Final Results
Oxford Biomedica PLC
03 March 2004
For release 7.00AM 3 March 2004
For further information, please contact:
Oxford BioMedica plc
----------------------
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
Andrew Wood, CFO
Nick Woolf, SVP Corporate Strategy
City/Financial Enquiries:
Mike Wort, James Chandler: Beattie Financial Tel: +44 (0)20 7398 3300
Scientific/Trade Press Enquiries:
Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150
OXFORD BIOMEDICA PLC
PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2003
Oxford, UK: 3 March 2004 - Oxford BioMedica (LSE:OXB) announced today its
preliminary results for the year ended 31 December 2003:
Financial Highlights:
• Cash balance at 31 December of £31.8 million (2002: £21.0 million),
strengthened by October 2003 rights issue, which raised £20.4 million net of
expenses.
• Revenue increased by 116% to £0.4 million (2002: £0.2 million).
• Cash burn reduced by 17% to £9.6 million (2002: £11.6 million).
• R&D expenses unchanged at £10.8 million (2002: £10.8 million). Clinical
and preclinical activities boosted by increased sponsorship from charities
and government agencies.
• Loss per share reduced by 15% to 3.9p (2002: 4.6p).
Oncology Highlights:
• TroVax: ongoing monitoring of Phase I/II trials in patients with
colorectal cancer shows improved survival correlated with immune response.
• TroVax: five Phase II trials started or planned. Encouraging initial
data from Phase II trial in colorectal cancer alongside chemotherapy.
• TroVax: Cancer Research UK to fund Phase II trial in colorectal cancer
patients with operable liver metastases.
• TroVax: preparations for pivotal trials underway and progress in
partnership discussions.
• Targeted Antibody Therapy: preclinical milestone achieved in cancer
antibody collaboration with Wyeth.
• MetXia: positive results from second Phase I/II trial confirm proof of
principle with improved formulation.
• MetXia: Phase I rolling into Phase II trial in patients with pancreatic
cancer to start in mid 2004.
• TroVax-Vet: option to license agreement signed with Intervet (a unit of
Akzo Nobel).
Neurotherapy Highlights:
• ProSavin: new preclinical data in model of Parkinson's disease
demonstrate compelling efficacy.
• RetinoStat: vision loss product optimised with proprietary
anti-angiogenesis genes.
• RetinoStat: preclinical funding secured from the US charity Foundation
Fighting Blindness.
• Pipeline: preclinical proof of principle achieved in motor neuron
disease, spinal muscular atrophy and spinal injury.
• LentiVector: research licence for the Company's LentiVector technology
granted to Merck & Co in February 2004.
• Intellectual property: 13 new patents granted including LentiVector US
patent.
Board Changes:
• Nick Rodgers, former head of Life Sciences and Joint Head of Corporate
Finance at Evolution Beeson Gregory, has been appointed non-executive
director.
• Andy Allars and Doug Jolly have left the board.
Commenting on the results Oxford BioMedica's Chief Executive, Prof. Alan
Kingsman said: 'I am very pleased to report on the continued progress of the
pipeline in 2003. As well as advancing our two clinical cancer products into
multiple trials, we have made considerable progress with our neurotherapy
portfolio. Our cancer antibody deal with Wyeth took a step forward with the
achievement of a key milestone and we have expanded our corporate partnerships
since the year end with the addition of Merck & Co as a licensee of the
LentiVector technology. The next 12-18 months could see some significant product
and commercial news flow as we reach key milestones for our pipeline candidates
and seek to secure new collaborations'.
-Ends-
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development of novel gene-based therapeutics with a focus on the areas of
oncology and neurotherapy. The pipeline is focused on the areas of oncology and
neurotherapy. The Company was established in 1995 as a spin out from Oxford
University, and is listed on the London Stock Exchange.
Oxford BioMedica's products use genes as the mediators of a therapeutic effect
and/or immune response. The Company's gene therapy products deliver therapeutic
molecules in vivo whilst its gene-based immunotherapy products deliver genes
that recruit the patient's immune system to mediate a therapeutic effect. The
genes are delivered by the Company's highly engineered viral systems.
In addition to its technical expertise in gene delivery, Oxford BioMedica has
in-house clinical, regulatory and manufacturing know-how. The development
pipeline includes two novel anti-cancer products in clinical trials; and two
neurotherapy products in advanced preclinical development for Parkinson's
disease and retinopathy. The Company is underpinned by an extensive preclinical
and research portfolio and about 70 patent families, which represents one of the
broadest patent estates in the field.
The Company has a staff of ca. 65 split between its main facilities in Oxford
and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford
BioMedica has corporate collaborations with Wyeth, Intervet, Merck & Co,
Amersham, Arius Research and Kiadis.
Further information is available at http://www.oxfordbiomedica.co.uk
Chairman's and Chief Executive's Report
In 2003, Oxford BioMedica made significant progress in the advancement of its
pipeline. The Company's lead cancer products, TroVax(R) and MetXia(R), moved
further down the product development pathway with six new clinical trials
initiated or planned for 2004. The Company also achieved a major milestone in
its cancer antibody collaboration with Wyeth. In neurotherapy, preclinical proof
of principle was demonstrated in four out of the five products, with the fifth
anticipated in the first half of 2004. In addition, cash consumption was reduced
and a successful rights issue raised £20 million, strengthening the balance
sheet and providing working capital through to 2007. At 31 December 2003, the
Group had a net cash position of £32 million.
During 2003, biotechnology was one of the best performing sectors of the London
Stock Exchange and Oxford BioMedica outperformed its benchmark indices. The
share price increased by over 225% during the year with significantly higher
average daily trading volumes. This compares to a rise of 54% in the FTSE
techMARK mediscience index and 42% in the NASDAQ Biotech index during 2003. In
October, the Company benefited from this improved sentiment by completing a
successful rights issue, which raised a total of £20 million net of expenses.
It was gratifying that the proportion of valid acceptances in the rights issue
was 66% and that the balance of rights shares was placed in the market at a
premium. The Company now has sufficient resources to reach key product
development milestones and has strengthened its negotiating position with
potential partners.
Oxford BioMedica has maintained its therapeutic focus in cancer and neurotherapy
and has concentrated resources on proof of principle preclinical studies and on
clinical trials. This strategy has resulted in the Company achieving several key
milestones over the year, which, in turn, have potentiated business development
efforts. During 2003, TroVax, RetinoStat(R) and ProSavin(R) have been the
subjects of significant discussions with potential partners. During 2004, the
scope of the Company's business development initiatives will expand to include
the seven lead product candidates as Oxford BioMedica increases its focus on
commercial as well as technical and clinical goals.
