Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the first quarter ended March 31,
2019.
“Celldex presented positive data across multiple programs at
AACR in April, including from our promising CDX-1140 program,” said
Anthony Marucci, Co-founder, President and Chief Executive Officer
of Celldex Therapeutics. “We have successfully cleared a critical
hurdle for CD40 agonists, reaching dose levels with good systemic
exposure that are biologically active and well tolerated.
Importantly, these dose levels exceed the maximum tolerated dose
levels reported with other CD40 agonists, which we believe may
support enhanced tissue and tumor penetration. We are also pleased
with the results to date in our unique combination of CDX-1140 with
CDX-301, where CDX-301 amplifies the numbers of dendritic cells in
patients prior to their activation with CDX-1140. To this end, we
continue to believe that CDX-1140 can play a very important role in
cancer immunotherapy, especially in combination with drugs that
target other key immune pathways and are actively planning
additional combination cohorts to begin later this year.”
“We also recently completed the first stage of the Phase 2 study
of CDX-3379 and are pleased that this portion of the study met the
clinical criteria that are required to progress the study to the
next stage. We look forward to presenting more detailed data from
this study at ASCO in early June. We are currently conducting a
thorough analysis of the overall CDX-3379 program in collaboration
with our clinical advisors to determine the optimal path for this
candidate. In conclusion, we continue to make considerable progress
across our entire pipeline and look forward to updating
shareholders over the course of the year,” said Marucci.
Recent Highlights:
- CDX-1140—a potent CD40 agonist that Celldex believes has the
potential to successfully balance systemic doses for good tissue
and tumor penetration with an acceptable safety profile.
- Enrollment is nearing completion in the monotherapy arm and
progressing on track in the CDX-301 combination arm of the Phase 1
dose-escalation study of CDX-1140 with recurrent, locally advanced
or metastatic solid tumors and B cell lymphomas. Seven monotherapy
dosing cohorts ranging from 0.01 to 1.5 mg/kg have been completed
and the dose limiting toxicity (DLT) window successfully cleared;
patients are currently being enrolled in the final monotherapy
cohort at 3.0 mg/kg. Two combination cohorts in solid tumors (0.09
and 0.18 mg/kg) with CDX-301 have been completed and the DLT window
successfully cleared. Patients enrolled in the third cohort at 0.36
mg/kg have been dosed and are currently completing the DLT
observation period. Assuming successful clearance, the 0.72 mg/kg
combination cohort with CDX-301 should open shortly.
- Additional patient enrollment (backfill) has been initiated to
characterize the effects of CDX-1140 in the tumor microenvironment
and expansion cohorts are being actively planned. Future
combination opportunities include PD-1 or PD-L1 inhibitors,
chemotherapy, radiation therapy and Celldex’s potent CD27 agonist
monoclonal antibody varlilumab.
- Data from the ongoing study were presented at the American
Association for Cancer Research (AACR) Annual Meeting 2019 in April
and support that CDX-1140 is a potent activator of CD40 and can be
safely administered at doses that Celldex believes will support
good tissue and tumor penetration.
- CDX-3379—a differentiated human monoclonal antibody designed to
block the activity of ErbB3 (HER3). ErbB3 is expressed in many
cancers, including head and neck squamous cell cancer (HNSCC) and
is believed to be an important receptor regulating cancer cell
growth and survival as well as resistance to targeted therapies.
- As previously reported, enrollment is complete in the first
stage of the Phase 2 study (n=13) of CDX-3379 in advanced HNSCC in
combination with Erbitux® in Erbitux-resistant patients who have
been previously treated with or are ineligible for checkpoint
therapy. According to the study’s Simon two-stage design, if at
least one patient achieves an objective response in the first
stage, enrollment may progress to the second stage. While a
confirmed complete response has been documented, Celldex is
currently conducting a comprehensive review to inform decisions on
potential future development. Celldex plans to present updated data
from the study in a poster session at the 2019 American Society for
Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1,
2019.
- Celldex continues to advance a robust preclinical portfolio
with data from multiple programs presented at AACR.
- Data from the Company’s CDX-527 bispecific candidate and its
TAM program were presented at the AACR Annual Meeting 2019 in
April. CDX-527 uses Celldex’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. TAM receptors (Tyro3, Axl,
MerTK) are receptor tyrosine kinases (RTKs) expressed in innate
immune cells. These receptors have been gaining importance in the
immunotherapy field due to their role as checkpoint molecules on
macrophages, dendritic cells, and other immune cells, where they
can negatively regulate anti-tumor immunity.
First Quarter 2019 Financial Highlights and 2019
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2019 were $85.1 million
compared to $94.0 million as of December 31, 2018. The decrease was
primarily driven by first quarter cash used in operating activities
of $13.2 million, partially offset by $4.2 million in net proceeds
from sales of common stock under the Cantor agreement. At March 31,
2019, Celldex had 12.8 million shares outstanding.
Revenues: Total revenue was $1.4 million in the
first quarter of 2019 compared to $4.1 million for the comparable
period in 2018. The decrease in revenue was primarily due to lower
revenue from the contract manufacturing and research and
development agreement with the International AIDS Vaccine
Initiative and the collaboration agreement with Bristol-Myers
Squibb Company.
