drugset / Press release

SPL to present DEP radiotheranostics at Wilsons Conference

2023-10-25 · Starpharma Pty Ltd · original starpharma.com ↗

SPL to present DEP radiotheranostics at Wilsons Conference Melbourne, Australia; 26 October 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that it will present at the Wilsons Drug and Device Conference tomorrow, 27 October 2023, at 10:00 AM AEST. The Wilsons Drug and Device Conference provides a forum for institutional investors to engage with ASX -listed healthcare companies through panel discussions , question-and- answer sessions, and 1 on 1 meetings. Starpharma’s CEO, Dr Jackie Fairley , will provide an over view of the Company, including recent clinical results from its Phase 2 trials of DEP® cabazitaxel and DEP® irinotecan, as well as recently released data on its novel DEP® radiotheranostics (radiodiagnostics and radiotherapeutics) programs. At the conference, Dr Jackie Fairley will also participate in a panel discussion, ‘Expanding the scope for theranostics and radioligand therapies’, alongside Clarity Pharmaceuticals (ASX: CU6) and Telix Pharmaceuticals (ASX: TLX). Dr Jackie Fairley, CEO, Starpharma, commented: “Starpharma is delighted to p resent at the Wilsons Drug and Device Conference this week, highlighting our DEP® platform, including our DEP® radiotheranostics pipeline. “Radiotheranostics is an innovative and rapidly growing area of cancer diagnosis and treatment, and Starpharma is pleased to participate in this panel , sharing recently reported data on Starpharma’s targeted DEP® radiodiagnostic, DEP® HER2-zirconium.” Starpharma’s conference presentation is appended. About Starpharma Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications. As an innovative Australian biopharmaceutical company, Starpharma is focused on developing and commercialising novel therapeutic produc ts that address significant global healthcare needs. Starpharma boasts a strong portfolio of products, partnerships, and intellectual property. Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications. Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing pharmaceuticals. Starpharma’s portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced Product (‘DEP ®’) drug delivery technology, and marketed products, including VIRALEZE ™ and VivaGel ® BV, which utilise SPL7013, a proprietary dendrimer with antimicrobial properties. Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related toxicities through controlled and specified drug delivery. In addition to Starpharma’s internal DEP ® programs, Starpharma has multiple DEP ® partnerships with international biopharmaceutical companies, including AstraZeneca (oncology), MSD (Antibody-Drug Conjugates), Chase Sun (anti-infectives), and other world-leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform, partnered DEP® programs have the potential to generate significant future milestones and royalties. Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including Europe, the UK, and Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 50 countries, including in the UK, Europe, Southeast Asia, South Africa, Australia and New Zealand. For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn. 2 WE Communications Hannah Howlett +61 450 648 064 WE-AUStarPharma@we- worldwide.com Starpharma Holdings Limited Dr Jackie Fairley, Chief Executive Officer Justin Cahill, CFO and Company Secretary +61 3 8532 2704 [email protected] 4-6 Southampton Crescent Abbotsford Vic 3067 Disclosure This ASX Announcement was authorised for release by the Chair, Mr Rob Thomas. 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”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, “outlook”, or similar expressions, or by express or im plied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such f orward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be mate rially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those descr ibed herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any for ward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product. ASX: SPL OTC: SPHRY 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”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, “outlook” or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document, nor any information made available to you is or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or future performance of any Starpharma product. FLEURSTAT BVgel (VivaGel® BV) for the treatment and prevention of recurrent BV and relief of symptoms: ASK YOUR PHARMACIST ABOUT THIS PRODUCT. Do not use for more than 7 days unless a doctor has told you to. See your doctor if symptoms persist after 7 days or recur within 2 weeks of completing a course, or if you consider you may be at risk of a sexually transmitted infection (STI). See a doctor if you are diabetic or pregnant/breastfeeding (or plan to be). VIRALEZE™: Not approved for use or supply in Australia. ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. This medical device is a regulated health product that bears, under this regulation, the CE marking in the EU. Do not use if you have a history of sensitivity to any ingredient in the formulation. Not for use in children under the age of 12 years. See a doctor If you are pregnant or breastfeeding. Always follow recommendations from health authorities, including vaccination and good hygiene practices, such as the use of masks, physical distancing, and regular handwashing to ensure the best possible protection against cold/respiratory viruses. Expanding the scope for theranostics and radioligand therapies Wilsons Drug and Device Conference 25 - 27 October 2023 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 investment risk. Deep portfolio of high-value assets Three promising internal clinical-stage assets are under development: improved, patented versions of widely used cancer medications; and a strong pipeline of preclinical-stage assets, including radiotheranostics. Multiple products on market. Multiple global pharma partnerships DEP® partnerships with three of the world’s top 10 pharmaceutical companies: MSD, Genentech and AstraZeneca. Starpharma generates returns via research fees, milestones & royalties. Funded by large pharma partners. DEP® platform offers the ability to partner widely without Starpharma funding programs. Strong financial position Cash balance of $35.2M (30 June 2023), excluding $6.6 M received from Mundipharma in August 2023; $7.2 M R&D tax incentive refund received in October 2023. Strong international institutional share register Institutions include Allianz, Allan Gray, M&G, Fidelity, and UIL/ICM VIRALEZE™ Nasal Spray VivaGel® BV VivaGel® Condom DEP® 2 Wilsons Drug and Device Conference 2023 Starpharma’s portfolio: multiple clinical-stage assets, partnerships and products in market Two DEP® ADC Research Agreements with MSD (Merck & Co., Inc.) Two DEP® Research Agreements with Genentech DEP® anti-infective research partnership with Chase Sun Multi-product DEP® license with AstraZeneca Commercialised products Partnered DEP® programs DEP® pipeline Products Target indication Preclinical Phase 1 Phase 2 DEP® cabazitaxel Prostate and other cancers DEP® irinotecan Colorectal and other cancers DEP® docetaxel Pancreatic and other cancers DEP® gemcitabine Solid cancers DEP® HER-2 ADC Solid cancers DEP® HER-2 radiotherapy Solid cancers DEP® HER-2 radiodiagnostic Diagnostic Partnerships Various Phase 2 complete & results reported Phase 2 monotherapy complete Phase 2 monotherapy complete VIRALEZE™ Antiviral Nasal Spray VivaGel® BV VivaGel® Condom 3 Wilsons Drug and Device Conference 2023 Starpharma's DEP® platform: highly versatile, enhancing the commercial and therapeutic value of a wide range of drugs Improved Efficacy / Performance DEP® achieves drug targeting, improved PK and controlled release New IP / Extended Patent Life DEP® creates new intellectual property and extends patent life Tumour Targeting DEP® delivers 40-70x more drug in tumour cf. the original drug Improved PK and Half-Life Tuning of drug release and plasma half-life to improve performance Improved Solubility Highly water-soluble, removing the need for toxic excipients Rx Broad Applicability Applicable to a wide range of therapeutic areas and treatment modalities (e.g., radiotheranostics, ADCs); DEP® is potentially applicable to ~70% of the top 200 pharmaceuticals (by sales) DEP® platform benefits Multiple DEP® therapeutic areas across partnered and internal programs Antibody-Drug Conjugates Chemotherapeutics Radiotheranostics Non-oncology Improved Safety / Reduced side effects Control release kinetics of drug to reduce Cmax-related toxicities 4 Wilsons Drug and Device Conference 2023 Starpharma’s internal DEP® oncology portfolio Multiple clinical-stage assets with high commercial value potential 5 DEP® cabazitaxel (Phase 2) Dendrimer version of leading prostate cancer drug cabazitaxel (Jevtana®) Cabazitaxel (Jevtana®) – global sales of ~US$500M for 2021 despite having multiple US FDA “Black