On August 21, 2024 Starpharma (ASX: SPL, OTCQX: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its annual report and full-year financial results for the year ended 30 June 2024 (Press release, Starpharma, AUG 21, 2024, View Source;mc_eid=bf52dd3418 [SID1234646036]).
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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
"Starpharma is pleased to present its annual report and full-year financial results for the 2024 financial year. Starpharma achieved several important milestones during the year, including reporting results from multiple clinical studies, advancing key projects in our pipeline, and forming new partnerships, all of which will contribute to our continued growth.
"Our primary focus remains on delivering impactful healthcare, medical, and pharmaceutical solutions that not only drive value for our shareholders but also make a meaningful difference in the lives of people, especially those battling serious illnesses like cancer.
"We are aware of the challenges we face with our underperforming share price and small market capitalisation. Everyone at Starpharma is committed to realising our strategic imperatives – maximising DEP asset value, accelerating early asset development, and building long-term sustainability – and we are taking the necessary steps to achieve them. We are confident that reaching these goals will help to increase shareholder value, and we look forward to sharing our progress with our shareholders as it unfolds.
"Importantly, we have sufficient capital to support our objectives, with a cash balance of $23.4 million as at 30 June 2024. The completion of several clinical programs has led to a reduction in our research and development expenses, extending our cash runway. Shareholders should know that we are focusing on increasing revenue, with a number of opportunities on the horizon."
Key Financial Results
Ended the 2024 financial year with $23.4 million cash on hand.
Reported loss down 48% to $8.2M (FY23: $15.6M).
Net cash outflow of $11.8 million (FY23 $14.8 million), with cash outflow from operations of $6.9 million, down $7.4 million from FY23 ($14.3 million)
Revenue up 132% to $9.8M (FY23: $4.2M), including the one-time $6.6M cash payment from Mundipharma on termination of the VivaGel BV license and supply agreement.
Starpharma received a $7.2 million FY23 R&D tax incentive refund in October 2023, with a further FY24 R&D tax incentive refund of approximately $5.0 million expected in H1 FY25.
Operational Highlights
Reported the results from all three Phase II clinical trial programs – DEP SN38, DEP cabazitaxel, and DEP docetaxel. All three programs provided clinical validation of the DEP technology; over 350 patients have now been treated using DEP products. The trials showed promising anti-tumour activity and improvements in efficacy, including longer median progression-free survival (mPFS) and higher overall survival (OS) rates, than published data on standard-of-care treatment regimens. The DEP products also demonstrated improved tolerability profiles in patients with advanced, heavily pre-treated cancers, including lower rates of severe adverse events, compared with standard-of-care treatments. Importantly, the DEP treatments extended the lives of many patients and allowed many to live more fulfilling and enriched lives.
Confirmed plans to progress Starpharma’s DEP HER2 radiodiagnostic program towards a first-in-human clinical trial, following promising early-stage imaging data in HER2-positive (HER2+) cancers. Starpharma’s DEP radiopharmaceuticals program continues to show that DEP dendrimers are a promising, versatile, and multifunctional platform for developing precision radiotheranostics for cancer imaging and therapeutic applications. This dendrimer technology bridges the gap between small molecules and large antibodies, offering the potential to improve performance and overcome limitations associated with existing technologies and treatments.
Partnered with Medicxi, a leading life sciences investment firm, to co-found Petalion Therapeutics, an asset-centric company focusing on developing a novel cancer therapy using Starpharma’s dendrimer technology. Starpharma receives an equity holding of 22.5% in Petalion in return for licensing certain intellectual property for the research, development, and commercialisation of this potential new cancer therapy.
Presented the advantages of Starpharma’s DEP dendrimer technology in oncology at multiple international industry conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the US, the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in the US, the International Conference on Molecular Targets, co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in the US, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Canada.
Partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel BV in 13 countries across the Middle East and North Africa region. Bacterial vaginosis is highly prevalent in this region, presenting a market need and commercial opportunity for new and effective therapeutic approaches. This agreement came shortly after Starpharma terminated the VivaGel BV license to Mundipharma, regained the commercial rights to Mundipharma’s territories, and received a one-time A$6.6 million cash payment from Mundipharma.
Generated clinical evidence demonstrating the effectiveness of Viraleze in humans. The results from the post-market clinical study of Viraleze in COVID-19 patients showed that Viraleze achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of patients aged 45 and over. This data will support the regulatory transition to the new European Medical Device Regulations, which come into full effect in 2029. The findings will also support ongoing marketing and commercial activities.
Achieved Great Place to Work certification for the second consecutive year. This external recognition is a testament to our team’s positive workplace environment and company culture.