Highlights                                                                     

• Progress against the company’s strategic priorities, including advancing licensing and collaboration opportunities.
• Positive feedback from the FDA on the clinical pathway options to registration for DEP® SN38 in Platinum-Resistant Ovarian Cancer in the US, including potential for Fast Track designation and accelerated approval for DEP® SN38.
• Advanced DEP® radiopharmaceuticals program and active engagement with potential global collaborators.
• VivaGel® BV is expected to launch in Saudi Arabia and the United Arab Emirates (UAE)  during the next quarter (Q4 FY25).
• Following six months of focused efforts on digital marketing initiatives, including launching a new website, online sales of Viraleze™ are improving, with sales exceeding the prior corresponding period.
• Cash balance at 31 December 2024 was $20.3 million.

Melbourne, Australia; 29 January 2025: Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, today releases its Quarterly Activities Report and Appendix 4C for the quarter ended 31 December 2024 (Q2 FY25).

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

“Last quarter was extremely busy for all of us at Starpharma, and the progress we made served as a great reminder to me of the strength and versatility of our unique dendrimer technology, our robust intellectual property, and the multiple commercial opportunities available to a platform technology. From confirming the clinical pathway to commercialisation for DEP® SN38 in the treatment of platinum-resistant ovarian cancer to accelerating our research with early-stage assets and strategic partners, significant strides were made.

“We were particularly pleased by the DEP® SN38 feedback from the FDA, which confirmed the significant unmet medical need for patients with platinum-resistant ovarian cancer, and the potential for Fast Track designation and accelerated approval.

“Our research and development teams are highly focused on producing exceptional outcomes for our partners and internal programs. We have been collaborating closely with Petalion for approximately nine months now, focusing on the development of a single oncology asset, which has allowed us to work quickly and efficiently toward the desired results.

“With a strong emphasis on achieving our strategic objectives, Starpharma concluded 2024 with multiple opportunities to convert our unique dendrimer technology to commercial opportunity in 2025. We look forward to sharing updates with our shareholders this year.”

Maximising DEP® Asset Value

Important clinical and regulatory progress for DEP® SN38 (DEP® irinotecan)

In December 2024, Starpharma met with the US Food and Drug Administration (FDA) to discuss the clinical pathway options for DEP® SN38 in Platinum-Resistant Ovarian Cancer (PROC), which the FDA recognises as a patient group with significant unmet medical need. During this meeting, Starpharma received positive feedback from the regulator on the proposed regulatory approval pathways aimed at obtaining registration for DEP® SN38.

The key outcomes from the meeting were:

• The FDA agreed with Starpharma’s proposal that DEP® SN38 could be considered for FDA Fast Track designation, acknowledging that PROC is a serious condition with significant unmet medical need.
• The FDA also agreed that a “505(b)(2)” regulatory pathway is appropriate for DEP® SN38, as the product delivers the active moiety of the FDA-approved drug, irinotecan (Camptosar®). The 505(b)(2) pathway allows Starpharma to utilise existing FDA findings of safety and efficacy for an already approved drug, potentially streamlining the approval process by removing the need for some additional studies.
• The FDA indicated that DEP® SN38 may qualify for accelerated approval based on an interim analysis of early surrogate endpoints from the proposed Phase 2/3 clinical trial program. Final outcomes will depend on the results of these studies and the overall data package; however, this accelerated approval pathway could provide early access to DEP® SN38 for patients with platinum-resistant ovarian cancer.

This feedback from the FDA provides confidence for an Investigational New Drug (IND) application for DEP® SN38, a valuable asset for a commercial partner to advance. Additionally, this feedback is also relevant to the DEP® cabazitaxel program.

In parallel with this important clinical and regulatory progress for the DEP® assets, Starpharma’s business development team has continued extensive engagement for both DEP® SN38 and DEP® cabazitaxel, which remain the company’s top priority.

DEP® platform benefits showcased at multiple industry conferences

During the quarter, Starpharma delivered presentations at several industry conferences, highlighting the advantages of its DEP® platform technology. These events offer valuable opportunities for the company to connect with industry experts and potential collaborators both locally and internationally.

