Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the first quarter ended March 31, 2024 and provided a
corporate update.
"During the first quarter we presented impressive best-in-field
data from a large, randomized Phase 2 study in CSU,” said Anthony
Marucci, Co-founder, President and Chief Executive Officer of
Celldex Therapeutics. “These results added to a rapidly growing
body of data across multiple indications that support
barzolvolimab’s impressive potential to treat mast cell mediated
diseases. This year, we continue to expand barzolvolimab’s profile
and, based on its unique mechanism of action and demonstrated
improvement in pruritus, we are actively planning for the
initiation of a Phase 2 study in atopic dermatitis, a setting where
mast cell numbers are known to be increased and activated in the
lesions associated with the disease and where, despite established
systemic therapies, a significant unmet need still exists.”
Mr. Marucci continued, “As the year progresses, we look forward
to building on our leadership in the development of mast
cell-targeted therapeutics. Importantly, the Company is well
capitalized with more than $820M in cash to support the continued
advancement and expansion of the barzolvolimab program and the
introduction of our first bispecific for inflammatory diseases
later this 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 February 2024, 12 week treatment results were reported from
the Phase 2 CSU study 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.Data from this study on the impact of barzolvolimab on
angioedema have been accepted for an oral presentation at the
European Academy of Allergy and Clinical Immunology (EAACI)
Congress 2024 on Saturday, June 2nd from 3:00-4:30 CET in Valencia,
Spain (9:00-10:30 am ET).
- Enrollment to the Phase 2 CIndU study has been completed and 12
week primary endpoint data from this study are expected to be
reported in the second half of 2024. The study enrolled 196
patients—97 patients with cold urticaria and 99 patients with
symptomatic dermographism.
- A Phase 2 subcutaneous study in prurigo nodularis (PN) was
initiated in early 2024. This randomized, double-blind,
placebo-controlled, parallel group study is evaluating 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, including patients who received prior
biologics. Patients are receiving 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.
- 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, in early
2024, the protocol was amended to dose 300 mg every 4 weeks rather
than 8 weeks. Approximately 75 patients will be enrolled in
total.
- Atopic Dermatitis has been selected as the fifth indication for
the development of barzolvolimab. Atopic dermatitis (AD) is a
chronically relapsing, inflammatory skin disease that is typified
by pruritus (itching), eczematous lesions, dry skin, thickening of
the skin and an increase in skin markings. AD is the most common
inflammatory skin condition, with a lifetime prevalence of up to
20% and has a high itch burden—almost 90% of individuals with AD
experience daily itching and 60% describe their itching as severe
or unbearable. Barzolvolimab’s novel mast cell depleting mechanism
could play an important role in addressing patients with moderate
to severe AD who do not achieve complete disease control on
currently available systemic therapies. Mast cell numbers are
increased and activated in AD lesions and produce key TH2 cytokines
and neuropeptides that trigger disease progression and itch.
Barzolvolimab has demonstrated impressive anti-pruritic effects in
other itch driven conditions, including chronic urticarias and
prurigo nodularis. Celldex plans to initiate a Phase 2 study in AD
by year end.
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.
First Quarter 2024 Financial Highlights and 2024
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2024 were $823.8 million
compared to $423.6 million as of December 31, 2023. The increase
was primarily driven by net proceeds of $432.3 million from our
March 2024 underwritten public offering, partially offset by cash
used in operating activities of $40.6 million. At March 31, 2024,
Celldex had 65.9 million shares outstanding.
Revenues: Total revenue was $0.2 million in the
first quarter of 2024, compared to $1.0 million for the comparable
period in 2023. The decrease in revenue was primarily due to a
decrease in services performed under our manufacturing and research
and development agreements with Rockefeller University.
R&D Expenses: Research and development
(R&D) expenses were $31.7 million in the first quarter of 2024,
compared to $26.8 million for the comparable period in 2023. The
increase in R&D expenses was primarily due to an increase in
barzolvolimab clinical trial and personnel expenses, partially
offset by a decrease in barzolvolimab contract manufacturing
expenses.
G&A Expenses: General and administrative
(G&A) expenses were $9.1 million in the first quarter of 2024,
compared to $6.6 million for the comparable period in 2023. The
increase in G&A expenses was primarily due to an increase in
stock-based compensation and barzolvolimab commercial planning
expenses.
Net Loss: Net loss was $32.8 million, or
($0.56) per share, for the first quarter of 2024, compared to a net
loss of $29.4 million, or ($0.62) per share, for the comparable
period in 2023.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31, 2024
are sufficient to meet estimated working capital requirements and
fund current planned operations through 2027.
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 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, |
|
2024 |
|
2023 |
|
(Unaudited) |
Revenues: |
|
|
|
Product development and licensing agreements |
$ |
2 |
|
|
$ |
- |
|
Contracts and grants |
|
154 |
|
|
|
967 |
|
|
|
|
|
Total revenues |
|
156 |
|
|
|
967 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
|
31,661 |
|
|
|
26,798 |
|
General and administrative |
|
9,103 |
|
|
|
6,640 |
|
|
|
|
|
Total operating expenses |
|
40,764 |
|
|
|
33,438 |
|
|
|
|
|
Operating loss |
|
(40,608 |
) |
|
|
(32,471 |
) |
|
|
|
|
Investment and other income, net |
|
7,800 |
|
|
|
3,110 |
|
|
|
|
|
Net loss |
$ |
(32,808 |
) |
|
$ |
(29,361 |
) |
|
|
|
|
Basic and diluted net loss per common share |
$ |
(0.56 |
) |
|
$ |
(0.62 |
) |
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
58,871 |
|
|
|
47,214 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
March 31 |
|
December 31, |
|
2024 |
|
2023 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
823,846 |
|
|
$ |
423,598 |
|
Other current assets |
|
11,478 |
|
|
|
8,095 |
|
Property and equipment, net |
|
4,061 |
|
|
|
4,060 |
|
Intangible and other assets, net |
|
29,462 |
|
|
|
29,874 |
|
Total assets |
$ |
868,847 |
|
|
$ |
465,627 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities |
$ |
26,291 |
|
|
$ |
31,125 |
|
Long-term liabilities |
|
3,943 |
|
|
|
5,331 |
|
Stockholders' equity |
|
838,613 |
|
|
|
429,171 |
|
Total liabilities and stockholders' equity |
$ |
868,847 |
|
|
$ |
465,627 |
|
|
|
|
|
Grafico Azioni Celldex Therapeutics (NASDAQ:CLDX)
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Grafico Azioni Celldex Therapeutics (NASDAQ:CLDX)
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Da Giu 2023 a Giu 2024