Life Sciences Investor Forum Presentation
2023-06-23 · Starpharma Pty Ltd · original starpharma.com ↗
Life Sciences Investor Forum Presentation Melbourne, Australia; 23 June 2023: Further to yesterday’s announcement, Starpharma (ASX: SPL, OTCQX: SPHRY) provides a copy of the investor presentation that w as aired during the OTCQX’s Virtual Life Sciences Investor Forum on Thursday, 22 June 2023 at 10:00 am EDT (Friday, 23 June 2023, at 12:00 am AEST). The presentation is appended below. About Starpharma Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a biopharmaceutical company, focused on the development of pharmaceutical and medical products for unmet patient needs, including in the areas of oncology and infectious diseases. 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 in Europe, in the UK, and in 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. * Note: VIRALEZE™ is not approved for use or supply in Australia. Starpharma.com | Twitter | LinkedIn Media: Sumit Media Grant Titmus Mob: +61 419 388 161 [email protected] 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 Starpharma Chair, Mr Rob Thomas. 2 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”, “estim ated”, “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 expre ssed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authori ties’ 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 produ cts, 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, estimat ed 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. 1 ASX:SPL OTC:SPHRY Life Sciences Investor Forum ASX:SPL | OTC:SPHRY Dr Jackie Fairley, CEO 22 June 2023 2 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 commercialization 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 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 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 the 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. 3 Starpharma snapshot 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 under development; improved, patented versions of widely used cancer medications. Multiple products on market and preclinical stage assets. Multiple global pharma partnerships DEP® partnerships with three of the world’s top 10 pharmaceutical companies: AstraZeneca, MSD & Genentech. Licenses projected to generate revenues through 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 $38.9M (at 31 Mar 2023) Strong institutional share register Significant shareholders include Allan Gray, Allianz, M&G, and Fidelity. International share register comprising ~55% institutions, ~40% retail, ~5% staff/other. VIRALEZE™ Nasal Spray VivaGel® BV VivaGel® Condom DEP® Starpharma Holdings Limited: Investor Presentation Starpharma is committed to ESG principles in all activities, governance arrangements, and environment and employment practices. 4 Starpharma’s portfolio of high-value assets Multiple clinical-stage DEP® assets, multiple corporate partnerships and products on market Marketed Products Partnered DEP® Products & Programs Multiproduct DEP® license with AstraZeneca, including the development of AZD0466 for multiple indications Two DEP® ADC Research Agreements with MSD (Merck & Co., Inc.) DEP® anti-infective research partnership with Chase Sun T wo DEP® Research Agreements with Genentech DEP® Products Product Active / Payload Target indication Preclinical Phase 1 Phase 2 DEP® cabazitaxel Cabazitaxel Prostate and other cancers DEP® irinotecan SN38 Colorectal and other cancers DEP® docetaxel Docetaxel Pancreatic and other cancers AZD0466 AZD4320 (BcL2/xL inhibitor) Haematological cancers DEP® gemcitabine Gemcitabine Solid cancers DEP® HER-2 ADC Not disclosed Solid cancers DEP® HER-2 radiotherapy 177Lu Solid cancers DEP® HER-2 radiodiagnostic 89Zr Diagnostic Other collaborations Various Various Ph 2 complete Developed by AstraZeneca Ph 2 Monotherapy complete Starpharma Holdings Limited: Investor Presentation 5 Key value drivers and outlook DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets • Complete and report results Phase 2 DEP® trials • Progress value-adding combination studies Partnered DEP® Programs • Progress existing partnerships with AstraZeneca, MSD, Chase Sun, and Genentech • Execute new and/or expand existing DEP® partnerships AZD0466 Clinical Program • AstraZeneca clinical progress - completion of dose escalation - Phase 2 start (milestone) Preclinical DEP® Programs • Advance/partner DEP® radiotheranostics, DEP® ADCs and other DEP® candidates VIRALEZE™ Nasal Spray • Further commercial roll-out, registrations and product launches • Complete recruitment and report UK clinical study • Further distribution arrangements with commercial partners • Continue to generate clinical and antiviral data to support and expand commercialisation VivaGel® BV • Commercialisation in Europe, Asia and in other markets • Further regulatory approvals and launches for VivaGel® BV; milestones, product sales/royalties • FDA review process VivaGel® condom • Approvals/launches in additional countries SPL7013 • Further development/co-development • Continued testing against important infectious pathogens Starpharma Holdings Limited: Investor Presentation 6 DEP® technology: • Based on proprietary, branched polymers called dendrimers • Represents a platform with significant optionality – applicable to many different 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 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 & Half-Life Tuning of drug release and plasma half life to improve performance Improved Solubility Highly water-soluble enabling the removal of 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® dendrimer-drug conjugate DEP® dendrimer antibody drug conjugate DEP® dendrimer radiotheranostic DEP® Platform Starpharma’s proprietary DEP® platform is highly versatile, conveys multiple benefits, and enhances the commercial value of a wide range of drugs Starpharma Holdings Limited: Investor Presentation 7 Antibody Drug ConjugatesChemotherapeutics Starpharma’s DEP® platform Broad applicability and exceptional optionality Multiple DEP® therapeutic areas across partnered and internal programs DEP® platform Radiotheranostics Non-oncology • Franchise extension • Generic differentiation • New chemical entities • Combinations including immuno-oncology • Flexible technology • Increased drug antibody ratio • Targeting group agnostic • Site selective payload attachment • Radiotheranostic applications • Can use a variety of isotopes and targeting approaches • Applicable to antivirals and anti-infectives • Endocrinology Starpharma Holdings Limited: Investor Presentation 8 DEP® anti-infective research partnership with Chase Sun Multiproduct license & option agreement with AstraZeneca Two DEP® ADC Research Agreements with MSD Two DEP® Research Agreements with Genentech DEP® platform offers significant optionality, enabling multiple licenses to run in parallel without Starpharma funding programs 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 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 Starpharma Holdings Limited: Investor Presentation 9 • 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 marketed Bcl2 inhibitor, venetoclax (Venclexta®). In 2021, Venclexta® had sales of ~US$1.82 billion • Clinical program significantly expanded – now includes two Phase 1/2 multi-centre trials with others under consideration • Phase 1/2 clinical trial in patients with advanced haematological malignancies (AML, ALL) • Phase 1/2 trial is aimed at seamless transition to Phase 2, to facilitate expedited marketing approval • AZD0466 is the first candidate in Starpharma’s multiproduct license with AstraZeneca; US$7M in milestones received to date • Total AZD0466 eligible milestone receipts of up to US$124M plus royalties (total estimated receipts up to A$2.4B to Starpharma over the product life) AZD0466 Clinical Program Trial Type & Indications Trial Status and Sites Preliminary Results Global Phase 1/2 study in advanced haematological malignancies (acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL)) 20 sites recruiting; >30 planned in total in Australia, US, EU & Asia • Multiple dose escalations successfully completed • AZD0466 dosed in 24 patients up to 3600mg (at 24 January 2023) • AZD0466 well tolerated; no dose-limiting toxicities (DLTs) to date • Initial clinical activity observed through reduction of bone marrow blasts following AZD0466 treatment. • Mean treatment duration of 4.4 months • Further dose escalation underway Global Phase 1/2 study in non-Hodgkin lymphoma >20 sites recruiting; 30 planned in total in Australia, US, Canada, EU & Asia Additional indication planned Details TBA AstraZeneca’s DEP® nanoparticle AZD0466 Global clinical development program in multiple indications Starpharma Holdings Limited: Investor Presentation Figure 1. Study design showing dose escalation of AZD0466 from the Phase 1/2 study in advanced haematological malignancies 10 AZD0466 active in small cell lung cancer models New data presented at AACR Meeting in April 2023 Starpharma Holdings Limited: Investor Presentation Small cell lung cancer (SCLC) is an aggressive malignancy with a 5-year survival rate of ~7%^ and a critical need for new therapies AZD0466, a dendrimer based BCL-2/XL inhibitor, was evaluated for efficacy in a panel of SCLC patient-derived models (xenografts) • AZD0466 was active in 50% of SCLC models, resulting in tumour regression in 33% of models. • Dual Bcl-2/xL inhibitor AZD0466 outperformed marketed Bcl-2 inhibitor venetoclax in 60% of SCLC models. • Notably, AZD0466 was also active in models resistant to the current standard- of-care treatment for SCLC: platinum/etoposide chemotherapy. “Data suggest BCL-2/XL inhibition has therapeutic potential in SCLC” – Andersen et al. (2023) AACR Abstract 6150/12: AZD0466, a dual BCL-2XL targeting nanomedicine, is active in small cell lung cancer models Clinical development status of AZD0466 • First-in-human trial treated 9 patients with advanced solid tumors (NCT04214093) at doses from 50- 200mg, all of which were well-tolerated. Responses (SD) observed in 33% patients for up to 5.5 months. • AZD0466 is now also under evaluation in patients with leukemias and non- Hodgkin lymphoma. • AZD0466 has been dosed in 33 patients up to 2400mg. No DLTs have been reported to date. Initial clinical activity has been observed through reduction of bone marrow blasts following AZD0466 treatment. • AZD0466 exhibits linear PK, consistent across solid tumor and leukemia patients. ^: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis- staging/survival-rates.html Abstract: https://www.abstractsonline.com/pp8/#!