BETHESDA, Md., Nov. 19, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology
company developing DCVax® personalized immune therapies for solid
tumor cancers, announced today two financings totaling $35 million. The financings include a
$25 million equity investment by UK
based C.F. Woodford Equity Income Fund ("Woodford"), and a
$10 million mortgage on the Company's
recently acquired UK facility.
Woodford purchased $25 million of
unregistered shares of the Company's common stock at $5.79 per share, for a total of 4,317,790
shares. The Company agreed to undertake registration of the
shares within the next couple of months.
"We are excited to have the UK's leading biotech investor come
on board with NW Bio," commented Linda
Powers, CEO of NW Bio. "Neil
Woodford has built an unparalleled investment track record
focusing on compelling long-term investment opportunities,
particularly in undervalued biotech and pharma assets. His
current fund, C.F. Woodford Equity Income Fund, which was
established in May and launched in June of this year, manages about
$5.25 billion."
This funding will be used to further expand and accelerate the
Phase III DCVax-L clinical trial in GBM brain cancer, the Company's
DCVax-Direct Phase II trials and the Company's early access
programs. The Company is continuing to expand the sites in
the DCVax-L trial as it moves toward completion of enrollment and
completion of the trial. These sites will serve not only in
the clinical trial but also in early access programs and in
subsequent commercialization.
"Looking across the landscape of products in development for
GBM, we believe DCVax-L offers particularly compelling potential,"
noted Linda Powers. "We
anticipate being able to show that DCVax-L can add substantially
longer survival, based on experience to date. In addition,
unlike many products in development, DCVax-L is not limited by
either tumor characteristics or patient characteristics. As a
result, DCVax-L can potentially address all GBM patients, and all
types and grades of glioma patients – not just a small fraction of
GBM patients, as is the case with products aimed at just one or a
few tumor targets, or one patient type. What is needed is a new and
better treatment for all GBM patients – a new standard of
care."
The Woodford funding will also be used to expand and accelerate
the Company's DCVax-Direct clinical program. Based upon
results to date in the Phase I stage of the Phase I/II trial, the
Company now plans to proceed with at least two Phase II trials, in
two different cancers, simultaneously. The Company will also
consider proceeding simultaneously with a third DCVax-Direct trial
in another cancer.
The $10 million mortgage is
secured solely by a UK facility acquired by the Company for its
previously announced expansion of manufacturing capacity in
Europe. The mortgage has a two-year term and interest-only
payments until maturity.
The mortgage funding will be used to continue building
manufacturing capacity for the Company's growing programs in
Europe: both the clinical trials and the early access
programs.
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 348-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. It has completed enrollment in
the Phase I portion of the trial. 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 has also received approval of a 5-year
Hospital Exemption for the treatment of all gliomas (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 ongoing
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.
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SOURCE Northwest Biotherapeutics, Inc.