Financial Performance - For the three months ended March 31, 2025, the company incurred a net loss of $6.7 million, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase in operating expenses [81]. - As of March 31, 2025, the company had an accumulated deficit of $117.8 million, indicating significant ongoing financial challenges [81]. - The net loss for the three months ended March 31, 2025, was $6.7 million, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase of $1.8 million [108]. - The company incurred net losses of $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively [117]. - Total operating expenses for the three months ended March 31, 2025, were $7.0 million, compared to $4.6 million in 2024, an increase of $2.4 million [108]. Cash Position and Funding Needs - The company had cash and cash equivalents of $6.2 million as of March 31, 2025, highlighting the need for additional funding to support operations [84]. - Cash and cash equivalents as of March 31, 2025, were $6.2 million, with cash flows from operating activities showing a net outflow of $4.7 million for the three months ended March 31, 2025 [119][129]. - The company anticipates needing at least $20 million in gross proceeds from a financing transaction to complete the Kineta merger [135]. - The company expects to finance cash needs through public or private equity offerings, debt financings, and collaborations, which may dilute existing stockholder ownership [137]. - The company expects existing cash and cash equivalents to meet anticipated cash requirements through late into the fourth quarter of 2025, excluding cash needed for the Kineta merger [134]. Research and Development - The company is preparing to initiate a Phase 3 trial for its lead product candidate, IFx2.0, as an adjunctive therapy to Keytruda® for advanced Merkel Cell Carcinoma patients, utilizing the FDA's accelerated approval pathway [79]. - The company is developing tumor microenvironment modulators targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the efficacy of immunotherapies [79]. - 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 of 2024, representing a $1.0 million increase [111]. - The company plans to significantly increase research and development expenses in the foreseeable future to support product candidate development [102]. Mergers and Acquisitions - The company completed a merger with Kintara Therapeutics on October 18, 2024, which included a 1-for-35 reverse stock split and resulted in Legacy TuHURA becoming a wholly-owned subsidiary of Kintara [85]. - The company has entered into a Clinical Trial Funding Agreement with Kineta, agreeing to fund up to $900,000 in clinical trial expenses for KVA12123, with approximately $852,000 already paid [95]. - The company has entered into an Exclusivity Agreement with Kineta for the potential acquisition of KVA12123, paying a total of $5 million in fees [90]. - 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][123]. Operational Challenges - The company anticipates that operating losses will increase substantially as it advances product candidates through clinical development and seeks regulatory approvals [82]. - The company has not generated any revenue from product sales and does not expect to do so in the near future [99]. - The company has not experienced any material differences between estimates of accrued expenses and actual amounts incurred [142]. - The company is exposed to interest rate and inflation risks, but does not believe inflation has materially affected its results of operations [150][152].
Kintara Therapeutics(KTRA) - 2025 Q3 - Quarterly Report