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What changed in Traws Pharma, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Traws Pharma, 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.

+311 added−341 removedSource: 10-K (2026-04-15) vs 10-K (2025-03-31)

Top changes in Traws Pharma, Inc.'s 2025 10-K

311 paragraphs added · 341 removed · 212 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

89 edited+40 added−29 removed310 unchanged
Biggest changeThe Health Insurance Portability and Accountability Act of 1996 (HIPAA) created new federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
Biggest changeFor these reasons, since 2004, False Claims Act lawsuits against biopharmaceutical companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, including settlements in excess of $3.0 billion and, more recently, settlements exceeding $5.0 billion in the aggregate, regarding certain sales practices and promotion of off-label uses.” Civil False Claims Act liability may further be imposed for known Medicare or Medicaid overpayments, for example, overpayments caused by understated rebate amounts, that are not refunded within 60 days of identifying the overpayment, even if the overpayment was not caused by a false or fraudulent act. 30 Table of Contents The Health Insurance Portability and Accountability Act of 1996 (HIPAA) created new federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
Knight Therapeutics, Inc. In November 2019, we entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”).
In November 2019, we entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”).
Additionally, there is currently one cap-dependent endonuclease (“CEN”) inhibitor, baloxavir marboxil (Xofluza), sold by Roche, currently approved for use in the treatment of influenza.
Additionally, there is currently one cap-dependent endonuclease (“CEN”) inhibitor, baloxavir marboxil (Xofluza), sold by Roche, approved for use in the treatment of influenza.
The steps required before a new drug may be marketed in the United States generally include: ● Completion of preclinical or nonclinical laboratory tests, animal studies and formulation studies in compliance 16 Table of Contents with the FDA’s good laboratory practice (“GLP”), regulations and other applicable laws and regulations; ● Submission to the FDA of an IND to support human clinical testing; ● Approval by an IRB at each clinical site or centrally before each trial may be initiated; ● Performance of adequate and well-controlled clinical trials in accordance with federal regulations and with current good clinical practices (“GCPs”) to establish the safety and efficacy of the investigational drug product for each targeted indication; ● Submission of an NDA to the FDA; ● Satisfactory completion of an FDA Advisory Committee review, if applicable; ● Satisfactory completion of an FDA inspection of the manufacturing facilities at which the investigational product is produced to assess compliance with cGMPs, and to assure that the facilities, methods and controls are adequate, as well as satisfactory completion of FDA inspections of selected clinical trial sites to ensure that clinical trials were conducted in accordance with GCPs; and ● FDA review and approval of the NDA.
The steps required before a new drug may be marketed in the United States generally include: ● Completion of preclinical or nonclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”), regulations and other applicable laws and regulations; ● Submission to the FDA of an IND to support human clinical testing; ● Approval by an IRB at each clinical site or centrally before each trial may be initiated; ● Performance of adequate and well-controlled clinical trials in accordance with federal regulations and with current good clinical practices (“GCPs”) to establish the safety and efficacy of the investigational drug product for each targeted indication; ● Submission of an NDA to the FDA; ● Satisfactory completion of an FDA Advisory Committee review, if applicable; ● Satisfactory completion of an FDA inspection of the manufacturing facilities at which the investigational 17 Table of Contents product is produced to assess compliance with cGMPs, and to assure that the facilities, methods and controls are adequate, as well as satisfactory completion of FDA inspections of selected clinical trial sites to ensure that clinical trials were conducted in accordance with GCPs; and ● FDA review and approval of the NDA.
The novel formulation patent for rigosertib expires in 2037. We have recently filed new patent applications covering methods of treatment in target indications that are projected to extend to 2042-2044 before any possible patent term extensions. Patent term extensions may be available, depending on various provisions in the law.
The novel formulation patent for rigosertib expires in 2037. We have filed new patent applications covering methods of treatment in target indications that are projected to extend to 2042-2044 before any possible patent term extensions. Patent term extensions may be available, depending on various provisions in the law.
(“Trawsfynydd”), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID and other infectious diseases. Prior to the Merger, the focus of our business was the discovery and development of novel products for patients with cancer.
(“Trawsfynydd”), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID-19 and other infectious diseases. Prior to the Merger, the focus of our business was the discovery and development of novel products for patients with cancer.
Per guidance issued by FDA in 2023 with respect to rare diseases, “[t]his flexibility extends from the early stages of development to the design of adequate and well-controlled clinical investigations required to demonstrate effectiveness to support marketing approval and to establish safety data needed for the intended use.” FDA states that it “is committed to helping sponsors create successful drug development programs that address the particular challenges posed by each disease….” 25 Table of Contents If a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity.
Per guidance issued by FDA in 2023 with respect to rare diseases, “[t]his flexibility extends from the early stages of development to the design of adequate and well-controlled clinical investigations required to demonstrate effectiveness to support marketing approval and to establish safety data needed for the intended use.” FDA states that it “is committed to helping sponsors create successful drug development programs that address the particular challenges posed by each disease….” If a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity.
One patient was not evaluable, and this patient initially completed 2 weeks of oral rigosertib therapy before stopping due to severe stool impaction, likely from opioid-induced constipation, and COVID infection.
One patient was not evaluable, and this patient initially completed 2 weeks of oral rigosertib therapy before stopping due to severe stool impaction, likely from opioid-induced constipation, and COVID-19 infection.
Following the Merger, we have four clinical programs: (i) tivoxavir marboxil, an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza; (ii) ratutrelvir, an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID19; (iii) narazaciclib (ON 123300), a multi-targeted kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer therapies; and (iv) rigosertib, administered alone or in combination for investigation in various cancers.
Following the Merger, we have four clinical programs: (i) tivoxavir marboxil, an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza; (ii) ratutrelvir, an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID-19; (iii) narazaciclib (ON 123300), a multi-targeted kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer therapies; and (iv) rigosertib, administered alone or in combination for investigation in various cancers.
Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug, and can often be substituted by pharmacists under prescriptions written for the original listed drug. 505(b)(2) applications provide for marketing of a drug product that may have the same active ingredients as the listed drug and contain the same full safety and effectiveness data as an NDA, but at least some of the information comes from studies not conducted by or for the applicant. 505(b)(2) applicants may rely on published literature or the FDA’s prior finding of safety and effectiveness for an NDA approved drug product.
Drugs 22 Table of Contents approved in this way are commonly referred to as “generic equivalents” to the listed drug, and can often be substituted by pharmacists under prescriptions written for the original listed drug. 505(b)(2) applications provide for marketing of a drug product that may have the same active ingredients as the listed drug and contain the same full safety and effectiveness data as an NDA, but at least some of the information comes from studies not conducted by or for the applicant. 505(b)(2) applicants may rely on published literature or the FDA’s prior finding of safety and effectiveness for an NDA approved drug product.
In addition, the Affordable Care Act provides that the 29 Table of Contents government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a per se false or fraudulent claim for purposes of the civil False Claims Act (discussed below), which imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
In addition, the Affordable Care Act 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 per se false or fraudulent claim for purposes of the civil False Claims Act (discussed below), which imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
Priority Review (United States), Accelerated Review (European Union) and other Expedited Programs The FDA has various programs, including Fast Track designation, accelerated approval, priority review and breakthrough designation, that are intended to expedite or simplify the process for the development and FDA review of certain drug products that are intended for the treatment of serious or life-threatening diseases or conditions, and demonstrate the potential to address unmet medical needs or present a significant improvement over existing therapy.
Priority Review (United States), Accelerated Review (European Union) and other Expedited Programs The FDA has various programs, including Fast Track designation, accelerated approval, priority review and breakthrough designation, that are intended to expedite or simplify the process for the development and FDA review of certain drug products that are intended for the treatment of serious or life-threatening diseases or conditions, and 26 Table of Contents demonstrate the potential to address unmet medical needs or present a significant improvement over existing therapy.
Certain changes to a drug, such as the addition of a new indication to the package insert, may be associated with a three-year period of exclusivity during which the FDA cannot approve an ANDA for a generic drug or a 505(b)(2) application that includes the change, if the applicant conducted clinical trials essential to the approval of the application, which are not bioavailability or 22 Table of Contents bioequivalence studies.
Certain changes to a drug, such as the addition of a new indication to the package insert, may be associated with a three-year period of exclusivity during which the FDA cannot approve an ANDA for a generic drug or a 505(b)(2) application that includes the change, if the applicant conducted clinical trials essential to the approval of the application, which are not bioavailability or bioequivalence studies.
Preclinical investigations demonstrated overexpression of polo like kinase 1 (“PLK1”) in RDEB-associated SCC tumor cells. These tumors show a highly aggressive, early metastasizing course, making them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by age 45 and 55, respectively (Mellerio, 2016), (Fine, 2016).
Preclinical investigations demonstrated overexpression of polo like kinase 1 (“PLK1”) in RDEB-associated SCC tumor cells. These tumors show a highly aggressive, early metastasizing course, 9 Table of Contents making them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by age 45 and 55, respectively (Mellerio, 2016), (Fine, 2016).
The Federal Food, Drug and Cosmetic Act (the “FDC Act”), and its implementing regulations, as well as various other federal and state statutes and regulations, set forth, among other things, requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising, marketing, and promotion of our product candidates.
The Federal Food, Drug and Cosmetic Act (the “FDC Act”), and its implementing regulations, as well as various other federal and state statutes and regulations, set forth, among other things, requirements for the research, testing, development, manufacture, quality control, safety, 16 Table of Contents effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising, marketing, and promotion of our product candidates.
Cancer cells can also lose Rb function through mutation and become resistant or insensitive to palbociclib. Generally, second generation CDK 4/6 inhibitors agents have not been shown to be suitable for single agent therapy and 7 Table of Contents must typically be used in combination with hormonal therapy in the treatment of HR+/HER2- mBC.
Cancer cells can also lose Rb function through mutation and become resistant or insensitive to palbociclib. Generally, second generation CDK 4/6 inhibitors agents have not been shown to be suitable for single agent therapy and must typically be used in combination with hormonal therapy in the treatment of HR+/HER2- mBC.
Although there are a number of statutory exceptions and regulatory safe harbors protecting some business arrangements from prosecution, the exceptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor, as well as if they do.
Although there are a number of statutory exceptions and regulatory safe harbors protecting some business arrangements from prosecution, the exceptions 29 Table of Contents and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor, as well as if they do.
As a result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to the Company (through its subsidiaries). ​ Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application 12 Table of Contents licensed under the agreement, whichever is later.
As a result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to the Company (through its subsidiaries). ​ Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application licensed under the agreement, whichever is later.
Rigosertib Patents As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering composition-of-matter, process, formulation and various indications for method-of-use for rigosertib filed worldwide, 13 Table of Contents including in the United States. The U.S. composition-of-matter patent for rigosertib, which we in-licensed pursuant to the license agreement with Temple, currently expires in 2026.
Rigosertib Patents As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering composition-of-matter, process, formulation and various indications for method-of-use for rigosertib filed worldwide, including in the United States. The U.S. composition-of-matter patent for rigosertib, which we in-licensed pursuant to the license agreement with Temple, currently expires in 2026.
It is uncertain whether the issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates or processes, obtain licenses or cease certain activities. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.
It is uncertain whether the issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates or processes, obtain licenses or cease certain activities. The biotechnology and 14 Table of Contents pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.
Although we periodically monitor the FDA compliance of our third-party CMOs, we cannot be certain that our present or future third-party CMOs will consistently comply with cGMP and other applicable FDA regulatory requirements. 15 Table of Contents Commercial Operations We do not currently have any relationships with organizations for the sale, marketing and distribution of biopharmaceutical products.
Although we periodically monitor the FDA compliance of our third-party CMOs, we cannot be certain that our present or future third-party CMOs will consistently comply with cGMP and other applicable FDA regulatory requirements. Commercial Operations We do not currently have any relationships with organizations for the sale, marketing and distribution of biopharmaceutical products.
The FDA periodically inspects or conducts remote regulatory assessments of manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural and substantive record keeping requirements. In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented.
The FDA periodically inspects or conducts remote regulatory assessments of manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural and substantive record keeping requirements. In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before 21 Table of Contents being implemented.
