Core Insights - Kintara Therapeutics and TuHURA Biosciences are merging, with Kintara's existing stockholders expected to own approximately 5.5% of the combined company's common stock at the merger's closing [2][13] - The merger is anticipated to close in the third quarter of 2024, with a $31 million financing from TuHURA expected to provide cash runway into late 2025 [3][7] Recent Corporate Achievements - Kintara has advanced enrollment and dosing in its open-label 15-patient REM-001 study for cutaneous metastatic breast cancer (CMBC) [4] - The inclusion criteria for the REM-001 study were expanded in March 2024 to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months, which is expected to accelerate enrollment [5] Clinical Advancements - Kintara's REM-001 therapy has shown an 80% clinical efficacy in achieving complete responses in evaluable lesions for CMBC, supported by a robust safety database of approximately 1,100 patients across multiple indications [20] - Four patients have been dosed in the REM-001 study as of June 26, 2024, with the majority of study costs covered by a $2 million Small Business Innovation Research (SBIR) grant from the NIH [16][17] Expected Near-term Milestones - By Q4 2024, Kintara aims to complete enrollment and the 8-week follow-up of 10 patients in the REM-001 study [10] - In the second half of 2024, TuHURA plans to commence a Phase 3 trial for its IFx-2.0 personalized cancer vaccine as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma under the FDA's accelerated approval pathway [14][19]
Kintara Therapeutics and TuHURA Biosciences Provide Update on Recent Corporate and Clinical Advancements and Outline Near Term Milestones