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What changed in TuHURA Biosciences, Inc./NV's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of TuHURA Biosciences, Inc./NV's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+591 added−564 removedSource: 10-K (2026-03-31) vs 10-K (2025-03-31)

Top changes in TuHURA Biosciences, Inc./NV's 2025 10-K

591 paragraphs added · 564 removed · 344 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

182 edited+147 added−121 removed253 unchanged
Biggest changeAt the effective time of the First Merger, and subject to the terms and conditions of the Kineta Merger Agreement, each share of Kineta’s common stock, par value $0.001 per share (“Kineta Common Stock”) issued and outstanding immediately prior to the effective time of the First Merger will be converted automatically into and will represent the right to receive, without interest, the number of shares of our common stock and cash consideration each calculated according to the terms of the Kineta Merger Agreement.
Biggest changePursuant to the terms of the TuHURA-Kineta Merger Agreement, the former stockholders of Kineta received merger consideration in the amount of an aggregate of approximately 4 million shares of Company common stock pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock, par value $0.001 per share (each, a “Kineta Share”), issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of the Company’s common stock, par value $0.001 per share, for an aggregate of approximately 3 2,868,169 shares of Company common stock.
In doing so, data from a primary endpoint of objective response rate, or ORR, that is of sufficient magnitude and duration and with a favorable risk/benefit profile could be sufficient to support accelerated approval.
In doing so, data from a primary endpoint of objective response rate, or ORR, that is of sufficient magnitude and duration and with a favorable risk/benefit profile could be sufficient to support accelerated approval.
Additionally, we may terminate the agreement with written notice to Moffitt in the event Moffitt commits a material breach and such breach is not cured within sixty (60) days following Moffitt’s receipt of such notice.
Additionally, we may terminate the agreement with written notice to Moffitt in the event Moffitt commits a material breach and such breach is not cured within sixty (60) days following Moffitt’s receipt of such notice.
Upon any termination prior to the expiration of the agreement for any reason, all licenses and rights granted pursuant to the agreement will automatically terminate.
Upon any termination prior to the expiration of the agreement for any reason, all licenses and rights granted pursuant to the agreement will automatically terminate.
Product Development Process In the United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Service Act, or PHSA, and their respective implementing regulations. Products are also subject to other federal, state and local statutes and regulations.
Product Development Process In the United States, the FDA regulates pharmaceutical and/or biological products under the Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Service Act, or PHSA, and their respective implementing regulations. Products are also subject to other federal, state and local statutes and regulations.
A CRL indicates that the review cycle of the application is complete and the application will not be approved in its present form. A CRL generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application.
A CRL indicates that the review cycle of the application is complete and the application will not be approved in its present form. CRL generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application.
The FDA may also review sections of the BLA for a fast track product on a rolling basis before the complete application is submitted, if the sponsor and the FDA agree on a schedule for the submission of the application sections and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.
The FDA may also review sections of the NDA/BLA for a fast-track product on a rolling basis before the complete application is submitted, if the sponsor and the FDA agree on a schedule for the submission of the application sections and the sponsor pays any required user fees upon submission of the first section of the NDA or NDA/BLA.
The Office of Inspector General, or OIG of the US Department of Health and Human Services, or DHHS, may seek civil monetary penalties and sometimes exclusion for a wide variety of conduct and is authorized to seek different amounts of penalties and assessments based on the type of violation at issue; • the federal Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters; 40 • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, for covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their business associates and covered subcontractors that provide services to, or on behalf of, the covered entity that involve individually identifiable health information; • The Physician Payments Sunshine Act (42 USC 1320a-7h) as known as “Open Payments” is a national disclosure program created by the Affordable Care Act, or ACA, that increases transparency into financial relationships between the health care industry (such as medical device manufacturers and pharmaceutical companies) and physicians or teaching hospitals.
The Office of Inspector General, or OIG of the US Department of Health and Human Services, or DHHS, may seek civil monetary penalties and sometimes exclusion for a wide variety of conduct and is authorized to seek different amounts of penalties and assessments based on the type of violation at issue; • the federal Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, for covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their business associates and covered subcontractors that provide services to, or on behalf of, the covered entity that involve individually identifiable health information; 40 • The Physician Payments Sunshine Act (42 USC 1320a-7h) as known as “Open Payments” is a national disclosure program created by the Affordable Care Act, or ACA, that increases transparency into financial relationships between the health care industry (such as medical device manufacturers and pharmaceutical companies) and physicians or teaching hospitals.
We are also required to make the following additional payments: 24 • Various milestone royalty payments based on specified development, approval, commercialization, and sales milestones, which payments range from $37,500 to $100,000 for milestones relating to the commencement of clinical trials up to $750,000 to $1.25 million based on sales thresholds in excess of $1.0 billion in sales; and • Running royalties based on net sales of licensed products with a royalty percentage in the middle-single digit and with escalating minimum annual royalties that do not exceed $0.1 million per year; and • Payment of all patent prosecution and maintenance costs and fees for the licensed patents.
We are also required to make the following additional payments: • Various milestone royalty payments based on specified development, approval, commercialization, and sales milestones, which payments range from $37,500 to $100,000 for milestones relating to the commencement of clinical trials up to $750,000 to $1.25 million based on sales thresholds in excess of $1.0 billion in sales; and • Running royalties based on net sales of licensed products with a royalty percentage in the middle-single digit and with escalating minimum annual royalties that do not exceed $0.1 million per year; and • Payment of all patent prosecution and maintenance costs and fees for the licensed patents.
The following are summaries of the material terms of these license agreements: 2019 License Agreement with Moffitt Cancer Center In March 2019, TuHURA Biopharma, as predecessor in interest to the Company, entered into an Exclusive License Agreement with Moffitt Cancer Center, which agreement was amended in September 2019, April 2021 and August 2022 (as amended, the “2019 Moffitt Agreement”), for the worldwide, exclusive license of patents for the development, commercialization and marketing of products derived from Moffitt’s rights to patents entitled “Conjugates for Immunotherapy” and “A Delta-Opioid Receptor Targeted 23 Agent For Molecular Imaging And Immunotherapy Of Lung Cancer” (the “2019 Moffitt Licensed Patents”).
The following are summaries of the material terms of these license agreements: 2019 License Agreement with Moffitt Cancer Center In March 2019, TuHURA Biopharma, as predecessor in interest to the Company, entered into an Exclusive License Agreement with Moffitt Cancer Center, which agreement was amended in September 2019, April 2021 and August 2022 (as amended, the “2019 Moffitt Agreement”), for the worldwide, exclusive license of patents for the development, commercialization and marketing of products derived from Moffitt’s rights to patents entitled “Conjugates for Immunotherapy” and “A Delta-Opioid Receptor Targeted Agent For Molecular Imaging And Immunotherapy Of Lung Cancer” (the “2019 Moffitt Licensed Patents”).
WVURC has the right to terminate, or convert all exclusive licenses to nonexclusive licenses in the event we fail to make payments due under the agreement within thirty (30) days following notice from WVURC; commit a material breach that is not cured, or capable of being cured, within ninety (90) days after receipt of notice from WVURC; or challenge the validity of any of the WVU Patents before a court or other administrative agency in any jurisdiction.
WVURC has the right to terminate, or convert all exclusive licenses to nonexclusive licenses in the event we fail to make payments due under the agreement within thirty (30) days following notice from WVURC; commit a material breach that is not cured, or capable of being cured, within ninety (90) days after receipt of notice from WVURC; or challenge the validity of any of the WVU Patents before a court or other 26 administrative agency in any jurisdiction.
Secondary objectives include tumor shrinkage (injected and non-injected lesions) and 16 correlative immune response analysis (transcriptomic, proteomic, humoral and cellular), pre-and post-IFx-2.0 administration to guide the choice of dose and schedule for our Phase 3 registration directed trial. Twenty-three (23) patients were enrolled: Merkel cell carcinoma (13), cSCC (10).
Secondary objectives include tumor shrinkage (injected and non-injected lesions) and correlative immune response analysis (transcriptomic, proteomic, humoral and cellular), pre-and post-IFx-2.0 administration to guide the choice of dose and schedule for our Phase 3 registration directed trial. Twenty-three (23) patients were enrolled: Merkel cell carcinoma (13), cSCC (10).
The Centers for Medicare & Medicaid Services, or CMS, collects data annually, and makes it publicly available and searchable online at openpaymentsdata.cms.gov. Applicable manufacturers are also be required to report information related to payments and other transfers of value provided in the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
The Centers for Medicare & Medicaid Services, or CMS, collects data annually, and makes it publicly available and searchable online at openpaymentsdata.cms.gov. Applicable manufacturers are also required to report information related to payments and other transfers of value provided in the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
If reports of requested pediatric studies are 33 submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application.
If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application.
The optimal cancer immunotherapy would make a patient’s entire tumor appear foreign and activate an innate immune response through the comprehensive and efficient packaging of tumor neoantigens which are presented to cytotoxic T cells, leading to their priming, activation, and proliferation of an immune attack against the tumor. Our IFx Technology is designed to accomplish this goal.
The optimal cancer immunotherapy would make a patient’s entire tumor appear foreign and activate an innate immune response through the comprehensive and efficient packaging of tumor neoantigens which are 8 presented to cytotoxic T cells, leading to their priming, activation, and proliferation of an immune attack against the tumor. Our IFx technology is designed to accomplish this goal.
Our Clinical Development Program For purposes of the below descriptions of our Phase 1 and 1b clinical trials, the response rates for IFx-2.0 are determined under best clinical practice by the principal investigators, evaluating and confirming clinical progression prior to or during therapy utilizing conventional and appropriate radiographic or metabolic (Positron Emission Tomography – PET) methodologies.
TuHURA's IFx Clinical Development Program For purposes of the below descriptions of our Phase 1 and 1b clinical trials, the response rates for IFx-2.0 are determined under best clinical practice by the principal investigators, evaluating and confirming clinical progression prior to or during therapy utilizing conventional and appropriate radiographic or metabolic (Positron Emission Tomography – PET) methodologies.
Concordant (near-complete) radiographic response of liver metastases has also been observed and response has been maintained to date (19 months) 18 Case study (MCC-002) Subject was treated with adjuvant pembrolizumab for stage II Merkel cell carcinoma on the STAMP trial but developed (nodal) progression after receiving 6 doses.
Concordant (near-complete) radiographic response of liver metastases has also been observed and response has been maintained to date (19 months) Case study (MCC-002) Subject was treated with adjuvant pembrolizumab for stage II Merkel cell carcinoma on the STAMP trial but developed (nodal) progression after receiving 6 doses.
In addition, the discovery of conditions that violate these rules, including failure to conform to cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including, among other things, voluntary recall and regulatory sanctions as described below.
In addition, the discovery of conditions that violate these rules, including failure to conform to cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved NDA/BLA, including, among other things, voluntary recall and regulatory sanctions as described below.
Historically, products launched in the European Union do not follow price structures of the United States and generally tend to be significantly lower. 39 The downward pressure on health care costs in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.
Historically, products launched in the European Union do not follow price structures of the United States and generally tend to be significantly lower. The downward pressure on health care costs in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.
The process required by the FDA before a biological product may be marketed in the United States generally involves the following: • completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations; • submission to the FDA of an investigational new drug, or IND, application, which must become effective before human clinical trials may begin; • approval by an independent institutional review board, or IRB, or ethics committee at each clinical trial site before each clinical trial may be initiated; 27 • performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as Good Clinical Practice, or GCP, and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the proposed biological product for its intended use; • submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical testing and clinical trials; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current Good Tissue Practices, or cGTPs, for the use of human cellular and tissue products; • potential FDA audit of the trial and clinical trial sites that generated the data in support of the BLA; and • FDA review and approval, or licensure, of the BLA.
The process required by the FDA before a pharmaceutical and/or biological products may be marketed in the United States generally involves the following: • completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations; • submission to the FDA of an investigational new drug, or IND, application, which must become effective before human clinical trials may begin; • approval by an independent institutional review board, or IRB, or ethics committee at each clinical trial site before each clinical trial may be initiated; • performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as Good Clinical Practice, or GCP, and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the proposed biological product for its intended use; • submission to the FDA of an NDA/NDA/BLA for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical testing and clinical trials; • satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the pharmaceutical and/or biological products is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current Good Tissue Practices, or cGTPs, for the use of human cellular and tissue products; • potential FDA audit of the trial and clinical trial sites that generated the data in support of the NDA/NDA/BLA; and • FDA review and approval, or licensure, of the NDA/NDA/BLA.
Intratumoral injection is thought to trigger both local and systemic immunological responses leading to tumor cell lysis, the release of tumor-associated antigens into the tumor microenvironment where they need to be recognized by antigen presenting cells leading to subsequent activation of innate and adaptive immune systems to induce tumor antigen-specific effector T-cell antitumor immunity. Tumor-associated antigen vaccines .
Intratumoral injection is thought to trigger both local and systemic immunological responses leading to tumor cell lysis, the release of tumor-associated antigens into the 9 tumor microenvironment where they need to be recognized by antigen presenting cells leading to subsequent activation of innate and adaptive immune systems to induce tumor antigen-specific effector T-cell antitumor immunity. Tumor-associated antigen vaccines .
