Final Results
Proteome Sciences Plc ("the Company")
29 June 2006
RESULTS FOR THE YEAR ENDED 31st DECEMBER 2005
HIGHLIGHTS
* Financial
* Headline loss (excluding non-cash items and associates) £4.17m (2004 : £
4.02m)
* Loss after tax £6.17m (2004 : £5.20m)
* Cash balance £2.59m (2004 : £2.43m)
* Additional £2m working capital provided by loan facility from CEO
* Consistent and predictable cash burn expected
* Biomarkers
+ Stroke - Licence agreements for high throughput stroke (HTS) with two
global leaders in clinical diagnostics
+ Discussions actively underway with other leading HTS stroke companies
+ Brain - New research programme discovered 195 proteins differentially
expressed in CSF across a broad range of diseases. Patent applications
have been filed
+ Rejection - from a 240 patent sample set, 17 potentially novel
biomarkers of kidney transplant rejection identified
+ Cancer - New ProteoSHOP® project in colorectal cancer discovers 11
novel biomarkers
+ Validation underway in lung and small cell lung cancers for Annexins
+ Possible use of Annexins as vaccines for lung and oesophagus cancers
+ vCJD - Novel test designed for disease specific peptide fragmentation
+ Huntington's - Plasma biomarkers showing correlation with disease
progression found. Six proteins of importance and IP filed
+ BSE - Additional validation and endorsement of existing biomarkers,
facilitating the discovery of new proteins for live detection of BSE
+ Alzheimer's - Study completed using three different approaches (qPSTâ„¢,
2DE, SELDI) in blood with 36 differentially expressed proteins revealed
+ Good start made in AD for validating new targets and designing a
virtual library of small molecule `hits'
* ProteoSHOP®
+ qPST - in combination with 2DE provides 50% increase in protein
coverage
+ High confidence in data and results from ProteoSHOP® through
cross-platform protein validation
+ Co-marketing agreement with Medical Solutions plc
+ Extensive marketing campaign launched with new contracts under
negotiation
* Reagents
+ Fully functioning six plex set of TMT® mass tags developed
+ Two streams of revenue expected from TMT licences: 1. the reagent
product 2. licence for the IP covering the field of isobaric mass
labelling
+ TMT® licences at advanced stage of negotiation
+ Development of isobaric mass labelling largely complete
+ Focus of efforts in chemistry switched to discovery and validation of
disease biomarkers
* Veri-Q Inc.
+ Presence of impurities has a significant adverse affect on gene
expression analysis using microarrays
+ Two high profile scientific papers in press awaiting publication
+ Pilot projects undertaken and in process for commercial licences
+ Shareholding in Veri-Q increased to 76.9%
* Intronn Inc.
+ In-vivo proof of principle of SMaRT® in dyslipidemia
+ Replicated high levels of improvement in the protein component of HDL -
`Good Cholesterol'
+ In-vivo proof of principle for AAT and most recently haemophilia 12
months ahead of schedule
+ Design of clinical trails now underway for two lead programmes
+ Advanced discussions to secure further funding to move SMaRT® RNA
therapy into clinical trials for dyslipidemia and haemophilia
* Current Outlook
+ Increased need to use protein biomarkers to improve clinical trial
data, accelerate drug development, reduce costs and expand the process
of personalised medicine
+ Following the two high throughput stroke licences, prospects for
commercialisation of the research programme remain strong
+ Highest priority is the completion of further external licences
+ Board looks to the future prospects with increasing confidence
Commenting on these results, Christopher Pearce, Chief Executive of Proteome
Sciences, said:
"The significant increase in the number of pharmaceutical companies approaching
us during 2006 in relation to our biomarker portfolio and ProteoSHOP® toolbox
is highly encouraging and reflects the recognition being placed on proteomics
for the discovery and validation of biomarkers for application in the
diagnosis, prognosis and therapy for diseases.
Over the last year, considerable progress has been made with the expansion of
applications across our research activities and through the discovery of novel
biomarkers in new disease areas including brain diseases, Huntington's,
colorectal cancer and kidney transplant rejection and the development of a
novel test designed for vCJD. We expect this process to continue in the future.
Our licensing programme is moving ahead with two deals signed in high
throughput screening for stroke in recent weeks, with us being at an advanced
stage of negotiations for TMT® licences and in active negotiations for a number
of new contracts using our ProteoSHOP® toolbox and for many of our disease
biomarkers.
As a result of the range of scientific and commercial developments from across
our activities, the Board looks to the future with increasing confidence with
our main priority being the further licensing and commercialisation of the
Company's portfolio of biomarkers and technologies."
ENDS
Attached: Full text of Chairman's statement, consolidated profit and loss
account, consolidated balance sheet, consolidated cashflow statement and notes
to the financial information.
