Starpharma Holdings Limited · ASX:SPL
Starpharma — OTCQX Virtual Life Sciences Investor Forum 2023
42 slides from Starpharma's conference presentation, Jun 23, 2023
Slide 1: Life Sciences Investor Forum Presentation
Life Sciences Investor Forum Presentation Melbourne, Australia; 23 June 2023: Further to yesterday’s announcement, Starpharma (ASX: SPL, OTCQX: SPHRY) provides a copy of the investor presentation that was aired during the OTCQX’s Virtual Life Sciences Investor Forum on Thursday, 22 June 2023 at 10:0
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: Life Sciences Investor Forum
For personal use only Life Sciences Investor Forum ASX:SPL | OTC:SPHRY Dr Jackie Fairley, CEO 22 June 2023 ASX:SPL OTC:SPHRY 1
Slide 4: Important notice and disclaimer
Important notice and disclaimer For personal use only This document is intended for investors and market participants 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 “promisi
Slide 5: Starpharma snapshot
Starpharma snapshot Innovative drug delivery platform, DEP® For personal use only Proprietary nanoparticle platform; ability to create innovative therapies and enhance existing drugs; DEP® significant optionality; accelerates path to market; and manages investment risk. Deep portfolio of high-value
Slide 6: Starpharma's portfolio of high-value assets
Starpharma’s portfolio of high-value assets Multiple clinical-stage DEP® assets, multiple corporate partnerships and products on market DEP® Products Marketed Products For personal use only Active / Target Product Preclinical Phase 1 Phase 2 Payload indication DEP® Prostate and cabazitaxel Cabazitax
Slide 7: Key value drivers and outlook
Key value drivers and outlook For personal use only DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets VIRALEZE™ Nasal Spray • Complete and report results Phase 2 • Further commercial roll-out, registrations and product launches DEP® trials • Complete recruitment and report UK c
Slide 8: DEP Platform
DEP® Platform Starpharma’s proprietary DEP® platform is highly versatile, conveys multiple benefits, and enhances the commercial value of a wide range of drugs Improved Safety / Reduced side effects DEP® technology: For personal use only Control release kinetics of drug to reduce Cmax related toxici
Slide 9: Starpharma's DEP platform
Starpharma’s DEP® platform Broad applicability and exceptional optionality Multiple DEP® therapeutic areas across partnered and internal programs For personal use only DEP® platform • Flexible technology • Radiotheranostic • Franchise extension • Increased drug antibody applications • Generic differ
Slide 10: DEP partnering creates significant value and optionality
DEP® partnering creates significant value and optionality Starpharma’s DEP® platform enhances the commercial and therapeutic value of a wide range of drugs, creating multiple potential revenue streams and significant IP leverage DEP® platform offers For personal use only significant optionality, Mul
Slide 11: AstraZeneca's DEP nanoparticle AZD0466
AstraZeneca’s DEP® nanoparticle AZD0466 Global clinical development program in multiple indications • AZD0466 is a highly optimised DEP® nanoparticle formulation of AstraZeneca’s dual Bcl2/xL inhibitor (AZD4320) For personal use only • Dual Bcl2/xL inhibition with AZD0466 has potential for broader a
Slide 12: AZD0466 active in small cell lung cancer models
AZD0466 active in small cell lung cancer models New data presented at AACR Meeting in April 2023 Clinical development status of AZD0466 For personal use only Small cell lung cancer (SCLC) is an aggressive malignancy with a 5-year • First-in-human trial treated 9 patients survival rate of ~7%^ and a
Slide 13: Starpharma's internal DEP oncology portfolio
Starpharma’s internal DEP® oncology portfolio Multiple clinical-stage assets with high commercial value potential DEP® Program Original Drug Formulation Advantages of DEP® Product#* For personal use only DEP® cabazitaxel Dendrimer version of Cabazitaxel (Jevtana®) – global sales of Improved toxicity
Slide 14: DEP cabazitaxel: Phase 2 trial
DEP® cabazitaxel: Phase 2 trial Encouraging efficacy signals across multiple tumour types enhancing market potential DEP® cabazitaxel Jevtana® DEP® cabazitaxel For personal use only • Phase 2 trial 2021 sales Starpharma’s patented, • 76 patients; enrolment and treatment of patients now complete ~US$
Slide 15: DEP cabazitaxel Phase 2 trial: prostate cancer cohort
DEP® cabazitaxel Phase 2 trial Positive Interim Results in Prostate Cancer Cohort Presented at ESMO 2022 DEP® cabazitaxel Phase 2 Trial Prior Chemotherapy Regimens in Trial Patients* For personal use only Prostate Cancer Cohort • 25 heavily pre-treated patients with Stage IV DEP® Cabazitaxel hormone