Oncology
The development of novel cancer therapies that combine efficacy and safety has
been a primary goal of the Company since its inception. Although the market for
cancer products is becoming increasingly fragmented and the design of clinical
trials increasingly complex, this is a potentially lucrative market with scope
for many novel products targeting specific types and stages of cancer. Oxford
BioMedica has created three major opportunities in this area: TroVax, an active
immunotherapy; MetXia, a potentiator of current chemotherapy; and an
antibody-targeted 'magic bullet', partnered with Wyeth.
TroVax(R)
TroVax is Oxford BioMedica's leading cancer immunotherapy product. It is
designed specifically to stimulate an anti-cancer immune response and has
potential application in most solid tumour types. TroVax targets one of the
Company's proprietary tumour antigens, 5T4, which is broadly distributed across
a wide range of solid tumours. The product consists of a pox virus (MVA) gene
transfer system, which delivers the gene for 5T4. MVA is known to induce the
breaking of immune tolerance to self-antigens that are expressed from the gene
delivery system.
In 2002, the Company completed Phase I/II trials of TroVax in late-stage (Stage
IV) colorectal cancer patients. The data showed that the product induced an
anti-tumour immune response in more than 95% of patients and that it was safe
and well tolerated. In addition clinical benefit was seen in some patients.
Since the completion of those trials, ongoing patient monitoring during 2003 has
shown a clear correlation between TroVax-induced antibody response and patient
survival post-vaccination. Furthermore, almost 60% of patients survived for 50%
longer than their expected median survival times. Although the number of
patients in the trials is small, these new data add to the body of encouraging
results for this product.
Following on from these successes, a comprehensive Phase II programme was
initiated during 2003, which comprises five Phase II trials. Patient recruitment
is underway in two of these.
The two Phase II trials that are enrolling patients are investigating TroVax
alongside current chemotherapy in Stage IV colorectal cancer patients. These two
studies build on the experience gained in the Phase I/II studies and are
designed such that a Phase III pivotal trial alongside chemotherapy can be
planned. The primary endpoint of the two trials is a demonstrable anti-5T4
immune response in the context of the chemotherapy. TroVax is being administered
with the two most common chemotherapy regimes used for colorectal cancer;
5-fluorouracil (5FU) with irinotecan in one trial and 5FU with oxaliplatin in
the other.
In March 2003, the Company received approval from the UK Gene Therapy Advisory
Committee (GTAC) and the Medicines and Healthcare products Regulatory Agency
(MHRA) to proceed with the 5FU plus irinotecan trial. The trial is being
conducted at two centres: the Christie Hospital in Manchester and the Queen
Elizabeth Hospital in Birmingham. To date, a total of ten patients have been
recruited. Four of these have been withdrawn from the trial because of an
inability to withstand or respond to the chemotherapy. This level of withdrawal
is normal and was anticipated in the design of the trial. The remaining patients
are partway through their TroVax immunisation regime. There have been no adverse
events that can be attributed to TroVax and there has been no reduction in
T-cell (CD4 and CD8) counts, which are indicators of immune competence,
supporting the notion that immunotherapy alongside chemotherapy is a feasible
strategy. Furthermore, initial analysis suggests that TroVax can induce an
anti-tumour immune response while chemotherapy is being used. The trial is
almost fully enrolled and the Company plans to report further data later in the
year.
In March 2003, the 5FU plus oxaliplatin trial was approved by the MHRA and
clearance from GTAC was obtained in May. The trial is being conducted at the St
James' Hospital in Leeds and the Hammersmith Hospital in London. Recruitment is
ongoing and initial data from this trial are expected in the next few months.
In addition to these two trials using TroVax alongside chemotherapy, the Company
is pursuing an application for TroVax in Stage IV colorectal cancer patients who
undergo surgery for resectable liver metastases. In August 2003, the Company
announced that this programme had attracted sponsorship from Cancer Research UK
(CR-UK). The decision by CR-UK followed extensive review of the successful Phase
I/II data of TroVax in colorectal cancer patients. In this adjuvant therapy
setting following surgery, the goal is to eradicate any remaining cancer cells.
In fact, adjuvant therapy offers promise for not just extending patients' lives,
but helping to promote full recovery without recurrence of cancer.
Patients in the CR-UK trial will receive injections of TroVax followed by
surgery approximately two weeks later. Biopsies of the tumour will be taken at
surgery and analysed for TroVax stimulated immune activity. Further vaccinations
will be given after surgery. Patients' management will then continue as
standard. Patients will be followed after the final vaccination to assess immune
responses and toxicity and then monitored over the longer term to assess for
clinical benefit. CR-UK has received regulatory approval to start the trial and
recruitment is expected to commence in April 2004.
While colorectal cancer is an excellent target market for TroVax, it is
relatively competitive and crowded in terms of treatment options. However, the
wide prevalence of the 5T4 antigen on different tumour types means that TroVax
could have benefit not only in colorectal cancer but in an estimated 75% of all
solid tumours. The Company is therefore expanding the commercial scope of the
product by conducting trials in patients with other types of cancer. Two trials
are to be conducted in the USA under an Investigational New Drug (IND)
application. The first is in patients with metastatic renal cancer and the
second is in patients with advanced breast cancer. Both diseases represent
important unmet medical needs, which in the case of renal cancer, is reflected
in the poor prognosis for patients. Only about 20% of patients respond to
current treatment for metastatic renal cancer and five-year survival rates are
about 10%. Both the renal cancer and breast cancer trials are expected to start
in Q3 2004.
In May 2003, the Company announced that TroVax had received clearance from the
United States Recombinant DNA Advisory Committee (RAC) to enter the renal cancer
trial. This is a prerequisite for a successful IND application. In December
2003, the Company submitted its IND application to the FDA and has subsequently
addressed all the issues raised by the US regulatory body. TroVax will be tested
alongside standard treatment with IL-2 in patients whose median survival is only
about 13 months. Safety and immunogenicity will be the primary goals but
patients will be monitored for clinical benefit including increased survival.
The trial will be conducted at the Columbian Presbyterian Medical Center in New
York and patient recruitment is expected to start in Q3 2004. The study should
be complete, as far as the primary end-points are concerned, within about twelve
months of initiation.
During 2003, the Southwest Oncology Group (SWOG), a clinical research consortium
funded by the US National Cancer Institute selected TroVax for sponsorship
following an extensive review of Oxford BioMedica's preclinical and clinical
data. The target disease is advanced breast cancer and the trial will recruit
120 patients. This size of trial has the potential to deliver very meaningful
efficacy data. The trial will be a multicentre study in the USA and should start
in Q3 2004. The study is expected to be fully recruited by the end of 2005.
