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What changed in Allarity Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Allarity Therapeutics, Inc.'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.

+203 added−262 removedSource: 10-K (2026-03-30) vs 10-K (2025-03-31)

Top changes in Allarity Therapeutics, Inc.'s 2025 10-K

203 paragraphs added · 262 removed · 164 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

62 edited+17 added−6 removed315 unchanged
Biggest changeAlong with the chairman of the board, Gerald W. McLaughlin, Dr. Benjamin and Mr. Vazzano took the decision to replace the prior CEO, Mr. James Cullem, with Thomas H. Jensen as interim CEO. Mr. Jensen is a co-founder of Allarity and has extensive experience not only with the core DRP® platform technology but also with capital fund raising. Mr.
Biggest changeJensen, co-founder of Allarity, was permanently installed as Chief Executive Officer due to his extensive experience not only with the core DRP® platform technology but also with capital fund raising. Mr. Jensen was tasked with streamlining the organization and its finances. To help Mr.
In the finalized Phase 1 study, the majority of subjects (35/41; 85.4%) received up to 8 cycles of treatment with 26 subjects (63.4%) who received up to 2 cycles ( 3 Table of Contents In the completed Phase 1 study the following safety results were reported: ● Dose Limiting Toxicities (DLTs) were reported in 5 of the 25 DLT evaluable subjects, 4 of these occurred at the 800 mg QD dose (1 Grade 3 fatigue and 3 Grade 2 fatigue resulting in administration of less than 75% of the planned dosage of stenoparib) and 1 occurred at the 600 mg QD dose (Grade 3 anaphylactic reaction).
In the finalized Phase 1 study, the majority of subjects (35/41; 85.4%) received up to 8 cycles of treatment with 26 subjects (63.4%) who received up to 2 cycles ( 5 Table of Contents In the completed Phase 1 study the following safety results were reported: ● Dose Limiting Toxicities (DLTs) were reported in 5 of the 25 DLT evaluable subjects, 4 of these occurred at the 800 mg QD dose (1 Grade 3 fatigue and 3 Grade 2 fatigue resulting in administration of less than 75% of the planned dosage of stenoparib) and 1 occurred at the 600 mg QD dose (Grade 3 anaphylactic reaction).
The FDA considers a retrospective observational study to be one in which the study identifies the population and determines the exposure/treatment from historical data (i.e., data generated prior to the initiation of the study) with the variables and outcomes of interest determined at the time the study is designed.
The FDA considers a retrospective observational study to be one in which the study identifies the population and determines the exposure/treatment from historical data (i.e., data generated prior to the initiation of the study) with the variables and outcomes of interest determined at the time the study is designed.
Throughout 2024, a deep dive review of our development programs, clinical progress, likelihood of clinical and regulatory success and an evaluation of commercial plausibility prompted new our management to terminate all development candidates except that of stenoparib. Not only does this streamline the focus on our most promising asset, but it also enabled critical cost saving measures.
Throughout 2024, a deep dive review of our development programs, clinical progress, likelihood of clinical and regulatory success and an evaluation of commercial plausibility prompted our new management to terminate all development candidates except that of stenoparib. Not only does this streamline the focus on our most promising asset, but it also enabled critical cost saving measures.
Moreover, the Patient Protection and Affordable Care Act ("PPACA") provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act. ● The federal false claims, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties law prohibit individuals or entities from, among other things, 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. ● HIPAA prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. 18 Table of Contents ● HIPAA, as amended by HITECH, and their implementing regulations also impose obligations on covered entities such as health insurance plans, healthcare clearinghouses, and certain healthcare providers and their respective business associates and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information. ● The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding certain payments and other transfers of value to physicians, as defined by such law, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members; additionally, the Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act, under the provision titled “Fighting the Opioid Epidemic with Sunshine,” in part, extended the reporting and transparency requirements for physicians under the Physician Payments Sunshine Act to physician assistants, nurse practitioners, and other mid-level practitioners, with reporting requirements having gone into effect in 2022 for payments made, or ownership and investment interests held, in 2021. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Moreover, the Patient Protection and Affordable Care Act ("PPACA") provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act. ● The federal false claims, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties law prohibit individuals or entities from, among other things, 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. ● HIPAA prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. 24 Table of Contents ● HIPAA, as amended by HITECH, and their implementing regulations also impose obligations on covered entities such as health insurance plans, healthcare clearinghouses, and certain healthcare providers and their respective business associates and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information. ● The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding certain payments and other transfers of value to physicians, as defined by such law, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members; additionally, the Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act, under the provision titled “Fighting the Opioid Epidemic with Sunshine,” in part, extended the reporting and transparency requirements for physicians under the Physician Payments Sunshine Act to physician assistants, nurse practitioners, and other mid-level practitioners, with reporting requirements having gone into effect in 2022 for payments made, or ownership and investment interests held, in 2021. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The process generally involves the following: ● completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP; ● submission to the FDA of an Investigational New Drug (IND) application, which must become approved and effective before human clinical trials may begin; ● submission to the FDA of an Investigational Device Exemption (IDE) application, which must become approved and effective before a drug-specific DRP ® companion diagnostic can be used in human clinical trials; ● approval by an independent Institutional Review Board (IRB) or ethics committee at each clinical trial site before each trial may be initiated; ● performance of adequate and well controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related protocols and regulations to establish substantial evidence of the safety and efficacy of the investigational product for each proposed indication; ● submission to the FDA of an NDA after completion of all pivotal trials; ● submission to the FDA of a Pre-Market Approval (PMA) application to allow use of a DRP ® companion diagnostic on the market together with its approved drug; ● determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; 12 Table of Contents ● potential FDA audit of the pre-clinical study and/or clinical trial sites that generated the data in support of the NDA filing; ● FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the U.S.; and ● compliance with any post-approval requirements, including the potential requirement to implement a REMS and the potential requirement to conduct post-approval studies.
The process generally involves the following: ● completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP; ● submission to the FDA of an Investigational New Drug (IND) application, which must become approved and effective before human clinical trials may begin; ● submission to the FDA of an Investigational Device Exemption (IDE) application, which must become approved and effective before a drug-specific DRP ® companion diagnostic can be used in human clinical trials; ● approval by an independent Institutional Review Board (IRB) or ethics committee at each clinical trial site before each trial may be initiated; ● performance of adequate and well controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related protocols and regulations to establish substantial evidence of the safety and efficacy of the investigational product for each proposed indication; ● submission to the FDA of an NDA after completion of all pivotal trials; ● submission to the FDA of a Pre-Market Approval (PMA) application to allow use of a DRP ® companion diagnostic on the market together with its approved drug; ● determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; 18 Table of Contents ● potential FDA audit of the pre-clinical study and/or clinical trial sites that generated the data in support of the NDA filing; ● FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the U.S.; and ● compliance with any post-approval requirements, including the potential requirement to implement a REMS and the potential requirement to conduct post-approval studies.
In the meantime, Clinical Trials Directive 2001/20/EC continues to govern all clinical trials performed in the EU. 20 Table of Contents European Union Drug Review and Approval In the European Economic Area (“EEA”), which comprises the 28 Member States of the European Union and three European Free Trade Association States (Norway, Iceland, and Liechtenstein), medicinal products can only be commercialized after obtaining a Marketing Authorization (“MA”).
In the meantime, Clinical Trials Directive 2001/20/EC continues to govern all clinical trials performed in the EU. 26 Table of Contents European Union Drug Review and Approval In the European Economic Area (“EEA”), which comprises the 28 Member States of the European Union and three European Free Trade Association States (Norway, Iceland, and Liechtenstein), medicinal products can only be commercialized after obtaining a Marketing Authorization (“MA”).
To our knowledge, there is currently no approved or in development PARP inhibitor, for the treatment of ovarian cancer or other indications, that has an identical therapeutic profile to stenoparib (especially with inhibitory activity against the WNT pathway), with or without its Stenoparib-DRP ® companion diagnostic. 10 Table of Contents For our core DRP ® platform technology (and its resulting drug specific DRP ® companion diagnostics), we are aware of a number of companies that are currently marketing approved companion diagnostic platforms, or are attempting to develop such platforms, that are or may be competitive to (although distinct from) our DRP ® platform, such as Foundation Medicine and Lantern Pharma.
To our knowledge, there is currently no approved or in development PARP inhibitor, for the treatment of ovarian cancer or other indications, that has an identical therapeutic profile to stenoparib (especially with inhibitory activity against the WNT pathway), with or without its Stenoparib-DRP ® companion diagnostic. 16 Table of Contents For our core DRP ® platform technology (and its resulting drug specific DRP ® companion diagnostics), we are aware of a number of companies that are currently marketing approved companion diagnostic platforms, or are attempting to develop such platforms, that are or may be competitive to (although distinct from) our DRP ® platform, such as Foundation Medicine and Lantern Pharma.
In intracranial survival models of melanoma (murine melanoma B16 cell line) and glioblastoma (human glioblastoma multiforme SJGBM2 cell line), the addition of stenoparib to TMZ resulted in a significantly increased survival benefit versus that derived from TMZ alone. 2 Table of Contents Prior Clinical Trials The initial planned first-in-human study of stenoparib (conducted by Eisai, Inc.) was an open-label, multi center, Phase 1 study of PARP Inhibitor stenoparib (formerly E7449) as single agent in subjects with advanced solid tumors or with B-cell malignancies and in combination with TMZ or with Carboplatin and Paclitaxel in Subjects with Advanced Solid Tumors.
In intracranial survival models of melanoma (murine melanoma B16 cell line) and glioblastoma (human glioblastoma multiforme SJGBM2 cell line), the addition of stenoparib to TMZ resulted in a significantly increased survival benefit versus that derived from TMZ alone. 4 Table of Contents Prior Clinical Trials The initial planned first-in-human study of stenoparib (conducted by Eisai, Inc.) was an open-label, multi center, Phase 1 study of PARP Inhibitor stenoparib (formerly E7449) as single agent in subjects with advanced solid tumors or with B-cell malignancies and in combination with TMZ or with Carboplatin and Paclitaxel in Subjects with Advanced Solid Tumors.
All these factors will be impacted by the value and superiority of our DRP ® companion diagnostics over any competing companion diagnostic approaches that currently exist or evolve in the oncology market. 11 Table of Contents Government Regulation Government authorities in the U.S. at the federal, state, and local level and in other countries regulate the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and biological products.
All these factors will be impacted by the value and superiority of our DRP ® companion diagnostics over any competing companion diagnostic approaches that currently exist or evolve in the oncology market. 17 Table of Contents Government Regulation Government authorities in the U.S. at the federal, state, and local level and in other countries regulate the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and biological products.
We commenced a Phase 2 clinical trial in April 2019 and as of the date of this Annual Report, Eisai has not indicated an intention to exercise its repurchase option. 8 Table of Contents LiPlaCis Support Agreement with Smerud, Chosa and LiPlasome Pursuant to the terms of the amendment on March 28, 2022 to the out-license agreement with Smerud Medical Research International (the "Amended License Agreement"), Chosa ApS, a company organized under the laws of Denmark (“Chosa”), replaced us as the exclusive licensee to the LiPlaCis ® technology.
We commenced a Phase 2 clinical trial in April 2019 and as of the date of this Annual Report, Eisai has not indicated an intention to exercise its repurchase option. 14 Table of Contents LiPlaCis Support Agreement with Smerud, Chosa and LiPlasome Pursuant to the terms of the amendment on March 28, 2022 to the out-license agreement with Smerud Medical Research International (the "Amended License Agreement"), Chosa ApS, a company organized under the laws of Denmark (“Chosa”), replaced us as the exclusive licensee to the LiPlaCis ® technology.
Solely for convenience, in some cases, the trademarks, trade names and service marks referred to in this Annual Report are listed without the applicable ® , ™ and SM symbols, but they will assert, to the fullest extent under applicable law, their rights to these trademarks, trade names and service marks. 5 Table of Contents BUSINESS This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our therapeutic candidate, stenoparib, including data regarding the estimated size of such markets and the incidence of certain medical conditions.
Solely for convenience, in some cases, the trademarks, trade names and service marks referred to in this Annual Report are listed without the applicable ® , ™ and SM symbols, but they will assert, to the fullest extent under applicable law, their rights to these trademarks, trade names and service marks. 8 Table of Contents BUSINESS This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our therapeutic candidate, stenoparib, including data regarding the estimated size of such markets and the incidence of certain medical conditions.
Overall, as we advance our investigational products through development, we will start by seeking multiple sources for raw materials and address other potential points in concern over time. 9 Table of Contents Commercialization We intend to retain significant development and commercial rights to our investigational products and, if marketing approval is obtained, to commercialize our investigational products on our own, or potentially with a partner, in the U.S. and other regions, either globally or on a region-by-region basis.
Overall, as we advance our investigational products through development, we will start by seeking multiple sources for raw materials and address other potential points in concern over time. 15 Table of Contents Commercialization We intend to retain significant development and commercial rights to our investigational products and, if marketing approval is obtained, to commercialize our investigational products on our own, or potentially with a partner, in the U.S. and other regions, either globally or on a region-by-region basis.
This group provides authorization for whether a trial may move forward at designated checkpoints based on access to certain data from the trial. 14 Table of Contents Concurrent with clinical trials, companies may complete additional animal safety studies and must develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
This group provides authorization for whether a trial may move forward at designated checkpoints based on access to certain data from the trial. 20 Table of Contents Concurrent with clinical trials, companies may complete additional animal safety studies and must develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Emerging clinical data from this ongoing trial in heavily pre-treated, advanced ovarian cancer patients show promising clinical benefit including a patient with a complete, confirmed response (i.e., absence of active disease by RECISTv1.1 criteria) as well as a patient with primary platinum refractory disease who stayed on therapy more than 10 months and two additional patients with ongoing stable disease still on therapy more than 17 months.
