Highlights

• Strategic partnership with Medicxi to develop a novel targeted cancer therapy using Starpharma’s dendrimer technology through Petalion Therapeutics was signed and has begun.
• Two abstracts on Starpharma’s DEP^® clinical programs were accepted for oral presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
• Starpharma’s Phase 2 clinical trial of DEP^® irinotecan as monotherapy and in combination with 5-fluorouracil (5FU) and leucovorin (LV) is nearing database lock. Preparations for analysis of the full data are well underway, with the final data to be released ahead of and presented at the ASCO meeting in early June.
• Closing cash position of $26.6 million for Q3 FY24, with cash outflows expected to reduce next quarter in line with the completion of the DEP^® clinical trials.

Melbourne, Australia; 30 April 2024: Starpharma (ASX: SPL, OTCQX: SPHRY), which is dedicated to enhancing the quality of life for patients with unmet medical needs, such as cancer, by creating innovative therapies using dendrimer technology, today releases its Quarterly Activities Report and Appendix 4C for the period ended 31 March 2024 (Q3 FY24). Starpharma’s closing cash balance as at 31 March 2024 was $26.6 million.

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

“During my first quarter at Starpharma, the management team and I have conducted a comprehensive review of the business that has shed light on areas of key opportunity and where we must improve and sharpen our focus. It is no secret that our industry is fiercely competitive, and our success hinges on our ability to adapt to evolving market dynamics while staying true to our core purpose of driving better patient outcomes through the application of Starpharma’s unique dendrimer technology.

“Starpharma has created substantial value by clinically validating its dendrimer technology platform, DEP^®, through multiple clinical programs. Our ability to successfully treat more than 350 patients with the dendrimer drug delivery technology and demonstrate patient benefit have provided significant benefit to the organisation and have been instrumental in securing collaboration partners, including Genentech, Merck, and Medicxi.

“Our future success requires a renewed emphasis on forging strategic partnerships and collaborations that enhance our licensing opportunities and expand the application of DEP^® in novel therapies. We aim to be discerning in our choice of collaborators, ensuring that each partnership aligns with our long-term vision and brings tangible value to our shareholders.

“We recently announced our collaboration with Medicxi, kickstarting a highly innovative partnership focused on developing a novel targeted cancer therapy using Starpharma’s dendrimer technology. The creation of a new company, Petalion Therapeutics, will allow Petalion to focus on this asset with the goal of accelerating its development. We are very enthusiastic about the potential of this partnership and have already commenced the first phase of work.

“We are pleased to have had two abstracts accepted for oral presentations at the renowned ASCO Annual Meeting in Chicago. The acceptance process for abstracts is highly competitive, and it is even more challenging to get selected for an oral presentation. This opportunity to present our DEP^® technology in a global forum is a significant achievement for Starpharma and highlights the clinical interest in the positive outcomes of the DEP^® clinical trials. In addition to presenting the DEP^® clinical trial results at ASCO during the next quarter, we look forward to presenting data from our radiotheranostics program at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting.

“Our business development activities for the DEP^® clinical assets are now more focused, with a clearer prioritisation of each asset, potential therapeutic indication, and partner opportunities. We also remain committed to advancing our novel therapy development programs, such as radiopharmaceuticals, with commercial assessments undertaken within the last quarter.

“We are focused on managing costs efficiently to extend our cash runway, and we expect our cash outflows to reduce during Q4 FY24. While our commitment to innovation is unwavering, we recognise the importance of maintaining fiscal discipline to safeguard our financial health and preserve shareholder value. This may necessitate difficult decisions and trade-offs, but any action we take is guided by a steadfast commitment to long-term sustainability and growth.”

New Strategic Partnership With Medicxi To Co-Found Petalion Therapeutics

On 8 April 2024, Starpharma announced a new strategic partnership with Medicxi, a leading life sciences investment firm, to co-found a new UK-based company called Petalion Therapeutics. Petalion will initially focus on developing a novel targeted dendrimer-drug conjugate therapy in oncology, utilising Starpharma’s proprietary DEP^® dendrimer platform technology.

Medicxi will fund Petalion with an initial investment of up to USD $25 million (~AUD $38 million) to finance the development of the novel oncology drug candidate. Starpharma will license certain intellectual property (Starpharma Background IP) to Petalion as required for the research, development, manufacture and commercialisation of this potential new therapeutic and, in exchange, will receive an equity holding of 22.5% in Petalion. Starpharma’s Background IP remains protected and remains the property of Starpharma.

Starpharma hosted an investor webinar on 9 April 2024 to discuss this announcement. A recording of the webinar is available on Starpharma’s website.

DEP^® Irinotecan And DEP^® Cabazitaxel Data Accepted For Oral Presentations At The Upcoming American Society Of Clinical Oncology (ASCO) Annual Meeting

Starpharma’s Phase 1/2 clinical data for DEP^® cabazitaxel and DEP^® irinotecan have both been accepted for oral presentations at the ASCO Annual Meeting, which will take place in Chicago, US, from 31 May to 4 June 2024.

ASCO is one of the world’s largest conferences for oncology professionals from industry and clinical practice. It provides a forum for presenting clinical trial results for new cancer treatments and updates on the latest advancements and emerging technologies in cancer treatment and care.

