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Medgenics, Inc. Message Board

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  • Adage Capital just reported holding 1,250,000 shares of Medgenics as of March 31, 2016. At the end of Q4, 12/31/15, they reported a new holding of 900,000, presumably from the October 2015 Secondary offering. This is significant in that Adage has increased their stake in the open market.

    Sentiment: Strong Buy

  • Darn yahoo - The table looked better when written but, I am sure the message translates.

    Sentiment: Strong Buy

  • Management did a fine job on the Q1 earnings call and today's Zack’s summary of the opportunity is very good. I have no doubt NFC-1 will transform the company into a multi-billion dollar organization. It was obvious from the call all efforts and money are focused on getting it to market soon (not soon enough of course but, soon). In fact, Cola noted that some work continues in Israel but, it appears this is now on the way back burner. The BOD needs to be aware that the shareholders that are here for NFC-1 will not put up with any abuse of the option plan that pays them outsized rewards for the quality work of current management. I have opined regarding specifics in other messages and I would hope a comparison of the voting results from 2015 to 2016 would get their attention. Below is a summary of the votes AGAINST (broker non-votes were similar). Shareholders must remain vigilant so our returns are not compromised by this BOD!!

    Nominee 2016 2015
    Sol J. Barer 19.6% 4.9%
    Eugene A. Bauer 5.3% 10.0%
    Isaac Blech 24.1% 2.7%
    Alastair Clemow 18.2% 0.1%
    Michael F. Cola 5.5% 0.1%
    Barbara G. Duncan 5.4%
    Wilbur H. (Bill) Gantz 13.9% 10.0%
    Joseph J. Grano, Jr. 18.2% 9.9%

    Sentiment: Strong Buy

  • The non-interventional trial data so far validates earlier estimates that 25% of all ADHD cases have an mGlur mutation. This is huge. From today's release:

    "With more than 700 subjects genotyped over the first 10 weeks of the study, approximately 25% have tested positive for genetic mutations that disrupt the mGluR network. This novel discovery identifies, for the first time, an underlying genetic cause of ADHD within a significant subpopulation of patients. The program is being conducted at 25 sites nationally, providing a representative sample of the pediatric patient population in the United States. Importantly, more than 95% of the subjects enrolled in the study have consented to be re-contacted for future trials, allowing the company to pre-identify patients for its Phase 2/3 adolescent mGluR+ ADHD trial expected to initiate in June."

    Sentiment: Strong Buy

  • Reply to

    Interesting Article

    by quinn_wins Apr 2, 2016 11:21 AM

    Good find Quinn. “This discovery alone may have a huge impact on millions of kids down the road,” It could also have a huge impact to MDGN's share price. Truly 10 bagger potential here.

    Sentiment: Strong Buy

  • Good news, 855,190 warrants issued in 2006 expired March 31, 2016. Bad news is they were priced at $2.49 therefore they were exercised (I wasn’t here but to issue a 10 year warranty at $2.49 smacks of some desperation – think it was around a refi). I estimate 530,000 of the warrants will need to be sold i.e. - cashed out to raise the purchase price and taxes on the profit (assumes a normal transaction). This has been a drag and will continue to be a drag on the stock price for several more months.

    The other good news is 1 million warrants with the strike price of $6.00 will expire April 12, 2016 and it appears that overhang will eliminate itself.

    Question: why do we pay so much to get people to leave us rather than stay and work to improve the company? It cost us $707,000 when Mr. Kanter left the board. It cost us $720,000 when Dr. McMurray left the board

  • More reasons to be bullish.

    Interesting article that mentions MDGN: http://btob.research.chop.edu/seeing-the-impact-of-a-decade-of-genomics-discoveries/

    MDGN relevant excerpt:

    Looking beyond rare cancers, Dr. Hakonarson is excited about a broad-scale population impact of more recent CAG discoveries of mutations in multiple genes that are part of a neurotransmitter signaling pathway regulating memory, attention, cognition, learning, behavior, among other biological processes. They found these mutations to be associated with several neuropsychiatric conditions in children including attention deficit hyperactivity disorder (ADHD) and have already completed the first proof of concept clinical trial in ADHD. These findings could rapidly lead to clinical therapies, as an investigational drug that targets this pathway is already in use in clinical trials for ADHD led by Medgenics Inc. (Medgenics licenses certain CAG assets and funds some of Dr. Hakonarson’s research.)*

    “This discovery alone may have a huge impact on millions of kids down the road,” Dr. Hakonarson said. “It would never have been discovered if not for the CHOP biobank we built.”

    *In addition, Dr. Hakonarson indirectly owns stock in Medgenics and CHOP and Dr. Hakonarson could benefit financially from their relationships with Medgenics.

