Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the fourth quarter and year ended
December 31, 2020.
“Celldex made significant progress across our pipeline in 2020
and today continued this momentum with the announcement of
compelling interim results from our ongoing Phase 1b study of
CDX-0159 in chronic inducible urticaria where we have observed an
80% complete response rate and a well-tolerated safety profile to
date,” said Anthony Marucci, Co-founder, President and Chief
Executive Officer of Celldex Therapeutics. “These data support the
novel mechanism of CDX-0159 and the potential broad applicability
of this compound in mast cell driven diseases. Based on these
results, we are expanding the study to also include patients with
cholinergic urticaria and look forward to presenting updated
results from the cold induced and symptomatic dermographism cohorts
this summer. We also anticipate results from the ongoing Phase 1b
study in chronic spontaneous urticaria by the end of the year and
are on track to initiate a third study in prurigo nodularis in the
fourth quarter.”
“In 2020, we also continued to advance our oncology programs,
presenting data from our CDX-1140 program supporting this candidate
as a best in class CD40 agonist and initiating a Phase 1 study of
CDX-527, the first candidate from our bispecific platform, into the
clinic. We anticipate data updates from both of these programs
later this year and look forward to what promises to be a busy and
exciting time for the Company.”
Recent Pipeline Highlights
While Celldex’s clinical development programs have not been
significantly, negatively impacted by COVID-19 to date, the Company
continues to carefully monitor the evolving situation closely
across all development programs and work to minimize potential
impact/disruptions.
CDX-0159—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. Results from a Phase 1a dose escalation study of
CDX-0159 were featured in a late breaking presentation in June at
the EAACI Annual Congress 2020. CDX-0159 demonstrated a favorable
safety profile as well as profound and durable reductions of plasma
tryptase, indicative of systemic mast cell ablation.
- Celldex initiated a Phase 1b open label study designed to
evaluate the safety of a single dose (3.0 mg/kg) of CDX-0159
administered intravenously in December of 2020. Up to 20 patients
with cold contact urticaria (ColdU; n=10) or symptomatic
dermographism (SD; n=10) who are refractory to antihistamines are
being enrolled. Patients' symptoms are induced via provocation
testing that resembles real life triggering situations. Secondary
and exploratory objectives include pharmacokinetic and
pharmacodynamic assessments, including changes from baseline
provocation thresholds, measurement of tryptase and stem cell
factor levels, clinical activity outcomes (impact on urticaria
symptoms, disease control, clinical response), quality of life
assessments and measurement of tissue mast cells through skin
biopsies. The study is being conducted by Dr. Marcus Maurer,
Professor of Dermatology and Allergy at Charité -
Universitätsmedizin in Berlin. Interim data from this study
were reported earlier today. Fifteen out of 20 planned patients
with antihistamine refractory CIndU had received a single
intravenous infusion of CDX-0159 at 3 mg/kg, including nine
patients with ColdU and six patients with SD. Safety results were
reported for all 15 patients; activity results were reported for
all patients assessed for at least 15 days/2 weeks after treatment
(n=10; 7 ColdU and 3 SD). Patients had high disease activity as
assessed by provocation threshold testing. In ColdU and SD pts,
baseline critical temperature thresholds were 18.7 +/- 2.7 °C
(range: 5-27°C) and FricTest® thresholds were 3.7 +/- 0.3 (range:
3-4) of 4.
- Eight of 10 patients (7 ColdU; 1 SD) experienced a complete
response (CR) as assessed by provocation threshold testing. The
remaining two patients (both with SD), had been recently treated
and were followed for two weeks. One patient experienced a partial
response (PR) thus far and one patient reported symptomatic
improvement (decreased itching). All patients will continue to be
assessed for response through week 12.
- Patient global assessment (Pat-GA) and physician global
assessment (Phy-GA) results were consistent with provocation
testing results.
- Measurements of serum tryptase levels are available for only
the first six patients evaluated for activity, all with ColdU. The
mean baseline was 3.3 +/- 0.2 ng/ml and levels on day 15 after
treatment were at or below the limit of detection. These patients
all experienced complete responses.
