Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the third quarter ended September 30,
2016.
“Celldex continues to demonstrate our commitment to combining
therapeutic approaches to drive innovation in immuno-oncology for
patients and their families,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “In
the third quarter, we presented important data from our Phase 2
study of glembatumumab vedotin in checkpoint-refractory metastatic
melanoma at ESMO, meeting the primary overall response endpoint and
demonstrating clinically meaningful duration of response in this
difficult-to-treat setting. Building on these promising signals, we
are now enrolling a combination arm with our CD27 agonist,
varlilumab, and are in the process of finalizing an additional arm
to explore a glembatumumab vedotin and checkpoint inhibitor
combination.”
“Last week, we also announced the proposed acquisition of
Kolltan Pharmaceuticals. This transaction would add a highly
compatible platform of unique antibodies targeting receptor
tyrosine kinases to our pipeline that we believe can be developed
both independently and in combination with Celldex's existing
product candidates. We are in the process of finalizing our
integrated clinical development strategy and look forward to
outlining these plans after closing the transaction. As multi-drug
combination regimens become the standard in oncology, we fully
recognize that the development programs to explore these
opportunities become increasingly complex. We believe Celldex is
well positioned to meet this challenge and will draw upon the
leadership and expertise of Elizabeth Crowley, whom we promoted to
the newly created role of Chief Product Development Officer in the
third quarter,” concluded Marucci.
Business Update:
Proposed Acquisition of Kolltan
Pharmaceutics
- On November 1, 2016, Celldex announced that the Company entered
into a definitive agreement to acquire Kolltan Pharmaceuticals,
Inc., a privately held clinical-stage company focused on the
discovery and development of novel, antibody-based drugs targeting
receptor tyrosine kinases (RTKs). Kolltan has reported clinical and
preclinical data that its drug candidates can help overcome tumor
resistance mechanisms associated with current tyrosine kinase
inhibitors and seen in patients who have failed other cancer
therapies. Celldex believes Kolltan’s clinical candidates and
preclinical platform are highly compatible with the Company’s
scientific approach and can be developed independently and in
combination with Celldex’s existing product candidates. The
transaction, which is subject to the receipt of Kolltan stockholder
approval and other customary closing conditions, is expected to be
completed by year-end. Upon closing, the following programs would
be included in Celldex’s pipeline:
- KTN0158 – a humanized monoclonal antibody that is a potent
inhibitor of KIT activation and receptor dimerization in tumor
cells and mast cells, which is currently in a Phase 1 dose
escalation study in refractory gastrointestinal stromal tumors
(GIST).
- KTN3379 – a human monoclonal antibody designed to block the
activity of ErbB3 (HER3), which recently completed a Phase 1b study
with combination cohorts where meaningful responses and stable
disease were observed in cetuximab (Erbitux®) refractory patients
in head and neck squamous cell carcinoma and in BRAF-mutant
non-small cell lung cancer (NSCLC).
- A multi-faceted TAM program – a broad antibody discovery effort
underway to generate antibodies that modulate the TAM family of
RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on
tumor-infiltrating macrophages, dendritic cells and some tumors.
Research supports TAMs having broad application and potential
across immuno-oncology and inflammatory diseases.
Program Updates:
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, Australia and the European
Union. Enrollment rates have increased, and the Company anticipates
providing guidance in early 2017 on projected enrollment
completion.
- Data from the Phase 2 single-agent study of glembatumumab
vedotin in metastatic melanoma, post-progression on checkpoint
therapy, were presented in October at the European Society for
Medical Oncology (ESMO) Congress. The primary endpoint of the study
(6 or more objective responses in the first 52 patients enrolled)
was exceeded. 7 of 62 (11%) patients experienced a confirmed
response, and an additional 3 patients also experienced single
time-point responses. The median duration of response in this
heavily pre-treated patient population was 6.0 months, and the
median progression-free survival (PFS) for all patients was 4.4
months.As previously announced, the Company has amended 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. This additional cohort is open to enrollment. The Company is
exploring opening a new arm in the study to assess a glembatumumab
vedotin and checkpoint inhibitor combination. This rationale is
strongly supported by preclinical data that suggest that the
anti-tumor activity may be enhanced with the
combination.
- 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.
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
- Preclinical data on combination regimens with varlilumab are
expected to be presented at the American Society of Hematology
Annual Meeting in December 2016.
- The Phase 2 portion of the varlilumab and nivolumab (Opdivo®)
study opened to enrollment in April 2016 and includes cohorts in
colorectal cancer (n=18), ovarian cancer (n=18), head and neck
squamous cell carcinoma (n=48), renal cell carcinoma (n=75) 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.
- Enrollment has been completed in the Phase 1 dose-escalation
portion of the Phase 1/2 study of varlilumab and Tecentriq®
(atezolizumab) in patients with multiple solid tumors. 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.
- Enrollment is expected to complete by year-end in the Phase 1
portion of 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.