Emerging clinical data from this ongoing trial in heavily pre-treated, advanced ovarian cancer patients show promising clinical benefit including a patient with a complete, confirmed response (i.e., absence of active disease by RECISTv1.1 criteria) as well as a patient with primary platinum refractory disease who stayed on therapy more than 10 months and two additional patients with ongoing stable disease still on therapy more than 30 months.
Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. 21 Table of Contents The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) established the Medicare Part D program to provide a voluntary prescription drug benefit to Medicare beneficiaries.
Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. 27 Table of Contents The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) established the Medicare Part D program to provide a voluntary prescription drug benefit to Medicare beneficiaries.
Cohort 2 in particular has provided promising clinical efficacy data showing durable clinical benefit in multiple patients including one confirmed, complete response (by RECIST v1.1 criteria) as well as 1 platinum refractory patient remaining on the drug more than 10 months and 2 additional patients with extended stable disease continuing on treatment now beyond 17 months.
Cohort 2 in particular has provided promising clinical efficacy data showing durable clinical benefit in multiple patients including one confirmed, complete response (by RECIST v1.1 criteria) as well as 1 platinum refractory patient remaining on the drug more than 10 months and 2 additional patients with extended stable disease continuing on treatment now beyond 30 months.
In general, all PMAs for the first-of-a-kind device are taken before the appropriate advisory panel for review and recommendation. 15 Table of Contents Before approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements.
In general, all PMAs for the first-of-a-kind device are taken before the appropriate advisory panel for review and recommendation. 21 Table of Contents Before approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements.
Clinical development in other major oncology markets, such as the EU, is subject to similar requirements and regulations. 13 Table of Contents A sponsor who wishes to conduct a clinical trial outside of the U.S. may, but need not, obtain FDA authorization to conduct the clinical trial under an IND.
Clinical development in other major oncology markets, such as the EU, is subject to similar requirements and regulations. 19 Table of Contents A sponsor who wishes to conduct a clinical trial outside of the U.S. may, but need not, obtain FDA authorization to conduct the clinical trial under an IND.
The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer. 22 Table of Contents There remain judicial and Congressional challenges to certain aspects of the PPACA, as well as efforts by the previous administration to repeal or replace certain aspects of the PPACA.
The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer. 28 Table of Contents There remain judicial and Congressional challenges to certain aspects of the PPACA, as well as efforts by the previous administration to repeal or replace certain aspects of the PPACA.
In cases of disapproval, a sponsor can respond to the deficiencies. 16 Table of Contents Expedited Development and Review Programs The FDA has a fast-track program that is intended to expedite or facilitate the process for reviewing new drugs that meet certain criteria.
In cases of disapproval, a sponsor can respond to the deficiencies. 22 Table of Contents Expedited Development and Review Programs The FDA has a fast-track program that is intended to expedite or facilitate the process for reviewing new drugs that meet certain criteria.
For example, in the EU, safeguarding the privacy, security and transmission of individually identifiable health information is subject to the General Data Protection Regulation (GDPR) and laws, which are widely considered to be the most stringent in the world. 19 Table of Contents U.S.
For example, in the EU, safeguarding the privacy, security and transmission of individually identifiable health information is subject to the General Data Protection Regulation (GDPR) and laws, which are widely considered to be the most stringent in the world. 25 Table of Contents U.S.
Retrospectively, both PRs were "predicted" by the DRP® for stenoparib after analyzing biopsies from 13 of the patients. 4 Table of Contents Development of Our Lead Clinical Asset, Stenoparib Stenoparib is a novel inhibitor of the key DNA damage repair enzyme PARP.
Retrospectively, both PRs were "predicted" by the DRP® for stenoparib after analyzing biopsies from 13 of the patients. 6 Table of Contents Development of Our Lead Clinical Asset, Stenoparib Stenoparib is a novel inhibitor of the key DNA damage repair enzyme PARP.
Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing. 17 Table of Contents The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing. 23 Table of Contents The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible. Corporate Information We were founded in Denmark in 2004 by our chief scientific officer, Steen Knudsen, Ph.D., and our Chief Executive Officer, Thomas H.
To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible. 7 Table of Contents Corporate Information We were founded in Denmark in 2004 by our chief scientific officer, Steen Knudsen, Ph.D., and our Chief Executive Officer, Thomas H.
We intend to use our Stenoparib-DRP ® to select patients from this group that will have a high likelihood of responding to our PARPi, stenoparib. 7 Table of Contents Existing PARP Inhibitors and Our Opportunity Numerous PARP inhibitors, including Lynparza ® (laparib), Rubraca ® (rucaparib camsylate), Zejula ® (niraparib) and Talzenna ® (talazoparib tosylate) have been approved by the FDA for multiple oncology indications, including ovarian, breast, prostate, and pancreatic cancer.
We intend to use our Stenoparib-DRP ® to select patients from this group that will have a high likelihood of responding to our PARPi, stenoparib. 10 Table of Contents Existing PARP Inhibitors and Our Opportunity Numerous PARP inhibitors, including Lynparza ® (olaparib), Rubraca ® (rucaparib camsylate), Zejula ® (niraparib) and Talzenna ® (talazoparib tosylate) have been approved by the FDA for multiple oncology indications, including ovarian, breast, prostate, and pancreatic cancer.
Our patent portfolio includes patents and applications in-licensed from Eisai Co., Ltd. (“Eisai”) that protect stenoparib compositions and methods of its use for treatment. Stenoparib Our stenoparib patent portfolio, which includes U.S. and foreign patents and patent applications, is positioned to protect aspects of our business in the United States and in key foreign jurisdictions.
Our patent portfolio includes patents and applications in-licensed from Eisai Co., Ltd. (“Eisai”) that protect stenoparib compositions and methods of its use for treatment. 12 Table of Contents Stenoparib Our stenoparib patent portfolio, which includes U.S. and foreign patents and patent applications, is positioned to protect aspects of our business in the United States and in key foreign jurisdictions.
While we previously had an exclusive in-license to develop this drug from LiPlasome Pharma ApS, on March 28, 2022, we agreed to transfer our exclusive development rights to Chosa ApS, an affiliate of Smerud Medical Research International AS and have out-licensed our DRP® companion diagnostic for LiPlaCis® to Chosa.
LiPlaCis® is an advanced, targeted liposomal formulation of Cisplatin. While we previously had an exclusive in-license to develop this drug from LiPlasome Pharma ApS, on March 28, 2022, we agreed to transfer our exclusive development rights to Chosa ApS, an affiliate of Smerud Medical Research International AS and have out-licensed our DRP® companion diagnostic for LiPlaCis® to Chosa.
Jensen re-focus our clinical development program, we also added a new President and Chief Development Officer, Jeremy R. Graff, PhD, who was brought in with deep experience in cancer drug development, including nearly 17 years at Eli Lilly and Company and 10 more years in various C-suite roles in biotech.
Jensen re-focus our clinical development program, we also added a new President and Chief Development Officer, Jeremy R. Graff, PhD, who was brought in with deep experience in cancer drug development, including nearly 17 years at Eli Lilly and Company and 10 more years in various C-suite roles in biotech. During 2025, Jeffrey Ervin was hired as Chief Financial Officer.
Stenoparib is currently in a Phase 2 clinical trial for the treatment of ovarian cancer patients who have had at least 3 prior lines of therapy. The trial has been running at numerous trial sites in the U.S. and Europe.
Stenoparib has been assessed in an ongoing Phase 2 clinical trial for the treatment of ovarian cancer patients who have had at least 3 prior lines of therapy. The trial has been running at numerous trial sites in the U.S. and Europe.
Pursuant to the terms of the Recapitalization Share Exchange, our Acquisition Sub acquired substantially all of the assets and liabilities of Allarity Therapeutics A/S in exchange for shares of our common stock on December 20, 2021, and our common stock began trading on the Nasdaq Global Market on that same day.
Pursuant to the terms of the Recapitalization Share Exchange, our Acquisition Sub acquired substantially all of the assets and liabilities of Allarity Therapeutics A/S in exchange for shares of our common stock on December 20, 2021, and our common stock began trading on the Nasdaq Global Market on that same day. Our principal executive offices are located at 123 E.
Development Milestone Payments Pursuant to the Eisai License Agreement, as amended, we have agreed to make milestone payments to Eisai in connection with the development of stenoparib by us or our affiliates, or by a third-party (a “Program Acquirer”) that assumes control of the stenoparib development program from us corresponding to: (i) successful completion of a Phase 2 clinical trial; (ii) dosing of the first patient in the first Phase 3 clinical trial; (iii) submission of the first NDA with the FDA; (iv) submission of an MAA to the EMA; (v) submission of an NDA to the Ministry of Health Labor and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan, or any successor thereto (the “MHLW”); (vi) receipt of authorization by the FDA to market and sell a licensed product; (vii) receipt of approval of an MAA by the EMA for a licensed product; and (viii) receipt of approval by the MHLW in Japan for a licensed product.
On August 2, 2024, we entered into a sixth amendment to the Eisai License Agreement with Eisai in order to (1) amend the definition of a successful Phase 2 study completion and (2) amend the terms related to Eisai's right of termination for development. 13 Table of Contents Development Milestone Payments Pursuant to the Eisai License Agreement, as amended, we have agreed to make milestone payments to Eisai in connection with the development of stenoparib by us or our affiliates, or by a third-party (a “Program Acquirer”) that assumes control of the stenoparib development program from us corresponding to: (i) successful completion of a Phase 2 clinical trial; (ii) dosing of the first patient in the first Phase 3 clinical trial; (iii) submission of the first NDA with the FDA; (iv) submission of an MAA to the EMA; (v) submission of an NDA to the Ministry of Health Labor and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan, or any successor thereto (the “MHLW”); (vi) receipt of authorization by the FDA to market and sell a licensed product; (vii) receipt of approval of an MAA by the EMA for a licensed product; and (viii) receipt of approval by the MHLW in Japan for a licensed product.
In addition, their names, logos and website names and addresses are their trademarks or service marks. Other trademarks, trade names and service marks appearing in this Annual Report are the property of their respective owners.
Other trademarks, trade names and service marks appearing in this Annual Report are the property of their respective owners.
Cells containing dysfunctional BRCA1 or BRCA2 have been shown to become profoundly sensitized to the inhibition of PARP enzymatic activity, resulting in chromosomal instability, cell cycle arrest and subsequent apoptosis.
PARP inhibitors are designed to compete with NAD+ for the substrate binding to PARP and inhibit PARP activity. Cells containing dysfunctional BRCA1 or BRCA2 have been shown to become profoundly sensitized to the inhibition of PARP enzymatic activity, resulting in chromosomal instability, cell cycle arrest and subsequent apoptosis.
As of Q3 2022, PARP inhibitors were withdrawn from the market for the treatment of active, advanced ovarian cancers. There is a current unmet need for treatment of patients with OC who have progressed on PARPi treatment. Our ongoing Phase 2 study in ovarian cancer allows for enrollment of patients previously treated with a PARPi.
As of Q3 2022, PARP inhibitors were withdrawn from the market for the treatment of active, advanced ovarian cancers. There is a current unmet need for treatment of patients with OC who have progressed on PARPi treatment.
These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition, and results of operations. 23 Table of Contents Human Capital As of December 31, 2024, we had 7 employees, 6 of whom were full-time and 1 half-time; and most of whom were engaged in research and development activities.
These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition, and results of operations. Table of Contents Human Capital As of December 31, 2025, we had eight employees; seven of whom were full-time and one part-time.
Intellectual Property Our commercial success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other major oncology markets and countries for our investigational products and our DRP ® companion diagnostics, to operate without being subject to the enforcement of third-party patents and proprietary rights, and to prevent others from infringing on our proprietary or intellectual property rights.
Accordingly, development of a potential PRP ® product and business is not currently part of our priority strategy. 11 Table of Contents Intellectual Property Our commercial success depends in large part on our ability to obtain and maintain patent protection and market exclusivity in the U.S. and other major oncology markets and countries for our investigational products and our DRP ® companion diagnostics, to operate without being subject to the enforcement of third-party patents and proprietary rights, and to prevent others from infringing on our proprietary or intellectual property rights.
We have also retained a number of expert advisors and consultants who help navigate us through different aspects of our business. 24 Table of Contents
We consider our relationship with our employees to be good. We have also retained a number of expert advisors and consultants who help navigate us through different aspects of our business. 30 Table of Contents
In contrast with other companion diagnostics technologies, we believe our DRP® platform enjoys several unique competitive advantages: ● Broadly Applicable . We believe our DRP® platform can successfully generate a drug-specific companion diagnostic for most cancer drug types, including DNA damaging agents, standard chemotherapeutics, targeted kinase inhibitors and epigenetic enzyme inhibitors. ● Retrospectively Validated .
We believe our DRP® platform can successfully generate a drug-specific companion diagnostic for most cancer drug types, including DNA damaging agents, standard chemotherapeutics, targeted kinase inhibitors and epigenetic enzyme inhibitors. ● Retrospectively Validated .
Market introduction and penetration of such personalized medicine diagnostic tests and reports is challenging and subject to close scrutiny of regulatory agencies such as the FDA, and also are very capital intensive to develop, bring to market, and expand sales. Accordingly, development of a potential PRP ® product and business is not currently part of our priority strategy.
Market introduction and penetration of such personalized medicine diagnostic tests and reports is challenging and subject to close scrutiny of regulatory agencies such as the FDA, and also are very capital intensive to develop, bring to market, and expand sales.
These data continue to mature and have prompted us to work with Key Opinion Leaders (KOLs) in gynecologic oncology to devise and finalize a follow-on clinical trial in advanced ovarian cancer patients that will more aggressively advance stenoparib toward regulatory approval. 6 Table of Contents Overview of Ovarian Cancer Ovarian Cancer (OC) is a lethal disease with a 5-year survival rate of 20-30% for advanced OC.
