BETHESDA, Md., April 7, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today again set the record straight: Adam Feuerstein's latest, sensationalized
headline claims about the Company's annual report and Phase III
trial are once again factually wrong and materially
misleading.
This is the second time in a week that Feuerstein has falsely
claimed that the Company itself stated negative information when,
in fact, the Company did no such thing. Accordingly, the
Company advises all interested parties not to rely on any claims by
Feuerstein about what the Company has said or done, and instead to
investigate the information for themselves.
This time, Feuerstein materially misrepresents the Company's
10-K annual report with a dramatic headline claiming that "NW Bio
Warns FDA May Throw Out Phase III Brain Cancer Study." In
fact, the Company's 10-K says no such thing and the Company has
issued no such warning.
Feuerstein also states that NW Bio "snuck a brand new risk
nugget…into its annual report filed with the Securities and
Exchange Commission on Tuesday." This claim is also
wrong. In fact, the exact same risk factor language was
included in the Prospectus filed last November which formed the
basis for NW Bio raising $27 million
from sophisticated institutional investors.
In attempting to support his false headline claim, Feuerstein
points to and misrepresents the "Risk Factors" section of NW Bio's
annual report. As all experienced investors and analysts are
well aware, the Risk Factors section of all companies' annual 10-Ks
is meant to alert investors to the full range of worst-case
scenarios, and describe all possible types of risks that could
conceivably impact any aspects of a company's operations. For
any biotech company, there are typically dozens of risk factors or
more. Likewise, the Risk Factors section in NW Bio's 10-K
annual report covering 2013 provides 14 pages of description of
over 40 different risk factors relating to most aspects of the
Company and its business. Feuerstein points to a portion of
one such risk factor and mischaracterizes it as some kind of new
announcement by the Company. It is not.
Contrary to Feuerstein's ongoing false claims, the Company's
Phase III clinical trial in brain cancer continues to
progress. The simple, and central, point remains the same as
always: as with all clinical trials, the results will
determine what is approvable.
Feuerstein's misrepresentation of NW Bio's annual report appears
to be another conscious effort to mislead and panic readers.
It is a perversion of the whole concept of Risk Factors.
Moreover, far from NW Bio being sneaky, the market has
already seen this exact same disclosure, and put up another
$27 million of funding for NW Bio
well before Feuerstein's claimed scoop.
Contrary to Feuerstein's continuing misrepresentations, it is
important for the investing public to understand the actual
facts.
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.
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. You should not place undue reliance on any
forward-looking statements. 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. 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.
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SOURCE Northwest Biotherapeutics