US Market News
3週前
TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate UpdateMay 15, 2026 5:00 PM
PR Newswire (US) 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 MCC2H 2026: Anticipate presenting data at a scientific conference2H 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 Keytruda® (pembrolizumab) in first-line treatment for advanced or metastatic MCCTBS-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 subsets2H 2026: Seek Orphan Drug Designation in AML2H 2026: Initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AMLMDSC Inhibitors (Bi-specific ADCs)1H 2026: Select lead ADC for proof-of-concept study in AML2H 2026: Presentations at key scientific meetingsSummary 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 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 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
Monique@GilmartinIR.com 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.htmlSOURCE TuHURA Biosciences, Inc. Original: TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update
US Market News
3週前
TuHURA Biosciences to Present at the 4th Annual H.C. Wainwright BioConnect Investor ConferenceMay 12, 2026 7:30 AM
PR Newswire (US) TAMPA, Fla., May 12, 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 announced James A. Bianco, M.D., President and Chief Executive Officer of TuHURA, will participate in a fireside chat, at the 4th Annual H.C. Wainwright BioConnect Investor Conference taking place in New York City.4th Annual H.C. Wainwright BioConnect Investor Conference
Date: Tuesday, May 19, 2026
Time: 2:00 pm ET
Links: To register and view presentation, click HERE.A live and archived webcast of the presentation will also be available through the investors page of TuHURA's corporate website at https://ir.tuhurabio.com/news-events/events.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 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 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.Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-to-present-at-the-4th-annual-hc-wainwright-bioconnect-investor-conference-302769078.htmlSOURCE TuHURA Biosciences, Inc. Original: TuHURA Biosciences to Present at the 4th Annual H.C. Wainwright BioConnect Investor Conference
US Market News
2月前
TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical OperationsApril 7, 2026 7:45 AM
PR Newswire (US)
Mrs. Garofalo brings over 20 years of experience in Phase I-IV drug and biologic developmentTAMPA, Fla., April 7, 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 announced Amanda Garofalo, MSHS, as Senior Vice President (SVP) of Clinical Operations.Mrs. Garofalo, who brings over 20 years of clinical and development experience, will work closely with Craig Tendler, M.D., and oversee day-to-day clinical operations."We warmly welcome Amanda to the TuHURA team," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "Her extensive experience across all stages of biotech drug development will greatly enhance our efforts as we continue to advance our clinical programs from our IFx-2.0 Phase 3 accelerated approval trial, to TBS-2025 advancing to its Phase 1b/2 trial, and pre-clinical planning for our early-stage antibody drug conjugates (ADCs) program. We look forward to working with her as we advance towards our clinical milestones this year."Mrs. Garofalo, a distinguished twenty-year industry veteran with global leadership experience in Phase I-IV drug and biologic development, joins TuHURA from Parabilis Medicines (formerly FOG Pharmaceuticals), where she enabled enrollment, data availability and due diligence activities necessary to execute an oversubscribed, privately funded $305M Series F funding round. Prior, Mrs. Garofalo was the Head of Oncology Delivery, Clinical Delivery & Patient Centricity at EMD Serono where she was responsible for a portfolio of over 200+ Oncology Ph I-IV sponsored and non-sponsored clinical trials, managed access programs, post-marketing surveillance and real-world evidence (RWE) studies. Before that, Mrs. Garofolo directed the submission of 3 new IND submissions in just 12 months, resulting in the successful commencement of the anti-TIGIT, CD-73 inhibitor, and A2a/A2b adenosine receptor antagonist programs at Arcus Biosciences. Mrs. Garofalo has also served as the Global Clinical Program Lead at Indivior; Senior Clinical Project Manager at Medimmune; and various positions at GlaxoSmithKline Pharmaceuticals including Clinical Investigation Lead and Operations and Science Leader. Mrs. Garofalo received a Master of Science in Health Science with a focus in Clinical Research Administration from George Washington University and a Bachelor of Science in Biology from the College of William and Mary. She also completed an Advanced Management Program at The Wharton School of Business.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 conducting a single randomized placebo-controlled Phase 3 accelerated approval 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 (MCC).In addition to its innate immune agonist product candidate, TuHURA acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb advancing to Phase 1b/2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional 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, 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
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-appoints-amanda-garofalo-mshs-as-senior-vice-president-of-clinical-operations-302735470.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations
US Market News
2月前
TuHURA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate UpdateApril 1, 2026 7:45 AM
PR Newswire (US)
