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GTC Biotherapeutics - Deel 13

1. [verwijderd] 23 februari 2010 18:40

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   nette voorwaarden
2. [verwijderd] 23 februari 2010 18:41

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   Gaaaaap.................................
   
   Kijk eens aan een lening van 7 miljoen.
   
   bingo di bango........
   
   Vroeger waren het altijd convertibles deze leningen.
   
   Vroeger vertelde men erbij hoelang men kon rondkomen met z'n centen.
   
   Nu weten we niet eens hoe ze het gaan aflossen na 3 jaar.
   
   Waarom hebben ze voor deze constructie gekozen?
   
   conclusie: transgeen is weinig transparant.
   
   ps : nu is er in China een bedrijfje dat geitenmelk verkoopt, omzet 26 miljoen, winst 1.5 miljoen en groeiende.
   
   Zou gtc...b niet jalours zijn op deze company?
   
   Wat is eigenlijk voor de aandeelhouders de toegevoegde waarde van deze geitenclub?...
   Tot vandaag in ieder geval nul........ ...
   
   Maar in de toekomst?
   
   met die vlla beginnen ze pas in de clinische fase
   dwz tot over een jaar of 5 .........hopelijk.
   
   succes........................................
   
   zou Nieuwberry er nog werken voor een mooi salaris?
   Ik denk het niet, immers 80% van alle aandelen is in vaste handen, dus je kunt je afvragen, wat is zijn toegevoegde waarde nog, ik denk ongeveer nul.
   
   Tip: koop ANX op de nasdaq, binnen een paar dagen bericht, doet 30 ct.
3. ludwig mack 26 februari 2010 21:59

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   van pharmingforum gejat:
   
   www.ema.europa.eu/pdfs/human/press/pr...
   
   zie schema annex 1.
   
   gr
4. ludwig mack 27 februari 2010 13:41

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   Startup funding rebounds after month's slow start
   Boston Business Journal - by Craig M. Douglas
   
   Massachusetts startups have pulled in more than $87 million in financing this week, a solid investment rebound for local tech and life sciences companies after a tepid funding stretch earlier in the month, according to regulatory filings and company announcements covered by the Boston Business Journal.
   
   The week's investments in 13 companies brought February's total take for local startups to just under $188 million, as of Friday morning. That's still down considerably from January, when Boston-area firms reported taking in more than $430 million in venture investments.
   
   For a year-to-date list of all of the local investments reported by the BBJ, CLICK HERE.
   This week's financings:
   
   * Mersana Therapeutics raises $2.5M in debt round
   * Ra Pharmaceuticals raises $10.3M in VC
   * GTC Biotherapeutics lands $7 million round
   * Allurent Inc. pulls in $2M in funding
   * Currensee Inc. takes in $8 million
   * Dexrex Inc. nets $1 million from investors
   * Luminus Devices Inc. lights up with $19 million
   * Seahorse Bioscience floods coffers with $5M
   * General Compression raises $17 million
   * Marathon Technologies Inc. runs down $6.5M round
   * Myriant Technologies LLC raises $5 million
   * Minerva Biotechnologies Corp. collects $1.6 million in backing
   * ConnectEDU Inc. connects on $3.5M round
   
   boston.bizjournals.com/boston/stories...
5. ludwig mack 27 februari 2010 13:42

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   Form 8-K for GTC BIOTHERAPEUTICS INC
   
   26-Feb-2010
   
   Entry into a Material Definitive Agreement, Creation of a Direct Financia
   
   Item 1.01 Entry into a Material Definitive Agreement.
   
   Note Purchase Agreement
   
   On February 22, 2010, we entered into a Note Purchase Agreement with LFB Biotechnologies S.A.S., or LFB, under which LFB agreed to purchase from us a $7,000,000 secured note. Issuance and sale of the secured note was subject to the satisfaction of certain conditions, including the accuracy of the representations and warranties of the parties and the satisfaction of other customary closing conditions. On February 24, 2010, upon the satisfaction of those conditions, we issued and sold the secured note to LFB upon receipt of the $7,000,000 in cash.
   
