Starpharma Holdings Limited · ASX:SPL
Starpharma — Shareholder Meeting (November 2023)
48 slides from Starpharma's shareholder meeting presentation, Nov 29, 2023
Slide 1: AGM Chairman's address and CEO's presentation
AGM Chairman’s address and CEO’s presentation Melbourne, Australia; 29 November 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) releases the attached Chairman’s address and the CEO’s presentation to the Annual General Meeting (AGM) of Starpharma Holdings Limited, to be held today at 2:00 pm (Melbourne tim
Slide 2: Chairman's Address to Shareholders
Starpharma Holdings Limited Annual General Meeting 29 November 2023 Chairman’s Address to Shareholders Good afternoon, fellow shareholders. On Behalf of the Board of Directors, I am pleased to welcome you to Starpharma’s Annual General Meeting. First, I want to acknowledge the disappointing performa
Slide 3: Chairman's Address (continued)
effects. The results have also compared favourably on several levels to the conventional formulation of these drugs. Pleasingly, we have also received very encouraging feedback from medical oncologists and clinical investigators involved in the DEP® trials, who have been impressed by the data. Of pa
Slide 4: Chairman's Address (continued)
agreement with Mundipharma in August 2023. Under this agreement, Starpharma received a $6.6 million cash payment and regained all rights to the product, allowing Starpharma to seek new commercial partners. We are progressing several discussions with a number of potential partners for either local, r
Slide 5: Starpharma Annual General Meeting 2023
ASX: SPL OTC: SPHRY Starpharma Annual General Meeting 2023 Dr Jackie Fairley, Chief Executive Officer 29 November 2023 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”, “antici
Slide 7: Starpharma is an innovative biopharmaceutical company and leader in dendrimer technology
Starpharma is an innovative biopharmaceutical company and leader in dendrimer technology Innovative drug delivery platform, DEP® Proprietary nanoparticle platform; ability to create innovative therapies and enhance existing drugs; significant optionality; accelerates path to market; and manages inve
Slide 8: 2022-23 Operational highlights
2022-23 Operational highlights Expanded partnership with Expanded partnership with leading Reported positive Phase 2 Completed recruitment for the multinational pharmaceutical biotech, Genentech, applying results on DEP® cabazitaxel in post-market clinical study of company, MSD, to explore the anti-
Slide 9: Financial summary
Financial summary Strong balance sheet with revenues from product sales and partnerships • Strong cash position with $35.6M (30 September 2023). Cash at 30 September 2023 o Excludes the $7.2M Research and Development Tax Incentive refund received in October 2023 and $35.6M repayment of $4M low-inter
Slide 10: Starpharma's portfolio: multiple clinical-stage assets, partnerships and products in market
Starpharma’s portfolio: multiple clinical-stage assets, partnerships and products in market DEP® pipeline Partnered DEP® programs Target Two DEP® ADC Research Two DEP® Research Agreements Product Preclinical Phase 1 Phase 2 Agreements with MSD (Merck & with Genentech indication Co., Inc.) DEP® Prost
Slide 11: DEP platform has broad applicability, creating multiple high-value commercial applications
Starpharma’s DEP® platform has broad applicability, creating multiple high-value commercial applications Chemotherapeutics Antibody-Drug Conjugates • Franchise extension • Flexible technology • Generic differentiation • Increased drug antibody • New chemical entities The DEP® platform can provide ra
Slide 12: DEP platform benefits
Starpharma's DEP® platform: highly versatile, enhancing the commercial and therapeutic value of a wide range of drugs Multiple DEP® therapeutic areas across DEP® technology: partnered Improved and internal Safety/Reduced programs side effects • Based on proprietary, branched polymers Control release
Slide 13: DEP partnering creates significant commercial value and optionality
DEP® partnering creates significant commercial value and optionality Multiple DEP® therapeutic areas across partnered and internal programs Benefits of DEP partnerships ® Two DEP® ADC Research • Funded by partners. Agreements with MSD • Leverage existing and create new intellectual property. Two DEP
