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Celldex Therapeutics, Inc. (CLDX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered strong pipeline execution (CSU/CIndU QoL data; EoE histology), but financials were in-line-to-soft: revenue $0.695M and diluted EPS ($0.81) with widening operating losses as Phase 3 and Phase 2 activity scaled .
  • Results missed Wall Street consensus: revenue $1.12M estimate vs $0.695M actual (−38%), EPS −$0.77 estimate vs −$0.81 actual (−$0.04); expense growth drove the EPS miss while revenue remains lumpy from services [Q1 2025]*.
  • Liquidity runway maintained through 2027 with cash, cash equivalents and marketable securities of $673.3M at quarter‑end; cash used in operations was $54.4M, reflecting increased clinical and manufacturing activity .
  • Near-term catalysts: late breaking 76‑week CSU data at EAACI on June 13 (Company webcast June 12), CIndU 20‑week data later this year, EoE Phase 2 data in 2H 2025; Phase 3 CSU enrollment ongoing; Phase 3 CIndU program under development .
  • No non‑GAAP metrics provided; management tone remained confident on barzolvolimab’s best‑in‑class profile and durability of control, positioning CLDX for potential registration progress and estimate revisions around data readouts .

What Went Well and What Went Wrong

  • What Went Well

    • Management emphasized “best‑in‑class efficacy” and “very high rates of complete response” in chronic urticaria, with meaningful quality‑of‑life gains translating clinical efficacy into patient impact .
    • QoL data highlighted depth and durability: in CSU, up to 82% reported no QoL impact at Week 52; ∼50% complete control by UCT; in CIndU, up to 60% no QoL impact and 69% well‑controlled by Week 12 .
    • Pipeline breadth advanced: Phase 3 CSU enrollment ongoing; Phase 3 CIndU being planned for 2025; EoE fully accrued with supportive histology showing mast cell elevation and correlation with eosinophils; PN and AD Phase 2 enrollment ongoing; CDX‑622 Phase 1 in healthy volunteers continues .

  • What Went Wrong

    • Operating loss and net loss widened on higher R&D spend (barzolvolimab trials, CMO, personnel) as programs scale; R&D rose to $52.6M vs $31.7M YoY, expanding operating loss to $(62.7)M .
    • Revenue underperformed consensus given dependence on variable services (Rockefeller agreements); management expects revenue to decrease over the next 12 months as services taper, which can pressure near‑term optics .
    • No earnings call transcript was available for Q1 (limits Q&A visibility), and no quantitative revenue/EPS guidance was provided; investors must anchor near‑term narrative to clinical milestones and cash runway [Search: none] .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$3.191 $1.175 $0.695
Diluted EPS ($USD)($0.64) ($0.71) ($0.81)
R&D Expense ($USD Millions)$45.263 $46.939 $52.614
G&A Expense ($USD Millions)$10.054 $10.263 $10.820
Operating Loss ($USD Millions)($52.126) ($56.027) ($62.739)
Net Loss ($USD Millions)($42.121) ($47.092) ($53.796)

YoY comparison

MetricQ1 2024Q1 2025
Revenue ($USD Millions)$0.156 $0.695
Diluted EPS ($USD)($0.56) ($0.81)
R&D Expense ($USD Millions)$31.661 $52.614
G&A Expense ($USD Millions)$9.103 $10.820
Net Loss ($USD Millions)($32.808) ($53.796)

Revenue breakdown

Category ($USD Thousands)Q3 2024Q4 2024Q1 2025
Product development & licensing$3 $8 $50
Contracts & grants$3,188 $1,167 $645
Total$3,191 $1,175 $695

KPIs and liquidity

MetricQ3 2024Q4 2024Q1 2025
Cash, cash equivalents & marketable securities ($USD Millions)$756.0 $725.3 $673.3
Shares Outstanding (Millions)66.3 66.4 66.4
Cash used in operating activities ($USD Millions)$55.3 $32.5 $54.4