/10828/presentation/1959 Poster: https://starpharma.com/assets/uploads/2023-04/2023_CLA_AACR_0466inSCLC_Final.pdf 11 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 Starpharma’s internal DEP® oncology portfolio Multiple clinical-stage assets with high commercial value potential 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#* Starpharma Holdings Limited: Investor Presentation 12 DEP® cabazitaxel • Phase 2 trial • 76 patients; enrolment and treatment of patients now complete Interim observations • Encouraging efficacy signals, including significant tumour shrinkage and substantial tumour biomarker reductions, observed in multiple cancers, including the original Jevtana® indication (prostate cancer), as well as new indications, including ovarian, gastro- oesophageal, cholangiocarcinoma and head & neck cancer. • These impressive tumour responses have been observed in heavily pre-treated patients, some of which have failed multiple other lines of cancer treatment, and hard-to-treat tumours. • Significantly fewer and less severe side effects, particularly bone marrow toxicity (myelosuppression), than published data on Jevtana®. Trial Sites DEP® cabazitaxel: Phase 2 trial Encouraging efficacy signals across multiple tumour types enhancing market potential Jevtana® 2021 sales ~US$500M DEP® cabazitaxel 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/high- risk patients (to prevent severe myelosuppression) Prophylactic G-CSF not required; significantly less myelosuppression in high-risk patients: e.g., patients with low neutrophil count and ≥75yrs Short-Term Patents • EU – expired • US – 2031 New / extended IP • EU – 2039 • US – 2039 (potential for 5- year extension) Starpharma Holdings Limited: Investor Presentation 13 • 25 heavily pre-treated patients with Stage IV hormone-refractory prostate cancer • Prior to entering the DEP® cabazitaxel study, patients had received: o Average of 4 prior anti-cancer treatments and >70 months/cycles o >95% had received prior taxanes, including docetaxel and cabazitaxel (Jevtana®) o 56% had received ≥ two prior chemotherapy regimens (compared to 16%^ of Jevtana® patients in published trial data) • DEP® cabazitaxel patients did not need prophylactic steroids or antihistamines as polysorbate-80 free aqueous formulation • DEP® cabazitaxel required no primary G-CSF1 prophylaxis, despite older patient cohort and low neutrophil counts 1: G-CSF: granulocyte-colony stimulating factor, is used as a therapy for myelosuppression 2: Evaluable patients are those who received ≥1 dose DEP® cabazitaxel and had an applicable efficacy assessment conducted post treatment. 3 patients were not evaluable for efficacy ^: Eisenberger, M, et al. J Clin Oncol, 2017;35(28):3198-206 . * Excludes hormonal therapies DEP® cabazitaxel Phase 2 trial Positive Interim Results in Prostate Cancer Cohort Presented at ESMO 2022 DEP® cabazitaxel Phase 2 Trial Prostate Cancer Cohort Starpharma Holdings Limited: Investor Presentation DEP® Cabazitaxel 32% 24% 40% Prior Chemotherapy Regimens in Trial Patients* • Only 16%* of Jevtana® patients had received ≥2 prior regimens whereas • 56% of DEP® cabazitaxel patients had received ≥2 prior regimens and • >95% of DEP® cabazitaxel patients and received prior taxanes, including docetaxel and cabazitaxel (Jevtana®) 14 Efficacy Measure DEP® cabazitaxel (20 mg/m2) Jevtana®1 (20 mg/m2) PSA Reduction ≥50% 52.4% 29.5% Partial Response# 18.2% 18.5% Improved/stable Bone Disease 83.3% Not reported 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% Longer Progression-Free Survival (PFS) (median) DEP® cabazitaxel (20 mg/m2) (N=25) Jevtana® 1 (20 mg/m2) (N=598*) Jevtana® 1 25 mg/m2) (N=602*) Jevtana® 2 (25 mg/m2) (N=378*) 3.9 months 2.9 months 3.5 months 2.8 months PFS = Composite endpoint from date of randomization to date of first tumour progression, PSA progression, or death. Note that the Jevtana studies1,2 also included pain progression * Intent-to-treat populations DEP® cabazitaxel had significantly fewer Grade 3/4 Treatment Related Adverse Events vs. Jevtana® DEP® cabazitaxel (20 mg/m2) (N=25) Jevtana® 1 (20 mg/m2) (N=580†) Jevtana®1 (25 mg/m2) (N=595†) 7.5% 39.7% 54.5% Key Efficacy Measures Key Safety Measures DEP® cabazitaxel Phase 2 trial Key interim efficacy and safety findings in prostate cohort vs. Jevtana®1,2 Starpharma Holdings Limited: Investor Presentation 1 – Eisenberger, M., et al., PROSELICA. J Clin Oncol, 2017, 35(28):3198-206. 2 – de Bono, JS, et al. Lancet, 2010;376(9747):1147-54. # Partial Response: ≥30% reduction in measurable target tumour size † Safety populations (received at least 1 dose) 15 DEP® cabazitaxel: clinical case study 69-year-old woman with stage IV platinum resistant ovarian cancer 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 Following treatment with DEP® cabazitaxel (6 cycles), the patient achieved: • 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 CT scans of lung metastases BASELINE AFTER 6 CYCLES 96% reduction in tumour marker Reduction in Tumour Marker on DEP® cabazitaxel treatment Starpharma Holdings Limited: Investor Presentation 16 DEP® irinotecan (SN38) : Advantages over Camptosar® DEP® irinotecan: Phase 2 trial ongoing Encouraging efficacy signals across multiple tumour types