Announcement PDF ASX Announcement Appendix 4E: Preliminary Financial Report under ASX Listing Rule 4.3A Current reporting period: Year ended 30 June 2024 Prior corresponding period: Year ended 30 June 2023 Results for announcement to the market $’000 Revenue from continuing operations (Appendix 4E item 2.1) Up (increase) Adjusted Revenue* Down (excluding Mundipharma settlement) Loss from continuing operations after tax attributable to members (Appendix 4E item 2.2, 2.3) Adjusted Loss* (excluding Mundipharma settlement) (decrease) 132% to $9,756 24% to $3,203 48% to $8,165 6% to $14,718 Down (decrease) Down (decrease) *Adjusted Revenue is calculated as Revenue ($9,756,000) from continuing operations less nonrecurring revenue of $6,553,000 relating to the commercial settlement and termination of the VivaGel® BV license and supply agreement with Mundipharma in August 2023. Adjusted Loss likewise subtracts the above nonrecurring revenue from the Loss for the period. Dividends (Appendix 4E items 2.4 and 2.5) No dividends have been paid or declared by the entity since the beginning of the current reporting period. No dividends were paid for the previous corresponding period. No record date for determining entitlements to dividends has been declared. Explanation of Revenue (Appendix 4E item 2.6) Revenue of $9,756,000 (2023: $4,208,000) for the year includes product sales, royalty and license, and research revenue from commercial partners of $8,289,000 (2023: $2,939,000), and interest income on cash invested in term deposits of $1,467,000 (2023: $1,269,000). Revenue included a nonrecurring $6,553,000 from the commercial settlement of the VivaGel® BV license and supply agreement with Mundipharma in August 2023. Excluding the Mundipharma settlement, half-year adjusted revenue was $3,203,000, an 24% decrease on prior corresponding period revenues, with lower product sales in the current period. For further details, refer to the Annual Report which follows this announcement. Explanation of Loss (Appendix 4E item 2.6) The loss after tax was $8,165,000 (2023: $15,638,000 loss) and includes nonrecurring revenue of $6,553,000 from the Mundipharma commercial settlement. After adjusting for the non-recurring revenue, the loss after tax is $14,718,000, $920,000 less than the prior year. Research and product development expense was $10,053000 (2023: $11,239,000) net of the Australian Government’s R&D tax incentive. Research expenditures are primarily associated with the internal DEP® drug delivery programs, including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan, DEP® ADCs and DEP® radiotheranostics, and the post-market study of Viraleze™. For further details, refer to the Annual Report which follows this announcement. Financial Statements (Appendix 4E items 3, 4 and 5) Refer to the Annual Report which follows this announcement. Accumulated Losses (Appendix 4E item 6) Refer to note 18 in the Annual Report, which follows this announcement. Net Tangible Asset Backing (Appendix 4E item 9) Net tangible asset (NTA) backing per ordinary share at 30 June 2024 is $0.07 (2023: $0.08). Other Significant Information (Appendix 4E item 12) Refer to the Annual Report which follows this announcement. Commentary on Results (Appendix 4E item 14) Refer to the Annual Report, which follows this announcement, including the Operating and Financial Review in the Directors’ Report. Audit (Appendix 4E items 15 to 17) The audit of the financial statements and notes has been completed and the Auditors’ Report to members is contained in the Annual Report, which follows this announcement. The above NTA backing calculation is considered a non-IFRS value and has not been audited or reviewed in accordance with Australian Accounting Standards. Appendix 4E items 7, 8, 10, 11, and 13 are not applicable. ASX Announcement Starpharma Annual Report and Full-Year Financial Results Melbourne, Australia; 22 August 2024: Starpharma (ASX: SPL, OTCQX: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, today releases its annual report and full-year financial results for the year ended 30 June 2024. Starpharma’s Chief Executive Officer, Cheryl Maley, commented: "Starpharma is pleased to present its annual report and full-year financial results for the 2024 financial year. Starpharma achieved several important milestones during the year, including reporting results from multiple clinical studies, advancing key projects in our pipeline, and forming new partnerships, all of which will contribute to our continued growth. “Our primary focus remains on delivering impactful healthcare, medical, and pharmaceutical solutions that not only drive value for our shareholders but also make a meaningful difference in the lives of people, especially those battling serious illnesses like cancer. “We are aware of the challenges we face with our underperforming share price and small market capitalisation. Everyone at Starpharma is committed to realising our strategic imperatives – maximising DEP® asset value, accelerating early