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Cartesian Therapeutics, Inc. (RNAC)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered clinical momentum but a wider operating loss: R&D rose with Phase 3 MG trial costs; net loss expanded to $35.9M ($1.38 diluted EPS) vs $24.2M ($1.13) YoY, while cash was $145.1M, supporting runway into mid-2027 .
  • Pipeline catalysts: enrollment on track in Phase 3 AURORA (MG) and initial SLE Phase 2 data showed a strong efficacy signal; RNAC is pausing SLE and Descartes-15 to prioritize MG and a myositis program with a seamless pivotal design targeted to begin 1H26 .
  • Governance updates: CEO Carsten Brunn named Chairman, CAO appointed, and CSO role eliminated—aligning leadership and cost structure ahead of late-stage execution .
  • Stock reaction catalysts near term: myositis IND filing by year-end, pediatric basket trial initiation by year-end, continued Phase 3 MG enrollment updates, and any additional SLE readouts or regulatory interactions .

What Went Well and What Went Wrong

What Went Well

  • Phase 3 AURORA (MG) enrollment on track; management reiterated conviction in outpatient Descartes-08 without lymphodepletion: “we remain focused on driving continued execution and enrollment…supported by compelling results from our Phase 2b trial” (CEO) .
  • Strong initial SLE efficacy signal: 100% LLDAS responses at Month 3 (n=3) and 2/3 DORIS remission; favorable safety with no CRS/ICANS, supporting outpatient administration .
  • Cash runway reaffirmed into mid-2027, further strengthened by pausing SLE and Descartes-15 to prioritize MG and myositis .

What Went Wrong

  • Operating loss widened and net loss increased YoY due to higher Phase 3 trial and headcount-driven R&D/G&A and a negative fair value change in CVR liability in Q3 (vs a large positive CVR fair value in Q2) .
  • Sequential OpEx remained elevated: R&D $13.8M (Q3) vs $14.9M (Q2); G&A $7.7M (Q3) vs $7.2M (Q2) as facilities and stock-based comp rose .
  • Organizational change signals: elimination of CSO role; Descartes-15 paused despite clean Phase 1 safety—raises questions on broader pipeline allocation and focus .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Total Revenue ($USD Thousands)$387 $1,100 $298 $452
Research & Development Expense ($USD Thousands)$11,400 $14,674 $14,869 $13,802
General & Administrative Expense ($USD Thousands)$6,562 $8,315 $7,240 $7,716
Operating (Loss) Income ($USD Thousands)$(17,575) $(21,889) $(21,811) $(21,066)
Net Income (Loss) ($USD Thousands)$(24,183) $(17,710) $15,886 $(35,902)
Diluted EPS ($USD)$(1.13) $(0.68) $0.50 $(1.38)
Revenue BreakdownQ3 2024Q1 2025Q2 2025Q3 2025
Collaboration & License ($USD Thousands)$0 $400 $0 $0
Grant Revenue ($USD Thousands)$387 $700 $298 $452
Total Revenue ($USD Thousands)$387 $1,100 $298 $452
Balance Sheet & LiquidityQ3 2024Q1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)N/A$182.1 $162.1 $145.1
Total Assets ($USD Millions)N/A$409.13 $388.89 $372.68
Total Liabilities ($USD Millions)N/A$430.92 $391.42 $408.52
CVR Liability – Non-current ($USD Millions)N/A$387.40 $352.10 $369.00

Notes: The Q2 net income reflected a $35.3M positive change in the CVR liability fair value; Q3 included a $(16.9)M negative change in CVR liability fair value .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough mid-2027Supported by $162.1M (Q2) and reiterated mid-2027 runway Reaffirmed mid-2027 runway; pausing SLE & Descartes-15 to prioritize MG/myositis Maintained (reinforced)
SLE Phase 2 Preliminary Data2H25 / End of 2025Expected 2H25/end of year Initial Month 3 data positive; program paused after readout Delivered then Paused
Pediatric Basket Trial (Descartes-08)By end of 2025Initiation expected in 2H25/end of year Still expected by end of year (no formal update beyond reiterations) Maintained
Myositis (Descartes-08)1H26 startNot previously guided in Q1–Q2; introduced Q3Seamless adaptive Phase 2 with potential single pivotal; IND by year-end; commence 1H26 New (Raised scope)
Descartes-15 (MM)2025Phase 1 dose escalation ongoing Favorable initial safety; development paused to prioritize MG/myositis Lowered (Paused)

