Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the second quarter ended June 30, 2023 and provided a
corporate update.
“Last month, we announced that enrollment in our Phase 2 chronic
spontaneous urticaria trial was completed well ahead of schedule,
exceeding projections by nearly 25%, driven by strong interest in
barzolvolimab,” said Anthony Marucci, Co-founder, President and
Chief Executive Officer of Celldex Therapeutics. “Enrollment also
continues to progress as planned in our Phase 2 study in chronic
inducible urticaria. We are extremely pleased with the progress we
have made across both of these studies and look forward to
presenting topline data from the CSU study by the end of the
year.”
“The rest of our pipeline also continues to advance and we were
excited to recently initiate a Phase 2 study in eosinophilic
esophagitis and are planning for the initiation of a Phase 2 study
in prurigo nodularis in early 2024. In June, barzolvolimab was
highlighted in multiple presentations at EAACI that continue to
position the program as a potential best-in-class addition to a
historically limited treatment landscape for patients and their
physicians. We look forward to building on this momentum in the
second half of the year,” concluded Marucci.
Recent Program Highlights
Barzolvolimab - KIT Inhibitor
Program
Barzolvolimab 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.
- In June and July 2022, Celldex announced that the first
patients had been dosed in the Phase 2 clinical studies of
barzolvolimab for the treatment of Chronic Spontaneous Urticaria
(CSU) and the two most common forms of chronic inducible urticaria
(CIndU) - cold urticaria (ColdU) and symptomatic dermographism
(SD). These randomized, double-blind, placebo-controlled, parallel
group Phase 2 studies are evaluating the efficacy and safety
profile of multiple dose regimens of barzolvolimab in patients who
remain symptomatic despite antihistamine therapy, to determine the
optimal dosing strategies. In July 2023, Celldex announced that
enrollment to the CSU study had been completed. Given strong
interest in barzolvolimab, enrollment projections were exceeded by
~25% and 208 patients were enrolled in the study. Topline data is
anticipated by the end of 2023.
- Updated data from the Phase 1b multiple dose study in patients
with antihistamine refractory CSU and new data from the Phase 1b
single-dose cholinergic cohort included in the CIndU trial were
presented at the European Academy of Allergy and Clinical
Immunology (EAACI) Annual Congress on June 10, 2023 by Dr. Marcus
Maurer, Professor of Dermatology and Allergy at Charité –
Universitätsmedizin in Berlin (CSU data) and Dr. Eva Grekowitz,
Clinical Investigator, Department of Dermatology, Venerology and
Allergy at Charité – Universitätsmedizin in Berlin (cholinergic
data).
CSU EAACI 2023 Data
Summary:
At EAACI 2023, data were presented on
the complete 24 week experience for all patients. 45 patients with
moderate to severe CSU refractory to antihistamines were enrolled
and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg;
n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo]. Treatment data
for the 0.5 mg/kg and placebo group are not included below because
as expected, most patients from these groups had significant
symptoms ahead of week 24 and discontinued follow up.
-
- Multiple doses of barzolvolimab resulted in rapid
dose-dependent decreases in itch and hives with durable and
prolonged symptom control in patients with moderate to severe CSU
refractory to antihistamines, including patients with prior
omalizumab treatment.
- Mean reduction from baseline in urticaria activity (UAS7) at
week 24 was 80% in the 1.5 mg/kg dose group (n=7), 70% in the 3.0
mg/kg dose group (n=6) and 77% in the 4.5 mg/kg dose group
(n=7).
- Complete response (UAS7=0) at week 24 was 57% in the 1.5 mg/kg
dose group, 67% in the 3.0 mg/kg dose group and 43% in the 4.5
mg/kg dose group. Well-controlled disease (UCT≥ 12) at week 24 was
75% in the 1.5 mg/kg dose group, 67% in the 3.0 mg/kg dose group
and 67% in the 4.5 mg/kg dose group. During post-treatment follow
up, 71% (10 of 14) of patients who had been treated with doses
greater than or equal to 1.5 mg/kg and had a complete response
(UAS7=0) at week 12, remained urticaria free at week 24.
- Profound and durable improvement in angioedema symptoms as
measured through the angioedema activity score over 7 days (AAS7)
was achieved across all dose levels evaluated with sustained
activity observed with the 1.5 mg/kg and greater dose levels. 31
patients on study (n=26 barzolvolimab; 5=placebo) reported
angioedema activity at baseline when enrolling in the study. 86% of
the barzolvolimab treated patients at 1.5 mg/kg or greater were
angioedema free at week 12 and 83% were angioedema free at week
24.
