Traws Pharma reports positive results of an accepted bird

Newtown, Pa., March 03, 2025 (Globe Newswire)-Traws Pharma, Inc. (Nasdaq: Traw) (“Traws Pharma”, “Traws” Or “The Company”), A Clinical Stage Biopharmaceutical Developing Oral Small Moleculer Therapy for the Treatment of Respiratory Viral Diseases, Today AnnoUnced Positive TopLine result from Ferrets Infected with H5N1 Bird Flu, to accepted animal model for human influenza if it is treated with Tivoxavir Marboxil as a single dose. This data matches the results specified in December 2024 in a mouse model. The new studies reported today evaluated the effectiveness of a single dose of Tivoxavir Marboxil as the treatment of bird flu, which isolated from a milk worker in Texas and showed an oppression of diseases with a reduced virus load in the lungs.

“Topline data from the Ferret model test show that Tivoxavir Marboxil has the potential to inhibit the disease after bird flu infection” C. David Pauza, PhD, Chief Science Officer For pharmaceutical drag. “The Ferret Challenge study builds on the robust protection against bird flu, which we have observed in a mouse model and expands our understanding of the disease process and the probable area of ​​human doses required for treatment. We carry out a similar challenge study in non -human primates, whereby the data in Q1 2025 is expected. “

“We are experiencing a steady increase in the spread of bird flu,” said Robert R. Redfield, MD, Chief Medical Officer for Traw's pharmaceutical and former director of the US Centers for Disease Control and Prevention (CDC). “Dramatic increase in the number of infected poultry and dairy cattle with increasing number of human exposure, including a fatal case in the USA, confirm the continued threat from bird flu and the increasing risk of broad spread in the human population. We believe that safe and effective antiviral drugs will be a critical component for the reaction to bird flu and that the development and examination of Tivoxavir Marboxil could be an important step to achieve this goal. The spread of bird flu in animals and the increasing number of human exposure underline the urgent need for effective medical countermeasures. “

“With the non -human primate data in hand, we intend to approach the FDA in order to discuss an accelerated approval under the“ animal rule ”¹“, Said Werner Cautreels, Chief Executive Officer from Traws Pharma. “We are planning to organize a virtual investor update on March 31, 2025 to carry out a detailed review of the bird flu program.”

TopLine -Preclinical results at FROTTCHE

After a single oral dose of Tivoxavir Marboxil in the ferret model of the bird flu using the A/Texas/37/2024 H5N1 virus, which was isolated from an infected milk worker in Texas, significant changes in the progress of the disease system were observed. A fatal challenge in ferret showed that Tivoxavir Marboxil increased the proportion of surviving animals and lowered the virus load in lungs and nasal tissues. Ferrets are an accepted animal model for evaluating treatments for influenza.

Source:

1. CFR314,600 to 314,650, October 2015,

About Tivoxavir Marboxil
Tivoxavir Marboxil was designed as an inhibitor of the highly preserved influenza protein cap-dependent endonuclease (CEN). It showed effectively in vitro Activity against a number of influenza tribes in preclinical studies, including the highly pathogenic bird flu H5N1 (bird flu). Completed and ongoing animal model studies evaluate the effects of a single oral dose of Tivoxavir Marboxil on the bird flu infection. We believe that this data supports the further development of Tivoxavir Marboxil as a one -off treatment for bird flu. It is estimated that bird flu and seasonal influenza represent a potential antiviral market chance that is largely driven by global health organizations, practical guidelines and state tenders.

About Traws Pharma, Inc.
Traws Pharma is a biopharmaceutical company in the clinical stage that develops potential oral small molecule therapies for the treatment of respiratory diseases. The Viral Respiratory Disease program includes two new phase 1, possibly with a small Molecule drug candidate: Tivoxavir Marboxil, in the development for bird flu and seasonal influenza, which aims at influenza cap-dependent endonuclease (CEN). and Ratutrelvir in development as a covid treatment, which aims at the MPro (3CL-protase) without having to administer Ritonavir at the same time.

Predicted statements

Some of the statements in this release are forward-looking statements within the meaning of securities act of 1933, as amended, section 21e of the securities excange 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 Opportity, Benefits and the Regulatory Plans for Tivoxavir Marboxil. The company has tried to identify future -oriented statements through terminology, including “faith”, “estimates”, “anticipated”, “expected”, “plans”, “intentions”, “may”, “,” power “,” sake “,” should “,”, “provisional”, “encouraging”, “encouraging”, “approximate” or other words, the insecure events Take over outcomes. Although Traws believe that the expectations that are reflected in such future statements are appropriate at the time of the date, the expectations may have differed significantly from the results that were expressed or implied by such future statements. These statements are only predictions and contain known and unknown risks, uncertainties and other factors, including the success and time of clinical studies, cooperation, market conditions, regulatory requirements of the buttons. The final data results of the Ferret Animal Model Test; Previously reported results of mouse studies; Studies in non -human primates; Potential to report the results of non -human primate studies in Q1 2025; The results of phase -1 studies previously reported; the intention of the company to apply for FDA instructions to the regulatory route; the extent of the spread and the risk of bird flu; The potential effectiveness of the use of Tivoxavir Marboxil for treatment in humans; And those who are discussed under the heading “Risk Factors” in the submissions of the US Securities and Exchange Commission (SEC). All future -oriented statements contained in this publication only speak to the date. Traws assumes no obligation to update future -oriented statements in this publication in order to reflect events or circumstances that occur according to his date or to reflect the occurrence of unexpected events, except to the statutory extent.

Traws Pharma Contact:
Nora Brennan
Traws Pharma, Inc.
nbrennan@trawsorma.com
www.trawsparma.com

Investor contact:
Bruce Mackle
Lifesci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com