On Monday, Northwest Biotherapeutics (OTCMKTS: NWBO) had an 8.59% increase, creating the largest rise in the past two months. The company has not yet released the top-line data of its phase III trial of DCVax®-L, so, should investors buy the stock now?
DCVax-L is the company's lead product for Glioblastoma multiforme, the most lethal form of primary brain cancer. The company has completed two phase I/II trials and is now well under way with a large phase III trial. Glioblastoma multiforme represents a potential market that it is expected to reach $1.4 billion by 2025. There have been indications that the top-line data for DCVax-L will be overwhelmingly positive. If the phase III trial of DCVax-L reached the primary endpoint, there is no limit to how high the NWBO can go.
The company is also pursuing development of DCVax-Direct for inoperable solid tumor cancers. It is currently conducting a 60-patient Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The trial is under way at MD Anderson in Houston, TX and MD Anderson in Orlando, FL, with additional sites in varying stages of preparation.
NWBO has also made great progress on other fronts. On May 12, the company reported that the initial production capacity of its Sawston, UK advanced manufacturing facility has been completed, and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority. The company previously said that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3. With all of this in mind, NWBO is a penny stock that investors should consider watching closely.
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