- Barzolvolimab was well tolerated with a favorable safety
profile; effects of multiple dose administration were consistent
with observations in single dose studies.
Cholinergic (CholU) EAACI
2023 Data Summary:
At EAACI 2023, 12 week treatment and
safety data were presented from the cohort of patients with
antihistamine refractory cholinergic urticaria (n=9) included in
the open-label, Phase 1 trial of chronic inducible urticaria.
Patients received a single intravenous 3.0 mg/kg barzolvolimab dose
with a 12-week follow-up.
-
- 56% (5/9) patients achieved a complete response (negative test)
with PCE (pulse-controlled ergometry) provocation testing with just
one dose of barzolvolimab and most responses remained durable
through to week 12. PCE testing included controlled exercise on a
stationary bicycle with monitoring for development of itch and
wheals.
- 63% (5/8) patients reported well controlled disease (UCT ≥12)
at week 8 and 50% (4/8) at week 12, respectively. 100% (6/6)
patients who reported on quality of life (QoL) measurements at week
8 had clinically significant improvements in QoL. These
improvements in QoL were sustained through week 12 for the majority
(5/7, 71%) of patients.
- The kinetics of tryptase and mast cell reduction mirrored
clinical activity.
- Barzolvolimab was generally well tolerated in patients with
CholU, with a similar safety profile to what was reported
previously in the cold contact and symptomatic dermographism
cohorts in this study.
- Celldex closed enrollment at 24 patients in the barzolvolimab
Phase 1b multi-center, randomized, double-blind, placebo-controlled
study in patients with prurigo nodularis (PN), a chronic skin
disease characterized by the development of hard, intensely itchy
(pruritic) nodules on the skin. The Company plans to present data
from the study, including 24 weeks of follow-up, in the fourth
quarter at a medical meeting and is planning for the initiation of
a Phase 2 subcutaneous study in PN in early 2024.
- In June, Celldex initiated a Phase 2 study of eosinophilic
esophagitis (EoE) and the first patient was dosed in July. EoE, the
most common type of eosinophilic gastrointestinal disease, is a
chronic inflammatory disease of the esophagus characterized by the
infiltration of eosinophils. The randomized, double-blind,
placebo-controlled, parallel group Phase 2 study is evaluating the
efficacy and safety profile of subcutaneous barzolvolimab in
patients with active EoE. Approximately 60 patients will be
enrolled. The primary endpoint of the study is reducing esophageal
intraepithelial infiltration of mast cells as assessed by peak
esophageal intraepithelial mast cell count. Secondary endpoints
include the reduction of symptoms of dysphagia and esophageal
intraepithelial infiltration of eosinophils and safety. When all
clinical trial sites are open, the study will include approximately
60 clinical trial centers across 8 countries, including the United
States.
Bispecific Antibody Platform
CDX-585 – Bispecific ILT4 &
PD-1
CDX-585 combines highly active PD-1 blockade with anti-ILT4
blockade to overcome immunosuppressive signals in T cells and
myeloid cells. ILT4 is emerging as an important immune checkpoint
on myeloid cells.
- In May 2023, Celldex announced that the first patient had been
dosed in the Phase 1 study of CDX-585. This open-label,
multi-center, intravenous study of CDX-585 is being evaluated in
patients with advanced or metastatic solid tumors that have
progressed during or after standard of care therapy. The
dose-escalation phase of the study (n=~30 patients) is designed to
determine a maximum tolerated dose (MTD) and to select CDX-585
dose(s) for future evaluation in tumor specific expansion
cohorts.
Second Quarter 2023 Financial Highlights and 2023
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2023 were $252.7 million
compared to $278.4 million as of March 31, 2023. The decrease was
primarily driven by second quarter cash used in operating
activities of $27.2 million, partially offset by net sales and
maturities of marketable securities of $1.6 million for the three
months ended June 30, 2023. At June 30, 2023, Celldex had 47.3
million shares outstanding.
Revenues: Total revenue was $0.3 million in the
second quarter of 2023 and $1.2 million for the six months ended
June 30, 2023, compared to $0.2 million and $0.3 million for the
comparable periods in 2022. The increase in revenue was primarily
due to an increase in services performed under our manufacturing
and research and development agreements with Rockefeller
University.
