Traws Pharma Reports First Quarter 2025 Results and Business Highlights

Rhea-AI Summary

Traws Pharma (NASDAQ: TRAW) reported its Q1 2025 financial results and provided updates on its antiviral drug development programs. The company's lead candidate tivoxavir marboxil (TXM) for bird/seasonal flu showed promising results in animal studies, with a FDA briefing document submitted on April 24, 2025. Their second candidate ratutrelvir for COVID treatment is preparing for regulatory briefings.

Financial highlights include: $15.9M in cash and equivalents (vs $21.3M in Q4 2024), revenue of $57K, R&D expenses of $2.5M, and net income of $21.5M ($2.17 per share). The company expects its cash runway to extend into Q1 2026.

Recent management changes include Iain D. Dukes appointment as Interim CEO and Jack Stover as Board Chairman. The company is also seeking partnership opportunities for its legacy oncology assets.

Positive

• Positive preclinical results for TXM in non-human primate and ferret studies showing reduced viral burden
• TXM maintained plasma levels above EC90 for ~3 weeks after single dose in Phase 1
• Strong net income of $21.5M in Q1 2025, compared to $5.0M loss in Q1 2024
• Potential multi-billion dollar market opportunities for both antiviral programs
• Reduced G&A expenses by $0.6M compared to previous year

Negative

• Cash position decreased from $21.3M to $15.9M quarter-over-quarter
• R&D expenses increased by $0.6M compared to previous year
• Limited revenue generation ($57K for the quarter)
• Both lead drug candidates still in early development stages

Insights

Biotechnology Analyst

Traws Pharma shows promising antiviral pipeline progress but faces cash runway concerns amid evolving regulatory pathways.

Traws Pharma's Q1 2025 results paint an interesting picture of a company at a pivotal stage in its development of novel antiviral treatments. The company has made significant regulatory moves, submitting a briefing document to the FDA for tivoxavir marboxil (TXM) seeking potential accelerated approval via the Animal Rule pathway for bird/seasonal flu. Their second asset, ratutrelvir for COVID treatment, is following close behind with regulatory submission planned in Q2.

Looking at their preclinical data, TXM demonstrated encouraging efficacy in non-human primate and ferret challenge studies - both considered gold standard models for influenza research. The single-dose pharmacokinetic profile showing three-week plasma levels above EC90 is particularly noteworthy, as this could potentially differentiate TXM from existing treatments requiring multiple doses. Similarly, ratutrelvir's ability to maintain trough levels at 4x EC90 without ritonavir boosting represents a potential advantage over existing protease inhibitors.

However, the financial position warrants careful consideration. While the $21.5 million net income appears impressive at first glance, it's actually driven by a $26.5 million change in warrant liability value - not operational success. The company's cash position of $15.9 million represents a $5.4 million burn from year-end 2024, giving them runway only into Q1 2026. With quarterly R&D expenses increasing to $2.5 million (up 31.6% YoY) and pipeline advancement likely requiring additional investment, their financial foundation appears somewhat precarious.

The leadership transition from Werner Cautreels to interim CEO Iain Dukes alongside the appointment of Jack Stover as Chairman adds another layer of transformation during this critical development phase.

The strategy to pursue the Animal Rule pathway for TXM is particularly significant as it could potentially accelerate approval without extensive human efficacy trials - critical for addressing pandemic threats like bird flu where traditional efficacy studies may be impractical or unethical. However, this regulatory pathway carries its own uncertainties, as the FDA has historically applied stringent standards for Animal Rule approvals.

Pharmaceutical Regulatory Expert

Traws pursues unconventional regulatory pathways for its antivirals, with the Animal Rule strategy representing both opportunity and significant hurdles.

The regulatory strategy outlined in this release merits close examination. Traws' pursuit of the FDA's Animal Rule pathway for tivoxavir marboxil (TXM) represents an ambitious but reasonable approach given the challenges of conducting efficacy trials for highly pathogenic influenza strains like H5N1. The Animal Rule allows approval based on animal efficacy studies when human trials are unethical or impractical, but it's a pathway with extremely high evidentiary standards and limited precedent.

