TuHURA Biosciences, Inc./NV

Item 1A. Risk Factors.

We are subject to various risks, including risk factors identified in our Annual Report on Form 10-K filed with the SEC on March 31, 2025. You should carefully consider those risk factors in addition to the risk factors set forth Except as set forth below and o, ther information in this Form 10-Q.

The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when approved. 

The prices of prescription pharmaceuticals have also been the subject of considerable discussion in the United States. There have been several recent U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manue have been no material changes to the risk facturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid. In addition, in October 2020, the Department of Health and Human Services (HHS) and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program (SIP), to import certain prescription drugs from Canada into the United States. That regulation was challenged in a lawsuit by the Pharmaceutical Research and Manufacturers of America (PhRMA) but the case was dismissed by a federal district court iors identified in our Annual Report on February 2023 after the court found that PhRMA did not have standing to sue HHS. Seven states (Colorado, Florida, Maine, New Hampshire, New Mexico, Texas and Vermont) have passed laws allowing for the importation of drugs from Canada. North Dakota and Virginia have passed legislation establishing workgroups to examine the impact of a state importation program.As of May orm 10-K for the year ended December 31, 2025,4 five states (Colorado, Florida, Maine, New Hampshire and New Mexico) had submitted Section 804 Importation Program proposals to the FDA. Vermont has submitted a concept letter to the HHS. On January 5led with the SEC on March 31, 2024, the FDA approved Floridas plan for Canadian drug importation. That state now has authority to import certain drugs from Canada for a period of two years once certain conditions are met. Florida will first need to submit a pre-imp5 and in our Quarterly Report request for each drug selected for importation, which must be approved by the FDA. The state will also need to relabel the drugs and perform quality testing of the products to meet FDA standards.

On August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden. The new legislation has implications for Medicare Pon Form 10-Q for the quart D, which is a program available to individuals who areer entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in ded March 31, 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces t5 which was filed with the Part D coverage gap discount program with a new discounting program (beginning in SEC on April 14, 2025). . 

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. 

Specifically, with respect to price negotiations, Congress authorized Medicare to negotifollowing risk factors reflect mate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid rial changes from those set for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. This provision applies to drug products that have been approved for at least nine years and biologics that have been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare th in our Annual Report and were previously disease or condition. Nonetheless, since CMS may establish a maximum price for these productsclosed in price negotiations, we would be fully at risk of government acour Registration if our products are the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk that we would not be able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products have beenStatement on Form S-1 (File No. 333-289532) filed with the SEC on the market for nine years.

The first cycle of negotiations for the Medicare Drug Price Negotiation Program commenced in the summer of 2023. On August 152, 2024, the HHS published the results of the first Medicare drug price negotiations for ten selected drugs that treat a range of conditions, including diabetes, chronic kidney disease, and rheumatoid arthritis. The prices of these ten drugs will become effective January 1, 2026. On October 2, 2024, in final guidance, CMS indicated that it would announce t5. These risk factors should be read in conjunction with the selection of up to 15 additional drugs covered by Part D for the second cycle of negotiations by February 1, 2025. That announcement was made on January 17, 2025. 

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Thother informatis second cycle of negotiations with participating drug companies will occur during 2025, and any negotiated prices for this second set of drugs will be effective starting January 1, 2027.

Further, the new legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated maximum fair price under the law or for taking price increases that exceed inflation. The legislation also requires manufacturers to pay rebates for drugs in Medicare Part D whose price increases exceed inflation. The new law also caps Medicare out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year. In addition, the IRA potentially raises legal rison contained in our Annual Report on Form 10-K and this Quarterly Report on Form 10-Q.

