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Cabaletta Bio, Inc. (CABA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 reflected continued investment ahead of registrational planning: total operating expenses rose to $33.8M, net loss was $32.6M and diluted EPS was -$0.65, while cash and investments were $164.0M with runway into 1H26 .
  • Clinical execution accelerated: ~1 patient/week enrollment since Nov-2024; 33 patients enrolled across 56 active trial sites as of Mar 14, 2025; FDA meeting to align on myositis registrational trial designs remains on track for 1H25 .
  • Safety profile remains manageable with protocol safeguards; after a Grade 4 ICANS in an LN patient (Q2) and a Grade 3 ICANS in SSc following a protocol deviation, the IDMC supported continuation and Cabaletta tightened pre-infusion fever/infection checks and monitoring requirements .
  • Manufacturing scale-up de-risked: expanded Lonza CDMO agreement to supply rese-cel clinical product as soon as 2H25; Cellares Technology Adoption Program concluded successfully to potentially integrate automated manufacturing .
  • Near-term catalysts: EULAR 2025 oral presentations (June), FDA alignment on registrational design in 1H25, ongoing multi-indication Phase 1/2 data flow (myositis, SLE/LN, SSc, gMG, PV without preconditioning) .

What Went Well and What Went Wrong

What Went Well

  • Accelerating enrollment and broader footprint: ~1 patient/week since November; 33 patients enrolled across 56 sites in the U.S. and Europe as of Mar 14, 2025 .
  • Clear regulatory path emerging: “We are looking forward to meeting with the FDA to align on registrational trial designs in myositis... by leveraging our emerging clinical data and our efficient development strategy.” — CEO Steven Nichtberger .
  • Manufacturing progress: Expanded Lonza CDMO to supply clinical product as early as 2H25 and successful Cellares automated manufacturing technology adoption program, supporting clinical and eventual commercial scale .

What Went Wrong

  • Safety incidents requiring protocol tightening: Grade 4 ICANS in an LN patient (Q2), resolved with standard management and IDMC support to continue at current dose; added seizure prophylaxis and enhanced monitoring (fever/neurologic symptoms) .
  • Protocol deviation in SSc (fever 3 days pre-infusion not escalated) followed by Grade 3 ICANS; IDMC endorsed proceeding at current dose but mandated affirmative written confirmation of no fever/infection within two weeks before infusion .
  • Higher operating costs ahead of registrational activities: total operating expenses rose to $33.8M in Q4 from $33.0M in Q3 and $30.3M in Q2; net loss widened to $32.6M in Q4 .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Revenues ($USD Millions)N/A*N/A*N/A*
Net Loss ($USD Millions)$27.6 $30.6 $32.6
Diluted EPS ($USD)-$0.56 -$0.62 -$0.65
Total Operating Expenses ($USD Millions)$30.3 $33.0 $33.8
R&D Expense ($USD Millions)$23.4 $26.3 $25.5
G&A Expense ($USD Millions)$6.9 $6.8 $8.3
Cash, Cash Equivalents & ST Investments ($USD Millions)$203.2 $183.0 $164.0

*Values retrieved from S&P Global.

KPIs

KPIQ2 2024Q3 2024Q4 2024
Patients Enrolled (RESET)9 16 33 (as of Mar 14, 2025)
Patients DosedNot disclosed10 Not disclosed
Active Clinical Trial Sites22 U.S. sites 40 U.S. sites 56 across U.S. & Europe

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough 1H26“Expected to support operations into the first half of 2026” (Q3) “Operational runway into 1H26” (Q4) Maintained
FDA meeting on registrational designs (myositis)1H25“Data permitting, anticipate meeting with FDA in 2025” (Q3) “FDA meeting… in 1H25 on track” (Q4) Refined timeline (raised confidence)
Clinical supply (Lonza CDMO)2H25New Lonza CDMO with tech transfer; support late-stage trials readiness (Q2) Expanded Lonza CDMO to supply rese-cel clinical product as soon as 2H25 (Q4) Raised/initiated timing
Site footprint & enrollment paceOngoing22 U.S. sites; 9 patients (Q2) ; 40 U.S. sites; 16 enrolled, 10 dosed (Q3) 56 sites across U.S. & Europe; ~1/week; 33 enrolled (as of Mar 14, 2025) (Q4) Raised
Safety monitoringImmediateEnhanced fever/neurologic monitoring and seizure prophylaxis after LN ICANS (Q2) Written confirmation of no fever/infection in 2 weeks pre-infusion after SSc deviation (Q4) Tightened
Scientific presentationsNear-termACR Convergence 2024 (Nov) new/update data (Q3) EULAR 2025 three oral presentations (June) (Q4) New event scheduled

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available in our document catalog [earnings-call-transcript search returned 0]. Themes below reflect disclosures from Q2/Q3 press releases and Q4 earnings 8-K/press release.