- CDX-0159 was generally well tolerated. Six of 15 patients had
mild infusion reactions, generally areas of localized redness and
itching, which resolved rapidly. A single severe infusion reaction
was observed (brief loss of consciousness, followed by shaking and
sweating). The patient was treated with antihistamines and
steroids; no epinephrine was administered. The patient rapidly
recovered and was hospitalized for observation with no further
manifestations of this event. Importantly, there was no evidence of
mast cell activation as measured by decreases in serum tryptase
levels shortly after the infusion and further at a later time
point.
- Through day 15, three patients had transient, mild decreases in
hemoglobin, and no patients had meaningful declines in white blood
cells.
- Enrollment is currently being completed in the ColdU and SD
cohorts. Based on these compelling results, the study is being
expanded to also include 10 patients with cholinergic urticaria and
enrollment of these patients is planned to begin in May of
2021.
- Updated results from additional patients with cold induced
urticaria and symptomatic dermographism and long term follow up
that continues to characterize magnitude and duration of treatment
effect and their link to changes in tryptase levels are expected
this summer.
- Celldex initiated dosing in a Phase 1b multi-center study of
CDX-0159 in chronic spontaneous urticaria (CSU) in October. This
study is a randomized, double-blind, placebo-controlled clinical
trial designed to assess the safety of multiple ascending doses of
CDX-0159 in up to 40 patients with CSU who remain symptomatic
despite treatment with antihistamines. Secondary and exploratory
objectives include pharmacokinetic and pharmacodynamic assessments,
including measurement of tryptase and stem cell factor levels and
clinical activity outcomes (impact on urticaria symptoms, disease
control, clinical response) as well as quality of life assessments.
Results from the study are expected by the end of 2021.
- In February 2021, Celldex announced that development of
CDX-0159 will be expanded into prurigo nodularis (PN), a chronic
skin disease characterized by the development of hard, intensely
itchy (pruritic) nodules on the skin. Mast cells through their
interactions with sensory neurons and other immune cells are
believed to play an important role in amplifying chronic itch and
neuroinflammation. Initiation of this study is planned for the
fourth quarter of 2021. Celldex is also exploring additional mast
cell driven diseases for potential future development, including
mast cell activation syndromes, asthma, allergic conditions and
mast cell driven gastrointestinal disorders.
- Manufacturing activities are also progressing as planned to
support the introduction of the CDX-0159 subcutaneous formulation
into the clinical program in the third quarter of 2021.
CDX-1140—a potent CD40 human agonist antibody developed by
Celldex that the Company believes has the potential to successfully
balance systemic doses for good tissue and tumor penetration with
an acceptable safety profile.
- In the Phase 1 dose-escalation study of CDX-1140 in patients
with recurrent, locally advanced or metastatic solid tumors and B
cell lymphomas, both the monotherapy and combination with CDX-301
dose escalation portions of the trial are complete with an
identified maximum tolerated dose (MTD) and recommended dose of
CDX-1140 at 1.5 mg/kg—one of the highest systemic dose levels in
the CD40 agonist class. Expansion cohorts are actively recruiting
including:
- CDX-1140 with KEYTRUDA® (pembrolizumab) in patients who have
progressed on checkpoint therapy; and,
- A combination of CDX-1140 with standard of care chemotherapy in
first line metastatic pancreatic cancer.
Updated data from this program are
expected to be presented later this year.
- Updated interim data from the ongoing Phase 1 study were
presented at the Society for Immunotherapy of Cancer’s (SITC) 35th
Anniversary Annual Meeting & Pre-Conference Programs (SITC
2020) in November 2020. Analysis was focused on patients treated at
the MTD and recommended dose of 1.5 mg/kg. 41 patients had been
treated at the 1.5 mg/kg dose at the time of data cutoff (n=25
monotherapy; n=16 in combination with CDX-301, a dendritic cell
growth factor used as a priming agent to increase the number of
dendritic cells in blood and tissue available for CDX-1140
activation). 29 patients had post-treatment scans performed and
five patients had not reached their first post-treatment response
assessment. In addition, preliminary safety data from the
combination cohort with pembrolizumab (n=9; 4 at 0.72 mg/kg and 5
at 1.5 mg/kg CDX-1140) were also presented. CDX-1140 monotherapy
and in combination with CDX-301 or pembrolizumab was generally well
tolerated with mostly grade 1 or grade 2 drug related adverse
events. Activity at 1.5mg/kg dose of CDX-1140 to date included:
- An ongoing (6+ months) complete response (CR) in a patient with
follicular lymphoma treated with CDX-1140 in combination with
CDX-301; notable tumor shrinkage and/or necrosis in 6 patients with
squamous cell head and neck cancer (SCCHN), including extensive
tumor cavitation/necrosis of a large baseline protruding neck mass
associated with decreased tumor pain in a patient; and stable
disease (n=10) for 11 to 32 weeks.
