RNS Number:5808J
Alizyme PLC
03 April 2003
The Company will not be conducting formal meetings but will be available for
interviews at Buchanan Communications. Please contact Buchanan Communications on
020 7466 5000 if you wish to meet with the Company.
For Immediate Release 03 April 2003
ALIZYME PLC
FINANCIAL RESULTS FOR THE YEAR ENDED 31 DECEMBER 2002
Cambridge UK, 03 April 2003: Alizyme plc (LSE:AZM) today announces its financial
results for the year ended 31 December 2002.
Highlights for 2002
COLAL-PRED (Ulcerative colitis; UC)
- Positive Phase II clinical trial results in treatment of active disease
- Regulatory approval for a Phase III clinical trial in maintenance of
remission
Renzapride (Irritable Bowel Syndrome; IBS)
- Commencement of Phase IIb trial in mixed-symptom IBS
- Completion of patient recruitment in constipation-predominant IBS Phase
IIb clinical trial
- Opening of IND application and start of first clinical trial in the USA
ATL-962 (Obesity)
- Regulatory approval for Phase IIb clinical development
- Commencement of Phase IIb clinical trial in clinically obese patients
ATL-104 (Mucositis)
- Completion of Phase I clinical programme
Financial
- #9.8 million loss after tax for the year ended 31 December 2002
- #5.3 million cash and liquid resources at 31 December 2002*
*Placing and Open Offer in February 2003 raised #16.1 million gross (#15.1
million net)
For further information, please contact:
Dr Richard Palmer, Chief Executive Officer
Mr Tim Mccarthy, Finance Director
Alizyme Plc Tel No: + 44 (0)1223 896000
Lisa Baderoon/ Tim Anderson
Buchanan Communications Tel No: + 44 (0) 20 7466 5000
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Chairman's statement
As we look back on 2002, it will be viewed as a crucial year in Alizyme's
progress towards determining the future success of all four of our products in
development.
During the year we obtained clinical trial results with COLAL-PRED that
exemplified its target product profile and justified investment to take it
forward into Phase III clinical development in preparation for application for
registration and potential commercialisation. We also moved renzapride into a
substantial Phase IIb clinical development programme, which if successful, will
also provide the platform and justification for investing in Phase III clinical
development in preparation for application for registration and potential
commercialisation. Similarly, the successful preliminary demonstration of the
target product profile of ATL-962 in its Phase Ib programme, justified the
investment in a large Phase IIb clinical trial, which will define its future
potential. Finally, we were able to complete the work necessary in Phase I,
which enables us to go forward and evaluate ATL-104 in cancer patients in Phase
IIa to provide a go/no go investment decision for the future.
We expect 2003 to be a year of significant newsflow with both renzapride and
ATL-962 due to report Phase IIb clinical results. Assuming successful outcomes
of these trials, we could be in the position by the end of 2003, of having three
products either in, or appropriate for progressing into, Phase III clinical
development with our fourth product in Phase II. As a result, the current
product portfolio should reach a stage over the coming year which will allow us
to evaluate the impact of our achievements on the future direction of the
Company.
It is worth reflecting that between its inception and 31 December 2002, Alizyme
has invested a net total of only #37.7 million of shareholders' funds in
developing its product opportunities. Compared with industry standards, this is
a remarkable achievement. This has been possible only by careful and strategic
investment in our product portfolio, whilst keeping our overheads to a minimum.
Thus, investment in research and development during the year 2002 makes up 89%
of the operating loss, in line with historic levels in Alizyme.
The steadfast support of our shareholders has been essential to enable us to
continue to invest in our product opportunities. After what has turned out to be
another difficult year in the equity markets and the biotech sector in
particular, we were delighted to be able to announce, in February 2003, the
success of our recent Placing and Open Offer, which raised #16.1 million gross.
The Board wishes to express its gratitude to both our longstanding and to our
new investors for their support which ensured this successful financing.
Our strong financial position will allow the Company to extract maximum value
for shareholders from the products under development and as we continue
outlicensing discussions, it will put us in a much stronger negotiating position
to secure financially attractive outlicensing deals.
In May 2002 we welcomed Richard Forrest onto the Board as a non-executive
Director. Richard brings with him a wealth of experience in commercial
operations in the global pharmaceutical industry. His contribution is already
proving valuable as we seek to commercialise our products.
