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TRAW 10-K & 10-Q changes, risk factors and insider trading

Traws Pharma, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1130598 · All filings on SEC.gov

Everything below is quoted or computed from Traws Pharma, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

5 / 19risk-factor paragraphs added / removed in latest 10-K
1new risk-factor headings
1Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-04-15 (period ending 2025-12-31) with 10-K filed 2025-03-31 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

5new paragraphs
19removed paragraphs
10reworded paragraphs
14,248 → 13,047words in section

New heading “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. 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.”

Removed heading “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. In addition, the presence of material weaknesses increases the risk of material misstatement of the consolidated financial statements.”

Removed heading “Risk Factors Relating to the Merger”

Removed heading “There is no guarantee that the Merger will increase stockholder value.”

Removed heading “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 all outstanding shares of our Series C Preferred issued in the Merger and Financing.”

Removed heading “The failure to successfully integrate the businesses of Onconova and Trawsfynydd in the expected timeframe would adversely affect Traws Pharma’s future results.”

Removed heading “Our future results will suffer if we do not effectively manage our expanded operations.”

Removed heading “We expect to incur substantial expenses related to the integration of Trawsfynydd.”

Removed heading “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.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: export control, sanction, liquidity, russia
“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. 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 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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Removed text topics: material weakness, regulation
“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. In addition, the presence of material weaknesses increases the risk of material misstatement of the consolidated financial statements.”
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New text topics: material weakness, regulation
“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. 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.”
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New text topics: material weakness, restatement
“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. Effective internal control over financial reporting is necessary for reliable financial reports and, together with adequate disclosure controls and procedures, such internal controls are designed to prevent fraud. …”
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Removed text topics: material weakness, restatement
“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. Effective internal control over financial reporting is necessary for reliable financial reports and, together with adequate disclosure controls and procedures, such internal controls are designed to prevent fraud. …”
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Removed text topics: material weakness, investigation
“As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls. In addition, we are required to furnish a report by management on the effectiveness of our internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act. As discussed elsewhere in this Annual Report, as of December 31, 2024, based on an analysis completed by management, our internal controls were not effective due to the existence of material weaknesses. …”
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Full comparison: every changed paragraph (34)

Green = added, red = removed. Unchanged paragraphs, 3 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We are a clinical-stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate could fail to gain regulatory approval or become commercially viable. 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. As a result, we are not profitable and have incurredexperienced lossesnegative cash flows from our operations in every reporting period since our inception in 1998. For the yearsyear 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. For the year ended December 31, 2024, and 2023, we reported net lossesloss of $166.5 million and $18.9 million, respectively, and we had an accumulated deficit of $649.2$640.0 million as of December 31, 2024.2025.

Removed

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. In addition, the presence of material weaknesses increases the risk of material misstatement of the consolidated financial statements.

Removed

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. Effective internal control over financial reporting is necessary for reliable financial reports and, together with adequate disclosure controls and procedures, such internal controls are designed to prevent fraud. Undetected material weaknesses in internal controls could lead to financial statement restatements and require us to incur the expense of remediation. We are required to disclose changes made in internal control and procedures on a quarterly basis.

Removed

As discussed elsewhere in this Annual Report, we completed the Merger in April 2024. Prior to the Merger, Trawsfynydd was a private company and, therefore, its controls were not required to be designed or maintained in accordance with Rules 13a-15 and 15d-15 under the Exchange Act. The design and implementation of internal control over financial reporting post-Merger has required, and will continue to require, significant time and resources from management and other personnel. Although we had internal controls in place prior to the Merger, and our management has determined in recent years that such internal controls over financial reporting were effective, during its assessment of our internal controls over financial reporting as of December 31, 2024 it was determined that our controls were not effectively updated and implemented to reflect the changes in processes and staffing during the period between completion of the Merger and December 31, 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.

Removed

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. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. 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. 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.

Reworded

We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instabilityinstability, andincluding the ongoing military conflicts between Russia and Ukraine and Israel and Hamas.Hamas and the recent military conflict in Iran. 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 theany conflict in Ukraine and the Middle East and/orsuch geopolitical tensions.

Removed

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. 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 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. 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. 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.

Removed

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. 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.

Reworded

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. 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.business, such as by potentially making it more difficult for us to access liquidity in capital markets. The extent and duration of the conflicts in Ukraine and the Middle East, geopolitical tensions, sanctions and resulting market disruptions are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described herein.

Reworded

International trade disputes couldhave resultresulted in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations.

Reworded

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. A number of other nations have proposed or instituted similar measures directed at trade with the United States in response. As a result of these developments, there may be greater restrictions and economic disincentives on international trade that could adversely affect our business. Additionally, tariffs could increase our costs, which could have a negative impact on our financial condition and results of operations. As additional trade-related policies are instituted, we may need to modify our business operations to comply and adapt to such developments, which may be time-consuming and expensive.

Reworded

Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitationslimitations, 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.

Reworded

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. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. 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.

Reworded

Certain states,states in the US,US have also enacted laws requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, cap or regulate price increases, negotiate or pay increased supplemental rebates and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing specified physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit other specified sales and marketing practices.

Reworded

We are highly dependent upon members of our executive management team and other employees. 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. 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. Although we have employment agreements with our executive officers, these agreements are at-will and do not prevent such persons from terminating their employment with us at any time. We do not maintain "key person" insurance for any of our executives or other employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

Removed

Risk Factors Relating to the Merger

Removed

There is no guarantee that the Merger will increase stockholder value.

Removed

As discussed elsewhere in this Annual Report, in April 2024, we merged with Trawsfynydd. We cannot guarantee that implementing the Merger and related transactions will not impair stockholder value or otherwise adversely affect our business. The Merger continues to pose integration challenges between our businesses and management teams, which could result in management and business disruptions, any of which could harm our results of operation, business prospects, and impair the value of the Merger to our stockholders.

Removed

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 all outstanding shares of our Series C Preferred issued in the Merger and Financing.

Removed

If we are unable to realize the full strategic and financial benefits currently anticipated from the Merger, stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent we are able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

Removed

The failure to successfully integrate the businesses of Onconova and Trawsfynydd in the expected timeframe would adversely affect Traws Pharma’s future results.

Removed

Our ability to successfully integrate the operations of Onconova and Trawsfynydd will depend, in part, on our ability to realize the anticipated benefits from the Merger. If we are not able to achieve these objectives within the anticipated time frame, or at all, the anticipated benefits of the Merger may not be realized fully, or at all, or may take longer to realize than expected, and the value of our common shares may be adversely affected. In addition, the integration of the Company’s and Trawsfynydd’s respective businesses has been, and will likely continue to be, a time-consuming and expensive process. Proper planning and effective and timely implementation will be critical to avoid any significant disruption to Traws Pharma’s operations. It is possible that the continuing integration process could result in the loss of key employees, the disruption of our ongoing business or the identification of inconsistencies in standards, controls, procedures and policies that adversely affect our ability to maintain relationships with suppliers, distributors, creditors, lessors, clinical trial investigators or managers or to achieve the anticipated benefits of the Merger. Delays encountered in the integration process could have a material adverse effect on Traws Pharma’s revenues, expenses, operating results and financial condition, including the value of its common shares.

