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HURA on Nasdaq

TuHURA Biosciences, Inc./NV

In its 2026 annual report the company says: “We are 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. Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors.”3 It is headquartered in Tampa, Florida.1 Its shares trade on Nasdaq under the symbol HURA.1

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Last updated Oct 21, 2026.

Overview

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  • TickerHURA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersTampa, Florida1
  • Incorporated inNV2
  • Business address10500 University Center Dr., Suite 110, Tampa, Fl 336122
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are 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.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-143.6%Return on equity4
-$27.7MFree cash flow4

Financial statements

Revenue54$0 in 2025
02023: $0$020232024: $0$020242025: $0$02025
Net income678954-$30.1M in 2025+273% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$8.0M-$8.0M20192020: -$9.1M-$9.1M2020+13%2021: -$38.3M-$38.3M2021+320%2022: -$22.7M-$22.7M2022−41%2023: -$29.3M-$29.3M2023+29%2024: -$21.7M-$21.7M2024−26%2025: -$30.1M-$30.1M2025+39%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Research and development expenses$20.5M$13.3M
Acquisition-related costs (note 5)$3.7M$440.3K
General and administrative expenses$7.6M$3.9M
Operating Loss-$31.8M-$17.6M
Employee Retention Tax Credit$113.6K
Grant income$713.5K$57.6K
Interest expense-$625.3K-$4.1M
Interest income$136.2K$361.6K
Change in fair value of derivative liability-$313.8K
Change in fair value of Kineta merger holdback shares$1.6M
Loss on Kineta employee separation payments assumed from merger-$185.0K
Total Other Income (Expense)$1.7M-$4.0M
Net Loss-$30.1M-$21.7M
Series A Preferred cash dividend-$8.4K-$2.1K
Deemed dividend on warrant modifications$0-$965.2K
Net Loss attributable to common stockholders-$30.1M-$22.6M
Net Loss per share, basic-$0.63-$1.21
Net Loss per share, diluted-$0.63-$1.21
Weighted-average shares outstanding, basic47.9M shares18.7M shares
Weighted-average shares outstanding, diluted47.9M shares18.7M shares

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Corporate structure

TuHURA Biosciences, Inc./NV sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TuHURA Biosciences, Inc./NV

  • James A. Bianco Filed SCHEDULE 13D/A on TuHURA Biosciences, Inc./NV, latest Aug 28, 2026 (2 filings since Oct 25, 2024)
  • HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on TuHURA Biosciences, Inc./NV, latest Feb 17, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on TuHURA Biosciences, Inc./NV, latest Oct 31, 2025 (2 filings since Jul 29, 2025)
  • CA Patel F&F Investments, LLC Filed SCHEDULE 13G/A on TuHURA Biosciences, Inc./NV, latest Aug 14, 2025 (2 filings since Oct 25, 2024)
  • KP Biotech Group LLC Filed SCHEDULE 13G/A on TuHURA Biosciences, Inc./NV, latest Aug 14, 2025 (2 filings since Oct 25, 2024)
  • Charles Steve Theofilos Filed SC 13G on TuHURA Biosciences, Inc./NV, latest Oct 25, 2024
  • Samir Rashmikant Patel Filed SC 13G on TuHURA Biosciences, Inc./NV, latest Oct 25, 2024
  • Vijay Patel Filed SC 13D on TuHURA Biosciences, Inc./NV, latest Oct 25, 2024
  • Lind Global Fund II LP Filed SC 13G/A on TuHURA Biosciences, Inc./NV, latest Feb 13, 2023 (2 filings since Apr 20, 2022)
  • Carolyn Pilkiewicz Filed SC 13G/A on TuHURA Biosciences, Inc./NV, latest Feb 7, 2022
  • TuHURA Biosciences, Inc./NV Tampa, Florida

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TuHURA Biosciences, Inc./NV reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.5M4 Dec 31, 2025$2.2M4 Dec 31, 2024+11.2%
Accumulated depreciation$2.2M4 Dec 31, 2025$2.1M4 Dec 31, 2024+3.4%
Property and equipment, net$300.6K4 Dec 31, 2025$123.4K4 Dec 31, 2024+143.7%
Operating-lease assets (leased space)$384.5K4 Dec 31, 2025$199.2K4 Dec 31, 2024+93.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$3.6M4 Dec 31, 2025$12.7M4 Dec 31, 2024−71.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$10.7M4 Dec 31, 2025

Properties, in its own words

The Company leases approximately 12,199 square feet of office and laboratory space in Tampa, Florida under a lease that is due to expire in March 2028. We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

