HURA

TAMPA, Fla., Aug. 14, 2026 /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 reported financial results for the Company's second quarter ended June 30, 2026, and provided a corporate update. "We have made significant progress in advancing all our programs forward and are positioned to continue driving towards several anticipated milestones targeted for the second half of the year," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "In the second half, we anticipate receiving safe-to-proceed feedback from FDA and to initiating our Phase 1b/2 trial of VISTA in mutNPM1 r/r AML, initiating our in vivo POC studies for MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)), potentially receiving orphan drug designation in Merkel cell carcinoma (MCC) for IFx-2.0, and potentially receiving orphan drug designation in AML for TBS-2025. The recent $50 million term credit facility made available to us by our largest shareholder provides us a non-convertible source of operating capital with adequate runway for us to achieve our strategic objectives and execute on our goals." Second Quarter and Recent Corporate Highlights: Filed Investigational New Drug (IND) Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and other Blood Related Cancers. The IND is aligned with guidance previously provided by the U.S. Food and Drug Administration (FDA) on the development pathway for both monotherapy and combination with menin inhibitors for Acute Myeloid Leukemia (AML). The FDA noted that the previously planned IND meeting would not be necessary and instead the FDA provided written responses to questions and information related to the Company's proposed Phase 1b/2 development plan for TBS-2025 in AML. In April 2026, the Company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date for April 21, 2031. The facility was provided by TuHURA's largest shareholder. Currently Anticipated Milestones by ProgramIFx-2.0 (Innate Immune Agonist) 2H 2026: Expect to receive orphan drug designation in MCC 1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda® for deep seated MCC 2H 2027: Expect to complete enrollment in the Phase 3 study of IFx-2.0 TBS-2025 (VISTA inhibiting mAb) 2H 2026: Expect to initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML 2H 2026: Expect to receive orphan drug designation in AML 1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML MDSC Inhibitors (Bi-specific ADCs) 2H 2026: Presentations at key scientific meetings 2H 2026: Initiation of ADC in vivo POC studies Summary of Financial Results for the Second Quarter 2026Cash and cash equivalents of $1.0 million at June 30, 2026. In April 2026 and July 2026, the Company received $0.3 million and $0.1 million, respectively, in gross proceeds under the ATM Program. Additionally, the Company has received $5.7 million in gross proceeds to date on the Parkview credit facility, which includes $2.15 million subsequent to June 30, 2026. TuHURA's total common shares outstanding were approximately 63.7 million at June 30, 2026. Research and development expenses were $6.6 million and $4.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $1.7 million was related to an increase in clinical development activity the Company's ongoing and planned clinical trials. General and administrative (G&A) expenses were $2.1 million and $1.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company. Net cash outflows from operating activities were ($13.0) million and ($10.9) million for the 6 months ended June 30, 2026, and 2025, respectively. Net cash flows from financing activities were $10.6 million and $8.1 million for the 6 months ended June 30, 2026, and 2025, respectively. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is enrolling patients in its randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, a VISTA inhibiting mAb moving into dose escalation/optimization Phase 1b trial in mutNPM1 r/r AML, a molecularly defined subgroup representing approximately 35% of patients with AML. TuHURA is also leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting MDSCs to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others: the risk that funds available under the Company's credit facility may be insufficient to fund the Company's operations and development programs to the extent anticipated; risks associated with conducting the ongoing Phase 3 trial for IFx.20; the risks associated with continuing the development of TBS-2025 and our DOR technologies; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of regulatory approvals; and the other risks described from time to time in detail in Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA's other reports and filings with the SEC from time to time, which are available on TuHURA's website and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Investor Contact: Monique KosseGilmartin [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-reports-second-quarter-2026-financial-results-and-provides-a-corporate-update-302851514.html

TAMPA, Fla., May 15, 2026 /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 reported financial results for the Company's first quarter ended March 31, 2026, and provided a corporate update. "I am very pleased with the progress we have made this past quarter as we continue to execute upon our corporate and development strategy. Importantly, we recently established a $50 million non-equity-based source of operating capital in the form of credit facility with our largest stockholder on attractive terms for the company allowing us to fund operations beyond anticipated top-line data in our lead IFx-2.0 program," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "With the financing optionality provided by the credit facility, we now look forward to several anticipated key upcoming milestones, including: meeting with the FDA to discuss our IND and development plan for our VISTA inhibitor, TBS-2025, and initiating a Phase 1b/2 trial of TBS-2025 in mutNPM1 r/r AML; selecting our lead ADC for proof-of-concept studies in AML; and completing enrollment in our Phase 3 study of IFx-2.0 in Merkel Cell Carcinoma (MCC)." First Quarter and Recent Corporate Highlights: In April 2026, the company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date for April 21, 2031. Announced Craig Tendler, M.D., will provide strategic, operational and other related services consistent with those of a Chief Medical Officer. Dr. Tendler will continue in his role as a member of the Board of Directors and also work with management to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025. Appointed Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations. Mrs. Garofalo has over 20 years of clinical and development experience and will work closely with Dr. Tendler in overseeing the day-to-day clinical operations. Received FDA Orphan Drug Designation (ODD) for IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD designation was based on data from the Company's previously completed Phase 1 study of IFx-2.0, which demonstrated IFx-2.0 to be safe with no serious dose limiting toxicities. Additionally, the study demonstrated that patients refractory to checkpoint inhibitor therapy (anti-PD1) experienced clinical benefit upon subsequent anti-PD1 based treatment. Anticipated Milestones by Program IFx-2.0 (Innate Immune Agonist) 1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC 2H 2026: Anticipate presenting data at a scientific conference 2H 2027: Complete enrollment in Phase 3 study of IFx-2.0 2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) in first-line treatment for advanced or metastatic MCC TBS-2025 (VISTA inhibiting mAb) 1H 2026: Planned FDA IND meeting regarding the Phase 1b/2 development plan inNPM1 mut r/r AML, and other molecularly defined subsets 2H 2026: Seek Orphan Drug Designation in AML 2H 2026: Initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML MDSC Inhibitors (Bi-specific ADCs) 1H 2026: Select lead ADC for proof-of-concept study in AML 2H 2026: Presentations at key scientific meetings Summary of Financial Results for the First Quarter 2026 Cash and cash equivalents of $6.3 million at March 31, 2026. TuHURA's total common shares outstanding were approximately 63.6 million. Research and development expenses were $5.2 million and $4.6 million for the 3 months ended March 31, 2026, and 2025, respectively. General and administrative (G&A) expenses were $2.3 million and $2.0 million for the 3 months ended March 31, 2026, and 2025, respectively. Net cash outflows from operating activities were ($4.4) million and ($4.7) million for the 3 months ended March 31, 2026, and 2025, respectively. Net cash flows from financing activities were $ 7.2 million and $ (0.5) million for the 3 months ended March 31, 2026, and 2025, respectively. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) compared to Keytrudaﾮ plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, a VISTA inhibiting mAb moving into Phase 1b/2 in mutNPM1 r/r AML, a molecularly defined subgroup of patients with AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others: the risk that funds available under the Company's credit facility may be insufficient to fund the Company's operations and development programs to the extent anticipated; risks associated with conducting the ongoing Phase 3 trial for IFx.20; the risks associated with continuing the development of TBS-2025 and our DOR technologies; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of regulatory approvals; and the other risks described from time to time in detail in Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA's other reports and filings with the SEC from time to time, which are available on TuHURA's website and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Investor Contact: Monique Kosse Gilmartin Group [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-reports-first-quarter-2026-financial-results-and-provides-a-corporate-update-302773858.html

