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Monday, September 20, 2021

The Powerful Run on Northwest Biotherapeutics, Inc (OTCMKTS: NWBO)

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has emerged as one of the most exciting stories in small caps in recent months seeing its stock skyrocket from $0.14 lows earlier this year to recent highs of $2.51 per share. For years NWBO showed huge promise but the stock went nowhere and attracted many long suffering longs who are now up at least 7 X their money.

NWBO recently saw a powerful move as the Company 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 for DCVax-L; unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025. A cornerstone of NWBO expanding program is completion of the buildout of the Sawston, UK manufacturing facility.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.  NW Bio’s proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines. NW Bio recently completed the acquisition of Flaskworks for $4.33 million, of which $1.65 million was paid in cash at closing. Flaskworks has developed a breakthrough system 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. Flashworks technical team has joined NW Bio as part of the acquisition.

NW Bio lead product, DCVax-L, is in Data Lock for the Phase III trial of DCVax®-L for Gliobastoma. Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.

NW Bio second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.  NW Bio previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.

Many, many patients have claimed DCVAX saved their lives including Alice a Metastic Merkel Cell patient from Florida. Brad Silver a GBM patient from Huntington Beach, California. Sarah Rigby a GBM patient from Hong Kong. Kristyn Power, the daughter of GBM patient from Canada. Kat Charles GBM patients from UK as related by her husband Jason (Kat’s Cure)

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NWBO

There have also been many media stories about DCVAX saving people’s lives including articles in NBC Channel 4 and a number of print magazines. NWBO – National Geographic’s Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson. NWBO GBM Brain Cancer Survival Story of Mark Pace. NWBO GBM Brain Cancer Suvivial Story of Brad Silver. NWBO, GBM Brain Cancer Survival Story of Mike Gregoire. UCLA – Real Stories Using DCVax.

On October 5 NWBO announced 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.

NWBO CEO Linda Powers stated: “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.”

Linda Powers previously stated “The UCLA Brain Tumor Program continues to shine as a beacon of hope, carrying a record of patients with brain tumors living longer than patients treated at any other hospital. Our personalized brain cancer vaccine, DCVax, is the first of its kind and is currently in Phase III clinical trials in 46 centers throughout America. It is on the road to FDA approval as well as clinical trials throughout Europe.  Using this vaccine, we are harnessing the patient’s immune system, genetics, pathology, brain mapping and a wide database of bioinformatics to optimize outcomes.”

 

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NWBO has emerged as one of the most exciting stories in small caps in recent months seeing its stock skyrocket from $0.14 lows earlier this year to recent highs of $2.51 per share. For years NWBO showed huge promise but the stock went nowhere and attracted many long suffering longs who are now up at least 7 X their money. NWBO recently saw a powerful move as the Company 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 for DCVax-L; unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 as NWBO are well aware of. A cornerstone of NWBO expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility. It has been noted that after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse-case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily 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.” Microcapdialy has been covering NWBO since 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 article.

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4 COMMENTS

  1. https://www.dropbox.com/sh/tlagm94xvkr4eah/AADYWl2TLEu9wzG5P1-nPp9ja?dl=0&preview=Cognate+PILOT+Application.pdf

    By Greg Akers – Editor-in-Chief, Memphis Business Journal
    Nov 13, 2020, 3:04pm CST Updated Nov 13, 2020, 3:29pm CST
    A bioscience company with a large local presence is planning a new investment that would create hundreds of jobs and see three industrial sites receive major renovations and new construction.

    Cognate BioServices Inc. plans to renovate three properties for “cell-therapy operations, contract development, and manufacturing for drug sponsors, and related logistics.”

    The company is seeking a 15-year Jobs PILOT (payment-in-lieu-of-taxes) from the Economic Development Growth Engine (EDGE) for Memphis and Shelby County. The incentive would be worth $52 million, and be based on a $212 million project investment.

    The investment would include $126 million in construction costs and $71 million in personal property. It covers sites at 4600 E. Shelby Drive, 5780 E. Shelby Drive, and 6100 Global Drive.
    See ihub 330449
    https://microcapdaily.com/the-powerful-run-on-northwest-biotherapeutics-inc-otcmkts-nwbo/128611/

  2. ae kusterer Sunday, 11/15/20 09:24:24 PM
    Re: None 0
    Post #
    330550
    of 330554

    COULD IT BE THAT NWBO WILL LICENSE THE FLASKWORKS TECHNOLOGY TO COGNATE?

    https://nwbio.com/northwest-biotherapeutics-acquires-flaskworks-breakthrough-automation-technology-for-cell-therapy-products-to-enable-scale-up-of-production-volumes-and-reduction-of-production-costs/

    “The Flaskworks system will follow the same batch-manufacturing process – doing so in a “closed” and automated manner.

    Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies. The Flaskworks technical team will work with NW Bio’s contract manufacturers to accomplish this. In the meantime, the Company’s DCVax products will continue to be made through the existing processes.”

    https://www.dropbox.com/sh/tlagm94xvkr4eah/AADYWl2TLEu9wzG5P1-nPp9ja?dl=0&preview=Cognate+PILOT+Application.pdf

    http://www.growth-engine.org/news/events/wednesday-november-18-2020-edge-board-meetings/

    https://www.bizjournals.com/memphis/

    KaOsiris Friday, 11/13/20 04:57:54 PM
    Re: None 0
    Post #
    330131
    of 330199
    Cognate BioServices plans $212M investment in Memphis ops

    Memphis Business Journal

    By Greg Akers
    Editor-in-Chief, Memphis Business Journal
    Nov 13, 2020, 3:04pm CST
    Updated 26 minutes ago

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