Kintara Therapeutics, Inc. announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. The topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With the GBM AGILE Study outcome, the Company is suspending the development of VAL-083 and turning its focus to its second program, REM-001.

The Company was recently awarded a $2 million grant from the National Institutes of Health (NIH) which is expected to cover the majority of the cost to run the CMBC study. In November 2022, the United States Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to Kintara's REM-001 Therapy for the treatment of patients with CMBC. REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications.

REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications.