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remember november'15

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  1. TheAdmiral 6 november 2015 11:33
    Op verzoek van Rotel74 ook even op dit draadje mijn eerdere post:

    Discussies van de afgelopen dagen op dit forum overziende, vermeld ik toch nog maar even 1 keer opnieuw de duidelijke, zeer zelfverzekerde en trotse uitspraken van de CEO Eduardo Bravo van Tigenix:

    “De grote verwezenlijkingen die we onlangs hebben bekendgemaakt, zijn uiterst belangrijke stappen die ons zullen helpen om ons potentieel volledig te benutten. Ze zullen een geweldige invloed hebben op de onderneming en haar toekomst”, zo zegt Eduardo Bravo, CEO van TiGenix. “We hebben de volledige commerciële rechten voor Cx601 met positieve fase III-gegevens en zijn klaar
    om een markttoelatingsaanvraag in te dienen in Europa. Bovendien beschikken we over een duidelijk Cx601-traject in de Verenigde Staten met goedkeuring van de FDA voor de aanvraag. Het gaat om een potentiële markt van 2 miljard euro. We hebben onlangs Coretherapix overgenomen,een onderneming met een platform van hartstamcellen. Het voornaamste product van Coretherapix,AlloCSC-01 voor acuut myocardinfarct, bevindt zich in een vergevorderde fase II-klinische studie.
    Met Cx611 verwachten we een fase II-studie te kunnen beginnen bij ernstige sepsis, de voornaamste doodsoorzaak in ziekenhuizen in het westen. We zijn uiterst trots dat we een van de weinige ondernemingen zijn met zulke veelbelovende vooruitzichten voor de nabije toekomst.”

    Het moge duidelijke zijn, dat ik long Tigenix zit en dat blijf ik ook. Eerder met Galapagos heb ik me door negatieve verhalen laten verleiden (groten)deels te vroeg uit te stappen en dat gaat me hier niet gebeuren. Tigenix is goed bezig, geen "one-trick-pony", met een breed palet aan veelbelovende ontwikkelingen en op dagen van zwakte koop ik plukjes bij. Bij Tigenix kent men, na de zeer positieve onderzoeksresultaten, de eigen sterke onderhandelingspositie en laat men zich gelukkig niet verleiden door een te snelle deal met partners en werkt men liever aan een gedegen samenwerkingsverband.
    Dat noem ik buitengewoon verstandig.
  2. marios 6 november 2015 13:17
    Waarom zouden we ingaan op sanderus zijn veronderstellingen, want dat zijn het,veronderstellingen. Alle nieuws is bekend, niks meer,niks minder. Alleen moet sanderus er steeds zijn eigen negatieve draai aan geven. Van mij mag iedereen zijn mening geven en iedereen mag hem volgen en zelfs verkopen. Ik doe zelf mijn huiswerk en weet waar ik in beleg. En ja,in biotech zijn er geen zekerheden,meer risico,maar als biotechbeleggers zijn we daar natuurlijk allemaal van op de hoogte. Dat mes snijdt aan weerszijden . Bij goed nieuws,mooie winst,bij slecht nieuws, ....
  3. [verwijderd] 6 november 2015 14:48
    quote:

    Nice guy schreef op 6 november 2015 10:39:

    [...]
    blijft natuurlijk wel opvallend dat je jezelf alleen laat zien als het aandeel daalt, afgelopen weken niet gehoord en sinds deze week weer actief met de slecht nieuws show

    Dan let je niet goed op, ik heb met Tig ook mooie rijtjes gemaakt en toen was ik ook positief, een beetje realiteit kan geen kwaad.
  4. [verwijderd] 8 november 2015 11:08
    TiGenix NV (TIG.BR)
    TiGenix Receives €5.4 million Grant for Development of Cx611 in Severe Sepsis
    Please click here for full report

    Company Update
    November 6, 2015
    On November 2, 2015, Tigenix (Euronext Brussels: TIG.BR) announced a €5.4 million grant from the European Commission to support the SEPCELL project, a Phase Ib/IIa trial designed to evaluate the safety and efficacy of Cx611 for the treatment of severe sepsis secondary to severe community-acquired pneumonia (sCAP). Tigenix expects to enroll patients at clinical facilities throughout Europe, including Center Hospitalier Universitaire of Limoges, the Cliniques Universiktaires Saint-Luc in Brussels, the Hospital Clinico San Carlos of the Servicion Madrileno de Salud in Madrid, and the Academic Medical Center of the University of Amsterdam. As project leader, Tigenix receives €1.3 million of non-dilutive funds, and will be responsible for managing the remaining €4.1 million to fund the project’s clinical and research activities.