Overall, apart from minor delays in patient recruitment in the UK, the TroVax
programme is proceeding well. In excess of 200 patients will have been treated
with TroVax once the planned Phase II trials are complete. Of particular note is
the endorsement of TroVax by prestigious independent cancer research
organisations. These organisations are supporting a significant part of the
development of TroVax, yet they receive no commercial rights in return for their
sponsorship. Clearly this enhances the value of the TroVax 'package'.
The next 12-18 months will be an exciting period for TroVax as data from the
Phase II trials emerge. Importantly, the Company is progressing in its
discussions with potential partners for TroVax, which will set the path for
moving into pivotal trials and commercial launch. In the meantime, the Company
is already preparing for registration trials. In 2003, a contract was signed for
large-scale and commercial manufacture of TroVax with a major biologicals
manufacturer. In addition, the Company has an ongoing interaction with the FDA
and the MHRA regarding the requirements for product approval.
Targeted Antibody Therapy Wyeth Collaboration
In January 2001, Oxford BioMedica licensed a proprietary antibody to Wyeth in an
agreement that has the potential to bring $24 million to the Company in
milestone payments, and then significant royalties on product sales.The antibody
targets one of the Company's proprietary tumour antigens. The product concept is
that Wyeth uses its proprietary technology to link a toxic molecule,
calicheamicin, to the anti-tumour antibody and the resulting conjugate is
injected into a patient with cancer. The antibody docks onto cancer cells and
the associated toxin then kills the cells. It is essentially the concept of the
'magic bullet' that only targets the intended victim. Wyeth funds and carries
out all of the preclinical development work for the product and will fund
clinical trials. Over the past two years they have been conducting experiments
to show that the Oxford BioMedica antibody, when linked to calicheamicin, can
pass a number of critical preclinical tests that would indicate that the
combined product might be successful.
During 2003, Wyeth achieved its objectives with the antibody in preclinical
proof of concept models. As a result Wyeth exercised its option to continue with
the programme and made a milestone payment to the Company.
TroVax-VETTM Intervet Collaboration
TroVax-VET is a veterinary version of TroVax that uses a canine or feline
version of 5T4 instead of the human form. The market is solid cancers in
companion animals (dogs and cats) and is likely to be $100-200 million in size.
In December 2003, an option to license agreement was signed with Intervet (a
division of Akzo Nobel) confirming its previous commitment to the development of
the product. Under the terms of the agreement Intervet funds all preclinical and
clinical studies and Oxford BioMedica will receive milestones and royalties on
sales. Key preclinical data in the target animals are expected in Q3 2004.
MetXia(R)
MetXia is Oxford BioMedica's leading gene-based cancer therapeutic. The product
is based on a highly engineered retrovirus that delivers a specific human
cytochrome P450 gene to tumour cells. The enzyme encoded by the P450 gene
activates the commonly used cancer chemotherapy drug, cyclophosphamide, to a
form that destroys cells. Therefore, MetXia converts the tumour into a 'drug
factory', enabling increased local production of the anti-tumour, cytotoxic
derivative of cyclophosphamide. MetXia is potentially useful in the treatment of
all solid tumours and their metastases, particularly those where
cyclophosphamide is commonly used.
In December 2003, the Company reported successful results from a second Phase
I/II trial with MetXia, mainly in breast cancer and melanoma patients. The two
completed Phase I/II trials have demonstrated proof of principle and enabled the
optimal formulation of MetXia to be determined. MetXia was shown to be safe and
to have the potential to enhance the efficacy of cyclophosphamide chemotherapy.
The product achieved the desired delivery of the therapeutic gene to the tumour.
The second trial used an improved formulation of MetXia that effectively
increases the dose level. Taken together the trials involved 19 advanced
patients with surface tumours. In line with expectations, the higher potency
version delivered the therapeutic gene more efficiently than the original
version of the product. Clinical benefit was seen in both trials including
tumour regression. Furthermore, five out of seven patients assessed so far from
the second trial have shown an increased immune response to known tumour
associated molecules, confirming the immunogenic properties of MetXia. Detailed
data from the Phase I/II trials will be published during 2004 in peer reviewed
journals and at conferences.
Having established that the basic concept of MetXia is sound the Company has
initiated a study in patients with pancreatic cancer. This is an ideal disease
setting for MetXia since both the product and the cyclophosphamide can be
administered directly to the tumour. This is in contrast to the first trials in
which cyclophosphamide was delivered orally. In October 2003, the Company
received approval from GTAC to proceed with the pancreatic cancer trial and, in
December 2003, the MHRA also approved the trial. The study will be conducted at
two leading clinical centres, the Royal Liverpool University Hospital and the
Leicester Royal Infirmary, and is expected to start in mid 2004. It is an open
label study with an initial Phase I stage that is then designed to roll into a
Phase II study. Initially, six patients will be recruited to assess the safety
of MetXia in this clinical setting and to identify the optimal dose for the
second stage.In the second part of the trial, the cyclophosphamide prodrug will
be gradually escalated to identify a maximum tolerated dose. Up to 21 patients
will be recruited and endpoints include safety, clinical response and time to
disease progression. Initial data should be available in Q1 2005.
Pancreatic cancer is amongst the most aggressive with median survival time of
only 6-12 months from diagnosis for patients with inoperable cancers. Current
treatment options are primarily based on the chemotherapeutic agents 5FU and,
more recently, gemcitabine. However, these have a minimal effect on median
survival underlining the need for novel therapeutic strategies. Given the short
survival times for pancreatic cancer, MetXia could benefit from accelerated
approval following pivotal trials.
Commercial Development
There has already been significant external validation of the Oxford BioMedica
oncology programme through the commercial commitments by Wyeth and Intervet and
the sponsorship of clinical trials by CR-UK and SWOG. In the spring of 2003 the
Company initiated a business development programme aimed at securing strategic
partnerships for the development of TroVax. That initiative has made good
progress and discussions are ongoing with multiple interested parties. In 2004,
MetXia will be introduced to potential partners with a view to securing a deal
as results from the pancreatic cancer trial emerge.
Neurotherapy
Nervous system disorders are the subject of intense research activity within the
pharmaceutical industry. This is because the market opportunities are
substantial and demographic changes mean that those markets are set to grow.
