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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Lipoxen | LSE:LPX | London | Ordinary Share | GB00B08NWV55 | ORD 0.5P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 7.875 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
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RNS Number : 9581Z
Lipoxen PLC
30 September 2009
+-----------------------------------------+-----------------------------------------+
| For Immediate Release | 30 September 2009 |
+-----------------------------------------+-----------------------------------------+
Due to technical formatting problems with RNS, Lipoxen's Interim Results
statement was issued with incomplete financial information. Specifically, some
figures were missing from the Condensed Consolidated Statement of Changes in Net
Equity table. The statement below contains the completed information and
replaces RNS Number: 9114Z.
Lipoxen PLC
("Lipoxen" or "the Company")
Interim Results for the six months ended 30 June 2009
London, UK - Lipoxen PLC (AIM:LPX), a bio-pharmaceutical company specialising in
the development of high value differentiated biologicals, vaccines and siRNA
delivery, is pleased to announce its interim results for the six months ended 30
June 2009.
Key Operational Highlights:
+----------+----------+----------+----------+----------------+
| | | ? | ErepoXen - a |
| | | | long-acting |
| | | | erythropoietin |
| | | | (EPO): |
+----------+----------+----------+---------------------------+
| | | | - | Successful |
| | | | | completion |
| | | | | of Phase I |
| | | | | trials |
+----------+----------+----------+----------+----------------+
| | | | - | Candidate |
| | | | | to be |
| | | | | fast |
| | | | | tracked |
| | | | | to a full |
| | | | | Phase II |
| | | | | program |
+----------+----------+----------+----------+----------------+
| | | ? | SuliXen - a long |
| | | | acting insulin: |
+----------+----------+----------+---------------------------+
| | | | - | Successful |
| | | | | completion |
| | | | | of Phase I |
| | | | | trials |
+----------+----------+----------+----------+----------------+
| | | | - | Phase II |
| | | | | trials |
| | | | | now |
| | | | | expected |
| | | | | to |
| | | | | commence |
| | | | | in |
| | | | | Russia |
| | | | | in early |
| | | | | Q4-09 |
+----------+----------+----------+----------+----------------+
| | | ? | ImuXen - platform |
| | | | liposomal |
| | | | technology |
+----------+----------+----------+---------------------------+
| | | | - | Preclinical |
| | | | | feasibility |
| | | | | project |
| | | | | agreement |
| | | | | signed with |
| | | | | the PATH |
| | | | | Malaria |
| | | | | Vaccine |
| | | | | Initiative |
| | | | | and the US |
| | | | | National |
| | | | | Institute |
| | | | | of Allergy |
| | | | | and |
| | | | | Infectious |
| | | | | Diseases to |
| | | | | stimulate |
| | | | | enhanced |
| | | | | immune |
| | | | | responses |
| | | | | against |
| | | | | malaria |
| | | | | protein |
+----------+----------+----------+----------+----------------+
| | | | - | Commencement |
| | | | | of ImuXen |
| | | | | HIV vaccine |
| | | | | formulation |
| | | | | project |
| | | | | funded by |
| | | | | the Bill and |
| | | | | Melinda |
| | | | | Gates |
| | | | | International |
| | | | | Aids Vaccine |
| | | | | Initiative in |
| | | | | Q2-09 |
+----------+----------+----------+----------+----------------+
| | | | - | New |
| | | | | Co-Delivery |
| | | | | DNA Vaccine |
| | | | | Patent |
| | | | | granted in |
| | | | | EU and US |
+----------+----------+----------+----------+----------------+
| | | ? | siRNAblate - gene |
| | | | silencing platform |
| | | | technology: |
+----------+----------+----------+---------------------------+
| | | | - | New |
| | | | | Technology |
| | | | | Evaluation |
| | | | | Agreement |
| | | | | signed |
| | | | | with |
| | | | | leading |
| | | | | global |
| | | | | pharmaceutical |
| | | | | company |
+----------+----------+----------+----------+----------------+
| | | ? | Appointed lead |
| | | | member of the grant |
| | | | consortium for its |
| | | | controlled-release |
| | | | nanoparticle |
| | | | vaccine program, |
| | | | which includes the |
| | | | Company's H1N1 |
| | | | influenza project, |
| | | | by the UK |
| | | | Government's |
| | | | Technology Strategy |
| | | | Board on 29 |
| | | | September 2009 |
+----------+----------+----------+---------------------------+
| | | ? | Dr David Moss |
| | | | appointed as |
| | | | Director of Project |
| | | | Management in |
| | | | September 2009 to |
| | | | drive forward |
| | | | Lipoxen's projects |
+----------+----------+----------+----------+----------------+
Key Financial Highlights:
+----------+----------+----------+---------------+
| | | ? | Placing |
| | | | completed |
| | | | in May |
| | | | 2009 |
| | | | raising |
| | | | GBP2.9m |
| | | | before |
| | | | expenses, |
| | | | led by |
| | | | cornerstone |
| | | | investor |
| | | | and |
| | | | partner, |
| | | | Baxter |
| | | | International |
| | | | Inc. |
+----------+----------+----------+---------------+
| | | ? | Turnover |
| | | | of |
| | | | GBP0.41 |
| | | | m (2008: |
| | | | GBP0.42 |
| | | | m) |
+----------+----------+----------+---------------+
| | | ? | Pre-tax |
| | | | loss of |
| | | | GBP1.43 |
| | | | m (2008: |
| | | | GBP1.96 |
| | | | m) |
+----------+----------+----------+---------------+
| | | ? | Non-cash |
| | | | component |
| | | | of total |
| | | | pre-tax |
| | | | loss |
| | | | GBP0.22 m |
| | | | (2008: |
| | | | GBP0.89 |
| | | | m) |
+----------+----------+----------+---------------+
| | | ? | Net cash |
| | | | at |
| | | | period |
| | | | end of |
| | | | GBP2.8 m |
| | | | (2008: |
| | | | GBP1.21 |
| | | | m) |
+----------+----------+----------+---------------+
| | | ? | Net |
| | | | asset |
| | | | value |
| | | | GBP4.3 m |
| | | | (2008: |
| | | | GBP4.6m) |
+----------+----------+----------+---------------+
| | | ? | Loss per |
| | | | share |
| | | | basic |
| | | | and |
| | | | fully |
| | | | diluted |
| | | | of 1.14 |
| | | | p (2008: |
| | | | 1.51 p) |
+----------+----------+----------+---------------+
| | | ? | Net |
| | | | asset |
| | | | value |
| | | | per |
| | | | share - |
| | | | basic |
| | | | 2.78 p |
| | | | (2008: |
| | | | 3.84 p) |
+----------+----------+----------+---------------+
| | | ? | Net |
| | | | asset |
| | | | value |
| | | | per |
| | | | share - |
| | | | fully |
| | | | diluted |
| | | | 2.69 p |
| | | | (2008: |
| | | | 3.65 p) |
+----------+----------+----------+---------------+
Commenting on the results, M. Scott Maguire, CEO of Lipoxen, said:
"Against a backdrop of very difficult economic conditions, we are delighted that
Lipoxen was able to complete a significant fundraising of GBP2.9m before
expenses. The fundraising, which was led by our cornerstone investor, Baxter
International Inc., demonstrates the confidence that our partners have in our
core technologies and their applications. Lipoxen has continued to work
successfully with, and sign new partnerships with, a number of world class
organisations, including PATH Malaria Vaccine Initiative, the US National
Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates
International Aids Vaccine Initiative.