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available in the filing catalog; themes are drawn from press releases and investor materials.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
AURORA Phase 3 (MG)Expected initiation (Q1); initiated and first patient enrolled (Q2) Enrollment on track; outpatient dosing without lymphodepletion reinforced Progressing
SLE ProgramPreliminary data expected in 2H25 (Q1/Q2) Strong efficacy signal at Month 3; favorable safety; program paused post-readout Delivered then Paused
Pediatric Basket TrialExpected initiation in 2H25 (Q1/Q2) Expected by end of year (reiterated) Pending
Myositis ExpansionNot guided earlierNew seamless design with potential single pivotal; IND by year-end; start 1H26 Added (Strategic expansion)
Manufacturing ReadinessNot emphasized in Q1/Q2 press; facility existsUS-based, in-house cGMP manufacturing; biologic-like margin potential Consistent capability
Capital & RunwayRunway into mid-2027 (Q1/Q2) Reaffirmed; strengthened by portfolio prioritization Stable/Improved
Descartes-15 (MM)Phase 1 ongoing (Q1/Q2) Favorable safety; paused to focus on MG/myositis Deprioritized

Management Commentary

  • “We remain focused on driving continued execution and enrollment in our Phase 3 AURORA trial…we firmly believe Descartes-08, if approved, has the potential to serve as an impactful new therapy for patients with MG…administered safely in the outpatient setting and without the need for preconditioning chemotherapy.” — Carsten Brunn, Ph.D., CEO .
  • “Following the recent initiation of our pivotal Phase 3 AURORA trial…we have entered the second half of the year with significant momentum…supported by deep and sustained responses observed through month 12 in the Phase 2b trial.” — Carsten Brunn, Ph.D. (Q2) .
  • “We are off to a strong start…we observed deep and sustained benefits at Month 12 following a single course of therapy…we look forward to commencing our Phase 3 AURORA trial by the end of this quarter.” — Carsten Brunn, Ph.D. (Q1) .
  • “The responses observed in all participants reaching Month 3…serves as strong validation…Descartes-08 was well-tolerated in the outpatient setting…we are now optimistic about the opportunity to initiate a Phase 2 trial in myositis.” — Carsten Brunn, Ph.D. (SLE data press) .

Q&A Highlights

  • No formal Q3 2025 earnings call transcript was cataloged; management addressed key investor topics in press releases and the corporate deck:
    • Clarified outpatient, non-lymphodepleting profile for Descartes-08 and Phase 3 endpoints (MG-ADL ≥3 improvement at Month 4; MGC ≥4) .
    • Explained SLE data and strategic pause to concentrate capital on MG/myositis; outlined myositis seamless design, IND by year-end, and 1H26 start .
    • Reiterated runway into mid-2027; noted portfolio prioritization’s positive impact on cash needs .

Estimates Context

  • Wall Street consensus (S&P Global) for quarterly EPS and revenue was unavailable for RNAC for Q1–Q3 2025; therefore, no beat/miss analysis versus estimates can be provided at this time.
  • Implication: Without published consensus, buyside models should focus on OpEx trajectory, fair value items (CVR, warrants), and clinical timelines rather than near-term revenue/EPS.

Key Takeaways for Investors

  • Late-stage MG program remains the core value driver; outpatient dosing and durable responses differentiate Descartes-08 vs chronic biologics and may support biologic-like margins if approved .
  • The SLE signal validates platform potential, but the pause concentrates capital where regulatory and commercial paths look faster (MG, myositis) .
  • New myositis program introduces an additional catalyst set (IND by year-end; 1H26 start; potential single pivotal), broadening the autoimmune opportunity .
  • Runway into mid-2027 reduces financing overhang near term; watch for updated OpEx cadence as programs sequence and manufacturing scales .
  • Expect continued P&L volatility from non-cash fair value changes (CVR, warrants); underlying cash burn tied to Phase 3 AURORA and myositis startup .
  • Governance and organizational changes (CEO as Chairman; CAO appointment; CSO role eliminated) align leadership and finance functions for pivotal execution .
  • Near-term trading catalysts: myositis IND filing; pediatric basket trial initiation; MG Phase 3 enrollment updates; any subsequent SLE data or regulatory clarity .