Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the year ended
December 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 plasmid vector
encased in a nanoparticle delivery system, which enables cell
transfection followed by persistent, local secretion of the IL-12
protein. The Company's lead program is ThermoDox® which is
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 Company's
immunotherapy program consists of GEN-1 and is currently in Phase I
development for the localized treatment of ovarian cancer.
“Celsion had an exceedingly productive 2016 as
our accomplishments, one after another, established meaningful
progress with respect to our two leading-edge technology platforms
designed to enhance clinically powerful therapies. With sound
fundamentals, the superb execution of our ongoing global, pivotal
Phase III OPTIMA Study in primary liver cancer, continues to
attract interest and support from the medical community,
international regulatory agencies, and research organizations like
the National Institutes of Health for this ground-breaking study,”
said Michael H. Tardugno, Celsion's chairman, president and
CEO. “Our efforts in immuno-oncology are equally important.
Over the past year, we have demonstrated the potential of our GEN-1
program to be an effective adjuvant, in both first and second-line
ovarian cancer. Recruiting the immune system to work in combination
with the standard of care in this patient population has been the
goal of medical researchers worldwide. With GEN-1, we believe
there is the potential for a break-through and we look forward to
reporting comprehensive clinical findings and translational data
from our nearly complete OVATION Study in the first half of
2017."
Recent Developments
ThermoDox®
Announced the Independent NIH Analysis
Showing Treatment with ThermoDox® Plus RFA may
Significantly Improve Overall Survival of Patients with Primary
Liver Cancer. In November 2016, the Company
announced the presentation of results from an independent
retrospective analysis conducted by the National Institutes of
Health (NIH) on the intent-to-treat population of the Company’s
HEAT Study during The Interventional Oncology Series:
Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd
Scientific Assembly and Annual Meeting of the Radiological Society
of North America (RSNA). The NIH analysis, which sought to
evaluate the correlation between RFA burn time per tumor volume
(min/ml) and clinical outcome, concluded that increased burn time
per tumor volume significantly improved overall survival (OS) in
patients with solitary lesions treated with RFA + ThermoDox®
compared to patients treated with RFA alone. More
specifically, the analysis showed that a one unit increase in RFA
duration per tumor volume improved OS by 20% in patients treated
with optimized RFA + ThermoDox® compared to RFA alone.These
findings are consistent with Celsion’s analysis of the HEAT Study
data showing that in patients treated with RFA for more than 45
minutes, standardized RFA plus ThermoDox® resulted in a
statistically significant improvement in overall survival of over
two years when compared to standardized RFA alone.
Announced Support for the OPTIMA Study
from the China FDA and Vietnam Ministry of Health.
The Company discussed ThermoDox® and the OPTIMA Study with
regulatory agencies in two key markets, China and Vietnam.
The Company met with the China Food and Drug Administration (CFDA)
to review the ongoing Phase III OPTIMA Study and regulatory pathway
for ThermoDox® in China. CFDA was presented with the final overall
survival data from the Chinese patient cohort of the HEAT study,
which demonstrated a survival benefit in patients treated with
ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA
informed the Company that if the ongoing Phase III OPTIMA Study is
successful, the trial could serve as the basis for a direct
regulatory filing in China without the need to file for prior
approval in the U.S. or European Union which is currently required
for foreign company application. This would allow the Company to
accelerate its plans for a regulatory filing in China and, if
approved, provide for a significantly earlier launch date in China
than originally expected. In addition, the Company's management
team met with the Ministry of Health in Vietnam and based on that
meeting, it will move forward with launching additional trial sites
for the OPTIMA Study in that country. The Company expects to have
approximately 5 additional clinical trial sites in Vietnam
activated in early 2017. Vietnam represents a significant market
for ThermoDox® where HCC incidence rates are among the highest in
the world.
Announced the Issuance of Two New
Patents for ThermoDox. In January 2017, the Company
announced the issuance of two patents which are directly applicable
to the method of treating cancer using our current ThermoDox®
formulation. These new patents further strengthen the
Company’s global patent portfolio around novel heat-sensitive
liposome engineered to address a broad range of difficult-to-treat
cancers.
