OXFORD
BIOMEDICA
Oxford Biomedica Interim Results for the Six Months Ended
30 June 2001
Oxford,
United Kingdom - 1 August 2001. Oxford Biomedica plc (LSE:OXB)
today announced its interim results for the six months to
30 June 2001. The key points of the results are as follows:
Highlights
-
Financing:
Successful £35.5 million Placing and Open Offer, the
proceeds of which have allowed investment in staff, expansion
of core programmes and establishment of a US subsidiary,
Biomedica inc. Admission to the Main List of the London
Stock Exchange.
-
Financial Performance: Turnover
for the period £0.3 million (2000: £0.3 million),
loss after tax £3.6 million (2000: £2.6 million).
Cash in the bank at 30 June 2001 was £39.9 million,
in line with budget.
- Commercial
development: Collaborative product development deal
with American Home Products/Wyeth, with a headline value
of $24 million, started in January 2001 and is making good
progress. Other ongoing collaborations with Nycomed Amersham,
Virbac S.A., IDM and Aventis are progressing well.
- Gene
Discovery: Business development programme initiated,
with 15 potential partners in discussion. Two of these,
Millenium and Biogen have progressed to feasibility studies.
-
Clinical development: Expansion
of MetXia® clinical development programme
to include two new formulations. To date, MetXia®
has proven to be safe and has demonstrated positive gene
transfer, thereby achieving primary goals of trial. TroVax
clinical programme started and is on track with one third
of patients enrolled.
-
Preclinical development: Initiation
of clinical development for ProSavin® and
BetOvaC®, expected for the end of 2002. ProCaStat®
(prostate cancer) has moved into the preclinical phase with
a planned accelerated clinical development programme.
- Therapeutic
research: Important developments, in particular two
in neurobiology - one with the method of the delivery of
genes to neurons and the other through a collaboration with
Kings College, London, with respect to a gene which induces
new nerve growth.
- Gene
discovery: Successful application of Smartomics®
to target discovery. Discovery of 250 potential new targets
for the treatment of stroke, heart disease, rheumatoid arthritis
and atherosclerosis.
- Intellectual
property: Nine new applications filed, three applications
moved to the international phase and nine new patents granted.
Commenting
on the interim results, Dr Peter Johnson, Chairman of Oxford
BioMedica said:
"This period has seen the further transformation of
Oxford BioMedica into a broad-based gene technology company
with financial stability and strong commercial collaborations.
We completed a successful fundraising in April which has allowed
us to establish a US subsidiary, increase our staffing levels
and accelerate several of our key programmes, in particular
for neurobiology and ProCaStat®. We continue
to focus on building our product pipeline and are pleased
with the progress we have made during the period."
|
| Oxford
BioMedica's move to the Official List of the London Stock
Exchange is the culmination of four years of successful growth
and development.
The most
significant event for BioMedica in the first half of 2001
was the fundraising and move to the Official List of the London
Stock Exchange that was completed in April. The Company raised
£35.5 million before costs from a placing and open offer,
despite the difficult market conditions at the time. This
was a landmark event in BioMedica's development. We were able
to achieve it because of the Company's excellent achievements
and potential that we were able to present to existing and
prospective shareholders. The strong position we now find
ourselves in is the direct product of our dedicated and talented
technical, commercial and business development teams. Credit
for this achievement also goes to our team of advisors.
COMMERCIAL
DEVELOPMENTS
Therapeutics
In January, the Company announced a new collaborative product
development deal with American Home Products/Wyeth. The contract
had a headline value of $24 million in access and milestone
payments, and in addition, royalties on sales of the product.
This is a good illustration of BioMedica's versatile and creative
commercial strategy. The subject of the deal is a spin-off
from the Company's TroVax tumour vaccine programme.
As part of the TroVax technology, the Company had an
antibody (OBA1-H8) directed against the tumour antigen (protein)
that is delivered by TroVax. Because that antigen is
present on a wide range of tumour cells and is not present
on normal tissue, the antibody directed against it is potentially
a valuable therapeutic agent. The team that produced Wyeth's
Mylotarg product for leukaemia considered BioMedica's OBA1-H8
antibody to be an ideal candidate for a Mylotarg-like product
but with, perhaps, broader use in a wide range of cancers.
