PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology
Company prepares for comprehensive discussion with FDA to determine appropriate next steps for technology while evaluating additional opportunities
PharmaCyte Biotech, Inc. (NASDAQ:PMCB) ("PharmaCyte" or the "Company") provides an update on its investigation of its Cell-in-a-Box technology and initial next steps in development. Following a comprehensive scientific review of amassed data, the Company is in the process of requesting a meeting with the U.S. Food and Drug Administration (FDA) for guidance on further development of the technology. The meeting is expected to occur during the first quarter of 2024. In the meantime, the Company is reviewing multiple potential opportunities that it believes would be prudent uses for its approximately $74.6 million cash position as of July 31, 2023, which was previously reported in the Company's Quarterly Report on Form 10-Q filed on September 18, 2023.
PharmaCyte's Board member, Professor of Surgery and Microbiology and Dean, College of Medicine – Tucson at the University of Arizona, Dr. Michael M.I. Abecassis stated, "Despite recent advances with modest improvements in survival, locally advanced non-metastatic disease remains a perplexing challenge and barrier to potentially curative surgical treatment and represents a significant unmet therapeutic need for a majority of patients diagnosed with pancreatic cancer. Cell-in-a-Box, along with several other potential delivery systems, provides a unique putative opportunity to treat patients systemically with non-toxic chemotherapeutic prodrugs, that can then be activated or ‘turned-on' in direct proximity to the cancer tissue, resulting in the targeted delivery of highly concentrated cancer-killing drugs, while significantly minimizing the systemic toxicity and side-effects that limit their systemic application, and hence their efficacy and effectiveness. We believe that discussions with the Food and Drug Administration regarding Cell-in-a-Box should provide a path forward as we continue to examine other promising local delivery technologies that may provide similar benefits for patients with this challenging and lethal clinical problem."
Pharmacyte Interim Chief Executive Officer Josh Silverman continued, "We have dedicated significant resources to comprehensively evaluate the status of the Cell-in-a-Box technology, and we look forward to future discussions with FDA, which may also compel us to seek partnership discussions. In the meantime, it is our intention to utilize our favorable $70 million cash position to create additional value to our stockholders by reviewing additional potential partnership and/or investment opportunities that we believe will be accretive. We anticipate providing additional updates regarding these opportunities in the near term."
About PharmaCyte Biotech
PharmaCyte is a biotechnology company that is currently evaluating its signature live-cell encapsulation technology, Cell-in-a-Box®, for potential development of cellular therapies for cancer, diabetes, and malignant ascites, while also exploring the opportunity for other strategic acquisitions.
The Cell-in-a Box technology involves encapsulating genetically engineered human cells that can then be reintroduced to attack disease. The Company is exploring possible utility in cancer (particularly pancreatic), Type 1 and insulin-dependent Type 2 diabetes, and malignant ascites.
However, until the review by the Business Review Committee and the Board is complete and the Board has determined the actions and plans to be implemented, the Board has curtailed spending on the foregoing programs.
Safe Harbor
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of PharmaCyte's management and Board of Directors. Any statements contained in this press release which do not describe historical facts are forward-looking statements subject to risks and uncertainties that could cause actual results, performance, and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to satisfactorily address the issues raised by the FDA in order to have the clinical hold on our IND removed, whether our exploration of additional opportunities to create new paths toward shareholder value is successful, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the SEC. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise. More information about PharmaCyte Biotech can be found at https://pharmacyte.com.
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