Removed

Our future results will suffer if we do not effectively manage our expanded operations.

Removed

As a result of the Merger, we have become a more diversified company and our business has become more complex. There can be no assurance that we will effectively manage the increased complexity without experiencing operating inefficiencies or control deficiencies. Significant management time and effort is required to effectively manage our increased complexity and our failure to successfully do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Removed

We expect to incur substantial expenses related to the integration of Trawsfynydd.

Removed

We have incurred, and expect to continue to incur, substantial expenses in connection with the Merger and the integration of Trawsfynydd. There are a large number of processes, policies, procedures, operations, technologies and systems that must be integrated, including purchasing, accounting and finance, billing, payroll, research and development, marketing and benefits. Both the Company and Trawsfynydd incurred significant transaction expenses in connection with the drafting and negotiation of the Merger Agreement, the Stock Purchase Agreement and the related ancillary agreements and significant severance expenses in connection with the reduction of employees in April 2024. While we have assumed that a certain level of expenses will be incurred, there are many factors beyond our control that could affect the total amount or the timing of the integration expenses. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. These integration expenses likely will result in our taking significant charges against earnings following the completion of the Merger, and the amount and timing of such charges are uncertain at present.

Added

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. 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.

Added

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. Effective internal control over financial reporting is necessary for reliable financial reports and, together with adequate disclosure controls and procedures, such internal controls are designed to prevent fraud. Undetected material weaknesses in internal controls could lead to financial statement restatements and require us to incur the expense of remediation. 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.

Added

As discussed elsewhere in this Annual Report, we completed the Merger in April 2024. Prior to the Merger, Trawsfynydd was a private company and, therefore, its controls were not required to be designed or maintained in accordance with Rules 13a-15 and 15d-15 under the Exchange Act. The design and implementation of internal control over financial reporting post-Merger has required, and will continue to require, significant time and resources from management and other personnel. Although we had internal controls in place prior to the Merger, and our management has determined in recent years that such internal controls over financial reporting were effective, during its assessment of our internal controls over financial reporting as of December 31, 2024 it was determined that our controls were not effectively updated and implemented to reflect the changes in processes and staffing during the period between completion of the Merger and December 31, 2024. 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.

Added

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. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. 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. 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. 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.

Added

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.

Removed

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.

Removed

As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls. In addition, we are required to furnish a report by management on the effectiveness of our internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act. As discussed elsewhere in this Annual Report, as of December 31, 2024, based on an analysis completed by management, our internal controls were not effective due to the existence of material weaknesses. 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. If we identify material weaknesses in our internal control over financial reporting (as we have for the period covered by this Annual Report), if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could decline, and we could also become subject to investigations by the stock exchange on which our common stock is listed, the Commission or other regulatory authorities, which could require additional financial and management resources.

Reworded

As discussed elsewhere in this Annual Report, we will need to obtain additional financing in the future to carry out our business objectives. We may do so through the sale and issuance of shares of our common stock or securities convertible or exercisable for shares of our common stock. Additionally, as of December 31, 2025, there are currently warrants to purchase an aggregate of 5,848,0823,375,457 shares of our common stock outstanding and shares of Series C Preferred Stock convertible into an aggregate of 2,959,1582,694,757 shares of our common stock outstanding. Any issuance of shares of our common stock, including upon the exercise or conversion of outstanding warrants and shares of Series C Preferred, respectively, or issuance of securities exercisable for or convertible into shares of our common stock, will result in the dilution of the ownership interests of our existing stockholders. 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.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

30new paragraphs
55removed paragraphs
21reworded paragraphs
9,202 → 7,644words in section

New heading “April 2026 Financing”

New heading “Asset Acquisition”

New heading “Other income, net”

New heading “Pro Forma Impact of the April 2026 Financing”

New heading “Unaudited Pro Forma Balance Sheet”

Removed heading “Reverse Stock Split”

Removed heading “Nasdaq Compliance”

Removed heading “December 2024 Purchase Agreement”

Removed heading “Support Agreements”

Removed heading “Lock-up Agreements”

Removed heading “Contingent Value Rights Agreement”

Removed heading “Private Placement and Securities Purchase Agreement”

Removed heading “Registration Rights Agreement”

Removed heading “Certificate of Designation”

Removed heading “Certificate of Amendment”

Removed heading “Transaction Costs”

Removed heading “Employment and Severance Agreements”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: fine, regulation
“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. …”
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Removed text topics: going concern
“Since our inception, we have incurred net losses and experienced negative cash flows from our operations. We incurred net losses of $166.5 million and $18.9 million for the years ended December 31, 2024 and 2023, respectively. 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. …”
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Reworded topics: going concern

Paragraph as it now reads, with added and removed wording marked:

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 sources of funding, including debt and equity financings (including pursuant to the ATM Agreement), strategic alliances, business development and/or combinations, and other sources. The future success of the Company is dependent upon our ability to obtain additional funding. There can be no assurance, however,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. 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.
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New text topics: going concern
“Based on our current projections, as of the date of this Annual Report, we believe that our existing cash and cash equivalents, together with the net proceeds received at closing from the April 2026 Financing, will not be sufficient to fund our operating requirements for at least the 12 months following the date that the consolidated financial statements included herein are issued. 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.”
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New text topics: going concern
“As of December 31, 2025, the Company had $3.8 million in cash and cash equivalents. 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 issued. 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.”
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Removed text topics: securities and exchange commission
“Pursuant to the Merger Agreement, the Company agreed to hold a stockholders’ meeting to submit, among other proposals, the following proposals to its stockholders for their consideration: …”
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Full comparison: every changed paragraph (106)

Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

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, 2024,2025, the Company had an accumulated deficit of $649.2$640.0 million. 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.

Added

As of December 31, 2025, the Company had $3.8 million in cash and cash equivalents. 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 issued. 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.

Removed

As of December 31, 2024, the Company had $21.3 million in cash and cash equivalents. 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. 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. 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.

Reworded

We are a clinical-stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral diseases and cancer. Following the closing of the Merger in which we acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, we are advancing the development ofhave four clinical programs:

Reworded

We are further advancingadvanced 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.Committee To(“HREC”). date, thisThis study enrolled four cohorts of 8 participants,participants each, with 6 participants randomized to receive study drug and 2 participants assigned to receive placebo in each cohort. 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,placebo. depending on the group they were assigned to. The doseDose levels thatevaluated werein evaluatedthis study included 80, 120, 240 mg, and 480 mg taken,in viacapsules, oraltaken capsules.orally. The primary endpoint of the study was the measurementdetermination of safety and tolerability, andtolerability; 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. 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. WeOn planMarch to21, meet2025, we submitted a request for a meeting 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. 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. 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. 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.