By John Vandermosten, CFA NASDAQ: HURA READ THE FULL HURA RESEARCH REPORT Operational and Financial Results On April 1st, 2026, TuHURA Biosciences, Inc. (NASDAQ: HURA) reported 2025 financial and operational results and filed its Form 10-K with the SEC. The company is conducting Phase III and Phase Ib/IIa trials in Merkel cell carcinoma (MCC) and is expected to soon start a Phase Ib/II trial for TBS-2025 in acute myeloid leukemia (AML). The IFx-2.0 Phase III is expected to read out in 2027. The TBS-2025 anti-VISTA asset is now the subject of FDA meetings centering on the development plan, and clinical trials could begin in 2H:26. Other program work includes the identification of a lead antibody drug conjugate (ADC) in AML, along with initiation of proof-of-concept studies. Outside of operational efforts, TuHURA added new team members and is presenting at scientific and investor conferences. Below, we summarize the company’s 2025 financial results. TuHURA generated no revenues in 2025 and expended $31.8 million on operational activities related to advancing IFx-2.0, TBS-2025, and other programs, producing a net loss of $30.1 million or $0.63 per share. For the year ending December 31st, 2025, and versus the same prior year period: Research & development expense totaled $20.5 million, increasing 54% from $13.3 million on higher facilities, salary and personnel related costs, greater clinical spending on IFx-2.0 and TBS-2025, and increased allocations to the preclinical IFx-3.0, myeloid derived suppressor cell (MDSC), and REM-001 programs; General & administrative expense totaled $11.2 million, which includes acquisition related costs of $3.7 million. The total was up markedly from $4.3 million, due to increases in non-cash stock compensation, merger transaction costs, and expenses related to being a public company; Other items included $2.2 million that consisted of grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services, and amounts related to share settlement to former Kineta employees, and employee retention tax credit. The most significant item was $1.6 million in income related to the fair value of Kineta merger holdback shares, partially offset by a $185,000 loss on Kineta employee separation payments; Net interest expense was $489,000; Net loss was $30.1 million or $0.63 per share. Removing the nonoperating items from the “Other” line item produces a net loss of $32.3 million or $0.67 per share. As of December 31st, 2025, TuHURA held $3.6 million in cash on its balance sheet. Cash burn for 2025 was $27.7 million while net cash generated from financing sources was $19.9 million, which consisted of proceeds from a bridge note, warrants, and common stock issuance, partially offset by capital raising costs and transaction and liability payments related to Kintara. In October, TuHURA entered into a $3.0 million loan agreement, of which $1.5 million of the loan was advanced upon execution. In November, TuHURA entered into an at-the-market (ATM) facility with HC Wainwright as its sales agent, along with the filing of a Form S-3 registration statement, making available $50 million in capacity for the ATM. Following the end of the reporting period, the second and third tranches of December’s $15.6 million raise were completed. This added gross proceeds of $7 million. Anti-VISTA (TBS-2025) Program TuHURA closed the Kineta acquisition in June 2025, bringing the latter’s anti-VISTA asset into the fold. Now designated TBS-2025, the candidate is a VISTA-blocking immunotherapy developed to reverse immunosuppression in the tumor microenvironment (TME). It is a fully-human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at physiologic and acidic pH levels. The product is being developed as an intravenous infusion. Under TuHURA’s aegis, TBS-2025 is expected to be the subject of a Phase Ib/II trial in patients with relapsed/refractory (r/r) mutated nucleophosmin 1 (mutNPM1) AML. Based on research that has demonstrated that mutated NPM1 and DNMT3A result in high expression of VISTA on the surface of leukemic blasts.[1] The presence of VISTA on these cells is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack, resulting in a low treatment response rate and a short duration of response in AML. This February, TuHURA filed an Investigational New Drug (IND) Application with the FDA for TBS-2025. It submitted the document to the Division of Hematologic Malignancies for the treatment of mutNPM1 r/r AML in combination with a menin inhibitor. If cleared, the Phase Ia portion plans to enroll 14 patients and the Phase II, 26 subjects. TuHURA’s next steps with the TBS-2025 program are to determine a starting dose in an abbreviated Phase Ib trial. The subsequent Phase II trial will investigate TBS-2025 in combination with a menin inhibitor for patients with mutNPM1 r/r AML who were previously untreated with a menin inhibitor. These studies are slated to begin in 2H:26. In the press release announcing the IND, Dr. Bianco pointed out that leukemogenic mutations common in AML may drive the expression of VISTA on the surface of leukemic cells, which in turn shut down the immune response. The anti-VISTA antibody’s mechanism raises the shield so the immune system can kill these cells. He continued, noting that complete response rates using menin inhibitors as monotherapy are below 25% and of short duration. Adding TBS-2025 to the treatment paradigm may markedly increase both the magnitude of response and its duration. Success in this endeavor would provide TuHURA the data it needs to seek an accelerated approval route with the FDA. In March 2026, TuHURA announced that Dr. Craig Tendler would lead the anti-VISTA program in AML. Dr. Tendler’s first public association with TuHURA was the company’s announcement that he would join TuHURA’s board of directors in March 2025. Last month, it was announced that he would take on the responsibilities consistent with those of Chief Medical Officer (CMO) and lead the TBS-2025 program. He will continue his role on the board. A press release provided a biography for the thirty-year industry veteran, noting his tenure at Johnson & Johnson. Joining Dr. Tendler is Amanda Garofalo, who was announced as SVP of Clinical Operations on April 7th, 2026. She will assist with the development of TBS-2025 and TuHURA’s other clinical programs. Menin Inhibitor Background Menin inhibitors are a targeted therapy for NPM1-mutated r/r AML that work by disrupting the menin-dependent transcriptional program that leukemic cells use to maintain HOX/MEIS1 expression, which helps drive survival and differentiation block.[2] In practice, these small molecules can induce differentiation and remissions in this disease, and they are now part of the treatment landscape for this molecular subtype, with activity seen most often in heavily pretreated patients. NPM1-mutated AML is biologically dependent on menin-mediated signaling, so blocking menin can turn off an oncogenic program rather than just broadly killing dividing cells. That makes menin inhibition especially relevant in r/r mutNPM1 AML, where options are limited and targeted therapy is needed.[3],[4] TBS-2025 may pair well with a menin inhibitor because the combination targets two different resistance layers in AML. Anti-VISTA antibodies may reverse immune suppression in the tumor microenvironment, while menin inhibitors suppress the leukemic oncogenic transcription program in mutNPM1 AML. In murine mutNPM1 AML, loss of VSIR (the gene encoding VISTA) was associated with an immune response and improved survival. This suggests VISTA blockade could help the immune system clear leukemic cells that remain after menin inhibition.[5] Financing and Corporate Update TuHURA announced a registered direct offering on December 9th that raised $15.6 million through the issuance of 9,462,423 shares of common stock and warrants. The purchase price for the equity shares was set at $1.65 and the exercise price for the warrants was $1.95. Warrants can be exercised six months after issue. The closing of the transaction was scheduled to occur in three tranches, with all completed by the end of February 2026. Phase III IFx-2.0 Trial in MCC TuHURA launched its pivotal Phase III study for its IFx-2.0 candidate in Merkel cell carcinoma (MCC) in June 2025. In the latest earnings report, TuHURA provided its latest set of milestones for the program. They include obtaining Orphan Drug Designation for IFx-2.0 in MCC in 1H:26, reporting preliminary data from the Phase Ib/IIa study of IFx-2.0 in 2H:26, and a topline readout of the Phase III study in 2H:27. IFx-2.0 will prepare for a new drug application using the FDA’s accelerated approval program under a special protocol assessment (SPA). The trial was designed with the input of the FDA’s Oncology Center of Excellence (OCE). Accelerated approval allows the sponsor to use surrogate endpoints that predict clinical benefit. In most cases, an accelerated approval will require post-market confirmatory trials to verify the clinical benefit. However, in this case, the FDA has indicated that secondary endpoints that demonstrate clinical benefit may be used. If successfully achieved, the trial may satisfy the requirements for full approval. Upcoming Milestones SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] NPM1 and DNA methyltransferase 3A (DNMT3A) are two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS). [2] Differentiation block refers to a state where leukemia cells are held in an immature, rapidly dividing stage and are unable to mature into functional white blood cells. [3] Isidori, A., Marconi, G. The role of menin inhibitors in acute myeloid leukemia. Current Opinion in Oncology. November 2025. [4] Fiskus, W., et al. Effective Menin inhibitor-based combinations against AML with MLL rearrangement or NPM1 mutation (NPM1c). Blood Cancer Journal. January 2022. [5]TuHURA Biosciences Pipeline. Accessed April 2026.