The benefit to public health must outweigh the risk due to the limited availability of clinical data at the time of marketing authorization. 27 Table of Contents The EMA has recently been conducting a pilot on ‘adaptive pathways’ — an iterative process building on existing regulatory processes involving gathering evidence through real-life use to supplement clinical trial data.
The benefit to public health must outweigh the risk due to the limited availability of clinical data at the time of marketing authorization. The EMA has recently been conducting a pilot on ‘adaptive pathways’ — an iterative process building on existing regulatory processes involving gathering evidence through real-life use to supplement clinical trial data.
The inhibitory effect of narazaciclib may provide a therapeutic strategy to optimize efficacy of CDK 4/6 inhibition and reduce the emergence of resistance and/or provide clinical benefit for patients with progression on palbociclib, ribociclib and/or abemaciclib. Another established driver of resistance to CDK4/6 inhibitors in breast cancer is FGFR1-3.
The inhibitory effect of narazaciclib may provide a therapeutic strategy to optimize efficacy of CDK 4/6 inhibition and 7 Table of Contents reduce the emergence of resistance and/or provide clinical benefit for patients with progression on palbociclib, ribociclib and/or abemaciclib. Another established driver of resistance to CDK4/6 inhibitors in breast cancer is FGFR1-3.
They are performed after preliminary evidence suggesting effectiveness of the investigational product has been obtained, and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the product, and to provide an adequate basis for product approval. Phase 3 clinical trials usually involve several hundred to several thousand participants.
They are performed after preliminary evidence suggesting effectiveness of the investigational product has been obtained, and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the product, and to provide 18 Table of Contents an adequate basis for product approval. Phase 3 clinical trials usually involve several hundred to several thousand participants.
The Company has established a Compensation Committee of the Board of Directors, which considers the impact of our corporate performance in determining compensation for named executive officers, as well as each named executive officer’s individual performance, macroeconomic conditions generally, and data from peer group companies. Corporate Information We were incorporated in Delaware in December 1998.
The Company has established a Compensation Committee of the Board of Directors, which considers the impact of our corporate performance in determining compensation for named executive officers, as well as each named executive officer’s individual performance, macroeconomic conditions generally, and data from peer group companies. 32 Table of Contents Corporate Information We were incorporated in Delaware in December 1998.
In all cases, again, the clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. 23 Table of Contents Expanded Access Under certain circumstances, regulators may permit unapproved drugs to be used by patients outside of clinical trials.
In all cases, again, the clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. Expanded Access Under certain circumstances, regulators may permit unapproved drugs to be used by patients outside of clinical trials.
Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.
Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without 25 Table of Contents incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.
In Study 19-01 in the US, narazaciclib was dosed on a continuous daily schedule in 28-day cycles. The study assessed the safety, tolerability, 8 Table of Contents pharmacokinetics and pharmacodynamics of narazaciclib administered orally at increasing doses starting at 40 mg daily for consecutive 28-day cycles in patients with relapsed/refractory advanced cancer.
In Study 19-01 in the US, narazaciclib was dosed on a continuous daily schedule in 28-day cycles. The study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally at increasing doses starting at 40 mg daily for consecutive 28-day cycles in patients with relapsed/refractory advanced cancer.
Many of these companies are multinational pharmaceutical or biotechnology organizations, which are pursuing the 14 Table of Contents development of, or are currently marketing, pharmaceuticals that target the key viruses, oncology indications or cellular pathways on which we are focused. Many of our competitors have significantly greater financial, technical and human resources than we have.
Many of these companies are multinational pharmaceutical or biotechnology organizations, which are pursuing the development of, or are currently marketing, pharmaceuticals that target the key viruses, oncology indications or cellular pathways on which we are focused. Many of our competitors have significantly greater financial, technical and human resources than we have.
The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years from the date of approval. Similar extension rules apply in the EU, though the specific calculations are different.
The time can be shortened if the FDA 23 Table of Contents determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years from the date of approval. Similar extension rules apply in the EU, though the specific calculations are different.
ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug.
ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect 20 Table of Contents the potential market and profitability of the drug.
In addition, M2 channel inhibitors, generic drugs include amantadine and rimantadine, both oral tablets that only inhibit the replication of the influenza virus have generally become ineffective because of significant viral resistance to the approved M2 channel inhibitors, especially in the US.
In addition, M2 channel inhibitors, generic drugs include amantadine and 15 Table of Contents rimantadine, both oral tablets that only inhibit the replication of the influenza virus have generally become ineffective because of significant viral resistance to the approved M2 channel inhibitors, especially in the US.
These studies are designed to evaluate the safety, metabolism, pharmacokinetics and pharmacologic actions of the investigational 17 Table of Contents drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness.
These studies are designed to evaluate the safety, metabolism, pharmacokinetics and pharmacologic actions of the investigational drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness.
These efforts may result in a decrease in the amount of reimbursement we receive for our drugs from Medicare or other government programs for our drugs, once approved, and any reduction in reimbursement from Medicare and other government programs may result in a similar 28 Table of Contents reduction in payments from private payors.
These efforts may result in a decrease in the amount of reimbursement we receive for our drugs from Medicare or other government programs for our drugs, once approved, and any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors.
International Government Regulation In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products.
International Government Regulation In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products.
Also, under the VHCA, manufacturers are required to offer drugs for sale at no more than a separate statutory ceiling price calculated by the manufacturer to Public Health Service designated entities in order to participate in other federal funding programs including Medicaid.
Also, under the VHCA, manufacturers are required to offer drugs for sale at no more than a separate statutory ceiling price calculated by the manufacturer to Public Health Service designated entities in order to participate 31 Table of Contents in other federal funding programs including Medicaid.
Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence 21 Table of Contents Evaluations, commonly known as the Orange Book.
Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
Regulatory approval of oncology products often requires that patients in clinical trials be 20 Table of Contents followed for long periods to determine the overall survival benefit of the drug.
Regulatory approval of oncology products often requires that patients in clinical trials be followed for long periods to determine the overall survival benefit of the drug.
Patent term extensions may be available, depending on various provisions in the law. ​ Virology COVID Asset ​ In addition to the Viriom Licensed IP that we have rights to pursuant to the Viriom License Agreement, we own several patent applications covering compounds, pharmaceutical compositions, methods of producing such compounds and pharmaceutical compositions, methods and uses of such compounds and pharmaceutical compositions for the prevention or treatment of a disease, disorder, or condition associated with coronavirus in, for example, Australia, Eurasia, Europe, Mexico, and the United States, among others.
Patent term extensions or adjustments may be available depending on regulatory timelines and applicable law. ​ Virology COVID-19 Asset ​ In addition to the Viriom Licensed IP that we have rights to pursuant to the Viriom License Agreement, we own several patent applications covering compounds, pharmaceutical compositions, methods of producing such compounds 13 Table of Contents and pharmaceutical compositions, methods and uses of such compounds and pharmaceutical compositions for the prevention or treatment of a disease, disorder, or condition associated with coronavirus in, for example, Australia, Eurasia, Europe, Mexico, and the United States, among others.
Human Capital We believe that our success is largely dependent upon our ability to attract and retain qualified employees. As of December 31, 2024, we had 7 employees (6 of which were full-time employees), in addition to various independent contractors working for us.
Human Capital We believe that our success is largely dependent upon our ability to attract and retain qualified employees. As of December 31, 2025, we had 7 employees (4 of whom were full-time employees), in addition to various independent contractors working for us.
In both the European Union and United States unapproved drug products may not be promoted or marketed. Compliance During all phases of development (pre- and post-marketing), failure to comply with applicable regulatory requirements may result in administrative or judicial sanctions.
National competent authorities may authorize early access program use. In both the European Union and United States unapproved drug products may not be promoted or marketed. Compliance During all phases of development (pre- and post-marketing), failure to comply with applicable regulatory requirements may result in administrative or judicial sanctions.
Certain reports must be submitted to FDA under the federal Right to Try law. There are also state level Right to Try statutes. In the European Union, early access programs are authorized by EU legislation and, through national laws, EU member states have implemented regulatory requirements related to these programs. National competent authorities may authorize early access program use.
Certain reports must be submitted to FDA under the federal Right to Try law. There are also state level Right to Try statutes. 24 Table of Contents In the European Union, early access programs are authorized by EU legislation and, through national laws, EU member states have implemented regulatory requirements related to these programs.
This is due to GI obstruction arising as a result of the presence of esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration. It is, therefore, important in these patients that the investigator has both dosing options for the appropriate dosing of their patients.
This is due to GI obstruction arising as a result of the presence of esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration. It is, therefore, important in these patients that the investigator has both dosing options for the appropriate dosing of their patients. The data presented here are preliminary and may be subject to change.
Medicines authorized across the EU with the results of studies from a pediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate by six months. This is the case even when the studies’ results are negative. For orphan medicines, the incentive is an additional two years of market exclusivity.
Medicines authorized across the EU with the results of studies from a pediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate by six months. This is the case 28 Table of Contents even when the studies’ results are negative.
Any agency or judicial enforcement action could have a material adverse effect on us. 24 Table of Contents Other Special Regulatory Procedures Animal Rule In 2002, the FDA amended its requirements applicable to NDAs to permit the approval of certain drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions based on evidence of safety from clinical trial(s) in healthy subjects and effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible.
Other Special Regulatory Procedures Animal Rule In 2002, the FDA amended its requirements applicable to NDAs to permit the approval of certain drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions based on evidence of safety from clinical trial(s) in healthy subjects and effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible.
Pursuant to the Pint SPA, closing of the upfront equity investment occurred on April 4, 2018 and Pint purchased 2,179 shares of common stock for $1,250,000. The total amount of the premium was $319,000 and this amount was allocated to the license.
Pursuant to the Pint SPA, closing of the upfront equity investment occurred on April 4, 2018 and Pint purchased 2,179 shares of common stock for $1,250,000.
The data presented here are preliminary and may be subject to change. 9 Table of Contents A total of 5 patients with SCC in the setting of RDEB have been treated with rigosertib to date. These patients had multiple surgical sections and treatments with systemic therapies such as cemiplimab, pembrolizumab and cetuximab, which all failed.
A total of 5 patients with SCC in the setting of RDEB have been treated with rigosertib to date. These patients had multiple surgical sections and treatments with systemic therapies such as cemiplimab, pembrolizumab and cetuximab, which all failed.
In addition, we could receive regulatory, development and sales-based milestone payments, as well as royalty payments at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio.
Under the terms of the SymBio License Agreement, we received an upfront payment of $7,500,000. In addition, we could receive regulatory, development and sales-based milestone payments, as well as royalty payments at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio.
Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop ratutrelvir for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir. Ratutrelvir was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years.
Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop ratutrelvir for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir. 5 Table of Contents Ratutrelvir was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases.
Pint International SA In March 2018, we entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”).
As a result, the Company recognized the $2,733,000 of deferred revenue as revenue on April 17, 2025. Pint International SA In March 2018, we entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”).
Sixteen AEs were recorded, of which three were reported as possibly related to study drug during the study; all were mild headaches. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 and within the predicted therapeutic window for more than 23 days.
Sixteen AEs were recorded, of which three were possibly related to study drug during the study; all were mild headaches and resolved without treatment. Topline data from this study showed that a single dose of tivoxavir marboxil maintained detectable plasma drug levels for 23 days.
Patent term extensions may be available, depending on various provisions in the law. ​ Oncology ​ Our intellectual property in oncology is derived through our internal research, the Temple Licensing Agreement with Temple University (“Temple”) and research agreements with the Mount Sinai School of Medicine (“Mount Sinai”). ​ License Agreement with Temple University ​ In January 1999, we entered into the Temple Licensing Agreement to obtain an exclusive, world-wide license to certain Temple patents and technical information to make, have made, use, sell, offer for sale and import several classes of novel compounds. ​ Under the terms of the Temple Licensing Agreement, we paid Temple a non-refundable up-front payment, and are required to pay annual license maintenance fees, as well as a low single-digit percentage of net sales as a royalty.
License Agreement with Temple University ​ In January 1999, we entered into the Temple Licensing Agreement with Temple University (“Temple”) to obtain an exclusive, world-wide license to certain Temple patents and technical information to make, have made, use, sell, offer for sale and import several classes of novel compounds. ​ Under the terms of the Temple Licensing Agreement, we paid Temple a non-refundable up-front payment, and are required to pay annual license maintenance fees, as well as a low single-digit percentage of net sales as a royalty.
Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
The STA License Agreement has a term of 15 years from the launch, on a country-by-country basis, in the STA Territory and contains customary provisions for termination by either party in the event of breach of the STA License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
The STA License Agreement has a term of 15 years from the launch, on a country-by-country basis, in the STA Territory and contains customary provisions for termination by either party in the event of breach of the STA License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee. 12 Table of Contents Intellectual Property Patents and Proprietary Rights Virology ​ License Agreement with Viriom, Inc. regarding Influenza Asset ​ In January 2023, Trawsfynydd entered into a License Agreement (the “Viriom License Agreement”) with Viriom, Inc.
Priority review is given to drugs intended to treat serious conditions and which, if approved would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of the serious condition.
Priority review is given to drugs intended to treat serious conditions and which, if approved would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of the serious condition. If criteria are not met for priority review, the standard FDA review period is 10 months from FDA filing, or 12 months from sponsor submission.
In addition, we agreed to pay Temple 25% of any consideration received from any sublicensee of the licensed Temple patents and technical information, which does not include any royalties on sales, funds received for research and development or proceeds from any equity or debt investment. ​ The Temple Licensing Agreement can be terminated by mutual agreement or due to the material breach or bankruptcy of either party.
In addition, we agreed to pay Temple 25% of any consideration received from any sublicensee of the licensed Temple patents and technical information, which does not include any royalties on sales, funds received for research and development or proceeds from any equity or debt investment. ​ On November 17, 2025, Temple provided notice of termination of the Temple Licensing Agreement, and the agreement subsequently terminated in accordance with its terms.
The 24-hour C trough levels were constant for 10 days, at roughly 110 nM total blood drug concentration, which is 13 times the EC 50 measured in vitro for a collection of omicron strains of SARS-CoV-2.
The toxicology studies did not reach the no adverse event limit (NOAEL) after treating animals with up to 1,000 mg/kg. The 24-hour C trough levels were constant for 10 days, at roughly 110 nM total blood drug concentration, which is 13 times the EC 50 measured in vitro for a collection of omicron strains of SARS-CoV-2.
We further advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee.
We advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee. The study 3 Table of Contents enrolled four cohorts of 8 participants, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and their implementing regulations, impose requirements relating to the privacy, security, breach notification, and transmission of protected health information.
In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and their implementing regulations, impose requirements relating to the privacy, security, breach notification, and transmission of protected health information.
If a complete response letter is issued, the applicant may either: resubmit the NDA, addressing all of the deficiencies 19 Table of Contents identified in the letter; withdraw the application; or request an opportunity for a hearing.
If a complete response letter is issued, the applicant may either: resubmit the NDA, addressing all of the deficiencies identified in the letter; withdraw the application; or request an opportunity for a hearing. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.
We may terminate the license agreement for any reason by giving Temple prior written notice. ​ Narazaciclib Patents As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering composition of matter, formulation and various indications for method-of-use for narazaciclib filed worldwide, including in the United States.
Patent term extensions may be available, depending on various provisions in the law. ​ Oncology ​ Narazaciclib Patents As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering composition of matter, formulation and various indications for method-of-use for narazaciclib filed worldwide, including in the United States.
Further, the export of investigational drug products outside of the United States is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FDC Act. 18 Table of Contents Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals. 31 Table of Contents In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of pharmaceutical products in a state, including, in some states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state.
To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
SymBio Pharmaceuticals Limited In July 2011, we entered into a license agreement (the “Symbio License Agreement”) with SymBio Pharmaceuticals Limited (“Symbio”), as subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the terms of the SymBio License Agreement, we received an upfront payment of $7,500,000.
The Chinese IND was approved in January 2020. We maintain global rights to narazaciclib outside of China. SymBio Pharmaceuticals Limited In July 2011, we entered into a license agreement (the “Symbio License Agreement”) with SymBio Pharmaceuticals Limited (“Symbio”), as subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
Accordingly, depending on the results of our studies, the FDA may be more conservative in granting accelerated approval or, if granted, may be more apt to withdrawal approval if clinical benefit is not confirmed. 27 Table of Contents Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group.
It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo).
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailed investigational drug product information is submitted to the FDA in the form of an NDA to request market approval for the product in specified indications.
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailed investigational drug product information is submitted to the FDA in the form of an NDA to request market approval for the product in specified indications. 19 Table of Contents New Drug Applications In order to obtain approval to market a drug in the United States, a marketing application must be submitted to the FDA, which provides data establishing the safety and effectiveness of the drug product for the proposed indication.
Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The Pint License Agreement also contains customary provisions for termination by either party in the event of breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
The Pint License Agreement also contains customary provisions for termination by either party in the event of breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party. Knight Therapeutics, Inc.
The single ascending dose portion of the study assessed oral ratutrelvir at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024.
Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024. There were few recorded adverse events reported up to the highest dose, and none were determined to be related to study drug.
As used in the Knight License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or controlled by us as of the effective date of the Knight License Agreement and all improvements thereto. 11 Table of Contents We are eligible to receive clinical, regulatory, and sale-based milestone payments as well as tiered, double-digit royalties based on net sales in the Knight Territory.
As used in the Knight License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or controlled by us as of the effective date of the Knight License Agreement and all improvements thereto.
The categories of covered recipients later was expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists.
The categories of covered recipients later was expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists. Payments made to physicians, other principal investigators, and certain research institutions for clinical trials are included within the ambit of this law.
Investigational drugs and active pharmaceutical ingredients imported into the United States are also subject to regulation by the FDA relating to their labeling and distribution.
Investigational drugs and active pharmaceutical ingredients imported into the United States are also subject to regulation by the FDA relating to their labeling and distribution. Further, the export of investigational drug products outside of the United States is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FDC Act.
Participants took either one dose of the study drug or one dose of placebo, depending on the assigned group. The dose levels that were evaluated included 80, 120, 240, and 480 mg, taken once via oral capsules.
Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo, depending on the assigned group. The evaluated dose levels included 80, 120, 240, and 480 mg administered orally in capsule form.
Our IND submission to the US FDA was submitted in November 2020 and the FDA Study May Proceed letter was issued in December 2020. Enrollment into the complementary US phase 1 study (Study 19-01) with narazaciclib commenced in May 2021.
Enrollment into the complementary US phase 1 study (Study 19-01) with narazaciclib commenced in May 2021.
If criteria are not met for priority 26 Table of Contents review, the standard FDA review period is 10 months from FDA filing, or 12 months from sponsor submission. Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.
Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.
In total, 2 of 3 patients treated with monotherapy at the 200mg dose had stable disease. These are noteworthy early clinical observations, considering that narazaciclib was being administered as a monotherapy in breast cancer patients when in clinical practice this would be combined with anti-estrogen therapy.
These are noteworthy early clinical observations, considering that narazaciclib was being administered as a monotherapy in breast cancer patients when in clinical practice this would be combined with anti-estrogen therapy. 8 Table of Contents Our IND submission to the US FDA was submitted in November 2020 and the FDA Study May Proceed letter was issued in December 2020.
The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee.
Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia.
In vitro laboratory tests that measured the impact of ratutrelvir on SARS-CoV-2 replication, demonstrated that ratutrelvir inhibited the replication of viral isolates of the original SARS-CoV-2 isolates, and viral variants in the delta and omicron types.
The main protease is an essential component in SARS-CoV-2 replication. Ratutrelvir inhibits Mpro and reduces SARS-CoV-2 virus replication. In vitro laboratory tests confirmed the impact of ratutrelvir on SARS-CoV-2 replication, including the original SARS-CoV-2 isolates, and variants in the delta and omicron groups.
Research and Development Since commencing operations, we have dedicated a significant portion of our resources to the development of our clinical-stage product candidates, particularly rigosertib, narazaciclib and, more recently, t ivoxavir marboxil and ratutrelvir . We incurred research and development expenses of $12.8 million and $11.4 million during the years ended December 31, 2024 and 2023, respectively.
Our objective for rigosertib is to establish one or more partnerships for further development of the compound, including in RDEB-SCC or other indications. Research and Development Since commencing operations, we have dedicated a significant portion of our resources to the development of our clinical-stage product candidates, particularly rigosertib, narazaciclib and, more recently, t ivoxavir marboxil and ratutrelvir .

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAny product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval. ● Clinical drug development involves a lengthy and expensive process with an uncertain outcome. ● Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval. ● Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action. ● Changes in product candidate manufacturing or formulation may result in additional costs or delay. ● Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain. ● Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation. ● We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. ● If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we could lose the ability to continue the development and potential commercialization of these product candidates. ● Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. ● There is no guarantee that the Merger will increase stockholder value, and stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger, including the issuance of our common stock upon conversion of the shares of Series C Preferred issued in the Merger and the concurrent financing. ● We expect to incur substantial expenses related to the integration of Trawsfynydd. ● We may engage in future business combinations or collaborations that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results. ● We depend on information technology and computer systems to operate our business; our business and operations would suffer in the event of any failures or interruptions of our computer system, such as a data breach or cybersecurity incident. ● Climate change, environmental, social and governance and sustainability initiatives may result in regulatory or structural industry changes that could require significant operational changes and expenditures, reduce demand for the Company’s products and adversely affect our business, financial condition, and results of operations. 33 Table of Contents ● Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses. ● Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel. ● Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from international conflicts, international trade disputes and geopolitical tensions. ● Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our shares. ● We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations. ● Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. ● We rely on third parties to conduct our preclinical and clinical trials.
Biggest changeAny product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval. ● Clinical drug development involves a lengthy and expensive process with an uncertain outcome. ● Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval. ● Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action. ● Changes in product candidate manufacturing or formulation may result in additional costs or delay. ● Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain. ● Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation. ● We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. ● If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we could lose the ability to continue the development and potential commercialization of these product candidates. 33 Table of Contents ● Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. ● We may engage in future business combinations or collaborations that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results. ● We depend on information technology and computer systems to operate our business; our business and operations would suffer in the event of any failures or interruptions of our computer system, such as a data breach or cybersecurity incident. ● Climate change, environmental, social and governance and sustainability initiatives may result in regulatory or structural industry changes that could require significant operational changes and expenditures, reduce demand for the Company’s products and adversely affect our business, financial condition, and results of operations. ● Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses. ● Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel. ● Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from international conflicts, international trade disputes and geopolitical tensions. ● Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our shares. ● We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations. ● Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. ● We rely on third parties to conduct our preclinical and clinical trials.
The ability of the FDA and foreign regulatory authorities to review or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions including a rapid substantial influx of applications from numerous sponsors, as occurred with COVID-19.
The ability of the FDA and foreign regulatory authorities to review or approve new products can be affected by a variety of factors, including government budget and funding levels, government shutdowns, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions including a rapid substantial influx of applications from numerous sponsors, as occurred with COVID-19.
In addition, there are risks inherent in conducting clinical trials in multiple jurisdictions, inside and outside of the US, such as: ● regulatory and administrative requirements of the jurisdiction where the trial is conducted that could burden or limit our ability to conduct our clinical trials; ● foreign exchange fluctuations; ● manufacturing, customs, shipment and storage requirements for clinical trial materials and supplies as well as shipment and storage of biological samples; ● cultural differences in medical practice and clinical research; and ● the risk that the patient populations in such trials are not considered representative as compared to the patient population in the target markets where approval is being sought. ​ Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
In addition, there are risks inherent in conducting clinical trials in multiple jurisdictions, inside and outside of the US, such as: ● regulatory and administrative requirements of the jurisdiction where the trial is conducted that could burden or limit our ability to conduct our clinical trials; ● foreign exchange fluctuations; ● manufacturing, customs, shipment and storage requirements for clinical trial materials and supplies as well as shipment and storage of biological samples; ● cultural differences in medical practice and clinical research; and ● the risk that the patient populations in such trials are not considered representative as compared to the patient population in the target markets where approval is being sought. ​ Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations, government shutdowns or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
Our future capital requirements will depend on many factors, including: ● timing and success of our clinical trials; ● continued progress of, and increased spending related to, our research and development activities; ● conditions in the capital markets and the biopharmaceutical industry, particularly with respect to raising capital or entering into strategic arrangements; 35 Table of Contents ● progress with preclinical experiments and clinical trials, including regulatory approvals necessary for advancement and continuation of our development programs; ● changes in regulatory requirements and guidance of the FDA and other regulatory authorities, which may require additional clinical trials to evaluate safety and/or efficacy, and thus have significant impacts on our timelines, cost projections, and financial requirements; ● ongoing general and administrative expenses related to our reporting obligations under the Exchange Act; ● cost, timing, and results of regulatory reviews and approvals; ● costs of any legal proceedings, claims, lawsuits and investigations; ● success, timing, and financial consequences of any existing or future collaborative, licensing and other arrangements that we may establish, including potential granting of licenses to one or more of our programs in various territories, or otherwise monetizing one or more of our programs; ● cost of filing, prosecuting, defending and enforcing any patent ● claims and other intellectual property rights; ● costs of commercializing any of our product candidates; ● technological and market developments; ● compliance with Nasdaq's continued listing requirements; ● cost of manufacturing development; and ● timing and volume of sales of products for which we obtain marketing approval.
