Announcement PDF Starpharma to present at Bell Potter Healthcare Conference Melbourne, Australia; 14 November 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Bell Potter Healthcare Conference, a virtual investor conference that showcases Australia's leading healthcare companies to institutional investors and Bell Potter’s retail network. Starpharma will present an overview of the business, with a focus on recent milestones, including the positive clinical data reported for DEP® cabazitaxel1 and DEP® irinotecan2 in multiple cancers, as well as the positive preclinical data from the DEP® radiotheranostics programs. The Bell Potter Healthcare 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 products 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. 1 2 ASX Announcement dated 18 October 2023: Positive DEP® Cabazitaxel Results in Multiple Cancers. ASX Announcement dated 13 September 2023: Positive DEP® irinotecan clinical results to be presented at international oncology conference. WE Communications Hannah Howlett WE-AUStarPharma@weworldwide.com Starpharma Holdings Limited Dr Jackie Fairley, Chief Executive Officer Justin Cahill, CFO and Company Secretary +61 3 8532 2704 investor.relations@starpharma.com 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 implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forwardlooking 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 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 described 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 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 the future performance of any Starpharma product. 2 ASX: SPL OTC: SPHRY Starpharma Overview Bell Potter Healthcare Conference Dr Jackie Fairley, Chief Executive Officer 14 November 2023 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 forwardlooking 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. 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. DEP® 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. VIRALEZE™ Nasal Spray 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 & and royalties. Funded by large pharma partners. DEP® platform offers the ability to partner widely without Starpharma funding programs. VivaGel® BV Strong financial position Cash balance of $35.6M (30 September 2023), including $6.6 M received from Mundipharma in August 2023; and excluding the $7.2 M R&D tax incentive refund received in October 2023. Strong international institutional share register VivaGel® Condom Institutions include Allianz, UIL/ICM, Allan Gray, M&G, and Fidelity. Bell Potter Healthcare Conference 2023 3 Starpharma’s portfolio: multiple clinical-stage assets, partnerships and products in market DEP® pipeline Commercialised products Products Target indication Preclinical DEP® cabazitaxel Prostate and other cancers Phase 2 complete & results reported DEP® irinotecan Colorectal and other cancers Phase 2 recruitment complete DEP® docetaxel Pancreatic and other cancers Phase 2 recruitment complete Phase 1 Phase 2 VIRALEZE™ Antiviral Nasal Spray VivaGel® BV VivaGel® Condom Partnered DEP® programs DEP® gemcitabine Solid cancers DEP® HER-2 ADC Solid cancers DEP® HER-2 radiotherapy Solid cancers DEP® HER-2 radiodiagnostic Diagnostic Partnerships Various 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 Bell Potter Healthcare Conference 2023 4 Financial Summary Strong balance sheet with revenues from product sales and partnerships Q1 FY24 Result. FY23 $M FY22 $M FY21 $M • Net cash inflow of $0.4M for Q1 FY24. Key Financials • Strong cash position with $35.6M at 30 September 2023. Revenue 4.2 4.9 2.2 • Other Income 0.1 0.3 1.3 Loss for the period (15.6) (16.2) (19.7) Net operating cash outflows (13.5) (13.2) (14.8) • • Includes $6.6M cash payment received from Mundipharma in relation to the settlement of VivaGel® BV rights. Excludes the $7.2M Research and Development Tax Incentive refund received in October 2023, and the R&D loan of $4M repaid in October 2023. Cash outflows ending 30 September 2023, included R&D costs of $3.4 million related to the completion of recruitment and treatment in multiple DEP® clinical programs; following completion of our clinical programs, Starpharma expects to see reductions in operating cash outflows in H2 FY24. Cash at 30 September 2023: $35.6 M* *Excludes the $7.2 M Research and Development Tax Incentive refund received in October 2023; and excludes the $4M R&D loan repaid in October 2023. Bell Potter Healthcare Conference 2023 5 Starpharma's DEP® platform: highly versatile, enhancing the commercial and therapeutic value of a wide range of drugs Improved Safety / Reduced side effects Control release kinetics of drug to reduce Cmax-related toxicities Improved Efficacy / Performance DEP® achieves drug targeting, improved PK and controlled release Multiple DEP® therapeutic areas across partnered and internal programs New IP / Extended Patent Life DEP® platform benefits 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 Chemotherapeutics Antibody-Drug Conjugates Radiotheranostics Rx Improved Solubility Highly water-soluble, removing the need for toxic excipients Non-oncology 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) Bell Potter Healthcare Conference 2023 6 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, enabling multiple licenses to run in parallel without Starpharma funding programs Two DEP® ADC