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OXFORD
BIOMEDICA PLC INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2003 Interim
results highlights: ¡
Fully underwritten
Rights Issue to raise approximately £20.4 million net of expenses (see separate
announcement issued today). ¡
Cash outflow before
financing reduced to £3.8 million (H1 2002: £6.2 million), which reflects the
ongoing rationalisation of research activities and the concentration of
resources on later-stage development programmes. ¡
Successful results were
reported from a second Phase I/II study with TroVax in colorectal cancer at the
American Association for Cancer Research meeting. An extensive Phase II trials
programme has been initiated in multiple cancer types and initial data are
expected before the end of 2003. ¡
As part of the TroVax
clinical programme, it was announced that Cancer Research UK would fund a Phase
II trial with TroVax in colorectal cancer patients with operable liver
metastasis. ¡
Encouraging initial
results were reported from a second Phase I/II trial with MetXia in breast
cancer. Further results from this trial are anticipated later in 2003 and the
Company plans to start a clinical trial with MetXia in pancreatic cancer. ¡
Wyeth exercised its
option to extend the collaboration on the Company’s anti-5T4 antibody.
Preclinical studies are ongoing with an antibody-toxin conjugate for the
treatment of cancer. ¡
Cash balance of £17.2
million as at 30 June 2003 (31 December 2002: £21.0 million). Pro-forma cash
balance as at 30 June 2003 (including estimated proceeds, net of expenses, of
the Rights Issue) of £37.6 million. Commenting
on the Interim Results, Dr Peter Johnson, Chairman of Oxford BioMedica, said: “Oxford
BioMedica has made considerable progress with its lead products, while
curtailing its spend through rationalisation of early stage research. With new
funds secured from the Rights Issue, the Company has a strong cash position and
is well positioned for future growth and success.” -Ends-
Notes
to editors Oxford
BioMedica Oxford
BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development of gene-based products for a range of unmet medical needs with an
emphasis on new cancer products, which combine novel mechanisms of action with
very low side effects, and innovative neurotherapy products, which address large
and, in several areas, untapped markets. The products are all protected by
multiple patents comprising a total intellectual property portfolio of some 69
patent families. In
addition to its technical research skill-base, Oxford BioMedica has in-house
clinical, regulatory and manufacturing know-how. The development pipeline
includes two novel anti-cancer products in clinical trials and a gene-based
treatment for Parkinson’s disease, which is in late preclinical studies. TroVax®,
Oxford BioMedica’s lead cancer immunotherapy product, is in Phase II trials
for colorectal cancer. Further Phase II trials are planned for breast and renal
cancer. MetXia®, Oxford BioMedica’s lead gene-based cancer
therapeutic, is based on a highly engineered retrovirus gene delivery system
expressing a specific human cytochrome P450 gene. MetXia is being investigated
in a Phase I/II trial in breast cancer, and regulatory submissions are under
review for trials in pancreatic cancer. Oxford
BioMedica has a wholly owned subsidiary in San Diego, USA. Oxford BioMedica has
corporate collaborations with Wyeth, Intervet, Kiadis, Amersham, Arius Research
and Viragen. Further
information is available at www.oxfordbiomedica.co.uk OXFORD
BIOMEDICA PLC INTERIM REPORT 2003 Chairman’s
Statement
In
the first half of 2003 Oxford BioMedica continued its progress, achieving key
milestones in its clinical programmes while reducing its cash burn through
research rationalisation. As a result, the development portfolio has been
focused on the Company’s two core therapeutic areas of oncology and
neurotherapy. Successful
results were reported from a second Phase I/II trial with TroVax® in
colorectal cancer and an extensive Phase II trials programme has been initiated.
Preliminary data from a second Phase I/II trial with MetXia® in
breast cancer were similarly promising and a Phase I/II trial in pancreatic
cancer is on-track to start around the end of 2003.
Also in the first half of 2003, Wyeth exercised its option in the
collaboration on an anti-cancer antibody-toxin product, currently in preclinical
development; and a new collaboration was secured with Intervet for companion
animal cancer vaccines. As
announced earlier in 2003 at its annual general meeting, the Company has
curtailed spending on early stage products and focused resources on its late
stage clinical and preclinical products. Overall, this has improved the cash
position without threatening the core value of the Company. During
the first half of 2003 the Company reduced the research head-count in its US
facility in San Diego, and further reductions have been made subsequently.