This causes antigen presenting cells like DCs to phagocytize (which is the process of “eating” and “digesting”) the tumor cell, thinking they are bacteria. DCs present the captured neoantigens on MHCI and MHCII molecules to T cells, resulting in the priming and activation of cytotoxic T cell responses against these cancer-specific neoantigens, which are viewed as foreign.
This causes antigen presenting cells (APCs) like DCs to phagocytize (which is the process of “eating” and “digesting”) the tumor cell, thinking they are bacteria. DCs present the captured neoantigens on MHCI and MHCII molecules to T cells, resulting in the priming and activation of cytotoxic T cell responses against these cancer-specific neoantigens, which are viewed as foreign.
The biological product is evaluated in a limited patient population to identify possible safety risks (adverse effects), optimize dosing and preliminarily evaluate the efficacy of the product for specific targeted diseases. • phase 3. Clinical trials are undertaken in an expanded patient population to further evaluate dosage, clinical efficacy, and safety, often at geographically dispersed trial sites.
The product is evaluated in a limited patient population to identify possible safety risks (adverse effects), optimize dosing and preliminarily evaluate the efficacy of the product for specific targeted diseases. • phase 3. Clinical trials are undertaken in an expanded patient population to further evaluate dosage, clinical efficacy, and safety, often at geographically dispersed trial sites.
Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.
Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. An IND becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.
Following completion of IFx-2.0 protocol therapy, subject was rechallenged with pembrolizumab, a checkpoint inhibitor, and experienced an obvious clinical response initially apparent approximately 3-4 weeks into therapy. Clinical response at 3 months (middle photo below) and 6 months (right photo below) are shown in the photos below.
Following completion of IFx-2.0 16 protocol therapy, subject was rechallenged with pembrolizumab, a checkpoint inhibitor, and experienced an obvious clinical response initially apparent approximately 3-4 weeks into therapy. Clinical response at 3 months (middle photo below) and 6 months (right photo below) are shown in the photos below.
The investigational biological product candidate is initially introduced into human subjects to test for safety, dosage tolerance, absorption, metabolism, distribution and excretion. The initial human testing is often conducted in patients, rather than in healthy volunteers, in the case of products for severe or life-threatening diseases. • phase 2.
The investigational product candidate is initially introduced into human subjects to test for safety, dosage tolerance, absorption, metabolism, distribution and excretion. The initial human testing is often conducted in patients, rather than in healthy volunteers, in the case of products for severe or life-threatening diseases. • phase 2.
The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
The FDA reviews the NDA/NDA/BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
If there are any modifications to the product, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or a supplement, which may require the applicant to develop additional data or conduct additional preclinical studies and clinical trials.
If there are any modifications to the product, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA/BLA or a supplement, which may require the applicant to develop additional data or conduct additional preclinical studies and clinical trials.
We continuously reassess the number and type of patent applications, as well as the pending and issued patent claims to pursue maximum coverage and value for our processes, and compositions, given existing patent office rules and regulations. Further, claims may be modified during patent prosecution to meet our intellectual property and business needs.
We continuously reassess the number and type of patent applications, as well as the pending and issued patent claims to pursue maximum coverage and value for our processes, and compositions, given existing 22 patent office rules and regulations. Further, claims may be modified during patent prosecution to meet our intellectual property and business needs.
The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
The FDA may refer applications for novel products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
Reference pricing used by various EU Member States and parallel distribution (arbitrage between low-priced and high- priced member states) can further reduce prices. Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements. Other U.S.
Reference pricing used by various EU Member States and parallel distribution (arbitrage between low-priced and high- priced member states) can further reduce prices. Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements. 39 Other U.S.
Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDA/NDA/BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. For immunotherapy products, the FDA also will not approve the product if the manufacturer is not in compliance with the cGTPs, to the extent applicable.
The FDA will not approve the product unless it determines that the manufacturing processes and facilities are compliant with cGMP requirements and adequate to assure consistent production of the product within required specifications. For immunotherapy products, the FDA also will not approve the product if the manufacturer is not in compliance with the cGTPs, to the extent applicable.
Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and deny approval or may require additional clinical or other data and information. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data.
Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the NDA/BLA does not satisfy its regulatory criteria for approval and deny approval or may require additional clinical or other data and information. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol, GCP, or other IRB requirements, or if the investigational product has been associated with unexpected serious harm to patients.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the 32 clinical protocol, GCP, or other IRB requirements, or if the investigational product has been associated with unexpected serious harm to patients.
Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use will be disclosed publicly by the FDA; the posting will also indicate whether the drug or biologic is no longer designated as an orphan drug.
Orphan drug designation must be requested before submitting an NDA/BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use will be disclosed publicly by the FDA; the posting will also indicate whether the drug or biologic is no longer designated 36 as an orphan drug.
Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method 21 for manufacturing it may be extended.
Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
Gram-positive bacterial proteins are recognized by Toll Like Receptor-2 (TLR-2) on antigen presenting cells, which engulf and ingest the entire intact tumor cell packaging all the foreign tumor neoantigens presenting them to and educating tumor killing T cells and B cells.
Gram-positive bacterial proteins are mostly recognized by Toll Like Receptor-2 (TLR-2) on antigen presenting cells, which engulf and ingest the entire intact tumor cell packaging all the foreign tumor neoantigens presenting them to and educating tumor killing T cells and B cells.
By mimicking a 10 bacterium, our technology makes a tumor cell look like bacteria. By making a tumor look like a bacterium, the molecular pattern of the bacterial protein is recognized by specific receptors on immune cells called pattern recognition receptors, also referred to as toll-like receptors or TLRs.
By mimicking a bacterium, our technology makes a tumor cell look like bacteria. By making a tumor look like a bacterium, the molecular pattern of the bacterial protein is recognized by specific receptors on immune cells called pattern recognition receptors, also referred to as toll-like receptors or TLRs.
Under the Prescription Drug User Fee Act, as amended, or PDUFA, each BLA must be accompanied by a significant user fee, and the sponsor of an approved BLA is also subject to an annual program fee. The FDA adjusts the PDUFA user fees on an annual basis.
Under the Prescription Drug User Fee Act, as amended, or PDUFA, each NDA/NDA/BLA must be accompanied by a significant user fee, and the sponsor of an approved NDA/NDA/BLA is also subject to an annual program fee. The FDA adjusts the PDUFA user fees on an annual basis.
For all BLAs, the ten and six-month time periods run from the filing date; for most other original applications, the ten and six-month time periods run from the submission date. Despite these review goals, it is not uncommon for FDA review of a BLA to extend beyond the goal date.
For all NDA/NDA/BLAs, the ten and six-month time periods run from the filing date; for most other original applications, the ten and six-month time periods run from the submission date. Despite these review goals, it is not uncommon for FDA review of a NDA/NDA/BLA to extend beyond the goal date.
A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months for an original BLA from the date of filing.
A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months for an original NDA/BLA from the date of filing.
The antibody carries the cancer fighting payload to the tumor cell improving the selectivity of the resulting anti-cancer activity. Next generation ADCs incorporate non-chemotherapeutic technologies to interfere with tumor cell cycle growth or to carry with the antibody a checkpoint inhibitor (so called “checkpoint ADCs”).
The antibody carries the payload to the tumor cell, improving the selectivity of the resulting anti-cancer activity. Next generation ADCs incorporate non-chemotherapeutic technologies to interfere with tumor cell cycle growth or to carry with the antibody a checkpoint inhibitor (so called “checkpoint ADCs”).
To exhibit their immunosuppressive phenotype, MDSCs have to be recruited to the tumor site, transitioning to tumor associated MDSCs which display maximum immunosupressive properties. This process is mediated mainly by chemokines secreted in the tumor microenvironment 14 and chemokine receptors expressed on MDSCs.
To exhibit their immunosuppressive phenotype, MDSCs have to be recruited to the tumor site, transitioning to tumor associated MDSCs which display maximum immunosupressive properties. This process is mediated mainly by chemokines secreted in the tumor microenvironment and chemokine receptors expressed on MDSCs.
Failure to obtain regulatory approvals or the restriction, suspension or revocation of regulatory approvals or licenses, as well as any 26 other failure to comply with regulatory requirements, would have a material adverse effect on our business, financial condition and results of operations.
Failure to obtain regulatory approvals or the restriction, suspension or revocation of regulatory approvals or licenses, as well as any other failure to comply with regulatory requirements, would have a material adverse effect on our business, financial condition and results of operations.
Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.
Any of these limitations on approval or marketing could restrict the commercial 37 promotion, distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.
The licenses granted by Moffitt are sublicensable by the Company to affiliates and third parties, subject to certain requirements, including providing Moffitt with a copy of each executed sublicense agreement, and ensuring that the sublicensee comply with the terms of the 2021 Moffitt Agreement.
The licenses granted 25 by Moffitt are sublicensable by the Company to affiliates and third parties, subject to certain requirements, including providing Moffitt with a copy of each executed sublicense agreement, and ensuring that the sublicensee comply with the terms of the 2021 Moffitt Agreement.
The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the NDA/NDA/BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
These license agreements were originally entered into with Moffitt and WVURC by TuHURA Biopharma, which assigned its interest under the agreements to us as a part of the acquisition of certain TuHURA Biopharma assets in January 2023.
These license agreements were originally entered into with Moffitt and WVURC by TuHURA Biopharma which assigned its interest under the agreements to TuHURA as a part of the acquisition of certain TuHURA Biopharma assets in January 2023.
Finally, the activated cytotoxic T cells traffic to and infiltrate the tumor bed, specifically recognizing and binding to cancer cells through the interaction between its T cell receptor (“TCR”) and its cognate antigen bound to MHCI and kill their target cancer cell.
Finally, the activated cytotoxic T cells traffic to and infiltrate the tumor bed, specifically recognizing and binding to cancer cells through the interaction between its T cell receptor and its cognate antigen bound to MHCI and kill their target cancer cell.
Furthermore, OCE requested that we consider incorporating a key secondary endpoint that is of clinical benefit, such that results from a key secondary endpoint of progression-free survival, or PFS, that is adequately powered with statistical assumptions in the statistical analysis plan provided to the FDA, if achieved without a detrimental effect on overall survival, or OS, could be adequate to support conversion to regular approval satisfying the requirement for a confirmatory trial.
Furthermore, OCE requested that the Company consider incorporating a key secondary endpoint that is of clinical benefit such that results from a key secondary endpoint of progression-free survival, or PFS, that is adequately powered with statistical assumptions in the statistical analysis plan provided to the FDA, if achieved without a detrimental effect on overall survival, or OS, could be adequate to support conversion to regular approval satisfying the requirement for a confirmatory trial.
Once an approval of a product is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Once approval of a product is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
We currently lease approximately 12,199 square feet of office and laboratory space under a lease that is due to expire in March 2026. We believe that such office and laboratory space will be sufficient for our planned operations for the foreseeable future. Corporate Information Our principal executive offices are located at 10500 University Center Drive, Suite 110, Tampa, Florida 33612.
We currently lease approximately 12,199 square feet of office and laboratory space under a lease that is due to expire in March 2028. We believe that such office and laboratory space will be sufficient for our planned operations for the foreseeable future. Corporate Information Our principal executive offices are located at 10500 University Center Drive, Suite 110, Tampa, Florida 33612.
Our study is designed to determine if IFx-2.0 can increase the objective response rate when used as adjunctive therapy to Keytruda in first line treatment of checkpoint inhibitor naïve patients with advanced Merkel cell carcinoma when compared to Keytruda alone. Note: “FPI” means first patient in, “LPI” means last patient in, and “TLR” means top-line results.
TuHURA’s study, is designed to determine if IFx-2.0 can increase the objective response rate when used as adjunctive therapy to Keytruda in first line treatment of checkpoint inhibitor naïve patients with advanced Merkel cell carcinoma when compared to Keytruda alone. Note: “FPI” means first patient in, “LPI” means last patient in, and “TLR” means top-line results.
These 7 patients are graphically presented below: This data demonstrating the potential for IFx-2.0 to overcome primary resistance to anti-PD(L)-1 therapy and formed the clinical rationale for examining IFx-2.0 as adjunctive therapy with Keytruda® (anti-PD-1) in first line therapy among checkpoint 17 inhibitor naïve patients with advanced or metastatic Merkel cell carcinoma.
These 7 patients are graphically presented below: 15 This data demonstrating the potential for IFx-2.0 to overcome primary resistance to anti-PD(L)-1 therapy and formed the clinical rationale for examining IFx-2.0 as adjunctive therapy with Keytruda® (anti-PD-1) in first line therapy among checkpoint inhibitor naïve patients with advanced or metastatic Merkel cell carcinoma.
Government authorities in the United States (at the federal, state and local levels) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of biopharmaceutical products such as those we are developing.
Government authorities in the United States (at the federal, state and local levels) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical and/or biopharmaceutical products such as those we are developing.
The study population, dose, schedule, and study design for the trial are based on the response rates observed in our Phase 1b trial in checkpoint inhibitor naïve patients with advanced Merkel cell carcinoma who exhibited primary resistance to anti PD(L)-1 checkpoint inhibitors such as Keytruda® The clinical study design for the Phase 3 registration trial is presented below.