    Sentiment: Strong Buy

  • Reply to

    Quinn, a couple thoughts -

    by mgs1066 Mar 21, 2016 12:27 AM

    An "optic" of $25+ sounds like a good optic to me. I am fine if he makes $16m pretax, if so. lol.

    Sentiment: Strong Buy

  • Reply to

    Quinn, a couple thoughts -

    by mgs1066 Mar 21, 2016 12:27 AM

    Mgs,

    Good stuff. Since I am relatively new to Biotech I appreciate the input/education. That said I think you are correct longer term but, I would prefer a more compassionate revenue generating path to the same place!

    It seems getting 22q approval is possible with a phase 2/pivotal trial late this year. With that revenue pending, it would allow for a debt placement (my bias since I hate to be diluted as you can tell from my option comments – see below!) to generate funds for production. They have the shelf registration in place for the raise. This allows for 1) 22q families to get their first EVER medication sooner than later noting CHOP is the world leader for this indication, 2) Concurrent ADHD trials will be benefited by the drug being in market and 3) A TR version can be developed over the next few years without compromising the current patent. This in effect, would make the compound under patent even longer than your scenario I believe.

    You mentioned safety. Remember Cola has mentioned that in studies elsewhere (escapes me right now where) many many patients have shown it safe. I believe we should have our first patient in the 22q study in the next few weeks if the plan as outlined is being executed. All of the items I mention seem to support my “speed” argument.

    On a current topic, we need to understand the decision process regarding former CFO Leaman. He worked less than 2.5 years for the company leaving last month. For some reason, all his options were accelerated and now have expiration in early ’18. This is not an insignificant amount – 800 THOUSAND shares (if the stock is 25+/- then…..a real possibility…..he would bank $16M before tax). Again, the optics are horrible. What are the circumstances of his leaving????

    Q

    Sentiment: Strong Buy

  • These are really just my thoughts and just thought I'd share them. There is only a usage patent on this chemical. Fasoracetam is an old chemical and the original discovery patent is long expired. So CHOP acquired a usage patent for Faso and currently 5 years of the 20 year lifetime of that patent has been consumed. The patent has aged 5 years.

    Everything that follows here assumes that faso will be shown to be safe and effective.

    These are just speculations on my part - I don't think MDGN will bring faso to market as just a chemical compound. I expect that they will develop a time release version. Why? Since none of the racetems are on the market there is no time release version that's for sure. So they can develop a TR version and that will be novel and new and - put a patent on it. Put a patent on the manufacturing process, possibly a couple patents. The current market life of faso patent will be about 12 years at best, but if they do a time release version they'll have much better patents, going for a longer number of years and they'll be the fat end of sales at the end of the patent lifetime that will be extended and really matter.

    So we'll see phase II with faso but I would not be surprised to see a TR version for phase III and - that will need to be developed, will take some amount of time to develop. Marketable patent life would increase from 12 years to about 16, maybe 17 years if they do that.

    All just speculation on my part.

  • Reply to

    Options

    by quinn_wins Mar 17, 2016 1:32 PM

    Mgs,

    You have well thought out and valid points but we do have an obligation to vote rather than just go along for the ride (or be taken for said ride). While I understand options are the currency of small companies to attract talent (and there seems to be very good talent here), I think they are taking too much off the top of our returns.

    There are some real governance issues that should be dealt with now! Cola told us 2015 was a transformative year and I agree. As shareholders we can help cure the apparent myopia before the company becomes more successful. VOTE NO on all questions put to the shareholders this year in order to get leadership’s attention.

    The board has awarded themselves options with only one year vesting. The vesting period that is in the best interest of shareholders is five years generally but, especially given the path laid out in the year end conference call. Board members are receiving 20,000 options per year and the Nonexecutive Chairman is receiving 80,000 options. 40,000 options for the chairman would be considered a huge windfall in most investors' opinion.

    In the good governance movement environment the chairman is also subject to outside attack because he would be considered "overboarded" i.e. he serves on more than three boards. Credit should be given to the board for eliminating the annual $120,000 consulting payments to the chairman. This is going to be a big company that needs to start fixing these issues before future secondary offerings. The optics are horrible and miss-portray the board as shortsighted and greedy as well as insensitive to good governance. These are the types of issues f*in shorts use to gin up stories to drive their agendas.

    Lastly, you wrote “big risk/really big gain”, I suggest moderate risk with 10x from this level the first step. Let’s help them by pointing out things that may seem easy or expedient from the Boardroom but, those of us putting up risk capital view quite differently.

