NW BIO ANNOUNCES FINANCINGS TOTALING $35 MILLION TO EXPAND AND ACCELERATE DCVAX®-L AND DCVAX®-DIRECT PROGRAMS
Funding Includes $25 Million Equity Investment By Leading UK Investment Fund and $10 Million Mortgage Financing
BETHESDA, Md., Nov. 19, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today two financings totaling $35 million. The financings include a $25 million equity investment by UK based C.F. Woodford Equity Income Fund ("Woodford"), and a $10 million mortgage on the Company's recently acquired UK facility.
Woodford purchased $25 million of unregistered shares of the Company's common stock at $5.79 per share, for a total of 4,317,790 shares. The Company agreed to undertake registration of the shares within the next couple of months.
"We are excited to have the UK's leading biotech investor come on board with NW Bio," commented Linda Powers, CEO of NW Bio. "Neil Woodford has built an unparalleled investment track record focusing on compelling long-term investment opportunities, particularly in undervalued biotech and pharma assets. His current fund, C.F. Woodford Equity Income Fund, which was established in May and launched in June of this year, manages about $5.25 billion."
This funding will be used to further expand and accelerate the Phase III DCVax-L clinical trial in GBM brain cancer, the Company's DCVax-Direct Phase II trials and the Company's early access programs. The Company is continuing to expand the sites in the DCVax-L trial as it moves toward completion of enrollment and completion of the trial. These sites will serve not only in the clinical trial but also in early access programs and in subsequent commercialization.
"Looking across the landscape of products in development for GBM, we believe DCVax-L offers particularly compelling potential," noted Linda Powers. "We anticipate being able to show that DCVax-L can add substantially longer survival, based on experience to date. In addition, unlike many products in development, DCVax-L is not limited by either tumor characteristics or patient characteristics. As a result, DCVax-L can potentially address all GBM patients, and all types and grades of glioma patients – not just a small fraction of GBM patients, as is the case with products aimed at just one or a few tumor targets, or one patient type. What is needed is a new and better treatment for all GBM patients – a new standard of care."
The Woodford funding will also be used to expand and accelerate the Company's DCVax-Direct clinical program. Based upon results to date in the Phase I stage of the Phase I/II trial, the Company now plans to proceed with at least two Phase II trials, in two different cancers, simultaneously. The Company will also consider proceeding simultaneously with a third DCVax-Direct trial in another cancer.
The $10 million mortgage is secured solely by a UK facility acquired by the Company for its previously announced expansion of manufacturing capacity in Europe. The mortgage has a two-year term and interest-only payments until maturity.
The mortgage funding will be used to continue building manufacturing capacity for the Company's growing programs in Europe: both the clinical trials and the early access programs.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products 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). 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 inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. It has completed enrollment in the Phase I portion of the trial. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has also received approval of a 5-year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside the clinical trial.
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 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.
CONTACTS: Les Goldman, 202-841-7909, [email protected], or Farrell Kramer, (Media), 212-710-9685