Full Press Release Details
Pharma Reports Second Quarter 2025 Results
and Business Highlights
novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza
(Tivoxavir marboxil, TXM)
of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection
risk and greater need, with waning vaccine utilization
submitted HREC study will enable initiation of Phase 2 studies of ratutrelvir in newly diagnosed COVID patients, with extensions to assess
rebound and Long COVID, as well as evaluation in PAXLOVID -ineligible subjects
program to emphasize focus on stockpiling readiness
to host a Q2 2025 business update call today, August 14th at 8:30 AM ET
PA, August 14, 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 June 30, 2025 and provided recent
business highlights for its antiviral programs. Importantly, unlike vaccines, antivirals are both therapeutic, eliminating viral infections,
as well as prophylactic, preventing viral infections or spreading of infection to others.
has made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. We have reprioritized
our clinical trial plans to reflect potential short and medium-term shareholder value with the following actions", said Iain
D. Dukes, MA, DPhil, Interim Chief Executive Officer of Traws Pharma:
current health risk has been determined to be low by the Centers for Disease Control and Prevention (CDC), which continues to monitor
for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase 2 study incorporating bird
flu-infected subjects would be low and initiation of this study has been deferred. During a Type D meeting, the FDA reaffirmed its position
that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. Recent approval
of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly
initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase."
the end of summer draws near, we are acutely aware that autumn is a time of heightened COVID and influenza awareness and vulnerability
for many people across the country, as both viruses continue to mutate and pose critical threats to human health," said Robert
Redfield, MD, Chief Medical Officer of Traws Pharma. "Furthermore, with close to one million COVID and influenza hospitalizations
and tens of thousands of deaths reported in the 2024-2025 virus season2,3, we know that COVID and influenza have not "gone
away". We also know from experience that each COVID and influenza hospitalization touches multiple lives and is a source of medical
costs, lost time and lost wages for families and caregivers. Current treatments do not provide full antiviral coverage, and in the case
of COVID, require accompanying agents that can result in drug-drug interactions, or enable rebound infections and long-term viral syndromes.
We believe that Traws' ritonavir-free COVID and once-daily flu candidates each have the potential to overcome the shortcomings
of current treatments and become the new standard of care."
is now established as a long-term public health challenge, with an increasing burden of disease for people suffering from post-acute
sequelae of COVID, also known as Long COVID4. The current approved antiviral, PAXLOVID , is frequently contra-indicated
in vulnerable populations, including the elderly and immunocompromised individuals, due to ritonavir-based drug-drug interactions5.
Ratutrelvir has an emerging profile that could position it for wide adoption, especially in vulnerable individuals, based on its broad
activity against a range of resistant strains," said C. David Pauza, Chief Science Officer of Traws. "In addition,
ratutrelvir's good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound
and, consequently, the risk of Long COVID. We intend to progress the development of ratutrelvir in the coming months, starting with a
Phase 2 study planned to begin soon in the Southern Hemisphere. Positive results could provide important proof-of-concept data and represent
a valuable inflection point for the program."
Highlights and Anticipated Milestones:
ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed to be administered as a single dose, with potential
for once-daily, 10-day dosing
Marboxil (TXM, Bird flu and seasonal flu)
single-dose, investigational CAP-dependent endonuclease inhibitor
Programs: Traws' strategic objective for its legacy oncology assets (rigosertib and narazaciclib) is to establish additional
partnerships for further development.
Call and Webcast Information
will host a conference call today, August 14, 2025, at 8:30 AM ET to discuss its Q2 results and pipeline progress.
replay of the webcast will be available on the Investors section of the Traws website at https://www.trawspharma.com/corporate-events-presentations.
cash equivalents and short-term investments: As of June 30, 2025, the Company had cash, cash equivalents, and short-term investments
of approximately $13.1 million, compared to approximately $21.3 million as of December 31, 2024.
for the quarter ended June 30, 2025, was $2.7 million, compared to $57 thousand for the comparable period in 2024. This increase
of $2.7 million is attributable to $2.7 million in deferred revenue, recognized as revenue in the second quarter 2025, related to the
mutual termination in April 2025 of a licensing agreement associated with our legacy oncology program.
and development (R&D) expense for the quarter ended June 30, 2025, totaled $2.3 million, compared to $4.0 million for the
comparable period in 2024. This decrease of $1.7 million primarily relates to a decrease in expenses related to the oncology program
and personnel expenses, partially offset by an increase in expenses related to our virology programs.
and administrative (G&A) expense for the quarter ended June 30, 2025, totaled $1.7 million, compared to $2.0 million for
the comparable period in 2024. This decrease of $0.3 million was primarily attributable to a decrease in personnel related expenses and
stock-based compensation, partially offset by an increase in professional and consulting fees
Income (loss): The net loss for the quarter ended June 30, 2025 was $0.9 million, or a net loss of $0.11 per basic common and
diluted common share. This compares to a net loss of $123.1 million, or a net loss of $20.52 per basic and diluted common share, for
the quarter ended June 30, 2024, which included a one-time charge of $117.5 million for acquired in-process research and development
related to Onconova's April 2024 acquisition of Trawsfynydd.
Outstanding: Traws had 7,063,829 shares of common stock outstanding as of August 13, 2025.
is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19
that is used without ritonavir. It has demonstrated in vitro activity against a range of virus 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 COVID4. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity6,7.
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 shown 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 tenders and inclusion in drug stock piling initiatives8,9, with upside potential from potential pandemic flu
outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu.
products mentioned herein are the trademarks of their respective owners.
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: COVID-19/Long COVID and bird flu
and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or
3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza
cap-dependent endonuclease (CEN).
is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib.
More details can be found on Traws' website at https://www.ir.trawspharma.com/partnering.
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, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir
marboxil, as well as plans for its legacy programs. 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 believes that the expectations