Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the second quarter ended June 30,
2019. The Company will host a conference call at 4:30 p.m. ET today
to provide an update on its pipeline and upcoming milestones for
the remainder of 2019.
“Celldex made considerable progress in the first half of the
year across multiple programs,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “We
presented exciting data from our CDX-3379 program in head and neck
squamous cell carcinoma at ASCO, where we observed intriguing
clinical activity across a number of patients with similar gene
mutation patterns. As a result, we have expanded the study to allow
for a deeper evaluation of these biomarkers for patient selection.
This could be important for the field as patients with refractory
head and neck cancer face extremely limited treatment options and a
particularly poor prognosis.
We also reported data from multiple programs at AACR, including
from our ongoing dose escalation study of CDX-1140. We recently
successfully completed the monotherapy dosing cohorts and are
advancing nicely through the combination cohorts with our dendritic
cell growth factor, CDX-301. We are currently finalizing plans to
initiate a combination cohort with a checkpoint inhibitor and look
forward to presenting data from the ongoing program this fall.
Finally, we made an important addition to the Celldex leadership
team. In June, we announced that Dr. Diane Young has joined Celldex
as Senior Vice President, Chief Medical Officer. Dr. Young brings a
deep background in successful drug development to Celldex that will
strengthen our clinical development efforts and support the
continued progress of our product pipeline,” concluded Marucci.
Recent Pipeline Highlights:
• CDX-1140—a 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.
- Enrollment is complete in the monotherapy arm and progressing
on track in the CDX-301 combination arm of the Phase 1
dose-escalation study of CDX-1140 in patients with recurrent,
locally advanced or metastatic solid tumors and B cell lymphomas.
Celldex plans to present data from the ongoing study at a medical
meeting this fall. -- Eight monotherapy dosing cohorts ranging
from 0.01 to 3.0 mg/kg have been completed and the dose limiting
toxicity (DLT) window successfully cleared. -- Three
combination cohorts in solid tumors (0.09, 0.18 and 0.36 mg/kg)
with CDX-301 have been completed and the DLT window successfully
cleared. Patients enrolled in the fourth cohort at 0.72 mg/kg have
been dosed and are currently completing the DLT observation period.
Assuming successful clearance, the 1.5 mg/kg combination cohort
with CDX-301 should open shortly. -- Additional patient
enrollment (backfill) has been initiated to characterize the
effects of CDX-1140 in the tumor microenvironment and expansion
cohorts are being actively planned. Future combination
opportunities include PD-1 or PD-L1 inhibitors, chemotherapy,
radiation therapy and Celldex’s potent CD27 agonist monoclonal
antibody varlilumab.
- Interim data from the study were presented at the American
Association for Cancer Research (AACR) Annual Meeting 2019 in April
and support that CDX-1140 is a potent activator of CD40 and can be
safely administered at doses that Celldex believes will support
good tissue and tumor penetration.
• CDX-3379—a differentiated human monoclonal antibody
designed to block the activity of ErbB3 (HER3). ErbB3 is expressed
in many cancers, including head and neck squamous cell cancer
(HNSCC) and is believed to be an important receptor regulating
cancer cell growth and survival as well as resistance to targeted
therapies.
- Enrollment continues in the Phase 2 study of CDX-3379 in
advanced HNSCC in combination with Erbitux® in Erbitux-resistant
patients who have been previously treated with or are ineligible
for checkpoint therapy.-- Interim data from the study (n=15)
were presented at the 2019 American Society for Clinical Oncology
(ASCO) Annual Meeting in June that suggested notable clinical
activity in this refractory patient population and a promising
biomarker strategy.-- Emerging data from the Phase 2 study and
earlier studies of CDX-3379 suggest that antitumor activity may be
associated with somatic mutations in the FAT1 and NOTCH1, NOTCH2 or
NOTCH3 (NOTCH1-3) genes—genes associated with tumor
suppression. -- In the exploratory analyses presented at
ASCO, seven patients were identified as having FAT1 mutated tumors
and four of these patients demonstrated clinical response (3
confirmed). - All four clinical responses occurred in
patients with the primary tumor site of oral cavity.
- Three of the four clinical responses occurred in patients
with NOTCH1-3 mutations. - Also, of note, all
patients (n=7 of 18) who experienced clinical benefit (objective
response or stable disease greater than or equal to 12 weeks) had
FAT1 and/or NOTCH1-3 mutations. -- Inactivating mutations
in the FAT1 and NOTCH genes occur in sizeable subsets of HPV
negative HNSCC tumors, having been identified in 32% (FAT1) and 26%
(NOTCH) of these tumors, respectively. -- Based on these
biomarker observations and the clinical activity observed in the
ongoing Phase 2 study, the study has been expanded (n= ~45
patients, including at least 15 patients with FAT1 mutations) to
allow for an evaluation of the utility of biomarkers for patient
selection. Enrollment is ongoing.
