OXFORD BIOMEDICA
PRELIMINARY RESULTS FOR THE 15 MONTHS ENDED 31 DECEMBER
1997
Highlights
- First
clinical trials, in breast and ovarian cancer, planned for
the end of 1998 - a year ahead of schedule
- Strong
pipeline of candidate products in development
- Now
situated in 10,000 sq. ft of state-of-the-art laboratories
and offices in the Oxford Science Park
- The
Company's intellectual property base has been expanded by
the acquisition of and filing of further patent applications
- First
commercial interaction signed with Rhone-Poulenc Rorer (post
year end)
- Loss
for the period £2.9 million within internal budgets
- Announcement
of Placing & Rights Issue to raise approximately £6 million
(before expenses) (See separate release)
Professor
Alan Kingsman, Chief Executive of Oxford BioMedica, commented:
"Oxford BioMedica's
first year as a public company has seen further growth and consolidation
of the business. We have now firmly established ourselves as
a major force in gene therapy with internationally competitive
technology and product pipelines.
"The
Company's proposed fund raising, also announced today, will
provide us with the working capital to further develop the
Company and its clinical programmes. I am particularly pleased
at the response of current institutional investors to the
placing - and it is encouraging to see professional biotechnology
investors providing a major proportion of the funds. With
the money raised we will be in a strong position to take a
significant share of the markets emerging out of the new medical
revolution of gene therapy."
Oxford
BioMedica
Preliminary Results for the 15 months ended 31 December 1997
SUMMARY
1997
has been a remarkable year of growth and development for Oxford
BioMedica, which is now clearly established in the international
gene therapy arena. The ground has been laid for the Company's
first clinical trials, in breast cancer and ovarian cancer,
which are scheduled to commence towards the end of 1998, and
a strong pipeline of candidate products for the treatment
of cancer, AIDS and neurodegenerative disease is in development.
The Company
has built on the foundations that were laid in 1996 and has
established itself as a major force in gene therapy with technology
and product pipelines that are internationally competitive.
The Company's first clinical trials are planned for the end
of 1998 and there is a strong pipeline of candidate products
in development. In short we believe that Oxford BioMedica
is equipped to take a significant share of the markets emerging
out of the new medical revolution of gene therapy.
REVIEW
OF OPERATIONS
Infrastructure
At the beginning
of the year Oxford BioMedica took possession of 8,000 sq.ft.
of space in the Medawar Centre on the Oxford Science Park. By
April this space had been converted into 3,000 sq.ft. of offices
and 5,000 sq.ft. of state-of-the-art laboratories. The laboratories
comprise facilities for the manipulation of therapeutic genes,
the construction of the Group's virus-based gene delivery systems
and the process development for the production of the first
clinical trial material. In October these facilities were increased
by 2,000 sq.ft. to accommodate planned expansion.
In parallel with the construction of the
offices and laboratories the Company embarked on an aggressive
recruiting plan. It was essential that critical mass was achieved
as quickly as possible in order to meet technical and clinical
objectives. Oxford BioMedica now employs 33 staff, 30 of whom
are graduates, with 18 also having Ph.Ds.
The Company has set demanding research objectives
and believes strongly that the most effective and efficient
development of gene-based therapeutics will be achieved through
close collaboration with the medical community. Additionally,
it is committed to building pre-eminent expertise to support
its research initiatives and have established close links
with a number of research organisations, groups and individuals
to complement the in-house team with specialised technical
and clinical support. A distinguished scientific advisory
board and consultant group has now been appointed with the
external scientific advisors all being leaders in their fields.
Commercial
Strategy
One of the
distinguishing features of a gene therapy company, and a considerable
strength, is its ability to market not only its products but
also to out-licence its supporting technology elements. Oxford
BioMedica's business strategy is to take its candidate products
to the market through commercial alliances with major players
in the pharmaceutical industry and to seek licensing opportunities
for certain of its technologies. The significant potential for
gene-based therapeutics is now recognised, and the Company's
technology base and development pipeline is already attracting
substantial interest from the pharmaceutical industry. In the
autumn Oxford BioMedica began the process of marketing its technology
and products to pharmaceutical and biotechnology companies on
a global scale. While this is a necessarily long process, good
progress has been made. The Company is delighted by the interest
that has been expressed in its programmes, particularly in the
USA. At present commercial discussions are taking place, at
various levels, with 20 companies who have expressed interest
in candidate products and individual components of technology.
