Slides
Page 1
Phase 2 Topline Prurigo Nodularis Results JULY 21, 2026 DATA CUTOFF: JUNE 25, 2026
Page 2
Safe Harbor Statement This communication contains "forward -looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward -looking statements through our use of words such as “may, ” “will, ” “can, ” “anticipate, ” “assume, ” “should, ” “indicate,” “would,” “believe, ” “contemplate, ” “expect,” “seek, ” “estimate, ” “continue, ” “plan, ” “point to, ” “project, ” “predict, ” “could, ” “intend, ” “target, ” “potential” and other similar words and expressions of the future. These forward- looking statements are subject to risks and uncertainties that may cause actual future experience and results to differ materially from those discussed in these forward -looking statements. Important factors that might cause such a difference include, but are not limited to, the timing, cost and uncertainty of obtaining regulatory approvals for product candidates; our ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; the validity of our patents and our ability to avoid intellectual property litigation, which can be costly and divert management time and attention; and the other factors listed under “Risk Factors” in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Celldex does not undertake any obligation to release publicly any revisions to such forward -looking statement to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 2
Page 3
Executive Summary Barzolvolimab: profound mast cell depleting agent; best-in-disease data across 3 indications to date—CSU, SD, ColdU • Unequivocal Phase 2 proof-of-concept data in these indications; all progressed quickly to Phase 3 studies • Phase 3 CSU topline data expected in September/October Topline results reported today for Phase 2 prurigo nodularis (PN) trial—chronic disease with highly symptomatic patient population • Trial did not meet primary or key secondary endpoints despite profound tryptase reductions • Data indicate mast cells may not be the key pathogenic driver in PN • Phase 2 trial in PN to be discontinued; will focus on higher priority indications New data continue to build barzolvolimab’s highly differentiated profile • Loading dose and more frequent dosing regimens were well tolerated • Loading dose rapidly decreased tryptase which was sustained with continued dosing, indicative of systemic mast cell depletion Focused on driving mast cell category creation and delivering on barzolvolimab’ s promise for patients Leading the Science in the Exploration of Mast Cell Biology to Deliver Life-Changing Therapies for Patients 3
Page 4
4 Phase 2 Study Design (n=140 patients) Study Overview Key Secondary Endpoints • Randomized, double-blind, placebo-controlled parallel group study in adults with moderate-to-severe PN (≥ 20 PN nodules, WI- NRS ≥ 7, IGA-CNPG-S ≥ 3) • 140 patients, 3 arms, 6 countries, 48 sites • % pts achieving itch response (WI-NRS ≥4-pt reduction from BL) at Weeks 4, 24 and over time • % pts achieving IGA-CNPG-S response (0 or 1) at Weeks 4, 12 & 24 • % pts achieving itch and IGA response at Weeks 4, 12 & 24 Primary Endpoint • % pts with itch response (reduction in WI-NRS by ≥ 4) from baseline to Week 12 • 80% powered to detect a 25% difference between each of the active arms and placebo *Primary endpoint
Page 5
Highly Symptomatic Patient Population Placebo Q4W (n=47) Barzolvolimab 150mg Q4W (n=47) Barzolvolimab 300mg Q4W (n=46) Age (years) 59.7 (12.60) 57.8 (12.84) 56.5 (16.37) Female, n (%) 27 (57.4) 33 (70.2) 27 (58.7) Weight (kg) 83.67 (18.73) 82.30 (14.82) 85.13 (20.49) Duration of PN (years) 6.97 (7.96) 7.93 (8.18) 6.38 (6.15) History of atopy (CRF), n (%) 19 (40.4) 16 (34.0) 16 (34.8) Concomitant AD, n (%) 5 (10.6) 6 (12.8) 5 (10.9) Prior systemic biologics/JAKi, n (%) 13 (27.7) 4 (8.5) 6 (13.0) WI-NRS 8.28 (1.14) 8.35 (1.17) 8.21 (1.44) IGA-CNPG-S 3.3 (0.47) 3.6 (0.50) 3.4 (0.53) DLQI 17.1 (7.51) 14.9 (6.96) 15.5 (7.46) Data are mean (SD) unless otherwise noted 5
Page 6
Primary Endpoint: WI-NRS Reduction by > 4 Points Intention to Treat Population Primary Estimand Approach for Wk12; logistic regression model p=0.428 p=0.868 6
Page 7
Intention to Treat Population Key Secondary Endpoints: IGA -CNPG-S and Itch & IGA Response Intention to Treat Population p=0.748 p=0.317 p=0.565 p=0.411 7
Page 8
Favorable Safety Profile through 24 Weeks 450mg loading dose combined with more frequent dosing demonstrates consistent safety profile with prior studies Patients, n (%) Placebo Q4W (N= 47) Barzolvolimab 150mgQ4W (N= 47) Barzolvolimab 300mgQ4W (N= 46) Any AE 24 (51.1) 25 (53.2) 34 (73.9) Treatment related SAE(s)1 0 0 1 (2.1) Discontinued study treatment due to AE2 2 (4.3) 6 (12.8)3 3 (6.5) Most frequent AEs (≥10% of participants in any treatment group) Hair Color Changes (G1,n=16; G2,n=2) 0 8 (17.0) 10 (21.7) Nasopharyngitis (G1,n=6; G2,n=5) 2 (4.3) 3 (6.4) 6 (13.0) 1Single SAE reported by investigator as aseptic meningitis and treatment related. Sponsor strongly disagrees with both diagnosis and relatedness. Sponsor assessment is that the clinical scenario is most consistent with a neuroinflammatory process of viral etiology, and not treatment related. Patient recovered fully. 2Most common: urticaria (related; n=2) and worsening prurigo (unrelated, n=2) 3(Unrelated) cardiac failure resulting in death in a 73 yr old male with multiple, concomitant risk factors (diabetes, hypertension, obesity, CAD/heart failure, COPD, smoking, low baseline oxygen saturation). 8
Page 9
Leading the Science in the Exploration of Mast Cell Biology to Deliver Life-changing Therapies KEY LEARNINGS • Data indicate mast cells may not be the key pathogenic driver in PN • New data continue to build barzolvolimab’ s highly differentiated profile • 450mg loading dose combined with more frequent dosing demonstrates consistent safety profile with prior studies • Loading dose led to rapid tryptase suppression • Phase 3 CSU topline data expected in September/October • Focused on driving mast cell category creation and delivering on barzolvolimab’s promise for patients 9
Page 10
Questions