BETHESDA, Md., June 30, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S.
biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, announced it had filed an 8-K
today relating to two outstanding Nasdaq issues, including progress
on a remediation plan relating to certain prior stock
issuances.
On June 24, 2016, Northwest
Biotherapeutics, Inc. (the "Company") received a written notice
(the "Notice") from Nasdaq Staff that the Company is not in
compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid
price of the Company's common stock has been below $1.00 per share for 30 consecutive business
days.
The Notice has no immediate effect on the Nasdaq listing of the
Company's common stock. The Company has a period of 180 days, or
until December 21, 2016, to regain
compliance with the minimum bid price requirement. To regain
compliance, the closing bid price of the Company's common stock
must meet or exceed $1.00 per share
for at least 10 consecutive business days during this 180-day
period.
In the event the Company does not regain compliance by
December 21, 2016, the Company may be
eligible for second 180-day grace period if it meets the initial
listing standards, with the exception of the bid price and market
value of publicly held shares requirements, for The Nasdaq Capital
Market and provides written notice to Nasdaq of its intention to
cure the deficiency during the second compliance period, by
effecting a reverse stock split, if necessary. If the Company does
not regain compliance within the allotted compliance period(s),
certain further procedures may also be available to the
Company.
The Company intends to monitor the closing bid price of its
common stock on an ongoing basis, and consider a range of available
options to regain compliance with the share price listing
standard. The Company could remedy the deficiency, either now
or at a later date, through a reverse stock split. However,
the Company currently plans to regain compliance by focusing on
progress in its multiple operational programs.
The Company has also made progress towards the remediation of an
outstanding Nasdaq compliance issue relating to certain prior stock
issuances. The Company has been engaged in ongoing dialog with
Nasdaq Staff, and has submitted a remediation plan, relating to
certain past stock issuances to Cognate BioServices, Inc.
("Cognate") which the Nasdaq Staff had previously notified the
Company did not comply with Nasdaq Listing Rules 5635(c) and (d).
As the Company previously reported in a Form 8-K filed on May 2,
2016, the Company received a letter from the Nasdaq Staff on April
26, 2016, about those stock issuances to Cognate. The Company
is engaged in an ongoing dialog with the Nasdaq Staff and Cognate
regarding the structure and terms of the proposed remediation plan.
Upon completion of this dialog and adoption of a resolution, the
Company will make a further announcement.
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 and uncertainties related to the
actions and decisions of Nasdaq, 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
including the actions and decisions of the FDA and other
regulators, 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