Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the fourth quarter and year ended December 31, 2023 and
provided a corporate update.
"In 2023, Celldex made transformational progress across the
barzolvolimab development program, reporting multiple positive data
sets across mast cell mediated diseases where patients desperately
need better treatment options,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “We
carried this momentum into 2024, presenting positive 12 week data
from our ongoing Phase 2 CSU study that directly support the
planned initiation of registrational studies in CSU this summer, a
major milestone for barzolvolimab and Celldex.”
“This year we will continue to build on our leadership position
in mast cell biology—reporting data from multiple barzolvolimab
studies, expanding barzolvolimab into additional mast cell mediated
diseases and introducing our first bispecific for inflammatory
diseases. We look forward to an exciting 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.
- Celldex is conducting 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 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.
- Celldex is currently planning two Phase 3 studies of
barzolvolimab in CSU, which are expected to initiate this
summer.
- In November 2023, Celldex reported positive topline data from
the Phase 2 CSU study and in February 2024, 12 week treatment
results were reported at the American Academy of Allergy, Asthma
& Immunology (AAAAI) Annual Meeting in a late breaking oral
presentation. Barzolvolimab achieved the primary efficacy endpoint
of the study, with a statistically significant mean change from
baseline to week 12 of UAS7 (weekly urticaria activity score)
compared to placebo across multiple dosing groups and was well
tolerated. Secondary and exploratory endpoints in the study,
including ISS7 (weekly itch severity score) and HSS7 (weekly hives
severity score) and responder analyses strongly support the primary
endpoint results. Importantly, barzolvolimab demonstrated rapid,
durable and clinically meaningful responses in patients with
moderate to severe CSU refractory to antihistamines, including
patients with prior omalizumab treatment. Approximately 20% (n=41)
of enrolled patients received prior treatment with omalizumab and
more than half of these patients had omalizumab-refractory disease.
These patients experienced a similar clinical benefit as the
overall treated population within their individual dosing groups
consistent with the barzolvolimab mechanism of action. Patients on
study will continue to receive barzolvolimab for 52 weeks and the
Company plans to report 52 week data in the second half of
2024.
- In October 2023, data on quality of life outcomes from the
Phase 1b CSU study were presented at the European Academy of
Dermatology & Venereology (EADV) Congress. The Dermatology Life
Quality Index (DLQI) assesses patients' perceptions of the impact
of their disease across different aspects of their health-related
quality of life and includes questions on symptoms and feelings,
daily activities, leisure, work and school performance, personal
relationships and treatment. A rapid improvement in the DLQI was
noted within 4 weeks in all barzolvolimab treated patients. DLQI
improvement was sustained at doses ≥1.5mg/kg. Physician Global
Assessment (PhysGA) for the treated cohorts also improved by week 1
and was sustained through week 24.
- Enrollment to the Phase 2 CIndU study is nearing completion and
12 week primary endpoint data from this study is expected to be
reported in the second half of 2024. The study is designed to
enroll approximately 180 patients with ColdU or SD.
- Celldex is currently planning for the initiation of a Phase 2
subcutaneous study in prurigo nodularis (PN) in early 2024. This
randomized, double-blind, placebo-controlled, parallel group study
will evaluate the efficacy and safety profile of barzolvolimab in
approximately 120 patients with moderate to severe PN who had
inadequate response to prescription topical medications, or for
whom topical medications are medically inadvisable. Patients will
receive barzolvolimab injections of 150 mg Q4W after an initial
loading dose of 450 mg, 300 mg Q4W after an initial loading dose of
450 mg, or placebo during a 24‑week Treatment Phase. Data from the
Phase 1b randomized, double-blind, placebo-controlled study in
patients with prurigo nodularis were reported in an oral
presentation at the 12th World Congress on Itch (WCI) in November
2023. A single IV dose of 3.0 mg/kg barzolvolimab resulted in rapid
and durable reductions in itch and healing of skin lesions in
patients with moderate to severe PN and barzolvolimab was generally
well tolerated.
- In July 2023, the first patient was dosed in the Phase 2
randomized, double-blind, placebo-controlled study in eosinophilic
esophagitis (EoE); enrollment is ongoing. To optimize potential
efficacy signal in this difficult to treat indication, we have
recently amended the protocol to dose 300 mg every 4 weeks rather
than 8 weeks. Approximately 75 patients will be enrolled in
total.
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, the first patient was dosed in the Phase 1 study
of CDX-585. This open-label, multi-center study of CDX-585 is
evaluating patients with advanced or metastatic solid tumors that
have progressed during or after standard of care therapy.
Enrollment is ongoing in the dose-escalation portion of the
study.
Fourth Quarter and Twelve Months 2023 Financial
Highlights and 2024 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2023 were $423.6 million
compared to $235.3 million as of September 30, 2023. The increase
was primarily driven by net proceeds of $216.2 million from our
November 2023 underwritten public offering, partially offset by
cash used in operating activities of $32.5 million, which includes
the $12.5 million payment to Shareholder Representative Services
(SRS), the representative of the former stockholders of Kolltan
Pharmaceuticals, Inc., pursuant to our settlement agreement. At
December 31, 2023, Celldex had 55.9 million shares outstanding.
Revenues: Total revenue was $4.1 million in the
fourth quarter of 2023 and $6.9 million for the year ended December
31, 2023, compared to $1.6 million and $2.4 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 $30.4 million in the fourth quarter of 2023
and $118.0 million for the year ended December 31, 2023, compared
to $22.9 million and $82.3 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 $8.8 million in the fourth quarter of 2023
and $30.9 million for the year ended December 31, 2023, compared to
$6.6 million and $27.2 million for the comparable periods in 2022.
The increase in G&A expenses was primarily due to higher
stock-based compensation, recruiting and barzolvolimab commercial
planning expenses, partially offset by a decrease in legal
expenses.
Changes in Fair Value Remeasurement of Contingent
Consideration: The Company recorded a $6.9 million gain on
fair value remeasurement of contingent consideration for the year
ended December 31, 2022, primarily due to the Company’s decision to
deprioritize the CDX-1140 program in the second quarter of
2022.
Litigation Settlement Related Loss: The Company
recorded a loss of $15.0 million in the second quarter of 2022
related to the $15.0 million initial payment made to SRS pursuant
to our settlement agreement. During the fourth quarter of 2023, the
Company announced positive topline results from our Phase 2
clinical trial of barzolvolimab in patients with moderate to severe
CSU, satisfying the “Successful Completion” of a Phase 2 clinical
trial of barzolvolimab milestone, thus triggering the payment of
the $12.5 million milestone pursuant to the settlement
agreement.
Net Loss: Net loss was $43.3 million, or
($0.83) per share, for the fourth quarter of 2023, and $141.4
million, or ($2.92) per share, for the year ended December 31,
2023, compared to a net loss of $26.5 million, or ($0.56) per
share, for the fourth quarter of 2022 and $112.3 million, or
($2.40) per share, for the year ended December 31, 2022. The
litigation settlement related loss had a ($0.26) impact on net loss
per share for the twelve months ended December 31, 2023.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at December 31,
2023 are sufficient to meet estimated working capital requirements
and fund current planned operations into 2026.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company leading the science at the
intersection of mast cell biology and the development of
transformative therapeutics for patients. 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 severe inflammatory, allergic,
autoimmune and other devastating diseases. 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) |
|
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Three
Months |
|
Year |
Consolidated Statements of Operations Data |
Ended December 31, |
|
Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
(Unaudited) |
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Product development and licensing agreements |
$ |
259 |
|
|
$ |
26 |
|
|
$ |
278 |
|
|
$ |
56 |
|
Contracts and grants |
|
3,873 |
|
|
|
1,587 |
|
|
|
6,605 |
|
|
|
2,301 |
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
4,132 |
|
|
|
1,613 |
|
|
|
6,883 |
|
|
|
2,357 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
30,427 |
|
|
|
22,900 |
|
|
|
118,011 |
|
|
|
82,258 |
|
General and administrative |
|
8,832 |
|
|
|
6,598 |
|
|
|
30,914 |
|
|
|
27,195 |
|
Gain on fair value remeasurement of contingent consideration |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6,862 |
) |
Litigation settlement related loss |
|
12,500 |
|
|
|
- |
|
|
|
12,500 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
51,759 |
|
|
|
29,498 |
|
|
|
161,425 |
|
|
|
117,591 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(47,627 |
) |
|
|
(27,885 |
) |
|
|
(154,542 |
) |
|
|
(115,234 |
) |
|
|
|
|
|
|
|
|
|
Investment and other income, net |
|
4,321 |
|
|
|
1,398 |
|
|
|
13,113 |
|
|
|
2,909 |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(43,306 |
) |
|
$ |
(26,487 |
) |
|
$ |
(141,429 |
) |
|
$ |
(112,325 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(0.83 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.92 |
) |
|
$ |
(2.40 |
) |
|
|
|
|
|
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
52,028 |
|
|
|
47,132 |
|
|
|
48,449 |
|
|
|
46,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
423,598 |
|
|
$ |
304,952 |
|
Other current assets |
|
|
|
|
|
8,095 |
|
|
|
12,741 |
|
Property and equipment, net |
|
|
|
|
|
4,060 |
|
|
|
3,747 |
|
Intangible and other assets, net |
|
|
|
|
|
29,874 |
|
|
|
31,295 |
|
|
Total
assets |
|
|
|
|
$ |
465,627 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
$ |
31,125 |
|
|
$ |
18,610 |
|
Long-term liabilities |
|
|
|
|
|
5,331 |
|
|
|
7,921 |
|
Stockholders' equity |
|
|
|
|
|
429,171 |
|
|
|
326,204 |
|
|
Total
liabilities and stockholders' equity |
|
|
|
|
$ |
465,627 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
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Celldex Therapeutics (NASDAQ:CLDX)
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