Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business
and financial highlights for the first quarter ended March 31,
2015.
"2015 began with a significant accomplishment for RINTEGA®—the
granting of Breakthrough Therapy Designation for the treatment of
adult patients with EGFRvIII-positive glioblastoma. We believe this
designation underscores RINTEGA's therapeutic potential for these
patients," said Anthony Marucci, Co-founder, President and Chief
Executive Officer. "To this end, we look forward to presenting
updated data from the ReACT study in the recurrent setting at ASCO
and eagerly await data from the fully enrolled ACT IV study in the
frontline setting.
"This momentum is further supported by our growing pipeline. In
the first quarter, we continued to advance several combination
studies specifically designed to intervene at key points of immune
regulation. The varlilumab/Opdivo® study and the
varlilumab/Yervoy®/CDX-1401 study are now both open to enrollment.
We also announced a clinical trial collaboration with Roche to
combine their anti-PDL1 agent with varlilumab in a Phase 1/2 study
that will initiate later this year. Additionally, glembatumumab
vedotin is enrolling patients in two trials with plans for a third
trial to start by year-end. Importantly, these initiatives,
including our ongoing efforts to prepare for the potential
commercial launch of RINTEGA, were further bolstered with the
successful completion of an over-subscribed public offering in
early March."
Program Updates:
RINTEGA® ("rindopepimut"; "rindo"; CDX-110), an
EGFRvIII(v3)-specific therapeutic vaccine for
glioblastoma (GBM)
- In February 2015, the U.S. Food and Drug Administration (FDA)
granted RINTEGA Breakthrough Therapy Designation for the treatment
of adult patients with EGFRvIII-positive glioblastoma.
- Enrollment was completed in late 2014 in ACT IV (n=745), the
Phase 3 registration study in newly diagnosed patients with GBM.
Interim analyses will be conducted by an independent Data Safety
and Monitoring Board at 50 and 75% of events. The first interim
analysis is expected in mid-2015.
- Data from the Phase 2 ReACT study in patients with recurrent
GBM will be presented in an oral session in the Clinical Science
Symposium "Immunotherapy for Central Nervous System Tumors:
Biomarkers and Novel Data" at the 2015 ASCO Annual Meeting on
Sunday, May 31, 2015 at 8:00 a.m. by David A. Reardon, M.D.,
Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer
Center and Associate Professor of Medicine, Harvard Medical School,
and the lead investigator of the ReACT study.
Glembatumumab vedotin ("glemba"; CDX-011), an
antibody-drug conjugate targeting gpNMB in multiple
cancers
- Patient enrollment is accelerating in the Company's Phase 2b
randomized study (METRIC) of glemba in patients with metastatic
triple negative breast cancers that overexpress gpNMB, a molecule
associated with poor outcomes for triple negative breast cancer
patients and the target of glembatumumab vedotin. To date, 95 sites
are open to enrollment across the United States, Canada
and Australia. Trial expansion into the European Union is
planned. Based on current projections, enrollment will extend into
2016.
- The METRIC study will be presented in a clinical trial in
progress poster session at the 2015 ASCO Annual Meeting on
Saturday, May 30, 2015.
- Data from the Phase 2 EMERGE study of glembatumumab vedotin in
metastatic breast cancer were published in the Journal of Clinical
Oncology. The data from this study supported the initiation of the
METRIC study.
- Patient enrollment continues in the Phase 2 study of
glembatumumab vedotin in metastatic melanoma. To date, eight of 10
planned sites are open to enrollment in the United States.
- Celldex continues to advance plans to expand the study of
glembatumumab vedotin into other cancers in which gpNMB is
expressed.
- Study design is being finalized for a Phase 2 study in squamous
cell lung cancer and the study will commence 2H 2015.
- Celldex and the National Cancer Institute have entered into a
Cooperative Research and Development Agreement (CRADA) under which
NCI will sponsor two studies of glembatumumab vedotin—one in uveal
melanoma and one in pediatric osteosarcoma. Protocols for the study
are currently being developed.
Varlilumab ("varli"; CDX-1127), a fully human monoclonal
agonist antibody that binds and activates CD27, a critical
co-stimulatory molecule in the immune activation
cascade
- In April 2015, the Company presented preclinical data that
support varlilumab's expansion into combination studies with PD-1
inhibitors in a poster session at the AACR Annual Meeting 2015.
