Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the fourth quarter and year ended
December 31, 2015.
“2015 was a year of considerable progress for Celldex and our
growing pipeline,” said Anthony Marucci, President and Chief
Executive Officer of Celldex Therapeutics. “Most importantly, we
completed the Phase 2 ReACT Study of RINTEGA in recurrent GBM,
confirming a highly statistically significant long-term overall
survival benefit. RINTEGA continues to tell a very consistent,
impressive story across multiple, clinically relevant endpoints in
both the recurrent and newly diagnosed setting, supporting our
belief that RINTEGA will be an important treatment option for all
patients with EGFRvIII-positive glioblastoma. With this in mind, we
look forward to completing the Phase 3 ACT IV trial in the newly
diagnosed setting and are confident we are preparing appropriately
for potential commercialization.”
“In addition to the strides made in the RINTEGA program, we
continued to execute across the entire pipeline in 2015, initiating
four new combination studies for the varlilumab program and
continuing to enroll patients to ongoing studies of glembatumumab
vedotin in both triple negative breast cancer and metastatic
melanoma. We also have multiple studies advancing across our
earlier-stage product candidates and recently received notice that
our IND is now active for CDX-014, our ADC targeting TIM-1. We look
forward to initiating the first Phase 1/2 study in renal cell
carcinoma for this candidate this year. We are also finalizing
preparations with Bristol-Myers Squibb to advance the varlilumab
combination study with nivolumab into a broad Phase 2 program. With
data reporting from multiple studies across our pipeline in 2016
and into early 2017, we believe the next twelve to eighteen months
have the potential to be transformational for the Company,”
concluded Marucci.
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) for superiority
and futility 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 required number of events
to perform the second interim analysis were reached in late 2015,
and the analysis will occur in March 2016. Final data from ACT IV
are expected by the end of 2016, although our expectations
regarding the timing for the final data read out may change based
on event rates.
- As previously reported, mature survival data from the Phase 2
ReACT study in patients with recurrent glioblastoma were presented
in a podium presentation at the 20th Annual Scientific Meeting of
the Society for Neuro-Oncology (SNO) 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 [hazard ratio = 0.53 (0.32, 0.88); p=0.0137],
and an impressive, long-term survival benefit was observed. At two
years, the survival rate for RINTEGA patients was 25% versus 0% for
control patients in the intent to treat (ITT) population, with five
patients extending beyond two years. 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. 33% of
patients on the RINTEGA arm who were receiving steroids at baseline
were able to stop steroids for six months or longer compared to
none on the control arm.
- As part of an ongoing initiative to expand RINTEGA’s potential
product profile, Celldex intends to initiate additional studies of
RINTEGA in 2016 including:
- A study designed to evaluate RINTEGA when administered earlier
in the treatment regimen in newly diagnosed glioblastoma. Patients
will receive RINTEGA administered after surgery but prior to and
concurrently with chemoradiation. In clinical trials conducted to
date in the front-line setting, RINTEGA has been administered after
surgery but upon completion of chemoradiation. This study is
expected to initiate in the second half of 2016.
- A study designed to evaluate the role alternative immune
modifiers could play in combination with RINTEGA. Previous studies
of RINTEGA have utilized GM-CSF. This new study will utilize
imiquimod. Imiquimod is a topically administered immune response
modifier that has broad commercial availability and could
potentially serve as a second source of adjuvant if needed,
especially outside the United States where GM-CSF is currently
available through specialty distribution channels. The study is
expected to initiate in March.
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. The
Company plans to open enrollment in up to 50 sites in the EU
beginning in the first quarter of 2016, and enrollment is expected
to be completed in the second half of 2016.
- Patient enrollment continues in the Phase 2 study of
glembatumumab vedotin in metastatic melanoma and is expected to be
completed in the first half of 2016 with data presented at an
appropriate medical meeting in the second half of 2016.
- 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 Q2 2016.
- Celldex and the National Cancer Institute (NCI) have entered
into a Cooperative Research and Development Agreement (CRADA) under
which the NCI is sponsoring two studies of glembatumumab
vedotin—one in uveal melanoma and one in pediatric osteosarcoma.
Both studies are currently open to enrollment.
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 multiple solid tumors has completed enrollment
to the dose escalation Phase 1 portion of the study. Celldex and
Bristol-Myers Squibb have decided to advance this combination into
Phase 2. While a maximum tolerated dose was not reached in Phase 1,
a 3 mg/kg varlilumab dose has been identified for study in Phase 2.
