Medgenics(Regs) Share Discussion Threads

[sicilian_kan] 08/11/2010 08:04

From the FDA filing, it is intended that the US issued shares are issued at a substantially higher price than the current AIM share price. This an excellent deal for current shareholders:

"The estimated initial public offering price of $ per share of common stock is substantially higher than the pro forma net tangible book value per share of our outstanding shares immediately after the offering. As a result, investors purchasing shares in the offering will incur immediate and substantial dilution of approximately $ per share or approximately % of the assumed offering price. Accordingly, existing shareholders will benefit disproportionately from this offering. If we raise additional capital through the sale of equity, including convertible securities, your percentage of ownership will be diluted. You may also experience additional dilution if stock options or warrants to purchase our shares are exercised at less than the offering price. As of the date of this prospectus, we have reserved 60,500,000 shares of our common stock for issuance under our 2006 Stock Incentive Plan, as amended (the 2006 Stock Plan), shares of our common stock for issuance upon exercise of the warrants issued in our private placements and to consultants and shares of our common stock for issuance upon the exercise of warrants to be issued to the underwriters at the completion of this offering".

[sicilian_kan] 08/11/2010 07:44

Excellent news out today. Medgenics has filed with the US SEC for a proposed US IPO. This should (a) help revalue the shares significantly upwards in due course as US Bios are much better valued than AIM ones, and (b) there will soon be a prosepectus setting out a lot of detail about the company and its pipeline.

8 November 2010

Medgenics, Inc.

("Medgenics" or the "Company")

Medgenics Announces Filing of Registration Statement for Proposed Initial Public Offering

of its Common Stock in the U.S.

Misgav, Israel and London, UK -8 November 2010 - Medgenics, Inc. (AIM: MEDG, MEDU), today announced the filing of a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") for the proposed initial public offering of its common stock in the U.S.. The number of shares of common stock to be offered and the price range for the offering have not yet been determined. Roth Capital Partners, LLC and Maxim Group LLC are acting as representatives of the underwriters in the offering.

A registration statement relating to the shares of common stock has been filed with the SEC but has not yet become effective. The shares of common stock to be sold in the offering may not be sold, nor may any offers to buy be accepted, prior to the time the registration statement becomes effective. This release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Sales of common stock under the registration statement cannot occur until it is declared effective by the U.S. Securities and Exchange Commission, There can be no assurance as to if and when the Securities and Exchange Commission will declare the Company's registration statement effective. The registration statement is available at the U.S. Securities and Exchange Commission's website at www.sec.gov.

This offering of common stock will be made only by means of a prospectus. When available, a written prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, may be obtained from Roth Capital Partners, LLC at 24 Corporate Plaza Dr., Newport Beach, CA 92660, attention: Equity Capital Markets or 800-678-9147 or from Maxim Group LLC at 405 Lexington Avenue, New York, New York 10174 or 800-724-0761.

[sicilian_kan] 01/11/2010 08:17

Interesting list of disclosures there!

[sicilian_kan] 01/11/2010 08:16

The above is from:

[sicilian_kan] 01/11/2010 08:13

The abstract to the presentation is below:

Further details on the first 12 months not yet seen, and "Now treating additional patients at higher doses, results to be presented". So cannot see the latest results yet.

F-FC270

Erythropoiesis Sustained 12 Months by the EPODURE Biopump in Patients with Chronic Kidney Disease: Further Results of Phase I/II Proof of Concept Trial Anatole Besarab,1 Allen R. Nissenson,2 Doron Schwartz,3 Andrew L. Pearlman,4 Philip Ng,5 Michal Elhalel.6 1Henry Ford Hospital, Detroit, MI; 2UCLA School of Medicine, LA, CA; 3Sourasky Medical Center, Tel Aviv, Israel; 4Medgenics, Inc., Misgav, Israel; 5Baylor College of Medicine, TX; 6Hadassah Hospital, Jerusalem, Israel.

The need for better hemoglobin (Hb) control during EPO therapy is paramount in view of studies linking hemoglobin variability with increased mortality, and concerns from supraphysiologic erythropoietin concentrations. Sustained delivery of EPO within the therapeutic window could reduce these risks and increase patient compliance. We are developing EPODURE to provide > 6 months of sustained EPO delivery from a single treatment. Autologous 30mm x 2mm dermis core biopsies excised from the patient's skin under local anesthetic are converted in days into "biopump" tissue EPO production units by introducing the EPO gene into cells of the intact explant. After a week the requisite dose is given by reimplanting the explants units subcutaneously into the patient. Dose can be varied by ablation or addition of more units.