For further information please contact:
Proteome Sciences plc
www.proteomics.com
Christopher Pearce, Chief Executive Tel: +44 (0)1932 865065
Email: christopher.pearce@proteomics.com
Public Relations for Proteome Sciences
IKON Associates
Adrian Shaw Tel: +44 (0)1483 535102
Mobile: +44 (0)797 9900733
Email: adrian@ikonassociates.com
Notes to Editors:
Proteome Sciences plc applies high sensitivity proteomics to identify and
characterise differential protein expression in diseases for diagnostic,
prognostic and therapeutic applications. It has to date developed sensitive
blood assays for stroke, vCJD, BSE, solid organ transplant rejection and
Alzheimer's disease. The main focus of its research currently addresses
neurological, neurodegenerative, diabetes/obesity, oncology and cardiovascular
conditions.
In addition to its own proprietary biomarkers, Proteome Sciences has developed
ProteoSHOP® (Proteome Sciences High Output Proteomics), a toolbox that offers
high sensitivity and high throughput gel and gel-free proprietary technologies
for the identification of potential biomarkers and drug targets. These include
specialisation in membrane proteins and protein phosphorylation.
The Company has developed a range of specialist reagents to improve the
performance and quantitation of protein separation and characterisation with
mass spectrometry, bioinformatics, statistics and pattern recognition. These
include Sensitizer®, PST®, qPST™ and TMT®.
Commercialisation is actively pursued across the portfolio of the Company's
programmes and technologies with licensing deals signed in biomarkers for
Stroke and TSEs and for ProteoSHOP®.
Proteome Sciences is headquartered in Cobham, Surrey in the UK and has
laboratories at Kings College Hospital, London and Frankfurt Innovations
Zentrum (FIZ), Frankfurt. It employs 34 full time scientists in addition to its
corporate and business development staff, and has collaborative research
agreements with leading academic institutes. The Company is listed on the
Alternative Investment Market.
CHAIRMAN'S STATEMENT for the year ended 31st December 2005
Dear Shareholder,
I am pleased to report on the progress made for the year ended 31st December
2005.
The Company has enjoyed considerable success from its research with strong
advances achieved in biomarker discoveries, methodologies and chemical tagging.
Against this, the pace of acceptance of protein related technology by the life
sciences industry, which has historically been dominated by genomics, was
slower than anticipated and this was reflected by the delayed timing of
commercial deals which were expected to conclude in the period.
The first half of 2006 has seen a significant increase in the number of
pharmaceutical companies approaching the company in connection with our
existing biomarker portfolio and the ProteoSHOP® toolbox. Other than for
diagnostic purposes, intended uses include measurement of our biomarkers on
model systems during pre-clinical development and testing of patients during
clinical trials. This reflects the pharmaceutical industry's increasing
awareness of the value of biomarkers in improving clinical development and is a
clear signal that they are responding positively to the challenges set out in
the U.S. FDA's Critical Path Initiative. This has resulted in an increased need
to use biomarkers, largely discovered through proteomics, to improve clinical
trial data, accelerate drug development, reduce costs and expand the process of
personalised medicine.
Against this background, the Board therefore believes that prospects for the
commercialisation of the company's research programmes remain strong.
Commercialisation of the company's research programmes will generate
considerable confidence in the company's technology and its applicability in
the use of biomarkers for diagnostic and therapeutic applications and in its
chemical mass tags as a key methodology for quantitative measurement of
differential protein expression in disease.
This has been reflected by the recent announcements of two non-exclusive
licences to test our biomarkers in blood for the high-throughput diagnostic
platforms with two of the global leaders in clinical diagnostics for the
detection, diagnosis and monitoring of stroke. Discussions are taking place
with a number of other players in stroke and further licences are expected.
Over the course of 2005, the problem of access to samples for validation of
previously discovered protein biomarkers improved considerably and strong
progress has been made which we are confident will result in the conclusion of
further licences with diagnostics and pharmaceutical companies, in particular
in the areas of Alzheimer's, cancer and TSEs.
The interim statement reflected the company's disappointment at the pace of TMT
® negotiations. With the termination of exclusivity, the field was re-opened to
other shortlisted parties in the last quarter of 2005, all of which are
suitable to undertake global commercialisation of the company's isobaric
tagging reagents and the Board is encouraged by the progress of discussions
which are at an advanced stage of negotiation.
There are initially two streams of revenue expected from licensing TMT®, one
from the direct reagent product itself and the second from the intellectual
property ("IP") relating to the field of isobaric mass labelling where the
Board believes that the company's patent filings are comfortably ahead of
competitors.
