Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the second quarter ended June 30,
2018. 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.
“During the second quarter, we continued to focus on advancing
CDX-1140, our promising antibody targeted to CD40, a key activator
of immune response, and CDX-3379, which blocks the ErbB3 receptor,
an important regulator of cancer cell growth and survival,” said
Anthony Marucci, Co-founder, President and Chief Executive Officer
of Celldex Therapeutics. “We have completed the third monotherapy
dose level in the ongoing Phase 1 study of CDX-1140 and are
encouraged with the tolerability, immune system activation and
early signs of biological activity we have seen to date. We will
also be exploring the potential of combining CDX-1140 with our
dendritic cell mobilizer, CDX-301, and plan to begin enrolling
those cohorts in September. In the next few months, we expect to
complete enrollment in the first stage of our Phase 2 combination
study of CDX-3379 and Erbitux® in advanced head and neck squamous
cell carcinoma. Additionally, we have IND enabling studies underway
with CDX-0159, our anti-KIT antibody, with the aim of adding it as
a new clinical program in 2019.”
Recent Highlights:
- Enrollment continues in the Phase 1 dose-escalation study of
CDX-1140 in multiple types of solid tumors. 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,
balancing systemic dosing and safety has proven elusive to date for
CD40 targeted 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. Three dosing cohorts
have been completed, 0.01, 0.03 and 0.09 mg/kg, and data to date
from these cohorts suggest that CDX-1140 has a desirable safety
profile and, based on biomarker data, is demonstrating early signs
of biological activity. The fourth cohort at 0.18 mg/kg is
currently being enrolled. As planned, the study protocol was
recently amended to explore CDX-1140 in combination with CDX-301,
and enrollment to this cohort is expected to begin in September.
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, combination with varlilumab
could have significant potential, especially in lymphomas which
co-express CD40 and CD27 receptors.
- Enrollment continues in the Phase 2 study of CDX-3379 in
advanced head and neck squamous cell carcinoma (HNSCC) in
combination with Erbitux in Erbitux-resistant patients who have
been previously treated with checkpoint therapy or are not
candidates for checkpoint therapy. Celldex intends to complete
enrollment to the first stage of the Phase 2 study and will use
these data to inform next decisions. In line with this, the Company
continues to explore potential other opportunities in additional
indications where ErbB3 is believed to play a role.
- Data from the Phase 1/2 study of varlilumab in combination with
Opdivo® across multiple solid tumors were presented in an oral
presentation at the 2018 ASCO Annual Meeting in June. In the
ovarian cancer cohort, for patients with paired tumor samples from
before and during treatment, increases in tumor expression of PD-L1
and CD8+ tumor infiltrating lymphocyte (TIL) levels were observed.
These increases were associated with improved clinical outcomes,
including improved progression-free survival (PFS) and response
rate. Celldex recently reviewed preliminary data from
the HNSCC and renal cell carcinoma (RCC) cohorts. Twenty-seven
patients with HNSCC were treated in the study (3 in Phase 1; 24 in
Phase 2). Patients had a median of two prior lines of therapy. 96%
had Stage IV disease. 63% had PD-L1 negative tumors. 52% had HPV
positive tumors. The overall response rate was 15% (n=4 confirmed)
across 27 response-evaluable patients. In this small sample size,
no correlation between PD-L1 status and clinical outcome was
observed. Given the changing treatment paradigm in renal cell
carcinoma, only 14 patients with RCC were treated in the study, all
in Phase 2. All patients had prior anti-angiogenic therapy, with a
range of 1 to 4 prior treatments. 100% had Stage IV disease, and
50% had PD-L1 negative tumors. 39% of patients experienced stable
disease. Celldex plans to present data from the glioblastoma cohort
at a medical meeting later this year.
Second Quarter and First Six Months 2018 Financial
Highlights and 2018 Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2018 were $114.0 million
compared to $123.2 million as of March 31, 2018. The decrease was
primarily driven by second quarter cash used in operating
activities of approximately $17.4 million, of which $5.5 million
were glembatumumab vedotin-related payments, partially offset by
the receipt of $8.3 million from sales of common stock under the
Cantor agreement. Celldex expects that it will make an additional
$5.0 to $6.0 million in glembatumumab vedotin-related payments
related to the discontinuation of that program. At June 30, 2018,
Celldex had 156.6 million shares outstanding.
Revenues: Total revenue was $2.8 million in the
second quarter of 2018 and $6.8 million for the six months ended
June 30, 2018, compared to $3.8 million and $5.4 million for the
comparable periods in 2017. The decrease in revenue for the second
quarter of 2018 compared to the second quarter of 2017 was
primarily due to lower contract revenue from the International AIDS
Vaccine Initiative. The increase in revenue for the six months
ended June 30, 2018 compared to the six months ended June 30, 2017
was primarily due to an increase in revenue related to the
collaboration agreement with Bristol-Myers Squibb Company.
R&D Expenses: Research and development
(R&D) expenses were $21.4 million in the second quarter of 2018
and $43.3 million for the six months ended June 30, 2018, compared
to $25.0 million and $50.8 million for the comparable periods in
2017. The decrease in R&D expenses was primarily due to lower
personnel, clinical trial, contract manufacturing and contract
research expense, partially offset by severance expense of $1.0
million.