Resources have been focused on the clinical and late-stage preclinical pipeline,
with savings in early-stage research. The cash outflow before management of
liquid resources and financing for the six months to June 2003 (H1 2003: £3.8
million) was lower than the same period in 2002 (H1 2002: £6.2 million),
reflecting operational efficiencies, increased grant income and higher receipts
of tax credits. The Company’s cash position as at 30th June 2003
stood at £17.2 million (31st December 2002: £21.0 million) and the
Group had 74 employees at the end of the period (31st December 2002:
81 employees). With
progress on several fronts in its clinical and preclinical pipeline, and despite
uncertainty in general market conditions, Oxford BioMedica is well placed to
advance its lead programmes through the final stages of development. Oxford
BioMedica announced a fully underwritten 27 for 50 Rights Issue, at a price of
17p per New Ordinary Share, on 16 September 2003. The offering will raise
approximately £20.4 million net of expenses. The increased resources enable the
Company to advance its two lead anti-cancer products, TroVax and MetXia, through
Phase II trials into Phase III development. In addition, the Company expects to
commence clinical trials with its two lead neurotherapy product candidates,
ProSavin® for Parkinson’s disease and RetinoStat™ for vision
loss. The extra funds also provide the Company with flexibility in its ongoing
collaboration discussions that span several product candidates and enabling
technologies. TroVax® Oxford
BioMedica’s lead cancer immunotherapeutic, TroVax, achieved further success
with follow-up data from the initial Phase I/II trial and results from a second
Phase I/II study in colorectal cancer patients. The results were presented at
two major oncology conferences in 2003, the American Society of Clinical
Oncology in May and the American Association for Cancer Research in July. The
second Phase I/II trial was a small, five-patient study to evaluate intradermal
delivery of TroVax as an alternative method of administration to intramuscular
delivery. As with the first trial,
all the primary end points of the intradermal study were achieved, in that the
product was found to be safe, and, encouragingly, all five patients in the trial
showed an anti-tumour immune response. Furthermore,
two patients who generated high levels of anti-5T4 antibodies experienced
periods of disease stabilisation and were on study for more than one year after
their first TroVax vaccination. Importantly, all five patients treated were
still alive, 6 to12 months after initiation of treatment. These
additional clinical trial data confirm the immunogenic efficacy of TroVax that
was seen in the earlier intramuscular study, and highlight the product’s
therapeutic potential. Two Phase II trials are underway in the UK investigating
TroVax in combination with current standard-of-care chemotherapy. Initial
immunological results from these Phase II trials are expected before the end of
2003. Recently, in August 2003, Cancer Research UK, one of the world’s leading
cancer research organisations, agreed to conduct and fund a clinical trial of
TroVax in colorectal cancer patients who have operable liver metastases. Two
further clinical trials are planned, which could be fully sponsored or co-funded
by outside organisations in the US. These trials expand the utility of TroVax to
include renal cancer and breast cancer, which markedly increase its commercial
potential. TroVax is on-track for Phase III trials in 2004 and the Company is
finalising plans for commercial-scale manufacturing during 2003 and initiating
regulatory discussions in the US and Europe on the design of suitable trials for
registration. MetXia® Oxford
BioMedica’s lead gene-based cancer therapeutic, MetXia, also reported
encouraging clinical progress. Initial results from the second Phase I/II trial
in breast cancer patients using an enhanced form of MetXia were announced in
July 2003 and showed that all end points had been reached. Data from the first
cohort of patients indicated that delivery of the therapeutic gene to tumour
cells is more than 10-fold better than in the previous trial and also that
patients are mounting anti-tumour immune responses. If this high level of
response to MetXia is maintained, there may be no need to recruit all 12
patients and the study could be terminated early. Furthermore, if the systemic
anti-tumour effect is a reproducible feature of MetXia as the trial continues,
then the product could be considered for treatment of disseminated metastatic
disease, which would greatly enhance its commercial potential. The
Company is proceeding with its plans to take MetXia into a Phase I/II study in
pancreatic cancer and is awaiting approval to start the trial from the UK Gene
