29
MAY
2014

NW Bio Refutes More False Claims By Feuerstein

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Company Reported Positive Preliminary Responses in Phase I/II Trial Patients;

Feuerstein Falsely Claims There Is No Positive Trial Information

BETHESDA, Md., May 29, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, refuted the latest blatantly false and misleading statements made by Adam Feuerstein, in an article on Tuesday, May 27.

Feuerstein’s headline:  “Cancer Patients Aren’t Responding to Northwest Bio’s DCVax-Direct.”

Feuerstein’s claim:  “None of the 19 patients with advanced, metastatic cancers have responded to treatment with DCVax-Direct in an ongoing Phase I clinical trial.”

Actual facts:   While still only part way through treatment, more than 50% of these patients (11 of the 19) have already shown tumor shrinkage of up to 28%, substantial tumor cell death and substantial accumulation of immune cells in the tumors.  These data were shown in imaging scans and biopsies provided by the world-renowned cancer centers conducting this clinical trial, as the Company made clear in its announcement and conference call.

Feuerstein claim:  “Under the globally accepted definition of tumor response known as RECIST (Response Evaluation Criteria in Solid Tumors), a partial response requires a 30% reduction in the size of the target lesion.”

Feuerstein claim:  “DCVax-Direct:  0% response rate.”

Actual facts:   There are numerous types of established measures of patient responses to treatments.

The measures reported in the Company’s announcement (partial tumor shrinkage, substantial tumor cell death and substantial accumulation of immune cells in the tumors) are considered clinically significant and are regularly the focus of peer reviewed scientific and medical publications in oncology, particularly for late stage disease which is the focus of the Company’s DCVax-Direct trial.

The RECIST criteria are just one set of measures, and the Company has made no claims about these measures.  Further, the RECIST criteria themselves include multiple categories:  they recognize not only a “Partial Response” of 30% or more — they also recognize “Stable Disease” (which includes tumor shrinkage of up to 28% as has been seen among the early responses in the Company’s DCVax-Direct trial).

“Feuerstein’s so-called “analyses” consist of false statements, serious misrepresentations and personal attacks and smears,” commented Linda Powers, CEO of NW Bio.  “Feuerstein’s “analyses” are contradicted by the concrete data from world renowned cancer centers, and by the validations NW Bio continues to achieve from regulators in both the US and Europe, key opinion leaders, healthcare system institutions, grant agencies and others.  Feuerstein’s commentaries seem designed to try to prevent investors from seeing the strength and progress in NW Bio.”

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products 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 312-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 under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression.  The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.  The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.  In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain cancer) patients outside the clinical trial.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings.  Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

CONTACTS

Les Goldman
202-841-7909
lgoldman@nwbio.wpengine.com

Lisa Sher (Investors)
212-661-2220
Lisa.Sher@mbsvalue.com

Farrell Kramer (Media)
212-710-9685
Farrell.kramer@mbsvalue.com

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