TAMPA, Fla., April 1, 2026 /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 reported financial results for the Company's fourth quarter and full year ended December 31, 2025, and provided a corporate update. "2025 was a strong year of executing upon our goals, and we continue to move all our programs forward this year. As we progress our clinical development pipeline, we have strategically strengthened our clinical and drug development expertise with Craig Tendler, M.D., providing the strategic and operational services consistent with those of a Chief Medical Officer to oversee clinical development strategy and operations of the company's pipeline, including our VISTA inhibiting antibody, TBS-2025," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "Craig brings a depth of experience that is invaluable to us as we look forward to several targeted key milestones in our VISTA program this year. Our IFx-2.0 Phase 3 study in front-line Merkel Cell Carcinoma (MCC) continues to enroll, and we now anticipate completing enrollment in mid-2027. Additionally, we continue to make important advancements toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates (ADC) program and anticipate presenting new data at a scientific conference later this year." Dr. Bianco continued, "We are grateful to have the unwavering support of our shareholders, who are committed to supporting our programs and realizing the potentially meaningful opportunity each one addresses." Corporate Highlights Initiated a randomized Phase 3 Accelerated Approval Trial for IFx-2.0 in first line treatment of patients with advanced or metastatic Merkel Cell Carcinoma (MCC) as adjunctive therapy to Keytrudaﾮ (pembrolizumab). Phase 3 study trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process. Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval. Initiated Phase 1b/2a Study of IFx-2.0 as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). Trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytrudaﾮ when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors. Closed acquisition of Kineta gaining rights to TBS-2025, a novel VISTA inhibiting antibody, for $10.5 million. Raised gross proceeds of $21.2 million in registered direct offerings and private placements Presented data demonstrating the Delta Opioid Receptor (DOR) as a new target in overcoming acquired resistance to immune checkpoint inhibitors at ASH. Selected for Oral Presentation by the Scientific Committee of American Society of Hematology new scientific evidence that DOR is expressed on tumor-associated Myeloid-Derived Suppressor Cells (MDSCs), and its inhibition decreases immune suppressing capabilities of MDSCs by downregulating expression of multiple genes associated with MDSC induced immunosuppression. Data also presented in the poster session demonstrated that the DOR is also expressed on tumor associated macrophages (TAMs) and DOR inhibition appears to reverse TAM mediated T cell suppression with the potential to overcome resistance to checkpoint inhibitors and other cancer immunotherapies. Upcoming Targeted Milestones by Program IFx-2.0 (Innate immune agonist) 1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC 2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP) 2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) in first line treatment for advanced or metastatic MCC TBS-2025 (VISTA inhibiting antibody) June 2026: Meeting with the FDA to discuss the development plan for TBS-2025 in NPM1 mut r/r AML 2H 2026: Anticipate initiation of Phase 1b/2 trial of VISTA in NPM1 mut r/r AML Lead ADC Selection 1H 2026: Select lead ADC in AML 2H 2026: Expect to initiate ADC in vivo proof of concept (POC) studies 2H 2026: Anticipate POC data in humanized model of AML 2H 2026: Presentations at key scientific meetings Summary of Financial Results for the Full Year 2025 Cash and cash equivalents of $3.6 million at December 31, 2025, with an additional $7.5 million received in Q1 2026 from the 2025 registered direct offering. As of December 31, 2025, TuHURA's total shares outstanding were approximately 52.9 million. Research and development expenses were $20.5 million and $13.3 million for the 12 months ended December 31, 2025, and 2024, respectively. On a pro forma basis, which includes a full year of Kineta research and development, these expenses were $22.1 million and $18.7 million for the 12 months ended December 31, 2025, and 2024, respectively. General and administrative (G&A) expenses were $7.6 million and $3.9 million for the 12 months ended December 31, 2025, and 2024, respectively. Net cash outflows from operating activities were ($27.7) million and ($14.7) million for the 12 months ended December 31, 2025, and 2024, respectively. Net cash flows from financing activities were $19.9 million and $29.7 million for the 12 months ended December 31, 2025, and 2024, respectively. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytrudaﾮ (pembrolizumab) compared to Keytrudaﾮ plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on TuHURA's website and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Investor Contact: Monique Kosse Gilmartin Group [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-reports-fourth-quarter-and-full-year-2025-financial-results-and-provides-a-corporate-update-302730804.html

By John Vandermosten, CFA NASDAQ:HURA READ THE FULL HURA RESEARCH REPORT Operational and Financial Results On November 14th, 2025, TuHURA Biosciences, Inc. (NASDAQ:HURA) reported third quarter 2025 financial and operational results and filed its Form 10-Q with the SEC. The company is conducting its IFx-2.0 Phase III trial in Merkel cell carcinoma (MCC), which is expected to read out in early 2027. It continues to advance Kineta’s VISTA asset, now designated TBS-2025, and start the Phase II trial in 1Q:26. Other announcements include planned participation at the American Society of Hematology (ASH) Annual Meeting taking place in Orlando, Florida. Below, we summarize TuHURA’s quarterly financial results. TuHURA generated no revenues in 3Q:25 and expended $6.7 million on operational activities related to advancing IFx-2.0 and other programs, producing a net loss of ($7.1) million or ($0.14) per share. For the quarter ending September 30th, 2025, and versus the same prior year period: Research & development expense totaled $5.0 million, increasing 69% from $2.9 million due to greater expenses for the IFx-2.0 and TBS-2025 programs, preclinical research related to IFx-3.0 and myeloid derived suppressor cell (MDSC) initiatives, and higher salary, personnel, and facilities costs: General & administrative expense totaled $1.8 million, due to increases in non-cash stock compensation, merger transaction costs and expenses related to being a public company; Other items included $138,000 in grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services and amounts related to share settlement to former Kineta employees; Net interest expense was $10,000; Net loss was ($7.1) million or ($0.14) per share. As of September 30th, 2025, TuHURA held $2.7 million in cash on its balance sheet. Cash burn for the first nine months of 2025 was ($22.1) million, while net cash generated from financing sources was $13.4 million, which consisted of warrant proceeds and issuance of common stock partially offset by stock issuance costs and transaction and liability payments related to Kintara. In October, TuHURA entered into a $3.0 million loan agreement, of which $1.5 million of the loan was advanced upon execution. In November, TuHURA entered into an at-the-market (ATM) facility with HC Wainwright as its sales agent. A Form S-3 registration statement was filed to enable $50 million in capacity for the ATM. TuHURA also has $500,000 remaining on its final tranche offering, which is expected to be executed prior to year end 2025. Phase III IFx-2.0 Trial in MCC TuHURA launched its pivotal Phase III study for its IFx-2.0 candidate in Merkel cell carcinoma (MCC) in June. In the latest quarterly report, TuHURA set forth two related milestones for the study. Enrollment is expected to be complete in 4Q:26 and topline results are anticipated in 1Q:27. IFx-2.0 will pursue a new drug application using the FDA’s accelerated approval program under a special protocol assessment (SPA). The trial was designed with the input of the FDA’s Oncology Center of Excellence (OCE). Accelerated approval allows the sponsor to use surrogate endpoints that predict clinical benefit. In most cases, an accelerated approval will require post-market confirmatory trials to verify the clinical benefit. However, in this case, the FDA has indicated that secondary endpoints that demonstrate clinical benefit may be used. If successfully achieved, the trial may satisfy the requirements for full approval. Upcoming Milestones Milestones IFx-2.0 trial launch – June 2025 IFx-2.0 IR basket trial launch – May 2025 Close of Kineta acquisition – June 2025 IFx-3.0 CD22 tumor-targeted mRNA in vivo proof of concept studies – 2026 Participation in the HC Wainwright Investment Conference – September 2025 Appointment of Dr. Michael Turner as VP of Immunology – November 2025 Form S-3 filed and agreement entered for ATM facility – November 2025 Delta Opioid Receptor presentation at ASH – December 7th, 2025 Enrollment progress update for IFx-2.0 - Year end 2025 Launch VISTA inhibitor (TBS-2025) Phase II trial in NPM1 mutated AML – 1Q:26 Selection of lead DOR inhibitor – 1Q:26 IFx-2.0 Phase Ib/IIa preliminary results – 2Q:26 TBS-2025 (VISTA) interim readout – mid-2026 First proof of concept with in-vivo results for lead antibody drug conjugate (ADC) – 3Q:26 IFx-2.0 Phase III topline results – 1Q:27 Company Pipeline Summary TuHURA reports 3Q:25 financial results with two active clinical trials on the IFx-2.0 platform and one to begin shortly for TBS-2025. Its ranks were augmented with the appointment of Dr. Michael Turner as VP of immunology in November. In December, the company will present its DOR technology at the ASH conference along with two other poster presentations. We expect to see a continuation of activity over the next several months as the IFx-2.0 studies enroll, preparations for the start of the Phase II TBS-2025 trial are completed and the trial is launched. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. 