These data continue to mature and have prompted us to work with Key Opinion Leaders (KOLs) in gynecologic oncology to devise and finalize a follow-on clinical trial in advanced ovarian cancer patients that will more aggressively advance stenoparib toward regulatory approval.
The peak incidence of BC occurred in the 41-50-year age group (28.3 per 1,000 person-years) for BRCA1 and in the 51-60-year group (30.6 per 1,000 person-years) for BRCA2 mutation carriers.
Mutation frequencies are estimated to be approximately 15-20% for those diagnosed with OC and 5% for those diagnosed with BC (15). The peak incidence of BC occurred in the 41-50-year age group (28.3 per 1,000 person-years) for BRCA1 and in the 51-60-year group (30.6 per 1,000 person-years) for BRCA2 mutation carriers.
The sponsor can request the FDA to designate the product for fast-track status any time before receiving NDA approval, but ideally no later than the pre-NDA meeting with the FDA.
The sponsor can request the FDA to designate the product for fast-track status any time before receiving NDA approval, but ideally no later than the pre-NDA meeting with the FDA. In Q3 2025, the FDA granted fast-track designation to Allarity Therapeutics for stenoparib in advanced, recurrent ovarian cancers.
Moreover, there is evidence that WNT pathway inhibition may itself disable or diminish DNA Damage Repair creating a “BRCA-mutant like” state in cancer cells that may not typically be susceptible to PARP inhibitor-induced death.
Tankyrases are key enzymes whose activation drives WNT pathway activity, enabling cancer cell survival, invasion, metastasis and therapeutic resistance. Moreover, there is evidence that WNT pathway inhibition may itself disable or diminish DNA Damage Repair creating a “BRCA-mutant like” state in cancer cells that may not typically be susceptible to PARP inhibitor-induced death.
Rationale for Targeting PARP in Ovarian Cancer Poly (ADP-ribose) polymerases (PARPs) are a family of DNA-dependent nuclear enzymes catalyzing the transfer of ADP-ribose moieties from cellular nicotinamide-adenine-dinucleotide (NAD+) to a variety of target proteins. There are 17 PARP family member proteins identified through sequence homology of the catalytic domain.
Poly (ADP-ribose) polymerases (PARPs) are a family of DNA-dependent nuclear enzymes catalyzing the transfer of ADP-ribose moieties from cellular nicotinamide-adenine-dinucleotide (NAD+) to a variety of target proteins. There are 17 PARP family member proteins identified through sequence homology of the catalytic domain. PARP1, 2 and 3 have all been implicated in DNA repair, with PARP1 being the most abundant.
Of our employees, the majority are in Hoersholm, Denmark. Among our executive management team members, one is located in Sweden, one near New York, NY, and one near Tampa, FL. None of our employees are represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.
Most employees are engaged in research and development activities. Of our employees, the majority are in Hoersholm, Denmark. Among our executive management team members, one is located in Sweden, one near Nashville, TN, and one near Tampa, FL. None of our employees are represented by labor unions or covered by collective bargaining agreements.
Additionally, there has been heightened governmental scrutiny recently over the way drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products.
These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations. 29 Table of Contents Additionally, there has been heightened governmental scrutiny recently over the way drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products.
Cells lacking a functional BRCA1/2 are also deficient in HR and show a high-degree of chromosomal instability as well as increased sensitivity to ionizing radiation and chemotherapeutic agents that lead to double-stranded breaks.
Cells lacking a functional BRCA1/2 are also deficient in HR and show a high-degree of chromosomal instability as well as increased sensitivity to ionizing radiation and chemotherapeutic agents that lead to double-stranded breaks. Rationale for Targeting PARP in Ovarian Cancer Ovarian Cancer (OC) is a lethal disease with a 5-year survival rate of 20-30% for advanced OC.
Partnerships and Out-Licensing Leverage the DRP ® Platform for Other Cancer Therapeutics We have also developed external partnerships and out-licensing arrangements to enable the advance of LiPlaCis® leveraging a platinum-specific DRP® companion diagnostic for development in partnership with Chosa Oncology. LiPlaCis® is an advanced, targeted liposomal formulation of Cisplatin.
These patents would extend the exclusivity period for stenoparib in combination with DRP®-guided patient selection beyond 2040. Partnerships and Out-Licensing Leverage the DRP ® Platform for Other Cancer Therapeutics We have also developed external partnerships and out-licensing arrangements to enable the advance of LiPlaCis® leveraging a platinum-specific DRP® companion diagnostic for development in partnership with Chosa Oncology.
We also control remaining composition of matter, formulation, and methods of use patent coverage on stenoparib which extends out to 2028 or 2032 depending on the relevant patents.
We also control remaining composition of matter, formulation, and methods of use patent coverage on stenoparib which extends out to 2028 or 2032 depending on the relevant patents. The patent for the stenoparib-DRP® has been granted recently in Australia and Europe and is currently under review in the United States of America.
We have received down payments in 2024 totaling approximately $0.2 million, are actively preparing the laboratory and required samples, and expect to start recognizing revenue in 2025. 1 Table of Contents Stenoparib: Allarity ’ s Novel, Dual Inhibitor of PARP and Tankyrases Our therapeutic candidate, stenoparib, is a dual inhibitor of the key DNA damage repair enzyme PARP, as well as Tankyrases, critical enzymes involved in the WNT signaling pathway commonly activated in many cancers.
Leveraging our gene expression and diagnostic capabilities, our laboratory generated $0.3 million of revenue in 2025. 3 Table of Contents Stenoparib: Allarity ’ s Novel, Dual Inhibitor of PARP and Tankyrases Our therapeutic candidate, stenoparib, is a dual inhibitor of the key DNA damage repair enzyme PARP, as well as Tankyrases, critical enzymes involved in the WNT signaling pathway commonly activated in many advanced cancers.
Allarity ’ s DRP ® Companion Diagnostic Platform Our patented DRP® platform is a proprietary technology that enables the development of cancer drug-specific companion diagnostics that may be used to identify patients most likely to benefit from a particular cancer therapy.
This randomized, biomarker-driven trial is fully funded by the US Veteran’s Administration and was opened for enrollment in January 2026. 1 Table of Contents Allarity ’ s DRP ® Companion Diagnostic Platform Our patented DRP® platform is a proprietary technology that enables the development of cancer drug-specific companion diagnostics that may be used to identify patients most likely to benefit from a particular cancer therapy.
Tankyrases and the WNT pathway also enable cancer cell survival and are commonly upregulated in advanced, chemo- and radio- resistant cancers including ovarian as well as colon and other cancers. There are multiple PARP inhibitors currently approved and used for the treatment of cancers, primarily ovarian and breast cancers but now also pancreatic and prostate cancers.
Tankyrases are also key activators of the WNT pathway which can enable cancer cell survival and are commonly upregulated in advanced, chemo- and radio- resistant cancers including ovarian as well as colon and other cancers.
Historically, we have generated DRP signatures for numerous anti-cancer therapeutics and had in-licensed numerous assets for DRP-guided development, including Liposomal CisPlatin (LiPlaCis), Irofulven and dovitinib as well as the novel PARP/tankyrase inhibitor, stenoparib. In the second half of 2023, we seated two new independent directors to our board of directors, Laura E. Benjamin, PhD and Joseph W. Vazzano, CPA.
Historically, we have generated DRP signatures for numerous anti-cancer therapeutics and had in-licensed numerous assets for DRP-guided development, including Liposomal CisPlatin (LiPlaCis), Irofulven and dovitinib as well as the novel PARP/tankyrase inhibitor, stenoparib. During 2024, Thomas H.
However, there are also patients with germline mutations in other HR pathway genes and patients who do not carry an inherited germline mutation but have tumors with sporadic HRD mutations. Data from the Cancer Genome Atlas (TCGA) demonstrates that approximately fifty percent of high grade serous ovarian cancers have aberrations in HR repair.
However, there are also patients with germline mutations in other HR pathway genes and patients who do not carry an inherited germline mutation but have tumors with sporadic HRD mutations.
We are now singularly focused on the development of stenoparib and the parallel development of the stenoparib DRP® as a companion diagnostic. All other assets including dovitinib, Irofulven and LiPlaCis, were terminated and are no longer part of our portfolio. Stenoparib was in-licensed with exclusive world-wide rights from the Japanese Pharmaceutical company, Eisai Pharmaceuticals.
He has a combined seven years of experience as CEO and CFO of Nasdaq- and NYSE-listed companies. We are now singularly focused on the development of stenoparib and the parallel development of the stenoparib DRP® as a companion diagnostic. All other assets including dovitinib, Irofulven and LiPlaCis, were terminated and are no longer part of our portfolio.
Information contained on or accessible through our website is not a part of this Annual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only. Allarity and its subsidiaries own or have rights to trademarks, trade names and service marks that they use in connection with the operation of their business.
Allarity and its subsidiaries own or have rights to trademarks, trade names and service marks that they use in connection with the operation of their business. In addition, their names, logos and website names and addresses are their trademarks or service marks.
Stenoparib is a novel, dual inhibitor of poly-ADP-ribose polymerase (PARP1/2) as well as tankyrases, enzymes critically important in the WNT cancer cell survival pathway. Stenoparib is currently being explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.
Stenoparib has been explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.
PARP inhibitors disable DNA repair. Tumors with genetic defects in DNA damage repair (e.g., tumors with BRCA mutations) are particularly vulnerable to the added effect of PARP inhibition. Coupling PARP inhibition to in-born defects in DNA Damage Repair creates “Synthetic Lethality,” selectively killing cancer cells while theoretically sparing most normal cells (as most normal cells have intact DNA repair mechanisms).
Coupling PARP inhibition to in-born defects in DNA Damage Repair creates “Synthetic Lethality,” selectively killing cancer cells while theoretically sparing most normal cells (as most normal cells have intact DNA repair mechanisms). Stenoparib is distinct from other PARP inhibitors in that it not only potently inhibits PARP but also the PARP family enzymes known as Tankyrases.
Patent applications for our DRP® companion diagnostics have been submitted for more than 70 anticancer agents. Studies involving our DRP® platform, and resulting putative DRP® companion diagnostics, have also been extensively published in peer reviewed literature and presented at major oncology conferences.
Studies involving our DRP® platform, and resulting putative DRP® companion diagnostics, have also been extensively published in peer reviewed literature and presented at major oncology conferences. 2 Table of Contents In contrast with other companion diagnostics technologies, we believe our DRP® platform enjoys several unique competitive advantages: ● Broadly Applicable .
Epidemiological studies have shown an association between germline BRCA1/2 (gBRCA1/2) mutations and the development of OC, BC, and to a lesser extent pancreatic and endometrial cancers. Mutation frequencies are estimated to be approximately 15-20% for those diagnosed with OC and 5% for those diagnosed with BC (15).
Data from the Cancer Genome Atlas (TCGA) demonstrates that approximately fifty percent of high grade serous ovarian cancers have aberrations in HR repair. 9 Table of Contents Epidemiological studies have shown an association between germline BRCA1/2 (gBRCA1/2) mutations and the development of OC, BC, and to a lesser extent pancreatic and endometrial cancers.
We paid Eisai $850,000 on August 20, 2024 and no payments are currently outstanding. On August 2, 2024, we entered into a sixth amendment to the Eisai License Agreement with Eisai in order to (1) amend the definition of a successful completion and (2) amend the terms related to Eisai's right of termination for development.
We paid Eisai $850,000 on August 20, 2024 and no payments are currently outstanding.
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Jensen was tasked with streamlining the organization and its finances. In June 2024, Mr. Jensen was permanently installed as our CEO. In the second half of 2024, we added a new Chief Financial Officer, Mr. Alexander Epshinsky, who comes to us after serving in accounting and controller roles in a series of small cap biotech companies. To help Mr.
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Stenoparib was in-licensed with exclusive world-wide rights from the Japanese Pharmaceutical company, Eisai Pharmaceuticals. Stenoparib is a novel, dual inhibitor of poly-ADP-ribose polymerase (PARP1/2) as well as tankyrases, enzymes critically important in the WNT cancer cell survival pathway.
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Leveraging our gene expression and diagnostic capabilities, our laboratory will provide the services to the external clients.
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This new trial protocol was initiated in June 2025 and is currently enrolling patients randomized into 2 dose levels: 600 mg daily given twice daily (200 mg in the morning and 400 mg in the evening) and 800 mg given twice daily (400 mg for each of the morning and evening doses).
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Stenoparib is distinct from other PARP inhibitors in that it not only potently inhibits PARP but also the PARP family enzymes known as Tankyrases. Tankyrases are key enzymes whose activation drives WNT pathway activity, enabling cancer cell survival, invasion, metastasis and therapeutic resistance.
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In total, the trial aims to enroll 20 patients on each dose level for a total of 40 patients. Importantly, in this trial, only patients with platinum resistant or platinum ineligible ovarian cancer (PROC) with no more than 1 line of chemotherapy beyond the PROC designation will be enrolled.
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Our principal executive offices are located at 24 School Street, 2nd Floor, Boston, MA 02108. Our telephone number is (401) 426-4664, and our email address is info@allarity.com. Our corporate website address is www.allarity.com .
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Moreover, all patients will be enrolled with a fresh tumor biopsy to assess the DRP® score that best aligns with extended, durable clinical benefit. Defining the DRP® score that best predicts clinical benefit will enable the DRP®to be used as a patient selection tool in subsequent pivotal trials.
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PARP1, 2 and 3 have all been implicated in DNA repair, with PARP1 being the most abundant. PARP inhibitors are designed to compete with NAD+ for the substrate binding to PARP and inhibit PARP activity.
