Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the third quarter ended September 30,
2015.
"Celldex continues to advance one of the most robust,
well-staged pipelines in immuno-oncology," said Anthony Marucci,
President and Chief Executive Officer of Celldex Therapeutics. "As
we move closer to final data from the ACT IV study in newly
diagnosed glioblastoma, we continue to build on the potential
promise of RINTEGA in the recurrent setting and look forward to
presenting long-term survival data from the ReACT study at the SNO
meeting later this month. In the third quarter we continued to
execute on all fronts, including enrolling patients to seven
ongoing Celldex-sponsored clinical trials. In addition, there are
now numerous investigator initiated studies ongoing with additional
concepts under discussion. We look forward to data in 2016 from
several of these studies that we believe will further support the
critical role of immunotherapy in oncology."
Program Updates:
RINTEGA® ("rindopepimut"; "rindo"; CDX-110), an
EGFRvIII(v3)-specific therapeutic vaccine for
glioblastoma (GBM)
- The ACT IV study is a randomized, double-blind, placebo
controlled study of RINTEGA plus GM-CSF added to standard of care
temozolomide in patients with newly diagnosed, surgically resected,
EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT
IV to reach the required 374 patients with minimal residual disease
(assessed by central review) needed for analysis of the primary
overall survival endpoint. All patients, including those with
disease that exceed this threshold, will be included in a secondary
analysis of overall survival as well as analyses of
progression-free survival, safety and tolerability, and quality of
life. The study design includes interim analyses conducted by an
independent Data Safety and Monitoring Board (DSMB) at 50 and 75%
of events (deaths). The first interim analysis occurred in June
2015, and the DSMB recommended continuation of the study as
planned. The Company anticipates that the study will reach the
required number of events to perform the second interim analysis in
late 2015 and that the analysis will occur in early 2016.
- As previously reported, data from the Phase 2 ReACT study in
patients with recurrent glioblastoma were presented in an oral
session at the 2015 ASCO Annual Meeting by David A. Reardon, M.D.,
Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer
Institute and Associate Professor of Medicine, Harvard Medical
School, and the lead investigator of the ReACT study. Patients on
the RINTEGA arm experienced a statistically significant overall
survival (OS) benefit, and an impressive, emerging long-term
survival benefit was observed. The primary endpoint of the study,
progression-free survival at six months (PFS6), was met, and a
clear advantage was demonstrated across multiple, clinically
important endpoints including long-term progression-free survival,
objective response rate (ORR) and need for steroids. The Company
will present an update on overall survival and long-term survival
in a podium presentation at the 20th Annual Scientific Meeting of
the Society for Neuro-Oncology (SNO) on Friday, November 20th at
1:30 PM CT/2:30 PM ET.
Glembatumumab vedotin ("glemba"; CDX-011), an
antibody-drug conjugate targeting gpNMB in multiple
cancers
- Enrollment continues in the Company's Phase 2b randomized study
(METRIC) of glembatumumab vedotin 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. Enrollment is
open across the United States, Canada and Australia.
Trial expansion into the European Union (EU) is underway, and the
Company plans to open enrollment in up to 50 sites in the EU in
early 2016. Based on current projections, enrollment will be
completed in the second half of 2016.
- Patient enrollment continues in the Phase 2 study of
glembatumumab vedotin in metastatic melanoma.
- Celldex continues to advance plans to expand the study of
glembatumumab vedotin in other cancers in which gpNMB is expressed.
- A Phase 2 study in squamous cell lung cancer is expected to
commence in Q1 2016.
- Celldex and the National Cancer Institute have entered into a
Cooperative Research and Development Agreement (CRADA) under which
the NCI will sponsor two studies of glembatumumab vedotin—one in
uveal melanoma and one in pediatric osteosarcoma.
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
- The Phase 1/2 study of varlilumab and nivolumab (Opdivo®) in
adult patients with advanced non-small cell lung cancer, metastatic
melanoma, colorectal cancer, ovarian cancer, and head and neck
squamous cell carcinoma is actively enrolling patients. This study
is being conducted by Celldex under a clinical trial collaboration
with Bristol-Myers Squibb. The companies are sharing development
costs.
- In April 2015, Celldex announced that it had entered into a
clinical trial collaboration with Roche to evaluate the combination
of varlilumab and atezolizumab (anti-PDL1) 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
Q4 2015.
- Additional combination studies of varlilumab continue to enroll
patients including:
- A Phase 1/2 safety and tolerability study examining the
combination of varlilumab and sunitinib (Sutent®) in patients with
metastatic clear cell renal cell carcinoma (CC-RCC); and,
- A Phase 1/2 safety and tolerability study examining the
combination of varlilumab and ipilimumab (Yervoy®) in patients with
Stage III or IV metastatic melanoma. In the Phase 2 portion of the
study, patients with tumors that express NY-ESO-1 will also receive
Celldex's CDX-1401.
- Celldex will present a preclinical poster on the contribution
of varlilumab's immune stimulating properties versus regulatory T
cell (Treg) depletion in multiple tumor models on Friday, November
6, 2015 at 6:15 PM ET at the 2015 Society for Immunotherapy of
Cancer (SITC) Annual Meeting.