Historically, small molecule drugs have achieved limited success in many central
and peripheral nervous system conditions. However, it has become clear in recent
years that the use of large biological molecules such as antibodies, growth
factors and enzymes may provide new therapies with substantially increased
efficacy and better safety profiles. However, the limiting step in exploiting
the huge potential of biologicals, particularly in the brain, is delivery across
the blood brain barrier. The Company's technology solves this problem.
Gene therapy, which can provide an endogenous factory within the nervous system
for therapeutic biological molecules, removes the need to cross the blood brain
barrier and therefore removes the limitations of systemic delivery. Thus, gene
therapy approaches open the way to the commercialisation of novel biologicals
for the treatment of disorders in the central and peripheral nervous system.
Oxford BioMedica's LentiVector gene delivery technology is arguably the most
powerful technology currently available to turn this concept into reality. The
Company has five LentiVector-based products in its neurotherapy pipeline, all in
preclinical development.
ProSavin(R)
The Company's lead neurobiology product, ProSavin, is an innovative approach to
the treatment of Parkinson's disease. Parkinson's disease affects 1% of the over
50 population, and approximately 10% of the over 60s. A patient with Parkinson's
disease progressively loses the ability to make the neurotransmitter dopamine,
the mediator of the control of movement. ProSavin is designed to convert a small
area of the brain into a replacement dopamine factory by supplying the genes for
dopamine synthesis to the target cells. The Company is completing preclinical
studies with ProSavin.
During 2003, the manufacturing process for ProSavin, which was developed by the
Company's San Diego team, has been transferred to Cobra Biomanufacturing's GMP
facility in the UK in preparation for taking the product into Phase I/II
clinical trials. In addition, quality control and release assays for the product
have been transferred to the external contract research organisation Q-One
Biotech, a unit of BioReliance. In short, the product is ready to enter clinical
trials with respect to the complete manufacturing process. This has been a major
undertaking because ProSavin is likely to be the first LentiVector-based product
to be tested directly in humans. Therefore, at every step in the process the
Company is breaking new ground with the requirements for regulatory approval.
Importantly, the infrastructure put in place by the Company to take ProSavin
into clinical trials can be used for all of the LentiVector-based products in
the portfolio.
In 2002, the Company demonstrated efficacy with ProSavin in a particular
preclinical model of Parkinson's disease. During the past year the Company has
conducted additional preclinical studies that are considered to be more
predictive of efficacy in man. The results suggest that ProSavin is highly
efficacious with an excellent safety profile. This puts ProSavin on track to go
into clinical development during 2004, a little later than originally
anticipated largely due to minor changes in the construction of the product that
have made it even more potent than the earlier version. Data from various
ProSavin preclinical studies will be published and presented at conferences
during 2004 and will be used in the ongoing business development initiative
aimed at securing a suitable development partner for the product.
RetinoStat(R)
RetinoStat is Oxford BioMedica's novel gene-based treatment for age-related
macular degeneration (AMD) and diabetic retinopathy (DR). Both of these diseases
lead to vision loss as a result of aberrant blood vessel growth in the retina of
the eye. Together, AMD and DR represent the most common causes of blindness in
the developed world. Several companies are attempting to reach this highly
lucrative market. However, whereas most of the development candidates in this
field require frequent intra-ocular administration, RetinoStat may only require
a single injection.
In 2002, the Company entered into a research collaboration for RetinoStat with
the Institute of Ophthalmology in London and, in May 2003, the first results
from the collaboration were reported in a presentation at the Annual Meeting of
the Association for Research in Vision and Ophthalmology, held in Florida. This
is the world's biggest forum for eye research, attended by all principal
commercial and scientific players in the field, a total of around 8,000
attendees. The preclinical data that were presented confirmed RetinoStat's
ability to target accurately the retina using the Company's LentiVector system.
In addition, the Company's Hypoxia Response Element technology was shown to
focus gene expression in those parts of the retina that are local to the
pathological changes associated with AMD and DR.
In September 2003, the Company entered into an agreement with EntreMed under
which it received exclusive rights to two of the most powerful anti-angiogenic
genes currently available, angiostatin and endostatin, for use in ocular
diseases. These genes form the therapeutic payload of RetinoStat. Finally, in
November 2003, the RetinoStat programme attracted funding from one of the
largest US charitable organisations for ocular disease, the Foundation Fighting
Blindness (FFB). Initially the FFB will fund preclinical studies at the Wilmer
Eye Institute, Johns Hopkins University in Baltimore, Maryland, under the
direction of one of the world's leading clinical ophthalmologists, Professor
Peter Campochiaro. Data from these studies will be central to moving RetinoStat
into clinical trials, probably in the USA, and will also provide the Company
with a powerful marketing package with which to attract partners. The
development plan is on schedule and the product is expected to enter clinical
trials in early 2005.
MoNuDinTM
As well as being able to use the LentiVector technology to deliver products
directly to local sites within the nervous system, the technology, with a minor
modification, can also be used to target motor neurons indirectly by injecting
the product into the major muscle groups. Injection into a particular muscle
efficiently targets the motor neurons that control that muscle. MoNuDin is based
on this approach and delivers a neuroprotective gene designed to treat the
degeneration of motor neurons that occurs in diseases such as amyotrophic
lateral sclerosis (ALS), the most common form of motor neuron disease. There is
currently no cure or effective treatment for ALS, a condition affecting about
100,000 people in Europe and the US.
During 2003, the Company established preclinical proof of principle for MoNuDin
in a collaboration with Professor Peter Carmeliet of the University of Leuven.
In an industry standard model of ALS, MoNuDin substantially improved
coordination of movement and increased survival time by a significant period.
These results alone support taking the product into human clinical studies. In
November 2003, some of these results were presented at the 14th International
Symposium on Amyotrophic Lateral Sclerosis and Motor Neuron Disease held in
Milan. This presentation has prompted a number of collaborative opportunities
that are under consideration by the Company. In addition, other aspects of the
MoNuDin programme have attracted funding from the US ALS Association via the
Company's collaboration with the leading ALS expert, Dr. Nicholas Boulis, at the
Cleveland Clinic Foundation in Ohio. The Company plans to start clinical
development with MoNuDin in 2005 but will pursue potential collaborations during
2004 on the basis of the encouraging preclinical data.
SMN-1G
In addition to the ALS programme, Oxford BioMedica is developing a specialised
product to treat a second motor neuron disease, spinal muscular atrophy (SMA).
