http://www.regentherapeutics.com/regen

Consider a company with a market cap of around 10 million which could well in the future be generating revenue well in excess of that figure every year. Interested then read on and DYOR on Regen Therapeutics.

For some time now I have been a shareholder of RGT who have been working with a patented product Colostrinin as a treatment for Alzheimers. Tests so far would seem to indicate that it is a success and they are currently refining a pharmaceutical product.

Meantime they are also pushing forward on the nutraceutical front as tests have shown positive results in respect of mild cognitive disorders (memory loss etc). Further research is being carried out regarding other major illnesses. As at mid 2007 a launch is scheduled in the US for Q4 and there are rumours of an earlier launch in Australia possibly imminent based on the fact that adverts are already starting to appear see:- http://www.quantumevolution.com.au/oscommerce/index.php

They have also acquired a contract research organisation which should mean that research money for clinical trials that had previously been spent will now be kept inside the group.

February 2006 has seen Regen acquire the rights, following a feasibility study, in respect of other uses for a well known drug (Zolpidem) that has undergone phase 2 clinical trials where results are expected around August 2007. The new use relates to the positive effects that have been seen when treating stroke victims with the drug. There has been a lot of press interest which a web search should reveal.

An interview with the chairman (Percy Lomax) in the summer of 2004 talked of a nutraceutical product producing royalty payments of 10% on a possible 100 million sales per annum. The pharmaceutical version which also requires a licensing partner will if successful have projected sales of 1-5 billion again which would generate royalty payments to Regen. I leave you to contemplate just how high the share price would be if this were the case but suffice to say it will be many many times what it is now.

Acquisition (Oct 2004) of Guildford Clinical Pharmacology unit demonstrates not only that they are progressive and expanding but also thinking strategically for GCPUL being a research based company no doubt Regen can now keep such costs within the group whereas before testing had to be paid for elsewhere. This acquisition also means that they have revenue and are therefore no longer a "virtual" company.

A share issue in July 2007 means that they should now have funds in hand to take them through to cash generation. Hopefully this means we have seen the last of the issues excepting any used by way of acquiring profitable companies.

The North America link is an interesting one as perhaps in readiness for the launch of Colostrinin out there Regen set up an ADR programme which became effective in March 2005. ADR's ( American Depositary Receipts) are a way for US investors to buy shares in UK companies. In Regen's case one ADR is equivalent to 200 Regen UK shares so when an ADR is purhased the Bank of New York will buy the proportionate number of UK shares and convert them into ADR's for the investor. At present this is not a factor however with the launch of Colostrinin out there if successful it may mean that US investors will want to be involved in the company and that will have a direct positive impact on our share price. In the US Colostrum (from which Colostrinin is produced )is already a recognised and popular health product and so demand should be good.

So all in all exciting times ahead. There can be few shares around that offer the potential of this one although as always DYOR and good luck with your investments whatever you decide here.

i take it everything we read on ADVFN is to be taken with a pinch of salt?? from being hugely bullish they have IMO turned somewhat bearish. I am not selling this till at least 5p where i will re assess the situation.

License agreement announced today with US neutraceutical developer, Metagenics, to commercialise Colostrinin.

good time to top up. low spread, good news, multibagger very soon .

More good news. CLN has Anti cancer and anti ageing properties. Should be a whole host of news to come with start of Zolpidem phase 2 trials, results of tox and GMP whilst all the time we draw closer to actual nutra sales via Metagenics. Need to see any overhang cleared from the issues and then we can see the positive effect of this news as it comes. Have a good long weekend everyone.

up again this morning

Still chugging along then!

ReGen Therapeutics says first-half sales figures are 55,000, reflecting what the company called 'the start of a healthy upturn in business.'

Turnover for the first two months of the second half of the year was 159,000, and the directors said that the current external pipeline looking forward is around 750,000.

The company said it now has over 1.2m of cash in the bank, taking into account its placing in July, which raised 1.1m gross.

