8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OFTHE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):

January 13, 2026

Traws

Pharma, Inc.

(Exact name of Registrant as specified in its charter)

Delaware	001-36020	22-3627252
(State or Other Jurisdiction<br><br> of Incorporation or Organization)	(Commission<br><br> File Number)	(I.R.S. Employer<br><br> Identification No.)
12 Penns Trail<br><br><br>Newtown, PA 18940
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(267 ) 759-3680

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive

Offices)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨	Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨	Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common<br> stock, par value $.01 per share	TRAW	The<br> Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

On January 13, 2026, Traws Pharma, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the filing of a U.S. Investigational New Drug Application with the U.S. Food and Drug Administration for tivoxavir marboxil and providing updated results from its ongoing study of ratutrelvir, a ritonavir-free treatment, in PAXLOVID®-eligible and ineligible patients with mild-to-moderate COVID-19. A copy of the Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference into this Item 8.01.

Forward-LookingStatements

This Current Report, including Exhibit 99.1, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to the Company or its management, are intended to identify such forward-looking statements.

Forward-looking statements in this Current Report, including Exhibit 99.1, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by the Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Securities and Exchange Commission, each of which could adversely affect the Company’s business and the accuracy of the forward-looking statements contained herein.

Item 9.01 FinancialStatements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, dated January 13, 2026.
104	Cover Page Interactive Data File (embedded within the inline XBRL Document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 13, 2026	TRAWS PHARMA, INC.
	By:	/s/ Iain Dukes
		Iain Dukes
		Chief Executive Officer

Exhibit 99.1

Traws Pharma Files Tivoxavir Marboxil InvestigationalNew Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID^®^-Eligibleand Ineligible COVID-19 Patients**

IND filing of tivoxavir marboxil representsfinal step for formal consideration by the Center for the Biomedical Advanced Research and Development Authority (BARDA) for inclusionin strategic stockpile

Updated clinical results with ratutrelvir confirma differentiated profile versus PAXLOVID^®^ with fewer adverse events, no viral rebounds and faster time to sustained symptomresolution

Ratutrelvir’s safety and efficacy advantagerecapitulated in PAXLOVID^®^-ineligible patients, representing a significant population with few effective treatment options

Full study enrollment expected in January 2026

NEWTOWN, PA, January 13, 2026 (GLOBAL 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 human health from respiratory viral diseases, today announced the filing of a U.S. IND application with the U.S. Food and Drug Administration (FDA) for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor as a single oral tablet administered for the treatment of influenza.

“This filing represents an important step towards formal consideration of TXM for influenza therapy and inclusion in the strategic national stockpile,” commented C. DavidPauza, PhD, Chief Scientific Officer of Traws Pharma. “Coupled with our ongoing positive interactions with the U.S. Department of Health and Human Services (HHS) regarding the unique properties of TXM as a broad pan-influenza strain therapeutic, we remain optimistic about the potential inclusion of this agent in the nation’s armamentarium against potential future disease outbreaks.”

Updated ratutrelvir interim clinical resultsfrom the Phase 2 COVID study

Separately, the Company announced updated analysis of its ongoing study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, confirming a differentiated clinical profile in a prespecified interim analysis of an ongoing randomized, open-label Phase 2 clinical study versus PAXLOVID*^®^* in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID*^®^*-ineligible subjects. Patients ineligible to receive PAXLOVID^®^ are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option.

The study, designed as an active-controlled comparator trial versus PAXLOVID^®^ (nirmatrelvir/ritonavir), evaluated patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications or clinically significant drug–drug interactions. To date, 50 patients have been included in the interim analysis, with 32 patients treated with ratutrelvir and 18 patients treated with PAXLOVID^®^. Of the planned 90-patient population, 95% has been enrolled.

Patients in the ratutrelvir arm received ratutrelvir 600 mg orally once daily for 10 days, while patients in the comparator arm received PAXLOVID^®^, administered as nirmatrelvir 300 mg twice daily plus 100mg ritonavir twice daily for 5 days, consistent with approved prescribing information.

“From a clinical perspective, these interim data confirm that ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable to receive ritonavir-boosted therapy,” commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “The favorable tolerability profile, together with a shortened time to symptom resolution and the absence of viral rebound events in ratutrelvir-treated patients, encourages and supports the continued clinical evaluation of ratutrelvir in both acute COVID-19 and in studies designed to better understand its potential impact on longer-term outcomes.”

Across the analysis, ratutrelvir-treated patients demonstrated time-to-sustained symptom alleviation and resolution that was numerically superior to PAXLOVID^®^ -treated patients, as assessed using the InFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus)/ COVID-19 Symptoms Diary (12 days versus 14 days, respectively (p<0.014)). Sustained alleviation was defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days.

No COVID-19 symptom or virologic rebound events have been observed to date in ratutrelvir-treated patients. One rebound event was observed in the PAXLOVID^®^ comparator arm, occurring shortly after completion of the standard 5-day dosing regimen.

Thirteen patients treated with ratutrelvir were ineligible for PAXLOVID^®^ due to contraindications or drug–drug interaction risk. These patients demonstrated patient-reported symptom improvement dynamics and safety, consistent with those observed in the broader ratutrelvir-treated cohort.

Ratutrelvir was well tolerated in the interim analysis, with fewer reported adverse events compared with the PAXLOVID^®^-treated cohort. Evaluating only subjects that had completed the 28 day period of assessment, the most commonly reported adverse event among ratutrelvir-treated patients was mild dyspepsia, reported in 2 patients (7.6%). No dysgeusia or ritonavir-associated adverse effects were reported, and no treatment discontinuations due to adverse events were observed.

In contrast, adverse events commonly associated with PAXLOVID^®^, including dysgeusia, dizziness, and dyspepsia, were reported in 4 patients (30%) in the comparator arm, consistent with prior clinical trial and real-world experience.

“The combination of early and sustained symptom improvement, extended dosing duration, absence of viral rebound observed to date, and favorable tolerability supports the strategic hypothesis that ratutrelvir may have utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID),” commented Dr. Redfield. “By enabling earlier and potentially more complete viral clearance, without the limitations associated with ritonavir boosting, ratutrelvir may offer a differentiated approach to both acute COVID-19 treatment and prevention of longer-term complications, pending confirmation in dedicated clinical studies.”

“Collectively, the interim data position ratutrelvir as a next-generation oral 3CL protease inhibitor with ritonavir-free administration, once-daily oral dosing, an improved time to symptom resolution and tolerability profile, with applicability to PAXLOVID*^®^*-ineligible populations, and potential relevance to long-COVID prevention strategies,” commented Iain Dukes MA DPhil, Chief Executive Officer of Traws Pharma.

About Ratutrelvir

Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions^1^, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID^2^. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity^3^.

About Tivoxavir Marboxil

Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives^4,5^, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu.

Source information

1.	https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646
2.	Carly Herbert et al. (2025) Clinical Infectious Diseases. https://pubmed.ncbi.nlm.nih.gov/39692474/
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3.	Pfizer Inc. annual report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange<br>Commission on February 27, 2025
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4.	Per link
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5.	TRAW data on file
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Third-party products mentioned herein are the trademarks of their respective owners.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN).

Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering.

For more information, please visit www.trawspharma.com and follow us on LinkedIn.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA; the success and timing of Traws’ clinical trials, including when Traws will report the final analysis of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.

Traws Pharma Contact:

Charles Parker

Traws Pharma, Inc.

cparker@trawspharma.com

www.trawspharma.com

Investor Contact:

John Fraunces

LifeSci Advisors, LLC

917-355-2395

jfraunces@lifesciadvisors.com