asset development, and building long-term sustainability – and we are taking the necessary steps to achieve them. We are confident that reaching these goals will help to increase shareholder value, and we look forward to sharing our progress with our shareholders as it unfolds. “Importantly, we have sufficient capital to support our objectives, with a cash balance of $23.4 million as at 30 June 2024. The completion of several clinical programs has led to a reduction in our research and development expenses, extending our cash runway. Shareholders should know that we are focusing on increasing revenue, with a number of opportunities on the horizon.” Key Financial Results • • • • • Ended the 2024 financial year with $23.4 million cash on hand. Reported loss down 48% to $8.2M (FY23: $15.6M). Net cash outflow of $11.8 million (FY23 $14.8 million), with cash outflow from operations of $6.9 million, down $7.4 million from FY23 ($14.3 million) Revenue up 132% to $9.8M (FY23: $4.2M), including the one-time $6.6M cash payment from Mundipharma on termination of the VivaGel® BV license and supply agreement. Starpharma received a $7.2 million FY23 R&D tax incentive refund in October 2023, with a further FY24 R&D tax incentive refund of approximately $5.0 million expected in H1 FY25. Operational Highlights • Reported the results from all three Phase II clinical trial programs – DEP® SN38, DEP® cabazitaxel, and DEP® docetaxel. All three programs provided clinical validation of the DEP® technology; over 350 patients have now been treated using DEP® products. The trials showed promising anti-tumour activity and improvements in efficacy, including longer median progression-free survival (mPFS) and higher overall survival (OS) rates, than published data on standard-of-care treatment regimens. The DEP® products also demonstrated improved tolerability profiles in patients with advanced, heavily pre-treated cancers, including lower • • • • • • rates of severe adverse events, compared with standard-of-care treatments. Importantly, the DEP® treatments extended the lives of many patients and allowed many to live more fulfilling and enriched lives. Confirmed plans to progress Starpharma’s DEP® HER2 radiodiagnostic program towards a first-in-human clinical trial, following promising early-stage imaging data in HER2-positive (HER2+) cancers. Starpharma’s DEP® radiopharmaceuticals program continues to show that DEP® dendrimers are a promising, versatile, and multifunctional platform for developing precision radiotheranostics for cancer imaging and therapeutic applications. This dendrimer technology bridges the gap between small molecules and large antibodies, offering the potential to improve performance and overcome limitations associated with existing technologies and treatments. Partnered with Medicxi, a leading life sciences investment firm, to co-found Petalion Therapeutics, an asset-centric company focusing on developing a novel cancer therapy using Starpharma’s dendrimer technology. Starpharma receives an equity holding of 22.5% in Petalion in return for licensing certain intellectual property for the research, development, and commercialisation of this potential new cancer therapy. Presented the advantages of Starpharma’s DEP® dendrimer technology in oncology at multiple international industry conferences, including the American Society of Clinical Oncology (ASCO) Annual Meeting in the US, the ASCO Gastrointestinal Cancers Symposium in the US, the International Conference on Molecular Targets, co-hosted by the American Association of Cancer Research (AACR), National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in the US, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Canada. Partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel® BV in 13 countries across the Middle East and North Africa region. Bacterial vaginosis is highly prevalent in this region, presenting a market need and commercial opportunity for new and effective therapeutic approaches. This agreement came shortly after Starpharma terminated the VivaGel® BV license to Mundipharma, regained the commercial rights to Mundipharma's territories, and received a one-time A$6.6 million cash payment from Mundipharma. Generated clinical evidence demonstrating the effectiveness of Viraleze™ in humans. The results from the post-market clinical study of Viraleze™ in COVID-19 patients showed that Viraleze™ achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of patients aged 45 and over. This data will support the regulatory transition to the new European Medical Device Regulations, which come into full effect in 2029. The findings will also support ongoing marketing and commercial activities. Achieved Great Place to Work® certification for the second consecutive year. This external recognition is a testament to our team’s positive workplace environment and company culture. 