Northwest Biotherapeutics Inc - NWBO stock

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OTC Symbol: NWBO | OTC Tier: OTCQB

Introduction

Northwest Biotherapeutics, Inc. (OTC: NWBO), is a development-stage biotechnology company that develops personalized immune therapies for cancer. The company is focused on producing more effective immunotherapy products that treat cancer better than the existing portfolio. The firm is keen to eliminate toxicities in those products associated with chemotherapies cost-effectively. Northwest therapeutics serves the U.S., Europe, and the international markets. The firm develops its products on the backbone of its DCVax technology, a platform that employs activated dendritic cells to marshal a patient’s immune system to counter cancer. DCVax-L, the company’s lead product, has completed a 331-patient international Phase III trial to treat Glioblastoma multiforme (GBM), the most aggressive and deadly brain cancer. It develops DCVax-Direct, undergoing Phase I/II clinical trials to treat inoperable solid tumors. The company has FDA clearance for a 612-patient Phase III trial in prostate cancer and clearance for Phase I/II trials for several other cancers. Northwest Biotherapeutics’ wholly owned subsidiaries include Aracaris Ltd, Aracaris Capital, Ltd, Flaskworks, Northwest Biotherapeutics B.V., and N.W. Bio GmbH. The company was incorporated in 1996. Its tocks publicly trade on OTC markets under the NWBO ticker symbol. The firm is headquartered in Bethesda, Maryland.

Operations

The company is focused on the discovery, development, and commercialization of its immunotherapy products which trigger and reinforce the immune system's response to cancer treatment. The company is committed to developing products free of side effects and marginal clinical results, as portrayed by some of the current products in the market. The firm uses its expertise science of dendritic cells, a type of white blood cell that triggers the immune system, to professionally develop its products. Its cancer therapies have displayed the significant ability to extend the time to recurrence and survival while advancing the superior quality of life with zero negative side effects compared to existing therapies. Its DCVax technology uses the patient’s dendritic cells to activate the immune system. The cells are extracted from the body and loaded with antigens to create a personalized therapeutic vaccine. When injected back into the patient's body, it instigates a potent immune response against cells, slowing the progression and prolonging survival.

Pipeline

DCVax-L

The product is made with cancer antigens from the patient’s tumor lysate. DCVax-L thus contains the full set of tumor antigens, making it more resilient to attacks by cancer pathogens. The Drax product has been used to engineer the company's GBM brain cancer and ovarian cancer clinical trials. It is expected to be applied to any solid tumor cancer patients whose tumors have been surgically removed. Following trials on DCVax-L, the company anticipates tabling a biologics license application for DCVax®-Brain with the FDA.

DCVax-Direct

It is designed for application in situations where a patient’s tumor cannot be surgically removed. DCVax-Direct is also made up of a full set of tumor antigens in the patient's body. It allows the fresh, new dendritic cells to partially mature in a special manner and directly identifies antigens from tumor tissues within the patient’s body. A 40-patient Phase I trial on the product has been completed and included treatment of a wide range of cancers.

DCVax-Prostate

This product is designed to cure late-stage prostate cancer. DCVax-Prostate has been developed using PSMA (Prostate Specific Membrane Antigen), essentially found in all late-stage prostate cancers. PSM is combined with fresh, personalized dendritic cells to develop DCVax-Prostate. The company has FDA clearance to begin Phase III clinical trial.

Critical Company and Industry Developments

On Nov. 17, 2022, the company announced significant increases in median survival and the "long tail" of extended survival on recurrent and newly diagnosed glioblastoma brain cancer patients administered with DCVax-L during Phase 3 clinical testing of the product. The trial was communicated to have adhered to all the primary and secondary requirements under the Statistical Analysis Plan for the underlying trial. The company expressed its excitement given that it might be the first time in nearly 20 that such a trial has manifested robust survival extension in newly diagnosed glioblastoma of the sort.

Northwest Biotherapeutics, on Aug. 28, 2022, closed a 100% acquisition of Flaskworks, LLC, a company with a system designed to wrap and automate the manufacture of cell therapy products like DCVax. Flaskwork’s technical team also joined Northwest Biotherapeutics as part of the acquisition agreement. The company believed the acquisition would simplify and streamline certain phases of its buildout.

The company reported its third quarter 2022 results for the period ended Sept. 30, 2022, on 11/09/2022. Highlights of the company’s financial performance for the period include:

• It reported USD 0.206 million in revenue compared to USD 0.35 million a year ago
• The company incurred a net loss of USD 32.85 million compared to a net income of USD 45.52 million in the same quarter in 2021
• USD 0.03 basic loss per share from continued operations was recorded against a USD 0.05 earnings per share in the same quarter last year
• The diluted loss per share was USD 0.03 compared to USD 0.01 a year ago.

Management Team

Company Management

Linda F. Powers, Chief Executive Officer

• Has served as the company’s chairperson since 2007 and as CEO since 2011
• She boasts over 15 years of experience working in corporate finance and restructurings, joint ventures and intellectual property licensing, and mergers and acquisitions
• She served as the Managing Director of Toucan Capital Fund II from 2001 to 2010
• She has also served on a myriad of boards, including the Chinese Biopharmaceutical Association, the Maryland Stem Cell Research Commission, and the Rosalind Franklin Society, among others
• Ms. Powers has a B.A. from Princeton University and a J.D. from Harvard Law School, magna cum laude

Marnix L. Bosch, Ph.D., Chief Technical Officer

• Joined the company in 2000 and has been the firm’s chief technical officer for a significant number of years
• Has a vital role in the preparation and submission of the company’s regulatory applications, advancing the development of product lines, and acquisition of emerging technologies
• Works with Cognate BioServices, Inc. on the next-generation further development of manufacturing and quality control processes
• He previously served as the HOD in the Department of Molecular Biology at the Dutch National Institutes of Health (RIVM)

Additional key management team members are Les Goldman, Senior Vice President, Business Development, and Alton L. Boynton, Chief Scientific Officer.

Corporate Governance and Code of Conduct

The company’s governance structure is designed to outlay a working platform for moral actions, critical and effective decision-making, and efficient compliance and performance monitoring. The board oversees the firm's operations under the entire legal framework, among other automatic functions. The company's code of conduct provides directors, employees, and officers with directions for ethical conduct.