TopicPrevious Mentions (Q-2, Q-1)Current Period (Q4 2024)Trend
Safety profile & protocolQ2: Grade 4 ICANS in LN; added seizure prophylaxis and enhanced fever/neurologic monitoring . Q3: Data set at ACR showed low-grade CRS in 3/8; one ICANS previously reported .SSc protocol deviation leading to Grade 3 ICANS; IDMC supported continuation; mandated written confirmation of no fever/infection within 2 weeks pre-infusion .Risk mitigation tightened; manageable safety profile sustained.
Enrollment pace & networkQ2: 9 enrolled; 22 U.S. sites . Q3: 16 enrolled; 10 dosed; 40 U.S. sites .~1/week since Nov; 33 enrolled across 56 sites in U.S. & Europe (as of Mar 14, 2025) .Accelerating; expanding footprint.
Regulatory engagementQ2: Fast Track, Rare Pediatric Disease, INDs active . Q3: Anticipated FDA meeting in 2025 .FDA meeting to align on registrational designs in 1H25 on track .Progressing to registrational alignment.
Manufacturing strategyQ2: Lonza CDMO and expanded Cellares partnership .Expanded Lonza to supply in 2H25; Cellares TAP concluded successfully .De-risked scale-up; automation optionality.
Europe expansionQ3: EMA CTA for RESET-SLE to proceed .56 active sites across U.S. & Europe .Globalizing clinical network.
Treatment experience innovationsQ2: Exploring apheresis elimination and PV without preconditioning .Advancing apheresis-free approach; evaluating RESET-PV cohort with no preconditioning .Advancing patient/physician experience.

Management Commentary

  • “Since presenting clinical and translational data from the RESET program... we have seen robust physician and patient interest... we are advancing innovations that have the potential to enhance the patient and physician experience, including an apheresis-free approach and evaluation of a RESET-PV cohort with no preconditioning.” — Steven Nichtberger, CEO .
  • “The clinical data... support the potential of the current dose of CABA-201 to provide immunosuppressant-free, compelling clinical responses... subjects who develop a fever prior to scheduled infusion will wait a minimum of two weeks... Other than this patient with a second, later peak expansion, CABA-201 displayed a consistent PK and PD profile in all other patients.” — David J. Chang, M.D., CMO .

Q&A Highlights

  • No Q4 2024 earnings call transcript found; Q&A highlights unavailable from our document sources (search returned 0 earnings-call-transcript for CABA).

Estimates Context

  • EPS compared to S&P Global consensus: CABA modestly missed in both quarters. Q3 2024 actual EPS -$0.62 vs consensus -$0.59 (miss of -$0.03); Q4 2024 actual EPS -$0.65 vs consensus -$0.63 (miss of -$0.02). Continued opex growth (R&D, G&A) likely contributed to the modest misses .
  • Revenue consensus was $0.00 in both quarters, consistent with pre-commercial status.
    Values retrieved from S&P Global.
MetricQ3 2024Q4 2024
EPS Actual ($USD)-$0.62 -$0.65
EPS Consensus Mean ($USD)-$0.59-$0.63
EPS Surprise ($USD)-$0.03-$0.02
Revenue Consensus Mean ($USD Millions)$0.00$0.00

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum is strong: enrollment pace and site expansion suggest increasing physician/patient engagement and faster data generation across indications .
  • Safety is manageable but demands vigilance: protocol upgrades post-ICANS (LN) and SSc deviation should mitigate risks while maintaining dose/regimen consistency endorsed by IDMC .
  • Regulatory inflection approaching: 1H25 FDA meeting on myositis registrational design is a key near-term milestone and stock catalyst; EULAR 2025 oral presentations can further validate translational/clinical signals .
  • Manufacturing scale-up de-risked: Lonza supply from 2H25 and Cellares automation readiness support registrational trial execution and future commercial scalability .
  • Financial runway into 1H26 provides buffer to reach pivotal decision points; however, elevated opex implies continued quarterly losses as the program scales .
  • Narrative evolution favors “drug-free remission” potential: consistent B-cell depletion, naïve B-cell repopulation, and clinical responses across SLE/myositis/SSc cohorts are directionally supportive of the thesis .
  • Near-term trading: watch for FDA alignment (timing/details), EULAR data (breadth and consistency across cohorts), and additional safety updates; medium-term thesis hinges on registrational pathway clarity, network expansion, and manufacturing execution .