The market for the TMT® product is considerably larger than was initially
contemplated and the rapid acceptance of new tools for biomarker discovery and
validation was clearly signposted as a key requisite in the FDA Critical Path
guidelines. The second stream of revenue, the licence to the chemistry behind
the isobaric mass labels should cover third party reagents/products in the
market which would sit under the IP umbrella. Both activities should provide
strong cash flow for the company when commercial licences are completed. The
Board remains determined to conclude the TMT® licensing process as soon as
possible.
Over 2005, eleven patents have been granted including lung and oesophagus
cancer, chronic rejection, TSE, oligonucleotides and protein sequence tags and
new patent applications have been filed for discoveries made in Alzheimer's,
Huntington's, colorectal cancer and Sensitizer® mass tags.
Biomarkers
From its research and through its collaborative partners, Proteome Sciences has
established a large portfolio of biomarkers that can be used for the early
detection and monitoring of disease, the evaluation of new compounds and
measuring the efficiency of treatment.
Considerable progress has been made during the year and into 2006 from the
portfolio of biomarkers that have been discovered through our research
programmes.
* Neurological
In stroke, additional stroke and stroke mimic samples were sourced during the
summer which has both expanded and provided robust validation of the data
supporting the sensitivity, specificity and performance of our existing stroke
biomarkers and their application in high throughput screening (HTS). This has
been reflected by the licenses announced in stroke with bioMerieux and, most
recently, with a second licencee in the top 10 in global clinical diagnostics.
Discussions are actively underway with other leading HTS diagnostics companies
in stroke.
Major new research has been underway at the Geneva University Hospital to
discover novel biomarkers uniquely present in brain disease in deceased
patients' cerebrospinal fluid (CSF) to further extend the leading position
Proteome Sciences has established in neurological disorders. This has been
highly successful and has resulted in the discovery of 195 proteins showing
differential expression in CSF with potential application across a broad range
of diseases. Patent applications have been filed and the process to
progressively start the exploitation of these biomarkers in a targeted way has
commenced.
*Transplant Rejection
In the middle of 2005, we received a large retrospective plasma sample set from
40 patients spanning 5 years post kidney transplantation from the Oxford
Transplant Centre. This takes Proteome Sciences into a new area of transplant
rejection alongside its existing research into acute and chronic rejection in
heart disease following transplantation. With ProteoSHOP®, we undertook a
depletion process to remove some of the highly-abundant proteins in serum which
make up around 90 per cent of the content of serum, in order to concentrate on
the differential protein expressions after transplant rejection. Across a 240
patient sample set, we identified 29 proteins differentially expressed of which
we consider 17 may be novel biomarkers of kidney transplant rejection. These
findings have subsequently been confirmed from the results of a recent second
validation study.
There is a serious unmet need for a diagnostic test in kidney transplantation
and the introduction of such a test should generate considerable medical
application and commercial value.
*Cancer
In the middle of 2005 we also entered into a collaborative agreement with a
French company, RNTech, who have provided a set of high quality colon cancer
samples, a disease Proteome Sciences had not previously addressed directly
itself. Again, using ProteoSHOP®, outstanding results have been forthcoming
with the discovery of 22 differentially expressed proteins, half of which would
appear to be novel biomarkers for colorectal cancer. Further validation is
underway to extend these results.
Similarly, Proteome Sciences has, for the first time, become directly involved
in supporting and further developing the granted patents in lung and
oesophageal cancer from its IP portfolio through an immunohistochemistry
validation study of Annexin 1 and 2 expression in a larger patient population.
The primary purpose of this new work was to extend the preliminary data in lung
cancer to all non-small cell lung cancers.
Most interestingly, recent data published in several scientific journals has
confirmed the central role that Annexins 1 and 2 play in tumour development,
particularly in lung cancers and other solid tumours. As a consequence, a
number of research groups propose using Annexins as vaccines for treatment.
Proteome Sciences has exclusively licensed granted patents for the use of
Annexins 1 and 2 for purposes of vaccination in lung and oesophagus cancer.
Not only does this validation of Annexins in histopathology significantly
increase the diagnostic value of our biomarkers as immunohistochemical markers
of non-small cell lung cancer (which accounts for over 70% of all lung
cancers), but it should also considerably enhance their therapeutic value and
utility.
This is enabling Proteome Sciences to expand and exploit some of the strong
intellectual property positions it had previously established in cancer, both
from differential protein expressions and also from the use of auto-antibodies
and secreted proteins in serum.
*Neurodegeneration / TSE
As stated in the Interim Report, encouraging results have been obtained in the
vCJD research programme with the MRC resulting in patents being filed for
plasma protein markers in vCJD and Huntington's. This work has continued to
progress well and the validation of previous experiments has enabled us to
design a novel test based on the disease specific fragmentation of peptides. An
additional patent application relating to this novel assay method and format
was filed earlier this year and we are progressing its development and
evaluation.
