Bell Potter Healthcare Conference Presentation
2024-11-17 · Starpharma Pty Ltd · original starpharma.com ↗
ASX Announcement Bell Potter Healthcare Conference Presentation Melbourne, Australia; 18 November 2024: Starpharma (ASX: SPL, US OTC : SPHRY) , an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, provides a copy of the presentation that will be delivered by CEO Cheryl Maley at the virtual Bell Potter Healthcare Conference today. About Starpharma Starpharma ASX: SPL, US OTC: SPHRY) is an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient. Our mission is to help patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology. Dendrimers are precise, synthetically manufactured, nanoscale molecules. Their unique properties—including their size, structure, high degree of branching, polyvalency, and water solubility—are advantageous in medical and pharmaceutical applications. Starpharma’s portfolio of dendrimer -based products includes three clinical -stage DEP® (dendrimer enhanced product) assets, preclinical radiopharmaceutical assets, research collaborations, and three commercially marketed over-the-counter (OTC) products. For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn. WE Communications Hannah Howlett +61 450 648 064 WE-AUStarPharma@we- worldwide.com Starpharma Holdings Limited Cheryl Maley, 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”, or similar expressions, or by express or implied discussions regarding potential filings or marke ting 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 fu ture results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory fil ings 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, mana gement’s expectations regarding the approval and commercialization of the product ca ndidates 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 abi lity to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public prici ng pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, fina ncial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual resu lts 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. Delivering Meaningful Patient Outcomes with Advanced Dendrimer Technology Bell Potter Healthcare Conference | 18 November 2024 CEO, Cheryl Maley ASX : SPL US OTC : SPHRY Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward-looking statements are reasonable at this time, Starpharma can give no assurance that these expectations will prove to be correct. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, risks associated with patent protection, future capital needs or other general risks or factors. 2 3 Our Mission “To help patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology. ” Starpharma is an Innovative Australian Biotechnology Company with 20 Years of Experience in Advancing Dendrimer Technology from the Lab to the Patient 4 Ticker Symbol ASX: SPL US OTC: SPHRY Industry/Sector Healthcare, Pharmaceuticals, Biotechnology Market Capitalisation ~A$40M Share Price ~A$0.10 Total Ordinary Shares On Issue 417M Cash Balance (30 Sept 2024) A$24.0M Starpharma’s DEP® Platform Technology: What Is It and How Does It Benefit Patients? 5 Starpharma – Founders and Experts in Dendrimer Drug Delivery Dendrimers are highly branched (tree-like) macromolecules with a well-defined, 3D structure 6 • Concentric layers of lysine monomers • Drugs, payloads, and/or targeting moieties attached via tailored linker strategies to achieve enhanced tumour targeting and pharmacokinetics (PK) • Easily scalable, precisely manufactured, and Good Manufacturing Practice (GMP) certified G1 G2 G3 G4 Dendrimer Generations Clinically validated technology More than 350 patients treated with DEP® across multiple clinical programs. Strong intellectual property position 19 active patent families with over 150 granted patents and more than 40 patent applications pending. Uniquely experienced team Expertise in dendrimer science. Staff of ~40 people. Pipeline of products and partnerships Portfolio includes clinical-stage assets, early-stage research, partnerships, and commercial