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]. - The company does not currently have sufficient cash and cash equivalents to support operations for more than one year, raising substantial doubt about its ability to continue as a going concern[163]. - The company has not achieved profitability since inception and expects to continue incurring operating losses for the foreseeable future[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]. - The company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[156]. - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms[114]. Clinical 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]. - The first-in-man clinical study of Tivoxavir marboxil showed good 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), acquired in the merger, 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]. - The company plans to report results from both Phase 2 studies evaluating 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]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for low-grade endometrioid endometrial cancer, with no dose-limiting toxicities observed in the initial cohort[120]. - Rigosertib showed an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients[122]. 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, with a significant 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]. - The 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]. Management and Corporate Actions - Management changes included the appointment of Iain Dukes as CEO and Charles Parker as CFO effective October 1, 2025[135][136][137]. - The company entered into an Asset Purchase Agreement with Viriom for $2,350,000 to acquire assets related to a pyrrolidine antiviral compound[123]. - The At The Market Offering Agreement allows the company to sell shares of common stock up to $50,000,000, with 62,003 shares sold for net proceeds of $0.1 million in Q3 2025[124][127]. - A one-for-25 reverse stock split was executed in September 2024, retroactively adjusting all share and per share amounts[139]. Market and Economic Conditions - The business faces significant risks from macroeconomic factors, 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 and is subject to ongoing monitoring[166]. - Significant expenses and operating losses are expected as the company seeks regulatory approval for its product candidates[164]. - The company may rely on licensing and co-promotion agreements for commercialization of its products in the future[164].

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] - Revenue for the nine months ended September 30, 2025, was $2,790,000, a significant increase compared to $170,000 for the same period in 2024 [27] - The net loss for the quarter was $4.0 million, or a net loss of $0.34 per share, an improvement from a net loss of $8.5 million, or $1.49 per share, in the same quarter of 2024 [12] - The net loss for the nine months ended September 30, 2025, was $16,613,000, a substantial improvement from a net loss of $136,601,000 in the same period of 2024 [27] - The company reported a net loss per share of common stock, basic, of $0.34 for the three months ended September 30, 2025, compared to a loss of $1.49 for the same period in 2024 [27] Expenses - 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] - 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, down from $137,266,000 in the same period of 2024, indicating a reduction of over 90% [27] - 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, a decrease of approximately 35% [27] Cash and Assets - 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 from $21,338,000 on December 31, 2024, to $6,420,000 on September 30, 2025, a decline of approximately 70% [25] - Total assets decreased from $24,962,000 on December 31, 2024, to $12,443,000 on September 30, 2025, representing a decline of approximately 50% [25] - Total current liabilities decreased from $11,533,000 on December 31, 2024, to $7,887,000 on September 30, 2025, reflecting a reduction of about 31% [25] - Total stockholders' equity improved from a deficit of $31,630,000 on December 31, 2024, to $4,545,000 on September 30, 2025 [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 [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] - 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] Intellectual Property and Acquisitions - Traws Pharma acquired significant intellectual property and assets for $2.6 million, enhancing its antiviral portfolio [8] - The company had a change in fair value of warrant liability resulting in a gain of $26,656,000 for the nine months ended September 30, 2025 [27]

Financial Performance - Revenue for Q2 2025 was $2.7 million, a significant increase from $57 thousand in Q2 2024, attributed to deferred revenue from a licensing agreement termination[12] - Revenue for Q2 2025 reached $2.73 million, a significant increase from $57,000 in Q2 2024, representing a growth of approximately 4,684%[30] - The net loss for Q2 2025 was $0.9 million, or $0.11 per share, compared to a net loss of $123.1 million, or $20.52 per share, in Q2 2024[15] - Net loss for Q2 2025 was $915,000, compared to a net loss of $123.14 million in Q2 2024, reflecting an improvement of approximately 99.26%[30] - The company reported a net income attributable to common stockholders of $14.86 million for the first half of 2025, compared to a net loss of $34.72 million in the same period of 2024[30] Cash and Investments - Cash, cash equivalents, and short-term investments as of June 30, 2025, totaled approximately $13.1 million, down from $21.3 million as of December 31, 2024[11] - Cash and cash equivalents decreased to $13.08 million as of June 30, 2025, down from $21.34 million at the end of 2024, a decline of about 38.67%[28] - Total current liabilities decreased to $7.35 million as of June 30, 2025, from $11.53 million at the end of 2024, a reduction of approximately 36.06%[28] Research