G&A Expenses: General and administrative
(G&A) expenses were $5.6 million in the second quarter of 2018
and $11.2 million for the six months ended June 30, 2018, compared
to $6.5 million and $13.8 million for the comparable periods in
2017. The decrease in G&A expenses was primarily due to lower
personnel and marketing expense.
Changes in Fair Value Remeasurement of Contingent
Consideration: Gain on the fair value remeasurement of
contingent consideration related to the Kolltan acquisition was
$7.4 million in the second quarter of 2018 and $21.0 million for
the six months ended June 30, 2018, primarily due to
discontinuation of the glembatumumab vedotin and CDX-014 programs
and updated assumptions for the varlilumab program.
Net Loss: Net loss was $16.4 million, or
($0.11) per share, for the second quarter of 2018, and $134.5
million, or ($0.93) per share, for the six months ended June 30,
2018, compared to a net loss of $28.6 million, or ($0.23) per
share, for the second quarter of 2017 and $62.8 million, or ($0.51)
per share, for the six months ended June 30, 2017.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 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.
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 4768019.
A replay of the call will be available approximately two hours
after the live call concludes through August 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 4768019. The
webcast will also be archived on the Company's website.
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 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 |
|
Six Months |
OF
OPERATIONS DATA |
|
Ended June 30, |
|
Ended June 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
(Unaudited) |
|
(Unaudited) |
REVENUE |
|
|
|
|
|
|
|
|
Product Development
and |
|
Licensing
Agreements |
|
$ |
1,667 |
|
|
$ |
694 |
|
|
$ |
2,662 |
|
|
$ |
1,250 |
|
Contracts
and Grants |
|
|
1,096 |
|
|
|
3,135 |
|
|
|
4,172 |
|
|
|
4,113 |
|
|
|
|
|
|
|
|
|
|
Total
Revenue |
|
|
2,763 |
|
|
|
3,829 |
|
|
|
6,834 |
|
|
|
5,363 |
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSE |
|
|
|
|
|
|
|
|
Research and
Development |
|
|
21,448 |
|
|
|
24,999 |
|
|
|
43,323 |
|
|
|
50,792 |
|
General and
Administrative |
|
|
5,621 |
|
|
|
6,534 |
|
|
|
11,215 |
|
|
|
13,763 |
|
Goodwill
Impairment |
|
|
- |
|
|
|
- |
|
|
|
90,976 |
|
|
|
- |
|
Intangible Asset
Impairment |
|
|
- |
|
|
|
- |
|
|
|
18,677 |
|
|
|
- |
|
(Gain)/Loss on Fair
Value Remeasurement |
|
|
|
|
|
|
|
|
of
Contingent Consideration |
|
|
(7,433 |
) |
|
|
1,000 |
|
|
|
(21,033 |
) |
|
|
4,400 |
|
Amortization of Acquired Intangible Assets |
|
- |
|
|
|
224 |
|
|
|
224 |
|
|
|
448 |
|
|
|
|
|
|
|
|
|
|
Total
Operating Expense |
|
|
19,636 |
|
|
|
32,757 |
|
|
|
143,382 |
|
|
|
69,403 |
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(16,873 |
) |
|
|
(28,928 |
) |
|
|
(136,548 |
) |
|
|
(64,040 |
) |
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
466 |
|
|
|
362 |
|
|
|
1,245 |
|
|
|
1,213 |
|
|
|
|
|
|
|
|
|
|
Net Loss
Before Income Tax Benefit |
|
|
(16,407 |
) |
|
|
(28,566 |
) |
|
|
(135,303 |
) |
|
|
(62,827 |
) |
|
|
|
|
|
|
|
|
|
Income
Tax Benefit |
|
|
- |
|
|
|
- |
|
|
|
765 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
Loss |
|
$ |
(16,407 |
) |
|
$ |
(28,566 |
) |
|
$ |
(134,538 |
) |
|
$ |
(62,827 |
) |
|
Basic and Diluted Net
Loss per |
|
Common Share |
|
$ |
(0.11 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.51 |
) |
Weighted Average
Common |
|
|
Shares Outstanding |
|
|
147,428 |
|
|
|
125,202 |
|
|
|
144,007 |
|
|
|
123,932 |
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
|
BALANCE
SHEETS DATA |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
$ |
114,009 |
|
|
$ |
139,427 |
|
Other Current
Assets |
|
|
|
6,271 |
|
|
|
5,329 |
|
Property and Equipment,
Net |
|
|
|
7,478 |
|
|
|
10,372 |
|
Intangible and Other
Assets, Net |
|
|
|
50,619 |
|
|
|
160,496 |
|
Total
Assets |
|
|
$ |
178,377 |
|
|
$ |
315,624 |
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
19,982 |
|
|
$ |
27,736 |
|
Long-Term
Liabilities |
|
|
|
30,348 |
|
|
|
51,519 |
|
Stockholders'
Equity |
|
|
|
128,047 |
|
|
|
236,369 |
|
Total Liabilities and Stockholders' Equity |
|
|
$ |
178,377 |
|
|
$ |
315,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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