Box” warnings. Improved toxicity profile; detergent-free formulation; no steroid pre-treatment; tumour-targeting, improved efficacy; patent filings to 2039 (plus up to an additional ~5 years). DEP® docetaxel (Phase 2) Dendrimer version of docetaxel (Taxotere®) – widely used for breast, lung & prostate cancer Docetaxel (Taxotere®) was a blockbuster cancer drug with peak global sales >US$3B despite having multiple US FDA “Black Box” warnings. Reduction in neutropenia; detergent-free formulation; no steroid pre-treatment; tumour-targeting (~70x more drug in tumour); improved efficacy; improved pharmacokinetics; patent filings to 2032 (plus up to an additional ~5 years). DEP® irinotecan (Phase 2) Dendrimer version of irinotecan (Camptosar®) - predominantly used for colorectal cancer Camptosar® had peak global sales of US$1.1B despite having multiple US FDA “Black Box” warnings. Tumour-targeting; irinotecan is a pro-drug converted to the active metabolite, SN38; DEP® solubilises SN38 and allows direct dosing, avoiding the need for liver conversion and patient variability; improved efficacy; patent filings to 2039 (plus up to an additional ~5 years). *Multiple preclinical studies have established improved efficacy, survival and safety with DEP® with many different drugs #Clinical studies have demonstrated reduction in important side effects with DEP® such as bone marrow toxicity, anaphylaxis, severe diarrhoea and hair-loss Create value through clinical proof-of- concept (Phase 2) COMMERCIAL OBJECTIVE License following Phase 2 clinical data; platform validation Utilise accelerated development/reg. pathways (i.e. 505(b)(2)) for optimal ROI Clinical data adds value to partnered programs DEP® Program Original Drug Formulation Advantages of DEP® Product#* Wilsons Drug and Device Conference 2023 DEP® cabazitaxel Ph2 trial: Positive results in multiple cancers; expanded market potential All efficacy response data reported are for evaluable patients that received ≥1 dose cycle of DEP® cabazitaxel and had a CT scan, or other efficacy assessment (e.g., PSA in prostate cancer) as applicable, to assess response to treatment at ≥~8 weeks after commencement of treatment with DEP® cabazitaxel. DCR comprises stable disease (SD), partial responses (PR) and complete responses (CR).; ORR comprises PR and CR. PFS, OS and safety data are reported for all patients who received treatment. Results reported in Starpharma’s ASX Announcement dated 18 October 2023 * Intent to treat (ITT) population; PFS = composite endpoint from date of randomisation to date of first tumour progression, PSA progression, or death (Jevtana® studies also included pain progression) Summary of Key Efficacy Results • Heavily pre-treated, advanced prostate cancer patients (mCRPC) treated with DEP® cabazitaxel achieved a median progression-free survival (PFS) that was more than 50% longer and a median overall survival (OS) that was 10% longer than published data for Jevtana® at the same dose2. • In advanced, platinum-resistant ovarian cancer patients who were heavily pre-treated with an average of 4 prior lines of chemotherapy, DEP® cabazitaxel achieved a disease control rate (DCR) of 66.7% and an objective response rate (ORR) of 17.6%, which compares favourably to standard-of-care therapies that report ORRs ranging from ~9 to 16%4,5,6. • In advanced gastro-oesophageal cancer patients, DEP® cabazitaxel achieved a median progression-free survival and median overall survival that were 53.1% and 28.5% longer, respectively, than similar patient cohorts treated with standard-of-care paclitaxel7. Longer progression-free survival and overall survival in advanced prostate cancer patients Key Efficacy Measures DEP® cabazitaxel (20 mg/m2) (N=25*) Jevtana®2 (20 mg/m2) (N=598*) Median PFS 4.4 months 2.9 months Median overall survival (OS) 14.7 months 13.4 months PSA Reduction ≥50% 52.4% 29.5% DEP® cabazitaxel had significantly fewer Grade 3/4 Treatment- Related Adverse Events (TRAEs) vs. Jevtana® in advanced prostate cancer patients Safety Outcomes DEP® cabazitaxel (20 mg/m2) (N=25*) Jevtana®2 (20 mg/m2) (N=580*) Neutropenia* ≥ grade 3 16.0% 41.8% Febrile neutropenia ≥ grade 3 0% 2.1% Thrombocytopenia* ≥ grade 3 0% 2.6% Neutropenic infection / sepsis 0% 2.1% * Lab detected neutropenia or thrombocytopenia, regardless of whether the event was reported as an adverse event; † Safety population (received at least 1 dose) DEP® cabazitaxel: excellent efficacy responses in platinum-resistant ovarian cancer and advanced gastro-oesophageal cancers, both significant unmet medical needs. Cancer Type Gastro-oesophageal Platinum-resistant Ovarian Patients’ Prior Anti-Cancer Therapy (Median) 1 line, 6 cycles 4 lines, 25 cycles Disease Control Rate (DCR) 80.0% 66.7% Objective Response Rate (ORR) 30.0% 17.6% Median PFS 4.0 months 3.1 months 2 Eisenberger, M., et al., PROSELICA. J Clin Oncol, 2017, 35(28):3198-206 4 Taxol® (paclitaxel) Injection label, https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf. 5 Mutch, DG, et al., J Clin Oncol, 2007;25(19):2811-2818. 