Hi all

Just got back from the EGM. Great shame there were such a few shareholders there as we got the chance to ask questions for around an hour. I think there were only about 5 or 6 holders and as far as Im aware only myself and Asmodeus from the boards. Peter Garrod wasnt there nor was Tim Shilton. Tim is doing the rounds of Sterling, Metagenics etc. Most other Directors were there and also Malcolm Beveridge who some may recall resigned as a Director a while back for personal reasons but it seems is still holding his shares which I found encouraging

So I will attempt to address things in turn.

Firstly there was great disappointment that I had not logged onto the Regen website this morning for after all my moaning at them they have now updated it. I cant see any other reference here to the new look so it seems no one else has noticed but it is much more informative on the home page now which will be a great help to new investors doing their research so well done to Martin Small.

Nutra.

The good news is that it is still on target for sales in the US in H1 2007. The other good news is that it would seem that the reason we have not seen financial details and will not see them is because Metagenics are a private company and the intimation was that the deal is a good one so would not be in Metagenics interest to publicise it. When talking to the room about Zolpidem, PL was giving an example of figures and saying that even if the Regen percentage were as low as say 5% etc etc and then went on to say that the nutra deal was significantly higher so it would seem that the Finn indication of 10%+ is probably correct. I also clarified the fact that the manufacturing cut would be payable at the start, basically cash on delivery. Royalties I assume would however result from actual sales.

After much badgering it became apparent that tox tests & GMP only actually started about a month ago. Regen had apparently submitted all they needed but the hold up was in the US so there has not been a hiccup with the tests just that they started later than envisaged but this will not hold anything up. They still envisage no problems in this area.

Questioning about the Express article the other day PL said that they were in talks with a number of possible European partners, most of which were talking in terms of food supplements. It gave the impression that we could see different types of deal, one in this food additive respect and one more in the tablet form like Metagenics. He pointed out that it can take a while from a contract being on the table to it actually being signed as was the case with Metagenics. It would not surprise me if they were around the sort of table stage with at least one possible partner based on his use of this analogy.

Zolpidem

Trials will start in November. They have now got a contract for a documentary with a TV company and this will start filming in November and will be shown on Discovery Channel next year. This PL feels will be great timing as it is envisaged that results from the trials will be out in Q1 next year as well. They are confident that the trials will be successful as they are to be on known Zolpidem responders. The key aspect of the trials are whether they can reduce the sedation effect.

They have various agreements in place in terms of the delivery system (spray) etc and the market estimate is based on $1 a day for treatment. They fully expect to be able to license this out to a larger company at an early stage and seem happy enough about the patent situation.

CLN Pharma.

I get the impression we are barking up the wrong tree thinking about imminent deals here. They are indeed progressing with work on the petides and one has been successful in respect of Parkinsons but the indication was that we would not hear more in this area until next year as they push on to identify others.

Money

It was again reiterated that they do not intend to do an issue at the present time. When reading out the resolutions PL seemed to hesitate after saying pursuant to any fundraising just before saying and/ or business acquisitions. It has to be said that I was perhaps listening attentively at this point so perhaps his hesitation was more apparent to me.

I did take the opportunity to seek clarification as to why we were sitting at an EGM granting authority to possibly issue shares if they were not looking to raise funds and whether this meant that they were currently looking at acquisition/s. With verbal dexterity I did not get a clear answer. Bearing in mind the statement this morning which said no shares were to be issued for the time being to raise funds I then asked whether it would be possible for them to acquire a company in a paper transaction and if so would this technically not be issuing shares to raise funds? I very much gained the impression that this could be the case but there was no clear answer which didnt really surprise me if they had something in their sights. The easiest answer would have been no if there was no possible acquisition but there was no negative indication.