SMA is one of the most common causes of death in childhood and is as yet
incurable. It is an inherited disorder caused by a defect in the SMN-1 gene that
leads to premature degeneration of motor neurons. The product strategy is simply
to replace the defective gene with the normal version by making use of the
LentiVector's ability to target motor neurons selectively and deliver to those
neurons the SMN-1 gene. During 2003, the Company achieved a key milestone with
its SMN-1G product candidate, which comprises a LentiVector system carrying the
SMN-1 gene. SMN-1G significantly increased motor neuron activity in a
preclinical efficacy model of SMA, proving that the product concept is sound.
These data represent the greatest impact on this model of the disease that has
ever been achieved, and planning for clinical development of the product is
underway.
The SMN-1G programme, like those for TroVax, RetinoStat and MoNuDin, has also
attracted independent financial backing, in this case from the US charitable
organisation FightSMA (formerly Andrew's Buddies) and it is the subject of a
collaboration with Dr. Arthur Burghes of the Ohio State University, a leading
authority on SMA.
Innurex(R)
Spinal cord and nerve injuries affect approximately 20,000 people per year in
Europe and the USA. There are virtually no products to treat these debilitating
conditions and prognosis for functional recovery is often very poor. Innurex
seeks to satisfy this unmet medical need that could represent a market of
$0.5-2.0 billion. The product comprises a LentiVector system carrying the RARss2
gene that induces nerve cells to regrow by a process known as 'sprouting'.
Again, 2003 was a year of demonstrable progress with further preclinical proof
of principle data reported.
In early 2001, the Company acquired exclusive rights to the RARss2 gene from
King's College London where the initial observation that this gene could
programme nerve cells to regrow in vitro was made. Since then the Company, in
collaboration with the team at King's College, has evaluated Innurex in a range
of preclinical models. In December 2003, results from the most recent studies
were presented at the 10th International Symposium on Neural Regeneration held
at Asilomar in California. The data showed that, in vivo as well as in vitro,
Innurex was extremely efficient at inducing nerve sprouting. These results are
highly encouraging and demonstrate that Innurex is achieving its objectives at
the cellular level. The next step is to show that Innurex can restore function
to the damaged limbs. These studies are ongoing and, if successful, could
trigger Innurex's advance into clinical development. Functional data is
anticipated around mid 2004.
Commercial Development
As with the cancer programmes the neurotherapy products have achieved
considerable external, independent validation via the support of three separate
funding bodies. To date, the Company has only embarked on preliminary dialogue
with potential partners for the neurotherapy products, preferring to wait until
key preclinical proof of principle studies were completed successfully. The
recent data with ProSavin in Parkinson's disease takes the product closer to
clinical trials and provides a comprehensive commercial package for partnering
discussions. In the case of MoNuDin, SMN-1G and Innurex, the preclinical results
achieved in 2003 have raised the profile of these products and increased the
prospects of securing suitable commercial partnerships. RetinoStat should
achieve the same status by mid 2004. Therefore, the coming year will see a major
drive towards finding appropriate partners for at least part of the neurotherapy
portfolio.
Corporate Developments
Oxford BioMedica has further improved its operational efficiency in 2003 and
since the year end. The patent estate has been expanded in several areas and new
commercial opportunities have opened for the LentiVector technology. Further
rationalisation of research activities and in-house process development has
enabled the Company to reduce cash consumption and report reduced losses for the
year. Going forward, the successful rights issue in 2003 has strengthened the
balance sheet and places the Company in an excellent position to pursue its
clinical and commercial goals.
Finance
The Company's financial position has improved significantly in 2003. The net
cash outflow before management of liquid resources and financing (often referred
to as the cash burn) was £2.0 million lower than last year at £9.6 million. The
improved cash burn was achieved despite increasing by £1.5 million the amount
spent on external clinical and preclinical development. This reflects the
Company's continuing careful management of resources, as well as some successes
in 2003 in increasing turnover and grant income. The net loss after tax was
£10.7 million (2002: £11.7 million).
The successful rights issue in October 2003 raised new funds of £20.4 million
net of expenses. The year-end bank balance of £31.8 million is sufficient to
fund the Company's presently planned activities into 2007, even in the absence
of revenue or other new sources of funds. Already in 2004, the Company is ahead
of these financial projections, following the announcement of a licence
agreement with Merck & Co, and further revenue from licensing and commercial
deals is anticipated.
Intellectual Property
In a biotech company the foundations of shareholder value reside in the
intellectual property portfolio. Oxford BioMedica's patent estate continues to
strengthen with four new patents filed during 2003 and thirteen granted. Of
particular note is the issue of a third LentiVector patent by the US patent
office in December 2003. This patent, together with previously awarded patents
in the USA and Europe, establish Oxford BioMedica as a dominant force in the
lentiviral vector field.
The Company's lentiviral vector patent estate is important for the in-house
development of LentiVector-based products but it has also become relevant in the
context of technology deals in this field following recent court decisions in
the US. In two recent cases in the US courts (Integra Lifesciences, Ltd. v.
Merck KGaA, 331 F.3d 860 (Fed. Cir. 2003) and Madey v. Duke University, 307 F.3d
1351 (Fed. Cir. 2002)) the ability to claim research exemption from patent
infringement narrowed significantly. The Company believes that this provides an
opportunity to secure valuable revenue through the granting of research licenses
to pharmaceutical and biotechnology companies that use lentiviral vectors.
Several companies have approached Oxford BioMedica for research licenses. The
first of these was agreed with Merck & Co on 5 February 2004.
Changes to the Board
Having served on the Board of Oxford BioMedica for six years, Andy Allars
resigned on 2 March 2004 in compliance with the recommendations of the new
Combined Code on corporate governance. Replacing him is Nick Rodgers, a former
investment banker with considerable experience in the life sciences sector. Nick
now works as an independent consultant, having been Head of Life Sciences and
Joint Head of Corporate Finance at Evolution Beeson Gregory until December 2003.
Nick joined Beeson Gregory in 1989 from accountants Ernst & Young, having also
worked in the Listing Department of the London Stock Exchange.
The transfer, during 2003, of the Company's LentiVector production technology to
Cobra Biomanufacturing was a major step towards the commercialisation of the
neurotherapy pipeline. The Company has signed a contract with Cobra for the GMP
production of ProSavin and Cobra may be contracted to manufacture more of the
Company's LentiVector products in the future. The Company believes that working
with Cobra is a more cost effective strategy than developing manufacturing
capabilities in-house, at least for the foreseeable future. This development,
together with the commitment of the Company to remain focussed on its current
pipeline has allowed further rationalisation of resources in San Diego. The
Company retains a strong US business development and intellectual property
capability but has closed its process development and manufacturing unit. This
will have no adverse impact on product timelines but will result in a net saving
of more than £1.0 million per annum. As a result of the changes in San Diego,
Doug Jolly has resigned from the Board but will be retained by the Company to
explore additional commercial opportunities for the LentiVector technology.
