LAWRENCEVILLE, N.J.,
May 16, 2016 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the
quarter ended March 31, 2016 and
provided an update on its development programs for ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin
and GEN-1, an IL-12 DNA-based immunotherapy.
"We are extremely pleased with our product portfolio, our
progress and the investment we have made in gene-based
therapeutics," said Michael H.
Tardugno, Celsion's chairman, president and CEO. "Over this
past quarter alone, we have reported meaningful developments with
both ThermoDox® and our immunotherapeutic, GEN-1. Positive
clinical, preclinical and translational data for GEN-1 in both
first line and second line ovarian cancer has provided important
insights on its potential clinical utility and safety, and
reinforced our confidence in the potential of this important
investigational product. We are looking forward to continued
meaningful data from our Phase I neoadjuvant trial, the OVATION
Study, throughout the year and its support for launching the Phase
I/II clinical study later this year to evaluate the combination of
GEN-1 with Avastin® and Doxil® in platinum-resistant ovarian cancer
patients."
Mr. Tardugno continued, "We have made great strides to advance
our global Phase III OPTIMA Study evaluating ThermoDox® in primary
liver cancer with clinical sites currently enrolling patients in 13
countries world-wide. With enrollment now open in
China and approximately 50% of the
850,000 new cases of primary liver cancer diagnosed each year
originating there, China
represents a significant market opportunity and key element of our
global development and commercialization strategy for ThermoDox®.
We expect to add up to 20 additional clinical sites and enroll more
than 200 patients in the China
territory, the minimum number required by the China FDA to file a
New Drug Application (NDA), assuming positive clinical
results."
Recent Developments
ThermoDox®
Enrolled the first patient in the OPTIMA Study in
China. On April 26, 2016, the Company announced that the
first patient in China has been
enrolled in its ongoing global Phase III OPTIMA Study. With China
FDA's approval of Celsion's Phase III Study in first line primary
liver cancer, the trial is now enrolling patients in 13 countries
globally. With the addition of these Chinese clinical sites,
the Company expects an increase in the rate of recruitment
sufficient to complete enrollment in the OPTIMA Study by the end of
2017 or early 2018. Results from the OPTIMA Study, if
successful, will provide the basis for a global registration filing
and marketing approval.
GEN-1 Immunotherapy
Announced positive data from the first cohort of patients in
the Phase 1b OVATION Study. In May
2016, the Company announced data from the first cohort of
patients in its Phase Ib dose escalating clinical trial (the
OVATION Study) combining GEN-1, the Company's DNA-based
immunotherapy, with the standard of care for the treatment of
newly-diagnosed patients with advanced ovarian cancer who will
undergo neoadjuvant chemotherapy followed by interval debulking
surgery. In the first three patients dosed, GEN-1 plus
standard chemotherapy produced positive clinical results, with no
dose limiting toxicities and promising efficacy signals leading to
successful surgical outcomes.
- Of the three patients treated in the first cohort, two patients
demonstrated stable disease (SD) and one patient demonstrated a
complete response (CR), as measured by RECIST criteria.
- All patients had successful resections of their tumors, with
two patients having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed, and one patient with
Stage IV ovarian cancer having an optimal R1 resection.
- One patient demonstrated a pathological complete response
(pCR). pCRs are typically seen in less than 7% of patients
receiving neoadjuvant chemotherapy followed by surgical resection,
and have been associated with a median overall survival (OS) of 72
months, which is more than three years longer than those who do not
experience a pCR.
- All patients experienced a dramatic > 96% drop in their
CA-125 protein levels as of their most recent study visit. CA-125
is used to monitor certain cancers during and after treatment.
CA-125 is present in greater concentrations in ovarian cancer cells
than in other cells. A 50% reduction in CA-125 levels is considered
meaningful. All patients' CA-125 levels were below the standard
cutoff level of 35 U/mL.
