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Celldex Therapeutics, Inc. (CLDX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 revenue of $0.73M and diluted EPS of -$0.85; EPS modestly beat S&P Global consensus (-$0.87) while revenue missed ($1.13M) as services with Rockefeller University declined; operating spend rose on barzolvolimab trials and manufacturing . Results vs estimates: EPS +$0.01 beat; revenue -$0.40M miss (see Estimates Context).*
  • Pipeline execution remained the core driver: unprecedented 76-week CSU durability (41% complete response, 48% DLQI 0/1 seven months post-dosing) and strong 52-week angioedema improvements presented at EAACI; Phase 3 CSU enrollment on track, targeting full enrollment next summer .
  • Balance sheet strong with $630.3M cash and securities; runway guided “through 2027,” supporting multiple Phase 2 readouts (EoE, CIndU) and CDX-622 Part 1 data in 2H 2025 .
  • Near-term stock catalysts: continued Phase 3 CSU enrollment progress; 2H25 CIndU 20-week data and EoE 12-week analysis; CDX-622 Phase 1 Part 1 biomarker/PK data; any CSU regulatory/timing updates .

What Went Well and What Went Wrong

  • What Went Well
    • Phase 2 CSU durability: 41% complete response (UAS7=0) and 48% no QoL impact at 76 weeks post-dosing; safety/tolerability events were KIT-related, mild, and reversible .
    • Angioedema outcomes: up to 77% angioedema-free at Week 52; patients angioedema-free up to 72% of time across 52 weeks .
    • Management execution/tone: “barzolvolimab is best in disease” and Phase 3 CSU “on track and expected to be fully enrolled next summer,” underscoring confidence and operational momentum .
  • What Went Wrong
    • Revenue contraction: $0.73M vs $2.50M YoY, driven by lower services under Rockefeller University agreements; revenue also missed consensus ($1.13M) .*
    • Rising R&D and OpEx: R&D $54.2M (+37% YoY) on trials, CMO, and personnel; G&A rose on stock comp and headcount, deepening net loss to -$56.6M .
    • Transcript/Q&A visibility: no Q2 2025 earnings call transcript available in our corpus, limiting color on enrollment pace, regulatory interactions, and OpEx cadence (see “Q&A Highlights”).

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$2.50 $0.70 $0.73
Diluted EPS ($)-$0.54 -$0.81 -$0.85
R&D Expenses ($USD Millions)$39.69 $52.61 $54.20
G&A Expenses ($USD Millions)$9.13 $10.82 $10.39
Net Loss ($USD Millions)-$35.84 -$53.80 -$56.60

Notes:

  • Management attributed revenue decline to lower services performed under Rockefeller University agreements .
  • R&D increase driven by barzolvolimab clinical trial activity, contract manufacturing, and personnel .

KPIs and Balance Sheet

KPIQ4 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$725.28 $673.29 $630.34
Cash Used in Operating Activities (Quarter) ($USD Millions)$32.5 (Q4) $54.4 (Q1) $44.0 (Q2)
Shares Outstanding (Millions)66.4 66.4 66.4

Segment breakdown: Not applicable (no commercial product revenue disclosed).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough 2027Through 2027 (Q1’25) Through 2027 (Q2’25) Maintained
CSU Phase 3 enrollmentCSU Phase 3Enrollment ongoing (Q1’25) On track; expected fully enrolled next summer Timing updated (more specific)
CIndU Phase 3 start2025Expected to initiate in 2025 (Q1’25) Expected to initiate in 2H 2025 Narrowed timing
CIndU Phase 2 20-wk data2025“Later this year” (Q1’25) “Later this year” (reaffirmed) Maintained
EoE Phase 2 data2025Data expected in 2025 (Q1’25) 12-week analysis in 2H 2025 Narrowed timing
CDX-622 Phase 1 Part 120252025 Data expected in 2H 2025 Narrowed timing
Financial metrics (revenue/margins)FY25None providedNone providedNo change

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not found in our corpus; themes below reflect press releases and 8-Ks.