"We look forward to delivering further tangible progress on all of our projects
and the Board remains confident that its corporate goals remain achievable in
time frames consistent with the nature of the business."
For further information:
+-------------------------------------------------+-------------------------+
| Lipoxen PLC | +44 (0)20 7691 3583 |
+-------------------------------------------------+-------------------------+
| M. Scott Maguire, Chief Executive Officer | |
+-------------------------------------------------+-------------------------+
| | |
+-------------------------------------------------+-------------------------+
| Singer Capital Markets (nominated adviser) | +44 (0)20 3205 7500 |
+-------------------------------------------------+-------------------------+
| Jeff Keating / Claes Spång | |
+-------------------------------------------------+-------------------------+
| | |
+-------------------------------------------------+-------------------------+
| Noble & Co | +44 (0)20 7763 2200 |
+-------------------------------------------------+-------------------------+
| John Llewellyn-Lloyd / Sam Reynolds | |
+-------------------------------------------------+-------------------------+
| | |
+-------------------------------------------------+-------------------------+
| Buchanan Communications | +44 (0)20 7466 5000 |
+-------------------------------------------------+-------------------------+
| Lisa Baderoon, Catherine Breen | |
+-------------------------------------------------+-------------------------+
Notes to Editors
About Lipoxen
Lipoxen plc is a biopharmaceutical company focused on the development of new and
improved biologic drugs and vaccines. Lipoxen has three proprietary patented
technology platforms:
1) PolyXen - for extending the efficacy and half life of biologic drugs
2) ImuXen - for creating new vaccines and improving existing vaccines
3) SiRNAblate - for the delivery of siRNA
Lipoxen's technology is designed to improve the efficacy, safety, stability,
biological half-life and immunologic characteristics of its products. Lipoxen
has multiple drug and vaccine programmes in development. Two products are in
clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting
erythropoietin (EPO). Lipoxen's preclinical pipeline includes vaccines against
HIV, influenza and malaria and Factor VIII through an exclusive license with
Baxter, the global healthcare company.
The Company has a low-risk business model and out-licenses its proprietary
technologies to biopharmaceutical companies that have strong manufacturing and
marketing capabilities. Lipoxen currently has commercial agreements with some of
the world's leading biotechnology and pharmaceutical companies including Baxter,
Schering-Plough, Sanofi-Aventis, the Serum Institute of India Limited,
Genentech, Amgen and Genzyme. Furthermore, Baxter led the GBP2.9 million
fundraising that the Company announced in May 2009, with a US$1 million
investment.
Lipoxen, which was founded in 1997, now trades on the AIM Market of the London
Stock Exchange under the ticker symbol LPX. More information can be found at the
Company's website: www.lipoxen.com.
CHAIRMAN'S STATEMENT
I am delighted to be able to update you on Lipoxen's progress. My last report
(5th May 2009) predated a successful fund raising completed in late-May this
year which generated gross new funds before expenses of GBP2.9m. The new capital
was raised at a price of 8.5p per share by means of a Placing led by Noble and
Company (Lipoxen's lead broker) and further supported by Singer Capital Markets
(the Company's co-broker and NOMAD). The Placing was "cornerstoned" by Baxter
International Inc. (our longest standing license partner) who invested US$1m
(circa UKGBP0.63m) and is now our third largest shareholder with an equity
holding of circa 4.8%. Management contributed some GBP0.36m of new capital with
the balance of funds (GBP1.91m) being raised from a range of City and Swedish
financial institutions. The new funds were raised against a continuing
background of financial uncertainty in the City and a degree of institutional
investor disenchantment with the AIM and small cap sector in general given the
significant liquidity issues in other than "Big Board" stocks both in the UK and
elsewhere. It is therefore a tribute to the inherent quality of Lipoxen's
technology and programs that the funding was concluded with relative ease, at a
reasonable price (as compared to some other secondary fundings at the time which
were done at very substantial discounts to prevailing market prices) and in such
a timely manner. The new capital has positioned the Company to better execute
its business plan over the upcoming 12-18 months and, while management must
continue to husband the Company's cash resources very carefully, the new capital
has made certain preferred initiatives possible to undertake sooner rather than
later.
In my most recent report I took the opportunity of offering a detailed review of
the business since its Admission to AIM in January 2006 - a period in which very
substantial positive technical development of our core patent-protected PolyXen
and ImuXen platform technologies took place. I am pleased to now update
shareholders as follows:
Baxter Factor VIII License Partner
Earlier this year the Company concluded its scope of work for the
characterisation and optimisation of this important product candidate, with
Baxter themselves taking in-house the final stage of development prior to the
targeted nomination of a Product Candidate in H1-2010. While we do not expect to
be advised of the attainment of this status until Q1/Q2 next year, we remain
confident that our PolyXen technology is meeting, and will continue to meet, the
performance targets set by Baxter such that the nomination will eventuate in the
indicated timeline.
