Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the second quarter ended June 30,
2020. The Company will host a conference call at 4:30 p.m. ET today
to provide an update on its pipeline and upcoming milestones.
“In the second quarter of 2020, we presented data from our KIT
inhibitor, CDX-0159, in a late breaking session at the EAACI Annual
Congress that suggested significant potential to dramatically
impact mast cell driven disorders,” said Anthony Marucci,
Co-founder, President and Chief Executive Officer of Celldex
Therapeutics. “These data provided important proof of concept for
the CDX-0159 program and helped support a $150 million public
offering driven by high quality health care investors to fully fund
the Company’s planned operations through 2023. We are on track to
initiate two studies in chronic urticaria later this year and are
vetting additional mast cell driven indications to support expanded
development in 2021.”
“We continue to focus our resources on the programs we believe
hold the most promise for patients and shareholders and have
prioritized the development of CDX-0159, CDX-1140, and the first
candidate from our bi-specific program, CDX-527. We are
discontinuing development of CDX-3379, which is in an exploratory
study with cetuximab to assess the utility of biomarkers in head
and neck cancer. The side effect profile of the combination remains
challenging even with prophylactic treatment and, when considered
with the emerging clinical activity, we believe our resources are
best utilized to expand the development of CDX-0159 and our other
pipeline programs. To this end, we intend to start the two planned
studies of CDX-0159 this fall and to initiate a combination cohort
of CDX-1140 with chemotherapy in treatment naïve metastatic
pancreatic cancer and a Phase 1 study of CDX-527 in refractory,
advanced cancers later this year. These programs will support data
read outs later this year and in 2021,” concluded Marucci.
Recent Pipeline Highlights
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 the Phase 1a dose escalation study of CDX-0159
were featured in a late breaking presentation in June at the
European Academy of Allergy and Clinical Immunology (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. Tryptase suppression
below the level of detection was observed after a single 1.0 mg/kg
dose and was maintained for more than 2 months at single doses of
both 3.0 and 9.0 mg/kg of CDX-0159.-- As indicated in the EAACI
presentation, a subset of subjects from the 3mg/kg and 9 mg/kg
cohorts agreed to continued follow up for tryptase suppression.
This follow up and analysis was completed in July and tryptase
levels remained below the level of detection for over 3 months (14
weeks) in 50% of subjects in the 3 mg/kg cohort and over 4 months
(18 weeks) in all subjects in the 9 mg/kg cohort.
- Celldex plans to initiate Phase 1b studies of CDX-0159 in
chronic spontaneous urticaria (CSU) and chronic inducible urticaria
(CIndU), both mast cell driven diseases, this fall. Celldex is
exploring cold-induced and symptomatic dermographism
(scratch-induced) urticarias. 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.
- Data from the Phase 1b studies in CIndU and CSU are anticipated
in the first quarter and second half of 2021,
respectively.
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 Phase 2
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,-- CDX-1140
with CDX-301 in patients with head and neck squamous cell carcinoma
(HNSCC); and,-- A combination of CDX-1140 with standard of care
chemotherapy in first line metastatic pancreatic cancer is expected
to initiate later this year.
- A data update from the ongoing Phase 1 study is planned for
presentation in the fall of 2020.
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.
- Celldex anticipates initiating 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 later this
year 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, 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 anticipated in the
first half of 2021.
Recent Business Highlights
- On June 18, 2020, Celldex announced the closing of an
underwritten public offering raising total gross proceeds of
approximately $150.0 million.
Second Quarter 2020 Financial Highlights and 2020
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2020 were $206.9 million
compared to $53.7 million as of March 31, 2020. The increase was
primarily driven by net proceeds of $141.4 million from our June
2020 underwritten public offering and net proceeds of $23.7 million
from sales of common stock under our Controlled Equity OfferingSM
agreement with Cantor completed in the second quarter prior to the
offering in June. These increases were offset by second quarter
cash used in operating activities of $11.2 million.
Revenues: Total revenue was $0.2 million in the
second quarter of 2020 and $3.0 million for the six months ended
June 30, 2020, compared to $0.7 million and $2.1 million for the
comparable periods in 2019. The increase in revenue for the six
months ended June 30, 2020 compared to the six months ended June
30, 2019 was primarily due to the $1.8 million milestone payment
from Rockefeller University related to our manufacturing and
development services agreement, 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 $9.7 million in the second quarter of 2020
and $21.4 million for the six months ended June 30, 2020, compared
to $10.1 million and $21.2 million for the comparable periods in
2019. The increase in R&D expense for the six months ended June
30, 2020 compared to the six months ended June 30, 2019 was
primarily due to an increase in clinical trial and contract
manufacturing expenses, partially offset by lower stock-based
compensation expense.
G&A Expenses: General and administrative
(G&A) expenses were $3.5 million in the second quarter of 2020
and $7.2 million for the six months ended June 30, 2020, compared
to $3.9 million and $8.8 million for the comparable periods in
2019. The decrease in G&A expenses was primarily due to lower
stock-based compensation expense.
Changes in Fair Value Remeasurement of Contingent
Consideration: The gain on fair value remeasurement of
contingent consideration was $5.1 million during the second quarter
of 2020 and $4.9 million during the six months ended June 30, 2020,
primarily due to updated assumptions for CDX-3379 related
milestones due to the discontinuation of the CDX-3379 program and
the passage of time.
