RNS Number:0922Z
Alizyme PLC
25 July 2002
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contact the numbers below.
For Immediate Release 25 July 2002
Alizyme plc
Interim Report for the six months ended 30 June 2002
Cambridge UK, 25 July 2002: Alizyme plc (LSE:AZM) today announces its interim
results for the six months ended 30 June 2002.
HIGHLIGHTS
COLAL-PRED(TM)
Ulcerative Colitis
COLAL-PRED(TM) uses Alizyme's COLAL(TM) technology for targeted delivery of an
established anti-inflammatory steroid for local action at the site of disease in
the colon.
• Positive Phase II results for treatment of ulcerative colitis
• Approval received for Phase III clinical trial in maintenance of
remission of ulcerative colitis
RENZAPRIDE
Irritable Bowel Syndrome
Renzapride interacts with two of the key receptors implicated in irritable bowel
syndrome (IBS) to modify gastrointestinal motility.
• Approval received for Phase IIb clinical trial in mixed-symptom IBS
(m-IBS) patients
• Clinical trial initiated in the USA at Mayo Clinic in
constipation-predominant IBS (c-IBS) patients under our first
Investigational New Drug (IND) application
ATL-962
Obesity
ATL-962 inhibits the lipase enzymes responsible for digesting fat in the diet,
blocking its absorption into the body.
• Approval received for Phase IIb clinical trial in obese patients
ATL-104
Mucositis
ATL-104 stimulates the production of the cells that line the gastrointestinal
tract, potentially protecting it from the damaging effect of anti-cancer
therapy.
• Successful completion of Phase Ia clinical trial
• Successful completion of Phase Ib clinical trial
Loss after tax - £4.5 million for the six months to 30 June 2002 (six months to
30 June 2001: £3.3 million).
Cash and liquid resources - £11.3 million at 30 June 2002 (£18.5 million at 30
June 2001).
For further information, please contact:
ALIZYME plc +44 (0) 1223 896000
Dr Richard Palmer, Chief Executive Officer
Tim McCarthy, Finance Director
BUCHANAN COMMUNICATIONS +44 (0) 20 7466 5000
Lisa Baderoon Mobile: 07721 413 496
Tim Anderson Mobile: 07710 328 560
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Chairman's and Chief Executive's Statement
Overview
During the period, we have made substantial progress with the development of our
clinical programmes. We have achieved our first regulatory approval for a Phase
III clinical trial with our product COLAL-PRED(TM); initiated a clinical trial in
the USA under our first IND application with renzapride; obtained approval for a
Phase IIb clinical trial for ATL-962, as well as completing the Phase I clinical
programme for ATL-104.
Our development portfolio has now reached a significantly later stage with
COLAL-PRED(TM) in Phase III, renzapride and ATL-962 in Phase IIb and ATL-104 being
prepared for Phase II clinical development. Collectively, these achievements
mark an important stage in the development of the Company.
COLAL-PRED(TM)
The Phase II clinical trial of COLAL-PRED(TM), in ulcerative colitis patients
with active disease, completed earlier this year. It demonstrated comparable
efficacy to conventional anti-inflammatory steroid treatments, but with no
evidence of the systemic side effects normally exhibited by this type of drug.
This excellent safety profile provided the basis of a submission to the UK
Medicines Control Agency (MCA) for approval to conduct a Phase III clinical
trial. This trial, which was approved in February, involves a 12-month treatment
period, in up to 600 patients, with planned involvement of an additional seven
European countries, with the objective of maintaining remission of the disease
in patients with ulcerative colitis.
In addition, work is progressing in preparation for an application for approval
to commence a Phase III clinical trial in patients with active disease.
RENZAPRIDE
During the period we received approval from the MCA in the UK and several other
European countries to conduct a Phase IIb clinical trial of renzapride in up to
160 m-IBS patients. This trial seeks to explore the unique combined mechanism
of action of renzapride in this distinct population of IBS patients, which are
not served by any existing therapies. This trial has the potential to
significantly expand the commercial value of this product.