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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. 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. 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. 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. 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.

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TRX01 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. 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. 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. 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 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. 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. 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. 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. 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®. 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. On January 13, 2026, we reported interim data in a larger sample of 50 patients, suggesting faster time to sustained symptom resolution for ratutrelvir versus PAXLOVID®, continued no rebounds with ratutrelvir, and consistent safety/benefit signals in PAXLOVID®-eligible patients. On January 26, 2026, we announced the completion of enrollment of our ongoing 90-patient, open-label Phase 2 study of ratutrelvir versus PAXLOVID® in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID®-ineligible subjects.

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Another Phase 1 study of narazaciclib as a monotherapy has also been conducted in patients with relapsed and/or refractory advanced cancer. The objectives of this study were to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally as escalating daily doses in patients with advanced cancer relapsed or refractory to at least 1 prior line of therapy. Narazaciclib was dosed on a continuous daily schedule in 28-day cycles. 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.ongoing.

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April 2026 Financing

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On April 15, 2026, we completed a financing transaction, with funding expected April 16, 2026, for aggregate gross proceeds of up to $60.0 million (the "April 2026 Financing"). The April 2026 Financing consisted of (i) $10.0 million of upfront gross proceeds at closing from the sale of 5,982,919 shares of our common stock (including pre-funded warrants in lieu thereof), (ii) the issuance of milestone-based warrants with an aggregate exercise price of $10.0 million that becomes exercisable upon receipt of approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") to conduct the human challenge trial in the UK, (iii) the issuance of additional milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable upon shareholder approval and the announcement of data from the human challenge trial and (iv) the issuance of common warrants, subject to shareholder approval, with a three-year term to purchase shares of our common stock, providing potential additional gross proceeds of $30.0 million if fully exercised. The milestone-based warrants and the common warrants each have an exercise price equal to the per share purchase price in the April 2026 Financing. The common warrants are subject to a forced exercise provision if the trading price of our common stock equals or exceeds 200% of the applicable exercise price for 30 consecutive trading days. The milestone-based warrants become exercisable only upon achievement of the applicable milestone conditions, and there can be no assurance that we will receive any additional proceeds from the exercise of the milestone-based warrants or the common warrants, or as to the timing thereof.

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At close, we paid transaction costs including a cash success fee equal to 6% of the upfront gross proceeds, and we intend to use the net proceeds for working capital and general corporate purposes, including funding our clinical and regulatory activities.

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Asset Acquisition

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On September 9, 2025, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Viriom, Inc. (“Viriom”), a related party, pursuant to which we purchased a patent from Viriom in exchange for $2,350,000 in cash. The patent includes certain intellectual property and other assets related to a pyrrolidine antiviral compound. We also incurred legal costs in consummating the Purchase Agreement of $235,000 to the acquired patent. 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.

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Reverse Stock Split

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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”). 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. 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. 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 share of common stock. 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.

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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. 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. 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.

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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 Company is not obligated to make any sales of common stock under the ATM Agreement and no assurance can be given that the Company will sell any shares under the ATM Agreement, or, if it does, as to the price or amount of shares that the Company will sell, or the dates on which any such sales will take place. 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.

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The shares of Company 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 Securities and Exchange Commission (the “Commission”)SEC on June 30, 2023, and declared effective by the Commission on July 11, 2023, including the base prospectus contained therein, as supplemented by athose prospectus supplementsupplements dated March 10, 2025 and April 7, 2025 (the “Prospectus SupplementSupplements”) and filed with the CommissionSEC pursuant to Rule 424(b) under the Securities Act, or subsequently filed prospectus supplements as applicable. 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,$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. 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.

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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.

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The Company made certain customary representations, warranties and covenants in the ATM Agreement concerning the Company and its subsidiaries andsubsidiaries, the registration statement and base prospectus contained therein, prospectus supplement and other documents and filings relating to the offering of the shares.shares under the ATM Agreement. In addition, the Company has also provided Citizens with customary indemnification rights.

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On February 17, 2025, the Company held a special meeting of its stockholders, at which, the Company’s stockholders approved (i) in accordance with Nasdaq Listing Rule 5653(d), the issuance of more than 19.99% of the outstanding shares of the Company’s common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to investors in a private placement on December 31, 2024 (the “December 2024 Offering”), and (ii) in accordance with Nasdaq Listing Rule 5653(c), the issuance of shares of the Company’s common stock upon exercise of the pre-funded warrants and Series A Warrants sold and issued to certain insiders in the December 2024 Offering. As a result of such approvals, the pre-funded warrants became immediately exercisable and limitations on the exercisability of the Series A Warrants under applicable Nasdaq rules were lifted. Subsequent to such shareholder meeting, and through December 31, 2025, certain purchasers have exercised their pre-funded warrants for an aggregate of 2,628,962 shares of the Company’s common stock.

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Nasdaq Compliance

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The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in 2024 regarding non-compliance with continued listing requirements. 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.

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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.

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December 2024 Purchase Agreement

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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. The purchase price per Class A Unit was $5.103 and the purchase price per Class B Unit was $5.093. The Units sold pursuant to the December 2024 Purchase Agreement were issued to the purchasers thereunder on December 31, 2024.

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The Series A Warrants have an exercise price of $13.42 per share of common stock, and, subject to certain beneficial ownership limitations described in the Series A Warrants, will be exercisable six months after issuance and will expire on the earlier of (a) subject to the fulfilment of the Equity Conditions (as defined in the December 2024 Purchase Agreement), thirty Trading Days (as defined in the Purchase Agreement) after the last of the following data readouts to occur, as announced by the Company: (i) Ferret animal model Bird Flu data, (ii) non-human primate Bird Flu data, or (iii) Phase 2a Influenza A human clinical data and (b) the 5-year anniversary of the closing date of the December 2024 Purchase Agreement. The pre-funded warrants have an exercise price of $0.01 per share, and subject to certain beneficial ownership limitations described in the pre-funded warrants, are exercisable and do not expire. The exercise price of the Series A Warrants and pre-funded warrants will be subject to adjustment for stock splits, reverse splits, and similar capital transactions, as described in the Series A Warrants and pre-funded warrants.

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The Company also entered into an agreement with Tungsten Advisors (through its Broker-Dealer, Finalis Securities LLC) (“Tungsten”), pursuant to which Tungsten agreed to serve as exclusive placement agent for the offering. The Company has agreed to pay Tungsten a cash fee equal to 8.25% of the aggregate gross proceeds raised in this offering from certain investors who are not affiliated with the Company and a cash fee equal to 4.125% of the aggregate gross proceeds raised in this offering with respect to certain investors that are affiliates of the Company.

