Clinical efficacy of VAL401

ValiRx is a clinical-stage biopharmaceutical company focused on the development of therapeutics for the treatment of cancer, associated biomarkers and companion diagnostics. The company’s two leading assets are in clinical trials: VAL201 (Phase I/II) – a peptide for advanced prostate cancer and potentially other hormone- induced indications; and VAL401 (Phase II) – a reformulation of risperidone, in trials for lung cancer. Early clinical analysis of its Phase II trial with VAL 401 has been released, meeting its primary endpoint by providing a statistically significant improvement in the overall survival rate. Further data will be revealed in due course.

• Strategy:  ValiRx operates as a virtual business, out-sourcing most of its activities. The core strategy is to develop its therapeutic assets through the clinical pathway and seek a partner/licensing deal to complete the development programme and regulatory submissions to commercialise the products.
• Overall survival data:  The newly published data on non-small cell lung cancer patients that exhausted all possible existing therapies, provide statistically significant improvement in the overall survival rate. Further analyses in quality of life and characterising the best responders will be revealed in due course.
• Valuation:  This data provides an important value inflection point which was not reflected previously in the share price. The market has reacted promptly to this news, with the share price jumping from 1p at the end of November (capital increase) to 7.73p – a near eight-fold increase!
• Next steps:  Safety and tolerability of VAL401 has been confirmed in late stage patients affected by non-small cell lung cancer. The study has provided also the dosing level that will be used in subsequent trials. Full data analysis is underway, and the final read-out of the study is expected in the near future.
• Investment summary:  The market has failed to recognise the potential of ValiRx, fretting more about the need for more capital to advance its clinical programmes that taking a rational view of the likely success of its clinical candidates. Given the clinical progress seen to date, the company will be attracting the attention of potential commercial partners and/or institutional investors in order to achieve the true value of its assets.