Medgenics(Regs) Share Discussion Threads

[20percent] 02/11/2009 18:58

I wonder if that late reported trade was another director buy?

[dawsonpaul] 02/11/2009 18:10

25k shares when he has 14 million. What for? A friend? :)

[sicilian_kan] 02/11/2009 17:26

I hope so simonparker5. There is definitely a lot going for this share.

[simonparker5] 02/11/2009 17:19

SK I agree with your points and have taken advantage of the drop today and bought some more. This could be huge!

[sicilian_kan] 02/11/2009 16:57

In addition, it is interesting that he chose to buy shares in the market, and not to convert his cheap warrants. It also suggests the recent deal has put the company on a strong medium term footing, not to require further injections from him, and that further anticipated deals would secure the long term financial future of the company, as per my post 3 above.

[sicilian_kan] 02/11/2009 16:54

It's only a drop in the Ocean, but why would Joel Kanter need to buy more shares? He already has 14,078,397. To me this is a signal / sign of strength, particularly given that Lord Steinberg paid 12p very recently.

Medgenics(Regs Director/PDMR Shareholding

TIDMMEDG

RNS Number : 7769B
Medgenics Inc
02 November 2009

?
Medgenics, Inc.
('Medgenics' or the 'Company')

2 November 2009

The Board of Medgenics announces that on 30 October 2009 Mr. Joel Kanter (a
Director of the Company) informed the Company that on 30 October he acquired in
the market 25,000 common shares of par value US$ 0.0001 each ("Common Shares")
in the Company at a price of 9.2 pence per Common Share.

The total interest in Shares of Mr. Kanter and his related parties following
this purchase is 14,078,397 Common Shares representing approximately 11.5 % of
the issued share capital of the Company (excluding his interest in warrants,
options and convertible debentures as previously announced).

[sicilian_kan] 30/10/2009 08:40

Based on the $7m dollar value of the biopump in the preclinical only deal with option for hemophilia, my view on EPODURE is a licensing deal of $30m with $500m milestones and 20% royalties, and INFRADURE, a deal of $15m with $500m milestones and 20% royalties.

Within 6 months, I can see the potential for a market cap of £50m, i.e. 5-bagging. Long term, it could 100-bag or more, but would more likely be taken out early.

[sicilian_kan] 30/10/2009 08:36

Thanks aj4.

[sicilian_kan] 30/10/2009 08:30

As a result of the above, I have moved my MEDU thread over to MEDG for the simple reason that it gets news updates in the header! It has a new name too "Medgenics - Blockbuster Alternative to 18th Century Syringe Technology". Feel free to have a look at:

[sicilian_kan] 30/10/2009 08:28

Following some discussions by others on iii, I spoke to TDW yesterday about the MEDG / MEDU difference and questioned them quite hard. They are adamant that I can buy MEDG online and uncertificated only and trade them as per a normal share.



I will not offer, sell or deliver the share to the US, if I sell it, it will go back to the UK based AIM MM; albeit there is no ban on selling to the US, just restrictions on such sales.

The online stock is marked with the S restriction.

As it states, "Trading of shares on AIM will generally meet the requirements of Regulation S, though some limitations apply with respect to sales to US Persons purchasing through AIM", but that would not apply to me.

The section stating that shares must be certificated is qualified by "or until the Company adopts a mechanism to facilitate electronic settlement of Regulation S securities"

etc., and I suggest you call your brokers to discuss.

IN SUMMARY The only difference for me as a Medgenics share buyer is that the restricted MEDG share has fewer potential buyers as US persons would buy it with restrictions (but I do not need to control that), i.e. if I have MEDU, there are arguable more people who might want to buy the shares.

However, looking back over the past few months in Medgenics, the fact that US people might prefer to buy MEDU shares appears to have little effect on the actual sps of MEDU and MEDG, which by and large largely track each others share price And at present MEDG is cheaper, so I did a fill and kill yesterday for a further £2,600 of shares on MEDG at 8.4p, where as the MEDU spread was 8.5p-9.5p and they wouldn't let me buy at 9.15p on fill or kill, so bargain.

[sicilian_kan] 30/10/2009 08:25

(Disclaimer: no information on this thread is intended as investment advice, do your own Research)




(A) Introduction

Medgenics is targetting a $95bn (2010) global market for protein therapy, including lead candidates for anemia, hemophilia. Its technology is the Biopump, which are made from 30 mm long tissue samples taken by needle biopsies from the lower layer of the patient's skin under local anaesthetic, and are processed during 10-14 days to become "biofactories" producing the required protein. The requisite number of Biopumps are then injected back under the patient's skin to provide sustained protein production and delivery for many months.



