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Traws Pharma Reports Full Year 2024 Results and Business Highlights Tivoxavir marboxil's potential as a single dose therapeutic agent for bird flu supported by significant antiviral activity in three well accepted animal

Key Takeaway: Traws Pharma has reported positive results for its lead candidate, tivoxavir marboxil, which shows potential as a single-dose therapeutic agent for bird flu, backed by strong antiviral activity in animal studies. The company is engaging with the FDA to explore accelerated approval under the Animal Rule. Financial results for the year ending December 31, 2024, included a significant net loss attributed primarily to research and financing expenses. Upcoming milestones include further regulatory discussions for bird flu treatment and continued development of COVID-19 therapies.

Market Sentiment Analysis

POSITIVE FACTORS

  • Significant antiviral activity of tivoxavir marboxil demonstrated in animal models.
  • Positive Phase 1 study results in healthy volunteers.
  • Successful financing that bolstered operational cash runway.
  • Ongoing discussions with the FDA regarding a path to accelerated approval.

CONCERNS & RISKS

  • Substantial net loss reported for the year ended December 31, 2024.
  • Increased research and development expenses over the previous year.
  • CEO retirement could lead to instability during transition.

Full Press Release Details

Traws Pharma Reports Full Year 2024 Results
and Business Highlights
Tivoxavir marboxil's potential as a single
dose therapeutic agent for bird flu supported by significant antiviral activity in three well accepted animal models and positive Phase
Ongoing FDA interaction to align on path forward
for tivoxavir marboxil, including potential for accelerated approval utilizing the "Animal Rule"
Cash Runway to support planned operations into
Investor Update call today, March 31, 2025 at
NEWTOWN, PA, March 31, 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 year ended December 31, 2024 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 ratutrelvir in development for COVID.
"I believe Traws made outstanding progress
over the last year. We re-defined our focus - to treat critical threats to human health from respiratory diseases -- with bird flu
as our top priority. Ongoing reports of farm infections and mutated viruses continue to raise the concern that bird flu could present
a pandemic risk. We declared tivoxavir marboxil (TXM) as our lead program, and presented preclinical data demonstrating TXM's potent
resistance profile, robust antiviral activity in three validated flu models, plus positive pharmacokinetic results from a Phase 1 study
in healthy volunteers. These data supported submission of our pre-IND meeting request to discuss a potential accelerated path to approval
under the Animal Rule. In addition, our successful financing, completed in December, provided Traws with $20 million in gross proceeds
and complemented our investor base with the addition of new top tier institutional health care investors," said Werner Cautreels,
PhD, Chief Executive Officer for Traws Pharma.
"During our upcoming investor call, planned
for today, we look forward to providing an overview of the public health risk and treatment landscape for H5N1 bird flu, and reviewing
the preclinical and clinical data, and regulatory strategy for tivoxavir marboxil. In addition, we plan to review the ongoing need for
improved COVID therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, the opportunity for ratutrelvir,
and next steps for both programs," concluded Dr. Cautreels.
Register for the Investor Event here.
Upcoming Milestones and Recent Highlights:
Upcoming Milestones:
Bird flu: Provide an update on FDA discussions regarding the Animal Rule: Q2 2025
Bird flu: Finalize formulation and CMC scale up
Bird flu: Finalize the development plan and move forward on the path to approval
COVID: Submit a pre-IND meeting request to engage with the FDA to understand long COVID endpoints: Q2 2025
Recent Product Development & Corporate
Traws Pharma Antiviral Bird Flu Program, Tivoxavir
Marboxil, Shows Positive Data in Non-human Primates - (March 24, 2025) Traws Pharma, Inc. today announced positive topline results
from a study evaluating the use of tivoxavir marboxil (TXM) as a treatment for non-human primates challenged with a non-lethal dose of
Traws Pharma's Bird Flu Drug Candidate,
Tivoxavir Marboxil, Presented at ICAR - (March 21, 2025) Traws Pharma, Inc. today announced that positive data supporting the
potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral
Research (ICAR 2025), being held in Las Vegas, Nevada.
Traws Pharma Reports Positive Results from