We thank Andy and Doug for their contribution to the development of Oxford
BioMedica and we welcome Nick to the team.
Conclusion
In 2003, Oxford BioMedica has made excellent progress with its clinical and
preclinical pipeline while maintaining costs at levels below those of 2002 and
well within budget. With a strengthened balance sheet from the October rights
issue, the Company is in a strong position to achieve its goals of bringing
novel medicines to market for unmet disorders in oncology and neurobiology.
A particularly gratifying development over 2003, has been the extent to which
external companies and funding agencies are 'buying in' to the Oxford BioMedica
story and contributing, financially and in kind, to the development of the
Company's products. In particular, Wyeth, Intervet, Cancer Research UK, the US
Southwest Oncology Group, the US Foundation Fighting Blindness, the US ALS
Association and FightSMA are all adding substantial real value to Oxford
BioMedica either through the work that is going on in their own laboratories and
clinics or through direct funding. It is worth noting that, in the case of the
non-commercial funding agencies, that value is added without the Company losing
any commercial rights. Oxford BioMedica will continue to pursue charitable and
government funding in order to maximise the value of a product prior to
licensing out to a commercial partner.
The progress of the product pipeline in 2003 has expanded the Company's
commercial business development efforts. Discussions are ongoing with multiple
potential partners for TroVax and a new marketing drive is underway for the
neurotherapy portfolio. The Company's objective is to secure, in the next two
years, a series of out-licensing deals which could generate substantial
licensing income. However, the timing of such deals is difficult to predict,
which was one of the main reasons for raising additional funds in 2003.
It is also pleasing to see the Oxford BioMedica share price recover from its
lows of early 2003. As valuations in the biotechnology sector continue to
recover, the Company will strive to deliver shareholder value through success in
product development and in business development. We are grateful to those
shareholders who have been with us over the years and to the new shareholders
who joined us at the time of the rights issue in October. Finally, as ever, we
thank our remarkable staff for their continued dedication and professionalism.
Dr Peter Johnson
CHAIRMAN
Professor Alan Kingsman
CHIEF EXECUTIVE OFFICER
Financial Review
Financial overview
In 2003 Oxford BioMedica improved its financial position and outlook. The
continuing close review of expenditure has delivered more resources to the
Company's key clinical and preclinical programmes, while the overall cash
outflow and net loss have been reduced. The amount of grant income increased,
and, while still modest at this stage, turnover from licensing deals was also
higher. Most importantly, through the rights issue in October 2003, the Company
brought in additional cash of £20.4 million, net of expenses. As a result of
this financing, the £31.8 million of cash in the 31 December 2003 balance sheet
is sufficient to cover the Company's planned activities well into 2007, without
any further sources of funds, and enables commercial discussions with potential
partners to progress from a position of financial strength.
The Company reported in the 2002 annual report that it had curtailed early-stage
research and development activities and reduced headcount to 81 at the end of
2002. Continuing the emphasis on the clinical and preclinical development of
later-stage products, the cost-base has been rationalised further in 2003.
Without compromising the output from the core programmes, the group headcount
was reduced at 31 December 2003 to 61 (51 in Oxford, UK and 10 in San Diego, USA
). Subsequent to the year-end, in 2004 the Company has initiated a further
rationalisation of the US activity to improve operational efficiency.
2003 results
The net cash outflow before management of liquid resources and financing (often
referred to as the cash burn) in 2003 was £2.0 million lower than last year at
£9.6 million (2002: £11.6 million). Both operational expenditure and capital
expenditure were lower in 2003.
The net loss for the year after tax was £1.0 million less than last year at
£10.7 million (2002: £11.7 million). The net loss attributable to UK operations
was £7.5 million (2002: £8.3 million), with the net loss from US operations £3.2
million (2002: £3.4 million). Due to the weakening US dollar, currency
translation differences on foreign currency net investments in the US subsidiary
in 2003 were £0.2 million (2002: £0.4 million), and the total recognised losses
for the year were £10.9 million (2002: £12.1 million).
Operating expenses in 2003 were £13.7 million (2002: £14.3 million).
Administration expenses were £0.5 million lower than last year at £2.9 million
(2002: £3.4 million) and research and development costs were unchanged at £10.8
million (2002: £10.8 million). Within research and development costs,
expenditure on external clinical and preclinical development was £1.5 million
higher than last year, reflecting a greater focus on the lead programmes matched
by a rationalisation of in-house research costs.
Grant income in 2003 was £0.7 million (2002: £0.1 million). The increase is
attributable to three new grants in 2003: a UK government Eureka grant related
to the TroVax programme, a UK government Link grant related to the Innurex
programme and a grant from the US charity FightSMA, related to the SMN-1G
programme.
Revenue of £0.4 million in 2003 (2002: £0.2 million) was principally from option
fees, triggered by the achievement of a preclinical milestone under the Wyeth
cancer antibody collaboration.
Interest receivable on bank deposits was £0.7 million (2002: £1.1 million).
Despite the additional funds from the rights issue in October 2003, the average
balance held on deposit in 2003 was lower than in 2002, and prevailing interest
rates have been lower. Due to the timing of the maturity of bank deposits in
2002, the cash received from bank interest in 2003 (£0.6 million) was £0.9
million lower than last year (2002: £1.5 million).
The tax credit for 2003 of £1.2 million (2002: £1.3 million) comprises mainly
the UK Research and Development Tax Credit.
There were no major capital expenditure projects initiated in 2003, and capital
expenditure in the year was insignificant at less than £0.1 million (2002: £1.3
million).
Issues of shares
In September 2003 the Company announced its intention to raise additional
capital through a fully underwritten 27 for 50 rights issue at 17p per share.
The rights issue was approved by shareholders at an extraordinary general
meeting on 2 October 2003, and was successfully closed at the end of October.
Acceptances under the rights issue were received for 85.6 million shares (66% of
the total available) with the balance of 44.2 million shares placed by Collins
Stewart at a small premium to the rights price. Before costs, the rights issue
raised £22.1 million. Costs associated with the issue were £1.7 million, and the
net proceeds were £20.4 million.
0.3 million shares were issued to EntreMed Inc. in September 2003 at an agreed
valuation of 26.075p per share as part of the consideration for the grant by
EntreMed of a licence for the use of its proprietary anti-angiogenic genes
endostatin and angiostatin. These genes are used in the RetinoStat programme for
the treatment of vision loss.
