Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the first quarter ended March 31,
2016.
“While the recent setback of the RINTEGA program was certainly a
disappointment, the Company is focused on executing across the
breadth and depth of our pipeline, including six ongoing
company-led clinical trials—the pivotal METRIC study in triple
negative breast cancer, two Phase 2 studies across a broad range of
indications and multiple Phase 1/2 studies that are actively
enrolling patients,” said Anthony Marucci, Co-founder, President
and Chief Executive Officer of Celldex Therapeutics.
“To this end, Celldex and our collaborators presented seven
posters at the recent AACR meeting across multiple compounds in our
pipeline and introduced a new preclinical program that has
identified promising agonist antibodies targeting the CD40
receptor. Most importantly, we reported favorable safety and immune
monitoring data from the Phase 1 study of varlilumab and Opdivo®.
The Phase 2 study enrolled its first patients last month and will
continue to add to a wealth of data slated for presentation later
in 2016 and throughout 2017, including the presentation of Phase 2
data from the glembatumumab vedotin study in metastatic melanoma
later this year. With the recent realignment of our pipeline, we
believe our current cash position will carry us through the first
half of 2018, allowing us to read out all current ongoing studies
and to initiate several new studies, as well,” concluded
Marucci.
Program Updates:
RINTEGA® (“rindopepimut”; “rindo”; CDX-110), an
EGFRvIII(v3)-specific therapeutic vaccine for
glioblastoma (GBM)
- In March, Celldex announced that the independent Data Safety
and Monitoring Board (DSMB) determined, based on a preplanned
interim analysis, that continuation of the Phase 3 ACT IV study of
RINTEGA in patients with newly diagnosed EGFRvIII-positive
glioblastoma would not reach statistical significance for overall
survival in patients with minimal residual disease, the primary
endpoint of the study, as both the RINTEGA arm and the control arm
were performing on par with each other. In the ACT IV study,
RINTEGA performed consistently with prior Phase 2 studies, but the
control arm significantly outperformed expectations. Based on this
recommendation, Celldex discontinued the study and does not
anticipate incurring substantial additional costs related to
RINTEGA at this time. The Company is conducting an analysis of the
data and plans to present the study at a future scientific/medical
meeting or in a peer-reviewed publication. All patients on the
RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing
compassionate use recipients have been offered ongoing access to
RINTEGA on a compassionate use basis.
Glembatumumab vedotin ("glemba"; CDX-011), an
antibody-drug conjugate (ADC) 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 and recently
opened in the European Union, with the goal of completing
enrollment by year-end 2016.
- Patient enrollment is complete in the Phase 2 single-agent
study of glembatumumab vedotin in metastatic melanoma. The Company
is currently amending the protocol to add a second cohort of
patients to a glembatumumab vedotin and varlilumab combination arm
to assess the potential clinical benefit of the combination and to
explore varlilumab’s potential biologic and immunologic effect when
combined with an ADC. The Company expects to present data from the
single-agent cohort at an appropriate medical meeting in the second
half of 2016.
- Celldex is also evaluating glembatumumab vedotin in other
cancers in which gpNMB is expressed.
- Celldex has entered into a collaborative relationship with
PrECOG, LLC, which represents a research network established by the
Eastern Cooperative Oncology Group (ECOG), and PrECOG, LLC is
conducting a Phase 1/2 study in squamous cell lung cancer. This
study opened to enrollment in April 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.
- Data enhancing the understanding of glembatumumab vedotin’s
mechanism of action and further validation of the overexpression of
its target, gpNMB, in a wide range of tumor types
were presented at the American Association for Cancer Research
(AACR) Annual Meeting 2016 in April. Using a validated
immunohistochemistry (IHC) assay to detect the expression of gpNMB,
the Company examined tissues from multiple types of solid tumors
and normal tissue. Overexpression of gpNMB in samples of tumor
tissue versus normal tissue was found in squamous cell carcinoma of
the lung (85%), osteosarcoma (62%), pancreatic cancer (55%), lung
adenocarcinoma (45%) and squamous cell carcinoma of the head and
neck (40%). These results support the potential broad applicability
of gpNMB as a therapeutic target across a wide range of tumor
types. In addition, in a preclinical study investigating resistance
mechanisms in melanoma, glembatumumab vedotin demonstrated
synergies with therapies for BRAF mutated melanoma and overcame
phenotypes associated with resistance, suggesting use of
glembatumumab vedotin may be particularly effective as a
single-agent or in combination in this refractory patient
population.
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 2 portion of the varlilumab and nivolumab (Opdivo®)
study opened to enrollment in April 2016. The study includes
cohorts in advanced non-small cell lung cancer (n=35), colorectal
cancer (n=18), ovarian cancer (n=18), head and neck squamous cell
carcinoma (n=18), renal cell carcinoma (n=25) and glioblastoma
(n=20). The study is being conducted by Celldex under a clinical
trial collaboration with Bristol-Myers Squibb Company. The
companies are sharing development costs.
- Data were presented from the Phase 1 portion of the varlilumab
and nivolumab study in a poster at the AACR Annual Meeting in April
2016. The Phase 1 portion of the study, conducted in patients with
solid tumors, has completed enrollment (n=36) and primarily
enrolled patients with colorectal and ovarian cancer. The primary
objective of the Phase 1 portion of the study was to evaluate the
safety and tolerability of the combination.
- The combination showed acceptable tolerability and safety
across all dose levels without any evidence of increased
autoimmunity or inappropriate immune activation.
- Marked changes in the tumor microenvironment including
increased infiltrating CD8+ T cells and increased PD-L1 expression,
which have been shown to correlate with a greater magnitude of
treatment effect from checkpoint inhibitors in other clinical
studies, were observed.
