Is the Storm Over for Northwest Biotherapeutics, Inc (OTCMKTS:NWBO)


Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) is a penny play in the biotech space that was destroyed last year on negative headline flow related to legal allegations of poor governance and an eventual delisting from the big boards. It has been a tumultuous time. That said, this month has finally provided some welcome news.

The company announced that the partial clinical hold on the Trial has been lifted by the FDA, and that the Trial has accumulated a sufficient number of events toward the progression-free survival endpoint, but not yet for the overall survival endpoint. The Company remains blinded to all trial data, and is only receiving and reporting updates on a blinded basis.

Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) bills itself as a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer.

The Company operates in the United States and is incorporated in Delaware, USA.

According to company materials, “Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company’s lead program is a 331-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM).  GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”  The Company is also pursuing a Phase I/II trial with DCVax-Direct for all types of inoperable solid tumor cancers.  It has completed the 40-patient Phase I portion of the trial, and is preparing for the Phase II portion.  The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania.”

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While it hasn’t been a rosy month, the good news is the past month of trading actually goes to the positive for the company. However, that positive move was minor (just 1%). That action is obviously running counter to the larger trend in the name. However, NWBO has a history of dramatic rallies. In addition, Northwest stock has witnessed a pop in interest, as transaction volume levels have recently pushed 10% above the average volume levels in play in this stock over the longer term.

According to the company’s latest release, there are 331 patients enrolled in the Trial. The Trial endpoints involve thresholds of 248 “events” for PFS and 233 “events” for OS. PFS events are primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. OS events are patient deaths.

The PFS and OS events are continuing to accumulate as the Trial continues. The PFS events have surpassed the 248-event threshold, but the OS events have not yet reached the 233-event threshold.  Based upon the pace of OS events during the last six to eight months, the Company’s current anticipation is that it will be several months until the Trial reaches 233 OS events.

Dr. Linda Liau, Principal Investigator of the DCVax-L Trial commented: “It is gratifying to have the hold removed from the Trial and exciting to see this Trial now moving towards completion, although of course the longer it takes for PFS and OS events to accrue, the better the patients in the Trial are doing.”

Earning a current market cap value of $63.9M, NWBO has a stash ($1.5M) of cash on the books, which compares with about $21.1M in total current liabilities. So the balance sheet isn’t in all that bad shape. One should also note that debt has been growing over recent quarters. NWBO is pulling in trailing 12-month revenues of $1.4M. However, the company is seeing declines on the top line on a quarterly y/y basis, with revenues falling at -45.4%. We will update the story again soon as further details emerge. For continuing coverage on shares of $NWBO stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!


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