Ventyx Biosciences and Tonix Pharmaceuticals have recently announced their third-quarter financial results and provided updates on their respective clinical development pipelines.
Ventyx Biosciences Advances NLRP3 Inhibitors
Ventyx Biosciences (VTYX) is making strides with its NLRP3 inhibitor portfolio. A Phase 2a trial of VTX3232 in patients with early Parkinson’s disease was initiated in Q3 2024, focusing on safety and inflammatory biomarkers. Topline results are expected in the first half of 2025. Additionally, a Phase 2 trial of VTX3232 in subjects with obesity and cardiometabolic risk factors is slated to begin by year-end, with topline results anticipated in the second half of 2025. These trials follow positive Phase 1 data, where VTX3232 demonstrated a dose-dependent pharmacokinetic profile and exceeded steady-state IL-1β IC90 coverage in both plasma and CSF.
The company also plans to initiate a Phase 2 trial of VTX2735 in patients with recurrent pericarditis by year-end, aiming to evaluate safety and the impact on disease-relevant biomarkers and pain scores. Ventyx believes VTX2735 could become the first approved oral therapy for recurrent pericarditis, an autoinflammatory disease linked to NLRP3 inflammasome activation.
Tonix Pharmaceuticals Awaits FDA Decision on Fibromyalgia Treatment
Tonix Pharmaceuticals (TNXP) has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL for the treatment of fibromyalgia, supported by two successful Phase 3 studies. The FDA granted Fast Track designation to TNX-102 SL in July 2024, with a decision expected in December 2024. If approved in 2025, TNX-102 SL would be the first new fibromyalgia drug in over 15 years, addressing a condition that affects approximately 10 million adults in the U.S.
In a Phase 3 RESILIENT study, TNX-102 SL significantly reduced daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia, while demonstrating broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints, including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function.
Financial Highlights
Ventyx Biosciences reported a cash balance of $274.8 million as of September 30, 2024, which is expected to fund operations into at least the second half of 2026. Research and development expenses for Ventyx were $30.6 million for the third quarter of 2024, compared to $49.8 million for the third quarter of 2023.
Tonix Pharmaceuticals reported $28.2 million in cash and cash equivalents as of September 30, 2024. The company's net product revenue for the third quarter of 2024 was approximately $2.8 million. Research and development expenses for Tonix were approximately $9.1 million for the third quarter of 2024, compared to $21.0 million for the same period in 2023.
Tonix Secures DoD Contract
Tonix Pharmaceuticals also secured a contract with the U.S. Department of Defense (DoD) for up to $34 million over five years to develop broad-spectrum antiviral agents. This contract aims to improve the medical readiness of military personnel in biological threat environments.
