Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2022)
46 slides from Starpharma's shareholder meeting presentation, Nov 29, 2022
Slide 1: AGM Chairman's address and CEO's presentation
AGM Chairman’s address and CEO’s presentation Melbourne, Australia; 29 November 2022: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting (AGM) of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 2:00pm (Melbourne time) today. Abou
Slide 2: Chairman's Address
Chairman’s Address Starpharma Holdings Limited Annual General Meeting 29 November 2022 Good afternoon fellow shareholders, On Behalf of the Board of Directors, it is my pleasure to welcome you to Starpharma’s Annual General Meeting. Since our last AGM, Starpharma has made significant progress across
Slide 3: Chairman's Address (continued): DEP cabazitaxel trial
Phase 2 DEP® cabazitaxel trial. In this trial cohort, DEP® cabazitaxel demonstrated longer progression-free survival and a lower incidence of key side effects, as well as a number of other advantages, compared to published data on conventional cabazitaxelii. These efficacy results are extremely enco
Slide 4: Chairman's Address (continued)
which highlights our commitments to good governance, our people, responsible supply chains, and mitigating our impact on the environment. I would like to acknowledge the Starpharma team, who have continued to demonstrate dedication to the Company, and resilience throughout the pandemic and within th
Slide 5: Annual General Meeting
Annual General Meeting 29 November 2022 Dr Jackie Fairley, CEO ASX:SPL OTC:SPHRY 1
Slide 6: Important notice and disclaimer
Important notice and disclaimer 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 “promising”, “plans”, “anticip
Slide 7: Starpharma snapshot
Starpharma snapshot Innovative drug delivery platform, DEP® 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 assets Three promising
Slide 8: Recent highlights
Recent highlights New and expanded DEP® Additional trial sites open for AstraZeneca’s Positive interim findings from the prostate DEP® Research Agreement with global Phase 1/2 clinical trial of AZD0466 in cancer cohort of the Phase 2 DEP® cabazitaxel patients with advanced haematological trial show
Slide 9: Momentum building for partnered DEP programs
Momentum building for partnered DEP® programs Starpharma has secured partnerships with several of the world’s largest biotechnology and pharmaceutical companies Additional DEP® Research Agreement with MSD AstraZeneca commences clinical program for AZD0466, triggering milestone payment Expanded DEP®
Slide 10: Starpharma's DEP platform
Starpharma’s DEP® platform Broad applicability and exceptional optionality Multiple DEP® therapeutic areas across partnered and internal programs DEP® platform • Flexible technology • Radiotheranostic • Franchise extension • Increased drug antibody applications • Generic differentiation • Applicable
Slide 11: Financial Summary
Financial Summary Strong balance sheet with revenues from product sales and partnerships FY22 Result FY22 Result FY22 FY21 Key Financial Data A$M A$M • Revenue up 128% to $4.9M on the rollout of VIRALEZE™ Revenue 4.9 2.2 • Lower Other Income with the completion of the Other Income 0.3 1.3 MRFF grant
Slide 12: 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 Active / Target Product Preclinical Phase 1 Phase 2 Payload indication DEP® Prostate and Cabazitaxel cabazitaxel other cancers DEP®
Slide 13: 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 significant optionality, Multiproduct license & op
Slide 14: 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) • Dual Bcl2/xL inhibition with AZD0466 has potential for broader activity than the marke
Slide 15: AstraZeneca to present preliminary AZD0466 clinical results
AstraZeneca to present preliminary AZD0466 clinical results at the American Society of Haematology AstraZeneca will present initial clinical results for AZD0466 in advanced haematological malignancies at the American Society of Haematology Meeting, 10 – 13 December 2022 in New Orleans • AZD0466 is a
Slide 16: 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#* DEP® cabazitaxel Dendrimer version of Cabazitaxel (Jevtana®) – global sales of Improved toxicity profile; detergent-fr
Slide 17: DEP cabazitaxel: Phase 2 trial ongoing