Only a handful of products have ever received approval through this mechanism, and the regulatory bar is exceptionally high. The submission of their briefing document on April 24th signals confidence in their preclinical package, particularly the non-human primate and ferret challenge studies showing reduced viral burden and pathology. However, success will ultimately depend on demonstrating that animal model results reliably predict human outcomes - a notoriously difficult hurdle.

For ratutrelvir, their COVID antiviral, the regulatory approach appears more conventional but still faces challenges. The intent to seek guidance on positioning for both acute treatment and Long COVID prevention indicates a broad label strategy. While acute COVID treatment has established regulatory precedents (like Paxlovid), Long COVID prevention represents uncharted regulatory territory with complex endpoint considerations.

The leadership of former CDC Director Robert Redfield as CMO potentially brings valuable regulatory insights, particularly his pointed commentary on waning vaccine utilization which suggests the company is positioning antivirals as increasingly important countermeasures in public health strategy.

The timing is notable - expecting regulatory feedback in Q2 2025 for both programs suggests parallel development tracks. However, with cash runway extending only into Q1 2026, Traws faces the challenge of advancing regulatory discussions while preserving capital. The regulatory pathway clarity expected in the coming quarter will be critical in determining whether their current financial resources are sufficient to reach meaningful value inflection points.

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 Q1 2026

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 quarter.”

“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:

Product Development

Tivoxavir Marboxil (TXM, Bird flu and seasonal flu)
A single-dose, investigational CAP-dependent endonuclease inhibitor

• Intended Indication: Treatment or prevention of H5N1 bird flu and seasonal flu
• U.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity, including, in the short-term, potential stockpiling^1,2
• Current Status: Preparations are underway to finalize the development plan and move forward on the path to approval
• Recent Updates (including International Conference for Antiviral Research (ICAR 2025) data):
  • Briefing package submitted to FDA on April 24, 2025, for a meeting to discuss the potential for accelerated approval under the FDA Animal Rule, per a meeting request submitted March 21, 2025
  • Topline data from a non-human primate challenge study showed that a single, oral dose of TXM significantly reduced viral burden and pathology in the lung with no weight loss compared to untreated controls, two key measures of antiviral activity in preclinical flu models
  • Topline data from a ferret challenge study showed that a single, oral dose of TXM increased the proportion of surviving animals and lowered the viral burden and pathology in lungs and nasal tissues; ferrets are widely accepted as an animal model for evaluating influenza treatments
  • Phase 1 data showed that TXM maintained plasma blood levels above the EC₉₀ for approximately three weeks after a single oral dose, with good overall tolerability; these data support the use of TXM as a single-dose treatment
• Next Steps:
  • Bird flu: Provide an update on FDA discussions regarding the Animal Rule: Q2 2025
  • Bird flu/Seasonal flu: Finalize the development plan and move forward on the path to approval
  • Bird flu/Seasonal flu: Finalize formulation and CMC scale-up

Ratutrelvir (COVID)
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

• Intended Indication: Treatment of acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVID
• U.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity^3,4
• Current Status: Preparations are underway for regulatory briefings and Phase 2 studies
• Recent Updates (primarily from the International Conference for Antiviral Research (ICAR 2025)):
  • Preclinical studies of ratutrelvir show potent suppression of resistant virus
  • Pharmacokinetic (PK) results provide support for ratutrelvir as a ritonavir-independent agent based on data showing that drug metabolism is not induced by 10-days of treatment at 600 mg/day and that trough blood plasma levels are maintained at four times the EC₉₀
  • Phase 1 data show good overall tolerability at all doses tested, with attractive (PK)
• Next Steps:
  • Submit a briefing package to regulatory authorities in Q2 2025 for the use of ratutrelvir in acute treatment/rebound prevention and Long COVID
    

Legacy Programs: Traws is seeking partnership opportunities for its legacy oncology assets (narazaciclib and rigosertib)

Corporate Updates

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.

Financial Results:

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 tenders^1,2, 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.

About Ratutrelvir

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 opportunity^3,4.

Source information:

1. Per link   
2. TRAW data on file
3. Pfizer.com 10K report 2024, Feb 27, 2025
4. Merck & Co 10K, Feb 25 2025
5. https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646
6. Carly Herbert et al. (2025) Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae539

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 and follow us on LinkedIn.

