Targeted Antibody Therapeutics to Address Devastating Diseases
NASDAQ: CLDX April 2024
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
Leading the science at the intersection of mast cell biology and the development of transformative antibody therapeutics
- Lead product barzolvolimab: unique mast cell depleting antibody; potential for pipeline within a product
-
- Rapid, profound & durable responses with favorable safety profile
-
- Topline Phase 2 CSU data presented 11/6/23, late breaking oral at AAAAI 2024 (2/24/24)
- Phase 2 topline 52 week CSU data and Phase 2 CIndU data expected 2H 2024
- Phase 1b PN data presented 11/7/23 ("Hot Topic" Oral; World Congress on Itch)
- Robust mAb and bsAb preclinical antibody platform supported by in-house manufacturing group developing next generation inflammatory and oncology programs
- Strong cash position - $423.6M as of 12/31/23; raised additional $400M+ 2/29/24
- Experienced team with extensive big pharma/biotech experience across multiple disease areas
3
Strong Clinical Pipeline with Multiple Inflection Points
PROGRAM
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
Inflammation
Barzolvolimab (CDX-0159)
KIT Antagonist mAb
Chronic spontaneous urticaria (CSU) to enter Phase 3 summer 2024
Chronic inducible urticaria (CIndU)
ColdU & SD - nearing enrollment completion
Prurigo nodularis (PN) to enter Phase 2 early 2024
Eosinophilic esophagitis (EoE)
Fifth indication (Phase 2) YE 2024
Bispecific Platform - Next Generation Inflammatory & Oncology
CDX-585 - CDX-622 -
PD-1 & ILT4
TSLP & SCF
Solid tumors
Inflammatory/
autoimmune
4
Barzolvolimab: KIT Antagonist
mAb for Mast Cell Driven Diseases
Barzolvolimab: Clinically Validated with Compelling Profile
6
Barzolvolimab: Multi-Billion Dollar Market Opportunity
Large |
Very high |
Limited |
Established |
Significant |
addressable |
disease |
current |
||
commercial |
market |
|||
patient |
burden on |
treatment |
||
footprint |
opportunity |
|||
populations |
patients |
options |
||
CSU |
CIndU |
PN |
EoE |
|
Addressable patient |
All antihistamine |
All antihistamine |
||
refractory and biologic |
Refractory to topical |
|||
refractory and biologic |
Refractory to 1L treatment |
|||
population |
experienced patients |
therapy |
||
experienced patients |
||||
Est # patients |
375,000 US, |
71,000 US |
80,000 US |
75,000 US |
750,000 w EU |
~140,000 w EU |
|||
Est Global Peak Sales |
$2.7 billion |
$694 million |
$752 million |
$769 million |
7 |
CONFIDENTIAL |
Chronic Urticaria Overview
Proof of Concept Established
in a Mast Cell Driven Disease
Skin Mast Cells are the Primary Effector Cell in Urticaria
Significant medical need with limited or no treatment options
Patients suffer both physically and psychologically with impaired quality of life
"…severely disturbing disease to have, devastating, long-lasting and basically impacts on every aspect of life; sleep, interpersonal relationships, performance at work and school, hobbies, traveling, sports, all of these patients have stories to tell where their disease dominated their life…" - Marcus Maurer, MD
9
Marcus Maurer, MD, Professor of Dermatology and Allergy, Charité - Universitätsmedizin, Berlin: Commentary from 7/12/21 data update call Image Sources: https://dermnetnz.org/topics/dermographism,
https://www.bbc.co.uk/bbcthree/article/d7ae42f3-b3ae-47ae-9464-eb8c328fe3dc
Barzolvolimab Phase 2 CSU Study 12 Week Results
Attachments
Disclaimer
Celldex Therapeutics Inc. published this content on 17 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 April 2024 12:56:21 UTC.