An interesting thing was that there were 2 people there who were working on raising awareness of the company, one in the US and one in Europe. I spoke to the Europe chap and gather that he has the task of getting institutional buyers. He said the main problem at the moment is that they want to see actual revenue so as the nutra money starts to come in this will be much easier. He also said that most of these companies are looking to invest a minimum of say 500,000 which is virtually impossible with a market cap of 7 million so again as the share price goes up and the Market cap grows this will be easier. There was talk about a possible institutional buyer (could have been Swiss) although I didnt quite catch whether they had bought yet or were going to perhaps Asmodeus got the info.

ADRs

This was raised in the meeting. The facility was set up by the Bank of New York and the impression gained was that it was perhaps set up by Regen more as a possible vehicle for acquisition of US companies than for trading. I pointed out that it didnt seem possible to trade them anyway and PL said he couldnt discuss it there but we would hear something soon in this respect.

Pet nutra

Sorry forgot all about this one but the impression I have gained before is that whilst this is on the to do list it is not a great revenue generator so they have more important areas on which to focus funds at present.

Final Thoughts

The overwhelming indication was that the company are very disappointed by the share price but very excited by future prospects and a number of times it was commented that they would expect to be self sustaining by 2008 possibly before depending on a Zolpidem licensing deal.

As I say there were handful of holders there and between us we asked numerous questions, sought clarification, moaned etc. Asmodeus had quite a lot of notes so will be able to fill in any gaps.

We did have a good moan about PR. I cited HML as an example of how to orchestrate PR leading up to a deal with numerous announcements of were getting closer and closer and yet closer and even now they have not yet actually said theyve signed a deal and yet their share price has gone up about 500% during this process. Regen who actually have sigend a deal seemed to throw out an RNS on a Thursday which was not particularly inspiring followed by a rushed GCPL one and our price then went down. They did seem to accept our comments although did point out that Zolpidem newspaper coverage had been good.

Another holder who was with Asmodeus had lots of great question and really gave the Directors a grilling over why they did not seem to show much faith in terms of their personal investment in the company. PL tried to defend this by saying that they dont get paid that much and they also have their employment based on the success of the company. This holder took no prisoners and said this wasnt much of a defence and he would like to see them having a bit more of a financial stake if they really are as confident as they make out. It was a point well made and would be great if we did see it acted upon as Im sure if we saw a couple of announcements about Director buying outside of share placements it would be positively received by the market.

There you have it. The market obviously hasnt made much of the interims but we have GCPL income increasing, news to come of the start of Zolpidem trials in November and perhaps about the documentary, the launch of the nutra getting nearer, people actively working on increasing awareness in Europe and the US, hopefully the sorting of the ADR facility, possible other deals to come in Europe on the nutra and longer term news on the CLN peptides. Furthermore we wait to see what why this authority was needed today when they are not looking to raise funds at this time. So theres a lot more to come.

As always, posted in good faith and as accurately as memory allows!

Gantenbrink - fantastic post. Many thanks for your time and effort. Sounds pretty good on the whole to me. A waiting game but then all good things.....

anyone know whats happening?

Rumour Maxtor, just rumour, apparently the Express says this:-

"Regen therapeutics was steady at 1.02p yesterday amid ongoing chatter that a European licensing deal was due in the next six weeks. There is also thought to be takeover interest from overseas pharma companies, and talk of a tie-up with Eirx Therapeutics, unchanged at .29p"

Not saying that it is unfounded but, at present it is just another rumour.
kim

cheers kim.

Smoke, fire? I'd be happier if the report had been in the FT rather than the Express though.....

Lots of media coverage about Zolpidem today after a UK judge refused a family's request in a right to die case where a lady is in PVS until such time as she has tried Zolpidem. Percy Lomax was on radio 4 this morning and Radio Five Live this afternoon.

There was press coverage in the Guardian and Mail as well as on the BBC website.

All in all good news for Regen if they are able to capitalise on this coverage by ensuring that Zolpidem is continually linked to Regen as a number of articles have appeared without mention of Regen. This will come down to Regens PR which to date hasn't been great but hopefully this is an area which they are improving.