enhancing market potential Camptosar® Peak sales - US$1.1B DEP® irinotecan (SN38 nanoparticle formulation) FDA “Black Box” warnings: 1. Severe, life-threatening diarrhoea 2. Myelosuppression • No severe diarrhoea observed; • Less myelosuppression / neutropenia Formulation requires conversion to SN-38 (active component of irinotecan) in the body DEP® conjugate of SN38 does not require hepatic conversion – less interpatient variability, reduced toxicity Other AEs include early diarrhoea which may be accompanied by cholinergic symptoms (salivation, diarrhoea, blurry vision, sweating, incontinence) No cases of severe diarrhoea and no cholinergic symptoms observed Indication: • Colorectal, in combination with 5-fluorouracil (5-FU) and leucovorin • Colorectal (single agent) Indication: • Colorectal • Additional potential indications include ovarian, gastro- oesophageal, and pancreatic Expired Patents • EU – expired • US – expired New/extended IP • EU – 2039 • US – 2039 (potential for 5-year extension) DEP® irinotecan • Phase 2 trial underway; encouraging efficacy signals observed • 94 patients recruited to date (monotherapy and combination) • Monotherapy recruitment in final stages Interim observations • Encouraging efficacy signals observed include prolonged stable disease, impressive tumour shrinkage and reductions in tumour marker levels for a number of tumour types, including colorectal and hard-to-treat tumours such as ovarian (including platinum resistant), gastroesophageal, and pancreatic cancers. • No cases of severe diarrhoea with DEP® irinotecan – this side effect is experienced by 20-40% of patients with conventional irinotecan, and often requires hospitalisation^. • Less severe side effects than typically associated with Camptosar®; AEs observed included nausea, vomiting, alopecia and neutropenia. Combination study (recruiting): • DEP® irinotecan + 5-FU + Leucovorin (‘FOLFIRI’) Trial Sites ^ H. Bleiberg. & E. Cvitkovic. (1996) Characterisation and Clinical Management of CPT -11 (Irinotecan)-induced Adverse Events. European Journal of Cancer, Volume 32 Supplement 3. Starpharma Holdings Limited: Investor Presentation 17 Gastro-intestinal toxicity much improved with DEP® irinotecan treatment: • ~20-40% of Camptosar® treated patients suffer from severe diarrhoea (≥ 7 stools per day), often require hospitalisation • DEP® irinotecan patients experienced no severe diarrhoea No cholinergic syndrome: • ~47% colorectal cancer patients treated with Camptosar® experienced cholinergic syndrome • No DEP® irinotecan patients experienced cholinergic syndrome Severe diarrhoea • Grade 3: ≥7 stools per day over baseline; hospitalisation indicated. • Grade 4: life-threatening consequences, and urgent intervention is required. Cholinergic syndrome Symptoms include sweats, flushing, diarrhoea, abdominal cramping, salivation, visual disturbances, miosis and lacrimation. DEP® irinotecan: improved safety profile Safety Outcome DEP® irinotecan* Camptosar®†^ GASTROINTESTINAL Diarrhoea ≥ grade 3 0 ∼20-40% Nausea ≥ grade 3 2.2% ∼10% Vomiting ≥ grade 3 1.1% ∼10% NERVOUS SYSTEM Cholinergic Syndrome 0% ~47% DEP® irinotecan - improved tolerability profile c.f. published data on Camptosar®† *(8 - 15 mg/m2 SN38) Q3W | N=90 ^(350 mg/m2) Q3W | N=765 †H. Bleiberg. & E. Cvitkovic. (1996) Characterisation and Clinical Management of CPT-11 (Irinotecan)-induced Adverse Events. European Journal of Cancer, Volume 32 Supplement 3. †https://www.medicines.org.uk/emc/product/6506- UK SmPC April 2022 Starpharma Holdings Limited: Investor Presentation 18 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%* 0 2000 4000 6000 8000 10000 12000 14000 16000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Tumour Marker Level CA-125 (U/mL) Cycle Patient was heavily pre-treated prior to entering the DEP® irinotecan study, following • 16 treatment cycles of 5 different kinds of anti- cancer therapy Following treatment with DEP® irinotecan, the patient achieved: • Complete resolution of cancer-related ascites and pleural effusion • >95% reduction in tumour biomarker (CA- 125) • Response maintained for more than 36 weeks *https://ocrahope.org/patients/about-ovarian-cancer/staging/ >95% reduction in tumour biomarker Starpharma Holdings Limited: Investor Presentation 19 DEP® docetaxel • Phase 2 trial; monotherapy recruitment and treatment complete; nintedanib combo complete; gemcitabine combo ongoing • 80 patients recruited (monotherapy and combination) to date Interim observations • Encouraging efficacy signals observed, including prolonged stable disease and significant tumour shrinkage in patients with a focus on pancreatic, gastro- oesophageal, and cholangiocarcinoma. Includes heavily pre-treated patients who have failed multiple other lines of treatment. • These impressive tumour responses with DEP® docetaxel include stable disease for up to 40 weeks and significant tumour shrinkage in late- stage oesophageal cancer. • Final patient recruitment is focused on hard-to-treat cancers, in parallel with the combination arm of DEP® docetaxel + gemcitabine. • No anaphylaxis, notable lack of bone marrow toxicity (e.g., neutropenia) and other common side effects including hair-loss, mouth ulcers and oedema. Combination studies • DEP® docetaxel + gemcitabine (Gemzar®) • DEP® docetaxel + nintedanib (Vargatef®) Trial Sites DEP® docetaxel Encouraging efficacy signals across multiple tumour types Taxotere® Peak sales ~US$3.1B DEP® docetaxel Starpharma’s patented, nanoparticle formulation FDA “Black Box” warnings: 1. Neutropenia 2. Severe hypersensitivity (polysorbate-80 detergent) No neutropenic deaths or severe hypersensitivity observed; detergent-free formulation; therefore, would not expect “black box” warnings Premedication required: Oral corticosteroids Premedication not required; polysorbate-80/detergent-free formulation Expired Patents • EU – expired • US – expired New/extended IP • EU – 2032 • US – 2032 (potential for 5- year extension) Starpharma Holdings Limited: Investor Presentation 20 DEP® docetaxel: clinical case study DEP® docetaxel in combination with gemcitabine 60-year-old woman with stage IV uterine cancer Patient heavily pre-treated prior to entering the study: • >11 treatment cycles of 3 different kinds of anti-cancer therapies Following treatment with DEP® docetaxel in combination with gemcitabine, the patient achieved: • Stable disease response maintained for >23 weeks • Tumour lesion reductions of up to 52% observed BASELINE AFTER 3 CYCLES 32% reduction in tumour lesion Starpharma Holdings Limited: Investor Presentation 21 • The innovative therapeutic area of ADCs continues to grow, with many high value deals signed in recent years • The ADC market is expected to reach to more than US$15 billion by 2030* • Starpharma’s DEP® technology represents a valuable partnering platform which has the potential to generate revenue through royalties and milestones • Starpharma has two DEP® research agreements with MSD for dendrimer-based ADCs using the DEP® technology. DEP® antibody drug conjugate (ADC) partnerships with leading companies Significant corporate activity in ADCs US$6B Jul 2020 US$2.75B Nov 2020 €1.2B Dec 2020 US$3.1B Jun 2021 US$1.7B Feb 2022 US$936M Jul 2022 US$1.1B Feb 2023 Significant corporate activity in ADCs *Colombo and Rich, The therapeutic window of antibody drug conjugates: A dogma in need of revision, Cancer Cell (2022), https://doi.org/10.1016/j.ccell.2022.09.016 Starpharma Holdings Limited: Investor Presentation DEP® ADC benefits include: • Can be tuned to provide optimal characteristics • Highly efficacious, providing enhanced anti-cancer activity • Penetrates deeply into tumours, binding strongly to target cells, and internalised for enhanced performance • Enhanced efficacy leading to enhanced survival 22 Starpharma has developed a HER2-targeted DEP® ADC, utilising the active metabolite of irinotecan, SN-38, which outperformed Enhertu®, showing significantly greater anti-tumour activity and improved survival in a HER2+ human cancer xenograft model. ADCs represent an innovative and growing area of cancer treatment. The global ADC market grew from USD ~$5.8 billion in 2021 to USD ~$8.0 billion in 2022 and is projected to reach USD ~$22.9 billion in 2030. HER2-targeted DEP® SN-38 ADC outperforms in HER2+ human cancer model Starpharma Holdings Limited: Investor Presentation SKOV-3 tumour growth rates - Mean ± S.E.M. Effect of HER2-targeted DEP® SN-38 ADC vs. Enhertu® on Tumour Volume Over Time HER2 ADCs Drug-to-Antibody Ratios, Drug Payload Key advantages of Starpharma’s DEP® platform for ADCs include: • Ability to achieve higher DAR, and higher drug payload than conventional ADCs Greater flexibility in terms of linker strategies to precisely control drug release profiles; • Capacity to widen the therapeutic index of toxic drug payloads; and • Flexibility in terms of compatible targeting agents, including biologics (whole antibodies and fragments), small molecules, peptides and other approaches. 23 DEP® ADCs offer multiple benefits Enhanced efficacy leads to enhanced survival* Highly efficacious – enhanced anticancer activity* * human ovarian cancer (SKOV-3) xenograft model 0 20 40 60 0 50 100 Days Percent survival Treatment phase 36 days 43 days 50 days >50 days p<0.0001 (Log-rank Mantel-Cox test) Vehicle Herceptin (40mg/kg) Kadcyla (40mg/kg) DEP ADC conjugate Benefits of DEP® ADCS Can be tuned to provide optimal characteristics 0 2 4 6 8 10 0 10 20 30 100 200 300 400 Tumour:Blood ratio over time Days Post Injection Tumour:Blood ratio G2 G3 G4 G5 % alive Day 50 Vehicle Herceptin Kadcyla DEP® HER2 ADC 0% 0% 33% 100% Penetrate deeply into tumours, bind strongly to target cells and are internalised for enhanced performance DEP® ADC (red) Target Cell Starpharma Holdings Limited: Investor Presentation 24 US$3.9B Oct 2017 US$2.1B Oct 2018 US$641M Oct 2019 €418M Jan 2021 US$300M Mar 2021 €520M Dec 2021 ~US$2B Nov 2022 • 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 recent years - over US$17 billion invested in M&A transactions between 2014 and June 2022* in the radiopharmaceutical market • Starpharma’s DEP® platform has yielded multiple radiotheranostic DEP® candidates and Starpharma continues to evaluate licensing opportunities for its internal radiotheranostic candidates and engages in discussions with potential partners exploring access to Starpharma’s DEP® platform ^MEDraysintell Nuclear medicine report Edition 2022 *https://www.medraysintell.com/_files/ugd/1beeab_6bc27b0bbe664527aca68f41bf7de2bc.pdf DEP® - a versatile platform with flexible applicability to a range