Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the quarter ended
March 31, 2017 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 continues to make major progress with
respect to our ongoing global, pivotal Phase III OPTIMA Study in
primary liver cancer. This ground-breaking study continues to
attract interest and support from the medical community,
international regulatory agencies, and research organizations like
the National Institutes of Health," said Michael H. Tardugno,
Celsion's chairman, president and CEO. "Our product
development efforts in immuno-oncology are equally important. We
have demonstrated the potential of our GEN-1 IL-12 immunotherapy
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 results and translational research
data from our Phase 1B OVATION Study at the ASCO Annual Meeting in
June 2017."
Recent Developments
ThermoDox®
Announced the Publication of Preclinical
Results of ThermoDox® for the Treatment of Bladder Cancer in the
International Journal of Hyperthermia. The Company
reported results from porcine in vivo studies to evaluate
ThermoDox® in combination with loco-regional mild hyperthermia for
targeted drug delivery to the bladder wall as a potential treatment
for bladder cancer. Doxorubicin accumulation and distribution
within the bladder wall with ThermoDox® plus mild bladder
hyperthermia was achieved at concentrations nearly ten times higher
than with free intravenous doxorubicin combined with mild bladder
hyperthermia. The study was conducted under a Cooperative Research
and Development Agreement (CRADA) with the National Institutes of
Health (NIH) to evaluate whether ThermoDox® combined with mild
heating of the bladder can target drug delivery in the bladder.
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. The Company's management team also 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 plans to activate 5
additional clinical trial sites in Vietnam by the second quarter of
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.
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. In February 2017, the Company
presented two posters at the American Society of Clinical Oncology
(ASCO) - Society for Immunotherapy of Cancer (SITC) Clinical
Immuno-Oncology Symposium held from February 23 - 25, 2017 in
Orlando, FL. The ASCO-SITC Clinical Immuno-Oncology Symposium
focused on the latest clinical and translational research in
immuno-oncology and the implications for clinical care.
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 quarter ended March 31, 2017, Celsion
reported a net loss of $5.2 million, or $0.12 per share, compared
to a net loss of $5.7 million, or $0.24 per share, in the same
period of 2016. Operating expenses were $4.9 million in the first
quarter of 2017 compared to $5.3 million in the same period of
2016. This decrease was primarily due to lower general and
administrative expenses.
Research and development (R&D) costs were
relatively constant at $3.5 million and $3.4 million in the first
quarters of 2017 and 2016, respectively. Clinical development
costs for the Phase III OPTIMA Study were $1.6 million in the first
quarter of 2017 compared to $1.0 million in the same period of 2016
due to higher patient enrollment and investigator grant 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 the first quarter of 2017
associated with the production of ThermoDox® clinical supplies to
support the OPTIMA Study. General and administrative expenses
decreased $0.4 million, from $1.9 million in the first quarter of
2016 to $1.5 million in the first quarter of 2017. This 21%
decrease in general and administrative expenses in 2017 is
primarily the result of reduction in personnel costs and lower
professional fees.
Net cash used in operations was $3.1 million in
the first quarter of 2017 compared to $4.7 million in the same
period of 2016. The Company ended the first quarter of 2017
with $4.5 million of total cash and cash equivalents. In
February 2017, the Company raised $5 million in gross proceeds
under a secondary public offering with various institutional and
retail investors.
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 Friday, May 12, 2017. To participate in
the call, interested parties may dial 1-888-282-4591
(Toll-Free/North America) or 1–719-457-2605 (International/Toll)
and ask for the Celsion Corporation First Quarter 2017 Earnings
Call (Conference Code: 4060768) 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 Friday,
May 12, 2017 and will remain available until May 26, 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: 4060768. An audio replay of the call will also be
available on the Company's website, www.celsion.com, for 90 days
after 2:00 p.m. ET Friday, May 12, 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. 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) |
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
125 |
|
|
$ |
125 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research
and development |
|
|
3,475 |
|
|
|
3,441 |
|
General
and administrative |
|
|
1,468 |
|
|
|
1,863 |
|
Total
operating expenses |
|
|
4,943 |
|
|
|
5,304 |
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
|
(4,818 |
) |
|
|
(5,179 |
) |
|
|
|
|
|
|
|
Other
(expense) income: |
|
|
|
|
|
|
Loss from
valuation of earn-out milestone liability |
|
|
(283 |
) |
|
|
(303 |
) |
Interest
expense, investment income and other income (expense), net |
|
|
(59 |
) |
|
|
(234 |
) |
Total
other (expense) income, net |
|
|
(342 |
) |
|
|
(537 |
) |
|
|
|
|
|
|
|
Net
loss |
|
$ |
(5,160 |
) |
|
$ |
(5,716 |
) |
|
|
|
|
|
|
|
Net
loss per common share - basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and
diluted |
|
|
42,425 |
|
|
|
23,388 |
|
|
|
|
|
|
|
|
Celsion Corporation |
Selected Balance Sheet Information |
(in thousands) |
|
|
|
|
|
|
|
ASSETS |
|
|
March 31,2017 |
|
|
December 31,2016 |
Current assets |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
4,470 |
|
|
$ |
2,624 |
|
Investment securities and interest receivable on investment
securities |
|
|
– |
|
|
|
1,684 |
|
Prepaid
expenses and other current assets |
|
|
141 |
|
|
|
204 |
|
Total
current assets |
|
|
4,611 |
|
|
|
4,512 |
|
|
|
|
|
|
|
|
Property and equipment |
|
|
370 |
|
|
|
463 |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
In-process research and development |
|
|
22,766 |
|
|
|
22,766 |
|
Other
intangibles assets, net |
|
|
967 |
|
|
|
1,023 |
|
Goodwill |
|
|
1,976 |
|
|
|
1,976 |
|
Deposits |
|
|
100 |
|
|
|
100 |
|
Other
assets |
|
|
9 |
|
|
|
9 |
|
Total
other assets |
|
|
25,818 |
|
|
|
25,874 |
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
30,799 |
|
|
$ |
30,849 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
6,871 |
|
|
$ |
5,363 |
|
Deferred
revenue - current portion |
|
|
500 |
|
|
|
500 |
|
Note
payable - current portion |
|
|
1,472 |
|
|
|
2,560 |
|
Total
current liabilities |
|
|
8,843 |
|
|
|
8,423 |
|
Earn-out
milestone liability |
|
|
13,472 |
|
|
|
13,188 |
|
Deferred
revenue and other liabilities - noncurrent portion |
|
|
2,378 |
|
|
|
2,513 |
|
Total
liabilities |
|
|
24,693 |
|
|
|
24,124 |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
Common
stock |
|
|
555 |
|
|
|
312 |
|
Additional paid-in capital |
|
|
252,176 |
|
|
|
247,878 |
|
Accumulated deficit |
|
|
(246,540 |
) |
|
|
(241,380 |
) |
|
|
|
6,191 |
|
|
|
6,810 |
|
Less:
Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total
stockholders' equity |
|
|
6,106 |
|
|
|
6,725 |
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
30,799 |
|
|
$ |
30,849 |
|
|
|
|
|
|
|
|
|
|
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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