products. DEP Platform Phase II Clinical Assets Rapidly Emerging Therapies OTC Products on Market Novel Areas of Unmet Need Strategic Partnerships Starpharma’s DEP® Platform Technology: Versatile and Multifunctional for Delivery of Therapeutics and Diagnostics Multiple Revenue Streams: Maximising Shareholder Returns 7 VivaGel® BV , VIRALEZE Nasal Spray, and VivaGel® Condom DEP® SN38 and DEP® cabazitaxel: commercial opportunities to address unmet needs in oncology Novel therapy areas & targets, & new partnerships Radiodiagnosis, radiotherapy & targeted dendrimers Starpharma’s Oncology Portfolio: Addressing Areas of High Unmet Clinical Need Three Clinical Assets and Three Pipeline Assets 8 Product Target indication Research Preclinical Phase I Phase II Phase III Strategy DEP® SN38 Ovarian and colorectal License/co-develop – ovarian, colorectal DEP® cabazitaxel Prostate and ovarian License – prostate, ovarian DEP® HER2 radiodiagnostic Diagnostic Optimise and accelerate to clinical DEP® HER2 radiotherapeutic Solid cancers Advance to clinical DEP® HER2 ADC Solid cancers Advance to preclinical DEP® docetaxel Pancreatic and other cancers Lower priority Phase II results reported Phase II results reported Phase II results reported Indication Evaluation Advanced colorectal cancer Platinum-resistant ovarian cancer Metastatic castration- resistant prostate cancer Platinum-resistant ovarian cancer Advanced gastro- oesophageal cancer DEP® SN38 & DEP® cabazitaxel Global Commercial Opportunity 9 DEP® SN38 DEP® cabazitaxel Both assets were developed using the DEP® technology to improve existing oncology products. Partnering Starpharma has created value through proof-of-concept and is seeking to license both products. Promising Phase II Results Phase II studies for each asset showed promising results of improved tolerability over the original compounds and comparable or improved efficacy. Trials have generated promising anti-cancer efficacy in very late-stage patients who have been heavily pre-treated. Value Proposition For a partner, both assets provide opportunity for new indications, new markets, and product life cycle extension. DEP® SN38 Phase II Results DEP® cabazitaxel Phase II Results Clinically meaningful outcomes were achieved for patients who were heavily pre-treated prior to entering the trial and had few options. Promising efficacy in patients with irinotecan-treated CRC and platinum-resistant/refractory ovarian cancer. Well-tolerated with mostly mild/moderate gastrointestinal AEs, no cholinergic toxicity. Clinical benefit even in patients previously exposed to taxanes, including standard cabazitaxel. Promising efficacy in patients with mCRPC, ovarian and gastro- oesophageal cancers. Well-tolerated with mostly mild/moderate AEs, no routine steroid premedication. DEP® SN38 Phase I/II Trial Patients – Advanced, Heavily Pre-treated, and Most CRC Patients had Progressed Following Prior Treatment with Irinotecan 10 BASELINE CHARACTERISTICS COLORECTAL OVARIAN PANCREATIC BREAST OTHER1 TOTAL Subjects enrolled (n, %) 55 (48%) 23 (20%) 15 (13%) 8 (7%) 13 (11%) 114 (100%) Subjects ongoing (n, %) 0 (0%) 1 (4%) 0 (0%) 0 (0%) 0 (0%) 1 (1%) Age (years) Median (range) 59 (31-78) 64 (42-74) 65 (48-76) 53 (42-66) 60 (38-73) 61 (31-78) Sex (n, %) Male 24 (44%) 0 8 (53%) 0 9 (69%) 41 (36%) Female 31 (56%) 23 (100%) 7 (47%) 8 (100%) 4 (31%) 73 (64%) ECOG PS 0 23 (42%) 6 (26%) 6 (40%) 2 (25%) - 40 (35%) 1 32 (58%) 17 (74%) 9 (60%) 6 (75%) 2 74 (65%) Stage at diagnosis III 2 (4%) 4 (17%) 0 (0%) 0 (0%) 2 (15%) 8 (7%) IV 53 (96%) 19 (83%) 15 (100%) 8 (100%) 11 (85%) 106 (93%) Prior systemic therapy (n, %) Irinotecan 54 (98%) 0 (0%) 11 (73%) 0 (0%) 3 (23%) 68 (60%) Platinum 29 (53%) 23 (100%) 9 (60%) 0 (0%) 12 (92%) 73 (64%) Taxanes 0 (0%) 23 (100%) 2 (13%) 7 (88%) 9 (69%) 41 (36%) Prior lines of therapy Median (range) 4 (2-9) 6 (3 to 9) 2 (2 to 5) 7 (3 to 12) 3 (1 to 6) 4 (1 to 12) 1Other cancer types included lung, upper gastrointestinal, and kidney. DEP® SN38 Phase II Study Shows Favourable Efficacy and Tolerability Data in Late-Stage Patients