This concept forms the basis of the deal. The development
programme started in January and is already making good progress.
The OBA1-H8
imaging project with Nycomed-Amersham is progressing well
and the TroVax-Vet collaboration with Virbac S.A. has
achieved its initial goal of demonstrating that the animal
version of OBA-1 is present on a number of canine and feline
tumours.
BioMedica
and its partner IDM have now identified defined clinical strategies
for TroVax-DC and MetXia®-MG (previously
described as MacroGen-CYP2B6). Protocols and clinical strategies
for these two products are being drafted with the first trials
planned for the second half of 2002.
The cardiovascular
collaboration with Aventis continues, including the ongoing
evaluation of BioMedica's LentiVector® system
for the delivery of angiogenic factors. There has been some
reorganisation within Aventis and the changes in the management
of their Gencell operation. The new Gencell organisation has
an increased focus on gene therapy to treat cardiovascular
disease, the subject of the collaboration.
Other
collaborations are proceeding according to plan and there
are several new contracts, at various stages, under discussion.
Gene
Discovery
Following the £8.5 million Gene Discovery fundraising
last August the Gene Discovery Division has been assembling
its marketing data and documentation. The business development
programme was then initiated in earnest in April. This has
already been successful, with currently 15 potential partners
at various stages of discussion. Two of these, Millennium
and Biogen, have already progressed to feasibility studies
and the Company is optimistic that these and other interactions
should lead to gene discovery deals later this year.
CLINICAL
DEVELOPMENT
We continue
to make good progress in our clinical programmes.
MetXia®
The
MetXia® clinical development programme is expanding
to include two new formulations. The first of these has obtained
ethical approval from GTAC and will be evaluated as part of
the current breast cancer clinical programme. The second,
MetXia®-MG, is being developed in collaboration
with IDM for use in all peritoneal cancers (ovarian, bladder,
pancreatic, colorectal and stomach cancers) and we anticipate
that it will enter clinical development in mid-2002. This
will broaden the data that we are obtaining from the ongoing
OC1 ovarian cancer trial.
The ability
to vary the configuration and formulation during an early
clinical development programme highlights one of the strengths
of the gene therapy approach and allows the product to be
enhanced prior to larger scale and more expensive testing.
To date MetXia® has been proven to be safe
and has given positive gene transfer to breast and ovarian
tumours and melanomas. This means that the primary goals of
these trials have been achieved.
TroVax
The
TroVax clinical programme in colorectal cancer is progressing
as predicted with one third of the patients now enrolled.
The trial is on track to deliver preliminary results early
in 2002. The Company already anticipates building on this
programme with a cell-based formulation, TroVax-DC,
in collaboration with IDM in 2002.
PRECLINICAL
DEVELOPMENT
Several
of the Company's products are moving successfully through
the preclinical phase. ProSavin®, a treatment
for late stage Parkinson's disease and BetOvaC®,
a gene-based immunotherapy for ovarian cancer, are progressing
through preclinical development as predicted and should both
begin clinical development by the end of 2002.
ProCaStat®,
a lentiviral based gene therapy for prostate cancer, moved
into the preclinical phase during early 2001. This product
is expected to outperform other vector systems in this particular
cancer type because of advances that we have made in gene
delivery and in the therapeutic gene. The ProCaStat®
clinical development programme is being accelerated and it
is now planned to be submitted for regulatory approval in
early 2002 with a view to starting a clinical programme in
the latter half of 2002.
The ImmStat®
AIDS product remains on hold, but it is ready to move into
a clinical development programme. Discussions around ImmStat®
are ongoing with a potential partner.
THERAPEUTIC
RESEARCH
There
have been several important developments in the Company's
hypoxia and ischaemia research programme, and in immunotherapy
and neurobiology. Two areas in the field of neurobiology are
worthy of special mention. Over the past two years, BioMedica
has been developing technologies for the selective delivery
of genes to neurones based on the LentiVector®
system. A key part of this technology has been the ability
to modify the surface of the gene delivery particles for specific
purposes. One of the most exciting developments has been the
construction of a system that enables the Company to deliver
genes to the central nervous system by the relatively non-invasive
injection of peripheral sites. This technology provides opportunities
in both therapy for peripheral neuropathies and pain, and
in gene discovery.
