RNS Number:2781N
Henderson Morley PLC
08 July 2003
FOR IMMEDIATE RELEASE 8 JULY 2003
HENDERSON MORLEY PLC
(AIM)
Business: Drug Discovery
AUDITED RESULTS FOR THE YEAR TO 30 APRIL 2003
CHAIRMAN'S STATEMENT
The last twelve months has been an exciting period in the development of
Henderson Morley. The most significant event was the negotiation, and subsequent
signing in May 2003, of a patent licence agreement for the ocular application of
ICVT (Ionic Contra Viral Therapy) with Croma Pharma GmbH.
Financial Summary
Turnover for the period under review was #10,931 (2002: #22,270) which related
to the sale of nutraceuticals from the company's websites. Research, development
and administrative expenses for the year amounted to #688,211 (2002: #598,492),
which resulted in a loss of #684,793 (2002: #587,058).
Patent Licence Agreement
The licence granted is an exclusive licence to manufacture and sell product in a
number of agreed territories. Croma will carry out and fund all clinical trials
and, on successful conclusion of the trials, will apply for all necessary
product licences, manufacturing and marketing authorisations in the territories
in accordance with a time schedule to be agreed with the Company.
Territories covered in the agreement include the following major markets:
Europe, Mexico, Central and South America.
Croma has been looking for a treatment for Adenovirus for some considerable time
and they have been very impressed with the data which has been supplied to them.
They have conducted some preliminary work in their own laboratories ahead of
recruitment for a Phase II clinical trial and have been very encouraged by the
results.
As the component drugs of ICVT have been used for treatment in other indications
for many years, the clinical studies are likely to be shorter than for a new
chemical entity. These clinical trials will therefore commence at Phase II.
Following the successful outcome of Phase III studies, approval for a marketing
licence may be sought from the licensing authorities. The approximate timescale
from Phase II to market is considered to be in the region of 2 1/2 to 3 1/2 years.
The market for the ocular application of ICVT
The most common viral pathogens of the eye is Adenovirus, against which ICVT has
already demonstrated efficacy. As far as the Directors are aware, there is still
no anti-viral treatment available for adenovirus infections, nor any under
commercial clinical development.
Statistics for this infection are not generally collated however it is accepted
as being the most common viral cause for conjunctivitis or 'red eye'. It is
known however that acute conjunctivitis has an episode rate of 13.5/1000
population per year and that as many as 75% of cases of infectious
conjunctivitis are caused by adenovirus. This equates to approximately 1% of the
population per year infected with adenovirus or 10 million cases in the target
market area.
Other ICVT Clinical Studies
As stated in my Interim Statement to shareholders in February 2003, a Phase ll
study to examine the use of ICVT against a genital infection known as VIN has
now started and the first patients are being treated.
VIN is caused by the Human Papilloma Virus, typically types 16 and 18. It
affects the genital tract of women and these viruses are also associated with
cancer of the vulva and vagina, and cancer and pre-cancer of the cervix.
The study is under the supervision of Professor Alison Fiander, a leading expert
in the field of Gynaecology, at the University Of Wales, College Of Medicine and
has been described by Professor Fiander's team as "a very important study".
Your Board believes that Women's' Health is one of the fastest growing areas of
healthcare and therefore the data which will be created by this study will
enable us to attract further commercial partners for the ICVT platform.
The Market for ICVT in Women's Health
Cancer of the cervix is the second most common cancer in women on a global basis
and causes an estimated 450,000 new cases and 200,000 deaths annually. More than
2.5 million women are diagnosed with low grade CIN (Cervical Intra-epithelial
Neoplasia or mild to moderate pre-cancerous changes) and a further
200,000-300,000 are diagnosed with high grade dysplasia (more severe
pre-cancerous changes) each year in the USA alone. Worldwide the incidence is
much higher. (WHO figures)
Outlook
We are continuing to seek potential partners for the ICVT applications other
than ocular. The Company is already working with Croma to seek potential
partners in the Far East and the United States for the ocular application.
Your Board is very excited in the level of interest being shown in ICVT and its
various applications and are confident that this will result in further licences
being signed.
Our recent round of funding raised #460,100 and the money raised has enabled us
to commit resources to further development in formulation and delivery across
the ICVT platform, including dermal, genital and women's health.
The Company has identified a clear path to exploitation of the ICVT product, and
the creation of potentially significant revenue streams. However, in the
intervening period, the Company has a fixed cost base of around #600,000 per
annum which will need funding. The Board continues to take the necessary steps
to minimise the Company's operating costs, and will seek further finance as and
when the need arises or the Board feels it appropriate.
