Executive Summary

Q3 delivered strong pipeline execution but a wider loss: revenue was $0.0M (vs $3.2M YoY), EPS $(1.01) vs $(0.64) YoY, driven by higher R&D as Phase 3/late-stage programs scale .
Results missed Wall Street: EPS $(1.01) vs $(0.91) consensus and revenue $0.0M vs $1.08M consensus; both below expectations as collaboration/services revenue declined to zero in the quarter (10 EPS ests; 12 revenue ests)* .
Barzolvolimab momentum continued: 20-week placebo-controlled CIndU data showed up to 66%/49% complete responses in ColdU/SD; CSU data showed deep, sustained responses through 52 weeks and sustained disease control post-treatment .
Strategic steps toward commercialization: Phase 3 in ColdU/SD to initiate December 2025 and Celldex hired a Chief Commercial Officer; cash runway reaffirmed through 2027, supporting multiple 2026 data readouts .

What Went Well and What Went Wrong

What Went Well
- Clinical efficacy across urticaria: in CIndU (20 weeks), up to 66% of ColdU and 49% of SD patients achieved complete response vs 16% and 10% on placebo; partial/complete responses reached 78% and 58% vs 25% and 16% on placebo .
- Sustained control in CSU: 71% complete response at 52 weeks on 150 mg Q4W; ~7 months post-dosing >40% remained complete responders, suggestive of potential disease modification .
- Management focus and readiness: “Celldex continued to demonstrate our leadership in the field of mast cell biology…” and announced hire of Teri Lawver as CCO to prepare for potential commercialization .
What Went Wrong
- EoE program discontinued: despite profound mast cell depletion (primary endpoint met), clinical symptoms and endoscopic outcomes did not improve vs placebo; Celldex halted EoE development .
- Revenue decline to zero: collaboration/services-related revenue fell to $0.0M vs $3.2M YoY as work with Rockefeller University tapered, contributing to a miss vs consensus .
- Higher operating spend and wider loss: R&D rose to $62.9M (vs $45.3M YoY); net loss widened to $(67.0)M (vs $(42.1)M YoY) with EPS $(1.01) vs $(0.64) YoY .

Revenue, EPS vs prior periods and estimates

Metric	Q3 2024	Q2 2025	Q3 2025	Consensus (Q3’25)
Revenue ($USD Millions)	$3.19	$0.73	$0.00	$1.08*
EPS (Diluted) ($)	$(0.64)	$(0.85)	$(1.01)	$(0.91)*

Operating P&L and cash (YoY and sequential context)

Metric ($USD Millions)	Q3 2024	Q2 2025	Q3 2025
R&D Expense	$45.26	$54.20	$62.93
G&A Expense	$10.05	$10.39	$10.69
Investment & Other Income, net	$10.01	$7.26	$6.57
Net Loss	$(42.12)	$(56.60)	$(67.04)
Cash, Cash Equivalents & Marketable Securities (period-end)	—	$630.3 (6/30)	$583.2 (9/30)

Notes: No margins/segment reporting applicable given de minimis revenue and clinical-stage status .

KPIs (clinical program highlights)

KPI	Value/Result	Source/Notes
CSU complete response at 52 weeks (150 mg Q4W)	71%
CSU complete response ~7 months post-treatment	>40%
ColdU complete response at 20 weeks	Up to 66% (vs 16% placebo)
SD complete response at 20 weeks	49% (vs 10% placebo)
ColdU partial/complete at 20 weeks	Up to 78% (vs 25% placebo)
SD partial/complete at 20 weeks	58% (vs 16% placebo)

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Multi‑year	Through 2027 (Q1/Q2 2025)	Through 2027 (Q3 2025)	Maintained
CSU Phase 3 enrollment timing	2025–2026	“On track; fully enrolled next summer” (from Q2 2025)	Not updated in Q3 PR	No update
CIndU Phase 3 (ColdU/SD) start	2H 2025	“Expected to initiate in 2H 2025” (Q2)	“To initiate December 2025” (Q3)	Narrowed/timed
Commercial readiness	2025	—	Hired Chief Commercial Officer (CCO)	New milestone

No revenue, margin, OpEx, OI&E or tax-rate quantitative guidance provided in Q3 materials .

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
CSU efficacy durability/quality of life	76-week data with up to 41% complete response; QoL/angioedema benefits at 52 weeks	Reinforced with sustained disease control post-treatment and rapid UCT7 improvements	Positive, durability emphasized
CIndU efficacy (ColdU/SD)	12-week endpoints met; 20-week readout pending	20-week placebo-controlled data: strong complete/partial responses and favorable safety	Positive, data maturation
EoE program	Awaiting data (Q1/Q2)	Primary histologic endpoint met; no clinical benefit; program discontinued	Negative, portfolio focus shift
CIndU Phase 3 plans	“Expected to initiate 2H 2025”	Start pinned to December 2025	Execution clarity
Commercial build	—	CCO hired to prep for potential barzolvolimab launch	Acceleration
Cash runway	Through 2027 (Q1/Q2)	Through 2027 reaffirmed	Stable

Note: Q3 earnings-call transcript not available in the document corpus; themes reflect company press releases/8-Ks – – –.

“This quarter, Celldex continued to demonstrate our leadership in the field of mast cell biology, presenting exciting data across our pipeline programs” — Anthony Marucci, CEO .
“Barzolvolimab is the first in the field to demonstrate clinical benefit in a large, randomized, placebo-controlled study of cold urticaria and symptomatic dermographism…” .
“We are actively preparing for the potential commercialization of barzolvolimab and… announce that Teri Lawver has joined Celldex as… Chief Commercial Officer” .
On pipeline focus: discontinuation of EoE after no clinical benefit despite mast cell depletion clarifies which diseases are mast cell driven .

The Q3 2025 earnings-call transcript was not available in the repository at the time of this recap; no Q&A details or guidance clarifications could be verified. Celldex did host a conference call/webcast for the EoE topline results on Aug 19, 2025 (separate from earnings) .

Consensus vs actual: EPS $(1.01) vs $(0.91) consensus (miss); revenue $0.0M vs $1.08M consensus (miss). Drivers: lower collaboration/services revenue in the quarter and higher R&D spend as Phase 3 advances .
Number of estimates: 12 for EPS; 10 for revenue*. Updates to estimates likely reflect continued operating expense scaling into Phase 3 and lack of near-term revenue.

Consensus vs Actual (Q3 2025)

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

Despite clinical momentum in urticaria, the print missed on both EPS and revenue; R&D growth and zero revenue remain the key financial overhangs near term .
Portfolio focus sharpened: EoE discontinuation removes a non-core drag and reallocates resources to urticarias, AD, PN and the bispecific CDX‑622 .
Commercial path signaling: December 2025 start for CIndU Phase 3 plus a new CCO underscore preparation for potential barzolvolimab launch upon successful Phase 3 outcomes .
Liquidity is ample with $583.2M in cash/securities and runway through 2027, enabling completion of ongoing/near-term Phase 3 and Phase 2 programs .
Near-term catalysts: Phase 3 ColdU/SD initiation (Dec 2025) and multiple 2026 readouts; estimate revisions may bias toward higher OpEx and continued GAAP losses until pivotal timelines mature .
Trading setup: stock likely remains data/catalyst-driven; watch for Phase 3 enrollment updates in CSU, the exact ColdU/SD Phase 3 design/start, and any regulatory interactions signaling timelines .
Medium term: if Phase 3 outcomes mirror Phase 2 durability and efficacy, the urticaria opportunity could be substantial; CCO hire indicates intent to internalize value capture .

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