Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the first quarter ended March 31, 2023 and provided a
corporate update.
“This quarter, we were excited to report additional positive
data from our barzolvolimab Phase 1b multi-dose study in chronic
spontaneous urticaria. We believe the rapid, durable and profound
responses and the favorable safety profile observed in this study
continue to position barzolvolimab as a potential best-in-class
addition to a historically limited treatment landscape for patients
and their physicians,” said Anthony Marucci, Co-founder, President
and Chief Executive Officer of Celldex Therapeutics. “We look
forward to presenting additional data from this study and also from
the cholinergic cohort in the Phase 1b CIndU study at EAACI next
month, where both data sets have been accepted for oral
presentations.”
“Importantly, our Phase 2 studies in chronic urticaria continue
to progress as planned and we are on track to complete enrollment
of the Phase 2 CSU study by the end of the third quarter, with
topline data expected late this year or in the first quarter of
2024. We continue to expand the barzolvolimab program into
indications where we believe its unique mechanism could potentially
provide new therapeutic options to patients suffering from these
difficult diseases and look forward to providing updates on our
eosinophilic esophagitis and prurigo nodularis studies throughout
the year.”
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. Based on current enrollment projections,
Celldex anticipates that enrollment to the CSU study will be
completed by the end of Q3 2023 and plans to report topline data
either late this year or in the first quarter of 2024.
- Data from the Phase 1b multiple dose study in patients with
antihistamine refractory CSU were presented at the American Academy
of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on
Sunday, February 26, 2023 by Dr. Marcus Maurer, Professor of
Dermatology and Allergy at Charité – Universitätsmedizin in Berlin
and a lead investigator on the study. Updated data from this study
have been accepted for oral presentation at the EAACI Hybrid
Congress 2023, to be held in Hamburg, Germany, June 9 - 11 and on
the EAACI Digital Events Platform.AAAAI 2023 Data Summary:As of the
data cut-off date on November 29, 2022, enrollment was complete
with 45 patients with moderate to severe CSU refractory to
antihistamines 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]. The 0.5 mg/kg, 1.5 mg/kg and 3.0 mg/kg cohorts had
completed study participation through 24 weeks; 6 of 9 patients in
the 4.5 mg/kg cohort had completed through the week 20 visit.
Complete data were included for all patients in dose levels through
3.0 mg/kg through 24 weeks. All available data for the 4.5 mg/kg
and placebo dose levels were presented for adverse events. Activity
data for the 4.5 mg/kg dose level were reported through week 20.
Activity data for the 0.5 mg/kg and placebo group were only
included through week 12 because, as expected, most patients from
these groups had significant symptoms ahead of week 24 and
discontinued follow up. Two patients did not receive all doses of
study treatment [4.5 mg/kg (1), placebo (1)].
- Barzolvolimab resulted in rapid, marked and durable responses
in patients with moderate to severe CSU refractory to
antihistamines, including patients with prior omalizumab treatment.
The 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups showed similar
markedly improved urticaria symptoms and disease control with
sustained durability up to 24 weeks.
- Mean reduction from baseline in urticaria activity (UAS7) at
week 12 of 67% in the 1.5 mg/kg dose group (n=8), 67% in the 3.0
mg/kg dose group (n=9) and 82% in the 4.5 mg/kg dose group (n=9).
Complete response (UAS7=0) at week 12 of 57% in the 1.5 mg/kg dose
group, 44% in the 3.0 mg/kg dose group and 67% in the 4.5 mg/kg
dose group.
- Well-controlled disease (UCT≥ 12) at week 12 of 75% in the 1.5
mg/kg dose group, 63% in the 3.0 mg/kg dose group and 89% in the
4.5 mg/kg dose group.
- Patients with prior omalizumab therapy had similar symptom
improvement as all patients.
- Barzolvolimab was well tolerated with a favorable safety
profile; effects of multiple dose administration were consistent
with observations in single dose studies. Most AEs were mild or
moderate in severity and resolved while on study.
- Celldex has completed enrollment in the barzolvolimab Phase 1b
open label study in chronic inducible urticaria. Data from the
cholinergic cohort in this study have been accepted for oral
presentation at the EAACI Hybrid Congress 2023, to be held in
Hamburg, Germany, June 9 - 11 and on the EAACI Digital Events
Platform.
