Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the first quarter ended March 31,
2017.
“In the first quarter of 2017, Celldex made considerable
progress across our pipeline,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “We
continue to expect enrollment completion in our ongoing study of
glembatumumab vedotin in triple negative breast cancer by the end
of September, and we recently completed enrollment in the Phase 2
glembatumumab vedotin plus varlilumab combination cohort in
checkpoint-refractory metastatic melanoma. Glemba’s target, gpNMB,
is highly expressed in melanoma and triple negative breast cancer,
among others, and is associated with more aggressive disease. We
believe taking an antibody-drug conjugate approach to targeting
gpNMB generates a potent cytotoxic effect within the tumor and its
environment and may ultimately result in improved outcomes for
patients.”
“We also look forward to presenting data from two programs in
oral sessions at ASCO in June—the Phase 2 single-agent study of
glembatumumab vedotin in metastatic melanoma and the Phase 1
combination study of varlilumab and Opdivo.”
Recent Highlights
- Continued progress in METRIC enrollment:
Celldex continues to expect that enrollment will be completed by
the end of September 2017. METRIC is a Phase 2b randomized study of
glembatumumab vedotin in patients with metastatic triple negative
breast cancers that overexpress gpNMB.
- Single-agent glembatumumab vedotin Phase 2 study in
checkpoint-refractory metastatic melanoma accepted for oral
presentation at ASCO: Updated data from the single-agent
cohort of the Phase 2 study will be presented in an oral
presentation at the 2017 American Society of Clinical Oncology
(ASCO) Annual Meeting in June. Enrollment recently completed in the
glembatumumab vedotin and varlilumab arm, with data from this
portion of the study expected in the fall of 2017. Enrollment
continues in the glembatumumab vedotin plus checkpoint inhibitor
(Opdivo® or Keytruda®) arm in patients who failed prior checkpoint
therapy, a population with limited treatment options.
- Phase 1 varlilumab/Opdivo® study accepted for oral
presentation at ASCO: Updated data from the Phase 1
portion of the varlilumab and Opdivo study will be presented in an
oral presentation at the 2017 ASCO Annual Meeting in June. The
Phase 2 portion of the combination study includes cohorts in
colorectal cancer, ovarian cancer, head and neck squamous cell
carcinoma, renal cell carcinoma and glioblastoma, and is currently
enrolling patients. The Company plans to complete enrollment across
all cohorts in the Phase 2 portion of the study in the first
quarter of 2018 and will work with Bristol-Myers Squibb to present
data from the study at a future medical meeting. Data from the
Phase 1 single-agent study of varlilumab in solid tumors were
recently published in the Journal of Clinical Oncology.
- Phase 1 study of CDX-0158 continues to enroll
patients: This dose escalation study in patients with
advanced refractory gastrointestinal stromal tumors (GIST) and
other KIT-positive tumors is designed to determine the maximum
tolerated dose, recommend a dose for further study and characterize
the safety profile of CDX-0158. Data from the study continue to be
expected by year-end 2017.
- CDX-3379 advancing to Phase 2: The Company is
currently finalizing plans for advancement into a Phase 2 study in
combination with cetuximab in patients with cetuximab-resistant
advanced head and neck squamous cell carcinoma.
- Enrollment ongoing in Phase 1 study of
CDX-014: The study in advanced renal cell carcinoma (clear
cell and papillary) is designed to determine the maximum tolerated
dose and to recommend a dose level for further study. Celldex
continues to expect the Phase 1 dose-escalation portion of the
study will complete enrollment by year-end 2017.
First Quarter 2017 Financial Highlights and Updated 2017
Guidance
Cash position: Cash, cash equivalents and
marketable securities as of March 31, 2017 were $167.0 million
compared to $189.8 million as of December 31, 2016. The decrease
was primarily driven by our first quarter cash used in operating
activities of approximately $35.3 million which included a payment
of $4.7 million in accrued amounts to a vendor of Kolltan. This
obligation was assumed in the Kolltan acquisition. This decrease
was partially offset by the receipt of $12.8 million from sales of
our common stock under our Cantor agreement. At March 31, 2017,
Celldex had 124.2 million shares outstanding.
Revenues: Total revenue was $1.5 million in the
first quarter of 2017, compared to $1.3 million for the comparable
period in 2016. The increase in revenue was primarily due to our
clinical trial collaboration with Bristol-Myers Squibb and our
research and development agreement with Rockefeller University.
R&D Expenses: Research and development
(R&D) expenses were $25.8 million in the first quarter of 2017,
compared to $27.4 million for the comparable period in 2016. The
decrease in R&D expenses was primarily due to a decrease in
Rintega product development expenses of $7.3 million, partially
offset by increases in glembatumumab vedotin, CDX-0158 and CDX-3379
product development expenses of $1.8 million, $0.8 million and $0.7
million, respectively, and increases in personnel and facility
costs related to the Kolltan acquisition.
