TILS.L Regulatory News (TILS)

3 Jun 2008 11:00



11am 3 June 2008

ReGen Therapeutics Plc

AGM Statement

Percy Lomax Executive Chairman of ReGen Therapeutics Plc ('ReGen' or the 'Company') highlighted the major achievements of the 2007 financial year and provided an update on significant progress made so far this year.

NUTRACEUTICALS

The key commercial event of 2007 was the launch of the Company's lead compound Colostrinin™ (branded as CogniSure™) into the professional healthcare channels of the USA, Australian and Canadian markets.

The International Division of Metagenics - ReGen's licensee for those three markets is currently trying to develop further markets. CogniSure™ has recently been test marketed in South Africa and Metagenics has also received further interest from South Korea.

Since the year-end we have signed a first licensing agreement within the European Union with Golgi Pharmaceutical Ltd of Cyprus and they have now given a firm launch date of September. 

 The Company is in active negotiations with three potential licensees in India and one in Israel and is actively pursuing further deals in Europe, China, Japan and Turkey.

In 2007 ReGen revenue from Colostrinin™ was £63,810. In the three months to the end of March 2008 the Company had received orders worth $168,000 not including royalties and stocking for Cyprus.

Since the end of the year ReGen has also had the report of a successful trial of Colostrinin™ for veterinary use. We are now actively pursuing licensing deals for this product.

PHARMACEUTICALS

In 2007 we successfully showed that 2.5mg was a non-sedating dose for zolpidem in our Phase II clinical trial in South Africa. We are applying to the UK authorities to conduct a second 'proof of concept' study in stroke patients to show that an effective and non-sedating multiple dose regimen is practical. Our intention is to license out this product if the trial is successful.

In December 2007 ReGen announced that several Colostrinin™ derived peptides had been identified for further development to a pre-clinical stage in 2009. Two such synthetic peptides may have potential utility in Alzheimer's disease and a further candidate potential utility in the management of obesity. Since the year-end further in-vitro and in-vivo work has been carried out and confirmed that yet another peptide has potential utility in the treatment of asthma.

PUBLICATIONS

There were three major scientific publications in 2007, which are set out in the Annual Report.

Since the year-end a most comprehensive review was published in the Journal of Alzheimer's Disease confirming Colostrinin's™ potential benefits in the prevention and treatment of chronic disorders relative to oxidative stress in ageing populations.*

On the 31 March an in-vivo study was published, which showed Colostrinin™ to be non-allergenic and able to prevent allergic inflammation.** This is consistent with the recent work showing that peptides within Colostrinin™ have potential utility in asthma. 

FINANCE

The Board continues to endeavour to place the business on a long-term sound financial footing and seeks the best way to exploit its intellectual property to the benefit of shareholders. To this end it is pleased to announce the appointment of Marino Capital Inc., a Californian based Investment Bank.*** Marino Capital are advising on the financing and structuring of the business and particularly utilising their extensive American and European contacts.

The Company is very pleased to have the active support of a company such as Marino Capital in these turbulent financial times. The shareholders will know that we have long looked at establishing a financial presence in the US because most of our research is there, all of our manufacturing is situated in the US and, in the long run, the US is overwhelmingly the most important market for our pharmaceutical products.

SUMMARY

I would like to thank shareholders for their continuing support over the year. I personally believe that our business is commercially stronger than at any time since our incorporation, and that for a small biotech company to get a novel compound onto the US market within just under nine years from our debut on Ofex, is a considerable achievement. We have also done this spending less than £20m. We now continue with our development and financing activities and look forward to another important year for the Company.

For further information:

Percy Lomax

ReGen Therapeutics Plc

Tel No 020 7153 4920

Roland Cornish/Felicity Geidt

Beaumont Cornish

Tel No 020 7628 3396

David Scott/Nick Bealer

Alexander David

Tel No 020 7448 9800

Adrian Duffield/Jon Davies

College Hill Associates

Tel No 020 7457 2020

Notes to Editors:

* Boldogh, I and Kruzel, M. An Oxidative Stress Modulator for Prevention and Treatment of Age-related Disorders. Journal of Alzheimer's Disease 2008;13(3):303-21.

** Boldogh, I, Aguilera-Aguirre L, Bacsi A, Choudhury BK, Saavedra-Molina A, Kruzel M. Colostrinin™ Decreases Hypersensitivity and Allergic Responses to Common Allergens, International Archives of Allergy Immunology 2008 Mar 26;146(4):298-306. This study was conducted by Dr Istvan Boldogh and Dr Marian Kruzel at the University of Texas Medical Branch, Galveston, Texas, USA. Dr Kruzel is also ReGen's Chief Scientific Consultant and Professor at the Department of Integrative Biology and Pharmacology, The University of Texas Medical School at Houston. Professor Kruzel has well-established interest and expertise in inflammation and age-related disorders.

*** Marino Capital Partners is an international investment-banking firm focused on representing companies seeking capital to accelerate the growth of their business, while providing services related to their capital needs.

We serve companies that have unique products or services, substantial growth prospects, and a seasoned management team with the vision and experience to execute on a well-conceived plan. Typically, these companies have been in business two to three years, have already had significant funding, and are seeking a second or third round of financing.

Our internal and external research resources provide us with a strong foundation for our capital raising, merger and acquisition, and corporate finance advisory activities for the benefit of our clients.

With representation in the United States, as well as in Europe, the firm's reach and resources are truly global, providing its principals with unique perspective and the opportunity to serve our clients' needs in worldwide markets.

We add value for all clients by participating in the preparation of all offering materials, including executive summaries, PowerPoint presentations, presentation binders, private placement memorandums, and supplemental due diligence documentation. Our systematic profiling and matching of an investment opportunity with our proprietary investor databases then enables us to conduct a targeted capital raising campaign. 

For further information visit www.marinocompany.com