and Development - Ratutrelvir, an investigational oral protease inhibitor for COVID-19, has shown plasma drug levels maintained four times above the EC90 over a 10-day treatment period in Phase 1 studies[8] - The TXM program for bird flu and seasonal flu is in discussions for inclusion in the drug stockpiling initiative, representing significant commercial potential[4] - Rigosertib demonstrated an overall response rate of 80% in treating RDEB SCC, with complete responses in 50% of evaluable patients[13] - Research and development expenses for Q2 2025 totaled $2.3 million, down from $4.0 million in Q2 2024, primarily due to reduced oncology program expenses[14] - The company has ongoing clinical trials and regulatory plans for its product candidates, including ratutrelvir and tivoxavir marboxil, with potential market opportunities being evaluated[25] Market Opportunities - Pfizer reported $427 million in sales for PAXLOVID in Q2 2025, a 70% increase compared to the same period in the prior year[4] - The U.S. market opportunity for Ratutrelvir and TXM is estimated to be multi-billion dollar markets, driven by the ongoing need for effective antiviral treatments[17][18] - Traws Pharma is actively seeking partnerships for its legacy oncology programs, including rigosertib and narazaciclib[22] Company Strategy - Traws Pharma's accumulated deficit as of June 30, 2025, was $(628.58) million, compared to $(649.15) million at the end of 2024, indicating a reduction in the deficit of approximately 3.16%[28] - The company is focused on improving therapy options to address Long COVID and other emerging health threats, highlighting its commitment to innovation and market expansion[25] - Total operating expenses for Q2 2025 were $3.98 million, down from $123.41 million in Q2 2024, indicating a reduction of about 96.77%[30] - The weighted-average shares of common stock outstanding increased to 7,359,825 for the first half of 2025, compared to 927,084 in the first half of 2024[30]

Financial Position - As of June 30, 2025, Traws Pharma had cash and cash equivalents of $13.1 million and an accumulated deficit of $628.6 million, indicating significant financial challenges ahead [110]. - 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 [110]. - The company plans to explore various dilutive and non-dilutive sources of funding to alleviate substantial doubt about its ability to continue as a going concern [151]. - The net decrease in cash and cash equivalents was $8.3 million for the six months ended June 30, 2025, compared to a decrease of $3.9 million for the same period in 2024 [154]. - The company had an accumulated deficit of $628.6 million and cash and cash equivalents of $13.1 million as of June 30, 2025 [150]. Operating Performance - Revenue for the three months ended June 30, 2025, was $2,733,000, a significant increase of $2,676,000 compared to $57,000 in the same period in 2024 [137]. - Revenues increased by $2.6 million, reaching $2.7 million for the six months ended June 30, 2025, compared to $0.1 million for the same period in 2024 [144]. - Total operating expenses for the same period were $3,982,000, down from $123,405,000 in 2024, reflecting a decrease of $119,423,000 [137]. - The net loss for the three months ended June 30, 2025, was $915,000, a reduction of $122,228,000 compared to a net loss of $123,143,000 in 2024 [137]. - Net cash used in operating activities was $11.4 million for the six months ended June 30, 2025, compared to $14.3 million for the same period in 2024 [154]. Research and Development - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms [111]. - The company has four clinical programs following the acquisition of Trawsfynydd Therapeutics, including Tivoxavir marboxil, which targets influenza virus replication [112]. - 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 [115]. - The proposed Phase 2 study for Tivoxavir marboxil will evaluate its effects on seasonal influenza and H5N1 bird flu, pending regulatory approvals [116]. - Ratutrelvir (TRX01), acquired in the merger, is designed to inhibit the main protease of SARS-CoV-2, showing non-inferiority to existing treatments in animal studies [117]. - The Phase 1 clinical trial for TRX01 included 40 participants, with no treatment-related adverse events reported up to the highest dose of 600 mg [118]. - The proposed Phase 2 study for ratutrelvir aims to enroll patients on a 10-day treatment regimen, comparing it to the approved 5-day regimen for PAXLOVID® [118]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for women with low-grade endometrioid endometrial cancer [119]. - Rigosertib demonstrated an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients [121]. - The company expects research and development expenditures in 2025 to be higher than in 2024 due to ongoing virology programs [159]. Compliance and Financial Reporting - The company received confirmation of regained compliance with Nasdaq's minimum stockholders' equity requirements on February 25, 2025 [136]. - The financial statements are prepared in accordance with GAAP, requiring estimates and judgments that affect reported amounts of assets, liabilities, revenues, and expenses [162]. - The company evaluates estimates related to accrued expenses, revenue recognition, deferred revenue, stock-based compensation, and acquired in-process research and development [162]. - As of June 30, 2025, there have been no significant changes in the company's critical accounting policies and estimates [162]. Capital Raising Activities - The company entered into an At The Market Offering Agreement to sell shares of common stock with an aggregate sales price of up to $50,000,000 [122]. - The company sold 1,522,947 shares under the ATM Agreement for net proceeds of $3.0 million in the quarter ended June 30, 2025 [123]. - The change in fair value of warrant liability was $26.7 million during the six months ended June 30, 2025 [149].