Presented preclinical data for GEN-1 IL-12 Immunotherapy in
combination with Avastin® and Doxil® at the American Association
for Cancer Research (AACR) Annual Meeting 2016. In
April 2016, the Company presented
compelling preclinical data demonstrating significant synergistic
anti-cancer effects when GEN-1 is combined with Avastin® and
Doxil®, a current standard of care (SoC) for platinum resistant
ovarian cancer patients at the 2016 AACR Annual Meeting. The
presentation showed that the three drug combination resulted in a
statistically significant reduction of tumor burden of greater than
98% compared to control, and a statistically significant 92%
reduction in tumor burden compared to Avastin® plus Doxil® alone.
In contrast, Avastin® and GEN-1 produced a 39% and 50%
reduction in tumor burden, respectively. These preclinical
data are consistent with the mechanism of action for GEN-1, which
exhibits certain anti-angiogenic properties in addition to its
well-characterized immunomodulatory activities. The combination of
GEN-1 with Avastin® and Doxil® was well-tolerated with no systemic
toxicities. These preclinical data will be used by the Company to
support a comprehensive IND protocol filing for a Phase I/II
clinical trial evaluating the combination in recurrent ovarian
cancer later this year.
Reported translational data from its Phase Ib Study of GEN-1
Immunotherapy in recurrent ovarian cancer. In
January 2016, the Company announced
new translational data from its Phase Ib study of GEN-1 in patients
with platinum-resistant ovarian cancer. The new data indicated that
intraperitoneally-administered GEN-1 produces an immunologically
distinct IL-12 protein that is localized at the tumor site and
lasts for up to one week after a single treatment. In
addition, concomitant increases in IFN-γ and
TNF-α indicate that the IL-12 produced following treatment
with GEN-1 treatment is immunologically active. Celsion
intends to collect additional translational data, including
cellular responses in primary tumor tissue and peritoneal ascites,
in its ongoing OVATION Study, a Phase I dose escalation study in
newly diagnosed ovarian cancer patients in the neoadjuvant
setting.
Financial Results
For the quarter ended March 31,
2016, Celsion reported a net loss of $5.7 million, or $0.24 per share, compared to a net loss of
$7.0 million, or $0.35 per share, in the same period of 2015.
Operating expenses were $5.3 million
for the quarter ended March 31, 2016
compared to $6.5 million in in the
same period of 2015. This decrease was primarily due to lower
research and development and general and administrative expenses in
the first quarter of 2016 compared to the first quarter of
2015.
Research and development costs were $3.4
million in the first quarter of 2016 compared to
$4.5 million in the same period of
the prior year. In the first quarter of 2015, the Company
produced clinical supplies to support both its ThermoDox® and GEN-1
clinical programs. General and administrative expenses were
$1.9 million in the first quarter of
2016 compared to $2.0 million in the
same period of the prior year.
Net cash used in operations was $4.7
million the first quarter of 2016 compared to $5.9 million in the same period of the prior
year. The Company ended the first quarter of 2016 with
$14.3 million of total cash and cash
equivalents.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss first quarter 2016 financial results at
11:00 a.m. EDT on Monday, May 16, 2016. To participate in the call,
interested parties may dial 1-888-359-3624 (Toll-Free/North America) or 1-719-457-2085
(International/Toll) and ask for the Celsion Corporation First
Quarter 2016 Conference Call (Conference Code: 7064110) to register
ten minutes before the call is scheduled to begin. The call will
also be broadcast live on the internet at www.celsion.com.
The call will be archived for replay on May 16, 2016 and will remain available until
May 30, 2016. The replay can be
accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820
(International/Toll) using Conference ID: 7064110. An audio
replay of the call will also be available on the Company's website,
www.celsion.com, for 30 days after 2:00 p.m.
EDT Monday, May 16, 2016.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on
developing a portfolio of innovative cancer treatments, including
directed chemotherapies, immunotherapies and RNA- or DNA-based
therapies. The Company's lead program is ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, currently in
Phase III development for the treatment of primary liver cancer and
in Phase II development for the treatment of recurrent chest wall
breast cancer. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian and brain
cancers. Celsion has two platform technologies for the
development of novel nucleic acid-based immunotherapies and other
anti-cancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. For more information on Celsion, visit our
website: http://www.celsion.com (CLSN-FIN).