(B) The Pipeline

(1) EPODURE (EPO / Anemia - Mid Phase 1)

At present, injections are required 1-3x/week for EPO injections (anemia etc). These form a $9.6bn global market (2009) that Medgenics can target. The revenue per patient is USD $15,000 to $25,000 per year in a typical anemia patient.

EPODURE from Medgenics is currently blowing this need out of water through clinical trials of its BioPump technology. Open phase I trials are taking place allowing for regular updates on their success (rather than the results being at the end of the trial). At the lowest dose, Medgenics smashed its primary end-points of 3-6 months elevated hemoglobin (primary endpoint) within the target range (secondary endpoint). The majority of the 7 patients treated had sustained levels of haemoglobin over 6-12 months and one formerly EPO dependent patient has gone 2 years without injections. The low dose was not expected to be sufficient for a sustained period.

Compare this to other EPO alternatives or treatments in clinical trials. The next best thing (hoped to knock Amgen's EPO treatments off top spot) was Hematide from Affymax and Takeda (13th biggest Pharma worldwide). This published some Phase III results in June 2010. They aimed at needing injections once a month (a target far inferior to Medgenics'). Though the endpoints were met, the drug stumbled on safety grounds an further analysis of the results is taking place before they discuss the matter / registration with the FDA. Other treatments in Phase II, such as Lipoxen's ErepoXen saw an increase in haemoglobin levels when compared to baseline and these effects lasted "up to 28 days after dosing".

One more point of note, Medgenics's Biopump technology is designed to maintain blood protein levels without peaks and troughs, as occur with traditional injections. The green line below is Medgenics's aim. The red line is traditional therapy.



In summary, Medgenics EPO results are best in class by a long, long way and if the results are confirmed in later trial results, Amgen and others have a lot to be worried about. Medgenics have said that "To the best of the Directors' knowledge, nothing approaching EPODURE'S length of sustained anemia relief in patients has been shown from a single treatment of any other kind".

The patient who has gone 24 months without injections said "For me the treatment has been and continues to be successful, without complications or discomfort. At 72 years old, I continue to do physical work in the citrus groves several hours a day, but unlike in the previous year, I have not needed injections. The treatment has improved my quality of life".

Medgenics have also just started to show that EPODURE can generate dose dependent results. In other words, by implanting more than one Biopump, they can increase the therapeutic response.

Only 3-4 Biopumps were needed in each patient to deliver a total of 40 IU/kg/day, double the target response for the low dose. This has now been followed at 4 weeks post-treatment by nearly double the haemoglobin response in these patients than was seen with the low dose patients. Showing that EPODURE is a dosable treatment will be key to its success. One patient on the lower dose has now also been given further Biopumps, to show that the treatment can be adjusted if need be.

Of the $9.6bn EPO market, Amgen's drugs have a $5.2bn share, with their at least weekly injections. This shows the potential and there is a huge opportunity here
for Medgenics.

The latest Phase I/IIa results of the clinical trial are to be presented at the annual convention of the American Society of Nephrology, one of the largest meetings of nephrologists in the world, on November 19th. The presentation will be given by, Prof. Anatole Besarab, of Ford Hospital, Detroit MI - a member of the Company's Strategic Advisory Board and a leading authority in renal anaemia.

Assuming continued positive results in the Phase I/IIa trial, Medgenics has said that it intends to seek a strategic partner for the license of the EPODURE Biopump.

So far as safety is concerned, "As of the end of October 2010, 12 patients had been treated...No related adverse events have been reported for any of the treated patients, with the exception of minor, local subcutaneous hematoma (bleeding) seen at the harvest and implantation sites, as can be expected for any invasive procedures dealing with the skin. The hematoma was generally seen to clear up within several weeks for all patients treated. In addition, no immune response to the implanted Biopumps was reported. Because the protein secreted by the implanted Biopumps is the patient's own naturally-produced human EPO and not a foreign substance, no adverse reaction was expected, and none has been noted. Evidence that the Biopumps were not rejected by the patients' immune system is seen in the sustained elevation and maintenance of hemoglobin levels in most of the patients. All of the patient procedures have been well tolerated and no complaints of discomfort have been received".

