Company Secretary +61 3 8532 2704 investor.relations@starpharma.com 4-6 Southampton Crescent Abbotsford Vic 3067 WWW.STARPHARMA.COM ASX:SPL OTC:SPHRY Disclosure: This ASX Announcement was author
Slide 38: Appendix: Key Risks
For personal use only Appendix: Key Risks 38
Slide 39: Key risks
Key risks This section discusses some of the key risks which may affect the value of Starpharma shares. These risks ought not to be taken as exhaustive of the risks faced by Starpharma or by investors in For personal use only Starpharma. The group operates in the biotechnology and pharmaceutical sec
Slide 40: Key risks (Continued)
Key risks (Continued) . Product acceptance and competitiveness: A developed product may not be considered by key opinion leaders (e.g. doctors), reimbursement authorities (e.g. Pharmaceutical Benefits Scheme listing) For personal use only or the end customer to be an effective alternative to product
Slide 41: Appendix: Foreign Selling Restrictions
For personal use only Appendix: Foreign Selling Restrictions 41
Slide 42: Foreign Selling Restrictions
Foreign Selling Restrictions This document does not constitute an offer of new ordinary shares ("New Shares") of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any cou
Slide 43: Foreign Selling Restrictions
Foreign Selling Restrictions United Kingdom . Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000
Slide 44: Foreign Selling Restrictions
Foreign Selling Restrictions Canada (British Columbia, Ontario and Quebec provinces) . This document constitutes an offering of New Shares only in the Provinces of British Columbia, Ontario and Quebec (the "Provinces"), only to persons to whom New Shares may be lawfully distributed in the Provinces,
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