During 2003 the Company issued a total of 1.4 million shares on the exercise of
share options by employees and former employees, raising net proceeds of £0.1
million. New options over 2.5 million shares were granted in 2003, and in
accordance with the relevant option scheme rules, following the rights issue in
October 2003, existing options were adjusted by 5.55%, increasing the number of
options by 1.2 million. 6.1 million options lapsed in 2003, mostly connected
with the reduction in staff numbers. At 31 December 2003 the number of options
outstanding was 23.2 million, an overall reduction of 3.8 million.
Future prospects
The Company's strong financial position as a result of funds raised in 2003,
continuing careful control of expenditure, and the maturing of the portfolio of
candidate products in 2003 to a stage where its business development potential
is higher than ever, puts it in a potentially very exciting position over the
coming months and years. Even without revenue from existing or future commercial
deals, the present cash is sufficient to fund currently projected activities
into 2007. This financial projection has already been exceeded, as a new licence
agreement was signed with Merck & Co in February 2004, which will result in an
upfront payment and annual licence fees. Oxford BioMedica anticipates receiving
further funds from existing deals, and expects to sign new deals in the future.
The Company therefore looks to the future with increased optimism and
confidence.
Andrew Wood
CHIEF FINANCIAL OFFICER
Consolidated profit and loss account
for the year ended 31 December 2003
------------------------- ------- ---------- ----------
Notes 2003 2002
£'000 £'000
------------------------- ------- ---------- ----------
Turnover 2 374 173
------------------------- ------- ---------- ----------
Research and development costs (10,773) (10,833)
Administrative expenses (2,922) (3,420)
------------------------- ------- ---------- ----------
Operating expenses (13,695) (14,253)
Other operating income: government and other
grants 669 63
receivable ------- ---------- ----------
-------------------------
Net operating expenses (13,026) (14,190)
------------------------- ------- ---------- ----------
Operating loss (12,652) (14,017)
Interest receivable 711 1,094
------------------------- ------- ---------- ----------
Loss on ordinary activities before taxation 2 (11,941) (12,923)
Tax credit on loss on ordinary activities 3 1,203 1,263
------------------------- ------- ---------- ----------
Loss for the year (10,738) (11,660)
------------------------- ------- ---------- ----------
Basic loss and diluted loss per ordinary share 4 (3.9p) (4.6p)
------------------------- ------- ---------- ----------
The results for the years above are derived entirely from continuing operations.
There is no difference between the loss on ordinary activities before taxation
and the loss for the years stated above, and their historical cost equivalents.
Statement of Group total recognised gains and losses
------------------------- ------- ---------- ----------
Note 2003 2002
£'000 £'000
------------------------- ------- ---------- ----------
Loss for the financial year (10,738) (11,660)
Currency translation differences on foreign
currency 8 (179) (395)
net investments ------- ---------- ----------
-------------------------
Total recognised losses for the year (10,917) (12,055)
------------------------- ------- ---------- ----------
Consolidated balance sheet
at 31 December 2003
---------------------------- ------- -------- --------
Notes 2003 2002
£'000 £'000
---------------------------- ------- -------- --------
Fixed assets
Intangible assets 135 185
Tangible assets 5 2,331 3,394
Investments 26 26
---------------------------- ------- -------- --------
2,492 3,605
---------------------------- ------- -------- --------
Current assets
Debtors 6 2,386 2,223
Cash at bank and in hand 31,836 20,964
---------------------------- ------- -------- --------
34,222 23,187
Creditors: amounts falling due within one year 7 (1,501) (1,254)
---------------------------- ------- -------- --------
Net current assets/(liabilities) 32,721 21,933
---------------------------- ------- -------- --------
Total assets less current liabilities 35,213 25,538
---------------------------- ------- -------- --------
Provisions for liabilities and charges - (6)
---------------------------- ------- -------- --------
Net assets 35,213 25,532
---------------------------- ------- -------- --------
Capital and reserves
Called-up share capital 3,703 2,388
Share premium account 78,045 58,762
Other reserve 711 711
Profit and loss account (deficit) (47,246) (36,329)
---------------------------- ------- -------- --------
Equity shareholders' funds 8 35,213 25,532
---------------------------- ------- -------- --------
Consolidated cash flow statement
for the year ended 31 December 2003
Notes 2003 2002
£'000 £'000
------------------------------ -------- -------- ---------
Operating activities
Net cash outflow from continuing operating
activities (11,488) (13,390)
(see below) -------- -------- ---------
------------------------------
Returns on investments and servicing of finance
Interest received 638 1,550
------------------------------ -------- -------- ---------
Taxation
UK R&D tax credit received 1,259 1,553
Overseas tax received/(paid) 8 (9)
------------------------------ -------- -------- ---------
1,267 1,544
------------------------------ -------- -------- ---------
Capital expenditure
Purchase of tangible fixed assets (51) (1,349)
------------------------------ -------- -------- ---------
Net cash outflow before management of liquid
resources (9,634) (11,645)
and financing -------- -------- ---------
------------------------------
Management of liquid resources
Transfer to deposit accounts (12,368) (6)
Transfer to current accounts 1,329 11,741
------------------------------ -------- -------- ---------
(11,039) 11,735
------------------------------ -------- -------- ---------
Financing
Issue of ordinary shares 22,215 79
Expenses of share issue (1,695) -
------------------------------ -------- -------- ---------
Net cash inflow from financing 20,520 79
------------------------------ -------- -------- ---------
(Decrease)/increase in cash in the year (153) 169
------------------------------ -------- -------- ---------
Reconciliation of operating loss to net cash outflow from operating activities
2003 2002
£'000 £'000
----------------------------------- -------- ---------
Continuing activities
Operating loss (12,652) (14,017)
Amortisation of intangible fixed assets 50 49
Depreciation of tangible fixed assets 943 1,166
Loss on disposal of fixed assets 71 138
Non-cash consideration for acquired intellectual
property rights 79 -
Increase in debtors due after more than one year - (329)
(Increase)/decrease in other debtors and other tax
receivable (232) 90
Increase in prepayments and accrued income (18) (11)
Decrease in trade creditors (74) (230)
Increase/(decrease) in other taxation and social
security 31 (17)
Increase/(decrease) in accruals and deferred income 360 (88)
Exchange rate differences (46) (141)
----------------------------------- -------- ---------
Net cash outflow from continuing operating activities (11,488) (13,390)
----------------------------------- -------- ---------
Notes to the accounts
for the year ended 31 December 2003
1 Basis of preparation
The figures and financial information for the years ended 31 December 2003 and
31 December 2002 do not constitute the statutory financial statements for the
respective years. Financial statements for the year ended 31 December 2002 have
been delivered to the Registrar of Companies and included the auditors' report.
