TuHURA Biosciences Provides Corporate Update Following Recent Financing

Rhea-AI Summary

TuHURA Biosciences (NASDAQ:HURA) provided a corporate update on December 11, 2025 outlining program milestones, recent financing and scientific data.

Key points: the lead Phase 3 IFx-2.0 trial in combination with Keytruda runs under an FDA SPA with enrollment targeted for completion in Q4 2026; a merger added a Phase 2‑ready VISTA antibody (TBS-2025); preclinical and ASH presentations highlighted the Delta Opioid Receptor target and ADC program; and a recent equity financing raised $15.6 million to fund multiple near-term milestones. Management will host a conference call on Dec 11, 2025.

Positive

• SPA granted for IFx-2.0 Phase 3 in MCC
• Enrollment targeted to complete in Q4 2026
• $15.6M equity financing provides near-term runway
• Merger added Phase 2‑ready VISTA antibody (TBS-2025)
• KOLs endorsed combining TBS-2025 with menin inhibitors
• Preclinical TBS-2025 showed survival benefit in murine AML

Negative

• None.

Key Figures

Equity financing $15.6M Recent equity financing providing cash runway for milestones across three programs

PIPE financing $15M June 2025 PIPE financing and warrant exercise referenced in corporate update

Shelf registration $250,000,000 Mixed Form S-3 base shelf for future debt and equity offerings

ATM program $50,000,000 At-the-market offering capacity under S-3 shelf

Cash balance $2.7M Cash and cash equivalents at Sept 30, 2025 (Q3 10-Q)

Operating cash outflow $22.1M Nine-month 2025 operating cash outflow reported in Q3 10-Q

Bridge loan facility $3,000,000 at 3%/month Secured bridge loan with initial $1.5M advance and high interest cost

Short interest 4.55% Short interest as percent of float; days to cover 8.48

Market Reality Check

$1.02 Last Close

Volume Volume 1,691,835 is 4.23x the 20-day average of 399,931, signaling elevated trading interest ahead of the update. high

Technical Shares at $1.03 are trading below the $2.77 200-day moving average and sit far under the $6.90 52-week high.

Peers on Argus

Price action appears stock-specific: HURA is down 11.97% with heavy volume, while close biotech peers show mixed, mostly modest moves (e.g., IOBT -2.41%, AVTX +2.41%, SKYE -5%).

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 08	ASH DOR data	Positive	+2.1%	Preclinical DOR data at ASH showing reduced myeloid immunosuppression.
Nov 14	Q3 earnings	Negative	+0.5%	Q3 loss, low cash and going concern disclosure alongside pipeline update.
Nov 03	ASH selection	Positive	-0.4%	DOR discovery research selected for ASH oral and poster presentations.
Aug 20	Investor conference	Neutral	-0.7%	Participation in H.C. Wainwright conference for company overview meetings.
Aug 14	Q2 earnings	Positive	+10.9%	Q2 results with Kineta acquisition, Phase 3 start, and new equity funding.

Pattern Detected

The stock has often reacted positively to larger financing/strategy updates but showed mixed or muted moves around scientific conference news.

Recent Company History

Over the last six months, TuHURA reported multiple financings and clinical milestones. An August Q2 2025 update tied to the Kineta acquisition, VISTA antibody TBS-2025, and a $12.5M equity raise saw a strong +10.87% move. Subsequent news about DOR research and ASH presentations in November–December 2025 produced smaller, mixed reactions around ±2%. The latest Q3 2025 earnings highlighted liquidity risk and a going-concern warning, yet shares nudged up 0.49%, showing prior divergence between fundamentals and price.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-03

$250,000,000 registered capacity

An effective mixed Form S-3 filed on Nov 3, 2025 registers up to $250,000,000 of securities, including an ATM component of up to $50,000,000 in common stock. This provides TuHURA with flexibility to issue various securities over time for working capital and program funding, while also covering resales of 9,321,545 existing and warrant shares by selling stockholders.

Market Pulse Summary

This announcement outlines TuHURA’s strategy following a recent $15.6M equity financing, emphasizing runway to progress its Phase 3 IFx‑2.0 MCC trial, planned Phase 2 VISTA antibody study in AML, and DOR‑targeted ADC work. In context of earlier disclosures of $2.7M cash and $22.1M nine‑month operating outflow, access to capital via the $250M S‑3 and $50M ATM remains a key consideration. Investors may monitor trial enrollment timelines, upcoming ASH‑related data readouts, and additional use of shelf or ATM capacity.

