Traws Pharma, Inc. (TRAW) Q2 2025 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the Traws Pharma, Inc. Second Quarter 2025 Financial Results and Business Update Call. [Operator Instructions] As a reminder, this call is being recorded today, August 14, 2025. At this time, I'd like to turn the call over to John Fraunces of Lifesci Advisors.

Thank you, operator, and welcome, everyone, to Traws Pharma's Second Quarter 2025 Financial Results and Business Update Conference Call. This morning, Traws 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 on the Investor Relations section of the company's website. Following my introduction, we will hear from Traw's Interim Chief Executive Officer, Dr. Iain Dukes; Chief Science Officer, Dr. David Pauza; Chief Medical Officer, Dr. Robert Redfield; and Interim Chief Financial Officer, Charles Parker. Before we begin, I would 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, Traws 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 Traw's Interim CEO, Dr. Iain Dukes.

Thanks, John, and thanks to everyone for joining us today. Traws has 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, HREC, a Phase II 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 instance of Long COVID development. Separately, we proposed to evaluate in a single-arm study, the effects of ratutrelvir 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 II 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 marboxil, or TXM, in the drug stockpiling initiative for influenza, including bird flu. We believe that this represents a 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 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 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 Pauza Porter; and our Chief Medical Officer, Dr. Robert Redfield, for more detailed comments on our COVID program. David?

Thank you, Iain. COVID-19 continues to be a major public health threat due to the evolution and rapid spread of new viral variants. Today, 6 major variants are spreading in the United States and the NB.1.8.1 variant, first appearing in April of this year, is already responsible for more than 40% of infections nationwide. The speed at which new variants arise and increase within the population tells us that the virus is spreading at a high rate and retains potential for causing severe disease. As vaccine immunity declines overall, increases in the rate of virus spread are increasingly likely. Effective antiviral drugs may now be the best option for managing COVID-19. Ratutrelvir is an investigational main protease inhibitor, developed and tested by Traws Pharma, has proven to be effective against all viral variants tested so far in preclinical studies and is expected to retain potency against existing and anticipated viral variants. We are now advancing ratutrelvir into Phase II clinical studies to accelerate its entry into the marketplace. Ratutrelvir is designed for use without ritonavir, a booster compound used to increase the effectiveness of PAXLOVID because ritonavir interferes with a number of commonly prescribed medications. Consequently, many patients seeking treatment for COVID-19 are ineligible to take PAXLOVID and need a safe alternative. Ratutrelvir was well tolerated in Phase I clinical studies, where we evaluated a once-daily oral dose for 10 consecutive days. The longer treatment interval is intended to eliminate the virus and prevent rebound, which is experienced by many individuals with or without treatment for COVID-19. We've applied for permission to conduct a Phase II clinical trial in patients with COVID-19, including those people eligible for PAXLOVID and people who are ineligible for PAXLOVID. By demonstrating ratutrelvir's benefit in COVID-19 patients, we expect to address the estimated $1.5 billion annual market opportunity of individuals who are seeking treatment but are ineligible for PAXLOVID and to demonstrate the multiple benefits of ratutrelvir therapy. Dr. Redfield, would you like to add comments?

Thanks, Dave. COVID-19 has become a nearly year-round public health problem with multiple peaks of infection throughout the year. Current treatments have significant limitations. For example, PAXLOVID includes the addition of ritonavir, a pharmacokinetic enhancer that can result in significant drug-drug interactions, limiting its use in many elderly patients on certain anticoagulants. Treatment is also complicated by the high rate of COVID rebound and the development of a prolonged post-infection symptoms known as Long COVID. Unfortunately, COVID vaccines do not effectively prevent infection. As a consequence, viral transmission continues unchecked in the community, whether or not vaccines are used. Many infected individuals do not seek treatment because they've heard of the unpleasant or only partially effective PAXLOVID and they're not able to take PAXLOVID due to drug-drug interactions caused by ritonavir. Traws Pharma answer is ratutrelvir, a new investigational drug that does not require ritonavir to reach its therapeutic levels and can be taken for 10 days instead of the 5 days recommend for PAXLOVID. Ratutrelvir treatment may expand access for all patients to receive COVID-19 therapy. We are hopeful that the longer duration will result in more complete elimination of the virus and will prevent vial rebounds and hopefully reduce the incidence of Long COVID. Traws Pharma is committed to providing broader access to COVID therapeutics that include the treatment and the prevention of Long COVID. Long COVID currently affects more than 15 million people in the United States. It can cause or reduce significant disability and reduce the quality of life. Ratutrelvir was designed specifically to address these factors that may contribute to Long COVID. Therefore, including the possibility for the virus to linger in the body after current treatments are completed. Our overall goal is to provide the best COVID-19 therapy for the greatest number of people while reducing the threat of Long COVID. Iain?