The conferences attended included the Australasian Gastro-Intestinal Trials Group (AGITG) Annual Scientific Meeting in Brisbane, AusBiotech in Melbourne, and the 6th Targeted Radiopharmaceuticals Summit Europe in Amsterdam, Netherlands. Several follow-up meetings have already been held following these events, expanding our network of potential partners and collaborators.

Accelerating Early Asset Development

DEP® radiopharmaceuticals program advances

Starpharma has made important progress in its DEP® radiopharmaceuticals program. During the quarter, several preclinical evaluations were completed, all of which contribute to creating a product that could offer a competitive edge in the HER2-positive (HER2+) cancer market. We are continuing to optimise our assets to achieve the desired characteristics for the products, including the optimal pharmacokinetic and biodistribution profile and the potential for accurate assessment of the HER2 status of tumours throughout the body. These characteristics and the targeted delivery of radioisotopes to tumours, combined with Starpharma’s dendrimer technology, could enhance both the patient and clinician experience by providing new options for the effective management of patients with HER2+ cancers.

We are confident that if this program succeeds, Starpharma’s HER2 radio products will offer distinct advantages for patients with HER2+ cancers. Given we already have two assets focused on the HER2 target, the decision has been made to redirect the focus of our current ADC program to explore other targets.

Additionally, we are actively engaging with potential collaborators in the radiopharmaceuticals sector to secure more partnerships and further demonstrate the advantages of our dendrimer platform in the development of radiodiagnostic and radiotherapeutic products.

Research collaborations update

Starpharma’s research collaborations typically involve companies evaluating the use of Starpharma’s dendrimer technology for the development of novel assets. During the quarter, Starpharma has made good progress with its ongoing DEP® partnerships while actively engaging potential future collaborators. The company has also increased its internal chemistry resourcing to meet the growing needs of our collaborators.

On 26 November 2024, Starpharma provided shareholders with an update on the AstraZeneca partnership, whereby both parties agreed to terminate our agreement after almost 18 months of inactivity. Starpharma took this action to provide clarity about the status of the partnership for investors and to allow Starpharma to pursue other opportunities.

Building Long-Term Sustainability

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

ITROM, Starpharma’s distribution partner for VivaGel® BV in the Middle East and North Africa (MENA) region, is making significant progress with the product launch in Saudi Arabia and the UAE. Starpharma is preparing to supply the product to ITROM next month, with the product launch expected to follow soon after.

Starpharma is actively engaging with potential partners for licensing VivaGel® BV in Europe, including in the UK, as this region is a key market for the product. Starpharma has already obtained regulatory certification under the new EU Medical Device Regulations.

During the quarter, Starpharma launched a new website for Viraleze™, enhancing the brand positioning and customer experience journey. This initiative is part of several digital activities being undertaken to boost revenue from the product. Online sales of Viraleze™ are showing a positive trend, with sales up 30% compared to the previous corresponding period.

Earlier this month, Starpharma received certification for Viraleze™ under the new European Union (EU) Medical Device Regulations (MDR). Under the new EU MDR classifications, medical device manufacturers must demonstrate compliance with certain essential requirements and undergo a new conformity assessment process with a European-based Notified Body. Achieving EU MDR certification demonstrates that Viraleze™ and the research supporting the product meet the necessary safety and performance standards set by the EU regulatory authorities.

Q2 FY25 Financial Summary

Starpharma’s cash balance as at 31 December 2024 was $20.3 million. Customer receipts in the quarter were $0.9 million related to sales of Viraleze™ and VivaGel® BV and R&D service fees. Net operating cash outflows for the quarter were $3.1 million, including research and development (R&D) costs of $1.2 million and staffing costs of $2.5 million, which included a one-off payment of $390,000, as highlighted in the FY24 Remuneration Report. Staffing costs included payments to non-executive and executive directors of $258,000. Other related party payments include $12,238 for consulting services to Centre for Biopharmaceutical Excellence Pty Ltd, of which Starpharma non-executive director Dr Jeff Davies is also a director and shareholder.

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