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Corbus Pharmaceuticals Holdings, Inc. (CRBP)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered strong clinical momentum (CRB-701 ORR up to 47.6% in HNSCC; 37.5% in cervical; 55.6% in mUC) alongside a widened net loss driven by higher R&D as dose-optimization progressed and programs advanced .
  • EPS was a miss versus Wall Street: reported -$1.90 vs consensus -$1.707; the variance primarily reflects an $8.9M increase in operating expenses tied to clinical development .
  • Balance sheet strengthened post quarter-end via a $75M public offering, extending cash runway into 2028 (vs Q2 outlook through Q2 2027) — a positive funding catalyst for upcoming registrational work .
  • Regulatory path clarified: FDA meeting targeted for Q1 2026 with a Phase 2/3 registrational study for CRB-701 planned to start mid-2026; fast track designations in HNSCC and cervical support expedited development .

What Went Well and What Went Wrong

What Went Well

  • Robust efficacy signals from CRB-701: HNSCC ORR 47.6% at 3.6 mg/kg (33.3% at 2.7 mg/kg); cervical 37.5% (3.6 mg/kg); mUC 55.6% (3.6 mg/kg) .
  • Favorable safety profile: no grade 4/5 treatment-related AEs; low peripheral neuropathy (8.4%, all Grade 1–2); discontinuation rate 6.0% .
  • Strategic funding and pipeline execution: $75M raised post quarter; CRB-913 SAD/MAD completion and Phase 1b initiation expected in Q4 2025; CRB-601 Phase 1 dose escalation ongoing .
  • CEO tone confident on execution: “We are encouraged by the clinical responses… and look forward to aligning with the FDA to find the most expedient path forward” .

What Went Wrong

  • EPS missed consensus amid higher OpEx: -$1.90 vs -$1.707*; OpEx rose $8.9M YoY to ~$24.4M, primarily clinical development spend .
  • Net loss widened YoY: -$23.3M vs -$13.8M in Q3 2024, reflecting intensified trial activity across CRB-701/913/601 .
  • Still pre-revenue with multi-program costs; investor focus remains on execution milestones and regulatory timelines to support value realization .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)$13.8 $17.0 $17.7 $23.3
Diluted EPS ($USD)-$1.15 -$1.39 -$1.44 -$1.90
Total Operating Expenses ($USD Millions)$15.5 $19.8 $19.2 $24.4
Cash and Equivalents ($USD Millions)N/A$18.9 $20.0 $27.0

EPS vs Estimates

QuarterActual EPSConsensus EPSSurprise
Q1 2025-$1.39 -$1.073*Miss
Q2 2025-$1.44 -$1.329*Miss
Q3 2025-$1.90 -$1.707*Miss

Revenue context

QuarterActual RevenueConsensus Revenue
Q1 2025N/A$0.0*
Q2 2025N/A$0.0*
Q3 2025N/A$0.0*

Values with asterisks (*) retrieved from S&P Global.

Clinical KPIs (CRB-701)

Tumor TypeDoseORRDCRNotes
HNSCC2.7 mg/kg33.3% 75.0% All confirmed responses at 2.7 mg/kg
HNSCC3.6 mg/kg47.6% 61.9% 7 confirmed, 3 unconfirmed (1 discontinued, 2 ongoing)
Cervical3.6 mg/kg37.5% 68.8% 3 confirmed, 3 unconfirmed (1 discontinued, 2 ongoing)
mUC3.6 mg/kg55.6% 88.9% 3 confirmed, 2 unconfirmed (1 discontinued, 1 ongoing)
Safety———No grade 4/5 TRAEs; peripheral neuropathy 8.4% (Grade 1–2)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearFunded through Q2 2027 (as of Q2) Funded into 2028 (post $75M raise) Raised
CRB-701 RP2DQ4 2025RP2D in Q4 2025 RP2D remains targeted Q4 2025 Maintained
CRB-701 FDA MeetingQ1 2026Not specified in Q2FDA meeting in Q1 2026 New/Added
CRB-701 Registrational Study StartMid-2026Registrational studies planned mid-2026 (signaled in Oct PR) Phase 2/3 registrational study mid-2026 Maintained/Confirmed
CRB-913 Phase 1b InitiationQ4 2025Phase 1b to start Q4 2025 Initiate Phase 1b in Q4 2025 Maintained
CRB-601 Phase 1 Dose Escalation2025Ongoing; data Q4 2025 Ongoing; SITC poster presented Maintained/Update

