Traws Pharma Provides Regulatory Update on Influenza Program (Form 8-K)

Traws Pharma Provides Regulatory Update on Influenza Program

NEWTOWN, PA - June 12, 2026 - (GLOBENEWSWIRE) Traws Pharma, Inc. (NASDAQ: TRAW, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that the planned test of tivoxavir marboxil (TXM) in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).

"Tivoxavir marboxil demonstrated potent efficacy in three animal models of highly pathogenic avian influenza and a pharmacokinetic profile consistent with its use for bird flu treatment and prevention," said C. David Pauza, PhD Chief Science Officer for Traws Pharma, "The product candidate retains potential for emergency use in a bird flu outbreak and for prevention in high-risk populations." The Company has a portfolio of back-up influenza antiviral compounds and is actively advancing candidates with TXM's long-duration pharmacokinetic and antiviral profile and devoid of any mutagenic potential.

"Influenza, including bird flu, continues to be a major public health threat in the US and worldwide," commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Head of the U.S. Centers for Disease Control and Prevention. "While we have had a setback in the development of our lead compound for influenza, the program continues to be a high priority. Influenza treatment and prevention is especially important for vulnerable populations including elderly and immunocompromised individuals who are at much greater risk for severe influenza compared to the general population.

"We remain committed to advancing long-acting influenza antivirals and continue to believe this modality has meaningful potential in seasonal influenza prophylaxis. While the recent regulatory feedback affects the timing of our planned challenge study, it does not change our conviction in the underlying scientific rationale. With our cash runway extending to Q1 2027, we are advancing alternative candidates designed to preserve TXM's pharmacokinetics and efficacy, and exclude potential regulatory concerns," said Iain Dukes, MA, DPhil, Chief Executive Officer for Traws Pharma.

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. The Company is advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health including seasonal influenza and H5N1 bird flu, negative-strand RNA viruses including Hantavirus, Ebola Virus Disease, Lassa Fever and COVID-19/Long COVID.

For more information, please visit www.trawspharma.com and follow us on LinkedIn.