In January 1998 the Company announced its first commercial interaction
with Rhone-Poulenc Rorer for the use of its novel lentiviral
vector systems in a functional genomics programme.
Research & Development Pipeline
Oxford BioMedica is developing novel gene-based
therapeutics in the fields of cancer, virus infection and neurodegenerative
disease. The Company also has a small external collaborative
programme in the field of inherited disorders. Within these
broad fields it is focused on treatments for solid tumours,
with an initial emphasis on breast and ovarian cancers, AIDS,
Parkinson's disease and cystic fibrosis.
Cancer
Oxford BioMedica's most advanced programme. Two candidate
products, MetXiaTM and BetOvaC®, will lead their clinical
development programme in this area and the first clinical
trials are expected to start at the end of 1998. The initial
strategy uses gene therapy to create factories for anti-tumour
drugs within the tumour itself. This process is known as prodrug
activation and it is believed that it has substantial commercial
potential. The prodrug activation products that Oxford BioMedica
plan to take to the clinic later in 1998 are unique to the
Company and are applicable to a wide range of solid tumours.
In addition Oxford BioMedica is developing novel systems that
enhance the ability of the immune system to clear tumours.
Products that combine both the prodrug and immune strategies
for some of the Group's future cancer products are also currently
in development.
AIDS
Oxford BioMedica's AIDS gene therapy is based on its extensive
experience in HIV molecular biology. As part of the LentiVectorTM
programme an emasculated derivative of HIV has been produced
that can carry anti-HIV genes to the cells of the immune system.
This strategy of using a derivative of HIV to destroy the
virus is powerful and forms the cornerstone of the ImmStat(CO)TM
product that is being developed for clinical evaluation within
the next couple of years.
Neurodegenerative
Disease
In neurodegenerative disease the key challenge is to deliver
therapeutic genes to the brain without causing inflammation.
Oxford BioMedica has achieved this during the past year in
model systems with its new PegasusTM vectors. This exciting
area of research and development is now being progressed with
a product, ProSavinTM, for the treatment of Parkinson's disease.
Cystic
Fibrosis
Cystic fibrosis has been a major gene therapy target for several
years. There is one key challenge and that is to achieve significant
gene transfer to lung epithelial cells. In an external co-operative
programme with the UK's cystic fibrosis research community
Oxford BioMedica is developing new approaches to this problem
including the use of LentiVectorTM technology and macrophage
delivery systems.
Intellectual
Property Portfolio
The substantial
technical foundation established by Oxford BioMedica to date
leads to the creation and maintenance of a powerful intellectual
property portfolio. As a result of in-house research programmes
and strategic in-licensing the Company has the benefit of 22
patent applications at various stages of prosecution. In addition
a therapeutic gene, in-licensed from Massachusetts General Hospital
and Boston University, is protected by an issued patent in the
USA. This gene will be used in the Company's first candidate
products that are expected to enter Phase I/II trials late in
1998. The accumulation of this intellectual property portfolio
provides the Company with all of the technology needed for its
first products and the commercial currency for the future. The
Company will continue to pursue an aggressive patenting policy.
Financial Review
Oxford BioMedica has managed its financial resources
prudently during this first accounting period and the overall
loss for the fifteen months of £2.9 million is within its internal
budgets. Following the end of the period the Directors have
proposed a rights issue and placing raising approximately £5.3
million net of expenses which will provide the resources to
take at least two candidate products into clinical trials and
continue its programme of research and development.
The Group's total expenditure over the period was £3.2 million.
£2.0 million of this was spent on research and development,
of which £0.3 million was spent on acquisition and protection
of intellectual property to further enhance the value of the
Company. The remaining £1.2 million was related to administrative
expenses.