Risks with respect to individuals participating in a Medicare Part D prescription drug plan who may experience a gap in coverage if they required coverage above their initial annual coverage limit before they reached the higher threshold, or catastrophic period of the plan. Individuals requiring services exceeding the initial annual coverage limit and below the catastrophic period, must pay 100% of the cost of their prescriptions until they reach the catastrophic period. Among other things, the IRA containsRelated to the Kineta Merger

The market price of our common stock many provisions aimed at reducing this financial burden on individuals by reducing y decline in the co-insurance and co-payment costs, expanding eligibility for lower income subsidy plans, and price caps on annual out-of-pocket expenses, each future as a result of which could have potential pricing and reporting implications.

On June 6, 2023, Merck  Co. filed a lawsuit against the HHS and CMS asserting that, among other things, the IRAs Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution. Subsequently, a number of other parties, including the U.S. Chamber of Commerce, Bristol Myers Squibb Company, the PhRMA, Astellas, Novo Nordisk, Janssen Pharmaceuticals, Novartis, AstraZeneca and Boehringer Ingelheim, also filed lawsuits in various courts with similar constitutional claims against the HHS and CMS. There have been various decisions by the courts consithe sale of shares of

our common stock held by former Kineta stockholders or current stockholdering these cases since they were filed. The HHS has generally won the substantive disputes ins.

Following these cases, and various federal district court judges have expressed skepticism regarding the merits ir receipt of the legal arguments being pursued by the pharmaceutical industry. Certain shares of these cases are now on appeal and, on October 30, 2024, the Court of Appeals for the Third Circuit heard oral argument in three of these cases. In April 2025, the U.S. Court of Appeals for the Seour common stock as merger cond Circuit and the U.S. Court of Appeals for the Third Circuit heard argument in an additional three cases. On May 8, 2025, the Third Circuit rejected AstraZenecas challenge to the Medicare price negotisideration (the Merger Consideration program), finding that the program did not violate the companys due process rights under the constitution since there is no protected property interest in selling goods to Medicare beneficiaries at a price higher than what the government is willing to pormer Kineta stockholders may in reimbursement. On May 8, 2025, the Third Circuit rejected AstraZenecas challenge to tseek to sell the Medicshare price negotiation program, finding that the program did not violate the s of our companys due process rights under the Constitution since there is no protected property interest in selling goods to Medicare beneficiaries at a price higher than what the gomon stock delivernment is willing to pay in reimbursement. We expect that litigation involving these and other provisions of ed to the IRA will continue, with unpredictable and uncertain results. Accordingly, while it is currently unclear how m, and, othe IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, resultsr than former directors and executive officers of operations and financial condition. 

On April 16, 2025, the U.S. Department of Commerce (the Commerce Department) announced an investigation under Section 232 of the Trade Expansion Act of 1962 into imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. The investigation will examine the impactKineta who are subject to a lock-up of one-third of these imports on U.S. national security culminating in a decision by the President whether to take action to remedy any identified threats, including by imposing additional tariffs. The statute provides that the Commerce Department report must be completed within 270 days of initiation and that the President must decide whether to act within 90 days of  shares of TuHURA common stock they receiving the report. 

At the state level, individual states are increasingly aggressive in passing legislation and implementing regule as Merger Considerations designed to control pharmaceutical and biological product pricing, including price or patient reimburs, the TuHURA-Kineta Merger Agreement constrtaints, discounts,s no restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from oththe ability of former countries and bulk purchasing. In addition, regional health care organizations and individual hospitals are increasingly using bidding procedureKineta stockholders to determine what pharmaceutical products and which suppliers wisell be included in their prescription drug and other health care programs. These measusuch shares could reduce the ultimate demand forof our products, once approved, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. 

Recent and furtcommon stock following consummation of the Kineta Merger. Other changes in the tariff and trade policies of the United Stateholders or of other countriesur could increase manufacturing and sourcing costs, decrease demand for our offerings, disrupt supply chains, or otherwise adversely affect our business and financial condition.