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In addition to this new trial protocol in Platinum Resistant Ovarian Cancer patients, we have also begun a trial combining stenoparib with Temozolomide in relapsed Small Cell Lung Cancer (SCLC).
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These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations.
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Patent applications for our DRP® companion diagnostics have been submitted for more than 70 anticancer agents.
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There are multiple PARP inhibitors currently approved and used for the treatment of cancers, primarily ovarian and breast cancers but now also pancreatic and prostate cancers. PARP inhibitors disable DNA repair. Tumors with genetic defects in DNA damage repair (e.g., tumors with BRCA mutations) are particularly vulnerable to the added effect of PARP inhibition.
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These compelling data in heavily pre-treated ovarian cancer patients have now prompted us to design a new clinical protocol, guided by key gynecologic oncology experts, to deepen and enrich the understanding of the clinical benefit from stenoparib treatment while also advancing the stenoparib-DRP® as a companion diagnostic used to select patients for stenoparib treatment.
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This new trial protocol was initiated in June 2025 and is currently enrolling patients randomized into 2 dose levels, 600 mg daily given twice daily (200 mg in the morning and 400 mg in the evening) and 800 mg given twice daily (400 mg for each of the morning and evening doses).
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In total, the trial aims to enroll 20 patients on each dose level for a total of 40 patients. Importantly, in this trial, only patients with platinum resistant or platinum ineligible ovarian cancer (PROC) with no more than 1 line of chemotherapy beyond the PROC designation will be enrolled.
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Moreover, all patients will be enrolled with a fresh tumor biopsy to assess the DRP® score that best aligns with extended, durable clinical benefit. Defining the DRP® score that best predicts clinical benefit will enable the DRP®to be used as a patient selection tool in subsequent pivotal trials.
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In addition to this new trial protocol in Platinum Resistant Ovarian Cancer patients, we have also begun a trial combining stenoparib with Temozolomide in relapsed Small Cell Lung Cancer (SCLC). This randomized, biomarker-driven trial is fully funded by the US Veteran’s Administration and was opened for enrollment in January 2026.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur need to effectively manage our operations, growth and various projects requires that we: ● manage our ongoing and future clinical trials effectively; ● manage our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors, and other third parties; ● continue to improve our operational, financial and management controls and reporting systems and procedures; and ● attract and retain sufficient numbers of talented employees.
Biggest changeOur need to effectively manage our operations, growth and various projects requires that we: ● manage our ongoing and future clinical trials effectively; ● manage our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors, and other third parties; ● continue to improve our operational, financial and management controls and reporting systems and procedures; and ● attract and retain sufficient numbers of talented employees. 32 Table of Contents We may utilize the services of vendors and research partners or collaborators to perform tasks including preclinical studies and clinical trial management, statistics and analysis, regulatory affairs, medical advisory, market research, formulation development, chemistry, manufacturing and control activities, other drug development functions, legal, auditing, financial advisory, and investor relations.
Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; ● the U.S. federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the PPACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; ● analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and ● European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers. 38 Table of Contents Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; ● the U.S. federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the PPACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; ● analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and ● European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers. 46 Table of Contents Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
These risks and uncertainties include, but are not limited to, the following: ● The remaining term of the initial patents filed with respect to a therapeutic candidate may be significantly less than the patent term for a newly discovered therapeutic candidate; ● Potential out-licensees, alliance partners and collaborators may view a therapeutic candidate identified with our proprietary DRP ® companion diagnostics platform with more skepticism, thereby requiring a higher level of additional data and further explanations of mechanisms of action in order to overcome this skepticism and obtain commercially reasonable terms for future development or collaboration; ● Key personnel and institutional knowledge relating to a therapeutic candidate that we couple with a DRP ® companion diagnostic may no longer be available for us; ● The current standard of care in the targeted therapeutic indication for the DRP ® companion diagnostic-selected patient population may be different than the standard of care that existed during the candidate’s last clinical trial, which will require more time and resources from us to reassess and redesign the regulatory development path for the DRP ® -coupled therapeutic candidate; and ● The DRP ® -coupled therapeutic candidate may be perceived to be in an “older” therapeutic drug type or focus area of oncology, thereby generating less enthusiasm and support compared to therapeutic focus areas of oncology that may be perceived as more recent. 35 Table of Contents Smerud Medical Research International and Chosa ApS are responsible for the development of our LiPlaCis ® in conjunction with our DRP ® companion diagnostic.
These risks and uncertainties include, but are not limited to, the following: ● The remaining term of the initial patents filed with respect to a therapeutic candidate may be significantly less than the patent term for a newly discovered therapeutic candidate; ● Potential out-licensees, alliance partners and collaborators may view a therapeutic candidate identified with our proprietary DRP ® companion diagnostics platform with more skepticism, thereby requiring a higher level of additional data and further explanations of mechanisms of action in order to overcome this skepticism and obtain commercially reasonable terms for future development or collaboration; ● Key personnel and institutional knowledge relating to a therapeutic candidate that we couple with a DRP ® companion diagnostic may no longer be available for us; ● The current standard of care in the targeted therapeutic indication for the DRP ® companion diagnostic-selected patient population may be different than the standard of care that existed during the candidate’s last clinical trial, which will require more time and resources from us to reassess and redesign the regulatory development path for the DRP ® -coupled therapeutic candidate; and ● The DRP ® -coupled therapeutic candidate may be perceived to be in an “older” therapeutic drug type or focus area of oncology, thereby generating less enthusiasm and support compared to therapeutic focus areas of oncology that may be perceived as more recent. 43 Table of Contents Smerud Medical Research International and Chosa ApS are responsible for the development of our LiPlaCis ® in conjunction with our DRP ® companion diagnostic.
We have not obtained final regulatory approval for any therapeutic candidate and it is possible that our existing therapeutic candidate or any therapeutic candidates we may seek to develop in the future will never obtain regulatory approval. 34 Table of Contents Stenoparib could fail to receive regulatory clearance or marketing approval for many reasons, including the following: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, including, but not limited to, the use of genomic or biomarker signatures to identify patients that may respond to drug efficacy; ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a therapeutic candidate is safe and effective for its proposed indication; ● we may be unable to identify and recruit a sufficient number of patients with relevant genomic or biomarker signatures in order to conduct clinical trials on our therapeutic candidate or the FDA or comparable foreign regulatory authorities may not approve a DRP ® companion diagnostic that is required to select patients responsive to our therapeutic candidate; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● the FDA 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 therapeutic candidate may not be sufficient to support the submission of an NDA, or other submission or to obtain regulatory approval in the U.S. or elsewhere; ● the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
We have not obtained final regulatory approval for any therapeutic candidate and it is possible that our existing therapeutic candidate or any therapeutic candidates we may seek to develop in the future will never obtain regulatory approval. 42 Table of Contents Stenoparib could fail to receive regulatory clearance or marketing approval for many reasons, including the following: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, including, but not limited to, the use of genomic or biomarker signatures to identify patients that may respond to drug efficacy; ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a therapeutic candidate is safe and effective for its proposed indication; ● we may be unable to identify and recruit a sufficient number of patients with relevant genomic or biomarker signatures in order to conduct clinical trials on our therapeutic candidate or the FDA or comparable foreign regulatory authorities may not approve a DRP ® companion diagnostic that is required to select patients responsive to our therapeutic candidate; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● the FDA 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 therapeutic candidate may not be sufficient to support the submission of an NDA, or other submission or to obtain regulatory approval in the U.S. or elsewhere; ● the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws. 43 Table of Contents In addition, later discovery of previously unknown adverse events or other problems with our drugs, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may have various consequences, including: ● restrictions on such drugs, manufacturers or manufacturing processes; ● restrictions and warnings on the labeling or marketing of a drug; ● restrictions on drug distribution or use; ● requirements to conduct post-marketing studies or clinical trials; ● warning letters or untitled letters; ● withdrawal of the drugs from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of drugs; ● fines, restitution or disgorgement of profits or revenues; ● suspension or withdrawal of marketing approvals; ● damage to relationships with any potential collaborators; ● unfavorable press coverage and damage to our reputation; ● refusal to permit the import or export of our drugs; ● drug seizure; ● injunctions or the imposition of civil or criminal penalties; or ● litigation involving patients using our drugs.
Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws. 51 Table of Contents In addition, later discovery of previously unknown adverse events or other problems with our drugs, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may have various consequences, including: ● restrictions on such drugs, manufacturers or manufacturing processes; ● restrictions and warnings on the labeling or marketing of a drug; ● restrictions on drug distribution or use; ● requirements to conduct post-marketing studies or clinical trials; ● warning letters or untitled letters; ● withdrawal of the drugs from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of drugs; ● fines, restitution or disgorgement of profits or revenues; ● suspension or withdrawal of marketing approvals; ● damage to relationships with any potential collaborators; ● unfavorable press coverage and damage to our reputation; ● refusal to permit the import or export of our drugs; ● drug seizure; ● injunctions or the imposition of civil or criminal penalties; or ● litigation involving patients using our drugs.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the size and health of the patient population required for analysis of the trial’s primary endpoints; ● the proximity of patients to study sites; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages of the therapeutic candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; ● our ability to obtain and maintain patient consents; ● sufficient number of patients willing to consent to a recent biopsy; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion. 32 Table of Contents In addition, our clinical trials will compete with other clinical trials for therapeutic candidates that are in the same therapeutic areas as our therapeutic candidate, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the size and health of the patient population required for analysis of the trial’s primary endpoints; ● the proximity of patients to study sites; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages of the therapeutic candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; ● our ability to obtain and maintain patient consents; ● sufficient number of patients willing to consent to a recent biopsy; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion. 40 Table of Contents In addition, our clinical trials will compete with other clinical trials for therapeutic candidates that are in the same therapeutic areas as our therapeutic candidate, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
Doing business internationally involves several risks, including but not limited to: ● multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; ● failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ● rejection or qualification of foreign clinical trial data by the competent authorities of other countries; ● delays or interruptions of clinical trial due to backup at ethical committees and staff shortages causing delays in processing the trials at investigator sites resulting in delayed and slow patient enrollment; ● additional potentially relevant third-party patent and other intellectual property rights; ● complexities and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property; ● difficulties in staffing and managing foreign operations; ● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; ● limits in our ability to penetrate international markets; ● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for stenoparib and exposure to foreign currency exchange rate fluctuations; ● natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease; ● certain expenses including, among others, expenses for travel, translation and insurance; and ● regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Doing business internationally involves several risks, including but not limited to: ● multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, tariffs, permits and licenses; ● failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ● rejection or qualification of foreign clinical trial data by the competent authorities of other countries; ● delays or interruptions of clinical trial due to backlogs at ethical committees and staff shortages causing delays in processing the trials at investigator sites resulting in delayed and slow patient enrollment; ● additional potentially relevant third-party patent and other intellectual property rights; ● complexities and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property; ● difficulties in staffing and managing foreign operations; ● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; ● limits in our ability to penetrate international markets; ● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for stenoparib and exposure to foreign currency exchange rate fluctuations; ● natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease; ● certain expenses including, among others, expenses for travel, translation and insurance; and ● regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Additionally, if the results of our clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with our therapeutic candidate, we may: ● be delayed in obtaining marketing approval, if at all; ● obtain approval for indications or patient populations that are not as broad as intended or desired; 31 Table of Contents ● obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; ● be subject to additional post-marketing testing requirements; ● be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; ● have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy, or REMS; ● be subject to the addition of labeling statements, such as warnings or contraindications; ● be sued; or ● experience damage to our reputation.
Additionally, if the results of our clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with our therapeutic candidate, we may: ● be delayed in obtaining marketing approval, if at all; ● obtain approval for indications or patient populations that are not as broad as intended or desired; 39 Table of Contents ● obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; ● be subject to additional post-marketing testing requirements; ● be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; ● have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy, or REMS; ● be subject to the addition of labeling statements, such as warnings or contraindications; ● be sued; or ● experience damage to our reputation.
In particular, our Certificate of Incorporation and bylaws and Delaware law, as applicable, among other things: ● provide for a classified board of directors; ● provide the board of directors with the ability to alter the by-laws without stockholder approval; ● establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and ● provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum. 60 Table of Contents Our Certificate of Incorporation designates the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain types of claims that the federal courts do not have exclusive jurisdiction, which may limit a stockholder ’ s ability to bring a claim in a judicial forum that it finds favorable.
In particular, our Certificate of Incorporation and bylaws and Delaware law, as applicable, among other things: ● provide for a classified board of directors; ● provide the board of directors with the ability to alter the by-laws without stockholder approval; ● establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and ● provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum. 68 Table of Contents Our Certificate of Incorporation designates the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain types of claims that the federal courts do not have exclusive jurisdiction, which may limit a stockholder ’ s ability to bring a claim in a judicial forum that it finds favorable.
Disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation related issues; ● the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology. 54 Table of Contents In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
Disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation related issues; ● the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology. 62 Table of Contents In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
International operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the U.S. Our business will be subject to risks associated with conducting business internationally. Some of our suppliers, industry partners and clinical study centers are located outside of the U.S.
International operations may expose us to business, regulatory, political, operational, financial, pricing, tariffs, and reimbursement risks associated with doing business outside of the U.S. Our business will be subject to risks associated with conducting business internationally. Some of our suppliers, industry partners and clinical study centers are located outside of the U.S.
Our results of operations could be materially adversely affected by proposed healthcare reforms, by the Medicare prescription drug coverage legislation, by the possible effect of such current or future legislation on amounts that private insurers will pay and by other health care reforms that may be enacted or adopted in the future. 45 Table of Contents In September 2007, the Food and Drug Administration Amendments Act of 2007 was enacted, giving the FDA enhanced post-marketing authority, including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA.
