Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the second quarter ended June 30, 2024 and provided a
corporate update.
“2024 has been a monumental year for Celldex. We presented data
establishing clinical benefit and safety for barzolvolimab in two
distinct forms of urticaria—chronic spontaneous urticaria and
inducible urticaria—both of which support advancement to
registration studies,” said Anthony Marucci, Co-founder, President
and Chief Executive Officer of Celldex Therapeutics. “Last month,
we initiated two of the largest, global studies to be conducted in
CSU and we are now planning for the initiation of a second Phase 3
program in CIndU. With ongoing Phase 2 trials also in prurigo
nodularis, eosinophilic esophagitis and, by year end, in atopic
dermatitis—barzolvolimab is actively delivering on its significant
pipeline in a product potential and we remain committed to our goal
of bringing this potential new medicine to patients.”
Mr. Marucci continued, “As the year progresses, we continue to
build on our leadership in the development of mast cell-targeted
therapeutics and plan to advance CDX-622, our first bispecific for
inflammatory diseases, into the clinic by year end. We think this
candidate is an exciting entrant to the field, targeting two
complementary pathways that drive chronic inflammation, TSLP and
stem cell factor. Importantly, the Company is well capitalized with
more than $800M in cash to support the continued
advancement and expansion of the barzolvolimab program and our
growing pipeline.”
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.
Chronic Urticarias
- Celldex initiated a global Phase 3 program in chronic
spontaneous urticaria (CSU) in July, consisting of two Phase 3
trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the
efficacy and safety of barzolvolimab in adult patients with CSU who
remain symptomatic despite H1 antihistamine treatment. The studies
will also include patients who remain symptomatic after treatment
with biologics. Both studies are actively enrolling patients.
- Celldex is completing 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.
- In July 2024, the Company reported topline 12 week primary
endpoint results from the Phase 2 CIndU study. Data from the 196
patients randomized in the study showed that barzolvolimab achieved
the primary efficacy endpoint, a statistically significant
difference between the percent of patients with a negative
provocation test (complete response) compared to placebo at Week
12, in ColdU and in SD across both dose groups. Importantly,
barzolvolimab demonstrated rapid, durable and clinically meaningful
responses. Barzolvolimab was well tolerated with a favorable safety
profile consistent with prior studies. Patients on study will
continue to receive barzolvolimab for 20 weeks and the Company
plans to present the full 12 week data from this study at an
upcoming medical meeting in the second half of 2024.
- 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. Barzolvolimab achieved the
primary efficacy endpoint of the study, 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
strongly support the primary endpoint results. Importantly,
barzolvolimab demonstrated rapid, durable and clinically meaningful
responses, including in patients with prior omalizumab treatment.
Patients on study continue to receive barzolvolimab for 52 weeks
and the Company plans to report 52 week data in the second half of
2024.In June 2024, data from this study on the impact of
barzolvolimab on angioedema were presented at the European Academy
of Allergy and Clinical Immunology (EAACI) Congress 2024.
Barzolvolimab profoundly improved angioedema at 12 weeks,
demonstrating statistically significant, rapid and durable
improvements in the weekly angioedema activity score (AAS7) and
additional measures of angioedema control across all doses at Week
12.
Additional Indications
- A Phase 2 study in prurigo nodularis (PN) was initiated in
early 2024 and enrollment is ongoing. 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.
- A Phase 2 study in eosinophilic esophagitis (EoE) was initiated
in July 2023 and enrollment is ongoing. This randomized,
double-blind, placebo-controlled study is evaluating the efficacy
and safety profile of barzolvolimab in approximately 75 patients
with active EoE.
- In May 2024, Celldex announced that atopic dermatitis (AD) has
been selected as the fifth indication for the development of
barzolvolimab. 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. Celldex plans to initiate a
Phase 2 study in AD by year end.
Bispecific Antibody Platform
CDX-622 – Bispecific SCF & TSLP
CDX-622 targets two complementary pathways that drive chronic
inflammation, potently neutralizing the alarmin thymic stromal
lymphopoietin (TSLP) and depleting mast cells via stem cell factor
(SCF) starvation. Combined neutralization of SCF and TSLP with
CDX-622 is expected to simultaneously reduce tissue mast cells and
inhibit Type 2 inflammatory responses to potentially offer enhanced
therapeutic benefit in inflammatory and fibrotic disorders.
