-
Cabaletta Bio reports positive rese-cel data at EULAR; registrational plans for SSc, DM/ASyS, JDM updated
83% (5/6) DM patients achieved immunomodulator-free moderate/major TIS response at 16 weeks; all maintained through 1.5 years.
-
Cabaletta Bio Q1: R&D $37.4M, cash $116.6M; $150M equity raise; rese-cel advances
R&D expenses $37.4M (up 29% YoY); G&A $6.9M (down 15% YoY); cash $116.6M as of March 31, 2026.
-
Cabaletta Bio presents preconditioning-free clinical data and automated manufacturing data for rese-cel at ASGCT 2026
Two of four pemphigus vulgaris patients at lowest PC-free dose maintained drug-free responses through 6 months.
-
Cabaletta Bio reports rese-cel activity without preconditioning in 4 PV patients; ASGCT presentation May 14
2 of 4 refractory PV patients on rese-cel at lowest dose showed compelling clinical activity through 6 months without preconditioning.
-
Cabaletta Bio prices $150M underwritten offering of 51.7M shares at $2.90; net proceeds ~$141M
51,725,000 shares offered at $2.90; net proceeds ~$141M after underwriting discounts and expenses.
-
Cabaletta Bio Q4/FY2025 cash $133.6M; myositis BLA on track for 2027; $30M raise
Q4 R&D expenses $36.2M, FY R&D $142.7M; cash $133.6M as of Dec 31, 2025; raised additional $30M in Q1 2026.
-
Cabaletta announces 2026 priorities: myositis trial enrolling, BLA 2027, Cellares IND cleared
Myositis registrational cohort actively enrolling; BLA submission for rese-cel projected in 2027.
-
Cabaletta Bio Q3 2025 R&D expenses $39.8M; rese-cel BLA submission targeted for 2027
R&D expenses of $39.8M in Q3 2025, up from $26.3M a year ago; cash $159.9M as of Sep 30, 2025.
-
Cabaletta Bio: all DM/ASyS myositis patients meet registrational endpoint; SSc and lupus data positive
All 4 DM/ASyS patients with sufficient follow-up achieved immunomodulatory-free moderate or major TIS response at week 16.
-
Cabaletta Bio presents first rese-cel data without preconditioning at ESGCT 2025
Rese-cel without preconditioning achieved complete B cell depletion in two of three PV patients, with rapid autoantibody reduction and near-complete symptom resolution.
-
Cabaletta Bio Q2 2025 R&D expenses $37.6M, cash $194.7M; myositis registrational cohort on track for 2H25
R&D expenses $37.6M (vs $23.4M in Q2 2024); G&A $8.3M (vs $6.9M).
-
Cabaletta Bio prices $100M public offering of common stock and warrants to fund rese-cel development
Offering includes 39.2M shares and 50M warrants at combined price of $2.00 per unit; net proceeds ~$94M.
-
Cabaletta Bio reports strong rese-cel efficacy data in myositis, SLE, and scleroderma at EULAR 2025
7 of 8 myositis patients achieved clinical response off all immunomodulators; all 4 ASyS/DM patients achieved meaningful TIS response.
-
Cabaletta Bio to file BLA for rese-cel in myositis in 2027 after FDA alignment; cash $131.8M
FDA aligned on two registrational cohorts for rese-cel in myositis (~15 patients each, 26-week primary endpoint); BLA submission expected in 2027.
-
Cabaletta Bio Q4/FY2024 results: cash $164M, R&D spend up, protocol deviation in SSc trial
Cash and equivalents $164M as of Dec 31, 2024, providing runway into first half of 2026.
-
Cabaletta reports deepened rese-cel responses: 3 SLE patients in DORIS remission, LN complete renal response
3 of 4 non-renal SLE patients achieved DORIS remission; first LN patient achieved complete renal response; all off immunosuppressants and steroids.
-
Cabaletta Bio: rese-cel shows deepening responses; 3/4 SLE in remission, first LN complete renal response
3 of 4 non-renal SLE patients achieved DORIS remission; first LN patient achieved complete renal response; all 6 SLE/LN patients off immunosuppressants and steroids.
-
Cabaletta Bio reports $164M cash, expands rese-cel trials into MS, MG, PV; FDA meeting planned 1H25
Unaudited cash $164M as of Dec 31, 2024; funds operations into H1 2026.