    Cx611 for the Treatment of Severe Sepsis. The SEPCELL project is a randomized, double-blind, placebo-controlled, Phase Ib/IIa study for Cx611 in severe sepsis secondary to sCAP. Subjects in the trial must have sCAP requiring mechanical ventilation and/or vasopressors. The trial is expected to enroll 180 patients, and will be conducted at approximately 50 centers throughout Europe. Subjects will be randomized 1:1 to receive Cx611 or placebo on days 1 and 3. All patients will also be treated with the standard of care, which generally includes antibiotics and anti-inflammatory drugs. The primary endpoint is the number of adverse events during a 90 day period. Secondary endpoints include the reduction in the duration of mechanical ventilation and/or vasopressors, improved survival, clinical cure of sCAP, and other infection-related endpoints. The trial is expected to launch in 2015.

    Analysts
    Jerry Isaacson, Ph.D. (AC)
    (646) 597-6991
    jisaacson@lifescicapital.com
    Market Data
    Price $1.07
    Market Cap (M) $171
    EV (M) $183
    Shares Outstanding (M) 168.2
    Avg Daily Vol 639,571
    52-week Range: $0.53 - $1.44
    Cash (M) $22.7
    Net Cash/Share $0.16
    Annualized Cash Burn (M) $14.5
    Years of Cash Left ~2.0
    Debt (M) $36.4
    Cash and debt are pro forma as of June 30, 2015
    Currency values converted at 1 Euro to 1.09 USD
    Financials
    FY Dec 2013A 2014A 2015A
    EPS H1 (0.12)A (0.08)A (0.08)A
    H2 NA NA NA
    FY (0.21)A (0.11)A NA
    Safety and Tolerability Demonstrated in CELLULA Phase I Study. Tigenix completed a placebo-controlled, dose-ranging study of Cx611 in 32 healthy male volunteers. Subjects were exposed to lipopolysaccharides (LPS), a common model for inducing inflammation, and then randomized to receive Cx611 or placebo at a ratio of 3:1. The volunteers received 250,000, 1 million, or 4 million eASCs/kg, or placebo, via IV injection. Primary endpoints were vital signs and symptoms, laboratory measures, and functional assays of innate immunity. Results from the trial suggest that the product was safe and well tolerated. No serious adverse events were reported with any of the three doses tested. With respect to anti-inflammatory activity, no significant effect of Cx611 on the lipopolysaccharide-induced symptoms could be detected.

    Cx611 is an Allogeneic Stem Cell Therapy. Cx611 is a cellular product candidate developed using TiGenix’s proprietary platform of allogeneic expanded adipose-derived stem cell (eASCs). The cells have low immunogenicity, and are designed to promote systemic immuno-modulatory effects. They are readily available from liposuction procedures with yields 100-1000 times higher than bone marrow cells, and can be easily expanded in culture. Pre-clinical data has demonstrated eASCs can protect against severe sepsis by reducing pro-inflammatory and inducing anti-inflammatory cytokines. Severe sepsis remains a significant unmet medical need with an estimated 15-19 million cases worldwide each year.
    Expected Upcoming Milestones
    Q4 2015 – Commence Phase Ib/IIa study of Cx611 in severe sepsis.
    Q4 2015 – Finalize enrollment of AlloCSC-01 Phase I/II study in AMI.
    Q1 2016 – File for marketing authorization of Cx601 in Europe.
    Q2 2016 – 1-year follow-up results from European Phase III trial of Cx601 in complex perianal fistulas in Crohn’s disease.
    H2 2016 – Interim analysis of AlloCSC-01 Phase II study in AMI.
    H2 2016 – Complete technology transfer to Lonza to manufacture Cx601 in the US.
    H2 2016 – File IND for a US Phase III trial with Cx601 in complex perianal fistulas in Crohn’s disease.
    Q1 2017 - Initiate US Phase III trial with Cx601 in complex perianal fistulas in Crohn’s disease.
    H1 2017 – Expected topline data from Phase II for AlloCSC-01 in AMI.
    H2 2017 – Potential EMA approval and commercial launch of Cx601 for complex perianal fistulas in Crohn’s disease.
    2020 – Potential FDA approval of Cx601 for complex perianal fistulas in Crohn’s disease.
    Risk to Investment
    We consider an investment in TiGenix to be a high-risk investment. The Company receives revenue from the ChondroCelect cell therapy product but this revenue is not sufficient to support ongoing operations. The Company may therefore need to rely in the future on other forms of financing that may be dilutive to existing shareholders and may subsequently decrease the valuation of the Company. While the eASC product platform contains numerous promising clinical candidates, this technology has not yet been validated by a regulatory approval. TiGenix may fail to develop and bring its pipeline products to market or find appropriate partners to help develop these products. Moreover, the Company’s future marketed products may fail to achieve expected levels of sales or may be overtaken by competing products.