Intangible Asset Impairment: The Company
recorded a non-cash impairment charge of $3.5 million during the
second quarter of 2020 due to the discontinuation of the CDX-3379
program.
Net Loss: Net loss was $11.0 million, or
($0.50) per share, for the second quarter of 2020, and $23.7
million, or ($1.20) per share, for the six months ended June 30,
2020, compared to a net loss of $11.8 million, or ($0.84) per
share, for the second quarter of 2019 and $29.0 million, or ($2.21)
per share, for the six months ended June 30, 2019.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 2020
are sufficient to meet estimated working capital requirements and
fund planned operations through 2023.
Webcast and Conference CallCelldex executives
will host a conference call at 4:30 p.m. ET today to discuss
financial and business results and to provide an update on key 2020
objectives. The conference call and presentation will be webcast
live over the internet and can be accessed by going to the "Events
& Presentations" page under the "Investors & Media" section
of the Celldex Therapeutics website at www.celldex.com. The call
can also be accessed by dialing (800) 446-2782 (within the United
States) or (847) 413-3235 (outside the United States). The passcode
is 49870841.
A replay of the call will be archived on the Company's
website.
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
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline
includes immunotherapies and other targeted biologics derived from
a broad set of complementary technologies which have the ability to
engage the human immune system and/or directly inhibit tumors to
treat specific types of cancer or other 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; the effects of the
outbreak of COVID-19 on our business and results of operations; our
ability to realize the cost benefits of consolidating our office
and laboratory space and to retain key personnel after that
consolidation; 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 and commercial grade 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.
CELLDEX
THERAPEUTICS, INC. |
(In
thousands, except per share amounts) |
|
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|
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CONSOLIDATED STATEMENTS |
|
Three
Months |
|
Six
Months |
OF OPERATIONS DATA |
|
Ended June 30, |
|
Ended June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUES: |
|
|
|
|
|
|
|
|
Product Development and |
|
|
|
|
|
|
|
|
|
Licensing
Agreements |
|
$ |
- |
|
|
$ |
195 |
|
|
$ |
2,285 |
|
|
$ |
325 |
|
Contracts and Grants |
|
|
236 |
|
|
|
520 |
|
|
|
680 |
|
|
|
1,815 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
236 |
|
|
|
715 |
|
|
|
2,965 |
|
|
|
2,140 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and Development |
|
|
9,705 |
|
|
|
10,081 |
|
|
|
21,400 |
|
|
|
21,232 |
|
General and Administrative |
|
|
3,528 |
|
|
|
3,908 |
|
|
|
7,194 |
|
|
|
8,804 |
|
Intangible Asset Impairment |
|
|
3,500 |
|
|
|
- |
|
|
|
3,500 |
|
|
|
- |
|
Other Asset Impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,800 |
|
(Gain) Loss on Fair Value Remeasurement |
|
|
|
|
|
|
|
|
|
of Contingent Consideration |
|
|
(5,132 |
) |
|
|
(1,017 |
) |
|
|
(4,898 |
) |
|
|
502 |
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
11,601 |
|
|
|
12,972 |
|
|
|
27,196 |
|
|
|
32,338 |
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(11,365 |
) |
|
|
(12,257 |
) |
|
|
(24,231 |
) |
|
|
(30,198 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
106 |
|
|
|
478 |
|
|
|
347 |
|
|
|
1,180 |
|
|
|
|
|
|
|
|
|
|
|
Net Loss Before Income Tax Benefit |
|
|
(11,259 |
) |
|
|
(11,779 |
) |
|
|
(23,884 |
) |
|
|
(29,018 |
) |
|
|
|
|
|
|
|
|
|
|
Income Tax Benefit |
|
|
228 |
|
|
|
- |
|
|
|
228 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(11,031 |
) |
|
$ |
(11,779 |
) |
|
$ |
(23,656 |
) |
|
$ |
(29,018 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per |
|
|
|
|
|
|
|
|
|
Common Share |
|
$ |
(0.50 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.20 |
) |
|
$ |
(2.21 |
) |
Shares Used in Calculating Basic |
|
|
|
|
|
|
|
|
|
and Diluted Net Loss per Share |
|
|
22,082 |
|
|
|
13,952 |
|
|
|
19,744 |
|
|
|
13,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED |
|
|
|
|
|
|
|
|
BALANCE SHEETS DATA |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash, Cash Equivalents and Marketable Securities |
|
|
|
|
|
$ |
206,915 |
|
|
$ |
64,383 |
|
Other Current Assets |
|
|
|
|
|
|
2,077 |
|
|
|
2,315 |
|
Property and Equipment, net |
|
|
|
|
|
|
4,044 |
|
|
|
4,031 |
|
Intangible and Other Assets, net |
|
|
|
|
|
|
48,365 |
|
|
|
52,204 |
|
|
Total
Assets |
|
|
|
|
|
$ |
261,401 |
|
|
$ |
122,933 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
$ |
10,841 |
|
|
$ |
11,643 |
|
Long-Term Liabilities |
|
|
|
|
|
|
12,116 |
|
|
|
17,264 |
|
Stockholders' Equity |
|
|
|
|
|
|
238,444 |
|
|
|
94,026 |
|
|
Total
Liabilities and Stockholders' Equity |
|
|
|
|
|
$ |
261,401 |
|
|
$ |
122,933 |
|
|
|
|
|
|
|
|
|
|
|
Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & AdministrationCelldex
Therapeutics, Inc.(781) 433-3161scavanaugh@celldex.com
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