BETHESDA, Maryland,
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.
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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.