Feb 28, 2024
Half Yearly Report and Accounts (ASX Announcement)
- Strong cash position with $32.1M as at 31 December 2023. Reported half-year revenue of $8M (H1 FY23 $1.6M), including $6.6M VivaGel® BV settlement from Mundipharma. The reported loss for the period was $1.0M (H1 FY23 $8.3M).
- Phase 2 clinical trials of DEP® cabazitaxel, DEP® docetaxel, and DEP® irinotecan showed positive results in treating multiple cancer types, providing further clinical validation of the DEP® platform and highlighting its value proposition in repurposing and enhancing the therapeutic and commercial utility of widely used cancer therapies.
- The DEP® platform showed imaging benefits in targeted radio diagnostic approaches. Specifically, DEP® HER2-zirconium demonstrated a favourable biodistribution profile, rapid uptake, and high levels of tumour accumulation in a HER2+ breast cancer model.
- Results from the Viraleze™ post-market study in participants with COVID-19 showed antiviral efficacy, with effects more pronounced in the older patient cohorts. Viraleze™ achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of participants aged 45 and over. The clinical evidence generated by the Viraleze™ post-market study will support ongoing commercial and regulatory activities.
- Following Starpharma’s successful commercial settlement agreement with Mundipharma for VivaGel® BV and the subsequent reversion of territorial rights over the product, Starpharma signed a regional sales and distribution agreement for VivaGel® BV with ITROM Pharmaceutical Group, covering 13 countries across the Middle East and North Africa (MENA) region.
Melbourne, Australia; 28 February 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2023 (H1 FY24).
Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
“Starpharma has made important progress towards achieving its objectives during this half. This includes completing and reporting the results from the Phase 2 clinical trials of its DEP® candidates and the clinical study of Viraleze™. The Company also presented the DEP® platform at multiple industry conferences and executed a new VivaGel® BV partnership in the Middle East and North Africa region.
“Starpharma is focused on advancing its DEP® platform towards commercialisation and building partnerships and collaborations. The DEP® platform is highly versatile and can be applied to a wide range of novel therapeutics, including but not limited to Antibody-Drug Conjugates (ADCs) and radiotheranostics, offering a range of therapeutic and commercial benefits. This is supported by the Phase 2 proof-of-concept clinical trial results and the early data in ADCs and radiotheranostics.
“In parallel, Starpharma is committed to leveraging the existing approvals of VivaGel® BV and Viraleze™ to expand their brand recognition and sales.
“With a strong cash balance of $32.1 million (at 31 December 2023), Starpharma is well-positioned to move forward with its pipeline and will allocate its resources in line with its strategic priorities.”
DEP® Programs
The final results from the Phase 2 clinical trial programs of DEP® cabazitaxel and DEP® docetaxel were reported. Recruitment for the Phase 2 clinical trial of DEP® irinotecan was completed, and interim results were reported. Multiple scientific posters highlighting the DEP® platform were also accepted for presentation at international cancer research conferences.
The DEP® cabazitaxel Phase 2 clinical trial met its objectives, with endpoints demonstrating anti-tumour efficacy in advanced, metastatic castration-resistant prostate cancer, platinum-resistant ovarian cancer, and gastro-oesophageal cancers. The trial also confirmed the safety and tolerability of DEP® cabazitaxel.
The key results from the Phase 2 trial of DEP® cabazitaxel in patients with advanced gastro-oesophageal cancers were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in the US in January 2024.
The DEP® docetaxel Phase 2 clinical program demonstrated encouraging anti-tumour activity in multiple advanced, metastatic cancers, including pancreatic cancer, gastro-oesophageal cancer, non-small cell lung cancer, and cholangiocarcinoma. The safety and tolerability of DEP® docetaxel were also confirmed. These results were demonstrated in the monotherapy and combination arms, where DEP® docetaxel was administered either as a monotherapy or combination therapy with other anti-cancer agents, nintedanib or gemcitabine.
The interim clinical data on DEP® irinotecan showed durable anti-tumour responses in advanced colorectal cancer and platinum-resistant/refractory ovarian cancer and good tolerability across the study. Enrolment has been completed for both the monotherapy and combination arms. Several patients with advanced cancers, including ovarian and colorectal cancers, are continuing therapy and are experiencing prolonged responses to treatment and significant clinical benefits.
These interim data on DEP® irinotecan were presented at the International Conference on Molecular Targets and Cancer Therapeutics, 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 in October 2023. Additional nonclinical data on DEP® irinotecan in combination with immuno-oncology agents were also presented at this conference.
The DEP® radiotheranostics program made progress, with Starpharma’s HER2-targeted radiodiagnostic candidate, DEP® HER2-zirconium, demonstrating a favourable biodistribution profile with excellent imaging contrast between tumour and normal tissues, as well as rapid uptake and high levels of tumour accumulation in a HER2-positive (HER2+) breast cancer model. These data were also presented at the AACR-NCI-EORTC Conference in the US in October 2023.