Financial statements for the year ended 31 December 2003 have not yet been
delivered to the Registrar. The auditors' reports on the financial statements
for the years ended 31 December 2002 and 31 December 2003 were unqualified and
did not contain statements under either section 237 (2) or section 237 (3) of
the Companies Act 1985.
Copies of this announcement are available from the Company Secretary. The
audited statutory financial statements for the year ended 31 December 2003 are
expected to be distributed to shareholders by 15 March 2004 and will be
available at the registered office of the Company, Medawar Centre, Oxford
Science Park, Oxford, OX4 4GA.
This announcement was approved by the Board of Oxford BioMedica plc on 2 March
2002.
2 Turnover and loss on ordinary activities before taxation
The Group's turnover and loss on ordinary activities before taxation are derived
entirely from its principal activity. The Group has operations in the United
Kingdom and in the United States of America.
Turnover 2003 2002
Geographical analysis Turnover by Turnoverby Turnover by Turnover by
destination origin destination origin
£'000 £'000 £'000 £'000
------------------------ --------- ------- -------- ------
United Kingdom 29 374 1 173
North America 345 - 172 -
------------------------ --------- ------- -------- ------
374 374 173 173
------------------------ --------- ------- -------- ------
Loss on ordinary activities before taxation 2003 2002
Geographical analysis £'000 £'000
-------------------------------- --------- ---------
United Kingdom 8,693 9,541
North America 3,248 3,382
-------------------------------- --------- ---------
11,941 12,923
-------------------------------- --------- ---------
Net assets 2003 2002
Geographical analysis £'000 £'000
-------------------------------- --------- ---------
United Kingdom 2,216 3,020
North America 1,161 1,548
-------------------------------- --------- ---------
Net operating assets 3,377 4,568
Cash at bank and in hand 31,836 20,964
-------------------------------- --------- ---------
35,213 25,532
-------------------------------- --------- ---------
3 Tax credit on loss on ordinary activities
The Group is entitled to claim tax credits in the United Kingdom for certain
research and development expenditure. The amount included in the financial
statements for the year ended 31 December 2003 represents the credit receivable
by the Group for the year. These amounts have not yet been agreed with the
relevant tax authorities.
2003 2002
£'000 £'000
------------------------------ --------- ----------
Current tax
United Kingdom corporation tax research and development
credit (1,200) (1,262)
Overseas taxation - -
------------------------------ --------- ----------
(1,200) (1,262)
Prior years' tax adjustments
United Kingdom corporation tax research and development
credit 3 7
Overseas taxation - (14)
------------------------------ --------- ----------
Total current tax net credit (1,197) (1,269)
Deferred tax
(Reversal)/origination of timing differences: overseas tax (6) 6
------------------------------ --------- ----------
Total deferred tax (note15) (6) 6
------------------------------ --------- ----------
Tax credit on loss on ordinary activities (1,203) (1,263)
------------------------------ --------- ----------
At 31 December 2003, the Group had tax losses to be carried forward of
approximately £32.6 million (2002: £26.0 million) of which £18.7 million has
been agreed with the Revenue Authorities. Of the Group tax losses, £32.1 million
(2002: £25.6 million) arose in the United Kingdom.
4 Basic loss and diluted loss per ordinary share
The basic loss per share has been calculated by dividing the loss for the year
by the weighted average number of shares of 273,876,723 in issue during the year
ended 31 December 2003 (2002: 251,920,367). The number of shares in issue prior
to the rights issue in October 2003 has been adjusted as required by FRS 14
(Earnings per Share).
The Company had no dilutive potential ordinary shares in either year which would
serve to increase the loss per ordinary share. There is therefore no difference
between the loss per ordinary share and the diluted loss per ordinary share.
5 Tangible fixed assets
Short Office Computer Laboratory Total
leasehold equipment, equipment equipment
improvements fixtures
and
fittings
£'000 £'000 £'000 £'000 £'000
------------- --------- -------- -------- ---------- -------
Cost
At 1 January 2003 2,288 243 379 3,059 5,969
Additions (9) - 3 57 51
Disposals - (6) (51) (160) (217)
Exchange (41) (6) (6) (85) (138)
differences --------- -------- -------- ---------- -------
-------------
At 31 December 2003 2,238 231 325 2,871 5,665
------------- --------- -------- -------- ---------- -------
Accumulated
depreciation
At 1 January 2003 875 133 200 1,367 2,575
Charge for the year 326 29 109 479 943
Disposals - (6) (51) (89) (146)
Exchange (6) (2) (4) (26) (38)
differences --------- -------- -------- ---------- -------
-------------
At 31 December 2003 1,195 154 254 1,731 3,334
------------- --------- -------- -------- ---------- -------
Net book amount at
31
December 2003 1,043 77 71 1,140 2,331
------------- --------- -------- -------- ---------- -------
Net book amount at
31
December 2002 1,413 110 179 1,692 3,394
------------- --------- -------- -------- ---------- -------
6 Debtors
2003 2002
£'000 £'000
------------------------------------ -------- -------
Amounts falling due after more than one year
Other debtors - rent deposit 263 291
------------------------------------ -------- -------
Amounts falling due within one year
Other debtors 374 123
Corporation tax receivable 1,200 1,262
Other tax receivable 107 115
Prepayments and accrued income 442 432
------------------------------------ -------- -------
2,123 1,932
------------------------------------ -------- -------
Total debtors 2,386 2,223
------------------------------------ -------- -------
7 Creditors: amounts falling due within one year
2003 2002
£'000 £'000
------------------------------------ -------- -------
Trade creditors 310 379
Other taxation and social security 195 164
Accruals and deferred income 996 711
------------------------------------ -------- -------
1,501 1,254
------------------------------------ -------- -------
8 Reconciliation of movements in Group shareholders' funds
2003 2002
£'000 £'000
---------------------------------- -------- --------
Loss for the year (10,738) (11,660)
New share capital issued 22,294 79
Expenses of share issue (1,696) -
Exchange differences (179) (395)
---------------------------------- -------- --------
Net addition to/(reduction in) shareholders' funds 9,681 (11,976)
Opening shareholders' funds 25,532 37,508
---------------------------------- -------- --------
Closing shareholders' funds 35,213 25,532
---------------------------------- -------- --------
This information is provided by RNS
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