   The Note Purchase Agreement is incorporated by reference into this Current Report on Form 8-K. Except for its status as the contractual document between the parties with respect to the agreements described therein, it is not intended to provide factual information about the parties. The representations and warranties contained in the Purchase Agreement were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and are subject to limitations agreed to by the contracting parties, including being qualified by disclosures between the parties. These representations and warranties have been made for the purposes of allocating contractual risk between the parties to the agreements instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Accordingly, they should not be relied upon by investors as statements of factual information.
   
   Secured Note
   
   The secured note has a 36-month term and accrues interest at a rate of 4%, with a single payment of principal and interest at maturity. After January 1, 2011 LFB may annually adjust the rate of interest upwards or downwards, based on LFB's then-current cost of capital, as determined by LFB in the exercise of its commercially reasonable discretion. Over the term of the secured note LFB may elect to participate in any of our future equity financing transactions by cancelling all or any portion of the principal and interest outstanding under the secured note for any shares of our common stock or securities convertible, exercisable or exchangeable into shares of our common stock that we issue and sell in the financing.
   
   Amendments to Existing Loan Agreements
   
   On February 24, 2010, we also entered into a Third Amendment to our Amended and Restated Security Agreement with LFB, dated June 18, 2009 and a Third Amendment to our Mortgage, Security Agreement and Fixture Filing dated as of December 22, 2008. The purpose of these amendments was to modify our existing security arrangements with LFB to add the secured note to our debt that is secured by a first priority security interest on all of our assets, including our intellectual property, but excluding livestock.
   
   LFB
   
   LFB is our largest stockholder. As of February 24, 2010, LFB owned 21,299,910 shares of our common stock, or approximately 71% of our outstanding common stock, as well as 100% of our Series D preferred stock, a warrant and convertible debt which were convertible into 7,169,564 shares of our common stock. If the convertible debt is converted, the warrants exercised and the Series D convertible preferred stock converted, LFB would own 28,469,474 shares, or approximately 76.7% of our common stock.
   
   biz.yahoo.com/e/100226/gtcb8-k.html
6. [verwijderd] 1 maart 2010 14:12

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   GTC PROVIDES UPDATE ON TG20 MONOCLONAL ANTIBODY TARGETING CD20
   
   
   
   FRAMINGHAM, MA – March 1, 2010 -- GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of the LFB-GTC joint venture. TG20 has enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), a key feature useful in the treatment of cancer and auto-immune diseases, and it has been shown to have 10-fold enhanced ADCC when compared side by side with rituximab in assays performed with B-cell chronic lymphocytic leukemia, or B-CLL, patient cancer cell isolates.
   
   
   
   “This result is an important demonstration of the ability of GTC’s transgenic technology platform to produce monoclonal antibodies with significantly enhanced ADCC”, said Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. “Furthermore, this is a critical milestone in our development of TG20, an antibody that has the potential of providing more efficacious and cost-effective treatments for cancers such as non-Hodgkin’s lymphoma as well as auto-immune diseases such as rheumatoid arthritis”.
   
   
   About TG20
   
   Under their joint venture, GTC and LFB are developing TG20, a MAb that targets the CD20 receptor of the immune system with target specificity similar to the rituximab MAb (Rituxan®, MabThera®). This antibody has demonstrated a significantly higher ADCC than rituximab. ADCC is one of the mechanisms that the immune system uses to kill cells targeted by a specific antibody. Therapeutic MAbs with increased ADCC are believed to offer more potent treatments for oncology indications. Rituximab is used as a single-agent treatment for relapsed or refractory indolent non-Hodgkin’s lymphoma, or NHL, and also in combination with chemotherapy for the treatment of aggressive NHL. Rituximab has received marketing approval in both the EU and the U.S. for rheumatoid arthritis. Worldwide sales of rituximab were approximately $5.6 billion in 2009.
   