Results Presented at the 2024 ASCO Annual Meeting 11 Advanced Colorectal Cancer Advanced Platinum-Resistant Ovarian Cancer Data for DEP® SN38 in combination with 5-FU/LV; Full Phase II results reported in ASX Announcement dated 27 May 2024; *From published data on irinotecan in combination with 5- FU/LV, Tournigand et al., Clin Oncol, 2023, 41(19):3469-3477; # https://www.medicines.org.uk/ emc/product/6506- UK SmPC April 2022 ^From published data on ICC (investigator chemotherapy of choice) (pegylated liposomal doxorubicin, paclitaxel, or topotecan), Pujade-Lauraine E, et al., J Clin Oncol, 2014, 32(13):1302-1308; 20% 10% 10% 47% 0.90% 0.90% 1.80% 0% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Diarrhea ≥ Grade 3 Vomiting ≥ Grade 3 Nausea ≥ Grade 3 Cholinergic Syndrome Irinotecan DEP® SN38 Q3W N=765 Q2W, Q3W N=114 Only 1 patient with grade 3 diarrhoea from 114 patients and more than 800 doses of DEP® SN38 No cases of cholinergic symptoms with DEP® SN38 Gastrointestinal Toxicity Profile Significantly Improved with DEP® SN38 Treatment, Compared to Published Data on Irinotecan# 2.8 4.2 mPFS (months) 4 14 ORR (%) 3.4 10.4 mPFS (months) 11.8 43 ORR (%) Benefits of Starpharma’s DEP® Platform Technology Extend to Radiopharmaceuticals 12 Ability to use a wide range of targeting moieties Site-specific attachment of dendrimer on targeting moiety DEP® dendrimers are precisely manufactured and easily scalable Drug-linker strategy flexibility Can select drug payload and radioisotope for the desired application Flexibility in chelator type Key Characteristics Valued by CollaboratorsBroad Applicability in Drug Development Biodistribution Challenges with Current Approaches: Starpharma’s DEP® Technology Solution: Addressing the Biodistribution Challenges of Current Approaches with DEP® Radiotheranostics 13 High kidney exposure Low tumour uptake Tumour:Kidney ratio highly negative Tumour Blood Liver Spleen Kidneys Heart Lungs Colon Bone 0 5 10 15 20 25 30 %Injected dose/g Tumour:Blood ratio >40 Tumour:Blood ratio >40 Tumour:Kidney/Organ ratios highly positive due to low uptake in normal tissue LHS Image from Lizak et al, 2024, SNMMI presentation – DLL3 Radio-DARPin in tumor mouse model DEP® HER2 radiodiagnostic: faster clearance from blood and sustained elevated tumour:blood ratios compared to trastuzumab-89Zr R&D collaboration Types of Partnerships and Collaboration Opportunities Applicable to a Wide Range of Therapeutic Areas Co-development Licence Technology access Extensive Partnership Experience, Broad DEP® Application Opportunity and a Flexible Approach to Collaboration 14 Partnerships Cash at 30 September 2024: $24.0M 3-Year Summary FY24 $M FY23 $M FY22 $M Revenue and other income 9.8 4.3 5.2 Loss for the period (8.2) (15.6) (16.2) Net operating cash outflows (7.0) (14.3) (13.2) Well Positioned to Accelerate Product Pipeline and Strategic Growth Initiatives 15 Multiple Revenue Streams • Licenses and Milestone Payments • Marketed Products: VivaGel® BV and Viraleze • R&D Income Recent Strategic Review Confirmed Three Key Focus Areas to Optimise Shareholder Returns Maximise DEP® asset value 01 Accelerate early asset development 02 Build long-term sustainability 03 16 Prioritising DEP® SN38 and DEP® cabazitaxel Advancing DEP® radiopharmaceuticals and partnerships Increasing revenue, strengthening IP position, and fostering a high-performance culture 5) Increasing revenue contributing to sustainability 1) License / collaboration for a DEP® asset to commercialise 2) Radiodiagnostic progress to the clinic 3) Strategic partnership – expansion and/or licence 4) New VivaGel® BV EU Partner Over 20 years of experience in advancing dendrimer technology from the lab to the patient. Clinical and commercial validation of platform technology. Catalysts to Anticipate in The Next 12 Months Poised for Value Creation 17 Thank you. Investor Relations [email protected] www.starpharma.com Corporate Office 4 – 6 Southampton Crescent Abbotsford, Victoria 3067 Australia ASX : SPL US OTC : SPHRY
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