DEP® cabazitaxel: Phase 2 trial ongoing Encouraging efficacy signals across multiple tumour types enhancing market potential DEP® cabazitaxel Jevtana® DEP® cabazitaxel • Phase 2 trial, ongoing 2021 sales Starpharma’s patented, • 75 patients recruited to date, with final recruitment focused on ~US$50
Slide 18: DEP cabazitaxel Phase 2 trial
DEP® cabazitaxel Phase 2 trial Positive Interim Results in Prostate Cancer Cohort Presented at ESMO 2022 DEP® cabazitaxel Phase 2 Trial DEP® cabazitaxel Phase 2 Trial Prostate Cancer Cohort Interim Results in Prostate Cancer • 25 heavily pre-treated patients with Stage IV • Highly encouraging anti-t
Slide 19: Key interim efficacy and safety findings
DEP® cabazitaxel Phase 2 trial Key interim efficacy and safety findings in prostate cohort vs. Jevtana®1,2 Key Efficacy Measures Key Safety Measures DEP® cabazitaxel Jevtana®1 DEP® cabazitaxel had significantly fewer Grade 3/4 Efficacy Measure (20 mg/m2) (20 mg/m2) Treatment Related Adverse Events v
Slide 20: DEP cabazitaxel: clinical case study
DEP® cabazitaxel: clinical case study 69-year-old woman with stage IV platinum resistant ovarian cancer 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, following: • 12 cycles o
Slide 21: DEP cabazitaxel: clinical case studies
DEP® cabazitaxel: clinical case studies 55-year-old woman with stage IV refractory 54-year-old woman with stage IV platinum oesophageal adenocarcinoma resistant ovarian cancer Patient had progressed prior to entering the DEP® Patient had progressed prior to entering the DEP® cabazitaxel study, follo
Slide 22: DEP docetaxel
DEP® docetaxel Encouraging efficacy signals across multiple tumour types DEP® docetaxel DEP® • Phase 2 trial, ongoing Taxotere® docetaxel • 75 patients recruited (monotherapy and combination) Peak sales Starpharma’s • Monotherapy recruitment expected to complete within 1-2 months ~US$3.1B patented,
Slide 23: 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 32% reduction in tumour lesion Patient heavily pre-treated prior BASELINE AFTER 3 CYCLES to entering the study: • >11 treatment cycles of 3 different kinds of anti-cancer
Slide 24: DEP irinotecan
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 • Phase 2 trial underway; encouraging efficacy results Camptosar® (SN38 nanoparticle Peak sal
Slide 25: DEP irinotecan: improved safety profile
DEP® irinotecan: improved safety profile DEP® irinotecan - improved tolerability profile c.f. published data on Camptosar®† DEP® Safety Outcome Camptosar®†^ irinotecan* Gastro-intestinal toxicity much improved with DEP® irinotecan treatment: • ~20-40% of Camptosar® treated patients suffer from seve
Slide 26: DEP irinotecan: clinical case study
DEP® irinotecan: clinical case study 55-year-old woman with stage IV colorectal cancer 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® irinotecan, the pati
Slide 27: DEP irinotecan: clinical case study
DEP® irinotecan: clinical case study 56-year-old woman with heavily pre-treated stage IV platinum resistant ovarian cancer 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, following Tumour Mark
Slide 28: DEP antibody drug conjugate partnerships
DEP® antibody drug conjugate (ADC) partnerships with leading companies • The innovative therapeutic area of ADCs continues to grow, with many Starpharma has two DEP® high value deals signed in recent years research agreements with • The ADC market is expected to reach to more than US$15 billion by 2
Slide 29: DEP ADCs offer multiple benefits
DEP® ADCs offer multiple benefits Can be tuned to provide optimal Penetrate deeply into tumours, characteristics 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 G4 100 G5 Target Cell 3
Slide 30: DEP radiotheranostics platform
DEP® - a versatile platform with flexible applicability to a range of radiopharmaceuticals • Radiotheranostics is a rapidly developing area of cancer treatment and diagnosis - the global radiopharmaceutical market is projected to reach US$35 billion by 2031^ • Significant corporate activity in recen
Slide 31: Targeted DEP radiotheranostics offer multiple benefits
Targeted DEP® radiotheranostics offer multiple benefits Radioisotope 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 targeting moiety DEP® conju
Slide 32: Novel DEP radiotheranostics
