Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $22.6 million, compared to a net loss of $29.3 million for the year ended December 31, 2023[81]. - The company incurred a net loss of $6.7 million for the three months ended March 31, 2025, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase in losses of $1.8 million[108]. - The company has incurred significant operating losses and anticipates these losses will increase as it advances product candidates through development[81]. - Total operating expenses for the three months ended March 31, 2025, were $7.0 million, an increase of $2.4 million from $4.6 million in 2024[108]. Cash Position - As of March 31, 2025, the company had an accumulated deficit of $117.8 million and cash and cash equivalents of $6.2 million[84]. - As of March 31, 2025, the company had cash and cash equivalents of $6.2 million, with investments in liquid money market accounts[119]. - The company used $4.7 million in cash from operating activities for the three months ended March 31, 2025, compared to $3.8 million used in the same period in 2024[117]. - For the three months ended March 31, 2025, net cash used in operating activities was $4.7 million, consisting of a net loss of $6.7 million and non-cash charges of $1.4 million[130]. - The company expects existing cash and cash equivalents to meet anticipated cash requirements through late Q4 2025, excluding cash needed for the Kineta Merger[134]. Research and Development - The company has not generated any revenue from product sales and does not expect to do so in the near future[99]. - The company is preparing to initiate a Phase 3 trial of its lead product candidate, IFx2.0, as an adjunctive therapy to Keytruda® for patients with advanced Merkel Cell Carcinoma[79]. - The company has initiated a Phase 1b/2a study of IFx-Hu2.0 in combination with Keytruda® for metastatic Merkel cell carcinoma[97]. - Research and development expenses increased to $4.6 million for the three months ended March 31, 2025, up from $3.6 million in the same period in 2024, representing a $1.0 million increase[111]. - The company anticipates continued increases in research and development and general administrative expenses to support ongoing activities and potential commercialization efforts[106]. Mergers and Acquisitions - The company completed a merger with Kintara Therapeutics on October 18, 2024, which included a 1-for-35 reverse stock split[85]. - The company anticipates needing at least $20 million in gross proceeds from a financing transaction to close the Kineta Merger[135]. - The company entered into a Clinical Trial Funding Agreement with Kineta, agreeing to fund clinical trial expenses for KVA12123 up to $900,000[95]. - The company raised approximately $41.6 million in net proceeds through preferred stock financings since inception, which were converted into shares of Kintara common stock as part of the Kintara Merger[121]. Expenses - General and administrative expenses rose to $2.4 million for the three months ended March 31, 2025, compared to $1.0 million in 2024, an increase of $1.4 million primarily due to non-cash stock compensation and merger transaction costs[112]. - The company expects to incur additional costs associated with operating as a public company, including legal, accounting, and compliance expenses[82]. - Stock-based compensation expense for the three months ended March 31, 2025, included $1.4 million related to stock-based compensation[130]. Financing Activities - For the three months ended March 31, 2025, net cash used in financing activities was $0.6 million, including $0.5 million from warrant exercises and $1.1 million in merger transaction costs[133]. - The TuHURA Notes financing raised an aggregate principal amount of $31.3 million, with a maturity date of December 1, 2025, and an interest rate of 20% per annum[122]. - The company may finance cash needs through public or private equity offerings, debt financings, or collaborations, which could dilute stockholder ownership[137]. Other Information - The company does not have any off-balance sheet arrangements as defined under SEC rules[149]. - The company has paid approximately $852,000 in clinical trial expenses under the Clinical Trial Funding Agreement and $250,000 in working capital loans[95]. - Grant income was $0.3 million for the three months ended March 31, 2025, related to the Kintara Health and Human Services grant[113]. - The company has not experienced material differences between estimated and actual accrued research and development expenses[142].
TuHURA Biosciences, Inc.(HURA) - 2025 Q3 - Quarterly Report