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Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC) is underway, conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) Company's Delta Opioid Receptor (DOR) technology selected for an oral presentation, along with 2 poster presentations at the 67th Annual American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in Orlando, Florida on December 6-9, 2025 TAMPA, Fla., Nov. 14, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company's third quarter ended September 30, 2025, and provided a corporate update. "TuHURA remains highly focused on the execution of its clinical development programs, including enrollment in our Phase 3 pivotal trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in the first line treatment of patients with advanced or metastatic MCC. This accelerated, registration-directed trial, conducted under an SPA Agreement with the FDA, has the potential, if successful, to satisfy the requirements for both accelerated and regular approval without the need to conduct a post-approval confirmatory trial," stated Dr. James Bianco, President and Chief Executive Officer of TuHURA. "In parallel to advancing our late-stage development candidate IFx-2.0, we are working with experts in the treatment of AML to complete the protocol design for our Phase 2 study of TBS-2025, our VISTA inhibiting antibody, in patients with NPM1 mutated AML. We are on track to submit our proposed Phase 2 plan to FDA next month and initiate the Phase 2 randomized study in the first quarter of next year." Dr. Bianco continued, "In addition to our clinical programs, we were excited to see validation of the scientific merit related to our discovery of the potential role of the DOR expression on Myeloid Derived Suppressor Cells (MDSCs) by being selected by the Joint Program Committees of the ASH 2025 Annual Meeting for an oral presentation. We look forward to presenting our data demonstrating that the DOR is a potential novel target to reprogram the immune suppressing capabilities of MDSCs and tumor-associated macrophages (TAMs). Together with regulatory T cells (Tregs), these immunosuppressive cells are collectively responsible for acquired resistance to cancer immunotherapies. The DOR technology is the backbone of our program to develop first-in-class bi-specific, bi-functional immune modulating antibody drug conjugates (ADCs). TuHURA's oral presentation at the ASH 2025 Annual Meeting is on December 7th at 5:15pm ET." Corporate Highlights Acceptance of Oral and Poster Presentations at ASH 2025 Annual Meeting and Exposition. TuHURA announced that ASH has accepted the following abstracts for presentation: Oral Presentation: Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs) Poster Presentation: Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype to Overcome Acquired Resistance and Enhance the Effectiveness of Cancer Immunotherapies Moffitt Cancer Center Poster Presentation: Delta opioid receptor signaling modulates myeloid suppression in Myelodysplastic Syndromes Strengthening of TuHURA Team Through the Appointment of Dr. Michael Turner. In November 2025, Michael Turner, Ph.D. was appointed as Vice President of Immunology. Dr. Turner has over 20 years of experience in immunology and oncology, with experience at leading industry companies such as Sanofi Genzyme, Alkermes, Ventus Therapeutics and Third Harmonic Bio. $50 Million At-The-Market (ATM) Facility Filed. In November 2025, TuHURA became eligible to file a "shelf" registration statement on Form S-3 and entered into agreement providing for an ATM facility of up to $50 Million. TuHURA will become able to sell shares under the ATM facility when the S-3 registration statement filed on November 3, 2025 becomes effective under the rules and regulations of the SEC. Upcoming Targeted Milestones by Program IFx-2.0 (Innate immune agonist) Q2 2026: Anticipate preliminary results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP). Q4 2026: Anticipate completion of enrollment in the randomized, placebo-controlled Phase 3 accelerated approval trial in first line treatment as adjunctive therapy to Keytruda® in advanced or metastatic MCC. Q1 2027: Anticipate topline results from the Phase 3 accelerated approval trial. TBS-2025 (VISTA inhibiting antibody) Q4 2025: Submission of the Phase 2 protocol and plan to the FDA for TBS-2025 in hematologic malignancies. Q1 2026: Initiation of a Phase 2 trial of VISTA inhibiting mAb in relapsed or refractory NPM1-mutated AML in combination with a menin inhibitor. Lead ADC Selection Q1 2026: TuHURA has developed a library of potent, highly selective DOR inhibitors to be evaluated in its MDSC assays. TuHURA expects to select a lead DOR inhibitor to conjugate to TBS-2025 for testing in preclinical models. Q3 2026: Anticipates first proof of concept in-vivo results from its lead immune modulating ADC. Financial Results for the Three Months and Nine Months Ended September 30, 2025 Research and development expenses were $4.9 million and $2.9 million for the three months ended September 30, 2025, and 2024, respectively. Net cash outflows from operating activities were ($22.1) million and ($12.1) million for the nine months ended September 30, 2025, and 2024, respectively. As of September 30, 2025, TuHURA's total shares outstanding was approximately 51.2 million. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's Delta Opioid Receptor Technology, its IFx-Hu2.0 product candidate and Phase 3 trial, and its TBS-2025 asset, and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique Kosse Gilmartin Group [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-inc-reports-third-quarter-2025-financial-results-and-provides-a-corporate-update-302615370.html

Completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody (mAb), now named "TBS-2025;" planning to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in combination with a menin inhibitor in 2H 2025 Initiated a Phase 3 accelerated approval trial of IFx-2.0 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 the U.S. Food and Drug Administration (FDA) Completed a $12.5 million equity financing transaction, and received an additional $3 million in warrant exercise proceeds TAMPA, Fla., Aug. 14, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported financial results for the Company's second quarter ended June 30, 2025, and provided a corporate update. "TuHURA had a strong first-half of the year with the initiation of its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab as a first line treatment for patients with advanced or metastatic MCC. Conducted under an SPA Agreement with the FDA, the Phase 3 trial is a single randomized placebo-controlled trial that, if successful, has the potential to both meet and satisfy the requirements for both accelerated and full approval without the need to conduct a post-accelerated approval confirmatory trial. This potentially translates to a meaningful time and cost savings to TuHURA," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA. "In addition to our accelerated approval Phase 3 trial of IFx-2.0, we also initiated a Phase 1b/2a trial employing interventional radiologic administration of IFx-2.0 as an adjunctive therapy to pembrolizumab in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin (MCCUP). This trial will enroll newly diagnosed patients who present metastatic, deep-seated tumors in the liver, lungs, or retroperitoneum, without accessible cutaneous, subdermal or nodal lesions. Patients with MCCUP represent approximately a thirty percent (30%) of all newly diagnosed advanced or metastatic MCC cases and can meaningfully augment IFx-2.0's commercial market opportunity." Dr. Bianco continued, "In addition to our trial initiations in MCC and MCCUP, we recently bolstered our development pipeline with the acquisition of Kineta and their novel VISTA inhibiting antibody, TBS-2025. The acquisition provides for synergies across both TuHURA's therapeutic focus as well as TuHURA's antibody peptide or drug candidate (APC, ADC) technologies as we continue to assemble a diversified, late-stage immuno-oncology pipeline. We plan to advance TBS-2025 into a randomized Phase 2 trial in patients with relapsed or refractory NPM1-mutated AML planned for the second half of this year to determine if the addition of TBS-2025 to a menin inhibitor can improve the results seen in patients receiving a menin inhibitor." Corporate Highlights Inclusion of TuHURA Biosciences in the Russell 3000® and Russell 2000® Indexes. In June 2025, TuHURA announced its addition to the Russell 3000® Index, with automatic inclusion in the Russell 2000® Index, as a part of the 2025 Russell annual reconstitution. The Company's addition was effective as of market close on June 27, 2025. Completion of Kineta, Inc. Acquisition and Kineta's VISTA Inhibiting mAb. In June 2025, TuHURA announced the closing of its acquisition of Kineta, and Kineta's novel VISTA inhibiting mAb, now referred to as "TBS-2025." TuHURA plans to initiate a Phase 2 randomized trial of TBS-2025 in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated AML, compared to a menin inhibitor alone, targeted for the second half of 2025. Initiation of Phase 3 Accelerated Approval Trial of IFx-2.0 as Adjunctive Therapy to Keytruda in 1L MCC. In June 2025, TuHURA announced that it had initiated its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in MCC. Conducted under an SPA agreement with the U.S. FDA, TuHURA is investigating the effectiveness of IFx-2.0 as an adjunctive therapy to Keytruda® compared to Keytruda® plus placebo in first line treatment in advanced or metastatic MCC. Completed $12.5 Million Equity Financing Transaction and Received an Additional $3.0 Million in Warrant Exercise Proceeds. In June 2025, TuHURA announced that it had entered into a definitive securities purchase agreement for the issuance and sale in a private placement of an aggregate of $12.5 million shares of its common stock. In addition to the offering, the Company secured $3.0 million in additional cash proceeds from the previously disclosed February 2025 cash exercise of approximately 1.0 million warrants to purchase shares of the Company common stock. Upcoming Targeted Milestones by Program IFx-2.0 Year-End 2025: TuHURA anticipates providing an update on enrollment progress in its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line MCC Q1 2026: Anticipated topline results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP) 2H 2026: Anticipated topline results from Phase 3 accelerated approval trial TBS-2025 2H 2025: Planned initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated AML APC and ADC Development Candidates TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the Delta Opioid Receptor (DOR) on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like TBS-2025 In 2025, TuHURA anticipates presenting non-clinical data at relevant medical meetings Financial Results for the Three Months and Six Months Ended June 30, 2025 Research and development expenses were $4.9 million and $2.8 million for the three months ended June 30, 2025, and 2024, respectively. Net cash outflows from operating activities were ($10.9) million and ($8.9) million for the six months ended June 30, 2025, and 2024, respectively. As of June 30, 2025, TuHURA's total shares outstanding was approximately 49.9 million. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. In June 2025, TuHURA initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in the merger with Kineta on June 30,2025. TBS-2025 is a VISTA inhibiting mAb asset moving into Phase 2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and Phase 3 trial, its Delta Opioid Receptor technology, its recent acquisition by merger of Kineta Inc., and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique Kosse Gilmartin Group [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-inc-reports-second-quarter-2025-financial-results-and-provides-a-corporate-update-302530551.html SOURCE TuHURA Biosciences, Inc.