The study population, dose, schedule, and study design for the trial are based on the response rates observed in the Company’s Phase 1b trial in checkpoint inhibitor naïve patients with advanced Merkel cell carcinoma who exhibited primary resistance to anti PD(L)-1 checkpoint inhibitors such as Keytruda ® The clinical study design for the Phase 3 registration trial is presented below.
Our candidates must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in a foreign country.
Our candidates must be approved by the FDA 30 before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in a foreign country.
The discovery that the Delta receptor is highly expressed on MDSCs was jointly discovered by scientists at Moffitt Cancer Center and TuHURA Biopharma, a separate company whose intellectual property assets we acquired in January 2023. Our CEO, Dr. James Bianco, is a 30-year veteran of the biopharmaceutical industry. Dr.
The discovery that the Delta receptor is highly expressed on MDSCs was jointly discovered by scientists at Moffitt Cancer Center and TuHURA Biopharma, a separate company whose intellectual property assets we acquired in January 2023. Our CEO, Dr. James Bianco, is a 33-year veteran of the biopharmaceutical industry. Dr.
Our IFx platform technology utilizes a proprietary plasmid DNA (“pDNA”) or messenger RNA (“mRNA”) which, when introduced into a tumor cell, results in the expression of a highly immunogenic gram positive bacterial protein (Emm55) from a rare variant of Streptococcus pyogenes on the surface of the tumor cell. This is graphically demonstrated above.
TuHURA's IFx platform technology utilizes a proprietary plasmid DNA (“pDNA”) or messenger RNA (“mRNA”) which, when introduced into a tumor cell, results in the expression of a highly immunogenic gram positive bacterial protein (Emm55) from a rare variant of Streptococcus pyogenes on the surface of the tumor cell. This is graphically demonstrated above.
To our knowledge we are the only company developing APCs or ADCs targeting MDSCs where our APCs, and ADCs are designed to be bi-specific/ bi-functional, i.e. , affecting two targets and having two functions: inhibiting tumor associated MDSC-related immune suppression and thereby making tumor susceptible to attack, while localizing checkpoint inhibitors where the tumor resides.
To our knowledge we are the only company developing ADCs targeting MDSCs where our ADCs are designed to be bi-specific/ bi-functional, i.e. , affecting two targets and having two functions: inhibiting tumor associated MDSC-related immune suppression and thereby making tumor susceptible to attack, while localizing checkpoint inhibitors where the tumor resides.
The CRL may require additional clinical or other data, additional pivotal phase 3 clinical trial(s) and/or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. If a CRL is issued, the applicant may choose to either resubmit the BLA addressing all of the deficiencies identified in the letter, or withdraw the application.
The CRL may require additional clinical or other data, additional pivotal phase 3 clinical trial(s) and/or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. If a CRL is issued, the applicant may choose to either resubmit the NDA/BLA addressing all the deficiencies identified in the letter, or withdraw the application.
If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in response to an issued CRL in either two or six months depending on the type of information included.
If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA/BLA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in response to an issued CRL in either two or six months 34 depending on the type of information included.
Consistent with the FDA’s Project Front Runner initiative, the FDA recommended investigating IFx-2.0 in the front line treatment setting rather than in patients who are progressing on checkpoint inhibitor therapy, the latter of which was the conduct in the phase 1b trial.
Consistent with the FDA’s Project Front Runner initiative, the FDA recommended the Company consider investigating IFx-2.0 in the front line treatment setting rather than in patients who are progressing on checkpoint inhibitor therapy, the latter of which was the conduct in the phase 1b trial.
Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.
Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies and are subject to risk-based, periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.
In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.
In this event, the NDA/NDA/BLA must be resubmitted with the additional information. The resubmitted application is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA/NDA/BLA.
Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Future inspections by the FDA and other regulatory agencies may identify compliance issues at the facilities of our contract manufacturing organizations, or CMOs, that may disrupt production or distribution or require substantial resources to correct.
Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Future inspections by the FDA and other regulatory agencies may identify compliance issues at the facilities of our contract development and manufacturing organizations, or CDMOs, that may disrupt production or distribution or require substantial resources to correct.
With this classification, commercial production of its potential products will need to occur in registered and licensed facilities in compliance with current good manufacturing practices (cGMP) established by the FDA for biologics.
With this classification, commercial production of its potential products will need to occur in registered and licensed facilities in compliance with current good manufacturing practices (cGMP) established by the FDA..
The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product.
The manufacturing process must be capable of consistently producing quality batches of the candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final product.
In particular, we are a party to a March 2019 Exclusive License Agreement with Moffitt Cancer Center under which, as amended, we license patent rights co-owned by Moffitt and University of South Florida relating to ADCs for immunotherapy and Delta receptor targeted agents for molecular imaging and immunotherapy of lung cancer.
In particular, TuHURA is a party to a March 2019 Exclusive License Agreement with Moffitt Cancer Center under which, as amended, we license patent rights co- owned by Moffitt and University of South Florida relating to ADCs for immunotherapy and Delta receptor targeted agents for molecular imaging and immunotherapy of lung cancer.
Sponsors typically use the end of phase 2 meeting to discuss their phase 2 clinical results with the agency and to present their plans for the pivotal phase 3 studies that they believe will support approval of the new drug or biological product. Human immunotherapy products are a new category of therapeutics.
Sponsors typically use the end of phase 2 meeting to discuss their phase 2 clinical results with the agency and to present their plans for the pivotal phase 3 studies that they believe will support approval of the new drug or biological product. Human immunotherapy products are rapidly evolving category of therapeutics.
In addition, MDSCs circulating in the blood of patients with cancer is highly correlated to poor clinical outcome. 12 We believe that inhibiting and reprograming MDSC function represents a promising novel approach to overcome MDSC-induced tumor microenvironment immunosuppression and the resulting acquired resistance to cancer immunotherapies.
In addition, MDSCs circulating in the blood of patients with leukemia is highly correlated to poor clinical outcome. 11 We believe that inhibiting and reprograming MDSC function represents a promising novel approach to overcome MDSC-induced tumor microenvironment immunosuppression and the resulting acquired resistance to cancer immunotherapies.
An EU Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the ompany placing the medicinal product on the market.
An EU Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.
In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the quality and long-term stability of the product. We expect to rely on third parties for the production of clinical and commercial quantities of our potential products in accordance with cGMP regulations.
In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the quality and long-term stability of the product. We expect to rely on third parties to produce clinical and commercial quantities of our potential products in accordance with cGMP regulations.
Under normal conditions, MDSCs represent less than 2% of circulating peripheral blood mononuclear cells (PBMCs) and lack potent immune suppressing characteristics In cancer, MDSCs are hijacked by tumors to create an immunosuppressive environment in the tissues in which the tumor lives. MDSCs are the primary driver of the immunosuppressive tumor microenvironment.
Under normal conditions, MDSCs represent less than 2% of circulating peripheral blood mononuclear cells (PBMCs) and lack potent immune suppressing characteristics In cancer, MDSCs are hijacked by tumors to create an immunosuppressive environment in the tissues in which the tumor lives.
In addition, the FDA will not recognize orphan drug exclusivity if a sponsor fails to demonstrate upon approval that the product is clinically superior to a previously approved product containing the same active moiety for the same orphan condition, regardless of whether or not the approved product was designated an orphan drug or had orphan drug exclusivity.
In addition, the FDA will not recognize orphan drug exclusivity if a sponsor fails to demonstrate upon approval that the product is clinically superior to a previously approved product for the same orphan condition, regardless of whether or not the approved product was designated an orphan drug or had orphan drug exclusivity.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose clinical holds on a biological product candidate at any time before or during a clinical trial due to safety concerns or non-compliance.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose clinical holds on a pharmaceutical and/or biological products/candidate at any time before or during a clinical trial due to safety concerns or non-compliance.
On the basis of the FDA’s evaluation of the BLA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue either an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
Based on the FDA’s evaluation of the NDA/BLA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue either an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
Concurrently with clinical trials, companies usually complete additional studies and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Concurrently with clinical trials, companies usually complete additional studies and must also develop additional information about the physical characteristics of the pharmaceutical and/or biological products as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
Within 60 days following submission of the application, the FDA reviews an NDA/BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may Refuse-to-File (RTF) any NDA/NDA/BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our product candidates. 43 • If we fail to attract and keep key personnel and members of management, we may be unable to successfully develop any of our existing or future product candidates, conduct our in-licensing and development efforts and commercialize any of our existing or future products. • Any failure by us to protect our intellectual property rights or maintain the right to use certain intellectual property may negatively affect our ability to compete. • Failure to complete the Kineta Merger could negatively impact our stock price, future business and financial results. • Even if we consummate the Kineta Merger, we may not realize the anticipated benefits of the Kineta Merger. • We expect to obtain financing in connection with the Kineta Merger and cannot guarantee that we will be able to complete such financing. • We expect that the price of our common shares will fluctuate substantially. • The potential significant amount of any costs, fees, expenses, impairments or charges related to the Kineta Merger.
Biggest changeIf these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our product candidates. • If we fail to attract and keep key personnel and members of management, we may be unable to successfully develop any of our existing or future product candidates, conduct our in-licensing and development efforts and commercialize any of our existing or future products. • Any failure by us to protect our intellectual property rights or maintain the right to use certain intellectual property may negatively affect our ability to compete. • We expect that the price of our common shares will fluctuate substantially. • Our shares of common stock could be delisted from Nasdaq Capital Market.
Restrictions under applicable domestic and foreign health care laws and regulations include, but are not limited to, the following: • the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal health care program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • U.S. federal false claims, false statements and civil monetary penalties laws, including the US False Claims Act, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; actions may be brought by the government or a whistleblower and may include an assertion that a claim for payment by federal health care programs for items and services which results from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; • HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any health care benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • analogous state and foreign laws and regulations relating to health care fraud and abuse, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving health care items or services reimbursed by non-governmental third-party payors, including private insurers; • the FCPA and other anti-corruption laws and regulations pertaining to our financial relationships and interactions with foreign government officials; • the U.S. federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act,” which requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Centers for Medicare & Medicaid Services (“CMS”), information related to physician payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as the ownership and 70 investment interests of physicians and their immediate family members.
Restrictions under applicable domestic and foreign health care laws and regulations include, but are not limited to, the following: • the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal health care program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • U.S. federal false claims, false statements and civil monetary penalties laws, including the US False Claims Act, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; actions may be brought by the government or a whistleblower and may include an assertion that a claim for payment by federal health care programs for items and services which results from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; • HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any health care benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • analogous state and foreign laws and regulations relating to health care fraud and abuse, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving health care items or services reimbursed by non-governmental third-party payors, including private insurers; • the FCPA and other anti-corruption laws and regulations pertaining to our financial relationships and interactions with foreign government officials; • the U.S. federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act,” which requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Centers for Medicare & Medicaid Services (“CMS”), information related to physician payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as the ownership and investment interests of physicians and their immediate family members.
Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following: • collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; • collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities; 61 • collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; • a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution; • collaborators may not properly maintain or defend our intellectual property rights, or may use its intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; • disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources; • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and collaborators may own or co-own intellectual property covering our products that results from our collaborations with them, and in such cases, we would not have the exclusive right to commercialize such products.
Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following: • collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; • collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities; • collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; • a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution; • collaborators may not properly maintain or defend our intellectual property rights, or may use its intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; • disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources; • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and collaborators may own or co-own intellectual property covering our products that results from our collaborations with them, and in such cases, we would not have the exclusive right to commercialize such products.
Beginning in 2022, applicable manufacturers are required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year; • analogous state and foreign laws that require pharmaceutical companies to track, report and disclose to the government and/or the public information related to payments, gifts, and other transfers of value or remuneration to physicians and other health care providers, marketing activities or expenditures, or product pricing or transparency information, or that require pharmaceutical companies to implement compliance programs that meet certain standards or to restrict or limit interactions between pharmaceutical manufacturers and members of the health care industry; • the U.S. federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under federal health care programs; • HIPAA, which imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses and their business associates that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and • state and foreign laws that govern the privacy and security of health information in certain circumstances, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Beginning in 2022, applicable manufacturers are required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year; • analogous state and foreign laws that require pharmaceutical companies to track, report and disclose to the government and/or the public information related to payments, gifts, and other transfers of value or remuneration to physicians and 74 other health care providers, marketing activities or expenditures, or product pricing or transparency information, or that require pharmaceutical companies to implement compliance programs that meet certain standards or to restrict or limit interactions between pharmaceutical manufacturers and members of the health care industry; • the U.S. federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under federal health care programs; • HIPAA, which imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses and their business associates that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and • state and foreign laws that govern the privacy and security of health information in certain circumstances, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Several factors will influence whether our product candidates are accepted in the market, including: • the clinical indications for which our product candidates are approved; • physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment; • the potential and perceived advantages of our product candidates over alternative treatments; • the prevalence and severity of any side effects; • product labeling or product insert requirements of the FDA or other regulatory authorities; • limitations or warnings contained in the labeling approved by the FDA; • the size of the market for such drug candidate, based on the size of the patient subsets that we are targeting, in their territories for which we gain regulatory approval and have commercial rights; • the safety of the drug candidate as demonstrated through broad commercial rights; • the adequacy of supply of our product candidates; • the timing of market introduction of our product candidates as well as competitive products; • the cost of treatment in relation to alternative treatments; • the amount of upfront costs or training required for physicians to administer our product candidates; • the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities; • the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities; • support from patient advocacy groups; • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and • the effectiveness of our sales and marketing efforts.