We reported (ASN 2008) the first month's results of the first two patients following treatment using low dose EPODURE Biopumps delivering 20 IU/kg/day in an open label, single-center, Phase I-II study in anemic CKD patients.
We now report results in 7 patients treated up to 12 months: 4 EPO-naïve, 3 EPO-dependent (last EPO injection 4-6 wks before EPODURE treatment). 6 received EPODURE 20 IU/kg/day, 1 received 40 IU/kg/day: no adverse events reported to date. In 3 of 3 EPO-dependent, Hb decline following ESA cessation was reversed, Hb remained between 9.8-11.5 g/dl for > 3-12 months, some 1.7 – 2.4 g/dl above projected nadir. In 2 of 3 EPO-naïve, Hb was increased 0.5 – 0.7 g/dl above baseline and remained between 10-12 g/dl for > 5-7 months. One had minimal response. In the EPO-naïve treated at 40 IU/kg/day Hb remained 10-10.7 g/dl for 4.5 months.Conclusions: a single EPODURE treatment can provide up to 12 months sustained ESA therapy in CKD patients. Now treating additional patients at higher doses, results to be presented.

Disclosure of Financial Relationships:

Consultancy: Amgen, Hoffman la Roche, Akebia, Affymax, Rockwell International;

Ownership: Vasc AlertResearch Funding: Abbott, Roche, Fibrogen, Luitpold;

Honoraria: Affymax, Amgen, ASN, Ash Access Technology, Bioconnect, FALLON MEDICA, FMC, Genentech, HemoSphere, Hoffman la Roche, Hospira, Indiana University, John Hopkins Univ, Luitpold Pharm, Merck and Co, National Kidney Fnd, NKF of Michigan, NKF of Georgia, New York Soc of Nephrology, QUINTILES, Renal Advantage, Rockwell Medical, Scientic Consulting Group (NIH) Soc of Nephrology of Puerto Rico, Speedel, St. Michael's Hosp. (Toronto), St. John's Hosp. (Detroit), Takeda, University of Cincinatti, University of Miami, University of Missouri, VascAlert, Walter Kluger (Publisher) Winthrop Univ., Watson Pharma;

Scientific Advisor: Amgen, Affymax, Akebia, Rockwell International.

[sicilian_kan] 01/11/2010 07:37

News out today, see above:

1) Yet another key development stage reached, with a patient just meeting the target having his Biopump topped up.

2) The clinical update news is limited as the newest results 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. If the results were not good, I doubt they would be "excited" to do the presentation. We have snippets of updates on those results we know already, e.g. one patient now gone two years without needing injections.

3) They now have Biopumps producing factor VIII, considered by many to be the most challenging of proteins to produce in vitro. This is in addition to the already proved IFN-a and EPO. If they can do this, they can probably do anything. Key here are two things:

(a) they are in "advanced discussions" with their major pharmaceutical partner regarding extending their Factor VIII collaboration and will update the market as this moves forward. This should mean more money on the table and they appear fairly confident stating that they "look forward to further improvements in output with continued collaboration with our pharmaceutical partner".

(b) at this stage they are not producing a medical level dose in vitro, but as seen above, they appear confident of an increase.

Overall, a very positive update with further detail on the trial results due by the 19th of this month.

[sicilian_kan] 01/11/2010 07:23

RNS Number : 3372V
Medgenics Inc
01 November 2010

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

Patient reaches 2 years Anaemia Relief from Single Treatment in Clinical Trial

Results to be presented at the American Society of Nephrology Annual Convention
on Nov 19, 2010

New Biopumps now producing clotting Factor VIII protein for Haemophilia treatment

Misgav, Israel and London, UK - November 1, 2010 - Medgenics, Inc. (AIM: MEDG, MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce further positive progress in the Company's ongoing Phase I/II clinical trial with EPODURE to treat anaemia, including the treatment of additional patients with the middle dose range of continuously produced erythropoietin ('EPO'). In addition, the Company announces that it has succeeded in creating Biopumps producing Factor VIII in vitro. The Company views this as further demonstration of the Biopump platform for producing a range of therapeutic proteins.

The Company is pleased to report the following updates on the clinical trial, platform development, and commercial partnering:

EPODURE Anaemia Clinical Trial

· 12 patients have now received their implanted EPODURE Biopumps in the Company's Phase I/II clinical trial, with 5 receiving the dose level of (40 IU/kg/day), and 7 receiving the lower dose (20 IU/kg/day).

· One patient has been successfully treated for anaemia for a full 2 years following his single low dose treatment with EPODURE Biopumps in 2008. His haemoglobin levels have remained continuously within the target range of 10-12 g/dl throughout this period without any adverse events and without receiving any EPO injections, whereas he was receiving frequent EPO injections before his EPODURE treatment. (EPO injections are the current standard of care for anaemia and are produced by recombinant DNA in rodent cell culture.)

