- Advancing tivoxavir marboxil toward MHRA resubmission in Q3 2026 with a revised toxicology package, supporting initiation of the Phase 2a human influenza Challenge study
- Completed the
April 2026 private placement and received shareholder approval of the Series B and Series C tranches, enabling access to up to$50 million in potential additional financing, subject to achievement of program milestones and investor participation
"Following the MHRA's review, we are moving quickly to generate the revised toxicology package the agency identified, and we expect to resubmit by the end of the third quarter of this year. Our conviction in tivoxavir marboxil’s potential as a prophylactic agent for seasonal influenza is unchanged. We look forward to progressing the program towards the initiation of the Phase 2a human influenza Challenge pending MHRA approval," commented Iain
"As we approach respiratory virus season, seasonal influenza remains a significant public health threat, particularly for vulnerable populations such as the elderly and immunocompromised," commented
Recent Highlights and Anticipated Milestones:
Investigational Programs:
Tivoxavir marboxil (TXM, influenza)
Intended Indication and Market Potential: Potential as a best-in-class oral prophylactic for seasonal flu and potential inclusion in pandemic preparedness initiatives, all-together, estimated to be a multi-billion-dollar opportunity1.
Next Steps:
Updated Preclinical Data Package to Support MHRA Resubmission — Following feedback from the MHRA on the Company's planned Phase 2a human influenza Challenge study, Traws is preparing an updated toxicology data package. The Company expects to resubmit this package at the end of the third quarter of 2026. If accepted by the MHRA, the study is planned to be conducted in healthy volunteers at hVIVO, a global leader in the conduct of human Challenge studies for infectious diseases and respiratory viruses, in the
Efforts Ongoing to Resolve the Clinical Hold — The
Emerging
Beyond its lead influenza and COVID-19 programs, Traws' platform has generated early leads with potential applicability to other emerging viral threats, including hantavirus, Ebola virus disease, and Lassa fever, reflecting the breadth of the Company's antiviral capabilities.
Financing Update:
In
- Series A warrant (
$10.0 million): exercisable upon MHRA approval of the Company's planned human influenza Challenge study. - Series B warrant (
$10.0 million): approved by shareholders and exercisable upon announcement of data from the Challenge study. - Series C warrant (up to
$30.0 million): approved by shareholders.
On
Financial Results:
Cash and cash equivalents: As of
The Company believes that its existing cash and cash equivalents, together with anticipated proceeds from its at-the-market equity program, will be sufficient to fund planned operations into the first quarter of 2027. However, based on current projections, the Company may not have sufficient cash and cash equivalents to support its operations subsequent to the first quarter of 2027, and may require additional financing.
Revenue: The Company recognized no revenue for the three months ended
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other operating income for the three and six months ended
Net Loss: Net loss for the three months ended
Shares Outstanding: Traws had 15,368,277 shares of common stock outstanding as of
About Tivoxavir Marboxil
Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose prophylactic agent for seasonal influenza and treatment of pandemic/bird flu. 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 initiatives1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu.
Source information
- Per link
- Traws data on file
Third-party products mentioned herein are the trademarks of their respective owners.
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.
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, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for 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 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 outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing of Traws’ clinical trials; the potential for tivoxavir marboxil to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the extent of the spread and threat of the bird flu; seasonal flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; 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:
Charles Parker
Traws Pharma, Inc.
cparker@trawspharma.com
www.trawspharma.com
Investor Contact:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com
| Traws Pharma, Inc. Condensed Consolidated Balance Sheets (unaudited) | ||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,016,000 | $ | 3,820,000 | ||||
| Tax incentive and other receivables | 3,454,000 | 3,794,000 | ||||||
| Prepaid expenses and other assets | 553,000 | 365,000 | ||||||
| Total current assets | 9,023,000 | 7,979,000 | ||||||
| Property and equipment, net | 5,000 | 7,000 | ||||||
| Intangible assets, net | 2,441,000 | 2,527,000 | ||||||
| Other assets | 1,000 | 104,000 | ||||||
| Total assets | $ | 11,470,000 | $ | 10,617,000 | ||||
| Liabilities and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,334,000 | $ | 5,653,000 | ||||
| Accrued expenses and other liabilities | 3,401,000 | 5,493,000 | ||||||
| Total current liabilities | 9,735,000 | 11,146,000 | ||||||
| Warrant liabilities | 44,000 | 100,000 | ||||||
| Total liabilities | 9,779,000 | 11,246,000 | ||||||
| Commitments and contingencies (Note 5) | ||||||||
| Stockholders’ deficit: | ||||||||
| Series C Preferred stock, | — | — | ||||||
| Common stock, | 152,000 | 90,000 | ||||||
| Additional paid-in capital | 651,689,000 | 639,259,000 | ||||||
| Accumulated deficit | (650,145,000 | ) | (639,984,000 | ) | ||||
| Accumulated other comprehensive (loss) income | (5,000 | ) | 6,000 | |||||
| Total stockholders’ equity (deficit) | 1,691,000 | (629,000 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 11,470,000 | $ | 10,617,000 | ||||
| Traws Pharma, Inc. Condensed Consolidated Statements of Operations (unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue | $ | — | $ | 2,733,000 | $ | — | $ | 2,790,000 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,101,000 | 2,291,000 | 6,013,000 | 4,797,000 | ||||||||||||
| General and administrative | 3,479,000 | 1,691,000 | 5,513,000 | 4,445,000 | ||||||||||||
| Other operating income | (1,405,000 | ) | — | (1,405,000 | ) | — | ||||||||||
| Total operating expenses | 3,175,000 | 3,982,000 | 10,121,000 | 9,242,000 | ||||||||||||
| Loss from operations | (3,175,000 | ) | (1,249,000 | ) | (10,121,000 | ) | (6,452,000 | ) | ||||||||
| Change in fair value of warrant liability | 215,000 | 146,000 | 56,000 | 26,659,000 | ||||||||||||
| Other (loss) income, net | (94,000 | ) | 188,000 | (96,000 | ) | 368,000 | ||||||||||
| Net (loss) income | $ | (3,054,000 | ) | $ | (915,000 | ) | $ | (10,161,000 | ) | $ | 20,575,000 | |||||
| Net (loss) income attributable to common stockholders, basic and diluted | $ | (2,611,000 | ) | $ | (625,000 | ) | $ | (8,446,000 | ) | $ | 14,860,000 | |||||
| Weighted-average shares of common stock outstanding, basic | 15,864,041 | 5,820,903 | 13,266,763 | 7,359,825 | ||||||||||||
| Net (loss) income per share of common stock, basic | $ | (0.16 | ) | $ | (0.11 | ) | $ | (0.64 | ) | $ | 2.02 | |||||
| Weighted-average shares of common stock outstanding, diluted | 15,864,041 | 5,820,903 | 13,266,763 | 7,614,325 | ||||||||||||
| Net (loss) income per share of common stock, diluted | $ | (0.16 | ) | $ | (0.11 | ) | $ | (0.64 | ) | $ | 1.95 | |||||
| Net (loss) income attributable to Series C Preferred stockholders, basic and diluted | $ | (443,000 | ) | $ | (290,000 | ) | $ | (1,715,000 | ) | $ | 5,715,000 | |||||
| Weighted-average shares of Series C Preferred outstanding, basic and diluted | 6,737 | 6,759 | 6,737 | 7,077 | ||||||||||||
| Net (loss) income per share of Series C Preferred, basic and diluted | $ | (65.76 | ) | $ | (42.91 | ) | $ | (254.56 | ) | $ | 807.55 | |||||
