Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Medgenics (MDGN): Turning Over a New Leaf with Biobank-Based Genomics Medicine - Full Report October 6, 2016 by Zack Fink at BioTerp Partners
http://media.wix.com/ugd/542edc_dd5bc1ea633b4e74a7a9b226cc7c6a29.pdf
Medgenics enters collaboration with Kyowa Hakko Kirin for the development and commercialization of its anti-LIGHT monoclonal antibody
Medgenics plans to initiate a signal finding study testing the drug in Severe Pediatric Onset Inflammatory Bowel Disease (:IBD) in collaboration with Dr. Robert Baldassano, Director of the Center for Pediatric IBD at The Children's Hospital of Philadelphia
Upon completion of the signal finding study in Severe Pediatric Onset IBD, the Company will have an option to license rights to develop the program. Following exercise of the option, Medgenics will make a one-time, upfront payment in the low single-digit millions to Kyowa Hakko Kirin. Kyowa Hakko Kirin will then select one of two potential collaboration structures: a co-development/co-commercialization partnership or a licensing arrangement. Medgenics will have commercialization rights in the United States and Canada in both structures, and will also add commercialization rights in Europe if Kyowa Hakko Kirin selects the licensing arrangement. Kyowa Hakko Kirin will have commercialization rights in the rest of the world under both structures, as well as Europe in the co-development/co-commercialization structure. Terms for both structures have been pre-agreed and include a combination of royalties and profit-sharing.
Sub $5... I have to add at this level!
Medgenics Licenses Novel GeneRide Gene Therapy Technology From Stanford University
PHILADELPHIA, Jan. 06, 2016 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE:MDGN), today announced the signing of a license with Stanford University providing exclusive rights to certain breakthrough gene therapy technologies developed in the labs of Professor Mark A. Kay, M.D., Ph.D., Dennis Farrey Family Professor in Pediatrics, Professor of Genetics, at Stanford University School of Medicine. Under the license, Medgenics gains the exclusive right for the autologous ex vivo use of Stanford’s GeneRide novel promoter-less gene therapy technology in combination with Medgenics’ proprietary TARGTTM technology. Medgenics also receives the exclusive right to use this technology for the delivery of hematopoietic stem cells for sickle cell anemia and beta thalassemia.
“We are excited to gain access to the GeneRide technology, combining the benefits of AAV vector gene transfer with the potential for permanent delivery of therapeutic proteins and peptides,” said Garry Neil, MD, Chief Scientific Officer of Medgenics. “Most importantly, this system is designed to allow efficient and predictable integration into precisely defined sites, using naturally occurring promoters.”
“By avoiding off-target integration the GeneRide system could provide a comparably safer approach than other competing gene therapies,” said Mike Cola, Medgenics CEO. “The additional capabilities afforded by the Stanford technology puts us in a position to be a leader in ex vivo gene therapy.”
About Medgenics, Inc.
Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is the developer of TARGTTM (Transduced Autologous Restorative Gene Therapy), a proprietary platform for the sustained production and delivery of therapeutic proteins, monoclonal antibodies and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases. For more information, visit the Company's website at www.medgenics.com.
Contacts:
Medgenics, Inc.:
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations:
Beth DelGiacco
212-362-1200
Beth@sternir.com
Mr. Isaac Blech's (Director) Share Sale Timing & Details.
Perfect timing Mr. Blech.... Nice, exercise the options @ $4.10 per share just before the dilution! And on a cashless basis no less by selling 94,825 @ $9.96 per share.
I wish I sold my own shares at $9.96. I would be buying them back right now hand over fist at around $6.90.
-----------
Insider Transaction: $MDGN Sale at $9.96 per share of 94825 shares by Director Blech Isaac on 2015-09-21
------
1. On September 21, 2015, the reporting person exercised a warrant to purchase 230,357 shares of Common Stock for $4.10 per share. The reporting person paid the exercise price on a cashless basis, resulting in the Issuer's withholding of 94,825 of the warrant shares to pay the exercise price and issuing to the reporting person of the remaining 135,532 shares.
------
$MDGN recent news/filings
bullish
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$MDGN DD Notes ~ http://www.ddnotesmaker.com/MDGN
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=MDGN+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=MDGN+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=MDGN+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/news - http://finance.yahoo.com/q/h?s=MDGN+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/MDGN/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=MDGN+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/MDGN
DTCC (dtcc.com): http://search2.dtcc.com/?q=Apple%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Apple%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Apple%2C+Inc.&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.apple.com/pr
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.apple.com/pr#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.apple.com/pr
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/MDGN
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000320193&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=MDGN&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=MDGN
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=MDGN+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=MDGN+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=MDGN
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=MDGN
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=MDGN+MDGNh+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/MDGN/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=MDGN+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/MDGN.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=MDGN
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/MDGN/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/MDGN/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/MDGN
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/MDGN
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/MDGN:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=MDGN
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=MDGN
StockTwits (stocktwits.com): http://stocktwits.com/symbol/MDGN
$MDGN DD Notes ~ http://www.ddnotesmaker.com/MDGN
MDGN: neuroFix Acquisition Could Be A Needle-Mover
Zacks Small Cap Research
September 11, 2015 12:20 PM
By Brian Marckx, CFA
http://finance.yahoo.com/news/mdgn-neurofix-acquisition-could-needle-162000992.html
MDGN Acquires CNS Compound
Medgenics (MDGN) will acquire neuroFix Therapeutics, LLC and its lead candidate NFC-1, a compound targeting CNS disorders associated with mutations of the metabotropic glutamate receptors (mGluRs). Initial focus will be on Attention Deficit Hyperactivity Disorder (ADHD), where Phase 1 data showed promising results and which a Phase 2/3 study is expected to commence in early 2016, and 22q11.2 Deletion Syndrome, a rare condition also associated with mGluR mutations and one which may offer orphan status opportunities (both specifically for 22q11.2 Deletion Syndrome as well as associated indications).