R&D Expenses: Research and development
(R&D) expenses were $11.2 million in the first quarter of 2019
compared to $21.9 million for the comparable period in 2018. The
decrease in R&D expenses was primarily due to lower clinical
trial, personnel and contract manufacturing costs.
G&A Expenses: General and administrative
(G&A) expenses were $4.9 million in the first quarter of 2019
compared to $5.6 million for the comparable period in 2018. The
decrease in G&A expenses was primarily due to lower personnel
and commercial planning costs.
Intangible Asset and Goodwill Impairments:
During the quarter ended March 31, 2018, the Company recorded $18.7
million in non-cash impairment charges related to fully impaired
glembatumumab vedotin-related intangible assets and $91.0 million
in goodwill impairment charges as the carrying value of the
Company’s net assets exceeded the Company’s fair value by an amount
in excess of the goodwill asset.
Changes in Fair Value Remeasurement of Contingent
Consideration: During the quarter ended March 31, 2019,
the Company recorded a $1.5 million loss on fair value
remeasurement of contingent consideration primarily due to changes
in discount rates and the passage of time. During the quarter ended
March 31, 2018, the Company recorded a $13.6 million gain on the
fair value remeasurement of contingent consideration primarily due
to updated assumptions for glembatumumab vedotin-related milestones
as a result of the METRIC study failure and discontinuation of the
glembatumumab vedotin program.
Net Loss: Net loss was $17.2 million, or
($1.40) per share, for the first quarter of 2019 compared to a net
loss of $118.1 million, or ($12.61) per share, for the comparable
period in 2018.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31,
2019, combined with the anticipated proceeds from future sales of
common stock under the Cantor agreement, are sufficient to meet
estimated working capital requirements and fund planned operations
through 2020. This could be impacted if Celldex elects to pay
Kolltan contingent milestones, if any, in cash.
Erbitux® is a registered trademark of Eli Lilly & Co.
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; our ability to obtain
additional 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; our ability to maintain compliance
with Nasdaq listing requirements; our ability to realize the
anticipated benefits from the acquisition of Kolltan; 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; 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.(781) 433-3161scavanaugh@celldex.com
|
CELLDEX THERAPEUTICS,
INC. |
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS |
Three Months |
OF OPERATIONS DATA |
Ended March 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
REVENUES: |
|
|
|
Product Development and Licensing Agreements |
$ |
129 |
|
|
$ |
992 |
|
Contracts and Grants |
|
1,296 |
|
|
|
3,076 |
|
|
|
|
|
Total
Revenue |
|
1,425 |
|
|
|
4,068 |
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
Research and
Development |
|
11,151 |
|
|
|
21,875 |
|
General and
Administrative |
|
4,896 |
|
|
|
5,593 |
|
Goodwill
Impairment |
|
- |
|
|
|
90,976 |
|
Intangible Asset
Impairment |
|
- |
|
|
|
18,677 |
|
Other Asset
Impairment |
|
1,800 |
|
|
|
- |
|
Loss/(Gain) on Fair Value
Remeasurement of Contingent Consideration |
|
1,519 |
|
|
|
(13,600 |
) |
Amortization of Acquired Intangible Assets |
|
- |
|
|
|
224 |
|
|
|
|
|
Total
Operating Expense |
|
19,366 |
|
|
|
123,745 |
|
|
|
|
|
Operating
Loss |
|
(17,941 |
) |
|
|
(119,677 |
) |
|
|
|
|
Investment and Other Income, Net |
|
702 |
|
|
|
780 |
|
|
|
|
|
Net
Loss Before Income Tax Benefit |
|
(17,239 |
) |
|
|
(118,897 |
) |
|
|
|
|
Income
Tax Benefit |
|
- |
|
|
|
765 |
|
|
|
|
|
Net
Loss |
$ |
(17,239 |
) |
|
$ |
(118,132 |
) |
|
Basic
and Diluted Net Loss per Common Share |
$ |
(1.40 |
) |
|
$ |
(12.61 |
) |
|
|
|
|
Shares
Used in Calculating Basic and Diluted Net Loss per Share |
|
12,297 |
|
|
|
9,370 |
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
BALANCE SHEETS DATA |
March 31, |
|
December 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
$ |
85,068 |
|
|
$ |
94,022 |
|
Other Current
Assets |
|
3,783 |
|
|
|
5,057 |
|
Property and
Equipment, net |
|
5,462 |
|
|
|
6,111 |
|
Intangible and
Other Assets, net |
|
53,264 |
|
|
|
50,619 |
|
Total Assets |
$ |
147,577 |
|
|
$ |
155,809 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
Current
Liabilities |
$ |
11,989 |
|
|
$ |
12,602 |
|
Long-Term
Liabilities |
|
22,895 |
|
|
|
19,147 |
|
Stockholders'
Equity |
|
112,693 |
|
|
|
124,060 |
|
Total Liabilities and Stockholders' Equity |
$ |
147,577 |
|
|
$ |
155,809 |
|
|
|
|
|
|
|
|
|
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