I understand that the phase 2 trials are about to start in S. Africa so if they can get that announcement out now whilst there is the media interest that would be great timing and should attract some new investment as so far there is nothing in the current SP to reflect the potential of this drug.

ReGen Therapeutics PLC
07 December 2006



ReGen Starts South African Zolpidem Clinical Study in Brain Damage Conditions


After approval by the South African regulatory agency, ReGen Therapeutics Plc
('ReGen' or 'the Company') has today announced that it has started dosing
subjects in a clinical study designed to explore the effects of zolpidem in
people who have suffered brain damage.


A significant body of 'open' clinical case observations has shown that zolpidem,
a long-established drug currently marketed for the treatment of insomnia, can
normalise areas of brain dormancy secondary to a primary lesion in brain damage
conditions e.g. stroke, traumatic brain injury, vascular dementia and Bell's
palsy.


The study is a double-blind, Phase IIa 'clinical proof of concept' study in
known zolpidem responders being performed in collaboration with ReGen's
subsidiary, Guildford Clinical Pharmacology Unit Ltd., UK and investigators at
the Walko Medical Centre in Springs, South Africa where the 'antidormancy'
effect of zolpidem was first discovered. This study will compare various doses
of a new orobuccal spray formulation with an existing tablet formulation.


In view of the current interest in the UK media in the use of zolpidem in
patients in a Persistent Vegetative State (PVS) ReGen would state that no
patients in this trial are in a PVS state and all are ambulant. Full results
from this study are expected to be available around the end of March 2007.


Based on over 150 case studies worldwide the clinical effects of zolpidem have
been the restoration of consciousness, swallowing, co-ordination and motor
function after stroke and traumatic brain injury. This reversal of dormancy has
been visualised by SPECT brain scanning on dosing with zolpidem. Work is ongoing
to clarify the basis of this activity.


The clinical effect is generally proportional to the size and position of the
dormant area and correlates with drug levels in the brain/plasma. Whilst to date
these effects have been achieved with existing formulations these are less than
ideal for the new use, with sedation as a significant limiting factor.


Commenting, Percy Lomax, ReGen Chairman and Chief Executive said 'We are pleased
that we are now able to get this study underway. In addition to objectively
confirming the effects of zolpidem in a clinical trial setting, we hope it will
show that new, low dose formulations have an anti-dormancy effect but in the
absence of sedation. If this is the case this will support the development of
several new formulations that we hope will allow the full benefits of zolpidem
to be delivered to patients'.


For more information, please contact:


Andrew Marshall
Greycoat Communications
Tel: 020 7960 6007
Mobile: 07785 297111


Notes to Editors:


1. Brain dormancy is an expression used to describe an area of
the brain where the cells are not dead, but are not functioning normally.

2. Ambulant means patients who are able to walk around.

3. PVS means Persistent Vegetative State. Patients do not display any
awareness of their surroundings and are unable to communicate. Sleep
alternates with apparent wakefulness.


ReGen's thesis is that zolpidem can reverse 'dormancy' at sites removed from a
primary site of brain damage (e.g. stroke, head trauma, viral infection,
near-drowning). This thesis is derived from observations of open case clinical
studies in over 150 patients.


Thus, where those functions controlled by the dormant brain areas have been
normalised the following improvements have been seen:


Aphasia (speech cognition)
Dysarthria (word articulation)
General cognition and IQ
Ataxia (limb coordination/posture)
Hearing
Basic reflexes (swallowing and continence)


ReGen has filed a use patent for the use of zolpidem in 'dormancy'.


ReGen is now carrying out background scientific research to discover, among
other things, the precise mode of action of zolpidem in this situation. ReGen
filed in May 2006 to carry out a Phase IIa clinical trial in South Africa which,
using known zolpidem responders, is intending to show whether or not a reduction
in dosage would mean a reduction in sedation, but continue the therapeutic
efficacy. The trial is also intended to include the use of a novel orobuccal
spray.