ErepoXen (long-acting erythropoietin/"EPO")
Our EPO product candidate, which is being taken through the clinic by the Serum
Institute of India ("Serum", a circa 22% equity shareholder of Lipoxen),
successfully completed Phase I trials earlier this year as announced on 6th May
2009. While the product candidate was expected to move into a Phase II(a) trial
in India by the end of Q2-09, the Company has since been informed by Serum that
they are sufficiently satisfied with the results to date that they have decided
to move into a full Phase II program with a new CRO (Clinical Research
Organisation) in order to shorten the overall time line required to bring the
product to market in the developing world at the earliest possible date -
currently expected to be mid-2013. While, prima facie, this appears perhaps to
be a delay in the project, the reality is that it further underpins Serum's
commitment to it by their entering into the next stage of clinical trials on a
more challenging and greatly more costly basis. The Company is delighted that
our partner has taken such decision and we remain confident that our product
candidate will continue to perform well as it progresses through the clinic. The
first patient dosing on the re-based Phase II trial is expected to occur in
early January 2010 with initial results due in Q4-2010.
Serum remains the lead on the proposed Canadian Phase II(a) regulated trial but,
in consideration of their decision to proceed to more robust Indian trials they
have informed the Company that they prefer to pend the start of the Canadian
trial until they have the expected level of positive indications from their
Phase II trials in India.
Serum and FDS Pharma ("FDS", our principal shareholder with circa 28% equity
holding) have also concluded a Memorandum of Understanding under which FDS will
take the EPO candidate through a Russian Phase II trial with a view to getting
the product to market in the former Commonwealth of Independent States (CIS) in
2012. It is notable that the Russian Federation has recently announced its
decision to make such quantum of investment as is consistent with making the CIS
substantially less dependent upon imported supplies of the more expensive
biologic and vaccine drugs by making substantial monetary grants to qualifying
domestic companies with the technological capabilities required to bring forward
domestic biosimilars and vaccines. This policy has considerable potential to
enhance Lipoxen's ability to work even more closely with FDS (and its partner
CIS companies) on the development of product candidates for both biologics and
vaccines whereby new candidates can be fast-tracked through to market in a
much-shortened time period than is required for the completion of FDA/EMEA
clinical trials. We will be looking at ways to capitalise on this efficient
clinical process that would allow early and cost effective proof of concept on a
number of potential candidates.
SuliXen (long-acting insulin/"INS")
Having successfully completed Phase I clinical trials as announced by the
Company on 9th March 2009, Phase II trials of SuliXen are now expected to
commence in Russia in early Q4 this year with results due end Q3-2010/early
Q4-2010.
In conjunction with Glide Pharmaceuticals, the Company is also looking at novel
approaches for the delivery of insulin in a needle-free manner. We are also
actively analysing a broadening of the therapeutic scope of our SuliXen product
and expect to report on both of these initiatives in Q1-2010.
Vaccines (ImuXen)
On 13th May 2009, the Company announced that it had entered into a pre-clinical
project with the PATH Malaria Vaccine Initiative (PATH MVI) and the US National
Institute of Allergy and Infectious Diseases (US NIAID) to determine the ability
of Lipoxen's proprietary liposomal technology to stimulate enhanced immune
responses against malaria protein. This is an important humanitarian initiative
upon which the Company still plans to report in Q2-2010.
The further application of Lipoxen's ImuXen technology to the development of a
novel HIV vaccine formulation funded by the Bill and Melinda Gates International
Aids Vaccine Initiative (IAVI) commenced later than first expected in Q2 this
year and is now expected to report in Q1-2010. This is another potentially
important humanitarian initiative, and, while disappointing, the delay in
reporting is not viewed by the Board as material.
siRNAblate (gene silencing)
In June we were pleased to announce that the Company had entered into a new
technology evaluation agreement with an un-named Large Pharma company for the
use of Lipoxen's siRNAblate technology to evaluate the effectiveness of
combining the Pharma company's proprietary siRNA with Lipoxen's platform
technology. The aim of the collaboration is to enhance the efficacy of the
siRNA via our siRNAblate delivery. The evaluation is expected to be completed in
Q4 this year and, if successful, could lead to a full development and licensing
agreement.
The generally recognised major problem with the Nobel Prize-winning interfering
RNAi technology is the ability to deliver the RNA intact to the targeted cells.
While still at a very early stage of development, Lipoxen's siRNAblate
technology has already shown promising results in a pre-clinical trial with its
ability to overcome this otherwise rather intractable delivery issue.
Intellectual Property
The Company views the protection of its IP position as crucial to the building
of long term shareholder value and expects to invest heavily in this area as our
proprietary technologies continue through the development process.
A truly important step was achieved in June this year when Lipoxen's co-Delivery
DNA Vaccine Patent was granted in the EU and the United States. This is a core
part of the Company's IP asset portfolio and looks to the very heart of our
vaccine platform technology. We are, therefore, extremely pleased to have
attained this important milestone.
Progress with Collaborations
Our collaborations remain core to the Company's growth strategy as we seek to
expand the application of our platform technologies with Big Pharma and Big Bio.
I set out below a brief review on current collaborations:
+----------+---------------------+------------------------------------------------------------+----------+----------+
| Baxter International | Technical progress continues to be made and we hope to see the nomination of a |
| | Factor VIII lead Product Candidate in H1-2010. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| Technology Strategy Board | The Company's H1N1 Influenza product candidate was first established as a |
| | project funded by the UK Technology Strategy Board (TSB) working alongside |
| | Cambridge Biostability Limited (CBL), the UK Health Protection Agency (HPA) and |
| | Cambridge University (CUMIC). In June this year CBL was placed into a Creditors |
| | Voluntary Liquidation which placed the project in some temporary difficulty |
| | while the remaining parties worked out what best to do. I am extremely pleased |
| | to advise that the project has been reinitiated with Lipoxen as the lead and |
| | with a strong focus on our H1N1 influenza candidate. The end-point of the new |
| | project is the "Completion of protective efficacy studies with stability sample" |
| | which, although perhaps up to 12 months away, in view of the potential |
| | importance of the product, has been given a high priority such that I expect |
| | that the Company will be reporting results to the market in no more than 9 |
| | months from now. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| | While the demise of CBL has obviously resulted in some delay, with Lipoxen as |
| | the "lead" going forward, your Company is better able to dictate the speed at |
| | which this project will advance and is committed to claw back as much as |
| | possible of the past delays for which Lipoxen had neither responsibility nor |
| | control. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| Barbara Davis | This project is designed to assess whether or not Lipoxen's SuliXen product has |
| | the potential to treat, reverse or prevent the underlying causes of Type 1 |
| | diabetes. The Barbara Davis Centre of Childhood Diabetes is one of the world's |
| | leading institutes in the field whose research work is applied both to children |
| | and adults. The project has now been running for several months and is expected |
| | to report in early Q4. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| IAVI | As noted (ante) this project remains on track to report in Q1-2010. |
| | Notwithstanding that the HIV virus itself is a powerfully mutating organism |
| | which represents a serious challenge to any proposed prophylactic vaccine, the |
| | end point of the project is the efficacy of the liposomal co-delivery platform |
| | in generating efficacious levels of both cell-mediated and immune system |
| | responses. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| PATH MVI | Also previously mentioned above, and with essentially the same performance |
| | end-points as for IAVI, this program is expected to report on time in Q2-2010. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| University of Nottingham | This program, for the improved delivery of antiviral drugs for the treatment of |
| | liver disease caused by Hepatitis C is nearing completion and we remain |
| | confident of being able to report on it before the end of 2009. |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| Glide Pharmaceuticals | In collaboration with Glide, the Company is continuing to drive the development |
| | of the delivery of our long-acting insulin in Glide's needle-free injector. This |
| | unique technological combination has the potential to address a circa US$12b |
| | market. We expect to provide an update before the end of this calendar year |
+--------------------------------+----------------------------------------------------------------------------------+
| | | | | |
+----------+---------------------+------------------------------------------------------------+----------+----------+
| Angel Bioscience | The Company continues to work on the incorporation of its PolyXen technology |
| | into Angel's GCSF compound with a view to being able to generate a |
| | Polysialated-GCSF with much improved performance in the treatment for |
| | neutropenia, being the treatment of patients whose white blood cell count |
| | becomes seriously challenged pursuant to chemotherapy treatment. The Company is |
| | also looking at broadening the therapeutic application of a Polysialated-GCSF |
| | candidate and will report further in Q1-2010. |
+----------+---------------------+------------------------------------------------------------+----------+----------+
Senior Management Appointment
In September 2009, the Company engaged the services of Dr David Moss as Director
of Project Management.
