LAWRENCEVILLE, N.J., Aug. 15, 2017 (GLOBE NEWSWIRE) -- 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
Ended
June 30, |
|
Six Months
Ended
June 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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