Traws Pharma Reports First Quarter 2025 Results and Business Highlights FDA briefing document submitted

Traws Pharma Reports First Quarter 2025 Results

and Business Highlights

FDA briefing document submitted

April 24, 2025 in support of a meeting to align on pathway for tivoxavir marboxil (TXM, bird flu/seasonal flu) including potential

for accelerated approval utilizing the "Animal Rule"

Additional briefing document in support of a

meeting to align on ratutrelvir for COVID

- including Long COVID - to be submitted to regulatory authorities in Q2 2025

Cash runway to support planned operations into

NEWTOWN, PA, May 15, 2025 (GLOBE NEWSWIRE)

- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage

biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today

reported financial results for the quarter ended March 31, 2025 and provided recent business highlights, with updates to the Company's

investigational programs including lead product candidate, tivoxavir marboxil (TXM) in development for bird flu and seasonal flu, and

ratutrelvir in development for acute treatment of COVID, with potential to prevent COVID-rebound and Long COVID.

"Traws continues to make excellent progress

this year with its two proprietary, investigational oral, small molecule antivirals for bird flu/seasonal flu and COVID. Identifying opportunities

to accelerate the path to approval is core to Traws' strategy. We are preparing to interact with regulatory authorities in the coming

months regarding both of our antiviral programs," said Iain D. Dukes, D.Phil, Interim CEO of Traws Pharma. "We

have submitted briefing materials to the FDA for our tivoxavir marboxil program, in preparation for a meeting to discuss the potential

for accelerated approval under the FDA Animal Rule. In addition, Traws intends to seek regulatory input on the use of ratutrelvir in acute

treatment/rebound prevention and Long COVID. We look forward to providing an update on our progress with these discussions over the next

"Viral diseases are an important

medical problem with high morbidity and mortality. The standard approach to viral disease has been vaccines. In my view, vaccine use is

waning dramatically due to the fast development of resistance and potential regulatory hurdles for new approvals. Antiviral agents can

be used to address an existing infection and virus spread, especially in cases where vaccines do not yet exist or are not sufficiently

effective or utilized. We believe that Traws' programs are each poised to make important progress in the coming months, supported

by potent antiviral activity in well accepted preclinical tests and animal models, and promising pharmacokinetic profiles from Phase 1

studies, that could enable differentiated activity," added Robert Redfield, MD, Chief Medical Officer at Traws Pharma and

former Director of the U.S. Centers for Disease Control and Prevention (CDC) and Senior Visiting Fellow, Biosecurity and Public Health

Policy, Asian Studies Center at the Heritage Foundation.

Recent Highlights and Anticipated Milestones:

Tivoxavir Marboxil (TXM, Bird flu and seasonal flu)

A single-dose, investigational CAP-dependent endonuclease inhibitor

A ritonavir-independent investigational oral Main protease (Mpro)

inhibitor designed to be administered as a single dose, with potential for once-daily, 10-day dosing

Legacy Programs: Traws is seeking partnership opportunities

for its legacy oncology assets (narazaciclib and rigosertib)

Management Updates: Iain D. Dukes, D. Phil

was named Interim CEO, following the retirement of Werner Cautreels, PhD, on March 31, 2025. With the expansion Dr. Dukes'

responsibilities, Jack Stover, an independent director, was named Chairman of Traws Board on April 15, 2025.

Cash, cash equivalents and short-term investments:

As of March 31, 2025, the Company had cash, cash equivalents, and short-term investments of approximately $15.9 million, compared

to approximately $21.3 million as of December 31, 2024. The Company believes its cash and cash equivalents will be sufficient to

support ongoing operations into Q1 2026.

Revenue for the quarter ended March 31,

2025, was $57 thousand, compared to $56 thousand for the comparable period in 2024.

Research and development (R&D) expense

for the quarter ended March 31, 2025, totaled $2.5 million, compared to $1.9 million for the comparable period in 2024. This increase

of $0.6 million primarily relates to an increase in expenses related to our virology programs, partially offset by a decrease in expenses

related to the oncology program.

General and administrative (G&A) expense

for the quarter ended March 31, 2025, totaled $2.8 million, compared to $3.4 million for the comparable period in 2024. This decrease

of $0.6 million was primarily attributable to a decrease in consulting fees, partially offset by an increase in expenses attributable

to severance expenses.

Net Income (loss): The net income for the

quarter ended March 31, 2025 was $21.5 million, driven by the change in fair value of warrant liability of $26.5 million associated

with the December 2024 financing. As a result, the net income for the quarter ended March 31, 2025 was $2.17 per basic common

share and $2.09 per diluted common share. This compares to a net loss of $5.0 million, or a net loss of $5.92 per basic and diluted common

share, for the quarter ended March 31, 2024.

Shares Outstanding: Traws had 5,564,315

shares of common stock outstanding as of May 13, 2025.

About Tivoxavir Marboxil

Tivoxavir marboxil (TXM) is an investigational

oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and

seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate

of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single

dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral

market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside

potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir

marboxil as a treatment for bird flu.

Ratutrelvir is an investigational oral, small

molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19 that is used without ritonavir. It has demonstrated

in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration

with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions5, and potentially

enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance of target

blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days,

which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID6. Industry data

indicate that COVID treatment represents a potential multi-billion dollar market opportunity3,4.

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.

We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant

virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single

dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development

as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease).

For more information, please visit www.trawspharma.com

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, effectiveness, safety, and

the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. 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