This is the first opportunity to come from MDGN's relationship with CHOP (management noted on the presentation call that they believe this is just the first of many to come). To be clear, this is an extension of the company's overall focus and MDGN remains highly committed to their TARGTEPO and overall gene therapy programs.
neuroFix was founded by Dr. Hakon Hakonarson, Director of the Center for Applied Genomics at CHOP, in order further develop NFC-1. Prior to MDGN's acquisition, neuroFix licensed certain technology related to ADHD and other neurological and neuropsychological indications from CHOP.
Terms of the deal;
$2M upfront in cash
$6M in cash and common stock upon earlier of achievement of a "corporate milestone" (specifics of which were not disclosed) or March 31, 2016
additional payments of up to $450M upon achievement of certain milestones (development, regulatory and sales) related to an oral formulation of NFC-1 and any new chemical entity (NCE) developed covering the same indication (specifics in terms of exactly what this relates to and what the triggers are were not disclosed)
sales royalties based on tiered rates ranging from mid-to-high single digits depending on the product or NCE
$25M for each FDA approved indication beyond the initial indication
Terms of License Agreement between neuroFix and CHOP;
up to $1.5M in regulatory and sales milestones for each FDA approved indication using IP covering the agreement
sales royalties based on a fluctuating rate in the low single digits - which adjust downward based on the extent of third party royalties
$100k or less in annual maintenance fees
a percentage (ranging from mid-single digits to mid-teens) of any sublicense income (ex-sublicensed sales by a certain party in Japan)
this license agreement terminates upon the later of the expiration of certain CHOP patent rights and January 1, 2025, at which time neuroFix owns the covered licensed rights
Metabotropic Glutamate Receptors (mGluRs)
The amino acid glutamate is the most prominent excitatory neurotransmitter in the brain. It binds to mGluRs which are involved in the modulation of synaptic transmission and neuronal excitability in the central and peripheral nervous system. Genetic mutations of genes within the mGluR network have been associated with certain conditions including ADHD, anxiety disorders, schizophrenia and other neuropsychiatric disorders.
Research conducted by Dr. Hakonarson and colleagues indicated that mutations in the mGluR gene network are associated with a 10x higher rate of ADHD. They found that disruptions specifically to GRM1 (glutamate receptor, metabotropic 5), GRM3, GRM 7 and GRM8 were associated with ADHD.
NFC-1 GREAT Study
neuroFix, in collaboration with CHOP, conducted a Phase 1, 30-patient, single arm study at Thomas Jefferson University (Philadelphia) assessing NFC-1 in adolescents with ADHD. Inclusion criteria included professionally diagnosed with ADHD and genotyped as having disruptions to the mGluR network. The background of the enrolled population had certain symptoms which could be considered particularly challenging to effectively treat including;
73% had severe ADHD (CGI-S>5, on a scale of 1=normal to 7=extremely ill)
67% had co-morbid psychiatric conditions such as anxiety, ODD and insomnia
30% were on antipsychotics and/or antidepressants
70% had been previously treated with ADHD drugs (with presumably little benefit)
One-week run-in on placebo was followed by four weeks of active treatment. Treatment was dose-escalating from 50mg (x2/day) to a maximum of 400mg (x2/day). Dose was escalated weekly. Patients were blinded, clinicians were not. Primary endpoint was safety, secondary endpoint efficacy measures were standard ADHD assessments including Vanderbilt and Clinical Global Impressions (CGI) scores.
Full results will be presented at AACAP in late October in San Antonio. Management also provided a glimpse of the data on the call announcing the transaction which included;
dose and time-dependent response on both the CGI-I and Vanderbilt measures
-over 80% of patients responded to NFC-1 treatment on Vanderbilt measure at week 5
-just under 80% of patients responded NFC-1 treatment on CGI-I measure at week 5
-Repeated measure analysis showed statistically significant response on both measures over time and at higher doses
Mutations to "tier 1" genes (i.e those in the mGluR receptors) and "tier 2" genes (i.e. those that encode proteins that influence mGluR but are not in the receptors) showed much higher response rates compared to "tier 3" genes (more distant from the receptors and therefore likely to show lower response)
Excellent safety with no treatment related serious adverse events
20 of the 30 patients chose to continue to receive NFC-1 therapy in an ongoing long-term safety trial. As management noted in their presentation, this is clearly a positive vote of confidence in the efficacy of NFC-1 given that there's a significant hassle involved in coming to the clinic on a regular basis to receive treatment (i.e. - it's unlikely patients/parents would continue if they experienced no positive effect)
View gallery
.