Our future capital requirements will depend on many factors, including: ● timing and success of our clinical trials; ● continued progress of, and increased spending related to, our research and development activities; ● conditions in the capital markets and the biopharmaceutical industry, particularly with respect to raising capital or entering into strategic arrangements; ● progress with preclinical experiments and clinical trials, including regulatory approvals necessary for advancement and continuation of our development programs; ● changes in regulatory requirements and guidance of the FDA and other regulatory authorities, which may require additional clinical trials to evaluate safety and/or efficacy, and thus have significant impacts on our timelines, cost projections, and financial requirements; ● ongoing general and administrative expenses related to our reporting obligations under the Exchange Act; ● cost, timing, and results of regulatory reviews and approvals; ● costs of any legal proceedings, claims, lawsuits and investigations; ● success, timing, and financial consequences of any existing or future collaborative, licensing and other arrangements that we may establish, including potential granting of licenses to one or more of our programs in various territories, or otherwise monetizing one or more of our programs; ● cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; ● costs of commercializing any of our product candidates; ● technological and market developments; ● compliance with Nasdaq's continued listing requirements; ● cost of manufacturing development; and ● timing and volume of sales of products for which we obtain marketing approval.
These potential disruptions may include but are not limited to delays or difficulties in clinical site initiation and patient recruitment, patient withdrawals, postponement of planned clinical or preclinical studies, redirection of site resources from studies, study modification, suspension, or termination, the introduction of remote study procedures and modified informed consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, delays in receiving approval from local regulatory authorities to initiate our planned clinical trials, delays in obtaining supplies of our product candidate or other materials that may be necessary for the conduct of our development program, delays in obtaining necessary inspections from the FDA or other regulatory authorities, changing laws and regulations, and changes or delays in site monitoring.
These potential disruptions may include but are not limited to delays or difficulties in clinical site initiation and patient 46 Table of Contents recruitment, patient withdrawals, postponement of planned clinical or preclinical studies, redirection of site resources from studies, study modification, suspension, or termination, the introduction of remote study procedures and modified informed consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, delays in receiving approval from local regulatory authorities to initiate our planned clinical trials, delays in obtaining supplies of our product candidate or other materials that may be necessary for the conduct of our development program, delays in obtaining necessary inspections from the FDA or other regulatory authorities, changing laws and regulations, and changes or delays in site monitoring.
We have adopted a code of 44 Table of Contents conduct for our directors, officers and employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
We have adopted a code of 43 Table of Contents conduct for our directors, officers and employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
This could delay completion of clinical trials; require the conduct of bridging clinical trials or studies, or the repetition of one or more clinical trials; increase clinical trial costs; delay approval of our product candidates; and jeopardize our ability to commence product sales and generate revenue. 42 Table of Contents We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations.
This could delay completion of clinical trials; require the conduct of bridging clinical trials or studies, or the repetition of one or more clinical trials; increase clinical trial costs; delay approval of our product candidates; and jeopardize our ability to commence product sales and generate revenue. 41 Table of Contents We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2024 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern for the next twelve months from the date of the financial statements included in this Annual Report.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2025 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern for the next twelve months from the date of the financial statements included in this Annual Report.
For example, in recent years, the US government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. 43 Table of Contents Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.
For example, in recent years, the US government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. 42 Table of Contents Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.
Any uncured, material breach under the license agreement could result in our loss of exclusive rights and may lead to a complete termination of our product development and any commercialization efforts for the applicable product candidates. 45 Table of Contents Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
Any uncured, material breach under the license agreement could result in our loss of exclusive rights and may lead to a complete termination of our product development and any commercialization efforts for the applicable product candidates. 44 Table of Contents Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
If we fail to satisfy the continued listing standards, such as, for example, Nasdaq’s minimum bid price requirement or stockholders equity requirements, Nasdaq may issue a non-compliance letter or initiate delisting proceedings. 53 Table of Contents ​ As previously disclosed, on November 20, 2024, we received a letter from the staff (the “Staff”) of the Listing Qualifications Department of Nasdaq notifying us that the Company was no longer in compliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on Nasdaq as set forth in Listing Rule 5550(b)(1) (the “Rule”).
If we fail to satisfy the continued listing standards, such as, for example, Nasdaq’s minimum bid price requirement or stockholders equity requirements, Nasdaq may issue a non-compliance letter or initiate delisting proceedings. ​ As previously disclosed, on November 20, 2024, we received a letter from the staff (the “Staff”) of the Listing Qualifications Department of Nasdaq notifying us that the Company was no longer in compliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on Nasdaq as set forth in Listing Rule 5550(b)(1) (the “Rule”).
If adequate funds are unavailable, we may be required, among other things, to: ● delay, reduce the scope of or eliminate one or more of our research or development programs; ● license rights to technologies, product candidates or products at an earlier stage or for indications or territories than otherwise would be desirable, or on terms that are less favorable to us than might otherwise be available; ● obtain funds through arrangements that may require us to relinquish rights to product candidates or products that we would otherwise seek to develop or commercialize by ourselves; or ● further reduce or cease operations.
If adequate funds are unavailable, we may be required, among other things, to: ● delay, reduce the scope of or eliminate one or more of our research or development programs; 36 Table of Contents ● license rights to technologies, product candidates or products at an earlier stage or for indications or territories than otherwise would be desirable, or on terms that are less favorable to us than might otherwise be available; ● obtain funds through arrangements that may require us to relinquish rights to product candidates or products that we would otherwise seek to develop or commercialize by ourselves; or ● further reduce or cease operations.
There can be no assurance that our efforts, or the efforts of our partners and vendors, will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could 46 Table of Contents result in financial, legal, business or reputational harm to us.
There can be no assurance that our efforts, or the efforts of our partners and vendors, will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could 45 Table of Contents result in financial, legal, business or reputational harm to us.
If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements are renegotiated or if the U.S. or Chinese governments take retaliatory actions due to the recent U.S.-China 39 Table of Contents tension, such changes could have an adverse effect on our business, financial condition and results of operations, our ability to raise capital and the market price of our shares.
If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements are renegotiated or if the U.S. or Chinese governments take retaliatory actions due to the recent U.S.-China tension, such changes could have an adverse effect on our business, financial condition and results of operations, our ability to raise capital and the market price of our shares.
If CROs or sites do not successfully carry out their 49 Table of Contents contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
If CROs or sites do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
The US government, including the SEC, has made statements and taken certain actions that led to changes to US and international relations, and will impact companies with connections to the United States or China, including imposing several rounds of tariffs affecting certain products manufactured in China, imposing certain sanctions and restrictions in relation to China and issuing statements indicating enhanced review of companies with significant China-based operations.
The US government, including the SEC, has made statements and taken certain actions that led to changes to US and international relations, and will impact companies with connections to the United States or China, including 38 Table of Contents imposing several rounds of tariffs affecting certain products manufactured in China, imposing certain sanctions and restrictions in relation to China and issuing statements indicating enhanced review of companies with significant China-based operations.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern.
We need to obtain additional funding to execute our business plans; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations. We do not currently have the funding resources necessary to carry out all of our proposed operating activities.
We need to obtain additional funding to execute our business plans; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations. 35 Table of Contents We do not currently have the funding resources necessary to carry out all of our proposed operating activities.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. Because we have relied on third parties, our internal capacity to perform these functions is limited.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. 47 Table of Contents Because we have relied on third parties, our internal capacity to perform these functions is limited.
The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives. 47 Table of Contents The widespread outbreak of a communicable disease, such as the recent COVID-19 pandemic, could adversely impact our business, including our clinical trials, drug manufacturing and nonclinical activities.
The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives. The widespread outbreak of a communicable disease, such as the recent COVID-19 pandemic, could adversely impact our business, including our clinical trials, drug manufacturing and nonclinical activities.
International trade disputes could result in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations.
International trade disputes have resulted in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations.
If our clinical trials do not produce favorable results for our product candidates, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted. 40 Table of Contents Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
If our clinical trials do not produce favorable results for our product candidates, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted. Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of our product candidates for any or all targeted 41 Table of Contents indications.
In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of our product candidates for any or all targeted indications.
Additionally, the issuance of a significant number of shares of our common stock could result in a decrease in the price of our common stock. ​ 54 Table of Contents We have used and intend to continue to use equity incentives for employees, advisors, directors, key consultants and select affiliates.
Additionally, the issuance of a significant number of shares of our common stock could result in a decrease in the price of our common stock. ​ We have used and intend to continue to use equity incentives for employees, advisors, directors, key consultants and select affiliates.
We are obligated to develop and maintain proper and effective internal control over financial reporting. If we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
If we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of existing stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of existing stockholders.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of existing stockholders will be diluted, and the terms may include 37 Table of Contents liquidation or other preferences that adversely affect the rights of existing stockholders.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference or derivation proceedings before the USPTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference or derivation proceedings 50 Table of Contents before the USPTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.
These include provisions that will: ​ ● permit our board of directors to issue up to 5,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate (as of March 26, 2025, we had 7,397.893 shares of Series C Preferred stock issued and outstanding); ● provide that all vacancies on our board of directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum; ● require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent; ● provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; ● not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of common 55 Table of Contents stock entitled to vote in any election of directors to elect all of the directors standing for election; and ● provide that special meetings of our stockholders may be called only by the board of directors or by such person or persons requested by a majority of the board of directors to call such meetings.
These include provisions that will: ​ ● permit our board of directors to issue up to 5,000,000 shares of preferred stock, with any rights, preferences and 53 Table of Contents privileges as they may designate (as of December 31, 2025, we had shares of 6,737 Series C Preferred stock issued and outstanding); ● provide that all vacancies on our board of directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum; ● require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent; ● provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; ● not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election; and ● provide that special meetings of our stockholders may be called only by the board of directors or by such person or persons requested by a majority of the board of directors to call such meetings.
In recent years, including after the most recent presidential election, the U.S. has instituted or proposed changes in trade policies that include the negotiation or termination of trade agreements, the imposition of higher tariffs on imports into the U.S., economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct our business, in particular China, Mexico and Canada.
In recent years, the U.S. has instituted or proposed changes in trade policies that include the negotiation or termination of trade agreements, the imposition of higher tariffs on imports into the U.S., economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct our business, in particular China, Mexico and Canada.
Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year from the date of such letter.
Pursuant to Listing Rule 5815(d)(4)(B), the 51 Table of Contents Company will be subject to a mandatory panel monitor for a period of one year from the date of such letter.
We or our contractors may also face enforcement actions. We have not yet qualified alternate suppliers in the event the current CMO we utilize is unable to 50 Table of Contents scale production, or if we otherwise experience any problems with them.
We or our contractors may also face enforcement actions. We have not yet qualified alternate suppliers in the event the current CMO we utilize is unable to scale production, or if we otherwise experience any problems with them.
Where we 51 Table of Contents have the right to do so under our license agreements, we seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and products that are important to our business.
Where we have the right to do so under our license agreements, we seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and products that are important to our business.
We do not have any products approved by regulatory authorities for marketing and have not generated any revenue from product sales to date, and we continue to 36 Table of Contents incur significant research, development and other expenses related to our ongoing operations.
We do not have any products approved by regulatory authorities for marketing and have not generated any revenue from product sales to date, and we continue to incur significant research, development and other expenses related to our ongoing operations.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability and the ongoing military conflicts between Russia and Ukraine and Israel and Hamas.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, including the ongoing military conflicts between Russia and Ukraine and Israel and Hamas and the recent military conflict in Iran.
