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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 1, 2025

 

Traws Pharma, Inc.

(Exact name of Registrant as specified in its charter)

 

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

 

12 Penns Trail

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 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Independent Director

 

On October 1, 2025, upon recommendation of the Nominating and Corporate Governance Committee of the Board of Directors (“Board”) of Traws Pharma, Inc. (the “Company”), the Board appointed John Leaman, MD as an independent director, with a term expiring at the Company’s 2025 annual meeting of stockholders. Dr. Leaman was also appointed as a member of the Audit Committee of the Board.

 

The compensation for Dr. Leaman’s service as a director will be consistent with that of the Company’s other non-employee directors, as described in Amendment No. 1 to the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 30, 2025. There are no arrangements or understandings between Dr. Leaman and any other persons pursuant to which Dr. Leaman was elected as a director. Dr. Leaman has not engaged in any related-person transactions required to be disclosed by Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

 

In connection with the appointment, Dr. Leaman entered into the Company’s standard form of indemnification agreement, a copy of which is filed as Exhibit 10.8 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025.

 

Change in Executive Titles

 

On October 1, 2025, the Board eliminated the “interim” notations in the titles of Dr. Iain Dukes and Charles Parker, who now hold the titles of Chief Executive Officer and Chief Financial Officer of the Company, respectively.

 

As previously disclosed, Mr. Parker has been retained to provide such services as a non-employee consultant of the Company through Stout, a global advisory firm specializing in corporate finance and accounting services. The Company will pay Stout $500 per hour, up to a maximum of $50,000 per month, for services provided by Mr. Parker in his capacity as Chief Financial Officer of the Company.

 

Item 7.01Regulation FD Disclosure.

 

On October 6, 2025, the Company issued a press release (the “Press Release”) announcing the appointment of Dr. Leaman to the Board and the change in Dr. Dukes’ and Mr. Parker’s titles. 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 7.01.

 

The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated October 6, 2025.
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: October 6, 2025 TRAWS PHARMA, INC.
     
  By: /s/ Iain Dukes
    Iain Dukes
    Chief Executive Officer

 

 

 

 Exhibit 99.1

 

Traws Pharma Adds John Leaman, MD as Independent Director and Formalizes Appointments of Two Key Executives

 

NEWTOWN, PA, October 6, 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 appointment of John Leaman, MD to its board of directors as an independent director, effective October 1, 2025. In addition, Traws’ Board of Directors (the “Board”) has eliminated the interim notation of its key executives Iain Dukes and Charles Parker, who are now Chief Executive Officer and Chief Financial Officer, respectively.

 

"Dr. Leaman brings more than a decade of experience in finance, M&A and corporate strategy, and we are excited to welcome him to our Board of Directors. In addition, eliminating the interim title of our key executive officers indicates the full support of them by the Board," said Jack E. Stover, Chairman of Traws Pharma.

 

"We believe Dr. Leaman’s insights and guidance will be invaluable as we prepare to enroll subjects in Phase 2 studies evaluating the safety and efficacy of ratutrelvir, designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that can be used without ritonavir,” added Iain D. Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma.

 

John H. Leaman, MD is currently the Chief Financial Officer at Cellarity Inc. During his tenure, he has helped oversee the close of a large pharma partnership, as well as leading the Company's Series D crossover financing. Prior to joining Cellarity in 2023, Dr. Leaman served as the Chief Financial Officer and Chief Business Officer at Impel Pharmaceuticals LLC, where he helped lead the Company's IPO in 2021. Before that, Dr. Leaman served as the Chief Financial Officer and Head of Corporate Development at Selecta Biosciences, Inc. and as Head of Corporate Development at InfaCare Pharmaceutical Corporation until it was acquired by Mallinckrodt pls in 2017. Earlier, Dr. Leaman was the Chief Financial Officer of Medgenics, Inc. and previously held senior roles at Shire plc and Devon Park Bioventures, a venture capital fund targeting investments in therapeutics companies. He began his career serving a range of life sciences companies as an Associate Principal at McKinsey & Company.

 

Dr. Leaman received an MD from the Perelman School of Medicine at the University of Pennsylvania, an MBA from the Wharton School at the University of Pennsylvania, a BA in Psychology, Philosophy and Physiology from Oriel College, University of Oxford while completing a Rhodes Scholarship, and a BS in Biology from Elizabethtown College.

 

"I am thrilled to join Traws’ Board of Directors as the Company progresses with its lead anti-viral product candidate, ratutrelvir, for COVID,” said Dr. Leaman. "I look forward to working with Traws’ Board and leadership team as it accelerates developing novel therapies to treat respiratory viral diseases."

 

The appointment further underscores Traws’ focus on strong governance, independent oversight, and disciplined execution.

 

 

 

 

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 interactions1, 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 COVID2. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3,4.

 

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 initiatives5,6, 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://doi.org/10.1093/cid/ciae539

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

4.    Merck & Co 10K, Feb 25, 2025

5.    Per link

6.    TRAW data on file

 

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, and the expected impact of new leadership appointments. 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 success and timing of Traws’ clinical trials, 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. 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.
[email protected]

www.trawspharma.com

 

Investor Contact:

 

John Fraunces
LifeSci Advisors, LLC
917-335-2395
[email protected]