Celsion wishes to inform readers that forward-looking
statements in this release are made pursuant to the "safe harbor"
provisions of the Private Securities Litigation Reform Act of
1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, unforeseen changes in the course of research and
development activities and in clinical trials; the uncertainties of
and difficulties in analyzing interim clinical data, particularly
in small subgroups that are not statistically significant; FDA and
regulatory uncertainties and risks; the significant expense, time,
and risk of failure of conducting clinical trials; the need for
Celsion to evaluate its future development plans; possible
acquisitions or licenses of other technologies, assets or
businesses; possible actions by customers, suppliers, competitors,
regulatory authorities; and other risks detailed from time to time
in the Celsion's periodic reports and prospectuses filed with the
Securities and Exchange Commission. Celsion assumes no
obligation to update or supplement forward-looking statements that
become untrue because of subsequent events, new information or
otherwise.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
Celsion
Corporation
|
Condensed
Statements of Operations
|
(in thousands
except per share amounts)
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Licensing
revenue
|
$
|
125
|
$
|
125
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
3,441
|
|
4,506
|
General and
administrative
|
|
1,863
|
|
2,032
|
Total operating
expenses
|
|
5,304
|
|
6,538
|
Loss from
operations
|
|
(5,179)
|
|
(6,413)
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
Loss from valuation of
earn-out milestone liability
|
|
(303)
|
|
(172)
|
Loss from valuation of
common stock warrant liability
|
|
–
|
|
(43)
|
Interest expense,
investment income and other income
(expense), net
|
|
(235)
|
|
(377)
|
Total other (expense) income, net
|
|
(538)
|
|
(592)
|
|
|
|
|
|
Net
loss
|
$
|
(5,717)
|
$
|
(7,005)
|
|
|
|
|
|
Net loss per
common share - basic and diluted
|
$
|
(0.24)
|
$
|
(0.35)
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
23,389
|
|
19,990
|
|
|
|
|
|
|
|
|
|
|
|
Celsion
Corporation
|
|
Selected Balance
Sheet Information
|
|
(in
thousands)
|
|
|
|
|
|
|
|
ASSETS
|
|
March
31,
2016
|
|
December
31,
2015
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
14,311
|
$
|
9,265
|
|
Investment securities
and interest receivable on investment
securities
|
|
–
|
|
10,827
|
|
Prepaid expenses and
other current assets
|
|
371
|
|
189
|
|
Total current
assets
|
|
14,682
|
|
20,281
|
|
|
|
|
|
|
|
Property and
equipment
|
|
757
|
|
855
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
25,802
|
|
Goodwill
|
|
1,976
|
|
1,976
|
|
Deposits
|
|
100
|
|
100
|
|
Other
assets
|
|
12
|
|
14
|
|
Total other
assets
|
|
27,890
|
|
27,892
|
|
|
|
|
|
|
|
Total
assets
|
$
|
43,329
|
$
|
49,028
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
4,862
|
$
|
4,750
|
|
Deferred revenue -
current portion
|
|
500
|
|
500
|
|
Note payable - current
portion
|
|
4,201
|
|
4,073
|
|
Total current
liabilities
|
|
9,563
|
|
9,323
|
|
|
|
|
|
|
|
Earn-out milestone
liability
|
|
14,224
|
|
13,921
|
|
Notes payable -
noncurrent portion
|
|
1,319
|
|
2,350
|
|
Other liabilities -
noncurrent portion
|
|
2,914
|
|
3,048
|
|
Total liabilities
|
|
28,020
|
|
28,642
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Common
stock
|
|
235
|
|
234
|
|
Additional paid-in
capital
|
|
240,282
|
|
239,668
|
|
Accumulated other
comprehensive loss
|
|
–
|
|
(4)
|
|
Accumulated
deficit
|
|
(224,024)
|
|
(218,130)
|
|
|
|
16,493
|
|
21,768
|
|
Less: Treasury
stock
|
|
(1,184)
|
|
(1,382)
|
|
Total stockholders' equity
|
|
15,309
|
|
20,386
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
43,329
|
$
|
49,028
|
|
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SOURCE Celsion Corporation