# EDGAR Filing Document

**Accession Number:** 0001130598
**File Stem:** 0001104659-25-098994
**Filing Date:** 2025-10
**Character Count:** 14146
**Document Hash:** 0802201175d8034f37235747b8fda85f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-098994.hdr.sgml**: 20251014

**ACCESSION NUMBER**: 0001104659-25-098994

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251014

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251014

**DATE AS OF CHANGE**: 20251014

**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:** 251389573

**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): October 14, 2025

**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:

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| | | |
|:---|:---|:---|
| **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. ◻

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

---

On October 14, 2025, Traws Pharma, Inc. (the "Company") issued a press release (the "Press Release") announcing the dosing of the first subject in its Phase 2 study to evaluate ratutrelvir, a ritonavir-free treatment, in newly diagnosed COVID subjects. 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.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2528641d2_ex99-1.htm) | [Press Release, dated October 14, 2025.](tm2528641d2_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL Document) |

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**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: October 14, 2025 | **TRAWS PHARMA, INC.** | **TRAWS PHARMA, INC.** |
|  | By: | /s/ Iain Dukes |
|  |  | Iain Dukes |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![](tm2528641d2_ex99-1img001.jpg)

**Traws Pharma Doses First Patient with Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025**

*Non-inferiority trial versus PAXLOVID<sup>®</sup> assessing safety and efficacy, including rates of disease rebound and incidence of Long COVID development, of ratutrelvir, a ritonavir-free anti-viral treatment*

*Separate single-arm trial assessing safety and efficacy in PAXLOVID<sup>®</sup>-ineligible subjects, who represent a significant, vulnerable population with few available treatment options*

*Top-line data from both trials expected by year-end 2025*

NEWTOWN, PA, October 14, 2025 (GLOBE NEWSWIRE) – Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed COVID subjects.

"The first trial will enable Traws to compare ratutrelvir, a potential best in class ritonavir-free agent, against the current gold standard, PAXLOVID<sup>®</sup>," said **Iain D. Dukes, MA, DPhil, Chief Executive Officer** of Traws Pharma. "This study will evaluate safety, as well as rates of infection, COVID symptoms, disease rebound and incidence of Long COVID. In addition, we will initiate a second trial to evaluate the safety and efficacy of ratutrelvir in PAXLOVID<sup>®</sup>-ineligible patients, a population at risk for poor outcomes from COVID infection with few available treatment options. Our expectation is to be able to report the results of both Phase 2 studies by year-end 2025."

"Across the US, we see multiple signs that COVID continues to threaten public health, especially among elderly and vulnerable individuals," said **Robert R. Redfield, MD, Chief Medical Officer** of Traws Pharma. "We believe that Traws' ritonavir-free COVID therapeutic candidate, ratutrelvir, has the potential to overcome the shortcomings of current treatments and become the new standard of care. Ratutrelvir's good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and the risk of Long COVID. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program."

**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 showed 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 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>.

**Source information:**

1. https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646

2. Carly Herbert
 et al. (2025) Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae539

3. Pfizer Inc.
 10K report 2024, Feb 27, 2025

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 <u>https://www.ir.trawspharma.com/partnering</u>.

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", "potential", "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 success and timing of Traws' clinical trials, including when Traws will report results of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or 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; 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> cparker@trawspharma.com

www.trawspharma.com

**Investor Contact:**

John Fraunces<br> LifeSci Advisors, LLC<br> 917-335-2395<br> jfraunces@lifesciadvisors.com