The other
noteworthy development comes from the collaboration with King's
College in London. BioMedica has acquired the rights to use
a gene, identified by the King's team, which induces new nerve
growth. Initial results in which this gene is delivered using
the Company's LentiVector® system suggest that
it may be possible to develop products for nerve repair. This
has substantial commercial potential, as there are no products
currently available for nerve injury or peripheral neuropathies.
GENE
DISCOVERY
The Gene
Discovery Division has successfully applied BioMedica's proprietary
Smartomics® to target discovery, using the
Company's gene transfer technologies to uncover novel parts
of disease-related biological pathways. The Company has protected,
in five patent applications, more than 250 potential new targets
for the treatment of stroke, heart disease, rheumatoid arthritis
and atherosclerosis. Our gene transfer technology opens the
way to various validation assays, which are crucially important
to prove the relevance of targets to the development of new
therapies. BioMedica has provided this technology to several
other companies including Aventis, AstraZeneca, Millennium
and Biogen, and it has been applied to the validation of the
Company's own targets. A number of targets are progressing
through validation. One gene in particular, which the Company
has shown to be implicated in ischaemic disease, seems to
play a role in programmed cell death in the brain. It may
be possible to improve the survival of brain cells after stroke
by targeting this gene with drugs which reduce its effect
on cell death.
INTELLECTUAL
PROPERTY
BioMedica
recognises the importance of a strong patent portfolio, and
we are pleased to report a number of significant developments.
Nine new patent applications have been filed, three applications
have gone to the international phase and nine have been granted.
The granted patents have been in the fields of LentiVector®,
retroviral vectors, Parkinson's disease therapy, MacroGen®,
the control of gene function by oxygen and HIV therapy. The
most significant of these are the LentiVector®
patents which give BioMedica a strong position in this key
field.
BIOMEDICA
INC.
Following
the fundraising in April, Oxford BioMedica established BioMedica
Inc. in California. The Company was delighted to appoint Dr.
Doug Jolly as the CEO of the new subsidiary. Doug has been
in the field of gene therapy for more than 15 years. He has
managed a number of clinical trials, he is an advisor to the
US Food and Drug Administration (FDA) and National Institutes
of Health, he has founded his own company, Viagene, and taken
it to a Nasdaq listing. Chiron subsequently acquired Viagene,
and Doug then joined Chiron as Vice President for Scientific
Affairs. He is a well known figure in the field, and he is
already having an impact on business development in the USA.
BioMedica
Inc. will move into temporary facilities in September 2001
and into a permanent building next year. Initial goals will
be to refine the Company's LentiVector® production
technology and to expand the neurobiology opportunities. In
addition BioMedica Inc. will act as a focal point for commercial
interactions in North America and it will start to build a
strong relationship with the FDA as BioMedica begins to conduct
clinical trials in the USA.
FINANCIAL
In April,
in conjunction with the move from AIM to the London Stock
Exchange Official List, BioMedica concluded a placing and
open offer, raising £35.5 million before expenses. A
total of 64.5 million new shares were issued at 55p per share.
59.2 million shares were placed with financial institutions,
and 5.3 million shares were taken up in the open offer. Net
of costs, the placing and open offer raised £32.3 million.
Subsequent to the placing and open offer, the Company's advisor
N.M. Rothschild & Sons Limited subscribed £250,000
at the placing price.
In addition,
the Company issued 204,360 shares in February to King's College
in a £150,000 subscription in connection with the acquisition
of rights to use the RARb2 gene,
and in April issued 102,900 shares at 15.5p per share on the
exercise of share options.
The proceeds
of the placing and open offer have allowed BioMedica to increase
its staff and to expand several of its programmes. At 30 June
2001 the headcount was 71, including three at BioMedica Inc.,
the newly-formed United States subsidiary. During the first
half of 2001 BioMedica renewed the lease on its 11,000 sq.ft.
facilities on the Oxford Science Park, and took out leases
on a further 17,000 sq.ft., also on the Science Park. Part
of the new space is being fitted out as state-of-the-art laboratories.
This expansion in staff and facilities was planned alongside
the placing and open offer and was within budget.
As a result
of increased activities, the loss after tax for the first
half of 2001 was £3.6 million, an increase of 39% on
the same period last year. Revenue was £0.3 million
(2000: £0.3 million), and net operating expenses were
£5.0 million compared to £3.2 million in 2000.
