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Sep 30, 2021
Cabaletta Bio Q3 2021 Earnings Report
Cabaletta Bio reported financial results for the third quarter ended September 30, 2021, and provided a business update.
Key Takeaways
Cabaletta Bio announced encouraging momentum in the DesCAARTes™ trial for DSG3-CAART, with dose-dependent increases in DSG3-CAART persistence observed. The company ended the quarter with $119.3 million in cash, extending the cash runway through at least Q1 2023.
Observed dose dependent increase in DSG3-CAART persistence in the third dose cohort with 500 million DSG3-CAART cells relative to the first two low dose cohorts in DesCAARTes™ Phase 1 clinical trial.
No dose limiting toxicities (DLTs) or clinically relevant adverse events observed as of October 31, 2021, in the first three dose cohorts.
Dosing initiated in fourth patient cohort at a dose of 2.5 billion DSG3-CAART cells. Top-line biologic activity data from first two low dose cohorts expected to be announced in 4Q21.
Lead preclinical program, MuSK-CAART, Investigational New Drug (IND) submission on track for 4Q21.
Forward Guidance
Cabaletta Bio expects to announce 28-day safety data for the fourth dose cohort in the first quarter of 2022 and top-line biologic activity data for the first two low dose cohorts in the fourth quarter of 2021. The company also expects to submit an IND to the FDA for MuSK-CAART in the fourth quarter of 2021 and conduct a pre-IND interaction with the FDA for PLA2R-CAART in the fourth quarter of 2021. Cash, cash equivalents and investments as of September 30, 2021, will enable it to fund its operating plan through at least the first quarter of 2023.
Positive Outlook
- Announce 28-day safety data for the fourth dose cohort in Q1 2022
- Announce top-line biologic activity data for the first two low dose cohorts in Q4 2021
- Submit an IND to the FDA for MuSK-CAART in Q4 2021
- Conduct a pre-IND interaction with the FDA for PLA2R-CAART in Q4 2021
- Fund operations through at least Q1 2023
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