- Celldex has completed preclinical, manufacturing and
IND-enabling activities for CDX-622 and plans to initiate a Phase 1
study of the candidate in healthy volunteers by the end of 2024. In
preclinical studies, CDX-622 inhibits TSLP and SCF with similar
potency to both its respective parental mAbs and comparator mAbs in
vitro. CDX-622 was well tolerated in a multi-dose 8 week toxicology
study in non-human primates and the No Adverse Event Level (NOAEL)
was established to be 75 mg/kg, the highest dose level tested. In
inflammatory and fibrotic disorders, TSLP is often upregulated and
associated with disease severity. Similarly, mast cells drive or
contribute to the pathophysiology of many of these disorders and
CDX-622 contains a unique SCF neutralizing function that is
expected to inhibit and deplete mast cells.
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.
Second Quarter 2024 Financial Highlights and 2024
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2024 were $802.3 million
compared to $823.8 million as of March 31, 2024. The decrease was
primarily driven by second quarter cash used in operating
activities of $29.3 million, partially offset by proceeds from
issuance of stock under employee benefit plans of $3.7 million. At
June 30, 2024, Celldex had 66.3 million shares outstanding.
Revenues: Total revenue was $2.5 million in the
second quarter of 2024 and $2.7 million for the six months ended
June 30, 2024, compared to $0.3 million and $1.2 million for the
comparable periods in 2023. 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 $39.7 million in the second quarter of 2024
and $71.3 million for the six months ended June 30, 2024, compared
to $26.3 million and $53.0 million for the comparable periods 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 second quarter of 2024
and $18.2 million for the six months ended June 30, 2024, compared
to $7.2 million and $13.9 million for the comparable periods 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 $35.8 million, or
($0.54) per share, for the second quarter of 2024, and $68.7
million, or ($1.10) per share, for the six months ended June 30,
2024, compared to a net loss of $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.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 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 |
|
Six Months |
Consolidated Statements of Operations Data |
|
Ended June 30, |
|
Ended June 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Product development and licensing agreements |
|
$ |
- |
|
|
$ |
16 |
|
|
$ |
2 |
|
|
$ |
16 |
|
Contracts and grants |
|
|
2,498 |
|
|
|
252 |
|
|
|
2,652 |
|
|
|
1,218 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
2,498 |
|
|
|
268 |
|
|
|
2,654 |
|
|
|
1,234 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
39,687 |
|
|
|
26,252 |
|
|
|
71,348 |
|
|
|
53,049 |
|
General and administrative |
|
|
9,128 |
|
|
|
7,221 |
|
|
|
18,231 |
|
|
|
13,861 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
48,815 |
|
|
|
33,473 |
|
|
|
89,579 |
|
|
|
66,910 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(46,317 |
) |
|
|
(33,205 |
) |
|
|
(86,925 |
) |
|
|
(65,676 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and other income, net |
|
|
10,475 |
|
|
|
2,703 |
|
|
|
18,275 |
|
|
|
5,813 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(35,842 |
) |
|
$ |
(30,502 |
) |
|
$ |
(68,650 |
) |
|
$ |
(59,863 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.54 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.27 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
|
66,019 |
|
|
|
47,253 |
|
|
|
62,445 |
|
|
|
47,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
802,317 |
|
|
$ |
423,598 |
|
|
|
|
|
Other current assets |
|
|
9,658 |
|
|
|
8,095 |
|
|
|
|
|
Property and equipment, net |
|
|
3,864 |
|
|
|
4,060 |
|
|
|
|
|
Intangible and other assets, net |
|
|
29,747 |
|
|
|
29,874 |
|
|
|
|
|
|
Total assets |
|
$ |
845,586 |
|
|
$ |
465,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
27,658 |
|
|
$ |
31,125 |
|
|
|
|
|
Long-term liabilities |
|
|
4,269 |
|
|
|
5,331 |
|
|
|
|
|
Stockholders' equity |
|
|
813,659 |
|
|
|
429,171 |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
845,586 |
|
|
$ |
465,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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