TuHURA Biosciences, Inc.(HURA) - 2024 Q1 - Quarterly Report

Funding and Grants - Kintara Therapeutics received a $2.0 million grant from the NIH to fund the REM-001 CMBC clinical study over two years[78]. - The company received a$2 million grant for the REM-001 project, which was announced on June 28, 2023[110]. - The company entered into a Sales Agreement allowing for the sale of up to $2.85 million in common stock, with$968,000 raised in net proceeds from the sale of shares under this agreement after September 30, 2023[110]. - The company is actively pursuing various financing alternatives to fund operations and maintain clinical trials, indicating substantial doubt about its ability to continue as a going concern[111]. Clinical Studies and Development - Preliminary results from the VAL-083 study indicated it did not outperform current glioblastoma treatments, leading to the suspension of its development[84]. - The company plans to start enrolling patients in the REM-001 CMBC clinical study in Q4 2023[80]. - In previous studies, REM-001 Therapy achieved a complete response in approximately 80% of evaluable tumor sites treated[82]. - The REM-001 program was previously paused to conserve cash but has been reinitiated following the NIH grant[78]. - Kintara's focus is on developing therapies for patients with solid tumors resistant to current treatments, particularly in orphan cancer indications[76]. - Kintara has received Fast Track Designation from the FDA for both VAL-083 and REM-001 in their respective indications[88][83]. Financial Performance - As of September 30, 2023, Kintara had cash and cash equivalents of $216,000, down from$1,535,000 on June 30, 2023[95]. - Total assets decreased from $3,979,000 on June 30, 2023, to$1,477,000 on September 30, 2023[95]. - The company's total stockholders' equity showed a deficiency of $2,026,000 as of September 30, 2023, compared to$731,000 on June 30, 2023[95]. - Net loss for the period was $2,962,000 for the three months ended September 30, 2023, compared to a net loss of$4,596,000 for the same period in 2022, indicating a 35% improvement[100]. - Cash flows from operating activities improved to $(1,317,000) for the three months ended September 30, 2023, from$(6,369,000) for the same period in 2022, a 79% reduction in cash outflow[106]. Expenses - Research and development expenses decreased to $1,859,000 for the three months ended September 30, 2023, from$3,171,000 for the same period in 2022, representing a 41% decrease[100]. - General and administrative expenses were $1,103,000 for the three months ended September 30, 2023, compared to$1,475,000 for the same period in 2022, a reduction of 25%[100]. - Non-cash, share-based compensation expense for research and development decreased to $86,000 in Q3 2023 from$140,000 in Q3 2022[101]. - Non-cash, share-based compensation expense for general and administrative costs decreased to $121,000 in Q3 2023 from$378,000 in Q3 2022[103]. Stock Options and Compensation - The company recognizes compensation costs from stock-based awards over the service period based on fair value measurements, with adjustments made for actual forfeitures[114]. - For the three months ended September 30, 2023, the company issued stock options to its officers, with fair value estimated using the Black-Scholes model[114]. Clinical Trial Expenses - The company estimates expenses related to clinical trials based on contracts with vendors and adjusts accruals as necessary, with no material adjustments reported for the three months ended September 30, 2023[115]. - The company does not have any off-balance sheet arrangements[116].