Financial Position and Challenges - As of March 31, 2025, Traws Pharma had cash and cash equivalents of $15.9 million and an accumulated deficit of $627.7 million, indicating significant financial challenges ahead[108]. - 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[108]. - The company has concluded that substantial doubt exists regarding its ability to continue as a going concern within one year after the issuance of the financial statements[140]. - The company will require substantial additional financing to fund ongoing clinical trials and operations[140]. - The company experienced negative cash flows from operations and expects to continue incurring significant expenses related to ongoing activities[138]. - The company has not achieved profitability since inception and expects to continue incurring operating losses for the foreseeable future[147]. - The company plans to explore various sources of funding, including debt and equity financings, to alleviate substantial doubt about its ability to continue as a going concern[140]. - The company is exploring various funding sources to support continued development and operations, indicating potential future financial challenges[148]. Clinical Programs and Trials - Traws Pharma has four clinical programs following the acquisition of Trawsfynydd Therapeutics, including Tivoxavir marboxil, which aims to treat influenza and has shown good tolerability in clinical trials[110]. - TRX01, another product candidate, demonstrated non-inferiority to existing treatments in animal studies and maintained plasma drug levels within the therapeutic window for 12 days in clinical trials[113]. - Narazaciclib, an oral CDK4-plus inhibitor, has been evaluated in a Phase 1/2a trial for recurrent metastatic low-grade endometrioid endometrial cancer, with a maximum tolerated dose established at 160 mg[115]. - The Phase 1 trial of TRX01 included 40 participants and assessed safety and tolerability, with no treatment-related adverse events reported[113]. - Traws Pharma's ongoing clinical trials are critical for its future, as the success of these trials will influence the company's ability to secure funding and achieve profitability[109]. - The company submitted a request for a meeting with the FDA to discuss potential accelerated approval for Tivoxavir marboxil under the "Animal Rule" on March 21, 2025[113]. Financial Performance - Revenue for the three months ended March 31, 2025, was $57,000, a slight increase of $1,000 compared to $56,000 for the same period in 2024[133]. - Research and development expenses increased by $594,000, or 31%, to $2,506,000 for the three months ended March 31, 2025, primarily due to a $1.7 million increase in virology program expenses[135]. - General and administrative expenses decreased by $602,000, or 18%, to $2,754,000 for the three months ended March 31, 2025, mainly due to a reduction in consulting fees[136]. - The change in fair value of warrant liability was $26,513,000 during the three months ended March 31, 2025, reflecting the remeasurement of the warrant liability[137]. - The company sold and issued 42,100 shares of common stock under the ATM Agreement for net proceeds of $0.1 million during the three months ended March 31, 2025[138]. - Net cash used in operating activities was $5.4 million for Q1 2025, compared to $4.4 million in Q1 2024, reflecting a year-over-year increase of approximately 23%[143][144]. - The company reported a net income of $21.5 million for Q1 2025, which was offset by non-cash charges of $26.4 million, primarily due to changes in fair value of warrant liability[143]. - The net decrease in cash and cash equivalents for Q1 2025 was $5.4 million, slightly higher than the $4.4 million decrease in Q1 2024[142]. - Significant changes in operating assets and liabilities included a net decrease in accounts payable and accrued expenses of $1.2 million in Q1 2025[143]. Market and Operational Risks - The company faces risks related to financing, regulatory approvals, and market acceptance of its product candidates, which could materially affect its operations and financial condition[103]. - The company does not currently have a relationship for sales, marketing, and distribution of pharmaceutical products, which may impact future commercialization efforts[148]. - There were no financing activities reported for Q1 2024, while net cash provided by financing activities in Q1 2025 was immaterial[145]. - As of March 31, 2025, there have been no significant changes in critical accounting policies and estimates since the last annual report[150].

