Traws Pharma reports Q2 EPS (11c) vs. ($20.52) last year

Reports Q2 revenue $2.7M vs. $57,000 last year. “Traws has made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. We have reprioritized our clinical trial plans to reflect potential short and medium-term shareholder value with the following actions”, said Iain D. Dukes, CEO. “In our COVID program, we have submitted to Human Research Ethics Committee a Phase 2 study of ratutrelvir, a potential best in class ritonavir-free agent, in newly-diagnosed COVID patients versus PAXLOVID to evaluate safety and efficacy, as well as rates of disease rebound and incidence of Long COVID development. Separately, we have proposed to evaluate ratutrelvir in a single-arm study in PAXLOVID-ineligible patients, who represent a significant vulnerable population with few treatment options. Our expectation is to be able to report the results of these Phase 2 studies by year-end 2025. Importantly, in second quarter 2025, Pfizer reported $427 million in sales for PAXLOVID, representing a 70% increase compared to the same period in the prior year. For the influenza program, we will continue our constructive discussions with the Biomedical Advanced Research and Development Authority regarding the inclusion of TXM in the drug stockpiling initiative for influenza, including bird flu. We believe that this represents the major short-to- medium-term commercial potential for this program. While H5N1 influenza is widespread in poultry and dairy herds, with several recent human cases in farm workers, it has not progressed to date in the U.S. at rates feared for a near-term potential pandemic. The current health risk has been determined to be low by the Centers for Disease Control and Prevention, which continues to monitor for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects would be low and initiation of this study has been deferred. During a Type D meeting, the FDA reaffirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. 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.”