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The net proceeds to the Company from the offering were approximately $18.1 million, after deducting placement agent’s fees and other estimated offering expenses, with approximately $20 million gross proceeds at closing through the sale of shares of common stock and pre-funded warrants and up to another $52.6 million upon exercise of Series A Warrants issued with the offering if exercised in full prior to expiration thereof.

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All of the securities in the offering were sold by the Company. The offering of common stock was made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-273081). The Series A Warrants, pre-funded warrants, and the shares of common stock underlying such warrants were offered in a concurrent private placement pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, as amended, contained in Section 4(2) thereof and/or Regulation D thereunder. On January 14, 2025, as required by the December 2024 Purchase Agreement, the Company filed a registration statement on Form S-3 to register the shares of common stock issuable upon exercise of the Series A Warrants and the pre-funded warrants for resale by the holders thereof, which registration statement was declared effective by the SEC on January 22, 2205.

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As required by the December 2024 Purchase Agreement, the Company obtained stockholder approval of the exercise of the Series A Warrants and pre-funded warrants, as required by Nasdaq rules, at that special meeting of stockholders held on February 17, 2025. Thereafter, certain investors exercised their pre-funded warrants for an aggregate of 1,382,559 shares of common stock.

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On 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.

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On March 27, 2025, the Company and certainthe holders of all outstanding pre-funded warrants issued in the purchasersDecember 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.

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Merger

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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. Pursuant to the Merger Agreement, First Merger Sub merged with and into Trawsfynydd, pursuant to which Trawsfynydd was the surviving corporation (the “First Merger”). Immediately following the First Merger, Trawsfynydd merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity and a wholly owned subsidiary of the Company (the “Second Merger” and together with the First Merger, the “Merger”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

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Under the terms of the Merger Agreement, upon the consummation of the Merger on April 1, 2024 (the “Closing”), in exchange for the outstanding shares of capital stock of Trawsfynydd immediately prior to the effective time of the First Merger, the Company issued to the stockholders of Trawsfynydd an aggregate of (A) 141,982 shares of Common Stock and (B) 10,359.0916 shares of Series C Preferred (as defined and described below). Each share of Series C Preferred converts into shares of common stock, subject to certain conditions and the Beneficial Ownership Limitation (defined below) as set forth in the Certificate of Designation. In addition, the Company assumed all Trawsfynydd stock options immediately outstanding prior to the First Merger, each becoming an option to purchase common stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Options”). The Assumed Options are exercisable for an aggregate of 365,547 shares of common stock. Following the effective time of the Second Merger, the Company changed its name to “Traws Pharma, Inc.”

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The Board approved the Merger Agreement and the related transactions, and the consummation of the Merger was not subject to approval of Company stockholders.

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In accordance with the Merger Agreement, each of Werner Cautreels, Iain Dukes, and Nikolay Savchuk were appointed to the Board effective as of the Closing. In accordance with the Merger Agreement, Werner Cautreels was appointed as Chief Executive Officer of the Company, Iain Dukes was appointed as Executive Chairman of the Company, and Nikolay Savchuk was appointed as Chief Operating Officer of the Company effective as of the Closing.

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Pursuant to the Merger Agreement, the Company agreed to hold a stockholders’ meeting to submit, among other proposals, the following proposals to its stockholders for their consideration: (i) the approval of the conversion of shares of Series C Preferred into shares of Common Stock in accordance with the rules of the Nasdaq Stock Market LLC, the Merger Agreement and the Certificate of Designation (the “Conversion Proposal”) and (ii) the approval of an amendment to the Company’s Certificate of Incorporation (as amended to date, the “Charter”), to increase the authorized shares of common stock from 125,000,000 to 250,000,000 (the “Share Increase Proposal” and together with the Conversion Proposal, the “Meeting Proposals”). In connection with these matters, the Company agreed to file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “SEC”). Such proxy statement was filed on August 9, 2024. At a special meeting of the stockholders held on September 16, 2024, the stockholders approved the Meeting Proposals and, subject to the Beneficial Ownership Limitation, the outstanding shares of Series C Preferred, automatically converted to shares of common stock. After the automatic conversion, there were 7,440 shares of Series C Preferred outstanding. In connection with the increase in common shares outstanding due to the December 2024 Purchase Agreement, certain investors converted an additional 42.45 Series C Preferred shares into an aggregate of 16,980 shares of the Company’s common stock to maintain the Beneficial Ownership Limitation. As of December 31, 2024, 7,398 shares of Series C remained outstanding.

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Support Agreements

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In connection with the execution of the Merger Agreement, the Company and Trawsfynydd entered into stockholder support agreements (the “Company Stockholder Support Agreements”) with certain of the Company’s stockholders (solely in their capacity as stockholders of the Company). Pursuant to the Support Agreements, among other things, each of the Company stockholder parties thereto agreed to vote or cause to be voted all of the shares of common stock owned by such stockholder in favor of the Meeting Proposals.

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In connection with the execution of the Merger Agreement, the Company and Trawsfynydd entered into stockholder support agreements (the “Trawsfynydd Stockholder Support Agreements”) with all of Trawsfynydd’s stockholders (solely in their capacity as stockholders of the Company). Pursuant to the Trawsfynydd Stockholder Support Agreements, among other things, each of the Trawsfynydd stockholders agreed to the terms and conditions of the Merger Agreement, to waive any dissenters’ rights and to release claims such stockholder may have against the Company and Trawsfynydd.

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Lock-up Agreements

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Concurrently and in connection with the execution of the Merger Agreement, certain Trawsfynydd stockholders as of immediately prior to the Closing, and certain directors, officers, and stockholders of the Company as of immediately prior to the Closing entered into lock-up agreements with the Company and Trawsfynydd, pursuant to which each such stockholder agreed to be subject to a 180-day lockup on the sale or transfer of shares of the Company held by each such stockholder at the Closing, including those shares of Common Stock received by each such stockholder in the Merger and Common Stock received upon conversion of Series C Preferred upon Board approval (the “Lock-up Agreements”).

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Contingent Value Rights Agreement

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Concurrently with the Closing of the Merger, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of common stock as of the applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the Merger, is entitled to one contractual contingent value right (each, a “CVR”), subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record time (5:00 p.m. ET on April 15, 2024).

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When issued, each contingent value right will entitle the holder (the “Holder”) thereof to distributions of the following, pro-rated on a per-CVR basis, during the CVR Term (as defined in the CVR Agreement):

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The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-pocket expenses incurred by us.

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Under the CVR Agreement, the Rights Agent has, and Holders of at least 30% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders of the CVRs.

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Private Placement and Securities Purchase Agreement

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On April 1, 2024, the Company entered into the April 2024 Securities Purchase Agreement with TPAV and OrbiMed. Pursuant to the April 2024 Purchase Agreement, the Company issued and sold an aggregate of (i) 19,879 shares of common stock and (ii) 1,578.2120 shares of Series C Preferred (the “Private Investment in Public Equity” or “PIPE Securities”) for an aggregate purchase price of approximately $14 million (collectively, the “Financing”). The closing of the Financing occurred concurrently with the closing of the Merger on April 1, 2024 (the “Financing Closing Date”). Subject to the Beneficial Ownership Limitation (defined below), each share of Series C Preferred converts into shares of common stock, as provided in the Certificate of Designation.