Therapy Advisory Committee (GTAC). ProSavin® The
Company’s lead gene-based neurotherapy product, ProSavin for Parkinson’s
disease, is progressing towards clinical trials in 2004. Having demonstrated
proof-of-efficacy in a recognised preclinical model for Parkinson’s disease in
2002, the Company has accelerated its preclinical programme in 2003 and is
discussing the design of Phase I/II trials with clinicians and regulatory
authorities in the US and UK. Further preclinical data on safety, toxicity and
efficacy are expected before the end of 2003 and the Company is on-track for its
first regulatory submission for the commencement of clinical trials around the
end of 2003. Oxford
BioMedica announced details of its novel manufacturing process for ProSavin and
other LentiVector-based products at the BIO 2003 Annual Convention in Washington
DC in June 2003. The establishment of an effective manufacturing process
represents a key milestone on the path to clinical development for ProSavin. The
new manufacturing process has the capacity to satisfy all of the Company’s
requirements up to Phase II clinical trials and the team is currently working on
a refinement of the process to scale-up for Phase III trials and commercial
production. RetinoStat™
RetinoStat
is Oxford BioMedica’s novel gene-based treatment for vision loss caused by
aberrant blood vessel growth in the retina of the eye. In 2002, Oxford BioMedica
entered into a research collaboration for RetinoStat with the Institute of
Ophthalmology, London, UK. 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 was 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 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
age-related macular degeneration and diabetic retinopathy, two of the major
causes of vision-loss in the developed world. These encouraging preclinical
results mean that the RetinoStat programme is on track to enter clinical
development in 2004. In September 2003 Oxford BioMedica entered into an
agreement with EntreMed Inc. under which it received exclusive rights to
EntreMed’s proprietary anti-angiogenic genes angiostatin and endostatin for
ocular diseases. Other
preclinical programmes
In
the neurotherapy field, the Company has three other in-house preclinical
programmes. These have all advanced over the first half of 2003, and are
expected to report further preclinical results in the next 12 months. Financial
support for the product candidates, MoNuDin® for motor neuron
disease and SMN-1G for spinal muscular atrophy, continues through grants awarded
by two US charitable organisations, the US ALS Association and Andrew’s
Buddies. Innurex™, the Company’s nerve repair product for spinal cord injury
is being assessed in well-established preclinical efficacy models, with initial
results expected before the end of 2003.
Collaborations During
the first half of 2003, the Company progressed its existing collaborations and
secured new deals on its product candidates and enabling technologies.
Discussions are ongoing with potential partners on Oxford BioMedica’s lead
products and several of its preclinical candidates, which could lead to a number
of major alliances over the next 12 months. In
February 2003, a key milestone was reached in the Company’s flagship corporate
partnership with Wyeth which was signed in 2001, under which Wyeth has licensed
rights to the anti-5T4 antibody (5T4 being the tumour antigen utilised in TroVax)
in a collaboration valued at $24 million in upfront and milestone payments,
subject to the successful achievement of clinical and regulatory goals. Wyeth
exercised its option to extend the collaboration and is proceeding with
preclinical development of an antibody-toxin conjugate for the treatment of
cancer. In
January 2003, the Company announced a collaboration with Intervet for the
development of TroVax-VET, a companion animal version of the cancer vaccine
TroVax. The deal superseded an earlier alliance with Virbac S.A. and triggered
the award of a £0.6 million EUREKA grant to Oxford BioMedica. Also
in January 2003, a research collaboration was signed with Kiadis BV to discover
small molecule product candidates against a novel enzyme that was identified
using Oxford BioMedica’s Focused Target Identification platform. The enzyme is
central to the control of blood vessel growth, which is likely to be of value in
several disease conditions with particular emphasis in cardiovascular
indications. Wound healing will be
the initial focus because this provides a clear route to clinical trials within
a short period. In
March 2003, the Company signed an option agreement with the US biotechnology
company Viragen Inc that may lead to a licence for the use of Oxford
BioMedica’s LentiVector gene transfer technology for the production of
therapeutic proteins from the eggs of transgenic chickens.
