Significant Progress in Immuno-oncology and
Chemotherapy Clinical Research Complimented with a 20% Reduction in
Operating Expenses
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the quarter and six
month period ended June 30, 2016 and provided an update on its
development programs for ThermoDox®, the Company’s proprietary
heat-activated liposomal encapsulation of doxorubicin and GEN-1, an
IL-12 DNA-based immunotherapy.
"We are extremely pleased with the momentum that
we have built throughout the first half of this year; and
especially proud of the meaningful developments in our two lead
programs,” said Michael H. Tardugno, Celsion's chairman, president
and CEO. “The data from our immunotherapy program, particularly the
initial data from our OVATION study in first line ovarian cancer,
continue to provide important insights into GEN-1’s favorable
clinical and safety profile and reinforce our confidence in its
potential to serve as an effective therapy in a broad range
of cancers."
Mr. Tardugno continued, “We have also 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 worldwide. In addition, data
presentations and publications in multiple peer-reviewed forums
continue to highlight the potential for a curative approach of
ThermoDox® plus optimized RFA. We are pleased to report that the
most recent analysis of the HEAT Study data is consistent with a
two year survival benefit in the ThermoDox® plus optimized RFA
group versus optimized RFA alone.”
Recent Developments
Immunotherapy - GEN-1
Announced Positive Data from the First
Two Cohorts of the OVATION Study. In July 2016, the
Company announced data from the second cohort 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 six patients dosed, 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 encouraging tumor
response rates, successful surgical resections of the eligible
patients’ tumors, impressive pathological responses and dramatic
drops in CA-125 protein levels. Enrollment in the third
cohort is completed. Celsion expects the 4th, and final,
Phase 1 cohort of the OVATION Study to be fully enrolled this
year.
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. 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. 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.
Established Manufacturing and Commercial
Supply Agreement with Hisun for GEN-1. In August
2016, Celsion signed a long term technology transfer, manufacturing
and commercial supply agreement with Zhejiang Hisun Pharmaceutical
Co. Ltd. The agreement relates to both the clinical and
commercial manufacture and supply of GEN-1 for the greater China
territory, with the option to expand into other countries in the
rest of the world after all necessary regulatory approvals are in
effect. With highly cost effective pricing, the agreement will help
to support supply for ongoing and planned clinical studies in the
United States and potential future studies of GEN-1 in
China.
Chemotherapy - ThermoDox®
Announced Final Overall Survival Data
from HEAT Study of ThermoDox® in Primary Liver
Cancer. On August 15, 2016, the Company announced
updated results from its final retrospective analysis of
701-patient HEAT Study. The overall survival (OS) analysis
demonstrated that in a large, well bounded, subgroup of patients
(n= 285, 41% of the HEAT Study patients), treatment with a
combination of ThermoDox® and optimized RFA provided an average 54%
risk improvement in OS compared to optimized RFA alone. The Hazard
Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a
p-value of 0.02. Median overall survival for the ThermoDox®
group has been reached which translates into a two year survival
benefit over the optimized RFA only group (projected to be greater
than 80 months for the ThermoDox® plus optimized RFA group compared
to less than 60 months projection for the optimized RFA only
group). In the population of 154 patients with single lesions
(70% of the HEAT Study Chinese patient cohort) who received
optimized RFA treatment for 45 minutes or more showed a 53% risk
improvement in OS (HR = 0.66) when treated with ThermoDox® plus
optimized RFA. These data continue to support and further
strengthen ThermoDox®'s potential to significantly improve OS
compared to an RFA control in patients with lesions that undergo
optimized RFA treatment for 45 minutes or more.
Announced a Peer Reviewed Publication in
Hepatic Oncology Highlighting the Potentially Curative Potential of
ThermoDox® in Primary Liver Cancer. On June 21,
2016, the Company announced publication of the article, “RFA plus
lyso-thermosensitive liposomal doxorubicin: In search of the
optimal approach to cure intermediate-size hepatocellular
carcinoma,” in the June 10, 2016 issue of Hepatic Oncology.
