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News on how the Phase IIb trial and Phase III will happen from the SEC filing. Key here is that they already have one major US clinical site that has agreed to take part in the Phase IIb trial and it could be converted into a Phase III trial in due course: "We believe that the phase IIb clinical trial would likely involve 60 to 120 patients, and seek to reproduce similar results to the phase I/II clinical trial in multiple centers (and in more patients), and further seek to test: · reliable preparation of Biopumps processed in sealed cassettes; · titration of the administered dose as needed to reach the desired therapeutic effect in each patient, like in intended clinical use, whether increasing dose by addition of further Biopumps, or reducing it via ablation of one of more of those implanted; · demonstration of same or better maintenance of hemoglobin within specified range; and · fewer interventions during the specified time interval (currently planning for six-month duration). 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".

News on the safety side of the Phase I/IIa trial re all 12 patients from the SEC filing: "As of the end of October 2010, 12 patients had been treated: seven at the low dose level of 20 IU/kg/day and five at the mid-dose level of 40 IU/kg/day. The mid-dose was administered after submission and approval of a safety report on the first six patients treated at the low dose. 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".

From the SEC filing: Will there be an EPO deal in the medium term, sounds like there could be at the end of Phase I/IIa...? "The demonstration of several months to over 24 months of sustained anemia treatment from a single administration of the EPODURE Biopump in patients with chronic kidney disease has shown that an appropriate administration of the EPODURE Biopump can provide sustained anemia therapy without any EPO injections and represents an unprecedented duration from a single treatment in patients – replacing scores of EPO injections. Assuming continued positive results in our trial, we intend to seek a strategic partner for the license of the EPODURE Biopump We anticipate taking a similar approach with our INFRADURE Biopump to treat hepatitis C. Subject to receipt of the required regulatory approvals, we intend to commence phase I/II clinical trials of the INFRADURE Biopump for the treatment of hepatitis C in patients prior to the end of 2011. Assuming receipt of successful initial results from such trials demonstrating proof of concept, we would then intend to seek a strategic partner for the license of the INFRADURE Biopump". If so, that could bring in excellent money in the next 12 months, more on this below: "Generally, a strategic partner is sought after sufficient Phase I/II data have been gathered to show proof of concept; however, as with hemophilia, we may reach feasibility or partnering agreements at an earlier stage, even before start of preclinical development. For most applications after the completion of phase I/II clinical trials, we would seek to continue clinical development through the product approval stage with a partner or collaborator who provides funding for the development. As a result, we would not be pursuing the regulatory process on our own. However, for some indications we may determine to conduct our own phase IIb clinical trial or even take a product candidate to final the product approval stage without a strategic partner".

A little bit more on the Factor VIII from the SEC filing: "Factor VIII Biopump for the Treatment of Hemophilia We are in early stage development of a Factor VIII Biopump for use in the treatment of hemophilia. We believe the Factor VIII Biopump represents a potential improved therapy in the treatment of hemophilia, because it would be prophylactic (preventing bleeding) and therefore could reduce the risk posed by bleeding in these patients. The current treatment is primarily to administer Factor VIII by injection after bleeding has already started. We also believe that if the Factor VIII Biopump succeeds in producing sufficient Factor VIII, and in delivering it into a patient’s circulation, it would represent a significant step towards rendering the patient’s life more normal. It could also provide significant cost savings for treatment of hemophiliacs, in which the cost of Factor VIII injections in a typical hemophilia patient typically exceeds $100,000 per year. The Factor VIII global market was $4 billion in 2009 according to La Merie Business Intelligence, R&D Pipeline News, Top 20 Biologics 2009 (May 10, 2009). We have successfully developed Biopumps producing active clotting Factor VIII protein in vitro. We believe this is a further confirmation of our Biopump technology as a platform for continuous production of a range of different proteins, by reproducibly producing Biopumps making a new protein, especially Factor VIII which is considered by many to be one of the more challenging of proteins. We are continuing to develop our Factor VIII Biopump to further increase Factor VIII output per Biopump to bring output to target levels thought sufficient to improve blood clotting, if they were administered to patients with hemophilia. We are in advanced discussions with the pharmaceutical company with whom we worked since October 2009 on the research and development of Factor VIII Biopumps regarding the continuation of our collaboration in Factor VIII Biopump development."

Also from the US filing, they have received a (small but not negligible) cash grant from the US government: "In addition, in November 2010 we were notified that we will receive a cash grant of $244,479 under the U.S. government’s Qualifying Therapeutic Discovery Project to further our Biopump research and development program." This is now evidenced in a second RNS today: Medgenics receives U.S. Government Grant for Research that Shows the Greatest Potential to Result in New Therapies Misgav, Israel and London, UK - 8 November 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 that has been awarded a cash grant under the U.S. Internal Revenue Service's Qualifying Therapeutic Discovery Project (QTDP) program. The QTDP program provides grants to companies with fewer than 250 employees whose research shows the greatest potential to result in new therapies. The QTDP's grants are provided under the new section 48D of the Internal Revenue Code (IRC), enacted as part of the Patient Protection and Affordable Care Act of 2010. The Company will use the grant totaling $244,479 to further the development of its core Biopump technology. CEO Andrew L. Pearlman said: "We very much appreciate the recognition of the US Government in granting a QTDP award to Medgenics, and for the tangible support it provides for our ongoing program to develop and apply the innovative Biopump technology into new and improved therapies."

Also from the SEC filing, you can see what the funds raised will be use for. Of particular note is that they are going to seek approval with the funds for a US Phase IIb trial. Now what does that suggest about the results of the current trial, due out on 19 Nov: "The principal purposes for this offering are to fund our product development activities, including clinical trials for our most advanced product candidates, EPODURE and INFRADURE, for patent maintenance fees and intellectual property support and for working capital and other general corporate purposes, which may include the acquisition or licensing of complementary technologies, products or business. We anticipate using the net proceeds from this offering as follows: · approximately $ for EPODURE development to include the following: · completion of the Phase I/II trial, and · preIND and IND for EPODURE and/or other indications; · preparations and approval to commence phase 2b (dose ranging clinical trial); · approximately $ for INFRADURE development in preparation for phase I trial in humans; · approximately $ for research and development of core technology and other product candidates; · approximately $ for patent maintenance fees and other intellectual property support; and · approximately the balance to fund working capital and other general corporate purposes, which may include the acquisition or licensing of complementary technologies, products or business.

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".

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.

Note at the bottom of that abstract this (I assume this relates to individuals writing the paper but cannot say): 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.

The abstract to the presentation is at: http://www.asn-online.org/education_and_meetings/renal_week/archives/ Includes 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. All to be revealed later this month!

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.

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.

As for newsflow: (1) Look at the RNS on 23/10/2009. Medgenics signed a development agreement with "a major international biopharmaceutical company that is a market leader in the field of hemophilia". This is believed to be one of the top two worldwide market leaders. Then turn to the deal terms, "Under the terms of the agreement, Medgenics will receive $4 million to work exclusively with this partner for one year to develop a Biopump to test the feasibility of continuous production and delivery of this clotting protein. Additional payments totaling $3 million are payable upon Medgenics meeting certain technical milestones and upon the partner's exercise of an option to extend the exclusivity through an additional period to negotiate terms to commercialize the Biopump technology for Factor VIII". So the exclusivity will run for around another month (assuming the 12 months ran from the RNS), before the market leader will have to decide to pay Medgenics more money to negotiate a deal (that's kind of cool, be paid to negotiate a deal). If a deal is negotiated, and we will know this fairly soon (but not in the very short term), then the sp should soar. I would expect around $10m - $15m upfront (they got $7m max for preclinical one year deal alone), with say $250m - $500m milestones and double figure % royalties. Any company with that kind of deal is worth a market cap of at least £50m. Now that is for the third drug in their pipeline. Then add in what they can get for EPODURE and INFRADURE thereafter, the two main treatments, and things are looking pretty. By the way, interesting that the directors were keen to get the funding sorted quickly in Sept (and also exercised warrants). My guess is that they are tanking up pre a late October / early November news release on the hemophilia... But then this is pure speculation...and dyor... (2) Based on previous history, we are due a further clinical update very soon.