CABA
Cabaletta Bio, Inc.2.3900
+0.0000+0%
Dec 16, 4:00:02 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
230.07MP/E (TTM)
-Basic EPS (TTM)
-2.40Dividend Yield
0%Recent Filings
8-K
Rese-cel shines in autoimmune trials
Cabaletta Bio unveiled promising Phase 1/2 data for rese-cel at ACR Convergence 2025, showing all four myositis patients with sufficient follow-up hit the registrational endpoint of moderate or major TIS responses at week 16, drug-free. Systemic sclerosis patients achieved rCRISS-25 responses off immunomodulators, while seven of eight lupus patients secured remission or renal responses, with median SLEDAI-2K dropping eight points. The company launches a myositis registrational cohort this quarter, eyes FDA alignment for lupus and SSc, and tests no-preconditioning dosing in lupus for 2026 data. Safety holds: mostly grade 1 CRS, rare ICANS. Yet interim results may not predict long-term outcomes.
8-K
Rese-cel data sans preconditioning
Cabaletta Bio unveiled initial data from the RESET-PV trial, showing rese-cel without preconditioning achieved complete B cell depletion in two of three pemphigus vulgaris patients, with PDAI scores dropping sharply—from 83 to 3 in one, 22 to 2 in another—while all stayed off immunomodulators. Safety held up well, with only mild cytokine release syndrome and no neurotoxicity. This simplifies treatment, broadening access for refractory cases. Yet early signs don't guarantee long-term resets.
8-K
FDA aligns on myositis BLA path
Cabaletta Bio updated its corporate presentation on September 3, 2025, highlighting FDA alignment on registrational cohorts for rese-cel in myositis, with BLA submission planned for 2027. Early Phase 1/2 data from RESET trials show transformative, drug-free responses in refractory myositis, SLE, and SSc patients, backed by a safety profile featuring mostly grade 1 CRS and no ICANS. Enrollment surges across 70+ sites in six indications. Risks persist in trial execution and regulatory paths.
10-Q
Q2 FY2025 results
Cabaletta Bio's Q2 FY2025 results showed operating expenses climbing 51.6% y/y to $45.9M, driven by higher R&D spend on rese-cel trials, while net loss widened to $45.1M from $27.6M a year earlier; diluted EPS fell to $(0.73) from $(0.56), consistent with 61.9M weighted shares. Cash and equivalents dipped q/q to $145.6M from $164.0M at year-end, bolstered by $93.6M net proceeds from a June equity offering, extending runway into H2 2026. No revenue yet, but clinical momentum builds with full Phase 1/2 enrollment across RESET trials. Yet, escalating burn signals funding needs; competition in CAR-T autoimmune therapies poses risks.
8-K
Cabaletta advances rese-cel trials
Cabaletta Bio reported Q2 2025 net loss of $45.1 million, up from $27.6 million last year, driven by $37.6 million in R&D spend as rese-cel trials advance. The company aligned with FDA on myositis registrational cohorts, targeting 2H25 enrollment and 2027 BLA submission, while five RESET cohorts are fully enrolled. A $100 million offering nets $94 million, extending cash runway to 2H26. Enrollment surges, yet clinical risks linger.
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