I would like to take this opportunity to welcome all our new shareholders and to
thank our existing shareholders for their continued support.
ANDREW KNIGHT
Executive Chairman
ENDS
Copies of this announcement will be available free of charge to the public at
the Company's registered office at Metropolitan House, 2 Salisbury Road,
Moseley, Birmingham, B13 8JS and at the offices of Brewin Dolphin Securities
Ltd, 34 Lisbon Street, Leeds LS1 4LX for 14 days.
Enquiries:
HENDERSON MORLEY PLC Tel: 0121 442 4600
Andrew Knight, Chairman
BREWIN DOLPHIN SECURITIES LTD Tel: 0113 241 0126
Neil Baldwin
BARNES AND WALTERS LTD Tel: 020 7430 1600
Maxine Barnes Mobile: 07860 489571
HENDERSON MORLEY PLC AND SUBSIDIARY
UNDERTAKINGS
Consolidated Profit and Loss Account
for the Year Ended 30 April 2003
30.4.03 30.4.02
---------- ----------
# #
TURNOVER 10,931 22,270
Cost of Sales 6,850 10,765
---------- --------
GROSS PROFIT 4,081 11,505
Administrative Expenses 470,021 387,885
Research & Development 218,190 688,211 210,607 598,492
--------- --------- --------- ---------
OPERATING LOSS (684,130) (586,987)
Interest receivable and
similar income 5,781 5,176
_______ _______
Interest payable and
similar charges (678,349) (581,811)
6,444 5,247
_______ _______
LOSS ON ORDINARY
ACTIVITIES BEFORE
TAXATION (684,793) (587,058)
Tax on loss on ordinary
activities (46,883) (44,105)
________ _______
LOSS FOR THE FINANCIAL
YEAR AFTER TAXATION (637,910) (542,953)
Deficit brought forward (1,138,457) (595,504)
_________ ________
DEFICIT CARRIED
FORWARD #(1,776,367) #(1,138,457)
============== ==============
Basic and Diluted Loss per
Ordinary Share (0.40p) (0.40p)
HENDERSON MORLEY PLC AND SUBSIDIARY UNDERTAKINGS
Consolidated Balance Sheet
30 April 2003
30.4.03 30.4.02
---------------------- ----------------------
# # # #
FIXED ASSETS:
Intangible assets 156,305 171,045
Tangible assets 94,813 117,654
-------- ---------
251,118 288,699
CURRENT ASSETS:
Stocks 18,409 22,316
Debtors 106,984 93,340
Cash at bank 40,838 398,761
-------- ---------
166,231 514,417
CREDITORS: Amounts
falling
due within one year 147,256 122,991
--------- ---------
NET CURRENT ASSETS: 18,975 391,426
-------- ---------
TOTAL ASSETS LESS CURRENT
LIABILITIES: 270,093 680,125
CREDITORS: Amounts
falling
due after more than one 23,476 22,014
year -------- --------
#246,617 #658,111
========== ==========
CAPITAL AND RESERVES:
Called up share capital 198,212 187,053
Share premium 1,824,772 1,609,515
Profit and loss account (1,776,367) (1,138,457)
------------- -------------
EQUITY SHAREHOLDERS'FUNDS: #246,617 #658,111
========== ==========
HENDERSON MORLEY PLC AND SUBSIDIARY
UNDERTAKINGS
Cash Flow Statement
for the Year Ended 30 April 2003
30.4.03 30.4.02
-------------------- ------------------
# # # #
Net cash outflow
from operating activities (638,707) (541,150)
Returns on investments and
servicing of finance (663) (71)
Taxation 44,027 43,345
Capital expenditure 17,038 (625)
-------- -------
(578,305) (498,501)
Financing 176,989 864,508
--------- ---------
(Decrease)/ Increase #(401,316) #366,007
in cash in the period ============ ==========
Reconciliation of net cash
flow to movement in net funds
(Decrease)/ Increase
in cash in the period (401,316) 366,007
Cash outflow
from decrease in
debt and lease financing 27,883 5,677
-------- -------
Change in net funds resulting
from cash flows (373,433) 371,684
New finance leases (20,500) (10,000)
---------- ----------
Movement in net funds in (393,933) 361,684
the period
Net funds at 1 May 371,613 9,929
--------- -------
Net (debt)/funds at 30 #(22,320) #371,613
April =========== ==========
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