Tens of thousands of abstracts are submitted for the ASCO Annual Meeting each year, yet only a small percentage are accepted as posters or oral presentations. This year, only about 7% of the accepted abstracts were granted oral presentations. Acceptance of both the DEP^® cabazitaxel and DEP^® irinotecan clinical data for oral presentations is a positive outcome for Starpharma and highlights the interest in the unique features and benefits of the two clinical candidates and the potential of and clinical interest in the DEP^® technology platform more broadly. The oral presentations will provide a significant opportunity for Starpharma to be featured on a global stage, highlighting the value of the DEP^® technology.

DEP^® Irinotecan Phase 2 Trial Data Analysis Preparations Underway

Starpharma’s Phase 2 clinical trial of DEP^® irinotecan as monotherapy and in combination with 5-fluorouracil (5FU) and leucovorin (LV) is nearing database lock. Preparations for analysis of the full data are well underway, with the data to be released ahead of and presented at the ASCO meeting in early June. The ASCO presentation will follow on from the interim DEP^® irinotecan clinical data that were announced in September 2023 and presented at the International Conference on Molecular Targets and Cancer Therapeutics, co-hosted by the American Association of Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) in October 2023.

Several heavily pre-treated patients with advanced cancers, including platinum-resistant ovarian and colorectal cancers, and who, in some cases, have been receiving DEP^® irinotecan treatment in the study for more than 12 months, continue to experience prolonged responses to treatment and significant clinical benefits. These patients will transition to a maintenance protocol that will allow these patients continued access to DEP^® irinotecan therapy.

DEP^® Radiotheranostic Data Accepted For Poster Presentation At The Society Of Nuclear Medicine And Molecular Imaging (SNMMI) Annual Meeting

Starpharma will present data from its internally developed DEP^® HER2 radiotheranostic program at the upcoming SNMMI Annual Meeting, which will be held from 8 to 11 June in Toronto, Canada. The SNMMI Annual Meeting is a leading conference for nuclear medicine and molecular imaging, attracting physicians and radiologists, amongst other industry professionals, to discuss the latest research and development in the field.

Starpharma’s R&D program for radiotheranostics has shown promising results, demonstrating that DEP^® dendrimers have strong potential as a versatile and multifunctional platform for the customisation of precision radiotheranostics for cancer imaging and therapeutic applications. As Starpharma continues to strengthen its radiopharmaceuticals program, presentation opportunities like the SNMMI Annual Meeting will become increasingly important for highlighting the benefits of dendrimer technology in novel diagnostic and therapeutic areas, including radiopharmaceuticals.

The data, which has been accepted for scientific poster presentation at the SNMMI Annual Meeting, will build on Starpharma’s previously reported results on its DEP^® HER2 radiotheranostic program.

TGA Interim Decision To Amend The Current Poisons Standard In Relation To SPL7013 (Astodrimer Sodium)

On 3 April 2024, the Therapeutic Goods Administration (TGA) announced an interim decision on Starpharma’s requested amendments to the Poisons Standard in relation to astodrimer sodium (SPL7013), Starpharma’s proprietary dendrimer that is used in its vaginal gel, condom, and nasal spray products.

Starpharma does not usually comment on these regulatory processes; however, the Company believes it is important to clarify the meaning of the interim decision for shareholders, as we have received questions about this.

The TGA’s recent interim decision about astodrimer sodium relates to the Poisons Standard, which specifies how any product containing astodrimer sodium must be labelled, advertised and the channels through which it can be sold, and is separate from the application to approve the SPL7013 nasal spray for sale.

The interim decision to amend the Poisons Standard published this month, and if implemented as a final decision on 1 June 2024, would mean 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. Starpharma has provided the TGA with its response to the interim decision and will await the final decision.

The regulatory review by the TGA for the SPL7013 nasal spray marketing application as a medical device is ongoing.

Partner Updates During Q3 FY24

Starpharma continued working with ITROM Pharmaceutical Group to transfer the VivaGel^® BV market authorisation from Mundipharma to ITROM. This will enable ITROM to launch VivaGel^® BV in the Middle East market.

Starpharma’s partnered research programs, including those with MSD and Genentech, continued to progress.

Financial Summary

Starpharma’s cash balance as at 31 March 2024 was $26.6 million. Total customer receipts of $0.4 million in the quarter included sales of Viraleze™ and VivaGel^® BV.

Starpharma has previously indicated that its operating costs are expected to begin reducing from previous levels in H2 FY24, and this is still the case. Net operating cash outflows for Q3 FY24 were $5.3 million, including research and development (R&D) costs of $3.3 million. This quarter’s R&D costs included clinical trial close-out costs of $1.6 million related to the completion of the DEP^® cabazitaxel, DEP^® docetaxel, and Viraleze™ clinical programs. With the majority of these clinical trial close-out costs now paid, Starpharma expects its R&D cash outflows to reduce next quarter.

Administration and corporate costs for the quarter were $0.3 million. Product manufacturing and operating costs were $0.4 million, including inventory costs. Staffing costs were $1.9 million, including $296,000 in non-executive and executive directors’ fees.

Starpharma is focused on managing its resources to extend the Company’s cash runway as it continues to prioritise the monetisation of its assets.

Shareholder Webinar

Starpharma is preparing to host a shareholder webinar in May and will announce details closer to the time.

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