View gallery
.
We note that there is the risk of unintended bias in the CGI-I score given that the clinician was not blinded in this study (management noted that the clinician is highly qualified in ADHD assessment, which we acknowledge is likely a mitigating factor). Risk of bias, however, is not relevant with Vanderbilt which is a parent-rated assessment as the parents were blinded in the study - and both CGI-I and Vanderbilt demonstrated dose and time dependent response, indicating that NFC-1 is effective in ADHD treatment. The planned upcoming Phase 2/3 will be double-blinded and therefore will not be at risk of bias.
Phase 2/3 Study
Given the more pronounced response in tier 1 and tier 2 gene mutations, which are believed to account for approximately 20% of the ADHD population, this will be an inclusion criteria in the Phase 2/3 trial. MDGN is still in process of putting the specific trial design together (hope to meet with FDA in that regard later this year) but expects;
primary efficacy endpoints to be ADHD RS (parent-assessment) and CGI-I
is expected to serve as the pivotal trial (although a Phase 3 confirmatory trial is anticipated)
aiming to initiate in Q1 2016 with initial data in H2 2016
Anticipated enrollment was not provided on the call but certainly expect it to be significantly larger than Phase 1 (n=30). It will be controlled, randomized, double-blind and powered for statistical significance - as such we think the initial data read-out could provide a lot more insight into the efficacy of NFC-1 in ADHD.
ADHD Market Is Attractive: Positive Phase 2/3 Data Could Be a Needle-Mover to Share Price
ADHD could be a hugely attractive market for MDGN and a genetic-based therapy including the significant size of the market, ambiguity of diagnosis and unmet need for therapies which are more effective and have less problematic side effect profiles.
~6M children (ages 3 - 7) are diagnosed with ADHD in the U.S. This equates to ~10%
ADHD is the most common neurobehavioral disorder diagnosed in the U.S.
No definitive test exists to diagnose ADHD - all ADHD diagnoses are arbitrary based on subjective assessment
Stimulants such as Adderrall (amphetamine and dextroamphetamine), Vyvanse (lisdexamfetamine) and ritalin (methylphenidate) account for over 90% of ADHD prescriptions. These drugs are associated with significant side effects including risk of addiction, irritability and difficulty sleeping, among others. They are highly regulated due to their risk of addiction. These stimulants do not always address all of the underlying symptoms which often can include anxiety and psychotic disorders - mGluR mutations have been associated with other psychiatric conditions which means NFC-1 may be able to address not only ADHD but other of these conditions as well.
Unlike stimulants NFC-1 (MDGN has not identified the molecule as additional IP is still being locked down) does address the underlying cause of ADHD. In addition, diagnosis (of mGluR mutations) is genetically-based, not arbitrary. It also (in clinical trials to-date, which includes a 1,000+ patient study in vascular dementia), has shown an excellent side-effect profile. And 10% - 20% of the entire U.S. ADHD market is ~600k - 1.2M people - which is very significant for a company of MDGN's size, particularly given that the benefits of NFC-1 over stimulants should offer the opportunity for premium pricing. We think it is conceivable that mGluR+ADHD could easily represent a multi-billion dollar market opportunity. As such, if the planned Phase 2/3 study confirms what was demonstrated in Phase 1, we think this could be a needle-mover to the share price.
22q11.2 Deletion Syndrome: Orphan Opportunity for NFC-1 to Address Related Psychological Disorders
22q11.2 Deletion Syndrome is a relatively rare disease with incidence (per The International 22q11.2 Foundation Inc.) estimated at one in every 1,000 live births - which equates to about 4,000 new cases every year in the U.S (~130k worldwide). We have not been able to find an estimate of prevalence rates, although management noted on the call that U.S. prevalence is believed to be approximately 75k - 100k.
22q11.2 Deletion Syndrome is characterized by the deletion on the long arm of one pair of chromosome 22 (region 1, band 1, sub-band 1). The disorder can affect most systems in the body and is associated with serious physical and neuropsychological problems including cardiovascular issues, cleft palate, abnormal facial features, immune disorders and behavioral, psychotic and anxiety disorders (including ADHD). And while many of the physical problems such as heart defects and cleft palate can be addressed by traditional medical intervention such as surgery, there are no current therapies available to address the psychological disorders. It is estimated that about 30% - 40% of individuals with 22q11.2 Deletion Syndrome will eventually progress to schizophrenia.
And mGluR mutations appear to play a roll in 22q11.2 Deletion Syndrome with over 90% of 22q11.2 Deletion Syndrome patients having at least one mGluR network related deletion. In fact two patients in the Phase 1 ADHD study had 22q11.2 mutations (one deletion and one duplication), both of which, per the company's presentation, reported "significant symptom improvement in both CGI-I and Vanderbilt" and both patients continue in the long-term safety trial.