Our results of operations could be materially adversely affected by proposed healthcare reforms, by the Medicare prescription drug coverage legislation, by the possible effect of such current or future legislation on amounts that private insurers will pay and by other health care reforms that may be enacted or adopted in the future. 53 Table of Contents In September 2007, the Food and Drug Administration Amendments Act of 2007 was enacted, giving the FDA enhanced post-marketing authority, including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA.
If we are required by the FDA, or other regulatory authorities such as the European Medicines Agency, or EMA, to perform studies and trials in addition to those currently expected, or if there are any delays in the development, or in the completion of any planned or future preclinical studies or clinical trials of our current therapeutic candidate, our expenses could increase, and profitability could be further delayed. 28 Table of Contents We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development program for stenoparib or its commercialization efforts.
If we are required by the FDA, or other regulatory authorities such as the European Medicines Agency, or EMA, to perform studies and trials in addition to those currently expected, or if there are any delays in the development, or in the completion of any planned or future preclinical studies or clinical trials of our current therapeutic candidate, our expenses could increase, and profitability could be further delayed. 36 Table of Contents We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development program for stenoparib or its commercialization efforts.
Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. 48 Table of Contents We are substantially dependent on third parties for the manufacture of stenoparib and Clinical Laboratory Improvements Act ( “ CLIA ” ) diagnostic laboratories to test patient biopsies in support of our clinical trials, and we intend to rely on third parties to produce commercial supplies of any approved therapeutic candidate.
Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. 56 Table of Contents We are substantially dependent on third parties for the manufacture of stenoparib and Clinical Laboratory Improvements Act ( “ CLIA ” ) diagnostic laboratories to test patient biopsies in support of our clinical trials, and we intend to rely on third parties to produce commercial supplies of any approved therapeutic candidate.
Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend, could result in adverse publicity and could have a material adverse effect on our business, financial condition, results of operations and prospects. 63 Table of Contents Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.
Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend, could result in adverse publicity and could have a material adverse effect on our business, financial condition, results of operations and prospects. 71 Table of Contents Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.
As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. 52 Table of Contents If we are found to infringe, misappropriate or otherwise violate a third-party’s intellectual property rights, we could be required to obtain a license from such third-party to continue developing, manufacturing, and marketing our technology and therapeutic candidates.
As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. 60 Table of Contents If we are found to infringe, misappropriate or otherwise violate a third-party’s intellectual property rights, we could be required to obtain a license from such third-party to continue developing, manufacturing, and marketing our technology and therapeutic candidates.
If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected. 55 Table of Contents We may be subject to claims by third parties asserting that our employees, consultants, contractors or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their trade secret or claiming ownership of what we regard as our own intellectual property.
If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected. 63 Table of Contents We may be subject to claims by third parties asserting that our employees, consultants, contractors or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their trade secret or claiming ownership of what we regard as our own intellectual property.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the therapeutic candidate covered by the license agreement which would have a material adverse effect on our business. 33 Table of Contents We may expend our limited resources to pursue a particular therapeutic candidate or indication and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the therapeutic candidate covered by the license agreement which would have a material adverse effect on our business. 41 Table of Contents We may expend our limited resources to pursue a particular therapeutic candidate or indication and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Our approach may not result in time savings, higher success rates or reduced costs as we expect it to, and if not, we may not attract collaborators or develop new drugs as quickly or cost effectively as expected and therefore we may not be able to commercialize our approach as originally expected. 36 Table of Contents Our proprietary DRP ® companion diagnostics platform may fail to help us select and treat likely responder patients for stenoparib or help us identify additional potential therapeutic candidates.
Our approach may not result in time savings, higher success rates or reduced costs as we expect it to, and if not, we may not attract collaborators or develop new drugs as quickly or cost effectively as expected and therefore we may not be able to commercialize our approach as originally expected. 44 Table of Contents Our proprietary DRP ® companion diagnostics platform may fail to help us select and treat likely responder patients for stenoparib or help us identify additional potential therapeutic candidates.
The decision by our collaborators to pursue alternative technologies or the failure of our collaborators to develop or successfully commercialize any therapeutic candidate to which they have obtained rights from us could materially harm our business, financial condition and results of operations. 50 Table of Contents Risks Related to Our Intellectual Property If we do not obtain patent term extension for stenoparib or obtain a patent on our DRP ® companion diagnostic for stenoparib, our business may be materially harmed.
The decision by our collaborators to pursue alternative technologies or the failure of our collaborators to develop or successfully commercialize any therapeutic candidate to which they have obtained rights from us could materially harm our business, financial condition and results of operations. 58 Table of Contents Risks Related to Our Intellectual Property If we do not obtain patent term extension for stenoparib or obtain a patent on our DRP ® companion diagnostic for stenoparib, our business may be materially harmed.
Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects. 57 Table of Contents Risks Related to Ownership of our Securities and Our Status as a Public Company If our business developments and achievements do not meet the expectations of investors or securities analysts or for other reasons the expected benefits do not occur, the market price of our common stock traded on Nasdaq may decline.
Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects. 65 Table of Contents Risks Related to Ownership of our Securities and Our Status as a Public Company If our business developments and achievements do not meet the expectations of investors or securities analysts or for other reasons the expected benefits do not occur, the market price of our common stock traded on Nasdaq may decline.
In the U.S., numerous federal and state laws, and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, such as Section 5 of the Federal Trade Commission Act, that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators and third-party providers. 62 Table of Contents In many jurisdictions, enforcement actions and consequences for noncompliance are rising.
In the U.S., numerous federal and state laws, and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, such as Section 5 of the Federal Trade Commission Act, that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators and third-party providers. 70 Table of Contents In many jurisdictions, enforcement actions and consequences for noncompliance are rising.
If reimbursement of our drugs is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially. 46 Table of Contents If we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.
If reimbursement of our drugs is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially. 54 Table of Contents If we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.
If we are unable to obtain or maintain third-party manufacturing for commercial supply of stenoparib, or to do so on commercially reasonable terms, we may not be able to develop and commercialize stenoparib successfully. 49 Table of Contents Our failure to find third-party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations.
If we are unable to obtain or maintain third-party manufacturing for commercial supply of stenoparib, or to do so on commercially reasonable terms, we may not be able to develop and commercialize stenoparib successfully. 57 Table of Contents Our failure to find third-party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations.
Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing drugs. 27 Table of Contents We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing drugs. 35 Table of Contents We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability. 37 Table of Contents We may be subject to extensive regulations outside the U.S. and may not obtain marketing approvals for stenoparib in Europe and other jurisdictions.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability. 45 Table of Contents We may be subject to extensive regulations outside the U.S. and may not obtain marketing approvals for stenoparib in Europe and other jurisdictions.
Risks Related to the Approval and Commercialization of Our Stenoparib Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing stenoparib.
Risks Related to the Approval and Commercialization of Stenoparib Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing stenoparib.
We will not be able to market and sell stenoparib in combination with any such unapproved cancer therapies that do not ultimately obtain marketing approval. 40 Table of Contents If the FDA or similar foreign regulatory authorities do not approve or revoke the approval of these other drugs, or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with stenoparib, we may be unable to obtain approval of or market stenoparib.
We will not be able to market and sell stenoparib in combination with any such unapproved cancer therapies that do not ultimately obtain marketing approval. 48 Table of Contents If the FDA or similar foreign regulatory authorities do not approve or revoke the approval of these other drugs, or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with stenoparib, we may be unable to obtain approval of or market stenoparib.
Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and our ability to protect, defend and enforce our patent rights in the future. 51 Table of Contents We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and our ability to protect, defend and enforce our patent rights in the future. 59 Table of Contents We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our drugs in any market. 42 Table of Contents If we are required by the FDA to obtain approval of a DRP ® companion diagnostic in connection with approval of stenoparib, and we do not obtain or face delays in obtaining FDA approval of a DRP ® diagnostic device, we will not be able to commercialize stenoparib and our ability to generate revenue will be materially impaired.
We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our drugs in any market. 50 Table of Contents If we are required by the FDA to obtain approval of a DRP ® companion diagnostic in connection with approval of stenoparib, and we do not obtain or face delays in obtaining FDA approval of a DRP ® diagnostic device, we will not be able to commercialize stenoparib and our ability to generate revenue will be materially impaired.
If we or our licensors fail to maintain the patents and patent applications directed to stenoparib, it would have a material adverse effect on our business, financial condition, results of operations, and prospects. 53 Table of Contents If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
If we or our licensors fail to maintain the patents and patent applications directed to stenoparib, it would have a material adverse effect on our business, financial condition, results of operations, and prospects. 61 Table of Contents If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
If we fail to attract new personnel or fail to retain and motivate our current personnel, our business and future growth prospects could be severely harmed. 25 Table of Contents Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
If we fail to attract new personnel or fail to retain and motivate our current personnel, our business and future growth prospects could be severely harmed. 33 Table of Contents Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
If we fail to produce positive results in our planned preclinical studies or clinical trials of our therapeutic candidate, the development timeline and regulatory approval and commercialization prospects for our therapeutic candidate, and, correspondingly, our business and financial prospects, would be materially and adversely affected. 30 Table of Contents We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
If we fail to produce positive results in our planned preclinical studies or clinical trials of our therapeutic candidate, the development timeline and regulatory approval and commercialization prospects for our therapeutic candidate, and, correspondingly, our business and financial prospects, would be materially and adversely affected. 38 Table of Contents We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
We have not submitted an application for or received marketing approval for stenoparib in the U.S. or in any other jurisdiction. 39 Table of Contents We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party clinical research organizations or other third-party consultants or vendors to assist us in this process.
We have not submitted an application for or received marketing approval for stenoparib in the U.S. or in any other jurisdiction. 47 Table of Contents We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party clinical research organizations or other third-party consultants or vendors to assist us in this process.
If any analyst who may cover us were to cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline. 64 Table of Contents Comprehensive tax reform bills could adversely affect our business and financial condition.
If any analyst who may cover us were to cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline. 72 Table of Contents Comprehensive tax reform bills could adversely affect our business and financial condition.
Failure to comply with Section 404 of the Sarbanes-Oxley Act could also potentially subject us to actions or investigations by the SEC or other regulatory authorities. 29 Table of Contents Risks Related to the Discovery and Development of Stenoparib Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes.
Failure to comply with Section 404 of the Sarbanes-Oxley Act could also potentially subject us to actions or investigations by the SEC or other regulatory authorities. 37 Table of Contents Risks Related to the Discovery and Development of Stenoparib Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes.
Foreign Corrupt Practices Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery laws in other countries. Any of these factors could harm our future international expansion and operations and, consequently, our results of operations. 26 Table of Contents Our failure to successfully acquire, develop, and market additional therapeutic candidates could impair our ability to grow.
Foreign Corrupt Practices Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery laws in other countries. Any of these factors could harm our future international expansion and operations and, consequently, our results of operations. 34 Table of Contents Our failure to successfully acquire, develop, and market additional therapeutic candidates could impair our ability to grow.
It is unclear how the new Trump administration will impact the scope of the orphan drug exclusivity. 41 Table of Contents A Breakthrough Therapy designation by the FDA for stenoparib may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that stenoparib will receive marketing approval.
It is unclear how the new Trump administration will impact the scope of the orphan drug exclusivity. 49 Table of Contents A Breakthrough Therapy designation by the FDA for stenoparib may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that stenoparib will receive marketing approval.
If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management. 58 Table of Contents Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our common stock to decline.
If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management. 66 Table of Contents Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our common stock to decline.
As a result, you may not receive any return on an investment in our common stock unless you sell your shares of Common Stock for a price greater than that which you paid for it. 59 Table of Contents There is no assurance that an active and liquid trading market in our common stock will develop.
As a result, you may not receive any return on an investment in our common stock unless you sell your shares of Common Stock for a price greater than that which you paid for it. 67 Table of Contents There is no assurance that an active and liquid trading market in our common stock will develop.
Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a small number of our competitors. 44 Table of Contents Competition may further increase because of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a small number of our competitors. 52 Table of Contents Competition may further increase because of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third-party, our competitive position would be materially and adversely harmed. 56 Table of Contents Intellectual property rights do not necessarily address all potential threats.
If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third-party, our competitive position would be materially and adversely harmed. 64 Table of Contents Intellectual property rights do not necessarily address all potential threats.
To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible. 61 Table of Contents We may be at risk of securities class action litigation. We may be at risk of securities class action litigation.
To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible. 69 Table of Contents We may be at risk of securities class action litigation. We may be at risk of securities class action litigation.
We may seek Fast Track designation for stenoparib. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation.
We achieved Fast Track designation for stenoparib. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation.
Any of these failures could have a material adverse effect on our operating results and financial condition. 47 Table of Contents Risks Related to Our Reliance on Third Parties We rely on third parties to conduct our preclinical studies and clinical trials.
Any of these failures could have a material adverse effect on our operating results and financial condition. 55 Table of Contents Risks Related to Our Reliance on Third Parties We rely on third parties to conduct our preclinical studies and clinical trials.
We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth. As of March 26, 2025, we employed a total of 6 full-time employees and 1 part-time employee. Our current internal departments include research and development, finance and administration.
We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth. As of March 24, 2026, we employed a total of seven full-time employees and one part-time employee. Our current internal departments include research and development, finance and administration.
Since our inception of our predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $119.0 million as of December 31, 2024. Our net losses were $24.5 million and $11.9 million for the years ended December 31, 2024, and 2023, respectively.
Since our inception of our predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $130.2 million as of December 31, 2025. Our net losses were $11.2 million and $24.5 million for the years ended December 31, 2025, and 2024, respectively.