We anticipate the Phase 2 portion of the study will open to
enrollment in the second quarter of 2016 and will include cohorts
in advanced non-small cell lung cancer, colorectal cancer, ovarian
cancer, head and neck squamous cell carcinoma, renal cell carcinoma
and glioblastoma. This study is being conducted by Celldex under a
clinical trial collaboration with Bristol-Myers Squibb. The
companies are sharing development costs.
- The Phase 1/2 study of varlilumab and atezolizumab (anti-PDL1)
is currently enrolling patients with multiple solid tumors in the
dose escalation Phase 1 portion of the study. The Phase 2 portion
of the study will be conducted in renal cell carcinoma. This study
is being conducted by Celldex under a clinical trial collaboration
with Roche. Roche is providing study drug, and Celldex is
responsible for conducting and funding the study.
- 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).
- A Phase 1/2 safety and tolerability study examining the
combination of varlilumab and ipilimumab 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 presented a preclinical poster on the contribution of
varlilumab’s immune stimulating properties versus regulatory T cell
(Treg) depletion in multiple tumor models in November at the 2015
Society for the Immunotherapy of Cancer (SITC) Annual Meeting.
Results suggested that cancers may respond to CD27 immune
modulation by independent mechanisms, such as immune co-stimulation
and regulatory T cell (Treg) depletion. Varlilumab has the unique
ability to act through both of these mechanisms.
CDX-1401, an antibody-based NY-ESO-1-specific
therapeutic vaccine for multiple solid tumors
- As discussed above, a Phase 1/2 study examining the
combination of varlilumab and ipilimumab 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 an NCI sponsored Phase 2 study of CDX-1401 and CDX-301
for patients with metastatic melanoma, which recently completed
enrollment. Based on results to date, plans for additional studies
are being considered by NCI. Additionally, Roswell Park Cancer
Center is conducting an investigator sponsored study evaluating
CDX-1401, poly-ICLC (Hiltonol®) and the IDO1 inhibitor epacadostat
(INCB24360) in patients in remission with ovarian, fallopian
tube or primary peritoneal cancer. Patients’ tumors must have
expressed NY-ESO-1 or the LAGE-1 antigen to be eligible for the
study. Celldex is providing CDX-1401 and poly-ICLC in support of
this study.
CDX-301 (recombinant human Flt3L), a potent
hematopoietic cytokine that uniquely expands dendritic cells and
hematopoietic stem cells
- A pilot study of CDX-301 alone and in combination with
plerixafor (Mozobil®) in hematopoietic stem cell transplantation
(HSCT) is currently enrolling patients and sibling-matched donors.
The Company presented early data from the non-plerixafor treated
arm in this study in February at the annual meeting of the American
Society for Blood and Marrow Transplantation. Three donor/patient
pairs showed that CDX-301 given as a single agent was well
tolerated and effective at mobilizing hematopoietic stem cells in
healthy donors. The stem cell graft contained notable increases in
naïve lymphocytes and plasmacytoid dendritic cells consistent with
preclinical data suggesting a possible better outcome. Recipients
experienced successful engraftment in an expected time frame.
Additional subjects are being accrued to assess the potential
synergy of combining CDX-301 with plerixafor in this setting.
- CDX-301’s potential activity is also being explored in a Phase
1/2 study of CDX-301 and poly-ICLC in combination with low-dose
radiotherapy in patients with low-grade B-cell lymphomas conducted
by the Icahn School of Medicine at Mount Sinai.
Fourth Quarter and Twelve Months 2015 Financial
Highlights and 2016 Guidance
Cash position: Cash, cash equivalents and
marketable securities as of December 31, 2015 were $289.9 million
compared to $304.6 million as of September 30, 2015. The decrease
was primarily driven by our fourth quarter cash used in operating
activities of approximately $22.9 million, partly offset by the
receipt of $9.2 million from the sale of New Jersey tax benefits.
As of December 31, 2015 Celldex had 98.7 million shares
outstanding.
Revenues: Total revenue was $1.8 million in the
fourth quarter of 2015 and $5.5 million for the twelve months ended
December 31, 2015, compared to $1.5 million and $3.6 million for
the comparable periods in 2014. 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 $23.9 million in the fourth quarter of 2015
and $100.2 million for the twelve months ended December 31, 2015,
compared to $27.0 million and $104.4 million for the comparable
periods in 2014. R&D expenses include stock-based compensation
expense of $2.0 million and $6.2 million in the three- and
twelve-month periods ended December 31, 2015 compared to $1.1
million and $3.5 million for the comparable periods in 2014.