Oxford BioMedica has also been successful in obtaining grant
support for some of its major programmes. This will bring
additional funds to the Company's activities and, because
the grant applications are reviewed within the scientific
community, it is a third party endorsement of the quality
of the science. In July the UK Biotechnology and Biological
Sciences Research Council awarded the Company a grant through
its Teaching Company Scheme to support the macrophage cell
targeting programme which seeks to treat metastatic cancer.
The Company's collaboration with the Institute of Virology
in Oxford to develop high efficiency production technology
is supported by a UK Department of Trade and Industry LINK
award. Together these amount to £375,000 of extra resource
for the Company. Oxford BioMedica will continue to pursue
additional grants wherever possible to enhance its R&D programmes.
Outlook
In summary, the achievements during this past year have been
substantial. The main focus is now on ensuring the pre-eminent
technology and clinical programmes are commercialised effectively
for the benefit of all the patients who are suffering from the
diseases Oxford BioMedica is seeking to treat and for all the
shareholders.
1998 will be another exciting and significant year for Oxford
BioMedica. The proceeds of the rights issue and placing will
provide the Group with funds to meet its present requirements,
including its key objective of getting two candidate products
into Phase I/II clinical trials by the end of 1998.
- Ends -
Oxford
BioMedica plc
Consolidated Profit and Loss Account
| |
15
months ended
31st December 1997
£ |
5
months ended 30th September 1996
£ |
| Turnover |
2,800 |
- |
| Research
and development |
(1,972,309) |
- |
| Administrative
expenses |
(1,180,416) |
(87,778)
|
| |
| Operating
loss |
(3,149,925) |
(87,778)
|
| |
| Interest
receivable |
224,591 |
2,562 |
| Interest
payable |
(432) |
- |
| |
| Loss
on ordinary activities before taxation |
(2,925,766) |
(85,216) |
| |
| Tax
on loss on ordinary activities |
- |
- |
| |
| Loss
for the period |
(2,925,766) |
(85,216) |
| |
| Loss
per ordinary share (pence) |
(5.2) |
(0.4) |
| The
results for the periods above are derived entirely
from continuing operations. The Group has no recognised
gains and losses other than the above results,
and therefore no separate statement of total recognised
gains and losses has been presented.
There is no difference between
the loss on ordinary activities before taxation
for the periods stated above, and their historical
cost equivalents. |
Oxford BioMedica plc
Consolidated Balance Sheet
| |
31st
December 1997
£ |
30th
September 1996
£ |
| Fixed
assets |
|
|
| Intangible
assets |
430,696 |
492,224 |
| Tangible
assets |
1,034,402 |
11,707 |
| |
| |
1,465,098 |
503,931 |
| |
| Current
assets |
|
|
| Debtors:
amounts falling due within one year |
224,982 |
40,578 |
| Cash
at bank and in hand |
1,512,128 |
707,648 |
| |
| |
1,737,110 |
748,226 |
| |
| Creditors:
amounts falling due within one year |
441,223 |
126,361 |
| |
| Net
current assets |
1,295,887 |
621,865 |
| |
| Net
assets |
2,760,985 |
1,125,796 |
| |
| Capital
and reserves |
|
|
| Called-up
share capital |
570,286 |
500,060 |
| Share
premium account |
4,490,729 |
- |
| Other
reserves |
710,952 |
710,952 |
| Profit
and loss account (deficit) |
(3,010,982) |
(85,216) |
| |
| Equity
shareholders' funds |
2,760,985 |
1,125,796 |
| |
Oxford BioMedica plc
Consolidated Cash Flow Statement
| |
15
months ended
31st December 1997 |
5
months ended 30th September 1996
|
|
£ |
£ |
| Operating
activities |
|
|
Net
cash outflow from continuing operating
activities
(Reconciliation to operating loss
on page 8) |
(2,876,638) |
(23,805) |
| |
| Returns
on investments and servicing of
finance |
|
|
| Interest
received |
226,696 |
189 |
| Interest
paid |
(432) |
|
| |
| |
226,264 |
189 |
| |
| Capital
expenditure and financial investment |
|
|
| Purchase
of tangible fixed assets |
(1,091,455) |
(2,168) |
| |
| Cash
