Interim Results

Futura Medical PLC
22 September 2003




Press Release                                                 22 September 2003




                               Futura Medical plc

             Interim Results for the six months ended 31 July 2003





Futura Medical plc ('Futura Medical', 'Futura' or 'the Company'), the
pharmaceutical and medical device group that develops innovative products for
the sexual healthcare market, reports Interim Results for the six months ended
31 July 2003.





Highlights


•   Completion of £1.7 million private placement, followed by introduction to 
    AIM on 22 July 2003


•   Completion of the Phase II study for MED2001; now patent-protected in 22 
    countries


•   Global distribution agreement for CSD500 product


•   Boardroom strengthened by two key appointments


•   Financial strategy in place, with costs strictly controlled


•   Operating loss of £966k (1H 2002 loss of £614k), including £351,000 of AIM 
    admission costs


•   Loss per share - basic 2.1p (1H 2002: 1.3p)


•   £2.05 million cash at 31 July 2003







Commenting on Futura's first set of Results since listing, James Barder, Chief
Executive, said:



'We are well on track in building a successful pharmaceutical and medical device
group to serve the growing sexual healthcare market, and I hope to report
further progress by the end of the year.'




For further information, please contact:



Futura Medical plc
James Barder, Chief Executive                         Tel: [phone]
Email: [e-mail]




Media enquiries:
Bankside
Peter Curtain / Alex Tweed                             Tel: [phone]
Email: [e-mail]







              Chairman and Chief Executive Joint Interim Statement



The six months to the end of July were a period of significant transformation
for Futura Medical plc ('Futura' or the 'Company'), leading to both the
Introduction of Futura to the Alternative Investment Market ('AIM') on 22 July
2003 as well as a successful private placement immediately preceding this, which
raised £1.7 million.



In addition, development continues apace with the completion of the Phase II
double-blind, placebo controlled, escalating-dose study for MED2001 and the
signing of a global distribution agreement for CSD500 with LRC Products Limited,
(a wholly owned subsidiary of SSL International plc, the distributors of the
DurexTM brand condom range).



Company Matters - Financial update



Both Richard Drury and Amanda Staveley stepped down from the Board due to their
other business commitments and in the knowledge of the increasing workload from
Futura following our Introduction to AIM.  We would like to take this
opportunity to thank them for their contribution to the Board over the past two
years.



In their place we welcomed both Jonathan Freeman, a former director of the
stockbrokers Beeson Gregory and current partner of Gambit Corporate Finance with
over 10 years experience in corporate finance, and Andrew Slater, a former main
board director of SSL International plc with over 20 years of international
healthcare marketing experience.



We continue to focus on maintaining a tight control on expenditure. Our overall
loss for the six months ended 31 July 2003 of £966,334 includes AIM Admission
costs of £351,299 (36% of the loss). The balance of operating loss of £615,035
is broadly in line with the prior year. Overall costs continue to be within our
internal budgets.  Cash at the end of July 2003 was in excess of £2 million.



The Board recently approved a change in our financial year-end, which will now
be 31 December as opposed to 31 January.  The next set of full financial
statements will therefore be for the 11 months ending 31 December 2003.  The
next Interim statement will be for the 6 months ending 30 June 2004.





Product Development
MED2001 - EroxonTM
Treatment for Erectile Dysfunction



Following the completion of our Phase II double-blind, placebo controlled,
escalating-dose ranging study, we are pleased to report a good safety profile
for the product.



The study was conducted to the standards of Good Clinical Practice, as defined
by the International Committee on Harmonisation, by internationally renowned and
experienced investigators who had conducted previous clinical trials of other
drugs for the treatment of erectile dysfunction ('ED').  67 subjects with an
average age of 48 years and average disease duration of two years were
recruited.  All subjects were diagnosed as suffering from mild to moderate ED
(based on medically accepted diagnostic criteria) from psychogenic, organic or
'mixed' origins.



The primary purpose of this study was to assess safety on a dose-escalating
basis and we were pleased to say that MED2001 was well tolerated.  The systemic
adverse events, which were mostly mild and moderate headaches in some subjects,
were in line with expectations and suggested a dose-related response.  Local
tolerability was also good.



