Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $23.3 million, compared to a net loss of $15.7 million for the same period in 2024, reflecting an increase in operating losses [109]. - The company incurred significant operating losses since inception, with a net loss of $22.6 million for the year ended December 31, 2024 [109]. - The net loss attributable to common shareholders for the three months ended September 30, 2025, was $7.10 million, compared to a loss of $6.54 million in 2024, an increase of 8.4% [136]. - Net losses for the nine months ended September 30, 2025, and 2024, were $23.3 million and $15.7 million, respectively, with accumulated deficits reaching $134.4 million as of September 30, 2025 [153]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $134.4 million and cash and cash equivalents of $2.7 million [109][113]. - The company completed a private placement on June 2, 2025, raising approximately $12.6 million by issuing 4,759,309 shares of common stock and warrants [114]. - The company entered into a Secured Promissory Note and Loan Agreement on October 27, 2025, for up to $3 million to support working capital [122]. - The company has initiated an at-the-market offering program with an aggregate offering price of up to $50 million, pending SEC approval [123]. - The company anticipates needing substantial additional funding for development programs and operations, with existing cash expected to meet requirements through the end of 2025 [165]. Research and Development - The company initiated a Phase 3 trial for its lead product candidate IFx-2.0 in June 2025, targeting advanced or metastatic Merkel cell carcinoma patients [105]. - The company is planning to investigate TBS-2025 in a randomized Phase 2 trial for mutated NPM1 acute myeloid leukemia [106]. - Research and development expenses increased to $4.97 million for the three months ended September 30, 2025, compared to $2.95 million for the same period in 2024, representing a 68.5% increase [136]. - For the nine months ended September 30, 2025, research and development expenses totaled $14.48 million, up from $9.36 million in 2024, an increase of 54.7% [145]. - Research and development expenses for the nine months ended September 30, 2025, included $5.65 million for IFx-2.0, an increase of 8.7% from $5.19 million in 2024 [146]. Operating Expenses - General and administrative expenses rose to $1.76 million for the three months ended September 30, 2025, up from $0.78 million in 2024, marking a 124.8% increase [138]. - General and administrative expenses for the nine months ended September 30, 2025, were $9.15 million, compared to $2.60 million in 2024, indicating a 253.5% increase [147]. - Total operating expenses for the three months ended September 30, 2025, were $6.73 million, compared to $3.73 million in 2024, reflecting an increase of 80.4% [136]. Income and Expenses - Grant income for the three months ended September 30, 2025, was $0.14 million, a new revenue stream following the assumption of the Kintara Health and Human Services grant [139]. - Interest expense decreased significantly to $16,532 for the three months ended September 30, 2025, from $2.00 million in 2024, a reduction of 99.2% [141]. - The total other income (expense) for the three months ended September 30, 2025, was a loss of $372,852, compared to a loss of $1.85 million in 2024, reflecting an improvement of 80.8% [136]. - Interest expense for the nine months ended September 30, 2024, was $3.6 million, with a total of $31.3 million in convertible notes issued under the TuHURA Notes at an interest rate of 20% per annum [149]. Acquisition and Merger - The company acquired rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody, through the acquisition of Kineta, Inc. on June 30, 2025 [106]. - The Kineta acquisition was completed on June 30, 2025, through a cash and stock transaction, with Kineta becoming a wholly-owned subsidiary [177]. - Each share of Kineta was converted into 0.185298 shares of common stock, totaling approximately 2,868,169 shares, plus a pro rata portion of 1,129,885 shares to be issued after six months [178]. - Goodwill and other intangible assets related to the Kineta Merger were recorded on the balance sheet as of September 30, 2025 [180]. - Acquired in-process research and development (IPR&D) is capitalized as indefinite-lived intangible assets and will not be amortized until regulatory approval is received [181]. Valuation and Fair Value - The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the merger date [179]. - A third-party valuation firm will assist in valuing the IPR&D, which has significant measurement uncertainty due to a lack of historical data [182]. - The company tests indefinite-lived intangible assets for impairment by assessing qualitative factors and performing quantitative tests if necessary [183]. - Following the reverse merger with Kintara, the fair value of common stock will be based on quoted market prices, with all preferred shares converted to common stock [176]. Cash Flow Activities - Net cash used in operating activities for the nine months ended September 30, 2025, was $22.1 million, primarily due to a net loss of $23.3 million and changes in operating assets and liabilities [160]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $13.4 million, including $12.1 million from the issuance of common stock [163]. - For the nine months ended September 30, 2025, net cash used in investing activities was $1.3 million, primarily for property and equipment purchases and payments related to the Kineta acquisition [162].
TuHURA Biosciences, Inc.(HURA) - 2026 Q1 - Quarterly Report