TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its merger with Kineta Inc. on Jun ...

Core Insights - TuHURA Biosciences is advancing its Phase 3 program of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma, with enrollment completion targeted for Q4-2026 [1][13] - The company raised $15.6 million in a recent equity financing transaction, providing a cash runway to achieve key milestones across its development programs [1][2] - A mini KOL symposium highlighted the potential of targeting VISTA in acute myeloid leukemia (AML) and the combination with menin inhibitors for NPM1 mutated relapsed/refractory AML [1][3] Company Developments - The Phase 3 trial of IFx-2.0 has been initiated, marking a significant step in the company's strategy to address resistance to cancer immunotherapy [2][13] - The merger with Kineta has added a Phase 2 ready VISTA inhibiting antibody to the company's pipeline, enhancing its therapeutic offerings [2][14] - Preliminary data from the IFx-2.0 basket trial and insights on inhibiting Delta Opioid Receptor (DOR) are expected to be presented at scientific conferences in 2026 [3] Clinical Insights - VISTA is identified as the only checkpoint significantly upregulated in AML, particularly in high-risk subtypes, contributing to low response rates in patients treated with menin inhibitors [11] - The combination of TBS-2025 (VISTA inhibiting antibody) with menin inhibitors shows promise in improving survival outcomes in murine models of AML [11] - Key opinion leaders expressed enthusiasm for the potential of TBS-2025 in combination therapies for high-risk AML and patients unfit for intensive treatments [3][11]

TAMPA, Fla., Dec. 9, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that it has entered into a definitive agreement for the purchase of an aggregate of 9,462,423 shares of its common stock, Series A warrants to purchase up to an aggregate of 9,462,423 shares of its common stock and Series B warrants to purchase up to an aggregate of 9,462,4 ...

Core Insights - TuHURA Biosciences presented new scientific evidence at the 67th American Society of Hematology Annual Meeting, highlighting the role of Delta Opioid Receptor (DOR) in modulating the immunosuppressive capabilities of Myeloid-Derived Suppressor Cells (MDSCs) and Tumor-Associated Macrophages (TAMs) [1][2][3] Group 1: DOR and MDSCs - DOR is expressed on MDSCs, and its inhibition reduces their immune suppressing capabilities by downregulating multiple genes associated with immunosuppression [1][2] - Pharmacological antagonism of DOR has been shown to reverse T cell suppression, indicating that DOR may serve as a novel target for reprogramming MDSC-induced immunosuppression in the tumor microenvironment [2][4] Group 2: DOR and TAMs - DOR is also expressed on TAMs, and targeting DOR can potentially reverse TAM-mediated T cell suppression, which may help overcome resistance to checkpoint inhibitors and other cancer immunotherapies [1][3] - The study indicates that the tumor microenvironment induces DOR upregulation in TAMs compared to peripheral macrophages, suggesting a promising strategy for reprogramming these suppressive cells [3][4] Group 3: Company Developments - TuHURA has developed a library of highly selective DOR antagonists and is advancing its first-in-class immune-modulating bi-functional, bi-specific antibody drug conjugates (ADCs) [4][5] - The lead ADC candidate is expected to consist of a DOR inhibitor conjugated to a VISTA inhibiting antibody, aiming to alleviate the immunosuppressive tone of the tumor microenvironment and enhance T cell activity [4][5][6] Group 4: Clinical Trials and Future Directions - TuHURA has initiated a Phase 3 trial for its innate immune agonist, IFx-2.0, as an adjunctive therapy to Keytruda for advanced or metastatic Merkel Cell Carcinoma [6][7] - The company is also developing TBS-2025, a VISTA inhibiting mAb asset, which is moving into Phase 2 development for mutNPM1 r/r AML [7]

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].