6 Pujade-Lauraine, E, et al., J Clin Oncol, 2014;32(13):1302-1308. 7 Stockton, S, et al., The Oncologist, 2023;28(9):827–e822. 6Wilsons Drug and Device Conference 2023 DEP® irinotecan Ph2 trial: Positive interim results in colorectal cancer and platinum-resistant/refractory ovarian cancer All efficacy response data reported are for evaluable patients. Evaluable patients are those that received ≥1 dose cycle of DEP® irinotecan and had a CT scan to assess response to treatment at ≥~8 weeks after commencement of treatment with DEP® irinotecan. DCR comprises stable disease (SD), partial responses (PR) and complete responses (CR); ORR comprises PR and CR. Interim results in advanced colorectal cancer patients treated with DEP® irinotecan monotherapy • Patients were heavily pre-treated with an average of 4 prior treatment regimens and 31 cycles; >97% progressed after prior treatment with conventional irinotecan. • Despite this heavy pre-treatment, DEP® irinotecan monotherapy achieved durable efficacy responses for up to 72 weeks with a disease control rate (DCR) of 48% in evaluable patients. • No severe diarrhoea or cholinergic syndrome. • Significantly fewer severe treatment-related adverse events. Interim clinical results in heavily pre-treated advanced colorectal cancer patients treated with DEP® irinotecan in combination therapy with 5-fluorouracil (5-FU) and leucovorin (LV) (ongoing) • DCR is 100% and ORR of 20% (cf. published data in advanced CRC patients for conventional irinotecan plus 5-FU/LV (FOLFIRI) as second-line therapy. (i.e., in patients less heavily pre-treated than in the current study) reported an ORR of 4%1). • Clinicians reported significant clinical benefit in these heavily pre-treated patients, including durable responses for up to 35 weeks (SD and partial response [PR]) with very good tolerability. Interim results in advanced, platinum-resistant ovarian cancer treated with DEP® irinotecan monotherapy • Patients were heavily pre-treated, with an average of 6 prior treatment regimens and 30 cycles and disease that was resistant or refractory to platinum-based therapies (standard-of-care, SoC); patients had exhausted available SoC options. • DEP® irinotecan monotherapy achieved a DCR of 100%, and an ORR of 43% in ovarian cancer patients dosed every 2 weeks (Q2W) (cf. standard-of- care single-agent therapies for platinum-resistant ovarian cancer, including paclitaxel, topotecan, gemcitabine or pegylated liposomal doxorubicin, which report ORRs ranging from ~9 to 16%4,5,6). • The DCR achieved in all ovarian cancer patients (Q2W and Q3W) is 72%, with several patients continuing to receive treatment and experiencing clinical benefit. • Tumour shrinkage of up to 60%. • Response durations of up to 45 weeks. • Tumour biomarker reductions of up to 98% in more than 75% of patients. • Clinical benefits reported by investigators in the study included complete resolution of a patient’s debilitating tumour-related ascites and pleural effusion. Multiple patients have provided positive feedback about the better tolerability experienced with DEP® irinotecan compared to conventional irinotecan therapy. 7Wilsons Drug and Device Conference 2023 1 Tournigand et al., FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study, Clinical Oncology, 2023;41(19):3469-3477. https://doi.org/10.1200/jco.22.02774 4 Taxol® (paclitaxel) Injection label, https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf. 5 Mutch, DG, et al., J Clin Oncol, 2007;25(19):2811-2818. 