Dr Moss has almost thirty years of research, development and project management
experience gained from roles in both academia and the private biotech sector.
His focus during this period has been on the development of vaccines for
veterinary and human applications. He joins Lipoxen from Cambridge Biostability
Limited (CBL) where he was Director of Research and was responsible for the
company's entire research program focused on the development of thermostable
vaccines and biopharmaceuticals. This included the Technology Strategy
Board-funded vaccine project. Prior to CBL, he was Project Manager at Intervet
UK (now Intervet Schering-Plough), a global veterinary vaccine and research and
development company.
Your Board considers this to be an important appointment as the Company engages
in more commercial contracts and seeks to further develop its proprietary
product pipeline.
Summary and Outlook
The nature of Lipoxen's business model tends towards projects which extend for
many months, or even years. It is therefore not always possible to report to
shareholders in terms other than that Lipoxen's business development strategy
continues to be executed as previously reported and that the Board remains
confident that its corporate goals remain achievable in time frames consistent
with the nature of the business.
* Our Baxter collaboration has moved to the next level and we are confident of
their being able to nominate a lead Product candidate within the next 6-9
months.
* While the PolyXen platform has seen no new product candidates entering into
clinical development in the period under review, our scientists continue to
develop the underlying IP in the extant applications, being, Baxter's Factor
VIII, and the SuliXen and EPO proprietary products. While the Company is
evaluating a large number of prospective candidates, your Board is conscious of
the need to find the shortest and most efficacious route to monetisation of the
IP and, to that end, we are committing more management resource to risk
assessment before a new project can gain approval for commencement and are
actively enhancing our project management systems for its efficient delivery
once authorised.
* Our ImuXen platform continues to generate much interest in both vaccine and
siRNA applications. The Board believes that we will bring one or more product
candidates to Phase I trials within 6-9 months, either directly or, preferably,
funded either by a sovereign government or leading commercial partner.
* The Company's cash position has been substantially strengthened through the
raising of circa GBP2.7m (net) in May by which means Management can, at the very
least, "maintain course and speed" towards the monetisation of the company's
proprietary IP which will be exemplified by the attainment of cash flow
positivity through new license transactions with Big Pharma and/or Big Bio.
Financial Review
The financial results for the Group in the period under review were:
+----------------------------------------------------+-----------+-----------+-----------+
| | Six | Six | Year |
| | months | months | |
+----------------------------------------------------+-----------+-----------+-----------+
| | to | to | to |
| | 30/06/09 | 30/06/08 | 31/12/08 |
+----------------------------------------------------+-----------+-----------+-----------+
| | Unaudited | Unaudited | Audited |
+----------------------------------------------------+-----------+-----------+-----------+
| | GBP'000 | GBP'000 | GBP'000 |
+----------------------------------------------------+-----------+-----------+-----------+
| Turnover | 411 | 416 | 1,160 |
+----------------------------------------------------+-----------+-----------+-----------+
| Total pre-tax losses for period | 1,433 | 1,962 | 3,791 |
+----------------------------------------------------+-----------+-----------+-----------+
| Non-cash component of total pre-tax loss | 217 | 894 | 2,142 |
+----------------------------------------------------+-----------+-----------+-----------+
| Net cash at end of period | 2,797 | 1,213 | 602 |
+----------------------------------------------------+-----------+-----------+-----------+
| Net asset value at the end of the period | 4,289 | 4,596 | 2,973 |
+----------------------------------------------------+-----------+-----------+-----------+
+----------------------------------------------------+------------+-----------+-----------+
| | pence | pence | pence |
+----------------------------------------------------+------------+-----------+-----------+
| Loss per share - basic and fully diluted | 1.14 | 1.51 | 2.89 |
+----------------------------------------------------+------------+-----------+-----------+
| Net asset value per share - basic | 2.78 | 3.84 | 2.48 |
+----------------------------------------------------+------------+-----------+-----------+
| Net asset value per share - fully diluted | 2.69 | 3.65 | 2.38 |
+----------------------------------------------------+------------+-----------+-----------+
+--------------------------------+---+--+---------------+------------+-----------+-----------+
| Non-cash component of total pre-tax losses: | GBP'000 | GBP'000 | GBP'000 |
+-------------------------------------------------------+------------+-----------+-----------+
| Depreciation of owned assets | 137 | 133 | 275 |
+-------------------------------------------------------+------------+-----------+-----------+
| R&D costs - equity settled | 75 | 697 | 1,773 |
+-------------------------------------------------------+------------+-----------+-----------+
| Share option expense - equity settled | 5 | 64 | 94 |
+-------------------------------------------------------+------------+-----------+-----------+
| | | | |
+-------------------------------------------------------+------------+-----------+-----------+
| Total principal non-cash items | 217 | 894 | 2,142 |
+-------------------------------------------------------+------------+-----------+-----------+
| | | | |
+-------------------------------------------------------+------------+-----------+-----------+
| | | | |
+-------------------------------------------------------+------------+-----------+-----------+
