Starpharma Holdings Limited · ASX:SPL
Starpharma — OTCQX Life Sciences Investor Forum 2020
36 slides from Starpharma's conference presentation, Sep 17, 2020
Slide 1: Starpharma to present at OTCQX Life Sciences Investor Forum
Starpharma to present at OTCQX Life Sciences Investor Forum Melbourne, Australia; 17 September 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that a pre-recorded presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 17 September 2020 (US ET) as part of OTCQX’s Life Science
Slide 2: OTCQX Life Sciences Investor Forum
OTCQX LIFE SCIENCES INVESTOR FORUM 17 SEPTEMBER 2020 DR JACKIE FAIRLEY ASX:SPL OTC:SPHRY CEO 1
Slide 3: Important notice and disclaimer
Important notice and disclaimer 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”, “estimate
Slide 4: Overview
1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 3
Slide 5: Starpharma's 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 Starpharma (ASX:SPL/OTC:SPHRY) is an ASX300 company (market cap ~A$640M) with a proven record of development & commercialisation including successful pa
Slide 6: Deep portfolio of high-value assets including products on market
Deep portfolio of high-value assets including products on market PRODUCTS ON MARKET LATE STAGE DEV’T VivaGel® BV is licensed in The VivaGel® SPL7013 COVID-19 more than 160 countries condom has been nasal spray to & currently for sale in the launched in prevent acquisition & UK, Europe, Asia, and Jap
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) SPL7013 has antiviral activity when applied before, or after, exposure of cells to virus BROAD SPECTRUM ANTIVIRAL MECHANISM SPL7013 POSITIVE FEATURES ANTIVIRAL SPRAY • SPL7013 has potent antiviral activity aga
Slide 8: Expediting development of the SPL7013 COVID-19 nasal spray
Starpharma is expediting the development of the SPL7013 COVID-19 nasal spray & the product is expected to be ready for market 1H CY2021 In addition to coronavirus (SARS-CoV-2), SPL7013 has also demonstrated activity in HIV, HSV, HPV, Adenovirus, HBV, Zika and H1N1 (influenza); SPL7013 is the active
Slide 9: DEP remdesivir: slow release & soluble version of Gilead's 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 authorisation from the US Food and Drug Administration for patients with severe disease DEP® REMDESIVIR REMDES
Slide 10: DEP Internal: Multiple clinical-stage assets with high commercial value potential
DEP® Internal: Multiple clinical-stage assets with high commercial value potential COMMERCIAL OBJECTIVE Create value through clinical proof- Utilise accelerated development / License following proof-of-concept clinical of-concept in one or more cancer regulatory pathways (i.e. 505b2) for data; platf
Slide 11: Financial summary
Financial summary FY20 FY19 Key Financial Data 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 of $7.1M (pcp: $2.7M),
Slide 12: Key highlights
Key highlights ►► AstraZeneca’s first ►► DEP® irinotecan ►► DEP® ►► DEP® docetaxel 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 milestone phase 2 ahead of po
Slide 13: DEP Overview
1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 12
Slide 14: DEP platform strategy creates significant optionality and upside
Starpharma’s DEP® platform strategy creates significant optionality and upside 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® • Application to • Application to
Slide 15: DEP platform conveys product benefits across many drugs
Starpharma’s DEP® platform conveys product benefits and enhances the commercial value of a wide range of drugs and therapeutic areas DEP® BENEFITS 3 x w e e k ly in je c t io n s Improved Efficacy Reproducible results with many candidates ) 3 1400 M e a n T u m o u r V o lu m e (m m 1200 & tumour ty
Slide 16: DEP platform for partnering
DEP® platform for partnering DEP® can be used by commercial partners to improve novel drugs or life-cycle management DEP® nanoparticles Starpharma can be used to attaches the Licences are structured to enhance the features partner’s drug allow for multiple DEP® to the programs to run in parallel of
Slide 17: AstraZeneca's DEP programs: AZD0466 phase 1 underway
AstraZeneca’s DEP® programs: novel oncology agent AZD0466 phase 1 underway Multiple commercial DEP® programs 1st AZ DEP® candidate (AZD0466) AZD0466 multi-centre phase 1 trial recruiting • Up to US$124M milestones + patients in the US with solid & haematological •US$7M in milestones escalating royal
Slide 18: DEP docetaxel phase 2 program – positive interim results