Several factors will influence whether our product candidates are accepted in the market, including: • the clinical indications for which our product candidates are approved; • physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment; 70 • the potential and perceived advantages of our product candidates over alternative treatments; • the prevalence and severity of any side effects; • product labeling or product insert requirements of the FDA or other regulatory authorities; • limitations or warnings contained in the labeling approved by the FDA; • the size of the market for such drug candidate, based on the size of the patient subsets that we are targeting, in their territories for which we gain regulatory approval and have commercial rights; • the safety of the drug candidate as demonstrated through broad commercial rights; • the adequacy of supply of our product candidates; • the timing of market introduction of our product candidates as well as competitive products; • the cost of treatment in relation to alternative treatments; • the amount of upfront costs or training required for physicians to administer our product candidates; • the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities; • the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities; • support from patient advocacy groups; • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and • the effectiveness of our sales and marketing efforts.
Our ability to generate revenue and achieve profitability depends significantly on our success in many endeavors, including: • completing research regarding, and nonclinical and clinical development of, our product candidates; • obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical trials; • developing a sustainable and scalable manufacturing process for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure; • launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor; • obtaining market acceptance of our product candidates as viable treatment options; • addressing any competing technological and market developments; • identifying, assessing, acquiring and/or developing new product candidates; 45 • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; • maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and • attracting, hiring, and retaining qualified personnel.
Our ability to generate revenue and achieve profitability depends significantly on our success in many endeavors, including: • completing research regarding, and nonclinical and clinical development of, our product candidates; • obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical trials; • developing a sustainable and scalable manufacturing process for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure; • launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor; • obtaining market acceptance of our product candidates as viable treatment options; • addressing any competing technological and market developments; • identifying, assessing, acquiring and/or developing new product candidates; • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; • maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and • attracting, hiring, and retaining qualified personnel.
In addition, clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to: • obtaining regulatory approval to begin a trial, if applicable; • the availability of financial resources to begin and complete the planned trials; • reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • obtaining approval at each clinical trial site by an IRB; • recruiting suitable patients to participate in a trial in a timely manner; • having patients complete a trial or return for post-treatment follow-up; • clinical trial sites deviating from trial protocol, not complying with GCP, or dropping out of a trial; • addressing any patient safety concerns that arise during the course of a trial; 64 • addressing any conflicts with new or existing laws or regulations; • adding new clinical trial sites; or • manufacturing qualified materials under cGMP for use in clinical trials.
In addition, clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to: • obtaining regulatory approval to begin a trial, if applicable; • the availability of financial resources to begin and complete the planned trials; • reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • obtaining approval at each clinical trial site by an IRB; • recruiting suitable patients to participate in a trial in a timely manner; • having patients complete a trial or return for post-treatment follow-up; • clinical trial sites deviating from trial protocol, not complying with GCP, or dropping out of a trial; • addressing any patient safety concerns that arise during the course of a trial; • addressing any conflicts with new or existing laws or regulations; • adding new clinical trial sites; or • manufacturing qualified materials under cGMP for use in clinical trials.
Some of the factors that may cause the market price of our common stock to fluctuate include: • results of clinical trials and preclinical studies of our current and future potential product candidates, or those of our competitors or our existing or future collaborators; • failure to meet or exceed financial and development projections we may provide to the public; • failure to meet or exceed the financial and development projections of the investment community; 77 • failure of us to achieve the perceived benefits of the Kintara Merger as rapidly or to the extent anticipated by financial or industry analysts; • announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; • actions taken by regulatory agencies with respect to our current and future potential product candidates, clinical studies, manufacturing process or sales and marketing terms; • disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; • additions or departures of key personnel; • significant lawsuits, including patent or stockholder litigation; • if securities or industry analysts do not publish research or reports about our business, or if we issue adverse or misleading opinions regarding our business and stock; • changes in the market valuations of similar companies; • general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors; • sales of securities by us or our securityholders in the future; • if we fail to raise an adequate amount of capital to fund our operations and continued development of our current and future potential product candidates; • trading volume of our common stock; • announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments; • adverse publicity relating to IL-6 inhibitor and IL-6R inhibitor product candidates, including with respect to other such products on the market; • the introduction of technological innovations or new therapies that compete with the products and services of ours; and • period-to-period fluctuations in our financial results.
Some of the factors that may cause the market price of our common stock to fluctuate include: • results of clinical trials and preclinical studies of our current and future potential product candidates, or those of our competitors or our existing or future collaborators; • failure to meet or exceed financial and development projections we may provide to the public; • failure to meet or exceed the financial and development projections of the investment community; • failure of us to achieve the perceived benefits of the Kintara Merger as rapidly or to the extent anticipated by financial or industry analysts; • announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; • actions taken by regulatory agencies with respect to our current and future potential product candidates, clinical studies, manufacturing process or sales and marketing terms; • disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; • additions or departures of key personnel; • significant lawsuits, including patent or stockholder litigation; • if securities or industry analysts do not publish research or reports about our business, or if we issue adverse or misleading opinions regarding our business and stock; • changes in the market valuations of similar companies; • general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors; • sales of securities by us or our securityholders in the future; • if we fail to raise an adequate amount of capital to fund our operations and continued development of our current and future potential product candidates; • trading volume of our common stock; • announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments; • adverse publicity relating to IL-6 inhibitor and IL-6R inhibitor product candidates, including with respect to other such products on the market; • the introduction of technological innovations or new therapies that compete with the products and services of ours; and 82 • period-to-period fluctuations in our financial results.
Regardless of the merits or eventual outcome, liability claims may also result in: • decreased demand for our products; • injury to our reputation; • withdrawal of clinical trial participants and inability to continue clinical trials; 63 • initiation of investigations by regulators; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • substantial monetary awards to trial participants or patients; • product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; • exhaustion of any available insurance and our capital resources; • the inability to commercialize any product candidate; and • a decline in our share price.
Regardless of the merits or eventual outcome, liability claims may also result in: • decreased demand for our products; • injury to our reputation; • withdrawal of clinical trial participants and inability to continue clinical trials; • initiation of investigations by regulators; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • substantial monetary awards to trial participants or patients; • product recalls, withdrawals or labeling, marketing or promotional restrictions; • loss of revenue; • exhaustion of any available insurance and our capital resources; • the inability to commercialize any product candidate; and • a decline in our share price.
If one or more of our product candidates receives marketing approval, and us or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, many potentially significant negative consequences could result, including: • regulatory authorities may withdraw or limit their approvals of such products; • regulatory authorities may require the addition of labeling statements, specific warnings or a contraindications; • we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use; • we may be required to change the way such products are distributed or administered, or change the labeling of the products; 54 • the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products; • we may decide to recall such products from the marketplace after they are approved; • we could be sued and held liable for harm caused to individuals exposed to or taking our products; and • our reputation may suffer.
If one or more of our product candidates receives marketing approval, and us or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, many potentially significant negative consequences could result, including: • regulatory authorities may withdraw or limit their approvals of such products; • regulatory authorities may require the addition of labeling statements, specific warnings or a contraindications; • we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use; 57 • we may be required to change the way such products are distributed or administered, or change the labeling of the products; • the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products; • we may decide to recall such products from the marketplace after they are approved; • we could be sued and held liable for harm caused to individuals exposed to or taking our products; and • our reputation may suffer.
Our biological product candidates could fail to receive, or could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following: • the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; • we may be unable to demonstrate to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities that a product candidate is safe and effective for our proposed indication; • the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or comparable foreign regulatory authorities for approval; • we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; • the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; • the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere; • upon review of our clinical trial sites and data, the FDA or comparable foreign regulatory authorities may find our record keeping or the record keeping of our clinical trial sites to be inadequate; • the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies may fail to meet the requirements of the FDA, EMA or comparable foreign regulatory authorities; 60 • the FDA, EMA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing internally or with partners; and • the change of the medical standard of care or the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner that renders our clinical data insufficient for approval.
Our biological product candidates could fail to receive, or could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following: • the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; • we may be unable to demonstrate to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities that a product candidate is safe and effective for our proposed indication; • the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or comparable foreign regulatory authorities for approval; • we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; 63 • the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; • the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere; • upon review of our clinical trial sites and data, the FDA or comparable foreign regulatory authorities may find our record keeping or the record keeping of our clinical trial sites to be inadequate; • the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies may fail to meet the requirements of the FDA, EMA or comparable foreign regulatory authorities; • the FDA, EMA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing internally or with partners; and • the change of the medical standard of care or the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner that renders our clinical data insufficient for approval.
Under the BPCIA, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar product, it must find that the product is “highly similar” to the reference product notwithstanding minor differences in clinically 74 inactive components and that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity, and potency.
Under the BPCIA, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar product, it must find that the product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity, and potency.
Furthermore, while we have implemented data privacy and security measures in an effort to comply with applicable laws and regulations relating to privacy and data protection, some PHI and other PII or confidential information may be transmitted to us by third parties, who may not implement adequate security and privacy measures, and it is possible that laws, rules and regulations relating to privacy, data protection, or information security may be interpreted and applied in a manner that is inconsistent with our practices or those of third parties who transmit PHI and other PII or confidential information to us.
Furthermore, while we have implemented data privacy and security measures in an effort to comply with applicable laws and regulations relating to privacy and data protection, some PHI and other PII or confidential information may be transmitted to us by third parties, who may not implement adequate security and privacy measures, and it is possible that laws, rules and regulations relating to privacy, data 66 protection, or information security may be interpreted and applied in a manner that is inconsistent with our practices or those of third parties who transmit PHI and other PII or confidential information to us.
If any of our CMOs cannot successfully manufacture material that conforms to its specifications and the regulatory requirements of the FDA, EMA, or other comparable foreign authorities, we would be prevented from obtaining regulatory approval for our drug candidates unless and until we engages a substitute CMO that can comply with such requirements, which we may not be able to do.
If any of our CMOs cannot successfully manufacture material that conforms to its 60 specifications and the regulatory requirements of the FDA, EMA, or other comparable foreign authorities, we would be prevented from obtaining regulatory approval for our drug candidates unless and until we engages a substitute CMO that can comply with such requirements, which we may not be able to do.
An investor should only purchase our securities if he, she or it can afford to suffer the loss of his, her or its entire investment. 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.
An investor should only purchase our securities if he, she or it can afford to suffer the loss of his, her or its entire investment. 46 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.
In addition, because our product candidates represent new approaches to treat cancer and other immune-related diseases, we cannot accurately estimate the potential revenue from our product candidates. Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
In addition, because our product candidates represent new approaches to treat cancer and other immune-related diseases, we cannot accurately estimate the potential revenue from our product candidates. 72 Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
It is not always possible to identify and deter misconduct by employees and other parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
It is not always possible to identify and deter misconduct by employees and other parties, and the precautions we take to detect and prevent this 73 activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and, for products administered multiple times, that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and, for products administered multiple times, that the biologic and the reference biologic may be switched after one has been 78 previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
Our technology could become subject to many of the challenges and risks that gene therapies face, including: • regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future; • the FDA could recommend follow-up observation period of up to 15 years for all patients who receive our treatment.
Our technology could become subject to many of the challenges and risks that gene therapies face, including: • regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future; 50 • the FDA could recommend follow-up observation period of up to 15 years for all patients who receive our treatment.
Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.
Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a 64 stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.
While operating under accelerated approval, we will be subject to certain restrictions that we would not be subject to upon receiving regular approval. 66 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.
While operating under accelerated approval, we will be subject to certain restrictions that we would not be subject to upon receiving regular approval. 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 also experience competition in the development of our immunotherapies from universities, other research institutions and others in acquiring technology from such universities and institutions. In addition, certain of our immunotherapies may be subject to competition from investigational new drugs and/or products developed using other technologies, some of which have completed numerous clinical trials.
We also experience competition in the development of our immunotherapies from universities, other research institutions and others in acquiring technology from such universities and institutions. 49 In addition, certain of our immunotherapies may be subject to competition from investigational new drugs and/or products developed using other technologies, some of which have completed numerous clinical trials.
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors and other financing sources may be unwilling to provide additional funding to it on commercially reasonable terms, if at all.
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue 47 as a going concern, investors and other financing sources may be unwilling to provide additional funding to it on commercially reasonable terms, if at all.
As a result, our board of directors could authorize the issuance of additional series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common 78 stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.
As a result, our board of directors could authorize the issuance of additional series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.
There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and 72 pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions.
There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions.
Any agreements governing our relationships with CROs or other contractors with whom we currently engages or may engage in the future may provide those outside contractors with certain rights to terminate a clinical trial under specified circumstances.
Any agreements governing our relationships with CROs or other contractors with whom we currently engage or may engage in the future may provide those outside contractors with certain rights to terminate a clinical trial under specified circumstances.
We are not permitted to market our biological product candidates in the United States until we receives the respective approval of a BLA from the FDA, or in any foreign countries until we receive the requisite approval from the respective regulatory authorities in such countries.