outflow before management of liquid
resources and financing |
(3,741,829) |
(25,784) |
| |
| Management
of liquid resources |
|
|
| Transfer
to deposit accounts |
(4,100,000) |
(550,000) |
| Transfer
to current accounts |
4,650,000 |
- |
| |
| |
| |
550,000 |
(550,000) |
| |
|
|
| Financing |
|
|
| Issue
of shares |
5,253,340 |
783,299 |
| Expenses
of share issue |
(707,031) |
(49,867) |
| |
|
|
| |
4,546,309 |
733,432 |
| |
|
|
| Increase
in cash in the period |
1,354,480 |
157,648 |
|
Oxford
BioMedica plc
| |
15
months ended
31st December 1997 |
5
months ended 30th September 1996 |
|
£ |
£ |
| Reconciliation
of operating profit to net cash outflow from operating activities |
|
|
| |
| Continuing
activities |
|
|
| Operating
loss |
(3,149,925) |
(87,778) |
| Amortisation
on intangible fixed assets |
61,528 |
- |
| Depreciation
on tangible fixed assets |
163,453 |
276 |
| Increase
in other debtors |
(111,194) |
(7,751) |
| Increase
in prepayments and accrued income |
(75,315) |
(30,452) |
| Increase
in trade creditors |
77,938 |
47,830 |
| Increase
in other taxation and social security |
26,411 |
5572 |
| Increase
in accruals and deferred income |
130,466 |
48,498 |
| |
| Net
cash outflow from continuing operating activities |
(2,876,638) |
(23,805) |
| Notes
to Editors:
1. This information does not constitute the Company's statutory
financial statements for the 15 months ended 31 December
1997 within the meaning of s227 of the Companies Act 1985
but is derived from those financial statements.
2.
The audited statutory financial statements for the period
ended 31 December 1997 will be posted to shareholders
on 26 February 1998 and will be available from the registered
office of the Company, Medawar Centre, Oxford Science
Park, Oxford OX4 4GA.
3.
The Company was incorporated and registered in England
and Wales on 20 September 1996 as a private limited company
with the name "Pinco 838 Limited" and was re-registered
as a public limited company under the name "Oxford BioMedica
plc" on 30 October 1996. On 29 October 1996 the Company
acquired the entire issued share capital of Oxford BioMedica
(UK) Limited. On 13 December 1996 the Company floated
on the Alternative Investment Market of the London Stock
Exchange and at the same time 5,709,723 new shares were
sold to new investors as part of the Placing and Offer
for Subscription. On 8 May 1997 a further 125,000 new
ordinary shares were issued for cash.
4.
The Company has adopted the merger method of accounting
for the acquisition of Oxford BioMedica (UK) Limited.
The profit and loss account includes the results of Oxford
BioMedica (UK) Limited for the whole of the fifteen month
period ended 31 December 1997 and the comparative figures
reflect the position that would have arisen if the Company
and Oxford BioMedica (UK) Limited had been combined throughout
the previous period. The figures in the balance sheet
as at 30 September 1996 are based on the audited balance
sheet of Oxford BioMedica (UK) Limited at that date.
5.
The basic loss per ordinary share has been calculated
on a weighted average number of 55,980,505 shares in issue
during the period (period ended 30 September 1996 - weighted
average of 21,024,179).
6.
The Annual General Meeting will be held on 24 March 1998
at Pinsent Curtis, Dashwood House, 69 Old Broad Street,
London EC2M 1NR.
Copies of the prospectus can be obtained from:
Oxford BioMedica plc, Medawar Centre, Robert Robinson
Avenue, The Oxford Science Park, Oxford, OX4 4GA. |
Return to the News
| For
more information contact: |
|
|
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive
Andrew Wood, Finance Director |
Tel:
+44 (0)1865 783000 |
| Beeson
Gregory
Nick Rodgers
|
Tel:
+44(0)171 488 4040 |
| City/Financial
Enquiries
Nicola How , Account
Director
HCC De Facto Financial |
Tel:
+44 (0)171 957 4600 |
| Trade/Scientific
Press Enquiries
Michaela Mahon
, Account Director
De Facto Consultants |
Tel:
+44 (0)1256 842274 |
|
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