Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the quarter and six
month period ended June 30, 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. The Company's
immunotherapy program consists of GEN-1 and is currently in Phase I
development for the localized treatment of ovarian cancer.
"We are extremely pleased with the momentum that
we have built and the meaningful developments in our two lead
programs," said Michael H. Tardugno, Celsion's chairman, president
and CEO. "The data from our immunotherapy program, both the
clinical data as well as the recently announced translational 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 14 countries worldwide. In addition, we are
pleased to report that the independent Data Monitoring Committee
recently recommended continuation of the OPTIMA Study after their
review of the safety and efficacy data for 275 patients enrolled in
the study. Enrollment momentum continues to improve with the
addition of new clinical sites in China and Vietnam."
Recent Developments
ThermoDox®
OPTIMA Study
Update. On August 7, 2017, the
Company announced that the independent Data Monitoring Committee
(DMC) for the Company's OPTIMA Study completed a regularly
scheduled review of the first 50% of patients enrolled in the trial
as of April 2017 and has unanimously recommended that the OPTIMA
Study continue according to protocol to its final data readout. The
DMC reviewed study data at regular intervals, with the primary
responsibilities of ensuring the safety of all patients enrolled in
the study, the quality of the data collected, and the continued
scientific validity of the study design. As part of its
review, the DMC monitored a quality matrix relating to the total
clinical data set, confirming the timely collection of data, that
all data are current as well as other data collection and quality
criteria.
The Company hosted an Investigators Meeting with
physicians in SE Asia and key opinion leaders on July 22-23, 2017
in Bangkok, Thailand. A second Investigators Meeting is being
planned for October with physicians in China. The Company has
initiated approximately 70 clinical sites in 14 countries with
plans to activate up to 8 additional clinical trial sites in China
or Vietnam by the end of 2017. China and Vietnam represent
significant markets for ThermoDox® where HCC incidence rates are
among the highest in the world.
In addition, the Company announced that patient
enrollment in the 550 patient Phase III global study has reached
over 60%. Based on current enrollment rates, the Company
expects to complete enrollment of the OPTIMA Study by mid -
2018.
GEN-1 Immunotherapy
Announced Latest Translational Data from
the OVATION Study Showing That Patients in All Cohorts Showed
Convincing Evidence of IL-12 Gene Transfer and Immune System
Activity. On August 2, 2017, the Company reported that
translational research data from its Phase Ib dose escalating
clinical trial was reviewed with leading immuno-oncology experts
from the Roswell Park Cancer Institute. The data showed evidence of
IL-12 gene transfer by dose dependent increases in IL-12 levels and
immune system activity and significant increases in
interferon-gamma (IFN- γ) and decreases in VEGF levels. The
treatment-related changes in immune activating cytokines and
pro-tumor VEGF levels followed a dose-dependent trend and were
predominantly in the peritoneal fluid compartment with little to no
changes observed in the patients’ systemic blood stream.
Key translational research findings from the
first 12 of 15 patients enrolled in four patient cohorts are
summarized below:
- The treatment-related changes in immune activating cytokines
and pro-tumor VEGF and IFN- γ levels followed a dose-dependent
trend and were predominantly in the peritoneal fluid compartment
with little to no changes observed in the patients’ systemic
circulation. The observed immunological changes are consistent with
an IL-12 based mechanism.
- Effects observed in the immunohistochemistry (IHC) analysis
were pronounced decreases in the density of immunosuppressive
T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) and increases in CD8+
cells in the tumor microenvironment.
- The ratio of CD8+ cells to immunosuppressive cells was
increased in approximately 75% of patients suggesting an overall
shift in the tumor microenvironment from immunosuppressive to
pro-immune stimulatory following treatment with GEN-1. An
increase in CD8+ to immunosuppressive T-cell populations is a
leading indicator and believed to be a good predictor of improved
overall survival.
