UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37823 TUHURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 99-0360497 ( State or other jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2025 TUHURA BIOSCIENCES, INC. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) Nevada 001-37823 99-0360497 (Commission File Number) (IRS Employer Identification No.) 10500 University Center Dr., Suite 110 Tampa, Florida 33612 (Addr ...

Financial Performance - For the three months ended March 31, 2025, the company incurred a net loss of $6.7 million, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase in operating expenses [81]. - As of March 31, 2025, the company had an accumulated deficit of $117.8 million, indicating significant ongoing financial challenges [81]. - The net loss for the three months ended March 31, 2025, was $6.7 million, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase of $1.8 million [108]. - The company incurred net losses of $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively [117]. - Total operating expenses for the three months ended March 31, 2025, were $7.0 million, compared to $4.6 million in 2024, an increase of $2.4 million [108]. Cash Position and Funding Needs - The company had cash and cash equivalents of $6.2 million as of March 31, 2025, highlighting the need for additional funding to support operations [84]. - Cash and cash equivalents as of March 31, 2025, were $6.2 million, with cash flows from operating activities showing a net outflow of $4.7 million for the three months ended March 31, 2025 [119][129]. - The company anticipates needing at least $20 million in gross proceeds from a financing transaction to complete the Kineta merger [135]. - The company expects to finance cash needs through public or private equity offerings, debt financings, and collaborations, which may dilute existing stockholder ownership [137]. - The company expects existing cash and cash equivalents to meet anticipated cash requirements through late into the fourth quarter of 2025, excluding cash needed for the Kineta merger [134]. Research and Development - The company is preparing to initiate a Phase 3 trial for its lead product candidate, IFx2.0, as an adjunctive therapy to Keytruda® for advanced Merkel Cell Carcinoma patients, utilizing the FDA's accelerated approval pathway [79]. - The company is developing tumor microenvironment modulators targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the efficacy of immunotherapies [79]. - Research and development expenses increased to $4.6 million for the three months ended March 31, 2025, up from $3.6 million in the same period of 2024, representing a $1.0 million increase [111]. - The company plans to significantly increase research and development expenses in the foreseeable future to support product candidate development [102]. Mergers and Acquisitions - The company completed a merger with Kintara Therapeutics on October 18, 2024, which included a 1-for-35 reverse stock split and resulted in Legacy TuHURA becoming a wholly-owned subsidiary of Kintara [85]. - The company has entered into a Clinical Trial Funding Agreement with Kineta, agreeing to fund up to $900,000 in clinical trial expenses for KVA12123, with approximately $852,000 already paid [95]. - The company has entered into an Exclusivity Agreement with Kineta for the potential acquisition of KVA12123, paying a total of $5 million in fees [90]. - The TuHURA Notes financing raised an aggregate principal amount of $31.3 million, with a maturity date of December 1, 2025, and an interest rate of 20% per annum [122][123]. Operational Challenges - The company anticipates that operating losses will increase substantially as it advances product candidates through clinical development and seeks regulatory approvals [82]. - The company has not generated any revenue from product sales and does not expect to do so in the near future [99]. - The company has not experienced any material differences between estimates of accrued expenses and actual amounts incurred [142]. - The company is exposed to interest rate and inflation risks, but does not believe inflation has materially affected its results of operations [150][152].

Financial Results and Updates - TuHURA Biosciences reported financial results for Q1 2025, with a focus on corporate updates[7]. - TuHURA's financial condition and operational results are detailed in the press release dated May 15, 2025[7]. - The company has not undertaken any obligation to update forward-looking statements unless required by securities laws[14]. Acquisition and Merger - The company is in the process of acquiring Kineta, Inc., with a registration statement filed on February 7, 2025[8]. - The merger with Kineta is expected to enhance TuHURA's capabilities in tumor microenvironment modulators[13]. - TuHURA is actively seeking additional capital to support the Kineta merger and its ongoing development programs[13]. - The company emphasizes the importance of reading the Joint Proxy Statement/Prospectus for detailed information regarding the merger[9]. Product Development - TuHURA's product candidate IFx-Hu2.0 is anticipated to enter Phase 3 trials, indicating progress in its development pipeline[13]. - The anticipated regulatory pathway and timing for TuHURA's development programs are outlined as part of their forward-looking statements[13]. Stock Information - TuHURA's stock is traded on The Nasdaq Capital Market under the symbol HURA[5].