ReGen wishes to stress that it believes the overwhelming market for this drug is
for ambulant patients and whilst it has a use in PVS this is not the main direct
audience.


Further ReGen wishes to state it does not consider it to be its place to enter
into the medical ethics debate about the use of zolpidem in PVS patients. What
ReGen is working on is a reversal of brain dormancy. The licensing of any drug
is the responsibility of the Health Authority and its use is within the doctor
patient relationship and ReGen will make no comment on that.

anyone got any news? sp on the rise

It was a great shame that Regen were not able to publicise in an RNS the fact that they along with Zolpidem were the focus of a documentary last night. It brought tears to the eyes to watch the miraculous effect of this drug and made me feel proud to be a shareholder.

I believe the programme "My shocking story" is being shown again on Saturday night on Discovery channel 520 at 10pm. Whether a holder or not it is certainly worth watching as it truly is the stuff of miracles. If the current trials go as well as is hoped then the sort of revenue that this drug could bring to Regen is potentially massive.

Just got back and slightly surprised to see such a small movement in the SP. I havent yet read what has been released but here goes for a resume of the AGM.

Firstly and on a personal level most importantly I have now actually held Colostrinin tablets in my hand. Suddenly after all the research, rumours and speculation I have actually seen and held different versions of the tablet, these being: the 100mg version that Metagenics are using to approach the retail market in the US currently packaged as NG550; a 200mg capsule for feline trials; a 600mg capsule for canine trials and a chocolate flavoured human version. Whilst there was much other positive news at the meeting for me to actually see the product was very reassuring.

Moving on. The meeting was well attended with most of Regen there including the scientists Andrew Sutton and Ralf Claus who are behind the Zolpidem story. Peter Garrod was there and Tigran as well as a number of PIs and various others amongst whom were various people connected with financial institutions.

CLN Nutra

This all seemed very positive with the long awaited news that Tox and Gmp are now sorted. Launch seems pretty definite for October. The question was asked about when we might actually see revenue and whilst this was not definitively answered because of being price sensitive information we did glean that there should be revenue coming from the manufacturing side on delivery. So whilst we probably wont know how much until we see the year end results I am expecting that perhaps in September the tap should begin to turn on in respect of first funds coming in from the nutra. Royalties will obviously follow based on sales.

Discussions are ongoing for deals elsewhere and I would not be surprised to hear more in that respect fairly soon.

There does seem to be a possible angle for use of CLN as a food additive and Regen have been approached with different ideas. I could not nail down whether this was in the immediate pipeline as they are so excited about the imminent launch of Colostrinin nutra and the results of Zolpidem that these were definitely the main areas of focus.


Pets nutra.

Trials are to begin on 1st June with results probably coming out around November. These are being carried out by Nick Mills who has a large vetinary practice in the South East and has been keen to research this for some time as I remember his name coming up in the past

Zolpidem.

We are advised that trials are going well and that the spray is definitely showing positive results. The spray is quite key as it shows faster results and by virtue of different delivery method adds further weight to the use patent. They are working with Novadel for spray delivery

Good news that the first use patent has now been granted in South Africa and is in the process elsewhere. This should be good news for those concerned about ownership.

The use patent is something I had not fully understood previously and I queried at length today just to try and be sure Id got it right as I had been hung up on the 5mg issue. Zolpidem is currently a 10 mg sleeping tablet. Regen know it works in terms of the Lazarus effect etc in many cases but needed to lose the sedative hence looking at a lower dosage.

They have sought to get a patent to prevent others producing doses of 5mg or less as they could argue they were just trying to muscle in on their area of market for at that level there is no sedative effect so why would someone want to produce it for anything other than the are Regen are researching. However my understanding today is that the use patent does not relate just to the lower dosage it relates to use at whatever dosage. So if Regen can lose the sedative effect in some way at a particular dosage then someone else could not mirror that dosage for the same use.

