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Caribou Biosciences, Inc. (CRBU)·Q3 2025 Earnings Summary

Executive Summary

  • Reported licensing and collaboration revenue of $2.20m, up 8.6% YoY; GAAP net loss per share improved to $-0.30 vs $-0.38 YoY .
  • Revenue beat Wall Street consensus ($1.86m*) and EPS beat (consensus $-0.357*), aided by lower R&D and G&A expenses and ongoing cost discipline; sequential revenue declined as expected from Q2’s higher collaboration activity .
  • Clinically, vispa-cel (CB-010) ANTLER Phase 1 data showed ORR 82%, CR 64% in the 2L LBCL confirmatory cohort and ORR 86%, CR 63%, 12-mo PFS 53% in the optimized cohort; CB-011 CaMMouflage dose escalation delivered ORR 92%, ≥CR 75%, MRD-negative 91% in BCMA-naïve at the RDE, supporting dose expansion initiation by YE25 .
  • FDA recommended a randomized, controlled pivotal Phase 3 in 2L LBCL (CD19-naïve, transplant/autologous CAR-T-ineligible); Caribou expects to refine protocol via continued FDA engagement; cash of $159.2m funds current plan into 2H 2027 while exploring options to fully fund the pivotal trial .
  • Catalyst path: pivotal trial clarity plus CB-011 dose expansion and 2026 data, offset by financing overhang to fully fund vispa-cel Phase 3 and safety vigilance (ICAHT event in CB-011) .

Note: Consensus values marked with * are retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • Best-in-class allogeneic efficacy narrative: vispa-cel demonstrated efficacy and durability “on par” with autologous CAR-T in confirmatory and optimized cohorts (82–86% ORR; 63–64% CR; 12-mo PFS ~51–53%), with safety supporting outpatient use .
  • Multiple myeloma data strength: CB-011 delivered ORR 92%, ≥CR 75%, MRD-negative 91% in BCMA-naïve patients at the RDE; management highlighted potential paradigm shift due to off-the-shelf single-dose approach .
  • Operating discipline: R&D fell to $22.4m (from $30.4m YoY), G&A to $9.2m (from $9.8m YoY), extending runway into 2H 2027 while focusing resources on CB-010 and CB-011 .

Management quote: “These results represent a defining moment for our company and the field of allogeneic CAR-T cell therapy… offering rapid treatment, scalable manufacturing, and the possibility of broad patient access.” — Rachel Haurwitz, PhD .

What Went Wrong

  • Financing overhang: Company states cash will fund “current operating plan” into 2H 2027 but is “exploring multiple options” to fully fund the vispa-cel pivotal trial, implying potential future capital needs .
  • Safety vigilance: In CB-011 RDE cohort, one CB-011-related grade 5 ICAHT (day 90) and one grade 4 Guillain-Barré Syndrome (resolving); infections in 67% (grade 3–4 in 25%) at the selected LD; underscores need for careful protocol management .
  • Sequential revenue volatility: Quarterly licensing/collaboration revenue declined from $2.67m in Q2 to $2.20m in Q3, reflecting non-linear partnering revenue cadence .

Financial Results

Sequential financials

MetricQ1 2025Q2 2025Q3 2025
Licensing & Collaboration Revenue ($USD Millions)$2.35 $2.67 $2.20
R&D Expenses ($USD Millions)$35.53 $27.69 $22.40
G&A Expenses ($USD Millions)$9.74 $10.40 $9.20
Net Loss ($USD Millions)$(39.99) $(54.10) $(27.55)
EPS (GAAP, basic & diluted) ($USD)$-0.43 $-0.58 $-0.30

YoY comparison (Q3)

MetricQ3 2024Q3 2025
Licensing & Collaboration Revenue ($USD Millions)$2.02 $2.20
R&D Expenses ($USD Millions)$30.42 $22.40
G&A Expenses ($USD Millions)$9.84 $9.20
Net Loss ($USD Millions)$(34.68) $(27.55)
EPS (GAAP) ($USD)$-0.38 $-0.30

Results vs Wall Street consensus (S&P Global)

Revenue

MetricQ1 2025Q2 2025Q3 2025
Actual ($USD Millions)$2.35 $2.67 $2.20
Consensus ($USD Millions)$1.44*$1.64*$1.86*

EPS (GAAP)

MetricQ1 2025Q2 2025Q3 2025
Actual ($USD)$-0.43 $-0.58 $-0.30
Consensus ($USD)$-0.4425*$-0.4025*$-0.35695*

Note: Values marked with * are retrieved from S&P Global.

Segment breakdown and KPIs

  • Segment reporting: Licensing and collaboration revenue only; no segment breakdown disclosed .

