[Form 8-K: Current Report](index=1&type=section&id=Form%208-K) This Form 8-K details company and filing information, recent financial results, a proposed merger, cautionary statements, and relevant exhibits [Company and Filing Details](index=1&type=section&id=Company%20and%20Filing%20Details) This Form 8-K was filed by TuHURA Biosciences, Inc. on May 15, 2025, with its common stock registered on The Nasdaq Capital Market under the symbol HURA - Filing entity: **TuHURA BIOSCIENCES, INC.**, a Nevada corporation[2](index=2&type=chunk) - Report date: **May 15, 2025**[2](index=2&type=chunk) Registered Securities | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common Stock, $0.001 par value per share | HURA | The Nasdaq Capital Market | [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) On May 15, 2025, TuHURA Biosciences issued a press release (Exhibit 99.1) announcing its financial results for the three months ended March 31, 2025, and providing a corporate update, with the information considered furnished, not filed - A press release was issued on **May 15, 2025**, detailing financial results for the quarter ended **March 31, 2025**[7](index=7&type=chunk) - Exhibit 99.1, the press release, includes a corporate update[7](index=7&type=chunk) - Information in this report and exhibit is furnished, not filed, under the Securities Exchange Act of 1934, unless explicitly referenced in future filings[7](index=7&type=chunk) [Proposed Merger with Kineta, Inc.](index=3&type=section&id=Proposed%20Merger%20with%20Kineta%2C%20Inc.) This section details the proposed merger with Kineta, Inc., referencing the Form S-4 registration statement filed with the SEC, clarifying that this 8-K is not a solicitation and identifying participants [Important Additional Information](index=3&type=section&id=Important%20Additional%20Information) TuHURA filed a Form S-4 registration statement on February 7, 2025, containing a preliminary joint proxy statement and prospectus regarding the proposed merger with Kineta, which will be available on the SEC and TuHURA websites - TuHURA filed a Form S-4 registration statement with the SEC on **February 7, 2025**, regarding the proposed merger with Kineta, Inc[8](index=8&type=chunk) - Investors are urged to review the Joint Proxy Statement/Prospectus for critical merger information[8](index=8&type=chunk) - Finalized documents will be mailed to stockholders and accessible on the SEC's website (www.sec.gov) and TuHURA's website (www.tuhurabio.com)[9](index=9&type=chunk) [No Offer or Solicitation](index=3&type=section&id=No%20Offer%20or%20Solicitation) This Form 8-K is explicitly not a proxy statement, an offer to sell, or a solicitation of an offer to buy any securities in relation to the merger, with any securities offering to be conducted via a prospectus - This Form 8-K is not a proxy statement or a solicitation for the merger[10](index=10&type=chunk) - It does not constitute an offer to sell or a solicitation to buy securities of TuHURA or Kineta[10](index=10&type=chunk) [Participants in the Solicitation](index=3&type=section&id=Participants%20in%20the%20Solicitation) The directors and executive officers of both TuHURA and Kineta may be considered participants in the solicitation of proxies for the merger, with details regarding their interests disclosed in SEC filings and the Joint Proxy Statement/Prospectus - Directors and officers of TuHURA and Kineta may be considered participants in the merger's proxy solicitation[11](index=11&type=chunk) - Information on TuHURA's directors and officers is available in its Form 10-K filed on **March 31, 2025**[11](index=11&type=chunk) - Further details on participant interests will be provided in the Joint Proxy Statement/Prospectus[11](index=11&type=chunk)[12](index=12&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements concerning TuHURA's product candidates, development programs, the proposed merger with Kineta, and capital requirements, which are based on current expectations and not guarantees of future performance, with no obligation to update them - Forward-looking statements cover TuHURA's **IFx-Hu2.0** product candidate, tumor microenvironment modulators program, and the potential acquisition of Kineta Inc[13](index=13&type=chunk) - Statements also address capital resources, additional capital needs (including for the Kineta merger), and regulatory pathways[13](index=13&type=chunk) - The company disclaims any obligation to publicly update or revise forward-looking statements unless legally mandated[14](index=14&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=4&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits filed with the Form 8-K, primarily the press release from May 15, 2025, containing financial results and a corporate update Exhibits | Exhibit No. | Document Description | | :--- | :--- | | 99.1 | Press Release, dated May 15, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=7&type=section&id=Signatures) The report was officially signed on May 15, 2025, by Dan Dearborn, the Chief Financial Officer of TuHURA Biosciences, Inc - The report is signed by **Dan Dearborn**, Chief Financial Officer[21](index=21&type=chunk) - Signature date: **May 15, 2025**[21](index=21&type=chunk)