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
CSU efficacy/durability52-week data: 71% CR at 52 weeks; best-in-disease positioning Teed up 76-week late-breaker at EAACI 76-week durability: 41% CR; 48% DLQI 0/1; reversibility of KIT AEs Strengthening
CSU angioedema77% angioedema-free at 52 wks; up to 72% angioedema-free time New supportive data
CSU Phase 3 enrollmentEnrollment ongoing; global trials Enrollment ongoing On track; fully enrolled next summer Positive clarity
CIndU programPhase 3 planned for 2025; strong 12-wk Phase 2 data 20-wk data later in 2025 Phase 3 planned 2H 2025; 20-wk data later in 2025 On plan
EoEFully accrued; data 2025 Data 2025; histology baseline data presented May 12-week analysis 2H 2025 On plan
CDX-622 (bispecific)Phase 1 initiated Phase 1 ongoing; 2025 Part 1 data Phase 1 ongoing; Part 1 data 2H 2025 On plan
Cash runwayThrough 2027 Through 2027 Through 2027 Stable

Management Commentary

  • CEO on barzolvolimab profile and execution: “barzolvolimab is best in disease and achieves the goal of treatment… rapid, profound, durable complete response… We remain focused on executing across our Phase 3 program in CSU, which is on track and expected to be fully enrolled next summer” .
  • CMO on CSU durability: “Barzolvolimab also presented a favorable safety profile… further supporting barzolvolimab’s significant potential to become a transformative treatment option” .
  • CMO on angioedema: “rapid, profound angioedema relief… benefit continued to improve over 52 weeks” .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available in our document set at the time of analysis; thus, Q&A themes and any guidance clarifications from a live call are unavailable. We searched common transcript sources but found no transcript posted.

Estimates Context

MetricActual (Q2 2025)Consensus (Q2 2025)Surprise
EPS (Primary)-$0.85*-$0.87*+$0.01*
Revenue ($USD)$0.73M*$1.13M*-$0.40M*

Values retrieved from S&P Global.*

Additional context:

  • Consensus inputs: EPS (11 ests), revenue (10 ests); CLDX also shows a mean target price of $53.14 (14 ests) as of the period.*
  • The company’s reported revenue decline vs. consensus reflects lower services performed under Rockefeller agreements, while EPS benefited modestly from investment income and spend pacing .*

Key Takeaways for Investors

  • Barzolvolimab’s 76-week durability and 52-week angioedema relief meaningfully de-risk CSU efficacy and safety; the durability narrative is now a differentiator vs. incumbents and late-stage competitors .
  • Phase 3 CSU enrollment timeline clarity (full enrollment targeted next summer) tightens the approval/launch window scenarios; continued recruitment updates will be stock-sensitive .
  • 2H 2025 is data-rich: CIndU 20-week, EoE 12-week analysis, and CDX-622 Part 1 pharmacodynamic/PK readouts provide multiple catalyst paths; negative EoE outcomes could modestly temper multi-indication optionality while not impairing CSU .
  • Balance sheet runway through 2027 reduces near-term financing overhang and supports multiple registrational/late-stage studies without immediate dilution risk .
  • Near-term trading setup: expect shares to be sensitive to trial enrollment updates and any EAACI/EADV follow-on analyses; incremental safety clarity (KIT-related AEs, neutropenia management) remains important for broad adoption narratives .
  • Revenue/OpEx optics are less relevant near-term given pre-commercial status; focus should remain on program execution and regulatory path milestones .

Supporting Documents (selected)

  • Q2 2025 Press Release and 8-K: financials, cash runway, pipeline updates .
  • EAACI data (76-week CSU durability; angioedema outcomes) .
  • Prior quarters: Q1 2025 8-K (financials, guidance) ; Q4 2024 8-K (year-end context) .