TRAW 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• 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…

• 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 pa…

• 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 specificall…

• 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 develop…

• 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.

相对上期删除的文字 · 来源: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

• 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…

• 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-fun…

• 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 m…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• 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 pa…

相对上期删除的文字 · 来源: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…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

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

• 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.

• 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 o…

• 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…

相对上期删除的文字 · 来源:10-Q · 2026-05-15

• There have not been any material changes to the risk factors disclosed in the Annual Report.