    For more information visit www.lifescicapital.com
    Analyst Certification
    The research analyst denoted by an “AC” on the cover of this report certifies (or, where multiple research analysts are primarily responsible for this report, the research analyst denoted by an “AC” on the cover or within the document individually certifies), with respect to each security or subject company that the research analyst covers in this research, that: (1) all of the views expressed in this report accurately reflect his or her personal views about any and all of the subject securities or subject companies, and (2) no part of any of the research analyst's compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst(s) in this report.

    DISCLOSURES
    This research contains the views, opinions and recommendations of LifeSci Capital, LLC (“LSC”) research analysts. LSC (or an affiliate) has received compensation from the subject company for producing this research report. Additionally, LSC expects to receive or intends to seek compensation for investment banking services from the subject company in the next three months. LSC (or an affiliate) has also provided non-investment banking securities-related services, non-securities services, and other products or services other than investment banking services to the subject company and received compensation for such services within the past 12 months. LSC does not make a market in the securities of the subject company.

    Neither the research analyst(s), a member of the research analyst’s household, nor any individual directly involved in the preparation of this report, has a financial interest in the securities of the subject company. Neither LSC nor any of its affiliates beneficially own 1% or more of any class of common equity securities of the subject company.
  5. [verwijderd] 9 november 2015 02:18
    Risk to Investment
    We consider an investment in TiGenix to be a high-risk investment. The Company receives revenue from the ChondroCelect cell therapy product but this revenue is not sufficient to support ongoing operations. The Company may therefore need to rely in the future on other forms of financing that may be dilutive to existing shareholders and may subsequently decrease the valuation of the Company. While the eASC product platform contains numerous promising clinical candidates, this technology has not yet been validated by a regulatory approval. TiGenix may fail to develop and bring its pipeline products to market or find appropriate partners to help develop these products. Moreover, the Company’s future marketed products may fail to achieve expected levels of sales or may be overtaken by competing products.


    Dat wisten we al, maar voor de koers op korte termijn is dit niet best :(
  6. Rotel74 9 november 2015 08:21
    quote:

    Hunter300 schreef op 9 november 2015 06:34:

    Wil je lager bijkopen, dat je dit oude nieuws nu zo post? Heb je vannacht wat geld op straat gevonden?
    Alle info is openbaar. Dit is wel echte info, echter deze info lijkt u niet wel te gevallen. Iedereen wordt geacht zelfstandig tot een besluit tot koop of verkoop te komen en dan al dan niet tot aktie over te gaan.
    Ik vind deze reactie van weinig respect getuigen.
    Ben ik nu de enige die hierover zo denkt? Reageren mag altijd!
  7. [verwijderd] 9 november 2015 08:41
    kbc

    Strong phase III results push Cx601 to market

    Tigenix is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics based on allogeneic expanded stem cells.

    • Tigenix develops and commercialises novel therapeutics from its proprietary platform of allogeneic (donor-derived) expanded adipose-derived stem cells, known as eASCs, for inflammatory and autoimmune diseases.

    • Two products from this technology platform are currently in clinical development. Cx601 is being developed for the treatment of complex perianal fistulas in Crohn’s disease patients. Last August, the product showed convincing phase III results and is heading towards EMA filing in 1Q16. Cx611 is in Phase II severe sepsis and completed a phase I/II for rheumatoid arthritis.

    • In 3Q15, Tigenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is in a phase II study in acute myocardial infarction (AMI) for which results are expected in 2H16.

    • Tigenix also developed ChondroCelect, an autologous cell therapy product for repairing knee cartilage, but poor sales prompted a licensing to Sobi in 2014.

    • End-June, cash funds available were € 23m, sufficient to support operations into 2H16. In 4Q13, the venture arm of Spanish Griffols became a reference shareholder (21%).

    • We value Tigenix at € 1.5/sh based on the prospects of Cx601 and solid news flow in the coming period, warranting a Buy rating. - See more at: beursig.nl/forum/viewtopic.php?f=4&am...

    STRENGTHS

    • Cx601 might prove to be a breakthrough for the treatment of complex perianal fistula in Crohn’s.
    • Proven leadership in cell therapy with several clinical-stage products and extensive clinical experience.
    • Strong expertise in development and manufacturing of cell-based products, including regulatory issues.
    • Well-filled pipeline of innovative cell products.

    OPPORTUNITIES

    • Allogeneic products could be used off-the-shelf.
    • Cell therapy market expected to be major growth industry, with growing interest from big pharma/medtech.
    • Clinical development products focus on blockbuster indications (cardiac and sepsis).
    • All rights on Cx601 and other products.

    WEAKNESSES

    •Immune-modulatory cell industry still in infancy.
    •?Regulatory and reimbursement frameworks are not yet adopted for innovative cell-based products.
    • Lead eASC product indicated for niche market.
    • Refinancing has been difficult in the past.