Financial Results - TuHURA Biosciences reported financial results for Q3 2025, ending September 30, with a focus on corporate updates[7] - The press release detailing the financial results was issued on November 14, 2025[7] - Specific financial metrics and performance data were not provided in the extracted content[7] - The report indicates that the information is not deemed "filed" under the Securities Act or the Exchange Act[7] - The Chief Financial Officer, Dan Dearborn, signed the report on November 14, 2025[13] - The financial statements and exhibits are referenced but not detailed in the extracted content[8] Company Information - The company is listed on the Nasdaq Capital Market under the symbol HURA[5] - The company has not indicated whether it is an emerging growth company[6] Future Outlook and Developments - No details on user data, future outlook, or new product developments were included in the extracted content[7] - There are no mentions of market expansion or acquisitions in the provided documents[7]

Core Insights - TuHURA Biosciences is advancing its Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda for advanced Merkel cell carcinoma, with potential for accelerated and regular FDA approval [2][7] - The company is also preparing to submit a Phase 2 study protocol for TBS-2025, a VISTA inhibiting antibody, targeting NPM1 mutated acute myeloid leukemia (AML) [2][8] - TuHURA's Delta Opioid Receptor (DOR) technology has been recognized for its potential in overcoming resistance to cancer immunotherapy, with presentations scheduled at the ASH 2025 Annual Meeting [3][15] Clinical Development - The Phase 3 trial of IFx-2.0 is designed to evaluate its effectiveness as an adjunctive therapy to pembrolizumab in first-line treatment for advanced or metastatic Merkel cell carcinoma [7] - The company is on track to submit the Phase 2 plan for TBS-2025 to the FDA next month and aims to initiate the trial in the first quarter of next year [2][8] Financial Performance - For the third quarter ended September 30, 2025, research and development expenses were reported at $4.9 million, compared to $2.9 million for the same period in 2024 [5] - Net cash outflows from operating activities for the nine months ended September 30, 2025, were ($22.1) million, up from ($12.1) million in 2024 [5] Corporate Developments - TuHURA appointed Dr. Michael Turner as Vice President of Immunology, bringing over 20 years of experience in the field [3] - The company has filed for a $50 million At-The-Market (ATM) facility, allowing it to sell shares under the facility once the registration statement becomes effective [3] Upcoming Milestones - Anticipated milestones include preliminary results from the Phase 1b/2a trial of IFx-2.0 in Q2 2026 and completion of enrollment in the Phase 3 trial by Q4 2026 [11] - The company expects to initiate the Phase 2 trial of TBS-2025 in combination with a menin inhibitor in Q1 2026 [11]

Core Insights - TuHURA Biosciences has demonstrated for the first time that the Delta Opioid Receptor (DOR) is expressed on tumor-associated myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs), indicating a new target for overcoming resistance to cancer immunotherapy [1][2][4] - The research highlights the potential of DOR antagonism to reprogram the immunosuppressive capabilities of MDSCs and TAMs, which are critical components of the tumor microenvironment [2][4] - TuHURA is set to present these findings at the 67th American Society of Hematology (ASH) Annual Meeting in December 2025, showcasing the implications of DOR inhibition in enhancing cancer treatment efficacy [1][3][4] Company Developments - TuHURA is developing novel technologies aimed at overcoming both primary and acquired resistance to cancer immunotherapy, which are common reasons for treatment failure [6][8] - The company is advancing its lead innate immune agonist, IFx-2.0, in a Phase 3 trial as an adjunctive therapy to Keytruda (pembrolizumab) for advanced or metastatic Merkel Cell Carcinoma [7][8] - TuHURA has also acquired TBS-2025, a VISTA inhibiting monoclonal antibody, which is moving into Phase 2 development for patients with mutant NPM1 relapsed/refractory acute myeloid leukemia (AML) [8] Research Presentations - An oral presentation titled "Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs)" will be presented by Mike Turner, Ph.D., on December 7, 2025 [3] - A poster presentation on "Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype" will be presented by Krit Ritthipichai, D.V.M., Ph.D., on December 6, 2025 [4] - The Moffitt Cancer Center will also present findings on the pathogenic role of DOR-expressing MDSCs in patients with myeloid dysplastic syndrome (MDS) [4]

Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immune-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy, which is a significant challenge in treating cancer patients [3][4]. - The company has recently acquired TBS-2025, a VISTA inhibiting monoclonal antibody asset, which is progressing into Phase 2 development for mutNPM1 relapsed/refractory acute myeloid leukemia (AML) [4]. Upcoming Event - TuHURA management will present at the 27th Annual H.C. Wainwright Global Investment Conference scheduled for September 8-10, 2025, in New York City [1][2]. - James Bianco, M.D., President and CEO of TuHURA, will provide an overview and is available for one-on-one meetings during the conference [2][7]. Product Development - The company is leveraging its Delta Opioid Receptor technology to create first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates aimed at targeting Myeloid Derived Suppressor Cells, which play a role in immune suppression within the tumor microenvironment [4].

