Earnings call transcript: Traws Pharma Q2 2025 sees stock surge on revenue boost

Traws Pharma Inc. (TRAW) reported its second-quarter earnings for 2025, showcasing a significant revenue increase to $2.7 million, a leap from $57,000 in the same quarter last year. This rise is attributed to deferred revenue from a licensing agreement termination. Despite a net loss of $900,000, or $0.11 per share, the stock surged over 17% in premarket trading, reflecting investor optimism. According to InvestingPro data, the company has shown a strong 11% return over the past week, maintaining a healthy current ratio of 1.81 and holding more cash than debt on its balance sheet. The company’s focus on innovative treatments for COVID-19 and influenza, alongside promising future guidance, has piqued market interest.

Key Takeaways

• Revenue soared to $2.7 million in Q2 2025, a substantial increase from Q2 2024.
• Stock surged 17.09% in premarket trading following the earnings announcement.
• Net loss narrowed significantly to $900,000 from $123.1 million a year ago.
• Promising developments in COVID-19 and influenza treatment programs.
• Future guidance projects strong EPS growth in upcoming quarters.

Company Performance

Traws Pharma’s performance in Q2 2025 marks a pivotal improvement compared to the previous year. The substantial revenue increase is a key highlight, driven largely by deferred revenue from a terminated licensing agreement. This positive shift is complemented by a significant reduction in net loss, indicating improved financial health. The company’s strategic focus on pandemic preparedness and antiviral treatments positions it favorably against industry peers.

Financial Highlights

• Revenue: $2.7 million, up from $57,000 in Q2 2024.
• Net Loss: $900,000, significantly improved from $123.1 million in Q2 2024.
• Cash, cash equivalents, and short-term investments: $13.1 million, down from $21.3 million as of December 31, 2024.
• Research and Development Expense: $2.3 million, down from $4 million in Q2 2024.

Outlook & Guidance

Traws Pharma has provided a robust forward guidance, with EPS forecasts for FY2025 and FY2026 set at $30.31 and $62.39, respectively. InvestingPro data confirms analysts expect the company to turn profitable this year, despite not being profitable over the last twelve months. This transition could represent a significant inflection point for investors tracking the company’s fundamentals. The company expects to report results from its COVID-19 phase two study by the end of 2025. Discussions with the FDA and BARDA are ongoing, emphasizing Traws Pharma’s commitment to advancing its antiviral candidates.

Executive Commentary

Dr. Ian Dukes, Interim CEO, expressed enthusiasm about the company’s potential, stating, "We’re excited about our two potential best-in-class antiviral product candidates." Dr. David Porter, Chief Scientific Officer, highlighted Racutrelvir’s unique design, "Racutrelvir is designed for use without Ritonavir," addressing a critical limitation in current treatments.

Risks and Challenges

• Market competition from established antiviral treatments could impact market share.
• Regulatory hurdles in obtaining approval for new treatments.
• Financial constraints due to reduced cash reserves.
• Uncertain market conditions for COVID-19 and influenza treatments.
• Dependence on successful partnerships for oncology asset advancement.

Traws Pharma’s latest earnings call underscores a significant turnaround in its financial trajectory, with a strong focus on innovative healthcare solutions. The market’s positive response reflects confidence in the company’s strategic direction and future growth potential.

Full transcript - Traws Pharma Inc (TRAW) Q2 2025:

Conference Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Trowz Pharma Incorporated Second Quarter twenty twenty five Financial Results and Business Update Call. At this time, all participants are in a listen only mode. Following management’s prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star followed by one on your touch tone phone.

If anyone has difficulty hearing the conference, please press 0 for operator assistance. As a reminder, this call is being recorded today, 08/14/2025. At this time, I’d like to turn the call over to John France of LifeSci Advisors.

John France, LifeSci Advisors Representative, LifeSci Advisors: Thank you, operator, and welcome everyone to Charles Pharma’s second quarter twenty twenty five financial results and business update conference call. This morning, Charles issued a press release reporting its second quarter twenty twenty five 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, will hear from TRA’s Interim Chief Executive Officer, Doctor. Ian Dukes Chief Science Officer, Doctor.