Item 2 of the 10-K filed Mar 31, 2026.3

Leadership

Who has led TuHURA Biosciences, Inc./NV, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Jeffrey Bacha2013–2017
  2. Saiid Zarrabian2017–2020
  3. Robert Hoffman2021–2023
  4. James A. Bianco2024–now

President

  1. Jeffrey Bacha2013–2015
  2. Saiid Zarrabian2018–2020
  3. Robert Hoffman2021–2023

Chief financial officer

  1. Scott Praill2013–2022
  2. Robert Hoffman2023
  3. Dan Dearborn2024–now
201520202025
Board members and other officers (21)

Former names

  • Kintara Therapeutics, Inc.Aug 21, 2020 to Oct 22, 20242
  • DelMar Pharmaceuticals, Inc.Jan 23, 2013 to Aug 18, 20202
  • Berry Only Inc.Aug 17, 2010 to Jan 18, 20132

Timeline

  1. Sep 24, 20268-K New debt or obligation40
  2. Sep 17, 20268-K Executive or director change41
  3. Sep 17, 20268-K New debt or obligation42
  4. Sep 16, 20268-K Executive or director change43
  5. Sep 4, 20268-K New debt or obligation44
  6. Aug 21, 20268-K New debt or obligation45
  7. Aug 19, 20268-K Unregistered sale of shares; Shareholder vote46
  8. Aug 14, 20268-K Results of operations47
  9. Aug 13, 20268-K New debt or obligation48
  10. Jul 29, 20268-K New debt or obligation49
  11. Jul 7, 20268-K New debt or obligation50
  12. Jun 17, 20268-K Director nominations51
  13. Oct 22, 2024New chief executive James A. Bianco becomes CEO13
  14. Nov 10, 2021New chief executive Robert Hoffman becomes CEO14
  15. Nov 7, 2017New chief executive Saiid Zarrabian becomes CEO15
  16. Feb 13, 2013New chief executive Jeffrey Bacha becomes CEO16

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.14) a share, on Nov 14, 2025.52

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results47
  2. May 15, 2026Reported quarterly or annual results53
  3. Apr 1, 2026Reported quarterly or annual results54
  4. Nov 14, 2025Reported quarterly or annual results55
  5. Aug 14, 2025Reported quarterly or annual results56
  6. May 15, 2025Reported quarterly or annual results57
  7. Apr 1, 2025Reported quarterly or annual results58
  8. Oct 21, 2024Reported quarterly or annual results59

Drug trials and FDA: coming up

  1. Mar 31, 2027Phase 2/3 trial readout expected Phase 2/3 trial of IFx-Hu2.0 and Pembrolizumab in Advanced Or Metastatic Merkel Cell Carcinoma: primary completion expected Mar 31, 2027 (ClinicalTrials.gov NCT06947928).60

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

302 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 118 major events, 49 insider forms, 15 large holders, 2 private raises, 97 other. The latest 20:

  1. Sep 24, 20268-K EDGAR
  2. Sep 17, 20268-K EDGAR
  3. Sep 17, 20268-K/A EDGAR
  4. Sep 16, 20268-K EDGAR
  5. Sep 4, 20268-K EDGAR
  6. Aug 28, 2026SCHEDULE 13D/A EDGAR
  7. Aug 21, 20268-K EDGAR
  8. Aug 19, 20268-K EDGAR
  9. Aug 14, 202610-Q EDGAR
  10. Aug 14, 20268-K EDGAR
  11. Aug 13, 20268-K EDGAR
  12. Jul 29, 20268-K EDGAR
  13. Jul 9, 2026ARS EDGAR
  14. Jul 9, 2026DEFA14A EDGAR
  15. Jul 9, 2026DEF 14A EDGAR
  16. Jul 7, 20268-K EDGAR
  17. Jun 26, 2026PRE 14A EDGAR
  18. Jun 17, 20268-K EDGAR
  19. May 29, 20268-K EDGAR
  20. May 29, 20264 EDGAR

The 302 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

5 open-market trades by officers, directors and large owners since October 2021: 5 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 15, 2022Hoffman Robert E.DirectorBuy55,000$0.47$25.9KForm 4
Dec 8, 2021Praill Anthony ScottChief Financial OfficerBuy28,700$0.68$19.5KForm 4
Dec 7, 2021Zarrabian SaiidHead of Strategic PartnershipsBuy38,109$0.64$24.4KForm 4
Dec 6, 2021Zarrabian SaiidHead of Strategic PartnershipsBuy11,891$0.59$7.0KForm 4
Nov 22, 2021Johnson Laura L.DirectorBuy3,000$0.74$2.2KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Dr. James Bianco69$544.6K$4.0M71
2025Dan Dearborn$380.6K$1.8M71
2024President and Chief Executive Officer$463.7K$6.1M71
2024Chief Financial Officer$339.1K$2.9M71