Announced Collaboration with the
Children’s Research Institute to Evaluate the Use of ThermoDox® and
High Intensity Focused Ultrasound in the Treatment of Solid Tumors
in Children and Young Adults. In October 2016, the
Company announced a collaboration with the Children’s Research
Institute to conduct a clinical study of ThermoDox® in combination
with magnetic resonance-guided high intensity focused ultrasound to
treat relapsed or refractory solid tumors in children and young
adults. This investigator-sponsored Phase I clinical study is
being partially funded by the National Institutes of Health and
commenced in the fourth quarter of 2016.
GEN-1 Immunotherapy
Announced Continuing Positive Data from
the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer
Patients. In January 2017, the Company announced
data from the first four cohorts of patients in its Phase Ib dose
escalating clinical trial (the OVATION Study) combining GEN-1 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 twelve patients dosed in the OVATION Study, GEN-1 plus
standard chemotherapy produced impressive results, with no dose
limiting toxicities and highly promising efficacy signals in this
difficult to treat cancer. The efficacy data included highly
encouraging tumor response rates - 100% disease control rate (DCR)
and 75% objective response rate (ORR), successful surgical
resections of the eligible patients’ tumors, impressive
pathological responses and dramatic, clinically meaningful drops in
CA-125 protein levels.
Announced the Issuance of Two New U.S.
Patents for GEN-1 Immuno-Oncology Product. In
November 2016, the Company announced the issuance of two patents
which expand the use of GEN-1 into additional cancer treatment
modalities in combination with other chemotherapeutics and extends
previous patent claims on the making of and composition of
formulations consisting of our PPC delivery polymer and nucleic
acids. These new patents further strengthen coverage of GEN-1 for
the localized treatment of ovarian cancer and glioblastoma
multiforme (GBM), which is already covered by a composition of
matter patent in the United States.
Corporate Development
Raised $6.8 Million Through Two Equity
Offerings in December 2016 and February 2017. The
Company completed two equity offerings of shares of common stock,
or pre-funded warrants in lieu thereof, to purchase common stock
with institutional healthcare and retail investors totaling $6.8
million in gross proceeds.
Financial Results
For the year ended December 31, 2016, Celsion
reported a net loss of $22.1 million, or $0.85 per share, compared
to a net loss of $22.5 million, or $1.03 per share, in 2015.
Operating expenses were $21.1 million in 2016 compared to $21.3
million in 2015. This decrease was primarily due to lower
general and administrative expenses and clinical supply costs
offset by higher clinical development costs for the Phase III
OPTIMA Study.
Research and development (R&D) costs were
constant at $14.6 million in 2016 and 2015. Clinical
development costs for the OPTIMA Study were $5.6 million in 2016
compared to $3.6 million in 2015 due to higher patient enrollment,
investigator grants and site initiation expenses in the
trial. R&D costs for other development programs were
lower as a result of the Company’s tighter clinical development
focus around the pivotal Phase III OPTIMA Study for the treatment
of primary liver cancer and the clinical development program for
GEN-1 IL-12 immunotherapy for the localized treatment of ovarian
cancer coupled with lower costs in 2016 associated with the
production of ThermoDox® to support the OPTIMA Study. General
and administrative expenses decreased $0.2 million, from $6.7
million in 2015 to $6.5 million in the current year. This
decrease in general and administrative expenses in 2016 is
primarily the result of reductions in personnel costs and
professional fees offset by $0.6 million of non-cash amortization
expense related to the covenant not to compete from the June 2014
EGEN acquisition.
Other expenses included a non-cash charge of
$1.4 million related to the impairment of in process research and
development for the Company’s RNA delivery system (TheraSilence)
offset by a $0.7 million reduction in the earn-out liability
related to potential milestone payments for the TheraSilence
asset. Interest expense decreased by $0.7 million in 2016 due
to lower principal balances outstanding under the Company’s current
debt facility.
Net cash used in operations was $18.4 million in
2016 compared to $20.8 million in the prior year. The Company
ended 2016 with $4.5 million of total cash, investments and accrued
interest on these investments. In February 2017, the Company
raised an additional $5 million in gross proceeds under a secondary
public offering.