of radiopharmaceuticals Significant Corporate Deals in Radiotheranostics Starpharma Holdings Limited: Investor Presentation DEP® radiopharmaceutical benefits include: • Flexibility in size and structure of nanoparticle (allowing different targeting groups and pharmacokinetics) • Enhanced tumour accumulation due to the enhanced permeability and retention (EPR) effect (10x nanobody alone) • Enhanced tissue targeting and retention due to specific receptor binding (and internalisation) o Enhanced entry and specific accumulation allows for enhanced PET visualisation (diagnostic) o Enhanced accumulation and cellular internalisation in tumours delivers enhanced efficacy and less off-target toxicity o Potential to use DEP® in diagnostic and therapeutic approaches 25 HER2- DEP® HER2-zirconium • Achieved significant tumour accumulation: >100x in tumour vs. blood in a preclinical human HER2-positive ovarian cancer model • DEP® HER2-zirconium pharmacokinetics allow for optimal visualisation in PET imaging DEP® HER2-lutetium • Achieved complete tumour regression in a preclinical human HER2-positive breast cancer model • Was extremely well tolerated • 100% survival throughout experiment • Anti-tumour effect was dose-dependent • Outperformed HER2 antibody, Herceptin®, labelled with 177Lu DEP® radiotherapeutics 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 0 50 100 150 500 1000 1500 2000 2500 Exposure Dose dependant Tumour Volume Change (% of Initial Volume) Mean Tumour Volume (% of Initial) Control DEP HER2 Lu 177 - 1x9 MBq DEP HER2 Lu 177 - 1x15 MBq Novel DEP® radiotheranostics (radiodiagnostic and radiotherapeutic) DEP® radiodiagnostic Starpharma Holdings Limited: Investor Presentation 26 Targeted DEP® radiotheranostics offer multiple benefits DEP® benefits include: • Flexibility in size and structure of nanoparticle (allowing different targeting groups and pharmacokinetics) • Enhanced tumour accumulation due to the enhanced permeability and retention (EPR) effect (10x nanobody alone) • Enhanced tissue targeting and retention due to specific receptor binding (and internalisation) o Enhanced entry and specific accumulation allows for enhanced PET visualisation (diagnostic) o Enhanced accumulation and cellular internalisation in tumours delivers enhanced efficacy and less off-target toxicity o Potential to use DEP® in diagnostic and therapeutic approaches DEP Chelator Radioisotope HER-2 targeting moiety DEP® conjugate *SKOV-3 In Vivo Tumour - Mouse High levels of accumulation in tumour tissue allows targeted DEP® radio conjugates to be valuable in radiotheranostics Starpharma Holdings Limited: Investor Presentation 27 DEP® irinotecan: clinical case study 55-year-old woman with stage IV colorectal cancer Patient was heavily pre-treated prior to entering the DEP® irinotecan study, following: • 19 treatment cycles of 4 different kinds of anti-cancer therapy • Progressed on prior irinotecan combination therapy Following treatment with DEP® irinotecan, the patient achieved: • Significant shrinkage of tumour lesions and reduction in tumour biomarkers • Up to 74% reduction in tumour biomarkers • Response maintained for more than 27 weeks BASELINE POST-TREATMENT Colorectal cancer is the 3rd most commonly diagnosed cancer and 4th leading cause of cancer death worldwide* 24% reduction in tumour after treatment with DEP® irinotecan *Favoriti et al, Worldwide burden of colorectal cancer: a review. Updates in Surgery: 68, 7-11, 2016. Starpharma Holdings Limited: Investor Presentation 28 VivaGel® Condom VivaGel® BV VIRALEZE™ Nasal Spray Marketed products Multiple revenue streams with a growing distribution network Starpharma Holdings Limited: Investor Presentation 29 VIRALEZE™ features • Broad-spectrum antiviral nasal spray • Contains a novel dendrimer molecule, SPL7013, which traps and blocks multiple cold/respiratory viruses including influenza, RSV, coronaviruses (including SARS-CoV-2) • Blocks virus replication in lab studies both before and after exposure of cells to virus • Well tolerated; acts locally in the nasal cavity and is not absorbed into the bloodstream • Provides a protective moisture barrier to help keep nasal tissue hydrated • Room temperature storage • Convenient for use in a range of settings, including travel, work, events, and other crowded environments Paull J.R.A., et al. Antiviral Res 2021;191:105089 VIRALEZE™ antiviral nasal spray How VIRALEZE™ works • Viruses infect human cells by using viral surface proteins, or “spikes”, to attach to receptor proteins on the surface of human cells • Antiviral agent in VIRALEZE™, SPL7013, physically traps and blocks viral spike proteins thus preventing infection of cells VIRALEZE™ acts as a barrier between the viral ‘spike’ proteins and the cell membrane, irreversibly trapping viral particles – blocking virus from entering the human cells VIRALEZE™ is not approved for use or supply in Australia Starpharma Holdings Limited: Investor Presentation 30 VIRALEZE™ treated animals showed markedly reduced infectious SARS-CoV-2 virus in the respiratory tract 100% of animals^ treated with VIRALEZE™ showed no evidence of infectious SARS-CoV-2 Omicron virus in • lung, • trachea, • nasal cavity, and • blood. VIRALEZE™ protects against SARS-CoV-2 Omicron and reduces infectivity in challenge model New