G&A Expenses: General and administrative
(G&A) expenses were $7.2 million in the first quarter of 2017,
compared to $9.3 million for the comparable period in 2016. The
decrease in G&A expenses was primarily due to a decrease in
Rintega commercial planning costs of $2.0 million.
Loss on Fair Value Remeasurement of Contingent
Consideration: In connection with the Kolltan Acquisition,
we agreed to pay Kolltan’s stockholders milestone payments of up to
$172.5 million in the event that certain specified preclinical and
clinical development milestones related to Kolltan’s development
programs and/or our development programs and certain commercial
milestones related to Kolltan’s drug candidates are achieved. These
milestone payments may be made in cash, in shares of our common
stock or a combination of both, subject to NASDAQ listing
requirements and provisions of the merger agreement. The range of
estimated milestone payments is from zero, if no milestones are
achieved, to $172.5 million if all milestones are met. We record
the fair value of these obligations to pay additional milestone
payments using various estimates, including probabilities of
success, discount rates and amount of time until the conditions of
the milestone payments are met. The $3.4 million loss on fair value
remeasurement of contingent consideration relates to an increase in
the estimate of the fair value of the contingent consideration
primarily due to changes in discount rates and the passage of
time.
Net loss: Net loss was $34.3 million, or
($0.28) per share, for the first quarter of 2017, compared to a net
loss of $34.7 million, or ($0.35) per share, for the comparable
period in 2016.
Financial guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31, 2017
combined with the anticipated proceeds from future sales of our
common stock under our Cantor agreement, are sufficient to meet
estimated working capital requirements and fund planned operations
through 2018; however, this guidance assumes we are able to and
elect to pay future Kolltan contingent milestones, if any, in stock
rather than cash.
Opdivo® is a registered trademark of Bristol-Myers Squibb.
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address
devastating diseases for which available treatments are inadequate.
Our pipeline includes antibodies, antibody-drug conjugates and
other protein-based therapeutics 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 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 integrate the business and programs of Kolltan with
our business and programs; our ability to successfully complete
research and further development and commercialization of
glembatumumab vedotin and other 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; 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; our ability to maintain and
derive benefit from the Fast Track designation for glembatumumab
vedotin which does not change the standards for regulatory approval
or guarantee regulatory approval on an expedited basis, or at all;
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.
|
|
CELLDEX THERAPEUTICS,
INC. |
|
(In thousands, except
per share amounts) |
|
|
|
|
|
|
CONSOLIDATED STATEMENT |
|
|
Quarter |
|
OF OPERATIONS
DATA |
|
|
Ended March 31, |
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
OPERATING REVENUE |
|
|
|
|
|
|
Product
Development |
|
|
and
Licensing Agreements |
|
|
$ |
556 |
|
|
$ |
453 |
|
|
Contracts and Grants |
|
|
|
978 |
|
|
|
850 |
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
|
1,534 |
|
|
|
1,303 |
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
|
|
|
|
|
|
Research
and Development |
|
|
|
25,793 |
|
|
|
27,447 |
|
|
General and
Administrative |
|
|
|
7,229 |
|
|
|
9,307 |
|
|
Loss on
Fair Value Remeasurement of Contingent Consideration |
|
|
3,400 |
|
|
|
- |
|
|
Amortization of Acquired Intangible Assets |
|
|
|
224 |
|
|
|
253 |
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
|
36,646 |
|
|
|
37,007 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
|
(35,112 |
) |
|
|
(35,704 |
) |
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
|
851 |
|
|
|
1,031 |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
$ |
(34,261 |
) |
|
$ |
(34,673 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
Diluted Net Loss per |
|
|
|
|
|
|
|
|
|
|
|
Common
Share |
|
|
$ |
(0.28 |
) |
|
$ |
(0.35 |
) |
|
Weighted
Average Common |
|
|
|
|
|
|
|
|
|
|
|
Shares
Outstanding |
|
|
|
122,648 |
|
|
|
98,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED |
|
|
|
|
|
|
BALANCE SHEETS
DATA |
|
|
March 31, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
$ |
167,023 |
|
|
$ |
189,776 |
|
|
Other
Current Assets |
|
|
|
6,440 |
|
|
|
5,793 |
|
|
Property
and Equipment, net |
|
|
|
12,411 |
|
|
|
13,192 |
|
|
Intangible
and Other Assets, net |
|
|
|
174,174 |
|
|
|
174,597 |
|
|
|
Total
Assets |
|
|
$ |
360,048 |
|
|
$ |
383,358 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
27,024 |
|
|
$ |
35,223 |
|
|
Long-Term
Liabilities |
|
|
|
85,188 |
|
|
|
82,704 |
|
|
Stockholders' Equity |
|
|
|
247,836 |
|
|
|
265,431 |
|
|
|
Total
Liabilities and Stockholders' Equity |
|
|
$ |
360,048 |
|
|
$ |
383,358 |
|
|
|
|
|
|
|
|
|
|
|
|
Company Contact
Sarah Cavanaugh
Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Associate Director of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
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