Quarterly Conference Call
The Company is hosting a conference call to
provide a business update and discuss year-end 2016 financial
results at 11:00 a.m. ET on Thursday, March 16, 2017. To
participate in the call, interested parties may dial 1-888-490-2763
(Toll-Free/North America) or 1–719-325-2481 (International/Toll)
and ask for the Celsion Corporation 2016 Year-End Earnings Call
(Conference Code: 8052561) 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 March
16, 2017 and will remain available until March 30, 2017. The
replay can be accessed at 1-888-203-1112 (Toll-Free/North America)
or 1-719-457-0820 (International/Toll) using Conference ID:
8052561. 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. ET Thursday, March 16, 2017.
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 Corporation |
Condensed Statements of Operations |
(in thousands except per share amounts) |
|
|
|
|
|
|
|
Year ended December
31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
500 |
|
|
$ |
500 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research
and development |
|
|
14,623 |
|
|
|
14,660 |
|
General
and administrative |
|
|
6,527 |
|
|
|
6,687 |
|
Total
operating expenses |
|
|
21,150 |
|
|
|
21,347 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(20,650 |
) |
|
|
(20,847 |
) |
|
|
|
|
|
|
|
Other
(expense) income: |
|
|
|
|
|
|
Gain
(loss) from valuation of earn-out milestone liability |
|
|
733 |
|
|
|
(258 |
) |
Loss from
impairment of in-process research and development |
|
|
(1,444 |
) |
|
|
– |
|
(Loss)
from valuation of common stock warrant liability |
|
|
– |
|
|
|
(61 |
) |
Interest
expense, investment income and other income (expense), net |
|
|
(693 |
) |
|
|
(1,295 |
) |
Total
other (expense) income, net |
|
|
(1,404 |
) |
|
|
(1,614 |
) |
|
|
|
|
|
|
|
Net
loss |
|
$ |
(22,054 |
) |
|
$ |
(22,461 |
) |
|
|
|
|
|
|
|
Net
loss per common share - basic and diluted |
|
$ |
(0.85 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and
diluted |
|
|
25,957 |
|
|
|
21,813 |
|
|
|
|
|
|
|
Celsion Corporation |
Selected Balance Sheet
Information |
(in thousands) |
|
|
|
|
|
|
ASSETS |
|
|
December 31,2016 |
|
December 31,2015 |
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
2,624 |
|
$ |
9,265 |
|
Investment securities and interest receivable on investment
securities |
|
|
1,684 |
|
|
10,827 |
|
Prepaid
expenses and other current assets |
|
|
204 |
|
|
189 |
|
Total
current assets |
|
|
4,512 |
|
|
20,281 |
|
|
|
|
|
|
|
Property and equipment |
|
|
463 |
|
|
855 |
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
In-process research and development |
|
|
22,766 |
|
|
24,211 |
|
Other
intangible assets, net |
|
|
1,023 |
|
|
1,591 |
|
Goodwill |
|
|
1,976 |
|
|
1,976 |
|
Deposits |
|
|
100 |
|
|
100 |
|
Other
assets |
|
|
9 |
|
|
14 |
|
Total
other assets |
|
|
25,874 |
|
|
27,892 |
|
|
|
|
|
|
|
Total
assets |
|
$ |
30,849 |
|
$ |
49,028 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
5,363 |
|
$ |
4,750 |
|
Deferred
revenue - current portion |
|
|
500 |
|
|
500 |
|
Note
payable - current portion |
|
|
2,560 |
|
|
4,073 |
|
Total
current liabilities |
|
|
8,423 |
|
|
9,323 |
|
Earn-out
milestone liability |
|
|
13,188 |
|
|
13,921 |
|
Notes
payable - noncurrent portion |
|
|
– |
|
|
2,350 |
|
Deferred
revenue and other liabilities - noncurrent portion |
|
|
2,513 |
|
|
3,048 |
|
Total
liabilities |
|
|
24,124 |
|
|
28,642 |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common
stock |
|
|
312 |
|
|
234 |
|
Additional paid-in capital |
|
|
247,878 |
|
|
239,668 |
|
Accumulated other comprehensive loss |
|
|
– |
|
|
(4 |
) |
Accumulated deficit |
|
|
(241,380 |
) |
|
(218,130 |
) |
|
|
|
6,810 |
|
|
21,768 |
|
Less:
Treasury stock |
|
|
(85 |
) |
|
(1,382 |
) |
Total
stockholders' equity |
|
|
6,725 |
|
|
20,386 |
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
30,849 |
|
$ |
49,028 |
|
|
|
|
|
|
|
|
|
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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