To date, we have not generated any revenues from commercial product sales. Our ability to generate revenue from product sales and achieve profitability will depend upon our ability to successfully commercialize products, including any of our current product candidates, or other product candidates that we may in-license or acquire in the future.
Our ability to generate revenue from product sales and achieve profitability will depend upon our ability to successfully commercialize products, including any of our current product candidates, or other product candidates that we may in-license or acquire in the future.
If we are unable to protect our intellectual property rights, our competitive position could be harmed. ● We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful. ● Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business. ● We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. ● If we are unable to maintain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock could be delisted, which could affect our common stock's market price and liquidity and reduce our ability to raise capital. ● Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders. ● We may be subject to securities litigation, which is expensive and could divert management attention. ● Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
If we are unable to protect our intellectual property rights, our competitive position could be harmed. ● We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful. ● Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business. ● We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. ● If we are unable to maintain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock could be delisted, which could affect our common stock's market price and liquidity and reduce our ability to raise capital. 34 Table of Contents ● We have identified material weaknesses in our internal control over financial reporting; if we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired. ● Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders. ● We may be subject to securities litigation, which is expensive and could divert management attention. ● Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
Although our business has not been materially impacted by the ongoing military conflicts between Russia and Ukraine or Israel and Hamas or geopolitical tensions to date, it is impossible to predict the extent to which our operations, or those of our suppliers and manufacturers, will be impacted in the short and long term, or the ways in which the conflict may impact our business.
Although our business has not been materially impacted by the ongoing military conflicts between Russia and Ukraine or Israel and Hamas or geopolitical tensions to date, it is impossible to predict the extent to which our operations, or those of our suppliers and manufacturers, will be impacted in the short and long term, or the ways in which the conflict may impact our business, such as by potentially making it more difficult for us to access liquidity in capital markets.
Summary of Principal Risk Factors ● Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings. 32 Table of Contents ● The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern. ● We have identified material weaknesses in our internal control over financial reporting; if we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired. ● We need to obtain additional funding to continue as a going concern; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations. ● Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. ● Our product development efforts may not be successful. ● Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates. ● The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results.
Summary of Principal Risk Factors ● Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings. ● The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern. ● We need to obtain additional funding to continue as a going concern; if we are unable to meet our needs for additional funding in the future, we will be required to limit, scale back or cease operations. ● Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. ● Our product development efforts may not be successful. ● Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates. ● The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results.
In addition, the presence of material weaknesses increases the risk of material misstatement of the consolidated financial statements. ​ We are a public company and are required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of its internal control over financial reporting on our annual report on Form 10-K.
We are a public company and are required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of its internal control over financial reporting on our annual report on Form 10-K.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates or products ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control, including a failure to synthesize and manufacture our product candidates or any products we may eventually commercialize in accordance with our specifications, and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us.
If we are unable to arrange for alternative third-party manufacturing sources, or to do so on commercially reasonable terms or in a timely manner, we may not be able to complete development of our product candidates, or market or distribute them. 48 Table of Contents Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates or products ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control, including a failure to synthesize and manufacture our product candidates or any products we may eventually commercialize in accordance with our specifications, and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us.
If we are unable to obtain regulatory approval or designations we may seek, such as orphan designation, for our product candidates in one or more jurisdictions, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of our product candidates.
If we are unable to obtain regulatory approval or designations we may seek, such as orphan designation, for our product candidates in one or more jurisdictions, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of our product candidates. 39 Table of Contents The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results.
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
In addition, many of the factors that could cause a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. 40 Table of Contents Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy. To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to explore various dilutive and non-dilutive opportunities, including equity financings, strategic alliances, business development and/or combinations, and other transactions.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to explore various dilutive and non-dilutive opportunities, including equity financings, strategic alliances, business development and/or combinations, and other transactions. The future success of the Company is dependent upon our ability to obtain additional funding.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. These losses may increase as we continue the research and development of, and seek regulatory approvals for, our product candidates, and potentially begin to commercialize any products that may achieve regulatory approval.
These losses may increase as we continue the research and development of, and seek regulatory approvals for, our product candidates, and potentially begin to commercialize any products that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
We are required to disclose changes made in internal control and procedures on a quarterly basis. ​ As discussed elsewhere in this Annual Report, we completed the Merger in April 2024.
The process of designing, implementing and testing the internal control over financial reporting required to comply with this obligation is time-consuming, costly and complicated. We are required to disclose changes made in internal control and procedures on a quarterly basis. As discussed elsewhere in this Annual Report, we completed the Merger in April 2024.
Additionally, it was determined that there was an inadequate segregation of duties over the preparation, review and posting of manual journal entries, which is the result of not having a sufficient risk assessment process in place post-Merger to identify and analyze risk of misstatement due to fraud and/or error. ​ In connection with the audit of our financial statements for the year ended December 31, 2024, we identified material weaknesses in our internal control over financial reporting, which relate to the determinations of management discussed above.
Additionally, it was determined that there was an inadequate segregation of duties over the preparation, review and posting of manual journal entries, which was the result of not having a sufficient risk assessment process in place post-Merger to identify and analyze risk of misstatement due to fraud and/or error.
Risks Related to Our Financial Position and Capital Needs Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings. 34 Table of Contents Management has concluded that substantial doubt exists about our ability to continue as a going concern for the next twelve months from the date of the financial statements included in this Annual Report.
Risks Related to Our Financial Position and Capital Needs Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new financings.
As of December 31, 2024, we had cash and cash equivalents of $21.3 million and current liabilities of $11.5 million. Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Annual Report to support our operations for more than one year following the date that the financial statements are issued.
Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Annual Report to support our operations for more than one year following the date that the financial statements are issued. We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy.
The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.
Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.
Encouraging results in preclinical testing and earlier clinical studies do not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of an investigational drug. Additionally, mechanisms of action, studies in small or single patient populations, and interim study results may not be predictive of later stage studies.
Any product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval. Encouraging results in preclinical testing and earlier clinical studies do not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of an investigational drug.
Additionally, there are currently warrants to purchase an aggregate of 5,848,082 shares of our common stock outstanding and shares of Series C Preferred Stock convertible into an aggregate of 2,959,158 shares of our common stock outstanding.
Additionally, as of December 31, 2025, there are warrants to purchase an aggregate of 3,375,457 shares of our common stock outstanding and shares of Series C Preferred Stock convertible into an aggregate of 2,694,757 shares of our common stock outstanding.
If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable.
Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine and the Middle East and/or geopolitical tensions .
Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from any such geopolitical tensions . U.S. and global markets are experiencing volatility and disruption, and the global economy has been, and may continue to be, negatively impacted by Russia’s ongoing military conflict with Ukraine.
The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and have in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patents, including those patent rights licensed to us by third parties, are highly uncertain.
The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and have in recent years been the subject of much litigation.
If we are unable to remedy our material weaknesses, or if we generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial statements, and we may continue to conclude that our internal control over financial reporting is not effective, which could adversely impact our investors’ confidence and our stock price. ​ 37 Table of Contents We currently have no source of product revenue and may never become profitable.
If we identify future material weaknesses in our internal control over financial reporting, or if we generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial statements, which could adversely impact our investors' confidence and our stock price. ​ 52 Table of Contents We could also become subject to investigations by the stock exchange on which our common stock is listed, the SEC or other regulatory authorities, which could require additional financial and management resources.
The future success of the Company is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all.
There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside the United States.
As a result, the issuance, scope, validity, enforceability and commercial value of our patents, including those patent rights licensed to us by third parties, are highly uncertain. 49 Table of Contents The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. 52 Table of Contents Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
Delisting could also impair our ability to raise capital. ​ ​ ​ If we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may decline.
Delisting could also impair our ability to raise capital. ​ We are obligated to develop and maintain proper and effective internal control over financial reporting. We have in the past identified, and in the future may identify, material weaknesses in our internal control over financial reporting.
An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly.
An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
As a result, we are not profitable and have incurred losses in every reporting period since our inception in 1998. For the years ended December 31, 2024, and 2023, we reported net losses of $166.5 million and $18.9 million, respectively, and we had an accumulated deficit of $649.2 million as of December 31, 2024.
As a result, we are not profitable and have experienced negative cash flows from our operations in every reporting period since our inception in 1998. For the year ended December 31, 2025, we reported net income of $9.2 million, primarily due to non-cash changes in fair value of our warrant liability of $26.6 million.
The development of a product candidate for one indication may further impact its development for other indications.
Additionally, mechanisms of action, studies in small or single patient populations, and interim study results may not be predictive of later stage studies. The development of a product candidate for one indication may further impact its development for other indications.
Although we intend to update our controls and implement additional controls, no assurance can be provided that we will be able to remediate the material weaknesses identified on a timely basis, or at all.
Although we were able to remediate these material weaknesses, there is no guarantee that we will not experience additional material weaknesses in the future or that we will be able to remediate any such material weakness in a timely manner or at all.
The effects of a health crisis may also increase the need for clinical trial patient monitoring and regulatory reporting of adverse effects. ​ Risk Factors Relating to the Merger There is no guarantee that the Merger will increase stockholder value. As discussed elsewhere in this Annual Report, in April 2024, we merged with Trawsfynydd.
The effects of a health crisis may also increase the need for clinical trial patient monitoring and regulatory reporting of adverse effects. ​ Risks Related to Our Dependence on Third Parties We rely on third parties to conduct our preclinical and clinical trials.
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We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.
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Management has concluded that substantial doubt exists about our ability to continue as a going concern for the next twelve months from the date of the financial statements included in this Annual Report. As of December 31, 2025, we had cash and cash equivalents of $3.8 million and current liabilities of $11.6 million.
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U.S. and global markets are experiencing volatility and disruption, and the global economy has been, and may continue to be, negatively impacted by Russia’s ongoing military conflict with Ukraine.
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For the year ended December 31, 2024, we reported net loss of $166.5 million and we had an accumulated deficit of $640.0 million as of December 31, 2025. We expect to continue to incur significant expenses and operating losses for the foreseeable future.
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As a result of Russia’s invasion of Ukraine in February 2022, the U.S., the European Union, the United Kingdom, other G7 countries, as well as various 38 Table of Contents other countries, have imposed substantial financial and economic sanctions on certain industry sectors and parties in Russia. Broad restrictions on exports to Russia have also been imposed.
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Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. We currently have no source of product revenue and may never become profitable. To date, we have not generated any revenues from commercial product sales.
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These measures include: (i) comprehensive financial sanctions against major Russian banks; (ii) additional designations of Russian individuals with significant business interests and government connections; (iii) designations of individuals and entities involved in Russian military activities; and (iv) enhanced export controls and trade sanctions limiting Russia’s ability to import various goods.
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In connection with the audit of our financial statements for the year ended December 31, 2024, we identified material weaknesses in our internal control over financial reporting, which relate to the determinations of management discussed above.
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Russian military actions and the resulting sanctions could continue to adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.
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As of December 31, 2025, these material weaknesses have been remediated, see “Part II – Item 9A – Remediation of Material Weakness in Internal Control over Financial Reporting” in this Annual Report on Form 10-K.
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Addition, in October 2023, Hamas militants and members of certain other organizations infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Shortly thereafter, Israel’s security cabinet declared war against Hamas and launched an aerial bombardment of various targets within the Gaza Strip.
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It is possible that other countries and/or regional organizations will join the hostilities as well, including without limitation Hezbollah in Lebanon, and Palestinian military organizations in the West Bank, resulting in further expansion of the conflict. The conflict between Israel and Hamas is ongoing, and the length and impact of the ongoing military conflict is highly unpredictable.
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The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results. Any product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive regulatory approval.
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In addition, many of the factors that could cause a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
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As discussed elsewhere in this Annual Report, Nora Brennan was appointed to serve as our Interim Chief Financial Officer in February 2025 and Iain Dukes, our Executive Chairman, will step in to serve as our Interim Chief Executive Officer, effective as of close of business on the date of this Annual Report, in connection with Dr.
Removed
Cautreels’ retirement from such role. Both Ms. Brennan and Dr. Dukes have provided services to the Company prior to these changes, which we believe will help minimize the transition period inherent in changes to executive management; however, no assurances can be provided.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThroughout the year, the board and its committees engage with management to discuss a wide range of enterprise risks, including cybersecurity. The audit committee assists the board of directors by overseeing the steps management has taken to monitor and mitigate cybersecurity threats and risks. The audit committee receives reports annually from management on our cybersecurity strategy and program.
