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Thursday, August 18, 2022

The Dynamic Rise of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO)

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) recently saw a powerful move up the charts from lows of $0.14 to recent highs over $0.40. The stock has formed a solid base in the $0.37 range and continues to trade significant volume and attract new shareholders.

It is easy to get excited about NWBO; Investors are waiting for data lock, unblinding and reporting of top line data from its 331-patient Phase 3 trial of DCVax®-L for Glioblastoma brain cancer. According to NWBO CEO Linda Powers “the current estimate of public disclosure of top line data would range from the end of June to early July.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a clinical stage biotechnology company focused on the development of personalized immunotherapy for a broad range of solid tumor cancers. The company has over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. The Company is led by Linda Powers, a successful entrepreneur who worked for many years in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011. NWBO platform technology is DCVax, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.

Northwest lead product is DCVax-L for Glioblastoma multiforme (“GBM”), the most lethal form of primary brain cancer. The Company has completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below. Northwest is currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is “Progression Free Survival,” meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures. The trial is under way at 51 sites (medical centers) across the US. The sites and the eligibility criteria are listed in the profile of the trial at ClinicalTrials.gov. The trial is also under way in Europe. The lead site is Kings College Hospital in London.

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On June 2 NWBO reported progress toward data lock for the Phase 3 trial of DCVax®-L for Glioblastoma brain cancer.  The Company reported that the final data collection process has been progressing steadily despite ongoing difficulties due to coronavirus-related limitations on operations and restrictions at trial sites.  The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs.  All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually).  The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations.  After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.

If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later.  The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded The statisticians will need several weeks to carry out all the relevant analyses and calculations.  Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded.  The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.

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Currently trading at a $270 million market valuation NWBO is fully reporting OTCQB and has $323k in the treasury, manageable debt and fast growing sales reporting $2.4 million in sales for the year ended December 31, 2019. NWBO is an exciting story developing in small caps; this little biotech is sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. NW Bio lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The stock has a significant shareholder base that continues to bid this one higher in recent trading. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.

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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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