# EDGAR Filing Document

**Accession Number:** 0001130598
**File Stem:** 0001104659-26-006460
**Filing Date:** 2026-1
**Character Count:** 18468
**Document Hash:** dabb523ba645e9db3723bf7784535d9f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-26-006460.hdr.sgml**: 20260126

**ACCESSION NUMBER**: 0001104659-26-006460

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260126

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260126

**DATE AS OF CHANGE**: 20260126

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Traws Pharma, Inc.
- **CENTRAL INDEX KEY:** 0001130598
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36020
- **FILM NUMBER:** 26558516

**BUSINESS ADDRESS:**
- **STREET 1:** 12 PENNS TRAIL
- **CITY:** NEWTOWN
- **STATE:** PA
- **ZIP:** 18940
- **BUSINESS PHONE:** 267-759-3680

**MAIL ADDRESS:**
- **STREET 1:** 12 PENNS TRAIL
- **CITY:** NEWTOWN
- **STATE:** PA
- **ZIP:** 18940

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Onconova Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20090526

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ONCONOVA THERAPEUTICS, INC.
- **DATE OF NAME CHANGE:** 20090526

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ONCONOVA THERAPEUTICS INC
- **DATE OF NAME CHANGE:** 20001226

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, DC 20549**

**FORM 8-K**

**CURRENT REPORT**

**PURSUANT TO SECTION 13 OR 15(d) OF THE**

**SECURITIES EXCHANGE ACT OF 1934**

Date of Report (Date of earliest event reported): January 26, 2026

**Traws Pharma, Inc.**

(Exact name of Registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-36020** | **22-3627252** |
| (State or Other Jurisdiction<br> of Incorporation or Organization) | (Commission<br> File Number) | (I.R.S. Employer<br> Identification No.) |

---

---

| |
|:---|
| **12 Penns Trail**<br> **Newtown, PA 18940** |
| **(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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 stock, par value $.01 per share | TRAW | The 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 26, 2026, Traws Pharma, Inc. (the "Company") issued a press release (the "Press Release") announcing the completion of its ongoing study of ratutrelvir, a ritonavir-free potential treatment, in PAXLOVID<sup>®</sup>-eligible and ineligible patients with mild-to-moderate COVID-19, and plans for additional indication for tivoxavir marboxil as a prophylactic treatment for seasonal influenza. 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-Looking Statements***

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. Financial Statements and Exhibits.**

(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm264027d1_ex99-1.htm) | [Press Release, dated January 26, 2026.](tm264027d1_ex99-1.htm) |
| 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 26, 2026 | **TRAWS PHARMA, INC.** | **TRAWS PHARMA, INC.** |
|  | By: | /s/ Iain Dukes |
|  |  | Iain Dukes |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![A logo with text on it Description automatically generated](tm264027d1_ex99-1.jpg)

**Traws Pharma Completes Enrollment of Ratutrelvir Clinical Study in PAXLOVID*<sup>®</sup>*-Eligible and Ineligible COVID-19 Patients; Announces Plans for Added Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza**

*Ongoing clinical results with ratutrelvir confirm a differentiated profile versus PAXLOVID<sup>®</sup> with fewer adverse events, no viral rebounds to date and faster time to sustained symptom resolution; results recapitulated in PAXLOVID<sup>®</sup>-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 challenge study time slot secured for June 2026* 

NEWTOWN, PA, January 26, 2026 (GLOBENEWSWIRE) -- 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 completion of enrollment in its ongoing 90-patient, open-label Phase 2 study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, versus PAXLOVID*<sup>®</sup>,* in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID*<sup>®</sup>*-ineligible subjects. Patients ineligible to receive PAXLOVID<sup>®</sup> 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 Company also provided an update on the progress of the tivoxavir marboxil program for influenza.

**Ratutrelvir Update**

The study, designed as an active-controlled comparator trial versus PAXLOVID<sup>®</sup> (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.

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

"From a clinical perspective, the ongoing data analysis confirms previous reports 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."

"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)," continued **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."

**Tivoxavir Marboxil Update**

The Company additionally announced that it is progressing an additional indication for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, as a single monthly oral tablet for the prophylactic treatment of seasonal influenza.

"In prior Phase 1 studies in healthy volunteers, an unformulated powder-in-capsule formulation provided blood levels exceeding 3X the EC<sub>50</sub> against a basket of common seasonal influenza variants for up to 22 days after drug administration. A new compressed tablet formulation may provide 28 day coverage, enabling a once-a-month prophylactic treatment," commented **C. David Pauza, PhD, Chief Science Officer** of Traws Pharma.

"Once a planned bridging healthy volunteer study has confirmed the extended exposure, we will progress TXM into a seasonal influenza virus prophylaxis Challenge Study in June 2026 at hVIVO, the pe-eminent CRO for such studies. Positive results will enable progression into registration studies," continued **Dr. Pauza**.

"Collectively, the advancement of our antiviral portfolio provides a number of significant value inflection points and could provide needed treatment and prevention options for clinically important viral diseases," 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<sup>1</sup>, 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 EC<sub>50</sub> 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<sup>2</sup>. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity<sup>3</sup>.

**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 the treatment or prophylaxis of 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<sup>4,5</sup>, 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. <u>https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646</u> 

2. Carly Herbert et al. (2025)
 Clinical Infectious Diseases. <u>https://pubmed.ncbi.nlm.nih.gov/39692474/</u> 

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 Commission on February 27, 2025

4. <u>Per link</u> 

5. TRAW data on file

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-19 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 potential efficacy and tolerability of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the success and timing of Traws' clinical trials, including when Traws will report results of its studies of tivoxavir marboxil; the potential efficacy of tivoxavir marboxil to provide 28-day coverage against seasonal influenza variants; the potential for ratutrelvir or tivoxavir marboxil 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.<br> <u>cparker@trawspharma.com</u>

www.trawspharma.com

**Investor Contact:**

John Fraunces<br> LifeSci Advisors, LLC<br> 917-355-2395<br> <u>jfraunces@lifesciadvisors.com</u>