Traws Pharma Q1 2024 Financial Results and Business Update

Traws Pharma Inc., a clinical-stage biopharmaceutical company, has reported its financial results for the first quarter of 2024 along with significant business updates. The company, which focuses on developing oral small molecule therapies for respiratory viral diseases and cancer, highlighted several key achievements and future plans in its recent announcement.

The year 2024 has been marked by transformative developments for Traws Pharma. Notably, the company completed the acquisition of Trawsfynydd and secured a concurrent $14 million private placement financing. This acquisition is expected to enhance Traws Pharma’s capabilities and accelerate its research and development efforts. Additionally, the company has initiated the first-in-human dosing for its COVID-19 product candidate, completing the first cohort dosing group. Another milestone includes completing the last dose escalation cohort for its CDK4+ inhibitor, narazaciclib.

Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma, expressed optimism regarding the company’s progress. He emphasized the potential for more significant advancements in the latter half of 2024, particularly with the initiation of expanded Phase 1 dose escalation studies for their influenza treatment and ritonavir-free COVID-19 protease inhibitor, and the commencement of Phase 2 developments.

According to Dr. Cautreels, the preclinical and early clinical data from Traws’ infectious disease candidates and narazaciclib are promising. He is optimistic about the outlook for the company’s portfolio and plans to keep investors updated on their progress throughout the year.

The proprietary portfolio of Traws Pharma includes several key candidates:

TRX100 (tivoxavir marboxil): This cap-dependent endonuclease inhibitor targets the influenza virus and has shown significant potential in preclinical studies. The first Phase 1 study demonstrated safety and tolerability in healthy volunteers, with pharmacokinetics and pharmacodynamics data supporting the potential use of a single oral dose for treatment or prophylaxis. A Phase 1 dose extension study is planned to evaluate a higher dose before initiating Phase 2 studies in the second half of 2024, with topline data expected in the first half of 2025.

TRX01 (ratutrelvir): This ritonavir-free Mpro protease inhibitor for COVID-19 has shown efficacy against various SARS-CoV-2 variants, including the original, delta, and omicron strains. The ongoing Phase 1 study involves a single ascending dose/multiple ascending dose study in healthy volunteers, with topline data anticipated in the second half of 2024. A Phase 2 study targeting patients with moderate to severe COVID-19 is also scheduled to begin in the second half of 2024, with topline data expected in the first half of 2025.

Narazaciclib: This CDK 4+ inhibitor is being developed to treat solid tumors. Preclinical and clinical data suggest narazaciclib is effective in various tumor types and has shown reduced neutropenia compared to palbociclib, along with inhibition of palbociclib-resistant cancer cells. The final cohort of a dose escalation study has recently been enrolled, and a review of the clinical data is underway to define the next steps in its development.

Financially, Traws Pharma reported cash and cash equivalents of $16.4 million as of March 31, 2024, compared to $20.8 million at the end of December 2023. In April 2024, the company raised $14 million from the sale of stock to TPAV, LLC, and OrbiMed Private Investments VIII, LP. Despite a slight decrease in first-quarter revenue, operating expenses saw a significant shift. General and administrative expenses rose to $3.4 million from $2.1 million the previous year, primarily due to higher legal and professional fees related to the Trawsfynydd acquisition. However, research and development expenses decreased to $1.9 million from $4.1 million, attributed to lower costs associated with narazaciclib manufacturing and clinical development.

The net loss for the first quarter of 2024 was $5.0 million, or $0.24 per share, compared to a net loss of $5.8 million, or $0.28 per share, for the same period in 2023. Despite the net loss, Traws Pharma remains confident in its financial position, with sufficient funds to support ongoing clinical trials and operations into the fourth quarter of 2024.

Traws Pharma continues to focus on developing innovative treatments for respiratory viral diseases and cancer, leveraging state-of-the-art drug development technology to address unmet medical needs. The company is committed to delivering novel compounds aimed at alleviating the burden of these critical health challenges.

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