Ark Therapeutics Group plc
Interim Management Statement
17 May 2012 - Ark Therapeutics Group plc ("Ark" or the "Company") today publishes its interim management statement for the period from 1 January 2012 to date. The Company intends to report its results for the six months to 30 June 2012 on 29 August 2012.
Manufacturing
Over the last 18 months, as part of the Company's overall transformation, an increasing emphasis has been placed on the revenue generating capability of the Company's manufacturing assets. As an indication of how important to the future of Ark the Board sees this activity, we were delighted to announce in April the appointment of Dr David Venables as Executive Director - Manufacturing Services. With an impressive track record in building manufacturing services businesses, Dr Venables will build on the success achieved to date and enable us to accelerate the development of our world-leading viral manufacturing capability into a major, self-sustaining business.
In January we reported that good progress had been achieved in our partnership with PsiOxus Therapeutics Ltd in supporting the development of PsiOxus' ColoAd1 programme for the treatment of colorectal cancer utilising Ark's suspension based single use system (ATOSUS). Then, in April we announced that the Finnish Medicines Agency had, following inspection, extended Ark's Good Manufacturing Practice (GMP) certification to include GMP3, the Company's newest and largest manufacturing facility. This certification has greatly increased Ark's manufacturing capacity, including an automated, high through-put "fill and finish" line.
With the arrival of Dr Venables and the recruitment of an experienced, senior manufacturing business development person, we are confident, not only of being able to announce further manufacturing partnerships in the short term, but also of achieving increased momentum in a core part of our business going forward.
Product Pipeline
Progress in the period has not solely been confined to manufacturing. In May we announced that a consortium including Ark had won a €5.3m EU Framework Programme 7 Grant for the clinical development of Ark's product candidate EG013 in Fetal Growth Restriction ("FGR"), further validation of the excellent science which underpins Ark's innovative early stage pipeline. In the same month we also announced the completion of the dose ranging phase of the academic Phase I clinical study of Ark's VEGF-D adenoviral vector treatment for refractory angina, being carried out in collaboration with the AIV Institute in Finland.
In February and May we announced that the United States Patent and Trademark Office had issued a Notice of Allowance in respect of a patent covering the structures of candidate compounds in Ark's neuropilin-1 ("NRP-1") small molecule antagonist programme and a patent with claims covering Ark's FGR programme respectively.
Neuropilin-1 Receptor Antagonists (EG014) - Ark has developed the only known drug-like small molecule antagonists of VEGF binding to the Neuropilin-1 receptor (NRP-1). The compounds display activities likely to be of benefit in the treatment of solid tumours, notably inhibition of tumour blood supply (angiogenesis) and of the proliferation and spread of tumour cells. Recent publications have highlighted the importance of the interaction between NRP-1 and VEGF in maintaining cancer stem cells, a target that Ark's programme is in a unique position to exploit. During the reporting period the priority of the programme has focused on functional characterisation of the NRP-1 antagonists and increasing the evidence of their therapeutic potential in a variety of diseases. In addition, progress has been achieved in scaling up the synthesis of these compounds and in defining how they interact with their target. Ark is actively promoting the possibility of partnership in this programme with companies with interests in such therapies.
Refractory Angina (EG011) - Refractory angina is a consequence of insufficient blood supply to the areas of heart muscle damaged by a heart attack. EG011 is an adenoviral vector carrying a transgene for expression of human VEGF-D which is directly administered to the ischemic heart muscle in order to stimulate new blood vessel generation. An academic clinical study of this treatment is in progress in Finland to gain early insights into the safety and efficacy of the treatment. In May we announced that the initial Phase I dose ranging phase of the study had been concluded and that this study will now progress to a controlled Phase II stage at the selected dose. The first patient is expected to be enrolled in the Phase IIa in Q3 of 2012.
Peripheral Vascular Disease (EG016) - This programme is designed to improve the outcome for people undergoing bypass procedures to overcome blockage of the main blood vessel to the lower leg. Like refractory angina, this programme utilises the angiogenic properties of adenoviral VEGF-D. The vector is delivered into the muscle of the affected limb a number of days before surgery to promote the growth of smaller vessels needed to take blood flow from the vessel that has been unblocked by bypass or angioplasty. As with refractory angina, early insights into the safety and efficacy of the treatment are anticipated from an academic clinical study being undertaken in Finland, the results of which will be used to form the basis of formal development programmes with partners.
Fetal Growth Restriction (FGR) (EG013) - The FGR programme represents another potential therapeutic application of Ark's pro-angiogenic adenoviral VEGF-D gene vector. Severe fetal growth restriction, which is a consequence of inadequate placental blood supply, is a major unmet clinical need. Ark's academic collaborators have demonstrated in models of the condition that treatment of the maternal uterine artery with adenoviral VEGF leads to increased maternal blood supply to the fetus with consequent improved fetal growth and neonatal outcome. Plans have been made and discussed with regulatory authorities for translation of this scientific breakthrough into a clinical therapy. An indication of this nature requires very stringent safety precautions and we have been pleased to announce in May the above mentioned EU grant that will support the required studies as well as initial clinical application.
Ark is active in engaging with other companies for potential partnership on our development programmes, whether early (above programmes) or late (e.g. Cerepro®) stage.
Board
As announced in March, Charles Spicer was appointed to the Board as Non-Executive Director and, as mentioned above, Dr David Venables was appointed as Executive Director - Manufacturing Services in April. Peter Keen will not be seeking re-election to the Board as a Non-Executive Director at the Annual General Meeting being held today.
Cash
We reported in our full-year results on 12 March 2012 that the Company had £9.5m in cash (excluding the Finnish working capital loan of €3m in restricted cash) at 31 December 2011.
The Board continues to review detailed cashflow forecasts on a regular basis. There have been no significant changes in the financial position of the Company in the period since publication of the results for the year ended 31 December 2011.
Martyn Williams, CEO of Ark, commented:
"Since the start of the year we have concentrated on implementing the next phase of our strategy, focusing on the revenue generating capability of our valuable manufacturing assets and progressing the development of our therapeutic pipeline in innovative ways. With the value-enhancing recruitments we have made in the period and the support received for our pipeline, I am confident we will deliver tangible evidence of further success during the rest of this year."
Enquiries
Ark Therapeutics Group plc | Tel: +44 (0)20 7388 7722 |
Martyn Williams, Chief Executive Officer |
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Iain Ross, Executive Chairman |
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FTI Consulting | Tel: +44 (0)20 7831 3113 |
Ben Atwell/Sue Quigley |
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Ark Therapeutics Group plc
Ark Therapeutics Group plc is an innovative gene-based medicine company with operations in the UK and Finland that seeks to capitalise through partnerships on its pipeline of programmes in high value areas of unmet medical need within vascular disease and cancer, and to exploit its unrivalled viral manufacturing capability based in Kuopio, Finland. Ark Therapeutics' biological manufacturing operations provide process development and manufacturing for a growing number of third party clients for a variety of stages of therapeutic development, as well as for its own internal programmes.
Ark's research is focused on discovering new approaches to gene delivery using viral vectors with particular emphasis on genes that control tissue vascularisation, especially VEGF, and is based on the work of its two world-leading research centres in Kuopio and London. The Finnish group is led by Professor Seppo Ylä-Herttuala and is expert in the exploitation of viral technology to address serious medical problems, while Professor John Martin leads a team in London who have complementary skills in the understanding of biological structures and the development of small molecule agonists and antagonists. This combination of skills has resulted in Ark identifying and bringing forward a number of attractive programmes in gene therapeutics and small molecules.
Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).
This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.