By John Vandermosten, CFA NASDAQ:HURA READ THE FULL HURA RESEARCH REPORT Operational and Financial Results On May 15th, 2025, TuHURA Biosciences, Inc. (NASDAQ:HURA) reported first quarter 2025 financial and operational results and filed its Form 10-Q with the SEC. The company updated investors on the status of its IFx-2.0 Phase III trial in Merkel cell carcinoma (MCC) and the acquisition of Kineta. The Phase III trial is expected to begin and the Kineta acquisition is expected to close in 2Q:25. TuHURA recently launched a Phase Ib/II study for IFx-2.0 in MCC patients not eligible for the Phase III trial. Other important developments include presentations of clinical data at the American Association of Cancer Research (AACR) annual meeting in Chicago and the addition of a new executive. Below, we summarize 1Q:25’s financial results. TuHURA generated no revenues in 1Q:25 and expended $7.0 million on operational activities related to advancing IFx-2.0 and other programs producing a net loss of ($6.7) million or ($0.16) on a per share basis. For the quarter ending March 31st, 2025 and versus the same prior year period: Research & development expense totaled $4.6 million primarily attributable to greater expenses for preclinical research related to IFx-3.0 and myeloid derived suppressor cell (MDSC) initiatives and higher salary, personnel and facilities costs. General & administrative expense totaled $2.4 million, due to increases in non-stock compensation, costs related to being a public company and merger transaction costs related to the Kineta transaction; Other items included $253,000 in grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services; Interest income was $100,000 related to income paid on cash balances held; Net loss was ($6.7) million or ($0.16) per share. As of March 31st, 2025, TuHURA held $6.2 million in cash on its balance sheet. 1Q:25 cash burn was ($4.8) million while cash used in financing was ($548,000) which consisted of warrant proceeds offset by transaction and liability payments related to Kintara. AACR Presentations TuHURA contributed to three presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois held from April 25th to 30th, 2025. The first was a poster that updated clinical data from the VISTA-101 trial for KVA12123 given by Dr. Thierry Guillaudeux of Kineta. The second poster was presented on behalf of the Markowitz Lab at Moffitt Cancer Center on TuHURA’s IFx-Hu2.0 candidate on Merkel cell carcinoma patients that progressed while on checkpoint inhibitor (CPI) therapy. Details of the presentation were provided in an April 28th press release. The anti-VISTA poster for KVA12123 is entitled Initial results from a first in human phase 1 study of KVA12123, an anti-VISTA antibody, alone and in combination with pembrolizumab in patients with advanced solid tumors. It presented updated results for the VISTA-101 trial which is a Phase I study evaluating KVA12123 alone and in combination with pembrolizumab in advanced solid tumors. No dose-limiting toxicities were shown in the data and KVA12123 presented a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels. At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose; No dose limiting toxicities were observed in the study, including at the 1,000 mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms The IFx-Hu2.0 poster reviewed patients on the therapy with advanced treatment refractory melanoma who progressed while on CPI therapy. Results from the study demonstrated that among heavily pre-treated patients with advanced melanoma who were resistant to anti-PD-1-based therapy, following IFx-Hu2.0, 75% (3 of 4) of patients achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI. The antibody specific response to IFx-Hu2.0’s expressed bacterial protein supports further development of the candidate. The second poster, entitled Mechanistic Insights into IFx-Hu2.0 Responses in the First Human Trial After Prior Anti-PD-1 Therapy Failure, demonstrated that IFx-Hu2.0 stimulated an innate immune response that increased T and B cell production in peripheral blood compared to tumor tissue. This evidence supported IFx-Hu2.0’s ability to generate an immune response to patients resistant to anti-PD1 checkpoint inhibitors. Additional information in the poster noted that IFx-Hu2.0 was generally safe and well tolerated with only mild Grade 1 and Grade 2 adverse reactions, mostly oriented around injection site reactions. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 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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 acquisition of Kineta, Inc. in Q2 2025 and initiate a Phase 2 trial of Kineta's VISTA inhibiting monoclonal antibody (mAb) in NPM1-mutated acute myeloid leukemia (AML) in Q3 2025 TAMPA, Fla., May 15, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported financial results for the Company's first quarter ended March 31, 2025, and provided a corporate update. "TuHURA has had an impressive start to 2025, and we continue to execute our corporate strategy as we drive towards TuHURA's four major clinical data readouts anticipated over the next 24 months. We recently initiated our Phase 1b/2a study of IFx-Hu2.0 in combination with pembrolizumab in checkpoint-naïve MCCUP patients. Evaluating IFx-Hu2.0 in MCCUP patients is an important component of our overall strategy for the program, as the Phase 1b/2a trial will include patients without skin lesions who present with metastatic deep-seated tumors in the liver, lungs or retroperitoneum (abdomen), who are not eligible to participate in our Phase 3 accelerated approval trial due to the trial's primary lesion enrollment criteria. Approximately 30% of MCC patients have unknown primary lesions, and demonstrating safety and efficacy in the MCCUP patient population would allow us the opportunity to provide IFx-Hu2.0 to more patients with MCC," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "We are also moving towards initiating our Phase 3 accelerated approval trial of IFx-Hu2.0 in first-line advanced and metastatic MCC and anticipate the lifting of the manufacturing-related partial clinical hold in the coming weeks. Our Phase 3 trial, for which we have an SPA agreement with the FDA, will be a single randomized placebo-controlled trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), and, if positive, may satisfy the requirement for a post-approval confirmatory trial, saving time, money and risk associated with a second trial." "In addition to our IFx-Hu2.0 drug candidate, we continue to assemble an exciting late-stage pipeline through our pending acquisition of Kineta, Inc. and its VISTA inhibitor antibody, KVA12123. We are targeting to close the acquisition later this quarter subject to financing and other conditions and advance KVA12123 into a Phase 2 trial in relapsed or refractory NPM1-mutated AML where VISTA expression on leukemic blasts is believed to be responsible for how leukemic cells escape immune recognition contributing to poor responses to therapy and high rates of relapse," stated Dr. Bianco. "We are also developing tumor microenvironment modulators in the form of bi-specific immune modulating Antibody Peptide Conjugates (APCs) and Antibody Drug Conjugates (ADCs) targeting myeloid-derived suppressor cells (MDSCs). We plan to present data at a scientific conference this year on the discovery of high-expression delta opioid receptor (DOR) and the effect on MDSCs and M2 macrophages in the tumor environment. We believe that our DOR program has the potential to reprogram the function of MDSCs and M2 macrophages within the tumor microenvironment, which could have broad implications," concluded Dr. Bianco. Corporate Highlights Initiation of Phase 1b/2a Study of IFx-Hu2.0 as Adjunctive Therapy to Keytruda in 1L MCCUP. In May 2025, TuHURA announced that it initiated its Phase 1b/2a trial of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in MCCUP. This Phase 1b/2a trial is investigating safety and feasibility of IFx-Hu2.0 when administered via interventional radiology to patients with deep-seated tumors who would not be eligible for the Phase 3 trial. Presentation of Two Posters at the American Association of Cancer Research (AACR) Annual Meeting. In April 2025, TuHURA presented a poster at the AACR Annual Meeting outlining a greater than 90% VISTA receptor occupancy following treatment with Kineta's VISTA inhibitor mAb as monotherapy and in combination with pembrolizumab in advanced solid tumors. Additionally, the Markowitz Lab at Moffitt Cancer Center presented a poster of IFx-Hu2.0, demonstrating increased T Cell and B Cell production in peripheral blood relative to tumor tissue following adjunctive administration of IFx-Hu2.0 in combination with pembrolizumab. Appointment of Dr. Bertrand Le Bourdonnec as Head of Drug Discovery. In April 2025, TuHURA announced the appointment of Dr. Le Bourdonnec as the Company's Executive Vice President, Head of Drug Discovery, Early Development and Program Management. Dr. Le Bourdonnec has extensive experience in the biology and molecular pharmacology of the DOR, TuHURA's core target on MDSCs for the Company's emerging suite of ADC and APC development candidates. Appointment of Dr. Craig L. Tendler to Board of Directors. In March 2025, TuHURA announced the appointment of industry veteran Dr. Craig Tendler to its Board of Directors. Dr. Tendler brings to TuHURA decades of experience in cancer therapeutic development, and most recently served as Johnson & Johnson's Vice President, Oncology Clinical Development. During his tenure at J&J, Dr. Tendler oversaw 30 major drug approvals, and led development planning from proof of concept through registration and life-cycle management, for J&J's treatments in hematological malignancies and more prevalent solid tumor diseases. Upcoming Anticipated Milestones by Program IFx-Hu2.0 Q2 2025: TuHURA anticipates the FDA's complete response letter lifting the partial clinical hold relating to completion of certain CMC requirements. Q2 2025: Initiation of Phase 3 accelerated approval trial in first line Merkel cell carcinoma VISTA Inhibiting Monoclonal Antibody Q2 2025: TuHURA expects to close its acquisition of Kineta, Inc. and Kineta's VISTA inhibiting mAb. Q3 2025: Initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of NPM1-mutated AML. ADC and APC Development Candidates TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the DOR on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like the VISTA inhibiting antibody. In 2025, TuHURA anticipates presenting non-clinical data at relevant medical meetings. Financial Results for the Three Months Ended March 31, 2025 Research and development expenses were $4.6 million and $3.6 million for the three months ended March 31, 2025, and 2024, respectively. General and administrative expenses were $2.4 million and $1.0 million for the three months ended March 31, 2025, and 2024, respectively. As of March 31, 2025, TuHURA's total shares outstanding was approximately 43.7 million. As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) in which, as amended, TuHURA agreed to acquire Kineta, including the rights to Kineta's novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions described in TuHURA's Form 8-Ks filed on December 12, 2024 and May 7, 2025. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain financing and other closing conditions. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. IMPORTANT ADDITIONAL INFORMATION REGARDING PROPOSED MERGER WITH KINETA In connection with the proposed acquisition by merger of Kineta, Inc. ("Kineta") by TuHURA (the "Merger"), TuHURA filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-4, dated February 7, 2025 (the "Registration Statement"), which, as amended, contains a preliminary joint proxy statement of Kineta and TuHURA and a preliminary prospectus of TuHURA (the "Joint Proxy Statement/Prospectus"), and TuHURA and Kineta may file with the SEC other relevant documents regarding the Merger. Investors and securityholders of TuHURA and Kineta are urged to read the Joint Proxy Statement/Prospectus and such other materials carefully when they become available because they will contain important information about TuHURA, Kineta, and the proposed Merger. This press release is not a substitute for the definitive Joint Proxy Statement/Prospectus, when it becomes available, or any other documents that TuHURA may file with the SEC or send to securityholders in connection with the proposed Merger. A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Kineta and TuHURA stockholders when that document is final. Investors and stockholders will be able to obtain free copies of the documents filed or that will be filed with the SEC by TuHURA, when they become available, through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, Florida 33612. NO OFFER OR SOLICITATION This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. PARTICIPANTS IN THE SOLICITATION TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders in connection with the Merger and other matters that may be set forth in the Joint Proxy Statement/Prospectus. Information about TuHURA's directors and executive officers is set forth in TuHURA's filings with the SEC, including TuHURA's Form 10-K filed on March 31, 2025. Additional information regarding the direct and indirect interests, by security holdings or otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Merger may be obtained by reading the Joint Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described above under "IMPORTANT ADDITIONAL INFORMATION REGARDING PROPOSED MERGER WITH KINETA". CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program and statements regarding the closing conditions for the transaction, TuHURA's needs and expectations regarding its existing capital resources and its need for additional capital (including financing to complete the Kineta merger), and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique Kosse Gilmartin Group [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-inc-reports-first-quarter-2025-financial-results-and-provides-a-corporate-update-302457139.html SOURCE TuHURA Biosciences, Inc.

Kineta presents updated clinical data from VISTA-101 trial of KVA12123, demonstrating >90% VISTA receptor occupancy at 1,000mg dose level throughout the trial's every two weekly dosing interval (Q2W) TuHURA's Phase 3-ready IFx2.0 produced clinically meaningful anti-tumor responses and abscopal effect, after checkpoint inhibitor (CPI) therapy failure in patients with advanced melanoma when rechallenged with CPI TAMPA, Fla., April 28, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported on poster presentations of Kineta Inc.'s ("Kineta") KVA12123 novel anti-VISTA antibody and TuHURA's IFx-Hu2.0 in advanced melanoma and at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. In the first poster presentation, (CT041/20) TuHURA and Kineta provided updated results from VISTA-101, a Phase I-II first-in-human study of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors (NCT05708950). The poster, was presented by Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. KVA12123 was found to be generally safe and well tolerated in all monotherapy and combination arms, with no dose-limiting toxicities observed. Additionally, KVA12123 demonstrated a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels, including: At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose. No dose limiting toxicities were observed in the study, including at the 1,000mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms "We are pleased to have Thierry present the latest data from the KVA12123 program, a valuable drug candidate that TuHURA will acquire following the closure of the proposed merger with Kineta which is currently targeted for the end of Q2 2025. TuHURA's exclusivity payment last July allowed Kineta the ability to restart and complete the Phase I study providing important data regarding receptor occupancy and other PK, PD and translational biomarker data at the previously unstudied 1,000mg dose level. The study demonstrated in excess of 90% VISTA receptor occupancy over the entire Q2W dosing interval where PK simulations would predict similar receptor occupancy even at 750mg Q2W dosing, which we believe will be the recommended Phase 2 dose and schedule", stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. Dr. Bianco continued, "Our primary interest in VISTA is its potential in immunologic tolerance in a variety of blood related cancers. Recent scientific data demonstrates that NPM1 mutation, present in 30% to 35% of patients with acute myeloid leukemia (AML) results in the high expression of VISTA on leukemic blasts. This is believed to be the mechanism by which leukemia escapes immune recognition and attack and is responsible for high rate of treatment failures in AML. We look forward to evaluating the VISTA inhibiting antibody in a Phase 2 randomized study in relapsed AML, which we expect to initiate in the fourth quarter of 2025 based on the anticipated closing of the proposed merger with Kineta." TuHURA also announced that the Markowitz Lab at Moffitt Cancer Center also presented a poster of TuHURA's IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who, like patients in TuHURA's Phase 1b Merkel cell carcinoma trial, progressed while on CPI therapy. The data demonstrated that, among heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD-1-based therapy, following IFx-Hu2.0, three of four patients achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI. "Demonstration of the development of antibody specific response to the Emm55 bacterial protein expressed on the surface of the tumor cell following IFx-Hu2.0 in the phase 1 study and an abscopal effect in murine model of melanoma is consistent with the data generated in patients with advanced cutaneous malignancies like melanoma or Merkel cell carcinoma," noted Dr. Bianco. "We look forward to that anticipated initiation of our Phase 3 accelerated approval trial in first line treatment of patients with advanced or metastatic Merkel cell carcinoma targeted for later this quarter." In the second poster presentation relating to IFx-Hu2.0 entitled: "Mechanistic Insights into IFx- Hu2.0 Responses in the First Human Trial After Prior Anti-PD-1 Therapy Failure," (3428/23) IFx-Hu2.0's first-in-human study demonstrated stimulation of an innate immune response, with increased T cell and B cell production in peripheral blood compared to tumor tissue. This innate immune activation underscores the potential of IFx-Hu2.0 to generate tumor specific activate T and B cells for patients who are resistant to anti-PD-1 CPIs. Additionally, IFx-Hu2.0 was generally safe and well tolerated, with only mild Grade 1 and Grade 2 adverse events, largely injection site reactions. As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) ("Kineta"), in which TuHURA agreed to acquire Kineta, including the rights to Kineta's novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions and subject to the conditions set forth in TuHURA's Form 8-K filed on December 12, 2024. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain closing conditions. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune- suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. IMPORTANT ADDITIONAL INFORMATION In connection with the proposed acquisition by merger (the "Merger") of Kineta, Inc. ("Kineta") by TuHURA Sciences, Inc. ("TuHURA"), TuHURA filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-4, dated February 7, 2025 (the "Registration Statement"), which contains a preliminary joint proxy statement of Kineta and TuHURA and a preliminary prospectus of TuHURA (the "Joint Proxy Statement/Prospectus"), and TuHURA and Kineta may file with the SEC other relevant documents regarding the Merger. Investors and securityholders of TuHURA and Kineta are urged to read the Joint Proxy Statement/Prospectus and such other materials carefully when they become available because they will contain important information about TuHURA, Kineta, and the proposed Merger. This press release is not a substitute for the definitive Joint Proxy Statement/Prospectus, when it becomes available, or any other documents that TuHURA may file with the SEC or send to securityholders in connection with the proposed Merger. A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Kineta and TuHURA stockholders when that document is final. Investors and stockholders will be able to obtain free copies of the documents filed or that will be filed with the SEC by TuHURA, when they become available, through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, Florida 33612. NO OFFER OR SOLICITATION This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. PARTICIPANTS IN THE SOLICITATION TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders in connection with the Merger and other matters that may be set forth in the Joint Proxy Statement/Prospectus. Information about TuHURA's directors and executive officers is set forth in TuHURA's filings with the SEC, including TuHURA's Form 10-K filed on March 31, 2025. Additional information regarding the direct and indirect interests, by security holdings or otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Merger may be obtained by reading the Joint Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described above under "IMPORTANT ADDITIONAL INFORMATION". CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program and statements regarding the closing conditions for the transaction, TuHURA's needs and expectations regarding its existing capital resources and its need for additional capital, and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Gilmartin Group Monique Kosse [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-and-kineta-present-updated-results-from-kinetas-phase-i-ii-study-of-kva12123-and-tuhuras-mechanism-of-ifx-hu2-0-responses-after-anti-pd-1-therapy-failure-in-advanced-melanoma-at-the-american-association-for-ca-302439358.html SOURCE TuHURA Biosciences, Inc.