Risks Related to Our Financial Position and Need for Additional Capital We have a limited operating history and have never generated any revenues other than from research grants and a limited number of DRP ® biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
Risks Related to Our Financial Position and Need for Additional Capital We have a limited operating history with no product revenues to date and a limited number of DRP ® biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
As such, we have a limited operating history and have not generated any revenues. In addition, we have not yet demonstrated an ability to successfully obtain marketing approvals, manufacture drugs on a commercial scale, or conduct sales and marketing activities necessary for successful commercialization.
As such, we have a limited operating history and generated no product revenues to date. In 2025, the company generated $0.3 million of lab revenues. In addition, we have not yet demonstrated an ability to successfully obtain marketing approvals, manufacture drugs on a commercial scale, or conduct sales and marketing activities necessary for successful commercialization.
In light of our financial condition and dependence on financing for our operations, we may be unable to meet the payment requirements under the amendment and we may lose our right to use stenoparib, which will adversely affect our ability to conduct our clinical trials and to achieve our business objectives and adversely affect our financial results.
In light of our financial condition and dependence on financing for our operations, we may be unable to meet the payment requirements under the amendment and we may lose our right to use stenoparib, which will adversely affect our ability to conduct our clinical trials and to achieve our business objectives and adversely affect our financial results. 31 Table of Contents Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and stock price. The global credit and financial markets have from time-to-time experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
The global credit and financial markets have from time-to-time experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. As of December 31, 2024, we had cash, cash equivalents and marketable securities of $19.5.
Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. As of December 31, 2025, we had cash of $14.7 million. We believe that our existing cash will enable us to fund our operating expenses at least into the second quarter of 2027.
Removed
We may utilize the services of vendors and research partners or collaborators to perform tasks including preclinical studies and clinical trial management, statistics and analysis, regulatory affairs, medical advisory, market research, formulation development, chemistry, manufacturing and control activities, other drug development functions, legal, auditing, financial advisory, and investor relations.
Added
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the “OBBBA”), which, among other things, modifies the international tax regime and extends or makes permanent various provisions from the Tax Cuts and Jobs Act, including bonus depreciation and research and development expensing.
Removed
In addition, in the first quarter of 2025, we issued and sold an aggregate of 9,719,173 shares of our common stock under our at-the-market offering program for aggregate net proceeds of $9.7 million, after deducting commissions and offering expenses payable by us.
Added
The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The legislation did not have a material impact on our 2025 effective tax rate.
Removed
We believe that our existing cash, cash equivalents and marketable securities, including the net proceeds from sales of common stock under our at-the-market offering program during the first quarter of 2025, will enable us to fund our operating expenses and capital expenditure requirements at least into the second half of 2026.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. Our principal executive office is located at 24 School St, 2nd Fl, Boston, MA 02108. We lease at-will, month-to-month the virtual office space, where we are not bound by any lease. Additionally, we lease a space in a technology park consisting of approximately 4,283 square feet in Hoersholm, Denmark.
Biggest changeItem 2. Properties. Our principal executive office is located at 123 E. Tarpon Ave., Tarpon Springs, FL 34689. We lease at-will, month-to-month the virtual office space, where we are not bound by any lease. Additionally, we lease a space in a technology park consisting of approximately 4,283 square feet in Hoersholm, Denmark.
The facility lease in continuing on a month-to-month basis. We believe that our facilities are adequate to meet our current needs and the additional space can be obtained on commercially reasonable terms as needed. 65 Table of Contents
The facility lease in continuing on a month-to-month basis. We believe that our facilities are adequate to meet our current needs and the additional space can be obtained on commercially reasonable terms as needed. 73 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. For information regarding our material legal proceedings, see “ Note 16. Commitments and Contingencies ” in the accompanying “ Notes to Consolidated Financial Statements ” in this Annual Report, which information is incorporated herein by reference. Item 4. Mine Safety Disclosures. Not applicable.
Biggest changeItem 3. Legal Proceedings. For information regarding our material legal proceedings, see “ Note 14. Commitments and Contingencies ” in the accompanying “ Notes to Consolidated Financial Statements ” in this Annual Report, which information is incorporated herein by reference. Item 4. Mine Safety Disclosures. Not applicable.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities None. 66 Table of Contents Item 6. [Reserved]
Biggest changeRecent Sales of Unregistered Securities None. 74 Table of Contents Item 6. [Reserved]

Item 7. Management's Discussion & Analysis

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

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Biggest changeResults of Operations Comparison of years ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Year ended December 31, Increase/ 2024 2023 (Decrease) (In thousands) Operating expenses: Research and development $ 6,096 $ 7,103 $ (1,007 ) Impairment of intangible assets 9,703 — 9,703 General and administrative 11,442 10,026 1,416 Total operating costs and expenses 27,241 17,129 10,112 Loss from operations (27,241 ) (17,129 ) (10,112 ) Other income (expense) — Interest income 533 22 511 Interest expenses (653 ) (498 ) (155 ) Foreign exchange gains (losses) (212 ) 133 (345 ) Fair value of inducement warrants — (4,189 ) 4,189 Loss on modification of warrants — (591 ) 591 Change in fair value adjustment of warrant derivative liabilities 2,677 10,434 (7,757 ) Total other income 2,345 5,311 (2,966 ) Loss before income tax expense (benefit) (24,896 ) (11,818 ) (13,078 ) Income tax expense (benefit) (381 ) 83 (464 ) Net loss $ (24,515 ) $ (11,901 ) $ (12,614 ) 76 Table of Contents Research and Development Expenses We currently do not track our research and development costs by product candidate.
Biggest changeWe expect our general and administrative expenses to increase for the foreseeable future due to anticipated increases in headcount to advance stenoparib and because of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, Nasdaq Stock Market, additional insurance expenses, investor relations activities and other administrative and professional services. 81 Table of Contents Results of Operations Comparison of years ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: Year ended December 31, Increase/ 2025 2024 (Decrease) (In thousands) Revenue: License Revenue $ 320 $ — $ 320 Total Revenue 320 — 320 Operating expenses: Research and development 6,601 6,096 505 Impairment of intangible assets — 9,703 (9,703 ) General and administrative 6,324 11,442 (5,118 ) Total operating costs and expenses 12,925 27,241 (14,316 ) Loss from operations (12,605 ) (27,241 ) 14,636 Other income (expense) — Interest income 801 533 268 Interest expenses (185 ) (653 ) 468 Foreign exchange gains (losses) 757 (212 ) 969 Change in fair value adjustment of warrant derivative liabilities 1 2,677 (2,676 ) Total other income 1,374 2,345 (971 ) Loss before income tax expense (benefit) (11,231 ) (24,896 ) 13,665 Income tax expense (benefit) — (381 ) 381 Net loss $ (11,231 ) $ (24,515 ) $ 13,284 Revenues We generated $0.3 million of service revenue for the year ended December 31, 2025 from the license of DRP testing services.
We expect our expenses will increase substantially in connection with our ongoing activities, as we: ● advance stenoparib through clinical trials; ● pursue regulatory approval of stenoparib; ● operate as a public company; ● continue our preclinical programs and clinical development efforts; ● continue research activities for stenoparib; and ● manufacture supplies for our preclinical studies and clinical trials. 75 Table of Contents Components of Operating Expenses Research and Development Expenses Research and development expenses include: ● expenses incurred under agreements with third-party contract organizations, and consultants; ● costs related to production of drug substance, including fees paid to contract manufacturers; ● laboratory and vendor expenses related to the execution of preclinical trials; and ● employee-related expenses, which include salaries, benefits and stock-based compensation.
We expect our expenses will increase substantially in connection with our ongoing activities, as we: ● advance stenoparib through clinical trials; ● pursue regulatory approval of stenoparib; ● operate as a public company; ● continue our preclinical programs and clinical development efforts; ● continue research activities for stenoparib; and ● manufacture supplies for our preclinical studies and clinical trials. 80 Table of Contents Components of Operating Expenses Research and Development Expenses Research and development expenses include: ● expenses incurred under agreements with third-party contract organizations, and consultants; ● costs related to production of drug substance, including fees paid to contract manufacturers; ● laboratory and vendor expenses related to the execution of preclinical trials; and ● employee-related expenses, which include salaries, benefits and stock-based compensation.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting years.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues, expenses, and taxes during the reporting years.
Critical Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of financial condition and results of operations is based upon our audited consolidated financial statements for the years ended December 31, 2024 and 2023, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Critical Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of financial condition and results of operations is based upon our audited consolidated financial statements for the years ended December 31, 2025 and 2024, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Other Income (Expense) Other income of $2.3 million recognized in the year ended December 31, 2024, consisted primarily of a $2.7 million fair value adjustment of warrant derivative liabilities, and $0.5 million in interest income, partially offset by $0.7 million in interest expense and $0.2 million in foreign exchange loss.
Other income of $2.3 million was recognized in the year ended December 31, 2024, which consisted primarily of a $2.7 million fair value adjustment of warrant derivative liabilities, and $0.5 million in interest income, partially offset by $0.7 million in interest expense and $0.2 million in foreign exchange loss.
We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
We disclaim any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission (the "SEC"), to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Funding and Capital Resources Since our inception through December 31, 2024, our operations have been financed primarily by the sale of preferred stock, convertible promissory notes, and the sale and issuance of our common shares. Since inception, we have had significant operating losses.
Funding and Capital Resources Since our inception through December 31, 2025, our operations have been financed primarily by the sale of preferred stock, convertible promissory notes, and the sale and issuance of our common shares. Since inception, we have had significant operating losses.
On September 9, 2024, we filed the Sixth Certificate of Amendment with the Secretary of State of the State of Delaware to decrease the number of authorized shares from 750,500,000 to 250,500,000, and to decrease the number of our common stock from 750,000,000 to 250,000,000.
Recent Developments Authorized Share Decrease On September 9, 2024, we filed the Sixth Certificate of Amendment with the Secretary of State of the State of Delaware to decrease the number of authorized shares from 750,500,000 to 250,500,000, and to decrease the number of our common stock from 750,000,000 to 250,000,000.
For the year ended December 31, 2024, we sold an aggregate of 6,953,259 shares of our common stock pursuant to the Sales Agreement, resulting in net proceeds of approximately $38.8 million after deducting underwriting discounts.
For the year ended December 31, 2024, the Company sold an aggregate of 6,953,259 shares of its common stock pursuant to the Sales Agreement, resulting in net proceeds of approximately $38.8 million, after deducting underwriting discounts.
The complaint asserted violations of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder against all defendants as well as violations of Section 20(a) of the Exchange Act against the individual defendants. On February 26, 2025, we issued a press release announcing the dismissal of this class action lawsuit.
The complaint asserted violations of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder against all defendants as well as violations of Section 20(a) of the Exchange Act against the individual defendants. On February 26, 2025, we issued a press release announcing the dismissal of this class action lawsuit, resolving that matter favorably for the Company.
Jensen re-focus our clinical development program, we also added a new President and Chief Development Officer, Jeremy R. Graff, PhD, who was brought in with deep experience in cancer drug development including nearly 17 years at Eli Lilly and Company and 10 more years in various C-suite roles in biotech.
Jensen re-focus our clinical development program, we also added a new President and Chief Development Officer, Jeremy R. Graff, PhD, who was brought in with deep experience in cancer drug development, including nearly 17 years at Eli Lilly and Company and 10 more years in various C-suite roles in biotech. During 2025, Jeffrey Ervin was hired as Chief Financial Officer.
There were no payments made to Novartis in 2024. As of December 31, 2024, the liability is recorded as a current liability on our condensed consolidated balance sheets as follows: $3.6 million in accounts payable and $1.6 million in convertible promissory notes and accrued interest.
There were no payments made to Novartis in 2024. As of December 31, 2025, the liability is recorded as a current liability on our consolidated balance sheets as follows: $3.6 million in accounts payable, $0.5 million interest recorded as accrued expenses, and $1.4 million in convertible promissory notes and accrued interest.
ATM Facility On March 19, 2024, we entered into an At-The-Market Issuance Sales Agreement, as amended (the "Sales Agreement") with Ascendiant Capital Markets, LLC ("Ascendiant") under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, par value $0.0001 per share, having an aggregate gross sales price of up to $50 million, to or through Ascendiant.
ATM Facility On March 19, 2024, the Company entered into an At-The-Market Issuance Sales Agreement, as amended (the “Sales Agreement”) with Ascendiant Capital Markets, LLC (“Ascendiant”) pursuant to which, the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share, having an aggregate gross sales price of up to $50 million, to or through Ascendiant.
Investing Activities Net cash used in investing activities was approximately $0.3 million for the year ended December 31, 2024, due to $0.3 million in purchases of lab equipment.
Investing Activities There was eight thousand of investing activity for the year December 31, 2025. Net cash used in investing activities was approximately $0.3 million for the year ended December 31, 2024, due to $0.3 million in purchases of lab equipment.
Since our inception of our predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $119.0 million as of December 31, 2024. Our net losses were $24.5 million and $11.9 million for the years ended December 31, 2024 and 2023, respectively.
Since our inception of our predecessor, Allarity Therapeutics A/S, we have incurred losses and have an accumulated deficit of $130.2 million as of December 31, 2025. Our net losses were $11.2 million and $24.5 million for the years ended December 31, 2025 and 2024, respectively.
There was no investing activity for the year ended December 31, 2023. 77 Table of Contents Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was $36.8 million, primarily related to $38.8 million in proceeds from ATM sales of common stock net of issuance costs, $2.9 million in net proceeds from the issuance of Series A Convertible Redeemable Preferred Stock, and $1.3 million in proceeds from 3i debt promissory notes, partially offset by the $3.5 million redemption of Series A Convertible Redeemable Preferred Stock and repayment of $1.3 million of 3i debt promissory notes.