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There is currentmmon stock may also seek to selly significant uncertainty about the future relationship between the United States and its trading partners, most significantly China, with respect to trade policies, tariffs, taxes, and similar policies affecting cross-border operations. For example, the U.S. government has made and continues to make significant additional changes in U.S. trade policy, specifically tariffs, and may continue to take future actions that cou shares of our common stock held negatively impact our business. The U.S. government recently escalated tariffs on the import of goods from most U.S. tradby them following partners. For example, since March 2025, the United States has placed an additional 20% tariff on most goods from China, imposed an addithe consummational 25% tariff on most products of Canada and Mexico (with an exception for goods that qualify for duty-free treatment under the U.S.-Mexico-Canada Agreement), and implemented 25% Section 232 tariffs on various artic of the Kineta Merger. These sales of steel and aluminum. In April 2025, (or the U.S. government imposed 25% Secperception 232 tariffs on passenger vehicles and lighthat trucks (with similar Section 232 tariffs on components for such vehichese sales expected to be imposed beginning in Mmay 2025); an additional reciprocal tariff of 125% on most imports from China; and an additional reciprocal tariff of 10% on most imports from U.S. trading partners other than China, Canada, Mexico, and countries occur), coupled with which the U.S. does not have normal trade relations. While certain products were excluded from some of these reciprocal tariff measures,increase including items subject to Section 232 tariffs; certain pharmaceuticals and pharmaceutical products; and certain semiconductors, computers, consumer electronics, and other products derivative of critical minerals, the scope of these exclusions is subject to change. In addition, the U.S. Department of Commerce has recently initiated Secti the outstanding number of shares of our common 232 investigations into additional products, including semiconductors and related manufacturing equipment, processed critical minerals and derivative products; and medium-dutstock, may and heavy-duty trucks and parts therefor. When these investigations are complete,ffect the U.S. government may decide to levy additional tariffs on such products.

As a result of changes in tariffs that have been announced and/or implementedmarket for, and the underlying uncertainty currently surrounding international trade, we could experienmarket price a negative impact toof, our costs of materials and production processes, and supply chain disruptions and delays as a result of any new tariff policies or trade restrictions. If we are unable to obtain necessary raw materials or product components in sufficient quantity and in a timely mmmon stock in an adverse manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clin.

We will incur significal trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business. We cannot yet predict the effect of the recently imposed U.S. tariffs on imports, or the extent to which other countries will impose quotas, duties, tariffs, taxes or other similar restrictions upon imports or exports in the future, nor can we predict future trade policy or the terms of any renegotiated trade agreements and their impact on our business.

Disruptions and changes at the United States Food and Drug Administration (the FDA) and other government agencies from funding cuts, personnel losses and changes, regulatory reform, government shutdownsnt costs in connection with the Kineta Merger.

We have incurred and other developments could hinder our abilityexpect to obtain guidance from the FDA regarding oincur clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.

The FDA and comparable regulatory agencies in foreign jurisdictions play an important role in the development of our product candidates by providia number of non-recurring guidance on our clinical development programs and reviewing our regulatory submissions, including investigational new drug applications (INDs), requests for specosts associal designations and marketing applications. If these oversight and review activities are disrupted or change, then correspondingly our ability to develop and secure timely approval of our product candidates could be impacted in a negative manner.

For example, ted with combining the recent loss of and changes in FDA leadership and personnel could lead to disruptioperations and delays in FDA guidance, review and approval of our product candidates. Pursuant to President Trumps E.O. 14210, Implementing tof the Presidents Department of Government Efficiency Workforce Optimization Initiative, the Secretary of the Department of Health and Human Services (HHS) announced on March 27, 2025, a reorganization and Reduction in Force (RIF) across HHS of approximately 20,000 employees (82,000 to 62,000), with the FDAs workforce to decrease by 3,500 full-time employees. Shortly thereafter, thousands of employees at the FDA were fired two companies, as well as transaction April 1, 2025. Subsequently, there have been reports from the preliminary budget memorandum for HHS that the administration will propose an additional 30% cut in the overall budget for HHS, with a reduction of $700 million in funding at the FDA ($7.2 billion to $6.5 billion) for the 2026 federal fiscal year.