Looking forward, the Board recognises that there are a number of strategic
options possible for the Company as we lay the foundations and progress towards
the next stage in our evolution. As critical clinical data on our products
emerge during the year ahead, we will be examining those strategic options in
more detail.
Finally, our thanks go to the small, but entirely dedicated staff of Alizyme,
who continue to work extremely hard to deliver the progress that both the Board
and our shareholders have come to expect.
Sir Brian Richards CBE
Chairman
3 April 2003
Chief Executive's report
The concentration and effort during 2002 was once again very much on the
progression of our product opportunities through their clinical development,
with the main objective of providing data that define their respective product
profiles, and allow the Company, or a licensing partner, to make effective
investment decisions in the future.
During 2002 we completed or initiated clinical trials on all four of our
products involving over 1,100 patients in Phase II and a further 68 volunteers
in Phase I. We also received regulatory approval to move our first product into
Phase III clinical trials and opened our first IND application, allowing
clinical development in the USA to commence. In addition, regulatory approval
was granted to take our third product into Phase IIb clinical trials in
patients.
COLAL-PRED
In February 2002, we announced our first Phase II clinical trial results with
the successful completion of a Phase II trial of COLAL-PRED in mild-to-moderate
UC. The results demonstrated comparable efficacy to conventional
anti-inflammatory steroid treatments, but without the debilitating side effects
of these regimens.
This clinical profile matches the target product profile and offers the
potential of a 'safe steroid' for use in patients suffering not only with acute
conditions, but also in longer term maintenance of remission in those same
patients. This efficacy/safety profile allowed us to obtain regulatory approval
for a twelve month Phase III trial to test COLAL-PRED in the maintenance of
remission of UC patients.
We are currently scaling up and optimising the manufacturing process for
COLAL-PRED for its Phase III trials and in preparation for eventual marketing
authorisation application, and are in discussions with potential licensing
partners.
Renzapride
It was a busy year for renzapride with three separate clinical trials in
progress in irritable bowel syndrome (IBS) patients, two in Europe and one in
the USA.
The largest of these is a 514 patient Phase IIb trial in
constipation-predominant IBS (c-IBS) patients in the UK. In September 2002, it
completed patient recruitment and we expect to announce the preliminary results
from this trial in May 2003.
Renzapride is also being evaluated in over 170 patients with mixed-symptom IBS
(m-IBS) in a Phase IIb clinical trial being undertaken across 5 European
countries, which commenced in June 2002. Patient recruitment completed in March
2003 and the preliminary results from this trial are expected to be announced in
October 2003.
At Mayo Clinic in the USA, renzapride is also undergoing a pharmacokinetic/
pharmacodynamic study in up to 48 c-IBS patients, to determine the relationship
between the effects of different doses on gastrointestinal motility and levels
of drug absorbed.
The purpose of all these trials is to define the product's profile in each
patient population, prepare it for Phase III development and to provide the data
necessary to attract and negotiate an outlicensing deal.
Across these three trials, renzapride is being tested in over 700 patients and
represents Alizyme's determination to conduct appropriately large robust Phase
II clinical trials. These should deliver results that allow us, and any future
licensing partners, to make informed decisions about the product's likelihood of
successfully completing development and being marketed.
ATL-962
In March 2003, we announced the completion of recruitment in the Phase IIb
clinical trial of ATL-962, Alizyme's gastrointestinal lipase inhibitor. This
trial, which commenced in November 2002, involves 370 clinically obese patients
and is being conducted in 5 European countries. Preliminary results from this
trial are expected to be announced in October 2003.
This trial is important in determining the differentiation and competitiveness
of ATL-962's product profile in the anti-obesity market. Should ATL-962
demonstrate either increased efficacy and/or a more favourable tolerability
profile, it should prove to be a serious contender in the ever-growing market
for anti-obesity drugs, which at the moment is poorly served with prescription
drugs.
In a series of three Phase Ib trials, the results of which we presented at the
International Obesity Congress in Sao Paulo in August 2002, ATL-962 demonstrated
similar efficacy to that of orlistat, the active ingredient of Xenical (the
gastrointestinal lipase inhibitor marketed by Roche), as measured by a surrogate
marker, together with improved tolerability effects.