· Another patient, whose haemoglobin level had responded positively to the low dose of EPODURE, but only reached the low end of the target range of 10-12 g/dl, has just become the first patient to receive an additional administration of low dose EPODURE Biopumps to increase haemoglobin level. This parallels intended clinical use whereby, if there is insufficient haemoglobin response to an initial dose of Biopumps, additional Biopumps would be administered to further increase the haemoglobin level to reach the desired range. All previous patients have received only a single administration of a fixed dose, without possibility of subsequent increase. The Company views as a significant advance the approval for and administration of a second dose of Biopumps in a patient, and will be closely monitoring to see if this assists further haemoglobin elevation.

· The latest 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.

Factor VIII ("FVIII") Biopump for Haemophilia

Medgenics is also pleased to announce 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.

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.

Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that one of our patients has now passed his second anniversary free of EPO injections and with his haemoglobin right in the target range, and all from a single treatment with EPODURE in October 2008. We are further pleased that we have now treated 12 patients, including 5 who have received the mid-dose level, and look forward to following their response in the coming months. We are further excited about the presentation of our study by Prof Besarab at the upcoming major nephrology conference. Last but not least, 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."

Dr. Eugene Bauer, Chairman of Medgenics commented: "Progress continues on Medgenics' EPODURE program. We are especially pleased that one patient has now been treated for two years without additional intervention. Further, our development program for haemophilia A has progressed to the point of reproducible in vitro expression of active Factor VIII by our proprietary tissue Biopumps, and we are hopeful that our continued development will advance the performance to meet levels we need to give us confidence to move to a clinical level program."

[sicilian_kan] 22/10/2010 12:49

A reasonably large order of 100,000 shares, or around £8,750 just went through at the mid price. Given previous buy/sell prices, it should be a buy.

[sicilian_kan] 22/10/2010 08:19

Share price seems to be triangulating nicely. Breakout soon perhaps?

[sicilian_kan] 20/10/2010 08:10

First tick up yesterday (4%) for a while for MEDG after news that the chairman Eugene Bauer has switched to an executive role to help increase the company's US activities. It was said that "This is the first step in building a significant presence in the US. In coming months, we anticipate hiring additional senior executives to join Dr Bauer in our growing US office".

So what is happening...

Well the following are possible reasons for expanding a bio in the US, either one of them is excellent news for Medgenics:

1) The progress in the Phase I EPODURE trial continues to be such a success that they are planning to do Phase II in the US; or

2) The progress with the preclinical tests with the major international pharma have been successful and the major pharma wants to take the drug into trials in the US; or

3) They want to be on NASDAQ so that they can be valued properly.

News on exclusivity extension and trial updates still due imminently too.

[sicilian_kan] 22/9/2010 19:56

Good result here. $4m raised (in excess of the $3m sought)! And at 13p convertible!! MEDG still at 8.65p!

Medgenics, Inc. (AIM: MEDG, MEDU), the company that has developed a novel
technology for the manufacture and delivery of therapeutic proteins continuously
in patients using their own tissue, is pleased to announce that, further to the
announcements dated 24 August 2010 and 15 September 2010, it has now received
firm commitments, on the terms announced on 24 August 2010, to subscribe for the
proposed new convertible debentures in excess of the $3 million originally
envisaged.

The Directors expect to raise $4 million through this debenture issue by the end
of this week. The Company will announce the final result of the debenture round
at such time.

[sicilian_kan] 05/9/2010 15:54

thanks jt, I hope so too.

[jammytass] 05/9/2010 12:23

some good posts > sicilian_kan 1 day the markets/pi will wake up to this little gem
and the share price will rocket!!!!!!

[sicilian_kan] 04/9/2010 22:26

For what it is worth, British Bulls posted a buy confirmed on MEDG and a sell confirmed on MEDU on Friday.

[sicilian_kan] 02/9/2010 19:36

This news is great as:

1) They are opening up a new market with much quicker revenue possibilities

2) The world leading experts are now flocking to Medgenics. This is truely amazing. First liver, with the former President of the American Association for the Study of Liver Diseases. Now a leading world expert in vetinary science. You cannot get these people easily. They have the absolute pick of all the best jobs in the world, and they are choosing to go to Medgenics, an undervalued AIM microcap. Now, why could that be. The Phase I EPODURE results are the reason. They are stunning. And add to the two world experts, the market leading pharma involved in the hemophilia partnership.

3) Note the comments "His addition to our Strategic Advisory Board will strengthen our team as we move forward towards strategic partnerships and the development of commercial versions of our Biopump platform technology to bring this personalized approach to the broad and growing protein therapeutic market".

So yet again there are partnerships references, this time stating "as we move forward towards strategic partnerships". I am convinced that there will be such a partnership on EPODURE and the permanent deal re hemophilia in the next 12 months, and the EPODURE one will be huge.