Note: Company did not provide non‑GAAP measures; margin percentages are less informative given minimal revenue base.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity runwayThrough 2027“Through 2027” (Q4 2024) “Through 2027” (Q1 2025) Maintained
CSU Phase 32024–2026Enrollment ongoing (Q4 2024) Enrollment ongoing (Q1 2025) Maintained
CIndU Phase 32025 startPlan to initiate in 2025 (Q4 2024) Program under development; expected 2025 (Q1 2025) Maintained
CSU Phase 2 76‑week dataJune 13, 2025“76‑week data in 2025” (Q4 2024) Specific EAACI late‑breaking oral, June 13; webcast June 12 (Q1 2025) Updated timing (narrowed)
CIndU 20‑week data2025“Data through week 44 in 2025” (Q4 2024) “20‑week treatment data later this year” (Q1 2025) Maintained (phrasing update)
EoE Phase 2 data2H 2025“Expected in 2025” (Q4 2024) “Expected in 2025; supportive histology” (Q1 2025) Maintained
PN Phase 2OngoingEnrollment ongoing (Q4 2024) Enrollment ongoing (Q1 2025) Maintained
AD Phase 2OngoingInitiated Dec 2024; enrolling (Q4 2024) Enrollment ongoing (Q1 2025) Maintained
CDX‑622 Phase 12025 Part 1 dataInitiated Nov 2024; enrolling (Q4 2024) Enrollment ongoing; Part 1 data expected 2025 (Q1 2025) Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available; themes reflect press release and 10‑Q commentary.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
R&D execution52‑week CSU efficacy; CIndU 12‑week primary met; Phase 3 CSU ongoing; PN/EoE enrolling Phase 3 CSU ongoing; CIndU Phase 3 planning; AD Phase 2 initiated; EoE fully accrued EAACI late‑breaking 76‑week CSU in June; CIndU 20‑week later in 2025; EoE histology supports mast cell role; PN/AD Phase 2 ongoing Positive momentum, data cadence tightening
Product performanceDeepening CSU response, high complete responses at 52 weeks Highest complete response observed; QoL benefits QoL: up to 82% no impact (CSU) at 52 weeks; 60% no impact (CIndU) at 12 weeks Sustained/expanding efficacy narrative
Regulatory/legalSettlement milestone paid 2023; future $52.5M approval milestone risk noted Same disclosures; runway through 2027 Same; optional future milestone payment method (cash/stock) noted Stable risk disclosure
Manufacturing/supply chainCDMO scale‑up for late‑stage; pre‑filled syringes ready Late‑stage readiness reaffirmed Continued manufacturing support for Phase 3 Stable, execution focus
Bispecific platformCDX‑622 IND‑enabling complete; plan to enter clinic Phase 1 initiated; PK/PD and mast cell depletion preclinical Phase 1 ongoing; initial data expected 2025; human skin signatures reduced Advancing per plan

Management Commentary

  • CEO: “Barzolvolimab has consistently demonstrated best‑in‑class efficacy in chronic urticaria, with very high rates of complete response, and it’s especially meaningful to see these results translate into improved quality of life…” .
  • On 2025 cadence: “We expect 2025 will be a year of continued execution… Next month, 76 week data from the Phase 2 CSU study will be presented… we will discuss barzolvolimab’s potential to achieve sustained disease control after treatment withdrawal.” .
  • EoE mechanistic support: EoE histology demonstrated elevated intraepithelial mast cells correlating with eosinophils, supporting barzolvolimab’s mast cell–depleting hypothesis .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; therefore, Q&A themes and any guidance clarifications from the call could not be assessed [Search: none].

Estimates Context

MetricConsensus (Q1 2025)Actual (Q1 2025)Surprise
Revenue ($USD)$1,120,820*$695,000*−$425,820
Primary EPS ($USD)−$0.7715*−$0.81*−$0.0385
  • Revenue miss driven by lower-than-expected services revenue (Rockefeller agreements) and management’s indication that services will decrease over the next 12 months, making quarterly revenue inherently variable .
  • EPS miss primarily reflects higher R&D (clinical trial and contract manufacturing) and higher stock‑based compensation in G&A as programs scale .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Liquidity runway through 2027 provides ample time to reach multiple clinical catalysts while funding Phase 3 CSU and Phase 2 programs; Q1 cash used in ops was $54.4M, consistent with scaling activity .
  • Near-term event path: EAACI late‑breaking CSU 76‑week data (June 13) and June 12 webcast, plus CIndU 20‑week and EoE Phase 2 data in 2H 2025—each represents potential estimate revision catalysts and sentiment drivers .
  • Barzolvolimab’s profile continues to strengthen with robust complete response rates and QoL improvements across CSU and CIndU; durability signals and off‑treatment control are key to commercial differentiation .
  • Expect expense intensity to remain elevated as Phase 3 and multiple Phase 2 trials progress; monitor R&D run‑rate, contract manufacturing spend, and timing of milestone obligations tied to regulatory approvals .
  • Revenue visibility is limited and not central to thesis near‑term; management expects services revenue to decline, reinforcing the focus on data milestones over quarterly revenue beats/misses .
  • CDX‑622 broadens the mast cell/TSLP franchise; initial human data in 2025 can add optionality beyond urticaria, with preclinical evidence of mast cell depletion and TSLP neutralization in human skin .
  • Position sizing should incorporate clinical readout timing and binary risk at Phase 3; short‑term trading around EAACI and subsequent CIndU/EoE updates may be attractive, but medium‑term thesis hinges on registration path clarity and durability of control narrative .

Appendix: Additional Data Points

  • Q1 2025 revenue composition: Product development/licensing $50k; contracts/grants $645k .
  • Q1 2025 R&D by program: Barzolvolimab/anti‑KIT $39.7M; CDX‑622 $5.5M; other programs $7.5M .
  • Shares used in EPS calc: 66.383M (Q1 2025) vs 58.871M (Q1 2024) .
  • Company expects investment income to decline as cash/investment balances decrease; revenue expected to decrease as services taper .