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$3.7M 2025–2025
Money received by yearMoney received by year, 2025–2025: $3.7M in all. Private raises (Form D) $3.7M.$0$1M$2M$3M$4M2025 · Private raises (Form D): $3.7M2025
Figures by year
YearPrivate raises (Form D)Total
2025$3.7M$3.7M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Oct 27, 2025Raised $1.5 million in a private offering of equity72 Form D: $3 million offered in all Form D
  2. Jun 2, 2025Raised $2.2 million in a private offering of equity73 Form D: $12.6 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 90. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC2,267,901$5.3M0.0%+193,673
Northern Trust Corp1,621,042$3.8M0.0%+1,322,855
BlackRock, Inc.690,088$1.6M0.0%−1,760,168
Geode Capital Management, LLC484,219$1.1M0.0%−502,703
Millennium Management LLC454,535$1.1M0.0%New
Aqr Capital Management LLC424,600$993.6K0.0%−182,568
Vanguard Fiduciary Trust Co251,186$587.8K0.0%−35,947
Citadel Advisors LLC232,319$543.6K0.0%New
State Street Corp188,404$440.9K0.0%−324,509
Jane Street Group, LLC163,891$383.5K0.0%New
Apollon Wealth Management, LLC156,519$366.3K0.0%−1,491
Qube Research & Technologies Ltd145,595$340.7K0.0%New
Morgan Stanley143,257$335.2K0.0%+119,424
Goldman Sachs Group Inc131,768$308.3K0.0%+61,522
Bank of New York Mellon Corp121,662$284.7K0.0%−89,906
XTX Topco Ltd100,424$235.0K0.0%+88,911
WealthShield Partners, LLC91,530$214.2K0.0%No change
Aster Capital Management (DIFC) Ltd89,690$209.9K0.0%New
Captrust Financial Advisors88,373$206.8K0.0%New
Cetera Investment Advisers61,620$144.2K0.0%−78,624
UBS Group AG56,321$131.8K0.0%−5,745
Catalyst Funds Management Pty Ltd47,201$110.5K0.0%New
Brighton Jones LLC47,010$110.0K0.0%−1,575
Tudor Investment Corp Et Al45,115$105.6K0.0%New
Bank Of America Corp /de/42,506$99.5K0.0%−35,636

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

3 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Jul 13, 2025Laurel M. LeeRepublican, HouseBuy$50,001 - $100,000−45.0%Report
Nov 25, 2024Laurel M. LeeRepublican, HouseBuy$1,001 - $15,000−74.7%Report
Oct 18, 2024Laurel M. LeeRepublican, HouseExchange$100,001 - $250,000Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How TuHURA Biosciences, Inc./NV is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTuHURA Biosciences, Inc./NV1
  • CIK0001498382
  • Employer ID (EIN)99-03604973
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inNevada3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address10500 University Center Dr., Suite 110, Tampa, FL 336121
  • Phone813-875-66001
  • Shares outstanding63,726,617 as of Aug 11, 202611
  • Public float$111.0M as of Jun 30, 20253
  • AuditorCherry Bekaert LLP, Tampa, Florida PCAOB ID 677; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceAug 17, 20101
  • Filings927 in all: 4 (274), 8-K (217), 10-Q (47), CORRESP (37), 425 (33), 3 (26), UPLOAD (24), EFFECT (22)1
    All 50 form types

    424B3 (21), S-1/A (21), SC 13G (21), SC 13G/A (16), 10-K (15), 424B5 (14), 8-K/A (11), DEF 14A (9), POS AM (8), S-1 (8), 424B4 (7), PRE 14A (7), S-4/A (7), D (6), S-3 (6), SC 13D (6), SC TO-I/A (6), DEFA14A (5), 3/A (4), ARS (4), S-8 (4), SC 13D/A (4), 10-K/A (3), 4/A (3), D/A (3), S-4 (3), SCHEDULE 13G/A (3), 10-Q/A (2), CT ORDER (2), NT 10-K (2), RW (2), SC TO-I (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 10-KT (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), NT 10-Q (1), POS EX (1), SC 14F1 (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jul 9, 2026
    Latest 8-K (8-K) Sep 24, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareHURANasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks TuHURA Biosciences, Inc./NV names in Item 1A of its 10-K filed Mar 31, 2026: 62 risks under these headings, as written.3

