Northwest Bio Stock Price, News & Analysis

Northwest Biotherapeutics (OTCQB: NWBO) has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP manufacturing of DCVax-L cell therapy products at its Sawston facility. This approval significantly enhances production capacity, enabling the facility to manufacture therapies for 45-50 patients per month, up from 4-6. The facility will also handle other cell therapy products under UK regulations. This license follows an earlier approval by the Human Tissue Authority and is a result of extensive preparations throughout 2021.

Northwest Biotherapeutics (NWBO) announced a successful closure of a $15 million financing on November 22, 2021, raising its cash reserves to over $20 million. The financing will support their brain cancer program, structured as a 22-month loan with an 8% annual interest rate.

Notably, this loan includes a provision allowing the lender to convert the outstanding balance into common shares following the announcement of top line data from a critical Phase III trial of DCVax®-L targeting Glioblastoma, potentially impacting future equity structure.

Northwest Biotherapeutics (NWBO) has reached two significant milestones for its DCVax® product manufacturing in Sawston, UK. The UK Human Tissue Authority (HTA) has granted a license for processing human tissues needed for DCVax-L. Additionally, the UK Medicines and Health Products Regulatory Authority (MHRA) recently completed a comprehensive inspection of the facility. The company anticipates receiving the official MHRA report soon, aiming for completion before year-end. These developments are vital for advancing its personalized immune therapies for solid tumor cancers.

Northwest Biotherapeutics (NWBO) announced the submission of a certification application for its manufacturing facility in Sawston, UK, to the MHRA. This marks the end of over two years of preparation, including extensive regulatory documentation and facility buildout. The next step involves an MHRA inspection, with hopes of production commencing by the end of Q3 2021. Additionally, the company provided updates on the DCVax-L Phase III trial, emphasizing ongoing data analysis and the importance of completing the trial process before public disclosure of results.

Northwest Biotherapeutics (OTCQB: NWBO) announced the submission of a Good Manufacturing Practice (GMP) certification application for its Sawston, UK facility to the Medicines and Healthcare Products Regulatory Agency (MHRA). This submission follows over two years of preparation, including overcoming COVID-19-related challenges. The next step involves an on-site inspection by the MHRA, with hopes of beginning production of DCVax-L products by Q3. Additionally, the company is progressing with its Phase III trial analysis, with upcoming results expected for public announcement.

Northwest Biotherapeutics (NWBO) has completed the initial production capacity of its Sawston, UK advanced manufacturing facility. This facility is set to increase production of dendritic cell vaccines from 4-6 patients per month to approximately 40-45 patients monthly, pending regulatory approval. An extensive recruitment program has successfully onboarded 30 specialists, with plans for over 300 staff in total. The facility is now in the Performance Qualification stage, with the certification application expected to be submitted to the UK Medicines and Health Products Regulatory Authority within 6-8 weeks.

On October 5, 2020, Northwest Biotherapeutics (NWBO) announced the locking of the database for its Phase III trial of DCVax®-L for Glioblastoma. This milestone allows independent statisticians to analyze unblinded raw data from the trial. The analysis will be reviewed by various committees and experts before public announcement. CEO Linda Powers expressed excitement about nearing the study's conclusion, emphasizing the urgent need for effective treatments for Glioblastoma. The company focuses on developing personalized immunotherapy for solid tumors, with ongoing trials in both North America and Europe.

Northwest Biotherapeutics (NWBO) announced the acquisition of Flaskworks for approximately $4.33 million on August 28, 2020. This acquisition is expected to enhance the manufacturing process of DCVax^® therapies by automating production, reducing costs, and increasing output. The Flaskworks system will transition from manual artisan methods to an assembly line approach, addressing major challenges of high costs and limited production capacity. The acquisition includes intellectual property and will streamline operations at NW Bio's facility in Sawston, UK.

Northwest Biotherapeutics (OTCQB: NWBO) announced its acquisition of Flaskworks on August 28, 2020, for approximately $4.33 million. This acquisition aims to enhance the manufacturing of DCVax^® personalized immune therapies by automating the production process, which will significantly scale-up volumes and reduce costs. The Flaskworks system transforms current 'open' manufacturing processes to 'closed', minimizing the need for expensive clean rooms. The integration of Flaskworks' technology is expected to streamline operations at the Sawston, UK facility while continuing the current DCVax production methods.