Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the second quarter ended June 30,
2016.
“Celldex continues to build one of the most robust pipelines in
immuno-oncology, most recently advancing CDX-014 into the clinic in
renal cell carcinoma,” said Anthony Marucci, Co-founder, President
and Chief Executive Officer of Celldex Therapeutics. “In
collaboration with our investigators, we also presented a
significant body of data in the second quarter with eight
presentations across both AACR and ASCO that spoke to the broad
utility of our product candidates in combination immunotherapy and
highlighted a number of the novel targets we are pursuing.”
“We continue to enroll patients to the pivotal METRIC study of
glembatumumab vedotin in triple negative breast cancer, with a
focus on a number of new sites in Europe that were added over the
last quarter and look forward to presenting data from the Phase 2
study of glembatumumab vedotin in metastatic melanoma later this
year,” concluded Marucci.
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, and Australia and opened in
the European Union in April, with close to 25 sites added in the EU
in the second quarter. Additional sites continue to be added to
support enrollment completion.
- Patient enrollment is complete, and the primary endpoint has
been met in the Phase 2 single-agent study of glembatumumab vedotin
in metastatic melanoma (post-progression on checkpoint therapy).
The primary endpoint of the study, objective response rate,
required a minimum of six responses in the first 52 patients to be
deemed successful. Celldex plans to present data from this study at
the European Society for Medical Oncology (ESMO) Congress in
October 2016. 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.
- 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
- The Phase 2 portion of the varlilumab and nivolumab (Opdivo®)
study opened to enrollment in April 2016. A protocol amendment was
recently finalized to include additional arms evaluating alternate
dosing schedules in both renal cell carcinoma and squamous cell
head and neck cancer. The non-small cell lung cohort was removed
prior to enrolling any patients to accommodate the addition of
these new arms. As amended, the overall study size has increased
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. Data from the Phase 1 portion (n=36) of the varlilumab
and nivolumab study were presented at the American Association for
Cancer Research (AACR) Annual Meeting in April. The combination
showed acceptable tolerability and safety across all dose levels
without any evidence of increased autoimmunity or inappropriate
immune activation. Combination therapy led to 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. 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 also suggested
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).
- Enrollment has been completed in the Phase 1 dose-escalation
portion of the Phase 1/2 study of varlilumab and atezolizumab
(Tecentriq®; anti-PDL1) in patients with multiple solid tumors. The
Company anticipates the Phase 2 portion of the study in renal cell
carcinoma will be initiated in the third quarter of this year. 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. The Company anticipates
the Phase 1 portion of the study will complete enrollment in the
next few months and that the Phase 2 portion of the study will
initiate by year-end.
- 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.
- As discussed above, a Phase 2 study of varlilumab and
glembatumumab vedotin in metastatic melanoma (post-progression on
checkpoint therapy).
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 (n=60 patients; not selected for NY-ESO-1 expression).
Initial data from this study were presented at the 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.
CDX-014, an antibody-drug conjugate
(ADC) targeting the transmembrane protein T-cell immunoglobulin
mucin-1 (TIM-1) in renal cell carcinoma
- In July 2016, Celldex announced that enrollment had opened in
the Phase 1 dose-escalation portion of the Company’s Phase 1/2
study of CDX-014 in advanced clear cell and papillary renal cell
carcinoma (RCC). The Phase 1 study will evaluate 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. Study closure activities are
substantially complete, and Celldex continues to anticipate that
the Company will not incur substantial additional costs related to
RINTEGA at this time. Celldex is in the process of conducting a
thorough review of the data and plans to present the ACT IV results
at the Society for Neuro-Oncology Annual Meeting in November of
2016. 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.
Second Quarter and First Six Months 2016 Financial
Highlights and Updated 2016 Guidance
Cash position: Cash, cash equivalents and
marketable securities as of June 30, 2016 were $220.1 million
compared to $254.0 million as of March 31, 2016. The decrease was
primarily driven by our second quarter cash used in operating
activities of $33.8 million, $5.9 million of which were
RINTEGA-related payments. At June 30, 2016, Celldex had 99.4
million shares outstanding.
Revenues: Total revenue was $1.4 million in the
second quarter of 2016 and $2.7 million for the six months ended
June 30, 2016, compared to $2.2 million and $2.7 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 $25.7 million in the second quarter of 2016
and $53.2 million for the six months ended June 30, 2016, compared
to $26.5 million and $51.6 million for the comparable periods in
2015.
The decrease in R&D expenses of $0.8 million between the
three-month periods was primarily due to lower clinical costs of
$3.2 million, offset in part by increased contract manufacturing
costs of $0.8 million and personnel costs of $1.6 million,
including higher stock-based compensation of $0.8 million.
The increase in R&D expenses of $1.6 million between the
six-month periods was primarily due to higher contract
manufacturing and other contract service costs and personnel costs,
including higher stock-based compensation of $1.3 million, offset
by lower clinical costs.
G&A Expenses: General and administrative
(G&A) expenses were $7.8 million in the second quarter of 2016
and $17.1 million for the six months ended June 30, 2016, compared
to $8.2 million and $14.3 million for the comparable periods in
2015.
The decrease in G&A expenses of $0.4 million between the
three-month periods was primarily due to lower commercial planning
costs of $1.1 million, partially offset by higher stock-based
compensation of $0.7 million.
The $2.8 million increase in G&A expenses between the
six-month periods was primarily due to higher stock-based
compensation of $1.8 million, facility costs and legal costs.
Net loss: Net loss was $32.0 million, or
($0.32) per share, for the second quarter of 2016 and $66.6
million, or ($0.67) per share, for the six months ended June 30,
2016, compared to a net loss of $32.4 million, or ($0.33) per share
and $62.5 million, or ($0.65) per share for the comparable periods
in 2015.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 2016
combined with the anticipated proceeds from future sales of our
common stock under our $60 million sales agreement with Cantor
Fitzgerald & Co. are sufficient to meet estimated working
capital requirements and fund planned operations through 2018.
Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET
today to discuss 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 53265640.
A replay of the call will be available approximately two hours
after the live call concludes through August 15, 2016. To access
the replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 53265640. 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. Tecentriq® is
a registered trademark of Genentech. 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter |
|
Six Months |
STATEMENTS OF |
|
Ended June 30, |
|
Ended June 30, |
OPERATIONS
DATA |
|
Consolidated |
|
|
|
Consolidated |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUE |
|
|
|
|
|
|
|
|
Product
Development and |
|
|
|
|
|
|
|
|
Licensing Agreements |
|
$ |
604 |
|
|
$ |
334 |
|
|
$ |
1,057 |
|
|
$ |
676 |
|
Contracts and Grants |
|
|
785 |
|
|
|
1,844 |
|
|
|
1,635 |
|
|
|
1,988 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
1,389 |
|
|
|
2,178 |
|
|
|
2,692 |
|
|
|
2,664 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
|
|
|
|
Research
and Development |
|
|
25,711 |
|
|
|
26,490 |
|
|
|
53,158 |
|
|
|
51,615 |
|
General and
Administrative |
|
|
7,790 |
|
|
|
8,184 |
|
|
|
17,097 |
|
|
|
14,273 |
|
Amortization of Acquired Intangible Assets |
|
|
|
254 |
|
|
|
254 |
|
|
|
507 |
|
|
|
507 |
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
33,755 |
|
|
|
34,928 |
|
|
|
70,762 |
|
|
|
66,395 |
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
(32,366 |
) |
|
|
(32,750 |
) |
|
|
(68,070 |
) |
|
|
(63,731 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
414 |
|
|
|
391 |
|
|
|
1,445 |
|
|
|
1,198 |
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(31,952 |
) |
|
$ |
(32,359 |
) |
|
$ |
(66,625 |
) |
|
$ |
(62,533 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and
Diluted Net Loss per |
|
|
|
|
|
|
|
|
Common Share |
|
$ |
(0.32 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.67 |
) |
|
$ |
(0.65 |
) |
Weighted
Average Common |
|
|
|
|
|
|
|
|
Shares Outstanding |
|
|
98,817 |
|
|
|
98,482 |
|
|
|
98,753 |
|
|
|
95,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE |
|
|
|
|
|
Consolidated |
|
SHEETS
DATA |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash, Cash Equivalents
and Marketable Securities |
|
|
|
|
|
|
|
|
$ |
220,128 |
|
|
$ |
289,889 |
|
Other
Current Assets |
|
|
|
|
|
|
8,654 |
|
|
|
5,047 |
|
Property
and Equipment, net |
|
|
|
|
|
|
11,293 |
|
|
|
11,461 |
|
Intangible
and Other Assets, net |
|
|
|
|
|
|
31,131 |
|
|
|
31,187 |
|
Total Assets |
|
|
|
|
|
$ |
271,206 |
|
|
$ |
337,584 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
$ |
20,003 |
|
|
$ |
30,240 |
|
Long-Term
Liabilities |
|
|
|
|
|
|
16,494 |
|
|
|
17,239 |
|
Stockholders' Equity |
|
|
|
|
|
|
234,709 |
|
|
|
290,105 |
|
Total
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
$ |
271,206 |
|
|
$ |
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
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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