The success achieved in Huntington's by the discovery of certain plasma
biomarkers showing a strong correlation with disease progression accelerated
our efforts to discover other new biomarkers and to further validate the
results already achieved by expanding the number of Huntington's samples
analysed. From this, six proteins of particular importance have been identified
and the behaviour and performance of these proteins is being further assessed
and validated. Patent applications have been filed to protect these
discoveries.
Considerable commercial opportunities are available for Huntington's biomarkers
for the early detection of neurodegeneration in this disease, monitoring its
progression in clinical trials of new compounds and for monitoring disease
progress and severity in patients undergoing treatment.
In the past, the lack of availability of samples in BSE has severely hampered
the development of the research programmes. This has now been resolved allowing
additional validation and endorsement of existing biomarkers and facilitating
the discovery of new differentially expressed proteins for the detection of BSE
in live cattle.
To expand and identify further potential diagnostic markers in Alzheimer's
disease, a ProteoSHOP® study comparing 50 disease versus 50 control patients in
blood has recently been completed using a combination of three complementary
approaches (2DE, SELDI and qPST). This has revealed 36 proteins with
differential protein expression of significance, ten of which were confirmed by
more than one method.
We have previously reported the discovery and patenting of novel tau kinase
activity in Alzheimer's and a good start has been made in validating these new
targets and designing a virtual library of small molecule `hits' against the
targets in order to file IP on novel inhibitors of the targets and to
strengthen further the patent position around tau. The first part of this
programme has delivered a selection of compounds possessing drug-like
properties and the second part will involve testing the compounds in activity
assays. Prospective partners have expressed interest in this research, and
particularly in the demonstration of drugability of the validated targets to
delay and/or prevent the progression of Alzheimer's, and this will add
significant value to the project.
Data and results from all the biomarker programmes at Proteome Sciences are
being actively presented to commercial partners by our scientists and business
development team to accelerate future revenue generation through outlicencing.
*ProteoSHOP®
ProteoSHOP® provides an integrated proteomics toolbox to enhance biomarker
discovery. Based on multiple technology platforms, ProteoSHOP® offers highly
cost- and time-effective means of increasing the output of biomarker discovery
programmes.
Development of new in vitro diagnostics for clinically difficult diseases such
as cancer and neurodegeneration, target validation, evaluation of safety
profiles early in drug development and surrogate markers of efficacy in
clinical trials, all require integration of biomarker measurements to expedite
the regulatory process. Critical insights in all of these areas are generated
using ProteoSHOP® to identify differential protein expression across a variety
of body fluids and tissue from diseased and/or treated individuals compared to
relevant controls.
The ProteoSHOP® toolbox of gel-based and gel-free proteomics technologies has
been developed to address differential protein expression for diagnostic and
pharmaceutical research and development. Built on our considerable expertise
across generic proteomic technologies in combination with proprietary
techniques (PST®, qPST™ and TMT®) for gel-free identification and relative
quantitation of proteins in cells, body fluids and tissues, ProteoSHOP®
provides customers with simple, cost-effective and timely access to protein
expression profiling across a broad range of human diseases and model systems.
ProteoSHOP® incorporates leading edge proprietary technology spanning sample
collection, storage, protein separation, identification and characterisation
with bioinformatics and data mining. The high sensitivity and high throughput
characteristics from ProteoSHOP® combine to deliver high output proteomic data
for biomarker discovery and validation.
Impressive progress has been made during the last year with the quantitative
protein sequence tags (qPST®). One of the key advantages offered by ProteoSHOP®
is the 50% increase in coverage of proteins identified using qPST® in
combination with two dimensional gel electrophoresis (2DE). It also provides a
very high level of confidence in the data and results, demonstrating
reproducibility and independent secondary validation of 50% of the total number
of proteins identified using separate and different approaches.
With qPST® now available for routine use, Proteome Sciences has a highly
competitive proprietary technology in its ProteoSHOP® toolbox which is being
actively marketed to the global pharmaceutical industry for discovering
biomarkers of efficacy, safety and toxicity in clinical trials, one of the main
areas highlighted in the FDA Critical Path guidelines in March 2006.
An extensive marketing campaign to raise the profile of ProteoSHOP® with
customers was started earlier this year and this has been extended by the
co-marketing agreement announced in March with Medical Solutions plc. By
combining the two companies' highly complementary technologies (Medical
Solutions concentrates on immunohistochemistry with automated image analysis
and histopathology), customers are provided with a one-stop-shop from biomarker
discovery through to implementation in diagnostics and drug development.
