ValiRx Plc (AIM: VAL), a life science company, which focuses on clinical stage cancer therapeutic development, taking proprietary & novel technology for precision medicines towards commercialisation and partnering, today announces its final results for the year ended 31 December 2018.
HIGHLIGHTS
Operational Highlights
- VAL201’s Phase l/ll Clinical Trial to treat prostate cancer has established that VAL201 is safe and well tolerated at doses up to 4mg/kg, and has seen early evidence of the drug’s potential activity in prostate cancer. At the current stage of the trial, ValiRx is establishing the maximum tolerated dose of VAL201, based on the safety and tolerability data that it continues to collate since the MHRA approved the protocol amendment. This is a dose-ranging study, which on trial conclusion, ValiRx will either out-license the VAL201 asset to a major pharmaceutical company or will proceed to a pivotal Phase llb study.
- Post period, ValiSeek has reported that it has agreed Letters of Intent with one European and one US partner, about the further advancement of VAL401 into the next proposed clinical trial, on a co-financing basis and that ValiSeek will seek external financing towards the next trial (announced 26 March 2019).
- VAL301 is in late pre-clinical phase initially for the treatment of the gynaecological condition, endometriosis. Key attributes of VAL301 are that unlike current treatments for this condition, pre-clinical studies suggest it does not compromise bone density or fertility. In the period, VAL301 received a US patent grant and post period, patent allowances covering China and the Russian Federation, providing protection for the compound in three of the most populous nations in the World;
- Positive results for the VAL101 compound showing it to be effective in inducing apoptosis (programmed cell death) in cancer cell models. The results suggest that VAL101 has significant apoptotic effect on cancer cells. The compound is an optimized, commercially viable, 2nd generation development of the VAL101 molecule.
- The period saw further strengthening of ValiRx’s VAL201 patent portfolio with grants in the US & Europe and ValiSeek’s VAL401 patent allowance in New Zealand.
Financial Highlights
- Placings during the period of £3.7m (2017: £3.072m)) applied to continue the advancement of the clinical trial of VAL201, the pre-clinical progress of VAL101 & VAL301 and the broadening of the Company’s IP portfolio;
- Total comprehensive loss for the year of £4,298,822 (2017: £3,019,684);
- Loss per share from continuing operations of 0.94p (2017: Loss 1.90p);
- Cash and cash equivalents as at 31 December 2018 of £372,872 (2017: £701,410), reflecting additional API and IMP (drug) required to meet dose-escalation study requirement, based on anticipated patient recruitment dosed at 16mg/kg, as opposed to 4mg/kg in 2017;
- Loss before income taxation of £4,829,138 (2017: £3,553,982).
Oliver de Giorgio-Miller, Non-Exec Chairman of ValiRx, commented:
“Given the risk-averse funding climate in the reporting period, we sustained momentum in terms of adding value to our assets by advancing VAL201 in the UCLH prostate cancer clinical trial and progressing the pre-clinical advancements of the VAL101 and VAL301 compounds, to bring these closer to the Phase I ready stage. We are also pleased to report post period, that ValiSeek has secured a robust solution and strategy for the advancement of VAL401 and that it has agreed Letters of Intent with two partners to progress VAL401 into its next proposed clinical trial“.
“New technologies and tools continue to revolutionise our understanding of cancer in the development of personalised and ‘precision’ drugs and I was delighted to see just after the period’s end, the NHS’s Long Term Plan being announced, with the Government now actively discussing and championing, in all but name, our therapeutic and diagnostic approaches”.
“Our drug candidates have been subjected to rigorous clinical and pre-clinical testing, the results of which have consistently given the green light to continue their progress. We aim to remain at the forefront of developing new enhanced therapeutics and I look forward keenly to patients and our supportive shareholders alike deriving the full benefit from our efforts”.
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