Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business
and financial highlights for the fourth quarter and year ended
December 31, 2014.
"2014 was another important year for Celldex, most notably for
our lead product candidate, rindopepimut, which was recently issued
the trade name Rintega®," said Anthony Marucci, Co-founder,
President and Chief Executive Officer. "We completed enrollment in
our Phase 3 study in newly diagnosed glioblastoma and reported
positive interim PFS-6 and overall survival data from our Phase 2
ReACT study in patients with recurrent GBM. Most recently, based on
these data, Rintega was issued Breakthrough Designation from the
FDA."
"In addition to the significant progress made with Rintega, we
advanced a number of key programs across our pipeline. The FDA and
central European regulatory authorities reviewed the revised
protocol design for glembatumumab vedotin in triple negative breast
cancer and we continue to believe with positive results that the
METRIC study could be suitable for full marketing approval in both
the US and Europe. Enrollment is accelerating in the METRIC study
and we have initiated a second Phase 2 glemba study in metastatic
melanoma. Varlilumab is now active in multiple combination studies,
including a study with Opdivo®, and will enter several new studies
later this year. Studies have also initiated for combination
approaches with CDX-1401 and CDX-301. We look forward to continuing
to build on this momentum in 2015 as we drive the Rintega program
towards completion and advance what we believe is one of the most
robust, well-staged pipelines in immuno-oncology," concluded
Marucci.
Program Updates:
Rintega® ("rindopepimut"; "rindo"; CDX-110) in
EGFRvIII(v3)-Positive 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.
- In December 2014, enrollment was completed (n=745) in ACT IV,
the Phase 3 registration study in newly diagnosed patients with
GBM. ACT IV is the most comprehensive study conducted by a biotech
company to date in this orphan disease and by far the largest study
ever conducted in the EGFRvIII patient population. 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.
- In November 2014, positive interim data from the Phase 2 ReACT
study in patients with recurrent GBM were presented in a platform
presentation at the 19th Annual Meeting of the Society for
Neuro-Oncology (SNO). Rintega plus bevacizumab was very well
tolerated. In bevacizumab-naïve patients treated with both Rintega
and bevacizumab, a statistically significant overall survival (OS)
benefit was reported (p=0.0208) with a hazard ratio of 0.47 (0.25,
0.91) in favor of the Rintega treated patients with early and
consistent separation of the curves (median difference of 12.0
versus 8.8 months). Progression-free survival at six months (PFS-6)
by investigator read was also positive with 27% of patients treated
with Rintega still progression-free compared to 11% of control
patients (p=0.048). Both OS and PFS-6 data continue to mature.
Final data is anticipated by mid-year and the Company intends to
present this data at a peer-reviewed medical meeting in this same
time frame.
- In October 2014, the United States Patent and Trademark Office
issued a registration mark for Rintega, the trade name for
rindopepimut. Rintega is also a registered trademark in Canada, the
European Union and Japan.
Glembatumumab vedotin ("glemba"; CDX-011) 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 glemba. To date, 95 sites are open to
enrollment across the United States,
Canada and Australia. In November 2014, the Company
announced that the protocol was amended to align with current
clinical practice, to pursue approval in Europe and to improve
enrollment. The FDA and central European regulatory authorities
have since reviewed the revised protocol design and the Company
continues to believe the METRIC study could support marketing
approval in both the US and Europe dependent upon data review.
Trial expansion into the European Union will be initiated this
year. Based on current projections, enrollment will extend into
2016.
- In December 2014, a Phase 2 study of glemba in metastatic
melanoma was initiated and is open to enrollment.
- Celldex continues to advance plans to expand the study of
glembatumumab vedotin into other cancers in which gpNMB is
expressed.
- Assay optimization and validation for a Phase 2 study in
squamous cell lung cancer was completed in late 2014 and the study
will commence in 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.