With these capabilities, Proteome Sciences is well positioned to secure further
revenue and deals for ProteoSHOP® accelerating the discovery of protein
biomarkers and targets relevant to major human diseases. A number of new
contracts are currently under negotiation.
*Reagents
The purpose behind the development and validation of reagents within Proteome
Sciences has been to establish and apply proprietary next generation proteomics
technologies to improve the discovery of protein biomarkers and targets
relevant to major human diseases and to capitalise on their value.
The Sensitizer® family of reagents developed in Frankfurt (including TMT®, qPST
â„¢ and Combi SMTâ„¢) have unique applications and utility but inherent in each is
a common feature which enables an increase in the number of peptides and
proteins that can be identified and quantified from complex protein mixtures.
Considerable progress has been made over the period and into 2006 with our TMT®
isobaric mass labelling technology. Over this time, a fully functioning six
plex set of mass tags has been developed which provide strong accuracy and
consistency to quantify simultaneously differential protein expression in six
samples. The elegance and simplicity of the chemical structure and design
allows the format to be readily expanded to a ten plex which will fully address
the needs of the marketplace.
There are initially two streams of revenue expected from licensing TMT®, one
from the reagent product itself and the second from the intellectual property
relating to the field of isobaric mass labelling where, having the earliest
priority date, the Board believes that the company's patent filings are
comfortably ahead of competitors.
The market for the TMT® product is considered to be larger than was initially
contemplated and the rapid acceptance of new tools for biomarker discovery and
validation was clearly signposted as a key requisite in the March 2006 FDA
Critical Path Guidelines. The second stream of revenue, the licence to the
chemistry controlling isobaric mass labels, will potentially cover third party
reagents/products in the market which come within the scope of the IP umbrella.
Both activities should provide strong cashflow for the Group.
The development of isobaric mass labelling is now largely completed and the
main focus of our efforts in chemistry has switched to applications in biology
to accelerate the discovery and validation of biomarkers in human diseases.
*Veri-Q Inc.
Synthetic oligonucleotides are widely used in biomedical research, in-vitro
diagnostics (microarrays) and more recently as therapeutic agents in antisense
drugs. These applications require exacting levels of product purity and
quality. Quality control is essential to ensure the effective and reproducible
performance of oligonucleotides and the FDA in the US has expressed concern
about quality control of oligonucleotides. Oligonucleotide quality is often
compromised by incomplete removal (de-protection) of chemical groups
(protecting groups) which are required for the proper chemical synthesis of
these polymers. The quality of oligonucleotides can also be decreased by the
presence of incomplete products.
Veri-Q has developed a toolbox of antibodies against oligonucleotide protecting
groups that can be used both for monitoring oligonucleotide quality and for the
selective removal of impurities. Using this technology, Veri-Q has demonstrated
that many commercially manufactured oligonucleotides are not fully deprotected
and this creates inaccurate and misleading results. In the last 12 months,
Veri-Q has shown that the presence of these impurities has a significant affect
on the performance of gene expression analysis using microarrays. Two high
profile scientific papers are in press awaiting publication.
Commercial discussions with prospective licencees started in 2005 and certain
pilot projects have been undertaken and are in process. The prospects for these
reagents look attractive and Veri-Q intends to outlicence the technology
principally as QC reagents in RNAi and for DNA microarrays as soon as
practicable.
In May 2005, Proteome Sciences converted its loan into further stock in Veri-Q,
increasing its shareholding to 76.9 per cent.
*Intronn Inc.
Following the development of the high capacity screen, the main objective was
to apply SMaRT® successfully in RNA therapeutics in liver disease by
demonstrating in-vivo proof of principle for one of its three primary
programmes in haemophilia, dyslipidemia (hypercholesterolemia) or AAT
deficiency.
Considerable progress was made in 2005, initially in March by confirming
in-vivo proof of principle in dyslipidemia, followed in June by the successful
stimulation of the production of the protein component of good cholesterol
(HDL) which confirmed SMaRT® transplicing at the RNA level. To put this into
context, there are two types of cholesterol, good cholesterol (HDL) and bad
cholesterol (LDL). For a healthy population, the goal is to raise the HDL
levels and to lower the LDL levels, and whilst statins (a high value class of
drugs) are able to lower levels of LDL, they do not moderate HDL levels. The
development of SMaRT® HDL may therefore provide a very positive improvement in
increasing HDL levels, which may be further enhanced with the use of statins.
Having achieved significant increase in the level of HDL, further studies have
been undertaken over the course of the year which have continued to reproduce
the same high levels of improvement in the protein component of HDL. These
results have provided the backcloth for Intronn to start to prepare the design
for a human clinical trial to assess the ability to raise HDL levels, the
timing of which will become more defined in the second half of 2006.
