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Traws Pharma, Inc.
8/14/2025
Incorporated's second quarter 2025 financial results and business update call. At this time, all participants are in listening mode. Following management's prepared remarks, we'll hold a question and answer session. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, August 14th, 2025. At this time, I'd like to turn the call over to John Frentz of LifeSci Advisors.
Thank you, Operator, and welcome everyone to TRAS Pharma's second quarter 2025 financial results and business update conference call. This morning, TRAS issued a press release reporting its second quarter 2025 financial results and provided a business update. If you have not yet seen this press release, it is available in the investor relations section of the company's website. Following my introduction, we will hear from TRAS Interim Chief Executive Officer, Dr. Ian Dukes, Chief Science Officer, Dr. David Pauza, Chief Medical Officer, Dr. Robert Redfield, and Interim Chief Financial Officer, Charles Parker. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, TRAS disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. For more information on forward-looking statements, please review the disclaimer in this morning's press release and the risk factors in the company's SEC filings. With that, I will now turn the call over to TRAS interim CEO, Dr. Ian Dukes.
Thanks, John, and thanks to everyone for joining us today. Trousers made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. This morning, we announced that we have reprioritized our clinical trial plans to reflect potential short- and medium-term shareholder value with the following actions. In our COVID program, we have submitted to Human Research Ethics Committee, HRAC, a Phase II study of racutrelvir, a potential best-in-class retronavir-3 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 propose to evaluate in a single-arm study the effects of rachytralvia in Paxlovid-ineligible patients who represent a significant vulnerable population with few treatment options. Our expectation is to be able to report results from these phase two studies by year-end 2025. Importantly, in second quarter of 2025, Pfizer reported $427 million in sales of Paxlovid, representing a 70% increase compared to the same period in the prior year. For the influenza program, we'll continue our constructive discussions with the Biomedical Advanced Research and Development Authority, or BARDA, regarding the inclusion of Tivoxavir and Marboxyl, or TXM, in the drug stockpiling initiative for influenza, including birth flu. We believe that this represents the major short and 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 CDC, which continues to monitor for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase II study incorporating bird flu-infected subjects would be low, and initiation of the 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 II bird flu seasonal flu protocol by both 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 rates of bird flu increase. I'll now hand over the call to our Chief Scientific Officer, Dr. David Porter, and our Chief Medical Officer, Dr. Robert Redfield, for more detailed comments on our COVID program. David?
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