Megenics believe that the planned "phase IIb clinical trial would likely involve 60 to 120 patients...in multiple centers...Initial discussions with our regulatory advisers indicate it is possible that following successful demonstration of these points in 60-120 patients in the phase IIb clinical trial, such trial could be converted into a broader pivotal phase III clinical trial for product approval. More than one major U.S. clinical site has asked to take part in the planned phase IIb clinical trial, with costs estimated in the $6-10m range. With sufficient funding, we could perform the phase IIb clinical trial on our own, or alternatively, if agreement is reached with an appropriate strategic partner as more of the Phase I/II data comes in, the phase IIb clinical trial could be conducted with such partner under that agreement".

(2) INFRADURE (IFN-a / Hepatitus C and Cancer - Entering Phase I)

Essentially, this is similar Biopump technology to the above, but releasing a different protein (IFN-a) aimed at treating Hepatitus C and some forms of cancer. In 2009, the IFN-a market was worth $2.6bn and there is an unmet need for an IFN-a therapy with greatly reduced side effects, which the Biopump promises.

Medgenics explains that "The current standard of care in treating hepatitis C involves weekly bolus IFN-α injections that are usually accompanied by mild to severe side effects in the great majority of patients...Experts believe the side effects are in large part due to the short-term substantial overdose of each injection. The overdose is deliberate to try to overcome the inherently short half life of the IFN-α (5.5 hours) and keep the concentration above the minimum effective level for sufficient time after each injection".

The biopump would offer continuous delivery at the right dosing level. Medgenics believes that based on their preclinical work and on the EPODURE trials that "a few biopumps may deliver the required IFN-α dose for six months or more in typical patients with hepatitis C".

In April 2010, Medgenics introduced in vivo and in vitro pre-clinical data on the Infradure Biopumps at a major European Liver conference (EASL, Vienna April 2010), drawing interest from experts and pharmaceutical companies in the major potential advantages that INFRADURE could provide in the treatment of hepatitis-C. The results paralleled those found with EPODURE which is now working in Phase I clinical trials. Medgenics hopes to bring INFRADURE to clinical trials in the near future and has now raised the funds required to do so.

What is important here is that if Medgenics can shortly show that the Biopump also works in clinical trials on IFN-a then they will be able to open up the whole $95bn protein market, rather than just the $11.9bn EPO market. This will have a radical effect on the share price and on partnering negotiations.

Medgenics will be launching INFRADURE into clinical trials in Q4 2011, with results available in 2012.

(3) (Factor 8 / Hemophilia - Preclinical)

Essentially, this is similar Biopump technology to the above, but releasing a different protein (Factor VIII) aimed at treating hemophilia. In 2009, the Factor VIII market was recorded as being worth $4bn. I note that the current cost of IFN-a injections typically exceeds $100,000 per year per patient.

Though preclinical, this is a very exciting technology for Medgenics. On 23 October 2009, Medgenics signed a development agreement with a major international biopharmaceutical company that is a market leader in the field of hemophilia. This has garnered further interest from other companies in the biopump. This market leader paid Medgenics $4m USD to work exclusively with them on a preclinical basis for a period of one year.

It has recently been confirmed that "Biopumps are now successfully producing active clotting factor VIII protein: considered by many to be the most challenging of proteins to produce in vitro. The Company views this as a further confirmation of the Biopump Platform, with Factor VIII now joining EPO and Interferon alpha as proteins continuously produced by Biopumps. The Company is continuing development of its FVIII Biopump to further increase FVIII output per Biopump to bring it to target levels thought sufficient to improve blood clotting if they were administered to patients with haemophilia. If successful, this would provide a unique and exciting new therapeutic option for haemophilic patients which could make a major difference in their lives".

In addition, it was said that "Medgenics is in advanced discussions with its pharmaceutical partner regarding continuation of collaboration in development of Factor VIII Biopumps for the treatment of haemophilia and will update the market as this moves forward".

The CEO stated that "we are proud to announce that we have shown we can make Biopumps producing clotting factor VIII for haemophilia, and look forward to further improvements in output with continued collaboration with our pharmaceutical partner."

All things considered, it looks very promising that a new agreement will be signed
up to in the near future.

