Celldex Therapeutics, Inc. · NASDAQ:CLDX

Celldex Therapeutics — European Academy of Dermatology and Venereology (EADV 2024)

16 slides from Celldex Therapeutics's conference presentation, 2024

1. Slide 1: Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in CSU

   Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria M. Maurer1,2, M. Metz1,2, I. Kobielusz-Gembala3, E. Mitha4, J. Leflein5, M. Gotua6, B. Kwiek7, D. Krasowska8, J. Peter9, N. Talreja10, D. Young11, R. Ma11, J. Fuentes-Duculan11, E.

2. Slide 2: Disclosures

   Disclosures Martin Metz has received honoraria as a speaker and/or advisor for: AbbVie, ALK- Abello, Almirall, Amgen, Argenx, AstraZeneca, Astria, Attovia, Celldex, Celltrion, Escient, Ga2len, Galderma, gsk, Incyte, Jasper, Lilly, Novartis, Pfizer, Pharvaris, Regeneron, Sanofi, Teva, ThirdHarmonicBi

3. Slide 3: Introduction

   Introduction • New therapies are urgently needed for chronic spontaneous urticaria (CSU), a mast cell-driven disease • Many patients remain symptomatic despite standard or up-dosed antihistamines and omalizumab therapy • Barzolvolimab is an anti-kit monoclonal antibody, which inhibits activation of

4. Slide 4: Study Design and Key Eligibility

   Study Design and Key Eligibility 52 Week Total Treatment Period 4 Week 16 Week Placebo Controlled 24 Week Follow Up Period Screening 36 Week Active Treatment Period Treatment Period -4 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 Arm 1 Barzolvolimab 75 mg Q4 weeks Arm 2 Barzolvolimab 150

5. Slide 5: Demographics and Baseline Characteristics

   Demographics and Baseline Characteristics • Well balanced across groups; majority of patients had severe urticaria symptoms Barzolvolimab Barzolvolimab Barzolvolimab Placebo 75 mg Q4W 150 mg Q4W 300 mg Q8W (N= 51) (N= 53) (N= 52) (N= 51) Age (years) 42.2 (18-69) 46.0 (21-81) 47.2 (20-80) 44.4 (20-76

6. Slide 6: Patient Disposition Through 52 Weeks

   Patient Disposition Through 52 Weeks Randomized patients (N=208) Barzolvolimab Placebo Barzolvolimab Barzolvolimab 75 mg Q4W Barzolvolimab 150 mg Q4W 300 mg Q8W 150mg / 300mg1 150mg / 300mg1 (n=52) (n=52) (n=53) (n=51) Discontinued Treatment, n (%) 13 (25%) 13 (25%) 13 (25%) 8 (16%)2 Adverse Event3

7. Slide 7: Significant Improvement in UAS7 vs Placebo at Week 12 (Primary Endpoint)

   Barzolvolimab Demonstrated Significant Improvement in UAS7 vs Placebo at Week 12 (Primary Endpoint) Mean Change from Baseline in UAS7 at Week 12 0 LS Mean Change from BL in UAS7 -5 -10 -10.47 -15 75 mg Q4W (n = 53) -17.06 -20 150 mg Q4W (n = 52) -23.02 -23.87 -25 300 mg Q8W (n = 51) Δ -13.41 (-17.47

8. Slide 8: Significant Improvement in Both Itch and Hives vs Placebo at Week 12

   Barzolvolimab Demonstrated Significant Improvement in Both Itch and Hives vs Placebo at Week 12 Mean Change from Baseline in HSS7 at Week 12 Mean Change from Baseline in ISS7 at Week 12 0 0 LS Mean Change from LS Mean Change from -4.95 -5.47 -5 -5 BL in HSS7 -8.25 BL in ISS7 -8.62 -10 -11.19 -10 -11

9. Slide 9: Improvements in UAS7 Observed as Early as Week 1, Sustained to Week 52

   Improvements in UAS7 With Barzolvolimab Were Observed as Early as Week 1 and Were Sustained to Week 52 40 Placebo controlled period (16 weeks) 35 UAS7 over time (Mean +- SE) 30 25 20 15 10 5 0 0 1 4 8 12 16 20 24 28 32 36 40 44 48 52 Weeks 9

10. Slide 10: Up to 74% of Patients Achieved Well-Controlled Disease at Week 52

    Up to 74% of Patients Achieved Well-Controlled Disease (UAS7≤6) With Barzolvolimab at Week 52 % of Patients with UAS7 ≤ 6 Week 12 and Week 52 100 W12 W52 80 73.7 with UAS7<=6 % of Patients 67.4 68.2 62.5 63.0 59.6 60 41.7 40 20 12.8 0 75mgQ4W→150/300mg 150mgQ4W 300mgQ8W Placebo→150/300mg Placebo and

11. Slide 11: Up to 71% of Patients Achieved Complete Control at Week 52

    Up to 71% of Patients Achieved Complete Control (UAS7=0) With Barzolvolimab at Week 52 % of Patients with UAS7 = 0 Week 12 and Week 52 100 W12 80 W52 71.1 % of Patients with UAS7=0 58.7 60 53.5 51.1 52.3 37.5 40 22.9 20 6.4 0 75mgQ4W→150/300mg 150mgQ4W 300mgQ8W Placebo→150/300mg Placebo and 75mg Q4W

12. Slide 12: Complete Responses Observed Early and Sustained or Improved to Week 52

    Complete Responses (UAS7=0) With Barzolvolimab Were Observed Early and Were Sustained or Improved to Week 52 Barzolvolimab 150mgQ4W Barzolvolimab 300mgQ8W 100 Placebo → 150mgQ4W or 300mgQ8W 95 Placebo controlled period (16 weeks) Barzolvolimab 75mgQ4W → 150mgQ4W or 300mgQ8W 90 85 80 75 UAS7 = 0 over

13. Slide 13: Robust Response Seen Regardless of Prior Omalizumab Experience

    Robust Response Seen Regardless of Prior Omalizumab Experience Change from Baseline in UAS7 at Week 52 by Omalizumab Experience 43 34 9 5 38 32 6 3 44 33 11 7 46 38 8 3 0 -10 Mean CFB in UAS7 -19 -19 -20 -23 -22 -22 -22 -23 All Patients -26 -25 -24 -28 -28 -27 -28 -27 -30 Omalizumab Naïve -30 Omaliz

14. Slide 14: Barzolvolimab was well tolerated through 52 weeks of treatment

    Barzolvolimab was well tolerated through 52 weeks of treatment • Most events were grade 1 (mild), mechanism-related (KIT) and expected to be reversible • Adverse events were not dose dependent • No association between infections and neutropenia/decreased neutrophil counts Placebo → Full Treatment Pl

15. Slide 15: Conclusions

    Conclusions • Barzolvolimab treatment resulted in rapid, profound and durable improvement in UAS7 with a deepening of response over 52 weeks in patients with antihistamine refractory CSU o Up to 71% of patients achieved complete response o Similar robust improvement seen in patients previously treat

16. Slide 16: Acknowledgements

    Acknowledgements We wish to thank all the investigators and their patients who contributed to this trial. We are especially grateful to Professor Dr. Marcus Maurer for his partnership in advancing barzolvolimab. Dr. Maurer’s steadfast commitment to improving the lives of patients with chronic urtica

Celldex Therapeutics — European Academy of Dermatology and Venereology (EADV 2024) on 6ix