Varlilumab ("varli"; CDX-1127), an immune modulating mAb
targeting CD27 in solid tumors and hematologic
malignancies:
- In November 2014, the Company presented data from the completed
solid tumor and B cell malignancy dose escalation cohorts and the
solid tumor expansion cohorts at the Society for the Immunotherapy
of Cancer (SITC) Annual Meeting. The study continues to maintain a
very favorable safety profile and proof of concept has been
observed with strong biological activity and clinical benefit in
selected patients including:
- An ongoing complete response in a patient with Hodgkin lymphoma
(18.9+ months)
- An ongoing partial response in a patient with renal cell
carcinoma (11.0+ months) that has continued to decrease in tumor
volume over time
- 13 patients with stable disease (3 - 30.7+ months)
- In May 2014, Celldex announced that it had entered into a
clinical trial collaboration with Bristol-Myers Squibb Company
(BMS) to evaluate the safety, tolerability and preliminary efficacy
of Opdivo and varlilumab in a Phase 1/2 study 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, which is being conducted by Celldex, is open
to enrollment.
- In May 2014, Celldex announced that it had entered into a
clinical trial collaboration with Oncothyreon Inc. to evaluate the
safety, tolerability and preliminary efficacy of varlilumab and
ONT-10, Oncothyreon's therapeutic vaccine targeting the
tumor-associated antigen MUC1, in a Phase 1b study in patients with
advanced breast or ovarian cancer. This study, which is being
conducted by Oncothyreon, is open to enrollment.
- Multiple efforts are underway for additional Phase 2 studies of
varlilumab and the Company will provide updates on these studies as
they are initiated, including but not limited to:
- A Phase 1/2 study of varlilumab and ipilimumab in patients with
metastatic melanoma; plus CDX-1401 in NY-ESO-1 positive
patients
- A Phase 1/2 study of varlilumab plus sunitinib in renal cell
carcinoma
- A Phase 1/2 study of varlilumab plus a mek pathway agent
(followed sequentially by a checkpoint inhibitor) for patients with
B-raf mutated metastatic melanoma
CDX-1401, an antibody-based dendritic cell targeted
vaccine aimed at tumors expressing the NY-ESO-1
oncoprotein:
- In April 2014, Celldex published Phase 1 results in Science
Translational Medicine.
- CDX-1401 was well tolerated, demonstrated potent immune
responses and 29% stable disease (median, 6.7 months).
- Data suggest that CDX-1401 may predispose patients to better
response to checkpoint blockade; 6 of 8 patients that received
checkpoint inhibitors as next therapy had significant clinical
responses.
- 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
- Additional studies of CDX-1401 combined with immune modulators
are planned to initiate in 2015, including in combination with
varlilumab and ipilimumab in NY-ESO-1 positive melanoma.
CDX-301 (Flt3L), a potent hematopoietic cytokine that
stimulates the expansion and differentiation of hematopoietic stem
cells and dendritic cells:
- 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.
Fourth Quarter and Twelve Months 2014 Financial
Highlights and 2015 Guidance
Cash position: Cash, cash equivalents and marketable
securities as of December 31, 2014 were $201.0 million compared to
$224.1 million as of September 30, 2014. The decrease was primarily
driven by our fourth quarter net cash burn of $23.1 million. As of
December 31, 2014 Celldex had 89.6 million shares outstanding.
Revenues: Total revenue was $1.5 million in the fourth
quarter of 2014 and $3.6 million for the twelve months ended
December 31, 2014, compared to $0.6 million and $4.1 million for
the comparable periods in 2013. The increase in the fourth quarter
of 2014 was primarily due to our clinical trial collaboration with
BMS and our Rockefeller University services agreement. The decrease
in the twelve months ended December 31, 2014 was primarily due to
the decrease in Rotarix® royalty revenue. Our agreement with
GlaxoSmithKline terminated upon the anticipated expiration of the
last relevant patent right covered by the GlaxoSmithKline
agreement. We do not expect additional royalty revenue or royalty
expense related to Rotarix.
R&D Expenses: Research and development (R&D)
expenses were $27.0 million in the fourth quarter of 2014 and
$104.4 million for the twelve months ended December 31, 2014,
compared to $17.8 million and $67.4 million for the comparable
periods in 2013. The increase in Celldex's R&D investment was
primarily due to the continued progression of our late-stage
clinical development programs, Rintega and glembatumumab vedotin,
and the continued expansion of the varlilumab program. During the
twelve months ended December 31, 2014 and 2013, we incurred $45.6
million and $32.3 million in clinical trial expense and $20.9
million and $6.6 million in contract manufacturing expense,
respectively.