So MDGN will look to capitalize on the potential affect of NFC-1 in 22q11.2 Deletion Syndrome and expects to initiate a Phase 1/2 indication and dose finding study early next year. First steps will be to submit an IND - which they hope to do later this year. The initial study is expected to parse out the first (of potentially other follow-on) indication - which MDGN noted could be related to ADHD, anxiety or mood disorders - and, if all goes well, could have initial read-out around mid-2016.
MDGN thinks a 22q11.2-related indication could be fairly fast-moving and ahead of mGluR+ADHD. Given the rarity of incidence and lack of any effective treatment, it's possible (assuming demonstrated NFC-1 effectiveness) this could be a quick-moving regulatory orphan candidate. While we caution that it's too early to jump on a bandwagon at this point (although positive results from 2 of 2 patients in the GREAT trial is encouraging), if the initial P1/2 study is positive, MDGN thinks they can go directly to a pivotal, regulatory approval-supporting study.
Given the benefits of orphan status (potentially massive pricing power, extended exclusivity, tax credits, fast-track regulatory advantage, etc) and no effective therapies that address the symptoms (much less the underlying cause), this could be a home-run type of candidate for MDGN (although remember, royalties and, potential milestones, will apply). And the beauty is, assuming enrollment in the study(ies) is not a challenge (CHOP is the leader in 22q11.2 research which presumably will facilitate this), evidence of efficacy (or not) may not be a long wait.
Our Take: Phase 2/3 Data May Be a Catalyst for Share Price…
MDGN most likely has at least $8 million in this acquisition - which includes $2M upfront and another $6M by 3/31/2016 - and since P2/3 mGluR+ADHD data is not expected until 2H 2016, it's fair to assume $8M is essentially spent - not an unreasonable figure given the strong Ph 1 data, likelihood to move the compound rapidly through development in a range of indications, orphan status potential (in addition to in ADHD) and what could very likely be a captive market given the lack of current effective therapies in these indications.
Terms of the acquisition also include "additional payments of up to $450 million upon the achievement of certain developmental, regulatory and sales milestones related to an oral formulation of NFC-1 (the “Product”) and any new chemical entity developed by the Company covering the same indication as the Product (an “NCE”)" as well as royalties on sales of a commercialized product. Specifics in terms of exactly what the 'up to $450M payments' relate to and what the triggers are were not disclosed - although presumably the bulk relates to a post-approved product. It's a big number but relative to the potential size of the market that NFC-1 may be able to address, including possibly a multi-billion dollar opportunity in mGluR+ADHD alone (and commanding big margins), there could be significant meat left on the bone for MDGN.
While it is still too early for use to model this candidate, we think the Phase 2/3 data, assuming it supports what was seen in Ph 1, could be catalyst for the stock price as this should provide much more insight into the potential of NFC-1 in both ADHD and 22q11.2.
MDGN: ADDITIONAL DATA SUPPORTS EFFICACY IN EPO AND GLP-2 APPLICATIONS
Click here to read the complete article from ZACKS
http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2015/MDGN-Additional-Data-Supports-Efficacy-in-EPO-and-GLP-2-Applications/default.aspx
Medgenics Awarded $3.4 Million Grant From the Israeli Office of the Chief Scientist
PHILADELPHIA, June 11, 2015 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that its wholly owned subsidiary, Medgenics Medical Israel Ltd. (MMI), was awarded a government grant of up to NIS 13.3 million (approximately USD 3.4 million) from the Office of the Chief Scientist (OCS) at the Ministry of Economy of Israel.
The grant will be used to cover R&D expenses for the 13-month period from December 2014 through December 2015 to support further research and clinical development of the Company's proprietary tissue-based TARGT (Transduced Autologous Restorative Gene Therapy) system with respect to the treatment of rare and orphan diseases.
The OCS awards grants to companies from various industries in Israel to foster technological innovations. Recipient selections are based on multiple criteria including the uniqueness of a company's technology, and the potential market it addresses, plus the robustness of the company's business including financial position, R&D capabilities and management experience.
Under the terms of the OCS grant, MMI will repay the grant in full, plus interest, through royalties on revenue received from commercializing the developed technology. The payment of royalties is contingent on such revenues and, in the absence of such revenues, no royalty payments to the OCS are required.
"We are once again honored to be a chosen recipient for non-dilutive funding from the Israeli OCS and are grateful for the continued support. The current funding represents a greater than 50% increase over prior years, and provides critical support as we initiate additional trials of our TARGT platform in the U.S. and Israel," stated Garry A. Neil, Chief Scientific Officer of Medgenics.
About Medgenics, Inc.
Medgenics is developing the TARGT(TM) (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will, " "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
CONTACT: Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations
Beth DelGiacco
212-362-1200
Beth@sternir.com
(END) Dow Jones Newswires
Kudos to the new management for choosing the right path!
Just read that "Alexion Pharma takes out Synageva BioPharma for $230 per share" This is a huge premium for a company that specializes in rare diseases.
Thanks to the new management, Medgenics is now a company that specializes in rare and orphan diseases...... and with the agreement with CHOP that pipeline will only grow.
As always, this is just my opinion and judging by the lack of any posts on this board I guess there is no interest by the retail investor in this stock!