David Pauza Chief Medical Officer, Doctor. 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, 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, Doctor. Ian Dukes.

Dr. Ian Dukes, Interim Chief Executive Officer, Traws Pharma: Thanks, John. And thanks to everyone for joining us today. Traw 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’ve submitted to a Human Research Ethics Committee, HRAC, a phase two study of Racutrelvir, a potential best in class Ritonavir-three agents in newly diagnosed COVID patients versus Paxlovid to provide safety and efficacy as well as rates of disease rebound and instance of long COVID development.

Separately, we propose to evaluate in a single arm study, the effects of Rachetralvia 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 twenty twenty five, Pfizer reported $427,000,000 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 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 is not progressed to date in The US 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 two study incorporating bird flu infected subjects will 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. Reasoned approval of our phase two 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 hemisphere respectively, should the incidence rates of bird flu increase.

I’ll now hand over the call to our Chief Scientific Officer, Doctor. David Porter, and our Chief Medical Officer, Doctor. Robert Redfield, for more detailed comments on our COVID program. David.

Dr. David Porter, Chief Scientific Officer, Traws Pharma: Thank you, Ian. COVID-nineteen continues to be a major public health threat due to the evolution and rapid spread of new viral variants. Today six major variants are spreading in The United States and the n b dot one dot eight dot one variant first appearing in April is already responsible for more than forty percent 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 nineteen. Ritutrelvir is an investigational main protease inhibitor developed and tested by Traspharma 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 Rutonavir into phase two clinical studies to accelerate its entry into the marketplace. Rutonavir 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-nineteen are ineligible to take Paxlovid and need a safe alternative.

Ritutrovir was well tolerated in phase one clinical studies where we evaluated a once daily oral dose for ten 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-nineteen. We’ve applied for permission to conduct a phase two clinical trial in patients with COVID-nineteen including those people eligible for Paxlovid and people who are ineligible for Paxlovid. By demonstrating Ritutrovir’s benefit in COVID-nineteen patients, we expect to address the estimated 1,500,000,000.0 annual market opportunity of individuals who are seeking treatment but aren’t eligible for Paxlovid and to demonstrate the multiple benefits of Rutrovir therapy. Doctor.

Redfield would you like to add comments?

Dr. Robert Redfield, Chief Medical Officer, Traws Pharma: Thanks Dave. COVID-nineteen 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. Proz Pharma answer is Rutanavir, a new investigational drug that does not require Ritonavir to reach its therapeutic levels and can be taken for ten days instead of the five days recommended for Baxlovid. Relativtegiravir treatment may expand access for all patients to receive COVID-nineteen therapy.

We are hopeful that the longer duration will result in more complete elimination of the virus and will prevent viral rebound and hopefully reduce the incidence of long COVID. Tra 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 fifteen million people in The United States. It can cause and reduce significant disability and reduce the quality of life. Ravlutegravir was designed specifically to address these factors and 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-nineteen therapy for the greatest number of people while reducing the threat of long COVID. Ian?

Dr. Ian Dukes, Interim Chief Executive Officer, Traws Pharma: Thank you, Bob. Turning to our influenza program, Drs. Porter and Redfield have the following observations. David?

Dr. David Porter, Chief Scientific Officer, Traws Pharma: Thank you, Ian. Seasonal influenza has a severe public health impact in The US. However, lurking 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 three decades or more showed more than fifty percent 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, Trost Pharma developed and tested Tevoxavir Marboxyl, 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 influenza 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. Tavoxavir 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. Tavoxavir Marboxyl is safe and produced blood drug levels that might control virus for twenty one days or longer after a single dose. Trost Pharma believes that Tavoxavir Marboxyl 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. Doctor.

Redfield.

Dr. Robert Redfield, Chief Medical Officer, Traws Pharma: 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 US population. We strongly believe that new measures are required to prepare for an H5N1 outbreak and that Traz Pharma is advancing trivoxavir marboxyl, 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-nineteen drugs and enough of it to prevent the spread and death within The United States.

