Ongoing clinical results with ratutrelvir confirm a differentiated profile versus PAXLOVID® with fewer adverse events, no viral rebounds to date and faster time to sustained symptom resolution; results recapitulated in PAXLOVID®-ineligible patients, representing a significant population with few effective treatment options Compressed tablets of tivoxavir marboxil predicted to provide 28-day protection from influenza against wide range of seasonal and pandemic-potential variants Human influenza prophylaxis c ...

Company Overview - Traws Pharma, Inc. (NASDAQ:TRAW) is currently trading at $1.61 with a target price of $0.73, indicating a potential downside of approximately -54.90% [1][4] - Imunon, Inc. (IMNN) is trading at $3.80 with a target price of $5.36, reflecting a growth potential of +41.18% [2][4] - Cocrystal Pharma, Inc. (COCP) is trading at $1.11 with a target price of $0.79, suggesting a growth potential of -28.68% [3] - Mustang Bio, Inc. (MBIO) trades at $1.09 with a target price of $0.97, resulting in a growth potential of -10.76% [3] Financial Metrics - Imunon, Inc. has a market cap of $9.58 million, despite a negative EPS of -12.53 and a P/E ratio of -0.68 [2] - Cocrystal Pharma, Inc. has a market cap of $11.38 million, with an EPS of -0.93 and a P/E ratio of -1.17 [3] - Mustang Bio, Inc. has a market cap of $7.96 million, an EPS of -6.71, and a P/E ratio of -3.44 [3]

Core Insights - Traws Pharma has filed a U.S. IND application for tivoxavir marboxil (TXM), a potential treatment for influenza, marking a significant step towards its inclusion in the strategic national stockpile [1][3][4] - Updated clinical results for ratutrelvir indicate a favorable profile compared to PAXLOVID, with fewer adverse events, no viral rebounds, and quicker symptom resolution, particularly in patients ineligible for PAXLOVID [1][5][8] Company Developments - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for respiratory viral diseases, including COVID-19 and influenza [18] - The company is advancing ratutrelvir as a ritonavir-independent treatment for COVID-19, targeting the Main protease (Mpro or 3CL protease) [18] - Traws Pharma is also developing tivoxavir marboxil as a single-dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease [18] Clinical Study Insights - The ongoing Phase 2 study of ratutrelvir has enrolled 50 patients, with 95% of the planned 90-patient population already enrolled [6] - Interim analysis shows that ratutrelvir-treated patients had a time to sustained symptom resolution of 12 days compared to 14 days for PAXLOVID-treated patients (p<0.014) [8][9] - Ratutrelvir demonstrated a better safety profile, with only 7.6% of patients reporting mild dyspepsia, while 30% of PAXLOVID patients reported adverse events [11][12] Market Potential - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government initiatives [15] - The COVID-19 treatment market also presents significant potential, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor [14][15]

Core Viewpoint - Ratutrelvir demonstrates a differentiated clinical profile compared to PAXLOVID™, showing fewer adverse events and no viral rebounds, making it a promising treatment option for patients with mild-to-moderate COVID-19, including those ineligible for ritonavir-boosted therapies [1][5][12]. Group 1: Clinical Study Overview - Traws Pharma announced interim data from a Phase 2 clinical study of ratutrelvir, an oral, ritonavir-free protease inhibitor, which showed a favorable clinical profile in patients with mild-to-moderate COVID-19 [2][3]. - The study is an active-controlled trial comparing ratutrelvir to PAXLOVID™, with 37 patients included in the interim analysis, of which 25 received ratutrelvir and 12 received PAXLOVID™ [3][4]. - More than 50% of the planned 90-patient population has been enrolled in the study [3]. Group 2: Efficacy and Safety - Ratutrelvir-treated patients showed comparable time-to-sustained symptom alleviation to those treated with PAXLOVID™, with sustained alleviation defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days [6]. - No COVID-19 symptom or virologic rebound events were observed in ratutrelvir-treated patients, while one rebound event occurred in the PAXLOVID™ group [7]. - Ratutrelvir was well tolerated, with fewer adverse events reported compared to the PAXLOVID™ cohort, where 30% of patients experienced adverse events [9][10]. Group 3: Implications for Long-COVID - The combination of early and sustained symptom improvement, absence of viral rebound, and favorable tolerability suggests that ratutrelvir may be useful in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID) [12]. - Ratutrelvir's design allows for broader patient use without the limitations associated with ritonavir, potentially offering a new approach to both acute COVID-19 treatment and prevention of long-term complications [12][13]. Group 4: Market Potential - The COVID treatment market represents a potential multi-billion dollar opportunity, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor that is ritonavir-free and has an improved tolerability profile [14].

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]