- Oncothyreon recently completed evaluation of two dosing cohorts
in the Oncothyreon-led Phase 1b trial of ONT-10, a therapeutic
vaccine targeting the tumor-associated antigen MUC1, in combination
with varlilumab in patients with advanced breast and ovarian
cancers. Preliminary data from these two cohorts did not
demonstrate sufficient activity to move forward with the program,
and Oncothyreon does not plan to enroll additional patients in the
Phase 1b trial. Varlilumab biomarker analyses from peripheral blood
samples from this study are consistent with prior experience
including an increase in activated T cells and natural killer cells
and a decrease in regulatory T cells.
- Patient treatment in the Phase 1 dose-escalation study of
varlilumab is complete. Any incremental data updates will be
included in a future scientific presentation/publication.
- 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
- A Phase 1/2 study examining the combination of varlilumab and
ipilimumab (Yervoy®) continues to enroll patients with Stage III or
IV metastatic melanoma. 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
recently completed 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 investigator-sponsored studies.
- A pilot study of CDX-301 alone and in combination with Mozobil®
in hematopoietic stem cell transplantation was initiated in
September 2014 and is currently enrolling patients and
sibling-matched donors. The Company anticipates presenting early
data from this study in Q1 2016.
Third Quarter and First Nine Months 2015 Financial
Highlights and 2015 Guidance
Cash position: Cash, cash equivalents and
marketable securities as of September 30, 2015 were $304.6 million
compared to $334.0 million as of June 30, 2015. The decrease of
$29.4 million was primarily driven by our third quarter net cash
used in operating activities of $27.8 million. As of September 30,
2015 Celldex had 98.6 million shares outstanding.
Revenues: Total revenue was $1.0 million
in the third quarter of 2015 and $3.7 million for the nine months
ended September 30, 2015, compared to $1.1 million and $2.1 million
for the comparable periods in 2014. The increase in the nine months
ended September 30, 2015 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 $24.7 million in the third quarter of 2015
and $76.3 million for the nine months ended September 30, 2015,
compared to $26.2 million and $77.4 million for the comparable
periods in 2014.
G&A Expenses: General and
administrative (G&A) expenses were $8.5 million in the third
quarter of 2015 and $22.8 million for the nine months ended
September 30, 2015, compared to $5.0 million and $14.4 million for
the comparable periods in 2014. The increase in G&A expenses
was primarily attributable to higher personnel-related expenses as
we prepare for potential product launches and a $3.3 million
increase year to date in RINTEGA and glembatumumab vedotin
commercial planning costs over the $2.6 million spent in the
comparable period in 2014.
Net loss: Net loss was $32.0 million, or
($0.32) per share, for the third quarter of 2015 and $94.5 million,
or ($0.98) per share, for the nine months ended September 30, 2015,
compared to a net loss of $28.1 million, or ($0.31) per share and
$86.3 million, or ($0.97) per share for the comparable periods 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. Sutent® is a registered trademark of Pfizer. 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.
CELLDEX
THERAPEUTICS, INC. |
(In thousands,
except per share amounts) |
|
|
|
|
|
|
|
|
|
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CONSOLIDATED
STATEMENTS |
Quarter |
Nine
Months |
OF OPERATIONS
DATA |
Ended September
30, |
Ended September
30, |
|
2015 |
2014 |
2015 |
2014 |
|
(Unaudited) |
(Unaudited) |
REVENUE |
|
|
|
|
Product Development and |
|
|
|
|
Licensing
Agreements |
$ 377 |
$ 284 |
$ 1,053 |
$ 518 |
Contracts and Grants |
649 |
817 |
2,636 |
1,591 |
|
|
|
|
|
Total Revenue |
1,026 |
1,101 |
3,689 |
2,109 |
|
|
|
|
|
OPERATING
EXPENSE |
|
|
|
|
Research and Development |
24,656 |
26,185 |
76,271 |
77,355 |
General and Administrative |
8,487 |
5,004 |
22,761 |
14,373 |
Amortization of Acquired
Intangible Assets |
254 |
254 |
760 |
760 |
|
|
|
|
|
Total Operating
Expense |
33,397 |
31,443 |
99,792 |
92,488 |
|
|
|
|
|
Operating Loss |
(32,371) |
(30,342) |
(96,103) |
(90,379) |
|
|
|
|
|
Investment and Other Income,
Net |
391 |
2,260 |
1,590 |
4,121 |
|
|
|
|
|
Net Loss |
$ (31,980) |
$ (28,082) |
$ (94,513) |
$ (86,258) |
|
|
|
|
|
Basic and Diluted Net Loss
per |
|
|
|
|
Common
Share |
$ (0.32) |
$ (0.31) |
$ (0.98) |
$ (0.97) |
Weighted Average Common |
|
|
|
|
Shares
Outstanding |
98,568 |
89,404 |
96,518 |
89,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
BALANCE
SHEETS |
|
|
September 30, |
December 31, |
|
|
|
2015 |
2014 |
|
|
|
(Unaudited) |
|
ASSETS |
|
|
|
|
Cash, Cash Equivalents and
Marketable Securities |
$ 304,610 |
$ 201,043 |
Other Current Assets |
|
|
4,646 |
3,942 |
Property and Equipment, net |
|
|
11,864 |
10,535 |
Intangible and Other Assets,
net |
|
|
31,512 |
32,494 |
Total Assets |
|
|
$ 352,632 |
$ 248,014 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current Liabilities |
|
|
$ 23,635 |
$ 24,491 |
Long-Term Liabilities |
|
|
10,370 |
11,863 |
Stockholders' Equity |
|
|
318,627 |
211,660 |
Total
Liabilities and Stockholders' Equity |
|
$ 352,632 |
$ 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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