Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business
and financial highlights for the second quarter ended June 30,
2017.
"In the second quarter, we continued to see strong physician
enthusiasm for our Phase 2 METRIC study of glembatumumab vedotin in
triple negative breast cancer and recently met our target
enrollment of 300 patients,” said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. “We
expect enrollment will be formally closed by the end of September
to allow all patients currently in the screening queue the
opportunity to complete the screening process and enroll in the
study.”
“In June, we presented data from glemba’s Phase 2 program in
checkpoint refractory metastatic melanoma and the Phase 1
dose-escalation varlilumab/Opdivo combination study in solid
tumors, both in oral presentations at ASCO. We anticipate a
productive second half of the year as we complete enrollment across
multiple early-stage studies and look forward to topline data from
the METRIC study in the first half of 2018.”
Recent Highlights
- Continued progress in METRIC enrollment:
Target enrollment (n=300) in METRIC has been reached. Given the
lack of treatment options for patients with triple negative breast
cancers, previously screened patients whose tumors overexpress
gpNMB will be allowed to enter the study before enrollment is
formally completed, which is estimated to occur by the end of
September 2017. The Company expects topline data from the study
approximately six to eight months after formal closing of
enrollment. METRIC is a Phase 2b randomized study of glembatumumab
vedotin in patients with metastatic triple negative breast cancers
that overexpress gpNMB.
- Single-agent glembatumumab vedotin Phase 2 study in
checkpoint-refractory metastatic melanoma presented in an oral
presentation at American Society of Clinical Oncology (ASCO) in
June: Mature data (n=62) from the study were presented at
ASCO. As previously reported in October 2016, the primary endpoint
of the cohort (threshold of 6 or more objective responses in 52
evaluable patients) was exceeded. 7 of 62 (11%) patients
experienced a confirmed response, and an additional three patients
also experienced single timepoint partial responses. Since data
were reported in October, one patient converted from a confirmed
partial response to a confirmed complete response. Median overall
survival (OS) for all patients was 9.0 months (95% CI: 6.1, 13.0).
Patients who experienced rash in Cycle 1 experienced a more
prolonged OS with a median of 15.8 months (p=0.026, HR=0.44) as
compared to those who did not experience rash.Enrollment recently
completed in the glembatumumab vedotin and varlilumab combination
arm, and data from this portion of the study are expected in the
fall of 2017. Enrollment continues in the glembatumumab vedotin
plus checkpoint inhibitor (Opdivo® or Keytruda®) arm in patients
who failed prior checkpoint therapy, a population with limited
treatment options.
- Phase 1 varlilumab/Opdivo® study presented in an oral
presentation at ASCO: Updated data (n=36) from the Phase 1
portion of this study were presented at ASCO. The majority of
patients enrolled in this study had PD-L1 negative tumor at
baseline and presented with stage IV, heavily-pretreated disease.
80% of patients enrolled presented with refractory or recurrent
colorectal (n=21) or ovarian cancer (n=8), a population expected to
have minimal response to checkpoint blockade. The primary objective
of the Phase 1 portion of the study was to evaluate the safety and
tolerability of the combination. The combination was well tolerated
at all varlilumab dose levels tested without any evidence of
increased autoimmunity or inappropriate immune activation. Notable
disease control was observed across multiple dosing regimens
(stable disease or better for at least 3 months). Three partial
responses (PR) were observed including a patient with PD-L1
negative, MMR proficient colorectal cancer, a patient with low
PD-L1 (5% expression) squamous cell head and neck cancer and a
patient with PD-L1 negative ovarian cancer. A subgroup analysis was
conducted in patients with ovarian cancer based on an observed
increase of PD-L1 and tumor-infiltrating lymphocytes in this
patient population. In patients with paired baseline and
on-treatment biopsies (n=13), only 15% were PD-L1 positive (≥ 1%
tumor cells) at baseline compared to 77% during treatment
(p=0.015). Patients with increased tumor PD-L1 expression and tumor
CD8 T cells correlated with better clinical outcome with treatment
(stable disease or better).The Phase 2 portion of the combination
study includes cohorts in colorectal cancer, ovarian cancer, head
and neck squamous cell carcinoma, renal cell carcinoma and
glioblastoma, and is currently enrolling patients. The Company
plans to complete enrollment across all cohorts in the Phase 2
portion of the study in the first quarter of 2018 and will work
with Bristol-Myers Squibb to present data from the study at a
future medical meeting.