   
7. ludwig mack 1 maart 2010 16:20

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   ben je er weer?
   
   ;-)
8. ludwig mack 5 maart 2010 22:32

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   Press Release Source: GTC Biotherapeutics, Inc. On Friday March 5, 2010, 3:59 pm
   
   FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. (Nasdaq: GTCB - News) (“GTC”) announced today that its financial results for the fourth quarter and year end 2009 will be released on Friday, March 12, 2010 followed by a webcast conference call starting at 10:00 a.m. Eastern Time. You may access the live internet broadcast or the subsequent archived recording, on GTC’s website at www.gtc-bio.com or access the conference call as follows:
   
   Live Call – In the United States, dial 1-877-407-0778
   Outside the United States, dial 201-689-8565
   
   Audio Archive – In the United States, dial 1-877-660-6853
   Outside the United States, dial 201-612-7415
   Reference call ID: when prompted Account #: 286 Conference ID #: 346748
   
   NOTE: a replay of the call will be available one hour following the end of the call and will be accessible until March 12, 2011.
9. welshterrier 5 11 maart 2010 08:57

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   GTC BIOTHERAPEUTICS TO WEBCAST CORPORATE PRESENTATION AT THE ROTH 22ND ANNUAL OC GROWTH STOCK CONFERENCE
   
   
   
   FRAMINGHAM, MA, March 10, 2010 -- GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced today that Geoffrey Cox, Ph.D., GTC’s Chairman and CEO, is scheduled to present on Wednesday, March 17, 2010 at 2:00 p.m. during the ROTH 22nd Annual OC Growth Stock Conference. The conference is being held at the Ritz-Carlton, Laguna Niguel, California from March 15-17, 2010.
   
   
   
   The presentation will be webcast live and can be accessed by logging onto www.gtc-bio.com. The replay can be accessed from this same website and will be available within 24 hours of the presentation.
   
   
10. [verwijderd] 12 maart 2010 12:35

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    quote:

    welshterrier schreef:

    GTC BIOTHERAPEUTICS TO WEBCAST CORPORATE PRESENTATION AT THE ROTH 22ND ANNUAL OC GROWTH STOCK CONFERENCE
    
    correctie:
    
    GTC BIOTHERAPEUTICS TO WEBCAST CORPORATE
    PRESENTATION AT THE ROTH 22ND ANNUAL OC SHRINK
    STOCK CONFERENCE
    
    GTC......THINK.....SHRINK
    
    
    
    
    
    

11. ludwig mack 12 maart 2010 15:40

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    GTC BIOTHERAPEUTICS REPORTS FOURTH QUARTER AND FISCAL YEAR END 2009 FINANCIAL RESULTS
    FRAMINGHAM, MA – March 12, 2010 -- GTC Biotherapeutics, Inc. ("GTC", NASDAQ: GTCB) today reported its financial results for the fourth quarter and fiscal year ended January 3, 2010. The total net loss for the fourth quarter was $1.7 million, or $0.09 per share, compared with $6.2 million, or $0.60 per share, for the fourth quarter of 2008. The total net loss for 2009 was $27.9 million, or $2.18 per share, compared to $22.7 million, or $2.31 per share, for 2008.
    
    
    “GTC has maintained strong progress in its core programs in recombinant plasma proteins and follow on biologics”, stated Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. “We are now on the threshold of bringing two additional programs into clinical development, rhFVIIa and rhAFP, both of which address large market opportunities”.
    
    
    
    Cash Position
    
    
    
    Cash at January 3, 2010 totaled $3.8 million, a $7.8 million decrease compared to $11.6 million at December 28, 2008. Last month, GTC obtained an aggregate of $7 million of new funding from LFB Biotechnologies (LFB) in the form of a 4%, 36-month term loan with a single payment of principal and interest at maturity. With this new funding from LFB and anticipated receipts from existing partnering agreements, GTC projects that its cash resources will be sufficient to support its operations to the end of the second quarter of 2010, exclusive of future cash proceeds from potential new partnering agreements.
    