-
Cabaletta Bio reports positive CABA-201 data at ACR 2024; all 8 patients drug-free responses
Eight patients dosed across RESET-Myositis, -SLE, -SSc trials; all off immunosuppressants through follow-up.
-
Cabaletta Bio Q3 2024: cash $183M, 40 U.S. sites recruiting; EMA greenlights lupus trial
R&D expenses $26.3M (up 91% YoY); G&A $6.8M (up 39%); cash $183.0M expected to fund ops into H1 2026.
-
Cabaletta Bio Q2: $203.2M cash, 9 patients enrolled, Grade 4 ICANS DLT resolved
R&D expenses $23.4M (Q2 2023: $11.8M); G&A $6.9M (Q2 2023: $4.1M).
-
CABA-201 shows no CRS/ICANS/SAEs in first two patients; B cell depletion and disease score improvements observed
First patient in IMNM cohort had creatinine kinase drop from 617 to 308 and TIS of 30 at week 12.
-
Cabaletta Q1 2024: $223.8M cash, no CRS/ICANS in CABA-201 trials; clinical data at EULAR June
Cash, cash equivalents and short-term investments of $223.8M as of March 31, 2024, down from $241.2M Dec 31, 2023; runway into H1 2026.
-
Cabaletta Bio reports Q4/FY2023 financials; first patient dosed with CABA-201 in myositis
Cash, cash equivalents and short-term investments $241.2M as of Dec 31, 2023, with runway into 1H26.
-
Cabaletta Bio receives FDA Orphan Drug Designation for CABA-201 in systemic sclerosis
FDA grants Orphan Drug Designation to CABA-201 for systemic sclerosis, a rare autoimmune disease.
-
FDA grants Fast Track to CABA-201 for dermatomyositis and systemic sclerosis; cash $241M
FDA Fast Track Designations for CABA-201 in dermatomyositis (improve disease activity) and systemic sclerosis (improve organ dysfunction).
-
Cabaletta Bio Q3 2023 cash $164.4M; CABA-201 data expected H1 2024; IND clearances for SSc and gMG
Cash, cash equivalents and short-term investments of $164.4M as of Sept 30, 2023, up from $106.5M at Dec 31, 2022.
-
Cabaletta Bio receives FDA clearance for fourth CABA-201 IND, now in generalized myasthenia gravis
FDA cleared IND for CABA-201 in generalized MG; fourth IND across autoimmune diseases.
-
Cabaletta Bio receives FDA clearance for third CABA-201 IND, now in systemic sclerosis
Third IND clearance for CABA-201 (CD19-CAR T) in systemic sclerosis within past 6 months.
-
Cabaletta Bio and WuXi ATU expand GMP manufacturing for CABA-201; dedicated suite for commercial readiness
WuXi ATU to provide GMP manufacturing for CABA-201, including commercial readiness, under expanded work orders.
-
Cabaletta Bio Q2 2023: cash $176.3M; IND cleared for CABA-201 in myositis
Cash, equivalents & investments of $176.3M as of June 30, 2023, extending runway into Q4 2025.
-
Cabaletta appoints ex-Kite Pharma CCO Shawn Tomasello to board; updates DSG3-CAART data
Shawn Tomasello, former Kite Pharma CCO, appointed to board effective July 21, 2023.
-
Cabaletta Bio closes $100M public offering of 8.34M shares at $12.00/share
Gross proceeds of approximately $100 million from sale of 8,337,500 shares, including full exercise of underwriters' option for 1,087,500 additional shares.
-
Cabaletta Bio prices $87M public offering of 7.25M shares at $12.00 per share
Pricing of 7,250,000 shares at $12.00 per share; gross proceeds expected $87M before expenses.
-
Cabaletta Bio receives FDA clearance for second CABA-201 IND, Phase 1/2 trial in myositis
FDA cleared IND for CABA-201 in active idiopathic inflammatory myopathy (myositis); second IND clearance within two months.
-
FDA clears CABA-201 IND for Phase 1/2 myositis study; DesCAARTes updates provided
FDA cleared second IND for CABA-201 (CD19-CAR T) for Phase 1/2 trial in active myositis (DM, ASyS, IMNM) at 1x10^6 cells/kg dose.
-
Cabaletta Bio Q1 2023: R&D spend $12.4M; CABA-201 IND cleared, Fast Track granted
R&D expenses $12.4M (Q1 2023) vs $9.2M (Q1 2022); G&A $4.5M vs $3.8M.