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Registration Rights Agreement

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On April 1, 2024, in connection with the April 2024 Purchase Agreement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the holders of common stock and Series C Preferred signatory thereto. Pursuant to the Registration Rights Agreement, we are required to prepare and file a resale registration statement with the SEC within 90 calendar days following the Financing Closing Date (the “Filing Deadline”), with respect to the shares of common stock underlying the PIPE Securities and the common stock and Series C Preferred issued to the signatories to the Registration Rights Agreement in the Merger. The Company filed such registration statement on July 1, 2024, which was declared effective on August 28, 2024.

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Certificate of Designation

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On April 1, 2024, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series C Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the Merger. The Certificate of Designation provides for the designation of shares of the Series C Preferred. Holders of Series C Preferred are entitled to receive dividends on shares of Series C Preferred equal to, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock.

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Except as otherwise required by law, the Series C Preferred does not have voting rights. However, as long as any shares of Series C Preferred are outstanding, we will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series C Preferred, (i) alter or change adversely the powers, preferences or rights given to the Series C Preferred or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or our bylaws, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series C Preferred, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series C Preferred, (iii) prior to the earlier of stockholder approval of the Conversion Proposal or the six-month anniversary of the Closing, consummate either: (A) any Fundamental Transaction (as in the Certificate of Designation) or (B) any stock sale to, or any merger, consolidation or other business combination with or into, another entity in which our stockholders immediately before such transaction do not hold at least a majority of the capital stock immediately after such transaction, or (iv) enter into any agreement with respect to any of the foregoing.

Removed

The Series C Preferred does not have a preference upon any liquidation, dissolution or winding-up of Traws Pharma. Following stockholder approval of the Conversion Proposal, each share of Series C Preferred automatically converted into 400 shares of common stock (on a post-split basis), subject to certain limitations, including that a holder of Series C Preferred was prohibited from converting shares of Series C Preferred into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 19.9% of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”). The Series C Preferred is redeemable for cash at the option of the holder thereof at any time following the date that is nine months after the initial issuance of the Series C Preferred or following any failure to deliver shares of common stock in accordance with the terms of the Series C Preferred, at a price per share equal to the then-current fair value of the Series C Preferred on an as-converted basis, as described in the Certificate of Designation.

Removed

Certificate of Amendment

Removed

On April 2, 2024, the Company changed its name to “Traws Pharma, Inc.” pursuant to a certificate of amendment to the Charter filed with the Secretary of State of the State of Delaware (the “Name Change”). Pursuant to the Delaware General Corporation Law, a stockholder vote was not necessary to effectuate the Name Change and it does not affect the rights of the Company’s stockholders. In addition, effective at the open of market trading on April 3, 2024, our common stock ceased trading under the ticker symbol “ONTX” and began trading on the Nasdaq Stock Market under the ticker symbol “TRAW”.

Removed

Transaction Costs

Showing the first 60 of 106 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-14 (period ending 2026-06-30) with 10-Q filed 2026-05-15 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

10new paragraphs
0removed paragraphs
1reworded paragraphs
110 → 1,015words in section

New heading “If our stock price continues to remain below $1.00, our common stock may be subject to delisting from The Nasdaq Capital Market, which would materially reduce the liquidity of our common stock and have an adverse effect on our market price.”

New heading “If we elect to implement a reverse stock split to regain compliance with the Nasdaq continued listing requirements, such reverse stock split could have a materially adverse effect on our business.”

New heading “Failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: delist, liquidity
“If our stock price continues to remain below $1.00, our common stock may be subject to delisting from The Nasdaq Capital Market, which would materially reduce the liquidity of our common stock and have an adverse effect on our market price.”
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New text topics: delist
“Failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.”
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New text topics: delist, liquidity
“On July 22, 2026, the SEC, acting under delegated authority, approved a Nasdaq rule change establishing a new continued listing requirement that companies maintain a MVLS of at least $5 million, calculated as the consolidated closing bid price of a company's common stock multiplied by the number of its listed securities. …”
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New text topics: delist, liquidity
“We are currently evaluating our alternatives to resolve the listing deficiency. To the extent that we are unable to resolve the listing deficiency, there is a risk that our common stock may be delisted from Nasdaq, which would adversely impact liquidity of our common stock, potentially result in even lower bid prices for our common stock, and make it more difficult for us to obtain financing through the sale of our common stock.”
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New text topics: delist
“We intend to continue actively monitoring the closing bid price for our common stock between now and January 25, 2027, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. …”
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New text
“If we elect to implement a reverse stock split to regain compliance with the Nasdaq continued listing requirements, such reverse stock split could have a materially adverse effect on our business.”
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Full comparison: every changed paragraph (11)

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Reworded

ThereExcept as set forth below, there have not been any material changes to the risk factors disclosed in the Annual Report.

Added

If our stock price continues to remain below $1.00, our common stock may be subject to delisting from The Nasdaq Capital Market, which would materially reduce the liquidity of our common stock and have an adverse effect on our market price.

Added

On July 29, 2026, we received a notification letter from Nasdaq notifying us that, because the closing bid price for our common stock was below $1.00 per share for at least 30 consecutive business days, we are not currently in compliance with the Minimum Bid Price Requirement for continued listing on The Nasdaq Capital Market. The notification has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market, and, therefore, the Company’s listing remains fully effective.

Added

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days from July 29, 2026 or until January 25, 2027, to regain compliance with the Minimum Bid Price Requirement. If at any time before January 25, 2027, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days (which may be extended to be a period of up to 20 consecutive business days at the discretion of Nasdaq), Nasdaq will provide written notification that we have regained compliance with the Minimum Bid Price Requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending on January 25, 2027, then Nasdaq may grant us a second 180 calendar day grace period to regain compliance, provided we (i) meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and (ii) notify Nasdaq of our intent to cure the deficiency during the second compliance period.

Added

We intend to continue actively monitoring the closing bid price for our common stock between now and January 25, 2027, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.

Added

We are currently evaluating our alternatives to resolve the listing deficiency. To the extent that we are unable to resolve the listing deficiency, there is a risk that our common stock may be delisted from Nasdaq, which would adversely impact liquidity of our common stock, potentially result in even lower bid prices for our common stock, and make it more difficult for us to obtain financing through the sale of our common stock.

Added

If we elect to implement a reverse stock split to regain compliance with the Nasdaq continued listing requirements, such reverse stock split could have a materially adverse effect on our business.

Added

In the event that we are unable to regain compliance with the Minimum Bid Price Requirement through other methods, we may be required to implement a reverse stock split in order to do so. There are a number of risks associated with implementing a reverse stock split, including, without limitation:

Added

There can be no assurances that implementation of a reverse stock split would allow us to prevent the delisting of our common stock, and it could have a materially adverse effect on our business.