Biggest changeOur board of directors has oversight responsibility for enterprise risk management, including risks from cybersecurity threats, which it administers directly and with assistance from its committees, primarily the audit committee. Throughout the year, the board and its committees engage with management to discuss a wide range of enterprise risks, including cybersecurity.
On an annual basis, our information technology risks, controls and procedures are reviewed by third-party experts as part of our Sarbanes-Oxley review and testing. Board Governance and Management Our management team is primarily responsible for assessing and managing our strategic risk exposures, including material risks from cybersecurity threats, with assistance from third-party service providers.
On an annual basis, our information technology risks, controls and procedures are reviewed by third-party experts as part of our Sarbanes-Oxley review and testing. Board Governance and Risk Management Management Oversight Our management team is primarily responsible for assessing and managing our strategic risk exposures, including material risks from cybersecurity threats, with assistance from third-party service providers.
We rely heavily on third party service providers for our clinical development activities and cloud-based documentation and communications. A cybersecurity incident at a vendor or other third-party service provider could have a material and adverse impact on our business, results of operations and financial condition.
We rely heavily on third party service providers for our clinical development activities and cloud-based documentation and communications. A cybersecurity incident at a vendor or other third-party service provider could 54 Table of Contents have a material and adverse impact on our business, results of operations and financial condition.
This impact could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action. See “Part I —Item 1A. Risk Factors” for further discussion of these risks. ​ ​
This impact could result 55 Table of Contents in reputational, competitive, operational or other business harm as well as financial costs and regulatory action. See “Part I —Item 1A. Risk Factors” for further discussion of these risks. ​ ​ ​ ​
Significant changes are reported to the audit committee from time to time. Cybersecurity incidents which are determined by management to be material will be reported immediately to the audit committee.
Cybersecurity incidents that are determined by management to be material, as well as significant cybersecurity matters (including significant changes in our risk profile), are escalated promptly to the audit committee, and the audit committee may report such matters to the full board, as appropriate.
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Management oversees our cybersecurity process on a day-to-day basis, including those described in “Risk Management and Strategy,” above. 56 Table of Contents Our board of directors has oversight responsibility for risk management, which it administers directly and with assistance from its committees, primarily the audit committee.
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Due to the size of our company, we rely on outsourced information technology (“IT”) and cybersecurity service providers to support certain operational and security functions, and our internal oversight is led by members of senior management.
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Management’s role in assessing and managing material risks from cybersecurity threats is led by our Chief Operating Officer and Chief Financial Officer, with oversight from our Chief Executive Officer. The Chief Operating Officer brings operational and technology-related experience, including prior experience in the information technology sector, and supports management oversight of our third-party IT environment.
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The Chief Financial Officer brings extensive experience in finance and accounting leadership, including experience with public company reporting, internal control environments and third-party service provider oversight. Collectively, these management roles provide the Company with executive-level oversight of cybersecurity risk governance, vendor coordination and incident escalation.
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Prevention, Detection, Mitigation and Remediation; Escalation and Reporting Our management team, in coordination with our outsourced IT and cybersecurity service providers, is responsible for monitoring and coordinating processes intended to support the prevention, detection, mitigation and remediation of cybersecurity incidents affecting our information systems and information residing with third-party providers.
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These processes are designed to be commensurate with our size, resources and risk profile and are informed by, among other things, the security capabilities embedded in key third-party systems we use (including cloud-based infrastructure and related security tools) and the ongoing monitoring and alerting performed by our outsourced IT providers.
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In general, our outsourced IT providers are expected to notify management of significant cybersecurity risks, suspicious activity or cybersecurity incidents that they identify in the course of providing services.
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Management evaluates such information to determine appropriate response actions, which may include engaging external technical specialists (as needed), containing and remediating the issue, restoring systems and data (as applicable), and implementing corrective actions intended to reduce the likelihood of recurrence. Management also coordinates internal communication and, where appropriate, external communications and notifications.
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The audit committee assists the board of directors by overseeing management’s processes to assess and manage cybersecurity risks and receives updates from management regarding our cybersecurity program periodically, including at least annually, and more frequently as circumstances warrant.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS For a description of our material pending legal proceedings, please see Note 5, Commitments and Contingencies, to our consolidated financial statements included in Part IV in this Annual Report.
Biggest changeITEM 3. LEGAL PROCEEDINGS For a description of our material pending legal proceedings, please see Note 6, Commitments and Contingencies, to our consolidated financial statements included in Part IV in this Annual Report.
MINE SAFETY DISCLOSURES Not applicable. ​ 57 Table of Contents PART II
MINE SAFETY DISCLOSURES Not applicable. ​ 56 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividend Policy We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. We do not intend to pay cash dividends on our common stock for the foreseeable future.
Biggest changeThis does not reflect beneficial stockholders who held their common stock in “street” or nominee name through brokerage firms. Dividend Policy We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business.
Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities During the fiscal year ended December 31, 2024, there were no unregistered sales of our securities that were not reported in a Current Report on Form 8-K or our Quarterly Reports on Form 10-Q.
Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities During the fiscal year ended December 31, 2025, there were no unregistered sales of our securities that were not reported in a Current Report on Form 8-K or our Quarterly Reports on Form 10-Q.
Issuer Repurchases of Equity Securities There were no repurchases of our capital stock during the fourth quarter of 2024. ​ ITEM 6. RESERVED
Issuer Repurchases of Equity Securities There were no repurchases of our capital stock during the fourth quarter of 2025. ​ ITEM 6. RESERVED
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed under the symbol TRAW on the Nasdaq Capital Market. Stockholders As of March 26, 2025, there were approximately 105 holders of record for shares of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed under the symbol TRAW on the Nasdaq Capital Market. Stockholders As of April 13, 2026, there were approximately 55 holders of record for shares of our common stock.
Removed
This does not reflect beneficial stockholders who held their common stock in “street” or nominee name through brokerage firms. Securities Authorized for Issuance Under Equity Compensation Plans Information regarding securities authorized for issuance under the Company’s equity compensation plans is contained in Part III, Item 11 of this Annual Report, and incorporated by reference herein.
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We do not intend to pay cash dividends on our common stock for the foreseeable future.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThereafter, certain investors exercised their pre-funded warrants for an aggregate of 1,382,559 shares of common stock. ​ On February 18, 2025, the Company and certain of the purchasers entered into amendments to the Series A Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to 63 Table of Contents be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted average price of the Company’s common stock over the eleven trading day period commencing five trading days immediately preceding such event and the five trading days immediately following such event. ​ On March 27, 2025, the Company and certain of the purchasers entered into amendments to the pre-funded warrants (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company. ​ Merger ​ On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of Merger, dated April 1, 2024 (the “Merger Agreement”), by and among the Company, Traws Merger Sub I, Inc., a Delaware corporation (“First Merger Sub”), Traws Merger Sub II, LLC, a Delaware limited liability company (“Second Merger Sub”), and Trawsfynydd.
Biggest changeOn February 18, 2025, the Company and certain of the purchasers of units in the December 2024 Offering entered into amendments to the Series A Warrants issued to such purchasers in the offering (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted average price of the Company’s common stock over the eleven trading day period commencing five trading days immediately preceding such event and the five trading days immediately following such event. ​ On March 27, 2025, the Company and the holders of all outstanding pre-funded warrants issued in the December 2024 Offering entered into amendments to the pre-funded warrants issued to such purchasers in the offering (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company. ​ Changes in Management and the Board of Directors ​ Effective as of the close of business on March 31, 2025, Werner Cautreels retired and resigned from his role as Chief Executive Officer of the Company and Iain Dukes, who was serving as Executive Chairman as of such date, was appointed as Interim Chief Executive Officer and his director role changed from Executive Chairman to Chairman of the Board.
Net cash provided by financing activities Net cash provided by financing activities was $34.0 million for the year ended December 31, 2024 and primarily attributable to the net proceeds received from the sale of our preferred and common stock in connection with the securities offerings in April and December 2024.
Net cash provided by financing activities was $34.0 million for the year ended December 31, 2024 and primarily attributable to the net proceeds received from the sale of our preferred and common stock in connection with the securities offerings in April and December 2024.
Accordingly, we do not allocate expenses to individual projects or product candidates, although we do allocate some portion of our research and development expenses by functional area and by compound.
Accordingly, we do not allocate expenses to individual projects or product candidates, although we do allocate some portion of our research and development expenses by functional area.
We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors. Research and development activities are central to our business model.
We record 64 Table of Contents costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors. Research and development activities are central to our business model.
We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and 70 Table of Contents liabilities that are not readily apparent from other sources.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. 68 Table of Contents Our research and development expenses are related to tivoxavir marboxil, ratutrelvir, narazaciclib, rigosertib, and potentially in-licensed products.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses are related to tivoxavir marboxil, ratutrelvir, narazaciclib, rigosertib, and potentially in-licensed products.
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in 73 Table of Contents payment flows that do not match the periods over which materials or services are provided to us under such contracts.
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts.
Narazaciclib is a multi-targeted kinase inhibitor targeting multiple CDK’s, AMP-activated protein kinase (“AMPK”), related protein kinase 5 (“ARK5”), and colony-stimulating factor 1 receptor (“CSF1R”) at low nM concentrations, as well as other tyrosine kinases believed to drive tumor cell proliferation, survival and metastasis.
Narazaciclib is a multi-targeted kinase inhibitor targeting 60 Table of Contents multiple CDK’s, AMP-activated protein kinase (“AMPK”), related protein kinase 5 (“ARK5”), and colony-stimulating factor 1 receptor (“CSF1R”) at low nM concentrations, as well as other tyrosine kinases believed to drive tumor cell proliferation, survival and metastasis.
Following the closing of the Merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, we are advancing the development of four clinical programs: ​ ● Tivoxavir marboxil, which we acquired as part of the Merger, is a small molecule cap-dependent endonuclease inhibitor. Cap-dependent endonuclease (“CEN”) is an enzyme that is important for influenza virus replication.
Following the closing of the Merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, we have four clinical programs: ​ ● Tivoxavir marboxil, which we acquired as part of the Merger, is a small molecule cap-dependent endonuclease inhibitor. Cap-dependent endonuclease (“CEN”) is an enzyme that is important for influenza virus replication.
The primary endpoint of the study was the measurement of safety and tolerability, and the secondary and other endpoints included the determination of the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use of tivoxavir marboxil as a one-time treatment for influenza.
The primary endpoint of the study was the determination of safety and tolerability; the secondary and other endpoints included the determination 58 Table of Contents of the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use of tivoxavir marboxil as a one-time treatment for influenza.
We are further advancing the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee. To date, this study enrolled four cohorts of 8 participants, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort.
We advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee (“HREC”). This study enrolled four cohorts of 8 participants each, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort.
Series A Warrant and pre-funded warrant expense Series A Warrant and pre-funded warrant expense represents the excess of the warrant liability compared to the net proceeds received as part of the December 2024 Purchase Agreement.
Series A Warrant and pre-funded warrant expense Series A Warrant and pre-funded warrant expense represents the excess of the warrant liability compared to the net proceeds received as part of the December 2024 Offering.
We expect 58 Table of Contents to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. ​ As of December 31, 2024, the Company had $21.3 million in cash and cash equivalents.
We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met. ​ As of December 31, 2025, the Company had $3.8 million in cash and cash equivalents.
In this study, the highest dose tested was 280mg once daily given continuously. This study is now closed to accrual and data analysis is ongoing in preparation for database lock, data analysis and a clinical study report. Narazaciclib is also being developed in greater China, under a 2017 license agreement between our company and HanX.
In this study, the highest dose tested was 280mg once daily given continuously. This study is now closed to accrual and data analysis is ongoing. Narazaciclib is also being developed in greater China, under a 2017 license agreement between our company and HanX. The development in greater China is entirely sponsored by HanX.
We plan to meet with the FDA in the first half of 2025 to align on a path forward, including to seek guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the treatment of H5N1 bird flu.
On March 21, 2025, we submitted a request for a meeting with the FDA to align on a path forward, including to seek guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the treatment of H5N1 bird flu.