• CDX-0159—a monoclonal antibody that specifically binds
the KIT receptor and potently inhibits its activity. The KIT
receptor tyrosine kinase is expressed in a variety of cells,
including mast cells. In certain inflammatory diseases, such as
chronic idiopathic urticaria (CIU), mast cell degranulation plays a
central role in the onset and progression of the disease.
- Celldex plans to submit an Investigation New Drug (IND)
Application and initiate a Phase 1a study of CDX-0159 by year-end
2019. The study is designed to evaluate the safety profile,
pharmacokinetics and pharmacodynamics of single ascending doses of
CDX-0159 in healthy subjects. Following completion of this study,
the Company plans to further study CDX-0159 in CIU, a mast
cell-related disease. CIU presents as itchy hives, angioedema or
both for at least six weeks without a specific trigger; multiple
episodes can play out over years or even decades. The prevalence of
CIU is estimated to be 0.5% to 1% of the total population or up to
3.2 million cases in the United States. About 50% of patients with
CIU achieve symptomatic control with antihistamines or leukotriene
receptor antagonists. Omalizumab, an IgE inhibitor, provides relief
for roughly half of the remaining antihistamine/leukotriene
refractory patients. Consequently, there is a need for more
effective later line therapies.
• Celldex continues to advance a robust preclinical
portfolio with data from multiple programs presented at AACR.
- Data from the Company’s CDX-527 bispecific candidate and its
TAM program were presented in April 2019 at the AACR Annual
meeting. CDX-527 uses Celldex’s proprietary highly active
anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation
with blockade of the PD-L1/PD-1 pathway. TAM receptors (Tyro3, Axl,
MerTK) are receptor tyrosine kinases (RTKs) expressed in innate
immune cells. These receptors have been gaining importance in the
immunotherapy field due to their role as checkpoint molecules on
macrophages, dendritic cells and other immune cells, where they can
negatively regulate anti-tumor immunity.
Recent Business
Highlights:
• Diane C. Young, M.D. joined Celldex as Senior Vice
President, Chief Medical Officer in July 2019. Over the span of a
30 year career in biopharmaceuticals, Dr. Young, a medical
oncologist, has led clinical and cross-functional research and
development teams responsible for the global development of
numerous novel therapies from Phase 1 through successful product
registrations. Dr. Young received her M.D. from Harvard Medical
School and is board certified in Internal Medicine and Medical
Oncology.
• Celldex continues to preserve our financial resources and
direct them towards reaching meaningful development milestones
across our pipeline. In June, the Company decided to consolidate
its Massachusetts lab and manufacturing facilities. The lease for
the Needham, MA facility will not be renewed and most functions and
employees will be integrated into the Company’s Fall River, MA
facility. The Company estimates that this consolidation along with
a reduction in square footage at our Hampton, NJ facility earlier
this year will decrease our facility footprint by over 35% and will
save the Company over $3.5 million annually, starting in the second
half of 2020.
Second Quarter 2019 Financial Highlights and 2019
Guidance
Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2019 were $81.3 million
compared to $85.1 million as of March 31, 2019. The decrease was
primarily driven by second quarter cash used in operating
activities of $11.0 million, partially offset by $7.2 million in
net proceeds from sales of common stock under the Cantor agreement.
At June 30, 2019, Celldex had 14.8 million shares outstanding.
Revenues: Total revenue was $0.7 million in the
second quarter of 2019 and $2.1 million for the six months ended
June 30, 2019, compared to $2.8 million and $6.8 million for the
comparable periods in 2018. The decrease in revenue was primarily
due to lower revenue from the collaboration agreement with
Bristol-Myers Squibb Company and the contract manufacturing and
research and development agreements with the International AIDS
Vaccine Initiative and Rockefeller University.
R&D Expenses: Research and development
(R&D) expenses were $10.1 million in the second quarter of 2019
and $21.2 million for the six months ended June 30, 2019, compared
to $21.4 million and $43.3 million for the comparable periods in
2018. The decrease in R&D expenses was primarily due to lower
clinical trial, personnel and contract manufacturing costs.
G&A Expenses: General and administrative
(G&A) expenses were $3.9 million in the second quarter of 2019
and $8.8 million for the six months ended June 30, 2019, compared
to $5.6 million and $11.2 million for the comparable periods in
2018. The decrease in G&A expenses was primarily due to lower
personnel and commercial planning costs and lower lease
restructuring expense.
Changes in Fair Value Remeasurement of Contingent
Consideration: The Company recorded a $1.0 million gain on
fair value remeasurement of contingent consideration during the
second quarter of 2019 and a $0.5 million loss on fair value
remeasurement of contingent consideration during the six months
ended June 30, 2019, primarily due to changes in discount rates and
the passage of time.
