Cabaletta Bio Reports First Quarter 2022 Financial Results and Provides Business Update
– DesCAARTes™ trial clinical and translational data from cohorts A3 and A4 and 28-day safety data from cohort A5 expected to be presented at upcoming scientific meetings in mid-2022 –
– Multiple abstracts accepted for presentation at upcoming ASGCT and SID Annual Meetings –
– MuSK-CAART first-in-human trial on track to commence in 2022 following Fast Track Designation and IND clearance from the FDA –
PHILADELPHIA, May 12, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2022, and provided a business update.
“The favorable safety profile from the first four cohorts in the dose escalation phase of our ongoing DesCAARTes™ Phase 1 trial supports our ability to increase in vivo DSG3-CAART exposure to treat patients diagnosed with mucosal pemphigus vulgaris. We look forward to presenting clinical and translational data from the DesCAARTes™ trial at the upcoming ASGCT and SID annual meetings. We continue to progress cohort A5 at a range of 5.0 to 7.5 billion cells. Absent any dose limiting toxicities, we believe we can advance to a dose as high as 10 to 15 billion cells as we continue to optimize our targeted cell therapy in patients with mPV,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “We are also applying our insights learned from the DesCAARTes™ trial as we plan for the initiation of our first-in-human trial of MuSK-CAART for MuSK antibody positive myasthenia gravis this year. We believe these data and learnings advance our efforts toward delivering deep, durable, and potentially curative, responses for patients with autoimmune diseases.”
Pipeline Highlights and Anticipated Upcoming Milestones
DSG3-CAART: Desmoglein 3 chimeric autoantibody receptor T (DSG3-CAART) cells as a potential treatment for patients with mucosal pemphigus vulgaris (mPV).
MuSK-CAART: Muscle-specific kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells as a potential treatment for patients with MuSK-associated myasthenia gravis.
PLA2R-CAART: Phospholipase A2 receptor (PLA2R) chimeric autoantibody receptor T (PLA2R-CAART) cells as a potential treatment for patients with PLA2R-associated membranous nephropathy.
First Quarter 2022 Financial Results
The Company expects that its cash, cash equivalents and investments as of March 31, 2022 will enable it to fund its operating plan through the third quarter of 2023.
About Cabaletta Bio
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that signs of biologic activity may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical and clinical trials of DSG3- CAART and MuSK-CAART; 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; risks related to the impact of public health epidemics, such as the ongoing COVID-19 pandemic, affecting countries or regions in which we have operations or do business; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation for DSG3-CAART for improving healing of mucosal blisters in patients with mucosal pemphigus vulgaris; Cabaletta’s ability to retain and recognize the intended incentives conferred by Fast Track Designation for MuSK-CAART to improve activities of daily living and muscle strength in patients with MuSK antibody-positive myasthenia gravis; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical and clinical trials of DSG3-CAART and MuSK-CAART; risks related to fostering and maintaining successful relationships with Cabaletta’s manufacturing partners; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.
Statements of Operations
Selected Balance Sheet Data