```markdown [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part covers financial statements, management's analysis, market risk, and internal controls [Item 1. Condensed Financial Statements.](index=7&type=section&id=Item%201.%20Condensed%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, liquidity, recent acquisitions, and other financial disclosures for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $8,512,824 | $12,657,178 | | Deposits, planned business acquisition | - | $5,994,503 | | Stock subscription receivable | $2,997,547 | - | | Total Current Assets | $12,539,459 | $19,610,389 | | Goodwill | $13,554,163 | - | | In-process research and development | $8,261,000 | - | | Total Assets | $34,621,304 | $19,966,684 | | Accounts payable and accrued expenses | $12,093,163 | $5,170,166 | | Total Current Liabilities | $15,171,776 | $5,330,010 | | Total Liabilities | $15,171,776 | $5,372,708 | | Total Stockholders' Equity | $19,449,528 | $14,593,976 | | Accumulated deficit | $(127,316,953) | $(111,124,569) | - **Total assets** increased significantly from **$19.97 million** at December 31, 2024, to **$34.62 million** at June 30, 2025, primarily due to the recognition of **goodwill** and **in-process research and development assets** from the **Kineta merger**[15](index=15&type=chunk) - **Cash and cash equivalents** decreased by approximately **$4.14 million** from December 31, 2024, to June 30, 2025[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's financial performance, including revenues, expenses, and net loss | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $4,926,936 | $2,823,064 | $9,508,608 | $6,412,077 | | General and administrative expenses | $4,949,020 | $795,660 | $7,384,371 | $1,812,401 | | Operating Loss | $(9,875,956) | $(3,618,724) | $(16,892,979) | $(8,224,478) | | Grant income | $322,655 | - | $575,209 | - | | Interest expense | - | $(1,357,458) | - | $(1,612,580) | | Net Loss | $(9,523,835) | $(5,265,235) | $(16,188,206) | $(10,107,377) | | Net Loss per share, basic and diluted | $(0.21) | $(0.43) | $(0.36) | $(0.83) | | Weighted-average shares outstanding | 44,555,095 | 12,178,522 | 44,983,198 | 12,176,127 | - **Net loss** for the three months ended June 30, 2025, increased to **$9.52 million** from **$5.27 million** in the prior year, primarily driven by higher **R&D** and **G&A expenses**, partially offset by grant income and reduced interest expense[17](index=17&type=chunk) - **Weighted-average shares outstanding** significantly increased from **12.18 million** to **44.55 million** for the three months ended June 30, 2025, impacting the **net loss per share**[17](index=17&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in equity, including common stock, paid-in capital, and accumulated deficit | Metric | January 1, 2025 | June 30, 2025 | | :----------------------------------- | :-------------- | :------------ | | Preferred Stock Dollars | $278,530 | $278,530 | | Common Stock Dollars | $42,324 | $49,913 | | Additional Paid in Capital | $125,397,691 | $146,438,038 | | Accumulated Deficit | $(111,124,569) | $(127,316,953) | | Total Stockholders' Equity (Deficit) | $14,593,976 | $19,449,528 | | Common Shares Outstanding | 42,323,759 | 49,913,946 | - **Total stockholders' equity** increased from **$14.59 million** at January 1, 2025, to **$19.45 million** at June 30, 2025, primarily due to increases in **additional paid-in capital** from common stock issuances and warrant exercises, despite an increased **accumulated deficit**[20](index=20&type=chunk) - The number of **common shares outstanding** increased from **42.32 million** at January 1, 2025, to **49.91 million** at June 30, 2025, reflecting issuances related to warrant exercises, the **Kineta merger**, and other capital raises[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash flows from operating, investing, and financing activities | Cash Flow Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash flows from Operating activities | $(10,986,584) | $(8,900,053) | | Net cash flows from Investing activities | $(1,307,511) | $(36,498) | | Net cash flows from Financing activities | $8,149,741 | $17,582,805 | | Net change in cash and cash equivalents | $(4,144,354) | $8,646,254 | | Cash and cash equivalents at end of period | $8,512,824 | $12,311,286 | - **Net cash used in operating activities** increased to **$(10.99 million)** for the six months ended June 30, 2025, from **$(8.90 million)** in the prior year, primarily due to higher **net losses**[22](index=22&type=chunk) - **Investing activities** used significantly more cash, **$1.31 million**, in the first half of 2025 compared to **$0.04 million** in 2024, largely due to the **Kineta acquisition**[22](index=22&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the unaudited financial statements [Note 1—Description of business and basis of presentation](index=11&type=section&id=Note%201%E2%80%94Description%20of%20business%20and%20basis%20of%20presentation) This note describes the company's business and the basis for financial statement presentation - **TuHURA Biosciences, Inc.