NW Bio Provides Update On Projected Timing For Data Lock For Phase 3 Trial of DCVax®-L for Glioblastoma Brain Cancer

Data Completion Process Nearing Finish Line

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Jun 02, 2020, 09:35 ET

BETHESDA, Md., June 2, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today reported progress toward data lock for the Phase 3 trial of DCVax®-L for Glioblastoma brain cancer.

The Company reported that the final data collection process has been progressing steadily despite ongoing difficulties due to coronavirus-related limitations on operations and restrictions at trial sites. The coronavirus-related difficulties have impacted most aspects of the process, including review processes at sites and even logistical matters such as the shipping of tissue slides.

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs. All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually). The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations. After the query resolution and data confirmation are finished for a trial site, the site's investigator needs to sign off on the data before it can be locked.

In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company's anticipated schedule at the time of the Annual Meeting in April.

If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a "soft lock" of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.

The steps that will take place after data lock remain the same as were outlined at the Company's Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.

The timing of such processes cannot be predicted with precision even in normal times, and especially not in the current unprecedented circumstances. However, the Company and the independent service firms that are carrying out these processes are committed to proceeding quickly. If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.

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 North America and Europe. The Company has a broad platform technology 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 development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.

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, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually 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 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 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 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.