Added

Failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.

Added

On July 22, 2026, the SEC, acting under delegated authority, approved a Nasdaq rule change establishing a new continued listing requirement that companies maintain a MVLS of at least $5 million, calculated as the consolidated closing bid price of a company's common stock multiplied by the number of its listed securities. Unlike many other Nasdaq deficiencies, the standard would provide no cure or compliance period: a company whose MVLS remains below $5 million for 30 consecutive business days would become immediately subject to suspension and delisting, and a request for a hearing would not stay the suspension of trading. On July 29, 2026, following the filing of notices of intention to petition for SEC review, the approval order was automatically stayed under Rule 431(e) of the SEC's Rules of Practice, and the new MVLS requirement is therefore not currently effective; we cannot predict whether, when, or in what form it may become effective. If the requirement becomes effective in its current or a similar form, we may face a heightened risk of delisting, particularly in light of the recent trading price of our common stock and our existing non-compliance with the Minimum Bid Price Requirement, and any resulting suspension or delisting would materially reduce the liquidity of our common stock, adversely affect its market price, and make it more difficult for us to raise capital, any of which could have a material adverse effect on our business, financial condition and results of operations

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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5,183 → 6,032words in section

New heading “Influenza Program Regulatory Developments”

New heading “Arbitration Ruling”

New heading “Nasdaq Compliance”

New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”

New heading “Research and development expenses”

New heading “General and administrative expenses”

Removed heading “April 2026 Financing”

Removed heading “Pro Forma Impact of the April 2026 Financing”

Removed heading “Unaudited Pro Forma Balance Sheet”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: delist
“On July 22, 2026, the SEC, acting under delegated authority, approved a Nasdaq rule change establishing a new continued listing requirement that companies maintain a Market Value of Listed Securities (“MVLS”) of at least $5 million, calculated as the consolidated closing bid price of a company’s common stock multiplied by the number of its listed securities. …”
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New text topics: delist
“We intend to continue actively monitoring the closing bid price for our common stock between now and January 25, 2027, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. …”
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New text
“Comparison of the Six Months Ended June 30, 2026 and 2025”
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Removed text
“Pro Forma Impact of the April 2026 Financing”
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New text
“Influenza Program Regulatory Developments”
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New text topics: investigation
“On June 12, 2026, we announced that the planned test of tivoxavir marboxil in a Phase 2a human influenza challenge study had been deferred following a negative review of the program by the MHRA. On June 22, 2026, we announced that, based on further feedback and guidance from the MHRA, we are developing an updated toxicology data package that we expect to resubmit to the MHRA during the third quarter of 2026 to enable the study to proceed, with a formal MHRA response anticipated within 30 days of resubmission. Separately, the FDA informed us that our U.S. …”
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Full comparison: every changed paragraph (48)

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Reworded

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with interim unaudited condensed consolidated financial statements contained in Part I, Item 1 of this quarterly report on Form 10-Q (this “Quarterly Report”), and the audited consolidated financial statements and notes thereto for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our annualAnnual reportReport on Form 10-K10-K, as amended, for the year ended December 31, 2025, filed with the SEC on April 15, 2026 (“Annual Report”). As used in this Quarterly Report, unless the context suggests otherwise, the “Company,” “we,” “us,” “our,” “Traws” or “Traws Pharma” refers to Traws Pharma, Inc. and its consolidated subsidiaries.

Reworded

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $3.1$5.0 million and an accumulated deficit of $647.1$650.1 million. 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. Based on current projections, we do not have sufficient cash and cash equivalents as of the date of this Quarterly Report to support our operations for at least the 12 months following the date that the condensed consolidated financial statements included herein are issued. 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.

Reworded

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. 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. 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. 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. In January 2026, we announced plans to progress an additional indication for TXM as a monthly oral tablet for prophylaxis of seasonal influenza, supported by Phase 1 exposure observations from an earlier capsule formulation and formulation work indicating that a compressed tablet may provide extended coverage; we also announced that a time slot was secured for a human influenza prophylaxis human challenge trial targeted for June 2026, contingent on completion of a planned bridging healthy volunteer study. On June 12, 2026, we announced that the planned challenge study was deferred following a negative review of the program by the UK’s Medicines and Healthcare products Regulatory Agency ("MHRA"). On June 22, 2026, we announced that, based on further MHRA feedback, we are developing an updated toxicology data package that we expect to resubmit during the third quarter of 2026 to enable the study to proceed, with a formal MHRA response expected within 30 days of resubmission. There can be no assurance that the MHRA will accept the updated data package, that the challenge study will proceed, or as to the timing thereof. Separately, FDA informed the Company that its US IND for tivoxavir marboxil was being placed on clinical hold due to concerns with the toxicology data package. The Company is actively engaging with the FDA to address the clinical hold and is working to develop and submit a comprehensive response, with the goal of resolving the hold and advancing the program in the USU.S. by the end of 2026.

Reworded

TRX01 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. 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.HREC. 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. 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. There were few recorded adverse eventsAEs 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 eventsAEs 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.

Reworded

TRX01 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. 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. 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. 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 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. 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. 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. 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. 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®. 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.-arm. Interim results also showed activity in PAXLOVID® -eligible patients. On January 13, 2026, we reported interim data in a larger sample of 50 patients, suggesting faster time to sustained symptom resolution for ratutrelvir versus PAXLOVID®, continued no rebounds with ratutrelvir, and consistent safety/benefit signals in PAXLOVID®-eligible patients. On January 26, 2026, we announced the completion of enrollment of our ongoing 90-patient, open-label Phase 2 study of ratutrelvir versus PAXLOVID® in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID®-ineligible subjects. In February 2026, we announced completion of the clinical analysis of the 90-patient, open-label Phase 2 study of ratutrelvir versus PAXLOVID®, together with a single arm in PAXLOVID®-ineligible subjects. We reported that completed clinical results confirmed a differentiated profile versus PAXLOVID® with fewer adverse events and no viral rebounds and equivalent time to sustained symptom resolution, and that results were recapitulated in PAXLOVID®-ineligible patients. In the PAXLOVID®-ineligible population specifically, we reported fewer treatment-related adverse events (3 events in 30 subjects; 10%) versus PAXLOVID® (7 events in 30 subjects; 23.3%) and faster symptom resolution compared to PAXLOVID® treatment (HR 1.31; 95% CI 0.78-2.20; p=0.018).

Added

Influenza Program Regulatory Developments

Added

On June 12, 2026, we announced that the planned test of tivoxavir marboxil in a Phase 2a human influenza challenge study had been deferred following a negative review of the program by the MHRA. On June 22, 2026, we announced that, based on further feedback and guidance from the MHRA, we are developing an updated toxicology data package that we expect to resubmit to the MHRA during the third quarter of 2026 to enable the study to proceed, with a formal MHRA response anticipated within 30 days of resubmission. Separately, the FDA informed us that our U.S. investigational new drug application for tivoxavir marboxil was placed on clinical hold. We are engaging with the FDA to address the clinical hold and intend to submit a comprehensive response, with the goal of resolving the hold and advancing the program in the United States.

