Traws Pharma Stock Price, News & Analysis

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.

Traws Pharma (NASDAQ: TRAW) announced positive topline Phase 1 results for ratutrelvir, its oral COVID-19 treatment candidate. The study showed that ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window without requiring ritonavir co-administration. Key findings include:

1. No treatment-related adverse events reported
2. Plasma concentrations above EC90 against SARS-CoV-2 viruses
3. Potential for once-daily, single-dose, 10-day antiviral therapy
4. Differentiated activity against drug-resistant viruses in preclinical studies

Traws Pharma plans to begin a Phase 2a study in H1 2025. The company aims to address the ongoing need for improved COVID care, noting approximately 50,000 US deaths in 2023 despite available treatments.

Traws Pharma (Nasdaq: TRAW) has announced significant changes to its Board of Directors. Luba Greenwood, an experienced life sciences executive, has been appointed as a new Director. Simultaneously, James J. Marino is stepping down after nearly a decade of service, including four years as Chairman.

Greenwood brings extensive experience as a Board Member, Investor, Strategic Advisor, and Company Executive. Her background includes roles as Managing Partner of Binney Street Capital and Vice President of Global Business Development and M&A at Roche. This appointment comes at a important time for Traws, as the company advances its respiratory antiviral therapies through Phase 1 studies and progresses its oncology strategy.

The company's recent developments include an April 2024 merger agreement with Trawsfynydd, one of the "Loch Companies" founded by the i2020 Accelerator. Traws has since advanced its flu and COVID programs through Phase 1 dosing studies and is preparing for Phase 2 studies.

Traws Pharma (NASDAQ: TRAW) announced the results of its 2024 Special Meeting of Stockholders held on September 16, 2024. All three proposals were approved, including:

• Authorization of common stock issuance upon conversion of Series C Preferred Stock
• Increase in authorized common shares from 125 million to 250 million
• Approval of a reverse stock split

Following the meeting, Traws' Board approved a 1-for-25 reverse stock split, effective September 20, 2024. Trading on a split-adjusted basis will begin on September 23, 2024. The split will reduce outstanding shares from approximately 45.67 million to 1.83 million. No fractional shares will be issued, and the stock will continue trading under the symbol 'TRAW' with a new CUSIP number.

Traws Pharma reported Q2 2024 financial results and provided recent business highlights. Key points include:

1. Merger with Trawsfynydd Therapeutics and $14 million private placement, extending cash runway through year-end.

2. Lead antiviral program, tivoxavir marboxil for influenza, dosing first cohort in Phase 1 dose extension study.

3. COVID-19 program, ratutrelvir, completed Phase 1 SAD and MAD study.

4. Oncology strategy includes investigator-sponsored trials for narazaciclib and continued support for rigosertib.

5. Q2 2024 financials: $16.9 million in cash and equivalents, $4.0 million R&D expense, $2.0 million G&A expense, and $123.1 million net loss (including $117.5 million non-cash charge for acquired in-process R&D).