Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the first quarter ended March 31,
2018.
“Celldex has made considerable progress on an important
strategic prioritization of our pipeline, following announcement in
April of the METRIC study results in triple-negative breast cancer
and discontinuation of the glembatumumab program across all
indications,” said Anthony Marucci, Co-founder, President and Chief
Executive Officer of Celldex Therapeutics. “In 2018, we will focus
primarily on continued clinical development of two
company-sponsored programs—CDX-1140, a promising CD40 agonist, and
CDX-3379, which blocks ErbB3, a receptor thought to play an
important role in regulating cancer cell growth and survival.
Development of varlilumab and CDX-301 will also continue externally
through investigator-sponsored initiatives and internally through
inclusion in combination studies.”
“In line with this, to extend our financial resources and direct
them to the advancement of the programs we believe can bring the
most value to both patients and shareholders, we made significant
cuts to our business operations, including executing a corporate
restructuring in late April. Based on our progress to date, we
believe our cash on hand combined with proceeds from our
established ATM will support the continued development of our
pipeline through 2020. This extended runway will provide for
multiple inflection points, and we are solely focused on executing
along these lines.”
Pipeline Prioritization:
Celldex is focusing its efforts and resources on the
continued research and development of:
- CDX-1140, an agonist human monoclonal antibody targeted to
CD40, a receptor expressed on dendritic cells and a key activator
of immune response, currently in a Phase 1 dose-escalation study in
multiple types of solid tumors. CD40 agonist antibodies have shown
encouraging results in early clinical studies, but systemic
toxicity associated with broad CD40 activation has limited their
dosing. CDX-1140 is differentiated by potent agonist activity that
is independent of Fc receptor interaction, allowing for more
consistent, controlled immune activation without promoting cytokine
production. Additionally, CD40 ligand binding is not blocked,
allowing for potential synergistic effects near activated T cells
in lymph nodes and tumors. Celldex is currently focusing its
efforts on executing the Phase 1 dose-escalation activities and
advancing to combination cohorts. The combination cohorts will
include CDX-301, which as a dendritic cell growth factor can
increase the number of cells responding to CDX-1140. In addition,
combination with varlilumab, especially in lymphomas which
co-express these receptors, could have significant potential.
- CDX-3379, a human monoclonal antibody designed to block the
activity of ErbB3 (HER3), currently in an early Phase 2 study in
advanced head and neck squamous cell cancer in combination with
Erbitux®. The proposed mechanism of action for CDX-3379 sets it
apart from other drugs in development in this class due to its
ability to block both ligand-independent and ligand-dependent ErbB3
signaling by binding to a unique epitope. It has a favorable
pharmacologic profile, including a longer half-life and slower
clearance relative to other drug candidates in this class. CDX-3379
also has potential to enhance anti-tumor activity and/or overcome
resistance in combination with other targeted and cytotoxic
therapies to directly kill tumor cells. Tumor cell death and the
ensuing release of new tumor antigens have the potential to serve
as a focus for combination therapy with immuno-oncology approaches,
even in refractory patients. Celldex intends to complete enrollment
to the first stage of the Phase 2 study and will use this 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.
- Varlilumab, an immune modulating antibody targeting CD27
designed to enhance a patient’s immune response against cancer,
being studied in multiple investigator initiated research studies
and currently completing a Phase 1/2 study across multiple solid
tumors in combination with Opdivo®. Celldex is conducting the study
in collaboration with Bristol-Myers Squibb Company (BMS) and plans
to present data at various medical meetings in 2018, including in
an oral presentation at the ASCO 2018 Annual Meeting in June. The
Company intends to explore varlilumab externally through several
investigator-initiated studies and internally through inclusion in
combination studies.
- CDX-301, a dendritic cell growth factor, currently being
evaluated in an investigator-initiated pilot study with radiation
therapy in patients with advanced non-small cell lung cancer
(NSCLC) and planned for combination study with CDX-1140. Celldex
believes CDX-301’s potential as a dendritic cell mobilizer could
play an important role in immuno-oncology regimens. The Company
will continue to support investigator initiated research and will
seek to combine CDX-301 with CDX-1140 in its ongoing Phase 1 study
of CDX-1140 in the future.
- Celldex’s preclinical pipeline includes CDX-0159, which is
planned to enter the clinic in 2019; the TAM program, comprised of
the targets Tyro3, AXL and MerTK; and a bispecific antibody (BsAb)
program. Celldex's initial BsAb candidate couples CD27
co-stimulation with blockade of the PD-L1/PD-1 pathway using novel,
highly active anti-PD-L1 antibodies. Data from this program were
presented in a poster at the AACR 2018 Annual Meeting. The BsAb was
more potent in human T cell activation and anti-tumor activity
compared to the combined CD27 and PD-L1 antibodies. Enhanced
efficacy has been attributed to more efficient cross-linking of the
CD27 receptor, resulting in stronger T cell activation.