G&A Expenses: General and administrative
(G&A) expenses were $11.1 million in the fourth quarter of 2015
and $33.8 million for the twelve months ended December 31, 2015,
compared to $6.2 million and $20.6 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 commercialization and a $6.5 million increase in RINTEGA
and glembatumumab vedotin commercial planning costs in 2015 as
compared to 2014. G&A expenses include stock-based compensation
expense of $2.1 million and $6.6 million in the three- and
twelve-month periods ended December 31, 2015 compared to $1.0
million and $3.4 million for the comparable periods in 2014.
Net loss: Net loss was $32.7 million, or
($0.33) per share, for the fourth quarter of 2015 and $127.2
million, or ($1.31) per share, for the twelve months ended December
31, 2015, compared to a net loss of $31.8 million, or ($0.36) per
share, and $118.1 million, or ($1.32) 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.
Webcast and Conference Call
Celldex executives will host a conference call at 8:00 a.m. ET
today to discuss 2015 financial and business results and to provide
an update on key 2016 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 50465153.
A replay of the call will be available approximately two hours
after the live call concludes through March 3, 2016. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 50465153. The
webcast will also be archived on the Company's website.
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. Hiltonol® is a
registered trademark of Oncovir.
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, CDX-014 and other products
and our goals for 2016. 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated |
|
|
|
Consolidated |
STATEMENTS |
|
Quarter Ended |
|
Year Ended |
OF OPERATIONS
DATA |
|
December 31, |
|
December 31, |
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
(Unaudited) |
|
|
REVENUE |
|
|
|
|
|
|
|
|
Product
Development and |
|
|
Licensing
Agreements |
|
$ |
389 |
|
|
$ |
320 |
|
|
$ |
1,442 |
|
|
$ |
838 |
|
Contracts and Grants |
|
|
1,401 |
|
|
|
1,157 |
|
|
|
4,038 |
|
|
|
2,748 |
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
1,790 |
|
|
|
1,477 |
|
|
|
5,480 |
|
|
|
3,586 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
|
|
|
|
Research
and Development |
|
|
23,900 |
|
|
|
27,026 |
|
|
|
100,171 |
|
|
|
104,381 |
|
General and
Administrative |
|
|
11,075 |
|
|
|
6,249 |
|
|
|
33,837 |
|
|
|
20,622 |
|
Amortization of Acquired Intangible Assets |
|
|
253 |
|
|
|
253 |
|
|
|
1,013 |
|
|
|
1,013 |
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
35,228 |
|
|
|
33,528 |
|
|
|
135,021 |
|
|
|
126,016 |
|
|
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
(33,438 |
) |
|
|
(32,051 |
) |
|
|
(129,541 |
) |
|
|
(122,430 |
) |
|
|
|
|
|
|
|
|
|
Investment
and Other Income, Net |
|
|
754 |
|
|
|
230 |
|
|
|
2,344 |
|
|
|
4,350 |
|
Interest Expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(32,684 |
) |
|
$ |
(31,821 |
) |
|
$ |
(127,197 |
) |
|
$ |
(118,080 |
) |
|
Basic and
Diluted Net Loss |
|
|
per
Common Share |
|
$ |
(0.33 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares Outstanding |
|
98,633 |
|
|
|
89,559 |
|
|
|
97,051 |
|
|
|
89,399 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated |
CONDENSED BALANCE
SHEETS |
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
$ |
289,889 |
|
|
$ |
201,043 |
|
Other
Current Assets |
|
|
|
5,047 |
|
|
|
3,942 |
|
Property
and Equipment, net |
|
|
|
11,461 |
|
|
|
10,535 |
|
Intangible
and Other Assets, net |
|
|
|
31,187 |
|
|
|
32,494 |
|
|
Total Assets |
|
|
$ |
337,584 |
|
|
$ |
248,014 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
30,240 |
|
|
$ |
24,491 |
|
Long-Term
Liabilities |
|
|
|
17,239 |
|
|
|
11,863 |
|
Stockholders' Equity |
|
|
|
290,105 |
|
|
|
211,660 |
|
|
Total Liabilities and
Stockholders' Equity |
|
|
$ |
337,584 |
|
|
$ |
248,014 |
|
|
|
|
|
|
|
|
|
|
|
Company Contact:
Sarah Cavanaugh
Vice President of Investor Relations &
Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Manager of Investor Relations &
Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
Media Inquiries:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Apr 2023 to Apr 2024