Net Loss: Net loss was $11.8 million, or
($0.84) per share, for the second quarter of 2019, and $29.0
million, or ($2.21) per share, for the six months ended June 30,
2019, compared to a net loss of $16.4 million, or ($1.67) per
share, for the second quarter of 2018 and $134.5 million, or
($14.01) per share, for the six months ended June 30, 2018.
Financial Guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 2019,
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 CallCelldex 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 2019
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 9256839.
A replay of the call will be available approximately two hours
after the live call concludes through August 14, 2019. To access
the replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 9256839. The
webcast will also be archived on the Company's website.
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 maintain compliance
with Nasdaq listing requirements; our ability to realize the cost
benefits of consolidating our office and laboratory space and to
retain key personnel after that consolidation; our ability to
realize the anticipated benefits from the acquisition of Kolltan;
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 Contact Sarah Cavanaugh Senior
Vice President, Corporate Affairs & Administration Celldex
Therapeutics, Inc. (781) 433-3161 scavanaugh@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, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUES: |
|
|
|
|
|
|
|
|
Product
Development and |
|
|
|
|
|
|
|
|
|
Licensing Agreements |
|
$ |
195 |
|
|
$ |
1,667 |
|
|
$ |
325 |
|
|
$ |
2,662 |
|
Contracts and Grants |
|
|
520 |
|
|
|
1,096 |
|
|
|
1,815 |
|
|
|
4,172 |
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue |
|
|
715 |
|
|
|
2,763 |
|
|
|
2,140 |
|
|
|
6,834 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
Research and
Development |
|
|
10,081 |
|
|
|
21,448 |
|
|
|
21,232 |
|
|
|
43,323 |
|
General and
Administrative |
|
|
3,908 |
|
|
|
5,621 |
|
|
|
8,804 |
|
|
|
11,215 |
|
Goodwill
Impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
90,976 |
|
Intangible Asset
Impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18,677 |
|
Other Asset
Impairment |
|
|
- |
|
|
|
- |
|
|
|
1,800 |
|
|
|
- |
|
(Gain)/Loss on
Fair Value Remeasurement |
|
|
|
|
|
|
|
|
|
of Contingent
Consideration |
|
|
(1,017 |
) |
|
|
(7,433 |
) |
|
|
502 |
|
|
|
(21,033 |
) |
Amortization of Acquired Intangible Assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
224 |
|
|
|
|
|
|
|
|
|
|
|
Total
Operating Expense |
|
|
12,972 |
|
|
|
19,636 |
|
|
|
32,338 |
|
|
|
143,382 |
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
(12,257 |
) |
|
|
(16,873 |
) |
|
|
(30,198 |
) |
|
|
(136,548 |
) |
|
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
478 |
|
|
|
466 |
|
|
|
1,180 |
|
|
|
1,245 |
|
|
|
|
|
|
|
|
|
|
|
Net
Loss Before Income Tax Benefit |
|
|
(11,779 |
) |
|
|
(16,407 |
) |
|
|
(29,018 |
) |
|
|
(135,303 |
) |
|
|
|
|
|
|
|
|
|
|
Income
Tax Benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
765 |
|
|
|
|
|
|
|
|
|
|
|
Net
Loss |
|
$ |
(11,779 |
) |
|
$ |
(16,407 |
) |
|
$ |
(29,018 |
) |
|
$ |
(134,538 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and Diluted
Net Loss per |
|
|
|
|
|
|
|
|
|
Common
Share |
|
$ |
(0.84 |
) |
|
$ |
(1.67 |
) |
|
$ |
(2.21 |
) |
|
$ |
(14.01 |
) |
Shares Used in
Calculating Basic |
|
|
|
|
|
|
|
|
|
and
Diluted Net Loss per Share |
|
|
13,952 |
|
|
|
9,829 |
|
|
|
13,129 |
|
|
|
9,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED |
|
|
|
|
|
|
|
|
BALANCE SHEETS DATA |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
|
|
$ |
81,342 |
|
|
$ |
94,022 |
|
Other Current
Assets |
|
|
|
|
|
|
3,023 |
|
|
|
5,057 |
|
Property and
Equipment, net |
|
|
|
|
|
|
5,086 |
|
|
|
6,111 |
|
Intangible and
Other Assets, net |
|
|
|
|
|
|
52,793 |
|
|
|
50,619 |
|
|
Total Assets |
|
|
|
|
|
$ |
142,244 |
|
|
$ |
155,809 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
$ |
11,509 |
|
|
$ |
12,602 |
|
Long-Term
Liabilities |
|
|
|
|
|
|
21,109 |
|
|
|
19,147 |
|
Stockholders'
Equity |
|
|
|
|
|
|
109,626 |
|
|
|
124,060 |
|
|
Total Liabilities and
Stockholders' Equity |
|
|
|
|
|
$ |
142,244 |
|
|
$ |
155,809 |
|
|
|
|
|
|
|
|
|
|
|
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