While COVID-nineteen 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. Traz Pharma is advancing trivoxavir marboxyl to support a national strategy for preparing to confront an outbreak of H5N1 influenza. Importantly, the target of trivoxavir marboxyl, 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 Triboxavir and Mirboxol will retain activity and be effective in treating and possibly preventing the threat of pandemic influenza.

Trial Pharma is engaged with the US Food and Drug Administration or the FDA and the Biomedical Advanced Research and Development Authority or BARDA regarding the development of triboxavir mirboxol for the national stockpile. The FDA has commented on the design of the clinical trials for proceeding with triboxavir mirboxol 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. Ian?

Dr. Ian Dukes, Interim Chief Executive Officer, Traws Pharma: Thank you both. Before we review our financial results, I’ll make a few remarks on our legacy oncology assets comprised of two unique kinase inhibitors, rigosertib and neritaciclib. Cloud strategic objectives of these programs is to establish by creating partnerships. In the second quarter, we published compelling efficacy data for rigosertib in a rare disease called recessive dystrophic epidermidis bullosa, associated local advanced or metastatic squamous cell carcinoma, or RDEB. In the study, rigosertib demonstrated a compelling overall response rate of eighty percent with complete responses in fifty percent of the viable patients and good overall tolerability.

These data suggest rigosertib as a potential treatment for RDEB SCC, where there is 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’ll now ask our interim CFO, Charles Parker, to review our financial results. Charles?

Charles Parker, Interim Chief Financial Officer, Traws Pharma: Thanks, Ian. This morning, Traws issued a press release for the quarter ended 06/30/2025. 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 06/30/2025, Traws had cash, cash equivalents and short term investments of approximately $13,100,000 compared to $21,300,000 as of 12/31/2024. Moving through our second quarter twenty twenty five financial results. Revenue for the quarter ended 06/30/2025 was $2,700,000 compared to $57,000 for the same period in 2024. The increase is attributable to $2,700,000 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. Research and development expense for the second quarter in twenty twenty five totaled $2,300,000 compared to $4,000,000 for the comparable period in 2024.

The decrease of $1,700,000 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

Dr. Ian Dukes, Interim Chief Executive Officer, Traws Pharma: for

Charles Parker, Interim Chief Financial Officer, Traws Pharma: the second quarter in twenty twenty five totaled $1,700,000 compared to $2,000,000 for the comparable period in 2024. This decrease of $300,000 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 2025 was $900,000 This was driven by the recognition of the licensing revenue of $2,700,000 As a result, the net loss for the second quarter in twenty twenty five was $0.11 per basic and diluted common share. This compares to a net loss of 123,100,000.0 or a net loss of $20.52 per basic and diluted common share for the comparable period in 2024. TRAW’s second quarter twenty twenty four net loss reflects a non cash charge of $117,500,000 related to in process R and D from Onconova’s April 2024 acquisition of Charles Finneet.

Now I’d like to turn the call back to Ian.

Dr. Ian Dukes, Interim Chief Executive Officer, Traws Pharma: Thanks, Josh. Before we open the line for questions, I’ll briefly summarize the topics we’ve covered on today’s call. We’re excited about our two potential best in class antiviral product candidates for two multibillion dollar markets, Restrelvir in development as a potential return of the treatment for COVID and tevoxavir and marboxyl in development as a single dose treatment for influenza, including bird flu. We’ve reprioritized our programs to maximize the opportunity to provide investors with a short and medium term value with acceleration of retroviral potential treatment for COVID. In regard to our influenza program with the waning cases of bird flu in The United States, we intend to focus our efforts on inclusion of Tivoxifil and 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 appropriate partner to assist in developing and commercializing our legacy oncology assets. As we begin the Q and A section, I want to thank everyone for joining us today. Now we’ll open up the call for questions. Operator, please go ahead.

Conference Operator: Thank you. Ladies and gentlemen, if you wish to register for a question in today’s question and answer session, you’ll need to press star then the number 1 on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star two. If you’re using a speakerphone, please pick up your handset before entering your request. One moment, please, while we assemble the queue for questions.

Once again, star one if you have a question at at this time. Thank you. Thank you, ladies and gentlemen. Thank you for your participation on today’s conference call. This concludes today’s event.

You may now disconnect.

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