In addition, in April, we initiated a clinical trial in up to 48 c-IBS patients
at Mayo Clinic in the USA under our first IND. This trial opens up development
in the world's largest pharmaceutical market.
These trials, combined with the ongoing Phase IIb trial in up to 500 c-IBS
patients in the UK, will allow definition of the product profile of this
compound in these potential populations, the generation of a large clinical
safety database and selection of the doses for Phase III clinical trials.
The ongoing trials are expected to report in the first half of next year.
Successful results from these trials would be a defining moment for this
product.
ATL-962
The Phase Ib programme of ATL-962, for the treatment of obesity, which involved
three studies in 66 healthy volunteers, was completed at the end of last year.
These studies demonstrated that ATL-962 was safe and generally well tolerated.
The data also provided evidence of dose-related efficacy, as indicated by a
surrogate marker. The profile exhibited was very encouraging and in June we
received approval from the MCA in the UK to conduct a Phase IIb study in up to
340 clinically obese patients, with planned involvement of an additional four
European countries. With no other company having a lipase inhibitor in
development, this trial will seek to define the product profile and competitive
position relative to that of Roche's lipase inhibitor, Xenical(R) , which is
approved for the management of obesity.
In the period, Roche published clinical data supporting the potential of lipase
inhibitors in the management of Type II diabetes. Roche has received approval
in some territories for the use of Xenical(R) in this indication. This opens up
the potential for ATL-962 also to be developed for the management of diabetes,
expanding its commercial value substantially.
ATL-104
During this period, we completed the Phase I clinical programme of this
compound, for the treatment of mucositis, which involved a single dose Phase Ia
study and a repeat dose Phase Ib study in healthy volunteers. Both of these
clinical trials demonstrated that ATL-104 was safe and generally well tolerated.
Successful completion of this programme has now allowed us to explore clinical
trial designs, in order to prepare an application for approval, to commence a
definitive proof of concept Phase IIa trial in cancer patients. This trial will
seek to define the utility of this product opportunity and will determine
whether the data obtained to date, translate into the patient setting.
Organisation
Two senior appointments were made in June. With the increasing number and
complexity of our clinical trial programmes, we appointed Roger Hickling, who
has extensive drug development management experience, to the position of Head of
Development Operations. Richard Forrest, who has extensive commercial experience
in global pharmaceutical companies, was appointed as a non-executive director.
Financial Review
In the six months ended 30 June 2002, Alizyme made a net loss of £4.5 million
(six months ended 30 June 2001 - £3.3 million; six months ended 31 December 2001
- £3.3 million). Net cash outflow before management of liquid resources and
financing for the period was £4.1 million (six months ended 30 June 2001 - £4.0
million; six months ended 31 December 2001 - £3.2 million). Cash and liquid
resources were £11.3 million at 30 June 2002 (£18.5 million at 30 June 2001;
£15.3 million at 31 December 2001).
In the first six months of 2002, 89% (first six months of 2001, 87%) of all
expenditure was directly related to research and development.
Prospects
We will continue to progress our portfolio, with one product in Phase III, two
in Phase II and our fourth product being prepared for Phase II, with the goal of
maximising its commercial potential. Following the commencement of our first
trial in the USA and other trials across Europe, we are increasing our clinical
development activity worldwide, optimising our position for negotiations with
potential marketing partners.
Through licensing agreements, we would begin to realise the value within our
portfolio with initial licensing fees in recognition of the progress made to
date, as well as further development milestone payments and royalties on future
product sales, allowing Alizyme a share in the products' ultimate success.
Again, the progress made in the period has been as a direct result of the
dedicated work from the Alizyme team and we would like to take this opportunity
to thank everyone for their efforts.
