Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the first quarter ended March 31, 2021 and provided a
corporate update.
“We are very encouraged by the recently reported positive
interim results from our ongoing Phase 1b study of CDX-0159 in
chronic inducible urticaria. These data demonstrated an 80%
complete response rate and a well-tolerated safety profile, which
we believe is a significant accomplishment in this complex disease
setting with limited treatment options,” said Anthony Marucci,
Co-founder, President and Chief Executive Officer of Celldex
Therapeutics. “Based on these exciting results, we recently amended
the protocol to add a third cohort in cholinergic urticaria, a
debilitating disease affecting mainly young adults, where passive
or active sweating induces hives and can severely impair their
quality of life. We are nearing completion of patient dosing across
both the cold induced and symptomatic dermographism cohorts from
this study and look forward to presenting updated results from
these cohorts this summer.”
Mr. Marucci continued, “We are also making progress advancing
our bispecific platform, presenting promising preclinical data at
AACR that supports the development of clinical bispecific
candidates that co-target ILT4 and PD-(L)1. We look forward to
continuing these efforts while also exploring important targets
controlling inflammation and auto-immune pathways.”
Recent Pipeline Highlights
CDX-0159 - KIT Inhibitor
Program
CDX-0159 is a humanized monoclonal antibody developed by Celldex
that binds the KIT receptor with high specificity and potently
inhibits its activity. The KIT receptor tyrosine kinase is
expressed in a variety of cells, including mast cells, which
mediate inflammatory responses such as hypersensitivity and
allergic reactions. KIT signaling controls the differentiation,
tissue recruitment, survival and activity of mast cells.
- Celldex initiated a Phase 1b open label study designed to
evaluate the safety of a single dose (3.0 mg/kg) of CDX-0159
administered intravenously in December of 2020. Up to 20 patients
with cold contact urticaria (ColdU; n=10) or symptomatic
dermographism (SD; n=10) who are refractory to antihistamines are
being enrolled. Patients' symptoms are induced via provocation
testing that resembles real life triggering situations. Secondary
and exploratory objectives include pharmacokinetic and
pharmacodynamic assessments, including changes from baseline
provocation thresholds, measurement of tryptase and stem cell
factor levels, clinical activity outcomes (impact on urticaria
symptoms, disease control, clinical response), quality of life
assessments and measurement of tissue mast cells through skin
biopsies. The study is being conducted by Dr. Marcus Maurer,
Professor of Dermatology and Allergy at Charité -
Universitätsmedizin in Berlin. Interim data from this study
were reported in late March. Fifteen out of 20 planned patients
with antihistamine refractory CIndU had received a single
intravenous infusion of CDX-0159 at 3 mg/kg, including nine
patients with ColdU and six patients with SD. Safety results were
reported for all 15 patients; activity results were reported for
all patients assessed for at least 15 days/2 weeks after treatment
(n=10; 7 ColdU and 3 SD). Patients had high disease activity as
assessed by provocation threshold testing.
- Eight of 10 patients, including all patients with ColdU, (7
ColdU; 1 SD) experienced a complete response (CR) as assessed by
provocation threshold testing. One patient experienced a partial
response (PR). All patients will continue to be assessed for
response through week 12. CDX-0159 was generally well
tolerated.
- Enrollment is nearing completion in the ColdU and SD cohorts.
Based on these compelling results, the study has been expanded to
also include 10 patients with cholinergic urticaria and patient
screening is expected to begin this month.
- Updated results from additional patients with cold induced
urticaria and symptomatic dermographism and long term follow up
that continues to characterize magnitude and duration of treatment
effect and their link to changes in tryptase levels are expected
this summer.
- Celldex initiated dosing in a Phase 1b multi-center study of
CDX-0159 in chronic spontaneous urticaria (CSU) in October. This
study is a randomized, double-blind, placebo-controlled clinical
trial designed to assess the safety of multiple ascending doses of
CDX-0159 in up to 40 patients with CSU who remain symptomatic
despite treatment with antihistamines. Secondary and exploratory
objectives include pharmacokinetic and pharmacodynamic assessments,
including measurement of tryptase and stem cell factor levels and
clinical activity outcomes (impact on urticaria symptoms, disease
control, clinical response) as well as quality of life assessments.
Results from the study are expected by the end of 2021.
- CDX-0159 development is being expanded into prurigo nodularis
(PN), a chronic skin disease characterized by the development of
hard, intensely itchy (pruritic) nodules on the skin. Initiation of
this study is planned for the fourth quarter of 2021.
- Manufacturing activities are also progressing as planned to
support the introduction of the CDX-0159 subcutaneous formulation
into the clinical program in the third quarter of 2021.
CDX-1140 - CD40 Agonist Program
CDX-1140 is a potent CD40 human agonist antibody developed by
Celldex that the Company believes has the potential to successfully
balance systemic doses for good tissue and tumor penetration with
an acceptable safety profile.
- In the Phase 1 study of CDX-1140 in patients with recurrent,
locally advanced or metastatic solid tumors and B cell lymphomas,
both the monotherapy and combination with CDX-301 portions of the
trial are complete. Expansion cohorts are actively recruiting
including:
- CDX-1140 with KEYTRUDA® (pembrolizumab) in patients with
squamous cell head and neck cancer and non small cell lung cancer
who have progressed on checkpoint therapy; and,
- CDX-1140 with standard of care chemotherapy in first line
metastatic pancreatic cancer.
Updated data from this program are expected to be presented later
this year.
CDX-527 - Bispecific Antibody Program
CDX-527 is the first candidate developed by Celldex from its
bispecific platform which utilizes the Company’s proprietary highly
active anti-PD-L1 and CD27 human antibodies to couple CD27
co-stimulation with blockade of the PD-L1/PD-1 pathway.
- In August 2020, Celldex initiated a Phase 1 dose-escalation
study in up to ~40 patients with advanced or metastatic solid
tumors that have progressed during or after standard of care
therapy to be followed by tumor-specific expansion cohorts. The
study is designed to determine the MTD during a dose-escalation
phase and to recommend a dose level for further study in the
subsequent expansion phase. The expansion is designed to further
evaluate the tolerability, and biologic and anti-tumor effects of
selected dose level(s) of CDX-527 in specific tumor types. Initial
data from the Phase 1 study focused on pharmacokinetic and
pharmacodynamic properties have been accepted for presentation at
the 2021 American Society of Clinical Oncology (ASCO) Annual
Meeting to be held June 4th-8th.
Preclinical Programs
- In April 2021, Celldex presented promising data from the
Company’s growing bispecific platform at the American Association
of Cancer Research (AACR) Annual Meeting. The Company described the
discovery and characterization of ILT4 inhibitory monoclonal
antibodies (mAbs) for engineering bispecific antibodies (bsAbs)
that revert myeloid cell suppression by antagonizing ILT4 and
activate T-cell responses through PD-(L)1 inhibition. Based on the
results, Celldex is developing clinical bispecific candidates that
co-target ILT4 and PD-(L)1. Celldex is also exploring important
targets controlling inflammation and auto-immune pathways.
- In direct support of our bispecific platform, Celldex has
entered into a research and collaboration agreement with Biosion,
Inc., a global biotechnology company focused on the discovery and
clinical development of innovative biologicals for unmet medical
needs, to construct and develop bispecific antibodies that combine
undisclosed components from both Celldex and Biosion
discoveries.
While Celldex’s clinical development programs have not been
significantly, negatively impacted by COVID-19 to date, the Company
continues to carefully monitor the evolving situation closely
across all development programs and work to minimize potential
impact/disruptions.
First Quarter 2021 Financial Highlights and 2021
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2021 were $176.1 million
compared to $194.4 million as of December 31, 2020. The decrease
was primarily driven by first quarter cash used in operating
activities of $18.1 million. At March 31, 2021, Celldex had 39.6
million shares outstanding.
Revenues: Total revenue was $0.7 million in the
first quarter of 2021 compared to $2.7 million for the comparable
period in 2020. The decrease in revenue was primarily due to the
$1.8 million milestone payment received from Rockefeller University
in the first quarter of 2020 related to Celldex’s manufacturing and
development services agreement.
R&D Expenses: Research and development
(R&D) expenses were $12.7 million in the first quarter of 2021
compared to $11.7 million for the comparable period in 2020. The
increase in R&D expenses was primarily due to an increase in
contract research and clinical trial expenses.
G&A Expenses: General and administrative
(G&A) expenses were $4.1 million in the first quarter of 2021
compared to $3.7 million for the comparable period in 2020. The
increase in G&A expenses was primarily due to higher
stock-based compensation expense.
Changes in Fair Value Remeasurement of Contingent
Consideration: During the quarter ended March 31, 2021,
the Company recorded a $0.5 million loss on fair value
remeasurement of contingent consideration primarily due to changes
in discount rates and the passage of time.
Net Loss: Net loss was $16.5 million, or
($0.42) per share, for the first quarter of 2021 compared to a net
loss of $12.6 million, or ($0.73) per share, for the comparable
period in 2020.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31, 2021
are sufficient to meet estimated working capital requirements and
fund planned operations through 2023.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ
USA.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company dedicated to developing
monoclonal and bispecific antibodies that address devastating
diseases for which available treatments are inadequate. Our
pipeline includes antibody-based therapeutics which have the
ability to engage the human immune system and/or directly affect
critical pathways to improve the lives of patients with
inflammatory diseases and many forms of cancer. Visit
www.celldex.com.
Forward Looking Statement This release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may,"
"should," or similar expressions. These forward-looking statements
reflect management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct or that those goals will be
achieved, and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
successfully complete research and further development and
commercialization of Company drug candidates; the effects of the
outbreak of COVID-19 on our business and results of operations; the
uncertainties inherent in clinical testing and accruing patients
for clinical trials; our limited experience in bringing programs
through Phase 3 clinical trials; our ability to manage and
successfully complete multiple clinical trials and the research and
development efforts for our multiple products at varying stages of
development; the availability, cost, delivery and quality of
clinical materials produced by our own manufacturing facility or
supplied by contract manufacturers, who may be our sole source of
supply; the timing, cost and uncertainty of obtaining regulatory
approvals; the failure of the market for the Company's programs to
continue to develop; our ability to protect the Company's
intellectual property; the loss of any executive officers or key
personnel or consultants; competition; changes in the regulatory
landscape or the imposition of regulations that affect the
Company's products; our ability to continue to obtain capital to
meet our long-term liquidity needs on acceptable terms, or at all,
including the additional capital which will be necessary to
complete the clinical trials that we have initiated or plan to
initiate; and other factors listed under "Risk Factors" in our
annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillSenior Director, Investor Relations & Corporate
Communications(484) 788-8560ptill@celldex.com
CELLDEX THERAPEUTICS, INC. |
(In thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements |
|
Three Months |
of Operations Data |
|
Ended March 31, |
|
|
|
2021 |
|
2020 |
|
|
|
(Unaudited) |
Revenues: |
|
|
|
|
Product development and |
|
|
|
|
|
licensing agreements |
|
$ |
3 |
|
|
$ |
2,286 |
|
Contracts and grants |
|
|
682 |
|
|
|
442 |
|
|
|
|
|
|
|
Total revenues |
|
|
685 |
|
|
|
2,728 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
12,720 |
|
|
|
11,695 |
|
General and administrative |
|
|
4,121 |
|
|
|
3,666 |
|
Loss on fair value remeasurement |
|
|
|
|
|
of contingent consideration |
|
|
483 |
|
|
|
234 |
|
|
|
|
|
|
|
Total operating expenses |
|
|
17,324 |
|
|
|
15,595 |
|
|
|
|
|
|
|
Operating loss |
|
|
(16,639 |
) |
|
|
(12,867 |
) |
|
|
|
|
|
|
Investment and other income, net |
|
|
101 |
|
|
|
242 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,538 |
) |
|
$ |
(12,625 |
) |
|
|
|
|
|
|
Basic and diluted net loss per |
|
|
|
|
|
common share |
|
$ |
(0.42 |
) |
|
$ |
(0.73 |
) |
Shares used in calculating basic |
|
|
|
|
|
and diluted net loss per share |
|
|
39,614 |
|
|
|
17,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated |
|
|
|
|
Balance Sheet Data |
|
March 31, |
|
December 31, |
|
|
|
2021 |
|
2020 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
176,083 |
|
|
$ |
194,422 |
|
Other current assets |
|
|
5,416 |
|
|
|
3,421 |
|
Property and equipment, net |
|
|
3,747 |
|
|
|
3,815 |
|
Intangible and other assets, net |
|
|
33,819 |
|
|
|
34,180 |
|
|
Total assets |
|
$ |
219,065 |
|
|
$ |
235,838 |
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities |
|
$ |
16,977 |
|
|
$ |
14,206 |
|
Long-term liabilities |
|
|
7,922 |
|
|
|
12,275 |
|
Stockholders' equity |
|
|
194,166 |
|
|
|
209,357 |
|
|
Total liabilities and stockholders' equity |
|
$ |
219,065 |
|
|
$ |
235,838 |
|
|
|
|
|
|
|
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