As a result of the increased cash balance following the placing
and open offer, interest receivable was substantially higher
at £0.6 million (2000: £0.2 million). The R&D
tax credit for 2001 was £0.4 million. The credit of
£0.1 million in 2000 covered a three month period following
the introduction of the tax credit in April 2000.
Fixed
asset additions of £1.5 million in 2001 included £0.8
million on configuring the new labs and offices, and £0.5
million for lab equipment.
The bank
balance at 30 June 2001 was £39.9 million, in line with
the budget.
IN
CLOSING
BioMedica
has continued to grow in its product pipeline, its technical
capabilities and its commercial interactions. The staff are
to be congratulated on another successful period in the Company's
history. We thank our loyal shareholders for their continued
support and we welcome our new shareholders from the April
fundraising. The Company will continue to strive to deliver
shareholder value.
| Professor
Alan Kingsman |
Dr.
Peter Johnson |
| Chief
Executive Officer |
Chairman |
|
Return to the News
| Consolidated
Profit & Loss Account |
| |
6
months
ended
30 June 2001
(unaudited)
£000's |
6 months
ended
30 June 2000
(unaudited)
£000's |
Year
ended
31 December
2000
(audited)
£000's
|
|
Turnover |
|
|
732
|
|
Research and development
Administrative expenses |
|
(2,507)
(805)
|
(5,033)
(1,731)
|
|
Operating expenses
Other operating income: government
grants receivable |
(4,991)
14
|
(3,312)
85
|
(6,764)
96
|
|
|
|
|
|
|
Net operating expenses |
|
|
(6,668)
|
|
Operating loss |
(4,630) |
(2,883) |
(5,936)
|
|
Interest receivable |
611 |
193 |
541 |
| Interest
payable |
(1) |
- |
- |
|
Loss on ordinary
activities before taxation |
|
(2,690) |
(5,395) |
|
Tax on loss on ordinary
activities |
435 |
110
|
393 |
|
Loss for the period |
|
(2,580)
|
(5,002)
|
|
Loss and diluted loss per ordinary share
|
(1.8p) |
(1.7p) |
(3.1p) |
| The
results for the above periods 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. |
| Consolidated
Balance Sheet |
| |
As
at
30 June
2001
(unaudited)
£000's
|
As
at
30 June
2000
(unaudited)
£000's
|
As
at
31 December
2000
(audited)
£000's
|
| Fixed
assets |
|
|
|
| Intangible
assets |
258 |
307
|
283
|
| Tangible
assets |
2,445 |
715
|
1,304
|
| Investments |
26 |
26
|
26
|
| |
2,729
|
|
|
| Current
assets |
|
|
|
| Debtors:
amounts
falling due within one year |
1,622
|
708
|
1,069
|
| Cash
at bank and in
hand |
39,853 |
5,915
|
11,635
|
| |
41,475
|
|
|
| Creditors:
amounts
falling due within one
year |
(2,059)
|
(1,087)
|
(1,340)
|
| Net
current assets
|
39,416
|
|
|
| Total
assets less current liabilities |
42,145
|
6,584
|
12,977
|
| Provisions
for liabilities and charges |
- |
(43) |
- |
| Net
assets |
42,145
|
6,541
|
12,977
|
| |
|
|
|
| Capital
and reserves |
|
|
|
| Called-up
share capital |
2,374 |
1,564
|
1,721
|
| Share
premium account |
58,528 |
17,727
|
26,428
|
| Other
reserves |
711 |
711
|
7111
|
| Profit
and loss account
(deficit) |
(19,468) |
(13,461)
|
(15,883)
|
| Equity
shareholders' funds |
42,145
|
|
|
| Consolidated
Cash Flow |
| |
6
months
ended
30 June
2001
(unaudited)
£000's |
6
months
ended
30 June
2000
(unaudited)
£000's |
Year
ended
31 December
2000
(audited)
£000's |
| Operating
activities |
|
|
|
| Net
cash outflow from continuing operating activities (reconciliation
to operating loss) |
(3,969)
|
(2,547)
|
(5,306)
|
|
Returns on investments
and servicing of finance
|
|
|
|
| Interest
received
Interest paid |
521
(1)
|
193
-
|
407
-
|
| |
520
|
193
|
407
|
| Capital
expenditure |
|
|
|
| Purchase
of tangible fixed assets |
(1,151) |
(90) |
(683)
|
| Net
cash outflow before management
of liquid resources and financing |
