Private financing of up to
Tivoxavir marboxil advancing towards a human influenza challenge trial as a once-monthly prophylactic agent
Advancing clinical candidates for the treatment of hantavirus infections
“Q1 2026 was a period of meaningful progress for Traws. The recently announced private financing of up to
Recent Highlights and Anticipated Milestones:
On
The upfront gross proceeds and milestone-based warrants, along with the current cash and cash equivalents, are estimated to provide sufficient resources to fund company operations into Q1 2027 including completion of a human challenge trial to evaluate TXM as a once-monthly prophylactic agent for influenza prevention.
Investigational Programs:
Tivoxavir Marboxil (TXM, influenza):
Intended Indication and Market Potential: Potential as a best-in-class once-monthly prophylactic for seasonal flu and potential inclusion in pandemic preparedness initiatives,2,3 all-together, estimated to be a multi-billion-dollar opportunity.
Next Steps:
- Completion of Phase 1 Bridging Study – The ongoing Phase 1 Bridging Study, conducted under an open IND in
Australia , is intended to evaluate if the compressed tablet formulation provides 28-days of coverage. - MHRA Approval and Initiation of Challenge trial – Following completion of the Phase 1 Bridging Study and receipt of MHRA approval, TRAW will conduct a single-dose influenza virus challenge trial of TXM at hVIVO, a global leader in the conduct of human challenge studies for infectious diseases and respiratory viruses, in the
UK . - Efforts Ongoing to Resolve the Clinical Hold – FDA placed the
U.S. IND for TXM on clinical hold due to concerns with the toxicology data package. The Company is preparing a comprehensive response, with the goal of resolving the hold and enabling initiation of global clinical studies by year end.
Hantavirus Program:
Intended Indication and Market Potential: Hantavirus, a rodent-borne negative-strand RNA virus that typically results in a 30-50% fatality rate when transmitted to humans and which has been implicated as the cause of several cruise ship fatalities and serious illnesses in recent days1.
Next Steps: Traws plans to move rapidly to advance a clinical candidate for hantavirus treatment.
Financial Results:
Cash and cash equivalents: As of
Revenue for the quarter ended
Research and development (R&D) expense for the quarter ended
General and administrative (G&A) expense for the quarter ended
Change in fair value of warrant liability for the quarter ended
Net Income (loss): The net loss for the quarter ended
Shares Outstanding: Traws had 15,150,669 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 initiatives 2,3, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu.
Source information
- Wall Street Journal. (2026,
May 7 ). The 33-day 'Atlantic Odyssey' that turned into a hantavirus nightmare. The Wall Street Journal. https://www.wsj.com/world/the-33-day-atlantic-odyssey-that-turned-into-a-hantavirus-nightmare-ae8c7f48 - Per link
- Traws data on file
About
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 and ratutrelvir, 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; Traws’ ability to identify and advance potential clinical candidates for the treatment of hantavirus infections, the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for tivoxavir marboxil and ratutrelvir 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 ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of pandemic flu including H5N1 bird 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:
cparker@trawspharma.com
www.trawspharma.com
Investor Contact:
917-355-2395
jfraunces@lifesciadvisors.com
| Traws Pharma, Inc. Condensed Consolidated Balance Sheets (unaudited) | |||||||
| 2026 | 2025 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 3,133,000 | $ | 3,820,000 | |||
| Tax incentive and other receivables | 1,687,000 | 3,794,000 | |||||
| Prepaid expenses and other assets | 845,000 | 365,000 | |||||
| Total current assets | 5,665,000 | 7,979,000 | |||||
| Property and equipment, net | 6,000 | 7,000 | |||||
| Intangible assets, net | 2,484,000 | 2,527,000 | |||||
| Other assets | 1,000 | 104,000 | |||||
| Total assets | $ | 8,156,000 | $ | 10,617,000 | |||
| Liabilities and stockholders’ deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 7,665,000 | $ | 5,653,000 | |||
| Accrued expenses and other liabilities | 5,543,000 | 5,493,000 | |||||
| Total current liabilities | 13,208,000 | 11,146,000 | |||||
| Warrant liabilities | 259,000 | 100,000 | |||||
| Total liabilities | 13,467,000 | 11,246,000 | |||||
| Commitments and contingencies (Note 5) | |||||||
| Stockholders’ deficit: | |||||||
| Series C Preferred stock, | — | — | |||||
| Common stock, | 101,000 | 90,000 | |||||
| Additional paid-in capital | 641,681,000 | 639,259,000 | |||||
| Accumulated deficit | (647,091,000 | ) | (639,984,000 | ) | |||
| Accumulated other comprehensive (loss) income | (2,000 | ) | 6,000 | ||||
| Total stockholders’ deficit | (5,311,000 | ) | (629,000 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 8,156,000 | $ | 10,617,000 | |||
| Traws Pharma, Inc. Condensed Consolidated Statements of Operations (unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Revenue | $ | — | $ | 57,000 | |||
| Operating expenses: | |||||||
| Research and development | 4,912,000 | 2,506,000 | |||||
| General and administrative | 2,034,000 | 2,754,000 | |||||
| Total operating expenses | 6,946,000 | 5,260,000 | |||||
| Loss from operations | (6,946,000 | ) | (5,203,000 | ) | |||
| Change in fair value of warrant liability | (159,000 | ) | 26,513,000 | ||||
| Other income, net | (2,000 | ) | 180,000 | ||||
| Net (loss) income | $ | (7,107,000 | ) | $ | 21,490,000 | ||
| Net (loss) income attributable to common stockholders, basic and diluted | $ | (5,692,000 | ) | $ | 15,083,000 | ||
| Weighted-average shares of common stock outstanding, basic | 10,640,625 | 6,965,927 | |||||
| Net (loss) income per share of common stock, basic | $ | (0.53 | ) | $ | 2.17 | ||
| Weighted-average shares of common stock outstanding, diluted | 10,640,625 | 7,215,125 | |||||
| Net (loss) income per share of common stock, diluted | $ | (0.53 | ) | $ | 2.09 | ||
| Net (loss) income attributable to Series C Preferred stockholders, basic and diluted | $ | (1,415,000 | ) | $ | 6,407,000 | ||
| Weighted-average shares of Series C Preferred outstanding, basic and diluted | 6,737 | 7,398 | |||||
| Net (loss) income per share of Series C Preferred, basic and diluted | $ | (210.03 | ) | $ | 866.04 | ||