data presented at International Virology Conference – Dec ‘22 VIRALEZE™ Regimen Tissue Reduction in SARS- CoV-2 Omicron Viral Load vs Saline Pre- and Post-challenge Lung >99.999% Post-challenge >99.999% Pre- and Post-challenge Trachea >99.999% Post-challenge 99.999% Pre- and Post-challenge Nasal Swab 99.4% Post-challenge 82.9% VIRALEZE™ treated animals showed markedly reduced viral load after challenge with SARS-CoV-2 virus VIRALEZE™ effectively eliminated SARS-CoV-2 Omicron virus (≥99.999% reduction in viral load) in lung and trachea of mice challenged with virus when compared with saline-treated animals, even when administered only after exposure to virus. VIRALEZE™- treated animals also showed significantly reduced proinflammatory cytokines vs saline and normal body-weight gain, indicating protection against disease. ^N=6 Reduced infectivity Full data presented at Respi DART 2022 Conference in Mexico Day 7 Day10 0 2 4 6 8 Lung Cytokine IL-6 Day Post-challenge IL-6 (pg/mg) ******** **** p < 0.0001 vs saline **** **** PBS VIRALEZE™ - Pre- and Post-challenge VIRALEZE™ - Post-challenge Starpharma Holdings Limited: Investor Presentation VIRALEZE™ is not approved for use or supply in Australia 31 VIRALEZE™ significantly outperformed comparator nasal sprays in: • reducing SARS-CoV-2 Omicron viral load by 99.4% vs saline; and • reducing the level of infectious virus in nasal cavity, lung, trachea^ VIRALEZE™ antiviral nasal spray outperforms comparators in SARS-CoV-2 Omicron challenge model New data presented at International Virology Conference – Dec ‘22 Nasal Spray Reduction in Infectious SARS- CoV-2 Omicron in Lung vs Saline VIRALEZE™ >99.9% Iota-carrageenan (e.g., Cold Defence) 49.9% Nitric Oxide (NONS™, SaNOtize) 74.9% HPMC/low pH (Vicks® First Defence) 74.9% Saline VIRALEZE™ Iota-carrageenan Nitric OxideHPMC/low pH Nasal Cavity Infectious Virus SARS-CoV-2 (PFU/swab) VIRALEZE™ prevented infectious SARS-CoV-2 Omicron virus in the nasal cavity (>99.9% vs saline) 10 100 1000 Saline VIRALEZE™ Iota-carrageenan Nitric OxideHPMC/low pH Lung Infectious Virus SARS-CoV-2 (PFU/mg) VIRALEZE™ prevented infectious SARS-CoV-2 Omicron virus in the lung (>99.9% vs saline) 10 100 1000 10000 ^Day 7 post-challenge NB: Y axis = log scale Full data presented at Respi DART 2022 conference in Mexico Starpharma Holdings Limited: Investor Presentation VIRALEZE™ is not approved for use or supply in Australia 32 • VIRALEZE™ antiviral nasal spray is registered in more than 35 countries around the world* • Available in pharmacies, retail outlets and online in a number of markets • Partnered with: • LloydsPharmacy in the UK; • ADMENTA Italia Group in Italy; • HealthCo/TBL & Nam Thanh Mel xxxxxxxx in Vietnam; • E&N in countries in the Middle East; and • Hengan in Hong Kong and Macau • Other VIRALEZE™ regulatory submissions are in progress and commercial discussions for multiple regions/countries underway • VIRALEZE™ post market clinical study well advanced in the UK, with >80% of participants recruited VIRALEZE™ market and regulatory activity Starpharma is also in discussions with multiple potential commercial partners in other regions with a focus on commercially attractive markets which have rapid regulatory pathways VIRALEZE™ Webstore www.Viraleze.co (outside Australia) EUROPE UK MIDDLE EAST ASIA *VIRALEZE™ is not approved for use or supply in Australia Starpharma Holdings Limited: Investor Presentation 33 VIRALEZE™ clinical trial in patients with COVID-19 underway • Small, post-market randomised clinical study of VIRALEZE™ vs. placebo nasal spray in patients with COVID-19 Will generate valuable clinical data to support ongoing marketing, commercialisation and regulatory activities • Will examine the antiviral performance and ability of VIRALEZE™ to reduce viral load, as well as to monitor its impact on duration of symptoms and disease progression • Study is recruiting patients at Ashford and St Peter’s Hospital, UK, an experienced site that has conducted other nasal spray studies; with other sites as necessary • Primary endpoint: cumulative SARS-CoV-2 viral load, or “area under the curve”, over a seven day treatment period • Trial design is based on other similar studies of products that VIRALEZE™ outperformed in nonclinical studies Starpharma Holdings Limited: Investor Presentation VIRALEZE™ is not approved for use or supply in Australia 34 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 reproductive health of women2 • BV treatment has typically involved antibiotics (e.g., metronidazole). Antibiotic resistance is a problem, antibiotics have unpleasant side effects, and there is demand for alternative approaches. Other current BV therapies do not prevent BV recurring *Registered indications may differ by market VivaGel® BV A breakthrough product for the treatment of BV and prevention of recurrent BV* 1. Peebles K, et al., (2019). High global burden and costs of bacterial vaginosis: a systematic review and meta- analysis. Sex Transm Dis 46(5), 304. 