----
"It's not what you look at that matters, it's what you see"
Henry David Thoreau
----
Medgenics Receives New Coverage from Analysts at JMP Securities / $15 PT (MDGN)
Edited from: http://sleekmoney.com/medgenics-receives-new-coverage-from-analysts-at-jmp-securities-mdgn/203176/
Medgenics Inc: JMP Securities assumed coverage on shares of Medgenics (NYSEMKT:MDGN) in a research note issued to investors on Monday The firm issued an outperform rating on the stock.
Separately, analysts at Piper Jaffray raised their price target on shares of Medgenics from $7.00 to $11.50 and gave the company a buy rating in a research note on Tuesday, January 20th.
Shares of Medgenics (NYSEMKT:MDGN) opened at 8.69 on Monday. Medgenics has a 1-year low of $3.68 and a 1-year high of $8.80. The stock’s 50-day moving average is $8. and its 200-day moving average is $6.. The company’s market cap is $215.45 million.
Medgenics (NYSEMKT:MDGN) last announced its earnings results on Friday, February 13th. The company reported ($0.30) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.22) by $0.08.
Q4 2014 Medgenics Inc Earnings Presentation PDF (LINK)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NTY5NDQ0fENoaWxkSUQ9MjcwMzMwfFR5cGU9MQ==&t=1
Should You Purchase Medgenics After Its Recent Run Up?
Link to Seeking Alpha Article:
http://seekingalpha.com/article/2858736-should-you-purchase-medgenics-after-its-recent-run-up
I've held MDGN for over 3 Years and I've never been more bullish.
I've held it when it was over $16 a share and never worried under $4.
In Time I'll Be A HERO to those who listened. MedGenics is not a cure............. it's compliance. Everyone has a glitch in their system and a solution like Medgenics allows those with rare or "orphan" glitches live their life without daily pills or injections that assault their body.
If I'm right, I'm right ..... if not, I'm sorry!
MDGN: Positive MDGN-201 Data Through 7 Months
http://finance.yahoo.com/news/mdgn-positive-mdgn-201-data-143000703.html
Link To PDF of Biotech Conference Presentation 1/13/15:
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NTY1OTAxfENoaWxkSUQ9MjY2MzY2fFR5cGU9MQ==&t=1
Amazing science, excellent management and the potential to really improve lives. Biotech investing is a marathon and I'm giddy with excitement to see this company run and progress over the next three Years.
Question on Hep C / IFN-a therapy: How would using INFRADURE biopump reduce or eliminate the severe side effects of this therapy? What are the reported side effects?
Medgenics CEO Cola Buys 60,976 Shares @$4.10/Share
Medgenics to Present at 26th Annual Piper Jaffray Healthcare Conference
PHILADELPHIA, Nov. 25, 2014 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Michael Cola, President and CEO, will participate in a fireside chat discussion at the 26th Annual Piper Jaffray Healthcare Conference in New York.
The event will take place at 12:00 p.m. EST on Wednesday, December 3, 2014 at The New York Palace Hotel. A live webcast of the presentation can be accessed under "Presentations" in the Investors section of the Company's website at www.medgenics.com or you may use the link: http://www.media-server.com/m/p/67nyj8e4.
About Medgenics, Inc.
Medgenics is developing TARGT(TM) (Transduced Autologous Restorative Gene Therapy), a proprietary ex vivo gene therapy platform for the sustained production and delivery of therapeutic proteins and peptides using a patient's own tissue, for the treatment of rare and orphan diseases. For more information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Contact:
Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations
Beth DelGiacco
212-362-1200
Beth@sternir.com
Great News!
It's done....Placement, pricing and with no warrants.
http://finance.yahoo.com/news/medgenics-prices-public-offering-common-140000908.html
I was expecting this towards the end of next Year.... However, they need 5M for CHOP and this is money very well spent.
You have the cash, now.... do good work!
I'm either a fool or a wise man... only time will tell. The brilliant Doctors at CHOP are smarter than I and I'm very proud to be main trumpet blower on iHub for MDGN.
New Positive Clinical Data Supports Quest Towards Orphan Designations
Seeking Alpha Article.
http://seekingalpha.com/article/2569135-new-positive-clinical-data-supports-quest-towards-orphan-designations?uprof=45
Summary
We view the new clinical data as highly promising.
2nd-Gen viral vector showing more controlled delivery and longer duration of effect.
MDGN reveals three orphan targets, two of which could enter clinical trials in 2015.
Highly Promising Trial Data with Next-Gen Vector, Orphan Indications Revealed. Q3 Results
Medgenics to Present Initial Clinical Data From MDGN-201 Study at European Society of Gene and Cell Therapy Congress
MDGN, the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that initial data from its ongoing Phase 1/2 clinical trial of MDGN-201 (TARGTEPOTM), formerly known as EPODURETM, will be presented at the 22nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) being held in The Hague, Netherlands from October 23rd-26th, 2014
Big Volume, Big Gain... Why?
I'm not complaining just curious. Has data from trials leaked?