Novel DEP® radiotheranostics (radiodiagnostic and radiotherapeutic) DEP® radiodiagnostic DEP® radiotherapeutics DEP® HER2-zirconium DEP® HER2-lutetium Exposure Dose dependant Tumour Volume Change (% of Initial Volume) • Achieved significant tumour accumulation: • Achieved complete tumour regression
Slide 33: Marketed products
Marketed products Multiple revenue streams with a growing distribution network VIRALEZE™ Nasal Spray VivaGel® BV VivaGel® Condom Starpharma Holdings Limited: AGM Presentation to Shareholders 29
Slide 34: VIRALEZE antiviral nasal spray
VIRALEZE™ antiviral nasal spray VIRALEZE™ features How VIRALEZE™ works • 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 SPL7013, which traps
Slide 35: VIRALEZE protects against SARS-CoV-2 Omicron
VIRALEZE™ protects against SARS-CoV-2 Omicron and reduces infectivity in challenge model New data to be presented at International Virology Conference – Dec ‘22 VIRALEZE™ treated animals showed markedly reduced VIRALEZE™ treated animals showed markedly viral load after challenge with SARS-CoV-2 viru
Slide 36: VIRALEZE outperforms comparators
VIRALEZE™ antiviral nasal spray outperforms comparators in SARS-CoV-2 Omicron challenge model New data to be presented at International Virology Conference – Dec ‘22 VIRALEZE™ significantly outperformed Nasal Spray Reduction in Infectious SARS- comparator nasal sprays in: CoV-2 Omicron in Lung vs Sa
Slide 37: VIRALEZE clinical trial in patients with COVID-19
VIRALEZE™ clinical trial in patients with COVID-19 UK Post-market Clinical Study of VIRALEZE™ Planned • Small, post-market randomised clinical study of VIRALEZE™ vs. placebo nasal spray in patients with COVID-19 (80 patients per group) • Will generate valuable clinical data to support ongoing market
Slide 38: VIRALEZE market and regulatory activity
VIRALEZE™ market and regulatory activity • VIRALEZE™ antiviral nasal spray is registered in more than 30 countries around the world* • Available in pharmacies, retail outlets and online in a number of markets EUROPE • Partnered with: UK • LloydsPharmacy in the UK; • ADMENTA Italia Group in Italy; AS
Slide 39: VIRALEZE product launches and partners' promotional activities
VIRALEZE™ product launches and partners’ promotional activities VIRALEZE™ recently launched in Hong Kong and Macau VIRALEZE™ promotional activity by Partners • Starpharma recently signed a supply and distribution agreement for VIRALEZE™ with Hengan in Hong Kong and Macau • Hengan is listed on the Ho
Slide 40: VivaGel BV
VivaGel® BV A breakthrough product for the treatment of BV and prevention of recurrent BV* About Bacterial Vaginosis (‘BV’) • Bacterial vaginosis or BV is the most common vaginal infection worldwide, affecting 1 in 3 women globally1. BV is associated with causing complications related to the reprodu
Slide 41: VivaGel BV distribution network and regulatory activity
VivaGel® BV distribution network and regulatory activity • Registered in >45 countries • 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 process is ongoing wit
Slide 42: VivaGel BV marketing activities
VivaGel® BV marketing activities Include multichannel promotions and publications to support clinical guidelines Marketing Campaigns by Partners to build Brand Awareness and Sales Consumer marketing, Healthcare professional Peer-reviewed journal including digital marketing marketing articles to supp
Slide 43: VivaGel Condom
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 market • Starpharma conti
Slide 44: Key value drivers and outlook
Key value drivers and outlook DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets VIRALEZE™ Nasal Spray • Complete Phase 2 trials • Further commercial roll-out and product launches • Progress value-adding combination studies • Further registrations in other regions • Further dist
Slide 45: Starpharma's continued commitment to Environment, Social and Governance
Starpharma’s continued commitment to Environment, Social and Governance (ESG) ENVIRONMENT SOCIAL GOVERNANCE Appropriate systems in place to >40% of roles, including Compliance with ASX Corporate Governance comply with relevant federal, state, leadership roles Principles and Recommendations. and loca
Slide 46: Investor Relations Queries
Investor Relations Queries: Dr Jackie Fairley, CEO +61 3 8532 2704 investor.relations@starpharma.com 4-6 Southampton Crescent Abbotsford VIC 3067 www.starpharma.com ASX:SPL | OTC:SPHRY 42
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