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 believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, Traws’ interactions with the FDA and similar foreign regulators, collaborations, market conditions, regulatory requirements and pathways for approval, the extent of the spread and threat of the bird flu, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID, and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.

Traws Pharma Contact:
Nora Brennan
Traws Pharma, Inc.
nbrennan@trawspharma.com
www.trawspharma.com

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Traws Pharma, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
		March 31,				December 31,
		2025				2024
Assets
Current assets:
Cash and cash equivalents		$	15,937,000			$	21,338,000
Tax incentive and other receivables			1,654,000				1,765,000
Prepaid expenses and other assets			1,265,000				1,848,000
Total current assets			18,856,000				24,951,000
Property and equipment, net			9,000				10,000
Other assets			198,000				1,000
Total assets		$	19,063,000			$	24,962,000
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable		$	7,656,000			$	8,186,000
Accrued expenses and other liabilities			2,519,000				3,121,000
Deferred revenue			226,000				226,000
Total current liabilities			10,401,000				11,533,000
Deferred revenue, non-current			2,508,000				2,565,000
Warrant liabilities			154,000				42,494,000
Total liabilities			13,063,000				56,592,000
Stockholders’ equity (deficit):
Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 7,398 shares outstanding at March 31, 2025 and December 31, 2024			—				—
Common stock, $0.01 par value, 250,000,000 shares authorized, 5,075,390 and 3,650,731 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively			50,000				36,000
Additional paid in capital			633,633,000				617,530,000
Accumulated deficit			(627,664,000	)			(649,154,000	)
Accumulated other comprehensive loss			(19,000	)			(42,000	)
Total stockholders’ equity (deficit)			6,000,000				(31,630,000	)
Total liabilities and stockholders’ equity (deficit)		$	19,063,000			$	24,962,000

Traws Pharma, Inc.
Condensed Consolidated Statements of Operations (unaudited)
		Three Months Ended March 31,
		2025				2024
Revenue		$	57,000			$	56,000
Operating expenses:
Research and development			2,506,000				1,912,000
General and administrative			2,754,000				3,356,000
Total operating expenses			5,260,000				5,268,000
Loss from operations			(5,203,000	)			(5,212,000	)
Change in fair value of warrant liability			26,513,000				—
Other income, net			180,000				229,000
Net income (loss)		$	21,490,000			$	(4,983,000	)
Net income (loss) attributable to common stockholders, basic and diluted		$	15,083,000			$	(4,983,000	)
Weighted-average shares of common stock outstanding, basic			6,965,927				841,738
Net income (loss) per share of common stock, basic		$	2.17			$	(5.92	)
Weighted-average shares of common stock outstanding, diluted			7,215,125				841,738
Net income (loss) per share of common stock, diluted		$	2.09			$	(5.92	)
Net income (loss) attributable to Series C Preferred stockholders, basic and diluted		$	6,407,000			$	—
Weighted-average shares of Series C Preferred outstanding, basic and diluted			7,398				—
Net income (loss) per share of Series C Preferred, basic and diluted		$	866.04			$	—

FAQ

What were Traws Pharma's (TRAW) Q1 2025 financial results?

Traws reported Q1 2025 revenue of $57K, net income of $21.5M ($2.17 per share), and cash position of $15.9M. R&D expenses were $2.5M and G&A expenses were $2.8M.

What is the status of Traws Pharma's tivoxavir marboxil (TXM) development?

TXM for bird/seasonal flu has completed Phase 1 trials with positive results. A FDA briefing document was submitted April 24, 2025, seeking potential accelerated approval under the Animal Rule.

Who are the new executives at Traws Pharma (TRAW)?

Iain D. Dukes was appointed Interim CEO following Werner Cautreels' retirement, and Jack Stover was named Chairman of the Board in April 2025.

How long will Traws Pharma's (TRAW) current cash runway last?

The company expects its current cash position of $15.9M to support ongoing operations into Q1 2026.

What are the market opportunities for Traws Pharma's antiviral programs?

Both the bird/seasonal flu (TXM) and COVID (ratutrelvir) programs are estimated to have multi-billion dollar market opportunities.