On January 31, 2024 Starpharma reported its its Quarterly Activities Report and Appendix 4C for the period ended 31 December 2023 (Q2 FY24) (Press release, Starpharma, JAN 31, 2024, View Source [SID1234643768]). Starpharma’s closing cash balance as at 31 December 2023 was $32.1 million.

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

"Since starting as CEO of Starpharma in January, I, along with the Management Team, have been reviewing Starpharma’s business, the current opportunities and the key challenges, and what is abundantly clear to us is that there remain significant opportunities to enhance the value and application of Starpharma’s dendrimer technology and to optimise the current value of Viraleze and VivaGel BV.

"The recently announced DEP clinical study results support Starpharma’s previous clinical studies and highlight the potential for this technology to add significant benefit to existing treatments, as well as the potential for new treatments that are currently in development.

"Key priorities for the DEP program are advancing partnering activity and our internal development program, which will allow us to maximise the potential of the technology across different therapeutic areas, to bring significant safety and efficacy benefits to patients, improve commercialisation opportunities for partners and improve shareholder value. Following Starpharma’s attendance at J.P. Morgan in January and other recent business development activities, our efforts will increasingly focus on these opportunities in the coming months.

"The recent results from the post-market study of Viraleze reinforced Starpharma’s existing dataset on the product. Importantly, the clinical data will support the new European Medical Device Regulations, which will come into full effect in 2029. We will also leverage the data from the study, particularly the 45+ cohort, to support ongoing regulatory, marketing, and distribution efforts.

"The recently executed lTROM sales and distribution agreement for VivaGel BV in the MENA region and other concurrent business development activity highlights our ongoing commitment to make VivaGel BV more accessible to women in regions with a high need.

"There is no doubt that the past few years have been challenging with regard to shareholder value. This can be attributed to a number of factors, some specific to Starpharma and some relating to the sector and macro environment. As we move forward, the learnings from the past few years will be invaluable to focus our efforts on what drives value for patients, partners, and shareholders.

"The Company ended the quarter with a strong cash position, and we remain committed to ensuring the allocation of resources matches our strategic priorities."

DEP Programs

During the quarter, Starpharma announced positive final results from the Phase 2 clinical program of DEP docetaxel. The Phase 2 trial objectives were met, with endpoints demonstrating encouraging anti-tumour activity of DEP docetaxel when administered as a monotherapy or in combination with other anti-cancer agents, nintedanib or gemcitabine in multiple, advanced, metastatic cancers, including pancreatic, gastro-oesophageal, non-small cell lung cancer (NSCLC) and cholangiocarcinoma.

The safety and tolerability of DEP docetaxel were also confirmed, with DEP docetaxel demonstrating an improved tolerability profile versus conventional docetaxel in terms of key adverse events, including myelosuppression (severe neutropenia), oedema (fluid retention), alopecia (hair loss) and allergic reactions (anaphylaxis/hypersensitivity).

The clinical trial also demonstrated the ability of DEP docetaxel to effectively target tumours, with treated patient biopsies showing that tumour tissues achieved tissue levels of docetaxel up to 60 times higher than levels in blood. This tumour-targeting effect was demonstrated across multiple cancer types. The findings confirm the ability of DEP to increase the delivery of drug to tumours, as also shown in multiple preclinical models.

In January 2024, Starpharma’s positive results from the Phase 2 clinical trial of DEP cabazitaxel in patients with advanced gastro-oesophageal cancers were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in San Francisco. ASCO (Free ASCO Whitepaper) is the world’s leading professional organisation for physicians and oncology professionals, and this specialist GI Cancers Symposium is the only global meeting of its kind focusing on the latest innovative science and clinical developments in GI cancer treatment, research and care. Starpharma’s presentation highlighted the key results from the Phase 2 trial of DEP cabazitaxel in patients with advanced gastro-oesophageal cancers, announced on 18 October 2023, and additional efficacy data for DEP cabazitaxel in two subgroups of the gastro-oesophageal cohort with different types of GI cancers: adenocarcinoma and squamous cell carcinoma (SCC).

The clinical trial of DEP irinotecan is also ongoing, as several patients with advanced cancers, including ovarian and colorectal cancers, are continuing therapy and are experiencing prolonged responses to treatment and significant clinical benefits.

In December 2023, Starpharma delivered a presentation on the application of its DEP platform for precision cancer radiotheranostics at the Targeted Radiopharmaceuticals Summit Europe in Berlin. This presentation covered the application, versatility and benefits of the DEP platform for targeted delivery of radiotheranostics and Starpharma’s two DEP HER2-targeted radiotheranostic products, DEP HER2-zirconium and DEP HER2-lutetium, which are designed to assist in improving the diagnosis, staging, monitoring, and treatment of HER2+ cancers.