Research Agreements with MSD DEP® partnering process • Research Phase - typically involves Starpharma making multiple DEP® candidates followed by testing by Partner; funded by Partner. • Commercial Phase – typically a license with milestones and royalties payable to Starpharma. • Development costs funded by Partners. Two DEP® Research Agreements with Genentech DEP® anti-infective research partnership with Chase Sun Multiproduct DEP® license & option agreement with AstraZeneca Bell Potter Healthcare Conference 2023 7 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 (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). COMMERCIAL OBJECTIVE Create value through clinical proof-ofconcept (Phase 2) License following Phase 2 clinical data; platform validation Clinical data adds value to partnered programs Utilise accelerated development/reg. pathways (i.e. 505(b)(2)) for optimal ROI #Clinical studies have demonstrated reduction in important side effects with DEP® such as bone marrow toxicity, anaphylaxis, severe diarrhoea and hair-loss *Multiple preclinical studies have established improved efficacy, survival and safety with DEP ® with many different drugs Bell Potter Healthcare Conference 2023 8 DEP® cabazitaxel Phase 2 trial – Positive Results Positive results across multiple tumour types enhancing market potential DEP® cabazitaxel • Phase 2 trial (N=75) – complete and results reported 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 (PFS) and median overall survival (OS) that were 53.1% and 28.5% longer, respectively, than similar patient cohorts treated with standard-of-care paclitaxel7. Trial Sites Jevtana® DEP® cabazitaxel 2021 sales ~US$500M Starpharma’s patented, nanoparticle formulation FDA “Black Box” warnings: 1. Neutropenic deaths (febrile neutropenia) 2. Severe hypersensitivity (polysorbate-80 detergent) Detergent-free formulation; no neutropenic deaths or severe hypersensitivity observed; therefore, would not expect “black box” warnings Extensive premedication: • Antihistamine (required) • Corticosteroid (required) • H2 antagonist (required) • Antiemetic prophylaxis (recommended) Premedication not required; polysorbate-80/detergent-free formulation Prophylactic G-CSF recommended for older/highrisk patients (to prevent severe myelosuppression) Short-Term Patents • EU – expired • US – 2031 Results reported in Starpharma’s ASX Announcement dated 18 October 2023 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. Bell Potter Healthcare Conference 2023 Prophylactic G-CSF not required; significantly less myelosuppression in high-risk patients: e.g., patients with low neutrophil count and ≥75yrs New / extended IP • EU – 2039 • US – 2039 (potential for 5year extension) 9 Key results for DEP® cabazitaxel in prostate cancer Clinically meaningful 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 patient cohort. • Median of 4 lines and 70 cycles of prior anti-cancer therapy. • 60% of DEP® cabazitaxel treated patients had received ≥ two prior chemotherapy regimens, compared to 16%2 of Jevtana® patients in published trial data. Highly encouraging efficacy results. • DEP® cabazitaxel achieved a disease control rate (DCR) of 70.6% and an objective response rate (ORR) of 16.7%. Longer progression-free survival and overall survival Key Efficacy Measures DEP® cabazitaxel (20 mg/m2) (N=25†) Jevtana® (20 mg/m2) (N=598†)2 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% Results reported in Starpharma’s ASX Announcement dated 18 October 2023. All efficacy response data are for evaluable patients. † Intent to treat (ITT) populations; PFS = composite endpoint from date of randomisation to date of first tumour progression, PSA progression, or death. (Jevtana® studies also included pain progression) 1 Prostate cancer: Statistcs https://www.cancer.net/cancer-types/prostate-cancer/statistics. 2 Eisenberger, M., et al., PROSELICA. J Clin Oncol, 2017, 35(28):3198-206 • DEP® cabazitaxel had significantly fewer Grade 3/4 TreatmentRelated Adverse Events (TRAEs) vs. Jevtana® in advanced prostate cancer patients. Comparative bone marrow toxicity in prostate cancer patients treated with DEP® cabazitaxel vs published data on Jevtana® Safety Outcomes DEP® cabazitaxel (20 mg/m2) (N=25^) Jevtana® (20 mg/m2)2 (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) Prostate cancer is the fourth most commonly diagnosed cancer in the world. It is the second leading cause of cancer death in men in the United States1. Bell Potter Healthcare Conference 2023 10 Key results for DEP® cabazitaxel in ovarian cancer Highly encouraging durable efficacy responses (DCR, ORR) in heavily pre-treated advanced, platinum-resistant ovarian cancer patients. Heavily pre-treated patient cohort. Cancer Type Patients’ Prior AntiCancer Therapy (Median) Platinum-resistant Ovarian • 100% of patients had received at least one prior taxane. • 45% of patients received 2 or more lines of taxane treatment. Highly encouraging efficacy results. 