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 HighlightsInitiated 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 Keytruda® (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 Keytruda® (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 Keytruda® 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 placementsPresented 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 MCC2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytruda® (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 Keytruda® (pembrolizumab) in first line treatment for advanced or metastatic MCCTBS-2025 (VISTA inhibiting antibody)June 2026: Meeting with the FDA to discuss the development plan for TBS-2025 in NPM1 mut r/r AML2H 2026: Anticipate initiation of Phase 1b/2 trial of VISTA in NPM1 mut r/r AMLLead ADC Selection1H 2026: Select lead ADC in AML2H 2026: Expect to initiate ADC in vivo proof of concept (POC) studies2H 2026: Anticipate POC data in humanized model of AML2H 2026: Presentations at key scientific meetingsSummary 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 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 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
Monique@GilmartinIR.com
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.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update
US Market News
2月前
Craig Tendler, M.D., JNJ's Former Global Head of Oncology Clinical Development, to Lead TuHURA Bioscience's VISTA Program in AML and other Blood Related CancersMarch 23, 2026 7:45 AM
PR Newswire (US)
Distinguished physician with a career spanning over 29 years in drug development and medical affairs highlighted by blockbuster successes in hematology and oncology Coordinated and achieved more than 30 Oncology regulatory approvals and 15 new medical entity approvals, including four biologic or cell therapy approvals for various stages of multiple myeloma currently generating more than $16 billion in worldwide sales TAMPA, Fla., March 23, 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 announced Dr. Craig L. Tendler will provide strategic, operational and other related services consistent with those of a Chief Medical Officer (CMO). He will also continue with his current role as member of the Board of Directors. Dr. Tendler will work with the Company to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025."Craig has been an active and valued member of our Board and enthusiastically agreed to provide strategic, operational and other related services consistent with those of a CMO. His decades of clinical and regulatory experience in accelerating drug development across therapeutic areas, notably in hematologic malignancies, will be of particular value to our TBS-2025 program," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "I am confident that his recent leadership role and strategic contributions to JNJ's menin inhibitor, bleximenib in NPM1 mutated AML, will prove invaluable to our regulatory pathway and development of TBS-2025 in AML and other blood related cancers. I look forward to working with Craig as we unlock the value in VISTA and other clinical programs."Dr. Craig Tendler, added, "I am excited about the potential benefits of TBS-2025 for blood- related cancers where the negative checkpoint, VISTA, has been implicated in playing a critical immunosuppressive role in both therapy failure and poor overall survival in AML, particularly in the molecularly defined subset of NPM1 mutated AML. We have already received preliminary feedback from the Division of Hematologic Malignancies I of the FDA on the early development plan and will continue to work closely with the Agency to accelerate the clinical development of TBS-2025, both as monotherapy and in combination with menin inhibitors, an area where I have substantial experience."Dr. Tendler, a distinguished thirty-year industry veteran, will provide strategic and operational services consistent with those of a CMO while continuing his role as a member on the TuHURA Board of Directors. Dr. Tendler is a seasoned professional, previously serving as the Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development. During his tenure at JNJ, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA®, AKEEGA®, and ERLEDA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®) as well as for lung (RYBREVANT®) and bladder cancer (BALVERSA®). He has been a leader and key participant in four Oncology Drug Advisory Committee (ODAC) presentations, achieved 13 FDA breakthrough designations, and led clinical diligence teams for numerous oncology business development opportunities culminating in Janssen's acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals, and TARIS Biomedical along with Janssen's co-development agreements with Legend Biotech, Pharmacyclics/AbbVie, Tesaro/GSK, Yuhan Corporation, and GenMab A/S.Prior to joining Johnson & Johnson Innovative Medicine, Dr. Tendler served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, he has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and an NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society.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 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 acquisition by 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, 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, 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
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/craig-tendler-md-jnjs-former-global-head-of-oncology-clinical-development-to-lead-tuhura-biosciences-vista-program-in-aml-and-other-blood-related-cancers-302721426.htmlSOURCE TuHURA Biosciences, Inc.