2 About Starpharma Starpharma ASX: SPL, OTCQX: 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@weworldwide.com Starpharma Holdings Limited Cheryl Maley, 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”, 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 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. 3 Delivering meaningful patient outcomes with advanced dendrimer technology Annual Report 2024 Starpharma 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. Contents 01 02 04 06 Highlights Chairman’s Report Chief Executive Officer’s Report Key Focus Area 1: Maximise DEP® Asset Value 09 11 13 14 Key Focus Area 2: Accelerate Early Asset Development Key Focus Area 3: Build Long-Term Sustainability Outlook Directors’ Report (including Remuneration Report) 55 56 86 87 Auditor’s Independence Declaration Annual Financial Report Directors’ Declaration Independent Auditor’s Report 91 93 95 Shareholder Information Intellectual Property Report Corporate Directory Starpharma Holdings Limited ABN 20 078 532 180 Annual Report 2024 Highlights Reported the results from all three Phase II clinical trial programs – DEP® SN38 (DEP® irinotecan), DEP® cabazitaxel, and DEP® docetaxel. All three programs provided clinical validation of the DEP® technology; over 350 patients have now been treated using DEP® products. The trials showed promising anti-cancer activity and improvements in efficacy, including longer median progression-free survival (mPFS) and higher overall survival (OS) rates, than published data on standard-ofcare regimens. The DEP® products also demonstrated improved tolerability profiles in patients with advanced cancers, including lower rates of severe adverse events, compared with standard-of-care treatments. Importantly, the DEP® treatments extended the lives of many patients who had failed other therapies and allowed many to live more fulfilling and enriched lives. Confirmed plans to progress Starpharma’s DEP® HER2 radiodiagnostic program towards a first-in-human clinical trial, following promising early-stage imaging data in HER2-positive (HER2+) cancers. Starpharma’s DEP® radiopharmaceuticals program continues to show that DEP® dendrimers are a promising, versatile, and multifunctional platform for developing precision radiotheranostics for cancer imaging and therapeutic applications. This dendrimer technology bridges the gap between small molecules and large antibodies, offering the potential to improve performance and overcome limitations associated with existing technologies and treatments. Partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel® BV in 13 countries across the Middle East and North Africa region. Bacterial vaginosis is highly prevalent in this region, presenting a market need and commercial opportunity for new and effective therapeutic approaches. This agreement came shortly after Starpharma terminated the VivaGel® BV license to Mundipharma, regained the commercial rights to Mundipharma’s territories, and received a one-time A$6.6 million cash payment from Mundipharma. Generated clinical evidence demonstrating the effectiveness of VIRALEZE™ in humans. The results from the post-market clinical study of VIRALEZE™ in COVID-19 patients showed that VIRALEZE™ achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of patients aged 45 and over. This data will support the regulatory transition to the new European Medical Device Regulations, which come into full effect in 2029. The findings will also support ongoing marketing and commercial activities. Partnered with Medicxi, a leading life sciences investment firm, to co-found Petalion Therapeutics, an asset-centric company focusing on developing a novel cancer therapy using Starpharma’s dendrimer technology. Starpharma receives an equity holding of 22.5% in Petalion in return for licensing certain intellectual property for the research,development, and commercialisation of this potential new cancer therapy. Received a $7.2 million research and development (R&D) tax incentive refund in October 2023 under the Australian Federal Government’s R&D Tax Incentive scheme. This tax refund pertains to eligible domestic and international R&D activities across Starpharma’s portfolio. The government scheme is important in supporting local companies like Starpharma to innovate and grow. Achieved Great Place to Work® certification for the second consecutive year. This external recognition is a testament to our team’s positive workplace environment and company culture. Starpharma Holdings Limited Presented the advantages of Starpharma’s DEP® dendrimer technology in oncology at multiple international industry conferences, including the American Society of Clinical Oncology (ASCO) Annual Meeting in the US, the ASCO Gastrointestinal Cancers Symposium in the US, the International Conference on Molecular Targets, co-hosted by the American Association of Cancer Research (AACR), National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in the US, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Canada. 