By John Vandermosten, CFA
NASDAQ: HURA
READ THE FULL HURA RESEARCH REPORT
Operational and Financial Results
On May 15th, 2026, TuHURA Biosciences, Inc. (NASDAQ: HURA) reported 1Q:26 financial and operational results and filed its Form 10-Q with the SEC. There have been several highlights recently, most notably the $50 million loan facility, which TuHURA believes is sufficient to provide a cash runway until 2028. There were also two new appointments to the executive suite. Dr. Craig Tendler will take on the responsibilities of Chief Medical Officer at TuHURA, and Amanda Garofalo will serve as Senior Vice President of Clinical Operations. TuHURA announced the receipt of an Orphan Drug Designation for IFx-2.0 in specific cutaneous melanoma settings and expects to receive another orphan designation for Merkel cell carcinoma (MCC) by mid-year. Management provided an update to its anticipated milestones for the IFx-2.0, TBS-2025, and ADC assets.
TuHURA generated no revenues in 1Q:26 and expended $7.5 million on operational activities related to advancing IFx-2.0, TBS-2025, and other programs, producing a net loss of $7.5 million or $0.13 per share. For the quarter ending March 31st, 2026, and versus the same prior period:
- Research & development expense totaled $5.2 million, increasing 14% from $4.6 million on higher non-cash stock compensation expenses and public company costs, along with greater personnel and facilities related costs. By program, spending was initiated on the TBS-2025 program, which was absent in the prior year period, while disbursements for the IFx-2.0 program and preclinical work declined;
- General & administrative expense totaled $2.3 million, falling 6% from $2.4 million. The change was predominantly due to the absence of acquisition-related costs in 1Q:26;[1]
- Net interest expense was $7,000 compared to net interest income of $100,000, with the change due to interest on notes issued to former Kineta employees;
- Net loss was $7.5 million or $0.13 per share.
As of March 31st, 2026, TuHURA held $6.3 million in cash on its balance sheet. Cash burn for 1Q:26 was $4.5 million. Net cash generated from financing sources was $7.1 million, which consisted of proceeds from common stock issuance offset by cash dividend, Kineta promissory note, and finance lease payments, along with transaction costs for the capital raise. In November 2025, TuHURA entered into an at-the-market (ATM) facility with HC Wainwright as its sales agent, along with the filing of a Form S-3 registration statement, making available $50 million in capacity for the ATM. In April 2026, TuHURA entered into a Loan Agreement with Parkview Holdings, which provides access to a $50 million revolving credit facility.
$50 Million Credit Facility
On April 22nd, TuHURA announced that it had entered into a loan agreement with Parkview Holdings One, providing a $50 million revolving credit facility. Parkview is an affiliate of TuHURA’s largest stockholder, K&V Investment One LLC. The agreement provides for a maximum of $50 million in borrowing at an annual rate of 12%. TuHURA may draw $1.7 million per month or agreed budgeted monthly expenses from the facility. Access to the funds is expected to provide sufficient capital to support operations into 1Q:28 without contributions from other sources. If TuHURA defaults, an additional 6% will be added to the interest rate. If TuHURA generates profits, under certain conditions, it must allocate 75% of the net profits to repay the loan.
Under the loan agreement, TuHURA must pay a one-time loan commitment fee of $5 million, or 10% of the total commitment. It also must pay an annual cash facility fee of 1.5% of the total commitment, which is equal to $750,000 annually. The arrangement also amends the terms of 4,364,873 warrants held by K&V, extending the warrant life until April 2031. Parkview may appoint a director to the company’s board. Parkview is also granted a low to mid-single digit royalty on sales of up to $450 million in sales that will continue until the last patent protecting IFx-2.0 expires. Additional details of the arrangement are included in the April 22nd, 2026 Form 8-K filing and related exhibits.
Anti-VISTA (TBS-2025) Program
TuHURA closed its acquisition with Kineta in June 2025, bringing the latter’s anti-VISTA asset into the fold. Now designated TBS-2025, the candidate is a VISTA-blocking immunotherapy developed to reverse immunosuppression in the tumor microenvironment (TME). It is a fully-human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at physiologic and acidic pH levels. The product is being developed as an intravenous infusion. Under TuHURA’s aegis, TBS-2025 is expected to be the subject of a Phase Ib/II trial in patients with relapsed/refractory (r/r) mutated nucleophosmin 1 (mutNPM1) Acute Myeloid Leukemia (AML). TuHURA has been speaking with the FDA about the trial design and has received helpful feedback regarding the safety component of the trial. Previous work conducted in solid tumors will help streamline the dose finding efforts in the trial and refine the combination work that is expected with a menin inhibitor. Management is planning for another FDA meeting in July to fine tune the study design, followed by anticipated IND clearance in August and trial start in September.
Research has demonstrated that mutated NPM1 and DNMT3A result in high expression of VISTA on the surface of leukemic blasts.[2] The presence of VISTA on these cells is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack, resulting in a low treatment response rate and a short duration of response in AML.
In February, TuHURA filed an IND Application with the FDA for TBS-2025. It submitted the document to the Division of Hematologic Malignancies for the treatment of mutNPM1 r/r AML in combination with a menin inhibitor. In response to the filing, the FDA provided valuable feedback and recommendations on how to transition from the trial design that appears in the existing IND in solid tumors to a design that would support an abbreviated Phase Ib trial in AML. The patient population for this study is expected to include individuals who have no approved or effective therapies available for treatment. Based on this feedback, TuHURA is planning a Phase Ib dose escalation study that will identify a recommended Phase II dose (RP2D) in blood related cancers including AML.
The development plan for TBS-2025 will seek patients with molecularly defined subsets of AML such as NPM1 mutated AML. This population lacks effective therapies and the majority of them are expected to be NPM1 mutated enrollees who failed to respond or who relapsed after treatment with a menin inhibitor. If the study generates favorable complete remission (CR), or complete remission with partial hematologic recovery (CRh) results, this may be sufficient to expand into an accelerated approval trial in this defined subset. Once the RP2D has been identified, TuHURA expects to proceed to a study evaluating NPM1 mutated r/r AML in combination with a menin inhibitor.
In the press release announcing the IND, Dr. Bianco pointed out that leukemogenic mutations common in AML may drive the expression of VISTA on the surface of leukemic cells, which in turn eliminate the immune response. The anti-VISTA antibody’s mechanism raises the shield so the immune system can kill these cells. He continued, noting that complete response rates using menin inhibitors as monotherapy are below 25% and of short duration. Adding TBS-2025 to the treatment paradigm may markedly increase both the magnitude of response and its duration. Success in this endeavor would provide TuHURA the data it needs to seek an accelerated approval route with the FDA.
In March 2026, TuHURA announced that Dr. Craig Tendler would lead the anti-VISTA program in AML. Dr. Tendler’s first public association with TuHURA was the company’s announcement that he would join TuHURA’s board of directors in March 2025. Last month, it was announced that he would take on the responsibilities consistent with those of Chief Medical Officer (CMO) and lead the TBS-2025 program. He will continue his role on the board. A press release provided a biography for the thirty-year industry veteran, noting his tenure at Johnson & Johnson. Joining Dr. Tendler is Amanda Garofalo, who was announced as SVP of Clinical Operations on April 7th, 2026. She will assist with the development of TBS-2025 and TuHURA’s other clinical programs.
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[1] Our review uses originally reported data for comparisons.
[2] NPM1 and DNA methyltransferase 3A (DNMT3A) are two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS).