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September - SAG meeting

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Pagina: «« 1 ... 36 37 38 39 40 ... 83 »» | Laatste | Omlaag ↓
  1. C200 10 september 2019 07:15
    Kiadis Pharma announces results for the six months ended June 30, 2019

    Kiadis to hold conference call with investors today at 15:00 CEST

    Amsterdam, The Netherlands, September 10, 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its unaudited interim results for the six months ended June 30, 2019, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
    Arthur Lahr, CEO of Kiadis Pharma, commented: “In the first six months of 2019, through the acquisition of Cytosen, we have transformed Kiadis into a company with two cell therapy platforms to help patients with life-threatening diseases. Kiadis now has a pipeline with therapies in all stages of development focused on both hematopoietic stem cell transplantation (HSCT) and novel cell therapies for patients with cancer. Through these programs we are leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.”
    Mr. Lahr continued: “While the review by the European Medicines Agency of the marketing authorization application continues, we have advanced the global phase 3 study for ATIR101 with major transplant centers in the US, EU, Canada and Israel participating in the study; and we plan to open the NK-REALM transplant phase 1/2 study for CSTD002 and a NK phase 1/2 study to treat AML R/R patients in 2020.”
    Operating highlights (including post-reporting period)
    • Kiadis’ marketing authorization application (MAA) for ATIR101 is currently under review. Kiadis responded to the day 180 outstanding issues in May 2019. In early September, the Committee for Advanced Therapeutics (CAT) convened a Strategic Advisory Group (SAG) related to the review of the application; the next step in the regulatory process is for the application to be reviewed by the CAT in October. The company continues to expect to receive a decision from the EMA in 2020.
    • The global phase 3 trial for ATIR101, CR-AIR-009, is ongoing. The study, which will enroll approximately 250 patients, is comparing ATIR101 to the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol.
    • In June, after receiving customary shareholder approvals, Kiadis closed the transaction to acquire US-based CytoSen Therapeutics, Inc. The combination of Kiadis and CytoSen creates a leader in cell-based cancer immunotherapy, with complementary T-Cell and NK-cell platforms.
    • In the first half of 2019, Kiadis raised gross proceeds of €27.6 million through a private placement of 3,684,200 shares. As of June 30, 2019 Kiadis had €62.7 million in cash and cash equivalents.
    Financial highlights for the six months ended June 30, 2019 (including post reporting period)
    (Amounts in EUR million, except per share data) 2019 2018 Change
    Total revenue and other income - - -
    Total operating expenses (25.7) (11.1) (14.6)
    Research and development (16.2) (7.7) (8.5)
    General and administrative (9.5) (3.4) (6.1)
    Operating result (25.7) (11.1) (14.6)
    Net financial result (0.2) (3.0) 2.8
    Net result (25.9) (14.1) (11.8)
    Net operating cash flow (21.4) (10.6) (10.8)
    Cash position at end of period 62.7 60.3 2.4
    Equity 59.7 44.1 15.6
    Earnings per share before dilution (EUR) (1.03) (0.74) (0.29)
    Financial highlights for the six months ended June 30, 2019, presented above and discussed below, include less than one month of activity related to the operations of CytoSen Therapeutics Inc. from the completion of the acquisition in early June 2019. The comparable period of 2018 does not include any results of CytoSen Therapeutics operations.
    Operating expenses
    • Operating expenses increased to EUR 25.7 million in 2019 from EUR 11.1 million in 2018, an increase of EUR 14.6 million.
    • Research and Development expenses increased to EUR 16.2 million in 2019 from EUR 7.7 million in 2018. Without the expenses for share-based compensation, Research and Development expenses increased to EUR 15.3 million in 2019 from EUR 7.3 million in 2018, an increase of EUR 8.0 million. This increase was primarily caused by a further expansion of the workforce in all areas of the organization, clinical expenses related to the CR-AIR-009 study, the move to a larger building which includes a commercial manufacturing facility, laboratories and office space.
    • General and Administrative expenses increased to EUR 9.5 million in 2019 from EUR 3.4 million in 2018. Without the expenses for share-based compensation, General and Administrative expenses were EUR 5.4 million higher at EUR 8.4 million in 2019 compared to EUR 3.0 million in 2018. The increase was due to the expansion of the workforce, higher consultancy expenses related to market access preparations, financing rounds and the acquisition of CytoSen.
    Operating results
    • As a result of the overall increase in total operating expenses, the Group's operating loss increased EUR 14.6 million from EUR 11.1 million in 2018 to EUR 25.7 million in 2019.
    Net financial result
    • Net finance expenses for 2019 decreased to EUR 0.2 million from EUR 3.0 million in 2018. The decrease of EUR 2.8 million is due to favorable results of the adjustments of loans of EUR 1.2 million, favorable results of net foreign exchange of EUR 1.1 million and favorable fair value adjustments of EUR 0.7 million related to the contingent consideration of CytoSen in 2019 and unfavorable fair value adjustment of derivatives in 2018.
    Net result
    • As a result of the above items, the loss for the year to date increased by EUR 11.8 million to
    EUR 25.9 million in 2019 versus a loss of EUR 14.1 million in 2018.
    Cash position
    • The Company strengthened cash position in 2019 with private placements of 3.7 million ordinary shares raising net proceeds of EUR 25.4 million
    • The cash position increased by EUR 2.4 million to EUR 62.7 million at June 30, 2019 compared to EUR 60.3 million at the end of 2018. This increase mainly results from the net proceeds of the share offering for a total amount of EUR 25.4 million and EUR 3.1 million cash balances as part of the assets of CytoSen. In 2019, the net operating cash outflow amounted to EUR 21.4 million and further included the acquisition of PP&E, repayments of loans and lease liabilities for a total amount of EUR 4.8 million.
    • The Company’s cash position at June 30, 2019 was EUR 62.7 million.
    Equity
    • The Company's equity position amounted to EUR 59.7 million at June 30, 2019 versus
    EUR 44.1 million at the end of 2018, an increase of EUR 15.6 million. The main drivers of this increase are net proceeds of the share offerings of EUR 25.4 million, shares issued upon the acquisition of CytoSen for EUR 14.5 million, partly offset by the loss for the year of EUR 25.9 million and currency translation of EUR 0.4 million.
    Earnings per share
    • The undiluted loss per share for 2019 increased to EUR 1.03 compared to EUR 0.74 in 2018.
    A full financial report for the six months ended June 30, 2019 is available on Kiadis Pharma’s website at www.kiadis.com/financial-news/.

