UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q 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: 001-39473 TUHURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 99-0360497 ( State or other jurisdiction of incorporation or organization) 10500 University Center Dr., Suite 110 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Nevada 001-37823 99-0360497 (Commission File Number) (IRS Employer (State or Other Jurisdiction of Incorporation) Identification No.) FORM 8-K 10500 University Center Dr., Suite 110 Tampa, Florida 33612 (Address of Principal Executive Offices, including zip code) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Registrant's Telephone Number, Including Area Code: (813) 875-6600 Date of Report (Date of ...

Anticipates initiating the Company's Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), in Q2 2025 Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP) Targeting to close the ...

Phase 1b/2a trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda® when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumorsTAMPA, Fla., May 5, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced the initiation of its Phase 1b/2a trial of ...

TAMPA, Fla., April 8, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that an abstract highlighting Kineta Inc.'s novel KVA12123 antibody and an abstract from Moffitt Cancer Center scientists examining the mechanisms of Company's IFx-Hu2.0 therapy in advanced melanoma have been selected for poster presentation at the American Association for Cancer Research ...

Proven 20-year career in drug discovery and development track record leading to 12 pre-clinical/clinical candidates and 7 investigational new drug / clinical trial applicationsExtensive knowledge in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR), the primary target in TuHURA's Antibody Drug Conjugate (ADC) and Antibody Peptide Conjugate (APC) technology platformInventor of first-in-class spirocyclic DOR agonists as potential analgesics; clinical- stage products licensed to PfizerLed th ...

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].