Core Insights - TuHURA Biosciences is advancing its clinical programs, including the initiation of a Phase 3 trial for IFx-Hu2.0 in combination with Keytruda for advanced Merkel cell carcinoma (MCC) [1][3] - The company is targeting the acquisition of Kineta, Inc. and plans to initiate a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated acute myeloid leukemia (AML) [2][3] Clinical Development - TuHURA has initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in patients with Merkel cell carcinoma of unknown primary origin (MCCUP) [1][4] - The Phase 3 trial for IFx-Hu2.0 is expected to begin in Q2 2025, pending the lifting of a partial clinical hold by the FDA [3][10] - The Phase 1b/2a trial will include patients with deep-seated tumors who are not eligible for the Phase 3 trial, addressing a significant patient population [3][4] Financial Overview - For the first quarter ended March 31, 2025, research and development expenses were $4.6 million, compared to $3.6 million for the same period in 2024 [6] - General and administrative expenses increased to $2.4 million in Q1 2025 from $1.0 million in Q1 2024 [6] Corporate Updates - TuHURA is in the process of acquiring Kineta, Inc., with the deal expected to close in Q2 2025, subject to financing and other conditions [2][8] - The company appointed Dr. Bertrand Le Bourdonnec as Head of Drug Discovery and Dr. Craig L. Tendler to its Board of Directors, enhancing its leadership team [10] Upcoming Milestones - Q2 2025: Anticipated initiation of the Phase 3 trial for IFx-Hu2.0 and closing of the Kineta acquisition [10] - Q3 2025: Planned initiation of a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated AML [10]

Core Insights - TuHURA Biosciences, Inc. is focused on developing novel technologies to address resistance to cancer immunotherapy, with a particular emphasis on its Phase 3 programs and innovative antibody drug conjugates [4][5][6] Group 1: Company Overview - TuHURA is a Phase 3 immune-oncology company that aims to overcome both primary and acquired resistance to cancer immunotherapy, which are common reasons for treatment failure [4] - The company is preparing to initiate a randomized placebo-controlled Phase 3 trial of its lead product, IFx-2.0, in combination with Keytruda® for advanced Merkel Cell Carcinoma [5] - TuHURA's acquisition of Kineta, Inc. is expected to enhance its portfolio, including the rights to Kineta's KVA12123 antibody, with the merger targeted to close in Q2 2025 [3] Group 2: Upcoming Events - James A. Bianco, M.D., CEO of TuHURA, will present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, highlighting the company's Phase 3 program and its bi-specific immune modulating antibody drug [1][2] - Management will also be available for one-on-one meetings with qualified investors during the conference [2] Group 3: Research and Development - TuHURA is leveraging its Delta Opioid Receptor technology to develop bi-specific immune modulating antibody drug conjugates targeting Myeloid Derived Suppressor Cells, aiming to prevent T cell exhaustion [7] - The company plans to initiate a randomized trial in Q3 2025 for a menin inhibitor combined with a VISTA inhibiting antibody in relapsed or refractory Acute Myeloid Leukemia (AML) [6]

Core Viewpoint - TuHURA Biosciences has initiated a Phase 1b/2a trial for IFx-Hu2.0 in combination with Keytruda® to evaluate safety and feasibility in patients with deep-seated tumors, expanding the potential patient population for this treatment [1][2][4]. Group 1: Trial Details - The Phase 1b/2a trial is designed to assess the safety and feasibility of IFx-Hu2.0 as an adjunctive therapy to Keytruda® in adult patients with non-cutaneous Merkel cell carcinoma (MCC) [4]. - The trial will enroll a total of nine patients with hepatic, pulmonary, or retroperitoneal lesions, administering IFx-Hu2.0 (0.1 mg) weekly for three weeks, followed by pembrolizumab [4]. - The primary endpoint is the safety and feasibility of IFx-Hu2.0 evaluated 28 days after the last dose, with secondary endpoints including efficacy assessed at three and six months [4]. Group 2: Future Plans - If the trial demonstrates safety and feasibility, TuHURA plans to extend enrollment to other non-MCC cancers that poorly respond to checkpoint inhibitors [3]. - The company is preparing to initiate a Phase 3 accelerated approval trial of IFx-Hu2.0 as an adjunctive therapy to Keytruda® for first-line treatment of advanced or metastatic MCC [5][9]. - The FDA has agreed to the trial's design under the accelerated approval pathway, with overall response rate (ORR) as the primary endpoint [6][7]. Group 3: Company Overview - TuHURA Biosciences is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [8]. - The lead product candidate, IFx-Hu2.0, is designed to overcome primary resistance to checkpoint inhibitors, with prior trials showing promise in various skin cancers [9][10].

