PharmaCyte Biotech, Inc.

PharmaCyte Biotech, Inc. is a biotechnology company that develops cellular therapies for cancer. The company utilizes a proprietary cellulose-based live cell encapsulation technology called "Cell-in-a-Box®." This technology serves as a platform for developing therapies for various cancer types, including locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC). The current version of their product candidate is named "CypCaps™." On November 17, 2023, the Board of Directors established the Strategic Scientific Committee, chaired by Dr. Michael Abecassis, to review business risks. The Board is also assessing risks related to development programs and its relationship with SG Austria Pte. Ltd. ("SG Austria"), noting that all licensed patents have expired and the know-how for Cell-in-a-Box® technology resides solely with SG Austria. The Board has reduced spending on programs, including pre-clinical and clinical activities, pending the completion of these reviews and the determination of future actions. The Scientific Committee's recommendations may include seeking a new framework for the relationship with SG Austria and its subsidiaries. PharmaCyte Biotech, Inc. is reevaluating programs dependent on SG Austria and the U.S. Food and Drug Administration's (FDA) acceptance of its technologies, including LAPC development programs. Reevaluation to address FDA concerns has caused delays due to the review of the nonclinical package from SG Austria and changes in the FDA review process. The Cell-in-a-Box® encapsulation technology is designed to deliver genetically engineered live human cells to specific tissues. It aims to create pinhead-sized, cellulose-based porous capsules that encapsulate genetically modified live human cells, allowing them to grow and be maintained in a cryopreserved (frozen) state until injection into a patient. Laboratory studies have demonstrated that this technology creates a micro-environment where encapsulated cells survive and thrive.