Traws Pharma Stock Price, News & Analysis

Traws Pharma (NASDAQ: TRAW) has announced positive topline results from testing their antiviral candidate, tivoxavir marboxil, in ferrets infected with H5N1 bird flu. The single-dose treatment demonstrated disease suppression and reduced viral burden in lungs, consistent with previous December 2024 murine model results.

The study utilized the A/Texas/37/2024 H5N1 virus strain isolated from a Texas dairy worker. The ferret model, widely accepted for human influenza studies, showed increased survival rates and lower viral presence in lungs and nasal tissues.

The company plans to conduct additional testing in non-human primates, with data expected in Q1 2025. Traws Pharma aims to discuss accelerated approval with the FDA under the 'Animal Rule' and will host a Virtual Investor Update on March 31, 2025, to review the bird flu program in detail.

Traws Pharma (NASDAQ: TRAW) has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement (Rule 5550(b)(1)), ensuring continued listing on The NASDAQ Capital Market. The compliance was achieved following a $20 million gross proceeds offering completed on December 30, 2024.

The company will remain under mandatory panel monitoring through February 25, 2026. During this period, if Traws falls below the $2.5 million stockholders' equity requirement, it would face delisting without a cure period, though with the option to request a new hearing.

Traws, a clinical-stage biopharmaceutical company, is developing oral small molecules for respiratory viral diseases. Their lead program for bird flu/influenza has recently completed a Phase 1 trial, with ongoing laboratory studies.

Traws Pharma (NASDAQ: TRAW) has announced the completion of Phase I clinical studies for tivoxavir marboxil, their investigational one-dose therapy for H5N1 bird flu treatment and prevention. The randomized, double-blind, placebo-controlled study evaluated safety, tolerability, and pharmacokinetics in healthy adult volunteers across four dose levels.

The topline results showed no significant treatment-related adverse events, and pharmacokinetic data supported dosing for both therapeutic use and prevention. Preclinical studies demonstrated that tivoxavir marboxil effectively inhibited drug-resistant influenza viruses and highly pathogenic bird flu viruses both in vitro and in vivo.

The company views these results as supportive of accelerated development in response to growing bird flu threats, particularly following the first U.S. death and spread into commercial poultry farms. The combined clinical and animal model data will guide upcoming regulatory meetings.

Expert Systems and Traws Pharma (NASDAQ: TRAW) have announced significant progress in their H5N1 bird flu antiviral program. Their investigational drug, Tivoxavir Marboxil, has demonstrated promising results as a single-dose treatment for avian influenza. The oral cap-dependent endonuclease inhibitor has shown broad-spectrum efficacy against various flu strains in preclinical studies.

In Phase 1 clinical trials, the drug showed no treatment-related adverse events and maintained effective plasma levels for over 23 days with a single dose. Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former CDC Director, emphasized the increasing risk of bird flu adaptation to humans and potential pandemic spread.

The company plans to initiate Phase 2 efficacy studies in the first half of 2025. The development leverages Expert Systems' hybrid AI-enabled drug discovery platform, combining artificial intelligence with human expertise for expedited therapy development.

Traws Pharma (NASDAQ: TRAW) has secured financing agreements worth up to $72.6 million from leading healthcare institutional investors to advance Tivoxavir Marboxil development for H5N1 bird flu. The financing includes an initial tranche of $20 million through issuance of common stock and pre-paid warrants, extending cash runway into 1H26, and a potential subsequent tranche of up to $52.6 million upon warrant exercise within 30 days of key data readouts.

The key readouts include Ferret Bird Flu Data and Non-Human Primate Bird Flu Data (expected early-1Q25) and Phase 2A Data (expected-2H25). Notable investors include Perceptive Advisors, OrbiMed, Alyeska, Torrey Pines, and Ikarian Capital. Tivoxavir Marboxil has shown potent inhibition of bird flu viruses and drug-resistant influenza viruses in both in vitro and in vivo studies.

Traws Pharma (NASDAQ: TRAW) reported progress in developing tivoxavir marboxil for H5N1 bird flu treatment. The company completed Phase 1 dosing in healthy volunteers, demonstrating safety and drug level maintenance above EC90 for over 23 days. Preclinical studies showed potent inhibition of drug-resistant influenza and bird flu viruses both in vitro and in vivo.

In laboratory testing with mice exposed to H5N1 from an infected dairy worker, oral treatment resulted in complete survival and reduced lung virus levels. The company plans to begin Phase 2 studies in H1 2025. The development addresses growing concerns about bird flu adaptation to humans, particularly among poultry and dairy workers.

Traws Pharma reported Q3 2024 financial results and provided updates on its antiviral programs. Phase 1 data showed promising results for both ratutrelvir (COVID-19 treatment) and tivoxavir marboxil (influenza treatment). The company reported cash position of $5.4 million as of September 30, 2024, down from $20.8 million at end-2023. Q3 net loss widened to $8.5 million ($8.81 per share) compared to $4.7 million ($5.64 per share) in Q3 2023. R&D expenses increased to $5.1 million from $2.5 million year-over-year, while G&A expenses rose to $3.5 million from $2.7 million. Phase 2 studies for both drugs are expected to commence in 2025.

Expert Systems celebrates a milestone in the clinical development of tivoxavir marboxil, a potential one-time influenza treatment. Developed by Traws Pharma (NASDAQ: TRAW), tivoxavir showed positive topline Phase 1 safety and pharmacokinetic results, supporting its potential as a broad-spectrum flu treatment.

Expert Systems' AI-enabled drug discovery platform helped de-risk and fast-track tivoxavir's development. The study demonstrated good overall tolerability and a pharmacokinetic profile supporting one-time use for flu, including pandemic flu. Tivoxavir is positioned as a potential best-in-class inhibitor of drug-resistant influenza and bird flu viruses.

Phase 2a trials are set to begin in early 2025, aiming to evaluate tivoxavir's potential in reducing flu-related hospitalizations and mortality, especially in vulnerable populations.

Traws Pharma (NASDAQ: TRAW) announced positive topline Phase 1 safety and pharmacokinetic results for its investigational one-dose influenza therapy, tivoxavir marboxil. The study demonstrated good overall tolerability and a pharmacokinetic profile supporting potential use as a one-time treatment for flu, including pandemic flu. Key findings include:

1. A single dose maintained plasma drug levels above the EC90 for over 5 days.
2. Preclinical data showed potent inhibition of drug-resistant and bird flu viruses.
3. The company plans to advance to a Phase 2 study in H1 2025.

Tivoxavir targets the highly-conserved influenza protein CAP-dependent endonuclease (CEN), potentially effective against a broad range of flu viruses. The Phase 1 trial identified the Phase 2 dose, with no treatment-related adverse events reported at this level.