VAL-083 for Glioblastoma Multiforme (GBM) - VAL-083 targets Glioblastoma Multiforme (GBM), representing a significant market opportunity estimated at approximately $1 billion[3, 37] - The company is enrolling in all three GBM AGILE patient subtypes: Newly-Diagnosed Unmethylated (over 60% of GBM patients), Newly-Diagnosed Methylated (under 40% of GBM patients), and Recurrent[8, 24] - Kintara initiated the GBM AGILE International Registrational Study in January 2021, with 44 sites actively enrolling in the Kintara arm[3, 15, 16, 17, 20, 37] - Top-line results from the GCAR GBM AGILE International Registrational Study are expected around the end of 2023, 12 months after the last patient is randomized[5, 33, 37] REM-001 for Cutaneous Metastatic Breast Cancer (CMBC) - REM-001 targets Cutaneous Metastatic Breast Cancer (CMBC), with a market opportunity of approximately $500 million, representing up to 40,000 patients in the US[3, 25, 37] - Prior Phase 2/Phase 3 clinical trials of REM-001 demonstrated an 80% complete response rate across 674 evaluable lesions[3, 27, 37] - A 15-patient confirmatory study initiation is planned for Mid-2022, prior to a Phase 3 trial, with top-line results projected for Mid-2023[3, 28, 29, 37] Additional Opportunities - The company has orphan drug designation for VAL-083 in the US and EU, providing seven years and ten years of market exclusivity, respectively, after approval[31]
Kintara Therapeutics (KTRA) Investor Presentation - Slideshow