Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial
results for the third quarter ended September 30, 2023 and provided
a corporate update.
"During the third quarter, we were pleased to complete
enrollment of our Phase 2 chronic spontaneous urticaria study well
ahead of schedule. We look forward to presenting topline data from
this study by end of year as we also plan for the potential
advancement of barzolvolimab into registrational studies in 2024,”
said Anthony Marucci, Co-founder, President and Chief Executive
Officer of Celldex Therapeutics. “Our Phase 1b study results in
prurigo nodularis met our internal hurdle for advancement and we
are actively planning for the initiation of a Phase 2 study early
next year. We are excited to discuss these data next week in an
oral presentation at the World Congress on itch and continue to
deepen our leadership role in furthering the science of mast cell
biology.”
“Enrollment continues as planned to our Phase 2 studies in
chronic inducible urticaria and eosinophilic esophagitis where we
anticipate important data read outs in 2024 and beyond. In closing,
we look forward to a data rich end of the year and remain focused
on successfully executing across our ongoing studies as we also
make plans to broaden barzolvolimab into other mast cell mediated
diseases,” 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.
- 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.
- In July 2023, Celldex announced that enrollment to the CSU
study (n=208) had been completed and that topline data is
anticipated by the end of 2023.
- 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. DLQI and PhysGA trended closely
with the dose-dependent improvement in UAS7 (Urticaria Activity
Score over 7 days) and UCT (Urticaria Control Test), tryptase
suppression, and increases in SCF.
- Enrollment to the Phase 2 CIndU study is ongoing.
- Celldex is currently planning for the initiation of a Phase 2
subcutaneous study in prurigo nodularis (PN) in early 2024. Data
from the Phase 1b randomized, double-blind, placebo-controlled
study in patients with prurigo nodularis have been accepted for
oral presentation at the 12th World Congress on Itch (WCI), being
held in Miami, November 5-7, 2023 and will be presented by Martin
Metz, M.D., Professor of Dermatology and Allergy at Charité -
Universitätsmedizin in Berlin.
- In July, the first patient was dosed in the Phase 2 randomized,
double-blind, placebo-controlled study in eosinophilic esophagitis
(EoE); enrollment is ongoing.
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.
Third Quarter 2023 Financial Highlights and 2023
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2023 were $235.3 million
compared to $252.7 million as of June 30, 2023. The decrease was
primarily driven by third quarter cash used in operating activities
of $19.0 million for the three months ended September 30, 2023. At
September 30, 2023, Celldex had 47.3 million shares
outstanding.
Revenues: Total revenue was $1.5 million in the
third quarter of 2023 and $2.8 million for the nine months ended
September 30, 2023, compared to $0.4 million and $0.7 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 $34.5 million in the third quarter of 2023
and $87.6 million for the nine months ended September 30, 2023,
compared to $21.6 million and $59.4 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 $8.2 million in the third quarter of 2023
and $22.1 million for the nine months ended September 30, 2023,
compared to $6.5 million and $20.6 million for the comparable
periods in 2022. The increase in G&A expenses was primarily due
to an increase in stock-based compensation and recruiting expenses,
partially offset by a decrease in legal expenses.
Changes in Fair Value Remeasurement of Contingent
Consideration: The gain on fair value remeasurement of
contingent consideration was $6.9 million for the nine months ended
September 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 $38.3 million, or
($0.81) per share, for the third quarter of 2023, and $98.1
million, or ($2.08) per share, for the nine months ended September
30, 2023, compared to a net loss of $26.8 million, or ($0.57) per
share, for the third quarter of 2022, and $85.8 million, or ($1.83)
per share, for the nine months ended September 30, 2022.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at September 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) |
|
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Three Months |
|
Nine Months |
Consolidated Statements of Operations Data |
|
Ended September 30, |
|
Ended September 30, |
|
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Product development and licensing agreements |
|
$ |
2 |
|
|
$ |
- |
|
|
$ |
19 |
|
|
$ |
30 |
|
Contracts and grants |
|
|
1,515 |
|
|
|
407 |
|
|
|
2,733 |
|
|
|
714 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
1,517 |
|
|
|
407 |
|
|
|
2,752 |
|
|
|
744 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
34,535 |
|
|
|
21,572 |
|
|
|
87,585 |
|
|
|
59,359 |
|
General and administrative |
|
|
8,221 |
|
|
|
6,531 |
|
|
|
22,082 |
|
|
|
20,596 |
|
Gain on fair value remeasurement of contingent consideration |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6,862 |
) |
Litigation settlement related loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
42,756 |
|
|
|
28,103 |
|
|
|
109,667 |
|
|
|
88,093 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(41,239 |
) |
|
|
(27,696 |
) |
|
|
(106,915 |
) |
|
|
(87,349 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and other income, net |
|
|
2,979 |
|
|
|
912 |
|
|
|
8,792 |
|
|
|
1,511 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(38,260 |
) |
|
$ |
(26,784 |
) |
|
$ |
(98,123 |
) |
|
$ |
(85,838 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.81 |
) |
|
$ |
(0.57 |
) |
|
$ |
(2.08 |
) |
|
$ |
(1.83 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in calculating basic and diluted net loss per
share |
|
|
47,261 |
|
|
|
46,916 |
|
|
|
47,243 |
|
|
|
46,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
September 30, |
|
December 31, |
|
|
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
235,348 |
|
|
$ |
304,952 |
|
|
|
|
|
Other current assets |
|
|
10,585 |
|
|
|
12,741 |
|
|
|
|
|
Property and equipment, net |
|
|
4,162 |
|
|
|
3,747 |
|
|
|
|
|
Intangible and other assets, net |
|
|
30,161 |
|
|
|
31,295 |
|
|
|
|
|
|
Total
assets |
|
$ |
280,256 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
27,836 |
|
|
$ |
18,610 |
|
|
|
|
|
Long-term liabilities |
|
|
5,702 |
|
|
|
7,921 |
|
|
|
|
|
Stockholders' equity |
|
|
246,718 |
|
|
|
326,204 |
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
280,256 |
|
|
$ |
352,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grafico Azioni Celldex Therapeutics (NASDAQ:CLDX)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Celldex Therapeutics (NASDAQ:CLDX)
Storico
Da Mag 2023 a Mag 2024