| Research and development - cash | | Note (1) | 934 | 1,046 | 2,004 |
| settled | | | | | |
+------------------------------------+--+---------------+------------+-----------+-----------+
| Other expenses - cash settled | Note (2) | 696 | 489 | 879 |
+---------------------------------------+---------------+------------+-----------+-----------+
| | | | | |
+---------------------------------------+---------------+------------+-----------+-----------+
| Total expenses - cash settled | | 1,630 | 1,535 | 2,883 |
+---------------------------------------+---------------+------------+-----------+-----------+
| Total non-cash items | | Note (3) | 217 | 894 | 2,142 |
+--------------------------------+------+---------------+------------+-----------+-----------+
| | | | | | |
+--------------------------------+------+---------------+------------+-----------+-----------+
| Total administrative expenses | | 1,847 | 2,429 | 5,025 |
+--------------------------------+----------------------+------------+-----------+-----------+
| | | | |
+-------------------------------------------------------+------------+-----------+-----------+
| | | | % | % | % |
+------------------------------------+--+---------------+------------+-----------+-----------+
| Research and development - cash | | | 57.3 | 68.1 | 69.5 |
| settled | | | | | |
+------------------------------------+--+---------------+------------+-----------+-----------+
| Other expenses - cash settled | | 42.7 | 31.9 | 30.5 |
+---------------------------------------+---------------+------------+-----------+-----------+
| | | | | |
+---------------------------------------+---------------+------------+-----------+-----------+
| Total expenses - cash settled | | 100.0 | 100.0 | 100.0 |
+---------------------------------------+---------------+------------+-----------+-----------+
| | | | |
+--------------------------------+---+--+---------------+------------+-----------+-----------+
NOTES
+----------+----------+----------------+
| 1. | The rate of |
| | expenditure in this |
| | area has been |
| | relatively constant |
| | in the last 18 |
| | months. The |
| | reduction this time |
| | is mainly comprised |
| | of a reduced level |
| | of external |
| | research costs |
| | compared to the |
| | same period in |
| | 2008. |
+----------+---------------------------+
| 2. | These costs have |
| | increased primarily |
| | due to: |
+----------+---------------------------+
| | a. | The |
| | | opening |
| | | in |
| | | January |
| | | of this |
| | | year of |
| | | the |
| | | Company's |
| | | corporate |
| | | offices |
| | | as |
| | | administration |
| | | space at the |
| | | laboratories |
| | | was no longer |
| | | adequate. |
+----------+----------+----------------+
| | b. | Increases |
| | | in audit, |
| | | legal and |
| | | regulatory |
| | | costs. |
+----------+----------+----------------+
| | c. | PR costs |
| | | associated |
| | | with the |
| | | fundraise |
| | | concluded |
| | | in May as |
| | | well as a |
| | | step |
| | | change in |
| | | the |
| | | Company's |
| | | PR-facing |
| | | activities |
| | | as we need |
| | | to better |
| | | and more |
| | | proactively |
| | | promote |
| | | both our |
| | | pre-clinical |
| | | and clinical |
| | | successes to |
| | | more |
| | | effectively |
| | | raise the |
| | | profile of |
| | | the |
| | | business. |
+----------+----------+----------------+
| 3. | The substantial |
| | reduction here |
| | reflects the |
| | reduced charge to |
| | the Income |
| | Statement relating |
| | to the SuliXen |
| | candidate which has |
| | now largely |
| | attained the |
| | milestones related |
| | to the prepaid |
| | value being written |
| | off progressively |
| | as the product |
| | candidate has |
| | advanced from |
| | pre-clinical |
| | through the |
| | successful |
| | completion of |
| | unregulated Phase I |
| | trials. The balance |
| | of the value |
| | currently held in |
| | the Balance Sheet |
| | is expected to be |
| | expensed in H2 this |
| | year as the SuliXen |
| | product enters |
| | regulated trials. |
+----------+----------+----------------+
Trading conditions in the sector remain challenging. There has been continuing
consolidation at the top end of the industry and feverish M&A lower down as some
of our small-cap competitors find that raising new cash is almost impossible and
are faced with few alternatives but to be acquired by larger companies with
stronger balance sheets. A corollary to this scenario is that, while "Big
Pharma/Bio" is awash with cash it is placing ever more demanding technical
hurdles for the smaller companies to clear before they will enter into license
discussions. The effect of this is that short term feasibility studies are not
generating the levels of cash income seen even as recently as 2008, with the
consequence that "small cap" companies such as Lipoxen are under continual
pressure, not just to make efficiency savings wherever possible (clearly a
"generally regarded as sensible" commercial stance) but to be highly cautious
about taking on new projects with high performance risk characteristics. In that
latter regard, your Company's technical offering on the PolyXen platform is
relatively low risk; the ImuXen platform for vaccine candidates (especially
for DNA co-delivery projects) currently might be characterised as having a
relatively higher risk than PolyXen, mainly by virtue of our not yet having been
able to take a new product candidate into the clinic. While the siRNA
application of our liposomal entrapment technology remains very early stage -
being entirely reasonable given the newness of the entire siRNA field - Lipoxen
has already proved in pre-clinical trials that its siRNAblate technology can be
highly effective in the knockdown of the "bad" cholesterol gene.
Our portfolio of proprietary technologies continues to attract interest from an
ever-increasing list of partners, so, once more I believe that the coming months
should deliver further tangible progress for the Company and I look forward to
updating you on our developments in my next report.