- Phase 1 study of CDX-0158 continues to enroll
patients: This dose escalation study in patients with
advanced refractory gastrointestinal stromal tumors (GIST) and
other KIT-positive tumors is designed to determine the maximum
tolerated dose, recommend a dose for further study and characterize
the safety profile of CDX-0158. Data from the study continue to be
expected by year-end 2017.
- CDX-3379 advancing to Phase 2: The Company has
finalized plans for an open-label Phase 2 study in patients with
recurrent/metastatic head and neck squamous cell cancer who are
refractory to Erbitux® (cetuximab). The Company anticipates
initiating this study in the fourth quarter of 2017.
- Enrollment ongoing in Phase 1 study of
CDX-014: This study in advanced renal cell carcinoma
(clear cell and papillary) is designed to determine the maximum
tolerated dose and to recommend a dose level for further study.
Celldex continues to expect the Phase 1 dose-escalation portion of
the study will complete enrollment by year-end 2017.
Second Quarter and First Six Months 2017 Financial
Highlights and Updated 2017 Guidance
Cash position: Cash, cash equivalents and
marketable securities as of June 30, 2017 were $154.0 million
compared to $167.0 million as of March 31, 2017. The decrease was
primarily driven by second quarter cash used in operating
activities of $20.8 million. This decrease was partially offset by
the receipt of $8.7 million from sales of common stock under the
Cantor agreement. At June 30, 2017, Celldex had 127.4 million
shares outstanding.
Revenues: Total revenue was $3.8 million in the
second quarter of 2017 and $5.4 million for the six months ended
June 30, 2017, compared to $1.4 million and $2.7 million for the
comparable periods in 2016. The increase in revenue was primarily
due to the manufacturing service agreement with the International
AIDS Vaccine Initiative.
R&D Expenses: Research and development
(R&D) expenses were $25.0 million in the second quarter of 2017
and $50.8 million for the six months ended June 30, 2017, compared
to $25.7 million and $53.2 million for the comparable periods in
2016.
The $0.7 million decrease in second quarter R&D expenses was
primarily due to a decrease in varlilumab contract manufacturing
expenses of $4.3 million, partially offset by an increase in
glembatumumab vedotin contract manufacturing expenses of $1.9
million and increases in personnel and facility costs related to
the Kolltan acquisition.
The $2.4 million decrease in year-to-date R&D expenses was
primarily due to decreases in varlilumab and Rintega contract
manufacturing expenses of $5.1 million and $2.6 million,
respectively, partially offset by an increase in glembatumumab
vedotin contract manufacturing expenses of $3.4 million and
increases in personnel and facility costs related to the Kolltan
acquisition.
G&A Expenses: General and administrative
(G&A) expenses were $6.5 million in the second quarter of 2017
and $13.8 million for the six months ended June 30, 2017, compared
to $7.8 million and $17.1 million for the comparable periods in
2016.
The $1.3 million decrease in second quarter G&A expenses was
primarily due to lower commercial planning costs of $0.6 million
and lower stock-based compensation of $0.4 million.
The $3.3 million decrease in year-to-date G&A expenses was
primarily due to lower commercial planning costs of $2.4 million
and lower stock-based compensation of $0.9 million.
Loss on Fair Value Remeasurement of Contingent
Consideration: Loss on the fair value remeasurement of
contingent consideration related to the Kolltan acquisition was
$1.0 million in the second quarter of 2017 and $4.4 million for the
six months ended June 30, 2017, primarily due to changes in
discount rates and the passage of time.
Net loss: Net loss was $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, compared to a net loss of $32.0 million, or ($0.32) per
share, and $66.6 million, or ($0.67) per share, for the comparable
periods in 2016.