6 Pujade-Lauraine, E, et al., J Clin Oncol, 2014;32(13):1302-1308. PEG layer to provide stealth and improve solubility • Can utilise a wide range of targeting moieties • DEP® dendrimers deliver high chelator number (4, 8, 16) per conjugate • Site specific attachment; precisely manufactured and easily scalable • Drug-linker strategy can be easily tailored to meet drug release requirements • Flexibility of payload choice – radioisotope, cytotoxic, ultra toxic, immunomodulator Pharmacokinetics • Clinically validated, safe, biodegradable • Easily scalable; precisely manufacturedDEP® dendrimer • Flexible – the type and number of chelators can be varied (e.g., DFO, NOTA, DOTA) Chelator / Isotope • Provides stealth • Controls clearancePEG • Flexible targeting moiety (antibody, peptide, small molecule) • Poly-valency easily achieved Tumour Targeting • Plasma half-life can be tuned • Dendrimer size and charge can be altered to regulate kidney glomerular filtration Chelator stably conjugated to dendrimer Biodegradable lysine core Scalable, clinically and commercially validated DEP® platform advantages in targeted radiotheranostics 8 Targeting moieties attached by specific linker strategies Mono- or poly-valency DEP® dendrimers are constructed in concentric layers called generations Wilsons Drug and Device Conference 2023 DEP® HER2-zirconium has demonstrated imaging benefits in a HER2+ breast cancer model, including: • More rapid tumour accumulation and superior PK than HER2 mAb, trastuzumab (Herceptin®), labelled with zirconium; • Favourable biodistribution profile, with excellent imaging contrast between tumour and normal tissues; • High tumour-to-organ ratios, delivering excellent specificity in imaging HER2+ tumours; and • Highly desirable “fast-in”/”fast-out” kinetics, meaning it accumulates rapidly in the tumour and is cleared quickly from the bloodstream. Tumour and normal tissue levels of DEP® HER2-zirconium at 120 hours. Tumour Blood Liver Spleen Kidneys Heart Lungs Colon Bone 0 5 10 15 20 25 30 %Injected dose/g Tumour:Blood ratio >40 DEP® HER2-lutetium has demonstrated therapeutic benefits in a breast cancer model. • Achieved complete tumour regression; well-tolerated; • Anti-tumour effect was radiation dose-dependent; • 100% survival throughout the experiment. 0 10 20 30 40 50 60 70 0 50 100 150 1000 2000 3000 Tumour Volume Change (% of Initial Volume) Days Post-Injection Volume (% of Initial) Vehicle (Control) 177Lu-Herceptin® DEP® HER2-lutetium ** p < 0.0001 DEP® HER2-zirconium (radiodiagnostic) HER2-targeted DEP® radiodiagnostic and radiotherapeutic pair 9 • HER2 is overexpressed in ~20%-30% of breast (HER2hi), gastric & gastro-oesophageal cancers (HER2hi); also expressed at low levels (HER2lo) in other carcinomas including colorectal, endometrial & lung • HER2+ breast cancer treatment market was $9.7 billion^ in 2021 and is expected to increase to $11.2 billion in 2025 (US, Japan, EU5) • Global HER2+ gastric cancer market is currently valued at ~US$ 1.3 billion in 2023 Wilsons Drug and Device Conference 2023 DEP® HER2-lutetium (radiotherapeutic) 10 Tumour Blood 0 10 20 30 % injected dose / gram of tissue 4h 1d 2d 3d 4d 5d Rapid and sustained tumour accumulation Cleared rapidly from blood, minimising potential bone marrow toxicity DEP® HER2- zirconium These characteristics are also desirable for a radiotherapeutic to maximise efficacy and minimise toxicity DEP® HER2-zirconium (radiodiagnostic): favourable imaging characteristics in a HER2+ breast cancer model Wilsons Drug and Device Conference 2023 11 Key value drivers and outlook Wilsons Drug and Device Conference 2023 DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets • Complete and report results from Phase 2 DEP® trials​, including value-adding combination arms • Licensing discussions continuing in parallel Partnered/Funded DEP® Programs • Progress existing partnerships with MSD, Genentech, AstraZeneca, and Chase Sun • New and/or expanded DEP® partnerships, increasing optionality of potential revenue streams Preclinical DEP® Programs • Advance/partner DEP® radiotheranostics • DEP® HER2-zirconium (radiodiagnostic) • DEP® HER2-lutetium (radiotherapeutic) • Advance/partner DEP® ADCs • Other DEP® candidates VIRALEZE™ Antiviral Nasal Spray • Further commercial roll-out, registrations and product launches • Complete recruitment and report UK post-market study • Further distribution arrangements with commercial partners​ • Continue to generate clinical and antiviral data to support and expand commercialisation VivaGel® BV • Execute new marketing and distribution arrangements • Further regulatory approvals and commercial launches • FDA review process VivaGel® Condom • Approvals/launches in additional countries SPL7013 • Further development/co-development​ • Continued testing against important infectious pathogens Investor Relations Queries: [email protected] 4-6 Southampton Crescent Abbotsford VIC 3067 www.starpharma.com ASX:SPL | OTC:SPHRY

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