BETHESDA, MD, October 10, 2019 – Northwest Biotherapeutics (NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has entered into a settlement with the SEC.
As previously reported, the Company has been investigated by the SEC and has cooperated with the investigation. The Company has now successfully entered into a settlement agreement with the SEC under Rule 13a-15. Under the settlement, in which the Company neither admits nor denies any violations, the Company will pay a fine of $250,000 in connection with past weaknesses in its internal controls, and the Company will retain an additional independent consultant to help the Company remediate its remaining weaknesses.
As also previously reported, the Company has retained an independent firm to handle the Company’s accounting and financial reporting for the last seven years, retained an independent SOX consulting firm for the last three years and expanded its internal personnel as part of strengthening its internal controls. By 2018, the Company had remediated six of seven material weaknesses that had originally been identified, and the Company had two new weaknesses (relating to information technology policies and procedures, and documentation of the Company’s system of policies and procedures), as reported in the Company’s Form 10-K.
The Company will work with the additional independent consultant to finish remediating the last weaknesses. The Company is pleased to put this matter behind it and concentrate its focus on progressing its clinical programs, including its Phase III trial of DCVax®-L for brain cancer.
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 North America and Europe. The Company has broad platform technologies for DCVax®dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is also pursuing a Phase I/II trial with DCVax®-Direct for all types of inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial, and is preparing for Phase II portions. The Company previously conducted a Phase I/II trial with DCVax®-L 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, although not all forward-looking statements contain these identifying words. We cannot guarantee that we will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in 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 complete its clinical trials on a timely basis, uncertainties about the clinical trial results and data, 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 ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its 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.