HURA

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 experi...

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 item...

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 (pembrolizu...

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...

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-asso...

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 ma...

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 Guilla...

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 I...

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 demo...

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 a...

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 target...