Financial Express (Holdings) Limited (“we”, “our”, “us” and derivatives) are committed to protecting and respecting your privacy. This Privacy Policy, together with our Terms of Use, sets out the basis on which any personal data that we collect from you, or that you provide to us, will be processed by us relating to your use of any of the below websites (“sites”).

  • FEAnalytics.com
  • FEInvest.net
  • FETransmission.com
  • Investegate.co.uk
  • Trustnet.hk
  • Trustnetoffshore.com
  • Trustnetmiddleeast.com

For the purposes of the Data Protection Act 1998, the data controller is Trustnet Limited of 2nd Floor, Golden House, 30 Great Pulteney Street, London, W1F 9NN. Our nominated representative for the purpose of this Act is Kirsty Witter.

WHAT INFORMATION DO WE COLLECT ABOUT YOU?

We collect information about you when you register with us or use any of our websites / services. Part of the registration process may include entering personal details & details of your investments.

We may collect information about your computer, including where available your operating system, browser version, domain name and IP address and details of the website that you came from, in order to improve this site.

You confirm that all information you supply is accurate.

COOKIES

In order to provide personalised services to and analyse site traffic, we may use a cookie file which is stored on your browser or the hard drive of your computer. Some of the cookies we use are essential for the sites to operate and may be used to deliver you different content, depending on the type of investor you are.

You can block cookies by activating the setting on your browser which allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies (including essential cookies) you may not be able to access all or part of our sites. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies as soon as you visit our sites.

HOW WE USE INFORMATION

We store and use information you provide as follows:

  • to present content effectively;
  • to provide you with information, products or services that you request from us or which may interest you, tailored to your specific interests, where you have consented to be contacted for such purposes;
  • to carry out our obligations arising from any contracts between you and us;
  • to enable you to participate in interactive features of our service, when you choose to do so;
  • to notify you about changes to our service;
  • to improve our content by tracking group information that describes the habits, usage, patterns and demographics of our customers.

We may also send you emails to provide information and keep you up to date with developments on our sites. It is our policy to have instructions on how to unsubscribe so that you will not receive any future e-mails. You can change your e-mail address at any time.

In order to provide support on the usage of our tools, our support team need access to all information provided in relation to the tool.

We will not disclose your name, email address or postal address or any data that could identify you to any third party without first receiving your permission.

However, you agree that we may disclose to any regulatory authority to which we are subject and to any investment exchange on which we may deal or to its related clearing house (or to investigators, inspectors or agents appointed by them), or to any person empowered to require such information by or under any legal enactment, any information they may request or require relating to you, or if relevant, any of your clients.

You agree that we may pass on information obtained under Money Laundering legislation as we consider necessary to comply with reporting requirements under such legislation.

ACCESS TO YOUR INFORMATION AND CORRECTION

We want to ensure that the personal information we hold about you is accurate and up to date. You may ask us to correct or remove information that is inaccurate.

You have the right under data protection legislation to access information held about you. If you wish to receive a copy of any personal information we hold, please write to us at 3rd Floor, Hollywood House, Church Street East, Woking, GU21 6HJ. Any access request may be subject to a fee of £10 to meet our costs in providing you with details of the information we hold about you.

WHERE WE STORE YOUR PERSONAL DATA

The data that we collect from you may be transferred to, and stored at, a destination outside the European Economic Area (“EEA”). It may be processed by staff operating outside the EEA who work for us or for one of our suppliers. Such staff may be engaged in, amongst other things, the provision of support services. By submitting your personal data, you agree to this transfer, storing and processing. We will take all steps reasonably necessary, including the use of encryption, to ensure that your data is treated securely and in accordance with this privacy policy.

Unfortunately, the transmission of information via the internet is not completely secure. Although we will do our best to protect your personal data, we cannot guarantee the security of your data transmitted to our sites; any transmission is at your own risk. You will not hold us responsible for any breach of security unless we have been negligent or in wilful default.

CHANGES TO OUR PRIVACY POLICY

Any changes we make to our privacy policy in the future will be posted on this page and, where appropriate, notified to you by e-mail.

OTHER WEBSITES

Our sites contain links to other websites. If you follow a link to any of these websites, please note that these websites have their own privacy policies and that we do not accept any responsibility or liability for these policies. Please check these policies before you submit any personal data to these websites.

CONTACT

If you want more information or have any questions or comments relating to our privacy policy please email publishing@financialexpress.net in the first instance.