It was reported that there have been no safety issues in the trials so far.

Certainly speaking with Andrew Sutton he is as excited now about the effects of Zolpidem as he was last time I saw him and despite his wealth of experience in this field he is resolute about the fact that this is the biggest potential market he has ever seen. Although of course whilst he might like to think that everything is going well they are carrying out the trials for a reason and once the massive volume of data is in it will probably take a month or so to assimilate the results hence if trials are completed by end June I would therefore expect results around end July/ beginning of August. Note that the Sciencom deal is based around Zolpidem showing positive results at trial whereupon the payment will be made in Regen shares so they will be keen to get to this stage whilst the share price is still depressed as it means they will get more shares for their money.

CLN Pharma

A lot of work has been going on in this area and full results are expected in Q4 of this year. They have identified a number of peptides which have displayed positive properties in different areas and once all data is in they would look to move forward with preclinical candidates and possible licensing deals. Again Percy seemed quite excited about this area of research but the more imminent news on Zolpidem and the nutra launch overshadowed it a little.

GCPL

Order book down on this time last year although I got the impression that there might not be a huge variation in actual sales.


Funding

They will need some funding before break even but are exploring possibilities. There were a number of financial questions from 2 fairly clued up investors. To one PL said that if there were a way of raising the funds without going to the market then he would do it as like us he does not like the idea of dilution.

I did ask about consolidation and he said that his advisors had said that it was not something they would recommend at the time of the last issue. He did appreciate the concerns of the smaller investor and any such move would be made with investors best interests at heart.

There was a question relating I believe to the need for resolution 8 which I have to confess I got a little lost in the answer. I think they were basically saying that the earlier authority gave them the right to issue shares but certain rules mean they were limited in the amount they could issue in one block without coming to the market and this resolution overcame it. Bearing in mind that there were institutions represented there today I did wonder whether this might have been geared up as a way for them to buy in a big block outside of the ordinary market. I am sure there are others who will understand the intricacies of the rules a little better to shed light on this point.

When asking about funding etc I did make the point that my interpretation of the accounts was that current cash should last until Mid July. This was not allowing for any GCPL revenue and if the nutra product were to be paid in part for manufacture prior to launch then this should mean that they ought not to have to raise too much money this year for working costs. This point was not disputed but not confirmed either. I came away with the impression that they will have to raise funds prior to the end of the year but as for whether this will be an issue in normal sense or an institutional investment I could not say.

I think that has covered everything. All in all a positive meeting with a general veiled optimism about everyone connected with the company. Both Peter Garrod and Tigran seemed very happy with their investments.

Certainly this is going to be an exciting few months with lots happening which I have roughly timelined as:-

1 June Start of vetinary trials
End June Zolpidem trials end
End July/ Begin Aug - Zolpidem results
October Nutra Launch
Oct Dec Results of research in for CLN peptides & assessment of preclinical candidates
Nov - Vetinary trial results

During this time we could also hear about further nutra deals and if Zolpidem results are very positive then perhaps a deal there too.

As always, posted in good faith and to the best of my recollection and interpretation.

It was good to see a bigger turn out today and six of us had a pleasant lunch afterwards. We did not crack open the champagne today, sticking to beer and wine but hopefully next time.

Gantenbrink - thank you for such an excellent and informative synopsis of the day.

more positive news today. marketing and development leading to a good end to this year..

watcher

BE VERY CAREFUL WITH THIS ONE, I HAVE HAD IT ON MY WATCH SCREEN FOR AGES!

CHECK THE TRADING RANGE FOR THE PAST YEAR IT WILL TAKE A BOMB FOR IT TO BREAK OUT OF THAT RANGE.

I dont think its going anywhere--I trust I AM WRONG FOR THE LONG TERM HOLDER'S SAKES.