- As discussed above, a Phase 2 study of varlilumab and
glembatumumab vedotin in metastatic melanoma (post-progression on
checkpoint therapy) continues to enroll patients.
- 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 was opened to enrollment in
April 2015. Since initiating the study, the standard of care has
evolved, and there has been increasing physician reluctance to use
Yervoy in this setting. As such, given the broad development
strategy in place for varlilumab, the Company has decided to close
this study.
CDX-1401, an NY-ESO-1-antibody fusion protein for
immunotherapy
- 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 (n=60 patients; not selected
for NY-ESO-1 expression). Data from this study were presented at
the 2016 American Society of Clinical Oncology (ASCO) Annual
Meeting. The data confirmed that CDX-1401 is effective at driving
NY-ESO-1 immunity and further demonstrated the value of CDX-301 as
a combination agent for enhancing tumor-specific immune response.
Based on results to date, plans for additional studies are being
considered, including a targeted study in NY-ESO-1 positive disease
to determine if these enhanced immune responses can translate to
improved clinical outcomes.
- 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 the number of
dendritic cells to prime the immune system for more robust immune
responses to cancer antigens
- As outlined above, data were presented from the Phase 2 study
of CDX-1401 and CDX-301 in metastatic melanoma that further
demonstrated the value of CDX-301 as a combination agent for
enhancing tumor-specific immune response. CDX-301 greatly expanded
peripheral blood dendritic cells and was highly effective at
increasing cancer antigen specific T cells and antibodies when
combined with CDX-1401. These results, which also showed rapid
cellular immune responses in a majority of patients, suggests that
pre-treatment with CDX-301 could provide a highly applicable,
effective immunologic approach.
- 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. Data from this
study will be shared in an oral presentation at the American
Society of Hematology Annual Meeting in December 2016.
CDX-014, an antibody-drug conjugate
(ADC) targeting the transmembrane protein T-cell immunoglobulin
mucin-1 (TIM-1) in renal cell carcinoma
- Enrollment continues in the Phase 1 dose-escalation portion of
the Phase 1/2 study of CDX-014 in advanced clear cell and papillary
renal cell carcinoma (RCC). The Phase 1 study is evaluating cohorts
of patients receiving increasing doses of CDX-014 to determine the
maximum tolerated dose and a recommended dose for Phase 2
study.
RINTEGA® (“rindopepimut”; “rindo”; CDX-110), an
EGFRvIII(v3)-specific therapeutic vaccine for
glioblastoma (GBM)
- As previously disclosed, in March, during a pre-planned interim
analysis, the independent Data Safety and Monitoring Board (DSMB)
recommended discontinuation of the Phase 3 ACT IV study of RINTEGA
(rindopepimut) in patients (n=745) with newly diagnosed
EGFRvIII-positive glioblastoma. Data from this study will be
presented in a plenary session at the Society for Neuro-Oncology
Annual Meeting in November. The Company continues to guide that it
will not incur substantial additional costs related to RINTEGA at
this time.
CDX-1140, a fully human antibody targeted to CD40 that
has demonstrated potent agonist activity.
- Preclinical data supporting this program will be presented at
the Society for Immunotherapy of Cancer Annual Meeting in November
2016 and at the American Society of Hematology Annual Meeting in
December 2016.
Third Quarter and First Nine Months 2016 Financial
Highlights and Updated 2016 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2016 were $203.2 million
compared to $220.1 million as of June 30, 2016. The decrease was
primarily driven by our third quarter cash used in operating
activities of $24.0 million. At September 30, 2016, Celldex had
101.2 million shares outstanding.
Revenues: Total revenue was $2.2 million in the
third quarter of 2016 and $4.9 million for the nine months ended
September 30, 2016, compared to $1.0 million and $3.7 million for
the comparable periods in 2015. Total revenue was primarily derived
from 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 $25.0 million in the third quarter of 2016
and $78.2 million for the nine months ended September 30, 2016,
compared to $24.7 million and $76.3 million for the comparable
periods in 2015.
The increase in R&D expenses of $0.4 million between the
three-month periods was primarily due to higher contract
manufacturing of $1.7 million and personnel costs of $1.1 million,
including higher stock-based compensation of $0.3 million, offset
in part by lower clinical costs of $2.4 million.
The $1.9 million increase in R&D expenses between the
nine-month periods was primarily due to higher contract
manufacturing costs of $4.0 million and personnel costs of $4.9
million, including higher stock-based compensation of $1.6 million,
offset by lower clinical costs of $8.1 million.
G&A Expenses: General and administrative
(G&A) expenses were $7.0 million in the third quarter of 2016
and $24.0 million for the nine months ended September 30, 2016,
compared to $8.5 million and $22.8 million for the comparable
periods in 2015.
The decrease in G&A expenses of $1.5 million between the
three-month periods was primarily due to lower commercial planning
costs of $0.4 million and lower personnel costs of $0.6 million,
including lower stock-based compensation of $0.4 million.
The $1.2 million increase in G&A expenses between the
nine-month periods was primarily due to higher stock-based
compensation of $1.4 million, offset by lower commercial planning
costs of $0.3 million.
Net Loss: Net loss was $29.6 million, or
($0.29) per share, for the third quarter of 2016 and $96.2 million,
or ($0.97) per share, for the nine months ended September 30, 2016,
compared to a net loss of $32.0 million, or ($0.32) per share and
$94.5 million, or ($0.98) per share for the comparable periods in
2015.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at September 30,
2016 combined with the anticipated proceeds from future sales of
our common stock under the Cantor agreement, are sufficient to meet
estimated working capital requirements and fund planned operations,
including the proposed acquisition and integration of Kolltan
Pharmaceuticals, through 2018; however, this could be impacted if
we elected to pay Kolltan's shareholders contingent milestones in
cash.
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. Tecentriq® is
a registered trademark of Genentech. Hiltonol® is a registered
trademark of Oncovir. Erbitux® is a registered trademark of Eli
Lilly & Co.
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. These statements are typically preceded by
words such as “believes,” “expects,” “anticipates,” “intends,”
“will,” “may,” “should,” or similar expressions. These
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, the ability
of Kolltan and the Company to satisfy the closing conditions of the
acquisition, including the risk that Kolltan’s stockholders may not
approve the merger; our ability to successfully integrate the
business and programs of Kolltan with our business and programs;
our ability to successfully complete research and further
development and commercialization of glembatumumab vedotin and
other Company and Kolltan 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 (or which Kolltan has initiated or
plans 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 and Kolltan’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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter |
|
Nine Months |
STATEMENTS |
|
Ended September 30, |
|
Ended September 30, |
OF OPERATIONS
DATA |
|
Consolidated |
|
|
|
Consolidated |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUE |
|
|
|
|
|
|
|
|
Product
Development and |
|
|
Licensing
Agreements |
|
$ |
493 |
|
|
$ |
377 |
|
|
$ |
1,551 |
|
|
$ |
1,053 |
|
Contracts and Grants |
|
|
1,727 |
|
|
|
649 |
|
|
|
3,362 |
|
|
|
2,636 |
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
2,220 |
|
|
|
1,026 |
|
|
|
4,913 |
|
|
|
3,689 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
|
|
|
|
Research
and Development |
|
|
25,009 |
|
|
|
24,656 |
|
|
|
78,168 |
|
|
|
76,271 |
|
General and
Administrative |
|
|
6,950 |
|
|
|
8,487 |
|
|
|
24,049 |
|
|
|
22,761 |
|
Amortization of Acquired Intangible Assets |
|
254 |
|
|
|
254 |
|
|
|
760 |
|
|
|
760 |
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
32,213 |
|
|
|
33,397 |
|
|
|
102,977 |
|
|
|
99,792 |
|
|
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
(29,993 |
) |
|
|
(32,371 |
) |
|
|
(98,064 |
) |
|
|
(96,103 |
) |
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
395 |
|
|
|
391 |
|
|
|
1,841 |
|
|
|
1,590 |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(29,598 |
) |
|
$ |
(31,980 |
) |
|
$ |
(96,223 |
) |
|
$ |
(94,513 |
) |
|
Basic and
Diluted Net Loss per |
|
|
Common
Share |
|
$ |
(0.29 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.97 |
) |
|
$ |
(0.98 |
) |
Weighted
Average Common |
|
|
|
Shares
Outstanding |
|
|
100,672 |
|
|
|
98,568 |
|
|
|
99,398 |
|
|
|
96,518 |
|
|
|
|
|
|
|
|
|
|
CONDENSED |
|
|
Consolidated |
|
|
BALANCE
SHEETS |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
$ |
203,248 |
|
|
$ |
289,889 |
|
Other
Current Assets |
|
|
|
6,466 |
|
|
|
5,047 |
|
Property
and Equipment, net |
|
|
|
11,355 |
|
|
|
11,461 |
|
Intangible
and Other Assets, net |
|
|
|
30,878 |
|
|
|
31,187 |
|
|
Total
Assets |
|
|
$ |
251,947 |
|
|
$ |
337,584 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
18,630 |
|
|
$ |
30,240 |
|
Long-Term
Liabilities |
|
|
|
16,225 |
|
|
|
17,239 |
|
Stockholders' Equity |
|
|
|
217,092 |
|
|
|
290,105 |
|
|
Total Liabilities and Stockholders' Equity |
|
|
$ |
251,947 |
|
|
$ |
337,584 |
|
|
|
|
|
|
|
|
Company Contact
Sarah Cavanaugh
Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Associate Director of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
Media Inquiries
Dan Budwick
BrewLife
(973) 271-6085
dbudwick@brewlife.com
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