Presented OVATION Study Findings in
Newly Diagnosed Advanced Ovarian Cancer Patients at the ASCO 2017
Annual Meeting. In June 2017, the
Company reported clinical data from the first fourteen patients who
have completed treatment in the OVATION Study. GEN-1 plus
standard chemotherapy produced positive results, with no dose
limiting toxicities and promising dose dependent efficacy signals
which appear to correlate well with successful surgical outcomes as
summarized below:
- Of the fourteen patients treated to date in the entire study,
two (2) patients demonstrated a complete response, ten (10)
patients demonstrated a partial response and two (2) patients
demonstrated stable disease, as measured by RECIST criteria. This
translates to a 100% disease control rate ("DCR") and an 86%
objective response rate ("ORR"). Of the five patients treated
in the highest dose cohort, there was a 100% objective response
rate with one (1) complete response and four (4) partial
responses.
- Fourteen patients had successful resections of their tumors,
with nine (9) patients (64%) having an R0 resection, which
indicates a microscopically margin-negative resection in which no
gross or microscopic tumor remains in the tumor bed. Of the
five patients treated at the highest dose cohort, all five patients
(100%) experienced a R0 surgical resection. Seven out of
eight (87%) patients in the highest two dose cohorts experienced a
R0 surgical resection.
- All patients experienced a clinically significant decrease 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.
- Of the seven patients who have received GEN-1 treatment over
one year ago and are being followed, only one patient’s cancer has
progressed after 11.7 months. This compares favorably to the
historical median progression free survival (PFS) of 12 months for
newly-diagnosed patients with Stage III and IV ovarian cancer that
undergo neoadjuvant chemotherapy followed by interval debulking
surgery. Of the remaining six patients who have been on the
study for over one year, their average PFS is 16.4 months with the
longest progression-free patient at over 22 months.
Corporate Development
Raised $10.1 Million through Warrant
Exercises and Registered Direct
Offering. During the second quarter
of 2017, the Company raised $5.1 million through the exercise of
outstanding common stock warrants. In July 2017, the Company
completed a $5 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 several institutional healthcare investors.
Financial Results
For the quarter ended June 30, 2017, Celsion
reported a net loss of $4.9 million, or $(0.79) per share, compared
to a net loss of $4.5 million, or $(2.63) per share, in the same
period of 2016. Operating expenses were $4.7 million in the second
quarter of 2017 compared to $4.9 million in the same period of
2016. This decrease was primarily due to a tighter clinical
development focus coupled with lower general and administrative and
interest expenses. For the six month period ended June 30,
2017, the Company reported a net loss of $10.1 million, or $(1.75)
per share, compared to $10.2 million, or $(6.04) per share, in the
same six month period of 2016. Operating expenses were $9.6
million in the first half of 2017 compared to $10.2 million in the
same period of 2016. Net cash used in operations was $7.3
million in the first half of 2017 compared to $9.0 million in the
same period last year. The Company ended the second quarter
of 2017 with $3.6 million of total cash and investments, which was
subsequently increased with proceeds from a $5 million registered
direct offering completed in early July 2017.
Research and development costs were $3.0 million
in the second quarter of 2017 compared to $3.3 million in the same
period last year. Research and development costs were $6.5
million in the first half of 2017 compared to $6.8 million in the
same period last year. Clinical development costs for the
Phase III OPTIMA Study remained relatively unchanged at $1.5
million in each of the second quarter of 2017 and 2016. 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 half of 2017 associated with the production of
ThermoDox® clinical supplies to support the OPTIMA Study.
General and administrative expenses were $1.6
million in the second quarter of 2017 compared to $1.5 million in
the same period of 2016. The increase during the second
quarter of 2017 was due to higher non-cash stock compensation
expense partially offset by reduced professional fees.
General and administrative expenses were $3.1 million in the first
half of 2017 compared to $3.4 million in the same period of
2016. The decrease during the first six months of 2017 was
primarily the result of lower personnel costs and professional
fees.
During the three and six months ended June 30,
2017, the Company recognized deemed dividends totaling $0.4 million
collectively in regard to multiple agreements with certain warrant
holders, pursuant to which these warrant holders agreed to
exercise, and the Company agreed to reprice, certain
warrants. Warrants to purchase 790,410 shares of common stock
were repriced at $2.70 and warrants to purchase 506,627 shares of
common stock were repriced at $1.65. The Company received
$3.0 million in gross proceeds from the sale of these repriced
warrants.