    Q

    Sentiment: Strong Buy

  • Reply to

    Options

    by quinn_wins Mar 17, 2016 1:32 PM

    I think we're just along for the ride. So what can we do? MDGN is - potentially - very miss-priced here. If we see good results from the trials they'll be doing, then really miss-priced, but first things first.

    24 months to market? No. After the open label trial for 22q MDGN will arrange a meeting with the FDA, come to agreement for a phase iii primary endpoint and possibly secondary endpoints, do a trial design, start and complete the trial. - oh - and they need to get an orphan drug approval along the way. That should be a no brainer but it takes - time.

    Do the phase 3 trial. FDA will require a minimum number of participants, no matter how sure MDGN is - based on genetics, so that will require a lead in time to get everyone enrolled. If you need 100 participants, it's not like you sign them up on Monday and start all 100 on drug the next Monday. - there's a matter of flow through logistics to get the trial enrolled.

    Then the trial is completed, take about 3 months to organize and submit the filing. The FDA will take 6 months to review and schedule a meeting to discuss. If the meeting goes well then the FDA will further review prescribing and scripting language, potential warnings needed. Review the Production facility and give final approval if all is well.

    They might ask for more data, etc. But a minimal critical path is more than two years.

    And no one has made this drug in real commercial quantities. Obviously that's why they brought someone like Rick Couch on board.

    But in two years time we'll have a lot of answers and maybe a clear vision of the future, one way or the other.
    Broadfin seems to like the odds here, but if they were correct 100% of the time with their investment selections they would have changed their name to "Really Big Broadfin" by now.

    But still, really interesting! I reviewed what others are doing with difficult to treat ADHD and MDGN looks like the one big risk / really big gain potential.
    = = =

  • Make no mistake, I AM EXCITED ABOUT THE PROJECTS UNDERWAY HERE! Over the next 24 months, I expect a 22q and ADHD drug to be in market. My beef is why is with the option plan. I am all for alignment of shareholder and management interests but, they are asking for 3M more options after just executing a secondary of 6M shares. If the proxy is approved as is, we will have 9M options against our 33M shares outstanding. This impedes the path to 10x from here.

    Sentiment: Strong Buy

  • Wednesday, January 27, 2016

    CHOP Researchers Identify Gene That Plays Important Role in Autism & Other Neuropsychiatric Conditions

    A team of researchers led by Tara Wenger, PhD of The Children's Hospital of Philadelphia's Center for Autism Research (CAR) have found that genetic mutations in a specific family of genes – the “metabotropic glutamate receptors” (mGluRs) – play a significant role in a person’s risk for autism spectrum disorder (ASD). One mGluR gene in particular- RANBP1- was the focus of a study published this month in the Nature journal Scientific Reports. The mGluR gene network typically contains two copies of RANBP1; however, in children who were missing one of those RANBP1 genes, the risk of autism increased dramatically.

    Previous studies have shown that RANBP1 contributes to “syndromic autism”- a form of ASD caused by genetic mutations that lead to complex medical problems. Syndromic ASD, which includes 22q11.2 Deletion Syndrome, Fragile X Syndrome, and Tuberous Sclerosis, accounts for about 20% of all ASD cases and are frequently more severe forms of ASD.

    The new CAR study confirms the important role of mGluR genes in other neuropsychiatric conditions, such as attention-deficit hyperactivity disorder (ADHD), in addition to autism. Moreover, this mGluR family of genes contains hints about how several well-known environmental factors may cause ASD, including prenatal exposure to thalidomide. The scientists say these findings pave the way for developing precision treatments targeted to those who carry this genetic variation.

    “This is another step in of a series of genetic findings that shine a spotlight on select aspects of early neurodevelopment that contribute most to ASD,” said Robert Schultz, PhD, Director of the CAR. “At CHOP we are extremely fortunate to be able to convene the resources and expertise of the Center for Applied Genomics (CAG), the 22q and You Center, and CAR in order to examine complex genetic questions – spanni

    Sentiment: Strong Buy

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    had a string of winners and I have already added 30% to my trading account following them for

    a few months.

  • Reply to

    great news this morning

    by jjgb072000 Feb 17, 2016 8:15 AM

    Good company to invest with. I wonder if they got their shares through the 7 Million share secondary offering of Oct. 1, 2015.

    Sentiment: Strong Buy

  • Reply to

    great news this morning

    by jjgb072000 Feb 17, 2016 8:15 AM

    Adage Capital Management, and Baker Brothers Advisors, (both respectable biotech money managers), took a large stake in MDGN last quarter. Broadfin also doubled there position and now own over 9%.

    Sentiment: Strong Buy

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MDGN
5.35+0.18(+3.48%)May 24 4:02 PMEDT