By John Vandermosten, CFA NASDAQ:HURA READ THE FULL HURA RESEARCH REPORT Operational and Financial Results On April 1st, 2025, TuHURA Biosciences, Inc. (NASDAQ:HURA) reported 2024 financial and operational results and filed its Form 10-K with the SEC. TuHURA provided updates on its Phase III trial in Merkel cell carcinoma (MCC), the acquisition of Kineta and introduced a new board member and executive. Initiation of the Phase III IFx-2.0 study in MCC is expected to begin in 2Q:25 and the acquisition of Kineta is targeted for 2Q:25. Below, we summarize 2024’s financial results. TuHURA generated no revenues in 2024 and expended $17.6 million on operational activities related to advancing IFx-2.0 and other programs producing a net loss of ($21.7) million or ($1.16) on a per share basis. For the year ending December 31st, 2024 and versus the same prior year period: Research & development expense totaled $13.3 million, up 42% from $9.4 million, primarily attributable to an increase in spending on the IFx-2.0 program, additional preclinical research for the IFx-3.0 and myeloid derived suppressor cell (MDSC) initiatives and higher salary, personnel and facilities costs. No in-process research and development expenses were recognized versus $16.2 million related to the ADC technology in 2023; General & administrative expenses totaled $4.3 million, up 4% from $4.1 million due to increases in non-stock compensation and costs related to being a public company partially offset by lower legal fees; Net interest expense was ($3.8) million versus net interest income of $71,000 due to interest paid on convertible notes which was absent in the prior year; Other items totaled ($256,000) vs. $377,000 as a small amount of grant income was more than offset by a reduction in the value of the derivative liability which compares to recognition of a small amount of grant income and an employee retention tax credit in 2023; Net loss was ($21.7) million vs ($29.3) million, or ($1.16) and ($2.47) per share, respectively. As of December 31st, 2024, TuHURA held $12.7 million in cash on its balance sheet. 2024 cash burn was ($14.8) million while cash flows from financing were $29.8 million related to proceeds from the convertible note and common stock issuance as well as stock option and warrant exercise partially offset by financing costs. Video Series with Dr. James Bianco Video links are included below: CEO Talks ADCs - (1:17) ADC Program Highlights - (8:18) IFx-2.0 Has Expedited Status - (1:23) Upcoming Trial for IFx-2.0 in Merkel Cell Carcinoma - (8:01) Anti-VISTA Asset Acquisition - (8:04) Lead Target in Merkel Cell Carcinoma - (3:34) How IFx-2.0 Works - (1:21) Fireside Chat - (12:36) Phase III IFx-2.0 Trial in MCC TuHURA plans to launch a pivotal Phase III study for its IFx-2.0 candidate in Merkel cell carcinoma (MCC) by the second quarter of 2025. It is working through chemistry, manufacturing and controls (CMC) requirements related to qualifying the potency assay and the mixing process[1] which put the study on track to begin in late 2Q:25. IFx-2.0 will pursue a new drug application using the FDA’s accelerated approval program under a special protocol assessment (SPA). The trial was designed with the input of the FDA’s Oncology Center of Excellence (OCE). Accelerated approval allows the sponsor to use surrogate endpoints that predict clinical benefit and is appropriate when pursuing serious indications that lack other therapies. In most cases, an accelerated approval will require post-market confirmatory trials to verify the clinical benefit. However, in the case of this trial, the FDA has indicated that secondary endpoints that demonstrate clinical benefit may be used. If successfully achieved, the trial may satisfy the requirements for full approval. The trial will be designed as a 1:1 randomized, placebo and injection-controlled trial in first-line, checkpoint inhibitor naïve, advanced metastatic MCC. It plans to enroll 118 subjects at 20 to 25 clinical centers in the United States. IFx-2.0 will be administered three times per week in combination with pembrolizumab vs. placebo with pembrolizumab. The primary endpoint will be overall response rate (ORR) which will allow for accelerated approval. The secondary endpoint, which indicates clinical benefit is progression free survival (PFS). If this endpoint is achieved, it will allow for full approval and satisfy the requirement for a confirmatory trial. For the primary endpoints to support an accelerated approval, ORR needs to be 75% compared to the 50% which is the historical rate from other trials. For full approval, based on a continuation of this same trial, PFS has to achieve a 50% or better result. The trial is expected to start in the second quarter of 2025 with enrollment lasting 12 months. ORR will be measured at six months, which indicates that top line results can be available 18 months after the trial begins. Accelerated approval will allow a rolling review and potential approval within six months of topline data. Anti-VISTA Phase II Proof of Concept Trial in AML Following the acquisition of Kineta, TuHURA anticipates launching a Phase II proof of concept trial with the anti-VISTA monoclonal antibody. This is expected to begin in 4Q:25. The interest in using KVA12 in AML emerged from research showing that VISTA is overexpressed on myeloid-derived suppressor cells (MDSCs). The NPM1 mutation, found in 30–35% of AML cases, is another important biomarker in AML. Work done by Vanderbilt University and presented at the December 2024 ASH meeting demonstrated that AML with mutated NPM1 expresses high levels of VISTA which creates an immunosuppressive environment. A recently approved class of drug called menin inhibitors, represented by Syndax Pharmaceuticals’ revumenib, can treat this group. Menin inhibitors bind to the menin protein and prevent it from binding to the KMT2A protein. This disrupts the interaction between the two, forcing leukemia cells to differentiate into normal cells. These AML cells may also express the VISTA checkpoint receptor that prevents T cells from recognizing and attacking them. TuHURA plans to evaluate the combination of its anti-VISTA candidate KVA12 along with a menin inhibitor to identify if there is a material benefit. If the combination can block the NPM1 cascade and VISTA receptor, it can eliminate two important therapeutic choke points represented by proliferation and escape mechanism respectively. TuHURA estimates that for a few million dollars they can design a study that will show if the combination of KVA12 with revumenib provides greater complete remission compared with revumenib alone. If the trial is successful, TuHURA will consult with the FDA to pursue a similar route to approval as IFx-2.0 with a Phase III trial. The candidate would seek the accelerated approval pathway and employ a trial design that obtains approval using a primary endpoint of a biomarker and a secondary endpoint demonstrating clinical benefit. Further details on the design and pathway forward are expected to be disclosed in upcoming quarters. Appointments Over the last few months, TuHURA has made two new additions to the company’s roster adding Craig Tendler, M.D. and Bertrand Le Bourdonnec, Ph.D. to serve as board member and head of drug discovery respectively. Dr. Tendler has broad experience shepherding oncology candidates through the drug approval process at Johnson & Johnson. He can be a valuable resource as TuHURA moves IFx-2.0, the delta opioid receptor ADC and anti-VISTA through the drug development process. His appointment as director was announced on March 11th, 2025. Dr. Le Bourdonnec was appointed as Head of Drug Discovery, Early Development and Program Management at TuHURA as detailed in an April 7th press release. He has a 20-year career in drug discovery and development honed at HDAX Therapeutics, Decipher Pharmaceuticals and Yumanity Therapeutics among other distinguished companies. His experience with the pharmacology and biochemistry of the Delta Opioid Receptor (DOR) will be valuable to TuHURA’s development of its ADC and APC assets. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] Before administration, IFx-2.0 requires a specific mixing or compounding process at the clinical site. The mixing process involves combining pAc/emm55 (pDNA), complexed with two excipients: in vivo-jetPEI (a transfection reagent) and dextrose (a pDNA/polyethylenimine complex stabilizer) before administration. This step ensures that the plasmid DNA is prepared correctly for injection into the tumor. The process must be qualified and validated to meet regulatory standards, as outlined by the FDA. Validation includes in vitro testing and development to confirm potency and consistency.

