Cabaletta Bio Q2 2024 Earnings Report
Key Takeaways
Cabaletta Bio reported its second quarter 2024 financial results, highlighting increased enrollment in clinical trials, expansion of clinical sites, and advancements in its manufacturing strategy through new agreements with Lonza and Cellares. The company's cash, cash equivalents, and short-term investments totaled $203.2 million as of June 30, 2024, which is expected to fund operations into the first half of 2026.
Nine patients enrolled as of August 5, 2024, across the RESET™ clinical development program, including four since EULAR in June, with 22 U.S. clinical sites now enrolling.
Additional clinical data from the RESET-Myositis™ and RESET-SLE™ trials, as well as initial clinical data from the RESET-SSc™ and RESET-MG™ trials, are anticipated in 2H24.
An LN patient dosed with CABA-201 in late June experienced a protocol-defined dose-limiting toxicity of Grade 4 ICANS, which resolved rapidly; the independent data monitoring committee recommended the study proceed as designed.
Recently signed Lonza and Cellares agreements support progression into the next stage of manufacturing strategy to support expansion of clinical supply and prepare for efficient commercial supply of CABA-201.
Cabaletta Bio
Cabaletta Bio
Forward Guidance
Cabaletta Bio expects to continue advancing its clinical trials and manufacturing capabilities for CABA-201, with anticipated data readouts and expanded clinical supply.
Positive Outlook
- Additional clinical data from RESET-Myositis™ and RESET-SLE™ trials expected in 2H24.
- Initial clinical data from RESET-SSc™ and RESET-MG™ trials expected in 2H24.
- Advancement of manufacturing strategy with new CDMO agreement with Lonza.
- Expansion of manufacturing collaboration with Cellares.
- Cash runway extended into the first half of 2026.
Challenges Ahead
- A lupus nephritis patient experienced a Grade 4 ICANS after being dosed with CABA-201.
- The company is implementing protocol modifications to improve patient safety.
- Clinical trials are subject to inherent risks and uncertainties.
- The initial or interim results of clinical studies may not be predictive of future results.
- The company may face challenges in manufacturing and commercializing its product candidates.