BETHESDA, Md., Dec. 7, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (Nasdaq: NWBO) ("NW Bio" or the "Company"), a
biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, today announced that the Nasdaq
Staff has not accepted the Company's plan of remediation for
certain violations of Listing Rules previously reported, and the
Company has notified Nasdaq of its intention to voluntarily
withdraw the Company's common stock from listing on Nasdaq.
Upon withdrawal from Nasdaq, the Company plans to begin
trading on the over-the-counter (OTC) market.
Pursuant to Nasdaq Listing Rule 5840(j), the Company is required
to give Nasdaq ten days' notice of the voluntary withdrawal, and
this period cannot be shortened. As a result, trading on
Nasdaq is expected to be suspended on or about December 19, 2016, and trading in the Company's
stock on the OTC is expected to begin the same day, as the Company
anticipates a seamless transition.
The Company will file a Form 25 with the Securities and Exchange
Commission on December 19. The
delisting is expected to become effective 10 calendar days later.
During this 10-day period, the Company's stock is anticipated
to be trading on the OTC market.
The Company has had discussions with the Staff of OTC Markets
Group Inc. and believes that it currently satisfies all
requirements for trading on The OTCQB Venture Market (the "OTCQB").
Accordingly, the Company plans to promptly file an application to
be traded on that market.
The Company desires to proceed with multiple Phase 2 trials in
addition to completing its current Phase 3 trial. The Company
believes that it will have enhanced ability to raise the funding
required for these programs on the OTC as compared with the Nasdaq
as the Company will not be subject to the type of the restrictions
on its ability to accept financing on the OTC that it has been
subject to on Nasdaq. If the Company were to remain listed on
Nasdaq, the Company's understanding is that the aggregation of the
financings completed by the Company since May of this year would
likely be deemed to preclude any substantial further fundraising
until at least sometime in Q1 of 2017.
As previously reported, on November 7,
2016 the Company received a letter from the Nasdaq Staff
indicating that the Staff had determined to aggregate a series of
financing transactions that were completed between
May 15, 2016 and October 13, 2016, although the transactions were
in many cases small and diverse, and involved a number of unrelated
parties. Based upon the aggregation, the Nasdaq Staff
determined that the transactions did not comply with Nasdaq's
Listing Rule 5635(d) since, in the aggregate, they exceeded 20% of
the number of shares outstanding prior to May 15, 2016. The Company engaged in
remediation discussions with the Nasdaq Staff. However, the
Nasdaq Staff ultimately determined not to accept the Company's
proposed plan of remediation. As noted above, given that the
Nasdaq Staff determined to aggregate these transactions and that
the last transaction did not occur until October 13, 2016, the Company's understanding is
that it would likely be foreclosed from completing further
significant financings until at least sometime in Q1 2017.
Due to the fact that the Nasdaq Staff has not accepted the
Company's plan of remediation, the Nasdaq Staff would have issued a
letter (the "Staff Determination") indicating that, unless the
Company requested a hearing before an independent Nasdaq Listing
Qualifications Panel (the "Panel") to review the Staff
Determination, the Company's common stock would be subject to
delisting from Nasdaq. If the Company requested such a
hearing, it would likely have taken place in February, 2017.
A request for a hearing would stay any suspension or
delisting action pending the hearing and the expiration of any
additional extension period granted by the Panel. The Panel
would have the discretion to grant the Company an extension period
of up to 180 calendar days from the date of the Staff Determination
within which the Company would be required to demonstrate
compliance with all applicable listing requirements.
In that regard, as previously announced on June 24, 2016, the Company is currently under a
grace period for compliance with the $1.00 per share bid price requirement, as set
forth in Listing Rule 5550(a)(2), which expires on December 21, 2016. The Company had planned
to conduct a Special Meeting shortly after the upcoming Annual
Meeting, to obtain shareholder approval for the reverse split and
the plan of remediation proposed to the Nasdaq Staff.
However, since the plan of remediation was not accepted, the
Company is not currently proceeding with the Special Meeting or the
reverse stock split.
Notwithstanding the right to a hearing before the Panel, there
can be no assurance that the Panel would determine to maintain the
listing of the Company on The Nasdaq Capital Market.
The Company's Board of Directors considered a variety of factors
and reached a unanimous decision for the Company to voluntarily
withdraw its listing on Nasdaq and undertake the actions necessary
to trade on the OTCQB, rather than seeking to remain on Nasdaq and
go through the hearing process. Such factors include the
likely expenses and uncertainty associated with the hearing process
and seeking to regain compliance with Nasdaq Listing Rules, the
value to the Company of being able to raise and accept financing to
proceed with multiple Phase 2 trials while also completing the
Phase 3 trial, the potential availability of such financing on the
OTCQB, the Company's obligations with respect to its outstanding
convertible notes as discussed in the next paragraph, and other
perceived potential advantages and drawbacks of seeking to maintain
the Company's Nasdaq listing as compared to moving the trading to
the OTCQB at this time.
Ceasing to be listed or quoted on Nasdaq will constitute a
"Fundamental Change" under the terms of the Company's Convertible
Senior Notes that were issued in August, 2014 and are otherwise due
in August, 2017. Following this change, the Company will have
a period of 20 business days, ending in January, within which the
Company is obligated to make an offer to repurchase the Notes in
accordance with the terms of the indenture relating to the Notes.
There is approximately $11.0
million in aggregate principal amount outstanding. The
Company believes that it has several options for addressing this
obligation, and will be evaluating those options over the coming
weeks, although there can be no assurance that such options will be
available or will be on acceptable terms. If the Company
fails to satisfy its obligation, that would result in an event of
default under the Notes.
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 Phase I/II
trial with DCVax-Direct for all types of inoperable solid tumor
cancers. It has completed enrollment in the 40-patient 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.
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 and uncertainties related to the
actions and decisions of Nasdaq, the Company's ability to
transition trading of its common stock to OTCQB, risks related to
the Company's ongoing ability to raise additional capital on the
OTC as compared with Nasdaq, risks relating to the Company's
outstanding convertible notes and its ability to repurchase such
notes if required, risks relating to any other contracts or
securities of the Company affected by the Company's move from
Nasdaq to the OTC, 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 relating to the Company's relationship with
Cognate, 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