A secondary objective of the study was to determine if a dose related efficacy
response could be seen.  Analysis is still ongoing and, although some dose
related trends against placebo were seen, these trends did not achieve
statistical significance.  This was in part due to the large degree of inter and
intra subject variability, taken together with an unexpectedly high placebo
response of nearly 60% and the limited size of the study.  All ED studies show a
significant placebo response, typically 30%, which is partly attributed to the
psychogenic issues surrounding ED sufferers.  The mode of application of MED2001
(a cream being massaged directly onto the glans of the penis versus taking a
pill) is thought to have contributed to this unexpectedly high placebo effect.
Analyses of the efficacy data using more appropriate statistical techniques to
accommodate the large inter and intra subject variability is continuing.



The phase III clinical trial program will recruit larger patient numbers.  This
is the phase of development where we would expect to generate statistically
significant results on efficacy.  Given our experience from the Phase II study,
close attention will be given to the study design and methods of analysis to
manage the placebo response and minimise the impact on the study conclusions.



In the past few weeks, we have conducted a rigorous review of all our clinical
studies using appropriate external advisers.  In light of this review we have
recently modified our regulatory strategy to seek to license MED2001 as a
pharmacy line product rather than a prescription only medicine within the EU.
ED is understandably considered an embarrassing condition, although the
publicity surrounding the launch and promotion of ViagraTM and more recently
LevitraTM has increased public awareness and acceptability of ED.  Nevertheless
it is widely recognised that only around one in five men will go to his General
Practitioner to seek treatment for ED.  We believe that MED2001, as potentially
the first ethical 'over the counter' treatment within the EU, will considerably
help address the embarrassment problem faced by many ED sufferers.  It could
also have the added advantage of removing the issues facing many governments
over the state funding of what is considered by some to be 'lifestyle'
medication.



Our patent applications for MED2001 continue, with the patent now granted in 22
territories.



It has always been our strategy to seek distribution agreements with
pharmaceutical distributors once we are at an advanced stage of development with
a particular product, thereby maximising the potential royalty stream to the
Company.  We have been able to adopt this strategy due to the loyalty and
financial support of our shareholders.  Over the past years we have received
significant interest from a number of pharmaceutical groups interested in
distribution rights for MED2001 in some 30 different territories throughout the
world.  Until recently, we have deliberately deferred serious discussions for
the reasons already outlined, however we will be working closely with a number
of these companies over the next few months with a view to concluding
distribution agreements and finalising the necessary development work as we move
into the final stages of the completion of the MED2001 dossier.



While both pharmaceutical development and commercial negotiation can proceed
slowly, we would hope to report to shareholders further progress by the end of
the year.





CSD500  - ZanifilTM

Condom safety device



Early in the year we signed a global distribution agreement with the world's
largest branded condom manufacturer and distributor, SSL International plc
(makers of the DurexTM condom range) for the lifetime of the patents.  The
precise terms of the agreement are commercially sensitive and therefore must
remain confidential.  The non-confidential details were disclosed in our AIM
Admission document at the time of our Introduction to AIM.  We are delighted to
have signed a distribution with such a powerful brand, which should generate
significant revenue for the Company once CSD500 is licensed.



Completion of the EU dossier continues, with an anticipated submission in 2004.
The approval process in other non-EU territories will be facilitated once
approval has been given within the EU.  Nevertheless, discussions have already
commenced with the FDA and we will be working closely in collaboration with the
FDA to achieve regulatory approval within the United States.





FLD500

Female lubrication device



The protocol for a proof of concept study, largely to determine a safe and well
tolerated dose, on 10 female subjects has recently been submitted to the
necessary authorities for ethical approval.  Once this is granted, we anticipate
the study commencing at the Porterbrook clinic in Sheffield.



Conclusion



The mandate from our shareholders has always been to seek to develop and license
MED2001 and CSD500.  One of the reasons for listing Futura on AIM was to
increase the public profile of Futura in order to identify potential product
distributors and also new development opportunities.  As both CSD500 and MED2001
progress to the more advanced stage of their development, we emphasise our
continuing interest in identifying and developing other pharmaceutical drugs or
devices.  They should be related to sexual health and well-being and be able to
justify commercially  their development costs.



Finally, what has been summarised in this report does little justice to the
amount of work undertaken not only by the staff of Futura but also by our small
army of extremely professional consultants and advisers, to whom we are
extremely grateful.