Key Terms

special protocol assessment (SPA) regulatory

"conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug"

A special protocol assessment (SPA) is a formal agreement between a drug developer and the regulatory authority on the key design and success measures of a pivotal clinical trial that will be used to decide approval. For investors, an SPA is like getting a building inspector’s sign-off on the blueprints before construction: it reduces regulatory uncertainty and makes the development timeline and the odds of approval more predictable, although it does not guarantee a positive result.

pembrolizumab medical

"IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

merkel cell carcinoma (MCC) medical

"first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under"

A rare, aggressive form of skin cancer that starts in small cells beneath the skin and often appears on sun-exposed areas; it tends to grow quickly and can spread to lymph nodes and other organs. Investors care because treatments, clinical trial results, regulatory approvals, or new diagnostic advances can meaningfully affect the commercial prospects and valuation of companies developing therapies—think of it like a fast-moving problem where effective solutions can create outsized market opportunity.

NPM1 medical

"combination with a menin inhibitor in NPM1 mutated relapsed/refractory AML"

NPM1 is a gene that helps organize proteins inside cells; certain changes (mutations) in NPM1 are common in a form of blood cancer and act like a faulty instruction in a blueprint that makes a cell behave abnormally. For investors, NPM1 status matters because it’s used as a diagnostic and risk indicator and can determine which drugs or tests are likely to succeed, influencing the value of companies developing targeted therapies, diagnostics, or companion tests.

delta opioid receptor (DOR) medical

"showed the Delta Opioid Receptor (DOR) to be a compelling new target"

A delta opioid receptor (DOR) is a specific protein on the surface of nerve and other cells that acts like a lock for certain opioid molecules (the keys); when these molecules bind, they change how the cell sends pain, mood, and stress signals. Investors care because drugs that target DOR can become treatments for pain, mood disorders or addiction, so progress in research or trials can significantly affect a company’s commercial prospects and regulatory risk.

antibody drug conjugates (ADCs) medical

"immune modulating Antibody Drug Conjugates (ADCs)Recent $15.6 million equity financing"

Antibody drug conjugates (ADCs) are specialized medicines that combine a targeted antibody with a powerful drug, designed to attack specific disease cells while minimizing harm to healthy ones. This approach allows for more precise treatment, often leading to better outcomes. For investors, ADCs represent innovative therapies with the potential for significant market impact and growth in the healthcare sector.

menin inhibitor medical

"clinical applications in NPM1 mutated r/r AML in combination with a menin inhibitor."

A menin inhibitor is a type of experimental drug that blocks the action of a protein called menin, which some cancers use to keep growing. Think of it as flipping off a switch that cancer cells rely on to survive; by doing so, these drugs can slow or stop tumor growth. Investors watch menin inhibitors because clinical trial results, regulatory approvals, and market demand determine whether they become valuable cancer treatments and potential revenue drivers.

AI-generated analysis. Not financial advice.

Company's lead Phase 3 program 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 a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) targeting completion of enrollment Q4-2026

A mini KOL symposium held on December 5, 2025, provided the scientific rational for targeting VISTA in AML and the clinical applications in combination with a menin inhibitor in NPM1 mutated relapsed/refractory AML

Oral and poster presentations at the recently concluded 57th ASH Annual Meeting showed the Delta Opioid Receptor (DOR) to be a compelling new target as the cornerstone for the Company's bi-functional, bi-specific immune modulating Antibody Drug Conjugates (ADCs)

Recent $15.6 million equity financing transaction provides cash runway to accomplish multiple key milestones across all three development programs

Management to host a call today, December 11, 2025, at 8:30 am ET

TAMPA, Fla., Dec. 11, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided updates across the company's portfolio of assets, including a summary from its mini symposium held on December 5, 2025 focused on targeting VISTA in AML, the scientific rational and clinical applications in NPM1 mutated r/r AML in combination with a menin inhibitor. The company's recently announced financing transaction, which provides for $15.6 million in gross proceeds, is expected to provide the cash runway to accomplish multiple key milestones across all three development programs.

"2025 was a transformational year for us, having initiated our accelerated approval Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda® in front-line MCC, having completed the merger with Kineta bringing a Phase 2 ready VISTA inhibiting antibody to our pipeline and having presented data positioning the DOR as a promising new target in overcoming resistance to checkpoint inhibitors. We were pleased to raise $15 million in our June 2025 PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs" said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.

"We look forward in 2026 to the expected completion of enrollment for our Phase 3 study of IFx-2.0 in MCC, and anticipate receiving FDA clearance to initiate our randomized Phase 2 trial of physician's choice of menin inhibitor vs a menin inhibitor+TBS-2025, our VISTA inhibiting antibody, in NPM1 mutated r/r AML. We also expect to present preliminary data from our IFx-2.0 basket trial; data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q; and proof-of-concept data in animal models for our lead ADC at a scientific conference in Q4 2026."

"In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025 prior to the ASH meeting, several key opinion leaders, provided valuable insights and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML. There was clear enthusiasm for the potential of combining TBS-2025 with a menin inhibitor both in NPM1 r/r/ AML, in high-risk AML and in patients with AML who are unfit for intensive therapies. The KOLs noted that while menin inhibitors have become standard of care in NPM1 mutated AML, there still exists a significant unmet medical need, citing the relatively low CR rate and short duration of response as the two obstacles to improving clinical benefit in these patients."