We are not permitted to market our biological product candidates in the United States until we receive the respective approval of a BLA from the FDA, or in any foreign countries until we receive the requisite approval from the respective regulatory authorities in such countries.
We may be subject to claims that us or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims.
We may be subject to claims that we or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims.
Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety, purity, and potency of the product candidates in humans.
Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety, purity, 51 and potency of the product candidates in humans.
Any of the foregoing circumstances could materially harm the commercial prospects for our drug candidates. We currently have no marketing and sales organization and has no experience in marketing products.
Any of the foregoing circumstances could materially harm the commercial prospects for our drug candidates. We currently have no marketing and sales organization and have no experience in marketing products.
These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, 69 marketing and education programs.
These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs.
Even if we is successful in achieving regulatory approval to commercialize a product candidate faster than our competitors, we may face competition from biosimilars. The Patient Protection and Affordable Care Act, which was signed into law in March 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”).
Even if we are successful in achieving regulatory approval to commercialize a product candidate faster than our competitors, we may face competition from biosimilars. The Patient Protection and Affordable Care Act, which was signed into law in March 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”).
If our efforts to obtain approval for IFx-2.0 or any other product candidate is not successful, then we may be required to conduct additional clinical trials beyond those we contemplate, which would likely result in a longer time period to potential approval and commercialization of such product candidate (if approved) and would likely increase the cost of development of such product candidate, all of which could harm the Company’s competitive position in the marketplace and shorten the remaining term of applicable patent coverage after product approval.
If our efforts to obtain approval for IFx-2.0 or any other product candidate is not successful, then we may be required to conduct additional clinical trials beyond those it contemplates, which would likely result in a longer time period to potential approval and commercialization of such product candidate (if approved) and would likely increase the cost of development of such product candidate, all of which could harm the company’s competitive position in the marketplace and shorten the remaining term of applicable patent coverage after product approval.
Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the year ended December 31, 2024 with respect to this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding.
Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the year ended December 31, 2025 with respect to this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding.
Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees. We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our product candidates.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to our management and employees. We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our product candidates.
We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our product candidates itself. We also face competition in our search for third parties to assist it with the sales and marketing efforts of our product candidates.
We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We also face competition in our search for third parties to assist it with the sales and marketing efforts of our product candidates.
In addition, governments may impose price controls on any of our products that obtain marketing approval, which may adversely affect our future profitability. 76 In some foreign countries, particularly the member states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
In addition, governments may impose price controls on any of our products that obtain marketing approval, which may adversely affect our future profitability. 80 In some foreign countries, particularly the member states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
In our financial statements for the years ended December 31, 2024 and 2023, we concluded that our recurring losses from operations and need for additional financing to fund future operations raise substantial doubt about our ability to continue as a going concern.
In our financial statements for the years ended December 31, 2025 and 2024, we concluded that our recurring losses from operations and need for additional financing to fund future operations raise substantial doubt about our ability to continue as a going concern.
If we fail to timely achieve announced milestones, the commercialization of any of our product candidates may be delayed, and our business and results of operations may be harmed. 51 Failure to successfully identify, develop, and commercialize additional therapeutics or product candidates could impair our ability to grow.
If we fail to timely achieve announced milestones, the commercialization of any of our product candidates may be delayed, and our business and results of operations may be harmed. 54 Failure to successfully identify, develop, and commercialize additional therapeutics or product candidates could impair our ability to grow.
Even if we successfully obtains regulatory approvals to manufacture and market our product candidates, our revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and has commercial rights.
Even if we successfully obtains regulatory approvals to manufacture and market our product candidates, our revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and have commercial rights.
Failure to obtain regulatory approval to market any of our product candidates would significantly harm our business, results of operations, and prospects. 53 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.
Failure to obtain regulatory approval to market any of our product candidates would significantly harm our business, results of operations, and prospects. 56 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.
Item 1A. R isk Factors. Investing in our common stock involves a high degree of risk.
Item 1A. R isk Factors. 45 Investing in our common stock involves a high degree of risk.
We cannot be certain that any of our product candidates will be successful in clinical trials and they may not receive regulatory approval even if they are successful in clinical trials. 48 Before we can generate any revenues from sales of our lead product candidates, we must complete the following activities for each of them, any one of which it may not be able to successfully complete: • conduct additional preclinical and clinical development with successful outcomes; • manage preclinical, manufacturing, and clinical activities; • obtain regulatory approval from the FDA and other comparable foreign regulatory authorities; • establish manufacturing relationships for the clinical and post-approval supply of the applicable drug candidate in compliance with all regulatory requirements; • build a commercial sales and marketing team, either internally or by contract with third parties; • establish and maintain patent and trade secret protection or regulatory exclusivity for our product candidates; • develop and implement marketing strategies for successful commercial launch of our product candidates, if, and when, approved; • secure and maintain acceptance of our products, if, and when approved, by patients, from the relevant medical communities and from third-party payors; • compete effectively with other therapies; • establish and maintain adequate health care coverage and reimbursement from third-party payors; • ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any required post-marketing clinical trials or the elements of any post-marketing Risk Evaluation and Mitigation Strategy (“REMS”), that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the product outweigh its risks; • maintain continued acceptable safety profile of the product candidates following approval; and • invest significant additional cash in each of the above activities.
Before we can generate any revenues from sales of our lead product candidates, we must complete the following activities for each of them, any one of which it may not be able to successfully complete: • conduct additional preclinical and clinical development with successful outcomes; • manage preclinical, manufacturing, and clinical activities; • obtain regulatory approval from the FDA and other comparable foreign regulatory authorities; • establish manufacturing relationships for the clinical and post-approval supply of the applicable drug candidate in compliance with all regulatory requirements; • build a commercial sales and marketing team, either internally or by contract with third parties; • establish and maintain patent and trade secret protection or regulatory exclusivity for our product candidates; • develop and implement marketing strategies for successful commercial launch of our product candidates, if, and when, approved; • secure and maintain acceptance of our products, if, and when approved, by patients, from the relevant medical communities and from third-party payors; • compete effectively with other therapies; • establish and maintain adequate health care coverage and reimbursement from third-party payors; • ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any required post-marketing clinical trials or the elements of any post-marketing Risk Evaluation and Mitigation Strategy (“REMS”), that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the product outweigh its risks; • maintain continued acceptable safety profile of the product candidates following approval; and • invest significant additional cash in each of the above activities.
SUMMARY OF RISK FACTORS • We have a limited operating history, are not profitable and may never become profitable. • We have expressed substantial doubt about our ability to continue as a going concern. • We may not realize the anticipated benefits of the Kintara Merger. • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our product candidates. • We will require substantial additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of any of our product candidates. • Our product candidates will face significant competition and may be unable to compete effectively. • Various government regulations could limit or delay our ability to develop and commercialize our products or otherwise negatively impact our business. • The commercial potential of our products is difficult to predict.
SUMMARY OF RISK FACTORS • We have a limited operating history, are not profitable and may never become profitable. • We have expressed substantial doubt about our ability to continue as a going concern. • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our product candidates. • We will require substantial additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of any of our product candidates. • Our product candidates will face significant competition and may be unable to compete effectively. • Various government regulations could limit or delay our ability to develop and commercialize our products or otherwise negatively impact our business. • The commercial potential of our products is difficult to predict.
IFx-2.0 and IFx-Hu3.0 are in late and early stages, respectively, of development and will require additional clinical and nonclinical development, regulatory review, and approval in each jurisdiction in which we intend to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales.
IFx-2.0 and TBS-2025 are in late and early stages, respectively, of development and will require additional clinical and nonclinical development, regulatory review, and approval in each jurisdiction in which we intend to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales.
This estimate is based on assumptions that may prove to be materially wrong, and we could use our available capital resources sooner than it currently expects because of circumstances beyond our control.
This estimate is based on assumptions that may prove to be materially wrong, and we could use our available capital resources sooner than we currently expect because of circumstances beyond our control.
Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product. 59 We plans to seek orphan drug designation for some or all of our product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products, but exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
We plans to seek orphan drug designation for some or all of our product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products, but exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
Events that may prevent successful or timely completion of clinical development include: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials; • delays in reaching a consensus with regulatory agencies on trial design; 49 • the FDA may not allow us to use the clinical trial data from a research institution to support an investigational new drug (“IND”) application if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in our clinical trials; • our INDs have been approved in a timely manner thus far, however, the FDA may not agree with our approach and strategy, which could result in potential delays and changes to our regulatory strategy; • we may be required to complete additional preclinical studies in human leukocyte antigens before we can proceed with our INDs; • delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • delays in obtaining required Institutional Review Board (“IRB”) approval at each clinical trial site; • imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical trial operations or trial sites; developments on clinical trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; • delays in recruiting suitable patients to participate in our clinical trials; • failure by our CROs, other third parties, or us to adhere to clinical trial requirements; • failure to perform in accordance with the FDA’s current good clinical practice regulations (“cGCPs”), requirements, or similar applicable regulatory guidelines in other countries; • delays in patients completing participation in a trial or returning for post-treatment follow-up; • patients dropping out of a trial; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, which may result in us deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; • delays in developing our manufacturing processes and transferring to new third-party facilities to support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and • delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing. 50 For example, our IND for our planned Phase 3 trial for IFx-2.0 contemplated by our SPA agreement with the FDA is subject to a partial clinical trial hold as described in a January 2024 letter from the FDA that relates to certain CMC matters for the trial.
Events that may prevent successful or timely completion of clinical development include: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials; 52 • delays in reaching a consensus with regulatory agencies on trial design; • the FDA may not allow us to use the clinical trial data from a research institution to support an investigational new drug (“IND”) application if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in our clinical trials; • our INDs have been approved in a timely manner thus far, however, the FDA may not agree with our approach and strategy, which could result in potential delays and changes to our regulatory strategy; • we may be required to complete additional preclinical studies in human leukocyte antigens before we can proceed with our INDs; • delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • delays in obtaining required Institutional Review Board (“IRB”) approval at each clinical trial site; • imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical trial operations or trial sites; developments on clinical trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; • delays in recruiting suitable patients to participate in our clinical trials; • failure by our CROs, other third parties, or us to adhere to clinical trial requirements; • failure to perform in accordance with the FDA’s current good clinical practice regulations (“cGCPs”), requirements, or similar applicable regulatory guidelines in other countries; • delays in patients completing participation in a trial or returning for post-treatment follow-up; • patients dropping out of a trial; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, which may result in us deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; • delays in developing our manufacturing processes and transferring to new third-party facilities to support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and • delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing. 53 Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for our product candidates.
If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. 62 If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.
If we obtain orphan drug designation and marketing approval for Ifx-Hu2.0 or any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As of December 31, 2024, we had cash and cash equivalents of $12.7 million.
If we obtain orphan drug designation and marketing approval for Ifx-Hu2.0 or any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As of December 31, 2025, we had cash and cash equivalents of $3.6 million.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting, maintaining, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can have a different scope and strength than do those in the United States.
Filing, prosecuting, maintaining, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can have a different scope and strength than do those in the United States.
To date, we have financed our operations primarily through private placements of our preferred stock and convertible notes. We have not commercialized any products and has never generated any revenue from product sales.
To date, we have financed our operations primarily through registered direct offerings, private placements of our common and preferred stock, and convertible notes. We have not commercialized any products and have never generated any revenue from product sales.
In addition, our ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances resulting from the ongoing military conflict between Russian and Ukraine, as well as the ongoing conflict between Israel and Hamas, and the global impacts of such conflicts.
In addition, our ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances resulting from the ongoing military conflict between Russian and Ukraine, the ongoing conflict between Israel and Hamas, as well as the recent United States and Israeli air-based military campaigns in Iran, and the global impacts of such conflicts.
A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met: • the risk-benefit balance of the medicinal product is positive; • it is likely that the applicant will be in a position to provide the comprehensive clinical data; • unmet medical needs will be fulfilled; and • the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required. 52 The granting of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete.
A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met: • the risk-benefit balance of the medicinal product is positive; • it is likely that the applicant will be in a position to provide the comprehensive clinical data; • unmet medical needs will be fulfilled; and 55 • the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.
We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, we would have a material adverse effect on our business.
We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, we would have a material adverse effect on our business. 61 We rely and will rely on third parties to conduct our clinical trials.
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.
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.
Failure to comply with any of these laws and regulations by us or third parties to whom we contract certain types of work (like clinical trials) could result in enforcement action against us or such third parties, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.
Failure to comply with any of these laws and regulations by us or third parties to whom we contract certain types of work (like clinical trials) could result in enforcement action against us or such third parties, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects. 71 There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information.