ATL-962 also has the prospect of being developed for Type II diabetes, a market
which is at least as big as the anti-obesity market. We shall be examining the
merits of conducting Phase II trials in this indication, either ourselves or in
conjunction with a licensing partner, once the preliminary results of the Phase
IIb trial are received later this year.
ATL-104
Mucositis is a condition which occurs when the lining of the mouth and/or
gastrointestinal tract of cancer patients is damaged by treatment with
chemotherapy or radiotherapy.
ATL-104, our product for mucositis, took a major step forward in 2002 with the
successful completion of its Phase I clinical programme. This involved a total
of 68 volunteers in two separate Phase I clinical trials. Results from these
trials were reported during 2002, providing evidence that ATL-104 was safe and
well tolerated. We are currently preparing ATL-104 for a Phase IIa proof of
concept clinical trial in cancer patients, which we expect to commence later
this year.
Management
In May 2002, we welcomed Roger Hickling into the Company as Head of Development
Operations. Roger has more than 25 years of experience in both product
development and international regulatory affairs. His appointment brings highly
experienced product development management, which will support the later stage
clinical development of our products and will assist me with my overall
responsibility for the Group's research and development activities.
Dr Richard Palmer
Chief Executive Officer
3 April 2003
Financial review
Alizyme reports an operating loss of #10.9 million for the year. This represents
an increase of #2.1 million over 2001 (#8.8 million) and is consistent with the
large clinical trials that we are currently undertaking and with having all four
products in clinical development during 2002.
Research and Development remains our most significant investment totalling #9.7
million in 2002 or 89% of the operating loss for the year. Management and
Administration expenses of #1.2 million increased slightly in the year from #1.0
million in 2001. Interest received of #0.4 million represents an average return
of 4.07% on our cash balances throughout the year. The tax credit for 2002
amounts to #0.7 million and is a continuing source of support for research and
development investment.
At 31 December 2002 the Company had cash and liquid resources of #5.3 million.
This was supplemented in February 2003 by the receipt of monies from the Placing
and Open Offer.
The Placing and Open Offer raised #16.1 million gross (#15.1 million net of
expenses) from the issue of 57,542,499 new shares at a price of 28 pence per
share. This represented a discount of 0.75 pence (2.6%) to the closing
mid-market price on the last day prior to announcement of the fundraising. We
are delighted to welcome a number of new institutional investors into the
Company.
Including the #16.1 million raised in February 2003, Alizyme has now raised a
total of #59.1 million from inception. As at 31 December 2002, a net total of
#37.7 million had been invested in developing Alizyme and its product
opportunities.
Tim McCarthy
Finance Director
3 April 2003
Consolidated Profit and Loss Account
For the year ended 31 December 2002
Notes 2002 2001
#000's #000's
Turnover
Operating expenses: - -
Research and development (9,692) (7,740)
Management and administrative (1,176) (1,028)
Operating loss (10,868) (8,768)
Interest receivable 396 958
Loss on ordinary activities before taxation (10,472) (7,810)
Taxation on loss on ordinary activities 710 1,175
Loss for the financial year being the retained loss for
the year attributed to the members of Alizyme plc (9,762) (6,635)
Loss per share for the year
- basic and diluted 2 (12.3p) (8.4p)
There were no recognised gains or losses in either year other than the loss for
that year.
All amounts relate to continuing activities.
