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Cabaletta Bio, Inc. (CABA)·Q2 2024 Earnings Summary

Executive Summary

  • Enrollment accelerated post-EULAR with nine patients enrolled as of August 5 and 22 U.S. sites recruiting, expanding the footprint across four RESET Phase 1/2 trials .
  • Q2 operating expenses rose materially YoY (R&D $23.427M; G&A $6.852M) and net loss widened to -$27.602M; cash and investments were $203.225M with runway into 1H26 .
  • A lupus nephritis patient experienced a protocol-defined Grade 4 ICANS that resolved rapidly; the DMC recommended proceeding at the current dose with added safety monitoring and seizure prophylaxis, an important de-risking signal for continued enrollment .
  • Manufacturing scale-up advanced via a new Lonza CDMO agreement and expanded Cellares collaboration, positioning CABA-201 for clinical supply expansion and potential commercial readiness; expect additional clinical data in 2H24 across myositis, SLE, SSc, and gMG .

What Went Well and What Went Wrong

What Went Well

  • Strong enrollment momentum and site activation following initial positive clinical and translational data at EULAR; nine patients enrolled and 22 U.S. sites recruiting .
  • Management strengthened manufacturing readiness: new Lonza agreement for technology transfer to GMP supply and expanded Cellares fully automated collaboration to facilitate clinical program incorporation .
  • CEO tone confident on trajectory: “we believe we are well positioned to realize our vision of developing and launching the first curative targeted cell therapy for patients with autoimmune diseases” .

What Went Wrong

  • Safety event: one LN patient had Grade 4 ICANS (DLT) post-CABA-201; although resolved quickly and the DMC endorsed continuation, protocols require enhanced monitoring and seizure prophylaxis, elevating safety vigilance .
  • Higher spend: R&D rose 99% YoY to $23.427M and G&A rose 67% YoY to $6.852M, increasing cash burn and widening net loss to -$27.602M .
  • CAART portfolio updates reflect narrowing near-term focus: DSG3-CAART no longer dosing while MuSK-CAART remains in A2 cohort without preconditioning, indicating prioritization around CARTA/CABA-201 .

Financial Results

Metric ($USD Millions unless noted)Q2 2023Q1 2024Q2 2024
Research & Development Expense$11.797 $21.954 $23.427
General & Administrative Expense$4.093 $6.077 $6.852
Total Operating Expenses$15.890 $28.031 $30.279
Interest Income$1.403 $2.984 $2.677
Net Loss-$14.487 -$25.047 -$27.602
EPS (basic & diluted, $)-$0.37 -$0.51 -$0.56

Liquidity

Metric ($USD Millions)Q4 2023Q1 2024Q2 2024
Cash, Cash Equivalents & Investments$241.249 $223.845 $203.225

KPIs

KPIQ1 2024Q2 2024
Patients Enrolled (RESET program)5 as of June 12, 2024 9 as of August 5, 2024
U.S. Clinical Sites Recruiting18 22

Notes:

  • Revenue and margin metrics are not applicable given Cabaletta Bio does not report commercial revenues in the press release “Selected Financial Data” tables for the periods presented .
  • No segment data applicable (clinical-stage).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 1H26Fund operating plan into 1H26 (as of March 31, 2024) Fund operating plan into 1H26 (as of June 30, 2024) Maintained
Clinical Data Readouts2H24Initial data expected for SSc & gMG; additional data for myositis & SLE Initial data for SSc & gMG; additional data for myositis & SLE Maintained
Manufacturing StrategyOngoingEvaluating commercial-ready process; Cellares program ongoing Lonza CDMO agreement; expanded Cellares partnership Enhanced/Expanded
Safety Protocols (RESET)OngoingNo CRS/ICANS in first patients; standard monitoring Enhanced monitoring for fever/neurology and seizure prophylaxis across sites post-ICANS event Strengthened

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in our document set; themes extracted from the Q2 press release and June 14 clinical data press release.

TopicPrevious Mentions (Q4 2023; Q1 2024)Current Period (Q2 2024)Trend
R&D Execution & Clinical DataFirst patient dosed; no CRS/ICANS at day 21; EULAR initial data planned Positive initial data presented; accelerated enrollment; additional data expected 2H24 Improving execution pace
Safety ProfileNo CRS/ICANS in first two patients within 28-day DLT window One Grade 4 ICANS (DLT) in LN patient; rapid resolution; DMC supports continuation; protocol strengthened Mixed—heightened vigilance but program continues
Manufacturing/Scale-upCommercial-ready process work; Cellares assessment ongoing Lonza CDMO added; Cellares expanded; CTO hire enhances capability Advancing toward scalability
Regulatory DesignationsFast Track and Orphan in multiple indications; Rare Pediatric in JDM Continued Fast Track status cited; multi-indication program momentum Stable-positive
Enrollment & SitesEnrollment underway; increasing sites Nine patients enrolled; 22 U.S. sites recruiting Accelerating
CAART PortfolioDSG3-CAART dosing ongoing in combo cohort; MuSK-CAART without preconditioning DSG3-CAART no longer dosing; MuSK in A2 cohort without preconditioning Focus shifting to CARTA/CABA-201

Management Commentary

  • CEO: “We have seen increased enrollment and additional clinical sites open since presenting positive initial clinical and translational data… we believe we are well positioned to realize our vision of developing and launching the first curative targeted cell therapy for patients with autoimmune diseases” .
  • CMO (June 14): “Initial safety, clinical and translational data… provide important early validation… we are looking forward to accelerating clinical trial enrollment… initial clinical data from RESET-SSc and RESET-MG as well as additional data from RESET-Myositis and RESET-SLE in the second half of this year” .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available in our sources; the company held a June 14 webcast tied to EULAR data, but no transcript was retrieved for Q&A review .

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global were unavailable due to access limits; therefore, estimate comparisons cannot be provided at this time. Values retrieved from S&P Global were not available for inclusion due to request limit constraints.

Key Takeaways for Investors

  • Enrollment momentum and site expansion increase the probability of timely 2H24 data readouts, a key stock catalyst across multiple RESET cohorts (myositis, SLE, SSc, gMG) .
  • The Grade 4 ICANS event, while serious, resolved rapidly with DMC support to proceed; protocol enhancements should mitigate risk and maintain program continuity—a critical de-risking signal for CABA-201’s path .
  • Operating spend increased as expected for a multi-cohort cell therapy program; cash of $203.225M and stated runway into 1H26 provide funding visibility through planned data milestones and manufacturing scale-up .
  • Manufacturing partnerships with Lonza and Cellares, plus CTO hire, position the company to transition from early clinical to late-stage/commercial-scale processes—important for investor confidence on scalability .
  • Near-term trading focus: watch for incremental safety updates and early efficacy signals; additional favorable signals from RESET trials could drive sentiment, while any further severe AEs could pressure shares .
  • Medium-term thesis: if CABA-201 demonstrates consistent safety/efficacy with immune “reset” and scalable manufacturing, multi-indication opportunities could be substantial; execution in SLE and myositis cohorts likely leads the narrative .
  • CAART reprioritization suggests resource concentration on CARTA/CABA-201; continued clarity on CAART milestones will help investors gauge optionality beyond CABA-201 .