BETHESDA, Md., April 7, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today again set the record straight: Adam Feuerstein's latest, sensationalized headline claims about the Company's annual report and Phase III trial are once again factually wrong and materially misleading.
This is the second time in a week that Feuerstein has falsely claimed that the Company itself stated negative information when, in fact, the Company did no such thing. Accordingly, the Company advises all interested parties not to rely on any claims by Feuerstein about what the Company has said or done, and instead to investigate the information for themselves.
This time, Feuerstein materially misrepresents the Company's 10-K annual report with a dramatic headline claiming that "NW Bio Warns FDA May Throw Out Phase III Brain Cancer Study." In fact, the Company's 10-K says no such thing and the Company has issued no such warning.
Feuerstein also states that NW Bio "snuck a brand new risk nugget…into its annual report filed with the Securities and Exchange Commission on Tuesday." This claim is also wrong. In fact, the exact same risk factor language was included in the Prospectus filed last November which formed the basis for NW Bio raising $27 million from sophisticated institutional investors.
In attempting to support his false headline claim, Feuerstein points to and misrepresents the "Risk Factors" section of NW Bio's annual report. As all experienced investors and analysts are well aware, the Risk Factors section of all companies' annual 10-Ks is meant to alert investors to the full range of worst-case scenarios, and describe all possible types of risks that could conceivably impact any aspects of a company's operations. For any biotech company, there are typically dozens of risk factors or more. Likewise, the Risk Factors section in NW Bio's 10-K annual report covering 2013 provides 14 pages of description of over 40 different risk factors relating to most aspects of the Company and its business. Feuerstein points to a portion of one such risk factor and mischaracterizes it as some kind of new announcement by the Company. It is not.
Contrary to Feuerstein's ongoing false claims, the Company's Phase III clinical trial in brain cancer continues to progress. The simple, and central, point remains the same as always: as with all clinical trials, the results will determine what is approvable.
Feuerstein's misrepresentation of NW Bio's annual report appears to be another conscious effort to mislead and panic readers. It is a perversion of the whole concept of Risk Factors. Moreover, far from NW Bio being sneaky, the market has already seen this exact same disclosure, and put up another $27 million of funding for NW Bio well before Feuerstein's claimed scoop.
Contrary to Feuerstein's continuing misrepresentations, it is important for the investing public to understand the actual facts.
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 312-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. 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.
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. You should not place undue reliance on any forward-looking statements. 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 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. 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.
SOURCE Northwest Biotherapeutics