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