vTv Therapeutics (NASDAQ: VTVT) is back on track. The clinical-stage biopharma firm announced that the U.S. FDA has lifted its clinical hold on cadisegliatin, its investigational oral adjunctive therapy for type 1 diabetes (T1D). With the regulatory pause now behind them, vTv plans to restart its Phase 3 CATT1 trial in the second quarter of 2025—this time with a shortened six-month design aimed at expediting topline results.
- The original 12-month trial protocol has been amended to eliminate an additional safety assessment period, maintaining the original study endpoints while accelerating the clinical timeline.
- Cadisegliatin (TTP399) is a liver-selective glucokinase activator designed to complement insulin in T1D patients.
- The FDA lifted its clinical hold in March 2025 following vTv’s complete response submission.
In tandem with its clinical update, vTv announced a key leadership move to reinforce its commercialization strategy. Martin Lafontaine, who previously held senior roles in diabetes treatment commercialization—including the sale of Nasal Glucagon to Eli Lilly—has joined as Chief Commercial Officer.
On the financials front, the company reported a solid year-end cash position of $36.7 million, up from $9.4 million at the close of 2023. The boost stems primarily from a February 2024 private placement and proceeds from an at-the-market (ATM) equity offering.
- Full-year R&D expenses dropped to $11.5 million from $13.6 million in 2023, mainly due to decreased spending on cadisegliatin-related trials and manufacturing.
- G&A expenses rose to $13.7 million, reflecting higher payroll and share-based compensation costs.
- Net loss for the year was $18.5 million, an improvement from the $20.3 million loss in 2023.
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