TuHURA Biosciences, Inc.(HURA) - 2024 Q3 - Quarterly Report

Clinical Development - On October 31, 2023, preliminary topline results for VAL-083 indicated it did not perform better than current standards of care in glioblastoma, leading to the termination of its development[75]. - The company received a $2,000 grant from the NIH to fund the majority of expenses related to the REM-001 CMBC 15-patient clinical study, with the grant awarded over a two-year period[77]. - As of May 14, 2024, treatment has been initiated in 2 patients for the REM-001 Study, with expectations to complete enrollment in the third calendar quarter of 2024[79]. - The REM-001 therapy has shown a complete response in approximately 80% of evaluable tumor sites treated in previous studies[78]. - The FDA has granted Fast Track Designation for REM-001 in CMBC, facilitating its clinical development[80]. - The company terminated the development of VAL-083 and assigned its rights to Valent, receiving a 5% royalty on future net sales[81]. Financial Performance - As of March 31, 2024, total assets increased to$ 7,446,000 from $3,979,000 as of June 30, 2023, representing an increase of 87.5%[87]. - Research and development expenses decreased by 70% to$ 592,000 for the three months ended March 31, 2024, compared to $2,005,000 for the same period in 2023[94]. - General and administrative expenses increased by 15% to$ 1,493,000 for the three months ended March 31, 2024, compared to $1,297,000 for the same period in 2023[96]. - The net loss for the three months ended March 31, 2024, was$ 2,011,000, a decrease of 38.4% from a net loss of $3,264,000 for the same period in 2023[93]. - For the nine months ended March 31, 2024, research and development expenses decreased to$ 2,562,000 from $7,235,000, a reduction of 65%[97]. - The company received$ 194,000 in grant proceeds during the three months ended March 31, 2024, compared to nil in the same period in 2023[95]. - The total stockholders' equity increased to $5,922,000 as of March 31, 2024, from$ 731,000 as of June 30, 2023[87]. - The company reported net losses of $5,996 for the nine months ended March 31, 2024, compared to$ 11,314 for the same period in 2023[102]. - Net cash used in operating activities was $5,734 for the nine months ended March 31, 2024, a 45% improvement from$ 10,357 in the same period in 2023[105]. - Net cash received from financing activities increased significantly to $10,570 for the nine months ended March 31, 2024, compared to$ 1,854 in the same period in 2023, marking a 470% increase[104]. Strategic Initiatives - A merger agreement was entered into on April 3, 2024, with TuHURA Biosciences, where existing stockholders are expected to own approximately 2.85% of the post-merger company on a fully diluted basis[76]. - The transaction with TuHURA is expected to close in the third calendar quarter of 2024, pending stockholder and regulatory approval[82]. - The company has initiated a process to explore strategic alternatives aimed at maximizing stockholder value as of December 2023[75]. - The company entered into a Merger Agreement with TuHURA, indicating a strategic move to maximize shareholder value[106]. - The company anticipates requiring significant additional funding to maintain clinical trials and operations, indicating substantial doubt about its ability to continue as a going concern[106]. Shareholder Information - The weighted average number of shares for the three months ended March 31, 2024, was 44,562, compared to 1,681 for the same period in 2023[89]. - The Series C Preferred Stock is convertible into common stock at prices ranging from $57.50 to$ 60.70 per share[86]. - The company raised $10,471 in net proceeds from the sale of shares under its ATM Facility from October 31, 2023, to March 31, 2024[106].