1. Organization and Description of Business
Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries
NW Bio GmbH, Aracaris Ltd, Aracaris Capital, Ltd, and Northwest
Biotherapeutics B.V. (collectively, the “Company”, “we”, “us” and
“our”) were organized to discover and develop innovative
immunotherapies for cancer. The Company has developed DCVax®
platform technologies for both operable and inoperable solid tumor
cancers.
The Company relies upon contract manufacturers for production of
its DCVax products, research and development services, distribution
and logistics, and related services, in compliance with the
Company’s specifications and the applicable regulatory
requirements.
On August 28, 2020, the Company acquired Flaskworks, LLC
(“Flaskworks”), a company that has developed a system to close and
automate the manufacturing of cell therapy products such as
DCVax®.
2. Financial Condition, Going Concern and Management Plans
The Company has incurred annual net operating losses since its
inception. Management believes that the Company has access to
capital resources through the sale of equity and debt financing
arrangements. However, the Company has not secured any commitments
for new financing for this specific purpose at this time.
The Company does not expect to generate material revenue in the
near future from the sale of products and is subject to all of the
risks and uncertainties that are typically faced by biotechnology
companies that devote substantially all of their efforts to R&D
and clinical trials and do not yet have commercial products. The
Company expects to continue incurring annual losses for the
foreseeable future. The Company’s existing liquidity is not
sufficient to fund its operations, anticipated capital
expenditures, working capital and other financing requirements
until the Company reaches significant revenues. Until that
time, the Company will need to obtain additional equity and/or debt
financing, especially if the Company experiences downturns in its
business that are more severe or longer than anticipated, or if the
Company experiences significant increases in expense levels
resulting from being a publicly-traded company or from expansion of
operations. If the Company attempts to obtain additional
equity or debt financing, the Company cannot assume that such
financing will be available to the Company on favorable terms, or
at all.
Because of recurring operating losses and operating cash flow
deficits, there is substantial doubt about the Company’s ability to
continue as a going concern within one year from the date of this
filing. The condensed consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern, and do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets,
or the amounts and classification of liabilities that may result
from the outcome of this uncertainty.
The COVID-19 situation, and related restrictions and lockdowns,
have adversely affected the Company’s programs. With the
incidence of COVID-19 now rising significantly in both the US and
Europe, and expected to continue at a high level through the rest
of the fall and the winter, the adverse effects on the Company’s
programs may increase and may continue at an increased level
throughout this period. The Company has been continuing to make
progress in its programs despite these difficulties, so that it can
reach data lock, unblind and report the results of the its Phase 3
clinical trial of DCVax-L for Glioblastoma brain cancer, and the
Company plans to continue these efforts. Examples of effects of the
COVID-19 situation include the following: the process for
completion of the final data collection from trial sites for the
Phase 3 trial was materially slowed by the limited availability or
capacity of independent service firms responsible for collecting
and confirming the data, by the inability to perform in-person
monitoring and other visits to trial sites, by very limited
availability of investigators and staff at trial sites (many of
whom have been reassigned to treating COVID-19 patients), and
substantially longer timeframes for Institutional Review Board or
Ethics Committee meetings and regulatory processes for matters
other than COVID-19. The Company has been unable to undertake
compassionate use cases during part of March and very limited since
then, due to lockdowns, travel restrictions and hospitals focusing
on COVID-19 patients. In addition, manufacturing of DCVax products
is impeded by personnel being under lockdown. The buildout of the
Sawston facility was delayed in starting due to the construction
sector shutdown and restrictions, and was substantially slowed