    
    
    Significant product development events for 2009 and outlook for 2010
    
    
    
    Factor VIIa
    
    
    
    GTC, together with its collaboration partner LFB, has established the transgenic rabbit production system for its rhFVIIa program and initiated the production of clinical lots to support the IND filing and subsequent clinical program. Following discussions with the FDA, GTC plans to file an IND in April, with the objective of initiating a Phase I study in the 2nd quarter of 2010. This is planned to be a safety, pharmacokinetic and pharmacodynamic study in comparison with NovoSeven®, in normal healthy volunteers. On the basis of current plans, GTC expects to have results from this study in the fourth quarter of 2010.
    
    Alpha-Fetoprotein (AFP)
    
    
    
    GTC in-licensed the AFP program in the middle of 2009. GTC has established a herd of transgenic goats that produce this product in significant quantities. Animal model tests are currently being conducted that are considered to be predictive for efficacy in autoimmune diseases such as myasthenia gravis and multiple sclerosis. GTC’s plan is to initiate a Phase II study in myasthenia gravis in the second half of 2010 once a partnering arrangement has been obtained.
    
    ATryn®
    
    
    
    Following approval of ATryn® by the FDA, Lundbeck, Inc. (Lundbeck), formerly Ovation Pharmaceuticals, Inc., launched ATryn® in the USA in May 2009. Lundbeck continues its commercialization of ATryn® in the hereditary deficiency indication. In addition, GTC is collaborating with Lundbeck to develop a protocol for a pivotal study of patients with acquired antithrombin deficiency who are undergoing cardiac surgery. GTC aims to initiate a clinical trial in this indication in the second half of 2010.
    
    
    
    In Europe, GTC is seeking to establish an alternative partnering arrangement for the commercialization and further development of ATryn® following the termination of GTC’s contract with LEO Pharma (LEO). At this time there is no final decision in the LEO arbitration proceedings which GTC initiated with the International Chamber of Commerce.
    
    
    
    Monoclonal Antibodies and Follow-on Biologics
    
    
    
    GTC, together with its collaboration partner LFB, has established transgenic goat production systems for the production of TG20, a monoclonal antibody that targets CD20. TG20, which is not identical to Rituximab (Rituxan®), has demonstrated in in-vitro studies that it has an approximately 10-fold greater antibody dependent cell-mediated cytotoxicity (ADCC) than Rituximab. This may translate into improved efficacy or reduced dosage in hematologic malignancies. GTC is seeking a partner to support its share of the commercialization and clinical development of TG20.
    
    
    
    GTC has established production animals which express Trastuzumab (Herceptin®) in their milk, and this protein is currently being characterized. GTC is also developing transgenic animals for the production of Adalimumab (Humira®), and, together with our collaboration partner AgResearch in New Zealand, transgenic animals for the production of Cetuximab (Erbitux®). For each of these products we will be seeking partners to support further clinical development and commercialization.
    
    
    
    This portfolio of product candidates addresses markets with total annual sales currently in excess of $16 billion. For our product candidates addressing oncology indications, the natural glycosylation of the transgenic production system may provide advantages in ADCC. GTC plans to characterize each of these proteins as they become available and to initiate non-clinical studies in support of future partnering activities.
    
    
    
    Other Financial Results
    
    
    
    Revenues were approximately $1.2 million for the current quarter, compared to approximately $1.0 million for the fourth quarter of 2008. Fourth quarter revenues for 2009 were primarily from the sale of ATryn® product to Lundbeck. The revenues for the fourth quarter 2008 were primarily from GTC’s program with PharmAthene for services provided for their Protexia® program. Revenues for the year 2009 totaled $2.8 million compared to $16.7 million for 2008. The 2009 revenues were primarily due to the sale of ATryn® product to Lundbeck and services provided to PharmAthene for their Protexia® program. Revenues for 2008 were primarily due to the sale of ATryn® product to LEO, our former marketing partner in the EU, as well as revenue derived from the PharmAthene program and from the completion of GTC’s production program for Merrimack Pharmaceuticals for their MM-093 product (AFP).
    