Dr. Bianco continued, "The VISTA gene is the only checkpoint upregulated in patients with AML, notably among high-risk AML. It has been shown that VISTA expression on leukemic blasts is the primary culprit in the low response rate and short duration of response in AML. Targeting VISTA represents the first potential for immunotherapy to improve the treatment outcomes in AML, not just NPM1 mutated AML was the consensus opinion from the group," concluded Dr. Bianco.

Participants at the mini symposium included: Geoffrey Uy, MD, Co-chair of the Leukemia Committee for the ALLIANCE for Clinical Trials in Oncology, and Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation at Washington University School of Medicine in St. Louis; Kevin Lin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program at the Washington University in St. Louis; and Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology at Vanderbilt University Medical Center.

Highlights from the Company's mini-symposium on TBS-2025. The Company's studies and data have shown the following:

• VISTA was shown to be the only checkpoint highly upregulated in patients with AML with the highest expression in poor-risk subtypes. Its expression is seen in AML with or without common mutations like DNMT3A, NPM1, FLT-3.
  
  
• VISTA expression on AML contributes to low response rate and short duration of response among patients with NPM1 mutated AML treated with menin inhibitors.
  
  
• TBS-2025 provided survival advantage comparable to standard front line combination chemotherapy while significantly improving survival when used in combination with front line chemotherapy in murine model of VISTA expressing AML
  
  
• Inhibition of VISTA, either through gene silencing or an inhibiting antibody, and inhibition of menin signaling pathway significantly improves survival in murine models of AML

Speaker Bios:
Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center. Dr. Kim investigates mechanisms of immune evasion in leukemia and develops new immunotherapeutic strategies. Trained under Dr. Lieping Chen, a pioneer in immuno-oncology, his work explores emerging co-inhibitory pathways and approaches to selectively prevent graft-versus-host disease while preserving graft-versus-leukemia activity. Selected Honors received by Dr. Kim include: American Society of Hematology Scholar Award; American Society of Clinical Oncology Career Development Award; Evans MDS Young Investigator Award; American Cancer Society Clinician Scientist Development Grant; Forbeck Scholar Award.

Geoffrey L. Uy, MD, Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, Research Member, Siteman Cancer Center. Dr. Uy is a hematopoietic stem cell transplant specialist and serves as Medical Director for Clinical Research in the Division of Oncology. His research centers on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with a focus on improving outcomes for patients with high-risk myeloid malignancies.

Kevin Yin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program Washington University in St. Louis. Dr. Yin studies how initiating mutations in AML shape immune escape mechanisms and contribute to leukemia progression. His work aims to define AML–immune interactions to support the development of next-generation immunotherapies. Dr. Yin's research is being conducted under Timothy J. Ley, MD, group who serves as his PhD advisor. Dr Ley's research group focuses on the genetics and genomics of acute myeloid leukemia (AML). His lab studies the development of normal and leukemic blood cells. His work is focused on identifying the mutations and epigenetic events that are responsible for the initiation and progression of AML. Dr. Ley led the team that sequenced the first cancer genome from an AML patient. He has gone on to develop projects that will use whole genome sequencing to help diagnose and treat patients with AML

Conference Call Information
Management will host a conference call and webcast today, December 11, 2025, at 8:30 am Eastern Time, to discuss the corporate update and recent financing.  Call details and dial-in information are as follows:

Thursday, December 11^th @ 8:30 am ET
Toll Free:                     1-800-225-9448
Alternate:                     1-203-518-9708
Webcast:                      Click HERE

For those who are not able to join the live call, a replay will be available on investor relations portion of the company's website.

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 asset 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 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. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's Delta Opioid Receptor Technology, its IFx-Hu2.0 product candidate and Phase 3 trial, and its TBS-2025 asset, and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 the combined company'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. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com

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SOURCE TuHURA Biosciences, Inc.

FAQ

What milestone did TuHURA (HURA) report for IFx-2.0 on December 11, 2025?

TuHURA reported that the IFx-2.0 Phase 3 trial has an FDA SPA and enrollment is targeted to finish in Q4 2026.

How much cash did TuHURA raise in the December 2025 financing and what is its purpose?

TuHURA announced an equity financing of $15.6 million intended to provide cash runway to advance multiple development milestones across three programs.

What is TuHURA's new VISTA program update (HURA) announced December 11, 2025?

Following a merger, TuHURA added a Phase 2‑ready VISTA inhibiting antibody (TBS-2025) and reported KOL enthusiasm for combining it with menin inhibitors in NPM1 mutated AML.

What preclinical or conference data did TuHURA present at ASH 2025?

TuHURA presented data supporting the Delta Opioid Receptor (DOR) as a target for its bi-functional ADCs and reported murine-model survival benefits for TBS-2025 combinations.

When is TuHURA hosting a conference call to discuss the December 11, 2025 update?

Management will host a conference call and webcast on December 11, 2025 at 8:30 am ET.