NorthWest Biotherapeutics Inc (NWBO)

[laser777]

From Smith on Stocks:

http://smithonstocks.com/northwest-biotherapeutics-dcvax-cancer-vaccines-may-be-a-game-changer-in-cancer-therapy-nwbo-0-22/


Northwest Biotherapeutics was founded in 1996 by Dr. Alton Boynton, the current chief science officer. He is credited with being the first person to conduct a clinical trial with dendritic cell cancer vaccines. During the 1990s, he treated over 100 prostate cancer patients in academic settings using technology that became the basis for the company’s DCVax technology platform. Prior to founding NWBO, he headed the molecular oncology research laboratory at Northwest Research Foundation, a predecessor to the Fred Hutchinson Cancer Center in Seattle.

The company came public in December 2001 in an offering that raised $20 million and valued the company at $100 million. The offering was made at a time when a biotechnology financing window was rapidly closing and the money raised was insufficient relative to the burn rate of the company. The company had hoped to come back to the equity market quickly feeling that data generated with its dendritic cell vaccine DCVax Prostate would be recognized by the market as significant validation of the technology, boost the valuation and allow the company to raise the capital needed to fund the company and conduct a phase III trial.

The company was unfortunate because by the end of 2002 the equity market was shut down for biotechnology financings. It was fast running out of cash and the stock price dropped sharply. NWBO failed to meet the minimum requirements of the NASDAQ National Market and was delisted resulting in relisting on the OTC bulletin board. This unfortunate financial beginning put the company on a tortured path that has lasted for a decade. Plagued by the stigma of being a bulletin board company, limited resources and low market valuation, it struggled to attract capital to keep development plans alive. NWBO was on the verge of insolvency by 2004 when Linda Powers, head of the Toucan venture capital funds, made a series of investments that allowed the company to continue its development efforts; Toucan went on to become the major shareholder.

At the time the company went public its focus was on developing DCVax-Prostate based on encouraging data that it had accumulated in phase I and II trials. In January of 2005, FDA Clearance was received to conduct a phase III trial in prostate cancer with DCVax-Prostate. The phase III was planned to be a double blinded, placebo controlled trial enrolling about 600 patients at 30-50 sites in the United States. However, a trial of this size was beyond the financial capability of the company to fund.

Northwest was concurrently developing a second product, DCVax-L, a dendritic cell vaccine for glioblastoma multiforme or GBM. In 2004, Northwest began a collaboration with investigators at UCLA who conducted two phase I trials for DCVax-L. The trials evaluated safety and efficacy in 20 newly diagnosed GBM patients and 9 recurrent GBM. The initial data from these trials was very impressive and DC Vax-L became the principal focus of the company. The impressive data along with the potential for a smaller, easier to fund trial were the primary factors in the decision. DCVax Prostate was put on the shelf until its phase III trial could be funded.