Slide 16: Key interim efficacy and safety findings in prostate cohort
DEP® cabazitaxel Phase 2 trial Key interim efficacy and safety findings in prostate cohort vs. Jevtana®1,2 Key Efficacy Measures Key Safety Measures For personal use only DEP® cabazitaxel Jevtana®1 DEP® cabazitaxel had significantly fewer Grade 3/4 Efficacy Measure (20 mg/m2) (20 mg/m2) Treatment Re
Slide 17: DEP cabazitaxel: clinical case study
DEP® cabazitaxel: clinical case study 69-year-old woman with stage IV platinum resistant ovarian cancer For personal use only CT scans of lung metastases BASELINE Patient’s cancer had progressed prior to entering the Reduction in Tumour Marker on DEP® cabazitaxel treatment DEP® cabazitaxel study, fo
Slide 18: DEP irinotecan (SN38) Phase 2 trial
DEP: Advantages DEP® irinotecan (SN38) irinotecan:over Phase 2 trial ®ongoing Camptosar ® Encouraging efficacy signals across multiple tumour types enhancing market potential DEP® irinotecan DEP® irinotecan Camptosar® For personal use only • Phase 2 trial underway; encouraging efficacy signals obser
Slide 19: DEP irinotecan: improved safety profile
DEP® irinotecan: improved safety profile DEP® irinotecan - improved tolerability profile c.f. For personal use only published data on Camptosar®† DEP® Safety Outcome Camptosar®†^ irinotecan* Gastro-intestinal toxicity much improved with DEP® irinotecan treatment: • ~20-40% of Camptosar® treated pat
Slide 20: DEP irinotecan: clinical case study
DEP® irinotecan: clinical case study 56-year-old woman with heavily pre-treated stage IV platinum resistant ovarian cancer For personal use only Stage IV ovarian cancer has a 5-year survival rate of approximately 17%* Patient was heavily pre-treated prior to 16000 entering the DEP® irinotecan study,
Slide 21: DEP docetaxel
DEP® docetaxel Encouraging efficacy signals across multiple tumour types DEP® docetaxel DEP® For personal use only • Phase 2 trial; monotherapy recruitment and treatment complete; Taxotere® docetaxel nintedanib combo complete; gemcitabine combo ongoing Peak sales Starpharma’s • 80 patients recruited
Slide 22: DEP docetaxel: clinical case study
DEP® docetaxel: clinical case study DEP® docetaxel in combination with gemcitabine 60-year-old woman with stage IV uterine cancer For personal use only 32% reduction in tumour lesion Patient heavily pre-treated prior BASELINE AFTER 3 CYCLES to entering the study: • >11 treatment cycles of 3 differen
Slide 23: DEP antibody drug conjugate (ADC) partnerships with leading companies
DEP® antibody drug conjugate (ADC) partnerships with leading companies • The innovative therapeutic area of ADCs continues to DEP® ADC benefits include: grow, with many high value deals signed in recent For personal use only years • Can be tuned to provide optimal characteristics • The ADC market is
Slide 24: HER2-targeted DEP SN-38 ADC outperforms in HER2+ human cancer model
HER2-targeted DEP® SN-38 ADC outperforms in HER2+ human cancer model Starpharma has developed a HER2-targeted DEP® ADC, utilising the active metabolite of irinotecan, SN-38, which outperformed Enhertu®, showing significantly greater anti-tumour activity and improved survival in a HER2+ human cancer
Slide 25: DEP ADCs offer multiple benefits
DEP® ADCs offer multiple benefits Can be tuned to provide optimal Penetrate deeply into tumours, characteristics For personal use only bind strongly to target cells and are internalised for enhanced 400 Tumour:Blood ratio over time Benefits of performance DEP® ADCS Tumour:Blood ratio 300 G2 G3 200 G
Slide 26: DEP - a versatile platform for radiopharmaceuticals
DEP® - a versatile platform with flexible applicability to a range of radiopharmaceuticals • Radiotheranostics is a rapidly developing area of cancer DEP® radiopharmaceutical benefits include: For personal use only treatment and diagnosis - the global radiopharmaceutical • Flexibility in size and st
Slide 27: Novel DEP radiotheranostics
Novel DEP® radiotheranostics (radiodiagnostic and radiotherapeutic) DEP® radiodiagnostic DEP® radiotherapeutics For personal use only DEP® HER2-zirconium DEP® HER2-lutetium Exposure Dose dependant Tumour Volume Change (% of Initial Volume) • Achieved significant tumour accumulation: • Achieved compl
Slide 28: Targeted DEP radiotheranostics offer multiple benefits
Targeted DEP® radiotheranostics offer multiple benefits Radioisotope For personal use only DEP DEP® benefits include: • Flexibility in size and structure of nanoparticle (allowing different targeting groups and pharmacokinetics) Chelator • Enhanced tumour accumulation due to the enhanced HER-2 targe