** is a clinical-stage immuno-oncology company developing novel therapeutics to overcome cancer immunotherapy resistance, utilizing three distinct technologies: **Immune FxTM (IFx)**, **TBS-2025** (**VISTA-inhibiting antibody**), and Delta Opioid Receptor technology[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - In June 2025, the company initiated a **Phase 3 registration trial** for its lead product candidate, **IFx-2.0**, as an adjunctive therapy to **Keytruda®** for advanced or metastatic Merkel cell carcinoma[25](index=25&type=chunk)[30](index=30&type=chunk) - The company acquired rights to **TBS-2025**, a novel **VISTA-inhibiting monoclonal antibody**, through the **Kineta acquisition** on June 30, 2025, and plans to investigate it in a Phase 2 trial for **mutated NPM1 AML**[26](index=26&type=chunk)[33](index=33&type=chunk) - A **private placement** in June 2025 raised approximately **$12.6 million** through the issuance of **common stock** and **warrants**, with **$8.9 million** purchased by June 30, 2025, and the remaining **$3.7 million** due by December 31, 2025[29](index=29&type=chunk)[31](index=31&type=chunk) [Note 2—Summary of significant accounting policies](index=13&type=section&id=Note%202%E2%80%94Summary%20of%20significant%20accounting%20policies) This note outlines key accounting principles and methods used in financial statements - The condensed consolidated financial statements are prepared in accordance with **U.S. GAAP** and include wholly-owned subsidiaries, with all intercompany balances eliminated[36](index=36&type=chunk)[37](index=37&type=chunk) - The company expenses **research and development costs** as incurred and accounts for **stock-based awards** using the fair value-based method with the **Black-Scholes valuation model**[40](index=40&type=chunk)[42](index=42&type=chunk) - Acquired businesses are accounted for using the **acquisition method**, with acquired **in-process research and development (IPR&D)** capitalized as an **indefinite-lived intangible asset** not subject to amortization until completion or abandonment[43](index=43&type=chunk)[45](index=45&type=chunk) - The company operates in one **reportable segment** focused on cancer treatment, consistent with how its chief operating decision maker reviews performance[46](index=46&type=chunk)[47](index=47&type=chunk) [Note 3—Liquidity and management's plans](index=17&type=section&id=Note%203%E2%80%94Liquidity%20and%20management's%20plans) This note discusses the company's liquidity and management's plans for future funding - The company has historically incurred negative **cash flows from operations**, with **$11.0 million** used in the six months ended June 30, 2025[52](index=52&type=chunk)[53](index=53&type=chunk) - As of June 30, 2025, **cash and cash equivalents** totaled **$8.5 million**, which is expected to fund operations into the late fourth quarter of 2025[53](index=53&type=chunk) - There is substantial doubt about the company's ability to continue as a **going concern** for the next 12 months, necessitating additional fundraising through equity, debt, grants, or commercial partnerships[55](index=55&type=chunk) [Note 4—Acquisition](index=18&type=section&id=Note%204%E2%80%94Acquisition) This note details the financial impact and accounting treatment of the recent acquisition - On June 30, 2025, **TuHURA** acquired **100% of Kineta**, a clinical-biotechnology company, for its **VISTA blocking immunotherapy** (renamed **TBS-2025**) and related assets[56](index=56&type=chunk) | Purchase Consideration | Amount | | :------------------------------------------ | :------------- | | Exclusivity cash deposit | $5,994,502 | | Equity issued to Kineta shareholders | $6,396,017 | | Holdback liability to be issued in equity | $2,519,644 | | Cash previously advanced | $1,650,000 | | **Fair value of consideration** | **$16,560,163** | | Assets Acquired: | | | Cash | $390,721 | | Acquired in-process research and development | $8,261,000 | | **Total assets acquired** | **$8,651,721** | | Liabilities Assumed: | | | Accrued expenses, assumed debt, severance | $(5,645,721) | | **Total liabilities assumed** | **$(5,645,721)** | | Net assets acquired | $3,006,000 | | **Goodwill** | **$13,554,163** | - The **acquisition** resulted in the recognition of **$13.55 million** in **goodwill** and **$8.26 million** in **in-process research and development (IPR&D)** intangible assets[59](index=59&type=chunk) - The company incurred approximately **$3.9 million** in initial transaction costs for the **Kineta merger**, recorded under **general and administrative expenses**[63](index=63&type=chunk) [Note 5—Net loss per share](index=20&type=section&id=Note%205%E2%80%94Net%20loss%20per%20share) This note explains the calculation of basic and diluted net loss per share | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(9,525,924) | $(5,265,235) | $(16,192,384) | $(10,107,377) | | Weighted-average common shares outstanding | 44,555,095 | 12,178,522 | 44,983,198 | 12,176,127 | | Net loss per share, basic and diluted | $(0.21) | $(0.43) | $(0.36) | $(0.83) | - Basic and diluted **net loss per share** for the three months ended June 30, 2025, was **$(0.21)**, an improvement from **$(0.43)** in the prior year, despite a higher **net loss**, due to a significant increase in **weighted-average shares outstanding**[66](index=66&type=chunk) - Potential dilutive securities, including preferred stock, convertible notes, **stock options**, and **warrants**, were excluded from diluted EPS calculations as their effect would be anti-dilutive due to **net losses**[67](index=67&type=chunk)[68](index=68&type=chunk) [Note 6—Other current assets](index=21&type=section&id=Note%206%E2%80%94Other%20current%20assets) This note provides a breakdown of the company's other current assets | Other Current Assets | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Employee Retention Tax Credit | $214,699 | $214,699 | | NIH Grant Receivable | $194,670 | $222,702 | | Clinical trial deposit | $204,955 | $204,955 | | Other current assets | $414,764 | $316,352 | | **Total** | **$1,029,088** | **$958,708** | - **Total other current assets** increased slightly to **$1.03 million** at June 30, 2025, from **$0.96 million** at December 31, 2024, primarily driven by an increase in 'Other current assets'[69](index=69&type=chunk) [Note 7—Property and equipment, net](index=21&type=section&id=Note%207%E2%80%94Property%20and%20equipment,%20net) This note details the company's property and equipment, net of depreciation | Property and Equipment | June 30, 2025 | December 31, 2024 | | :--------------------------- | :------------ | :---------------- | | Furniture and fixtures | $170,607 | $170,607 | | Leasehold improvements | $544,629 | $544,629 | | Machinery and office equipment | $1,471,417 | $1,423,183 | | Software | $72,394 | $72,394 | | Less accumulated depreciation | $(2,114,876) | $(2,087,447) | | **Net Property and equipment** | **$144,171** | **$123,366** | - **Net property and equipment** increased to **$0.14 million** at June 30, 2025, from **$0.12 million** at December 31, 2024, mainly due to additions in machinery and office equipment[70](index=70&type=chunk) - Depreciation and amortization expense for **property and equipment** was approximately **$0.03 million** for the six months ended June 30, 2025, compared to **$0.07 million** for the same period in 2024[70](index=70&type=chunk) [Note 8—Accounts payable, debt, and accrued expenses](index=21&type=section&id=Note%208%E2%80%94Accounts%20payable,%20debt,%20and%20accrued%20expenses) This note provides a breakdown of accounts payable, debt, and accrued expenses | Accounts Payable and Accrued Expenses | June 30, 2025 | December 31, 2024 | | :------------------------------------------ | :------------ | :---------------- | | Trade accounts payable | $3,646,806 | $3,152,816 | | Accrued compensation | $809,237 | $1,161,650 | | Assumed liabilities from Kineta merger | $5,211,727 | - | | Other accrued expenses | $2,425,393 | $855,700 | | **Total** | **$12,093,163** | **$5,170,166** | - **Total accounts payable and accrued expenses** significantly increased to **$12.09 million** at June 30, 2025, from **$5.17 million** at December 31, 2024, primarily due to **$5.21 million** in **liabilities assumed** from the **Kineta merger**[71](index=71&type=chunk) - The company assumed debt with a fair value of **$0.43 million** from the **Kineta merger**, which was settled and paid in July 2025[71](index=71&type=chunk) [Note 9—Income taxes](index=23&type=section&id=Note%209%E2%80%94Income%20taxes) This note discusses the company's income tax position and valuation allowances - The company has provided a full **valuation allowance** for **deferred tax assets** as of June 30, 2025, and December 31, 2024, due to its history of **operating losses**, indicating that the benefit of these assets is not likely to be realized[73](index=73&type=chunk) [Note 10—Stockholders' equity](index=23&type=section&id=Note%2010%E2%80%94Stockholders'%20equity) This note details changes in stockholders' equity, including stock and warrants - As of June 30, 2025, the company had **49.91 million shares** of **common stock outstanding**, authorized up to **200 million shares**[75](index=75&type=chunk) - The June 2025 **Private Placement** involved the issuance of **4.76 million common shares** and an equal number of **warrants** for approximately **$12.6 million**, with **$8.9 million** received by June 30, 2025, and the remaining **$3.7 million** due by December 31, 2025[77](index=77&type=chunk) | Warrant Type | Outstanding at June 30, 2025 | Weighted Average Exercise Price | Expiration Dates | | :------------------------------------------ | :--------------------------- | :------------------------------ | :----------------------------- | | Legacy TuHURA common stock warrants | 8,324,808 | $4.52 | Oct 2025 to Aug 2029 | | Historical Kintara common stock warrants | 10,199 | $757.65 | June 2025 to April 2027 | | TuHURA Warrants from 2025 Securities Purchase Agreement | 3,363,076 | $3.32 | December 2030 | | TuHURA Warrants issued to placement agent | 134,523 | $3.32 | December 2030 | | 2024 common stock warrants issued to financial advisor | 297,029 | $0.01 | April 2027 | | **Total** | **12,129,635** | | | [Note 11—Stock option