Merger and Corporate Changes - Kintara Therapeutics completed a merger with TuHURA Biosciences, issuing approximately 40,441,605 shares of common stock to TuHURA stockholders based on an exchange ratio of 0.1789[74]. - Following the merger, Kintara's common stock began trading under the new symbol "HURA" on October 18, 2024, after a 1-for-35 reverse stock split[76]. - The company completed the merger with TuHURA on October 18, 2024, and changed its name to TuHURA Biosciences, Inc.[86]. - TuHURA stockholders owned approximately 97.15% of Kintara on a fully-diluted basis immediately prior to the merger[76]. - The merger agreement included provisions for contingent value rights, allowing stockholders to receive approximately 1,539,918 shares of common stock upon achieving specific clinical milestones[76]. Clinical Development and Research - The company received a $2,000 grant from the NIH to fund the REM-001 CMBC clinical study, which is expected to complete patient enrollment in Q4 2024[77]. - REM-001 therapy demonstrated a complete response in approximately 80% of evaluable tumor sites treated in previous studies for cutaneous metastatic breast cancer[78]. - Kintara received Fast Track Designation from the FDA for REM-001 in CMBC, facilitating its clinical development[80]. - The company has initiated treatment in four patients as part of the REM-001 study at Memorial Sloan Kettering Cancer Center as of November 14, 2024[79]. - The development of VAL-083 was terminated after preliminary results showed it did not perform better than current standards of care for glioblastoma[81]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of $3,020,000, down from $4,909,000 as of June 30, 2024[87]. - For the three months ended September 30, 2024, research and development expenses decreased to $252,000 from $1,859,000 for the same period in 2023, a reduction of 86%[88]. - General and administrative expenses increased to $1,957,000 for the three months ended September 30, 2024, compared to $1,103,000 for the same period in 2023, an increase of 77%[88]. - The net loss for the three months ended September 30, 2024, was $2,161,000, an improvement from a net loss of $2,962,000 for the same period in 2023[88]. - The company reported a negative cash flow from operating activities of $1,889,000 for the three months ended September 30, 2024, compared to a negative cash flow of $1,317,000 for the same period in 2023, a change of 43%[95]. - The accumulated deficit as of September 30, 2024, was $162,052,000, with no revenues generated to date[100]. - The company raised approximately $10,471,000 in net proceeds from the sale of common stock under the ATM Facility from October 31, 2023, to September 30, 2024[100]. - The company recorded $13,000 in dividends related to Series C Preferred Stock for the three months ended September 30, 2024, down from $173,000 for the same period in 2023[94]. Operational Strategies - The company aims to address unmet medical needs in cancer therapy, focusing on orphan cancer indications[72]. - The company is exploring various financing alternatives to fund operations and maximize shareholder value following the merger[101]. Accounting and Estimates - The company provided a detailed presentation of significant accounting policies and estimates in its Annual Report on Form 10-K for the year ended June 30, 2024, filed on October 7, 2024[103]. - For the three months ended September 30, 2024, the company issued stock options to its officers, with fair value determined using the Black-Scholes model, which includes variables such as expected volatility, interest rates, and dividend yields[104]. - The company estimates expenses related to research and development and clinical trials based on contracts with vendors and clinical research organizations, adjusting accrual estimates as necessary[105]. - There were no material adjustments to prior period estimates of accrued expenses for clinical trials for the three months ended September 30, 2024, and 2023[105]. - The company does not have any off-balance sheet arrangements[106].
Kintara Therapeutics(KTRA) - 2025 Q1 - Quarterly Report