Patents
The
intellectual property portfolio continues to underpin the Group’s fundamental
value. One new filing was made in the first six months of this year and ten
patents were granted. Of particular note was the grant in August 2003 of a
patent covering the LentiVector technology. This additional patent compliments
the Group’s earlier US patent issued in November 2001 and gives coverage of
broad composition of matter claims and methods of production claims for
lentiviral vector gene delivery systems of both human and non-human origin. Financial
Oxford
BioMedica has continued to manage its finances prudently. The re-focusing of
resources in the UK operation that was implemented in 2002 has delivered cost
savings in the first half of 2003. Restructuring of the US operation began in
April 2003 and is continuing in the second half of 2003, to concentrate
resources on later-stage development programmes and to conserve cash. The impact
of these changes, together with reduced capital expenditure and higher tax
credit receipts has reduced the net cash outflow before management of liquid
resources and financing (the ‘cash burn’) to £3.8 million (H1 2002: £6.2
million). The £20.4 million proceeds net of costs of the fully underwritten
rights issue announced on 16 September 2003 will significantly strengthen the
balance sheet, and will enable the Company to maintain its investment in the
clinical development of its candidate products. It also provides the Company
with flexibility in its ongoing collaboration discussions that span several
product candidates and enabling technologies. Revenue
of £110,000 in the first half of 2003 included an initial payment from Wyeth on
the exercise of their option in connection with the antibody-toxin conjugate
collaboration, and also revenues from the collaboration with Viragen. The
revenue in the first half of 2002 all arose from the Wyeth collaboration. Net
operating expenses of £6.5 million for the first half of 2003 were lower than
the previous year (H1 2002: £6.7 million). There was increased investment in
external preclinical and clinical development of candidate products as a result
of increased activity in this area, and in-house research and development costs
in the US were higher as a result of growth in the US that took place during
2002. In contrast, in-house research and development expenditure in the UK, and
administration costs, were lower as a result of cost saving measures. Grant
income of £0.4 million (H1 2002: £19,000) included a new EUREKA grant linked
to the TroVax programme and a grant from the US charity Andrew’s Buddies
linked to SMN-1G. Interest
receivable in the first half of 2003 was lower than the first half of 2002 as a
result of lower cash balances and lower prevailing interest rates. The tax
credit, which is linked to the amount of payroll taxes paid in the UK, was lower
in 2003 as a result of the reduced payroll. However, due to the timing of
receipts, the cash received for tax credits in 2003 was higher than the first
half of 2002 (£1.3 million vs. £0.4 million), contributing to the reduced cash
burn. As a consequence of reduced interest and tax credits for the period, the
retained loss for the first half of 2003 was slightly higher than in the first
half of 2002 at £5.6 million (H1 2002: £5.3 million). Capital
expenditure was £35,000 compared to £0.9 million in the first half of 2002.
The issue of shares on the exercise of share options generated cash of £90,000
(H1 2002: £79,000). Conclusion
2003
sees Oxford BioMedica complete its transformation from a research biased company
to a company almost exclusively focussed on clinical development of its
products. As the products pass down the development pathway, the scope to form
corporate partnerships increases substantially and the Company will continue to
pursue deals that reflect the value of its products. The
Company continues to be strong with sound technology and intellectual property,
an innovative product portfolio, success in all of the current clinical
programmes and a balance sheet that allows us to pursue our goals aggressively.
We thank our staff, our collaborators and our shareholders for their
contributions to this success. Dr
Peter Johnson
Chairman Oxford
BioMedica plc Consolidated
profit and loss account for
the six months ended 30 June 2003 For
further information, please contact: Oxford
BioMedica plc: Professor Alan Kingsman, Chief Executive, +44 (0)1865
783 000 City/financial
enquiries: Mike Wort/James Chandler, Beattie Financial, +44 (0)20 7398 3300 Scientific/trade
press enquiries: Katja Stout/Sue Charles, Northbank Communications, +44 (0)20
7886 8150
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