- Celldex has 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 study remains
blinded. Celldex plans to present data from the ongoing 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 late 2023 or early 2024.
- Celldex plans to initiate a Phase 2 international trial of
barzolvolimab in eosinophilic esophagitis (EoE), the most common
type of eosinophilic gastrointestinal disease, in June of
2023.
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.
- CDX-585 has successfully completed GMP manufacturing and
IND-enabling studies to support clinical development. CDX-585 will
initially be developed for the treatment of solid tumors either as
monotherapy or in combination with other oncologic treatments and
is expected to enter the clinic in mid-2023 in patients with
advanced malignancies.
First Quarter 2023 Financial Highlights and 2023
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2023 were $278.4 compared to
$305.0 million as of December 31, 2022. The decrease was primarily
driven by cash used in operating activities of $28.6 million,
partially offset by proceeds from stock issuances under employee
benefit plans and unrealized gains due to higher interest rates. At
March 31, 2023, Celldex had 47.2 million shares outstanding.
Revenues: Total revenue was $1.0 million in the
first quarter of 2023, compared to $0.2 million for the comparable
period in 2022. The increase in revenue was primarily due to an
increase in services performed under our manufacturing and research
and development agreement with Rockefeller University.
R&D Expenses: Research and development
(R&D) expenses were $26.8 million in the first quarter of 2023,
compared to $17.1 million for the comparable period 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 $6.6 million in the first quarter of 2023,
compared to $6.9 million for the comparable period in 2022. The
decrease in G&A expenses 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 Company recorded a $0.5 million gain on
fair value remeasurement of contingent consideration for the three
months ended March 31, 2022, primarily due to changes in discount
rates.
Net Loss: Net loss was $29.4 million, or
($0.62) per share, for the first quarter of 2023, compared to a net
loss of $23.1 million, or ($0.49) per share, for the comparable
period in 2022.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31, 2023
are sufficient to meet estimated working capital requirements and
fund planned operations through 2025, which include our ongoing
Phase 1b studies in urticaria and prurigo nodularis and our ongoing
and planned Phase 2 studies in CSU, CIndU and EoE.
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 |
Consolidated Statements of Operations Data |
|
Ended March 31, |
|
|
|
2023 |
|
2022 |
|
|
|
(Unaudited) |
Revenues: |
|
|
|
|
Product development and licensing agreements |
|
$ |
- |
|
|
$ |
30 |
|
Contracts and grants |
|
|
967 |
|
|
|
144 |
|
|
|
|
|
|
|
Total revenues |
|
|
967 |
|
|
|
174 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
26,798 |
|
|
|
17,056 |
|
General and administrative |
|
|
6,640 |
|
|
|
6,911 |
|
Gain on fair value remeasurement of contingent consideration |
|
|
- |
|
|
|
(536 |
) |
|
|
|
|
|
|
Total operating expenses |
|
|
33,438 |
|
|
|
23,431 |
|
|
|
|
|
|
|
Operating loss |
|
|
(32,471 |
) |
|
|
(23,257 |
) |
|
|
|
|
|
|
Investment and other income, net |
|
|
3,110 |
|
|
|
207 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(29,361 |
) |
|
$ |
(23,050 |
) |
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.62 |
) |
|
$ |
(0.49 |
) |
|
|
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
|
47,214 |
|
|
|
46,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
March 31, |
|
December 31, |
|
|
|
2023 |
|
2022 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
278,387 |
|
|
$ |
304,952 |
|
Other current assets |
|
|
11,210 |
|
|
|
12,741 |
|
Property and equipment, net |
|
|
3,995 |
|
|
|
3,747 |
|
Intangible and other assets, net |
|
|
30,927 |
|
|
|
31,295 |
|
|
Total assets |
|
$ |
324,519 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities |
|
$ |
15,219 |
|
|
$ |
18,610 |
|
Long-term liabilities |
|
|
6,560 |
|
|
|
7,921 |
|
Stockholders' equity |
|
|
302,740 |
|
|
|
326,204 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
324,519 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
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