Sir Brian Richards CBE
Chairman
Dr Richard Palmer
Chief Executive Officer
25 July 2002
Consolidated Profit and Loss Account
for the six months ended 30 June 2002
Six months ended Six months ended Twelve months
ended
30 June 30 June 31 December
2002 2001 2001
£000's £000's £000's
Turnover - - -
Operating expenses:
Research and development costs (4,635) (3,362) (7,740)
Management and administrative expenses (567) (483) (1,028)
__________ __________ __________
Operating loss (5,202) (3,845) (8,768)
Interest receivable 246 545 958
__________ __________ __________
Loss on ordinary activities before taxation (4,956) (3,300) (7,810)
Tax on loss on ordinary activities 430 - 1,175
__________ __________ __________
Loss for the period (4,526) (3,300) (6,635)
__________ __________ __________
Dividends - - -
__________ __________ __________
Retained loss for the period attributable to the (4,526) (3,300) (6,635)
members of Alizyme plc
__________ __________ __________
Loss per share - basic and diluted (note 2) (5.7p) (4.2p) (8.4p)
__________ __________ __________
There were no recognised gains and losses in any period other than the loss for
that period.
All amounts relate to continuing activities.
The accompanying notes form an integral part of this Consolidated Profit and
Loss Account.
Consolidated Balance Sheet
As at 30 June 2002
As at As at As at
30 June 30 June 31 December
2002 2001 2001
£000's £000's £000's
Fixed assets
Tangible fixed assets 299 103 292
__________ __________ __________
Current assets
Debtors 1,762 352 1,281
Liquid resources (short term cash deposits) 11,132 18,436 15,081
Cash at bank and in hand 210 40 236
__________ __________ __________
13,104 18,828 16,598
Creditors: Amounts falling due within one year (3,743) (1,490) (2,805)
__________ __________ __________
Net current assets 9,361 17,338 13,793
__________ __________ __________
Total assets less current liabilities 9,660 17,441 14,085
__________ __________ __________
Provisions for liabilities and charges (note 3) (10) (29) (8)
__________ __________ __________
Net assets 9,650 17,412 14,077
__________ __________ __________
Capital and reserves
Called-up share capital 1,587 1,583 1,583
Share premium account 35,986 35,891 35,891
Capital reserve 1,530 1,530 1,530
Profit and loss account (29,453) (21,592) (24,927)
__________ __________ __________
Equity shareholders' funds 9,650 17,412 14,077
__________ __________ __________
The accompanying notes form an integral part of this Consolidated Balance Sheet.
Consolidated Cash Flow Statement
for the six months ended 30 June 2002
Six months Six months Twelve months
ended ended ended
30 June 30 June 31 December
2002 2001 2001
£000's £000's £000's
__________ __________ __________
Net cash outflow from operating activities (note 4) (4,984) (4,503) (8,368)
__________ __________ __________
Returns on investments and servicing of finance
Interest received 287 497 941
__________ __________ __________
Net cash inflow from return on investments and servicing of finance 287 497 941
__________ __________ __________
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 (70) (16) (236)
__________ __________ __________
Net cash outflow from capital expenditure and financial investment (70) (16) (236)
__________ __________ __________
Cash outflow before management of liquid resources and financing (4,074) (4,022) (7,181)
__________ __________ __________
Management of liquid resources
Cash withdrawn from money market deposits 3,949 3,578 6,933
__________ __________ __________
Net cash inflow from management of liquid resources 3,949 3,578 6,933
__________ __________ __________
Financing
Issue of ordinary share capital (net of expenses) 99 142 142
__________ __________ __________
Net cash inflow from financing 99 142 142
__________ __________ __________
__________ __________ __________
Decrease in cash in the period (26) (302) (106)
__________ __________ __________
The accompanying notes form an integral part of this Consolidated Cash Flow
Statement.
Notes to the financial information
1 Basis of preparation
The interim financial information has been prepared on the basis of the
accounting policies set out in the Group's statutory 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 had no effect on either the current period or prior periods.