Core Insights - TuHURA Biosciences, Inc. is advancing its Phase 3 immune-oncology initiatives, focusing on overcoming resistance to cancer immunotherapy [5][6] - The company announced that abstracts from Kineta Inc. and Moffitt Cancer Center will be presented at the AACR Annual Meeting 2025, showcasing novel therapies for advanced melanoma [1][2] Group 1: Company Developments - TuHURA is set to present initial results from a Phase 1 study of KVA12123, an anti-VISTA antibody, in combination with pembrolizumab for advanced solid tumors [2] - The company is preparing to initiate a Phase 3 trial for its lead product, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced Merkel Cell Carcinoma [6] - TuHURA has entered into a merger agreement with Kineta, Inc. to acquire the rights to KVA12123, with the merger expected to close in Q2 2025 [4] Group 2: Research and Presentations - The accepted abstracts for the AACR Annual Meeting include mechanistic insights into IFx-Hu2.0 responses after prior anti-PD-1 therapy failure [2] - Presentations will take place on April 28, 2025, with specific sessions dedicated to experimental therapeutics and immunology [2][3]

Core Insights - TuHURA Biosciences, Inc. has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management, bringing extensive experience in drug discovery and development [1][3][4] Company Overview - TuHURA is a Phase 3 registration-stage immuno-oncology company focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [6][8] - The company is preparing to initiate a Phase 3 trial for its lead candidate, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [7] Leadership and Expertise - Dr. Le Bourdonnec has a proven track record in leading R&D programs across various therapeutic areas, including oncology and pain management, and is an expert in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR) [2][4] - His previous roles include Chief Scientific Officer at HDAX Therapeutics and VP at Deciphera Pharmaceuticals, where he managed significant teams and contributed to the development of novel therapeutics [4][5] Technology and Innovation - TuHURA is leveraging its DOR technology to develop first-in-class bi-specific Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the immune response in the tumor microenvironment [8] - The company aims to address unmet medical needs and transform treatment paradigms for cancer patients through innovative drug development [4][6]

Financial Results - TuHURA Biosciences reported its financial results for the year ended December 31, 2024, with a focus on corporate updates[6]. Merger with Kineta, Inc. - The company is in the process of merging with Kineta, Inc., which involves a registration statement filed with the SEC on February 7, 2025[7]. - The merger is subject to conditions, including the adoption of the Merger Agreement by stockholders of both companies[12]. - TuHURA is expected to realize synergies from the merger, although specific amounts and timing are uncertain[12]. - The estimated net working capital deficit for Kineta at closing should not exceed $12 million[12]. - TuHURA's management anticipates potential risks related to the merger, including market conditions and integration challenges[12]. - The company emphasizes the importance of reading the Joint Proxy Statement/Prospectus for detailed information regarding the merger[8]. - TuHURA's stockholders may experience dilution of ownership percentage post-merger[12]. - The merger could impact TuHURA's business relationships and operational strategies[12]. Availability of Financial Documents - TuHURA's financial statements and additional documents will be available on the SEC and company websites[8].