(4,600)
|
(2,444) |
(5,582)
|
| |
|
|
|
| Management
of liquid resources |
|
|
|
| Transfer
to deposit accounts |
(43,282) |
(7,740) |
(14,729) |
| Transfer
to current accounts |
14,679 |
1,899 |
3,637 |
| |
(28,603) |
(5,841) |
(11,092) |
| Financing
|
|
|
|
| Issue
of ordinary shares |
35,909
|
5,481 |
14,603
|
| Expenses
of share issue |
(3,091)
|
(161) |
(425) |
| |
32,818 |
5,320 |
14,178
|
|
Decrease in cash in the year
|
|
(2,965)
|
|
| Reconciliation
of operating profit to net cash outflow from operating activities
|
|
|
|
| |
6 months
ended
30 June
2001
(unaudited)
£000's |
6
months
ended
30 June
2000
(unaudited)
£000's |
Year
ended
31 December
2000
(audited)
£000's |
| Continuing
activities |
|
|
|
| Operating
loss |
(4,630) |
(2,883)
|
(5,936) |
Amortisation
on intangible
fixed assets |
25 |
25 |
49 |
| Depreciation
on tangible fixed assets |
318 |
152 |
321 |
| Loss
on disposal of tangible fixed assets |
1 |
3 |
5 |
| Decrease
in debtors falling due after more than one year |
37 |
- |
- |
| (Increase)/Decrease
in trade debtors |
- |
(27)
|
(24) |
Increase
in other
debtors and other tax receivable |
(5) |
(102) |
(52) |
| Increase
in prepayments and accrued income |
(60) |
(37) |
(82) |
| Increase
in trade creditors |
146 |
6 |
99 |
| (Decrease)/Increase
in other taxation and social security |
(30) |
(10) |
57 |
| Increase
in accruals and deferred income |
229 |
283 |
209
|
| Increase
in provisions for liabilities and charges |
-
|
43 |
-
|
| Net
cash outflow from continuing operating activities |
(3,969)
|
(2,547)
|
(5,306)
|
| Notes
| 1. |
Copies of this statement are being sent to all shareholders.
Copies are also available at the registered office of
the Company, Medawar Centre, Oxford Science Park, Oxford
OX4 4GA.
|
| 2. |
On 5 February 2001 the Company issued 204,360 new ordinary
shares of 1p each at 73.4p per share, raising cash proceeds
of £150,000. On 12 April 2001 the Company issued
64,532,359 new ordinary shares of 1p each at 55p per
share, raising cash proceeds of £35,493,000 before
expenses. On 30 April 2001 the Company issued 102,900
new ordinary shares of 1p each at 15.5p per share, raising
cash proceeds of £16,000. On 22 May 2001 the Company
issued 454,545 new ordinary shares of 1p each at 55p
per share, raising cash proceeds of £250,000.
|
| 3. |
The
interim results are unaudited and do not constitute statutory
accounts within the meaning of section 240 of the Companies
Act 1985. The interim results are prepared in accordance
with the accounting policies set out in the Report and
Accounts for the year ended 31 December 2000 but have
not been reviewed by the auditors. The financial information
relating to the year ended 31 December 2000 has been extracted
from the full report and accounts for that period which
have been filed with the Registrar of Companies. The report
of the auditors on those accounts was unqualified.
|
| 4. |
The basic loss per share has been calculated by dividing
the loss for the period by the weighted average number
of 200,765,989 shares in issue during the six months ended
30 June 2001 (six months ended 30 June 2000: 154,885,490,
year ended 31 December 2000: 161,851,789). The Company
had no dilutive potential ordinary shares in any of the
periods 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.
|
|
| For
further information please contact: |
|
|
Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel:
+44 (0)1865 783 000 |
| City/Financial
Enquiries
Melanie Toyne Sewell/Fiona Noblet
Financial Dynamics |
Tel:
+44 (0)20 7831
3113 |
| Scientific/Trade
Enquiries
Chris
Gardner, HCC De Facto Group
|
Tel:
+44 (0)20 7496 3300 |
|
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