Brian Richards, CBE
Non-Executive Chairman
London: 30th September 2009
CONDENSED CONSOLIDATED INCOME STATEMENT
FOR THE SIX MONTHS ENDED 30th JUNE 2009
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | Six | Six | Year |
| | | months | months | To |
| | | to | to | 31/12/08 |
| | | 30/06/09 | 30/06/08 | Audited |
| | | Unaudited | Unaudited | |
+---------------------------------------------+-------+ + + +
| | | | | |
+---------------------------------------------+-------+ + + +
| | Note | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | GBP | GBP | GBP |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| REVENUE | 4 | 411,097 | 415,968 | 1,160,324 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| ADMINISTRATIVE EXPENSES | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Research and development expenditure | | 1,008,861 | 1,743,287 | 3,776,636 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Administrative expenses | | 838,556 | 685,529 | 1,247,817 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Total | | 1,847,417 | 2,428,816 | 5,024,453 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| OPERATING LOSS | | (1,436,320) | (2,012,848) | (3,864,129) |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Finance income | | 3,280 | 51,174 | 72,926 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Finance costs | | - | - | - |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| LOSS BEFORE TAXATION | | (1,433,040) | (1,961,674) | (3,791,203) |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Income tax credit | | - | 157,916 | 332,916 |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| LOSS FOR THE YEAR ATTRIBUTABLE TO EQUITY | | (1,433,040) | (1,803,758) | (3,458,287) |
| HOLDERS OF THE PARENT | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
| Loss per share - basic and fully diluted | 6 | (1.14)p | (1.51)p | (2.89)p |
+---------------------------------------------+-------+-------------+-------------+-------------+
| | | | | |
+---------------------------------------------+-------+-------------+-------------+-------------+
CONDENSED CONSOLIDATED BALANCE SHEET AS AT 30th JUNE 2009
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | As at | As at | As at |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | 30/06/09 | 30/06/08 | 31/12/08 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | Note | Unaudited | Unaudited | Audited |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | GBP | GBP | GBP |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| NON-CURRENT ASSETS | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Property, plant and equipment | | 548,864 | 769,586 | 665,972 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Goodwill | | 1,061,476 | 1,061,476 | 1,061,476 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | 1,610,340 | 1,831,062 | 1,727,448 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| CURRENT ASSETS | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Trade and other receivables | 7 | 468,740 | 1,764,324 | 1,118,559 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Cash and cash equivalents | | 2,796,603 | 1,213,476 | 602,065 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | 3,265,343 | 2,977,800 | 1,720,624 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| CURRENT LIABILITIES | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Trade and other payables | | (586,299) | (212,479) | (474,849) |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| NET CURRENT ASSETS | | 2,679,044 | 2,765,321 | 1,245,775 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| NET ASSETS | | 4,289,384 | 4,596,383 | 2,973,223 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| EQUITY ATTRIBUTABLE TO EQUITY | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| HOLDERS OF THE PARENT | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Share capital | 8 | 2,403,790 | 2,231,468 | 2,232,790 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Share premium account | | 25,081,916 | 22,508,165 | 22,508,793 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Reverse acquisition reserve | | (8,252,127) | (8,252,127) | (8,252,127) |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Accumulated losses | | (14,944,195) | (11,891,123) | (13,516,233) |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| TOTAL EQUITY | | 4,289,384 | 4,596,383 | 2,973,223 |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Net assets per share - basic | 9 | 2.78p | 3.84p | 2.48p |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
| Net assets per share - fully diluted | 9 | 2.69p | 3.65p | 2.38p |
+---------------------------------------------+-------+--------------+--------------+--------------+
| | | | | |
+---------------------------------------------+-------+--------------+--------------+--------------+
CONDENSED CONSOLIDATED CASH FLOW STATEMENT
FOR THE SIX MONTHS TO 30th JUNE 2009
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | Six | Six | Year |
| | | months | months | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | to | to | to |
| | | 30/06/09 | 30/06/08 | 31/12/08 |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | Note | Unaudited | Unaudited | Audited |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | GBP | GBP | GBP |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Cash flows from operating activities | 5 | (532,961) | (1,405,932) | (2,177,421) |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Interest received | | 3,280 | 51,174 | 72,926 |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Taxation received | | - | 157,916 | 332,916 |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Net cash outflow from operating activities | | (529,681) | (1,196,842) | (1,771,579) |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Cash flows from investing activities | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Purchase of property, plant and equipment | | (19,904) | (35,618) | (74,242) |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Cash flows from financing activities | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Issue of equity share capital | | 2,744,123 | - | 1,950 |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Net increase/(decrease) in cash and cash | | 2,194,538 | (1,232,460) | (1,843,871) |
| equivalents | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Cash and cash equivalents at beginning of | | 602,065 | 2,445,936 | 2,445,936 |
| year | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| Cash and cash equivalents at end of year | | 2,796,603 | 1,213,476 | 602,065 |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
| | | | | |
+----------------------------------------------+-------+-----------+-------------+-------------+
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN NET EQUITY
FOR THE SIX MONTHS TO 30th JUNE 2009
+-------------+-------------+-------------+-------------+---------------+--------------+
| | Share | Share | Reverse | Accumulated | Total |
| | capital | premium | Acquisition | losses | |
| | | | reserve | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | GBP | GBP | GBP | GBP | GBP |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| At 1st | 2,231,468 | 22,508,165 | (8,252,127) | (10,151,635) | 6,335,871 |
| January | | | | | |
| 2008 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Loss for | - | - | - | (1,803,758) | (1,803,758) |
| six | | | | | |
| months | | | | | |
| ended | | | | | |
| 30th | | | | | |
| June | | | | | |
| 2008 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Share-based | - | - | - | 64,270 | 64,270 |
| payments | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| At 30th | 2,231,468 | 22,508,165 | (8,252,127) | (11,891,123) | 4,596,383 |
| June | | | | | |
| 2008 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Loss for | - | - | - | (1,654,529) | (1,654,529) |
| six | | | | | |
| months | | | | | |
| ended | | | | | |
| 31st | | | | | |
| December | | | | | |
| 2008 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Shares | 1,322 | 628 | - | - | 1,950 |
| issued | | | | | |
| for cash | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Share-based | - | - | - | 29,419 | 29,419 |
| payments | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| At 31st | 2,232,790 | 22,508,793 | (8,252,127) | (13,516,233) | 2,973,223 |
| December | | | | | |
| 2008 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Loss for | - | - | - | (1,433,040) | (1,433,040) |
| six | | | | | |
| months | | | | | |
| ended | | | | | |
| 30th | | | | | |
| June | | | | | |
| 2009 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Shares | 171,000 | 2,736,000 | - | - | 2,907,000 |
| issued | | | | | |
| for cash | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Share | - | (162,877) | - | - | (162,877) |
| issue | | | | | |
| expenses | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| Share-based | - | - | - | 5,078 | 5,078 |