4 lines, 25 cycles Disease Control Rate (DCR) 66.7% Objective Response Rate (ORR) 17.6% Median PFS 3.1 months • Tumour shrinkage of up to 40% and response durations of up to 34 weeks. • Objective response rate (ORR) of 17.6% in evaluable patients. Compares favourably to standard-of-care single-agent therapies that report ORRs ranging from ~9 to 16% (paclitaxel [Taxol®], topotecan [Hycamtin®], gemcitabine [Gemzar®] or pegylated liposomal doxorubicin [Caelyx®])2,3,4. • 75% of the evaluable ovarian cancer patients achieved reductions of up to 95% in ovarian cancer biomarkers, CA125, or CEA. Platinum-resistant ovarian cancer represents a significant unmet clinical need with: • a median survival of 9-12 months and • fewer than 15% of patients respond to subsequent chemotherapy5. Results reported in Starpharma’s ASX Announcement dated 18 October 2023. All efficacy response data are for evaluable patients. https://ocrahope.org/get-the-facts/staging 2 Taxol® (paclitaxel) Injection label, https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf. 3 Mutch, DG, et al., J Clin Oncol, 2007;25(19):2811-2818. 4 Pujade-Lauraine, E, et al., J Clin Oncol, 2014;32(13):1302-1308. Bell Potter Healthcare Conference 2023 5: https://erc.bioscientifica.com/view/journals/erc/25/5/ERC-17- 0336.xml#:~:text=Platinum%2Dresistant%20ovarian%20cancer%20has,2014). 11 Key results for DEP® cabazitaxel in gastrooesophageal cancers DEP® cabazitaxel achieved excellent efficacy responses in advanced gastro-oesophageal cancers, which represent a significant unmet medical need. Cancer Type Gastrooesophageal Highly encouraging efficacy results. Patients’ Prior Anti-Cancer Therapy (Median) 1 line, 6 cycles Disease Control Rate (DCR) 80% Objective Response Rate (ORR) 30% Median PFS 4.0 months Median overall survival (OS) 8.6 months • DEP® cabazitaxel results compare favourably to standard-of-care paclitaxel treatment in patients with oesophageal or gastro-oesophageal junction cancers. • DEP® cabazitaxel achieved a more than 50% longer median progressionfree survival (PFS) and a 30% longer median overall survival (OS) than paclitaxel administered weekly as a second-line treatment1. • The majority of these patients were refractory to first-line therapy. Despite this, DEP® cabazitaxel achieved a disease control rate (DCR) of 80%, and an ORR of 30% in evaluable gastro-oesophageal cancer patients. Responses included stable disease (SD) for up to 27 weeks and partial responses (PR) for up to 17 weeks. Advanced gastro-oesophageal cancers are a significant unmet medical need with limited treatment options. These cancers progress rapidly and have a very poor one-year survival rate of only 20%2. Results reported in Starpharma’s ASX Announcement dated 18 October 2023. All efficacy response data are for evaluable patients. 1 Stockton, S, et al., The Oncologist, 2023;28(9):827–e822. 2 https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival Bell Potter Healthcare Conference 2023 12 DEP® cabazitaxel: patient 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 DEP® cabazitaxel study, following: • • • 12 cycles of two different platinum treatment regimens Extensive surgery and radiation therapy Extensive lung metastases with long-standing cough and related findings on chest examination Reduction in Tumour Marker on DEP® cabazitaxel treatment Following treatment with DEP® cabazitaxel (6 cycles), the patient achieved: • • • • • AFTER 6 CYCLES 96% reduction in tumour marker Partial response (significant tumour shrinkage); Up to 43% reduction in size of individual lung metastasis Anticancer response maintained for 34 weeks 96% reduction in CEA tumour marker Cough and chest exam abnormalities resolved after cycle 3 Bell Potter Healthcare Conference 2023 13 Key Opinion Leaders (KOLs) comments on DEP® cabazitaxel Phase 2 results “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 patients, not only in prostate cancer patients but also platinum-resistant ovarian cancer, and advanced gastro-oesophageal cancers. These advanced patients have few treatment options and we have had many patients who benefited from DEP® cabazitaxel therapy. It was also pleasing to see the limited impact on bone marrow function of this agent given these advanced patients are often at risk of complications of chemotherapy-induced bone marrow toxicity, especially low neutrophil counts.” Professor James Spicer, FRCP, MBBS, PhD, Professor of Experimental Cancer Medicine at King’s College London and Consultant in Medical Oncology and the Principal Investigator for the trial at Guy’s Hospital in London. “I am impressed with the data on Starpharma's novel dendrimer formulation of cabazitaxel, not only in prostate cancer patients, but in patients with other difficult-to-treat diseases such as advanced platinum-resistant ovarian and gastro-oesophageal cancers. DEP® cabazitaxel showed very encouraging efficacy signals in these heavily pre-treated patients who have few options remaining.” “For example, in elderly patients with prostate cancer who typically would not tolerate standard cabazitaxel due to low neutrophil counts and other adverse effects, treatment with DEP® cabazitaxel was possible due to its lack of significant effects on the bone marrow and its generally well-tolerated safety profile, and achieved some excellent outcomes for these patients. “Based on the data and my experience with DEP® cabazitaxel, it represents a well-tolerated and promising treatment alternative, not only to standard cabazitaxel for prostate cancer patients, but also for ovarian, gastro-oesophageal and potentially other cancers for which standard cabazitaxel is not indicated.” Dr David Pinato, MD, MRCP (UK), MRes, PhD, Clinical Reader and Consultant Medical Oncologist, Director of Developmental Cancer Therapeutics