Traws Pharma Q2 2024 Financial Results and Business Highlights

Traws Pharma, Inc., a clinical-stage biopharmaceutical company focusing on developing oral small molecules for respiratory viral diseases and cancer, has recently provided an update on its business milestones and financial performance for the second quarter ending June 30, 2024. The company has scheduled a conference call and webcast to discuss these updates on August 15, 2024.

Chief Executive Officer Werner Cautreels, PhD, highlighted the transformative period for Traws Pharma, marked by strategic progress and capital growth. The recent merger with Trawsfynydd Therapeutics, Inc. significantly broadened Traws Pharma’s investor base and enhanced its portfolio. This merger introduced new compounds with significant potential to address influenza, including avian flu, and COVID-19. Additionally, investigator-sponsored trials (ISTs) are advancing Traws Pharma’s multi-kinase inhibitors for cancer treatment, specifically narazaciclib and rigosertib.

One of the lead antiviral programs, tivoxavir marboxil, targets influenza cap-dependent endonuclease and is being evaluated in a Phase 1 dose extension study in Australia. This program is on track to report Phase 1 results and initiate Phase 2 studies by the end of 2024. The preclinical and initial clinical data suggest that tivoxavir marboxil could become a single-dose treatment for influenza, including strains resistant to other treatments such as oseltamivir and baloxavir.

The COVID-19 program for the candidate ratutrelvir, which targets the Mpro (3CL protease), has completed its Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) studies in Australia. The data indicate potential effectiveness without needing a CYP-inhibitor and activity against virus strains resistant to existing treatments like nirmatrelvir. Phase 2 studies for ratutrelvir are expected to commence soon.

For oncology, Traws Pharma is advancing narazaciclib, a multi-kinase inhibitor evaluated in Phase 1/2 dose escalation studies. The studies aim to establish the recommended Phase 2 dose and explore its use in multiple cancer types, including myeloma and breast cancer. Additionally, rigosertib, another multi-kinase inhibitor targeting cell cycle proteins, continues to be supported for use in rare diseases like RDEB-associated SCC.

In terms of financial performance, Traws Pharma reported cash, cash equivalents, and short-term investments totaling approximately $16.9 million as of June 30, 2024, sufficient to fund operations through the end of 2024. Research and development expenses increased to $4.0 million in Q2 2024, reflecting the costs associated with ongoing and upcoming clinical studies. General and administrative expenses were $2.0 million for the same period. The net loss for the quarter was $123.1 million, significantly impacted by a non-cash charge related to acquired in-process R&D from the merger with Trawsfynydd.

Recent key developments include:
1. Commencement of dosing in the Phase 1 dose extension study for tivoxavir marboxil.
2. Completion of the Phase 1 SAD/MAD study for ratutrelvir in Australia.
3. Finalization of Phase 1/2 dose escalation studies for narazaciclib, with impending topline data analysis.
4. Presentation of data from ongoing ISTs for rigosertib at the Society for Investigative Dermatology.

The successful merger with Trawsfynydd and a concurrent $14 million private placement have positioned Traws Pharma to advance its clinical portfolio, encompassing potentially best-in-class therapies for influenza, COVID-19, and various cancers. This strategic move has also strengthened the company’s investor base with notable healthcare investors like Orbimed and Torrey Pines.

Traws Pharma's upcoming milestones include the announcement of Phase 1 trial results and the initiation of Phase 2 efficacy studies for tivoxavir marboxil and ratutrelvir, along with the release of Phase 1/2 study results for narazaciclib. The company remains committed to developing innovative treatments for unmet medical needs and advancing its clinical programs toward key readouts anticipated in 2025.