Financial guidance: Celldex believes that the
cash, cash equivalents and marketable securities at June 30, 2017,
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
2018; however, this guidance assumes Celldex elects to pay future
Kolltan contingent milestones, if any, in stock rather than
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 2017 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 52336196.
A replay of the call will be available approximately two hours
after the live call concludes through August 15, 2017. To access
the replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 52336196. The
webcast will also be archived on the Company's website.
Opdivo® is a registered trademark of Bristol-Myers Squibb.
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp. 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 |
|
Quarter |
|
Six Months |
OF OPERATIONS
DATA |
|
Ended June 30, |
|
Ended June 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
REVENUE |
|
|
|
|
|
|
|
|
Product
Development and |
|
|
Licensing
Agreements |
|
$ |
694 |
|
|
$ |
604 |
|
|
$ |
1,250 |
|
|
$ |
1,057 |
|
Contracts and Grants |
|
|
3,135 |
|
|
|
785 |
|
|
|
4,113 |
|
|
|
1,635 |
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
|
3,829 |
|
|
|
1,389 |
|
|
|
5,363 |
|
|
|
2,692 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSE |
|
|
|
|
|
|
|
|
Research
and Development |
|
|
24,999 |
|
|
|
25,711 |
|
|
|
50,792 |
|
|
|
53,158 |
|
General and
Administrative |
|
|
6,534 |
|
|
|
7,790 |
|
|
|
13,763 |
|
|
|
17,097 |
|
Loss on
Fair Value Remeasurement |
|
|
|
|
|
|
|
|
|
of Contingent
Consideration |
|
|
1,000 |
|
|
|
- |
|
|
|
4,400 |
|
|
|
- |
|
Amortization of Acquired Intangible Assets |
|
224 |
|
|
|
254 |
|
|
|
448 |
|
|
|
507 |
|
|
|
|
|
|
|
|
|
|
Total Operating Expense |
|
|
32,757 |
|
|
|
33,755 |
|
|
|
69,403 |
|
|
|
70,762 |
|
|
|
|
|
|
|
|
|
|
Operating
Loss |
|
|
(28,928 |
) |
|
|
(32,366 |
) |
|
|
(64,040 |
) |
|
|
(68,070 |
) |
|
|
|
|
|
|
|
|
|
Investment and Other Income, Net |
|
|
362 |
|
|
|
414 |
|
|
|
1,213 |
|
|
|
1,445 |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(28,566 |
) |
|
$ |
(31,952 |
) |
|
$ |
(62,827 |
) |
|
$ |
(66,625 |
) |
|
Basic and
Diluted Net Loss per |
|
|
Common
Share |
|
$ |
(0.23 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.67 |
) |
Weighted
Average Common |
|
|
|
Shares
Outstanding |
|
|
125,202 |
|
|
|
98,817 |
|
|
|
123,932 |
|
|
|
98,753 |
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED |
|
|
|
|
|
BALANCE SHEETS
DATA |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
Cash, Cash
Equivalents and Marketable Securities |
|
|
$ |
153,984 |
|
|
$ |
189,776 |
|
Other
Current Assets |
|
|
|
6,068 |
|
|
|
5,793 |
|
Property
and Equipment, net |
|
|
|
12,069 |
|
|
|
13,192 |
|
Intangible
and Other Assets, net |
|
|
|
173,950 |
|
|
|
174,597 |
|
|
Total Assets |
|
|
$ |
346,071 |
|
|
$ |
383,358 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current
Liabilities |
|
|
$ |
28,788 |
|
|
$ |
35,223 |
|
Long-Term
Liabilities |
|
|
|
85,826 |
|
|
|
82,704 |
|
Stockholders' Equity |
|
|
|
231,457 |
|
|
|
265,431 |
|
|
Total
Liabilities and Stockholders' Equity |
|
|
$ |
346,071 |
|
|
$ |
383,358 |
|
|
|
|
|
|
|
|
Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Associate Director, Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(617) 383-3433
cliles@celldex.com
Dan Budwick
Founder, 1AB Media
(973) 271-6085
dan@1abmedia.com
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