Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the fourth quarter and year ended
December 31, 2017. The Company will host a conference call at 4:30
p.m. ET today to provide an in-depth update on its pipeline and
upcoming milestones for 2018.
“2017 was a significant year for Celldex. Notably we completed
enrollment in the METRIC study of glembatumumab vedotin for
patients with triple negative breast cancer whose tumors
overexpress gpNMB. We are hopeful that glemba will offer patients,
families and caregivers a potential new option, where there are few
approved therapies and none that target gpNMB, which is associated
with a more aggressive form of the disease,” said Anthony Marucci,
Co-founder, President and Chief Executive Officer of Celldex
Therapeutics. “We anticipate topline primary endpoint data from the
study will be available in the second quarter of 2018.”
"We also made considerable progress across our pipeline in the
fourth quarter, including initiating the Phase 2 study of CDX-3379
in combination with Erbitux for patients with advanced head and
neck squamous cell carcinoma and the Phase 1 study of CDX-1140, a
CD40 agonist antibody that we believe holds great potential as an
immune activating agent. Both of these antibodies are engineered to
be best-in-class molecules. Recently, we completed enrollment in
the glemba plus checkpoint inhibitor cohort in our Phase 2
metastatic melanoma study and also in all cohorts in the varlilumab
plus Opdivo collaborative Phase 2 study with BMS. In 2018, we
expect to present data across multiple programs and execute across
our clinical pipeline of novel biologics to improve outcomes and
change the standard of care for patients who suffer from
life-threatening diseases.”
Recent Highlights
- Topline primary endpoint data from the METRIC study of
glembatumumab vedotin in triple negative breast cancer anticipated
in the second quarter of 2018: Enrollment was closed
in August 2017 with 327 patients whose tumors overexpressed gpNMB.
Patients were randomized 2 to 1 to either glembatumumab vedotin or
to Xeloda® (capecitabine). The primary endpoint of the study is
progression-free survival (PFS), which is defined as the time from
randomization to the earlier of disease progression or death due to
any cause. The study calls for 203 progression events for
evaluation of the primary endpoint, which will be assessed based on
an independent, central reading of patient scans. The sum of the
data, including the secondary endpoints of response rate, overall
survival (OS), duration of response and safety, will be important
in assessing clinical benefit. Efforts to ensure delivery of
manufactured drug that is ready for commercialization and a
companion diagnostic are underway. As previously disclosed, Celldex
made the decision to stage some of the more costly work in these
areas to begin after the Company has received results from the
study. Assuming positive data, Celldex plans to work with the FDA
on a regulatory strategy that would support submitting a Biologics
License Application (BLA) in the second half of 2019.
- Fourth arm added to glembatumumab vedotin Phase 2 study
in metastatic melanoma: Enrollment has opened in a
glembatumumab vedotin plus CDX-301 cohort for patients who failed
checkpoint therapy. Enrollment recently completed in the
glembatumumab vedotin plus checkpoint inhibitor cohort.
- Enrollment complete in Phase 2 varlilumab/Opdivo®
collaborative study: Enrollment was completed in
January 2018. Cohorts include colorectal cancer (n=21), ovarian
cancer (n=58), head and neck squamous cell carcinoma (n=24), renal
cell carcinoma (n=14) and glioblastoma (n=22). The primary
objective of the Phase 2 cohorts is objective response rate (ORR),
except glioblastoma, where the primary objective is the rate of
12-month OS. Secondary objectives include pharmacokinetic
assessments, determining the immunogenicity of varlilumab when
given in combination with Opdivo, evaluating alternate dosing
schedules of varlilumab and further assessing the anti-tumor
activity of combination treatment. Working with Bristol-Myers
Squibb, data from the study will be presented at appropriate
medical meetings in 2018.
- Initiated Phase 2 study of CDX-3379/Erbitux® in head
and neck squamous cell carcinoma: In November 2017,
Celldex opened enrollment to an open-label Phase 2 study in
combination with Erbitux in approximately 30 patients with HPV
negative, Erbitux-resistant, advanced head and neck squamous cell
carcinoma. Patients must have been treated previously with an
anti-PD1 checkpoint inhibitor, a population with limited options
and a particularly poor prognosis. The primary objective of the
study is ORR. Secondary objectives include assessments of clinical
benefit rate, duration of response, PFS and OS, and safety and
pharmacokinetics associated with the combination.
- Ongoing Phase 1 study of CDX-014 expanded to include
patients with ovarian cancer: Enrollment is ongoing
in a Phase 1 study of CDX-014, an antibody-drug conjugate that
targets TIM-1. The study initially enrolled patients with both
clear cell and papillary renal cell carcinoma. In January 2018, we
amended the protocol, expanding enrollment to include patients with
ovarian clear cell carcinoma, an indication where TIM-1 expression
is also upregulated, and enabling the evaluation of alternate
dosing regimens. The study includes a dose-escalation portion
across three separate cohorts to determine the maximum tolerated
dose (MTD) followed by expansion cohorts of up to 15 patients each
to assess the preliminary anti-tumor activity of CDX-014, as
measured by ORR. Secondary objectives include safety and
tolerability, pharmacokinetics, immunogenicity and additional
measures of anti-tumor activity.
- Initiated Phase 1 study of CDX-1140: A
Phase 1 study of CDX-1140 was initiated in November 2017. The study
is expected to enroll up to approximately 105 patients with
recurrent, locally advanced or metastatic solid tumors and is
designed to determine the MTD during a dose-escalation phase and to
recommend a dose level for further study in a subsequent expansion
phase. The expansion is designed to further evaluate the
tolerability and biologic effects of selected dose(s) of CDX-1140
in specific tumor types. Secondary objectives include assessments
of safety and tolerability, pharmacodynamics, pharmacokinetics,
immunogenicity and additional measures of anti-tumor activity,
including clinical benefit rate. The Company believes that the
potential for CDX-1140 will be best defined in combination studies
with other immunotherapies or conventional cancer treatments.
Fourth Quarter and Twelve Months 2017 Financial
Highlights and 2018 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2017 were $139.4 million
compared to $140.5 million as of September 30, 2017. The decrease
was primarily driven by fourth quarter cash used in operating
activities of $19.5 million and partially offset by $18.4 million
in net proceeds from sales of common stock under the Cantor
agreement. At December 31, 2017, Celldex had 138.5 million shares
outstanding.
Revenues: Total revenue was $3.5 million in the
fourth quarter of 2017 and $12.7 million for the year ended
December 31, 2017, compared to $1.9 million and $6.8 million for
the comparable periods in 2016. The increase in revenue was
primarily due to the manufacturing service agreements with the
International AIDS Vaccine Initiative and Frontier Biotechnologies,
Inc.
R&D Expenses: Research and development
(R&D) expenses were $23.5 million in the fourth quarter of 2017
and $96.2 million for the year ended December 31, 2017, compared to
$24.6 million and $102.7 million for the comparable periods in
2016. The decrease in R&D expenses for the year ended December
31, 2017, as compared to 2016, was primarily due to lower contract
manufacturing and clinical trial costs of $9.9 million and $7.6
million, respectively, related to varlilumab and Rintega. These
decreases were partially offset by increases in (i) glembatumumab
vedotin contract manufacturing expenses of $2.7 million, (ii)
glembatumumab vedotin, anti-KIT and CDX-3379 clinical trial costs
of $3.6 million and (iii) personnel and facility costs related to
the Kolltan acquisition.
G&A Expenses: General and administrative
(G&A) expenses were $5.9 million in the fourth quarter of 2017
and $25.0 million for the year ended December 31, 2017, compared to
$11.9 million and $36.0 million for the comparable periods in 2016.
The decrease in G&A expenses for the year ended December 31,
2017, as compared to 2016, was primarily due to lower commercial
planning costs of $4.5 million, lower stock-based compensation of
$1.9 million and lower severance expense related to the Kolltan
acquisition of $2.6 million.
In-Process Research and Development Impairment:
The Company recorded a non-cash partial impairment charge of $13.0
million on the anti-KIT program IPR&D asset acquired from
Kolltan during the year ended December 31, 2017 due to changes in
the anti-KIT program projected development and regulatory
timelines.
Income Tax Benefit: The Company recorded a
non-cash income tax benefit of $24.3 million during the year ended
December 31, 2017 relating to the partial impairment of the
anti-KIT program IPR&D asset and the impact of the Tax Cuts and
Jobs Act of 2017.
Gain on Fair Value Remeasurement of Contingent
Consideration: The Company recorded a gain on the fair
value remeasurement of contingent consideration related to the
Kolltan acquisition of $0.8 million for the year ended December 31,
2017.
Net Loss: Net loss was $3.8 million, or ($0.03)
per share, for the fourth quarter of 2017 and $93.0 million, or
($0.72) per share, for the year ended December 31, 2017, compared
to a net loss of $32.3 million, or ($0.30) per share, and $128.5
million, or ($1.27) per share, for the comparable periods in
2016.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at
December 31, 2017 combined with the (i) $6.1 million in net
proceeds from sales of common stock under the Cantor agreement from
January 1, 2018 through February 28, 2018 and (ii) anticipated
proceeds from future sales of common stock under the Cantor
agreement, are sufficient to meet estimated working capital
requirements and fund planned operations through 2019. This could
be impacted by clinical data results from the METRIC study and
their impact on the pace of commercial manufacturing and the rate
of expansion of commercial operations. This could also be impacted
if Celldex elects to pay Kolltan contingent milestones, if any, in
cash.
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 2018 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 8296067.
A replay of the call will be available approximately two hours
after the live call concludes through March 15, 2018. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 8296067. The
webcast will also be archived on the Company's website.
Xeloda® is a registered trademark of Genentech, Inc. Opdivo® is
a registered trademark of Bristol-Myers Squibb. 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 includes antibodies, antibody-drug conjugates and
other protein-based therapeutics derived from a broad set of
complementary technologies which have the ability to engage the
human immune system and/or directly inhibit tumors to treat
specific types of cancer or other diseases. 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, our ability
to successfully complete research and further development and
commercialization of glembatumumab vedotin and other Company 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; our
ability to realize the anticipated benefits from the acquisition of
Kolltan and to operate the combined business efficiently; 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS |
|
Three Months |
|
Year |
OF OPERATIONS
DATA |
|
Ended December 31, |
|
Ended December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product Development and |
|
|
Licensing
Agreements |
|
$ |
665 |
|
|
$ |
623 |
|
|
$ |
3,153 |
|
|
$ |
2,174 |
|
Contracts and Grants |
|
|
2,791 |
|
|
|
1,251 |
|
|
|
9,590 |
|
|
|
4,612 |
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
3,456 |
|
|
|
1,874 |
|
|
|
12,743 |
|
|
|
6,786 |
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
Research and Development |
|
|
23,464 |
|
|
|
24,558 |
|
|
|
96,171 |
|
|
|
102,726 |
|
General and Administrative |
|
|
5,894 |
|
|
|
11,933 |
|
|
|
25,003 |
|
|
|
35,979 |
|
In-Process Research and Development Impairment |
|
- |
|
|
|
- |
|
|
|
13,000 |
|
|
|
- |
|
Gain
on Fair Value Remeasurement |
|
|
|
|
|
|
|
|
|
of Contingent
Consideration |
|
|
(600 |
) |
|
|
- |
|
|
|
(800 |
) |
|
|
- |
|
Amortization of Acquired Intangible
Assets |
|
|
224 |
|
|
|
235 |
|
|
|
896 |
|
|
|
997 |
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
28,982 |
|
|
|
36,726 |
|
|
|
134,270 |
|
|
|
139,702 |
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(25,526 |
) |
|
|
(34,852 |
) |
|
|
(121,527 |
) |
|
|
(132,916 |
) |
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
2,603 |
|
|
|
2,545 |
|
|
|
4,214 |
|
|
|
4,386 |
|
|
|
|
|
|
|
|
|
|
Net Loss Before Income Tax Benefit |
|
|
(22,923 |
) |
|
|
(32,307 |
) |
|
|
(117,313 |
) |
|
|
(128,530 |
) |
|
|
|
|
|
|
|
|
|
Income Tax Benefit |
|
|
19,082 |
|
|
|
- |
|
|
|
24,282 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(3,841 |
) |
|
$ |
(32,307 |
) |
|
$ |
(93,031 |
) |
|
$ |
(128,530 |
) |
|
Basic
and Diluted Net Loss per |
|
|
Common Share |
|
$ |
(0.03 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.27 |
) |
Shares Used in Calculating Basic |
|
|
|
and
Diluted Net Loss per Share |
|
|
136,515 |
|
|
|
107,876 |
|
|
|
128,543 |
|
|
|
101,529 |
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
|
BALANCE SHEETS
DATA |
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Cash,
Cash Equivalents and Marketable Securities |
|
|
$ |
139,427 |
|
|
$ |
189,776 |
|
Other
Current Assets |
|
|
|
5,329 |
|
|
|
5,793 |
|
Property and Equipment, net |
|
|
|
10,372 |
|
|
|
13,192 |
|
Intangible and Other Assets, net |
|
|
|
160,496 |
|
|
|
174,597 |
|
|
Total
Assets |
|
|
$ |
315,624 |
|
|
$ |
383,358 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
$ |
27,736 |
|
|
$ |
35,223 |
|
Long-Term Liabilities |
|
|
|
51,519 |
|
|
|
82,704 |
|
Stockholders' Equity |
|
|
|
236,369 |
|
|
|
265,431 |
|
|
Total
Liabilities and Stockholders' Equity |
|
|
$ |
315,624 |
|
|
$ |
383,358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company Contact
Sarah CavanaughSenior Vice President, Corporate Affairs &
AdministrationCelldex Therapeutics, Inc.(781)
433-3161scavanaugh@celldex.com
Charles LilesAssociate Director, Investor Relations & Corp
CommunicationsCelldex Therapeutics, Inc.(617)
383-3433cliles@celldex.com
Dan BudwickFounder, 1AB Media(973) 271-6085dan@1abmedia.com
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