TRAW Traws Pharma Inc

 

 

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): March 3, 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 8.01

Other Events.

 

On March 3, 2025, Traws Pharma, Inc. (the “Company”) issued a press release announcing positive topline data results from a preclinical animal model study for its investigational one-dose influenza therapy, tivoxavir marboxil, for treatment of H5N1 avian influenza. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated March 3, 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: March 3, 2025	TRAWS PHARMA, INC.
	By:	/s/ Werner Cautreels
		Werner Cautreels
		Chief Executive Officer

 

 

Exhibit 99.1

 

Traws Pharma Reports Positive Results from An Accepted Bird Flu Model for Anti-Viral Candidate, Tivoxavir Marboxil

 

NEWTOWN, PA, March 3, 2025 (GLOBE NEWSWIRE) – Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as a single dose. These data are consistent with results reported in December 2024 in a murine model. The new studies reported today evaluated the efficacy of a single dose of tivoxavir marboxil as a treatment for bird flu isolated from a Texas dairy worker and showed suppression of disease, with reduced viral burden in lungs.

 

“Topline data from the ferret model testing show that tivoxavir marboxil has the potential to inhibit disease after bird flu infection,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “The ferret challenge study builds on the robust protection from bird flu that we observed in a murine model and broadens our understanding of the disease process and the likely range of human doses that will be needed for treatment. We are conducting a similar challenge study in non-human primates, with data expected in Q1 2025.”

 

“We are witnessing a steady increase in the spread of bird flu,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “Dramatic increases in the number of infected poultry and dairy cattle, with increasing numbers of human exposures including one fatal case in the USA, confirm the ongoing threat of bird flu and the increasing risk for wider spread in the human population. We believe safe and effective antiviral drugs will be a critical component in the response to bird flu and that the development and testing of tivoxavir marboxil could be an important step to achieving that goal. The spread of bird flu in animals and increasing numbers of human exposures underscore the pressing need for effective medical countermeasures.”

 

“With the non-human primate data in hand, we intend to approach the FDA to discuss an accelerated approval under to the “Animal Rule¹,” said Werner Cautreels, Chief Executive Officer of Traws Pharma. “We plan to host a Virtual Investor Update on March 31, 2025 to provide a detailed review of the bird flu program.

 

 

Topline Preclinical Results in Ferrets

 

Substantial changes in disease progression were observed after a single oral dose of tivoxavir marboxil in the ferret model of bird flu using the A/Texas/37/2024 H5N1 virus isolated from an infected dairy worker in Texas. A lethal challenge in ferrets showed that tivoxavir marboxil increased the proportion of surviving animals and lowered the viral burden in lungs and nasal tissues. Ferrets are an accepted animal model for evaluating treatments for influenza.

Source:

 

1.

CFR314.600 thru 314.650, October 2015, https://www.fda.gov/media/88625/download

 

About Tivoxavir Marboxil

 

Tivoxavir marboxil was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains in preclinical studies, including the highly pathogenic avian flu H5N1 (bird flu). Completed and ongoing animal model studies are assessing the impact of a single oral dose of tivoxavir marboxil on bird flu infection. We believe that these data support further development of tivoxavir marboxil as a one-time treatment for bird flu. Bird flu and seasonal influenza are estimated to represent a potential multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders.

 

About Traws Pharma, Inc.

 

Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases. The viral respiratory disease program includes two novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir.

 

 

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, benefits and the regulatory plans for tivoxavir marboxil. 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, collaborations, market conditions, regulatory requirements; the final data results of the ferret animal model testing; previously reported results of murine studies; studies underway in non-human primates; potential to report the results of non-human primate studies in Q1 2025; the previously reports results of Phase 1 studies; the Company’s intention to seek FDA guidance on the regulatory path; the extent of the spread and threat of bird flu; the potential effectiveness of the use of tivoxavir marboxil for treatment in humans; 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:

Nora Brennan

Traws Pharma, Inc.

nbrennan@trawspharma.com

www.trawspharma.com

 

Investor Contact:

Bruce Mackle

LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

 

 

 

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Cover	Mar. 03, 2025
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Document Type	8-K
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Document Period End Date	Mar. 03, 2025
Entity File Number	001-36020
Entity Registrant Name	Traws Pharma, Inc.
Entity Central Index Key	0001130598
Entity Tax Identification Number	22-3627252
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	12 Penns Trail
Entity Address, City or Town	Newtown
Entity Address, State or Province	PA
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Title of 12(b) Security	Common stock, par value $.01 per share
Trading Symbol	TRAW
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Entity Emerging Growth Company	false

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