Acquired in-process research and development ​ In connection with the Merger, we recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition which requires immediate expense recognition.
Acquired in-process research and development ​ In connection with the acquisition of Trawsfynydd in the Merger, during year ended December 31, 2024, the Company recognized a non-cash in-process research and development expense of $117.5 million related to the acquired virology programs that had no alternative future use at the time of acquisition, which required immediate expense recognition.
This subject experienced hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir marboxil, and erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered to be a serious adverse event (“SAE”) believed unlikely to be related (doubtful per the protocol) to the study drug. 59 Table of Contents There were no other AEs in the trial, including at higher doses.
This subject experienced hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir marboxil, and erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered to be a serious adverse event (“SAE”) believed unlikely to be related (doubtful per the protocol) to the study drug.
Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo, depending on the group they were assigned to. The dose levels that were evaluated included 80, 120, 240 mg, and 480 mg taken, via oral capsules.
Participants were required to be healthy males or females ages 18-64 years. Participants took either one dose of the study drug or one dose of placebo. Dose levels evaluated in this study included 80, 120, 240 and 480 mg in capsules, taken orally.
You should review the “Risk Factors” section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis .
You should review the “Risk Factors” section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis . Overview As of December 31, 2025, the Company had an accumulated deficit of $640.0 million.
Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop TRX01 for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir. ​ TRX01 w as studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants were required to be healthy males or females ages 18-64 years.
Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop TRX01 for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir. ​ 59 Table of Contents TRX01 w as studied in a Phase 1 clinical trial that included single and multiple ascending dose phases.
In accordance with the terms of the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $5,514,200, from time to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6. of Form S-3 as of the date of filing the Prospectus Supplement.
In accordance with the terms of the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $7.4 million (which is in addition to the gross proceeds of approximately $0.1 million from sales completed prior to April 7, 2025), from time to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6. of Form S-3 as of the date of filing the Prospectus Supplement.
Rigosertib is currently being studied in investigator initiated trials for epidermolysis bullosa-associated squamous cell carcinoma. Both studies included the use of either IV or oral rigosertib, depending on the clinical need of the patient. This is due to GI obstruction arising as a result of the presence of esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration.
Both studies included the use of either IV or oral rigosertib, depending on the clinical need of the patient. This is due to GI obstruction arising as a result of the presence of esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration.
Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued. 71 Table of Contents The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
The pharmacokinetic measurements indicated a small food effect for tivoxavir marboxil, with increased exposure when drug was taken after a meal but otherwise showed increasing exposure with increasing dose.
There were no other AEs in the trial, including at higher doses. The pharmacokinetic measurements indicated a small food effect for tivoxavir marboxil, with increased exposure when drug was taken after a meal but otherwise showed increasing exposure with increasing dose.
Research and development expenses The details of our research and development expenses are: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2024 2023 Virology ​ $ 4,589,000 ​ $ - Oncology ​ ​ 5,290,000 ​ ​ 8,444,000 Personnel related ​ 2,787,000 ​ 2,400,000 Stock based compensation ​ 181,000 ​ 586,000 ​ ​ $ 12,847,000 ​ $ 11,430,000 ​ Research and development expenses increased by $1.4 million, or 12.4%, to $12.8 million for the year ended December 31, 2024, from $11.4 million for the year ended December 31, 2023.
Research and development expenses The details of our research and development expenses are: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Virology ​ $ 9,513,000 ​ $ 4,589,000 Oncology ​ ​ 654,000 ​ ​ 5,290,000 Personnel related ​ 1,852,000 ​ 2,787,000 Stock based compensation ​ 124,000 ​ 181,000 ​ ​ $ 12,143,000 ​ $ 12,847,000 ​ Research and development expenses decreased by $0.7 million, or (6%), to $12.1 million for the year ended December 31, 2025, from $12.8 million for the year ended December 31, 2024.
The shares of Company common stock will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the Securities and Exchange Commission (the “Commission”) on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by a prospectus supplement dated March 10, 2025 (the “Prospectus Supplement”) and filed with the Commission pursuant to Rule 424(b) under the Securities Act, or subsequently filed prospectus supplements as applicable.
The ATM Agreement may be terminated by the Company at any time with five business days’ notice to Citizens, by Citizens at their discretion, or as otherwise permitted in the ATM Agreement. ​ The shares of common stock sold to Citizens under the ATM Agreement will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the SEC on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by those prospectus supplements dated March 10, 2025 and April 7, 2025 (the “Prospectus Supplements”) and filed with the SEC pursuant to Rule 424(b) under the Securities Act, or subsequently filed prospectus supplements as applicable.
The development in greater China is entirely sponsored by HanX. The compound is being studied in China in a clinical trial of patients with Grade III and IV glioma. ​ Our objective for narazaciclib is to establish additional partnerships for further development of the compound. ​ ● Rigosertib is our second asset in oncology.
The compound is being studied in China in a clinical trial of patients with Grade III and IV glioma. ​ Our objective for narazaciclib is to establish additional partnerships for further development of the compound. ​ ● Rigosertib is our second asset in oncology. Rigosertib is currently being studied in investigator initiated trials for epidermolysis bullosa-associated squamous cell carcinoma.
The Company will pay Citizens a commission at a fixed rate of 3.0% of the gross proceeds of each sale of shares of Company common stock sold through or to Citizens under the ATM Agreement and will reimburse Citizens for the fees and disbursements of its legal counsel incurred in connection with entering into the transactions contemplated by the ATM Agreement in an amount not to exceed $50,000 in the aggregate, in addition to up to $5,000 per “Representation Date” (as defined in the ATM Agreement) in connection with ongoing diligence arising from the transactions contemplated by the ATM Agreement.
In the year ended December 31, 2025, the Company sold and issued an aggregate of 2,517,270 shares of its common stock under the ATM Agreement for net proceeds of $5.2 million. ​ The Company will pay Citizens a commission at a fixed rate of 3.0% of the gross proceeds of each sale of shares of common stock sold through or to Citizens under the ATM Agreement and will reimburse Citizens for the fees and disbursements of its legal counsel incurred in connection with entering into the transactions contemplated by the ATM Agreement in an amount not to exceed $50,000 in the aggregate, in addition to up to $5,000 per “Representation Date” (as defined in the ATM Agreement) in connection with ongoing diligence arising from the transactions contemplated by the ATM Agreement. ​ The Company made certain customary representations, warranties and covenants in the ATM Agreement concerning the Company and its subsidiaries, the registration statement and base prospectus contained therein, prospectus 62 Table of Contents supplement and other documents and filings relating to the offering of the shares under the ATM Agreement.
Please see “Risk Factors” for additional risks associated with our substantial capital requirements. Critical Accounting Policies and Estimates This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US generally accepted accounting principles (“GAAP”).
No proceeds from warrant exercises are reflected. ​ Critical Accounting Policies and Estimates This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US generally accepted accounting principles (“GAAP”).
Cash Flows The following table summarizes our cash flows for the year ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Net cash (used in) provided by: ​ ​ Operating activities ​ $ (29,792,000) ​ $ (17,932,000) Investing activities ​ (3,648,000) ​ (14,000) Financing activities ​ 33,976,000 ​ — Effect of foreign currency translation ​ (19,000) ​ 10,000 Net increase (decrease) in cash and cash equivalents ​ $ 517,000 ​ $ (17,936,000) ​ Net cash used in operating activities Net cash used in operating activities was $29.8 million for the year ended December 31, 2024 and consisted primarily of a net loss of $166.5 million and a $6.5 million change in operating assets and liabilities.
Cash Flows The following table summarizes our cash flows for the year ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Net cash (used in) provided by: ​ ​ ​ ​ Operating activities ​ $ (18,185,000) ​ $ (29,792,000) Investing activities ​ (2,585,000) ​ (3,648,000) Financing activities ​ 3,204,000 ​ 33,976,000 Effect of foreign currency translation ​ 48,000 ​ (19,000) Net increase (decrease) in cash and cash equivalents ​ $ (17,518,000) ​ $ 517,000 ​ Net cash used in operating activities Net cash used in operating activities was $18.2 million for the year ended December 31, 2025 and consisted primarily of non-cash charges of $25.8 million primarily attributable to the change in fair value of warrant liability of $26.6 million and a $1.6 million change in operating assets and liabilities, partially offset by net income of $9.2 million.
Series A Warrant and pre-funded warrant expense Series A Warrant and pre-funded warrant expense of $24.4 million during the year ended December 31, 2024 represents the excess fair value of the warrant liabilities of $42.5 million over the $18.1 million in net proceeds in connection with the December 2024 Purchase Agreement. ​ Other income, net Other income, net, decreased by $1.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Change in fair value of warrant liability Change in fair value of warrant liability of $26.6 million during the year ended December 31, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants issued in the December 2024 Offering, the exercise of pre-funded warrants, and the remaining Series A Warrants as of December 31, 2025. ​ Series A warrant and prefunded warrant expense Series A Warrant and pre-funded warrant expense of $24.4 million during the year ended December 31, 2024 represents the excess fair value of the warrant liabilities of $42.5 million over the $18.1 million in net proceeds in connection with the December 2024 Purchase Agreement.
Net cash used in investing activities was $14,000 for the year ended December 31, 2023 and primarily attributable to the purchase of property and equipment.
Net cash used in investing activities Net cash used in investing activities was $2.6 million for the year ended December 31, 2025 and was attributable to the purchase of intangible assets.
All common stock, per share and related information presented in this Annual Report for periods prior to the date of the Reverse Stock Split, including the financial statements and accompanying notes, have been retroactively adjusted to reflect the Reverse Stock Split. ​ At the Market Offering Agreement ​ On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement), from time to time, to or through Citizens, acting as sales agent and/or principal.
See Note 3, Asset Acquisition, to our consolidated financial statements included in Part I of this Quarterly Report for more information regarding the Purchase Agreement. ​ At the Market Offering Agreement ​ On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement, including the “baby shelf” limitation under General Instruction I.B.6. of Form S-3), from time to time, to or through Citizens, acting as sales agent and/or principal.
The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group.
It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo).
The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition.
There can be no assurance that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition.
The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024.
Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024. There were few recorded adverse events reported up to the highest dose, and none were determined to be related to study drug.
Other Income, Net Other income, net consists principally of interest income earned on cash and cash equivalent balances and foreign exchange gains and losses. 69 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ ​ ​ ​ 2024 2023 Change Revenue ​ $ 226,000 ​ $ 226,000 ​ $ — Operating expenses: ​ ​ ​ ​ Acquired in-process research and development ​ ​ 117,464,000 ​ — ​ 117,464,000 Research and development ​ ​ 12,847,000 ​ ​ 11,430,000 ​ ​ 1,417,000 General and administrative ​ ​ 12,289,000 ​ 9,094,000 ​ 3,195,000 Total operating expenses ​ 142,600,000 ​ 20,524,000 ​ 122,076,000 Loss from operations ​ (142,374,000) ​ (20,298,000) ​ (122,076,000) Series A warrant and prefunded warrant expense ​ (24,438,000) ​ — ​ (24,438,000) Other income, net ​ 289,000 ​ 1,350,000 ​ (1,061,000) Net loss ​ $ (166,523,000) ​ $ (18,948,000) ​ $ (147,575,000) ​ Revenues Revenues for the years ended December 31, 2024 were consistent with the year ended December 31, 2023 and were due to the recognition of deferred revenue from our collaboration with SymBio.
Other Income, Net Other income, net consists principally of interest income earned on cash and cash equivalent balances and foreign exchange gains and losses. 65 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Change Revenue ​ $ 2,790,000 ​ $ 226,000 ​ $ 2,564,000 Operating expenses: ​ ​ ​ ​ ​ ​ ​ Acquired in-process research and development ​ ​ — ​ 117,464,000 ​ (117,464,000) Research and development ​ ​ 12,143,000 ​ ​ 12,847,000 ​ ​ (704,000) General and administrative ​ ​ 8,522,000 ​ 12,289,000 ​ (3,767,000) Total operating expenses ​ 20,665,000 ​ 142,600,000 ​ 121,935,000 Loss from operations ​ (17,875,000) ​ (142,374,000) ​ 124,499,000 Change in fair value of warrant liability ​ ​ 26,567,000 ​ ​ — ​ ​ 26,567,000 Series A warrant and prefunded warrant expense ​ — ​ (24,438,000) ​ 24,438,000 Other income, net ​ 478,000 ​ 289,000 ​ 189,000 Net income (loss) ​ $ 9,170,000 ​ $ (166,523,000) ​ $ 175,693,000 ​ Revenues Revenues were $2.8 million and $0.2 million for the years ended December 31, 2025 and 2024, respectively, related to the Company’s license agreement with Symbio.