Vispa-cel (ANTLER Phase 1) efficacy

CohortORRCR Rate12-mo PFSMedian Follow-up
Confirmatory (2L LBCL; ≥4 HLA matched; N=22)82% 64% 51% 6.0 months
Optimized profile (≥2 HLA matched, young donor; N=35)86% 63% 53% 11.8 months

Vispa-cel safety (≥25% TEAEs, all treated N=84; highlights)

EventAll Grade≥Grade 3
Thrombocytopenia62% 60%
CRS55% 1%
Anemia52% 43%
Infections51% 25%
Prolonged cytopenias (Day 28)N/A28% (22/80)

CB-011 (CaMMouflage Phase 1) efficacy (selected LD regimen, RDE 450M dose)

CohortORR≥CR RateMRD-negativeMedian Follow-up
BCMA-naïve at RDE (N=12)92% 75% 91% (10/11) 8.3 months

CB-011 safety (selected LD regimen)

EventAny Grade (N=35)≥Grade 3 (N=35)Any Grade (RDE N=12)≥Grade 3 (RDE N=12)
Infections49% 14% 67% 25%
CRS31% 3% 33% 8%
ICANS9% —25% —
IEC-HS9% 3% 8% 8%
Prolonged cytopenias (≥D35)—33% (11/33) —42% (5/12)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateFund current plan into H2 2027 (Q1/Q2) Fund current plan into 2H 2027; exploring options to fully fund vispa-cel pivotal Maintained runway; added funding exploration
Vispa-cel pivotal design2L LBCLInteracting with FDA; pivotal after alignment (Q1/Q2) FDA recommended randomized, controlled trial; ~250 patients; PFS primary; further refinement ongoing Clarified/advanced regulatory path
CB-011 developmentr/r MM (CaMMouflage)Report dose escalation and recommend expansion doses in H2 2025 RDE = 450M; initiate dose expansion by YE25; data in 2026 Raised specificity/timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Regulatory path (vispa-cel)Plan pivotal post-FDA alignment Plan pivotal; alignment pending FDA recommends randomized controlled pivotal; design details shared Advancing clarity
R&D executionTwo robust datasets planned H2 2025 Enrollment completed confirmatory and dose escalation; data H2 2025 Positive ANTLER and CaMMouflage datasets disclosed; CB-011 moving to expansion Delivery achieved
Manufacturing/AccessOff-the-shelf rapid treatment emphasis Reinforced off-the-shelf scaling Safety enables outpatient, community sites; scale/cost advantages Strengthening
Cost discipline/cash runwayPipeline prioritization, workforce reduction; runway to H2 2027 Non-recurring impairment; runway reiterated Runway reiterated; funding options for Phase 3 Stable/financing watch
Safety profile vigilanceN/AN/AICAHT (grade 5) and GBS (grade 4) noted in CB-011; manageable overall Heightened monitoring

Management Commentary

  • “We were thrilled to recently share positive clinical data… These results represent a defining moment for our company and the field of allogeneic CAR-T cell therapy.” — Rachel Haurwitz, PhD, President & CEO .
  • “This clinical dataset demonstrates vispa-cel’s efficacy and durability are comparable to autologous CAR-T therapies… suited for outpatient administration.” — Mehdi Hamadani, MD, ANTLER investigator .
  • “I believe the promising responses we are seeing with CB-011… could represent a paradigm shift for patients… who simply cannot wait for autologous CAR-T manufacturing.” — Adriana Rossi, MD, CaMMouflage investigator .

Q&A Highlights

  • No published earnings call transcript was available for Q3; the company hosted a live webcast and released detailed slides (Exhibit 99.3) outlining pivotal design, efficacy/safety datasets, and commercialization considerations .
  • Clarifications from webcast materials: primary endpoint for 2L LBCL pivotal is PFS with interim analysis; comparator is investigator’s choice of immunochemotherapy; RDE for CB-011 set at 450M with selected LD; dose expansion to begin YE25 .
  • Safety management protocols for CB-011 were emphasized (prophylaxis for cytopenias/infections; early IEC-HS intervention), and outpatient/community deployment for vispa-cel highlighted .

Estimates Context

  • Q3 2025 revenue beat: Actual $2.20m vs consensus $1.86m*; EPS beat: Actual $-0.30 vs consensus $-0.35695* .
  • Sequential context: Q2 revenue $2.67m vs consensus $1.64m* (beat) but GAAP EPS missed ($-0.58 actual vs $-0.4025*), reflecting impairment and higher other items; Q1 revenue $2.35m vs $1.44m* (beat) and EPS roughly in-line/better ($-0.43 vs $-0.4425*) .
  • Implication: Street models likely to lift CB-011 probability of success and vispa-cel pivotal expectations; near-term opex and trial funding assumptions may rise given pivotal scale and safety management needs.

Note: Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum is strong: vispa-cel efficacy/durability and CB-011 depth of response underpin a differentiated, off-the-shelf narrative with outpatient potential — a core driver of multiple expansion upon pivotal initiation and expansion dataflow .
  • Expect regulatory de-risking to continue: FDA-recommended pivotal structure (PFS primary, ~250 patients) signals a clear path; upcoming protocol refinement is a catalyst .
  • Watch funding strategy: management flagged need to fully fund vispa-cel Phase 3; monitor equity/convert/partnering options and potential dilution vs. partnering economics .
  • Operational discipline continues: opex declines and GAAP EPS improvement YoY; still, quarterly revenue is partner-driven and lumpy — avoid over-extrapolation from sequential moves .
  • Safety is manageable but non-trivial: CB-011 ICAHT/GBS events require vigilance; protocols appear responsive; risk management remains central to valuation .
  • Trading lens: Near-term upside bias on pivotal clarity and YE25 CB-011 expansion start; pullbacks likely on financing headlines or safety events — use volatility to build risk-adjusted positions with milestone visibility .
  • Medium-term thesis: If pivotal executes and CB-011 maintains depth with manageable safety, the off-the-shelf scale/cost/outpatient profile can expand access and support a durable franchise across LBCL and MM .