Traws Pharma, Inc. - TRAW STOCK NEWS

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).

Traws Pharma, a clinical stage biopharmaceutical company, has announced a corporate update call scheduled for August 15, 2024, at 8:00 AM ET. This call follows the release of their second quarter financial results. The company, which focuses on developing oral small molecules for respiratory viral diseases and cancer, will provide insights into their current operations and future plans.

Investors and interested parties can access the webcast through a provided link or join via phone using specific dial-in numbers for US and international callers. The financial results press release will be available on the company's website prior to the call, and a replay will be accessible afterwards in the Investor Relations section.

This corporate update presents an opportunity for stakeholders to gain valuable information about Traws Pharma's progress and financial standing, potentially impacting investment decisions related to the TRAW stock.

Traws Pharma presented a poster at ICAR2024, showcasing positive preclinical results for their COVID-19 candidate, ratutrelvir. This Mpro protease inhibitor, which does not require ritonavir, demonstrated superior activity against various Omicron variants compared to nirmatrelvir. The differentiation in resistance profiles between the two drugs was highlighted, with ratutrelvir showing fewer resistance mutations. These findings support the potential of ratutrelvir as a leading therapy for COVID-19. Phase 1 trials are ongoing, with Phase 2 expected to begin in H2 2024.

Traws Pharma announced its Q1 2024 financial results and provided a business update, highlighting significant developments. The company completed the acquisition of Trawsfynydd and raised $14 million in private placement financing.

Key pipeline advancements include the initiation of first-in-human dosing for their COVID-19 product candidate and completion of the last dose escalation cohort for their CDK4+ inhibitor, narazaciclib. They plan to advance their influenza treatment and ritonavir-free COVID-19 protease inhibitor into expanded Phase 1 and Phase 2 studies in H2 2024.

First quarter financials show cash and equivalents at $16.4 million, a slight decrease from $20.8 million at the end of 2023. Revenue remained consistent at $56,000. G&A expenses rose to $3.4 million due to acquisition-related costs, while R&D expenses decreased to $1.9 million. The net loss narrowed to $5.0 million from $5.8 million in Q1 2023.