 Information  X 
Enter a valid email address

Lipoxen PLC (XEN)

  Print      Mail a friend

Wednesday 30 September, 2009

Lipoxen PLC

Interim Results (Replacement)

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 £2.9m before expenses, led by cornerstone 

investor and partner, Baxter International Inc.



Turnover of £0.41 m (2008: £0.42 m)



Pre-tax loss of £1.43 m (2008: £1.96 m)



Non-cash component of total pre-tax loss £0.22 m (2008: £0.89 m)



Net cash at period end of £2.8 m (2008: £1.21 m)



Net asset value £4.3 m (2008: £4.6m)



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 £2.9m 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 £2.9 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 £2.9m. 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 UK£0.63m) and is now our third largest shareholder with an equity holding of circa 4.8%. Management contributed some £0.36m of new capital with the balance of funds (£1.91m) 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 £2.7m (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 months

Six months

Year


to 

30/06/09

to 

30/06/08

to

31/12/08


Unaudited

Unaudited

Audited


£'000

£'000

£'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:

£'000

£'000

£'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 settled


Note (1)

934

1,046

2,004

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 settled



57.3

68.1

69.5

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

London30th September 2009





CONDENSED CONSOLIDATED INCOME STATEMENT 

FOR THE SIX MONTHS ENDED 30th JUNE 2009    

                

                    



Six months

to 

30/06/09

Unaudited

Six months

to

30/06/08

Unaudited

Year

To

31/12/08

Audited




Note



£

£

£






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 HOLDERS OF THE PARENT


(1,433,040)

(1,803,758)

(3,458,287)











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



£

£

£






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 months

Six months

Year



to 

30/06/09

to 

30/06/08

to

31/12/08


Note  

Unaudited

Unaudited

Audited



£

£

£






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 equivalents  


2,194,538

(1,232,460)

(1,843,871)






Cash and cash equivalents at beginning of year


602,065

2,445,936

2,445,936






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

capital


Share premium

Reverse

Acquisition

reserve


Accumulated

losses



Total


£

£

£

£

£







At 1st January 2008

2,231,468

22,508,165

(8,252,127)

(10,151,635)

6,335,871

Loss for six months ended 30th June 2008


-


-


-


(1,803,758)


(1,803,758)

Share-based payments

-

-

-

64,270

64,270







At 30th June 2008

2,231,468

22,508,165

(8,252,127)

(11,891,123)

4,596,383

Loss for six months ended 31st December 2008


-


-


-


(1,654,529)


(1,654,529)

Shares issued for cash

1,322

628

-

-

1,950

Share-based payments

-

-

-

29,419

29,419







At 31st December 2008

2,232,790

22,508,793

(8,252,127)

(13,516,233)

2,973,223

Loss for six months ended 30th June 2009


-


-


-


(1,433,040)


(1,433,040)

Shares issued for cash

171,000

2,736,000

-

-

2,907,000

Share issue expenses

-

(162,877)

-

-

(162,877)

Share-based payments

-

-

-

5,078

5,078







At 30th June 2009

2,403,790

25,081,916

(8,252,127)

(14,944,195)

4,289,384








    

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 £2.9m 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 £2.8m 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 months

Six months

Year



to 

30/06/09

to 

30/06/08

to

31/12/08



Unaudited

Unaudited

Audited



£

£

£







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 months

Six months

Year



to 

30/06/09

to 

30/06/08

to

31/12/08



Unaudited

Unaudited

Audited



£

£

£







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 

30/06/09

to 

30/06/08

to

31/12/08



  

Unaudited

Unaudited

Audited




£

£

£








Weighted average number of ordinary shares in issue 


126,093,444

119,593,552

119,668,535














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 £75,000 (6 months to 30/06/08 - £697,257; year to 31/12/08 -£1,773,126) has been charged to the income statement in the period in respect of services provided by FDS. An amount of £236,725 (30/06/08 - £1,387,594; 31/12/08 - £311,725) 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 shares of 0.5p

Deferred shares of 0.01p

Total



Number

£

Number

£

£









At 1st January 2009

119,858,085

599,290

16,335,000,000

1,633,500

2,232,790


Shares issued for cash

34,200,000

171,000

-

-

171,000









At 30th June 2009

154,058,085

770,290

16,335,000,000

1,633,500

2,403,790
















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 £2,744,123 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 StreetLondonNW1 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
 
 
IR LMMMTMMIJBLL