          Dr William D Potter                                    James H Barder
          Non-Executive Chairman                                 Chief Executive



CONSOLIDATED PROFIT AND LOSS ACCOUNT

For the six months ended 31 July 2003


                                                            Unaudited       Unaudited         Audited
                                                           six months      six months      year ended
                                                        ended 31 July   ended 31 July      31 January 
                                                                 2003            2002            2003
                                                                    £               £               £
                                                    Notes                   

Research and development costs                              (349,942)       (369,499)       (810,754)
AIM admission costs                                   2     (351,299)               -               -
Other administrative costs                                  (265,093)       (244,826)       (485,322)
Administrative expenses                                     (616,392)       (244,826)       (485,322)

Operating loss                                              (966,334)       (614,325)     (1,296,076)
Other interest receivable and similar income                   20,290          30,081          59,534
Interest payable and similar charges                            (362)           (505)           (714)

Loss on ordinary activities before taxation                 (946,406)       (584,749)     (1,237,256)
Tax on loss on ordinary activities                    3        58,786          77,505         152,175

Loss on ordinary activities after taxation and        4     (887,620)       (507,244)     (1,085,081)
loss for the period
(Loss) per share - basic                              5         (2.1)           (1.3)           (2.7)
(Loss) per share - full diluted                       5             -               -               -



All amounts relate to continuing activities.


Statement of Total Recognised Gains and Losses


There were no recognised gains and losses in the period, or in the prior
periods, other than those passing through the profit and loss account above and
therefore no separate statement of total recognised gains and losses has been
presented.



CONSOLIDATED BALANCE SHEET

For the six months ended 31 July 2003


                                                                  Unaudited     Unaudited       Audited
                                                                    31 July       31 July    31 January
                                                                       2003          2002          2003
                                                       Notes              £             £             £

Fixed Assets
Tangible assets                                                      25,470        38,471        32,228
                                                                     25,470        38,471        32,228

Current Assets
Debtors                                                             207,128       244,590       223,151
Cash at bank and in hand                                          2,046,433     1,475,711     1,511,319
                                                                  2,253,561     1,720,301     1,734,470

Creditors: amounts falling due within one year                    (137,596)     (266,045)     (234,896)
Net current assets                                                2,115,965     1,454,256     1,499,574
Total assets less current liabilities                             2,141,435     1,492,727     1,531,802
Provision for liabilities and charges                              (37,894)      (12,416)      (12,416)
Net assets                                                        2,103,541     1,480,311     1,519,386

Capital and reserves
Called up share capital                                    6         88,051        80,724        83,194
Share premium account                                      7      5,088,345     3,006,985     3,621,427
Other reserves                                                    1,152,165     1,152,165     1,152,165
Profit and loss account                                         (4,225,020)   (2,759,563)   (3,337,400)
Equity shareholders' funds                                 8      2,103,541     1,480,311     1,519,386



CONSOLIDATED CASH FLOW STATEMENT

For the six months ended 31 July 2003


                                                           Unaudited      Unaudited           Audited
                                                          six months     six months              Year
                                                               ended          ended             ended
                                                             31 July        31 July        31 January
                                                                 2003          2002              2003
                                                                    £             £                £
                                                     Notes

Net cash outflow from operating activities             9  (1,091,880)      (658,296)      (1,265,974)

Returns on investments and servicing of finance
Interest received                                              27,284         30,081           50,888
Interest paid                                                   (362)          (505)            (714)

Net cash inflow/(outflow) from returns on                      26,922         29,576           50,174
investments and servicing of finance

Corporation Tax
Research and development tax credit received                  128,297         29,998          153,876
                                                              128,297         29,998          153,876
Capital expenditure
Payments to acquire tangible assets                                 -        (2,174)          (2,776)

Net cash outflow from capital expenditure                           -        (2,174)          (2,776)

Net cash outflow before use of liquid                       (936,661)      (600,896)      (1,064,700)
resources and financing

Management of liquid resources
(Increase) / Decrease in short term deposits          10    (404,172)        541,086          483,411

Financing
Issue of ordinary shares                                    1,700,000              -          617,500
Expenses paid in connection with share issues               (228,225)       (83,634)         (84,222)
Cash received pending share issue                                   -        117,500                -

Net cash inflow from financing                              1,471,775         33,866          533,278

Increase / (Decrease) in net cash                     10      130,942       (25,944)         (48,011)





NOTES TO THE INTERIM FINANCIAL INFORMATION

For the six months ended 31 July 2003


1.      Basis of preparation



The Interim Report was approved by the Board of Directors on 19 September 2003.



The financial information contained in this Interim Report has been prepared on
the basis of the accounting policies set out in the Group's audited accounts for
the year ended 31 January 2003.