The article provided a comprehensive overview of the clinical
evaluation conducted to date of ThermoDox® for the treatment of
primary liver cancer and detailed learnings from the Company’s 701
patient HEAT Study, a computational modeling study, an experimental
animal study and the HEAT Study post hoc subgroup analysis.
All of these studies are consistent with each other and
collectively demonstrate ThermoDox‘s heat-based mechanism of
action, that the longer the target tissue is heated, the greater
the doxorubicin tissue concentration. Additionally, the article
explores the potential for ThermoDox®, when used in combination
with Radio Frequency Ablation (RFA) standardized to a minimum dwell
time of 45 minutes, to increase the overall survival of patients
with primary liver cancer.
Announced Presentation Highlighting
Phase III OPTIMA Study at the Asia-Pacific Primary Liver Cancer
Expert Meeting. On July 11, 2016, the Company
announced that its ongoing Phase III OPTIMA trial evaluating
ThermoDox® in primary liver cancer was featured during an oral
presentation at the 7th Asia-Pacific Primary Liver Cancer Expert
(APPLE) Meeting. The presentation highlighted the potential
of ThermoDox® plus standardized RFA to significantly improve
overall survival of newly diagnosed patients.
Corporate Developments
Raised $6 Million Through A Registered
Direct Offering. In June 2016, the Company completed
a $6 million registered direct equity offering of shares of common
stock, or pre-funded warrants in lieu thereof, and a concurrent
private placement of warrants to purchase common stock with an
institutional healthcare investor. If exercised, the short
dated (six months) private placement warrants will provide an
additional $6 million of operating cash.
Financial Results
For the quarter ended June 30, 2016, Celsion
reported a net loss of $4.5 million, or $(0.19) per share, compared
to a net loss of $5.7 million, or $(0.27) per share, in the same
period of 2015. Operating expenses were $4.9 million in the second
quarter of 2016 compared to $5.4 million in the same period of
2015. For the six month period ended June 30, 2016, the
Company reported a net loss of $10.2 million, or $(0.43) per share,
compared to $12.7 million, or $(0.62) per share, in the same six
month period of 2015. Operating expenses were $10.2 million
in the first half of 2016 compared to $11.9 million in the same
period of 2015. Net cash used in operations was $9.0 million
in the first half of 2016 compared to $11.6 million in the same
period last year. The Company ended the second quarter of
2016 with $14.5 million of total cash, investments and accrued
interest on these investments, which included the proceeds of a $6
million registered direct offering completed during the second
quarter.
Research and development costs were $3.3 million
in the second quarter of 2016 compared to $3.6 million in the same
period last year. Research and development costs were $6.8
million in the first half of 2016 compared to $8.1 million in the
same period last year. The decreases in 2016 are primarily
the result of lower clinical supply costs for the ThermoDox® and
GEN-1 studies partially offset by increased costs associated with
the enrollment in the OPTIMA and the OVATION studies. General
and administrative expenses were $1.5 million in the second quarter
of 2016 compared to $1.8 million in the same period of 2015.
General and administrative expenses were $3.4 million in the first
half of 2016 compared to $3.8 million in the same period of
2015. These decreases were primarily the result of lower
personnel related costs and professional fees.
