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Sunday, April 18, 2021

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Surges as DCVax-L Top Line Data Imminent

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is the most exciting stock in small caps that has seen a historic rise in 2020 to highs of $2.51 and a new base over $1. NWBO just went into full beast mode and looks to be breaking out of its recent trading range. A break over $2.51 is confirmation of the next leg up.

Northwest recently reported Data Lock for the Phase III trial of DCVax®-L for Gliobastoma. This comes after a long 13 – year wait for investors. Expectations are sky high as we wait for top line data from the Phase III trial of DCVax®-L. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numberous times as many recovered patients have come forward crediting DCVax®-L for saving their lives.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) operating out of Bethesda, Maryland  is a clinical stage biotechnology company focused on the development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers. The Company’s platform technology, DCVax, is a personalized immune therapy that uses a patient’s own dendritic cells, or DCs, the master cells of the immune system, as the therapeutic agent. The patient’s DCs are obtained through a blood draw, or leukapheresis. The DCs are then activated and loaded with biomarkers (“antigens”) from the patient’s own tumor. For DCVax-L, the antigen loading process takes place during the manufacturing of the product. For DCVax-Direct, the antigen loading process takes place in situ in the tumor after the product is directly injected into the patient’s inoperable tumor. The loading of antigens into the DCs “educates” the DCs about what the immune system needs to target. NWBO’s, 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. The Company is working on preparations for Phase II trials of DCVax-Direct.

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. The Company is currently building a manufacturing facility in Sawston, Uk. The buildout is the culmination of several years of design, development and preparatory activities, including clean room suites, quarantined storage, quality control testing suites, controlled cryostorage (freezing) facilities for the finished products, as well as specialized systems such as full air changes every 60 seconds in the clean room suites, and precise monitoring of particle counts in the clean room air. This accelerated effort is being supported by the Company’s recent financings and by a special purpose competitive loan of £1.35 (~$1.77) million from the Department for Business, Energy & Industrial Strategy which is administered locally in the Cambridge/Sawston region by the Cambridgeshire & Peterborough Combined Authority. The project cost is approximately $4.6 million.

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NWBONorthwest has an integrated strategy for protection of its technology through both patents and other mechanisms, such as Orphan Drug status. Currently the Company holds 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to its DCVax products. In the United States and Europe, some of its patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.

The Company’s lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product is in a 331-patient Phase III trial for newly diagnosed Glioblastome multiforme (GBM). Several weeks ago Northwest reported the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked. With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial.  Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage. The statisticians will proceed as quickly as possible with analyses of the raw data and prepare 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, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

CEO Linda Powers said: “We are excited to be so close to the finish line now, after such a long road. We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer. We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges. We are also very grateful to our shareholders for their patience and support, which has made all this possible.”

 

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Currently making a powerful move up NWBO just went into full beast mode and looks to be breaking out of its recent trading range. A break over $2.51 is confirmation of the next leg up. Northwest recently reported Data Lock for the Phase III trial of DCVax®-L for Gliobastoma. This comes after a long 13 – year wait for investors. Expectations are sky high as we wait for top line data from the Phase III trial of DCVax®-L. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and 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. Microcapdialy first reportted on NWBO when the stock was $0.15 per share. 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 a

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