The financial information for the six months ended 31 July 2003 and for the six
months ended 31 July 2002 is unaudited.



The financial information for the Group set out above does not constitute '
statutory accounts' within the meaning of Section 240 of the Companies Act 1985.
The information for the year ended 31 January 2003 has been extracted from the
statutory accounts of Futura Medical plc for that year which received an
unqualified audit report and has been delivered to the Registrar of Companies.



2.      Introduction to the Alternative Investment Market of the 
        London Stock Exchange



On 22 July 2003, Futura Medical plc listed by way of an Introduction to the
Alternative Investment Market of the London Stock Exchange. Exceptional costs
were incurred of £351,299 in respect of the listing and these are included with
administrative expenses contributing to the operating loss.



3.      Taxation



Taxation represents tax credits for certain research and development expenditure
based on the expenditure incurred in the relevant period or year. Deferred tax
assets have not been recognised on the basis that their future economic benefit
is not certain.



4.      Dividends



No dividends have been paid and none are proposed.



5.      Loss per ordinary share



The calculation of the loss per ordinary share is based on a loss of £887,620
(six months to 31 July 2002: loss of £507,244; year to 31 January 2003: loss of
£1,085,081) and on a weighted average of 41,731,175 shares in issue (six months
to 31 July 2002: 40,362,000 shares; year to 31 January 2003: 40,730,808 shares).



The loss attributable to ordinary shareholders and weighted average number of
ordinary shares for the purpose of calculating the diluted earnings per ordinary
share are identical to those used for basic earnings per share. This is because
the exercise of share options would have the effect of reducing the loss per
ordinary share and is therefore not dilutive under the terms of Financial
Reporting Standard 14.



6.      Share capital



On 22 July 2003 the Company issued 2,428,571 ordinary shares of 0.2 pence each
through a private placing at 70 pence each.  The shares were issued at a premium
of £1,695,143.


7.      Share premium


                                                       Unaudited        Unaudited          Audited
                                                      Six months       Six months             Year 
                                                           ended            ended            ended
                                                         31 July          31 July       31 January
                                                            2003             2002             2003
                                                               £                £                £

Opening share premium                                  3,621,427        3,018,212        3,018,212
Premium on shares issued                               1,695,143                -          615,030
Less: share issues costs                               (228,225)         (11,227)         (11,815)

Closing share premium                                  5,088,345        3,006,985        3,621,427



8.              Reconciliation of movements in shareholders' funds


                                                        Unaudited        Unaudited        Audited
                                                       Six months       Six months           Year
                                                            ended            ended          ended
                                                          31 July          31 July     31 January        
                                                             2003             2002           2003
                                                                £                £              £

Retained loss for the period                            (887,620)        (507,244)    (1,085,081)
Net proceeds from issue of shares                       1,471,775         (11,227)        605,685

Net addition/(reduction) in shareholders' funds           584,155        (518,471)      (479,396)
Opening shareholders' funds                             1,519,386        1,998,782      1,998,782

Closing shareholders' funds                             2,103,541        1,480,311      1,519,386



9.              Reconciliation of operating profit to operating cashflows


                                                       Unaudited        Unaudited        Audited
                                                      Six months       Six months           Year
                                                           ended            ended          ended
                                                         31 July          31 July     31 January
                                                            2003             2002           2003

                                                               £                £              £

Operating loss                                         (966,334)        (614,325)     (1,296,076)
Depreciation                                               6,758            6,730          13,575
Loss on sale of tangible fixed assets                          -              259             259
(Increase) in debtors                                   (60,481)         (22,116)        (28,822)
(Decrease) / Increase in creditors                      (71,823)         (28,844)          45,090

Net cash outflow from operating activities           (1,091,880)        (658,296)     (1,265,974)




10.          Reconciliation of net cash flow to movement in net funds


                                                   Unaudited       Unaudited       Audited
                                                   Six months      Six months      Year
                                                   ended           ended           ended
                                                   31 July         31 July         31 January
                                                   2003            2002             2003
                                                   £               £               £

Increase / (Decrease) in cash in the period        130,942          (25,944)        (48,011)
Cash outflow / (inflow) from changes in liquid     404,172         (541,086)       (483,411)
resources

Movement in net funds in the period                535,114         (567,030)       (531,422)
Net funds at start of period                     1,511,319         2,042,741       2,042,741

Net funds at end of period                       2,046,433         1,475,711       1,511,319




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