| payments | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| At 30th | 2,403,790 | 25,081,916 | (8,252,127) | (14,944,195) | 4,289,384 |
| June | | | | | |
| 2009 | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
| | | | | | |
+-------------+-------------+-------------+-------------+---------------+--------------+
LIPOXEN PLC
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS TO 30th JUNE 2009
+---+------+------+----------+------------------------------------------------------------------------------+
| 1. | GENERAL INFORMATION |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | The interim financial statements for the six months ended 30th June 2009 are unaudited and |
| | were approved by the Directors of the Company on 30th September 2009. The condensed financial |
| | information set out above does not constitute statutory accounts within the meaning of Section |
| | 434 of the Companies Act 2006. The comparative figures for the year ended 31st December 2008 |
| | were derived from the statutory accounts for that year which have been delivered to the |
| | Registrar of Companies. Those accounts received an unqualified audit report, which included a |
| | reference by way of emphasis without qualifying the report to the preparation of the accounts |
| | on the going concern basis of accounting. The audit report contained no statements under |
| | sections 237(2) or (3) (accounting records or returns inadequate, accounts not agreeing with |
| | records and returns, or failure to obtain necessary information and explanations) of the |
| | Companies Act 1985. |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | The financial information has been prepared in accordance with the accounting policies set out |
| | below. The accounts are drawn up in compliance with IAS 34 "Interim Financial Reporting". |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| 2. | ACCOUNTING POLICIES |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | The principal accounting policies of the Group have remained unchanged from those set out in |
| | the Group's 2008 financial statements. |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | Fundamental accounting concept - going concern |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | As an early-stage development life sciences business, the Group has incurred operating losses |
| | in the period under review, notwithstanding that substantial clinical and technical progress |
| | was also made in the continuing successful development of its proprietary technologies; |
| | consequently, the Group was a net consumer of cash. |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | In order to maintain the level of scientific effort required to develop the Group's |
| | technologies and to commercialise them to such degree as will be necessary to become a |
| | cash-generative business, the Group will need to access new cash in addition to that available |
| | to it at the period end; such new cash will either be generated internally from, as yet, |
| | non-contractual feasibility and licensing sources and/or from the raising of new capital. |
+----------+------------------------------------------------------------------------------------------------+
| | |
+----------+------------------------------------------------------------------------------------------------+
| | The Directors have prepared a financial forecast for the period through to 31st December 2011. |
| | The forecast includes assumptions that the Group will generate cash inflows in this period |
| | from: |
+----------+------------------------------------------------------------------------------------------------+
| | | a. | the ongoing roll-out and licensing of the Group's technologies with its |
| | | | existing collaborative partners; |
+---+-------------+----------+------------------------------------------------------------------------------+
| | | b. | the roll-out and licensing of the Group's technologies with new |
| | | | collaborative partners; and |
+---+-------------+----------+------------------------------------------------------------------------------+
| | | c. | the raising of new capital. |
+---+------+------+----------+------------------------------------------------------------------------------+
+-----+---+---+-----------------+---------+---+---+---+---+---+---+-----+---+---+---+---+---+---+-----+-------+---+
| | In May 2009 the Company successfully raised new capital of GBP2.9m before expenses - |
| | notwithstanding continuing uncertainties in the capital markets (given the ongoing |
| | global financial difficulties) especially for small cap companies. The Board was very |
| | much encouraged by that success which they consider as a positive endorsement of their |
| | underlying confidence in the economic prospects for monetisation of the Company's core |
| | IP in protein drug development, novel vaccines and gene silencing technologies; that |
| | said, markets remain volatile and, should it prove necessary, the Company's ability to |
| | raise further new capital will remain dependent upon prevailing market conditions at |
| | the time. |
| | While considering that platform technology applications to known and marketed drugs |
| | confer lower commercial risks than in new drug development, the Directors recognise |
| | that there are uncertainties surrounding these core issues. |
| | If the Group was to prove unable to generate these additional cash inflows, the cash |
| | balance of circa GBP2.8m as at 30th June 2009 would be insufficient to fund the Group's |
| | activities at their current level for a period of twelve months from the date of |
| | approval of these interim financial statements. |
| | However, the Directors have a reasonable expectation that these uncertainties can be |
| | managed to successful outcomes, and that, based on such assessment, the Group will have |
| | adequate resources to continue in operational existence for the foreseeable future. |
| | They have therefore prepared the financial information contained herein on a going |
| | concern basis. |
| | The financial information does not reflect any adjustments that would be required to be |
| | made if they were to be prepared on a basis other than the going concern basis. |
| | New accounting standards materially affecting the Group |
| | -IFRS 8: Operating segments |
| | This is mandatory for accounting periods beginning on or after 1st January 2009, and |
| | requires entities to adopt a 'management approach' to report on the financial |
| | performance of their operating segments. The information to be reported is that which |
| | management uses internally for allocating resources to operating segments. As a result, |
| | the Group has identified that it has one operating segment, the development of drug and |
| | vaccine delivery systems and proprietary products in the fields of protein drugs, |
| | vaccines and oncology, consistent with the business segment identified under IAS 14 in |
| | the 2008 Annual Report. No changes to disclosure requirements for the Interim Report |
| | arose on adoption of IFRS 8. |
| | -IAS 1 (Revised): Presentation of Financial Statements |
| | This is mandatory for accounting periods beginning on or after 1st January 2009, and |
| | requires the presentation of either one statement (a statement of comprehensive income) |
| | or two statements (a separate income statement and a statement of comprehensive income) |
| | which will include those changes in equity which arise other than from transactions |
| | with shareholders in their capacity as shareholders. |
+-----+-------------------------------------------------------------------------------------------------------+
| 3. | SEGMENTAL ANALYSIS |
+-----+-------------------------------------------------------------------------------------------------------+
| | |
+-----+-------------------------------------------------------------------------------------------------------+
| | The revenue and loss before tax are attributable to the one principal activity of the |
| | Group. The net assets of the Group at 30th June 2009, 31st December 2008 and 30th June |
| | 2008 are wholly attributable to the principal activity. The Group comprises one |
| | business segment for reporting purposes. |
+-----+-------------------------------------------------------------------------------------------------------+
| | |
+-----+-------------------------------------------------------------------------------------------------------+
| 4. | REVENUE |
+-----+-------------------------------------------------------------------------------------------------------+
| | |
+-----+-------------------------------------------------------------------------------------------------------+
| | An analysis of revenue (by location of customer) is given below: |
+-----+-------------------------------------------------------------------------------------------------------+