- CDX-1140 at 1.5 mg/kg provided good systemic exposure that
enhanced the distribution into tissues and tumor and resulted in
marked changes in the tumor microenvironment (TME) consistent with
a more inflammatory and less immunosuppressive state as
demonstrated by gene expression analysis. Interferon signaling and
cytotoxicity pathways were most highly upregulated, while
immunosuppression via TGFb signaling and metastatic pathways were
downregulated, marking the first clear demonstration in patients of
biological activity within the TME for a systemically administered
agonist anti-CD40 mAb.
CDX-527—the first candidate developed by Celldex from its
bispecific platform which utilizes the Company’s proprietary highly
active anti-PD-L1 and CD27 human antibodies to couple CD27
co-stimulation with blockade of the PD-L1/PD-1 pathway.
- In August 2020, Celldex initiated a Phase 1 dose-escalation
study in up to ~90 patients with advanced or metastatic solid
tumors that have progressed during or after standard of care
therapy to be followed by tumor-specific expansion cohorts. The
study is designed to determine the MTD during a dose-escalation
phase and to recommend a dose level for further study in the
subsequent expansion phase. The expansion is designed to further
evaluate the tolerability, and biologic and anti-tumor effects of
selected dose level(s) of CDX-527 in specific tumor types. Initial
data from the Phase 1 study are expected to be presented later this
year.
Fourth Quarter and Twelve Months 2020 Financial
Highlights and 2021 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2020 were $194.4 million
compared to $199.6 million as of September 30, 2020. The decrease
was primarily driven by fourth quarter cash used in operating
activities of $5.2 million. At December 31, 2020, Celldex had 39.6
million shares outstanding.
Revenues: Total revenue was $3.8 million in the
fourth quarter of 2020 and $7.4 million for the year ended December
31, 2020, compared to $0.9 million and $3.6 million for the
comparable periods in 2019. The increase in revenue was primarily
due to the $1.8 million milestone payment from Rockefeller
University related to our manufacturing and development services
agreement and an increase in services performed under our
manufacturing and research and development agreements with
Rockefeller University and Gilead Sciences, partially offset by a
decrease in services performed under our manufacturing and research
and development agreement with Duke University.
R&D Expenses: Research and development
(R&D) expenses were $10.4 million in the fourth quarter of 2020
and $42.5 million for the year ended December 31, 2020, compared to
$10.3 million and $42.7 million for the comparable periods in 2019.
The decrease in R&D expenses was primarily due to a decrease in
contract research and facility expenses, partially offset by an
increase in clinical trials and contract manufacturing
expenses.
G&A Expenses: General and administrative
(G&A) expenses were $3.6 million in the fourth quarter of 2020
and $14.5 million for the year ended December 31, 2020, compared to
$3.2 million and $15.4 million for the comparable periods in 2019.
The decrease in G&A expenses was primarily due to a decrease in
stock-based compensation and facility expenses.
Intangible Asset Impairment: The Company
recorded a non-cash partial impairment charge of $14.5 million
related to the TAM program IPR&D asset in the fourth quarter of
2020 as a result of changes in the projected development and
regulatory timelines for the program. The Company recorded a
non-cash impairment charge of $3.5 million related to the CDX-3379
IPR&D asset in the second quarter of 2020 as a result of the
discontinuation of the CDX-3379 program.
Changes in Fair Value Remeasurement of Contingent
Consideration: During the year ended December 31, 2020,
the Company recorded a $4.2 million gain on the fair value
remeasurement of contingent consideration primarily due to updated
assumptions for CDX-3379 related milestones due to the
discontinuation of the CDX-3379 program partially offset by changes
in discount rates and the passage of time.
Net Loss: Net loss was $21.9 million, or
($0.55) per share, for the fourth quarter of 2020 and $59.8
million, or ($2.02) per share, for the year ended December 31,
2020, compared to a net loss of $10.4 million, or ($0.64) per
share, for the fourth quarter of 2019 and $50.9 million, or ($3.51)
per share, for the year ended December 31, 2019.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at December 31,
2020 are sufficient to meet estimated working capital requirements
and fund planned operations through 2023.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ
USA.