Further, while the FDAfees and other costs review of marketing applications and other activities for new drugs and biologics is largely funded throughlated to the user fee program established under the Prescription Drug User Fee Act (PDUFA), it remains unclear how the administrations RIF, budget cuts and personnel changes will impact this program aKineta Merger. These costs and the ability of the FDA to provide guidance and review our product candidates in a timely manner. For example, while the FDA RIF did not reportedly specifically target FDA reviewers, many operations, administrative and policy staff that help support such reviews were affected and those losses could leaexpenses include fees paid to delays in PDUFA reviews and related activities. In addition, while currently unclear, there is a risk that the RIF afinancial, legal and budget cutbacks accould threaten the integrity of the PDUFA program itself. That is because, for the FDA to obligate user fees collected under PDUFA in the first place, a certain amount of non-user fee appropriations must be spent on the process for the review of applications plus certain other costs during the same fiscal year.

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There is alsnting advisors, facilities and systems co substantial uncertainty as to how regulatory reform measures being implemented by the Trump Administrnsolidation across the gocosts, severnment will impact the FDA ance and other federal agencies with jurisdiction over our activities. For example, since taking office, the President has issued a number of executive orders that could have a significant impact on the manner in which the FDA conducts its operations and engages in regupotential employment-relatory and oversight activities. These ed costs, include E.O. 14192, Unleashing Prosperity Through Deregulation, January 31, 2025; E.O. 14212, Establishing the Presidents Make America Healthy Again Commission, February 13, 2025; aretention and E.O. 14219, Ensuring Lawful Gosevernance and Implementingpayments the Presidents Department of Government Efficiency Deregulatory Initiative, February 21, 2025. If these or other orders or executive actions impose constraints on the FDAs ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. 

Similarly, actions by the U.S. government have significantly disrupted the operations of U.S. government agencies such as the National Institutes of Health, National Science Foundation, Centers for Disease Control and Prevention, and the FDA, which have traditionally provided fundinat may be made to certain our employees and Kineta employees, filing for basic research, research and development, and clinical testees, printing. These U.S. government actions have included, among other things, suspending, terminating and withhold and mailing of disbursements of funds owed under ongoing contracts, grants, anexpenses and other financial assistance agreements; declining to continue multi-year research projects for additional annual budget periods; canceling or delaying solicitations for new contract, grant and other financial assistance awards; canceling or delaying proposal evaluation processes and issuance of such new awards; substantially reducing federal agency staff responsible for managing contract and financial assistance prorelated charges.

We will also incur integrams; eliminating agency information and resources for facilitating research activity; delaying or terminating federal agency procedures for authorizing international transation costs in connections; initiating aggressive enforcement actions that may disrupt t with the operations of major research universities that are significant contributors to life sciences research in the U.S.; and threatening access to federal agency contracts and other funding awards based on companies otherwise lawful corporate policies and choice of counsel. These U.S. government actions could, directly or indirectly, significantly disrupt, delay, prevent, or increase the costs of our research and product commercialization programs, including our ability to develop new product candidateKineta Merger. There are a large number of processes, policies, conduct clinical trials, implement research collaborations with other companies or institutions, and obtain approvals to market and sell new products. 

In addition, government funding of the SEC and other government agencies on which our oprocedures, operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and the ability of the SEC to timely review our public filings, to the extent such review is necessary, and our ability to access the public markets.

Accordingly, if any of the foregoing developments , technologies and systems that must be integrated in connection with the Kineta Merger and others impact the ability of the FDA to provide us with guidance regarding our clinical development programs or delay the FDAs review and processing integration of our regulatory submissions, including INDs and new drug applications or biologics license applications, our business would be negatively ithe two compacted. Further, any future government shutdown could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operationsnies businesses.