R&D Expenses: Research and development
(R&D) expenses were $26.3 million in the second quarter of 2023
and $53.0 million for the six months ended June 30, 2023, compared
to $20.7 million and $37.8 million for the comparable periods in
2022. The increase in R&D expenses was primarily due to an
increase in barzolvolimab clinical trial, barzolvolimab contract
manufacturing and personnel expenses.
G&A Expenses: General and administrative
(G&A) expenses were $7.2 million in the second quarter of 2023
and $13.9 million for the six months ended June 30, 2023, compared
to $7.2 million and $14.1 million for the comparable periods in
2022. The decrease in G&A expenses for the six months ended
June 30, 2023, as compared to the six months ended June 30, 2022,
was primarily due to a decrease in legal expenses, partially offset
by an increase in stock-based compensation expense.
Changes in Fair Value Remeasurement of Contingent
Consideration: The gain on fair value remeasurement of
contingent consideration was $6.3 million for the second quarter of
2022 and $6.9 million for the six months ended June 30, 2022,
primarily due to the Company’s decision to deprioritize the
CDX-1140 program in the second quarter of 2022.
Net Loss: Net loss was $30.5 million, or
($0.65) per share, for the second quarter of 2023, and $59.9
million, or ($1.27) per share, for the six months ended June 30,
2023, compared to a net loss of $36.0 million, or ($0.77) per
share, for the second quarter of 2022, and $59.1 million, or
($1.26) per share, for the six months ended June 30, 2022.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 2023
are sufficient to meet estimated working capital requirements and
fund planned operations through 2025, which include our ongoing and
planned Phase 2 studies in CSU, CIndU, EoE and PN.
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 StatementThis 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, including
barzolvolimab (also referred to as CDX-0159), in current or future
indications; 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 effects of the outbreak of
COVID-19 on our business and results of operations; 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 TillMeru Advisors(484)
788-8560ptill@meruadvisors.com
CELLDEX
THERAPEUTICS, INC. |
|
(In
thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months |
|
Six
Months |
|
Consolidated Statements of Operations Data |
|
Ended June 30, |
|
Ended June 30, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product development and licensing agreements |
|
$ |
16 |
|
|
$ |
- |
|
|
$ |
16 |
|
|
$ |
30 |
|
|
Contracts and grants |
|
|
252 |
|
|
|
163 |
|
|
|
1,218 |
|
|
|
307 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
268 |
|
|
|
163 |
|
|
|
1,234 |
|
|
|
337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
26,252 |
|
|
|
20,731 |
|
|
|
53,049 |
|
|
|
37,786 |
|
|
General and administrative |
|
|
7,221 |
|
|
|
7,154 |
|
|
|
13,861 |
|
|
|
14,066 |
|
|
Gain on fair value remeasurement of contingent consideration |
|
|
- |
|
|
|
(6,326 |
) |
|
|
- |
|
|
|
(6,862 |
) |
|
Litigation settlement loss |
|
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
33,473 |
|
|
|
36,559 |
|
|
|
66,910 |
|
|
|
59,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(33,205 |
) |
|
|
(36,396 |
) |
|
|
(65,676 |
) |
|
|
(59,653 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Investment and other income, net |
|
|
2,703 |
|
|
|
392 |
|
|
|
5,813 |
|
|
|
599 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,502 |
) |
|
$ |
(36,004 |
) |
|
$ |
(59,863 |
) |
|
$ |
(59,054 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.65 |
) |
|
$ |
(0.77 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
|
47,253 |
|
|
|
46,759 |
|
|
|
47,233 |
|
|
|
46,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
252,697 |
|
|
$ |
304,952 |
|
|
|
|
|
|
Other current assets |
|
|
12,123 |
|
|
|
12,741 |
|
|
|
|
|
|
Property and equipment, net |
|
|
3,938 |
|
|
|
3,747 |
|
|
|
|
|
|
Intangible and other assets, net |
|
|
30,553 |
|
|
|
31,295 |
|
|
|
|
|
|
|
Total
assets |
|
$ |
299,311 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
15,646 |
|
|
$ |
18,610 |
|
|
|
|
|
|
Long-term liabilities |
|
|
6,128 |
|
|
|
7,921 |
|
|
|
|
|
|
Stockholders' equity |
|
|
277,537 |
|
|
|
326,204 |
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
299,311 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celldex Therapeutics (NASDAQ:CLDX)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Celldex Therapeutics (NASDAQ:CLDX)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024