In the interim report, it was announced that the AAT programme had successfully
completed in-vivo proof of principle with SMaRT® for the first time. Good
progress has continued to be made with AAT and we are pleased to announce that
exciting in-vivo proof of principle results have now also been generated in the
haemophilia programme (Factor VIII) where the levels of Factor VIII have been
significantly increased using SMaRT® transplicing. These results have
subsequently been repeated with similar outcomes and have been achieved nearly
twelve months ahead of schedule. Development of the pre-transplicing molecules
(PTM) for human studies in haemophilia is straightforward, and with the benefit
of the results and data from other programmes using SMaRT®, it suggests that
Phase 1 studies for haemophilia could be significantly earlier that previously
considered.
As expected, the funding provided in 2004 has taken Intronn through into 2006
and up to the position where it can now prepare for clinical trials. Intronn
has been in active discussions with a broad range of commercial parties to
establish strategic partners/alliances for the clinical and commercial
development of SMaRT® across its main programmes and in advanced negotiations
to secure further funding to move SMaRT® RNA therapy into clinical trials for
dyslipidemia and haemophilia. That process has not as yet been completed and,
in order to protect the valuable SMaRT® technology/intellectual property, the
US Board for the time being has downsized and focussed the scale of its
research activities until the process is completed.
In conclusion, the science has moved on strongly last year and into 2006 with
in-vivo proof of principle achieved in the three lead programmes, and with the
design of clinical trials now underway for dyslipidemia and haemophilia.
*Results
The financial results for the twelve month period ended 31st December 2005 show
a headline loss (being the loss for the financial year excluding non-cash costs
and share of associate company's losses) of £4,166,673 compared with £4,016,637
in 2004. Non cash costs (amortisation of goodwill, amounts written off fixed
asset investment, depreciation and National Insurance on notional share option
gains, as extracted from the profit and loss account) were £1,262,689 against £
589,198 in 2004. The period to 31st December 2005 also contains a share of
associate's losses at Intronn Inc. of £735,684 (2004 : £593,366).
The loss on ordinary activities after taxation for the twelve month period
ended 31st December 2005 was £6,165,046 (2004: £5,199,201). The net cash
outflow from operating activities for the year was £4,908,985 (2004 : £
4,542,774).
At the year end, cash held on deposit stood at £2,587,155 (2004: £2,425,943).
The cash spend in 2005 was consistent with previous years and this pattern is
expected to continue in 2006. The licences announced this year to date and the
commercialisation anticipated, combined with grant income and the R&D tax
credit, should provide significant cash inflows and have a positive effect on
the financial requirements of the Company. In addition, in order to provide
further working capital, a loan facility of up to £2 million has been made
available to the Company from C.D.J. Pearce, the Chief Executive, details of
which are disclosed in Note 6 to the Financial Information which accompanies
this statement.
The directors have assumed that the timing of the cash inflows from the
anticipated commercial income will be appropriate to meet the cash requirements
of the business; however, the margin of cash available over the cash
requirements is not large and, inherently, there can be no certainty in
relation to these matters.
Having regard to the assumptions made in respect of the timing of receipt of
the anticipated commercial income, combined with grant income, the R&D tax
credit and other cash inflows including the loan facility of up to £2 million
made available by C.D.J. Pearce, the directors continue to adopt the going
concern basis in preparing the accounts, and accordingly the financial
statements do not contain any adjustments that would result if sufficient
commercial income were not to be received on a timely basis.
In relation to the loan facility from C.D.J. Pearce, the Directors of the
Company, (with the exception of C.D.J. Pearce who, in view of his interest in
the transaction, has taken no part in the consideration thereof), having
consulted with its nominated adviser, consider that the terms of this
transaction are fair and reasonable insofar as shareholders are concerned.
On 29th December 2005, the company filed a claim in the District Court of
Frankfurt am Main ("the Court") against Sanofi-Aventis Deutschland GmbH
("Sanofi-Aventis") under which it is seeking damages, amongst other things, for
the breach of certain warranties provided by Sanofi-Aventis at the time of the
acquisition of Xzillion Proteomics GmbH & Co. KG (now Proteome Sciences R&D
GmbH & Co. KG) on 4th July 2002. On 7th June 2006 Sanofi-Aventis filed a notice
with the Court of its intention to defend the claim.
Full provision for all costs arising in 2005 in connection with the claim has
been made in the 2005 financial statements. Whilst it is not possible to
predict the outcome of this matter, the Directors intend to pursue this action
vigorously and will keep shareholders informed of material developments.
*Current Outlook
The recent text of the U.S. FDA's Critical Path Initiative has considerably
raised the profile and potential to use biomarkers and biomarker data to
accelerate and improve drug development and to expand the advancement of
personalised medicine which has been reflected by the pharmaceutical industry's
increasing awareness of the value and importance of biomarkers in improving
clinical development.
At the same time, the FDA has clearly signalled its willingness to widen the
scope of biomarker data that it will consider in voluntary submissions for new
drug approval applications, specifically stating it is "open minded" to
reviewing proteomic biomarkers. This is a significant and positive result which
augurs well for the position and results that the company has established from
its research.
The Board is encouraged by the recent progress that has been achieved in
advancing and concluding licences and remains convinced that it will
successfully commercialise the three main areas of the company's research:
biomarkers, ProteoSHOP® and TMT®. It would also like to re-affirm toshareholders that it attaches the highest priority to the completion of further
external licences and looks to the future prospects with increasing confidence.
Steve Harris
Chairman 29 June 2006
UNAUDITED CONSOLIDATED PROFIT AND LOSS ACCOUNT for the year ended 31st December
2005
2005 2004
£ £
Turnover - continuing operations 16,200 72,971
Cost of sales (11,340) (40,801)
__________ __________
Gross profit 4,860 32,170
Administrative expenses excluding (4,764,026) (4,655,426)
non-cash items
Amortisation of goodwill (648,960) (648,960)
Depreciation (425,843) (529,313)
National Insurance on notional share (75,008) (701,953)
option gains
Administrative expenses (5,913,837) (5,131,746)
__________ __________
Operating loss - continuing operations (5,908,977) (5,099,576)
Share of associate's operating loss (735,684) (593,366)
__________ __________
Group operating loss - continuing (6,644,661) (5,692,942)
operations
Interest receivable and similar income 140,628 151,969
Interest payable and similar charges (882) (1,942)
Amounts written off fixed asset (112,878) (112,878)
investment
__________ __________
Loss on ordinary activities before (6,617,793) (5,655,793)
taxation
Tax credit on loss on ordinary 452,747 456,592
activities
__________ __________
Loss for the financial year (6,165,046) (5,199,201)
__________ __________
Headline loss (4,166,673) (4,016,637)
__________ __________
Loss per share
Basic and diluted loss per share (4.77p) (4.27p)
Headline loss per share (3.22p) (3.30p)
__________ __________
Unaudited reconciliation of loss per share to headline loss per share
The headline loss and headline loss per share is presented by the Directors as
an additional measurement of financial performance. The calculations of
headline loss per ordinary share are based on the following losses and on the
numbers of shares shown above.
2005 2005 2004 2004
Loss per Loss per
share share
£ pence £ pence
Loss for the financial year (6,165,046) (4.77) (5,199,201) (4.27)
Add back/(deduct):
Amortisation of goodwill 648,960 0.50 648,960 0.53
Amounts written off fixed asset 112,878 0.09 112,878 0.09
investment
Depreciation 425,843 0.33 529,313 0.44
National Insurance on notional 75,008 0.06 (701,953) (0.58)
share option gains
Share of associate's operating loss 735,684 0.57 593,366 0.49
__________ _____ _________ _____
Headline loss (4,166,673) (3.22) (4,016,637) (3.30)
__________ _____ _________ ____
UNAUDITED CONSOLIDATED BALANCE SHEET as at 31st December 2005
2005 2004
£ £
Fixed assets
Intangible assets 4,218,241 4,867,201
Tangible assets 489,058 740,662
Investments in associates 954,837 1,514,792
Other investments - 112,878
__________ __________
5,662,136 7,235,533
__________ __________
Current assets
Debtors 1,326,592 680,924
Cash held on deposit as short term investment 1,900,000 1,800,000
Cash at bank and in hand 687,155 625,943
__________ __________
3,913,747 3,106,867
__________ __________
Creditors: Amounts falling due within one (1,433,260) (1,387,097)
year
__________ __________
Net current assets 2,480,487 1,719,770
__________ __________
Total assets less current liabilities 8,142,623 8,955,303
Creditors: Amounts falling due after more (188,043) (123,000)
than one year
Provisions for liabilities and charges (103,937) (28,929)
__________ __________
Net assets 7,850,643 8,803,374
__________ __________
Capital and reserves
Called-up share capital 1,314,512 1,225,418
Share premium account 29,145,773 24,207,928
Other reserve 10,755,000 10,755,000
Profit and loss account (33,364,642) (27,384,972)
___________ ___________
Equity shareholders' funds 7,850,643 8,803,374
__________ __________
Unaudited consolidated statement of total recognised gains and losses
For the year ended 31st December, 2005
2005 2004
£ £
Loss for the financial year (6,165,046) (5,199,201)
Gain/(loss) on foreign currency translation 73,840 (19,850)
Gain on deemed part disposal of associate 111,536 -
__________ __________
Total recognised losses relating to the year (5,979,670) (5,219,051)
__________ _________
UNAUDITED CONSOLIDATED CASH FLOW STATEMENT for the year ended 31st December
2005
2005 2004
£ £
Net cash outflow from operating (4,908,985) (4,542,774)
activities
Returns on investments and servicing of 139,746 150,027
finance
Taxation - 622,337
Capital expenditure and financial (181,334) (2,122,149)
investment
__________ __________
Cash outflow before use of liquid (4,950,573) (5,892,559)
resources and financing
Management of liquid resources (100,000) 2,995,161
Financing 5,111,785 2,158,118
__________ __________
Increase/(decrease) in cash in the year 61,212 (739,280)
___ ___
Reconciliation of operating loss to operating cash flows
2005 2004
£ £
Operating loss (5,908,977) (5,099,576)
Depreciation charges 425,843 529,313
Amortisation charges 648,960 648,960
Increase/(decrease) in provisions 75,008 (701,953)
(Profit)/loss on sale of tangible fixed (5,805) 2,986
assets
(Increase)/decrease in debtors (139,862) 271,813
Decrease in creditors (4,152) (194,317)
__________ __________
Net cash outflow from operating (4,908,985) (4,542,774)
activities
___ ___
NOTES TO THE FINANCIAL INFORMATION
1. There has been no change to any of the accounting policies set out in the
2004 statutory accounts.
