Highlights

• Phase 2 clinical trial results of DEP® irinotecan (DEP® SN38) and DEP® cabazitaxel, Starpharma’s priority candidates for licensing, were showcased in two oral podium presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
• Highly promising Phase 2 clinical results on DEP® SN38 in advanced colorectal cancer and platinum-resistant ovarian cancer were reported. DEP® SN38 showed clinically meaningful improvements in efficacy compared with published data on the standard-of-care regimens and a consistently improved tolerability profile.
• DEP® platform benefits in radiopharmaceuticals were highlighted in a scientific poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.
• Starpharma’s strategic priorities – 1) maximise DEP® asset value, 2) accelerate early asset development, and 3) build long-term sustainability – were shared with the market following a comprehensive business review led by CEO Cheryl Maley.
• Closed the financial year with a cash position of $23.4 million as at 30 June 2024.

Melbourne, Australia; 30 July 2024: Starpharma (ASX: SPL, OTCQX: SPHRY), dedicated to helping patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology, today releases its Quarterly Activities Report and Appendix 4C for the period ended 30 June 2024 (Q4 FY24).

Starpharma’s closing cash balance as at 30 June 2024 was $23.4 million. The net cash outflow for Q4 was $3.2 million, down from Q3, as expected, in line with the completion of the DEP® clinical trials. Net cash outflows for FY24 were $11.8 million (FY23: $14.7 million). The Company is anticipating an inflow of ~$5 million under the Australian Government’s R&D Tax Incentive scheme in H1FY25.

Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

“Since sharing our strategic priorities with the market in May 2024, the entire team at Starpharma has been highly focused on achieving specific milestones relating to the three strategic imperatives: maximising DEP® asset value, accelerating early asset development, and building long-term sustainability.

“We were pleased to receive positive feedback from investors and other market participants on the details of our strategy. Our immediate focus includes securing a licensing deal for a priority DEP® asset, driving forward the DEP® HER2 radiopharmaceutical assets, advancing our partnerships, and boosting revenue from VivaGel® BV and Viraleze™. We have realigned our internal resources to rigorously pursue these strategic imperatives.

“Starpharma’s DEP® presentations at the ASCO and SNMMI annual meetings in June marked an important step towards our goal of maximising DEP® asset value. These presentations showcased the value of the dendrimer technology in chemotherapy, radiopharmaceuticals and other novel applications, and attracted great interest from global companies. Additionally, we have achieved important progress in advancing our DEP® HER2 radiopharmaceutical assets. We have also launched a new Viraleze™ digital marketing campaign and initiated an online brand refresh aimed at enhancing the customer experience and driving revenue growth.”

Maximising DEP® Asset Value

Presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

In June 2024, the clinical results of DEP® SN38 and DEP® cabazitaxel were presented as podium presentations at the highly prestigious ASCO Annual Meeting in Chicago, United States. The clinical investigators delivered compelling presentations, highlighting the benefits of dendrimers in advancing chemotherapy options for patients with advanced cancers.

While in the US for ASCO, Starpharma also attended the BIO 2024 Conference in Chicago and delivered a presentation on its radiopharmaceutical program at the SNMMI Annual Meeting in Toronto, Canada. Attending all three of these conferences proved highly valuable from a partnering perspective, as many meetings with companies interested in applying dendrimers to their pipeline products were generated.

Promising Phase 2 clinical results for DEP® SN38

During the quarter, Starpharma was pleased to report positive final results from its Phase 2 clinical trial of DEP® irinotecan (DEP® SN38). The trial met its objectives, with endpoints demonstrating positive anti-tumour efficacy in multiple cancers and confirming the product’s favourable safety and tolerability profile. Key efficacy results included longer median progression-free survival (mPFS) compared to published data on irinotecan in advanced colorectal cancer and to standard-of-care (SoC) single-agent therapies in platinum-resistant/ refractory ovarian cancer.

DEP® SN38 was very well tolerated, with a notable lack of gastrointestinal adverse events and no instances of cholinergic syndrome, in contrast to irinotecan. Several patients who have had prolonged responses to therapy and are experiencing ongoing clinical benefit continue to receive access to DEP® SN38 treatment and will be monitored for safety and any changes to their disease.

Ongoing business development activities to maximise DEP® asset value

Following Starpharma’s business update in May 2024, the Company has been acutely focused on achieving its goal of securing a DEP® licensing deal and has recruited an additional business development resource to support these efforts.

Accelerating Early Asset Development

DEP® radiopharmaceuticals program advancing towards a clinical study

In the May 2024 business update, Starpharma announced plans to advance its DEP® HER2 radiodiagnostic candidate towards a first-in-human clinical study in 2025. Additionally, the Company presented a scientific poster at the SNMMI Annual Meeting in Toronto, Canada, in June 2024, highlighting the promising utility of dendrimers in precision radiotheranostics for cancer imaging and therapeutic applications.