1 Annual Report 2024 Chairman’s Report We are deeply committed to our mission of helping patients with significant illnesses, such as cancer, achieve improved treatment outcomes and quality of life through the application of our unique dendrimer technology. Rob Thomas AO Chairman Dear shareholders, On behalf of the Board of Directors, I am pleased to present Starpharma’s 2024 Annual Report to our fellow shareholders. 2024 marks a significant year of transition for Starpharma, highlighted by Cheryl Maley assuming the role of CEO after an international search and Jackie Fairley’s retirement. Jackie dedicated over 17 years to our company; we are grateful for her service and leadership, as well as her assistance during the transition. This leadership transition provided us with a valuable opportunity to reflect on Starpharma’s journey and learnings and critically evaluate our current position. While we believe the current share price does not reflect the true value of our dendrimer technology and current assets, the Board recognises that the market requires further commercial validation of our technology. This is our prime focus. We are deeply committed to our mission of helping patients with significant illnesses, such as cancer, achieve improved treatment outcomes and quality of life through the application of our unique dendrimer technology. Under Cheryl’s leadership, we are confident in our ability to execute our strategy effectively and improve shareholder value. Cheryl has already Starpharma Holdings Limited made a profound impact on our organisation, and we look forward to the future with great anticipation. During FY24, we were pleased to report positive outcomes from our Phase II clinical trials of DEP® SN38, DEP® cabazitaxel, and DEP® docetaxel. These trials have shown promising anti-tumour efficacy, including longer progression-free survival than published data on standard-of-care treatment options, and excellent tolerability profiles in patients with challenging-to-treat cancers. These are positive achievements and demonstrate the abilities of Starpharma’s DEP® technology in cementing our core mission of providing improved treatment options for patients with significant illnesses. We went on to showcase our leading candidates, DEP® SN38 and DEP® cabazitaxel, at the prestigious ASCO Annual Meeting in Chicago in June 2024. This recognition not only underscores the clinical interest in our Phase II results but also validates the potential of these treatments in cancer therapy. Starpharma’s dendrimer drug delivery technology has now demonstrated clinical benefits in over 350 patients, garnering strong support from clinical investigators and reinforcing our leadership in this field. We are at the forefront of this innovative technology. 2 350+ patients have experienced clinical benefits from Starpharma’s dendrimer drug delivery technology While chemotherapy remains fundamental in cancer treatment, emerging technologies such as radiopharmaceuticals and antibodydrug conjugates (ADCs) necessitate continuous adaptation and acceleration of our research and development efforts. Recent high-value mergers and acquisitions, as well as product approvals and successes, underscore the industry’s growing interest in these technologies. Looking forward, our focus on advancing our DEP® radiopharmaceuticals, including a radiodiagnostic and radiotherapeutic, reflects our commitment to research and development in novel therapeutic areas. Collaborations are integral to Starpharma’s strategy, enabling broader application of our dendrimer technology across various therapeutic areas. We value our partnerships deeply and continue to evolve our collaboration models to expedite progress and maximise value. Annual Report 2024 The formation of Petalion Therapeutics in partnership with Medicxi exemplifies our dedication to exploring new partnership models and accelerating early asset development. An important advantage of the asset-centric approach is Petalion’s ability to accelerate development, and this partnership is progressing well. Our partnerships with Genentech and MSD continued to progress, and our chemistry teams are diligently working to deliver the desired outcomes for both partners. Our commercial products, VivaGel® BV and VIRALEZE™ Nasal Spray are important for generating additional revenue for the company and supporting our sustainable growth objectives. We were pleased to announce that the post-market clinical study of VIRALEZE™ had shown positive results, demonstrating its antiviral efficacy. Additionally, we partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel® BV in the Middle East and North Africa region after successfully negotiating an exit from the Mundipharma distribution agreement. We consider these developments to be important steps towards growing revenue from both products. Starpharma places great importance on Environmental, Social, and Governance (ESG) initiatives, ensuring responsible business practices. We aim to minimise our environmental impact relative to the scale of our Starpharma Holdings Limited During FY24, we were pleased to report positive outcomes from our