To conserve resources, Celldex is discontinuing
development of:
- Glembatumumab vedotin, a targeted antibody-drug conjugate
(ADC), across all indications, as previously disclosed;
- CDX-014, an ADC (which are typically more costly to develop
than other therapeutics), in early Phase 1 development in renal
cell and clear cell ovarian carcinomas; and
- CDX-1401, an NY-ESO-1-antibody fusion protein, that was being
explored in investigator-sponsored and collaborative studies.
Recent Program Highlights Presented at the American
Association for Cancer Research (AACR) 2018 Annual Meeting in
April
- Data from the CDX-1140 program were presented in a
poster session. Building off previously presented
preclinical work, CDX-1140 was further characterized showing tumor
shrinkage and prolonged survival in several xenograft models. These
preclinical studies support the potential of CDX-1140 having direct
anti-tumor effects on CD40-positive tumors that may supplement its
activity as an immune activating agent.
- Data from the CDX-3379 program were presented in two
poster sessions.
- Data were presented from a preoperative "window of opportunity"
study in 12 patients with head and neck squamous cell carcinoma
(HNSCC). The study was designed to evaluate the effect of CDX-3379
on phosphorylated ErbB3 (pErbB3) and other potential biomarkers in
patients with HNSCC. Patients with newly diagnosed HNSCC received
two doses of CDX-3379, at a two-week interval prior to tumor
resection. CDX-3379 reduced pErbB3 levels in 83% (10/12) of patient
samples, with greater than or equal to 50% decreases in 58% of
patients (7/12), which met the primary study objective. Stable
disease was observed in 92% (11/12) of patients prior to surgery,
and a patient with HPV-negative disease experienced significant
tumor shrinkage (92% in primary tumor; 26% in metastatic lesion).
CDX-3379 was well-tolerated, and no treatment-related adverse
events were observed.
- Data were presented from a study that explored the reduction of
PD-L1 expression by simultaneous blockade of EGFR and ErbB3 in
HNSCC. Investigators examined the effects of combining CDX-3379 and
cetuximab, a monoclonal antibody targeting EGFR, in xenograft
models of HNSCC. Combining CDX-3379 and cetuximab inhibited tumor
growth more potently than cetuximab alone. Mechanistic studies
demonstrated a reduction of PD-L1 expression from the
combination.
- Early promising data (n=9) from an ongoing,
investigator-initiated pilot study of CDX-301 were presented in a
plenary session. This Phase 2 study is evaluating the
combination of CDX-301 and stereotactic body radiotherapy (SBRT) in
up to 29 patients with advanced non-small cell lung cancer (NSCLC).
The presentation included data from nine patients, seven of whom
were previously treated with anti-PD(L)1 checkpoint inhibitors. The
one-week course of treatment included subcutaneous injections of
CDX-301 and SBRT directed to a single lung tumor lesion.
Non-irradiated tumors were evaluated for response. Enrollment is
ongoing.
- Progression-free survival at four months (PFS4), the primary
endpoint of the study, was achieved in 56% (5/9) of patients
overall and in 100% (5/5) of patients who experienced partial
responses (PRs) by PERCIST.
- Notably, PRs were observed in non-irradiated tumors in 56%
(5/9) of patients at two months; 3 PRs (3/9) were confirmed by
immune-related response criteria (irRC).
- In the patients previously treated with immune checkpoint
inhibitors, 71% (5/7) experienced PRs and PFS4 versus 0% (0/2) in
patients not treated with an anti-PD(L)1 therapy.
- SBRT in combination with CDX-301 induced and reactivated
anti-tumor immune responses in patients who had progressive disease
on checkpoint inhibitors.
- No dose-limiting toxicities were observed.
First Quarter 2018 Financial Highlights and Updated 2018
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2018 were $123.2 million
compared to $139.4 million as of December 31, 2017. The decrease
was primarily driven by first quarter cash used in operating
activities of approximately $28.0 million and partially offset by
the receipt of $11.7 million from sales of common stock under our
Cantor agreement. At March 31, 2018, Celldex had 143.4 million
shares outstanding.
Revenues: Total revenue was $4.1 million in the
first quarter of 2018, compared to $1.5 million for the comparable
period in 2017. The increase in revenue was primarily due to the
contract manufacturing and research and development agreements with
International AIDS Vaccine Initiative and Frontier Biotechnologies,
Inc. signed in the second quarter of 2017.
R&D Expenses: Research and development
(R&D) expenses were $21.9 million in the first quarter of 2018,
compared to $25.8 million for the comparable period in 2017. The
decrease in R&D expenses was primarily due to lower varlilumab,
CDX-3379 and anti-KIT program product development expenses of $0.9
million, $0.7 million and $0.3 million, respectively, and lower
personnel and facility costs of $1.4 million.