These interim financial statements do not constitute statutory financial
statements within the meaning of section 240 of the Companies Act 1985. Results
for the six-month periods ended 30 June 2002 and 30 June 2001 have not been
audited. The results for the year ended 31 December 2001 have been extracted
from the statutory financial statements, which have been filed with the
Registrar of Companies and upon which the auditors reported without
qualification.
Copies of the interim results for the six months ended 30 June 2002 are being
sent to all shareholders. Details can also be found on the Company's website at
www.alizyme.com. Further copies of the interim results and copies of the full
financial statements for the year ended 31 December 2001 can be obtained by
writing to the Company Secretary, at Alizyme plc, Granta Park, Great Abington,
Cambridge CB1 6GX or by sending an electronic mail to info@alizyme.com.
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
do 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
£4,526,000 for the six months ended June 2002 (six months ended June 2001 -
£3,300,000; twelve months ended December 2001 - £6,635,000) and on 79,227,000
ordinary shares (June 2001 - 79,095,000; December 2001 - 79,135,000) being the
weighted average number of equity shares in issue.
3 Provision for employer's National Insurance on gains on share options
A provision of £10,000 (30 June 2001 - £29,000; 31 December 2001 - £8,000) has
been recognised for National Insurance contributions that will be payable on
gains realised upon the exercise of share options issued after 6 April 1999. Any
liability that may arise will be incurred in the period 1 July 2002 to 20 July
2006. The provision is based upon the closing share price of the Company on 30
June 2002, which was 57.5p (30 June 2001 - 86.5p; 31 December 2001 - 53.5p) and
calculated at a National Insurance rate of 11.8% (30 June 2001 - 11.9%; 31
December 2001 - 11.9%). The provision has been allocated over the performance
period of each employee, where the performance period is the period during which
the employee must perform the services necessary to become unconditionally
entitled to the options.
4 Reconciliation of Operating Loss to Operating Cash Flows
Six months Six months Twelve months
ended ended ended
30 June 30 June 31 December
2002 2001 2001
£000's £000's £000's
Operating loss (5,202) (3,845) (8,768)
Depreciation charge 63 25 56
Increase in debtors (785) (51) (318)
Increase/(decrease) in creditors 938 (624) 691
Increase/(decrease) in provision 2 (8) (29)
__________ __________ __________
Net cash outflow from operating activities (4,984) (4,503) (8,368)
__________ __________ __________
INDEPENDENT REVIEW REPORT TO ALIZYME PLC
Introduction
We have been instructed by the Company to review the financial information for
the six months ended 30 June 2002 which comprises the profit and loss account,
the balance sheet, the cash flow statement and related notes 1 to 4. We have
read the other information contained in the interim report and considered
whether it contains any apparent misstatements or material inconsistencies with
the financial information.
Directors' responsibilities
The interim report, including the financial information contained therein, is
the responsibility of, and has been approved by, the directors. The directors
are responsible for preparing the interim report in accordance with the Listing
Rules of the Financial Services Authority which require that the accounting
policies and presentation applied to the interim figures should be consistent
with those applied in preparing the preceding annual accounts except where any
changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with the guidance contained in Bulletin
1999/4 issued by the Auditing Practices Board for use in the United Kingdom. A
review consists principally of making enquiries of group management and applying
analytical procedures to the financial information and underlying financial data
and, based thereon, assessing whether the accounting policies and presentation
have been consistently applied unless otherwise disclosed. A review excludes
audit procedures such as tests of controls and verification of assets,
liabilities and transactions. It is substantially less in scope than an audit
performed in accordance with United Kingdom auditing standards and therefore
provides a lower level of assurance than an audit. Accordingly, we do not
express an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that
should be made to the financial information as presented for the six months
ended 30 June 2002.
Deloitte & Touche
Chartered Accountants
Leda House
Station Road
Cambridge
CB1 2RN
25 July 2002
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