Consolidated Balance Sheet
As at 31 December 2002
Notes 2002 2001
#000's #000's
Fixed assets
Tangible assets 231 292
Current assets
Debtors 1,659 1,281
Short term investments 5,204 15,081
Cash at bank and in hand 116 236
6,979 16,598
Creditors: Amounts falling due within one year (2,796) (2,805)
Net current assets 4,183 13,793
Total assets less current liabilities 4,414 14,085
Provisions for liabilities and charges - (8)
Net assets 4,414 14,077
Capital and reserves
Called-up share capital 1,587 1,583
Share premium account 35,986 35,891
Capital reserve 1,530 1,530
Profit and loss account (34,689) (24,927)
Equity shareholders' funds 3 4,414 14,077
Consolidated Cash Flow Statement
For the year ended 31 December 2002
2002 2001
#000's #000's
Net cash outflow from operating activities (11,188) (8,368)
Returns on investments and servicing of finance
Interest received 470 941
Net cash inflow from returns on investments
and servicing of finance 470 941
Taxation
Research and development tax credit received 693 482
Net cash inflow from taxation 693 482
Capital expenditure and financial investment
Purchase of tangible fixed assets (71) (236)
Net cash outflow from capital expenditure
and financial investment (71) (236)
Cash outflow before management of liquid
resources and financing (10,096) (7,181)
Management of liquid resources
Cash withdrawn from money market deposits 9,877 6,933
Net cash inflow from management of
liquid resources 9,877 6,933
Financing
Issue of ordinary share capital (net) 99 142
Net cash inflow from financing 99 142
Decrease in cash (120) (106)
NOTES TO THE CONSOLIDATED CASH FLOW STATEMENT
Reconciliation of operating loss to operating cash flows
2002 2001
#000's #000's
Operating loss (10,868) (8,768)
Depreciation charge 132 56
Increase in debtors (435) (318)
(Decrease)/increase in creditors (9) 691
Decrease in provision (8) (29)
Net cash outflow from operating activities (11,188) (8,368)
Analysis and reconciliation of net funds
At At
1 January 31 December
2002 Cash flow 2002
#000's #000's #000's
Cash at bank and in hand 236 (120) 116
Liquid resources
(short term cash deposits) 15,081 (9,877) 5,204
Net funds 15,317 (9,997) 5,320
Reconciliation of net cash flow to movement in net funds
2002 2001
#000's #000's
Decrease in cash in the year (120) (106)
Cash inflow from decrease in liquid resources (9,877) (6,933)
Movement in net funds in the year (9,997) (7,039)
Net funds at 1 January 15,317 22,356
Net funds at 31 December 5,320 15,317
Notes
1. FINANCIAL INFORMATION
The financial information set out in the preliminary statement does not comprise
the Company's statutory accounts within the meaning of section 240(5) of the
Companies Act 1985.
The preliminary statement is prepared on the basis of the accounting policies as
stated in the financial statements for the year ended 31 December 2001, with the
exception that the company has adopted FRS 19 'Deferred Tax' which became
effective for years ending on or after 23 January 2002, in order to comply with
the latest United Kingdom accounting standards. This has no effect on either
the current year of the preceding year.
The financial information for 2002 has been extracted from the statutory
accounts of the Company for the year ended 31 December 2002, which have been
audited by the Company's auditors Deloitte & Touche and whose report thereon is
unqualified and did not contain any statement under section 237(2) or (3) of the
Companies Act 1985. The Company's statutory accounts will be delivered to the
Registrar of Companies for England and Wales in due course and will also be sent
to shareholders.
The financial information for 2001 has been extracted from the statutory
accounts for the year ended 31 December 2001, which have been delivered to the
Registrar of Companies. The auditors' report on those accounts was unqualified
and did not contain any statement under section 237(2) or (3) of the Companies
Act 1985.
The preliminary statement was approved by the Board on 3 April 2003.
2. LOSS PER SHARE
The diluted loss per share takes into account the dilutive effect of share
options. Ordinary shares which are potentially issuable are only included in the
calculation of diluted earnings per share if their issue would decrease net
profit per share or increase net loss per share. The exercise of share options
does not increase the basic loss per share and therefore the basic and diluted
loss per share remain the same. The loss per share is based on the loss of
#9,762,000 for the year ended 31 December 2002 (year ended 31 December 2001 -
loss of #6,635,000) and on 79,291,000 ordinary shares (2001 - 79,135,000
ordinary shares), being the weighted average number of ordinary shares in issue
and ranking for dividend during the year.
3. RECONCILIATION OF MOVEMENTS IN GROUP SHAREHOLDERS' FUNDS
2002 2001
#000's #000's
Loss for the year (9,762) (6,635)
New ordinary shares issued net of expenses 99 142
Net reduction in shareholders' funds (9,663) (6,493)
Opening shareholders' funds 14,077 20,570
Closing shareholders' funds 4,414 14,077
(Note: COLAL and COLAL-PRED are trademarks of Alizyme Therapeutics Limited)
The identification of compounds for successful research, their progress through
development and the obtaining of regulatory approvals or authorisations before
marketing, manufacture and/or distribution of products is not certain or a
formality.
This information is provided by RNS
The company news service from the London Stock Exchange
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