Added

There can be no assurance that the MHRA will accept the updated data package, that the FDA clinical hold will be resolved, that the affected studies will proceed, or as to the timing of any of the foregoing. See “—Our Portfolio/ Product Candidates/ Compounds” above and “Item 1A. Risk Factors” in Part II of our Annual Report for additional information regarding these developments and the related risks.

Added

Arbitration Ruling

Added

In July 2026, the arbitration proceeding relating to the claims asserted by Dr. Steven M. Fruchtman was resolved in our favor pursuant to a final award issued under the auspices of the American Arbitration Association, which denied in full the claims asserted against us. As a result, we do not expect to incur any liability, including any severance or change in control payments, in connection with that matter, and no loss contingency has been recorded with respect to this matter as of June 30, 2026. See Note 5, Commitments and Contingencies, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report.

Added

Nasdaq Compliance

Added

On July 29, 2026, we received a notification letter from the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, because the closing bid price for our common stock was below $1.00 per share for at least 30 consecutive business days, we are not currently in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The notification has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market, and, therefore, the Company’s listing remains fully effective.

Added

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days from July 29, 2026 or until January 25, 2027, to regain compliance with the Minimum Bid Price Requirement. If at any time before January 25, 2027, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days (which may be extended to be a period of up to 20 consecutive business days at the discretion of Nasdaq), Nasdaq will provide written notification that we have regained compliance with the Minimum Bid Price Requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending on January 25, 2027, then Nasdaq may grant us a second 180 calendar day grace period to regain compliance, provided we (i) meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and (ii) notify Nasdaq of our intent to cure the deficiency during the second compliance period.

Added

We intend to continue actively monitoring the closing bid price for our common stock between now and January 25, 2027, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.

Added

On July 22, 2026, the SEC, acting under delegated authority, approved a Nasdaq rule change establishing a new continued listing requirement that companies maintain a Market Value of Listed Securities (“MVLS”) of at least $5 million, calculated as the consolidated closing bid price of a company’s common stock multiplied by the number of its listed securities. Unlike many other Nasdaq deficiencies, the standard would provide no cure or compliance period: a company whose MVLS remains below $5 million for 30 consecutive business days would become immediately subject to suspension and delisting, and a request for a hearing would not stay the suspension of trading. On July 29, 2026, following the filing of notices of intention to petition for SEC review, the approval order was automatically stayed under Rule 431(e) of the SEC’s Rules of Practice. Accordingly, the new MVLS requirement is not currently in effect, and there can be no assurance as to whether or when the stay will be lifted or the rule will become effective. If the stay is lifted and the rule becomes effective, and if we fail to satisfy its requirements, Nasdaq may commence delisting procedures against the Company, regardless of the Company’s compliance with the Nasdaq Minimum Bid Price Requirement. See “Risk Factors – Failure to maintain compliance with Nasdaq’s continued listing requirements could result in delisting of our common stock” in Part II of this Quarterly Report.

Removed

April 2026 Financing

Removed

In April 2026, we completed a financing transaction, for aggregate gross proceeds of up to $60.0 million (the "April 2026 Financing"). The April 2026 Financing consisted of (i) $10.0 million of upfront gross proceeds at closing from the sale of 5,982,919 shares of our common stock (including pre-funded warrants in lieu thereof), (ii) the issuance of milestone-based warrants with an aggregate exercise price of $10.0 million that becomes exercisable upon receipt of approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") to conduct the human challenge trial in the UK, (iii) the issuance of additional milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable upon shareholder approval and the announcement of data from the human challenge trial and (iv) the issuance of common warrants, subject to shareholder approval, with a three-year term to purchase shares of our common stock, providing potential additional gross proceeds of $30.0 million if fully exercised. The milestone-based warrants and the common warrants each have an exercise price equal to the per share purchase price in the April 2026 Financing. The common warrants are subject to a forced exercise provision if the trading price of our common stock equals or exceeds 200% of the applicable exercise price for 30 consecutive trading days. The milestone-based warrants become exercisable only upon achievement of the applicable milestone conditions, and there can be no assurance that we will receive any additional proceeds from the exercise of the milestone-based warrants or the common warrants, or as to the timing thereof.

Removed

At close, we paid transaction costs including a cash success fee equal to 6% of the upfront gross proceeds, and we intend to use the net proceeds for working capital and general corporate purposes, including funding our clinical and regulatory activities.

Reworded

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Added

Revenue was $0 for the three months ended June 30, 2026, compared to $2,733,000 for the three months ended June 30, 2025. Effective April 17, 2025, the Company and Symbio Pharmaceuticals Limited (“Symbio”) mutually terminated the license agreement originally entered into by and between the parties in 2011.

Reworded

Research and development expenses increaseddecreased by $2.4$1.2 million, or 96%,52%, to $4.9$1.1 million for the three months ended MarchJune 31,30, 2026 from $2.5$2.3 million for the three months ended MarchJune 31,30, 2025. This increasedecrease was primarily relatedattributable to a $2.2$0.8 million increasedecrease in virology expenses due to ourlower ongoingspending development activities for ratutrelvir, tivoxavir marboxil, and TRX01, including the completion ofon our Phase 2a clinical trial for ratutrelvir and the initiation of a bridging study for tivoxavir marboxil in March 2026program and a $0.5 million increase in stock based compensation expenses, partially offset by a $0.2$0.4 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets and a $0.1 million decrease in personnel expenses.assets.

Reworded

General and administrative expenses decreasedincreased by $0.8$1.8 million, or (26)%,106%, to $2.0$3.5 million for the three months ended MarchJune 31,30, 2026 from $2.8$1.7 million for the three months ended MarchJune 31,30, 2025.

Added

Other operating income of $1.4 million consists of the removal of a legacy accrued research and development obligation, which was initially recognized in a prior reporting period. During the second quarter of 2026, we concluded that the accrued liability was no longer probable of settlement and that no future cash outflows related to the obligation were expected. Because the amount was originally recorded as research and development expense, its removal is presented within operating expenses rather than as non-operating income. No such income was recognized in the three months ended June 30, 2025.

Added

Change in fair value of warrant liability during the three months ended June 30, 2026 and 2025 was $0.2 million and $0.1 million, respectively.

Added

Comparison of the Six Months Ended June 30, 2026 and 2025

Added

Revenue was $0 for the six months ended June 30, 2026, compared to $2,790,000 for the six months ended June 30, 2025. Effective April 17, 2025, the Company and Symbio mutually terminated the license agreement originally entered into by and between the parties in 2011.