MDGN: Trial / Development Timelines Remain On-Track
http://finance.yahoo.com/news/mdgn-trial-development-timelines-remain-160000572.html
Medgenics Announces Global Head, Research and Development, Garry Neil, M.D. Receives FDA Commissioner's Special Citation Award
WAYNE, Pa. and MISGAV, Israel, June 18, 2014 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Garry Neil, M.D., Global Head, Research and Development, has been awarded the Food and Drug Administration's (FDA) Commissioner's Special Citation. The Citation was established as an expression of the Commissioner's personal appreciation, recognizing outstanding and significant service in the public interest related to activities of the FDA. Dr. Neil has been extensively involved with many aspects of FDA policy work, including his work with the Reagan-Udall Foundation for the FDA. The Foundation fosters collaborations between patient groups, industry, academia, and FDA scientists to design and conduct regulatory science research.
About Medgenics, Inc.
Medgenics is developing and commercializing BioPump(TM), a proprietary platform for the sustained production and delivery of therapeutic proteins using ex-vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Contact:
Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations
Beth DelGiacco
212-362-1200
Beth@sternir.com
More insider buying.
6/13/2014 - Sol J Barer - Director - Buy - 28,000@$7.96 = $222,880.00
Medgenics to Present at Two Upcoming Healthcare Investor Conferences
WAYNE, Pa. and MISGAV, Israel, Jun 16, 2014 (GLOBE NEWSWIRE via COMTEX)
Medgenics, Inc. (nyse mkt:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that members of the senior management team will be participating in the following upcoming healthcare investor conferences.
Piper Jaffray GenomeRx Symposium on Monday, June 23, 2014 at the Yale Club in New York, NY. Dr. Garry Neil, Global Head of Research and Development, will participate in a panel entitled Novel Delivery Approaches: Evolving an Evolving Field at 2:35 p.m. ET.
9th Annual JMP Securities Healthcare Conference on Wednesday, June 25, 2014 at the Westin New York Grand Central in New York, NY. Dr. John Leaman, Chief Financial Officer, will present at 3:30 p.m. ET.
About Medgenics
Medgenics is developing and commercializing BioPump™, a proprietary platform for the sustained production and delivery of therapeutic proteins using ex vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com .
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
CONTACT: Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Stern Investor Relations
Beth DelGiacco
1 212 362 1200
beth@sternir.com
Medgenics Looking To Exploit Orphan Drug Market With Its Novel Biopump Protein Therapy Technology
Seeking Alpha Article:
LINK: http://seekingalpha.com/article/2261123-medgenics-looking-to-exploit-orphan-drug-market-with-its-novel-biopump-protein-therapy-technology
Summary
Biopump offers an innovative method of producing and delivering therapeutic proteins or peptides through the use of a patient's own skin.
Biopump offers potentially significant advantages over traditional intravenous protein therapy.
In September 2013, the company brought on new executive management with a specific goal of accelerating development of the Biopump technology, with a particular emphasis on orphan diseases.
Biopump will be further validated in just-commenced Phase I/II trial in treatment of anemia via production and delivery of erythropoietin to patients with chronic kidney disease and end-stage renal disease.
Game plan includes in-house development of Biopump for orphan indications and potentially partnering for further development for an ESRD/CKD indication.
Snapshot
Medgenics, Inc. (MDGN) was founded in January 2000 in Israel, and remains a development-stage company with research focused on bringing a novel therapeutic protein platform technology to market. Research and development is done primarily from a Misgav, Israel facility, while the principal office is located in Wayne, PA.
The company is led by a highly experienced management team and board of directors. This includes chairman of the Board, Sol Barer, the founder and former chairman of Celgene. In September 2013, the company brought on new executive management with highly impressive and relevant backgrounds, including a new CEO, CFO and global head of R&D, with a specific goal of accelerating development of the Biopump technology. Michael Cola, the newly-appointed CEO, comes most recently from Shire Plc's Specialty Pharmaceuticals division ($2.5B annual sales), where he served as president and was involved in all aspects of the business. Dr. Garry Neil, head of Global R&D, brings over 30 years of clinical development experience to the company, previously head appointments as corporate vice-president of Science and Technology and group president of Pharmaceutical Research and Development at Johnson & Johnson, and he has been actively involved in over twenty worldwide drug approvals.
Medgenics Announces First Patient Implanted in Phase 1/2 Clinical Trial of MDGN-201 (EPODURE)
Trial to Validate a Second Generation Viral Vector for Potential Use in Future Clinical Studies in Rare and Orphan Diseases
WAYNE, Pa. and MISGAV, Israel, June 5, 2014 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its Phase 1/2 clinical trial of MDGN-201 (EPODURETM).
The aim of the trial is to validate the potential of the Company's BioPump(TM) platform using a second generation vector, which was developed to enhance durability of the proposed therapeutic effect. The study will evaluate the potential of the updated platform to offer sustained production and delivery of erythropoietin (EPO) to treat anemia in dialysis patients with end-stage renal disease (ESRD) or chronic kidney disease (CKD).
"The initiation of this trial is a testament to the capabilities and dedication of the Medgenics Research and Development Group. Our goal in conducting this clinical trial is to validate the new BioPump platform using an updated protocol and second generation viral vector. While we expect to see the same advantages over other forms of protein replacement that we saw with the first generation vector, we also hope to see substantially sustained levels of protein production," commented Dr. Garry Neil, Global Head, Research and Development of Medgenics. "Treatment alternatives for EPO-dependent anemia patients are still needed, so we hope to demonstrate the BioPump's capability to produce physiologically relevant levels of autologous EPO in patients with CKD and ESRD. We also hope to validate the new platform as a delivery mechanism for multiple rare and orphan diseases. As part of this strategy, we expect to initiate several in vivo proof-of-concept studies in established mouse models in rare and orphan disease indications later this year."