Original: Craig Tendler, M.D., JNJ's Former Global Head of Oncology Clinical Development, to Lead TuHURA Bioscience's VISTA Program in AML and other Blood Related Cancers
US Market News
3月前
TuHURA Biosciences Regains Compliance with Nasdaq Minimum Bid Price RequirementFebruary 27, 2026 7:30 AM
PR Newswire (US)
TAMPA, Fla., Feb. 27, 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 announced that on February 26, 2026, it received written notice from the Nasdaq Stock Market LLC (Nasdaq) confirming that the Company has regained compliance with Nasdaq's $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550 (a)(2) (the "Listing Rule"). Nasdaq confirmed that for the last 11 consecutive business days, from February 10, 2026, through February 25, 2026, the closing bid price of the Company's common stock has been at $1.00 per share or greater, and as a result, the matter is now closed."We are pleased to have regained full compliance with Nasdaq's listing standards and continue to remain fully focused on advancing our pipeline of assets," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "We continue to progress enrollment in our Phase 3 accelerated approval trial for IFX-2.0 in front-line Merkel Cell Carcinoma; are readying TBS 2025, our VISTA inhibiting antibody, for the initiation of our Phase 2 study in relapsed/refractory NPM1 mutated AML; and are continuing to advance toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates."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 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. 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
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-regains-compliance-with-nasdaq-minimum-bid-price-requirement-302699243.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences Regains Compliance with Nasdaq Minimum Bid Price Requirement
US Market News
3月前
TuHURA Biosciences Announces Participation in Upcoming Investor ConferencesFebruary 24, 2026 5:20 PM
PR Newswire (US)
TAMPA, Fla., Feb. 24, 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 announced that Dr. James Bianco, President and Chief Executive Officer, will participate in the following upcoming investor conferences:Citizens Life Science Conference
Date: Tuesday, March 10, 2026
Time: 4:00 pm ET
Links: To register and view presentation, click HERE. A live and archived webcast of the presentation will also be available through the investors page of TuHURA's corporate website at https://ir.tuhurabio.com/news-events/events.Leerink Global Healthcare Conference
Date: Wednesday, March 11, 2026
Time: TuHURA will be available to meet 1x1 with investors
Links: To request a meeting, please contact your Leerink representativeAbout 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 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.Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-announces-participation-in-upcoming-investor-conferences-302696268.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences Announces Participation in Upcoming Investor Conferences
US Market News
4月前
TuHURA Biosciences to Present at the Oppenheimer 36th Annual Healthcare Life Sciences ConferenceFebruary 12, 2026 7:45 AM
PR Newswire (US)
TAMPA, Fla., Feb. 12, 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 announced that Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference.Date: February 26, 2026
Time: 3:20 pm ET
Links: To register and view presentation, click HEREA live and archived webcast of the presentation will be available through the investors page of TuHURA's corporate website at https://ir.tuhurabio.com/news-events/events.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 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.Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-to-present-at-the-oppenheimer-36th-annual-healthcare-life-sciences-conference-302686189.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
US Market News
4月前
TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous MelanomaFebruary 2, 2026 7:45 AM
PR Newswire (US)
TAMPA, Fla., Feb. 2, 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 announced that the U.S Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to 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, results of which were published in the journal Molecular Therapeutics and entitled: "First-in-Human Stage II/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0," authored by Dr. Joseph Markowitz, Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute. The study demonstrated IFx-Hu2.0 to be safe with no serious dose limiting toxicities in addition to demonstrating that patients refractory to checkpoint inhibitor therapy (anti-PD1) experienced clinical benefit upon subsequent anti-PD1 based treatment.Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences, said, "Our current focus with IFx-2.0 is targeting completion of enrollment in our Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma. We believe receiving ODD in advanced cutaneous melanoma demonstrates not only the significant need for new treatments in skin cancer but also highlights IFx-2.0 as a potential new therapeutic approach in this patient population."Orphan drug designation provides seven years of market exclusivity benefits, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. The FDA's Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 individuals in the United States.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 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.Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-received-fda-orphan-drug-designation-for-ifx-2-0-for-the-treatment-of-stage-iib-to-stage-iv-cutaneous-melanoma-302675770.htmlSOURCE TuHURA Biosciences, Inc.
Original: TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous Melanoma