Ratutrelvir shows a differentiated profile versus PAXLOVID™ with fewer adverse events and no viral rebounds Activity shown in Paxlovid®-ineligible patients, representing a significant population with few effective treatment options Final data analysis to be reported in January 2026 NEWTOWN, Pa., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to hu ...

Financial Position - As of September 30, 2025, Traws Pharma had cash and cash equivalents of $6.4 million and an accumulated deficit of $632.5 million, indicating significant financial challenges ahead[113]. - Traws Pharma's ability to continue as a going concern is in doubt due to insufficient cash to support operations for at least the next 12 months[113]. - The company believes it does not have sufficient cash and cash equivalents to support operations for more than one year following the issuance of the financial statements[163]. - Net cash used in operating activities was $15.4 million for the nine months ended September 30, 2025, compared to $25.8 million for the same period in 2024[158]. - Net cash provided by financing activities was $3.0 million for the nine months ended September 30, 2025, compared to $14.0 million for the same period in 2024[162]. - Change in fair value of warrant liability was $26.7 million during the nine months ended September 30, 2025, reflecting the remeasurement of the warrant liability[153]. Operating Losses and Financial Challenges - The company expects to incur substantial operating losses for the foreseeable future as it continues to develop and seek regulatory approval for its product candidates[113]. - The company has not achieved profitability since inception and expects to continue incurring operating losses for the foreseeable future[163]. - Significant expenses and operating losses are expected as the company continues development and clinical trials of product candidates[164]. Funding and Financing - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms[114]. - The company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[156]. - The company entered into an At The Market Offering Agreement allowing for the sale of up to $50,000,000 in common stock[124]. - In the quarter ended September 30, 2025, the company sold 62,003 shares under the ATM Agreement for net proceeds of $0.1 million[127]. Clinical Programs and Product Development - Traws Pharma has four clinical programs following the merger with Trawsfynydd Therapeutics, Inc., including Tivoxavir marboxil, aimed at treating influenza and bird flu[115]. - A Phase 1 study of Tivoxavir marboxil showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for over 23 days[117]. - Traws Pharma submitted a request for a meeting with the FDA regarding the potential for accelerated approval of Tivoxavir marboxil under the "Animal Rule" for bird flu treatment[117]. - The proposed Phase 2 study for Tivoxavir marboxil will evaluate its effects on seasonal influenza and H5N1 bird flu, pending regulatory review[118]. - Ratutrelvir (TRX01), another product candidate, is designed to inhibit the main protease of SARS-CoV-2, showing non-inferiority to existing treatments in animal studies[119]. - TRX01 Phase 1 clinical trial included 40 participants, with no treatment-related adverse events reported up to the highest dose of 600 mg[120]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for low-grade endometrioid endometrial cancer[120]. - Rigosertib showed an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients[122]. - The company intends to report results from both Phase 2 studies of ratutrelvir by year-end 2025[120]. - The Phase 1 study of narazaciclib as a monotherapy is now closed to accrual, with data analysis ongoing[120]. Management and Administrative Changes - Management changes included the appointment of Iain Dukes as CEO effective October 1, 2025[136]. Revenue and Expenses - Revenue for the three months ended September 30, 2025 was $0, a decrease of $57,000 from $57,000 in the same period of 2024[141]. - Research and development expenses decreased by $2.8 million, or 55%, to $2.3 million for the three months ended September 30, 2025, primarily due to a $1.7 million decrease in virology expenses[143]. - General and administrative expenses decreased by $1.7 million, or 50%, to $1.7 million for the three months ended September 30, 2025, mainly due to a $1.0 million decrease in professional and consulting fees[146]. - For the nine months ended September 30, 2025, revenue was $2.8 million, an increase of $2.6 million from $0.2 million in the same period of 2024, primarily due to the recognition of $2.7 million of previously deferred revenue[149]. - Research and development expenses for the nine months ended September 30, 2025 decreased by $3.9 million, or 35%, to $7.1 million, mainly due to a $3.0 million decrease in oncology expenses[151]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.6 million, or 30%, to $6.2 million, primarily due to a $1.3 million decrease in professional and consulting fees[152]. Economic Risks - The business faces significant risks from economic conditions, including financial market volatility, inflation, and potential government shutdowns[165]. - The ultimate impact of global and domestic economic conditions on the business remains highly uncertain[166]. Accounting Policies - There have been no significant changes in critical accounting policies and estimates as of September 30, 2025[168].