About the Trial (MG-EP-RF-02)
The trial will enroll up to 18 patients with either CKD or ESRD who require erythropoietin treatment for anemia. Each patient will receive one or more BioPumps and will be followed for at least one year. The trial endpoints include plasma erythropoietin levels, blood counts and safety assessment. Preliminary results are expected by the end of 2014. Additional details may be found on www.clinicaltrials.gov using identifier NCT02117427.
About Chronic Kidney Disease and End-stage Renal Disease
CKD is a progressive loss of kidney function over months to years. The three most common causes of CKD are diabetes mellitus, hypertension and glomerulonephritis. ESRD is also known as Stage 5 CKD. ESRD requires kidney replacement therapy, either dialysis or kidney transplantation.
About Medgenics, Inc.
Medgenics is developing and commercializing BioPump(TM), a proprietary platform for the sustained production and delivery of therapeutic proteins using ex-vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Contact:
Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations
Beth DelGiacco
212-362-1200
Beth@sternir.com
Medgenics director just picked up 60,000 shares
http://www.conferencecalltranscripts.org/summary/?id=1009589
Sol J Barer, a director of Medgenics, recently acquired 60,000 shares of the company. The buys took place at $6.91 per share, on May 12, 2014. Barer now owns 179,000 shares of the company. Barer operates out of Wayne, PA. Some additional info was provided as follows:
The price reported in Column 4 is a weighted average price. These shares were purchased in multiple transactions at prices ranging between $6.84 and $6.99, inclusive. The reporting person undertakes to provide to Medgenics, Inc., any security holder of Medgenics, Inc. or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares purchased at each separate price within the range set forth in this footnote.
The above information was disclosed in a filing to the SEC.
Medgenics Reports First Quarter Financial Results
WAYNE, Pa. and MISGAV, Israel, May 8, 2014 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today reported financial results for the three months ended March 31, 2014 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company's Quarterly Report on Form 10-Q.
First Quarter 2014 and Recent Highlights
Medgenics's wholly owned subsidiary, Medgenics Medical Israel, Ltd., was awarded a $2.2 million grant from the Office of the Chief Scientist (OCS) at the Ministry of Industry, Trade and Labor of Israel for the continued development of the Company's BioPump(TM) platform technology for the treatment of rare and orphan diseases, and anemia.
Medgenics' shareholders approved the cancellation of the Company's admission to the London Stock Exchange Alternative Investment Market (AIM) at the Annual Meeting of Stockholders held on April 8, 2014.
Management Commentary
"This first quarter of 2014 has been a productive one for us. With our new management team in place, we have focused our attention on our clinical development platform and have further evolved our pipeline strategy towards identifying and evaluating BioPump targets in the rare and orphan disease market," stated Michael Cola, President and Chief Executive Officer of Medgenics. "We are excited by the progress we have made so far in developing the BioPump platform and expect to initiate our EPODURE trial in the second quarter of 2014. We are likewise pleased with the advancement of the multiple preclinical programs that represent our ongoing strategic shift into the rare and orphan disease space."
First Quarter 2014 Financial Results
Gross and net research and development expense for the three months ended March 31, 2014 increased to $2.15 million from $2.03 million for same period in 2013. This increase was due mainly to increased stock-based compensation expenses related to options granted to research and development personnel.
General and administrative expense for the three months ended March 31, 2014 was $3.09 million, up from $2.55 million for the same period in 2013 primarily due to an increase in personnel and increased stock-based compensation expenses related to options granted to general and administrative personnel.
Financial expense for the three months ended March 31, 2014 increased to $0.12 million from $0.01 million for the same period in 2013, mainly due to the change in valuation of the warrant liability.
Financial income for the three months ended March 31, 2014 was de minimis, decreasing from $0.92 million for the same period in 2013. The decrease was primarily due to the change in valuation of the warrant liability.
For the three months ended March 31, 2014, the Company reported a net loss of $5.36 million or $0.28 per share, compared with a net loss of $3.68 million or $0.24 per share for the three months ended March 31, 2013.
About Medgenics
Medgenics is developing and commercializing BioPump(TM), a proprietary platform for the sustained production and delivery of therapeutic proteins using ex-vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, please visit www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
Medgenics awarded $2.2 mln grant from the Israeli office of the chief scientist (MDGN) :
Co announced that its wholly owned subsidiary, Medgenics Medical Israel was awarded a government grant of up to NIS 7.7 million (approximately USD 2.2 million), from the Office of the Chief Scientist at the Ministry of Economy of Israel.
The grant will be used to cover Research & Development expenses for the 12-month period from December 2013 through November 2014 to support further research and clinical development of the Company's proprietary, tissue-based BioPump platform technology with respect to the treatment of new rare and orphan diseases and anemia.
No News = 10% gain and 3 X normal volume..... Okay, what's up?