Data demonstrated that the combination of varlilumab and anti-PD-L1
induces a potent immune-mediated effect that results in important
changes in the tumor microenvironment. Most notably, it was
observed that the combination strategy improved the ratio of
effector T cells to regulatory T cells, which was accompanied by a
reduction in the expression of PD-1 on both effector and regulatory
T cells.
- In April 2015, Celldex announced the initiation of a Phase 1/2
study examining the combination of varlilumab and ipilimumab
(Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV
metastatic melanoma. This study is currently open to enrollment. In
the Phase 2 portion of the study, patients with tumors that express
NY-ESO-1 will also receive CDX-1401, Celldex's off-the-shelf
antibody-based dendritic cell vaccine that targets tumors
expressing the NY-ESO-1 oncoprotein.
- In April 2015, Celldex announced that it had entered into a
clinical trial collaboration with Roche to evaluate the combination
of varlilumab, Celldex's CD27 targeting investigational antibody,
and MPDL3280A (anti-PDL1), Roche's investigational cancer
immunotherapy in a Phase 1/2 study in renal cell carcinoma. Under
the terms of this agreement, Roche will provide study drug and
Celldex will be responsible for conducting and funding the study,
which is expected to open to enrollment in 2H 2015.
- In January 2015, Celldex announced that enrollment had opened
in the Phase 1/2 study of varlilumab and Opdivo® in adult patients
with advanced non-small cell lung cancer, metastatic melanoma,
colorectal cancer, ovarian cancer, and head and neck squamous cell
carcinoma. This study is being conducted by Celldex under a
clinical trial collaboration with Bristol-Myers Squibb Company. The
companies are sharing development costs.
- The Phase 1b study of varlilumab and ONT-10, Oncothyreon's
therapeutic vaccine targeting the tumor-associated antigen MUC1,
continues to actively enroll patients with advanced breast or
ovarian cancer. Celldex is providing study drug and Oncothyreon is
conducting the study.
- Efforts are underway for additional Phase 2 studies of
varlilumab and the Company will provide updates on these studies as
they are initiated.
CDX-1401, an antibody-based NY-ESO-1-specific
therapeutic vaccine for multiple solid tumors
- In April 2015, Celldex announced the initiation of a Phase 1/2
study examining the combination of varlilumab and ipilimumab
(Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV
metastatic melanoma. This study is currently open to enrollment. In
the Phase 2 portion of the study, patients with tumors that express
NY-ESO-1 will also receive CDX-1401, an off-the-shelf
antibody-based dendritic cell targeted vaccine.
- Celldex continues to support several external collaborations,
including a National Cancer Institute sponsored Phase 2 study of
CDX-1401 and CDX-301 for patients with metastatic melanoma, which
is open to enrollment.
CDX-301 (recombinant human Flt3L), a potent
hematopoietic cytokine that uniquely expands dendritic cells and
hematopoietic stem cells
- CDX-301 is being developed as a combination product with other
immuno-oncology agents in a number of investigator-sponsored
studies.
- A pilot study of CDX-301 alone and in combination with Mozobil®
in hematopoietic stem cell transplantation was initiated in
September of 2014 and is open to enrollment.
First Quarter 2015 Financial Highlights and 2015
Guidance
Cash position: Cash, cash equivalents and
marketable securities as of March 31, 2015 were $359.8 million
compared to $201.0 million as of December 31, 2014. The increase
was primarily driven by net proceeds to Celldex of $188.8 million
from an underwritten financing; partially offset by our first
quarter net cash burn of $30.0 million. As of March 31, 2015
Celldex had 98.5 million shares outstanding.
Revenues: Total revenue was $0.5 million
in the first quarter of 2015 compared to $0.4 million for the
comparable period in 2014. The increase in the first quarter of
2015 was primarily due to our clinical trial collaboration with
BMS, partially offset by a decrease in revenue related to our
Rockefeller University services agreement.