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]. - The estimated net working capital deficit for Kineta at closing should not exceed $12 million[12]. - The merger aims to enhance TuHURA's business operations and financial performance through synergies[12]. - TuHURA's stockholders may experience dilution of ownership percentage post-merger[12]. - The company emphasizes the importance of reading the Joint Proxy Statement/Prospectus for detailed information on the merger[8]. - TuHURA's management is focused on integrating Kineta's business and realizing anticipated benefits from the merger[12]. - The completion of the merger is expected to impact TuHURA's business relationships and competitive positioning[12]. Risks and Uncertainties - TuHURA cautions that forward-looking statements regarding the merger and future performance involve risks and uncertainties[12].

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[82][83]. - Research and development expenses for the years ended June 30, 2024, and 2023 were approximately $2.7 million and $9.3 million, respectively[77]. - 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[85]. - The company has expressed substantial doubt about its ability to continue as a going concern due to the lack of generated revenues and the need for additional funding[81][82]. Clinical Development and Studies - The REM-001 therapy demonstrated an 80% complete response rate in evaluable tumor sites treated in previous studies[9]. - The company is conducting a 15-patient open-label study for REM-001, with four patients dosed as of October 7, 2024[7]. - The proposed merger with TuHURA is expected to be completed in mid-October 2024, subject to regulatory approval[7]. - The company plans to conduct a Phase 3 clinical study in CMBC following the initial 15-patient study[12]. - The REM-001 program was re-initiated after receiving the NIH grant, with enrollment expected to be completed in Q4 2024[10]. - The company has received Fast Track Designation from the FDA for REM-001 in CMBC[11]. - REM-001 has been safely administered to over 1,100 patients in prior clinical studies, indicating a strong safety profile[15]. - In a Phase 1/2 clinical study for BCCNS, REM-001 showed a 91% overall response rate, with a 68% complete response rate[22]. - The most common treatment-related adverse event in CMBC studies was pain, with transient photosensitivity also reported[16]. - Current standard treatments for CMBC are often inadequate due to limited efficacy and side effects, indicating a significant unmet medical need[24]. Regulatory and Compliance - The company is dependent on regulatory approvals for commercialization, which involves rigorous testing and compliance with various regulations[44][46]. - The FDA offers expedited approval mechanisms for selected drugs, including fast track and breakthrough designations, but it is currently undetermined if these will apply to the company's drug candidates[53]. - Regulatory approval processes for products are lengthy and require substantial resources, with an average NDA review taking 10 months[50][51]. - The company may need to conduct post-marketing studies and comply with ongoing regulatory requirements, which could incur additional costs[160]. - The company is subject to extensive government regulations that require approval for manufacturing and marketing therapeutic products, which can be costly and time-consuming[116]. Market and Competition - The estimated market opportunity for the treatment of CMBC is approximately $500 million[19]. - The company faces significant competition in the oncology market, with major pharmaceutical and biotechnology companies actively developing similar products[66]. - Many competitors have greater financial resources and expertise in R&D, manufacturing, and obtaining marketing approvals, which could impact the company's market position[71]. - The oncology market is characterized by a large unmet medical need and competitive dynamics, with numerous therapies currently available for treating conditions like CMBC[69]. - If competitors obtain FDA approval before the company, they may establish a strong market position, reducing the company's commercial opportunity[164]. Merger and Corporate Structure - The merger agreement with TuHURA is expected to result in stockholders owning approximately 2.85% of the combined company on a pro forma fully diluted basis, increasing to 5.45% including CVR shares[73]. - TuHURA stockholders are expected to own approximately 97.15% of the combined company on a pro forma fully diluted basis[74]. - A reverse stock split was approved by stockholders to be executed prior to the consummation of the proposed merger, with a ratio between 1-for-20 and 1-for-40[89]. - The company operates with a "virtual" corporate structure, employing one full-time employee and approximately 10 independent contractors[78]. - The anticipated benefits and cost savings from the merger may not be realized, with risks including integration challenges and potential litigation[199]. Intellectual Property and Patents - The company holds two INDs for REM-001 in oncology and ophthalmology, and one NDA for treating age-related macular degeneration[43]. - The patent applications for REM-001 include methods for production and treatment of cutaneous metastatic cancers, with some applications pending in various countries[41][42]. - 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[110]. - The company is dependent on obtaining certain patents and protecting proprietary rights, which are crucial for its success in the market[101]. Risks and Uncertainties - Failure to successfully complete clinical studies or obtain regulatory approvals could adversely affect the company's financial condition and operational results[72]. - The company may encounter delays in obtaining coverage and reimbursement for newly approved drugs, which could negatively impact revenue generation[98]. - The company may experience unforeseen events during clinical studies that could delay or prevent marketing approval of product candidates[129]. - Delays in patient enrollment for clinical studies could significantly impact the development timeline and regulatory approval of product candidates, including REM-001[131]. - The company faces challenges in maintaining effective internal control over financial reporting, which could impact the accuracy and timeliness of financial results[92]. Funding and Financial Obligations - The company is obligated to pay a total of $300,000 upon the completion of a Phase 2B clinical study and $700,000 upon receipt of regulatory approval for REM-001 Therapy[37][38]. - A royalty fee of 6% of net sales will be paid to St. Cloud and Steven Rychnovsky, PhD, with St. Cloud receiving 4.8% and Rychnovsky receiving 1.2%[39]. - The company may incur a termination fee of $1,000 to TuHURA if the merger is not completed under specified circumstances[197]. - The company does not intend to pay cash dividends on common stock for the foreseeable future, with all earnings expected to be retained for future expansion[195].

