as of 08-20-2026 4:00pm EST
TuHURA Biosciences Inc is a phase 3 clinical stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies. The company's personalized cancer vaccine candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. The company operates in one reportable segment, which includes all activities related to advancing therapies for cancer treatment.
| Founded: | 2009 | Country: | United States |
| Employees: | N/A | City: | TAMPA |
| Market Cap: | 160.5M | IPO Year: | 2010 |
| Target Price: | $9.50 | AVG Volume (30 days): | 251.5K |
| Analyst Decision: | Strong Buy | Number of Analysts: | 2 |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -0.27 | EPS Growth: | 47.93 |
| 52 Week Low/High: | $0.41 - $3.43 | Next Earning Date: | 05-15-2026 |
| Revenue: | N/A | Revenue Growth: | N/A |
| Revenue Growth (this year): | N/A | Revenue Growth (next year): | N/A |
| P/E Ratio: | -8.44 | Index: | N/A |
| Free Cash Flow: | -27705233.0 | FCF Growth: | N/A |
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SEC 8-K filings with transcript text
Aug 14, 2026 · 100% conf.
1D
-6.46%
$2.31
Act: -7.69%
5D
-16.73%
$2.06
20D
-41.88%
$1.44
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TuHURA Biosciences Reports Second Quarter 2026 Financial Results and Provides a Corporate Update
TAMPA, Fla., August 14, 2026 -- 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 Program
IFx-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 2026
Cash 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 fai
May 15, 2026
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TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update
TAMPA, Fla., May 15, 2026 -- 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 Keytruda® (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 r
Apr 1, 2026
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TuHURA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update
TAMPA, Fla., Apr. 01, 2026 -- 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 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 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 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 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
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