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Sep 30, 2022
Cabaletta Bio Q3 2022 Earnings Report
Cabaletta Bio reported financial results for the third quarter ended September 30, 2022 and provided a business update.
Key Takeaways
Cabaletta Bio reported its third-quarter financial results, highlighting the progress of its CARTA and CAART platform, including CABA-201, DSG3-CAART, and MuSK-CAART. The company plans to submit an IND application to the FDA for CABA-201 in the first half of 2023 and expects initial clinical data by the first half of 2024. Cabaletta had cash, cash equivalents and investments of $85.9 million as of September 30, 2022, which is expected to fund operations through the second quarter of 2024.
Cabaletta plans to submit an IND application to the FDA for CABA-201 in the first half of 2023, with initial clinical data expected by the first half of 2024.
Exclusive, worldwide license was obtained from Nanjing IASO Biotherapeutics, Co., Ltd. (IASO Bio) for binder to be used in new product candidate CABA-201.
An exclusive translational research partnership with Georg Schett, M.D. was established.
FDA granted Orphan Drug Designation to MuSK-CAART for the treatment of muscle-specific tyrosine kinase myasthenia gravis.
Cabaletta Bio
Cabaletta Bio
Forward Guidance
Cabaletta Bio expects that its cash, cash equivalents and investments as of September 30, 2022, will enable it to fund its operating plan through the second quarter of 2024.
Positive Outlook
- Submission of IND application for CABA-201 planned for 1H 2023.
- Initial clinical data for CABA-201 expected by the first half of 2024.
- 1-month safety and persistence data for the combination cohort in the DesCAARTes™ trial expected in the first quarter of 2023.
- First-in-human trial for MuSK-CAART to initiate in the fourth quarter of 2022.
- 6-month data for the combination cohort of the MusCAARTes™ trial for MuSK-CAART expected in the first half of 2024.