Presentations at conferences like this are important for demonstrating the advantageous application of dendrimers in radiopharmaceuticals and raising the profile of Starpharma’s DEP® platform within the radio imaging and therapeutic community. They also present significant opportunities for business development.

Ongoing collaborations

Starpharma was delighted to host Dr Mehdi Shahidi, CEO of Petalion Therapeutics and Venture Partner at Medicxi, and Shyam Masrani, Principal at Medicxi and Board Chair of Petalion, at its office in Melbourne in June 2024. The visit allowed Starpharma’s team to meet Mehdi and Shyam in person and discuss the Petalion project.

Starpharma’s partnered research programs, including those with MSD and Genentech, continued during the quarter.

Starpharma’s dendrimers to be applied to the research and development of an mRNA vaccine in collaboration with The University of Technology Sydney (UTS) and CSIRO, funded by the Medical Research Future Fund (MRFF)

Starpharma will collaborate with UTS and CSIRO on the research and development of an mRNA vaccine for antimicrobial-resistant (AMR) urinary tract infections (UTIs). The Australian Government’s MRFF Global Health Initiative has awarded $1.8 million to this project, which will be led by Associate Professor Iain Duggin from UTS.

As part of the program, Starpharma’s DEP® dendrimer technology will be investigated for its ability to improve the formulation and performance of the nanoparticle-based mRNA vaccine candidates being developed by UTS and CSIRO.

If successful, Starpharma’s DEP® dendrimers could potentially be investigated for broader application to mRNA vaccines to improve their delivery by providing better encapsulation and greater protection, stability, cellular uptake, and endosomal escape of mRNA in order to achieve the best immunogenic response.

Building Long-Term Sustainability

Ongoing initiatives to increase revenue from VivaGel® BV and Viraleze™

During the quarter, Starpharma successfully achieved regulatory certification of VivaGel® BV under the new EU Medical Device Regulations (MDR), which recently introduced a range of more stringent requirements to demonstrate medical device safety and performance, including an increased need for clinical evidence. Certification under the EU MDR gives renewed certainty about the status of VivaGel® BV in Europe, and is an important factor for potential commercial partners in this region, as the new regulations introduce significant hurdles that other products that make claims for treatment of BV may not be able to overcome.  

Starpharma continued working with ITROM Pharmaceutical Group to transfer the VivaGel® BV market authorisations from Mundipharma to ITROM. In parallel, ITROM achieved registration for VivaGel® BV in Saudi Arabia. ITROM is planning to launch VivaGel® BV in Saudi Arabia and the United Arab Emirates (UAE) markets first, following the marketing authorisation transfer for UAE from Mundipharma.

For Viraleze™, as part of Starpharma’s focus on increasing revenue, the Company has implemented a targeted digital marketing campaign focused on the UK market and is initiating an online brand refresh to enhance the customer experience and optimise online sales.

In last quarter’s update, Starpharma noted the Therapeutic Goods Administration’s (TGA) interim decision to amend the Poisons Standard in relation to SPL7013 (astodrimer sodium). The TGA announced its final decision in May 2024, in support of Starpharma’s application to amend the Standard. This outcome means that if a nasal spray containing astodrimer sodium were approved for sale in Australia, the product could be labelled appropriately for nasal spray applications and sold in pharmacies. This outcome is separate from, and does not influence, the application for marketing authorisation. Viraleze™ is not approved for use or supply in Australia, where the regulatory review by the TGA for the SPL7013 nasal spray marketing application as a medical device is ongoing.

Q4 FY24 Financial Summary

Starpharma’s cash balance as at 30 June 2024 was $23.4 million. Total customer receipts of $1.0 million in the quarter included sales of Viraleze™ and VivaGel® BV and R&D service fees.

Net operating cash outflows for Q4 FY24 were $3.0 million, including research and development (R&D) costs of $1.8 million. As expected, the June quarter outflows decreased from Q3, which had R&D costs of $3.3 million. The Q3 costs included clinical trial close-out expenses associated with the completion of the DEP^® cabazitaxel, DEP^® docetaxel, and Viraleze™ clinical programs.

Administration and corporate costs for the quarter were $0.3 million. Staffing costs were $2.1 million, including accrued leave entitlements paid to former CEO Jackie Fairley upon the completion of her employment with the company in June 2024. Non-executive and executive directors’ fees were $253,000.

Based on Starpharma’s 4C, which is appended, the Company’s cash balance of $23.4 million as at 30 June 2024 represents eight quarters of cash. Starpharma is focused on increasing revenue and managing resources to extend the Company’s cash runway as it continues to prioritise the monetisation of its assets.

View/download the ASX Announcement: Quarterly Activities Report & Appendix 4C.