GALT, CNAT, ICPT, & MEDGENICS (MDGN) treat liver disease. MDGN technology targeting LIVER HEPATITIS etc.
Medgenics director just picked up 7,000 shares
Stephen D McMurray, a director of Medgenics, recently acquired 7,000 shares of the company. Mcmurray now owns 93,835 shares of the company. Mcmurray operates out of Wayne, PA. Some additional info was provided as follows:
Includes 3,500 shares of restricted stock which will vest on January 2, 2015. The option award vests in three equal annual installments beginning on January 2, 2015.
The above information was disclosed in a filing to the SEC.
You beat me to it with your question. Looking at past trading history. Should continue upward tomorrow
Rvl
8% Afternoon Bump On Above Average Volume. No News... any idea why?
Medgenics announced Director entered into stock trading plan & change of adviser
(MDGN) : Co announced that, on 23 December 2013, Andrew Pearlman, founder and a director, has established a personal stock trading plan in accordance both with the guidelines established by Rule 10b5-1 under the U.S. Securities Exchange Act of 1934, as amended, and the AIM Rules for Companies as well as the Company's policies with respect to insider sales. The transactions under the plan will be disclosed publicly through Form 144 and Form 4 filings as required by the U.S. Securities and Exchange Commission and in the UK through a Regulatory Information Service.
INSIDER BUYING CONTINUES!!!
Medgenics Reports Open Market Purchase of Common Stock by Director.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the Company), the developer of Biopump(TM) a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that the Company was informed today by Dr. Alastair Clemow, a director of the Company that he purchased 4,500 shares of common stock on the open market on December 16, 2013 at an average price of $5.7787 per share.
Following this purchase, Dr. Clemow now owns 18,500 shares of common stock, which represents approximately 0.1 per cent of the total issued shares of common stock. Dr. Clemow also has the right to purchase up to 105,714 shares of common stock pursuant to options previously granted (in aggregate Dr. Clemow's shares of common stock and options represent 124,214 shares of common stock which represent approximately 0.7 per cent of the Company's total issued shares of common stock).
This announcement is being made pursuant to the London Stock Exchange's AIM Rules for Companies admitted to trading on the AIM market.
Another 20K Insider Buy at 5.37
Chairman Sol Barer = 7.7% of MDGN.
Medgenics to Present at the Oppenheimer 24(th) Annual Healthcare Conference.
MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--December 04, 2013--
Medgenics, Inc. (NYSE MKT:MDGN and AIM:MEDU, MEDG) (the Company), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that Company management will participate in the Oppenheimer 24(th) Annual Healthcare Conference taking place from December 10-11, 2013 in New York City.
Michael Cola, President and Chief Executive Officer of Medgenics, will present a corporate overview on Wednesday, December 11th at 4:30 p.m. Eastern time.
Medgenics Reports Open Market Purchase of Common Stock by Chairman of the Board.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the Company), the developer of Biopump(TM) a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that on December 2, 2013, was informed by Dr. Sol Barer, Medgenics' Chairman of the Board of Directors, that he purchased 20,000 shares of common stock on the open market on that day at an average price of $6.5890 per share.
Following this purchase, Dr. Barer now owns 92,000 shares of common stock, which represents approximately 0.5 percent of the total issued shares of common stock. Dr. Barer, directly or through trusts for the benefit of Dr. Barer and his family, also has the right to purchase up to 1,315,000 shares of common stock pursuant to options previously granted (in aggregate Dr. Barer's shares of common stock and options represent 1,407,000 shares of common stock which represent approximately 7.6 percent of the Company's total issued shares of common stock).
This announcement is being made pursuant to the London Stock Exchange's AIM Rules for Companies admitted to trading on the AIM market.
Another 25,000 shares bought at market for Sol Barer.
http://www.sec.gov/Archives/edgar/data/1138776/000114420413060657/xslF345X03/v360190_4.xml
72,000 owned by public purchase.
Nov 11 2013
MDGN Medgenics, Inc. Barer Sol J Director 25,000 Purchase at $6.80 $170,123
Sep 20 2013
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $6.50 $129,996
Sep 19 2013
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $5.57 $111,478
SolBarer buys addn'l 20Kshares 1day aft.prev.buy.
Sep 20 12:43pm
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $6.50 $129,996
Sep 19 03:22
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $5.57 $111,478
Dir SOL BARER Buys 20,000 Of MEDGENICS INC at 5.57 on 9/19
http://www.sec.gov/Archives/edgar/data/1138776/000114420413051582/xslF345X03/v355477_4.xml
Followers
|
5
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
125
|
Created
|
02/08/12
|
Type
|
Free
|
Moderators |
About Medgenics, Inc.
Medgenics is developing TARGT™ (Transduced Autologous Restorative Gene Therapy), a proprietaryex vivo gene therapy platform for the sustained production and delivery of therapeutic proteins and peptides using a patient's own tissue, for the treatment of rare and orphan diseases. For more information, visit the Company's website at www.medgenics.com.
Our core strategy is based upon three fundamental strengths:
TECHNOLOGY:![]() Transduced Autologus Restorative Gene Theraphy |
| | | ||
|
|
|
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |