Celldex Therapeutics, Inc. · NASDAQ:CLDX
Celldex Therapeutics — FY2021 Earnings Presentation
25 slides from Celldex Therapeutics's earnings presentation, February 2022
Slide 1: 2021 Year in Review Call and Corporate Update
2021 Year in Review Call and Corporate Update NASDAQ: CLDX February 2021
Slide 2: Safe Harbor Statement
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-
Slide 3: Agenda
Agenda Participants Agenda Anthony S. Marucci • Completed Phase 2 Readiness Activities Co-founder & Chief Executive Officer – Phase 1 Subcutaneous CDX-0159 Study Results Tibor Keler, Ph.D. Co-founder & Chief Scientific Officer – 6 Month Chronic Toxicology Study Results Diane C. Young, M.D. Chief Med
Slide 4: Strong Clinical Pipeline with Multiple Inflection Points
Strong Clinical Pipeline with Multiple Inflection Points PROGRAM PRECLINICAL PHASE 1 PHASE 2/3 Inflammation Chronic inducible urticaria (CIndU) to enter Ph2 2Q 2022 ColdU, SD & CholU CDX-0159 Chronic spontaneous urticaria (CSU) to enter Ph2 2Q 2022 KIT Antagonist mAb Prurigo nodularis (PN) Eosinophi
Slide 5: Completed Phase 2 Readiness Activities
Completed Phase 2 Readiness Activities Phase 1 Single Ascending Doses of Subcutaneous CDX-0159 Trial Healthy Volunteers
Slide 6: Phase 1 Single Ascending Doses of Subcutaneous CDX-0159 Trial Design
Phase 1 Single Ascending Doses of Subcutaneous CDX-0159 Trial Design Healthy Volunteers Cohort 1 50 mg SubQ Screening Randomization CDX-0159 subjects: 6 Placebo: 2 Cohort 2 Phase 1 SAD HV SubQ 150 mg SubQ CDX-0159 subjects: 6 Placebo: 2 Week 0 Trial Size: CDX-0159 12 Week Follow Up Period Single Dos
Slide 7: Positive data support planned Phase 2 programs with SubQ
Phase 1 Single Ascending Doses of Subcutaneous CDX-0159 Trial Positive data support planned Phase 2 programs with SubQ Subcutaneous (SubQ) formulation demonstrated well tolerated safety profile at patient convenient dosing volumes • SubQ delivery of CDX-0159 resulted in dose dependent, rapid and sus
Slide 8: CDX-0159 SubQ Resulted in Dose-Dependent Tryptase Suppression
CDX-0159 SubQ Resulted in Dose-Dependent Tryptase Suppression • Dose-dependent, rapid and sustained decreases in serum tryptase • Profound tryptase suppression indicative of systemic MC ablation SubQ CDX-0159 Dose Dependent Serum Tryptase Suppression 125 Tryptase (% Baseline) 100 Placebo 50 mg 75 15
Slide 9: Serum Tryptase Kinetics in SubQ Formulation Comparable to IV
Serum Tryptase Kinetics in SubQ Formulation Comparable to IV • SubQ tryptase reduction kinetics are comparable to IV formulation used in previous clinical studies to date • SubQ tryptase decreases were rapid and not significantly delayed relative to IV administration Comparison of Serum SubQ (300 mg
Slide 10: CDX-0159 SubQ Resulted in Dose Dependent Increase in SCF
CDX-0159 SubQ Resulted in Dose Dependent Increase in SCF • SCF levels increase rapidly and mirror tryptase dose response – Plateau of effect implies systemic stem cell factor blockade • SubQ kinetics of SCF increase are comparable to the IV formulation SubQ CDX-0159 Dose Dependent Increase in SCF Co
Slide 11: Favorable SubQ Preliminary Pharmacokinetic Properties
Favorable SubQ Preliminary Pharmacokinetic Properties • Preliminary data demonstrate sufficient exposures to lead to tryptase suppression levels in line with previous IV studies Pharmacokinetics Pharmacokinetics 50, 150 and 300mg CDX0159 SubQ Cohorts* 150 and 300mg SubQ Doses vs 1 and 3mg/kg IV* CDX