Merger and Corporate Changes - Kintara Therapeutics 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]. - Following the merger, Kintara's common stock began trading under the new symbol "HURA" on October 18, 2024, after a 1-for-35 reverse stock split[76]. - The company completed the merger with TuHURA on October 18, 2024, and changed its name to TuHURA Biosciences, Inc.[86]. - TuHURA stockholders owned approximately 97.15% of Kintara on a fully-diluted basis immediately prior to the merger[76]. - The merger agreement included provisions for contingent value rights, allowing stockholders to receive approximately 1,539,918 shares of common stock upon achieving specific clinical milestones[76]. Clinical Development and Research - The company received a $2,000 grant from the NIH to fund the REM-001 CMBC clinical study, which is expected to complete patient enrollment in Q4 2024[77]. - REM-001 therapy demonstrated a complete response in approximately 80% of evaluable tumor sites treated in previous studies for cutaneous metastatic breast cancer[78]. - Kintara received Fast Track Designation from the FDA for REM-001 in CMBC, facilitating its clinical development[80]. - The company has initiated treatment in four patients as part of the REM-001 study at Memorial Sloan Kettering Cancer Center as of November 14, 2024[79]. - The development of VAL-083 was terminated after preliminary results showed it did not perform better than current standards of care for glioblastoma[81]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of $3,020,000, down from $4,909,000 as of June 30, 2024[87]. - For the three months ended September 30, 2024, research and development expenses decreased to $252,000 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 three months ended September 30, 2024, was $2,161,000, an improvement from a net loss of $2,962,000 for the same period in 2023[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 a negative cash flow of $1,317,000 for the same period in 2023, a change 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 $10,471,000 in net proceeds from the sale of common stock under the ATM Facility from October 31, 2023, to September 30, 2024[100]. - The company recorded $13,000 in dividends related to Series C Preferred Stock for the three months ended September 30, 2024, down from $173,000 for the same period in 2023[94]. Operational Strategies - The company aims to address unmet medical needs in cancer therapy, focusing on orphan cancer indications[72]. - The company is exploring various financing alternatives to fund operations and maximize shareholder value following the merger[101]. Accounting and Estimates - 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[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 Exchange Ratio for the merger was calculated to be 0.1789 following a 1-35 reverse share split[6]. - The merger transaction was completed on April 2, 2024, with TuHURA continuing as a wholly owned subsidiary of Kintara[16]. - The pro forma financial statements reflect the merger as if it had been consummated on January 1, 2023, with no historical operating relationship between the companies prior to the merger[5]. - The pro forma combined entity reflects a reverse share split of 1-35, impacting the number of shares outstanding[17]. - TuHURA's existing shareholders will own approximately 96.0% of the combined company post-merger, while Kintara's existing public stockholders will own about 4.0%[18]. 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, TuHURA's total current assets amounted to $23,069,000, with cash and cash equivalents at $22,043,000[9]. - Total liabilities for TuHURA as of June 30, 2024, were reported at $5,124,000, with current liabilities at $4,813,000[10]. - For the six months ended June 30, 2024, TuHURA reported total operating expenses of $12,694,000, with research and development expenses at $7,105,000[12]. - The net loss for TuHURA for the same period was $12,494,000, resulting in a net loss per share of $0.30[12]. - TuHURA's total stockholders' equity (deficit) was reported at $3,757,000 as of June 30, 2024[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]. 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]. - Initial results from KVA12123 showed partial response and stable disease in combination cohorts, with durable stable disease in monotherapy cohorts[31]. - 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[31]. - KVA12123 has cleared five of six monotherapy dose levels and two of four cohorts in combination with Merck's KEYTRUDA® therapy[31]. Financing and Debt - The convertible promissory notes issued by TuHURA were increased to an aggregate principal amount of $35 million, with a simple interest rate of 20% per annum[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 Convertible Debt bears simple interest at a rate of 20% per annum, computed on a 365-day year[30]. - The company plans to convert Convertible Debt of $22,242,770 into 55,489,176 shares upon merger completion[34]. - The company recorded a reversal of interest expense on Convertible Debt of $1,612,610 for the six months ended June 30, 2024[34]. - The fair value of the derivative liability related to the Convertible Debt was recorded at $2,884,000[34]. 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 of KVA12123[8]. - TuHURA made nonrefundable payments of $5,000,000 for exclusive rights to acquire Kineta's patents and related assets[33]. - Estimated transaction costs related to the merger amount to $3,827,530, including a one-time special bonus of $327,030[34]. - The issuance of 4,009,623 shares in July 2024 Private Placement generated proceeds of $5,000,000, netting $4,695,990 after costs[32].