  3. forum rang 4 Kompas 10 september 2019 07:17
    quote:

    BassieNL schreef op 10 september 2019 07:11:

    Review bij CAT in oktober.
    Dus precies zoals @kompas steeds meldde.
    Ja, dat is volgens mij ook goed nieuws Bassie!

    Vanuit Kiadis begreep ik dat dit de snelst mogelijke route zou zijn in geval van een mogelijk direct positief SAG advies.

    Dit kan/mag men vanuit Kiadis nu natuurlijk niet hardop uitspreken.
  5. forum rang 8 BassieNL 10 september 2019 07:26
    quote:

    Mozes kriebel schreef op 10 september 2019 07:17:

    De cash positie valt mij erg mee. Had lager verwacht.
    Mij niet. Ik kan de kaspositie niet plaatsen.

    42 mio eind mei (volgens emissie document)
    +25,4 mio aan netto emissie opbrengsten
    + 5,2 mio cash Cytosen (6 mio USD, verder een cashless deal)
    =
    72,6 mio cash exclusief de cashburn van juni.

    En dan is er eind juni nog maar 62,7 mio over.

    Dus er is 10 mio doorheen gedraaid in de maand juni?
    Dat kan toch niet? Waar zit mijn fout?

    Als de cash van Cytosen niet is meegeteld klopt klopt het sommetje wel aardig.

  8. Dag Trader 10 september 2019 07:46
    quote:

    mr.Franz schreef op 10 september 2019 07:20:

    We kunnen in ieder geval met deze cashpositie nog een jaar vooruit. Verder valt of staat alles met de goedkeuring.
    Bij de laatste 2 emissies was er nog ca. 42 miljoen in kas, als ze die trend doorzetten, zit je met de huidige cashburn al in november/december tegen een nieuwe emissie aan te kijken...
  15. Badeend 10 september 2019 08:27
    quote:

    Kouwe 81 schreef op 10 september 2019 08:14:

    Conclusie?
    Of er wel of geen goedkeuring is vanuit de SAG is nog niet bekend --> in Oktober weten we dit pas?

    Tussen de lijnen door lees ik dat het SAG-team geen belemmeringen ziet, Kiadis krijgt namelijk gelijk terugkoppeling conform informatie Bassie. Nu moet de CAT kijken naar het oordeel van de SAG, daarna CHMP, dus ik denk dat we kunnen concluderen dat we de heuvel SAG goed hebben beklommen! CC van vanmiddag afwachten, zal wel de nodige vragen hiernaar gesteld worden.
  17. forum rang 4 Kompas 10 september 2019 08:30
    quote:

    BassieNL schreef op 10 september 2019 08:15:

    [...]had je dan minder cash verwacht?
    Nee, was meer een bevestiging deze voor dit moment prima te vinden.
    Met de mogelijkheid van een direct positief SAG advies nog openstaand en op de CAT agenda voor Oktober ben ik absoluut tevreden met het halfjaarbericht van vandaag. Theoretische openings koersen zijn uberhaupt nietszeggend en "de daghandel" kan altijd eerst nog wat aan de boom proberen te schudden maar ik zie het aandeel nu wel verder gaan oplopen richting Oktober.
  18. ArnoNieme 10 september 2019 08:31
    quote:

    Kouwe 81 schreef op 10 september 2019 08:14:

    Conclusie?
    Of er wel of geen goedkeuring is vanuit de SAG is nog niet bekend --> in Oktober weten we dit pas?

    Goedkeuring zou niet komen vanuit de SAG. Die is geraadpleegd. Goedkeuring wordt in 2020 verwacht. Signalen wijzen m.i. de goede kant uit.

    The company continues to expect to receive a decision from the EMA in 2020, p.3.
  20. Badeend 10 september 2019 08:33
    quote:

    ArnoNieme schreef op 10 september 2019 08:31:

    [...]

    Goedkeuring zou niet komen vanuit de SAG. Die is geraadpleegd. Goedkeuring wordt in 2020 verwacht. Signalen wijzen m.i. de goede kant uit.

    The company continues to expect to receive a decision from the EMA in 2020, p.3.
    Klopt, maar een conclusie van SAG krijg je wel te horen. E.e.a. is door Bassie destijds in een officieel document gedeeld, echter ben ik niet van plan 38 pagina's terug ernaar te zoeken :-)
1.642 Posts
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