In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, we will have to comply with requirements including submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs, cGTP and cGCPs for any clinical trials that we conduct post-approval. 65 Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following among other things: • restrictions on the manufacturing of the product, the approved manufacturers or the manufacturing process; • restrictions on the labeling or marketing of a product; • restrictions on product distribution or use; • requirements to conduct post-marketing studies or clinical trials; • withdrawal of the product from the market; • product recalls; • warning or untitled letters from the FDA or comparable notice of violations from foreign regulatory authorities; • refusal of the FDA or other applicable regulatory authority to approve pending applications or supplements to approved applications; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • suspension of any of our ongoing clinical trials; • product seizure or detention or refusal to permit the import or export of products; and • consent decrees, injunctions or the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following among other things: • restrictions on the manufacturing of the product, the approved manufacturers or the manufacturing process; 69 • restrictions on the labeling or marketing of a product; • restrictions on product distribution or use; • requirements to conduct post-marketing studies or clinical trials; • withdrawal of the product from the market; • product recalls; • warning or untitled letters from the FDA or comparable notice of violations from foreign regulatory authorities; • refusal of the FDA or other applicable regulatory authority to approve pending applications or supplements to approved applications; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • suspension of any of our ongoing clinical trials; • product seizure or detention or refusal to permit the import or export of products; and • consent decrees, injunctions or the imposition of civil or criminal penalties.
As a result, our actual or proposed immunotherapies could become obsolete before we recoup any portion of our related research and development and commercialization expenses. Competition in the biopharmaceutical industry is based significantly on scientific and technological factors.
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As a result, our actual or proposed immunotherapies could become obsolete before we recoup any portion of our related research and development and commercialization expenses. Competition in the biopharmaceutical industry is based significantly on scientific and technological factors.
Any potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent liabilities; • assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel; • our inability to achieve desired efficiencies, synergies or other anticipated benefits from such acquisitions or strategic partnerships; • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition; • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and • our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. 62 In addition, if we undertake future acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.
Any potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent liabilities; • assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel; 65 • our inability to achieve desired efficiencies, synergies or other anticipated benefits from such acquisitions or strategic partnerships; • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition; • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and • our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
However, we cannot predict: • if and when any patents will issue; • the degree and range of protection any issued patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents; 71 • whether others will apply for or obtain patents claiming aspects similar to those covered by our patents and patent applications; or • whether we will need to initiate litigation or administrative proceedings to defend our patent rights, which may be costly whether we win or lose.
However, we cannot predict: • if and when any patents will issue; • the degree and range of protection any issued patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents; • whether others will apply for or obtain patents claiming aspects similar to those covered by our patents and patent applications; or • whether we will need to initiate litigation or administrative proceedings to defend our patent rights, which may be costly whether we win or lose. 75 For biological and pharmaceutical products, claims directed to compositions of matter are generally considered to be the strongest form of intellectual property protection.
As a result, even if one of our drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease.
As a result, even if one of our drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product.
The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
Conditional marketing authorizations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
Our operations have required substantial amounts of cash since inception. We expect to continue to spend substantial amounts to continue the clinical development of our product candidates, particularly as we advance the development of our lead product candidate Ifx-Hu2.0 as a potential treatment for patients with melanoma, bladder and cervical cancers.
We expect to continue to spend substantial amounts to continue the clinical development of our product candidates, particularly as we advance the development of our product candidates, including our lead product candidate Ifx-Hu2.0 as a potential treatment for patients with melanoma, bladder and cervical cancers and TBS-2025, our VISTA inhibiting antibody .
Legacy TuHURA, our main operating subsidiary, has 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.
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.
We expect these losses to increase as it continues to incur significant research and development and other expenses related to our ongoing operations, seeks regulatory approvals for our product candidates, scales-up manufacturing capabilities and hires additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems. 44 A critical aspect of our strategy is to invest significantly in our technology platform to improve the efficacy and safety of our product candidates.
We expect these losses to increase as we continue to incur significant research and development and other expenses related to our ongoing operations, seeks regulatory approvals for our product candidates, scales-up manufacturing capabilities and hires additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems.
The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug and biological products vary widely from country to country. Current and future legislation may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed.
Current and future legislation may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed.
The evidence of clinical response rates received to date for Ifx-2.0, our principal product candidate, as well as the other clinical activity and results described in this Report, does not mean that Ifx-2.0 or any other product candidate has demonstrated, or that such clinical response data will predict, sufficient clinical efficacy and prove the required level of safety in order to receive FDA approval or any other required regulatory approval. 47 In addition, we have entered into a Special Protocol Assessment (“SPA”) agreement with the FDA regarding the initiation of a single registration-directed trial utilizing the FDA’s accelerated approval pathway for Ifx-2.0.
The evidence of clinical response rates received to date for Ifx-2.0, our principal product candidate, as well as the other clinical activity and results described in this Report, does not mean that Ifx-2.0 or any other product candidate has demonstrated, or that such clinical response data will predict, sufficient clinical efficacy and prove the required level of safety in order to receive FDA approval or any other required regulatory approval.
As a result, our future product revenue will suffer and we may incur significant additional losses. Risks Related to Our Common Stock The market price of our common stock is expected to be volatile, and the market price of the common stock may drop. The market price of our common stock could be subject to significant fluctuations.
As a result, our future product revenue will suffer and we may incur significant additional losses. Risks Related to Our Common Stock Our shares of common stock could be delisted from the Nasdaq Capital Market.
Recently, we entered into a SPA agreement with the FDA for a single Phase 3 randomized placebo and injection controlled trial for IFx-2.0, which we believe will lead to initiation of the Phase 3 study in of the second quarter of 2025.
Recently, we entered into the SPA agreement with the FDA for a single Phase 3 randomized placebo and injection controlled trial for IFx-2.0. We initiated the Phase 3 trial in June 2025.
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. 67 We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, processing, storage and use of personally-identifying information including comprehensive regulatory systems in the U.S. and EU, which, among other things, impose certain requirements relating to the privacy, security and transmission of personal information.
We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, processing, storage and use of personally-identifying information including comprehensive regulatory systems in the U.S. and EU, which, among other things, impose certain requirements relating to the privacy, security and transmission of personal information.
Recently, due to changes in U.S. law referred to as patent reform, procedures including inter parties review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of challenge to our patents in the future.
Recently, due to changes in U.S. law referred to as patent reform, procedures including inter parties review and post-grant review have been implemented.
We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourself. 46 Any of the above events could significantly harm our business, prospects, financial condition, and results of operations and cause the price of shares of our common stock to decline.
We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourself.
Any such failure to comply with data protection and privacy laws could result in government-imposed fines or orders requiring that we change its practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect our business. 68 Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects.
Any such failure to comply with data protection and privacy laws could result in government-imposed fines or orders requiring that we change its practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect our business.
Our proposed personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us. Depending on the number of patients we ultimately enroll in our trials, and the number of trials we may need to conduct, our overall clinical trial costs may be higher than for more conventional treatments.
Depending on the number of patients we ultimately enroll in our trials, and the number of trials we may need to conduct, our overall clinical trial costs may be higher than for more conventional treatments.
If we are not able to generate revenue from the sale of any approved products, we may never become profitable. 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.
If we are not able to generate revenue from the sale of any approved products, we may never become profitable. We will require substantial additional capital to finance our operations in the future.
The manufacture of biological drug products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. 57 Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process (including the absence of contamination).
Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process (including the absence of contamination).
We expect to have to negotiate budgets and contracts with CROs and trial sites, which may result in delays to our development timelines and increased costs. 58 We rely and will rely heavily on third parties over the course of our clinical trials, and as a result will have limited control over the clinical investigators and limited visibility into our day-to-day activities.
We rely and will rely heavily on third parties over the course of our clinical trials, and as a result will have limited control over the clinical investigators and limited visibility into our day-to-day activities.
Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all.
If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all. Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs.
The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States.
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. 67 The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeAdditionally, as an added layer of security, all of our data is stored on the cloud. 81 Despite being a small organization, we are committed to maintaining governance and oversight of these risks and to implementing standard operating procedures (“SOPs”) and training to help us assess, identify, monitor and respond to these risks.
Biggest changeDespite being a small organization, we are committed to maintaining governance and oversight of these risks and to implementing standard operating procedures (“SOPs”) and training to help us assess, identify, monitor and respond to these risks. Employees are trained to avoid phishing emails, and our internal controls system is designed to mitigate the risk of payments of fraudulent invoices .
During the reporting period, we have not experienced any material cyber incidents, nor have we experienced a series of immaterial incidents, which would require disclosure. In the ordinary course of our business, we collect and store sensitive data, including intellectual property.
During the reporting period, we have not experienced any material cyber incidents, nor have we experienced a series of immaterial incidents, which would require disclosure. 84 In the ordinary course of our business, we collect and store sensitive data, including intellectual property.
The Chief Executive Officer reports to our board of directors. Our Chief Executive Officer provides periodic updates to the board of directors on (1) any critical cybersecurity risks; (2) ongoing cybersecurity initiatives and strategies; (3) applicable regulatory requirements; and (4) industry standards.
Our Chief Executive Officer provides periodic updates to the board of directors on (1) any critical cybersecurity risks; (2) ongoing cybersecurity initiatives and strategies; (3) applicable regulatory requirements; and (4) industry standards.
Under the guidance and supervision of our Chief Executive Officer, we further limit risk by delegating our information technology and cybersecurity to a leading third-party IT consultant to safeguard our networks.
Under the guidance and supervision of our Chief Executive Officer, we further limit risk by delegating our information technology and cybersecurity to a leading third-party IT consultant to safeguard our networks. Additionally, as an added layer of security, all of our data is stored on the cloud.
Employees are trained to avoid phishing emails, and our internal controls system is designed to mitigate the risk of payments of fraudulent invoices . Governance We aim to incorporate industry best practices for companies of our size and financial strength throughout our cybersecurity program. Our board of directors has ultimate oversight of cybersecurity risk.
Governance We aim to incorporate industry best practices for companies of our size and financial strength throughout our cybersecurity program. Our board of directors has ultimate oversight of cybersecurity risk. The Chief Executive Officer reports to our board of directors.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Pro perties. 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 2026.
Biggest changeItem 2. Pro perties. 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.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Lega l 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. Item 4. Mine Saf ety Disclosure. Not applicable. Part II
Biggest changeItem 3. Lega l Proceedings. From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business.
Added
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”).
Added
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.
Added
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. Item 4. Mine Saf ety Disclosure. Not applicable.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market f or Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “HURA.” Stockholders As of March 31, 2025, there were approximately 606 registered holders of record of our common stock.
Biggest changeItem 5. Market f or Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “HURA.” Stockholders As of March 31, 2026, there were approximately 883 registered holders of record of our common stock.
This number does not include “street name” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees. Recent Sales of Unregistered Securities; Purchases of Equity Securities by the Issuer or Affiliated Purchaser None. Dividend Policy We currently do not anticipate paying any cash dividends in the foreseeable future.
This number does not include “street name” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees. 85 Recent Sales of Unregistered Securities; Purchases of Equity Securities by the Issuer or Affiliated Purchaser None. Dividend Policy We currently do not anticipate paying any cash dividends in the foreseeable future.
In addition, if we were to enter into a credit facility in the future, we anticipate that the terms of such facility could limit or prohibit our ability to pay dividends. Item 6. [ Reserved] 82
In addition, if we were to enter into a credit facility in the future, we anticipate that the terms of such facility could limit or prohibit our ability to pay dividends. Item 6. [ Reserved] 86

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

46 edited+48 added−63 removed40 unchanged
Biggest changeResults of Operations Comparisons for the Years Ended December 31, 2024, and December 31, 2023 87 Year ended December 31, Change 2024 2023 (in thousands) Operating expenses: Research and development $ 13,335,316 $ 9,402,417 $ 3,932,899 Acquired in process research and development ("IPR&D") - 16,217,655 (16,217,655 ) General and administrative 4,314,176 4,144,648 169,528 Total operating expenses 17,649,492 29,764,720 (12,115,228 ) Loss from operations (17,649,492 ) (29,764,720 ) 12,115,228 Other income (expense) Employee retention tax credit - 334,443 (334,443 ) Grant income 57,627 42,466 15,161 Interest expense (4,138,301 ) (18,688 ) (4,119,613 ) Interest income 361,632 89,673 271,959 Change in fair value of derivative liability (313,772 ) - (313,772 ) Total other income (expense) (4,032,814 ) 447,894 (4,146,265 ) Net loss $ (21,682,306 ) $ (29,316,826 ) $ 7,968,963 Series A Preferred cash dividend (2,089 ) - (2,089 ) Warrant modification (965,177 ) - (965,177 ) Net loss attributable to common shareholders $ (22,649,572 ) $ (29,316,826 ) $ 6,667,254 Research and Development Expenses .
Biggest changeResults of Operations Comparisons for the Years Ended December 31, 2025, and December 31, 2024 92 Year ended December 31, Change 2025 2024 Operating expenses: Research and development $ 20,532,670 $ 13,335,316 $ 7,197,354 Acquisition-related costs 3,679,618 440,340 3,239,278 General and administrative 7,583,651 3,873,836 3,709,815 Total operating expenses 31,795,939 17,649,492 14,146,447 Loss from operations (31,795,939 ) (17,649,492 ) (14,146,447 ) Other (expense) income Employee retention tax credit 113,574 - 113,574 Grant income 713,508 57,627 655,881 Interest expense (625,283 ) (4,138,301 ) 3,513,018 Interest income 136,233 361,632 (225,399 ) Change in fair value of derivative liability - (313,772 ) 313,772 Change in fair value of Kineta merger holdback shares 1,590,949 - 1,590,949 Loss on Kineta employee separation payments assumed from merger (185,019 ) - (185,019 ) Total other income (expense) 1,743,962 (4,032,814 ) 5,776,776 Net loss $ (30,051,977 ) $ (21,682,306 ) $ (8,369,671 ) Series A Preferred cash dividend (8,356 ) (2,089 ) (6,267 ) Warrant modification - (965,177 ) 965,177 Net loss attributable to common shareholders $ (30,060,333 ) $ (22,649,572 ) $ (7,410,761 ) Research and Development Expenses .
Financing Activities For the year ended December 31, 2024, net cash provided by financing activities was $29.8 million, which consisted of $27.5 million net proceeds from convertible notes issued as part of the TuHURA Note Financing, $4.7 million net proceeds from the Legacy TuHURA private placement in July 2024, and $2.0 million proceeds from stock options and warrants exercises, offset by $4.4 million in merger transaction costs and net liabilities attributable to Kintara.
For the year ended December 31, 2024, net cash provided by financing activities was $29.8 million, which consisted of $27.5 million net proceeds from convertible notes issued as part of the TuHURA Note Financing, $4.7 million net proceeds from the Legacy TuHURA private placement in July 2024, and $2.0 million proceeds from stock options and warrants exercises, offset by $4.4 million payment in merger transaction costs and net liabilities attributable to Kintara.
Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and could force it to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market itself.
Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial 87 condition and could force it to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market itself.
If we raise funds through collaborations, or other similar arrangements with third parties, we may need to relinquish valuable rights to our product candidates, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.
If we raise funds through collaborations, or other similar arrangements with third parties, we may need to relinquish valuable rights to our product candidates, future revenue streams or 96 research programs or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.
Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. 85 Research and development expenses include: • salaries, payroll taxes, employee benefits; • external research and development expenses incurred under agreements with contract research organizations (“CROs”), and consultants to conduct our clinical studies; • laboratory supplies; • costs related to manufacturing product candidates, including fees paid to third-party manufacturers and raw material suppliers; • stock-based compensation charges for those individuals involved in research and development efforts; and • facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent.
Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. 90 Research and development expenses include: • salaries, payroll taxes, employee benefits; • external research and development expenses incurred under agreements with contract research organizations (“CROs”), and consultants to conduct our clinical studies; • laboratory supplies; • costs related to manufacturing product candidates, including fees paid to third-party manufacturers and raw material suppliers; • stock-based compensation charges for those individuals involved in research and development efforts; and • facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent.
For the years ended December 31, 2024 and 2023, respectively, interest income was earned on deposits at various banks. Change in fair value of derivative liability . For the year ended December 31, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
For the years ended December 31, 2025 and 2024, respectively, interest income was earned on deposits at various banks. Change in Fair Value of Derivative Liability . For the year ended December 31, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
The dividend has been recorded as a direct increase in accumulated deficit. Warrant modification Warrant modification represents an extension of the exercise period of common stock purchase warrants issued in connection with Legacy TuHURA Series A Preferred Stock (the “Series A Warrants”) for an additional six months, with a new expiry date of February 12, 2025.
The dividend has been recorded as a direct increase in accumulated deficit. Warrant Modification Warrant modification represents an extension of the exercise period of common stock purchase warrants issued in connection with Legacy TuHURA Series A Preferred Stock for an additional six months, with a new expiry date of February 12, 2025.
Recent Developments Merger with Kintara Therapeutics On October 18, 2024, we completed the transactions contemplated by the Kintara Merger Agreement. Pursuant to the Kintara Merger Agreement, Merger Sub merged with and into Legacy TuHURA with Legacy TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary. In connection with the completion of the Kintara Merger, effective at 12:01 a.m.
Merger with Kintara Therapeutics On October 18, 2024, we completed the transactions contemplated by the Kintara Merger Agreement. Pursuant to the Kintara Merger Agreement, Merger Sub merged with and into Legacy TuHURA with Legacy TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary. In connection with the completion of the Kintara Merger, effective at 12:01 a.m.
Off-Balance Sheet Arrangements 93 During the periods presented, we do not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
Off-Balance Sheet Arrangements During the periods presented, we do not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
While our significant accounting policies are described in more detail in Note 2 of our consolidated financial statements for the year ended December 31, 2024, contained in Item 8 in this Annual Report, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
While our significant accounting policies are described in more detail in Note 2 of our consolidated financial statements for the year ended December 31, 2025, contained in Item 8 in this Annual Report, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Our future capital requirements will depend on many factors, including: • the initiation, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of IFx-Hu2.0, IFx-Hu3.0 and any other future product candidates; • the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase; • the outcome, timing and costs of seeking regulatory approvals; • the cost of manufacturing IFx-Hu2.0 and IFx-Hu3.0 and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization; • the emergence of competing therapies and other adverse market developments; • the ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements; and • the costs of operating as a public company.
Our future capital requirements will depend on many factors, including: • the initiation, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of IFx-2.0, TBS-2025, and any other future product candidates; • the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase; • the outcome, timing and costs of seeking regulatory approvals; • the cost of manufacturing IFx-2.0, TBS-2025, and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization; • the emergence of competing therapies and other adverse market developments; • the ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements; and • the costs of operating as a public company.
We are preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel Cell Carcinoma who are checkpoint inhibitor naïve, utilizing the FDA’s accelerated approval pathway.
In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda ® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway.
Warrant modification – For the year ended December 31, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of the Series A Warrants for an additional six months.
Deemed Dividend on Warrant Modifications – For the year ended December 31, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of our warrants for an additional six months.
We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through the private placement of capital stock and convertible notes.
We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through the issuance of capital stock, warrants and convertible notes.
If we fail to become profitable or are unable to sustain 83 profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. As of December 31, 2024, we had cash and cash equivalents of $12.7 million. See “ — Liquidity and Capital Resources ” below.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. As of December 31, 2025, we had cash and cash equivalents of $3.6 million. See “ — Liquidity and Capital Resources ” below.
Investing Activities For the year ended December 31, 2024, net cash used in investing activities was $6.1 million, which consisted of purchases of property and equipment and deposits and exclusivity payments in connection with the planned business acquisition of Kineta. For the year ended December 31, 2023, net cash used in investing activities was $1.3 million.
For the year ended December 31, 2024, net cash used in investing activities was $6.1 million, which consisted of purchases of property and equipment and deposits and exclusivity payments in connection with the Kineta Merger.
The increase of $3.9 million related to the following. • an increase of approximately $1.6 million due to ongoing clinical development of IFx-2.0; • an increase of approximately $0.4 million due to preclinical research of IFx-3.0 and MDSCs; and • an increase of approximately $1.9 million in facilities, salary and personnel related costs.
The increase of $7.2 million related to the following. • an increase of approximately $1.0 million due to ongoing clinical development of IFx-2.0; • an increase of approximately $0.6 million due to ongoing clinical development of TBS-2025; • an increase of approximately $0.9 million due to preclinical research of IFx-3.0, MDSCs and REM-001; and • an increase of approximately $4.6 million in facilities, salary and personnel related costs. 93 Acquisition-related costs.
As of December 31, 2024, we had an accumulated deficit of $111.1 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses.
Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses.
Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources.
Pursuant to the term of the TuHURA Notes, upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share.
The convertible notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock.
See Note 2 of our financial statements for information concerning certain of the specific assumptions we use in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted. Common stock valuations We are required to estimate the fair value of the common stock underlying our equity awards when performing fair value calculations.
See Note 2 of our financial statements for information concerning certain of the specific assumptions we use in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted.
Our future clinical development costs may vary significantly based on factors such as: • per-patient trial costs; • the number of trials required for regulatory approval; • the number of sites included in the trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients that participate in the trials; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the phase of development of the product candidate; and • the efficacy and safety profile of the product candidate. 86 Acquired In-Process Research and Development (“IPR&D”) Acquired in-process research and development expenses consist of existing research and development projects at the time of the acquisition.
Our future clinical development costs may vary significantly based on factors such as: • per-patient trial costs; • the number of trials required for regulatory approval; • the number of sites included in the trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients that participate in the trials; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the phase of development of the product candidate; and • the efficacy and safety profile of the product candidate. 91 Acquisition-related costs Acquisition-related costs consist of expenses incurred to effect a business combination, including legal, advisory, accounting, and valuation fees and were expensed as incurred.
The $0.5 million change in net operating assets and liabilities was due to an increase in accounts payable and accrued expenses of approximately $0.3 million due to timing of invoices and vendor payments, and a decrease in current and non-current assets of approximately $0.2 million.
The $3.1 million net change in operating assets and liabilities is primarily due to decreases in accounts payable and accrued expenses of approximately $3.8 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately $0.6 million.
We incurred net losses of $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively, and used $14.7 million and $12.0 million of cash from our operating activities for the years ended December 31, 2024, and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $111.1 million.
We incurred net losses of $30.1 million and $21.7 million for the years ended December 31, 2025 and 2024, respectively, and used $27.6 million and $14.7 million of cash from our operating activities for the years ended December 31, 2025, and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $141.2 million.
Warrant Exercise Notes On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants (the “Warrants”) of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3,011,373 as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers.
Since inception, Legacy TuHURA and the Company have raised approximately $99.7 million in net proceeds through the issuance and sale of capital stock, warrants and debt instruments Warrant Exercise Notes 94 On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3,011,373 as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers.
Research and Development Expenses To date, our research and development expenses have related primarily to the development of IFx-Hu2.0, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio.
Research and Development Expenses To date, our research and development expenses have related primarily to the development of IFx-2.0, IFx-3.0 (which we are no longer advancing), TBS-2025, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio.
For the year ended December 31, 2023, net cash used in operating activities was $11.9 million, which primarily consisted of a net loss of $29.3 million and a change in net operating assets and liabilities of $0.5 million, partially offset by non-cash charges of $16.9 million.
For the year ended December 31, 2024, net cash used in operating activities was $14.7 million, which primarily consisted of a net loss of $21.7 million, a change in net operating assets and liabilities of $3.3 million, and net non-cash charges of $3.7 million.
Cash Flows The following table sets forth a summary of the net cash flow activity for the years ended December 31, 2024 and 2023, respectively: 90 Year Ended December 31, 2024 2023 (in thousands) Net cash provided by (used in): Operating activities $ (14,728,138 ) $ (11,950,856 ) Investing activities (6,052,409 ) (1,296,879 ) Financing activities 29,772,693 2,660,249 Net increase (decrease) in cash $ 8,992,146 $ (10,587,486 ) Operating Activities For the year ended December 31, 2024, net cash used in operating activities was $14.7 million, which primarily consisted of a net loss of $21.7 million, a change in net operating assets and liabilities of $3.3 million, and by non-cash charges of $3.7 million.
Cash Flows The following table sets forth a summary of the net cash flow activity for the years ended December 31, 2025 and 2024, respectively: Year Ended December 31, 2025 2024 Net cash provided by (used in): Operating activities $ (27,629,150 ) $ (14,728,138 ) Investing activities (1,335,361 ) (6,052,409 ) Financing activities 19,927,282 29,772,693 Net increase (decrease) in cash $ (9,037,229 ) $ 8,992,146 Operating Activities For the year ended December 31, 2025, net cash used in operating activities was $27.6 million, which primarily consisted of a net loss of $30.1 million, a change in net operating assets and liabilities of $3.1 million, and net non-cash charges of $5.6 million.
The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of the Warrants, the Company issued to the Makers an aggregate of 1,034,836 Warrant Shares, all of which are “restricted securities” within the meaning of the federal securities laws.
The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of such warrants, the Company issued to the Makers an aggregate of 1,034,836 shares of common stock. The amounts due under the Warrant Exercise Notes were collected in full in the second quarter of 2025.
Recently Issued and Adopted Accounting Pronouncements A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements.
If we conclude it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed. Recently Issued and Adopted Accounting Pronouncements A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023. References to “we”, “our” and “the Company” refers to Legacy TuHURA for periods prior to the closing of the Kintara Merger, and to TuHURA Biosciences, Inc.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2025 compared to the year ended December 31, 2024.
(formerly Kintara Therapeutics, Inc.) for all other periods, as the context requires. Overview We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors.
References to “we”, “our” and “the Company” refers to Legacy TuHURA for periods prior to the closing of the Kintara Merger, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc.) for all other periods, as the context requires. Overview We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies.
Preferred Stock Series A cash dividend – The holder of our the Series A Preferred Stock received dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
In August 2025 we issued shares to former Kineta employees for separation payments assumed in the Kineta Merger resulting in a loss on settlement of $0.2 million. Series A Preferred Cash Dividend – The holder of our the Series A Preferred Stock received dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31,253,000. The convertible notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount.
In October 2024, we assumed the Kintara Health and Human Services grant on REM-001 and received reimbursements for related expenses associated with the grant. Interest Expense . From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31,253,000.
Year ended December 31, Change 2024 2023 (in thousands) Direct program costs: IFx-2.0 $ 7,286,319 $ 5,679,869 $ 1,606,450 Preclinical research costs 702,628 316,178 386,450 Indirect program costs: Personnel and facilities related costs 5,346,370 3,406,370 1,940,000 Total research and development expenses $ 13,335,316 $ 9,402,417 $ 3,932,899 Research and development expenses were $13.3 million and $9.4 million for the years ended December 31, 2024, and 2023, respectively.