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 Statement This 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; the effects of the
outbreak of COVID-19 on our business and results of operations; 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 & AdministrationCelldex
Therapeutics, Inc.(508) 864-8337scavanaugh@celldex.com
CELLDEX
THERAPEUTICS, INC. |
(In
thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS |
|
Three
Months |
|
Year |
OF OPERATIONS DATA |
|
Ended December 31, |
|
Ended December 31, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
(Unaudited) |
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product Development and |
|
|
|
|
|
|
|
|
|
Licensing
Agreements |
|
$ |
3 |
|
|
$ |
94 |
|
|
$ |
2,301 |
|
|
$ |
473 |
|
Contracts and Grants |
|
|
3,783 |
|
|
|
793 |
|
|
|
5,117 |
|
|
|
3,100 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
3,786 |
|
|
|
887 |
|
|
|
7,418 |
|
|
|
3,573 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and Development |
|
|
10,425 |
|
|
|
10,339 |
|
|
|
42,534 |
|
|
|
42,672 |
|
General and Administrative |
|
|
3,623 |
|
|
|
3,219 |
|
|
|
14,456 |
|
|
|
15,426 |
|
Intangible Asset Impairment |
|
|
14,500 |
|
|
|
- |
|
|
|
18,000 |
|
|
|
- |
|
Other Asset Impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,800 |
|
Loss (Gain) on Fair Value Remeasurement |
|
|
|
|
|
|
|
|
|
of Contingent Consideration |
|
|
18 |
|
|
|
318 |
|
|
|
(4,218 |
) |
|
|
(1,294 |
) |
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
28,566 |
|
|
|
13,876 |
|
|
|
70,772 |
|
|
|
58,604 |
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(24,780 |
) |
|
|
(12,989 |
) |
|
|
(63,354 |
) |
|
|
(55,031 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
1,941 |
|
|
|
2,542 |
|
|
|
2,407 |
|
|
|
4,153 |
|
|
|
|
|
|
|
|
|
|
|
Net Loss Before Income Tax Benefit |
|
|
(22,839 |
) |
|
|
(10,447 |
) |
|
|
(60,947 |
) |
|
|
(50,878 |
) |
|
|
|
|
|
|
|
|
|
|
Income Tax Benefit |
|
|
939 |
|
|
|
- |
|
|
|
1,167 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(21,900 |
) |
|
$ |
(10,447 |
) |
|
$ |
(59,780 |
) |
|
$ |
(50,878 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per |
|
|
|
|
|
|
|
|
|
Common Share |
|
$ |
(0.55 |
) |
|
$ |
(0.64 |
) |
|
$ |
(2.02 |
) |
|
$ |
(3.51 |
) |
Shares Used in Calculating Basic |
|
|
|
|
|
|
|
|
|
and Diluted Net Loss per Share |
|
|
39,577 |
|
|
|
16,442 |
|
|
|
29,640 |
|
|
|
14,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED |
|
|
|
|
|
|
|
|
BALANCE SHEETS DATA |
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash, Cash Equivalents and Marketable Securities |
|
|
|
|
|
$ |
194,422 |
|
|
$ |
64,383 |
|
Other Current Assets |
|
|
|
|
|
|
3,421 |
|
|
|
2,315 |
|
Property and Equipment, net |
|
|
|
|
|
|
3,815 |
|
|
|
4,031 |
|
Intangible and Other Assets, net |
|
|
|
|
|
|
34,180 |
|
|
|
52,204 |
|
|
Total
Assets |
|
|
|
|
|
$ |
235,838 |
|
|
$ |
122,933 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
$ |
14,206 |
|
|
$ |
11,643 |
|
Long-Term Liabilities |
|
|
|
|
|
|
12,275 |
|
|
|
17,264 |
|
Stockholders' Equity |
|
|
|
|
|
|
209,357 |
|
|
|
94,026 |
|
|
Total
Liabilities and Stockholders' Equity |
|
|
|
|
|
$ |
235,838 |
|
|
$ |
122,933 |
|
|
|
|
|
|
|
|
|
|
|
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