Financial Performance - Revenue for the quarter ended September 30, 2025, was zero, compared to $57 thousand for the same period in 2024, reflecting a decline in sales activity[10] - The net loss for the quarter was $4.0 million, or a net loss of $0.34 per share, compared to a net loss of $8.5 million, or $1.49 per share, for the same quarter in 2024, showing an improvement in loss[12] - Total revenue for the nine months ended September 30, 2025, was $2,790,000, compared to $170,000 for the same period in 2024, representing a significant increase[27] - The net loss for the nine months ended September 30, 2025, was $16,613,000, compared to a net loss of $136,601,000 for the same period in 2024, indicating improved financial performance[27] - The company reported a loss from operations of $4,055,000 for the three months ended September 30, 2025, compared to a loss of $8,536,000 for the same period in 2024[27] - The net loss per share of common stock, basic, was $(0.34) for the three months ended September 30, 2025, compared to $(1.49) for the same period in 2024[27] Cash and Liquidity - Cash and cash equivalents as of September 30, 2025, were approximately $6.4 million, down from $21.3 million as of December 31, 2024, indicating a significant decrease in liquidity[7] - Cash and cash equivalents decreased to $6,420,000 as of September 30, 2025, from $21,338,000 as of December 31, 2024[25] - Total current liabilities decreased to $7,887,000 as of September 30, 2025, from $11,533,000 as of December 31, 2024[25] Research and Development - Research and development (R&D) expenses for the quarter totaled $2.3 million, down from $5.1 million in the comparable period in 2024, a decrease of approximately 55%[10] - Research and development expenses for the nine months ended September 30, 2025, were $7,108,000, down from $10,989,000 in the same period of 2024[27] Operating Expenses - General and administrative (G&A) expenses for the quarter were $1.7 million, compared to $3.5 million in the same period in 2024, a reduction of about 49%[11] - Operating expenses for the nine months ended September 30, 2025, totaled $13,297,000, a decrease from $137,266,000 in the same period of 2024[27] Assets and Deficits - The total assets as of September 30, 2025, were $12,443,000, a decrease from $24,962,000 as of December 31, 2024[25] - The company had an accumulated deficit of $(632,541,000) as of September 30, 2025, compared to $(649,154,000) as of December 31, 2024[25] Product Development and Market Opportunities - Ratutrelvir is expected to provide topline data by year-end 2025 from Phase 2 studies, with prior Phase 1 studies showing plasma drug levels maintained four times above the EC90 over a 10-day treatment period[4] - The U.S. market opportunity for Ratutrelvir is estimated to be multi-billion dollars, targeting treatment for acute COVID infection and Long COVID[4] - Tivoxavir Marboxil (TXM) is positioned as a potential best-in-class single-dose treatment for bird flu and seasonal flu, with a similar multi-billion dollar market opportunity[3] - Traws Pharma acquired significant intellectual property and assets for $2.6 million, enhancing its antiviral portfolio[8] - The overall response rate for rigosertib in treating recessive dystrophic epidermolysis bullosa associated squamous cell carcinoma was reported at 80%, with complete responses in 50% of evaluable patients[9]

Core Insights - Traws Pharma is advancing its Phase 2 studies for ratutrelvir, a ritonavir-free protease inhibitor aimed at treating Acute and Long COVID, with topline data expected by year-end 2025 [1][3] - The company has acquired significant intellectual property and assets, enhancing its portfolio [1][6] - Traws Pharma has achieved notable cost reductions in its financials quarter over quarter [1][7] Product Development - Ratutrelvir is positioned as a potential best-in-class therapy to minimize the risk of viral rebound and Long COVID, designed for single-dose administration with a target regimen of 600 mg/day for ten days [3][12] - Tivoxavir Marboxil (TXM) is being developed as a single-dose treatment for bird flu and seasonal flu, showing promising preclinical results [3][13] - The U.S. market opportunity for both ratutrelvir and TXM is estimated to be multi-billion dollars, with potential government stockpiling for pandemic preparedness [4][12] Financial Results - As of September 30, 2025, Traws Pharma reported cash and cash equivalents of approximately $6.4 million, a decrease from $21.3 million as of December 31, 2024 [5][21] - Revenue for the quarter ended September 30, 2025, was zero, compared to $57 thousand for the same period in 2024 [7][24] - Research and development expenses decreased to $2.3 million from $5.1 million year-over-year, reflecting cost management efforts [7][8] Management Updates - The company is actively seeking partnerships for its legacy oncology assets, including rigosertib and narazaciclib, to support further development [4][16] - Recent management changes include the appointment of John Leaman, MD, as Independent Board Director and the confirmation of Iain Dukes as CEO [11]