Financial Performance - For the fiscal year ended June 30, 2024, the company reported a net loss of approximately $8.5 million and an accumulated deficit of approximately $159.9 million[97][99]. - Research and development expenses for the years ended June 30, 2024, and 2023 were approximately $2.7 million and $9.3 million, respectively[91]. - As of June 30, 2024, the company had cash and cash equivalents of approximately $4.9 million, which is expected to fund operations for less than one year[101]. - The company has expressed substantial doubt about its ability to continue as a going concern within one year from the date of filing the consolidated financial statements[96][98]. - The company is not currently in compliance with Nasdaq's minimum bid price requirement and may face delisting if compliance is not regained[105][106]. Clinical Development and Studies - The REM-001 therapy has shown a complete response in approximately 80% of evaluable tumor sites treated in previous studies for cutaneous metastatic breast cancer (CMBC)[12]. - As of October 7, 2024, four patients had been dosed in the open-label 15-patient REM-001 study in CMBC[10]. - The company plans to complete enrollment of patients in the REM-001 Study in the fourth calendar quarter of 2024[13]. - REM-001 has been safely administered to over 1,100 patients in prior clinical studies, with an approvable letter from the FDA for an aspect of AMD in 2004[19]. - The Phase 2/3 studies of REM-001 for CMBC indicated higher tumor response rates compared to alternative treatments[29]. - The average rate of clinical success in study CA013 was 88%, while study CA019 reported an 83% success rate[39]. - Positive results from previous clinical studies of REM-001 may not predict future outcomes, potentially resulting in development delays or failure to obtain marketing approval[151]. - Clinical studies are inherently uncertain, and unfavorable results could delay or prevent marketing approval[143][147]. Regulatory and Compliance - The company has received Fast Track Designation from the FDA for REM-001 in CMBC[14]. - The FDA granted orphan drug designation for tin ethyl etiopurpurin, the active ingredient in REM-001, for treatment of basal cell carcinoma nevus syndrome[54]. - The approval process for new products involves rigorous preclinical and clinical testing, with an average NDA review process taking 10 months[62][63]. - The FDA offers various expedited approval mechanisms for drug candidates, including accelerated approval and breakthrough drug designation, which may apply to the company's current candidates[65]. - Regulatory approval timelines vary, with the FDA review process potentially taking over 12 months even for products designated as fast track[169]. Market Opportunity and Competition - The estimated market opportunity for the treatment of cutaneous metastatic breast carcinoma (CMBC) is approximately $500 million[23]. - The oncology market is characterized by a large unmet medical need, making it highly competitive with numerous existing therapies and ongoing developments[78]. - The company faces significant competition in the oncology market from major pharmaceutical and biotechnology companies, which may impact the commercialization of its product candidates[78]. - Many competitors have greater financial resources and expertise, which could hinder the company's ability to compete effectively in drug development and marketing[84]. Strategic Initiatives - A merger agreement was entered into with TuHURA, with existing stockholders expected to own approximately 2.85% of the post-merger company on a fully-diluted basis[10]. - The proposed merger with TuHURA is expected to be consummated in mid-October 2024, subject to regulatory approval[10]. - The company initiated a process to explore strategic alternatives focused on maximizing stockholder value in December 2023[9]. Product Liability and Risks - The company faces inherent risks of product liability claims due to clinical testing of product candidates, which could lead to substantial liabilities and limit commercialization efforts[191]. - The company may incur significant costs related to product liability litigation, which could adversely affect its financial condition and operational results[192]. - The company may face litigation risks related to patent infringements, which could distract management and incur substantial costs[132][133]. Intellectual Property and Proprietary Rights - The company relies on patent protection and trade secrets to maintain its proprietary position for REM-001 and its related technologies[49]. - The company does not hold any patents covering its laser light source or light delivery device for REM-001, which may allow competitors to offer similar products[127]. - The company is dependent on obtaining certain patents and protecting its proprietary rights, which are crucial for its competitive advantage[118]. Operational Structure - The company operates with a "virtual" corporate structure, having only one full-time employee and approximately 10 independent contractors[92]. - The company is currently focused on the development of one product candidate, REM-001 for CMBC, with enrollment for a 15-patient clinical study expected to complete in Q4 2024[111]. Third-Party Relationships - The company expects to continue relying on third-party clinical research organizations (CROs) for clinical studies, and any failure by these parties to meet obligations could delay market introduction of product candidates[195]. - The company relies on third parties, including academic institutions and private oncology centers, for conducting clinical studies, which may jeopardize the validity of clinical data and delay regulatory approvals[193].