DEP® docetaxel phase 2 program – ongoing recruitment and positive interim results MONOTHERAPY ARM COMBINATION ARM (+ VARGATEF) 35 patients treated DEP® DOCETAXEL 13 patients treated Open-label, two-stage design to allow for exploration of efficacy Encouraging efficacy signals observed - Encouraging
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 Stage IV metastatic • Non-Small Cell Lung Cancer (NSCLC) accounting for lung cancer 84% of all lung cancers (NSCLC) patient: • Stage IV lung cancer patients have a 5 year survival rate of 4.7%1 46 yea
Slide 20: DEP cabazitaxel – positive phase 1 results & phase 2 underway
DEP® cabazitaxel – positive phase 1 results & phase 2 underway PHASE 1 RESULTS PHASE 2 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 between 2 mg/m2 to 25 mg/
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: ~1 in 7 men will be diagnosed with prostate cancer in their lifetime. Stage III Prostate PSA level following DEP® cabazitaxel Cancer Patient: • Stable Disease >47 12
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 of women’s cancer* and is the eighth most commonly occurring cancer in women Stage IV (metastatic) Ovarian Cancer Patient: • 7 cycles DEP® cabazitaxel • 56% decrease in CA-125 levels 73-year old woman
Slide 23: DEP irinotecan - positive phase 1 results & 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 the irinotecan active moiety • 7 patients were enrolled and received DEP® irinotecan at a range of (SN38) and is an improved doses up to 12.5 mg/
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 affecting women and is the second leading cause of cancer-related death in Australian women, accounting for 14.9% of all female cancer deaths Stage IV breast cancer patient with extensive liver met
Slide 25: DEP irinotecan in combination with anti PD-1 antibody
DEP® irinotecan in combination with immuno-oncology agent (anti PD-1 antibody) boosts efficacy and survival in multiple colon cancer models Figure 1: Mean Tumour Volume Over Time MC-38 These results indicate that DEP® irinotecan in combination with an anti PD-1 antibody could boost the efficacy over
Slide 26: First DEP radiotherapeutics candidate, DEP lutetium, shows efficacy in prostate cancer model
First DEP® radiotherapeutics candidate, DEP® lutetium, shows impressive efficacy in human prostate cancer model • Starpharma has developed multiple novel radiotherapeutic DEP® lutetium and radiodiagnostic candidates Starpharma’s first DEP® radiotherapy • DEP® radiopharmaceutical conjugates have the
Slide 27: SPL7013 & VivaGel Portfolio
1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 26
Slide 28: 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 Management of BV is an area of significant unmet need: • Untreated, BV is associated with miscarriage, infertility & PID as 1 in 3 well as having a significant impact on quality of life women
Slide 29: VivaGel BV licensed in >160 countries
VivaGel® BV licensed in >160 countries Asia – 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 - launched AUSTRALIA F
Slide 30: 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- Fleurstat BVgel 3 months now and totally BV free.” BV Patient (unsolicited c
Slide 31: Marketing campaigns for VivaGel BV in multiple regions
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 for more than 7 days u
Slide 32: VivaGel BV in the US
VivaGel® BV in the US Progress with regulatory strategy FAST TRACK STATUS • Regulatory options thoroughly explored; ongoing input QIDP +5 YEARS EXCLUSIVITY from a team of expert FDA consultants (regulatory, statistical, clinical, legal - including senior ex-FDA staffers) FDA Administrative review pr
Slide 33: VivaGel antiviral condom launched in Japan and approved in Europe
VivaGel® antiviral condom launched in Japan and recently approved in Europe • 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 STI prevention Three (00
Slide 34: Outlook
1 Overview 2 DEP® 3 SPL7013 & VivaGel® Portfolio 4 Outlook 33
Slide 35: Outlook
Outlook SPL7013 for Coronavirus • Expedite development and launch of SPL7013 nasal spray LEVERAGE EXISTING APPROVALS VIVAGEL® COMMERCIAL OUTCOMES • Commercial roll-out of VivaGel® BV in Europe, Asia & other markets • Further regulatory approvals and launches for VivaGel® BV; building revenues - mile
Slide 36: For investor relations enquiries contact
FOR INVESTOR RELATIONS ENQUIRIES CONTACT: Dr Jackie Fairley, CEO Nigel Baade, CFO & Company Secretary +61 3 8532 2704 investor.relations@starpharma.com WWW.STARPHARMA.COM ASX:SPL OTC:SPHRY 35
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