Financial Performance - Revenue for the quarter ended March 31, 2025, was $57 thousand, a slight increase from $56 thousand in the same period in 2024[10] - Total revenue for the three months ended March 31, 2025, was $57,000, a slight increase from $56,000 in the same period of 2024, representing a growth of approximately 1.79%[24] - The net income for the quarter was $21.5 million, significantly improved from a net loss of $5.0 million in the same period in 2024, driven by a change in fair value of warrant liability[12] - The net income for Q1 2025 was $21,490,000, compared to a net loss of $4,983,000 in Q1 2024, indicating a significant turnaround[24] - Net income per share of common stock, basic, was $2.17 in Q1 2025, compared to a loss of $5.92 per share in Q1 2024[24] - The change in fair value of warrant liability contributed $26,513,000 to the income statement in Q1 2025, with no comparable figure in Q1 2024[24] Expenses - Research and development (R&D) expenses for the quarter totaled $2.5 million, up from $1.9 million in the comparable period in 2024, primarily due to increased expenses related to virology programs[10] - Research and development expenses increased to $2,506,000 in Q1 2025, up from $1,912,000 in Q1 2024, reflecting a rise of about 30.96%[24] - General and administrative (G&A) expenses decreased to $2.8 million from $3.4 million in the same period in 2024, mainly due to reduced consulting fees[11] - General and administrative expenses decreased to $2,754,000 in Q1 2025, down from $3,356,000 in Q1 2024, a reduction of approximately 17.91%[24] Cash and Assets - As of March 31, 2025, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $15.9 million, down from $21.3 million as of December 31, 2024[9] - Total current assets decreased to $18,856,000 as of March 31, 2025, from $24,951,000 as of December 31, 2024, a decline of approximately 24.5%[22] - Stockholders' equity improved to $6,000,000 as of March 31, 2025, compared to a deficit of $31,630,000 as of December 31, 2024[22] Liabilities - Total liabilities significantly decreased to $13,063,000 as of March 31, 2025, down from $56,592,000 as of December 31, 2024, a reduction of about 76.98%[22] Product Development and Partnerships - Traws Pharma is preparing to submit a briefing package for ratutrelvir to regulatory authorities in Q2 2025, targeting acute COVID treatment and Long COVID[6] - Tivoxavir marboxil (TXM) is positioned for a multi-billion dollar market opportunity in the U.S. for bird flu and seasonal flu, with preparations underway for finalizing the development plan[7] - Phase 1 data for TXM indicated that it maintained plasma blood levels above the EC90 for approximately three weeks after a single oral dose, supporting its use as a single-dose treatment[7] - Ratutrelvir's pharmacokinetic profile showed maintenance of target blood plasma levels approximately 13 times above the EC50, indicating potential effectiveness against COVID-19[15] - Traws Pharma is seeking partnership opportunities for its legacy oncology assets, narazaciclib and rigosertib[6]

Company Focus and Clinical Programs - Traws Pharma, Inc. focuses on developing novel antiviral therapies targeting respiratory viral diseases, expanding its business after a merger with Trawsfynydd Therapeutics, Inc. on April 1, 2024[18]. - The company has four clinical programs: tivoxavir marboxil for influenza, ratutrelvir for COVID-19, narazaciclib for cancer, and rigosertib for various cancers[18]. - The merger with Trawsfynydd Therapeutics has shifted the company's focus from cancer therapies to include critical respiratory viral diseases[18]. Clinical Trial Results - Tivoxavir marboxil demonstrated a 100% protection rate in mice against H5N1 bird flu at a dose of 50 mg/kg, which is comparable to a human dose of 240 mg[26]. - In a Phase 1 clinical trial in Australia, tivoxavir marboxil maintained plasma drug levels above the EC90 for over 23 days after a single dose[22]. - Ratutrelvir showed non-inferiority to the combination of nirmatrelvir and ritonavir in an animal study, indicating its potential effectiveness against SARS-CoV-2[35]. - The Phase 1 trial for ratutrelvir included 40 participants, with a maximum dose of 600 mg showing no adverse events related to the study drug[36]. - Narazaciclib is a multi-targeted kinase inhibitor with a differentiated profile, potentially overcoming limitations of current CDK 4/6 inhibitors[38]. - Narazaciclib demonstrates a favorable kinase inhibitory profile compared to approved CDK4/6 inhibitors, potentially leading to both tumorigenic and safety benefits[45]. - In a Phase 1 study in China, 75% of enrolled patients had metastatic breast cancers, with 2 out of 3 patients at the 200 mg dose achieving stable disease[47]. - The Phase 1/2a trial