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Mar 31, 2023
Cabaletta Bio Q1 2023 Earnings Report
Cabaletta Bio reported financial results for Q1 2023 and provided a business update.
Key Takeaways
Cabaletta Bio reported first quarter 2023 financial results, including research and development expenses of $12.4 million and general and administrative expenses of $4.5 million. As of March 31, 2023, the company had cash and cash equivalents of $93.8 million, expected to fund operations into the first quarter of 2025. The IND application for CABA-201 has been cleared and Fast Track Designation was granted by the FDA.
IND application for CABA-201 cleared within 30 days for clinical trial in patients with LN and SLE.
FDA granted Fast Track Designation for CABA-201 to deplete CD19-positive B cells and improve disease activity in patients with LN and SLE.
Phase 1/2 trial planned to evaluate CABA-201 in six patients with active LN and six patients with SLE without renal involvement.
Cabaletta plans to present on CD19-CAR T in SLE and poster presentations for CABA-201 and DSG3-CAART at the upcoming ASGCT 26th Annual Meeting.
Cabaletta Bio
Cabaletta Bio
Forward Guidance
Cabaletta anticipates three-month clinical efficacy endpoint and tolerability data for CABA-201 and six-month data for the combination cohort of the MusCAARTes™ trial in the first half of 2024.
Positive Outlook
- Cabaletta’s ability to grow its autoimmune-focused pipeline
- Leverage the potential benefits from using the initial dose used in the September 2022 Nature Medicine publication
- Cabaletta’s ability to retain and recognize the intended incentives conferred from the Fast Track Designation for CABA-201
- The progress and results of its DesCAARTes™ Phase 1 trial and MusCAARTes™ Phase 1 trial
- Statements regarding regulatory filings for its development programs, including the planned timing of such regulatory filings and potential review by such regulatory authorities
Challenges Ahead
- Risks related to regulatory filings and potential clearance
- The risk that signs of biologic activity or persistence may not inform long-term results
- Risks related to clinical trial site activation or enrollment rates that are lower than expected
- Risks related to unexpected safety or efficacy data observed during clinical studies
- The risk that the results observed with the similarly-designed construct employed in the recent Nature Medicine publication, including due to the dosing regimen, are not indicative of the results we seek to achieve with CABA-201