Core Insights - TuHURA Biosciences has filed an Investigational New Drug Application (IND) for TBS-2025, a novel VISTA inhibiting antibody, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor [1] - The company plans to initiate a Phase 2 study in early Q2 2026, targeting menin inhibitor naïve patients, with preliminary results expected in Q3 2026 [1] - TBS-2025 is expected to address the unmet medical need in AML treatment, as current therapies have low complete response rates of less than 25% [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapy [1] - The company’s lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial for advanced Merkel Cell Carcinoma [1] - TBS-2025 was acquired through the merger with Kineta Inc. and is moving into Phase 2 development for mutNPM1 r/r AML [1] Scientific Rationale - Scientific evidence indicates that mutations like mutNPM1 drive VISTA expression on leukemic cells, contributing to poor therapy responses and high relapse rates in AML [1] - The removal of the VSIR gene, which encodes for VISTA, in murine models has shown enhanced immune response and improved survival rates [1] - TBS-2025 demonstrated a favorable safety profile in a Phase 1 trial, with an optimal Phase 2 dose anticipated to be 750mg every three weeks [1]

Core Insights - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy [1] - The company will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 3:20 pm ET [1] Company Overview - TuHURA is developing technologies to overcome primary and acquired resistance to cancer immunotherapy, which are common reasons for the failure of these treatments [1] - The lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 registration trial as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [1] Recent Developments - TuHURA acquired TBS-2025 through its merger with Kineta Inc. on June 30, 2025; TBS-2025 is a VISTA inhibiting monoclonal antibody moving into Phase 2 development for mutNPM1 r/r AML [1] - The company is also leveraging Delta Opioid Receptor technology to develop first-in-class bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells [1]

Core Insights - TuHURA Biosciences, Inc. has received Orphan Drug Designation from the FDA for its product IFx-2.0, aimed at treating stage IIB to stage IV cutaneous melanoma [1][3] - The designation is based on positive results from a Phase 1 study, which indicated that IFx-Hu2.0 is safe and provides clinical benefits to patients who are refractory to checkpoint inhibitor therapy [2] - The company is currently focused on completing enrollment for a Phase 3 study of IFx-2.0 in combination with Keytruda® for advanced or metastatic Merkel Cell Carcinoma [3] Company Overview - TuHURA Biosciences is a Phase 3 immuno-oncology company that develops novel therapeutics to address resistance to cancer immunotherapy [4] - The lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is being tested in a randomized Phase 3 trial [5] - The company has also acquired TBS-2025, which is moving into Phase 2 development for mutNPM1 r/r AML, and is developing bi-specific antibody drug conjugates targeting immune-suppressing cells in the tumor microenvironment [6]

Core Insights - TuHURA Biosciences, Inc. has achieved a milestone in its clinical trial for REM-001, demonstrating safety and signs of clinical efficacy in ten metastatic cutaneous breast cancer patients after eight weeks of follow-up [1][2] Group 1: Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy, a significant challenge in cancer treatment [3] - The company's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [4] Group 2: Recent Developments - Following the successful completion of the REM-001 trial, TuHURA will release an aggregate of 1,539,958 shares of common stock to legacy Kintara Therapeutics stockholders as per the Contingent Value Rights Agreement [2] - TuHURA has also acquired TBS-2025 through its merger with Kineta Inc., which is moving into Phase 2 development for mutNPM1 r/r AML [5]

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]

Core Viewpoint - TuHURA Biosciences, Inc. has announced a definitive agreement for a registered direct offering to raise capital through the sale of common stock and warrants, aimed at funding working capital and addressing a bridge note obligation [1][4]. Group 1: Offering Details - The company will sell a total of 9,462,423 shares of common stock at a price of $1.65 per share, along with Series A and Series B warrants for the same number of shares [1]. - The offering will occur in three tranches: the first closing on or about December 10, 2025, the second by January 30, 2026, and the third by February 27, 2026 [3]. - The gross proceeds from the first closing are expected to be approximately $8.6 million, $5 million from the second closing, and $2 million from the third closing, before deducting fees and expenses [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for working capital, to satisfy a $3.4 million bridge note obligation, and for general corporate purposes [4]. - The bridge note obligation carries an interest rate of 3% per month and requires repayment by December 31, 2025, or within 30 days after a successful equity financing exceeding $12 million [4]. Group 3: Company Overview - TuHURA Biosciences, Inc. is focused on developing novel therapeutics to overcome resistance to cancer immunotherapy, particularly in advanced or metastatic Merkel Cell Carcinoma [7][8]. - The company’s lead product, IFx-2.0, is currently in a Phase 3 trial as an adjunctive therapy to Keytruda® [8]. - TuHURA has also acquired TBS-2025, which is moving into Phase 2 development for a specific type of leukemia, and is developing innovative antibody drug conjugates targeting immune-suppressing cells in the tumor microenvironment [9].

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]