Table of Contents Net cash provided by financing activities for the year ended December 31, 2025 was $10.9 million, primarily related to $14.0 million from equity issuances and $3.2 million of stock repurchases Net cash provided by financing activities for the year ended December 31, 2024 was $36.8 million, primarily related to $38.8 million in proceeds from ATM sales of common stock net of issuance costs, $2.9 million in net proceeds from the issuance of Series A Convertible Redeemable Preferred Stock, and $1.3 million in proceeds from 3i debt promissory notes, partially offset by the $3.5 million redemption of Series A Convertible Redeemable Preferred Stock and repayment of $1.3 million of 3i debt promissory notes.
We record the expense for option awards using either a graded or straight-line vesting method. We account for forfeitures as they occur. For stock-based awards granted to employees, directors and non-employee consultants, the measurement date is the date of grant. The compensation expense is then recognized over the requisite service period, which is the vesting period of the respective award.
We record the expense for option awards using either a graded or straight-line vesting method. We account for forfeitures as they occur. For stock-based awards granted to employees, directors and non-employee consultants, the measurement date is the date of grant.
On January 14, 2024, pursuant to the terms of the January 14th, 2024, 3i, LP Bridge Loan, we modified the conversion price of the 3i Exchange Warrants from $1.00 to $0.4476, thereby increasing the number of Exchange Warrants outstanding from 4,407,221 at December 31, 2023, to 9,846,339 outstanding at January 14, 2024.
The Private Placement (PIPE Financing) and Amendments to the Certificate of Designation of Series A Preferred Stock On January 14, 2024, pursuant to the terms of the January 14th, 2024, 3i, LP Bridge Loan, we modified the conversion price of the 3i Exchange Warrants from $1.00 to $0.4476, thereby increasing the number of Exchange Warrants outstanding from 4,407,221 at December 31, 2023, to 9,846,339 outstanding at January 14, 2024.
As of March 26, 2025, no more shares of our common stock remained available for the sale under the ATM program. 68 Table of Contents August 2024 Series A Convertible Redeemable Preferred Stock On August 19, 2024 (the "Closing Date") we entered into a Securities Purchase Agreement (the “August 2024 SPA”) with certain purchasers (the “August 2024 Purchasers”), pursuant to which we issued and sold, in a private placement (the “August 2024 Offering”), 35,000 shares of our Series A Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “August 2024 Preferred Stock”), for net proceeds of approximately $2.9 million, after the deduction of discounts, fees and offering expenses.
The Sales Agreement was fully utilized and terminated as of December 31, 2025. 76 Table of Contents August 2024 Series A Convertible Redeemable Preferred Stock On August 19, 2024 (the "Closing Date") we entered into a Securities Purchase Agreement (the “August 2024 SPA”) with certain purchasers (the “August 2024 Purchasers”), pursuant to which we issued and sold, in a private placement (the “August 2024 Offering”), 35,000 shares of our Series A Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “August 2024 Preferred Stock”), for net proceeds of approximately $2.9 million, after the deduction of discounts, fees and offering expenses.
From the proceeds of the July Offering, on July 10, 2023, we redeemed the 3i June Promissory Note for $351,000 in cash. 3i Convertible Senior Promissory Notes (2024) During the year ended December 31, 2024, we entered into a Securities Purchase Agreement ("SPA") with 3i, pursuant to which three senior convertible promissory notes (the "2024 Notes") were issued as follows: ● On January 18, 2024, in an aggregate principal amount of $440,000 due on January 18, 2025, and with a set conversion price of $268.50 per share, for an aggregate purchase price of $400,000, representing an approximate 10% original issue discount (the “First Note”). ● On February 13, 2024, in an aggregate principal amount of $440,000 due on February 13, 2025, and with a set conversion price of $243.00 per share, for an aggregate purchase price of $400,000, representing an approximately 10% original issue discount (the “Second Note”). ● On March 14, 2024, in an aggregate principal amount of $660,000 due on March 14, 2025, and with a set conversion price of $210.00 per share, for an aggregate purchase price of $600,000, representing an approximately 10% original issue discount (the “Third Note”).
In the year ended December 31, 2024, we received $37.3 million in proceeds from ATM sales net of issuance costs, $1.3 million in proceeds from 3i promissory notes, and $2.9 million in proceeds from the issuance of Convertible Redeemable Series A Preferred Stock; and we repaid $1.3 million of 3i promissory notes, and redeemed $3.5 million of Convertible Redeemable Series A Preferred Stock. 3i Convertible Senior Promissory Notes (2024) During the year ended December 31, 2024, we entered into a Securities Purchase Agreement ("SPA") with 3i, pursuant to which three senior convertible promissory notes (the "2024 Notes") were issued as follows: ● On January 18, 2024, in an aggregate principal amount of $440,000 due on January 18, 2025, and with a set conversion price of $268.50 per share, for an aggregate purchase price of $400,000, representing an approximate 10% original issue discount (the “First Note”). ● On February 13, 2024, in an aggregate principal amount of $440,000 due on February 13, 2025, and with a set conversion price of $243.00 per share, for an aggregate purchase price of $400,000, representing an approximately 10% original issue discount (the “Second Note”). ● On March 14, 2024, in an aggregate principal amount of $660,000 due on March 14, 2025, and with a set conversion price of $210.00 per share, for an aggregate purchase price of $600,000, representing an approximately 10% original issue discount (the “Third Note”).
Our net loss was $24.5 million and $11.9 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had $19.5 million in cash, and an accumulated deficit of $119.0 million.
Our net loss was $11.2 million and $24.5 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had $14.7 million in cash, and an accumulated deficit of $130.2 million.
Allarity Therapeutics, Inc., et al , 1:24-cv-06952, was filed in the United States District Court for the Southern District of New York against us and certain of our current and former officers.
Class Action On September 13, 2024, a purported class action captioned Osman Mukeljic v. Allarity Therapeutics, Inc., et al , 1:24-cv-06952, was filed in the United States District Court for the Southern District of New York against us and certain of our current and former officers.
The offer and sales of the shares are made pursuant to a previously filed shelf registration statement on Form S-3 (File No. 333-275282), originally filed with the Securities and Exchange Commission (the "SEC") on November 2, 2023 and declared effective on November 29, 2023, and the related prospectus supplement dated September 9, 2024 and filed with the SEC on such date.
The offer and sale of the shares will be made pursuant to a previously filed shelf registration statement on Form S-3 (File No. 333-275282), originally filed with the SEC on November 2, 2023 and declared effective by the SEC on November 29, 2023, and the related prospectus supplement dated September 9, 2024 and filed with the SEC on such date pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”).
Our historical accrual estimates have not been materially different from the actual costs. Convertible debt instruments We follow ASC 480-10, Distinguishing Liabilities from Equity in its evaluation of the accounting for a hybrid instrument.
Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from our estimates. Our historical accrual estimates have not been materially different from the actual costs. Convertible debt instruments We follow ASC 480-10, Distinguishing Liabilities from Equity in its evaluation of the accounting for a hybrid instrument.
We review stock award modifications when there is an exchange of original award for a new award. We calculate the incremental fair value based on the difference between the fair value of the modified award and the fair value of the original award immediately before it was modified.
We calculate the incremental fair value based on the difference between the fair value of the modified award and the fair value of the original award immediately before it was modified.
Liquidity, Capital Resources and Plan of Operations Cash Flows for the Years Ended December 31, 2024 and 2023 The following table summarizes our cash flows for the years indicated: Year Ended December 31, (In thousands) 2024 2023 Total cash provided by (used in): Operating activities $ (17,352 ) $ (12,745 ) Investing activities (298 ) — Financing activities 36,792 10,995 Effect of foreign exchange rates on cash 225 (113 ) Net increase (decrease) in cash $ 19,367 $ (1,863 ) Operating Activities Net cash used in operating activities was approximately $17.4 million for the year ended December 31, 2024, primarily comprised of our $24.5 million net loss and $2.7 million reduction in fair value of warrant derivative liability, $0.4 million reduction in deferred income tax, and $0.1 million unrealized foreign exchange gain, partially offset by $9.7 million intangible asset impairment, $0.3 million in common stock issued for services, $0.2 million non-cash interest expense, $0.1 million stock-based compensation and $0.1 million change in operating assets and liabilities.
Net cash used in operating activities was approximately $17.4 million for the year ended December 31, 2024, primarily comprised of our $27 million net loss and $2.7 million reduction in fair value of warrant derivative liability, $0.4 million reduction in deferred income tax, and $0.1 million unrealized foreign exchange gain, partially offset by $9.7 million intangible asset impairment, $0.3 million in common stock issued for services, $0.2 million non-cash interest expense, $0.1 million stock-based compensation and $0.1 million change in operating assets and liabilities.
Stenoparib is a novel, dual inhibitor of poly-ADP-ribose polymerase (PARP1/2) as well as tankyrases, enzymes critically important in the WNT cancer cell survival pathway. Stenoparib is currently being explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.
Stenoparib is currently being explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.
On March 13, 2025, we issued a press release that we have reached a final settlement with the SEC relating to our previously disclosed SEC investigation, and as part of the settlement, we have agreed to pay a one-time civil penalty of $2.5 million. Class Action On September 13, 2024, a purported class action captioned Osman Mukeljic v.
On March 13, 2025, we issued a press release that we have reached a final settlement with the SEC relating to our previously disclosed SEC investigation, and as part of the settlement, we paid a one-time civil penalty of $2.5 million in April 2025 and all regulatory/legal challenges related to those issues are now concluded.
The fair value of stock options (“options”) on the grant date is estimated using the Black-Scholes option-pricing model using the single-option approach. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, including the option’s expected term and the price volatility of the underlying stock, to determine the fair value of the award.
The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, including the option’s expected term and the price volatility of the underlying stock, to determine the fair value of the award. The Company applies the Black-Scholes model as it believes it is the most appropriate fair value method for all option awards.
In connection with the Series C Offering, we and 3i, L.P. entered into a limited waiver agreement pursuant to which 3i, L.P. confirmed that the sale and issuance of the Shares will not give rise to any, or trigger any, rights of termination, defaults, amendment, anti-dilution or similar adjustments, acceleration or cancellation under the existing agreements with 3i, L.P. 72 Table of Contents Risks and Uncertainties We are subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability to secure additional capital to fund operations.
At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price of $0.405 per share results in the 1,296 shares being convertible into 3,456,000 common shares. 77 Table of Contents Risks and Uncertainties We are subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability to secure additional capital to fund operations.
Historically, we have generated DRP signatures for numerous anti-cancer therapeutics and had in-licensed numerous assets for DRP-guided development, including Liposomal CisPlatin (LiPlaCis), Irofulven and dovitinib as well as the novel PARP/tankyrase inhibitor, stenoparib. In the second half of 2023, we seated two new independent directors to our board of directors, Laura E. Benjamin, PhD and Joseph W. Vazzano, CPA.
Historically, we have generated DRP signatures for numerous anti-cancer therapeutics and had in-licensed numerous assets for DRP-guided development, including Liposomal CisPlatin (LiPlaCis), Irofulven and dovitinib as well as the novel PARP/tankyrase inhibitor, stenoparib. During 2024, Thomas H.
We agreed to pay Ascendiant a commission of 3.0% of the gross proceeds from the sales of shares sold through Ascendiant under the Sales Agreement. We agreed to reimburse Ascendiant for certain expenses incurred in connection with the Sales Agreement. Both we and Ascendiant may each terminate the Sales Agreement at any time upon specified prior written notice.
The Company agreed to pay Ascendiant a commission of 3.0% of the gross proceeds from the sales of shares sold through Ascendiant under the Sales Agreement and has provided Ascendiant with customary indemnification and contribution rights. The Company also agreed to reimburse Ascendiant for certain expenses incurred in connection with the Sales Agreement.
On December 5, 2023, we received exercise notices from holders of certain warrants pursuant to which we authorized (i) the issuance of 938 shares of common stock pursuant to exercise of common stock purchase warrants at $600.00 per share for $0.6 million in cash, and (ii) the issuance of 833 shares of common stock pursuant to partial exercise of Exchange Warrant on a cashless exercise basis. 67 Table of Contents Amendments to the Certificate of Designation of Series A Preferred Stock On January 14, 2024, pursuant to the terms of the First Note, we modified the conversion price of the 3i Exchange Warrants from $600.00 to $268.50, thereby increasing the number of Exchange Warrants outstanding from 7,346 at December 31, 2023 to 16,411 outstanding at January 14, 2024.
Amendments to the Certificate of Designation of Series A Preferred Stock On January 14, 2024, pursuant to the terms of the First Note, we modified the conversion price of the 3i Exchange Warrants from $600.00 to $268.50, thereby increasing the number of Exchange Warrants outstanding from 7,346 at December 31, 2023 to 16,411 outstanding at January 14, 2024.
Changes in the fair value of our derivative and warrant liabilities and convertible debt are measured using level 3 inputs as described in our consolidated financial statements. Income taxes During the years ended December 31, 2024, and 2023, we recognized $0.4 million in income tax recovery and $0.1 million in income tax expense, respectively.
Changes in the fair value of our derivative and warrant liabilities and convertible debt are measured using level 3 inputs as described in our consolidated financial statements.
Recently Issued Accounting Pronouncements See the section titled in Note 2 to the Company’s consolidated financial statements for the year ended December 31, 2024, appearing elsewhere herein.
In March 2026, Allarity issued $20 million in promissory notes to Streeterville Capital as a debt financing. Recently Issued Accounting Pronouncements See the section titled in Note 2 to the Company’s consolidated financial statements for the year ended December 31, 2025, appearing elsewhere herein. 84 Table of Contents
A breakdown by nature of type of expense for the years ended December 31, 2024 and 2023, is provided below.
There was no revenue for the year ended December 31, 2024. Research and Development Expenses Our research and development costs were primarily for stenoparib. A breakdown by nature of type of expense for the years ended December 31, 2025 and 2024, is provided below.
