Traws Pharma Provides Updated Guidance on Influenza Prophylaxis Program

NEWTOWN, Pa., June 22, 2026 — Traws Pharma, Inc. (NASDAQ: TRAW, Traws, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that an updated toxicology data package is in the process of being developed in response to information requirements from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the planned testing of tivoxavir marboxil (TXM) in a Phase 2a human influenza Challenge study. The updated data package is expected to be resubmitted to MHRA during the third quarter of 2026. “Based upon recent feedback and further guidance from the MHRA, we believe our updated data package will support the proposed seasonal influenza Challenge study to be conducted in healthy volunteers and provide important proof of concept data for TXM’s use as an oral prophylaxis medicine,” commented Iain D. Dukes, MA, DPhil, Chief Executive Officer for Traws Pharma.

Following Traws’ announcement on June 12,.2026, the MHRA provided more detailed feedback that has enabled the Company to prepare additional preclinical safety information for inclusion in the TXM data package. Following the resubmission, the Company expects a formal response from MHRA within 30 days.

“TXM demonstrated broad in vitro efficacy across multiple strains of seasonal influenza and a pharmacokinetic profile consistent with its use as a chemoprophylactic agent,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “The Company will also initiate profiling of additional molecules for advancement in its program for influenza treatment.”

“Seasonal influenza continues to be a major public health threat in the US and worldwide,” commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma. “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.”

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.

Traws Pharma Contact

Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com

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