Quarterly Conference Call
The Company is hosting a conference call to
provide a business update and discuss second quarter 2016 financial
results at 11:00 a.m. EDT on Monday, August 15, 2016. To
participate in the call, interested parties may dial
1-877-723-9521(Toll-Free/North America) or 1-719-325-4925
(International/Toll) and ask for the Celsion Corporation Second
Quarter 2016 Conference Call (Conference Code: 3335946) 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 August
15, 2016 and will remain available until August 29, 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:
3335946. 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, August 15, 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 Corporation |
|
Condensed Statements of
Operations |
|
(in thousands except per share
amounts) |
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
$ |
125 |
|
$ |
125 |
|
$ |
250 |
|
$ |
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
3,336 |
|
|
3,568 |
|
|
6,777 |
|
|
8,074 |
|
General
and administrative |
|
1,530 |
|
|
1,802 |
|
|
3,392 |
|
|
3,834 |
|
Total operating expenses |
|
4,866 |
|
|
5,370 |
|
|
10,169 |
|
|
11,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(4,741 |
) |
|
(5,245 |
) |
|
(9,919 |
) |
|
(11,658 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Gain
(loss) from valuation of common stock warrant liability |
|
409 |
|
|
(69 |
) |
|
106 |
|
|
(242 |
) |
Loss from
valuation of common stock warrant liability |
|
– |
|
|
(18 |
) |
|
– |
|
|
(61 |
) |
Interest
expense, investment income and other income (expense), net |
|
(199 |
) |
|
(343 |
) |
|
(434 |
) |
|
(719 |
) |
Total other income (expense), net |
|
210 |
|
|
(430 |
) |
|
(328 |
) |
|
(1,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(4,531 |
) |
|
(5,675 |
) |
|
(10,247 |
) |
|
(12,680 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.19 |
) |
$ |
(0.27 |
) |
$ |
(0.43 |
) |
$ |
(0.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
24,124 |
|
|
20,970 |
|
|
23,752 |
|
|
20,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Corporation |
|
Selected Balance Sheet
Information |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
ASSETS |
|
2016 |
|
2015 |
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
|
12,308 |
|
$ |
|
9,265 |
|
|
Investment securities and interest receivable on investment
securities |
|
|
2,160 |
|
|
|
10,827 |
|
|
Prepaid
expenses and other current assets |
|
|
501 |
|
|
|
189 |
|
|
Total
current assets |
|
|
14,969 |
|
|
|
20,281 |
|
|
|
|
|
|
|
|
Property and equipment |
|
|
658 |
|
|
|
855 |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
In-process research and development |
|
|
25,802 |
|
|
|
25,802 |
|
|
Goodwill |
|
|
1,976 |
|
|
|
1,976 |
|
|
Deposits |
|
|
100 |
|
|
|
100 |
|
|
Other
assets |
|
|
10 |
|
|
|
14 |
|
|
Total
other assets |
|
|
27,888 |
|
|
|
27,892 |
|
|
|
|
|
|
|
|
Total
assets |
$ |
|
43,515 |
|
$ |
|
49,028 |
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
|
5,328 |
|
$ |
|
4,750 |
|
|
Deferred
revenue - current portion |
|
|
500 |
|
|
|
500 |
|
|
Note
payable - current portion |
|
|
4,579 |
|
|
|
4,073 |
|
|
Total
current liabilities |
|
|
10,407 |
|
|
|
9,323 |
|
|
|
|
|
|
|
|
Earn-out
milestone liability |
|
|
13,815 |
|
|
|
13,921 |
|
|
Notes
payable - noncurrent portion |
|
|
– |
|
|
|
2,350 |
|
|
Other
liabilities - noncurrent portion |
|
|
2,781 |
|
|
|
3,048 |
|
|
Total
liabilities |
|
|
27,003 |
|
|
|
28,642 |
|
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
Common
stock |
|
|
258 |
|
|
|
234 |
|
|
Additional paid-in capital |
|
|
245,973 |
|
|
|
239,668 |
|
|
Accumulated other comprehensive loss |
|
|
– |
|
|
|
(4 |
) |
|
Accumulated deficit |
|
|
(228,755 |
) |
|
|
(218,130 |
) |
|
|
|
|
17,476 |
|
|
|
21,768 |
|
|
Less:
Treasury stock |
|
|
(964 |
) |
|
|
(1,382 |
) |
|
Total
stockholders' equity |
|
|
16,512 |
|
|
|
20,386 |
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
|
43,515 |
|
$ |
|
49,028 |
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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