plans](index=25&type=section&id=Note%2011%E2%80%94Stock%20option%20plans) This note outlines the company's stock option plans and related compensation | Stock Option Activity | Number of Options | Weighted Average Exercise Price | | :-------------------------- | :---------------- | :------------------------------ | | Outstanding at Dec 31, 2024 | 6,403,818 | $5.11 | | Forfeited and cancelled | (131,193) | $3.69 | | Exercised | (271,853) | $2.09 | | Granted | 505,298 | $3.39 | | **Outstanding at June 30, 2025** | **6,506,070** | **$5.13** | | Exercisable at June 30, 2025 | 2,312,493 | $5.99 | - Total **stock-based compensation expense** for the six months ended June 30, 2025, was **$2.83 million**, significantly higher than **$0.61 million** in the prior year, allocated to **general and administrative** (**$0.99 million**) and **research and development** (**$1.84 million**)[84](index=84&type=chunk) - As of June 30, 2025, approximately **$14.0 million** of unrecognized **stock compensation expense** remains, to be recognized over the next three years[83](index=83&type=chunk) [Note 12—Commitments and contingencies](index=26&type=section&id=Note%2012%E2%80%94Commitments%20and%20contingencies) This note discloses contractual commitments and potential contingent liabilities | Lease Commitments | Amount | | :-------------------------------- | :------- | | Year ending December 31, 2025 (6 months) | $86,823 | | Year ending December 31, 2026 | $43,411 | | Interest portion of right of use liability | $(5,265) | | **Operating lease liabilities** | **$124,969** | | Employment Agreement Commitments | Amount | | :----------------------------------- | :--------- | | Year ending December 31, 2025 (6 months) | $437,000 | | Year ending December 31, 2026 | $874,000 | | **Total** | **$1,311,000** | [Note 13—Subsequent events](index=26&type=section&id=Note%2013%E2%80%94Subsequent%20events) This note reports significant events occurring after the reporting period - Subsequent to the **Kineta Merger**, the company entered into consulting agreements with six former Kineta employees, involving cash payments and **stock awards** (approximately **0.13 million shares** at **$2.50** per share) and notes payable totaling **$0.59 million**[90](index=90&type=chunk) - The company filed a registration statement on **Form S-1** on August 12, 2025, for the resale of **common stock** and shares underlying **warrants** issued in the June 2025 **Private Placement**[91](index=91&type=chunk)[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's financial condition, results of operations, and liquidity, highlighting recent developments such as the Kineta merger and private placement [Overview](index=29&type=section&id=Overview) This section covers the company's business, financial performance, and future outlook - **TuHURA Biosciences** is a clinical-stage immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapies, leveraging its **Immune FxTM**, **TBS-2025**, and Delta Opioid Receptor technologies[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - The company has incurred significant **operating losses** since inception, with **net losses** of **$16.2 million** and **$10.1 million** for the six months ended June 30, 2025 and 2024, respectively, and an **accumulated deficit** of **$127.3 million** as of June 30, 2025[100](index=100&type=chunk) - The company expects **operating losses** to increase substantially as it advances product candidates through preclinical and clinical development and incurs costs associated with operating as a public company, requiring substantial additional funding[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) This section highlights key recent events impacting the company's financial and operational status - In June 2025, the company completed a **private placement** offering of **common stock** and **warrants**, raising approximately **$12.6 million**, with **$8.9 million** received by June 30, 2025, tied to key milestones including **FDA clearance** and **Phase 3 trial initiation**[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The **Kineta Merger** closed on June 30, 2025, resulting in Kineta stockholders receiving approximately **2.87 million shares** of **TuHURA common stock**, plus deferred shares and potential cash consideration[111](index=111&type=chunk)[112](index=112&type=chunk) [Components of Our Results of Operations](index=33&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details the primary revenue and expense categories contributing to the company's financial results - The company has not generated any revenue from product sales and does not expect to in the near future[113](index=113&type=chunk) - **Research and development expenses**, recognized as incurred, primarily relate to the development of **IFx-2.0**, **IFx-3.0**, manufacturing, clinical studies, and preclinical activities, and are expected to increase substantially[114](index=114&type=chunk)[115](index=115&type=chunk)[117](index=117&type=chunk) - **General and administrative expenses**, consisting of salaries, legal, accounting, and facility costs, are also anticipated to increase to support **R&D**, potential commercialization, and public company compliance[119](index=119&type=chunk) - Other income (expense) includes interest income, interest expense on convertible notes (now converted), grant income, and non-cash changes in the fair value of derivative liabilities[120](index=120&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance over the reported periods [Comparisons for the Three Months Ended June 30, 2025, and June 30, 2024](index=36&type=section&id=Comparisons%20for%20the%20Three%20Months%20Ended%20June%2030,%202025,%20and%20June%2030,%202024) This section compares the company's financial performance for the three-month periods ended June 30, 2025, and 2024 | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------------- | :------------ | :------------ | :----------- | | Research and development | $4,926,936 | $2,823,064 | $2,103,872 | | General and administrative | $4,949,020 | $795,660 | $4,153,360 | | Total operating expenses | $9,875,956 | $3,618,724 | $6,257,232 | | Loss from operations | $(9,875,956) | $(3,618,724) | $(6,257,232) | | Grant income | $322,655 | - | $322,655 | | Interest expense | - | $(1,357,458) | $1,357,458 | | Net loss | $(9,523,835) | $(5,265,235) | $(4,258,600) | - **Research and development expenses** increased by **$2.10 million**, driven by ongoing clinical development of **IFx-2.0**, preclinical research for **IFx-3.0** and MDSCs, and higher personnel costs[123](index=123&type=chunk)[126](index=126&type=chunk) - **General and administrative expenses** surged by **$4.15 million**, primarily due to increased non-cash **stock compensation**, **Kineta acquisition merger transaction costs**, and public company **operating expenses**[124](index=124&type=chunk) [Comparisons for the Six Months Ended June 30, 2025, and June 30, 2024](index=38&type=section&id=Comparisons%20for%20the%20Six%20Months%20Ended%20June%2030,%202025,%20and%20June%2030,%202024) This section compares the company's financial performance for the six-month periods ended June 30, 2025, and 2024 | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------------- | :------------ | :------------ | :----------- | | Research and development | $9,508,608 | $6,412,077 | $3,096,531 | | General and administrative | $7,384,371 | $1,812,401 | $5,571,970 | | Total operating expenses | $16,892,979 | $8,224,478 | $8,668,501 | | Loss from operations | $(16,892,979) | $(8,224,478) | $(8,668,501) | | Grant income | $575,209 | - | $575,209 | | Interest expense | - | $(1,612,580) | $1,612,580 | | Net loss | $(16,188,206) | $(10,107,377) | $(6,080,829) | - For the six months, **R&D expenses** increased by **$3.10 million**, primarily due to **IFx-2.0** clinical development, preclinical research for **IFx-3.0** and MDSCs, and a **$2.20 million** increase in personnel and facilities-related costs[131](index=131&type=chunk) - **General and administrative expenses** rose by **$5.57 million**, mainly attributable to higher non-cash **stock compensation**, **Kineta acquisition transaction costs**, and expenses associated with being a public company[132](index=132&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations and fund future operations - The company has an **accumulated deficit** of **$127.3 million** as of June 30, 2025, and has consistently incurred **net losses** and negative **cash flows from operations**[137](index=137&type=chunk) - **Net cash used in operating activities** was **$(10.99 million)** for the six months ended June 30, 2025, compared to **$(8.90 million)** for the same period in 2024[137](index=137&type=chunk) - As of June 30, 2025, **cash and cash equivalents** totaled **$8.51 million**, with an additional **$3.00 million** in gross proceeds received in July 2025 from the **Securities Purchase Agreement**, expected to fund operations through late Q4 2025[138](index=138&type=chunk)[150](index=150&type=chunk) - Future funding requirements are substantial and will depend on the progress of product candidates, regulatory approvals, and commercialization efforts, necessitating additional capital through equity, debt, or collaborations[151](index=151&type=chunk)[152](index=152&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines the accounting policies requiring significant management judgment and estimation - Key **accounting policies** requiring significant estimates and judgments include accrued **research and development expenses**, **stock-based compensation expense** (using the **Black-Scholes model**), common stock valuations, and the valuation of **intangible assets** from the **Kineta acquisition**[153](index=153&type=chunk)[154](index=154&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - The valuation of acquired **in-process research and development (IPR&D)** involves significant measurement uncertainty due to a lack of historical data, relying on life science studies, industry data, and peer company information[167](index=167&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=47&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) This section discusses new accounting standards and their impact on the company's financial