Thank you, Bob. Turning to our influenza program. Dr. Pauza and Dr. Redfield have the following observations. David?

Well, thank you, Iain. Seasonal influenza has a severe public health impact in the U.S. However, looking behind the risk for seasonal disease is a larger problem of influenza spreading in wild birds and mammals where the virus is evolving rapidly and in unpredictable ways. The current global outbreak of avian influenza or bird flu caused massive die-offs of birds and marine mammals throughout the world, impacted milk production in dairies and wiped out many poultry operations. Bird flu also poses an extreme risk to human beings. The history of human bird flu dating back 3 decades or more showed more than 50% of reported infections were fatal. Thus, bird flu is a very high-risk agent and only a few changes in the virus already present in animals are needed to allow for more efficient spread within the human population. In response to this threat, Traws Pharma developed and tested tivoxavir marboxil, an investigational oral drug intended to be taken once after infection for treatment and prevention of bird flu. The bird flu virus, circulating currently in wild and domestic animals, is rewriting the books on lethal influenza. This virus grows faster than seasonal influenzas and has extraordinary capacity to kill all animal species where it has been tested. The high viral growth rate renders it less susceptible to common influenza therapies and requires the specific development of treatments targeting this bird flu threat. Tivoxavir marboxil was evaluated in human clinical studies using dose levels that are predicted based on our animal studies to be effective for treating bird flu. Tivoxavir marboxil is safe and produce blood drug levels that might control virus for 21 days or longer after a single dose. Traws Pharma believes that tivoxavir marboxil is the first influenza therapy developed specifically for bird flu and it was designed to overcome the extraordinary challenges of a highly virulent influenza virus. Dr. Redfield?

As the former Director for the United States Center for Disease Control and Prevention and a lifelong infectious disease physician, I understand the need to promote health measures for the current threats and to be prepared for high-risk emerging diseases. We believe that avian H5N1 virus is one of the great threats to public health and must be addressed with serious preparedness measures, including stockpiling effective treatments. A highly infectious influenza that cannot be effectively treated with current medications poses an extreme risk to the U.S. population. We strongly believe that new measures are required to prepare for an H5N1 outbreak and that Traws Pharma is advancing tivoxavir marboxil as a valuable option. Imagine how much suffering could have been prevented if we had had a national drug stockpile that could contain the right kind of COVID-19 drugs and enough of it to prevent the spread in death within the United States. While COVID-19 was unexpected, the global spread of H5N1 virus among animals presents a clear risk for viral adaptation and efficient human-to-human transmission. With the known potential -- lethal potential of H5N1 in humans, a human adapted H5N1 outbreak could be catastrophic. Traws Pharma is advancing tivoxavir marboxil to support a national strategy for preparing to confront an outbreak of H5N1 influenza. Importantly, the target of tivoxavir marboxil, a viral protein called cap-dependent endonuclease is an essential component of the influenza virus replication and is highly conserved among all influenza virus types. Whether pandemic threats arise from H5N1 or almost any other type of influenza virus, it is likely that tivoxavir marboxil will retain activity and be effective in treating and possibly preventing the threat of pandemic influenza. Traws Pharma is engaged with the U.S. Food and Drug Administration, or the FDA, and the Biomedical Advanced Research and Development Authority, or BARDA, regarding the development of tivoxavir marboxil as a national -- for the national stockpile. The FDA has commented on the design of the clinical trials for proceeding with tivoxavir marboxil development and BARDA has provided advice regarding drug development for pandemic preparedness. We continue our interactions with these agencies as part of our overall effort to provide an effective countermeasure to the risk of pandemic influenza. Iain?