Slide 14: AstraZeneca's DEP nanoparticle AZD0466, a dual Bcl2/xL inhibitor
AstraZeneca’s DEP® nanoparticle AZD0466, a dual Bcl2/xL inhibitor AZD0466: a highly optimised DEP® nanoparticle formulation Clinical development of AZD0466 was discontinued by AstraZeneca in July following a of AstraZeneca’s dual Bcl2/xL inhibitor (AZD4320) handful of asymptomatic AEs in 5 leukemia
Slide 15: Overview of Starpharma's internal DEP oncology portfolio
Overview of Starpharma’s internal DEP® oncology portfolio Multiple clinical-stage assets with high commercial value potential DEP® cabazitaxel DEP® irinotecan DEP® docetaxel Phase 2 Phase 2 Phase 2 DEP® docetaxel is a dendrimer DEP® irinotecan is a dendrimer version version of docetaxel (Taxotere®),
Slide 16: Potential indications & market opportunity for DEP cabazitaxel, irinotecan and docetaxel
Potential indications & market opportunity for DEP® cabazitaxel, DEP® irinotecan, and DEP® docetaxel Starpharma’s clinical Annual Cases products have Cancer Type Market Sales (US$) 2020 demonstrated impressive benefits in a range of Prostate 1.4 million1 11.0 billion6 cancers where significant Ovari
Slide 17: DEP cabazitaxel: Positive Phase 2 results across multiple tumour types
DEP® cabazitaxel: Positive Phase 2 results across multiple tumour types, enhancing market potential Jevtana® DEP® cabazitaxel: Phase 2 trial status (conventional cabazitaxel) Starpharma’s patented, • Trial complete (N=75) and positive final results reported. 2021 sales: ~US $500M nanoparticle formul
Slide 18: Key results for DEP cabazitaxel in prostate cancer
Key results for DEP® cabazitaxel in prostate cancer Highly encouraging efficacy outcomes were achieved with DEP® cabazitaxel despite these advanced mCRPC patients being significantly more heavily pre-treated prior to trial entry vs. patients in published trials of Jevtana®. Heavily pre-treated patie
Slide 19: Key results for DEP cabazitaxel in ovarian cancer
Key results for DEP® cabazitaxel in ovarian cancer Highly encouraging durable efficacy responses in heavily pre-treated advanced, platinum-resistant ovarian cancer patients. Heavily pre-treated patient cohort Platinum-resistant Cancer Type Ovarian • 100% of patients had received at least one prior t
Slide 20: DEP cabazitaxel: patient case study
DEP® cabazitaxel: patient case study 69-year-old woman with stage IV platinum-resistant ovarian cancer Patient’s cancer had progressed prior to CT scans of lung metastases Reduction in tumour marker on entering the DEP® cabazitaxel study, DEP® cabazitaxel treatment following: BASELINE SCAN • 12 cycl
Slide 21: Key results for DEP cabazitaxel in gastro-oesophageal cancers
Key results for DEP® cabazitaxel in gastro-oesophageal cancers DEP® cabazitaxel achieved excellent efficacy responses in advanced gastro-oesophageal cancers, which represent a significant unmet medical need. Gastro- Highly encouraging efficacy results Cancer Type oesophageal • DEP® cabazitaxel resul
Slide 22: DEP cabazitaxel results – clinical and market feedback
DEP® cabazitaxel results – clinical and market feedback “In our cancer early phase trials unit at Guy’s Hospital, we conduct many studies of novel oncology therapeutics. The results with DEP® cabazitaxel clearly demonstrate promising and durable anti-cancer activity in very hard-to-treat cancer pati
Slide 23: DEP irinotecan Phase 2 trial
DEP® irinotecan Phase 2 trial Encouraging efficacy signals across multiple tumour types enhancing market potential Camptosar® DEP® irinotecan: Phase 2 trial status (conventional Starpharma’s irinotecan) patented, • Positive interim results reported. Peak sales: nanoparticle • Recruitment now complet
Slide 24: DEP irinotecan Phase 2 trial: advanced colorectal cancer
DEP® irinotecan Phase 2 trial Positive interim results in advanced colorectal cancer Monotherapy arm Combination arm “The results of the DEP® irinotecan trial to date have been very promising for patients with DEP® irinotecan monotherapy in DEP® irinotecan in advanced colorectal cancer who have exha
Slide 25: DEP irinotecan: patient case study
DEP® irinotecan: patient case study DEP® irinotecan in combination with 5-FU/leucovorin (FOLFIRI regimen) 61-year-old man with heavily pre-treated, advanced, bone metastatic colorectal cancer The patient’s cancer had progressed prior to entering the DEP® irinotecan BASELINE SCAN plus 5-FU/LV study.