Merger and Corporate Changes - The company completed a merger with TuHURA Biosciences, issuing approximately 40,441,605 shares of common stock to TuHURA stockholders based on an exchange ratio of 0.1789[74]. - The merger with TuHURA was completed on October 18, 2024, and the company changed its name to TuHURA Biosciences, Inc.[86]. - TuHURA stockholders owned approximately 97.15% of the company on a fully-diluted basis immediately prior to the merger[76]. - A 1-for-35 reverse stock split was completed on October 18, 2024, with the company's common stock trading under the new symbol "HURA" on the Nasdaq Capital Market[76]. Clinical Studies and Developments - The company received a $2,000 grant from the NIH to fund the REM-001 CMBC clinical study, which will be received over a two-year period[77]. - As of November 14, 2024, the company has initiated treatment in four patients for the REM-001 Study and expects to complete enrollment in Q4 2024[77]. - The company reported that in previous studies, REM-001 Therapy achieved a complete response in approximately 80% of evaluable tumor sites treated[78]. - The company received Fast Track Designation from the FDA for REM-001 in CMBC[80]. - The company has opened enrollment for the REM-001 program at Memorial Sloan Kettering Cancer Center[79]. - The company expects to receive approximately 1,539,918 shares of common stock upon achieving a milestone related to the REM-001 Study[76]. - The company terminated the development of VAL-083 after preliminary results showed it did not perform better than current standards of care in glioblastoma[81]. Financial Performance - As of September 30, 2024, cash and cash equivalents were $3,020,000, down from $4,909,000 as of June 30, 2024, representing a decrease of 38.5%[87]. - Research and development expenses decreased to $252,000 for the three months ended September 30, 2024, from $1,859,000 for the same period in 2023, a reduction of 86%[88]. - General and administrative expenses increased to $1,957,000 for the three months ended September 30, 2024, compared to $1,103,000 for the same period in 2023, an increase of 77%[88]. - The net loss for the period was $2,161,000 for the three months ended September 30, 2024, compared to a net loss of $2,962,000 for the same period in 2023, a decrease of 27%[88]. - The company reported a negative cash flow from operating activities of $1,889,000 for the three months ended September 30, 2024, compared to $1,317,000 for the same period in 2023, an increase of 43%[95]. - The accumulated deficit as of September 30, 2024, was $162,052,000, with no revenues generated to date[100]. - The company raised approximately $2,008,000 in net proceeds from the issuance of common stock under a Purchase Agreement as of September 30, 2024[100]. Future Financing and Accounting - The company has initiated a process to explore various financing alternatives to fund operations and maximize shareholder value following the merger[101]. - Future funding requirements will depend on various factors, including clinical study costs, manufacturing capabilities, and regulatory approvals[101]. - The company provided a detailed presentation of significant accounting policies and estimates in its Annual Report on Form 10-K for the year ended June 30, 2024, filed on October 7, 2024[103]. - For the three months ended September 30, 2024, the company issued stock options to its officers, with fair value determined using the Black-Scholes model, which includes variables such as expected volatility, interest rates, and dividend yields[104]. - The company estimates expenses related to research and development and clinical trials based on contracts with vendors and clinical research organizations, adjusting accrual estimates as necessary[105]. - There were no material adjustments to prior period estimates of accrued expenses for clinical trials for the three months ended September 30, 2024, and 2023[105]. - The company does not have any off-balance sheet arrangements, indicating a straightforward financial structure[106].