The application, versatility, and benefits of the DEP® platform for targeted delivery of radiotheranostics, including an overview of Starpharma’s two DEP® HER2-targeted radiotheranostic products, DEP® HER2-zirconium and DEP® HER2-lutetium, were also presented at the Targeted Radiopharmaceuticals Summit in Berlin in December 2023.
On 31 July 2023, following communication from AstraZeneca on 28 July 2023 and the subsequent release of their H1 and Q2 2023 results announcement that day, Starpharma reported that AstraZeneca had made the decision to discontinue the development of AZD0466 after an internal review prompted by a small number of asymptomatic adverse events that were unrelated to Starpharma’s dendrimer drug delivery technology.
Starpharma’s in-house preclinical DEP® Antibody-Drug Conjugates (ADCs) programs continued progressing alongside our partnered programs, including MSD and Genentech. The Company’s partner programs involve a number of therapeutic areas, including ADCs.
A key focus for Starpharma is advancing its DEP® platform and assets towards commercialisation through partnerships and licensing. The Company is actively supporting its existing partners and, in parallel, is seeking and targeting new partnerships to leverage its dendrimer technology.
Viraleze™ and VivaGel® BV
The results of the post-market clinical study of Viraleze™ nasal spray in participants with COVID-19 were reported in January 2024. Viraleze™ achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of participants aged 45 and over. Other antiviral effects were also observed, including increased viral clearance rate from the nose, reduced time to negative PCR[1] test and improvement in key symptoms, including recovery from loss of smell. As seen in a previously announced trial in healthy volunteers, Viraleze™ was well-tolerated.
The results from the Viraleze™ clinical study provide significant clinical evidence of the performance of Viraleze™ 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 data will also support ongoing marketing and commercial activities for the product.
Starpharma continues to market Viraleze™ online through Amazon and dedicated product websites. Starpharma also has commercial partners in several international markets, where the product is distributed online and in retail outlets, including pharmacies.
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.
In February 2024, Starpharma completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel® BV. The FDA maintained its position that they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel® BV for bacterial vaginosis (BV) in the US. Starpharma is not planning to pursue additional clinical studies for VivaGel® BV on its own at this time but remains committed to leveraging the VivaGel® BV development program and will work to maximise the commercial potential for VivaGel® BV in the more than 45 markets where it is already approved. The decision by the FDA does not alter the approval status in the countries where VivaGel® BV is already registered.
In January 2024, Starpharma partnered with ITROM Pharmaceutical Group for the sales and distribution of VivaGel® BV across 13 countries in the Middle East and North Africa region. ITROM has a strong presence throughout the region’s public and private health sectors, maintaining strong relationships with key opinion leaders, specialist physicians, hospital chains and retail outlets.
This new partnership with ITROM followed the reversion of VivaGel® BV rights to Starpharma under a settlement agreement with Mundipharma in August 2023. Under the settlement, Starpharma received a $6.6M cash payment from Mundipharma in August 2023, and the VivaGel® BV commercial rights reverted to Starpharma.
Starpharma’s partner, Aspen, continues to market VivaGel® BV in Australia and New Zealand. In Australia, VivaGel® BV is the number 1 topical brand by sales for the treatment of BV and prevention of BV recurrence.
The Company continues pursuing additional commercial opportunities for the Viraleze™ and VivaGel® BV products.
Starpharma and Okamoto signed a contract extension for the VivaGel® Condom product. This agreement covers Japan and several other Asian markets. Okamoto continues marketing in Japan and regulatory activities in a number of other Asian markets.
Financial Summary
Half-year revenues were $8.0M, including revenue from commercial partners of $7.2M (H1 FY23: $1.1M) and interest income of $0.8M (H1 FY23: $0.5M). Revenue included a nonrecurring $6.6M from the commercial settlement of the VivaGel® BV licence and supply agreement with Mundipharma in August 2023. Excluding the Mundipharma settlement, the half-year adjusted revenue was $1.5M, an 8% decrease on H1 FY23, with lower product sales in the current period.
The half-year loss after tax was $1.0M (H1 FY23: $8.3M) and includes research and product development expenses of $5.3M (H1 FY23: $5.6M) net of the Australian Government’s R&D tax incentive. Research expenditures were primarily associated with Starpharma’s internal DEP® drug delivery programs, including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan, DEP® ADCs and DEP® radiotheranostics, and the Viraleze™ post-market study.
During the period, Starpharma received a $7.2M R&D tax incentive and repaid the $4.0M low-interest R&D loan with the Treasury Corporation of Victoria. Starpharma’s balance sheet remains strong, with a closing cash position of $32.1M at 31 December 2023.
View/download the ASX Announcement: Half Yearly Report and Accounts.
[1] Polymerase chain reaction.
This contains certain forward-looking statements.