    THREATS

    ??New technologies from established players may increase competitive pressure.
    • Failure of Cx601 regulatory path would be a serious setback.
  8. [verwijderd] 9 november 2015 09:23
    Voor de liefhebbers . Ik heb Tigenix nog 2 verduidelijkende vragen gesteld waar we veel aan (kunnen ) hebben .

    1 mbt de productie van stamcellen / veiligheid -erfelijkheid / controle etc. Hoe doen ze dat ?

    2 het verschil tussen de cardio ontwikkeling/product bij Celyad en het cardio product van Tigenix

    Hartelijk dank voor het antwoord van Tigenix /Claudia D'Augusta
    ( wie is ze ? tigenix.com/en/page/6/management-team )

    Dear Bioscience

    Thanks for your emails and for your interest in TiGenix.

    1 Your first request of elucidation around the regulatory environment for cell therapy products is a very legitimate one and entitles a broad experience from our regulatory experts to be properly addressed. As a matter of fact, the text posted by Charlie Boon covers the classical challenges of the manufacturing and characterization of this therapies. Some of them are relevant to autologous product, derived from the same patient, and would not apply to Cx601 (which is allogeneic or from donors).

    Anyway, I would say that the field in general, and definitely ourselves are very aware of them and have developed our products under those considerations. We´ve been in the working groups commenting those aspects with regulators and involved in the development of current guidelines. I want to remind you that we´ve extensively discussed these aspects with regulators by means of scientific advice, at the European medicine agency and also in the member states. Besides, Cx601 was approved in 8 countries for the ADMIRE trial including the toughest European agencies so went already to a deep scrutiny there.

    We indeed perform exhaustive donor selection and serology testing according to tissue and cells directives (and beyond!), control raw materials and excipients, test adventitious agents at appropriate stages of production etc. We perform genetic stability to discard any genetic problem. We can demonstrate that our manufacturing process operates under predefined conditions in a consistent and reproducible manner and that batches of predefined quality can be obtained. We have used and tested different donors in the different stages of development showing a consistent and robust manufacturing process and that products are equivalent independently of donor.

    2 As per your request about “What is the different between the cardio product of Tigenix and Celyad ?” the difference is the indication and the source of the cells. We are treating patients who have undergone an AMI (Acute Myocardial Infarction) therefore in an acute setting to limit the extent of tissue damage and reduce the formation of a non-functional scar with the consequence process of ventricular remodelling. Celyad is addressing the so called Congestive Heart Failure (CHF) which is not an acute setting but addresses patients with chronic advanced symptomatic heart failure, a terminal condition. The product used by Celyad is autologous while AlloCSC-01 is allogeneic (or from donor) and can be used within few days after the stent is inserted. Therefore we are not addressing the same indication.

    I hope that this helps. Please do not hesitate to come back to us if you have any additional question.

    Have a nice week-end!

    Claudia
  9. [verwijderd] 9 november 2015 10:50
    Je kent mijn drama verhaal mbt Genfit . Uitgestapt op ca 4 euro en daarna binnen 2 jaar richting de 60 euro . Heb daar wat hoogtevrees .

    Zit mbt biotech in Tigenix Ablynx en MDX .

    Denk dat ABlynx en Tigenix op dit moment de beste papieren hebben (op dit moment 100% LT).Voor beide kan 2016 een grote doorbraak betekenen . MDX misschien ook al trek ik daar iets meer twijfel bij na alle recente ontwikkelingen MDX van LT naar MT bij mij . Uiteraard kan dit alles veranderen bij belangrijke ontwikkelingen .

    Iedereen zit zo gebrand op GLPG . Ik denk echter dat Ablynx voor nu een veel voordeliger alternatief is en een mooiere toekomst verwachting heeft .(mijn mening )

  10. forum rang 4 aossa 9 november 2015 12:31
    @bioscience:

    Hoe schat jij de financieringspositie in van deze aandelen?

    GLPG: ruime kaspositie, op zoek naar partner voor feelgood-tinib; deal waarschijnlijk nog dit jaar.

    ABLX: ruime kaspositie dank zij Merkel deal, doch veel ijzers in het vuur.

    TIG: niet zo rooskleurige kaspositie; financieringsproblemen blijven de koers parten spelen. Op zoek naar partner USA en mogelijk Nasdaq IPO.
    (Vandaag gelezen in de Tijd dat participatie +30% mogelijk is zonder overnameverplichting indien voortkomt door aankoop van rechten bij kapitaalsverhoging).

    MDX: geschrapt van mijn lijstje (wegens financieringsperikelen dacht ik).

    Graag verbetering en/of aanvulling aub!
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