statements - The company adopted ASU 2023-07, **Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures**, which did not have a material impact on its condensed consolidated financial statements[46](index=46&type=chunk)[169](index=169&type=chunk) [Off-Balance Sheet Arrangements](index=47&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any off-balance sheet arrangements that could materially affect the company's financial condition - The company does not have any **off-balance sheet arrangements** as defined under SEC rules[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily interest rate risks and inflation risks, and management's assessment of their impact - The company is exposed to **interest rate risk** through its cash and short-term money market investments, though historical fluctuations in interest income have not been significant[171](index=171&type=chunk)[172](index=172&type=chunk) - **Inflation risk** primarily affects the company's labor and **research and development contract costs**, but management believes it has not had a material effect on results of operations during the periods presented[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the effectiveness of the company's disclosure controls and procedures and internal control over financial reporting, as evaluated by management - Management, with the participation of the CEO and CFO, concluded that the company's **disclosure controls and procedures** were effective at the reasonable assurance level as of June 30, 2025[175](index=175&type=chunk) - Management also concluded that the company's **internal control over financial reporting** was effective as of June 30, 2025, based on the **COSO framework**[176](index=176&type=chunk) - There were no material changes in **internal control over financial reporting** during the most recently completed fiscal quarter[178](index=178&type=chunk) [PART II. OTHER INFORMATION](index=49&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part includes legal proceedings, risk factors, equity sales, and other corporate information [Item 1. Legal Proceedings.](index=49&type=section&id=Item%201.%20Legal%20Proceedings.) This section confirms the absence of any material legal proceedings or claims against the company - As of the date of this quarterly report, the company is not a party to any material legal matters or claims[180](index=180&type=chunk) [Item 1A. Risk Factors.](index=49&type=section&id=Item%201A.%20Risk%20Factors.) This section updates the risk factors, noting no material changes from the Annual Report on Form 10-K, except for new risks specifically related to the Kineta Merger - No material changes to **risk factors** were identified from the Annual Report on **Form 10-K**, except for those related to the **Kineta Merger**[181](index=181&type=chunk)[182](index=182&type=chunk) - **Risks related to the Kineta Merger** include potential declines in the market price of **common stock** due to sales by former Kineta stockholders and significant non-recurring and integration costs associated with combining operations[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses the details of unregistered sales of equity securities, specifically the June 2025 private placement - On June 2, 2025, the company entered into a **securities purchase agreement** for a **private placement** of **4.76 million shares** of **common stock** and equal number of **warrants**, for an aggregate offering amount of approximately **$12.6 million**, under Section 4(a)(2) and/or Rule 506(b) of the **Securities Act**[186](index=186&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This section confirms that there have been no defaults upon senior securities - There were no defaults upon senior securities[187](index=187&type=chunk) [Item 4. Mine Safety Disclosures.](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[188](index=188&type=chunk) [Item 5. Other Information.](index=51&type=section&id=Item%205.%20Other%20Information.) This section provides other information, including details on director and officer trading arrangements - None of the company's directors or officers adopted or terminated a **Rule 10b5-1 trading plan** or arrangement, or a non-Rule 10b5-1 trading plan or arrangement, during the six months ended June 30, 2025[191](index=191&type=chunk) [Item 6. Exhibits.](index=52&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Form 10-Q, including merger agreements, articles of incorporation, bylaws, warrant forms, and certifications - The exhibits include the **Agreement and Plan of Merger** for the **Kineta acquisition**, Articles of Incorporation, Amended and Restated Bylaws, various forms of **common stock purchase warrants**, and certifications of principal executive and financial officers[193](index=193&type=chunk)[194](index=194&type=chunk) [Signatures](index=55&type=section&id=Signatures) This section contains the signatures of authorized officers, certifying the report - The report is duly signed on August 14, 2025, by James A. Bianco, M.D., President and Chief Executive Officer, and Dan Dearborn, Chief Financial Officer[201](index=201&type=chunk) ```