R&D Expenses: Research and development
(R&D) expenses were $25.1 million in the first quarter of 2015
compared to $27.1 million for the comparable period in 2014. The
decrease in Celldex's R&D investment was primarily due to the
one-time $2.5 milestone payment incurred in the first quarter of
2014 as a result of the METRIC initiation and a decrease in ACT IV
clinical trial costs, partially offset by increases in
glembatumumab vedotin and varlilumab clinical trial costs.
G&A Expenses: General and
administrative (G&A) expenses were $6.1 million in the first
quarter of 2015 compared to $4.6 million for the comparable period
in 2014. The increase in G&A expenses was primarily
attributable to higher personnel-related expenses and RINTEGA and
glembatumumab vedotin commercial planning costs in 2015.
Net loss: Net loss was $30.2 million, or
($0.33) per share, for the first quarter of 2015 compared to a net
loss of $29.9 million, or ($0.33) per share for the comparable
period in 2014.
Financial guidance: Celldex expects that
its cash, cash equivalents and marketable securities will be
sufficient to fund our operating expenses and capital expenditure
requirements through 2017, however, this could be impacted by our
clinical data results from the RINTEGA program and their potential
impact on our pace of commercial manufacturing and the rate of
expansion of our commercial operations.
RINTEGA® is a registered trademark of Celldex Therapeutics.
Opdivo® and Yervoy® are registered trademarks of Bristol-Myers
Squibb. Mozobil® is a registered trademark of sanofi-aventis U.S.
LLC.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address
devastating diseases for which available treatments are inadequate.
Our pipeline is built from a proprietary portfolio of antibodies
and immunomodulators used alone and in strategic combinations to
create novel, disease-specific therapies that induce, enhance or
suppress the body's immune response. 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, including those related to the Company's
strategic focus and the future development and commercialization
(by Celldex and others) of RINTEGA® ("rindopepimut"; "rindo";
CDX-110), glembatumumab vedotin ("glemba"; CDX-011), varlilumab
("varli"; CDX-1127), CDX-1401, CDX-301 and other products and our
goals for 2015. 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 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 RINTEGA, glembatumumab vedotin and other 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 Breakthrough Therapy Designation for
RINTEGA, 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.
—table follows—
CELLDEX
THERAPEUTICS, INC. |
(In thousands,
except per share amounts) |
|
|
|
CONSOLIDATED
STATEMENT |
Quarter |
OF OPERATIONS
DATA |
Ended March
31, |
|
2015 |
2014 |
|
(Unaudited) |
OPERATING REVENUE |
|
|
Product Development and Licensing
Agreements |
$ 342 |
$ 35 |
Contracts and Grants |
144 |
381 |
|
|
|
Total Revenue |
486 |
416 |
|
|
|
OPERATING EXPENSE |
|
|
Research and Development |
25,125 |
27,070 |
General and Administrative |
6,089 |
4,582 |
Amortization of Acquired Intangible
Assets |
253 |
253 |
|
|
|
Total Operating Expense |
31,467 |
31,905 |
|
|
|
Operating Loss |
(30,981) |
(31,489) |
|
|
|
Investment and Other Income,
Net |
807 |
1,586 |
|
|
|
Net Loss |
$ (30,174) |
$ (29,903) |
|
|
|
Basic and Diluted Net Loss
per Common Share |
$ (0.33) |
$ (0.33) |
Weighted Average Common Shares
Outstanding |
92,437 |
89,270 |
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
BALANCE SHEETS
DATA |
March 31, |
December 31, |
|
2015 |
2014 |
|
(Unaudited) |
|
ASSETS |
|
|
Cash, Cash Equivalents and Marketable
Securities |
$ 359,773 |
$ 201,043 |
Other Current Assets |
4,356 |
3,942 |
Property and Equipment, net |
11,236 |
10,535 |
Intangible and Other Assets, net |
32,335 |
32,494 |
Total Assets |
$ 407,700 |
$ 248,014 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current Liabilities |
$ 21,148 |
$ 24,491 |
Long-Term Liabilities |
11,000 |
11,863 |
Stockholders' Equity |
375,552 |
211,660 |
Total Liabilities and Stockholders'
Equity |
$ 407,700 |
$ 248,014 |
CONTACT: Company Contact:
Sarah Cavanaugh
Vice President of Investor Relations &
Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Media Inquiries:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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