The increases were partially offset by a $3.2 million decrease in oncology costs and a $0.4 million decrease in stock based compensation. 70 Table of Contents General and administrative expenses The details of our general and administrative expenses are: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Professional & consulting fees ​ $ 5,954,000 ​ $ 2,162,000 Stock based compensation ​ ​ 1,209,000 ​ ​ 715,000 Personnel related ​ 3,035,000 ​ 3,264,000 Public company costs ​ 1,231,000 ​ 1,968,000 Insurance & other ​ ​ 860,000 ​ ​ 985,000 ​ ​ $ 12,289,000 ​ $ 9,094,000 ​ General and administrative expenses increased by $3.2 million, or 35.1%, to $12.3 million for the year ended December 31, 2024, from $9.1 million for the year ended December 31, 2023.
The decrease was primarily driven by a $4.6 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets, a $0.9 million decrease in personnel expenses, and a $0.1 million decrease in stock based compensation, partially offset by a $4.9 million increase in virology expenses due to our focus on initiating Phase 2 studies for both tivoxavir marboxil and TRX01. 66 Table of Contents General and administrative expenses The details of our general and administrative expenses are: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Professional & consulting fees ​ $ 3,474,000 ​ $ 5,954,000 Stock based compensation ​ ​ 604,000 ​ ​ 1,209,000 Personnel related ​ 2,457,000 ​ 3,035,000 Public company costs ​ 1,150,000 ​ 1,231,000 Insurance & other ​ ​ 837,000 ​ ​ 860,000 ​ ​ $ 8,522,000 ​ $ 12,289,000 ​ General and administrative expenses decreased by $3.8 million, or (31)%, to $8.5 million for the year ended December 31, 2025, from $12.3 million for the year ended December 31, 2024, primarily due to a decrease in professional and consulting fees as a result of a decrease in legal expenses related to oncology patent fees.
The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was approved by the Human Research Ethics Committee.
Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia.
Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that these financial statements are issued. ​ We are exploring various sources of funding for development and applying for regulatory approval of our research compounds as well as for our ongoing operations.
Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that such financial statements are issued. ​ We are exploring various sources of funding for development and applying for regulatory approval of our research compounds as well as for our ongoing operations.
Deferred revenue decreased $0.2 million due to recognition of the unamortized portion of the upfront payment under our collaboration agreement with SymBio. Net cash used in investing activities Net cash used in investing activities was $3.6 million for the year ended December 31, 2024 and primarily related to the transaction costs of $3.6 million in connection with the Merger.
Net cash used in investing activities was $3.6 million for the year ended December 31, 2024 and primarily related to the transaction costs of $3.6 million in connection with the Merger. 68 Table of Contents Net cash provided by financing activities Net cash provided by financing activities was $3.2 million for the year ended December 31, 2025 and was attributable to the proceeds received from the sale of shares of our common stock under the ATM and proceeds from exercised warrants, partially offset by the payment of offering costs.
Net cash used in operating activities was $17.9 million for the year ended December 31, 2023 and consisted primarily of a net loss of $18.9 million, including $1.3 million of noncash stock-based compensation and depreciation expense. Changes in operating assets and liabilities resulted in a net decrease in cash of $0.3 million.
Net cash used in operating activities was $29.8 million for the year ended December 31, 2024 and consisted primarily of a net loss of $166.5 million and a $6.5 million change in operating assets and liabilities.
Based on current projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than one year following the date that these financial statements are issued. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern.
Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Annual Report to support our operations for at least the 12 months following the date that the consolidated financial statements included herein are 57 Table of Contents issued.
The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled human trial would be unethical or infeasible. ​ ● Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID19.
The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled human trial would be unethical or infeasible. Our meeting request was granted, and we submitted our briefing package to the FDA on April 24, 2025.
We expect net cash expended in 2025 to be higher than 2024 due to clinical trials and increased headcount in our clinical and regulatory groups. We also expect an increase in costs for potential in-licensing, the timing of which will be determined by the timing of any potential in-licensing.
Material Cash Requirements We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable future. We expect net cash expended in 2026 to be higher than 2025 due to clinical trials and increased headcount in our clinical and regulatory groups.
Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days. ​ 60 Table of Contents ● Narazaciclib is our oral CDK4-plus inhibitor intended initially to treat low grade endometrioid endometrial cancer and other cancers.
Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days.
Cautreels will continue to serve as a director on the Board after the Termination Date, and will also continue to provide certain consulting services to the Company for a period of time after the Termination Date. ​ Iain Dukes, the Company’s Executive Chairman, has been appointed as Interim Chief Executive Officer, effective as of the Termination Date. ​ ​ 67 Table of Contents Financial Overview Revenue During the years ended December 31, 2024 and 2023, our revenues were derived exclusively from activities conducted in accordance with our collaboration arrangement with SymBio.
Leaman was also appointed as a member of the Audit Committee of the Board. ​ Financial Overview Revenue During the years ended December 31, 2025 and 2024, our revenues were derived exclusively from activities conducted in accordance with our collaboration arrangement with SymBio Pharmaceuticals Limited (“Symbio”).
Our operating activities used $29.8 million and $17.9 million of net cash during the year ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $649.2 million, working capital of $13.4 million, and cash and cash equivalents of $21.3 million.
Liquidity and Capital Resources As of December 31, 2025, we had cash and cash equivalents of $3.8 million, an accumulated deficit of $640.0 million, and a working capital deficit of $3.2 million.
Removed
Overview The Company’s net losses were $166.5 million and $18.9 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company had an accumulated deficit of $649.2 million.
Added
On May 27, 2025, we received written responses from the FDA for a Type B pre-Investigational New Drug Application meeting (“pre-IND”). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil for bird flu and seasonal flu, including on the potential use of the Animal Rule.
Removed
On December 29, 2024, the Company entered into the Securities Purchase Agreement described below (the “December 2024 Purchase Agreement”), for the sale of shares of Company common stock, pre-funded warrants, and Series A Warrants and raised gross proceeds of $20.0 million at closing on December 31, 2024.
Added
On June 30, 2025, we announced our submission of briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu, as a follow up to the pre-IND FDA interactions. ​ In addition, on June 30, 2025, we announced our proposed Phase 2 dose-ranging, non-inferiority study, which will evaluate the effects of tivoxavir marboxil in patients with seasonal influenza.
Removed
In addition, on April 1, 2024, in connection with the Merger, the Company entered into a Securities Purchase Agreement (the “April 2024 Securities Purchase Agreement”) for the sale of common and preferred stock to TPAV, LLC (“TPAV”), an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP (“OrbiMed”), an affiliate of OrbiMed Advisors (together, the “Investors”) and raised gross proceeds of $14.0 million.
Added
A separate single arm will evaluate the effects of tivoxavir marboxil in patients infected with H5N1 bird flu. The proposed study has been submitted for HREC review and, once initiated, is expected to enroll subjects in Australia and selected countries in Southeast Asia with high rates of human bird flu infections.
Removed
There were few recorded adverse events reported up to the highest dose, and none were determined to be related to study drug. Topline data from the study showed no treatment related adverse events reported up to the highest dose.
Added
During a Type D meeting, the FDA affirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. We have determined to defer the initiation of this study at this time due to the low immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects.
Removed
Our objective for this program is to establish partnerships for the development of rigosertib in this indication. ​ Recent Developments ​ Reverse Stock Split ​ In September 2024, our board of directors (the “Board”) approved a one-for-25 reverse stock split of the Company’s outstanding shares of common stock (the “Reverse Stock Split”).
Added
However, we believe that recent approval of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase.
Removed
Each 25 shares of the common stock of the Company, par value of $0.01 per share, issued and outstanding immediately prior to the Reverse Stock Split automatically reclassified, combined, converted and changed into one fully paid and non-assessable share of common stock.
Added
On January 26, 2026, we announced our progression of an additional indication for tivoxavir marboxil as a single monthly oral tablet for the prophylactic treatment of seasonal influenza. ​ ● Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID-19.
Removed
In addition, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding options, warrants and convertible preferred stock entitling the holders to purchase shares of the Company’s common stock, and the number of shares reserved for issuance pursuant to the Company’s 2021 Incentive Compensation Plan (as amended and restated, the “2021 Plan”), including pursuant to outstanding restricted stock units outstanding thereunder, was reduced proportionately.
Added
Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses.
Removed
No fractional shares were issued as a result of the Reverse Stock Split. Instead, the Company’s stockholders who otherwise would have been entitled to a fraction of a share received a full 61 Table of Contents share of common stock.
Added
Topline data from the study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained plasma drug levels within the predicted therapeutic window for 12 days. ​ TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases.
Removed
Sales of shares of common stock, if any, pursuant to the ATM Agreement will be made by any method permitted that is deemed an “at the market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on or through the Nasdaq Capital Market or any other existing trading market in the United States for the Company’s common stock, directly to Citizens as principal, in privately negotiated transactions, in block transactions and/or in any other method permitted by law.
Added
Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was conducted in Australia.
Removed
Subject to the terms and conditions of the ATM Agreement, Citizens will use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market to sell shares, from time to time, based upon the Company’s instructions, including any price, time or size limits specified by the Company.
Added
It was sponsored by the Company and was approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received study drug and two received placebo).
Removed
The ATM Agreement may be terminated by the Company at any time with five business days’ notice to Citizens, by Citizens at their discretion, or as otherwise permitted in the ATM Agreement.
Added
Subjects in the single ascending dose phase received one oral dose of the study drug or placebo, depending on their assigned group. The single ascending dose portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses.
Removed
The Company made certain customary representations, warranties and covenants in the ATM Agreement concerning the Company and its subsidiaries and the registration statement and base prospectus contained therein, prospectus supplement and other documents and filings relating to the offering of the shares.
Added
Subjects in the multiple ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo in each cohort) for 10 consecutive days. The study was completed in September 2024. There were few recorded AEs reported up to the highest dose, and none were determined to be related to study drug.
Removed
In addition, the Company has also provided Citizens with customary indemnification rights. ​ Nasdaq Compliance ​ The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in 2024 regarding non-compliance with continued listing requirements.
Added
On June 30, 2025, we announced our proposed Phase 2 non-inferiority study, which will evaluate the effects of ratutrelvir in newly diagnosed COVID-19 patients, and on August 18, 2025, we announced receipt of approval from the HREC to proceed with the Phase 2 study.
Removed
On February 25, 2025, the Company received a letter from Nasdaq confirming that the Company has regained compliance with Listing Rule 5550(b)(1) related to minimum stockholders’ equity requirements, as required by the Hearings Panel of Nasdaq’s decision dated December 13, 2024. 62 Table of Contents Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year from the date of such letter.
Added
The study is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID ® . In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID-19.
Removed
December 2024 Purchase Agreement ​ On December 29, 2024, the Company entered into the December 2024 Purchase Agreement with several investors for the sale of (i) up to 3,630,205 Class A Units (“Class A Units”), each Class A Unit consisting of (a) one share of common stock or one pre-funded warrant to initially purchase one share of common stock, and (b) one Series A Warrant to purchase one share of common stock and (ii) 289,044 Class B Units (“Class B Units” and, together with the Class A Units, the “Units”), each Class B Unit consisting of one pre-funded warrant and one Series A Warrant.
Added
On October 14, 2025, we announced the dosing of the first subject in our Phase 2 study to evaluate ratutrelvir. We intend to initiate a separate single arm to evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID-19 patients who are ineligible for treatment with PAXLOVID ® .
Removed
The purchase price per Class A Unit was $5.103 and the purchase price per Class B Unit was $5.093.
Added
On December 17, 2025, we reported positive interim Phase 2 data showing ratutrelvir had a favorable tolerability profile versus PAXLOVID ® and no viral rebound events were observed in ratutrelvir-treated patients, while a rebound occurred in the PAXLOVID ® arm. Interim results also showed activity in PAXLOVID ® -eligible patients.

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