BETHESDA, Md., Dec. 8, 2015 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S.
biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, responded today to shareholder
questions about appointments relating to the Company's Board, and
an independent investigation of recent allegations in an anonymous
internet report and a derivative lawsuit which cites the anonymous
internet report.
With respect to the Board, the Company agrees with the view
Neil Woodford has expressed that an
additional independent board member with financial expertise can
help build and advance the Company at its current stage of
development. The Company has expanded the financial personnel
and clinical personnel on its management team this year, and
expanding the Board as well makes sense.
The Company appreciates Mr. Woodford suggesting Elliott Leary as a potential board
candidate. The Board greatly enjoyed getting acquainted with
Mr. Leary personally, and thanks Mr. Leary for the time he spent
meeting with NW Bio's Board members. After such meetings and
further deliberations, the Board came to the conclusion that it was
not a fit for Mr. Leary to join NW Bio's Board for a number of
reasons.
These reasons include the Board's understanding that Mr. Leary
has never served on any board, has no biotech experience and no
pharma experience other than certain government investigations, has
no experience working with companies subjected to stock
manipulation, has no experience interacting with investors or
helping with corporate fundraising, has not worked with companies
on developing business plans or strategies, has never been asked to
go on the board of any other company where he has conducted
investigations, and does not anticipate playing an ongoing role on
NW Bio's board after the investigation is completed and indicated
he would probably resign at that time.
The Company emphasizes that it respects Mr. Leary's professional
experiences and expertise, and greatly appreciated Mr. Leary's
willingness to talk with NW Bio's Board on several
occasions.
The Company is in advanced discussions with several other high
caliber potential candidates for the new independent Director
position, and expects to complete the appointment process soon.
The Company is pursuing candidates with expertise to help
build and advance the Company (such as corporate governance,
finance and business strategy, fundraising and interaction with
institutional investors, the biotech or pharma sector, corporate
partnering, governmental and regulatory affairs, and/or
professional experiences with bear raids and/or stock
manipulation), and who are interested in remaining long term,
conflict free members of the Board.
Mr. Charles Price has been
engaged to be available as a resource for the independent
investigation, and to help seek action by the authorities in regard
to manipulation of the Company's stock. Mr. Price is a highly
decorated, nationally recognized former FBI Special Agent and
certified public accountant (CPA) who retired from the FBI
approximately a year ago after a 28-year career with the Bureau,
and is now a Managing Director with MorganFranklin Consulting, LLC
where he is a leader in their Corporate Investigations and Dispute
Solutions practice. Mr. Price received the FBI Director's
Award for Excellence in HUMINT (human intelligence), the Bureau's
highest award, in 2011, and received more than a dozen Outstanding
Public Service Awards from US Attorney's offices, as well as
numerous commendations and awards from the FBI for excellence in
investigation. Prior to joining the FBI, Mr. Price worked as
a CPA at Arthur Andersen & Co. performing financial statement
audits in the financial services industry.
In regard to the Freeh Group, the Company also appreciates
Neil Woodford suggesting this
candidate firm for the conduct of the investigation. However,
the Company agrees with Mr. Woodford that the investigation needs
to be entirely independent, and be conducted by parties and their
personnel who are also entirely independent.
Following review, NW Bio's Board came to the conclusion that the
Freeh Group would not be a fit for the Company's investigation
because, based on interviews and other information, the Board's
understanding is that the Freeh Group is not fully
independent. The Board's understanding is that the Freeh
Group is an affiliate of the Pepper Hamilton law firm, and there
have been and are various connections and involvement of these
entities and their personnel with companies who are competitors of
NW Bio or adverse to NW Bio. In addition, the Board's
understanding is that the Freeh Group is on a broader retainer with
Mr. Woodford including matters other than this NW Bio
investigation.
The Company respects the Freeh Group and its team. The
Company's Board simply believes that there needs to be more
complete independence in the party leading the investigation.
In regard to consulting arrangements, NW Bio has ceased working
with Ondra Partners for several reasons. As part of the
recent $30 million financing, NW Bio
was required to engage Ondra (with fees starting at $150,000 per month) and NW Bio did so. The
engagement agreement included confidentiality provisions and
requirements. The first stage of working with Ondra involved
numerous requests by Ondra for all of NW Bio's internal business
information, including confidential business plans, strategies,
un-redacted contracts, costs and pricing information, financial
models and other information. It also involved a full day of
briefings to several Ondra partners in NW Bio's offices about this
confidential information, with extensive notes taken by the Ondra
personnel.
NW Bio subsequently discovered that one of the Ondra partners
who participated in the full day briefing in NW Bio's offices,
taking extensive notes, and who pressed repeatedly for NW Bio's
confidential business documents and information, is a Director on
the Board of an Israeli company against which NW Bio's contract
manufacturer has been in very intensive litigation in US Federal
court for several years, for alleged extensive misappropriation of
intellectual property of the manufacturer and its clients,
including NW Bio. There was never any disclosure of this conflict
of interest by Ondra Partners. NW Bio ceased all
communications with Ondra Partners.
Following Neil Woodford's filing
of Form 13D on November 24, Ondra
Partners also notified NW Bio that it was terminating the
engagement to avoid potential conflict of interest. NW Bio is
actively seeking the return of all of its sensitive confidential
business information, including the extensive notes taken by Ondra
personnel in the day-long briefing session and all documents or
derivative information produced in Ondra based on or containing NW
Bio information. All of these documents and information are
required to be returned to NW Bio under the confidentiality
provisions of the engagement agreement.
About Northwest Biotherapeutics
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 348-patient Phase III trial in newly
diagnosed Glioblastoma multiforme (GBM), which is on a partial
clinical hold in regard to new screening of patients. 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 types of inoperable solid
tumors cancers. It has completed enrollment in the Phase I
portion of the trial. The Company previously conducted a
Phase I/II trial with DCVax-L for metastatic ovarian cancer
together with the University of
Pennsylvania. The Company previously received
clearance from the FDA for a 612-patient Phase III trial in
prostate cancer. In Germany,
the Company has received approval of a 5-year Hospital Exemption
for the treatment of all gliomas (primary brain cancers) 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 and
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