TuHURA Biosciences, Inc.(HURA) - 2025 Q1 - Quarterly Report

Merger and Corporate Changes - The company 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]. - The merger with TuHURA was completed on October 18, 2024, and the company changed its name to TuHURA Biosciences, Inc.[86]. - TuHURA stockholders owned approximately 97.15% of the company on a fully-diluted basis immediately prior to the merger[76]. - A 1-for-35 reverse stock split was completed on October 18, 2024, with the company's common stock trading under the new symbol "HURA" on the Nasdaq Capital Market[76]. Clinical Studies and Developments - The company received a $2,000 grant from the NIH to fund the REM-001 CMBC clinical study, which will be received over a two-year period[77]. - As of November 14, 2024, the company has initiated treatment in four patients for the REM-001 Study and expects to complete enrollment in Q4 2024[77]. - The company reported that in previous studies, REM-001 Therapy achieved a complete response in approximately 80% of evaluable tumor sites treated[78]. - The company received Fast Track Designation from the FDA for REM-001 in CMBC[80]. - The company has opened enrollment for the REM-001 program at Memorial Sloan Kettering Cancer Center[79]. - The company expects to receive approximately 1,539,918 shares of common stock upon achieving a milestone related to the REM-001 Study[76]. - The company terminated the development of VAL-083 after preliminary results showed it did not perform better than current standards of care in glioblastoma[81]. Financial Performance - As of September 30, 2024, cash and cash equivalents were$ 3,020,000, down from $4,909,000 as of June 30, 2024, representing a decrease of 38.5%[87]. - Research and development expenses decreased to$ 252,000 for the three months ended September 30, 2024, 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 $1,103,000 for the same period in 2023, an increase of 77%[88]. - The net loss for the period was$ 2,161,000 for the three months ended September 30, 2024, compared to a net loss of $2,962,000 for the same period in 2023, a decrease of 27%[88]. - The company reported a negative cash flow from operating activities of$ 1,889,000 for the three months ended September 30, 2024, compared to $1,317,000 for the same period in 2023, an increase of 43%[95]. - The accumulated deficit as of September 30, 2024, was$ 162,052,000, with no revenues generated to date[100]. - The company raised approximately $2,008,000 in net proceeds from the issuance of common stock under a Purchase Agreement as of September 30, 2024[100]. Future Financing and Accounting - The company has initiated a process to explore various financing alternatives to fund operations and maximize shareholder value following the merger[101]. - Future funding requirements will depend on various factors, including clinical study costs, manufacturing capabilities, and regulatory approvals[101]. - 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, indicating a straightforward financial structure[106].