Slide 26: DEP irinotecan Phase 2 trial: ovarian cancer
DEP® irinotecan Phase 2 trial Positive interim results in platinum-resistant/refractory ovarian cancer DEP® irinotecan monotherapy in advanced metastatic Platinum-resistant/refractory ovarian cancer represents a significant ovarian cancer patients unmet medical need and a potential Heavily pre-treat
Slide 27: DEP irinotecan: ovarian cancer case study
DEP® irinotecan: ovarian cancer case study 61-year-old woman with heavily pre-treated, advanced, platinum-resistant ovarian cancer The patient was heavily pre-treated prior to entering the study, and her cancer had progressed. • DEP® irinotecan was the patient’s 6th line of treatment. CT scans of re
Slide 28: DEP irinotecan: improved tolerability and safety profile
DEP® irinotecan: improved tolerability and safety profile DEP® irinotecan - improved tolerability profile c.f. DEP® published data on Camptosar®† Safety Outcome Camptosar®†^ irinotecan* Gastro-intestinal toxicity much improved with DEP® irinotecan treatment: GASTROINTESTINAL • ~20-40% of Camptosar®
Slide 29: DEP docetaxel Phase 2 trial
DEP® docetaxel Phase 2 trial Encouraging efficacy signals across multiple tumour types Taxotere® DEP® docetaxel: Phase 2 trial status (conventional Starpharma’s • Recruitment now complete (N=80); monotherapy and combinations. docetaxel) patented, Peak sales: nanoparticle • Trial was conducted at mul
Slide 30: DEP docetaxel: patient case study
DEP® docetaxel: patient case study DEP® docetaxel in combination with gemcitabine 74-year-old man heavily pre-treated with stage IV pancreatic cancer The patient was heavily pre-treated prior to entering the study. • DEP® docetaxel combination was the patient’s 4th line of treatment. • The patient’s
Slide 31: Clinical validation of DEP platform benefits
Clinical validation of DEP® platform benefits • 4 DEP® products with >350 patients treated across 4 clinical programs • DEP® clinical-stage products span multiple drug classes • Excellent translation from preclinical findings (pharmacokinetics, efficacy and safety) • Demonstration of DEP® tumour tar
Slide 32: DEP poster presentations at AACR-NCI-EORTC 2023 oncology conference
DEP® poster presentations at AACR-NCI-EORTC 2023 oncology conference Starpharma presented three scientific posters at the International Conference on Molecular Targets and Cancer Therapeutics in Boston, US, co-hosted by the American Association of Cancer Research (AACR), National Cancer Institute (N
Slide 33: Targeted DEP conjugates provide unique flexibility
Targeted DEP® conjugates provide unique flexibility A platform for the development of DEP® ADCs and DEP® radiotheranostics Starpharma’s Dendrimers: • Branched polymers with near-monomodal molecular weight distributions • Produced by controlled and reproducible synthesis: high purity, GMP • Built up
Slide 34: Antibody-drug conjugates (ADCs) and radiotheranostics
Antibody-drug conjugates (ADCs) and radiotheranostics Significant commercial activity continues Radiotheranostics is a rapidly developing area of cancer The innovative therapeutic area of ADCs continues to grow, treatment and diagnosis. with many high-value deals signed in recent years. • The global
Slide 35: HER2-targeted DEP radiodiagnostic and radiotherapeutic pair
HER2-targeted DEP® radiodiagnostic and radiotherapeutic pair • HER2 is overexpressed in ~20%-30% of breast (HER2hi), gastric and gastro-oesophageal cancers (HER2hi); also expressed at a low levels (HER2lo) in other carcinomas including colorectal, endometrial and lung. • HER2+ breast cancer treatmen
Slide 36: DEP HER2-zirconium: favourable imaging characteristics in a HER2+ breast cancer model
DEP® HER2-zirconium (radiodiagnostic): favourable imaging characteristics in a HER2+ breast cancer model DEP® HER2- These characteristics are zirconium Rapid and sustained also desirable for a tumour accumulation radiotherapeutic to maximise efficacy and minimise 4h toxicity % injected dose / gram o
Slide 37: HER2-targeted DEP SN38 ADC outperforms in HER2+ human cancer model
HER2-targeted DEP® SN38 ADC outperforms in HER2+ human cancer model Starpharma’s HER2-targeted DEP® SN38 ADC, which uses the active metabolite of irinotecan, SN38, outperformed Enhertu®, showing significantly greater anti-tumour activity and improved survival in a HER2+ human cancer xenograft model.
Slide 38: Marketed products: multiple revenue streams with a growing distribution network
Marketed products Multiple revenue streams with a growing distribution network VIRALEZE™ Antiviral Nasal Spray VIRALEZE™ is a broad-spectrum antiviral nasal spray intended to provide a moisturising and protective barrier in the nose that traps and blocks cold/respiratory viruses. VIRALEZE™ is regist
Slide 39: VIRALEZE antiviral nasal spray
VIRALEZE™ antiviral nasal spray Broad-spectrum antiviral nasal spray Contains a novel dendrimer, SPL7013, which traps and blocks multiple cold/respiratory viruses, including influenza, RSV, and coronaviruses (including SARS-CoV-2) Blocks virus replication both before and after exposure of cells to v
Slide 40: VIRALEZE antiviral nasal spray
VIRALEZE™ antiviral nasal spray VIRALEZE™ consistently outperforms marketed comparator nasal sprays: • The intact nasal epithelium plays an important role VIRALEZE™ achieved significant in protecting against viral and bacterial respiratory inhibition of SARS-CoV-2 infections. Omicron infection vs. m
Slide 41: VIRALEZE antiviral nasal spray
VIRALEZE™ antiviral nasal spray VIRALEZE™ has demonstrated virucidal activity in lab How VIRALEZE™ works studies against the broad spectrum of SARS-CoV-2 • Viruses infect human cells by using viral surface variants, including recently emerging Omicron proteins, or “spikes”, to attach to receptor pro
Slide 42: VIRALEZE global market and regulatory activity
VIRALEZE™ global market and regulatory activity • Starpharma has registered VIRALEZE™ antiviral nasal spray in more Post-market clinical study in patients with than 35 countries around the world. COVID-19 • VIRALEZE™ is marketed by Starpharma online through dedicated Study design: A small, post-mark
Slide 43: VivaGel BV: A breakthrough product for the treatment of BV
VivaGel® BV: A breakthrough product for the treatment of BV and prevention of recurrent BV* About Bacterial Vaginosis (BV) Therapeutic Benefits of VivaGel® BV • Bacterial vaginosis or BV is the most common vaginal infection worldwide, affecting 1 in 3 women globally1. BV is associated with causing c
Slide 44: VivaGel BV commercial and regulatory activities
VivaGel® BV commercial and regulatory activities Renewed commercial opportunity VivaGel® BV commercialisation and regulatory VivaGel® BV rights to multiple territories reverted to Starpharma • Starpharma has registered VivaGel® BV in more than 50 following negotiation of a favourable commercial sett
Slide 45: VivaGel BV marketing activities
VivaGel® BV marketing activities Multichannel promotions by Aspen to build category awareness and normalise the condition among consumers and healthcare professionals. Consumers Healthcare Professionals Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 41
Slide 46: Outlook
Outlook DEP® SPL7013 Internal DEP® Clinical Programs VIRALEZE™ Antiviral Nasal Spray • Complete and report results from Phase 2 DEP® trials, including value- • Further commercial roll-out, registrations and product launches. adding combination arms. • Further distribution arrangements with commercia
Slide 47: Starpharma's continued commitment to ESG
Starpharma’s continued commitment to Environment, Social and Governance (ESG) ENVIRONMENT SOCIAL GOVERNANCE Appropriate systems in place to comply with 52% of roles, including Compliance with ASX Corporate relevant federal, state, and local government leadership and Governance Principles and environ
Slide 48: Thank you.
Thank you. Investor Relations Queries investor.relations@starpharma.com Head Office 4-6 Southampton Crescent Abbotsford VIC 3067 www.starpharma.com ASX: SPL OTC: SPHRY
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