TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update
Rhea-AI Summary
TuHURA Biosciences (NASDAQ:HURA) reported first quarter 2026 results and a corporate update. The company secured a $50 million credit facility and royalty transaction, extending its anticipated cash runway into 2028. TuHURA received FDA Orphan Drug Designation for IFx-2.0 in stage IIB–IV cutaneous melanoma and outlined key milestones across IFx-2.0, VISTA antibody TBS-2025, and MDSC-inhibiting ADCs. At March 31, 2026, cash and equivalents were $6.3 million, with R&D expenses of $5.2 million and G&A expenses of $2.3 million for the quarter.
Positive
- $50 million credit facility extends anticipated cash runway into 2028
- Facility allows drawdowns as needed, with principal due April 21, 2031
- FDA Orphan Drug Designation for IFx-2.0 in cutaneous melanoma
- Phase 3 IFx-2.0 program targeting topline results in 2H 2027
- Net cash inflows from financing activities of $7.2 million in Q1 2026
Negative
- Q1 2026 R&D expenses increased to $5.2 million from $4.6 million
- Q1 2026 G&A expenses rose to $2.3 million from $2.0 million
- Net cash outflows from operating activities were $4.4 million in Q1 2026
- Quarter-end cash and cash equivalents totaled $6.3 million
News Market Reaction – HURA
In the May 18 session, HURA gained 10.39%, reflecting a significant positive market reaction. Argus tracked a peak move of +4.3% during that session. Argus tracked a trough of -2.6% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 01 | Annual results | Positive | -9.5% | Full-year 2025 results plus Phase 3 IFx-2.0 and Kineta/TBS-2025 updates. |
| Nov 14 | Quarterly earnings | Positive | +0.5% | Q3 2025 results with Phase 3 MCC enrollment and ATM facility filing. |
| Aug 14 | Quarterly earnings | Positive | +10.9% | Q2 2025 results, Kineta acquisition progress and $15.5M equity/warrant funding. |
| May 15 | Quarterly earnings | Positive | +2.1% | Q1 2025 results with plans for Phase 3 IFx-Hu2.0 and Kineta acquisition. |
| Apr 01 | Annual results | Positive | -9.9% | FY 2024 results, 2025 financing plans and Phase 3 IFx-2.0 initiation plans. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and financial updates have produced mixed reactions, with an average move of about -1.19% and several instances of sharp selloffs following fundamentally positive strategic updates.
Over the past two years, TuHURA has consistently used earnings updates to pair financial results with pipeline and financing milestones. Prior reports highlighted progress in the Phase 3 IFx‑2.0 Merkel cell carcinoma program, acquisition and integration of Kineta and VISTA antibody TBS‑2025, and multiple equity financings. Reactions ranged from double‑digit gains to sharp pullbacks, including -9.5% on Apr 1, 2026 and -9.91% on Apr 1, 2025. Today’s Q1 2026 update continues that pattern of combining cash runway details with clinical and corporate milestones.
Key Terms
orphan drug designation regulatory
phase 3 medical
phase 1b/2 medical
vista inhibitor medical
adc medical
merkel cell carcinoma medical
aml medical
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"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
First Quarter and Recent Corporate Highlights:
- In April 2026, the company announced a
$50 million 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
Research and development expenses were
General and administrative (G&A) expenses were
Net cash outflows from operating activities were
Net cash flows from financing activities were
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
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SOURCE TuHURA Biosciences, Inc.