Starpharma’s in-house preclinical DEP Antibody-Drug Conjugates (ADCs) and DEP radiotheranostics programs continue progressing alongside our partnered programs, including with MSD and Genentech.

As part of its business development program, Starpharma executives attended the J.P. Morgan Healthcare Conference in San Francisco in January 2024. Starpharma met with existing partners, healthcare investors, and other interested companies at the conference. In the oncology space, antibody-drug conjugates, radiopharmaceuticals and immunotherapies garnered much attention at the conference, while obesity and other metabolic diseases were also of interest.

Viraleze and VivaGel BV

Starpharma recently announced the results of the post-market clinical study of Viraleze nasal spray in participants with COVID-19. The results showed that Viraleze reduced SARS-CoV-2 viral load and increased the rate of virus clearance from the nose, and in parallel, improved key symptoms of COVID-19, including loss of smell (anosmia), and was well-tolerated.

Viraleze achieved a statistically significant reduction in SARS-CoV-2 viral load, the primary endpoint of the study, in the cohort of participants aged 45 and over (N=118, p=0.017). Viraleze reduced viral load in the full study population including all patient age groups (N=197), although the difference vs placebo was not statistically significant.

The results from this study provide significant clinical evidence of the performance of Viraleze in humans that will support regulatory processes for the transition to the new European Medical Device Regulations (MDR), which will come into full effect in 2029. The positive data will also support ongoing marketing and commercial activities for the product.

In this clinical study, the benefits of Viraleze were more pronounced in older participants and have potential relevance to older individuals who are typically more susceptible to respiratory infection and disease. These findings are consistent with Starpharma’s nonclinical in vivo and in vitro studies of Viraleze in SARS-CoV-2 and other cold/respiratory viruses, including influenza, and provide further support for Viraleze in helping to protect against respiratory infection and disease. Reduced viral load and increased viral clearance have the potential to protect against infection, improve symptoms, and reduce onward transmission.

In January 2024, Starpharma signed a sales and distribution agreement for its VivaGel BV product with ITROM Pharmaceutical Group, covering 13 countries across the Middle East and North Africa (MENA). ITROM specialises in introducing new pharmaceutical products to the MENA region and has a proven track record of successfully launching and growing the market share of new pharmaceutical products in multiple therapeutic areas within its region. The prevalence of bacterial vaginosis among a female population of 238 million in the MENA region is 25%, indicating a high need for new effective therapeutic approaches and a significant opportunity for VivaGel BV. This new partnership with ITROM follows the recent reversion of VivaGel BV rights to Starpharma under a settlement agreement with Mundipharma, announced in August 2023. Starpharma has now commenced the transferral processes for the existing VivaGel BV registrations.

As foreshadowed at Starpharma’s Annual General Meeting in November 2023, Starpharma lodged a further VivaGel BV submission to the US Food and Drug Administration (FDA) during Q2 FY24. Starpharma has since also met with the FDA to discuss this submission. Starpharma will provide an update on this submission upon receiving an outcome from the FDA.

Starpharma’s partner, Aspen, continues to market VivaGel BV in Australia and New Zealand; Fleurstat BVgel is the top-selling BV treatment by sales in Australia.

Starpharma continues to market Viraleze through Amazon UK and a dedicated product website. Starpharma also has commercial partners in several international markets, where the product is distributed online and in retail outlets, including pharmacies. The Company continues to pursue additional commercial opportunities for the product.

Viraleze is not approved for use or supply in Australia, where the review by the Therapeutic Goods Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing.

Financial Summary

Starpharma’s cash balance as at 31 December 2023 was $32.1 million, with net cash outflows of $3.5 million for the quarter. Total receipts of $7.4 million in the quarter included $7.2 million received under the Australian Government’s R&D Tax Incentive scheme and receipts from customers of $0.2 million. Customer receipts include sales from Viraleze and VivaGel BV.

Cash outflows for the quarter included research and development costs of $3.4 million related to the concurrent completion of multiple DEP clinical programs and the post-market clinical study of Viraleze nasal spray. R&D expenditure also included development costs for Starpharma’s targeted DEP radiotheranostics and DEP antibody-drug conjugates programs. Administration and corporate costs of $0.7 million include insurance costs. Product manufacturing and operating costs for the quarter were $0.5 million. Staffing costs were $2.6 million and included non-executive and executive directors’ fees of $417,000. Cash outflows from financing activities included the one-off repayment of the $4.0 million low-interest R&D Loan with Invest Victoria in October 2023.