NanoCarrier Co., Ltd. recently began the first administration of VB-111 in Japan as part of a joint, global phase III trial involving platinum-resistant ovarian cancer patients (OVAL study). VB-111 is a gene therapy product and the company have acquired exclusive domestic development and marketing rights to the product from the Israel company VBL Therapeutics (VBL). The company are planning to administer the drug to 30 patients at 12 institutions in Japan. The OVAL study is global trial, and patients are smoothly being enrolled overseas. More than 260 patients have already been enrolled. The design of the study calls for the enrollment of a total of 400 patients including the patients in Japan. The clinical trial amendment included a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Based upon the changes that were reviewed by the U.S. Food and Drug Administration (FDA), successfully meeting either primary endpoint is expected to be sufficient to support a Biologic License Applications (BLA) submission. Successful meeting of the PFS endpoint, with a readout anticipated in 2022, could accelerate BLA submission by approximately one year compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023. The company is doing best to conduct OVAL study in Japan in order to achieve BLA as early as possible in consultation with Regulatory Agency in Japan. This news release will not affect business results for the fiscal year ending March 2022. This is expected to be completed within the fiscal year. The OVAL study is the final stage before applying for approval. As Japan began to take part in this global phase III trial as it was already underway, the company are able to quickly pursue approval by significantly shortening the development period and reducing development costs.