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Dec 31, 2019
Cabaletta Bio Q4 2019 Earnings Report
Announced financial results for the fourth quarter and full year ended December 31, 2019
Key Takeaways
Cabaletta Bio reported its Q4 and full-year 2019 financial results, highlighting the FDA clearance of the IND for their lead product candidate, DSG3-CAART, and ending the year with approximately $136 million in cash and cash equivalents.
DSG3-CAART IND clearance was received in October 2019, and Orphan Drug Designation was granted by the FDA in January 2020.
IND-enabling studies for MuSK-CAART, targeting the MuSK form of myasthenia gravis, are to be initiated in 2020.
The company ended 2019 with approximately $136 million in cash and cash equivalents, sufficient to fund operations through at least the third quarter of 2022.
A delay in reporting the acute safety data from the first cohort of the DesCAARTesTM trial is anticipated due to the COVID-19 pandemic.
Cabaletta Bio
Cabaletta Bio
Forward Guidance
Cabaletta Bio anticipates a delay in reporting acute safety data from the DesCAARTesTM trial due to COVID-19 but expects cash on hand to fund operations through at least Q3 2022.
Positive Outlook
- Plans to initiate patient dosing in an open-label Phase 1 clinical trial to evaluate DSG3-CAART safety and tolerability in relapsed/refractory mPV patients.
- Plans to initiate IND-enabling studies of MuSK-CAART in 2020.
- Has the ability and the potential to successfully maintain or secure the necessary cell processing capacity and supply for its product candidates for clinical trials.
- Expects cash on hand as of December 31, 2019 will be sufficient to fund operations through at least the third quarter of 2022.
- Cabaletta expects to be able to further extend its cash runway into 2023 if needed, while continuing to invest in its lead candidates.
Challenges Ahead
- Anticipates a delay in reporting the acute safety data from the first cohort of the DesCAARTesTM trial due to the COVID-19 pandemic
- Risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19
- Risks related to Cabaletta’s ability to protect and maintain its intellectual property position
- Risks related to Cabaletta’s relationship with third parties, including its licensors and licensees
- The risk that any one or more of Cabaletta’s product candidates will not be successfully developed and commercialized