Thank you, Bob. Before we review our financial results, I will make a few remarks on our legacy on quality assets comprised of 2 unique kinase inhibitors, rigosertib and narazaciclib. Traws' strategic objectives for these programs is to establish value-creating partnerships. In the second quarter, we published compelling efficacy data for rigosertib in a rare disease called recessive dystrophic epidermolysis bullosa associated local advanced or metastatic squamous cell carcinoma, or RDEB. In the study, rigosertib demonstrated a compelling overall response rate of 80% with complete responses in 50% of evaluable patients and good overall tolerability. These data suggest rigosertib as a potential treatment for RDEB SCC where there's substantial unmet need and no approved therapies. We're excited by the compelling efficacy and tolerability of rigosertib in this rare disease, and we're committed to finding an appropriate partner to advance this important potential medicine to approval. I will now ask our Interim CFO, Charles Parker, to review our financial results. Charles?

Thanks, Iain. This morning, Traws issued a press release for the quarter ended June 30, 2025. I'll refer you to our recent 10-Q filing for a review of the full financial statements. You can also access the press release and the 10-Q on our website. Turning to our financials. As of June 30, 2025, Traws had cash, cash equivalents and short-term investments of approximately $13.1 million compared to $21.3 million as of December 31, 2024. Moving through our second quarter 2025 financial results. Revenue for the quarter ended June 30, 2025, was $2.7 million compared to $57,000 for the same period in 2024. The increase is attributable to $2.7 million in deferred revenue, recognized as revenue in the second quarter, related to mutual termination of a licensing agreement associated with our legacy oncology program in April of this year. Research and development expense for the second quarter in 2025 totaled $2.3 million compared to $4 million for the comparable period in 2024. The decrease of $1.7 million primarily relates to a decrease in expenses of our oncology program and a decrease in personnel expenses. This was partially offset by an increase in expenses related to our virology programs. General and administrative expense for the second quarter in 2025 totaled $1.7 million compared to $2 million for the comparable period in 2024. This decrease of $0.3 million is primarily attributable to a decrease in personnel-related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees. The net loss for the second quarter of 2025 was $0.9 million. This was driven by the recognition of the licensing revenue of $2.7 million. As a result, the net loss for the second quarter in 2025 was $0.11 per basic and diluted common share. This compares to a net loss of $123.1 million or a net loss of $20.52 per basic and diluted common share for the comparable period in 2024. Traws' second quarter 2024 net loss reflects a noncash charge of $117.5 million related to in-process R&D from Onconova's April 2024 acquisition of Trawsfynydd. Now I'd like to turn the call back to Iain.

Thanks, Charles. Before we open the line for questions, I will briefly summarize the topics we've covered on today's call. We're excited about our 2 potential best-in-class antiviral product candidates for 2 multibillion-dollar markets. Ratutrelvir in development as a potential ritonavir-free treatment for COVID and tivoxavir marboxil in development as a single-dose treatment for influenza, including bird flu. We reprioritized our programs to maximize the opportunity to provide investors with the short- and medium-term value with acceleration of ratutrelvir, our potential treatment for COVID. In regard to our influenza program, with the waning cases of birth flu in the United States, we intend to focus our efforts on inclusion of tivoxavir marboxil in the drug stockpiling initiative to help ensure pandemic readiness and continue our constructive discussions with BARDA. And lastly, we remain committed to finding an appropriate partner to assist in developing and commercializing our legacy oncology assets. As we begin the Q&A session, I want to thank everyone for joining us today. Now we will open up the call for questions. Operator, please go ahead.

[Operator Instructions] Thank you. Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.