2. Turovskiy Y, et al., (2011). The aetiology of bacterial vaginosis. J Appl Microbiol 110(5), 1105. VivaGel® BV • Novel, non-antibiotic therapy • Prevents pathogenic bacteria from adhering to the vaginal wall and disrupts and inhibits the formation of pathogenic bacterial biofilms • Well tolerated, with vulvovaginal candidiasis being the only treatment-related adverse event reported to occur more often than with the placebo 35 • Registered in >45 countries • Launched in Europe, the UK, Asia, South Africa, Australia & New Zealand • Further launches and regulatory submissions progressing in multiple regions VivaGel® BV distribution network and regulatory activity *In the US, a formal dispute resolution process is ongoing with the FDA for VivaGel® BV. As part of this process, Starpharma has had extensive external advice, met with FDA multiple times and made a number of submissions of data and analyses to FDA. Starpharma continues to work with its advisors, and the FDA, as part of this ongoing dispute resolution process and we are planning a further submission in 2023. ON MARKET ON MARKET NORTH AMERICA* LATAM AFRICA ASIA MIDDLE EASTEUROPE AUSTRALIA NZ Pre-launch preparations ON MARKET ON MARKET ON MARKET 36 • The VivaGel® condom incorporates SPL7013 antiviral, which has demonstrated activity in HIV, HSV-2, HPV • Okamoto launched an additional VivaGel® condom range in Japan, under the brand name Pure Marguerite, targeting youth and female segments of the market • Starpharma continues to support its marketing partner, Okamoto, to progress registration in multiple countries in Asia to support further commercialisation of the VivaGel® condom SPL7013 VivaGel® Condom Starpharma Holdings Limited: Investor Presentation 37 FY22 Result • Strong cash position with $38.9M as at 31 March 2023 • Completed enrolment and treatment of patients for the Phase 2 monotherapy trials of DEP® cabazitaxel and DEP® docetaxel • AstraZeneca’s AZD0466 DEP® program reported encouraging results and progress at AACR Annual Meeting • HER2-targeted DEP® SN-38 ADC outperformed the marketed ADC product, Enhertu®, with significant anti- tumour activity • VIRALEZE™ post-market study well advanced, with more than 70% of participants recruited Key Financials H1 FY23 A$M H1 FY22 A$M FY22 A$M FY21 A$M Revenue 1.6 1.9 4.9 2.2 Other Income 0.1 0.1 0.3 1.3 Loss for the period (8.3) (8.4) (16.2) (19.7) Net operating cash outflows (5.1) (11.2) (13.2) (14.8) Starpharma Holdings Limited: Investor Presentation Financial Summary Strong balance sheet with revenues from product sales and partnerships Q3 FY23 Highlights Cash as at 31 Mar 2023: $38.9M 38 Key value drivers and outlook DEP® Drug Delivery SPL7013 Products Internal DEP® Clinical-stage Assets • Complete and report results Phase 2 DEP® trials • Progress value-adding combination studies Partnered DEP® Programs • Progress existing partnerships with AstraZeneca, MSD, Chase Sun, and Genentech • Execute new and/or expand existing DEP® partnerships AZD0466 Clinical Program • AstraZeneca clinical progress - completion of dose escalation - Phase 2 start (milestone) Preclinical DEP® Programs • Advance/partner DEP® radiotheranostics, DEP® ADCs and other DEP® candidates VIRALEZE™ Nasal Spray • Further commercial roll-out, registrations and product launches • Complete recruitment and report UK clinical study • Further distribution arrangements with commercial partners • Continue to generate clinical and antiviral data to support and expand commercialisation VivaGel® BV • Commercialisation in Europe, Asia and in other markets • Further regulatory approvals and launches for VivaGel® BV; milestones, product sales/royalties • FDA review process VivaGel® condom • Approvals/launches in additional countries SPL7013 • Further development/co-development • Continued testing against important infectious pathogens Starpharma Holdings Limited: Investor Presentation 39 Director Independence Compliance with ASX Corporate Governance Principles and Recommendations. ‘Having a diverse workforce drives better outcomes for our business and provides the company with greater breadth of experience and ideas’. Starpharma is committed to the principles underpinning best practice in corporate governance, with a commitment to the highest standards of legislative compliance and financial and ethical behaviour. Starpharma has adopted documented procedures and processes to ensure all waste products are disposed of strictly in accordance with relevant environmental regulations. ENVIRONMENT Starpharma is committed to conducting its operations in an environmentally responsible manner. Appropriate systems in place to comply with relevant federal, state, and local government environment regulations. 43% of roles, including leadership roles are held by women. 50% of all roles held by women. Starpharma’s supplier code includes a wide range of business practices to provide suppliers with clear expectations regarding their conduct. 18 countries represented by a small, diverse group of employees. No breaches of: - Code of Conduct - Anti-bribery - Whistleblowing View our Climate Change Position Statement online GOVERNANCESOCIAL COMMITTEES 100% BOARD 80% The nature of Starpharma's products affords the opportunity of changing lives for the better Download ESG Report Starpharma’s continued commitment to Environment, Social and Governance (ESG) Starpharma Holdings Limited: Investor Presentation 40 Investor Relations Queries: [email protected] 4-6 Southampton Crescent Abbotsford VIC 3067 www.starpharma.com ASX:SPL | OTC:SPHRY
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