  • Risks Relating to Our Business and Industry
  • We are a clinical-stage company and has a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.
  • We have incurred significant losses since inception and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future.
  • Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern.
  • We have never generated any revenue from product sales for our human drug candidates and our ability to generate revenue from product sales and become profitable depends significantly on our success in numerous endeavors.
  • We will require substantial additional capital to finance our operations in the future. If we fail to obtain additional financing on acceptable terms or at all, we may be unable to complete the development and commercialization of our product candidates.
  • The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises.
  • The successful development of immunotherapies is highly uncertain.
  • Our technology platforms, including our proprietary, multi-indication immunomodulatory platform (ImmuneFx Ifx, and Delta receptor targeting ADCs) technologies are a new approach to treat cancer and other immune-related diseases that present significant challenges.
  • Our immuno-oncology product candidates are based on novel technologies that target the tumor microenvironment (“TME”), which makes it difficult to predict the results, timing and cost of product candidate development and likelihood of obtaining regulatory approval.
  • If our clinical trials with our immune-oncology product TBS-2025 do not show any functionality in the TME, our development plans, financial position, results of operations and prospects may be materially adversely affected.
  • Our near-term ability to generate product revenue is dependent on the success of one or more of our product candidates, each of which are at an early stage of development and will require significant additional clinical testing before we can seek regulatory approval and begin commercial sales.
The other 51 risks
  • We may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect.
  • If we do not achieve our projected development and commercialization goals in accordance with our expected and announced timeframes, the commercialization of any of our product candidates may be delayed, and our business will be harmed.
  • Failure to successfully identify, develop, and commercialize additional therapeutics or product candidates could impair our ability to grow.
  • The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
  • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Clinical trials are expensive, time-consuming, and difficult to design and implement, and our clinical trial costs may be higher than those for more conventional therapeutic technologies or drug products.
  • Our product candidates are biologics and the manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • We rely on third parties to manufacture our clinical product supplies, and we intend to rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide it with sufficient quantities of product or fail to do so at acceptable quality levels or prices or fail to maintain or achieve satisfactory regulatory compliance.
  • Our third-party manufacturers may be unable to successfully scale up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing any approved product candidates.
  • Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.
  • We rely and will rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We plan to seek orphan drug status for some or all of our product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • The review processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions and our business could be substantially harmed.
  • We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.
  • We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • If us, our CROs or our CMOs use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Our internal computer systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Our Risks Relating to Government Regulation
  • The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community.
  • We are and will be subject to stringent privacy laws, cybersecurity laws, regulations, policies and contractual obligations related to privacy and security, and changes in such laws, regulations, policies or how they are interpreted or changes in related contractual obligations could adversely affect our business.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our relationships with prescribers, purchasers, third-party payors and patients will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Risks Relating to Our Intellectual Property
  • We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our products or product candidates.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  • Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery and development efforts.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming, and unsuccessful.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign authority.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our product candidates.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Risks Relating to the Commercialization of Our Product Candidates
  • Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
  • Biologics carry unique risks and uncertainties, which could have a negative impact on future results of operations.
  • Even if we are able to commercialize any of our product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or health care reform initiatives, which would harm our business.
  • We have no experience selling, marketing or distributing products and currently have no internal marketing and sales force. If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.
  • Risks Related to Our Common Stock
  • Our shares of common stock could be delisted from the Nasdaq Capital Market.
  • The market price of our common stock is expected to be volatile, and the market price of the common stock may drop.
  • Our Articles of Incorporation, as amended, allow for our board of directors to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.
  • Because we became public by means of a reverse acquisition, we may not be able to attract, or maintain, the attention of brokerage firms.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • General Risk Factors
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our articles of incorporation, as amended, allow for our board of directors to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.
  • Our bylaws designate a state court located in the State of Nevada and, to the extent enforceable, the U.S. federal district courts in Nevada as the exclusive forums for substantially all disputes between us and our stockholders, which will restrict the ability of stockholders to choose the judicial forum for disputes with us or our directors, officers or employees.

Legal proceedings

From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. As of the date of this Annual Report, we are not party to any material legal matters or claims other than the following:

On December 12, 2025, we filed an action filed in the Delaware Court of Chancery styled TuHURA Biosciences, Inc. v. VGXI, Inc. and GeneOne Life Sciences, Inc., C.A. No. 2025-1447-NAC (the “Action”). This is an action for breach of contract concerning the defendants’ alleged failures to produce GMP-grade plasmid DNA on a timeline that would enable us to fulfill our obligations to the FDA for our clinical trial for its Merkel cell carcinoma treatment and the defendants’ alleged fraud in inducing us to enter the contract and subsequently refrain from exercising our rights to terminate the contract and seek cover. The case is in its early stages and discovery has not yet commenced. The complaint was filed on December 12, 2025, and we are waiting for defendants’ response to the complaint. We intend to vigorously pursue our claims against the defendants while remaining open to engaging in reasonable and productive settlement discussions.

The opening of Item 3, Legal Proceedings.3

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