Core Viewpoint - Kintara Therapeutics, Inc. has announced a reverse stock split of its common stock at a ratio of 1-for-35, effective October 18, 2024, following its merger with TuHURA Biosciences, Inc. [1][2] Company Overview - Kintara Therapeutics is focused on developing new solid tumor cancer therapies and is headquartered in San Diego, California [7][9] - The company is dedicated to addressing unmet medical needs in cancer treatment, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer (CMBC) [7][8] Reverse Stock Split Details - The reverse stock split will reduce the number of Kintara's outstanding common shares from approximately 55.6 million to about 1.6 million [3] - The par value of Kintara's common stock will remain unchanged at $0.001 per share, and the authorized number of shares will not change [3] - The reverse stock split will apply uniformly to all stockholders, with adjustments made for any fractional shares [3] Merger with TuHURA Biosciences - Following the merger, the combined company's total outstanding common stock is expected to be approximately 42.0 million shares [4] - TuHURA Biosciences is a Phase 3 registration-stage immuno-oncology company developing technologies to overcome resistance to cancer immunotherapy [5] - TuHURA's lead candidate, IFx-2.0, aims to enhance the effectiveness of checkpoint inhibitors in treating advanced Merkel Cell Carcinoma [5][6]

Core Viewpoint - Kintara Therapeutics has approved a reverse stock split at a ratio of 1-for-35, which will take effect on October 17, 2024, coinciding with the merger with TuHURA Biosciences, Inc. The company will trade under the new name TuHURA Biosciences, Inc. with the symbol "HURA" [1][4]. Summary by Sections Reverse Stock Split - The reverse stock split was approved by Kintara's stockholders on October 4, 2024, with a final ratio of 1-for-35 determined by the Board [2]. - This action will reduce the number of outstanding shares from approximately 55.6 million to about 1.6 million shares, while the par value remains at $0.001 per share [3]. - The reverse stock split will not change the authorized number of shares and will uniformly affect all stockholders, with no fractional shares issued [3]. Merger with TuHURA Biosciences - Following the merger, the combined company's total outstanding common stock is expected to be approximately 42.0 million shares [4]. - TuHURA Biosciences is focused on developing novel immuno-oncology therapies, including a personalized cancer vaccine candidate, IFx-2.0, which is set to enter a Phase 3 trial [5][6]. Company Background - Kintara Therapeutics is dedicated to developing novel cancer therapies, particularly for patients with unmet medical needs, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer [7][8]. - The company has a proprietary photodynamic therapy platform that has shown an 80% clinical efficacy in previous trials for its lead therapy [8].