G&A Expenses: General and administrative
(G&A) expenses were $5.6 million in the first quarter of 2018,
compared to $7.2 million for the comparable period in 2017. The
decrease in G&A expenses was primarily due to lower personnel
expenses of $0.7 million, lower commercial planning costs of $0.4
million and lower legal, consulting and professional services
expense of $0.3 million.
Changes in Fair Value Remeasurement of Contingent
Consideration: The $13.6 million gain on the fair value
remeasurement of contingent consideration in the first quarter of
2018 was primarily due to updated assumptions for glemba-related
milestones and discount rates. The $3.4 million loss on fair value
remeasurement of contingent consideration in the first quarter of
2017 was primarily due to changes in discount rates and the passage
of time.
Intangible Asset and Goodwill Impairments: The
Company recorded $18.7 million in non-cash impairment charges
related to fully impaired glemba-related intangible assets and
$91.0 million in goodwill impairment charges as the carrying value
of the Company’s net assets exceeded the Company’s fair value by an
amount in excess of the goodwill asset in the first quarter of
2018.
Income Tax Benefit: The Company recorded a $0.8
million non-cash income tax benefit related to the impaired glemba
in-process research and development (IPR&D) assets in the first
quarter of 2018.
Net Loss: Net loss was $118.1 million, or
($0.84) per share, for the first quarter of 2018, compared to a net
loss of $34.3 million, or ($0.28) per share, for the comparable
period in 2017.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at March 31, 2018,
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
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 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.
|
CELLDEX THERAPEUTICS,
INC. |
(In thousands, except
per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS |
|
Three Months |
OF OPERATIONS
DATA |
|
Ended March 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
REVENUES: |
|
|
|
|
Product Development and |
|
|
Licensing
Agreements |
|
$ |
992 |
|
|
$ |
556 |
|
Contracts and Grants |
|
|
3,076 |
|
|
|
978 |
|
|
|
|
|
|
Total Revenue |
|
|
4,068 |
|
|
|
1,534 |
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
Research and Development |
|
|
21,875 |
|
|
|
25,793 |
|
General and Administrative |
|
|
5,593 |
|
|
|
7,229 |
|
Goodwill Impairment |
|
|
90,976 |
|
|
|
- |
|
Intangible Asset Impairment |
|
|
18,677 |
|
|
|
- |
|
(Gain)/Loss on Fair Value Remeasurement |
|
|
|
|
|
of Contingent
Consideration |
|
|
(13,600 |
) |
|
|
3,400 |
|
Amortization of Acquired Intangible
Assets |
|
|
224 |
|
|
|
224 |
|
|
|
|
|
|
Total Operating Expense |
|
|
123,745 |
|
|
|
36,646 |
|
|
|
|
|
|
Operating Loss |
|
|
(119,677 |
) |
|
|
(35,112 |
) |
|
|
|
|
|
Investment and Other Income, Net |
|
|
780 |
|
|
|
851 |
|
|
|
|
|
|
Net Loss Before Income Tax Benefit |
|
|
(118,897 |
) |
|
|
(34,261 |
) |
|
|
|
|
|
Income Tax Benefit |
|
|
765 |
|
|
|
- |
|
|
|
|
|
|
Net Loss |
|
$ |
(118,132 |
) |
|
$ |
(34,261 |
) |
|
Basic
and Diluted Net Loss per |
|
|
Common Share |
|
$ |
(0.84 |
) |
|
$ |
(0.28 |
) |
Shares Used in Calculating Basic |
|
|
and
Diluted Net Loss per Share |
|
|
140,548 |
|
|
|
122,648 |
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
BALANCE SHEETS
DATA |
|
March 31, |
|
December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
Cash,
Cash Equivalents and Marketable Securities |
$ |
123,248 |
|
|
$ |
139,427 |
|
Other
Current Assets |
|
|
7,724 |
|
|
|
5,329 |
|
Property and Equipment, net |
|
|
9,785 |
|
|
|
10,372 |
|
Intangible and Other Assets, net |
|
|
50,619 |
|
|
|
160,496 |
|
|
Total
Assets |
|
$ |
191,376 |
|
|
$ |
315,624 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
Current Liabilities |
|
$ |
24,012 |
|
|
$ |
27,736 |
|
Long-Term Liabilities |
|
|
33,282 |
|
|
|
51,519 |
|
Stockholders' Equity |
|
|
134,082 |
|
|
|
236,369 |
|
|
Total
Liabilities and Stockholders' Equity |
$ |
191,376 |
|
|
$ |
315,624 |
|
|
|
|
Company ContactSarah 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
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