Form 8-K - Current report

 

 

 

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 23, 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

[phone]

(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 23, 2025, Traws Pharma, Inc. (the “Company”) issued a press release announcing the completion of the Phase 1 studies 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 January 23, 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: January 23, 2025	TRAWS PHARMA, INC.
	By:	/s/ Mark Guerin
		Mark Guerin
		Chief Financial Officer

 

 

 

Exhibit 99.1

 

Traws Pharma Announces Completion of Phase I studies with Tivoxavir marboxil, a single dose oral investigational drug for the treatment and prevention of H5N1 Bird Flu

 

Phase I completed in healthy volunteers with pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention

 

 

NEWTOWN, PA, January 23, 2025 (PR 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 completion of Phase 1 clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.

 

“We believe that our clinical data in healthy volunteers support accelerated development of tivoxavir marboxil in response to the growing threat of bird flu,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.

 

“The first U.S. death from the bird flu² and the spread into commercial poultry farms highlights a growing threat to public health” 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). “We believe that new antiviral therapies, with proven activity against the H5N1 bird flu, are needed to address this potential threat. Continued circulation of this H5N1 virus in wild birds and mammals, plus spread of the virus from cattle or poultry to agricultural workers, sustains the risk for virus adaptation and human to human transmission.³”

 

“Topline data from the Phase I study demonstrated safety and tolerability of tivoxavir marboxil in humans at levels of exposure that have demonstrated potent inhibition of H5N1 and informs dose selections for further testing in relevant animal models of bird flu,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “The combined clinical and animal model data package will guide our upcoming regulatory meetings as we advance this product and, hopefully, provide an important medical countermeasure against bird flu.”

 

Topline Phase 1 Results

 

The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending doses of one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers.

 

No significant treatment related adverse events were reported during the Phase 1 study, which evaluated four dose levels. Preclinical studies showed that tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses¹, both in vitro and in vivo.

 

 

 

 

About Tivoxavir Marboxil

 

Seasonal influenza represents an estimated multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders¹, with upside potential from pandemic flu outbreaks. 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 dose of tivoxavir marboxil on lethal bird flu infection. We believe that these data support further development of tivoxavir marboxil as a one-time treatment for bird flu.

 

Source information:

1.

TRAW data on file

2.

https://www.cdc.gov/media/releases/2025/m0106-h5-birdflu-death.html

3.

http://dx.doi.org/10.15585/mmwr.mm7344a3

 

About Traws Pharma, Inc. antiviral programs

 

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 oral, novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, 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.

 

Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a commitment to patients in need and vulnerable populations, we aim to build solutions for important medical challenges and alleviate the burden of viral infectious disease.

 

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 extent of the spread and threat of the bird flu, 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:

 

Mark Guerin

Traws Pharma, Inc.

267-759-3680

www.trawspharma.com

 

 

 

Cover	Jan. 23, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 23, 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
Entity Address, Postal Zip Code	18940
City Area Code	267
Local Phone Number	759-3680
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, par value $.01 per share
Trading Symbol	TRAW
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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