Quarterly Conference Call
The Company is hosting a conference call to
provide a business update and discuss second quarter 2017 financial
results at 11:00 a.m. ET on Tuesday, August 15, 2017. To
participate in the call, interested parties may dial 1-888-576-4382
(Toll-Free/North America) or 1–719-325-2460 (International/Toll)
and ask for the Celsion Corporation Second Quarter 2017 Earnings
Call (Conference Code: 7987329) 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 Tuesday,
August 15, 2017 and will remain available until August 29,
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: 7987329. 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 Tuesday, August 15, 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; 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 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 EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
$ |
125 |
|
$ |
125 |
|
$ |
250 |
|
$ |
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
3,047 |
|
|
3,336 |
|
|
6,522 |
|
|
6,777 |
|
General
and administrative |
|
1,649 |
|
|
1,530 |
|
|
3,117 |
|
|
3,392 |
|
Total operating expenses |
|
4,696 |
|
|
4,866 |
|
|
9,639 |
|
|
10,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(4,571 |
) |
|
(4,741 |
) |
|
(9,389 |
) |
|
(9,919 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Gain
(loss) from valuation of common stock warrant
liability |
|
(292 |
) |
|
409 |
|
|
(576 |
) |
|
106 |
|
Interest
expense, investment income and other income (expense), net |
|
(27 |
) |
|
(199 |
) |
|
(85 |
) |
|
(434 |
) |
Total other income (expense), net |
|
(319 |
) |
|
210 |
|
|
(661 |
) |
|
(328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(4,890 |
) |
|
(4,531 |
) |
|
(10,050 |
) |
|
(10,247 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend related
to warrant Modification |
|
(346 |
) |
|
- |
|
|
(346 |
) |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
$ |
(5,236 |
) |
$ |
(4,531 |
) |
$ |
(10,396 |
) |
$ |
(10,247 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted |
$ |
(0.79 |
) |
$ |
(2.63 |
) |
$ |
(1.75 |
) |
$ |
(6.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted |
|
6,629 |
|
|
1,723 |
|
|
5,949 |
|
|
1,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Corporation |
|
Selected Balance Sheet
Information |
|
(in thousands) |
|
|
|
|
|
|
|
ASSETS |
|
June 30,2017 |
|
December 31,2016 |
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
3,629 |
|
$ |
2,624 |
|
|
Investment securities and interest receivable on investment
securities |
|
- |
|
|
1,684 |
|
|
Prepaid
expenses and other current assets |
|
110 |
|
|
204 |
|
|
Total
current assets |
|
3,739 |
|
|
4,512 |
|
|
|
|
|
|
|
|
Property and equipment |
|
257 |
|
|
463 |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
In-process research and development |
|
22,766 |
|
|
22,766 |
|
|
Other
intangibles assets, net |
|
909 |
|
|
1,023 |
|
|
Goodwill |
|
1,976 |
|
|
1,976 |
|
|
Deposits |
|
- |
|
|
100 |
|
|
Other
assets |
|
9 |
|
|
9 |
|
|
Total
other assets |
|
25,660 |
|
|
25,874 |
|
|
Total assets |
$ |
29,656 |
|
$ |
30,849 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
6,456 |
|
$ |
5,363 |
|
|
Deferred
revenue - current portion |
|
500 |
|
|
500 |
|
|
Note
payable - current portion |
|
- |
|
|
2,560 |
|
|
Total
current liabilities |
|
6,956 |
|
|
8,423 |
|
|
|
|
|
|
|
|
Earn-out
milestone liability |
|
13,764 |
|
|
13,188 |
|
|
Deferred
revenue and other liabilities - noncurrent portion |
|
2,287 |
|
|
2,513 |
|
|
Total
liabilities |
|
23,007 |
|
|
24,124 |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common
stock |
|
59 |
|
|
22 |
|
|
Additional paid-in capital |
|
258,105 |
|
|
248,168 |
|
|
Accumulated deficit |
|
(251,430 |
) |
|
(241,380 |
) |
|
|
|
6,734 |
|
|
6,810 |
|
|
Less:
Treasury stock |
|
(85 |
) |
|
(85 |
) |
|
Total
stockholders' equity |
|
6,649 |
|
|
6,725 |
|
|
Total liabilities and stockholders' equity |
$ |
29,656 |
|
$ |
30,849 |
|
|
|
|
|
|
|
|
|
|
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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