TRAW — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• ●Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease (also known as 3CL protease) of the SARS-CoV-2 virus, the causative agent in COVID-19. The main

• protease is an essential component in the mechanism for SARS-CoV-2 replication. TRX01 is intended to inhibit this protease and reduce SARS-CoV-2 virus replication. In vitro laboratory tests that measured the impact of TRX01 on SARS-CoV-2 replication, demonstrated that TRX01 inhibited the replication…

• 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…

• 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…

• 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 c…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• ●Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease (also known as 3CL protease) of the SARS-CoV-2 virus, the causative agent in COVID19. The main protease is an essential component in the mechanism for SARS-CoV-2 replication. TRX01 is intended to in…

• 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…

• ●Narazaciclib is our oral CDK4-plus inhibitor intended initially to treat breast, endometrial and other cancers. Narazaciclib is a multi-targeted kinase inhibitor targeting multiple CDK’s, AMP-activated protein kinase (“AMPK”), related protein kinase 5 (“ARK5”), and colony-stimulating factor 1 recep…

• 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 da…

• Narazaciclib is also being developed in greater China, under a 2017 license agreement between our company and HanX. The development in greater China is entirely sponsored by HanX. The compound is being studied in China in a clinical trial of patients with Grade III and IV glioma.

Text added vs the prior filing · source: 10-Q · 2026-05-15

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control …

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• future conditions. Projections of any evaluation of the effectiveness of controls to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.

• Our management, with the participation of our principal executive and principal financial officers, evaluated any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our most recently complete…

• As previously disclosed in Item 9A of our Annual Report, management identified material weaknesses in our internal control over financial reporting due to the fact that our controls were not effectively updated and implemented to reflect the changes in processes and staffing as a result of the Merge…

• As of September 30, 2025, we have made progress against the remediation plan that we previously disclosed under Item 9A. Controls and Procedures in our Annual Report. In furtherance of such remediation efforts, we have engaged various consultants with finance and accounting experience; taken steps t…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• For a description of our material pending legal proceedings, please see Note 5, Commitments and Contingencies, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report. We may, in the

• ordinary course of business, face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• For a description of our material pending legal proceedings, please see Note 6, Commitments and Contingencies, to our unaudited condensed consolidated financial statements included in Part I of this Quarterly Report. We may, in the ordinary course of business, face various claims brought by third pa…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.

• Any disruption in the operations of the U.S. government, including as a result of the recent prolonged shutdown or future temporary or prolonged shutdowns resulting from the failure of Congress to enact appropriations bills or raise the federal debt ceiling, could materially and adversely affect our…

• Additionally, a prolonged or future shutdown of the U.S. federal government could materially impact the operations of the SEC. For example, the SEC announced that during the recent U.S. federal government shutdown, it would not review or declare registration statements effective. In the event of an …

• Government shutdowns, if prolonged, can significantly impact the ability of government agencies upon which rely, such as the FDA and SEC, to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Even the threat of a government shutdown or p…

• Federal budget and debt-ceiling disputes may adversely affect capital markets and our financing activities.