ReGen Therapeutics Limited – Trading Update 19th October 2012

19/10/2012

This bulletin seeks to update shareholders on the trading situation of ReGen Therapeutics Limited (RGTL’s) or (the Company) since the Trading Update given on the 22nd September 2012 in association with the publication of the Company’s accounts and prior to the General Meeting (GM)* of the Company on 22nd October.

 ColostrininTM

  • USA:

o    Metagenics have confirmed their commitment to introducing a Colostrinin combination product via the ‘professional’ channel, during the first half of 2013. For commercial reasons the nature of this combination is not being publicly disclosed but it will be launched as part of a concerted marketing push for several products in the neurological area.

o    Preliminary discussions continue with several potential USA ‘retail’ distribution companies. One is actively evaluating a combination formulation.

  • India (USV): Facilitated by our business agent there, USV are in active discussions with several major Indian companies about co-distribution of their Cognate brand Colostrinin tablets. This has the potential to significantly increase the volume of Colostrinin active ingredient sold to USV.
  • Poland (Tagerr) – Tagerr is planning to switch to RGTL tablets. Discussions are also ongoing between Tagerr and a major Polish company with regard to the company becoming a sub-distributor of RGTL tablets in Poland. This has the potential to increase sales in Poland several fold. Direct discussions are also ongoing between RGTL and the same Polish company with regard to it potentially distributing RGTL tablets in Russia and CIS countries.
  • Cyprus: RGTL bulk tablets for local blistering and packing are ready to be supplied to Golgi upon completion of regulatory formalities there. Once in production Cyprus could be a source of packed RGTL tablets to other licensees.
  • Middle East/North Africa (MENA) Countries:

o    Iran: A Distribution and Licensing Agreement (conditional to regulatory approval being achieved) has recently been signed to supply a major local company (Arian Salamat) with active ingredient for local formulation.

o    UAE/Other Countries: A draft Distribution and Licensing Agreement (conditional to regulatory approval being achieved) is currently being negotiated with a major local company.

  • Brazil: A sachet formulation of Colostrinin was launched by Micrex mid-July 2012. Launch was later than expected due to packaging problems with the local formulation.
  • It was previously announced that a UK based company (that wished to remain anonymous) was developing a Colostrinin combination product under a Material Transfer Agreement. This development continues but was delayed due to problems with the other active ingredient in the combination.
  • Argentina: Framingham has decided not to convert the Material Transfer Agreement (signed 15/12/10) into a formal License and Distribution Agreement.
  • Australasia – HealthWorld (Metagenics): Colostrinin has been discontinued due to increased regulatory demands for importing colostrum based products into Australia from the USA. Sales were not however significant as the regulatory approval only allowed limited distribution and promotion.
  • South Korea: After deciding they could not proceed with Colostrinin produced using methanol as the extraction solvent, LG Life Sciences are now re-evaluating the product based on our preliminary data showing that production of Colostrinin with ethanol is viable.
  • China: Discussions with several companies, via two different agents, have led to the conclusion that “Colostrinin is not marketable with a meaningful promotional claim in the absence of a local clinical trial”. No company there seems prepared to fund such a trial.

The Use of Zolpidem post Brain Trauma (BT):

  • No further research on the use of zolpidem in BT has been sponsored by RGTL since the demerger. Independent work has continued however, and RGTL and Drs Nel and Clauss continue to receive correspondence from individuals around the world seeking information on the use of zolpidem in BT. Many report positive benefits when it is tried. We continue to approach potential licensees. Through agents we are currently talking to a prospective licensee in India. Expenditure on the prosecution and maintenance of zolpidem patents has been significantly reduced to conserve financial resources. Being a significant expense any patent expenditure is critically reviewed against its commercial potential as patenting milestones arise.

Colostrinin-derived Peptides as Potential Pharmaceuticals:

  • No further research on this project has been sponsored by RGTL since the demerger. We continue to approach potential licensees. Expenditure on the maintenance of ‘peptide’ patents has been significantly reduced to conserve financial resources. Being a significant expense any patent expenditure is critically reviewed against its commercial potential as patenting milestones arise.

Sales Update/Future Prospects:

  • Despite initial indications to the contrary, revenue from Colostrinin sales has not improved significantly during 2012. As can be seen from the above however, there are several initiatives ongoing with existing licensees and several negotiations ongoing with new potential distributors that could significantly improve the revenue situation and move us to the point of breakeven during 2013. As ever though, accurately predicting the outcome of these initiatives and discussions and therefore when breakeven might occur remains difficult.

With the above in mind, further funding will be required to carry the Company through 2013. By definition, this needs to be in excess of that which might actually be needed to achieve profitability – both to insure against delays and ideally make this the last funding for some time. As such, the Directors continue to explore various ways of financing and developing the company with its advisers and contacts. Ways of achieving this will be discussed ‘in-principle’ at the GM on Monday 22nd October*. As soon as there is anything substantial to report in this regard further Shareholder Bulletins will be issued as appropriate.

* Please note that the above meeting will be held on Monday the 22nd October 2012 at the offices of Bird and Bird LLP, 15 Fetter Lane, London EC4A 1JP. The meeting will start at 10.30am and aim to end no later than 1pm.

The meeting is open to all shareholders of ReGen Therapeutics Limited at that date. If you intend to come to the meeting and you have not already confirmed your intention to do so please confirm by e-mail to (head.office @regentherapeutics.com)

For Further Information:

Tim Shilton, Chief Executive Officer
Norman Lott, Finance Director
44 (0)20 7153 4920