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NW Bio 2012 Annual Report Shows Strong Progress And Enhancement Of Leadership Position
Date:4/8/2013

DCVax-L for brain cancer, in both the US and Europe;
  • initiation of the DCVax-Direct program;
  • commencement of a "Specials" program (similar to compassionate use) for brain cancer patients not eligible for the Phase III trial in the UK to obtain DCVax-L on a self-pay basis;
  • completion of a 6-month Scientific Advice process with regulators, with positive feedback, and application for a "Hospital Exemption" program (similar to compassionate use) in Germany for brain cancer patients not eligible for the Phase III trial to obtain DCVax-L on a self-pay basis;
  • assistance to 10 major hospital centers in Germany (including all key opinion leaders in brain cancer) preparing and submitting applications to the German healthcare system requesting authorization of reimbursement for DCVax-L;
  • doubling of manufacturing capacity for DCVax-L in US;
  • completion of extensive regulatory processes and inspections, and receipt of approval, for manufacturing of DCVax-L in Germany for Phase III clinical trial; 
  • additional regulatory processes in both UK and Germany for supply of DCVax-L products from Germany to UK for Phase III trial in UK;
  • technology transfer and regulatory processes for manufacturing of DCVax-L in UK;
  • partnering arrangements with several large marquee partners in the US and Europe;
  • initiation of manufacturing preparations in US for DCVax-Direct Phase I/II trial;
  • award of a $5.5 million non-dilutive matching grant from the German government (one of the largest such grants ever awarded), which the Company plans to start drawing  in Q2 of 2013;
  • comprehensive clean-up of the Company's balance sheet (eliminating more than $36 million in debt);
  • financings totaling over $32 million;
  • listing of the Company's Common Stock and Warrants on the Nasdaq Capital Markets;
  • expansion of the Company's management team with a veteran sen
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  • SOURCE Northwest Biotherapeutics
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