DYOR

[sicilian_kan] 02/9/2010 19:27

Here's the RNS:

Medgenics appoints world leading veterinary expert, Dr. Stephen Ettinger
to Strategic Advisory Board

Misgav, Israel and London, UK - 2 September, 2010 - Medgenics, Inc. (AIM: MEDG,
MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is delighted to announce the appointment to the Company's Strategic Advisory Board of Dr. Stephen Ettinger, a world-renowned expert in veterinary medicine, who has held senior lecturing positions in many top universities and had over 150 books and papers published, with over 40 years of experience. Among his many honours and committee recognitions, Dr. Ettinger sits on the Board of Trustees at Cornell University and holds memberships at the California Veterinary Medical Association, the American College of Cardiology and the American Heart Association. Dr. Ettinger's appointment reflects the Company's decision to expand its Strategic Advisory Board to include members possessing a wider range of professional and commercial skills that will be required going forward, and to explore new directions and strategies for its Biopump technology.

Commenting on the appointments, Dr. Andrew Pearlman, CEO of Medgenics said: "The appointment of Dr Ettinger to the advisory board is an important strategic move for Medgenics as it opens the possibility of extending application of our
Biopump platform techonology into veterinary medicine. While the process for
manufacture and insertion of Biopumps is similar for animals and for humans, the regulatory route is much less arduous, possibly offering our Company earlier revenue-generating products. In addition to his eminence in veterinary medicine and academics, Dr. Ettinger will enhance Medgenics' contacts in the pharmaceutical world. His addition to our Strategic Advisory Board will strengthen our team as we move forward towards strategic partnerships and the development of commercial versions of our Biopump platform technology to bring this personalized approach to the broad and growing protein therapeutic market."

[sicilian_kan] 02/9/2010 19:25

It just gets better and better here with the news. There has been so much here recently, and there will be more to come.

Today's RNS shows the appointment of a world expert in vetinary science to the Scientific Board, Stephen Ettinger. Here is a summary of some of the things he has done:

"Dr. Stephen J. Ettinger, DVM, DACVIM (Cardiology, Small Animal Internal Medicine), FACC, FAHA:

Born and raised in New York City, Dr. Stephen Ettinger graduated as a Doctor of Veterinary Medicine from CornellUniversity . After completing an internship at the Animal Medical Centre, he then completed one of the first-ever residency programs in cardiology. In 1970, Dr. Ettinger published Canine Cardiology, the first monograph on cardiovascular disease in animals.

In 1973, he and his colleagues created the American College of Veterinary Internal Medicine, the largest body of board-certified veterinary internal medicine specialists in the world, followed soon afterwards by the development of an LP/CD of Canine Heart Sounds, the best source of normal and abnormal heart sounds in the dog.

In 1975, Dr. Ettinger published one of the most referenced veterinary medicine texts, the "Textbook of Veterinary Internal Medicine. His clinical research work has been prolific: he was primary investigator and lead author of a clinical trial that produced the first placebo-controlled trial of a veterinary cardiac drug (the ACE inhibitor enalapril) and he was lead investigator and presenter of the first prospective study to evaluate blood-based cardiac biomarkers in over 1,000 cases from one study in a single year.

Dr. Ettinger presently is chief medical officer of XLNT, Inc. (PetDRx), a provider of veterinary primary care services to companion animals through a network of veterinary hospitals. He continues to practice with the California Animal Hospital Veterinary Specialty Group in Los Angeles."

[sicilian_kan] 27/8/2010 17:49

nice pick back up to over 8p there.

[sicilian_kan] 26/8/2010 20:27

I think 28p would be a fair price at the moment, with MEDU hovering around 15-18p.

[jammytass] 26/8/2010 19:53

good luck> take out is my thoughts 28p target

[sicilian_kan] 26/8/2010 18:33

In fact, let me correct that, I have three bagging opportunities for the price of one:

1. MEDG catches up with MEDU as it should (bags)
2. MEDG converts into MEDU in 12 months if the disparity remains (bags)
3. Medgenics works as a company - the normal route (multi-bags)

Now none of these three may happen. I'm here because I think at least one of the three will.

[sicilian_kan] 26/8/2010 18:30

There aren't many shares that give you two multibagging opportunities. With MEDG, I can hold on in the hope that a deal is struck, which will bag the share price Or alternatively, I can convert my MEDG shares into MEDU after 12 months and bag as well, if the disparity remains. Will do this, sell the MEDU and buy double the MEDG again. It's a great opportunity.

[jammytass] 26/8/2010 18:16

welcome on board geff

[sicilian_kan] 26/8/2010 17:44

Welcome geoff.

[geoffmanana] 26/8/2010 09:42

Just added.