of narazaciclib in combination with letrozole for recurrent metastatic endometrial cancer established a maximum tolerated dose of 160 mg[51]. - Narazaciclib inhibits CSF1R with IC50 values between 0.7 to 10 nM, indicating potential efficacy in cancers dependent on CSF1R signaling[40]. - The Phase 1 study in the US (Study 19-01) commenced in May 2021, assessing safety and pharmacokinetics of narazaciclib in patients with advanced cancer[48]. - In the Phase 1 study in China, dose-limiting toxicities were observed in 2 patients at the 200 mg dose, including Grade 4 ALT increase and Grade 3 platelet count decrease[47]. - Rigosertib has shown promising results in treating advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, with 2 complete responses observed[56]. Regulatory and Approval Processes - The company plans to meet with the FDA in the first half of 2025 to discuss accelerated approval for tivoxavir marboxil under the "Animal Rule" for H5N1 bird flu treatment[24]. - The process of obtaining regulatory marketing approvals is time-consuming and requires substantial financial resources[107]. - The FDA aims to complete its review of New Drug Applications (NDAs) for new molecular entities within 10 months of acceptance for filing[124]. - An approval letter from the FDA authorizes commercial marketing of the drug with specific prescribing information for designated indications[128]. - Post-approval requirements may include Phase 4 clinical trials and ongoing safety monitoring to assess the drug's effectiveness after commercialization[131]. - The FDA's approval process for new chemical entities (NCE) grants five years of marketing exclusivity, preventing ANDA or 505(b)(2) applications for the same active moiety during this period[143]. - The FDA allows for a patent term extension of up to five years for relevant drug patents, calculated based on the drug's testing and review phases, with a maximum total patent term of 14 years from the date of approval[145]. - The FDA's Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[159]. - The FDA's priority review designation sets a target action date of six months for drugs that provide significant improvements in treatment for serious conditions[165]. - The FDA's Fast Track designation allows for more frequent development meetings and a rolling review process for drugs addressing unmet medical needs[164]. - The Clinical Trials Regulation (EC) 536/2014 enables a single application for cross-border trials within the EU, streamlining the approval process[147]. - The FDA's regulations allow for expanded access to investigational drugs for patients with serious or life-threatening diseases under certain conditions[150]. - The FDA's Animal Rule permits approval of certain drugs based on animal studies when human efficacy studies are not ethical or feasible[154]. Financial Performance and Concerns - The company reported recurring operating losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern without obtaining adequate new financings[198]. - The independent registered accounting firm's report for the fiscal year ended December 31, 2024, contains an explanatory paragraph regarding the company's ability to continue as a going concern[200]. - The company has identified material weaknesses in its internal control over financial reporting, which could impair its ability to produce timely and accurate financial statements[200]. - The company needs to obtain additional funding to continue operations; failure to do so may require scaling back or ceasing operations[200]. - The company reported net losses of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for the year ended December 31, 2023, with an accumulated deficit of $649.2 million as of December 31, 2024[210]. - The company has incurred recurring losses from operations, leading to substantial doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[205]. - The company plans to explore various financing options, including equity financings and strategic alliances, to alleviate liquidity concerns and fund ongoing clinical trials and operations[204]. - The company has not generated any revenue from product sales to date and may never become profitable, depending on the successful commercialization of its product candidates[215]. - The company anticipates continuing to incur significant expenses and operating losses for the foreseeable future, which may increase as it seeks regulatory approvals for its product candidates[211]. - The company may need to delay or pause planned clinical trials until adequate additional funding is secured, impacting its development efforts[206]. Market and Competitive Landscape - The biotechnology and pharmaceutical industries are highly competitive, with many competitors having greater financial and