Slide 12: CDX-0159 SubQ Demonstrates a Favorable Safety Profile
CDX-0159 SubQ Demonstrates a Favorable Safety Profile • SubQ formulation was well tolerated at all dose levels • No injection site reactions • Most treatment adverse events were grade 1 and resolved quickly during the study without treatment • Only 3 treatment adverse events were grade 2 (dermatitis
Slide 13: Hematology Results Consistent with Prior Studies
Hematology Results Consistent with Prior Studies • Findings consistent with earlier IV studies; mild and asymptomatic decreases in heme parameters CDX-0159 SubQ vs IV Healthy Volunteer Hematology (cohort means and placebo 95% confidence interval) Sub Q Neutrophils SubQ Leukocytes 5.0 8.0 CDX-0159 (6
Slide 14: 6 Month Chronic Toxicology Study
Completed Phase 2 Readiness Activities 6 Month Chronic Toxicology Study
Slide 15: Completed In-life Dosing Portion of 6 Month Chronic Toxicology Study
Completed In-life Dosing Portion of 6 Month Chronic Toxicology Study Results strongly support initiation of Phase 2 urticaria studies and future indications Celldex has completed in life dosing of 6 month chronic toxicology study to support long term dosing: ✓ As expected and consistent with other K
Slide 16: 2022 Development Plans
s% Celidex therapeutics
Slide 17: CDX-0159 Planned Development Timeline
CDX-0159 Planned Development Timeline Programs 2H 2021 1H 2022 2H 2022 2023 ✓ Completed Dosing Subcutaneous Formulation SubQ HV Study SubQ advanced into future studies (including Phase 2 urticaria) Ongoing Ph 1b CSU Study Ph 1b CSU Data EAACI 2022 Ongoing Ph 1b CIndU Chronic Urticaria Study Initiate
Slide 18: CDX-0159 Clinical Development Expansion: Eosinophilic Esophagitis (EoE)
CDX-0159 Clinical Development Expansion: Eosinophilic Esophagitis (EoE)
Slide 19: CDX-0159 Expands into Eosinophilic Esophagitis (EoE)
CDX-0159 Expands into Eosinophilic Esophagitis (EoE) Fourth Indication and Additional Disease Setting with Mast Cell Involvement EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils • Ch
Slide 20: Strong Evidence for Mast Cell Involvement in EoE
Strong Evidence for Mast Cell Involvement in EoE Potential for CDX-0159 in EoE driven by robust established and emerging scientific evidence • Mast cells are significantly increased in biopsies of the esophagus in patients with EoE, including the esophageal epithelium • There is also strong evidence
Slide 21: 2022 Milestones
s% Celidex therapeutics
Slide 22: CDX-0159 Profile Offers Unique Potential
CDX-0159 Profile Offers Unique Potential CDX-0159 profile suggests a potential treatment option which could represent a significant advancement over current standard of care in the treatment of diseases with mast cell involvement ✓ Convenient administration route for patients: subcutaneous formulati
Slide 23: Driving Value Through Expected 2022 Milestones
Driving Value Through Expected 2022 Milestones Programs and Anticipated Milestones Inflammation CDX-0159 ▪ July 2022 - Ph 1b CSU Data (0.5, 1.5 and 3 mg/kg dosing cohorts expected to be presented at EAACI 2022) ▪ 2Q 2022 - Initiate Ph 2 CIndU Study ▪ 2Q 2022 - Initiate Ph 2 CSU Study ▪ 4Q 2022 - Ini
Slide 24: Financial Overview (as of 12/31/2021)
Financial Overview (as of 12/31/2021) Well-capitalized through cash $408.3M $0.0 46.7M Projeced Runway Shares Cash Debt Outstanding Cash runway through 2025 24
Slide 25: Targeted Antibody Therapeutics to Address Devastating Diseases
Targeted Antibody Therapeutics to Address Devastating Diseases NASDAQ: CLDX