Merger and Acquisition - The merger between Kintara and TuHURA resulted in TuHURA stockholders owning approximately 96.0% of the combined company post-merger[4]. - The merger is accounted for as a reverse recapitalization, treating Kintara as the acquired company for financial reporting purposes[4]. - The pro forma financial statements reflect the merger as if it had occurred on January 1, 2023, with no historical operating relationship between the companies prior to the merger[5]. - The merger transaction was completed on April 2, 2024, with TuHURA continuing as a wholly owned subsidiary of Kintara[16]. - The pro forma adjustments for the merger and related transactions are based on preliminary information and may differ materially from actual results[25]. - The merger was accounted for as a reverse recapitalization, treating Kintara as the accounting acquiree and TuHURA as the accounting acquirer[24]. Financial Performance - Total assets held by TuHURA and Kintara as of June 30, 2024, were $14,093 thousand and $6,202 thousand, respectively, with cash and cash equivalents of $12,311 thousand and $4,909 thousand[4]. - As of June 30, 2024, total current assets amounted to $23,069,000, with cash and cash equivalents at $22,043,000[9]. - Total liabilities were reported at $5,124,000, with current liabilities of $4,813,000 and long-term liabilities of $311,000[10]. - For the six months ended June 30, 2024, total operating expenses were $12,694,000, with research and development expenses at $7,105,000[12]. - The net loss for the same period was $12,494,000, with a net loss per share of $0.30[12]. - The combined balance sheet as of June 30, 2024, showed total assets of $24,198,000[11]. - Total operating expenses for the pro forma combined entity amounted to $49,525,000, with research and development expenses contributing $20,753,000[14]. - The net loss for the pro forma combined entity was $49,011,000, resulting in a net loss per share of $1.17[14]. - Pro forma net loss for the six months ended June 30, 2024, is projected at $12,494,000, with a net loss per share of $(0.30)[37]. - Pro forma net loss for the year ended December 31, 2023, is projected at $49,011,000, with a net loss per share of $(1.17)[37]. Capital Structure and Financing - The convertible promissory notes issued by TuHURA were increased to an aggregate principal amount of $35 million, with a 20% annual interest rate[7]. - The exercise price for TuHURA Warrants issued in the Note Financing is set at $1.02 per share, with a three-year exercise period[7]. - TuHURA's board approved a private offering of Convertible Debt, increasing the aggregate principal amount to $35 million, primarily for clinical development and corporate expenses[19]. - The issuance of 4,009,623 shares in July 2024 Private Placement generated proceeds of $5,000,000, netting $4,695,990 after costs[33]. - The conversion of $22,242,770 of Convertible Debt will result in the issuance of 55,489,176 shares[35]. - The fair value of the derivative liability related to the Convertible Debt is recorded at $2,884,000[35]. Research and Development - TuHURA plans to launch the REM-001 Study, a second-generation PDT photosensitizer agent, to test a 0.8 mg dose and optimize study design ahead of a Phase 3 trial initiation[4]. - TuHURA anticipates successful enrollment of ten CMBC patients for the REM-001 Study, with no significant value expected from Kintara's in-process research and development assets at the time of the merger[4]. - Kintara entered into a Contingent Value Rights Agreement, allowing holders to receive shares based on achieving a milestone related to the REM-001 study[20]. - As of August 19, 2024, 30 out of a projected 39 patients have been enrolled in the ongoing VISTA-101 Phase 1/2 clinical trial, which includes both monotherapy and combination therapy arms[31]. - KVA12123 has cleared five of six monotherapy dose levels and two of four cohorts in combination with Merck's KEYTRUDA®, with initial results showing partial response and stable disease[31]. Agreements and Transactions - TuHURA has entered into an Exclusivity Agreement with Kineta for the potential acquisition of the KVA12123 anti-VISTA antibody and related assets[7]. - TuHURA paid Kineta a total fee of $5,000,000 under the Exclusivity Agreement, with $2,500,000 paid at signing and another $2,500,000 due on July 15, 2024[8]. - The company has not allocated any of the $5,000,000 purchase price consideration to the royalty agreement due to uncertainties surrounding regulatory approval[8]. - The accounting treatment for the Exclusivity Agreement and the July Private Placement is preliminary and will be finalized based on further analysis[8]. - TuHURA made nonrefundable payments of $5,000,000 for exclusive rights to acquire Kineta's patents and related assets, with additional payments of $150,000 each for two renewal periods[34]. - Estimated transaction costs related to the merger amount to $3,827,530, including a one-time special bonus of $327,030[35].