- Additional favorable immune biomarkers, such as increase in
inflammatory chemokines and decrease in T regulatory cells, were
also noted.
- In a subset of patients (n=17) on study who had both pre- and
post-tumor biopsies available, preliminary evidence suggest a
correlation between biomarker data and stable disease or better in
seven of these patients (4 ovarian cancer, 2 colorectal cancer, 1
squamous cell carcinoma of the head and neck).
- 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 (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, an NY-ESO-1-antibody fusion protein for
immunotherapy.
CDX-1401, an NY-ESO-1-antibody fusion protein for
immunotherapy
- 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.
- 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 has 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
- The Company presented early data from the pilot study of
CDX-301 alone and in combination with plerixafor (Mozobil®) in
hematopoietic stem cell transplantation (HSCT) in February at the
annual meeting of the American Society for Blood and Marrow
Transplantation (ASBMT). Data on three donor/patient pairs from the
non-plerixafor treated arm 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. Given that hematopoietic stem cell
transplantation is outside of Celldex’s core focus, in an effort to
prioritize human and capital resources, the Company has decided not
to advance CDX-301 in this particular indication at this time and
instead to focus near-term efforts on its potential role in
combination immunotherapy.
- CDX-301’s potential activity is 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.
First Quarter 2016 Financial Highlights and Updated 2016
Guidance
Cash position: Cash, cash equivalents and
marketable securities as of March 31, 2016 were $254.0 million
compared to $289.9 million as of December 31, 2015. The decrease
was primarily driven by our first quarter cash used in operating
activities of approximately $34.9 million. As of March 31, 2016
Celldex had 98.7 million shares outstanding.
Revenues: Total revenue was $1.3 million in the
first quarter of 2016, compared to $0.5 million for the comparable
period in 2015. The increase in revenue was primarily due to our
clinical trial collaboration with Bristol-Myers Squibb, our
research and development agreement with Rockefeller University and
an increase in grant revenue.
R&D Expenses: Research and development
(R&D) expenses were $27.4 million in the first quarter of 2016,
compared to $25.1 million for the comparable period in 2015. The
increase in R&D expenses was primarily attributable to
increased headcount.
G&A Expenses: General and administrative
(G&A) expenses were $9.3 million in the first quarter of 2016,
compared to $6.1 million for the comparable period in 2015. The
increase in G&A expenses was primarily due to higher
stock-based compensation of $1.1 million, increased headcount, and
RINTEGA and glembatumumab vedotin commercial planning costs.
Net loss: Net loss was $34.7 million, or
($0.35) per share, for the first quarter of 2016, compared to a net
loss of $30.2 million, or ($0.33) per share, for the comparable
periods in 2015.
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 the first half of 2018.
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 glembatumumab vedotin ("glemba";
CDX-011), varlilumab (“varli”; CDX-1127) 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 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 complete research and further
development and commercialization of 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 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STATEMENTS
OF |
|
|
Consolidated Quarter |
|
Quarter |
|
OPERATIONS
DATA |
|
|
Ended March
31, |
Ended March
31, |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(Unaudited) |
|
OPERATING
REVENUE |
|
|
|
|
|
|
Product Development |
|
|
and Licensing
Agreements |
|
|
$ |
453 |
|
|
$ |
342 |
|
|
Contracts and Grants |
|
|
|
850 |
|
|
|
144 |
|
|
|
|
|
|
|
|
Total Revenue |
|
|
|
1,303 |
|
|
|
486 |
|
|
|
|
|
|
|
|
OPERATING
EXPENSE |
|
|
|
|
|
|
Research and Development |
|
|
|
27,447 |
|
|
|
25,125 |
|
|
General and Administrative |
|
|
|
9,307 |
|
|
|
6,089 |
|
|
Amortization of Acquired Intangible
Assets |
|
|
|
253 |
|
|
|
253 |
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
|
37,007 |
|
|
|
31,467 |
|
|
|
|
|
|
|
|
Operating Loss |
|
|
|
(35,704 |
) |
|
|
(30,981 |
) |
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
|
1,031 |
|
|
|
807 |
|
|
|
|
|
|
|
|
Net Loss |
|
|
$ |
(34,673 |
) |
|
$ |
(30,174 |
) |
|
|
Basic
and Diluted Net Loss per |
|
|
Common Share |
|
|
$ |
(0.35 |
) |
|
$ |
(0.33 |
) |
|
Weighted Average Common |
|
|
|
|
Shares Outstanding |
|
|
|
98,689 |
|
|
|
92,437 |
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
BALANCE |
|
|
Consolidated |
|
|
|
SHEETS
DATA |
|
|
March 31, |
|
December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(Unaudited) |
|
ASSETS |
|
|
|
|
|
|
Cash,
Cash Equivalents and Marketable Securities |
|
$ |
254,017 |
|
|
$ |
289,889 |
|
|
Other
Current Assets |
|
|
|
6,938 |
|
|
|
5,047 |
|
|
Property and Equipment, net |
|
|
|
11,392 |
|
|
|
11,461 |
|
|
Intangible and Other Assets, net |
|
|
|
29,584 |
|
|
|
31,187 |
|
|
|
Total
Assets |
|
|
$ |
301,931 |
|
|
$ |
337,584 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
$ |
25,307 |
|
|
$ |
30,240 |
|
|
Long-Term Liabilities |
|
|
|
16,592 |
|
|
|
17,239 |
|
|
Stockholders' Equity |
|
|
|
260,032 |
|
|
|
290,105 |
|
|
|
Total Liabilities
and Stockholders' Equity |
|
|
$ |
301,931 |
|
|
$ |
337,584 |
|
|
|
|
|
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
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