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Thursday, October 6, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Bull Run as Biotech Set to Release Phase III Top Line Data for DCVax®-L May 10 / Dr. Linda Liau Will Present “Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma” at the New York Academy of Sciences

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is tearing up the charts making a powerful run northbound easily eclipsing the $1.50 mark where the stock had previously formed a base during the first six months of 2021.  We gave the heads up on NWBO on April 23 in our last article just as the stock was moving northbound in the low $0.90s range. Since than NWBO has rocketed northbound topping $15 million in dollar volume on Wednesday alone as we anxiously await Dr. Linda Liau’s May 10 presentation entitled “Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma” at the Frontiers of Cancer Immunotherapy Conference of the New York Academy of Sciences. It is anticipated top line date for DCVax®-L will be announced after or during the presentation. This day will be Dr. Liau’s day to shine. The presentation will be made on May 10, 2022 at 11:10 a.m., and can be viewed virtually by registering online at the Academy’s website at­­­ https://events.nyas.org/event/28ca5e39-51a7-4e73-be3d-78089c92d596/summary 

Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range.  

https://www.youtube.com/watch?v=e4JT6nQR2BI

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotechnology company focused on developing personalized immune therapies for cancer. The Company has developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Northwest’s lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. The Company has completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM). As previously reported, the data collection and confirmation process was conducted by the independent contract research organization (CRO) who managed the trial and by other independent service firms.  On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts. 

There have been indications that the top line date for DCVax®-L will be overwhelmingly positive; according to date published from 2018 at the Society for Neuro-Oncology Annual Meeting in New Orleans shows the following: Median overall survival (OS) from surgery in the intent-to-treat population at data cutoff was 23.1 months, the same OS benefit identified in 2017. The survival rate at year 2 was 46.4%, on par with 46.2% in 2017. In patients with methylated MGMT genes, median OS after surgery was 35.1 months, slightly better than 34.7 months observed in 2017. This represents a vast improvement over the median OS of only 14.6 months. “The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.”  

NWBO has amassed a valuable intellectual property portfolio; as of December 31, 2021, the Company had 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products. During 2021, seven new patents were issued to the Company as part of its worldwide patent portfolio. The newly issued patents cover methods for manufacturing dendritic cells related to its DCVax products, as well as encompassing certain methods of use and compositions that may be potential future markets for related DCVax products. Additionally, with the acquisition of Flaskworks, Northwest gained ownership of a portfolio of patents and patent applications which include those held by Flaskworks as well as patents and patent applications exclusively licensed by Flaskworks from Northeastern University. The portfolio includes a total of thirteen patent families, with issued patents and pending applications worldwide. Collectively these patents and patent applications cover key aspects of the design and function of automated cell culture systems.  

In addition to its patent portfolio, Northwest has obtained Orphan Drug designation for its lead product, DCVax-L for glioma brain cancers. Such designation brings with it a variety of benefits, including potential market exclusivity for seven years in the U.S. and ten years in Europe if its product is the first of its type to reach the market. 

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NWBO acquired 100% of now subsidiary Flaskworks, LLC, a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.  

The Company’s second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers.  

NWBO is pursuing an intensive program of manufacturing preparations and planning as the Company approaches top line data from its Phase III trial of DCVax®-L.  An intensive recruitment program has been underway for well over a year, and has successfully hired and trained the necessary 30 senior technical managers, scientists and staff technicians and operators for manufacturing, quality control and other operations of the first two production suites. Northwest continues to develop its manufacturing facility in Sawston, U.K. To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have anticipated potential capacity to produce dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The buildout of Phase 1A of the facility was completed in Q4 2020. 

During 2021, work continued for technology transfer from the London facility to the Sawston facility, recruitment of contract technical personnel for Sawston, development of some 1,000 regulatory documents for operations in the Sawston facility, and applications to both the Human Tissue Authority (HTA) and the MHRA for inspections of the facility and its operations, and issuance of licenses for manufacturing in the facility. These applications and inspections were successfully completed.  The HTA license was issued in October 2021 and the MHRA license was issued in December 2021. Following some required validation work after the licenses were issued, production of DCVax-L began this month. 

The initial production capacity will occupy only a small fraction of the total space in the Sawston facility. In light of this, and in light of its obligation in connection with the buildout loan from the Cambridge development authority to make the Sawston facility benefit the regional business ecosystem and not just us, on December 31, 2021 Northwest entered into a sub-lease for a small portion of the space to its contract manufacturer, Advent BioServices. It is anticipated that, as and when feasible, the subleased space may enable some production of third-party cell therapy products Such production of other products will fulfill the loan-related commitment to the Cambridge authority, will help support the capital-intensive Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility. 

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Currently trading at a $1.2 billion market valuation NWBO has over $15 million in the treasury and is fully funded moving forward. This is a really exciting story developing in small caps; NWBO has rocketed northbound topping $15 million in dollar volume on Wednesday alone and is quickly developing a loyal shareholder base that swears this one goes higher as we anxiously await Dr. Linda Liau’s May 10 presentation entitled “Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma” at the Frontiers of Cancer Immunotherapy Conference of the New York Academy of Sciences. It is anticipated top line date for DCVax®-L will be announced after or during the presentation. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. NWBO is under heavy accumulation and among the most active in small caps, investors are looking for NWBO to take out the $2.50 from October 2020 before TLD is even announced. Microcapdaily gave the heads up on NWBO on February 3, 2020 when the stock was $0.18 per share in our article: The Exciting Story of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) We will be updating on NWBO as more details emerge so make sure you are subscribed to Microcapdaily.

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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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