(C) Anticipated Newsflow

19 November 2010 - Phase I/IIa EPODURE results (mid dose) released
19 November 2010 - Presentation of Phase I/IIa (mid dose) results at American Society of Nephrology conference
Q4 2010 - Factor VIII collaboration contract extension with market leader in field
Q4 2010 - US IPO
Q1 2011 - Phase I/IIa high dose to be trialed
Q2 2011 - INFRADURE approval to start clinical trials
H2 2011 - EPODURE licencing deal to be structH2
2011 - EPODURE to enter Phase IIb
H2 2011 - INFRADURE enters Phase I/IIa

(D) Some Strengths and Weaknesses

(1) Strengths

You are buying into the technology, i.e. the fact that it works in the EPO trials and that the preclinical trials are showing similar success, shows that the Biopump has a good chance of success in releasing other proteins too.
The patents should go across all medical conditions that might use the technology, which makes the patent process much easier.
Biopumps are expected to have increased efficacy, improved safety, be reversable treatment, have reduced side effects, lower costs, eliminate frequent injections and is hoped to extend treatment to those who are not treated at present due to side effects.
This is not like cancer, where a patient may have got better for a number of reasons or treatments. If these patients have sustained improvements, then this is almost certainly down to the Biopump. There is a huge market for protein therapies.
The trial results are stunning. Exisiting EPO treatments require weekly injections. Companies are struggling to get both safe and successful Phase III trials with EPO lasting a month. EPODURE has shown the majority of patients at 6 months or other with no significant side effects and one patient has lasted a year.
Deal talks re Factor VIII are advanced and further deal talks for EPO are expected once the Phase I/IIa trial has finished.
A US IPO is planned and the initial forms are now filed with the US SEC. This should increase interest in the Biopump and the share price too. Realistically, bios are better valued in the US than in the UK. This dual listing must be of benefit.
On Medgenics advisory board are three world renowned former Presidents of major US organisations, the American Society of Gene Therapy, the Renal Physicians Association, the American Association for the Study of Liver Diseases. They also have a world renowned vet on board, who writes the "must-have text" that "remains the only encyclopedic resource for veterinary internal medical problems. The internationally acclaimed 'gold standard'" book as described by Waterstones. These people have the pick of all the companies in the world to work for and all three choose to be with Medgenics. Ask yourself why this might be...
Medgenics Board of Directors is an experienced one and with the Kanter family, have people connected to the company who are willing to fairly fund it through any difficult patches. That the directors hold lots of shares (30%) and warrants will protect the value of the share price as their interests are alligned with ours.
Low market cap considering what it has achieved.
Few shareholders, so when this catches on, there should be serious spikes in the share price. After a RHPS tip, MEDU shot up to 30p intraday before falling slowly back to 12p. Further spikes should happen on key news / tips.
US IPO will mean funding secured to start of Phase IIb, by when an EPODURE deal should be signed.

(2) Weaknesses

If the Biopump technology fails, then it is likely it will fail for multiple treatments, i.e. the pipeline.
There are a large number of warrants outstanding.
Liquidity is not the best and fill and kills rather than live online quotes appear to be the best way to trade
Lord Steinberg passed away a year ago and his shares could be sold though they have not been yet.
There could be patent challenges

(E) US IPO SEC

Registration Form
If you want to know about Medgenics, this document is a comprehensive overview as to the current state of play. I suggest reading it all:


You are buying into the technology, i.e. the fact that it works in the EPO trials and that the preclinical trials are showing similar success, shows that the Biopump has a good chance of success in releasing other proteins too.

(F) MEDG OR MEDU?

The company has two tickers, MEDG and MEDU. This is for historical reasons. All shares used to be MEDG shares, but since November 2008, there have been MEDU (unrestricted) shares on the market.

MEDG, not MEDU, shareholders who are US persons have additional requirements to comply with and the shares are marked as restricted. This does not affect my UK rights to buy and sell MEDG shares on AIM as I am selling those shares to a UK broker, not a US citizen. So from a day to day point of view, holing MEDG shares does not affect me.

Both MEDG and MEDU have the same nominal value so dividends will be the same as will be any takeover sum due per share.

MEDG shares can have their restrictions removed if held for one year, so you can convert MEDG to MEDU with time.

At differing times, MEDG and MEDU have been the ticker with the higher share price
.
You may need to complete a Form W-8BEN before you can trade.

About which ticker you should buy, forms, restrictions etc., you should of
course speak to you broker.

There have been two main RNS's re the different tickers, I put
the links below for assistance:

[andrbea] 27/10/2009 07:48

so why did it fall yesterday?
and why the ugly spread?

This is a crazy market, should be 15p by now (not 10p) on the back of news like this:



nia dyor