We are now singularly focused on the development of stenoparib and the parallel development of the stenoparib-DRP® as a companion diagnostic. All other assets including dovitinib, Irofulven and LiPlaCis, were terminated and are no longer part of our portfolio. Stenoparib was in-licensed with exclusive world-wide rights from the Japanese Pharmaceutical company, Eisai Pharmaceuticals.
He has a combined seven years of experience as CEO and CFO of Nasdaq- and NYSE-listed companies. We are now singularly focused on the development of stenoparib and the parallel development of the stenoparib-DRP® as a companion diagnostic. All other assets including dovitinib, Irofulven and LiPlaCis, were terminated and are no longer part of our portfolio.
At a stated value of $1.1 million for each share of Series A Preferred Stock, the revised price of $268.50 per share results in the 1,417 shares being convertible into 5,699 shares of common stock as of January 14, 2024.
At a stated value of $1.1 million for each share of Series A Preferred Stock, the revised price of $268.50 per share results in the 1,417 shares being convertible into 5,699 shares of common stock as of January 14, 2024. 75 Table of Contents On February 13, 2024, pursuant to the terms of the Second Note, we modified the conversion price of the 3i Exchange Warrants from $268.50 to $243.00 and thereby increased the number of Exchange Warrants outstanding from 16,411 on January 18, 2024, to 18,137 on February 13, 2024.
Year ended December 31, Increase/ 2024 2023 (Decrease) (In thousands) Research study expenses $ 2,906 $ 2,887 $ 19 Tax credit (798 ) (800 ) 2 Milestone payments 150 150 — Manufacturing & supplies 1,715 2,906 (1,191 ) Contractors 855 996 (141 ) Staffing 1,197 873 324 Other 71 91 (20 ) $ 6,096 $ 7,103 $ (1,007 ) The decrease of $1.0 million in research and development cost was primarily due to decreases of $1.2 million in manufacturing and supplies, and $0.1 million in contractor costs, partially offset by an increase of $0.3 million in staffing costs.
Year ended December 31, Increase/ 2025 2024 (Decrease) (In thousands) Research study expenses $ 3,091 $ 2,906 $ 185 Tax credit (833 ) (798 ) (35 ) Milestone payments — 150 (150 ) Manufacturing & supplies 1,549 1,715 (166 ) Contractors 340 855 (515 ) Staffing 2,333 1,197 1,136 Other 121 71 50 $ 6,601 $ 6,096 $ 505 The increase of $0.5 million in research and development cost was the result of a $0.5 million decrease in contractor spending, and an $1.1 million increase in staff costs.
As of December 31, 2024, and 2023, we had warrants outstanding for stock-based compensation that were classified as equity, and outstanding investor warrants that were classified as derivative liabilities and classified as “Warrant liability” in the Consolidated Balance Sheets. 74 Table of Contents Derivative financial instruments We do not use derivative instruments to hedge exposures to interest rate, market, or foreign currency risks.
As of December 31, 2025, and 2024, we had warrants outstanding for stock-based compensation that were classified as equity, and outstanding investor warrants that were classified as derivative liabilities and classified as “Warrant liability” in the consolidated balance sheets. Stock-based compensation We account for stock-based compensation in accordance with ASC 718, Compensation — Stock Compensation (“ASC 718”).
Actual results could differ from those estimates or assumptions. While our significant accounting policies are described in the notes to our consolidated financial statements for the years ended December 31, 2024 and 2023, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.
While our significant accounting policies are described in the notes to our consolidated financial statements for the years ended December 31, 2025 and 2024, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results. 78 Table of Contents Research contract costs and accruals We have entered into various research and development contracts with companies both inside and outside of the United States.
There was no impairment charge in 2023. General and Administrative Expenses General and administrative expenses increased by $1.4 million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
General and Administrative Expenses General and administrative expenses decreased by $5.1 million for the year ended December 31, 2025, compared to the year ended December 31, 2024. The decrease was primarily due to a $5.7 million decrease in legal and professional fees which included a $2.5 million SEC settlement charge.
Research contract costs and accruals We have entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. We record accruals for estimated ongoing research costs.
These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. We record accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or trials, including the phase or completion of events, invoices received and contracted costs.
In the year ended December 31, 2023, we received $11 million, net, from financing activities inclusive of: $19.1 million from equity issuances in April, July and September; $1 million from the issuance of a note to 3i; and $1.1 million from the issuance of Series C Preferred Stock; and we repaid $3.7 million in debt and redeemed $6.7 million in Series A Preferred Stock.
In the year ended December 31, 2025, we received $10.9 million, net, from financing activities inclusive of: $14.0 million from equity issuances and $3.2 million of stock repurchases.
Along with the chairman of the board, Gerald W. McLaughlin, Dr. Benjamin and Mr. Vazzano took the decision to replace the prior CEO, Mr. James Cullem, with Thomas H. Jensen as interim CEO. Mr. Jensen is a co-founder of Allarity and has extensive experience not only with the core DRP® platform technology but also with capital fund raising. Mr.
Jensen, co-founder of Allarity, was permanently installed as Chief Executive Officer due to his extensive experience not only with the core DRP® platform technology but also with capital fund raising. Mr. Jensen was tasked with streamlining the organization and its finances. To help Mr.
Other income of $5.3 million recognized in the year ended December 31, 2023, consisted primarily of a $10.4 million fair value adjustment of warrant derivative liabilities and $0.2 million in foreign exchange gain, partially offset by $4.2 million fair value of inducement warrants, $0.6 million loss on modification to warrants, and $0.5 million in interest expense.
Other Income (Expense) Other income of $1.4 million was recognized in the year ended December 31, 2025, and consisted primarily of a $0.2 million increase in interest income and decrease of interest expense ($0.5 million) due to an improved cash position for the company throughout the year.
Removed
Jensen was tasked with streamlining the organization and its finances. In June 2024, Mr. Jensen was permanently installed as the CEO. In the second half of 2024, we added a new Chief Financial Officer, Mr. Alexander Epshinsky, who comes to us after serving in accounting and controller roles in a series of small cap biotech companies. To help Mr.
Added
Stenoparib was in-licensed with exclusive world-wide rights from the Japanese Pharmaceutical company, Eisai Pharmaceuticals. Stenoparib is a novel, dual inhibitor of poly-ADP-ribose polymerase (PARP1/2) as well as tankyrases, enzymes critically important in the WNT cancer cell survival pathway.
Removed
Recent Developments Authorized Share Increase On March 20, 2023 we filed a Second Certificate of Amendment of Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the number of authorized shares from 30,500,000 to 750,500,000 and to increase the number of common stock from 30,000,000 to 750,000,000.
Added
On May 2, 2024, the Company's public float increased above $75.0 million and, as a result, the Company was not subject to the limitations contained in General Instruction I.B.6 of Form S-3.
Removed
The amendment was approved by the holders of the majority of our outstanding common stock and Series C Preferred Stock.
Added
Under the Sales Agreement, Ascendiant may sell shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act.
Removed
Reverse Stock Splits On June 28 and March 24, 2023, April 9, 2024, and September 11, 2024, we effected a 1-for-40 reverse stock split, 1-for-35 reverse stock split, 1-for-20 reverse stock split, and 1-for-30 reverse stock split, respectively, of our shares of common stock (collectively, the “Reverse Stock Splits”).
Added
Ascendiant will use commercially reasonable efforts to sell the shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose).
Removed
All share and per share information has been retroactively adjusted to give effect to the Reverse Stock Splits for all periods presented.
Added
The Company and Ascendiant may each terminate the Sales Agreement at any time upon specified prior written notice. For the year ended December 31, 2025, the Company sold 9,719,173 shares of its common stock for net proceeds of $9.7 million.
Removed
Proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options, restricted stock, preferred stock and warrants outstanding on September 12, 2024, which resulted in a proportional decrease in the number of shares of our common stock reserved for issuance upon exercise or vesting of such stock options, restricted stock and warrants, and, in the case of stock options and warrants, a proportional increase in the exercise price of all such stock options and warrants.
Added
As a result of the redemption of the August 2024 Preferred Stock, we presented a deemed dividend of $0.6 million during the twelve months ended December 31, 2024.
Removed
No fractional shares were issued in connection with the Reverse Stock Splits. If, as a result of the Reverse Stock Splits, a stockholder would otherwise have been entitled to a fractional share, each fractional share was rounded up to the next whole number.
Added
Actual results could differ from those estimates or assumptions.
Removed
Chief Executive Officer On December 8, 2023, James G. Cullem was terminated as our Chief Executive Officer and effective January 27, 2024, Mr. Cullem resigned as a director of Allarity. On December 8, 2023, Thomas H. Jensen was appointed by our board of directors as Interim Chief Executive Officer to replace Mr. Cullem.
Added
The compensation expense is then recognized over the requisite service period, which is the vesting period of the respective award. 79 Table of Contents We review stock award modifications when there is an exchange of original award for a new award.
Removed
Prior to his appointment as Chief Executive Officer, Mr. Jensen was paid consulting fees for his services to us. Effective June 1, 2024, we entered into a Management Services Agreement (“MSA”) with Ljungaskog Consulting AB, a Swedish limited liability company owned and managed by Mr. Jensen, which superseded and replaced the existing consulting agreement.
Added
The fair value of restricted stock units is based on the fair value of the Company's common stock on the date of the grant. The fair value of stock options (“options”) on the grant date is estimated using the Black-Scholes option-pricing model using the single-option approach.
Removed
In the year ended December 31, 2024, we received $37.3 million in proceeds from ATM sales net of issuance costs, $1.3 million in proceeds from 3i promissory notes, and $2.9 million in proceeds from the issuance of Convertible Redeemable Series A Preferred Stock; and we repaid $1.3 million of 3i promissory notes, and redeemed $3.5 million of Convertible Redeemable Series A Preferred Stock.
Added
The Black-Scholes model requires several assumptions, of which the most significant are the share price, expected volatility and the expected award term.
Removed
April 2023 Offering In April 2023, we issued 119 shares of our common stock and 119 common stock purchase warrants, each exercisable for one share of common stock, at a combined public offering price of $18,000.00, and 297 pre-funded warrants, each exercisable for one share of common stock, and 297 common stock purchase warrants, each exercisable for one share of common stock only (the common stock purchase warrants sold in the public offing hereinafter referred to as the “April 2023 Common Warrants”) at a combined public offering price of $18,000.00 less the $0.001 for the pre-funded warrants, for aggregate net proceeds of approximately $6.8 million, after deducting placement agents fees and offering expenses paid by us of approximately $0.7 million, or (the "April Offering").
Added
Since the Company has limited option exercise history, it has generally elected to estimate the expected life of an award based upon the "simplified method" with the continued use of this method extended until such time the Company has sufficient exercise history.
Removed
The common stock, pre-funded warrant and April 2023 Common Warrants were sold pursuant to a securities purchase agreement with the purchaser signatory thereto or pursuant to the prospectus which was part of an effective registration statement on Form S-1 filed with the SEC.
Added
The Company has no foreseeable plans to pay dividends on its common stock, and therefore, uses an expected dividend yield of zero in the option pricing model. The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms.
Removed
The common stock, pre-funded warrants and April 2023 Common Warrants were immediately separable and were issued separately in the offering. All the pre-funded warrants from the April Offering were exercised in exchange for 297 common shares.
Added
The expected share price volatility for the Company's common shares is estimated by taking the average historical price volatility for industry peers. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances.
Removed
July 2023 Offering In July 2023, we issued 596 shares of our common stock pre-funded warrants to purchase up to 3,478 shares of common stock (the “July Pre-Funded Warrants”), and common warrants to purchase up to 4,075 shares of common stock (the “2023 July Common Warrants”) at an effective combined purchase price of $2,700.00 per share and related common stock purchase warrants for aggregate net proceeds of approximately $10 million, after deducting placement agent fees and offering expenses paid by us of approximately $0.9 million on July 10, 2023 (the “July Offering”).
Added
The Company classifies stock-based compensation expense in its Consolidated Statements of Operations and Comprehensive Loss in the same way the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Removed
The securities in the July Offering were registered pursuant to the registration statement on Form S-1, as amended (File No. 333-272469). The purchase price of each July Pre-Funded Warrant and 2023 July Common Warrant was equal to $2,700.00 less the $0.001 per share exercise price of each Pre-Funded Warrant.
Added
Manufacturing and research study expenses remained consistent year over year. 82 Table of Contents Impairment of Intangible Assets For the year ended December 31, 2024, a full impairment charge of $9.7 million was applied against the intangible assets. There is no impairment charge nor any remaining intangible asset value as of the year ending December 31, 2025.
Removed
Such securities were sold pursuant to a securities purchase agreement with the purchaser signatory thereto or pursuant to the prospectus which was part of an effective registration statement on Form S-1 filed with the SEC.
Added
General operating and IT costs decreased $0.1 million along with a $0.1 million drop in franchise tax expense, while other administrative cost increased $0.7 million with an increase of $0.2 million in personnel costs related to staff severance.
Removed
All July Pre-Funded Warrants were exercised prior in exchange for 3,478 common shares. 3i Convertible Secured Promissory Notes (2023) On November 22, 2022, we entered into a Secured Note Purchase Agreement (the “Secured Note Purchase Agreement”) with 3i, LP ("3i"), for a bridge loan to extend our cash runway beyond December 31, 2022, in order to provide us with more time to complete the process of amending our Certificate of Incorporation to increase our authorized share capital and proposed reverse stock split to facilitate additional capital investments (the “Bridge Loan”).
Added
With no warrant liability during the year, a $2.7 million change in fair value adjustment of warrant derivative liabilities and change of $1.0 million foreign exchange gain comprise the $1.0 total decrease in other income from the prior year.

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