Core Insights - ChemDiv announced an extension of its Chemistry, Manufacturing and Controls (CMC) services collaboration to support the clinical development of ratutrelvir, an oral antiviral treatment for COVID-19, following Traws Pharma's initiation of Phase 2 studies [1][3] - Ratutrelvir is a ritonavir-free Main protease inhibitor, designed to offer high potency against various SARS-CoV-2 strains, with a simplified 10-day treatment regimen [2][4] - The ongoing collaboration between ChemDiv, Traws Pharma, and Expert Systems aims to enhance the clinical development of ratutrelvir through advanced predictive safety pharmacology [3][5] Company Overview - ChemDiv is a global provider of integrated drug discovery solutions, offering a wide range of services including medicinal chemistry, CMC, and AI-powered drug design [9] - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel antiviral therapies for respiratory viral diseases, including ratutrelvir for COVID-19 [8] - Expert Systems is an advanced AI-based platform that supports drug discovery and development, contributing to the predictive pharmacology of ratutrelvir [5] Clinical Development - Ratutrelvir is currently being evaluated in two Phase 2 studies: one comparing it to PAXLOVID® in newly diagnosed patients and another for PAXLOVID®-ineligible patients [3][4] - Phase 1 studies indicated that ratutrelvir maintained plasma levels approximately 13 times above the effective concentration with a once-daily dosing regimen, potentially reducing the risk of viral rebound and Long COVID [3]

Core Insights - Expert Systems Inc. continues to support Traws Pharma as it initiates Phase 2 clinical studies of Ratutrelvir (TRX01), an oral antiviral for newly diagnosed COVID-19 patients [1][5] Company Overview - Expert Systems Inc. is a life sciences accelerator focused on advancing precision therapeutics through an AI/ML-enabled platform that integrates drug design, predictive pharmacology, and regulatory strategy [6][7] Product Development - Ratutrelvir (TRX01) shows broad-spectrum in vitro activity against various SARS-CoV-2 strains and has a unique formulation that does not require ritonavir, thus avoiding drug-drug interactions that affect about 20% of COVID patients [3][4] - In Phase 1 studies, a daily oral dose of 600 mg maintained plasma concentrations approximately 13 times above the effective concentration (EC50) for the entire 10-day course, with trough levels above EC90, crucial for preventing viral rebound [4][5] - The Phase 2 program includes a non-inferiority trial against PAXLOVID® and a trial for populations ineligible for PAXLOVID®, addressing a significant unmet need [8] Strategic Collaboration - Expert Systems will provide ongoing strategic, scientific, and technological support as Ratutrelvir progresses through human efficacy studies, highlighting its capability to de-risk innovation and accelerate clinical translation [5]

Core Insights - Traws Pharma is conducting a Phase 2 study to evaluate ratutrelvir, a ritonavir-free antiviral treatment for COVID-19, with top-line data expected by year-end 2025 [1][2][3] Group 1: Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases [5] - The company aims to address critical health threats, including COVID-19, Long COVID, bird flu, and seasonal influenza [5] Group 2: Product Development - Ratutrelvir is designed as an oral, small molecule Mpro (3CL protease) inhibitor, showing in vitro activity against various virus strains [3] - The treatment does not require co-administration with ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [3] - Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels approximately 13 times above the EC50, which may reduce the likelihood of clinical rebound and Long COVID risk [3] Group 3: Clinical Trials - The first trial compares ratutrelvir against PAXLOVID, evaluating safety, infection rates, COVID symptoms, disease rebound, and Long COVID incidence [2] - A second trial will assess ratutrelvir's safety and efficacy in PAXLOVID-ineligible patients, a vulnerable population with limited treatment options [2] - Results from both Phase 2 studies are anticipated by the end of 2025 [2] Group 4: Market Potential - The COVID treatment market represents a potential multi-billion dollar opportunity, highlighting the significance of effective antiviral therapies [3]