Phase II clinical trials of DEP® SN38, DEP® cabazitaxel, and DEP® docetaxel. These trials have shown promising anti-tumour efficacy, including longer progression-free survival than published data on standard-of-care treatment options, and excellent tolerability profiles in patients with challenging-to-treat cancers. business operations, support our people, and operate with good governance. Our people are at the core of our organisation, and we were delighted to have achieved Great Place to Work® certification for the second consecutive year, recognising our team’s positive workplace and company culture. We encourage you to read our ESG Report 2024, which provides more details about our ESG initiatives. In closing, on behalf of the Board, I wish to thank Cheryl, our leadership team, and the entire Starpharma team for their efforts in recent months. Transition is not easy, but the Board could not be more pleased with how it has gone. The Company’s underperforming share price places additional pressure on all of us. I want shareholders to know that the stock performance has been explicitly considered in determining remuneration. For the 2025 financial year, we have revised the remuneration framework to increase the proportion of at-risk performance-based incentives, 3 both short-term and long-term, for all employees. This change is designed to further align employee rewards more closely with shareholder returns. The Board of Directors extend sincere thanks to our shareholders, customers, and partners for their continued support. Starpharma is acutely focused on executing its strategic objectives, which include maximising DEP® asset value, accelerating early asset development, and building a financially sustainable business that will generate benefits for patients and shareholders alike. Rob Thomas AO Chairman Annual Report 2024 Chief Executive Officer’s Report A key milestone in our plan to maximise DEP® asset value was the successful presentation of two oral podium sessions at the esteemed American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024. Cheryl Maley Chief Executive Officer Dear fellow shareholders, I am pleased to present Starpharma’s 2024 Annual Report for the first time as Chief Executive Officer. Since joining Starpharma, I have observed a culture of passion and determination towards realising our mission of helping patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology. This mission and our commitments to advancing dendrimer technology and boosting shareholder value are at the forefront of our priorities. In acknowledging the current share price, we are diligently working at Starpharma to enhance value for our shareholders. We are not content with the current position and firmly believe that it does not reflect the true value of our company. As you know, soon after I started with the company, I, along with the Board and leadership team, conducted a comprehensive review of the business. This rigorous assessment encompassed every facet of our operations, from programs, partnerships, sales, and marketing to regulatory compliance and research. The insights gained from this review, shared with shareholders in May, underscored our strengths in innovation, expertise in dendrimer science, and collaborative ethos. Starpharma Holdings Limited This evaluation also identified key opportunities, prompting us to refine our core value proposition, enhance execution focus, allocate resources to strategic priorities, strengthen commercial capabilities, and improve shareholder engagement. Guided by these findings, we established three pivotal focus areas: maximising DEP® asset value, accelerating early-stage development, and building longterm sustainability. Since sharing these strategic imperatives with shareholders approximately three months ago, our team has been dedicated to their realisation. A key milestone in our plan to maximise DEP® asset value was the successful presentation of two oral podium sessions at the esteemed American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024. The acceptance of Starpharma’s Phase II clinical data reinforces the promising potential of DEP® SN38 (DEP® irinotecan) and DEP® cabazitaxel for patients with cancer. Our participation at ASCO was extremely valuable, as it provided Starpharma with the opportunity to establish meaningful connections with companies with an interest in exploring dendrimer applications in their product pipelines. Our presence at the BIO 2024 Conference and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting further increased our visibility and potential partner opportunities that could maximise the value of our assets and DEP® technology. 4 Our focus on radiopharmaceuticals is particularly timely, given the current momentum in this sector. Starpharma’s dendrimer technology has great potential in radiopharmaceuticals, offering advantages such as enhanced tumour targeting, rapid blood clearance, excellent imaging contrast, and minimal exposure to radiationsensitive organs. By ad