Phase 3 IFx-2.0 accelerated approval trial as adjunctive therapy with Keytruda® (pembrolizumab) in 1st line therapy for advanced Merkel cell carcinoma (MCC) planning to initiate enrollment in Q2 2025 MCC Phase 3 trial to be conducted under Special Protocol Assessment (SPA) Agreement with FDA Acquisition of Kineta's Phase 2 ready, VISTA inhibiting antibody targeted for completion in Q2 2025 Expanded discovery team for first-in-class immune modulating Antibody Drug or Peptide Conjugate Program TAMPA, Fla., April 1, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided financial results for fiscal year 2024 and provided a corporate update. "2024 was a transformative year for TuHURA. We became a NASDAQ-listed Company, raised capital to meet FDA's manufacturing requirements to initiate our Phase 3 program anticipated for Q2 as forecasted and entered into a definitive agreement for, what we believe, is a best-in-class VISTA inhibiting antibody adding a Phase 2 program in AML to our development pipeline," commented James Bianco, President and CEO of TuHURA. "As we advance our late stage clinical programs in 2025 with the goal of completing enrollment in our Phase 3 trial next year, we are also making significant progress in the development of the first novel class of non-tumor targeting Antibody Drug or Antibody Peptide Conjugates that are demonstrating the potential ability to remove the immunosuppressive functions of key cellular populations that create an immunologic sanctuary for tumors leading to acquired resistance to cancer immunotherapies." 2024 Highlights Successful SPA agreement with FDA Entered into definitive agreement with Kineta Inc. to acquire Phase 2 ready VISTA inhibitor; Transaction targeted to close in Q2 2025 NASDAQ (HURA) listing via successful reverse merger with Kintara Therapeutics, Inc. Raised $36 million in 2024 to fund development programs and operations through late fourth quarter of 2025 and secure right to acquire VISTA inhibiting antibody Advancing Novel Technologies to Overcome Resistance to Cancer Immunotherapy Innate Immune Agonists: TuHURA's IFx technology utilizes a proprietary plasmid DNA or messenger RNA ("mRNA") which, when introduced into or targeted to a tumor, results in the expression of a highly immunogenic gram-positive, bacterial protein (Emm55) on the surface of the tumor cell, making the tumor look like a bacterium. Gram-positive bacterium has molecular patterns, or motifs, preserved over evolution which are recognized by receptors on our immune cells called "toll like receptors" (TLR). TLR 2 specifically recognizes the pattern of gram-positive bacterial proteins, like Emm55, leading to the activation of antigen presenting cells (APCs). Once activated, APCs digest the tumor cell and present non-self, tumor neoantigens to newly produced T and B cells, activating a tumor-specific adaptive immune response. Through its activation of tumor-specific T cells, IFx-2.0 administration can potentially overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single, randomized, placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) versus pembrolizumab plus placebo in first line treatment for checkpoint inhibitor-naïve patients with advanced or metastatic MCC. The data from the Company's Phase 1b trial in patients with advanced or metastatic MCC who exhibited primary resistance to CPI was used to support a potential single registration directed trial. Consistent with the FDA's Project Front Runner Initiative, the FDA's Oncology Center of Excellence (OCE) recommended investigating IFx-2.0 in the first line setting rather than in patients progressing on first line therapy. Project Front Runner is an FDA OCE initiative to encourage drug sponsors to consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. The FDA also requested the Company to consider designing the trial to include a key secondary endpoint shown to be of clinical benefit like PFS allowing this accelerated approval trial to potentially satisfy both the requirements for accelerated approval based on ORR, while satisfying the requirement for a post-approval confirmatory trial if the secondary PFS endpoint is achieved. The trial will be conducted under an SPA agreement with the FDA. Tumor Microenvironment Modulators: Leveraging its delta opioid receptor technology, TuHURA is developing the first class of non-tumor targeting bi-specific immune modulating Antibody Drug Conjugates or Antibody Peptide Conjugates targeting MDSCs to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Potential Acquisition of Novel Anti-VISTA Checkpoint Inhibitor: As previously announced, the Company entered into a definitive merger agreement in which TuHURA would acquire Kineta, Inc. (OTC Pink: KATN) including the rights to Kineta's novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction. The merger is currently targeted to close in Q2 2025 pending the satisfaction of funding conditions and other closing conditions. 2025 Milestone Targets IFx-2.0 Q2: FDA complete response letter lifting partial clinical hold Q2: Initiating enrollment in IFx-2.0 Phase 3 accelerated approval trial Q3: Initiate checkpoint inhibitor resistant metastatic cancer "basket" trial IFx-3.0 Q4: Advance characterization toward lead compound selection VISTA Inhibiting mAb Q2: Target closing of Kineta acquisition Q2: Phase 1 VISTA inhibitor +/- pembrolizumab results Q4: Initiate Phase 2 trial VISTA trial in NPM1 mutated AML Novel bi-specific non-tumor targeting immune modulating Antibody Drug or Antibody Peptide Conjugates Advance delta opioid receptor technology platform Presentations at key scientific meetings Summary of Financial Results for the Full Year 2024 Research and development (R&D) expense was $13.3 million and $9.4 million for the years ended December 31, 2024 and 2023, respectively. The increase in R&D of $3.9 million is mainly related to: an increase of approximately $1.6 million due to ongoing clinical development of IFx-2.0; an increase of approximately $0.4 million due to preclinical research of IFx-3.0 and MDSCs; and an increase of approximately $1.9 million in salary and personnel related costs. General and administrative (G&A) expenses were $4.3 million and $4.1 million for the years ended December 31, 2024 and 2023, respectively. The increase in G&A of $0.2 million was mainly attributable to increases in non-cash stock compensation expense and costs associated with being a public company incurred in 2024 offset by decrease in legal fees associated with the subsequently terminated proposed merger with CohBar, Inc. which were incurred in 2023. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in the second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist candidates, following the anticipated closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the delta opioid receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. IMPORTANT ADDITIONAL INFORMATION In connection with the proposed acquisition by merger of Kineta, Inc. ("Kineta") by TuHURA (the "Merger"), TuHURA filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-4, dated February 7, 2025 (the "Registration Statement"), which contains a preliminary joint proxy statement of Kineta and TuHURA and a preliminary prospectus of TuHURA (the "Joint Proxy Statement/Prospectus"), and TuHURA and Kineta may file with the SEC other relevant documents regarding the Merger. Investors and securityholders of TuHURA and Kineta are urged to read the Joint Proxy Statement/Prospectus and such other materials carefully when they become available because they will contain important information about TuHURA, Kineta, and the proposed Merger. This press release is not a substitute for the definitive Joint Proxy Statement/Prospectus, when it becomes available, or any other documents that TuHURA may file with the SEC or send to securityholders in connection with the proposed Merger. A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Kineta and TuHURA stockholders when that document is final. Investors and stockholders will be able to obtain free copies of the documents filed or that will be filed with the SEC by TuHURA, when they become available, through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, Florida 33612. NO OFFER OR SOLICITATION This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the "Securities Act"). PARTICIPANTS IN THE SOLICITATION TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders in connection with the Merger and other matters that may be set forth in the Joint Proxy Statement/Prospectus. Information about TuHURA's directors and executive officers is set forth in TuHURA's filings with the SEC, including TuHURA's Form 10-K filed on March 31, 2025. Additional information regarding the direct and indirect interests, by security holdings or otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Merger may be obtained by reading the Joint Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described above under "IMPORTANT ADDITIONAL INFORMATION". CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding statements about TuHURA's IFx-Hu2.0 product candidate and anticipate Phase 3 trial, its IFx-Hu3.0 preclinical program, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program, TuHURA's needs and expectations regarding its existing capital resources and its need for additional capital, and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] 1 Trial currently subject to partial clinical hold relating to completion of certain CMC requirements for initiation of Phase 3 registration trial View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-inc-reports-financial-results-for-fiscal-year-2024-and-provides-corporate-update-302416402.html SOURCE TuHURA Biosciences, Inc.