technical resources[96]. - The company anticipates intense competition as new drugs enter the market and advanced technologies become available[97]. - Several companies have advanced drug candidates for COVID-19, including remdesivir and oral Paxlovid, both of which have received full FDA approval[99]. - The company faces substantial competition, which may result in others discovering, developing, or commercializing products before it does[201]. - The company expects to incur substantial expenses related to the integration of Trawsfynydd[201]. Regulatory Compliance and Risks - The company is subject to extensive regulation by the FDA and other agencies, impacting research, development, and marketing of product candidates[105]. - Manufacturers must comply with stringent regulations regarding advertising and promotion, ensuring claims are consistent with FDA-approved labeling[130]. - Changes to approved applications, such as modifications in indications or manufacturing processes, require submission of a new NDA or NDA supplement[129]. - The Hatch-Waxman Amendments require applicants to list all relevant patents with the FDA upon drug approval, which are published in the Orange Book[137]. - The FDA conducts periodic inspections to ensure compliance with current Good Manufacturing Practices (cGMP) after drug approval[132]. - Compliance with regulatory requirements is critical, as failure may result in sanctions including product recalls, fines, or withdrawal of approval[152]. Economic and Geopolitical Factors - The company is currently operating in a period of economic uncertainty and capital markets disruption, which could materially adversely affect its business and financial condition[219]. - The ongoing military conflicts and geopolitical tensions may impact the company's operations and access to funding, although it has not been materially affected to date[223]. - International trade disputes may lead to tariffs and protectionist measures, adversely affecting the company's business and financial condition[224]. - Changes in U.S.-China relations and regulations could impact the company's operating results and ability to raise capital[225]. - Potential new legislation or tariffs could have negative effects on the company's financial condition and market share[227]. - Inflation may increase the company's overall cost structure, affecting liquidity and financial results[228]. - Higher interest rates and capital costs due to inflation could lead to supply shortages and increased operational costs[228].

Financial Performance - Traws Pharma reported a net loss of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for 2023, resulting in a net loss per share of $35.21[16] - Total revenue for 2024 remained unchanged at $226 million compared to 2023[28] - Operating expenses increased significantly to $142.6 million in 2024 from $20.5 million in 2023, primarily due to acquired in-process research and development costs of $117.5 million[28] - Net loss for 2024 was $166.5 million, a substantial increase from a net loss of $18.9 million in 2023[28] - Net loss attributable to common stockholders was $54.7 million, with a net loss per share of $35.21 for 2024[28] - Net loss attributable to Series C Preferred stockholders was $111.8 million, with a net loss per share of $14,085.00[28] - The company reported a loss from operations of $142.4 million in 2024, compared to a loss of $20.3 million in 2023[28] Cash and Investments - Cash, cash equivalents, and short-term investments as of December 31, 2024, were approximately $21.3 million, up from $20.8 million at the end of 2023, reflecting $20 million in gross proceeds from financing[13] Expenses - Research and development (R&D) expenses for 2024 totaled $12.8 million, an increase of $1.4 million from $11.4 million in 2023, primarily due to clinical and preclinical trials[14] - General and administrative (G&A) expenses rose to $12.3 million in 2024, up from $9.1 million in 2023, mainly due to increased consulting fees[15] - Other income decreased to $289,000 in 2024 from $1.35 million in 2023[28] Liabilities - The total liabilities of Traws Pharma increased significantly to $56.6 million as of December 31, 2024, compared to $12.0 million in 2023, largely due to warrant liabilities[26] Product Development - Traws Pharma's lead product candidate, tivoxavir marboxil, demonstrated robust antiviral activity in three validated flu models and positive Phase 1 pharmacokinetic results[3] - The company plans to provide an update on FDA discussions regarding the Animal Rule for tivoxavir marboxil in Q2 2025[6] - Traws Pharma aims to finalize the development plan for tivoxavir marboxil and move forward on the path to approval in 2025[6] - Ratutrelvir, the company's COVID-19 candidate, showed promising data at the International Conference for Antiviral Research (ICAR 2025)[11] Share Information - As of March 26, 2025, Traws had 5,073,790 shares of common stock outstanding, reflecting the issuance of 3.9 million shares related to the December 2024 financing[17] - The weighted-average shares of common stock outstanding increased to 1,552,685 in 2024 from 839,554 in 2023[28]