Core Insights - Traws Pharma, Inc. has appointed Dr. John Leaman as an independent director to its board, effective October 1, 2025, and has removed the interim titles of its key executives, indicating strong board support for the leadership team [1][2][6] Company Developments - Dr. Leaman brings over a decade of experience in finance, M&A, and corporate strategy, which is expected to be valuable as the company prepares for Phase 2 studies of its lead product, ratutrelvir, aimed at treating COVID-19 [2][3] - The removal of interim titles for CEO Iain Dukes and CFO Charles Parker signifies the board's confidence in their leadership [1][2] Product Pipeline - Ratutrelvir is an investigational oral small molecule designed to treat SARS-CoV-2/COVID-19 without the need for ritonavir, showing promising preclinical and Phase 1 study results [7] - The pharmacokinetic profile of ratutrelvir indicates maintenance of target blood plasma levels approximately 13 times above the EC50 with a dosing regimen of 600 mg/day for ten days, potentially reducing the risk of Long COVID [7] - Tivoxavir marboxil (TXM) is another investigational product targeting bird flu and seasonal influenza, demonstrating potent in vitro activity against various influenza strains [8][9] Market Opportunity - The COVID treatment market represents a potential multi-billion dollar opportunity, driven by ongoing health challenges and the need for effective antiviral therapies [7] - Seasonal influenza and bird flu treatments also present significant market potential, supported by global health initiatives and government tenders [8][9]

Core Viewpoint - Traws Pharma is advancing the development of ratutrelvir, a ritonavir-free treatment for COVID-19, through two Phase 2 trials aimed at evaluating its safety and efficacy compared to PAXLOVID®, with top-line data expected by the end of 2025 [1][2][3]. Group 1: Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 and Long COVID [6]. - The company integrates antiviral drug development with medical intelligence and regulatory strategy to address challenges in treating viral diseases [6]. Group 2: Product Development - Ratutrelvir is an investigational oral small molecule Mpro (3CL protease) inhibitor designed to treat SARS-CoV-2 without the need for ritonavir, potentially avoiding drug-drug interactions [3]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels significantly above the effective concentration, which may reduce the likelihood of clinical rebound and Long COVID [3]. Group 3: Market Context - In Q2 2025, Pfizer reported $427 million in sales for PAXLOVID®, marking a 70% increase from the same period the previous year, highlighting the ongoing demand for effective COVID-19 treatments [2]. - The rapid emergence of new viral variants, such as NB.1.8.1, which now accounts for 40% of COVID cases, underscores the need for effective antiviral therapies [2]. Group 4: Clinical Trials - The first trial will compare ratutrelvir against PAXLOVID® in newly diagnosed COVID patients, while a second trial will focus on PAXLOVID®-ineligible patients, a vulnerable group with limited treatment options [1][2]. - Results from both Phase 2 studies are anticipated by the end of 2025, which could provide critical proof-of-concept data for ratutrelvir [2].

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.1 million, down from $21.3 million as of December 31, 2024 [26] - Revenue for the quarter ended June 30, 2025, was $2.7 million, a significant increase from $57,000 for the same period in 2024, primarily due to $2.7 million in deferred revenue recognized from a licensing agreement termination [26] - Research and development expenses for the second quarter of 2025 totaled $2.3 million, down from $4 million in the comparable period in 2024, reflecting decreased oncology program expenses [27] - General and administrative expenses decreased to $1.7 million from $2 million in the same period in 2024, mainly due to lower personnel-related expenses [27] - The net loss for the second quarter of 2025 was $900,000, or $0.11 per share, compared to a net loss of $123.1 million, or $20.52 per share, for the same period in 2024 [28] Business Line Data and Key Metrics Changes - The company is advancing its COVID program with a phase two study of Racutrelvir, aimed at newly diagnosed COVID patients, and expects to report results by year-end 2025 [6][7] - The influenza program is in discussions with BARDA regarding the inclusion of Tivoxavir and Marboxyl in the drug stockpiling initiative, indicating potential commercial opportunities [7][8] Market Data and Key Metrics Changes - Pfizer reported $427 million in sales of Paxlovid for the second quarter of 2025, representing a 70% increase compared to the same period in the prior year, highlighting the competitive landscape in antiviral treatments [7] Company Strategy and Development Direction - The company has reprioritized its clinical trial plans to enhance shareholder value, focusing on antiviral candidates for COVID and influenza [6][29] - The strategy includes maximizing opportunities in the short and medium term, particularly through the development of Racutrelvir and Tivoxavir [29] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing public health threat posed by COVID-19 and the need for effective antiviral treatments, particularly as vaccine immunity wanes [10][14] - The company is committed to addressing the long COVID issue, which affects over 15 million people in the U.S., through its investigational therapies [15] - The management expressed concerns about the potential risks of avian influenza and the need for preparedness measures, advocating for the development of new treatments [21][22] Other Important Information - The company is seeking partnerships to advance its legacy oncology assets, particularly rigosertib, which has shown promising efficacy in a rare disease [24] Q&A Session Summary - The Q&A session was not conducted as the call concluded without any questions being taken from participants [32]