Earnings Call Themes & Trends

Note: We did not locate a Q3 2025 earnings call transcript; company hosted an ESMO “Special Call” around CRB-701 data (Oct 20, 2025) . The below synthesizes themes from Q1–Q3 press materials and ESMO updates.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
CRB-701 efficacyEarly responses incl. HNSCC; safety aligned with partner data ESMO poster planned; >100 participants ORR up to 47.6% HNSCC; favorable safety; registrational plan Strengthening efficacy signal; moving to registrational path
Safety/tolerabilityLow neuropathy; manageable skin toxicity Ongoing dose optimization No grade 4/5 TRAEs; neuropathy 8.4% Consistent favorable profile
RegulatoryFast Track in cervical Fast Track cervical reiterated Fast Track HNSCC and cervical; FDA meeting Q1 2026 Expanded regulatory momentum
CRB-913 obesitySAD/MAD started; Phase 1b planned Q4 2025 MAD initiated; SAD/MAD data later in 2025 SAD/MAD completion and Phase 1b initiation in Q4 2025 On-time execution
CRB-601First patient dosed Dec 2024 Dose escalation ongoing Dose escalation ongoing; SITC poster Progressing on plan
Funding runway~$132.8M cash/investments; runway through Q2 2027 $116.6M; runway through Q2 2027 $104.0M at 9/30; +$73.8M post-Q3; runway into 2028 Improved after financing

Management Commentary

  • CEO perspective: “We are encouraged by the clinical responses observed in HNSCC and cervical cancer… and look forward to aligning with the FDA to find the most expedient path forward.”
  • On obesity program timing: “We… expect to report SAD/MAD data and initiate a Phase 1b dose-ranging study in obese, non-diabetic patients before the end of 2025.”
  • CMO view on CRB-701: “The emerging CRB-701 safety and efficacy data is showing differentiation from other experimental agents in HNSCC.”
  • External KOL sentiment: “Lower systemic toxicity burden… is quite exciting along with this preliminary efficacy signal.”

Q&A Highlights

  • Q3 2025 earnings call transcript not available. Company hosted a “Special Call” related to ESMO CRB-701 data on Oct 20, 2025; details emphasize efficacy and safety with KOL participation .
  • Guidance clarifications stem from PRs: FDA meeting timing (Q1 2026) and registrational start (mid-2026) reiterated; CRB-913 Phase 1b initiation in Q4 2025 remained on track .

Estimates Context

  • EPS missed in Q1–Q3 2025 versus S&P Global consensus; principal driver was higher operating expenses reflecting accelerated clinical activity across programs (R&D ramp) .
  • Revenue consensus was $0 in all periods given pre-revenue biotech status; estimate models likely focus on operating burn, milestones, and financing rather than near-term revenue contributions .
  • Expect sell-side to update cash runway assumptions (into 2028) and probability-weighted timelines post ESMO efficacy and clarified regulatory path .

Values with asterisks (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical efficacy and safety for CRB-701 continue to strengthen, particularly in HNSCC at 3.6 mg/kg; this supports the mid-2026 registrational start and raises the program’s strategic value .
  • Near-term catalysts: CRB-913 SAD/MAD readout and Phase 1b initiation by year-end; CRB-701 FDA meeting in Q1 2026; SITC/ESMO-related data visibility aids sentiment .
  • EPS misses reflect intentional spending to accelerate pipeline; cash runway extended into 2028 mitigates financing overhang and supports pivotal readiness .
  • Regulatory de-risking with Fast Track in HNSCC and cervical improves potential timelines and market access upon success .
  • Trading lens: stock likely sensitive to additional CRB-701 updates (response durability, biomarker work), CRB-913 safety/PK and early efficacy signals, and any FDA feedback in Q1 2026 .
  • Medium-term thesis: execution on registrational design and dose strategy, maintaining favorable safety, and broadening efficacy across tumor types are key to valuation inflection .