| | | Six | Six months | Year |
| | | months | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | to | to | to |
| | | 30/06/09 | 30/06/08 | 31/12/08 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | Unaudited | Unaudited | Audited |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | GBP | GBP | GBP |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | United States | 262,149 | 339,790 | 1,060,636 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Europe | 148,948 | 76,178 | 99,688 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | 411,097 | 415,968 | 1,160,324 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| 5. | RECONCILIATION OF LOSS BEFORE TAXATION TO |
+-----+---------------------------------------------------------------------------------+
| | CASH OUTFLOWS FROM OPERATING ACTIVITIES |
+-----+---------------------------------------------------------------------------------+
| | | Six | Six months | Year |
| | | months | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | to | to | to |
| | | 30/06/09 | 30/06/08 | 31/12/08 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | Unaudited | Unaudited | Audited |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | GBP | GBP | GBP |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Loss before taxation | (1,433,040) | (1,961,674) | (3,791,203) |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Adjustments for: | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Equity-settled share options | 5,078 | 64,270 | 93,689 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Equity-settled research and development | 75,000 | 697,257 | 1,773,126 |
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Depreciation | 137,012 | 132,584 | 274,822 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Investment income | (3,280) | (51,174) | (72,926) |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | (1,219,230) | (1,118,737) | (1,722,492) |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Decrease/(increase) in receivables | 574,819 | (205,941) | (636,045) |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Increase/(decrease) in payables | 111,450 | (81,254) | 181,116 |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | Net cash outflow from operating activities | (532,961) | (1,405,932) | (2,177,421) |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| | | | | |
+-----+-----------------------------------------------------------+-------------+---------------+-----------------+
| 6. | LOSS PER SHARE |
+-------------+-----------------------------------------------+
| | | | Six months | Six months | Year |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | to | to | to |
| | | | 30/06/09 | 30/06/08 | 31/12/08 |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | Unaudited | Unaudited | Audited |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | GBP | GBP | GBP |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | Weighted average number of | | 126,093,444 | 119,593,552 | 119,668,535 |
| | ordinary shares in issue | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | Loss after taxation | | 1,433,040 | 1,803,758 | 3,458,287 |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | Loss per share | | 1.14p | 1.51p | 2.89p |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | | | | | |
+-------------+-----------------------------------+---+---------------------+-------------------+-----------------+
| | There is no dilutive effect of share options on |
| | the basic loss per share. |
+-------------+---------------------------------------------------------+
| | |
+-------------+-----------------------------------------------------------------------------------------------+
| 7. | OTHER RECEIVABLES |
+-------------+-----------------------------------------------------------------------------------------------+
| | |
+-------------+-----------------------------------------------------------------------------------------------+
| | In October 2005, Lipoxen Technologies Limited entered into an agreement with |
| | its then major shareholder, FDS Pharma Ass ('FDS'), under which 15,000,000 |
| | ordinary shares were allotted in consideration for the provision by FDS of |
| | manufacturing and clinical development services. As per a Novation Agreement |
| | between FDS, Lipoxen Technologies Limited and the Company dated 16th January |
| | 2006, the agreement provides for the allotment of up to 10,174,340 ordinary |
| | shares in Lipoxen Plc upon achievement of certain future milestones to the |
| | financial value of US$2,670,764 as approved by shareholders at the |
| | Extraordinary General Meeting of the Company held on 16th January 2006. An |
| | amount of GBP75,000 (6 months to 30/06/08 - GBP697,257; year to 31/12/08 |
| | -GBP1,773,126) has been charged to the income statement in the period in |
| | respect of services provided by FDS. An amount of GBP236,725 (30/06/08 - |
| | GBP1,387,594; 31/12/08 - GBP311,725) is included in the balance sheet under |
| | other receivables in respect of services still to be provided under the |
| | agreement, which are expected to be provided within one year from the balance |
| | sheet date. |
+-------------+-----------------------------------------------------------------------------------------------+
| | |
+-------------+-----------------------------------------------------------------------------------------------+
| 8. | SHARE CAPITAL |
+-------------+-----------------------------------------------------------------------------+
| | |
+-------------+-----------------------------------------------------------------------------+
| | The changes in the Company's issued share capital in the period |
| | have been as follows: |
+-------------+-----------------------------------------------------------------------------+
| | |
+-------------+-----------------------------------------------------------------------------+
| | | Ordinary | Deferred shares of 0.01p | Total |
| | | shares of | | |
| | | 0.5p | | |
+-------------+---------------------------+---------------+-------------------------------------------+-----------+
| | | Number | GBP | Number | GBP | GBP |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | At 1st January | 119,858,085 | 599,290 | 16,335,000,000 | 1,633,500 | 2,232,790 |
| | 2009 | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | Shares issued | 34,200,000 | 171,000 | - | - | 171,000 |
| | for cash | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | At 30th June | 154,058,085 | 770,290 | 16,335,000,000 | 1,633,500 | 2,403,790 |
| | 2009 | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | | | | | | |
+-------------+-----------------+-------------+-----------+-------------------------+-----------------+-----------+
| | In May 2009, the Company issued 34,200,000 ordinary shares by way of a placing. The |
| | shares were priced at 8.5p per share and raised GBP2,744,123 net of expenses |
+---------+---------------------------------------------------------------------------------------------------+
| | |
+---------+---------------------------------------------------------------------------------------------------+
| 9. | NET ASSET VALUE PER SHARE |
+---------+---------------------------------------------------------------------------------------------------+
| | |
+---------+---------------------------------------------------------------------------------------------------+
| | The "basic" net asset value per share figures are calculated on the basis of the |
| | net assets attributable to equity shareholders divided by the number of ordinary |
| | shares in issue at the relevant dates. |
+---------+---------------------------------------------------------------------------------------------------+
| | |
+---------+---------------------------------------------------------------------------------------------------+
| | The "fully diluted" net assets per share figures are calculated by adjusting the |
| | number of ordinary shares on the assumption of the exercise in full of all options |
| | and warrant instruments extant as at the relevant dates where the exercise price of |
| | any such instrument is less than the "basic" net asset value per s hare. |
| | |
+---------+---------------------------------------------------------------------------------------------------+
| 10. | Copies of the interim report are available to the public free of charge from the |
| | Company at London Bioscience Innovation Centre, 2 Royal College Street, London, NW1 |
| | 0NH during normal office hours, Saturdays and Sundays excepted, for 14 days from |
| | today. |
+-----+---+---+-----------------+---------+---+---+---+---+---+---+-----+---+---+---+---+---+---+-----+-------+---+
This information is provided by RNS
The company news service from the London Stock Exchange
END
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