Added

Research and development expenses

Added

The details of our research and development expenses are:

Added

Research and development expenses increased by $1.2 million, or 25%, to $6.0 million for the six months ended June 30, 2026 from $4.8 million for the six months ended June 30, 2025. This increase was primarily related to a $1.5 million increase in virology expenses due to our ongoing development activities for Ratutrelvir and tivoxavir marboxil, including the completion of our Phase 2a clinical trial for ratutrelvir and the initiation of a bridging study for tivoxavir marboxil in March 2026 and a $0.4 million increase in stock-based compensation expenses, partially offset by a $0.6 million decrease in oncology expenses as we continue to pursue strategic partnerships for our oncology assets.

Added

General and administrative expenses

Added

General and administrative expenses increased by $1.1 million, or 24%, to $5.5 million for the six months ended June 30, 2026 from $4.4 million for the six months ended June 30, 2025.

Added

Other operating income of $1.4 million consists of the removal of a legacy accrued research and development obligation, which was initially recognized in a prior reporting period. During the second quarter of 2026, we concluded that the accrued liability was no longer probable of settlement and that no future cash outflows related to the obligation were expected. Because the amount was originally recorded as research and development expense, its removal is presented within operating expenses rather than as non-operating income. No such income was recognized in the six months ended June 30, 2025.

Reworded

Change in fair value of warrant liability during the threesix months ended MarchJune 31,30, 2026 was $0.2$0.1 million. Change in fair value of warrant liability of $26.5$26.7 million during the threesix months ended MarchJune 31,30, 2025 represents the remeasurement of the warrant liability upon amendment of the pre-funded and Series A Warrants, whereas the previously liability-classified warrants were reclassified to permanent equity, the exercise of pre-funded warrants, and the remaining Series A Warrants as of MarchJune 31,30, 2025.

Reworded

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $3.1$5.0 million, an accumulated deficit of $647.1$650.1 million, and a working capital deficit of $7.9$0.7 million. Since inception, we have experienced negative cash flows from our operations and expect to continue to incur significant expenses in connection with our ongoing activities.

Reworded

In April 2026, we completed the April 2026 Financing. The April 2026 Financing consisted of (i) $10.0 million of upfront gross proceeds at closing from the sale of shares of our common stock (or 989,507 pre-funded warrants in lieu thereof), (ii) a milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable upon receipt of approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") to conduct the human challenge trial in the UK, (iii) a second milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable upon shareholder approval and the announcement of data from the human challenge trial and (iv) common warrants, subject to shareholder approval, with a three-year term to purchase shares of our common stock, providing potential additional gross proceeds of $30.0 million if fully exercised.

Reworded

Based on our current projections, as of the date of this Quarterly Report, we believe that our existing cash and cash equivalents, together with the net proceeds received at closing from the April 2026 Financing, will not be sufficient to fund our operating requirements for at least the 12 months following the date that the consolidated financial statements included herein are issued. 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.

Reworded

The following table summarizes the Company’s cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

Reworded

Net cash used in operating activities was $2.6$10.1 million for the threesix months ended MarchJune 31,30, 2026, which consisted of net loss of $7.1$10.2 million, non-cash charges, partially offset by $0.8$1.5 million of non-cash charges primarily attributable to stock-based compensation, and a $4.1 million change in operating assets and liabilities.compensation. Significant changes in operating assets and liabilities included a decrease in accrued expenses related to the removal of our legacy accrued research and development obligation, which was partially offset by an increase in accounts payable due to timing of invoices and payments to our vendors,vendors whichand wasa partially offset by net decreasesdecrease in prepaid expenses and other assets.receivables.

Reworded

Net cash used in operating activities was $5.4$11.4 million for the threesix months ended MarchJune 31,30, 2025, which consisted of non-cash charges of $26.4 million primarily attributable to the change in fair value of warrant liability of $26.5$26.7 million and stock-baseda compensation$5.6 ofmillion $0.2change million,in operating assets and liabilities, partially offset by net income of $21.5$20.6 million and a $0.6 million change in operating assets and liabilities.million. Significant changes in operating assets and liabilities included a net decrease in accounts payablepayable, accrued expenses, and accrueddeferred expensesrevenue of $1.2$6.9 million due to timing of invoices and payments to our vendors, which was partially offset by net decreases in prepaid expenses and other assets and receivables of $0.7$1.3 million.

Reworded

Net cash provided by financing activities was $1.9$11.3 million for the threesix months ended MarchJune 31,30, 2026, and was attributable to the$10.0 million of upfront proceeds from April 2026 Financing and $2.0 million of proceeds received from the sale of shares of our common stock under our ongoingthe At The Market equity offering, offered pursuant to that certain At Thethe Market Offering Agreement, dated March 10, 2025,2025 by and between the Company and Citizens JMP Securities, LLC (“Citizens”) (the “ATM Agreement”), pursuantpartially tooffset whichby the Company may offer and sell sharespayment of itsoffering 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.costs.

Added

Net cash provided by financing activities was $3.1 million for the six months ended June 30, 2025, and was attributable to the net proceeds received from the sale of shares of our common stock under the ATM Agreement and proceeds from exercised warrants, partially offset by the payment of offering costs.

Reworded

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. We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that, currently, our non-cancelable obligations under these agreements are not material. 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 from ourthis Quarterly Report on Form 10-Q are issued. These conditions raise substantial doubt about our ability to continue as a going concern through the one-year period after the date that the financial statements are issued.

Removed

Pro Forma Impact of the April 2026 Financing

Removed

The following financial information has been developed by application of pro forma adjustments to the historical financial statements of the Company appearing elsewhere in this Quarterly Report. The unaudited pro forma information gives effect to the 2026 private placement.

Removed

The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do they purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Quarterly Report.

Removed

Unaudited Pro Forma Balance Sheet

Removed

The unaudited pro forma balance sheet as of March 31, 2026 gives effect to an assumed $10.0 million gross equity financing completed after March 31, 2026. Offering costs are assumed to be $0.6 million (6% of gross proceeds) and are reflected as a reduction of additional paid-in capital in accordance with U.S. GAAP. No proceeds from warrant exercises are reflected.

Reworded

This Management’s Discussion and Analysis of our Financial Condition and Results of Operations is based on our interim unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, stock-based compensation, and the contingent value rights. 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. Actual results may differ from these estimates under different assumptions or conditions. As of MarchJune 31,30, 2026, there have been no significant changes in our critical accounting policies and estimates as discussed in our Annual Report.

TRAW insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 597,729 shares, about $998.2K) and open-market sales in 0 filings. Net open-market shares: 597,729 (purchases minus sales); net value about $998.2K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-04-16Orbimed Capital Gp Viii Llc
10% owner
Open-market purchase 597,729$1.67 $998.2K1,203,250 SEC

Well-known investors holding TRAW (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Two Sigma Investments COM NEW2026-06-3019,244$35.2K—Sold out

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when TRAW files, watchlists and downloadable comparisons.