Polaris Group received notice from US FDA to schedule pre-BLA meeting on March 23, 2023. ATOMIC trial is a global, multi-center, randomized, double-blind, placebo-controlled trial of ADI-PEG 20 in combination with Pemetrexed and Cisplatin in patients with unresectable Malignant Pleural Mesothelioma (MPM) with biphasic or sarcomatoid histology. The primary and secondary endpoints of the trial were both statistically significant.

Polaris Group will use the FAST TRACK designation granted from the FDA to accelerate the BLA process. Current development stage: A.File application/approved/disapproved/Each of clinical trials (includeinterim analysis): BLA application B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significantsense, the risks and the associated measures the Company may occur: NA C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: NA D. A ccumulated investment expenditure incurred: No disclosure due to confidentiality (5)Upcoming development plan: BLA application (6)Market: ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow.

ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient's normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine dependency. The difference in the primary efficacy endpoint of Overall Survival (OS) is statistically significant, and the secondary endpoint is also statistically significant for ATOMIC trial.

The safety profile of ADI-PEG 20 observed in ATOMIC was similar to that of the previous clinical trial. Given these results, Polaris Group will proceed with regulatory submissions in the United States in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA.