Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the third quarter ended September 30,
2018.
“We made considerable progress in the third quarter,
particularly in the development program for CDX-1140, our promising
antibody targeted to CD40,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “We
have completed four of the potential eight monotherapy dose levels
in the ongoing Phase 1 study and remain encouraged by the safety
and biological profile we have observed to date. We look forward to
sharing interim data at the SITC Annual Meeting later this week.
During the third quarter, we also began enrolling patients in a
combination cohort of CDX-1140 with our dendritic cell mobilizer,
CDX-301. We are very interested to explore the potential of
CDX-1140 in the presence of greater dendritic cell activity.”
“Additionally, we are nearing completion of enrollment to the
first stage of the Phase 2 study of CDX-3379 in advanced head and
neck squamous cell cancer and anticipate data from this portion of
the study in the first quarter of 2019,” continued Marucci. “We are
also advancing several preclinical programs that we believe can
play an important role in enhancing the immune system’s response to
cancer, including CDX-0159, our TAM program targeting Tyro3, AXL
and MerTK, and our growing bispecific antibody program.”
Recent Highlights:
- Enrollment continues in the Phase 1 dose-escalation study of
CDX-1140 in solid tumors. Interim data from the ongoing study have
been accepted for presentation on Friday, November 9, 2018 at the
Society for Immunotherapy of Cancer (SITC) Annual Meeting. This
study is designed to enroll up to 150 patients with recurrent,
locally advanced or metastatic solid tumors and was recently
amended to also include B-cell lymphomas. CD40 has long been an
important target for immunotherapy, as it plays a critical role in
the activation of innate and adaptive immune responses; however,
effectively balancing systemic dosing and safety has proven
challenging to date for CD40-activating therapeutics. CDX-1140 is a
unique, potent CD40 agonist that Celldex believes has the potential
to successfully balance systemic doses for good tissue and tumor
penetration with an acceptable safety profile. Data to date from
the four completed dosing cohorts (0.01, 0.03, 0.09 and 0.18 mg/kg)
suggest that CDX-1140 is exhibiting a desirable safety profile and
demonstrating early signs of biological activity based on biomarker
analysis. The fifth monotherapy cohort at 0.36 mg/kg is currently
being enrolled, along with the combination therapy cohort of
CDX-1140 (0.09 mg/kg) with CDX-301 which was initiated in late
August. CDX-301 is a dendritic cell growth factor that will be used
as a priming agent to potentially increase the number of cells
available to respond to CDX-1140. In addition, Celldex is
evaluating the potential for combination with varlilumab,
especially in lymphomas which co-express CD40 and CD27 receptors.
- Enrollment is nearing completion in the first stage of the
Phase 2 study (n=13) of CDX-3379 in advanced head and neck squamous
cell cancer in combination with Erbitux® in Erbitux-resistant
patients who have been previously treated with or are ineligible
for checkpoint therapy. According to the study’s Simon two-stage
design, if at least one patient achieves an objective response in
the first stage, enrollment may progress to the second stage. While
a confirmed partial response has been documented, Celldex will wait
to review the full data set before making decisions on future
development, as a number of patients are still undergoing treatment
and are not yet eligible for response evaluation.
- Data from the glioblastoma cohort in the Phase 1/2 study of
varlilumab and Opdivo® have been accepted for presentation on
Saturday, November 17, 2018 at the Society for Neuro-oncology (SNO)
Annual Meeting.
- As previously disclosed, on May 29, 2018, Celldex received
written notice from the Listing Qualifications department of the
Nasdaq Stock Market indicating that the Company was not in
compliance with the $1.00 minimum bid price requirement for
continued listing on the Nasdaq Global Market. As is standard, the
Company was afforded 180 days to regain compliance. Unless Celldex
regains compliance with the minimum bid requirement by November 26,
2018 (the 180th day), the Company plans to apply to transfer to the
Nasdaq Capital Market. Assuming Celldex’s application is accepted,
the proposed transition should be seamless for Celldex shareholders
and should allow the company an additional 180-day period in which
to regain compliance. If Celldex is unable to regain compliance
with the minimum bid price requirement, the Company may implement a
reverse stock split to maintain its listing, a measure that was
approved by shareholders at the Company’s 2018 Annual Meeting.
Third Quarter 2018 and First Nine Months 2018 Financial
Highlights and 2018 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2018 were $105.6 million
compared to $114.0 million as of June 30, 2018. The decrease was
primarily driven by third quarter cash used in operating activities
of approximately $14.4 million, of which $3.2 million were
glembatumumab vedotin-related payments, partially offset by the
receipt of $5.5 million from sales of common stock under the Cantor
agreement. Celldex expects that it will make an additional $2.0
million in glembatumumab vedotin-related payments related to the
discontinuation of that program. At September 30, 2018, Celldex had
168.6 million shares outstanding.
Revenues: Total revenue was $0.9 million in the
third quarter of 2018 and $7.8 million for the nine months ended
September 30, 2018, compared to $3.9 million and $9.3 million for
the comparable periods in 2017. The decrease in revenue was
primarily due to lower contract revenue from the International AIDS
Vaccine Initiative.
R&D Expenses: Research and development
(R&D) expenses were $11.9 million in the third quarter of 2018
and $55.2 million for the nine months ended September 30, 2018,
compared to $21.9 million and $72.7 million for the comparable
periods in 2017. The decrease in R&D expense was primarily due
to lower clinical trial, contract manufacturing and personnel
expenses.
G&A Expenses: General and administrative
(G&A) expenses were $3.7 million in the third quarter of 2018
and $14.9 million for the nine months ended September 30, 2018,
compared to $5.3 million and $19.1 million for the comparable
periods in 2017. The decrease in G&A expenses was primarily due
to lower personnel and marketing expenses.
Changes in Fair Value Remeasurement of Contingent
Consideration: Gain on the fair value remeasurement of
contingent consideration related to the Kolltan acquisition was
$6.9 million in the third quarter of 2018 and $28.0 million for the
nine months ended September 30, 2018, primarily due to
discontinuation of the glembatumumab vedotin and CDX-014 programs
and updated assumptions for the varlilumab and anti-KIT
programs.
Net Loss: Net loss was $7.2 million, or ($0.04)
per share, for the third quarter of 2018, and $141.8 million, or
($0.94) per share, for the nine months ended September 30, 2018,
compared to a net loss of $26.4 million, or ($0.20) per share, for
the third quarter of 2017 and $89.2 million, or ($0.71) per share,
for the nine months ended September 30, 2017.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at September 30,
2018, combined with the 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 2020. This could be impacted if Celldex elects to pay
Kolltan contingent milestones, if any, in cash.
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 immunotherapies and other targeted biologics 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 StatementThis 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 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 meet, and with
respect to the minimum bid price requirement, to regain compliance
with, Nasdaq listing requirements; 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; 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.
Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & AdministrationCelldex
Therapeutics, Inc.(781) 433-3161scavanaugh@celldex.com
CELLDEX THERAPEUTICS,
INC.(In thousands, except per share
amounts)
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS |
|
Quarter |
|
Nine Months |
OF OPERATIONS DATA |
|
Ended September 30, |
|
Ended September 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUE |
|
|
|
|
|
|
|
|
Product Development
and |
|
|
|
|
|
|
|
|
Licensing
Agreements |
|
$ |
131 |
|
|
$ |
1,238 |
|
|
$ |
2,792 |
|
|
$ |
2,488 |
|
Contracts
and Grants |
|
|
810 |
|
|
|
2,686 |
|
|
|
4,982 |
|
|
|
6,799 |
|
|
|
|
|
|
|
|
|
|
Total
Revenue |
|
|
941 |
|
|
|
3,924 |
|
|
|
7,774 |
|
|
|
9,287 |
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSE |
|
|
|
|
|
|
|
|
Research and
Development |
|
|
11,918 |
|
|
|
21,915 |
|
|
|
55,242 |
|
|
|
72,707 |
|
General and
Administrative |
|
|
3,722 |
|
|
|
5,346 |
|
|
|
14,936 |
|
|
|
19,109 |
|
Goodwill
Impairment |
|
|
- |
|
|
|
- |
|
|
|
90,976 |
|
|
|
- |
|
Intangible Asset
Impairment |
|
|
- |
|
|
|
13,000 |
|
|
|
18,677 |
|
|
|
13,000 |
|
Gain on Fair Value
Remeasurement |
|
|
|
|
|
|
|
|
of
Contingent Consideration |
|
|
(6,935 |
) |
|
|
(4,600 |
) |
|
|
(27,968 |
) |
|
|
(200 |
) |
Amortization of Acquired Intangible Assets |
|
- |
|
|
|
224 |
|
|
|
224 |
|
|
|
672 |
|
|
|
|
|
|
|
|
|
|
Total
Operating Expense |
|
|
8,705 |
|
|
|
35,885 |
|
|
|
152,087 |
|
|
|
105,288 |
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(7,764 |
) |
|
|
(31,961 |
) |
|
|
(144,313 |
) |
|
|
(96,001 |
) |
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
521 |
|
|
|
398 |
|
|
|
1,767 |
|
|
|
1,611 |
|
|
|
|
|
|
|
|
|
|
Net Loss
Before Income Tax Benefit |
|
|
(7,243 |
) |
|
|
(31,563 |
) |
|
|
(142,546 |
) |
|
|
(94,390 |
) |
|
|
|
|
|
|
|
|
|
Income
Tax Benefit |
|
|
- |
|
|
|
5,200 |
|
|
|
765 |
|
|
|
5,200 |
|
|
|
|
|
|
|
|
|
|
Net
Loss |
|
$ |
(7,243 |
) |
|
$ |
(26,363 |
) |
|
$ |
(141,781 |
) |
|
$ |
(89,190 |
) |
|
|
|
|
|
|
|
|
|
Basic and Diluted Net
Loss per |
|
|
|
|
|
|
|
|
Common
Share |
|
$ |
(0.04 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.71 |
) |
Weighted Average
Common |
|
|
|
|
|
|
|
|
Shares
Outstanding |
|
|
163,679 |
|
|
|
129,640 |
|
|
|
150,636 |
|
|
|
125,856 |
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
|
BALANCE SHEETS DATA |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
$ |
105,618 |
|
|
$ |
139,427 |
|
Other Current
Assets |
|
|
|
5,351 |
|
|
|
5,329 |
|
Property and Equipment,
net |
|
|
|
6,699 |
|
|
|
10,372 |
|
Intangible and Other
Assets, net |
|
|
|
50,619 |
|
|
|
160,496 |
|
Total
Assets |
|
|
$ |
168,287 |
|
|
$ |
315,624 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
16,851 |
|
|
$ |
27,736 |
|
Long-Term
Liabilities |
|
|
|
23,302 |
|
|
|
51,519 |
|
Stockholders'
Equity |
|
|
|
128,134 |
|
|
|
236,369 |
|
Total Liabilities and Stockholders' Equity |
|
|
$ |
168,287 |
|
|
$ |
315,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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