2. Following the loss for the financial year of £6,165,046, the Directors do
not recommend the payment of a dividend.
3. a. The calculation of the loss per share for the year ended 31st December
2005 is based on the loss for the financial period of £6,165,046 and on
129,243,696 Ordinary Shares, being the weighted average number of shares in
issue and ranking for dividend during the period (year ended 31st December 2004
- loss £5,199,201, weighted average number of Ordinary Shares in issue and
ranking for dividend, 121,648,577).
b. The losses used to calculate the headline loss per share are as follows:
2005 2005 2004 2004
Loss per Loss per
share share
£ pence £ pence
Loss for the financial year (6,165,046) 4.77 (5,199,201) (4.27)
Add back/(deduct):
Amortisation of goodwill 648,960 0.50 648,960 0.53
Amounts written off fixed asset 112,878 0.09 112,878 0.09
investment
Depreciation 425,843 0.33 529,313 0.44
National Insurance on notional 75,008 0.06 (701,953) (0.58)
share option gains
Share of associate's operating 735,684 0.57 593,366 0.49
loss
__________ _______ _________ _______
Headline loss (4,166,673) (3.22) (4,016,637) (3.30)
_______ _______ _________ _______
The headline loss per share is presented by the Directors as an additional
measure of financial performance.
4. The preceding financial information does not constitute statutory accounts
as defined in Section 240 of the Companies Act 1985. The financial
information for the year to 31st December 2004 is based on the statutory
accounts for that year. These accounts, upon which the auditors issued an
unqualified opinion, and which did not contain any statement under Section
237(2) or (3) of the Companies Act 1985, have been delivered to the Registrar
of Companies.
The statutory accounts for the year ended 31st December 2005 will be finalised
on the basis of the financial information presented by the Directors in this
preliminary announcement and will be posted to shareholders this month. After
that time, they will also be available at the Company's registered office:
Coveham House, Downside Bridge Road, Cobham, Surrey KT11 3EP.
5. Whilst it is anticipated that the company will receive an unqualified audit
report for the year ended 31st December, 2005, the audit report will contain
the following additional paragraph:
"Emphasis of matter - Going Concern
Without qualifying our opinion, we draw attention to the disclosures made in
note 2(b) of the financial statements concerning the Group's ability to
continue as a going concern. The Group incurred a net loss of £6,165,046 during
the year ended 31st December 2005, with a headline loss of £4,166,673 (being
the loss for the financial year excluding non-cash costs and share of associate
company losses) and a net outflow from operating activities of £4,908,985.
This, along with other matters as set forth in note 2(b), indicates the
existence of a material uncertainty which may cast significant doubt about the
company's ability to continue as a going concern. The financial statements do
not include the adjustments that would result if the company was unable to
continue as a going concern."
6. On 29th June, 2006 the company entered into an agreement with C.D.J. Pearce,
the Chief Executive of the company, under which he agreed to provide an
unsecured loan facility of up to £2m to the company. The loan facility will be
available from the 1st August, 2006 and carries interest at 2.5% above the base
rate of Barclays Bank Plc.
It is repayable on seven days notice, or immediately in the event of:
(i) C.D.J. Pearce ceasing to be an executive director of the company.
(ii) A general offer to the shareholders of the company being announced to
acquire its issued share capital.
(iii) The occurrence of any of the usual events of default attaching to this
sort of agreement.