Financial Performance - As of September 30, 2024, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $5.4 million, down from $20.8 million at December 31, 2023[6] - The net loss for Q3 2024 was $8.5 million, or $8.81 per share, compared to a net loss of $4.7 million, or $5.64 per share, for the same period in 2023[9] - Traws Pharma's total operating expenses for Q3 2024 were $8.6 million, compared to $5.1 million in Q3 2023, reflecting a significant increase in R&D and G&A costs[15] - The company reported total liabilities of approximately $10.97 million as of September 30, 2024, down from $12.01 million at the end of 2023[14] - Traws Pharma's accumulated deficit increased to approximately $619.2 million as of September 30, 2024, compared to $482.6 million at the end of 2023[14] Research and Development - Research and development (R&D) expenses for Q3 2024 totaled $5.1 million, an increase of 104% compared to $2.5 million for the same period in 2023[7] - Phase 1 data for ratutrelvir indicates potential for once-a-day dosing without ritonavir, showing no treatment-related adverse events and consistent plasma drug levels[3] - Tivoxavir marboxil demonstrated good tolerability in Phase 1 studies, maintaining plasma drug levels above the EC90 for over five days, supporting its potential as a single-dose treatment for influenza[4] - Traws Pharma plans to initiate Phase 2 clinical proof of concept studies for both tivoxavir marboxil and ratutrelvir in community-acquired settings in 2025[3] General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2024 were $3.5 million, up from $2.7 million in Q3 2023, primarily due to a $1.2 million increase in professional and consulting fees[8]

Financial Performance - Traws Pharma reported a net loss of $123.1 million for Q2 2024, equating to $4.87 per basic and diluted common share, significantly higher than the net loss of $4.3 million or $0.20 per share in Q2 2023[9]. - Revenue for Q2 2024 was $57,000, consistent with Q2 2023[16]. - Total operating expenses for Q2 2024 were $123,405,000, compared to $4,667,000 in Q2 2023[16]. - Net loss for Q2 2024 was $123,143,000, compared to a net loss of $4,250,000 in Q2 2023[16]. - Loss from operations for Q2 2024 was $(123,348,000), significantly higher than $(4,610,000) in Q2 2023[16]. - Basic and diluted net loss per share for Q2 2024 was $(4.87), compared to $(0.20) in Q2 2023[16]. - Acquired in-process research and development expenses were $117,464,000 for Q2 2024, with no prior year comparison[16]. - Research and development expenses increased to $3,964,000 in Q2 2024 from $2,456,000 in Q2 2023[16]. - General and administrative expenses decreased to $1,977,000 in Q2 2024 from $2,211,000 in Q2 2023[16]. - Other income for Q2 2024 was $205,000, down from $360,000 in Q2 2023[16]. Cash and Liabilities - The company had cash, cash equivalents, and short-term investments of approximately $16.9 million as of June 30, 2024, down from $20.8 million at the end of 2023, which is expected to support operations through year-end 2024[7]. - Traws Pharma's total liabilities as of June 30, 2024, were approximately $12.6 million, compared to $12.0 million at the end of 2023[15]. Research and Development - Research and development (R&D) expenses for Q2 2024 totaled $4.0 million, an increase from $2.5 million in the same period of 2023, primarily due to costs associated with ongoing clinical studies[8]. - Traws Pharma completed a merger with Trawsfynydd Therapeutics and a concurrent private placement of $14 million, expanding its clinical portfolio to include two oral small molecule programs for influenza and COVID-19[5]. - The company is advancing its antiviral program, with Phase 1 results for tivoxavir marboxil expected in Q4 2024 and initiation of Phase 2 studies planned for Q4 2024/Q1 2025[3]. - Ratutrelvir, targeting COVID-19, completed Phase 1 studies in Australia, with topline results expected in Q4 2024 and Phase 2 studies to follow[4]. - The oncology strategy includes investigator-sponsored trials for narazaciclib, with topline results from Phase 1/2 studies anticipated in H2 2024[3]. - The company plans to announce the recommended Phase 2 dose for narazaciclib and initiate ISTs in multiple myeloma and breast cancer in H2 2024[3]. Corporate Communication - A corporate update call is scheduled for August 15, 2024, to discuss recent business progress and financial results[1].