G&A Expenses: General and administrative (G&A)
expenses were $6.2 million in the fourth quarter of 2014 and $20.6
million for the twelve months ended December 31, 2014, compared to
$4.7 million and $14.8 million for the comparable periods in 2013.
The increase in G&A expenses was primarily attributable to
higher personnel-related expenses and Rintega and glembatumumab
vedotin commercial planning costs in 2014.
Net loss: Net loss was $31.8 million, or ($0.36) per share,
for the fourth quarter of 2014 and $118.1 million, or ($1.32) per
share, for the twelve months ended December 31, 2014, compared to a
net loss of $22.1 million, or ($0.27) per share and $81.6 million,
or ($1.02) per share for the comparable periods in 2013.
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
2016, 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® is a registered trademark of Bristol-Myers Squibb. Mozobil®
is a registered trademark of sanofi-aventis U.S. LLC. Rotarix® is a
registered trademark of GlaxoSmithKline.
Webcast and Conference Call
Celldex executives will host a conference call at 8:00 a.m. ET
today to discuss 2014 financial and business results and to provide
an update on key 2015 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 (866) 743-9666 (within the United States) or (760) 298-5103
(outside the United States). The passcode is 89115872.
A replay of the call will be available approximately two hours
after the live call concludes through March 2, 2015. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 89115872. The
webcast will also be archived on the Company's website.
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 2014. 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
rindopepimut, 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
STATEMENTS |
Quarter
Ended |
Year
Ended |
OF OPERATIONS
DATA |
December
31, |
December
31, |
|
2014 |
2013 |
2014 |
2013 |
|
(Unaudited) |
|
REVENUE |
|
|
|
|
Product Development and Licensing
Agreements |
$ 320 |
$ 43 |
$ 838 |
$ 160 |
Contracts and Grants |
1,157 |
577 |
2,748 |
1,617 |
Product Royalties |
-- |
-- |
-- |
2,334 |
|
|
|
|
|
Total Revenue |
1,477 |
620 |
3,586 |
4,111 |
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
Research and Development |
27,026 |
17,804 |
104,381 |
67,401 |
Royalty |
-- |
-- |
-- |
2,334 |
General and Administrative |
6,249 |
4,677 |
20,622 |
14,805 |
Amortization of Acquired Intangible
Assets |
253 |
253 |
1,013 |
1,013 |
|
|
|
|
|
Total Operating Expense |
33,528 |
22,734 |
126,016 |
85,553 |
|
|
|
|
|
Operating Loss |
(32,051) |
(22,114) |
(122,430) |
(81,442) |
|
|
|
|
|
Investment and Other Income, Net |
230 |
137 |
4,350 |
819 |
Interest Expense |
-- |
(85) |
-- |
(927) |
|
|
|
|
|
Net Loss |
$ (31,821) |
$ (22,062) |
$ (118,080) |
$ (81,550) |
|
|
|
|
|
Basic and Diluted Net Loss per Common
Share |
$ (0.36) |
$ (0.27) |
$ (1.32) |
$ (1.02) |
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares
Outstanding |
89,559 |
83,042 |
89,399 |
79,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
BALANCE
SHEETS |
|
|
December 31, |
December 31, |
|
|
|
2014 |
2013 |
|
|
|
|
|
ASSETS |
|
|
|
|
Cash, Cash Equivalents and Marketable
Securities |
|
|
$ 201,043 |
$ 302,983 |
Other Current Assets |
|
|
3,942 |
2,206 |
Property and Equipment, net |
|
|
10,535 |
9,973 |
Intangible and Other Assets, net |
|
|
32,494 |
31,933 |
Total Assets |
|
|
$ 248,014 |
$ 347,095 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
Current Liabilities |
|
|
$ 24,491 |
$ 20,350 |
Long-Term Liabilities |
|
|
11,863 |
6,950 |
Stockholders' Equity |
|
|
211,660 |
319,795 |
Total Liabilities and
Stockholders' Equity |
|
|
$ 248,014 |
$ 347,095 |
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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