For Release on January 6, 2023….9:15 am Eastern
Northwest Biotherapeutics Announces Positive Votes At Annual Meeting;
Reviews 2022 Progress and Looks Forward to Strong 2023
78% Of All Shares Were Voted; Proposals Received ≥90% of Votes Cast
BETHESDA, MD, January 6, 2023 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.
Annual Meeting Results
There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
There were 6 Proposals for shareholders to decide, and all of them were approved by shareholders with ≥90% of the votes cast. The votes were as follows:
Proposal 1: Re-Election of Class III Directors for a new 3-year term
- Ms. Linda Powers was re-elected with 97.20% of the votes cast.
- Dr. Navid Malik was re-elected with 97.51% of the votes cast.
Proposal 2: Appointment of Auditors – Cherry Bekaert
- Ratified with 98.81% of the votes cast.
Proposal 3: Ratification of Stock Options awarded to Management in 2020.
- Ratified with 90% of the votes cast.
Proposal 4: Advisory vote on 2021 Management compensation.
- Approved, on an advisory basis, with 91.9% of the votes cast.
Proposal 5: Approval of Stock Options awarded to the independent directors in 2020.
- Approved with 90.42% of the votes cast.
Proposal 6: Amendment of the Company’s Certificate of Incorporation to increase the number of authorized common shares by 500 million.
- Approved with 95.09% of the votes cast (74.28% of the total outstanding) of common and preferred stock combined, voting together as a single class.
- Approved with 94.96% of the votes cast (73.79% of the total outstanding) of common stock alone, voting as a separate class.
Review of 2022 Progress
During the Annual Meeting, the Company also conducted a Q & A session, which was publicly available by audio link. The Q&A included discussion of the Company’s progress in 2022 and plans for 2023.
The Company believes that 2022 was one of its strongest years to date. Three major achievements included (i) reporting what the Company believes are strong positive results from its Phase 3 clinical trial of DCVax-L for Glioblastoma brain cancer, (ii) having the trial results published in JAMA Oncology, a top peer-reviewed medical/scientific journal, and (iii) commencing a major lawsuit to begin fighting back against what the Company believes has been manipulation of its stock.
The Company provided some additional examples of progress during 2022. These included work with teams of consultants on pre-requisites for an application for product approval, and on portions of the application package itself. One of the pre-requisites -- obtaining regulatory approval of a Pediatric Investigation Plan (PIP) -- was completed on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial. Additionally, substantial progress was made on preparing the Trial Master File to be inspection-ready for regulators.
Development continued at the Sawston facility during 2022, with the Phase 1A buildout previously completed and the Phase 1B buildout under way. Manufacturing of DCVax-L products for patients began in Q1 2022 after manufacturing licenses for Specials and clinical trials was obtained at the end of 2021. The application package for a commercial manufacturing license was submitted in June, the dual inspection for the commercial manufacturing license and review/renewal of the existing license took place in October, and post-inspection interactions with the regulator continued through year-end. In parallel, R&D work on the Flaskworks system also proceeded, with multiple versions of the system being evaluated, and with a test system established and operating at Sawston. In the US, the Company entered into contract discussions for resumption of manufacturing capacity there.
The Company also continued process and infrastructure improvements that will be needed for scale-up, including systems to avoid bottlenecks in quality control testing and product “release,” and capacity for controlled cryostorage of millions of doses.
Plans for 2023
Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year. The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license, which is one of the pre-requisites for submission of an application for product approval. In parallel, the top priority and intensive focus will be continued preparation of an application package for product approval, as well as the supporting documentation. The Company already made substantial progress on the application package during 2022, and the Company plans to submit an application as soon as possible after the pre-requisites and preparations are completed.
During 2023, the Company anticipates that additional key areas of focus will include:
- continued preparations for scale-up capability, with further implementation of streamlining product “release” processes;
- expansion of the operation in Sawston following completion of the Phase 1B buildout;
- continued development of the Flaskworks system, including choice of the system version to take forward;
- commencing the pediatric clinical program required under the PIP;
- as resources permit, pursuing clinical trials with combination treatment regimens.
Linda Powers, the Company’s CEO, commented: “2022 has been a year of major accomplishments, and we look forward to an even stronger 2023. We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting.”
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 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.” This Phase III trial has been completed, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue 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. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products will be viewed as demonstrating 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.
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