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]

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]

Table of Contents As filed with the Securities and Exchange Commission on September 18, 2025. Registration No. 333-289532 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TUHURA BIOSCIENCES, INC. 10500 University Center Drive, Suite 110 Tampa, Florida 33612 (813) 875-6600 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) James Bianco C ...