NW Bio Reports Favorable Results and Progress in Resolving Lawsuits

BETHESDA, Md., Oct. 25, 2017 /PRNewswire/ -- Northwest Biotherapeutics, Inc., a U.S. biotechnology company developing DCVax® personalized immune therapies for operable and inoperable solid tumor cancers, is pleased to report meaningful progress in resolving four lawsuits that were brought against it as reported in the Company’s periodic filings.

All four of the lawsuits have been or are being resolved without any negative findings against the Company or its management, despite allegations of misconduct and misrepresentation, and resolved without any monetary damages. One of the cases was dismissed outright, in its entirety, by the court. Two further cases were settled after NW Bio announced the Nasdaq remediation plan on September 6, 2016 and agreed to take certain future actions to enhance its corporate governance practices. The fourth case is in the process of being settled on similar terms, with a settlement agreement having been entered into and currently under review by a court.

From the outset, the Company has disputed the allegations made in the cases, and expressed an intention to vigorously defend the cases. The cases are summarized below.

Lerner v. Northwest Biotherapeutics, Inc.

Lerner v. Northwest Biotherapeutics, Inc. was filed on August 26, 2015, as a class action securities fraud lawsuit against NW Bio and its CEO in the U.S. District Court for the District of Maryland making a variety of claims about purportedly false reporting about the results of the DCVax-Direct Phase I trial and the DCVax-L Phase III GBM trial, among other things. On March 21, 2017, the court granted NW Bio’s motion to dismiss the Complaint in its entirety, with an extensive opinion that included the following conclusion: “Upon review of the pleadings, arguments, and relevant case law, the Court finds that Plaintiffs have failed to establish an actionable misrepresentation or omission.”

Every claim was dismissed. On April 12, 2017, the lead plaintiffs submitted a letter to the court advising it that they were not going to file an amended complaint, and the deadline for filing an appeal has now expired. This action is over.

Tharp, et al. v. Cognate, et al.

Tharp, et al. v. Cognate, et al. was filed on June 19, 2015, in the Delaware Court of Chancery challenging transactions between NW Bio and Cognate and the Toucan entities. This was a class action and derivative lawsuit purportedly on behalf of the Company and its shareholders naming Cognate, various Toucan entities, and NW Bio’s Board of Directors as defendants and seeking disgorgement of purportedly improper benefits and an unspecified amount of damages, among other relief. After extensive litigation and negotiations, and the Nasdaq remediation plan announced by NW Bio on September 6, 2016, a settlement was reached with mutual releases of any liability, and NW Bio’s agreement to adopt several expanded corporate governance practices and policies, and no payment of monetary settlement consideration.

This settlement was approved by the court on October 17, 2017 and this case is over.

Yonemura v. Powers, et al.

Yonemura v. Powers, et al. was filed on November 19, 2015, in Maryland federal court as yet another derivative action very similar to the Tharp case described above. The Yonemura plaintiff joined in the settlement with Tharp and committed to release all of her claims as well.

As a result, the plaintiff has agreed to dismiss the Yonemura case in the near future.

Wells v. Powers, et al.

Wells v. Powers, et al. was filed on November 28, 2016, in the Circuit Court for Montgomery County Maryland. The allegations in this case copy the derivative claims filed by the plaintiffs in Tharp and Yonemura, and tack on additional derivative claims that appear to echo the now-dismissed allegations in the Lerner case. The parties have reached a settlement similar to Tharp and Yonemura, with mutual releases, the Company agreeing to adopt several expanded corporate governance practices and policies, and no payment of monetary settlement consideration.

On October 12, 2017, the plaintiff submitted the settlement to the Court for preliminary approval. The parties are now awaiting the decision on the preliminary approval motion.

Conclusion

Company CEO Linda Powers stated “lawsuits like these can be a distraction from the important work of companies like ours. In my opinion, disposing of these cases is an important step forward in our vindication from the relentless and false campaign to discredit our science, our operations and our ethics, and hopefully helps remove what have been delaying obstacles in our path forward. These resolutions come with no further price tag to shareholders, allowing us to focus our resources on the Company’s mission of providing our promising vaccines to as many solid tumor cancer patients as possible, at the earliest time possible.”

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 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 also pursuing a Phase I/II trial program 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 the Phase II portion. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic 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. 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 payments by third parties, risks related to the Company’s ability to complete its clinical 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, risks relating to the manufacture and distribution of the Company’s products, 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. 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.

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SOURCE Northwest Biotherapeutics, Inc.