An Accepted Bird Flu Model for Anti-Viral Candidate, Tivoxavir Marboxil - (March 03, 2025) Traws Pharma, Inc. today announced
positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir
marboxil as a single dose.
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 -
(January 23, 2025) Traws Pharma, Inc. today announced completion of Phase I clinical studies of its investigational one-dose influenza
(flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.
Traws Pharma's COVID-19 Candidate, Ratutrelvir,
Presented at ICAR - (March 25, 2025) Traws Pharma, Inc. today announced that positive data supporting the potential for ratutrelvir,
a main protease inhibitor, as a treatment for COVID-19, were presented at the International Conference for Antiviral Research (ICAR 2025).
Traws Pharma Announces Management Updates
- (March 28, 2025) Traws Pharma, Inc. today announced the retirement of Werner Cautreels, PhD, Chief Executive Officer (CEO), effective
on or about the close of business on March 31, 2025. Iain D. Dukes, D Phil, will assume the role of Interim CEO. In addition to his new
responsibilities, Dr. Dukes will continue to serve as Traws' Chairman.
Cash, cash equivalents and short-term investments:
As of December 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $21.3 million, compared to
cash, cash equivalents, and short-term investments of approximately $20.8 million at December 31, 2023. The cash balance reflects $20
million in gross proceeds from the December 31, 2024 financing. The Company believes its cash and cash equivalents will be sufficient
to support ongoing operations into Q1 2026.
Research and development (R&D) expense
for the 12 months ended December 31, 2024, totaled $12.8 million, compared to $11.4 million for the comparable period in 2023. This increase
of $1.4 million primarily relates to the conduct of clinical and preclinical trials for the Company's antiviral agents, and increased
personnel related expenses due to restructuring activities. These increases were partially offset by a decrease in costs related to the
General and administrative (G&A) expense
for the 12 months ended December 31, 2024, totaled $12.3 million, compared to $9.1 million for the comparable period in 2023. This increase
of $3.2 million was primarily attributable to an increase in consulting fees in connection with seeking strategic alternatives which was
partially offset by a decrease in public company costs.
Net loss: The net loss for the 12 months
ended December 31, 2024 was $166.5 million, driven by the acquired in-process research and development expense of $117.5 million and the
warrant expense of $24.4 million associated with the December 2024 financing. As a result, the net loss per basic and diluted common share
for 2024 was $35.21. This compares to a net loss of $18.9 million, or a net loss of $22.57 per basic and diluted common share, for the
year ended December 31, 2023.
Shares Outstanding: Traws had 5,073,790
shares of common stock outstanding as of March 26, 2025. The shares outstanding reflect the issuance of 3.9 million shares related to
the December 31, 2024 financing.
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 demonstrated potent in vitro activity against a range of influenza strains in preclinical studies, including
the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three 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, to be 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 interactions3, 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 COVID.4 Industry data
indicate that COVID treatment represents a potential multi-billion dollar market opportunity5,6.
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. We are advancing
novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human
health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies
with a commitment to patients who are especially vulnerable.
The Company's two antiviral programs are
investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as

Frequently Asked Questions

What is tivoxavir marboxil used for?

Tivoxavir marboxil is being developed as a single-dose treatment for bird flu.

What recent developments has Traws Pharma reported?

Traws Pharma reported positive data for tivoxavir marboxil and outlined its FDA strategy.

What is ratutrelvir's role?

Ratutrelvir is an investigational COVID-19 treatment without the need for ritonavir.

What is the company's financial status as of December 2024?

Traws Pharma had approximately $21.3 million in cash and short-term investments.

What milestone is expected in Q2 2025?

An update on FDA discussions regarding the Animal Rule for tivoxavir marboxil.

Last updated: Mar 31, 2025