Cabaletta Bio Q4 2019 Earnings Report
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