Year ended December 31, Change 2025 2024 Direct program costs: IFx-2.0 $ 8,291,119 $ 7,286,318 $ 1,004,801 TBS-2025 622,796 - 622,796 Preclinical research costs 1,650,881 702,628 948,253 Indirect program costs: Personnel and facilities related costs 9,967,874 5,346,370 4,621,504 Total research and development expenses $ 20,532,670 $ 13,335,316 $ 7,197,354 Research and development expenses were $20.5 million and $13.3 million for the years ended December 31, 2025, and 2024, respectively.
Components of Our Results of Operations Revenue We did not generate any revenue and do not expect to generate any revenue from the sale of products in the near future.
Following the achievement of certain prescribed milestones, each CVR received in December 2025 its pro rata portion of 1,539,918 shares of TuHURA common stock. Components of Our Results of Operations Revenue We did not generate any revenue and do not expect to generate any revenue from the sale of products in the near future.
The net non-cash charges were primarily related to a $16.2 million write-off of in-process research and development expense on the asset acquisition of TuHURA Biopharma, depreciation and amortization expense of $0.2 million, and stock-based compensation of $0.5 million.
The net non-cash charges were primarily related to a $1.6 million change in fair value of holdback shares, amortization of debt discount of $0.5 million, depreciation and amortization expense of $0.1 million, and stock-based compensation of $6.4 million.
This excludes the cash needed to complete the Kineta Merger, as the Kineta Merger Agreement provides that it is a condition to the closing of the Kineta Merger that we complete a financing transaction resulting in net proceeds of no less than $35 million, and there is no assurance that we will be able to complete such a financing transaction. 91 Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.
The increase of $0.2 million was primarily due to increases in non-cash stock 88 compensation expense and costs associated with being a public company incurred in 2024 offset by decrease in legal fees associated with the subsequently abandoned proposed merger with CohBar, Inc. which were incurred in 2023. Employee Retention Tax Credit .
The increase of $7.0 million was primarily due to increases in non-cash stock compensation expense, and costs associated with being a public company. Employee Retention Tax Credit . The IRS provided a refundable tax credit for businesses that had employees that were affected during the COVID-19 pandemic.
In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the anticipated payment of the Warrant Exercise Notes, will be sufficient to meet our anticipated cash requirements through late into the fourth quarter of 2025.
We believe that our existing cash and cash equivalents, together with the ATM and the proceeds received in the Offering, will be sufficient to meet our anticipated cash requirements through the second quarter and into the third quarter of 2026.
Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, compliance and other expenses that we did not previously incur as a private company. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
Funding Requirements We expect to incur costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations.
Other Income (Expense) Other income (expense) consists of interest income on our cash and cash equivalents, interest expense on borrowings under our convertible note agreements, and non-cash changes in the fair value of our derivative liability associated with the make-whole premium on our convertible notes.
Other (Expense) Income Other expense income (expense) consists of grant income from a NIH-funded research grant from Legacy Kintara REM-001, employee retention tax credit for companies affected by the COVID-19 pandemic, loss on settlements related to Kineta former employees separation payments, interest income on our cash and cash equivalents, interest expense on borrowings under our convertible note agreements and 2025 bridge loan, and non-cash changes in the fair value of our derivative liability associated with the make-whole premium on our convertible notes and holdback shares on the Kineta Merger.
At the effective time of the First Merger, and subject to the terms and conditions of the Kineta Merger Agreement, each share of Kineta Common Stock issued and outstanding immediately prior to the effective time of the First Merger will be converted automatically into and will represent the right to receive, without interest, the number of shares of our common stock and cash consideration each calculated according to the terms of the Kineta Merger Agreement.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock.
We are not profitable and has incurred significant operating losses in each period since its inception, including net losses of $22.6 million for the year ended December 31, 2024, and $29.3 million for the year ended December 31, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, of which $15.0 million was paid in the form of Legacy TuHURA common stock).
We are not profitable and has incurred significant operating losses in each period since our inception, including net losses of $30.1 million for the year ended December 31, 2025, and $21.7 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $141.2 million.
Grant income was $0.1 million and less than $0.1 million for the years ended December 31, 2024 and 2023, respectively. In April 2021, we received approval from the Department of Health and Human Services for a $0.4 million grant to study cervical cancer and received reimbursements for related expenses associated with the grant.
In October 2022, we applied for a credit under this program and we received a credit $0.1 million in 2025. Grant Income . Grant income was $0.7 million and less than $0.1 million for the years ended December 31, 2025 and 2024, respectively.
The Kineta Merger Agreement contemplates that, at the closing of the merger transaction, Hura Merger Sub I will (a) merge with and into Kineta, with Kineta being the surviving corporation of the First Merger, and (b) immediately following the First Merger and as part of the same overall transaction as the First Merger, the Surviving Entity will merge with and into Hura Merger Sub II, with Hura Merger Sub II being the surviving company of the Second Merger.
Pursuant to the terms of the TuHURA-Kineta Merger Agreement, among other things, Merger Sub I (a) merged with and into Kineta (the “First Merger”), with Kineta being the surviving corporation of the First Merger, also known as the “Surviving Entity” and (b) immediately following the First Merger, the Surviving Entity merged with and into Merger Sub II (the “Second Merger”, and together with the First Merger, the “Kineta Merger”), with Merger Sub II being the surviving company of the Second Merger and subsequently changing its name to Kineta, LLC.
Removed
In addition to our innate immune agonist candidates, we are leveraging our Delta receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”).
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A discussion of our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023 can be found under Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Annual Report on Form 10-K for the year ended December 31, 2024 which was filed with the SEC on March 31, 2025 and is available on the SEC’s website at www.sec.gov as well as our website at ir.tuhurabio.com.
Removed
Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Added
Our proprietary Immune Fx TM 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.
Removed
Each CVR shall entitle the holder thereof to receive its portion of 1,539,918 shares of TuHURA common stock if TuHURA achieves the following milestones: (i) TuHURA enrolls a minimum of ten cutaneous metastatic breast cancer patients in a study to determine whether a dose of TuHURA’s REM-001 lower than 1.2 mg/kg elicits a treatment effect similar to that seen in prior studies of REM-001 at the 1.2 mg/kg dose and (ii) such patients enrolled in the study complete eight weeks of follow-up, in each case, on or before December 31, 2025.
Added
In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA1213, through our acquisition of Kineta on June 30, 2025.
Removed
Kineta Exclusivity Agreement, July 2024 Private Placement and Kineta Merger Agreement On July 8, 2024, we issued a press release announcing that we had entered into the Exclusivity Agreement with Kineta for the potential acquisition of Kineta’s KVA12123 anti-VISTA antibody and related rights and assets associated with and derived from the asset.
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VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation ) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low relapse rates and high rates of recurrence in acute myeloid leukemia, or AML.
Removed
KVA12123 is a rationally targeted, anti-VISTA antibody checkpoint inhibitor designed to reverse VISTA immune suppression and remodel the tumor microenvironment (TME) to overcome acquired resistance to immunotherapies.
Added
Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 ( mut NPM1) AML.
Removed
Pursuant to the Exclusivity Agreement, among other things, Kineta granted us an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123 during a specified period commencing as of July 3, 2024.
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Recent Developments ATM Offering On November 3, 2025, the Company and H.C. Wainwright & Co., LLC (“Wainwright”) entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with respect to an at-the-market offering program under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent.
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Under the terms of the Exclusivity Agreement, we paid Kineta a fee in the amount of $5,000,000, with $2,500,000 paid at signing and an additional $2,500,000 paid on July 15, 2024, and we thereafter paid $300,000 in extension payments under the Exclusivity Agreement (the “Exclusivity Payments”).
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As of the date of this Annual Report, we have not sold any shares of common stock through the program. December 2025 Registered Direct Offering On December 9, 2025, TuHURA Biosciences, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with certain investors (collectively, the “Purchasers”).
Removed
The Exclusivity Payments will be credited against the initial cash consideration payable to under the below-described Kineta Merger Agreement. 84 In conjunction with the Exclusivity Agreement, we sold 717,321 shares of our common stock in a private offering with a purchase price of $5,000,000 (the “July Private Placement”) to an existing (the “Investor”).
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The Purchase Agreement relates to the sale and issuance in a registered direct offering (such sale and issuance, the “Offering”), by the Company of an aggregate of: (i) 9,462,423 shares of the Company’s common stock, (ii) Series A common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series A Warrants”), and (iii) Series B common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants”).The offering price for each share of common stock and accompanying Series A Warrant and Series B Warrant was $1.65.
Removed
In connection with the July Private Placement, the Investor is entitled to a 1.5% royalty on certain sales by us of products based on KVA12123 as set forth in the Investor’s subscription agreement.
Added
Each Common Warrant has an exercise price of $1.95 per share and is exercisable beginning six months after the date of issuance.
Removed
Due to the inherent uncertainties surrounding the regulatory approval of KvA12123 and future monetization, we have not allocated any of the $5,000,000 purchase price consideration to the royalty agreement. On December 12, 2024, we announced that we had entered into the Kineta Merger Agreement for the acquisition of Kineta via a merger transaction.
Added
On the same date, the Company and K&V Investment One LLC (“K&V”), a Purchaser in the Offering, entered into a side letter to the Purchase Agreement (the “Side Letter”), whereby the Company and K&V agreed that, for purposes of K&V’s funding requirements under the Purchase Agreement, K&V shall fund (i) with respect to $5 million of K&V’s subscription amount, at a date chosen by K&V that is no later than January 30, 2026 (the “Second Closing”), and (ii) with respect to $2 million of K&V’s subscription amount, at a date chosen by K&V that is no later than February 27, 2026 (the “Third Closing”).
Removed
The proposed Kineta Merger currently is expected to be consummated in the second quarter of 2025, subject to the satisfaction or waiver of closing conditions (including the financing condition) under the Kineta Merger Agreement.
Added
The Company will issue to K&V the shares of common stock and Warrants purchased at each of the Second Closing and Third Closing following receipt of consideration thereof, with such issued Warrants exercisable six months following the date of the Second Closing and the date of the Third Closing, respectively, and expiring on the same date as the Warrants issued to the other Purchasers on December 10, 2025, the first closing date (the “First Closing”).
Removed
Clinical Trial Funding Agreement In connection with the Kineta Merger Agreement, we entered into a Clinical Trial Funding Agreement (the “CTF Agreement”) with Kineta under which we agreed to continue to fund clinical trial expenses for KVA12123 in an amount of up to $900,000, which may be increased upon mutual agreement.
Added
Pursuant to the terms of the Purchase Agreement and the Side Letter, the closing of the Offering occurred in three tranches.
Removed
Pursuant to the terms of the CTF Agreement, Kineta granted a security interest to us in the assets, rights, including patents, patent rights, patent application, product and development program assets, and other rights and assets, associated with, derived from, relating to, or used in connection with KVA12123 and the KVA12123 development program and clinical trial.
Added
At the First Closing, the Company issued an aggregate of 5,219,999 Shares, Series A Warrants to purchase up to an aggregate of 5,219,999 shares of common stock and Series B Warrants to purchase up to an aggregate of 5,219,999 shares of common stock.
Removed
Any amounts loaned to Kineta under the CTF Agreement will be evidenced by a secured promissory note, bearing interest at 5% simple interest per annum, payable on the earlier of (a) following the closing of the Kineta Merger, any date on which we demand payment by written notice to Kineta or (b) if the Kineta Merger Agreement is terminated, within ten days following the date of such termination.
Added
At the Second Closing, the Company issued to K&V an aggregate of 3,030,303 Shares, Series A Warrants to purchase up to an aggregate of 3,030,303 shares of common stock and Series B Warrants to purchase up to an aggregate of 3,030,303 shares of common stock.
Removed
The Kineta Merger Agreement also provides that Kineta may request the extension of up to $2,000,000 in working capital loans from us, $1,750,000 of which will be contingent on the completion of a financing transaction by us.
Added
At the Third Closing, the Company issued to K&V an aggregate of 1,212,121 Shares, Series A Warrants to purchase up to an aggregate of 1,212,121 shares of common stock and Series B Warrants to purchase up to an aggregate of 1,212,121 shares of common stock.
Removed
Special Protocol Assessment Agreement On January 25, 2024, we entered into a Special Protocol Assessment Agreement for a single registration directed, randomized, placebo controlled Phase 3 trial for IFx-Hu2.0 as adjunctive therapy to pembrolizumab (Keytruda®) in first line treatment for patients with advanced or metastatic Merkel Cell carcinoma who are checkpoint inhibitor naive.
Added
The Series A Warrants will expire five and one-half years from the date of the First Closing and the Series B warrants will expire twenty-four months from the date of the First Closing.
Removed
The trial utilizes a novel design recommended by the FDA which incorporates Objective Response Rate (ORR) as the primary endpoint for accelerated approval.
Added
The Offering resulted in gross proceeds to the Company of approximately $8.6 million from the First Closing, approximately $5.0 million from the Second Closing and approximately $2.0 million from the Third Closing, before deducting the placement agents’ fees and other offering expenses payable by the Company.

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