12 Aug 2008 07:00
Financing and Commercial Update
Embargoed for 7am 12 August 2008
ReGen Therapeutics Plc
Financing
As announced by ReGen Therapeutics Plc ("ReGen" or the "Company"), (AIM: RGT) on 14 September 2005, ReGen had entered into a £2,000,000 equity credit facility agreement with Headstart Group of Funds ("Headstart") to provide a draw down of monies in exchange for shares in the Company (the "Facility").
In accordance with the terms of the Facility and pursuant to a draw down notice from the Company issued on 15 July 2008, Headstart has now subscribed for 309,598 new ordinary shares at 16.15p per share. This will provide the Company with £50,000, before expenses.
The 309,598 new ordinary shares, which will represent 2.63 per cent of the enlarged issued share capital of the Company (11,792,050 ordinary shares), will rank pari passu in all respects with the existing ordinary shares in the Company.
Application has been made to the London Stock Exchange for the new ordinary shares to be admitted to trading on AIM and dealings in the new ordinary shares are expected to commence on 15 August 2008.
Commercial Update
Colostrinin™ roll out continues
The roll out of Colostrinin™ as a nutraceutical, which has been developed to support healthy brain aging and cognition is continuing in line with the Company's expectations.
The product is already being sold (under the brand name CogniSure™) via healthcare professionals in the US and Australia through Metagenics, ReGen's licensing partner for North America. Retail opportunities in that market are also currently being explored.
At the beginning of March 2008, the Company announced its first European distribution agreement for Colostrinin™ with Golgi Pharmaceuticals Ltd of Cyprus. The European launch of the nutraceutical product under the brand name Cognase™ is now expected in September. The product is also being test marketed in South Africa and South Korea and discussions are now underway with two companies in India and other businesses in Turkey, Poland/Germany and Israel with a view to signing licensing agreements.
The Board wishes to remind shareholders that the estimated market value of the product ordered by Metagenics in the first half of the year would be approximately $2.2m (assuming it is all sold). Furthermore, whilst the main Colostrinin™ use patent expires in October 2016, we are pleased to announce that the patent, which protects our manufacturing process, has been granted and this expires in March 2024. The manufacture of Colostrinin™ is proprietary and complex so that this patent grant is of considerable commercial significance.
Scientific development
A new contract has been entered into with the University of Texas Medical Branch (UTMB) for the development of its peptides derived from Colostrinin™. The peptide programme involves in-vivo studies in Alzheimer's disease and obesity and is expected to show some initial results by the end of the year. ReGen already has indications from one global company that it is interested in the initial results on one of these peptides.
Zolpidem
In June, the Company announced that collaborators at Aston University, Birmingham UK had significantly clarified the basis of zolpidem's beneficial effects in brain injured subjects using pharmaco-magnetoencephalography (MEG) brain imaging. ReGen has filed a new patent application around this important discovery.
Following the successful completion of a Phase II trial in August 2007, which established that a 2.5mg dosage of a new sublingual formulation of zolpidem is non-sedating. ReGen has been planning a further trial in the UK to establish an effective and non-sedating multiple dose regimen to allow practical treatment for extended periods. Defining the criteria for the zolpidem trial has involved extensive consultation with outside personnel (hospital consultants) and we believe that we are close to achieving the protocol we need.
Alzheimer's Conference on September 17th
Professor Marian Kruzel, the Company's Chief Scientific Advisor will be presenting a poster reviewing how Colostrinin™ achieves its clinical effect at the first Clinical Trials in Alzheimer's Disease Conference, to be held in Montpellier, France, September 17th 2008.
Summarising the contents of his poster, Professor Kruzel said:
"In this presentation I will explain how such a low dose of Colostrinin™ can produce significant medical benefits in AD patients. I will focus on our findings from recent genomic microarray work, which shows that Colostrinin™ can favourably modulate the expression of several molecules involved in the pathology of Alzheimer's disease (upregulation of bleomycin hydrolase, downregulation of APP and effect on Tau phosphorylation). This enables the body's own multiple responses to reduce neuronal pathology and achieve homeostasis. The effect on Tau is said to be the reason for the response witnessed by the patients taking the drug Rember*. This data suggests that Colostrinin™, may be one of the first compounds with the potential to impact both Tau tangles and beta amyloid plaques, the two key pathologies of Alzheimer's disease."
Percy Lomax, Chief Executive of ReGen added:
"For a long time we have had compelling experimental and clinical data that suggest Colostrinin™ can support healthy brain aging and cognition. In discussions with potential licensing partners, investors and healthcare practitioners however, there has always been a degree of scepticism that a small dose of peptides given orally could lead to significant clinical effects. Our recent work, which shows that Colostrinin™ absorbed in the lining of the mouth triggers the production of other molecules that lead to the final outcome, should go a considerable way to removing this as an issue and lead to greater use of the product."
An abstract of the poster will be available at the conference site: www.ctad.fr after the presentation and a copy of the poster will be appended to the ReGen Website (www.regentherapeutics.com) after the presentation.
International PrimeQX
On 14 July 2008 ReGen announced that it was listing its American Depositary Receipts (ADRs) on the OTC market's prestigious tie, International PrimeQX. Pink OTC Markets Inc., is the leading electronic inter-dealer quotation system, trading technology and financial information provider for over-the-counter (OTC) securities.
Note:
* Product/trademark of TauRx
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