Slide 29: DEP irinotecan: clinical case study
DEP® irinotecan: clinical case study 55-year-old woman with stage IV colorectal cancer For personal use only Colorectal cancer is the 3rd most commonly diagnosed cancer and 4th leading cause of cancer death worldwide* Patient was heavily pre-treated prior to entering the Following treatment with DEP
Slide 30: Marketed products
Marketed products Multiple revenue streams with a growing distribution network For personal use only VIRALEZE™ Nasal Spray VivaGel® BV VivaGel® Condom Starpharma Holdings Limited: Investor Presentation 28
Slide 31: VIRALEZE antiviral nasal spray
VIRALEZE™ antiviral nasal spray VIRALEZE™ features How VIRALEZE™ works For personal use only • Broad-spectrum antiviral nasal spray • Viruses infect human cells by using viral surface proteins, or • Contains a novel dendrimer molecule, “spikes”, to attach to receptor proteins on the surface of human
Slide 32: VIRALEZE protects against SARS-CoV-2 Omicron
VIRALEZE™ protects against SARS-CoV-2 Omicron and reduces infectivity in challenge model New data presented at International Virology Conference – Dec ‘22 VIRALEZE™ treated animals showed markedly reduced VIRALEZE™ treated animals showed markedly For personal use only viral load after challenge with
Slide 33: VIRALEZE outperforms comparators in Omicron challenge model
VIRALEZE™ antiviral nasal spray outperforms comparators in SARS-CoV-2 Omicron challenge model New data presented at International Virology Conference – Dec ‘22 VIRALEZE™ significantly outperformed Reduction in Infectious SARS- For personal use only Nasal Spray comparator nasal sprays in: CoV-2 Omicr
Slide 34: VIRALEZE market and regulatory activity
VIRALEZE™ market and regulatory activity • VIRALEZE™ antiviral nasal spray is registered VIRALEZE™ Webstore in more than 35 countries around the world* www.Viraleze.co For personal use only (outside Australia) • Available in pharmacies, retail outlets and online in a number of markets EUROPE • Partn
Slide 35: VIRALEZE clinical trial in patients with COVID-19 underway
VIRALEZE™ clinical trial in patients with COVID-19 underway For personal use only • Small, post-market randomised clinical study of VIRALEZE™ vs. placebo nasal spray in patients with COVID-19 Will generate valuable clinical data to support ongoing marketing, commercialisation and regulatory activiti
Slide 36: VivaGel BV
VivaGel® BV A breakthrough product for the treatment of BV and prevention of recurrent BV* About Bacterial Vaginosis (‘BV’) For personal use only • Bacterial vaginosis or BV is the most common vaginal infection worldwide, affecting 1 in 3 women globally1. BV is associated with causing complications
Slide 37: VivaGel BV distribution network and regulatory activity
VivaGel® BV distribution network and regulatory activity • Registered in >45 countries For personal use only • Launched in Europe, the UK, Asia, South Africa, Australia & New Zealand • Further launches and regulatory submissions progressing in multiple regions *In the US, a formal dispute resolution
Slide 38: VivaGel Condom
For personal use only VivaGel® Condom • The VivaGel® condom incorporates SPL7013 antiviral, which has demonstrated activity in HIV, HSV-2, HPV SPL7013 • Okamoto launched an additional VivaGel® condom range in Japan, under the brand name Pure Marguerite, targeting youth and female segments of the mar
Slide 39: Financial Summary
Financial Summary Strong balance sheet with revenues from product sales and partnerships For personal use only H1 H1 FY22 FY21 Q3 FY23 FY22Highlights Result Key Financials FY23 FY22 • Strong cash position with $38.9M as at 31 March 2023 A$M A$M A$M A$M • Completed enrolment and treatment of patients
Slide 40: Key value drivers and outlook
Key value drivers and outlook For personal use only DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets VIRALEZE™ Nasal Spray • Complete and report results Phase 2 • Further commercial roll-out, registrations and product launches DEP® trials • Complete recruitment and report UK c
Slide 41: Starpharma's continued commitment to ESG
Starpharma’s continued commitment to Environment, Social and Governance (ESG) ENVIRONMENT SOCIAL GOVERNANCE For personal use only Appropriate systems in place to 43% of roles, including Compliance with ASX Corporate Governance comply with relevant federal, state, leadership roles Principles and Reco
Slide 42: Investor Relations Queries
For personal use only Investor Relations Queries: investor.relations@starpharma.com 4-6 Southampton Crescent Abbotsford VIC 3067 www.starpharma.com ASX:SPL | OTC:SPHRY 40
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