    
    
    Costs of revenue and operating expenses were $8.7 million for the current quarter, compared to $8.4 million for the fourth quarter 2008. For the year, costs of revenue and operating expenses were $39.1 million for 2009, compared to $39.9 million for 2008. The reduction in headcount that GTC implemented in the fourth quarter of 2009, together with other expense reductions, is expected to produce approximately $6 million in expense savings for 2010.
    
    Cost of revenue was $1.1 million for the current quarter, compared to $582,000 for the fourth quarter 2008. For the year, cost of revenue was $2.3 million for 2009, compared to $8.6 million for 2008, a $6.4 million reduction reflecting the timing of ATryn® shipments to LEO as well as higher level of activities on both the PharmAthene and Merrimack programs during 2008.
    
    
    Research and development expenses were $4.5 million for the current quarter compared to $5.3 million for the fourth quarter of 2008. For the year, research and development expenses totaled $25.4 million for 2009 compared to $21.0 million for 2008, an increase of $4.4 million. The increase in the comparison year over year was primarily due to the impact of LFB fully funding GTC’s portion of the joint venture programs in 2008 while GTC funded the majority of its share o
12. [verwijderd] 12 maart 2010 17:34

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    GTC Biotherapeutics bids adieu to Nasdaq
    
    boston.bizjournals.com/boston/stories...
13. ludwig mack 12 maart 2010 21:05

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    uit p.b.:
    
    At this time there is no final decision in the LEO arbitration proceedings which GTC initiated with the International Chamber of Commerce.
    
14. ludwig mack 12 maart 2010 22:22

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    het uitblijven arbitrage resultaat drukt de koers. de zaak zal toch complexer zijn, dan we dachten ...
    
    fijn weekeinde.
    gr
15. [verwijderd] 13 maart 2010 13:06

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    Als ze binnenkort van de Nasdaq verdwijnen zal de koers vast nog verder zakken. Zou instappen dan nog iets kunnen opleveren of is het echt een aflopende zaak? Een buyout door LFB lijkt me ook niet echt een optie, want waarom zouden ze de nog aanwezige aandeelhouders geld geven als de techniek ook gratis kan worden overgenomen bij een eventueel faillissement.
16. [verwijderd] 13 maart 2010 13:53

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    Q&A antwoorden toch lachwekkend en ontwijkend
17. ludwig mack 14 maart 2010 13:52

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    quote:

    Klaaz o J schreef:

    Als ze binnenkort van de Nasdaq verdwijnen zal de koers vast nog verder zakken. Zou instappen dan nog iets kunnen opleveren of is het echt een aflopende zaak? Een buyout door LFB lijkt me ook niet echt een optie, want waarom zouden ze de nog aanwezige aandeelhouders geld geven als de techniek ook gratis kan worden overgenomen bij een eventueel faillissement.
    

    ik zie het totaal anders en kan je niet helpen;
    zit er dan ook nog steeds in.
    
    gr
18. ludwig mack 15 maart 2010 16:29

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    quote:

    crackedtooth schreef:

    Q&A antwoorden toch lachwekkend en ontwijkend
    

    vind ik nog al meevallen. ach, je hoeft ook niet steeds te zeggen dat je eet dat je het moeilijk hebt, amerikanen zijn zo, en dat keep up geeft me in ieder geval ook een beter idee, dan dat ze er ook de moed bij laten zitten.
    
    gr
19. [verwijderd] 16 maart 2010 22:03

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    16-03-2010 slotkoers GTC Biotherapeutics $ 0,82
20. ludwig mack 17 maart 2010 15:42

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    nu ze van verhandelforum veranderen, zal de koers verder dalen vandaag;
    verder is er niets gewijzigd en is het puur daardoor dat de koers daalt;
    dat moet je gewoon erkennen, maar ik wacht af en koop eventueel bij.
    
    gr