Meaningful Progress with the ThermoDox® OPTIMA
Study and GEN-1 Immunotherapy Program, Including Highly Encouraging
Data from Primary Liver and Ovarian Cancer Studies
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the quarter and nine
month period ended September 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.
"Over the last nine months, we have realized
meaningful progress with respect to our two lead programs,
ThermoDox® and GEN-1. Importantly, we are well positioned to
sustain this momentum through the balance of 2016 and beyond,” said
Michael H. Tardugno, Celsion's chairman, president and CEO. “The
initial data from our GEN-1 program provides highly valuable
insights into its favorable clinical and safety profile indicating
a great deal of potential in both first and second-line ovarian
cancer, and we look forward to reporting additional data from our
ongoing OVATION study before year-end."
Mr. Tardugno continued, “Our ongoing global,
pivotal Phase III OPTIMA Study of ThermoDox® in primary liver
cancer remains on track with clinical sites currently enrolling
patients in 13 countries worldwide. Investigators continue to
recognize the value of findings from the HEAT Study and their
continued interest reinforces substantial and mounting support for
the OPTIMA Study. The recent independent analysis conducted by the
National Institutes of Health provides further confirmatory support
indicating that the use of radiofrequency ablation (RFA) for more
than 45 minutes in patients treated with ThermoDox® can have a
correlative impact on reductions in tumor size and overall survival
in patients with primary liver cancer.”
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 highly
encouraging tumor response rates, successful surgical resections of
the eligible patients’ tumors, impressive pathological responses
and dramatic, clinically meaningful drops in CA-125 protein
levels.
Positive DSMB Review of OVATION Study in
Ovarian Cancer. In September 2016, the independent
Data Safety Monitoring Board (DSMB) completed its safety review of
data from the first three patient cohorts in the ongoing Phase Ib
OVATION Study. Based on the DSMB's recommendation, the study
will continue as planned and the Company will proceed with dosing
in its fourth and final patient cohort at an escalated dose.
Celsion expects the fourth cohort to be fully enrolled this
year.
Established a 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 support economically advantaged supply for ongoing
and planned clinical studies in the United States and potential
future studies of GEN-1 in China as well as Europe.
Chemotherapy - ThermoDox®
Announced the Final Overall Survival
Data from HEAT Study of ThermoDox® in Primary Liver
Cancer. In August 2016, the Company announced
updated results from its final retrospective analysis of the
701-patient HEAT Study. The overall survival analysis
demonstrated that in a large, well bounded, subgroup of 285
patients (41% of the HEAT Study patients), treatment with a
combination of ThermoDox® and optimized RFA provided an average 54%
risk improvement in overall survival 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. Importantly, after 3.5 years
of follow up, the median overall survival for the ThermoDox® group
has yet to be reached and is showing over 80 months survival
benefit compared to less than 60 months projection for the
optimized RFA only group, which translates into a two year survival
benefit.
Announced the Independent NIH Analysis
Showing Treatment with ThermoDox® Plus RFA may
Significantly Improve Overall Survival of Patients with Primary
Liver Cancer. In September 2016, the Company
announced that the National Institutes of Health (NIH) has
conducted an independent retrospective analysis of data from the
Company’s HEAT Study. The NIH analysis, which sought to
evaluate the correlation between RFA burn time per tumor volume
(min/ml) and clinical outcome in patients treated with ThermoDox®,
concluded that increased RFA burn time per tumor volume
substantially improved survival in patients with solitary lesions
treated with RFA + ThermoDox® compared to patients treated with 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.
Detailed findings from the NIH study will be
presented during oral sessions on Monday, November 28, 2016 at 1:50
pm CT during the 102nd Scientific Assembly and Annual Meeting of
the Radiological Society of North America (RSNA) to be held on
November 26 – December 2, 2016 in Chicago, IL.
Announced Presentations Highlighting
Phase III OPTIMA Study at Two Asia-Pacific Primary Liver Cancer
Expert Meetings.
In July 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 in Hong
Kong, China. The presentation highlighted the potential of
ThermoDox® plus optimized RFA to significantly improve overall
survival of newly diagnosed patients.
In October 2016, the Company announced the
presentation of data from the Company’s HEAT Study, highlighting
the curative potential for ThermoDox® plus optimized RFA in
intermediate primary liver cancer at the 3rd Asian Conference on
Tumor Ablation (ACTA) in Seoul, Korea.
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 is
expected to commence in the fourth quarter of 2016.
Financial Results
For the quarter ended September 30, 2016,
Celsion reported a net loss of $6.4 million, or $(0.23) per share,
compared to a net loss of $4.3 million, or $(0.19) per share, in
the same period of 2015. Operating expenses were $5.7 million in
the third quarter of 2016 compared to $4.4 million in the same
period of 2015. For the nine month period ended September 30,
2016, the Company reported a net loss of $16.7 million, or $(0.66)
per share, compared to $16.9 million, or $(0.79) per share, in the
same nine month period of 2015. Operating expenses were $15.9
million in the first nine months of 2016 compared to $16.3 million
in the same period of 2015. Net cash used in operations was
$13.7 million in the first nine months of 2016 compared to $16.9
million in the same period last year. The Company ended the
third quarter of 2016 with $8.7 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 $4.2 million
in the third quarter of 2016 compared to $2.9 million in the same
period last year. Research and development costs were $11.0
million in the first nine months of 2016 and 2015. R&D
costs in 2016 reflect lower clinical supply costs for the
ThermoDox® and GEN-1 clinical studies offset by increased costs
associated with the enrollment in the OPTIMA and the OVATION
studies when compared to 2015. General and administrative
expenses were $1.5 million in the third quarter of 2016 and
2015. General and administrative expenses were $4.9 million
in the first nine months of 2016, down 8 percent when compared to
the same period of 2015. This decrease was 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 third quarter 2016 financial
results at 11:00 a.m. ET on Thursday, November 10, 2016. To
participate in the call, interested parties may dial 1-800-533-7619
(Toll-Free/North America) or 1-785-830-1923 (International/Toll)
and ask for the Celsion Corporation Third Quarter 2016 Conference
Call (Conference Code: 9409290) 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 November
10, 2016 and will remain available until November 24, 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: 9409290. 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, November 10, 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; the risk that if
Celsion is not able to raise additional capital when needed, there
would be a delay, reduction in the scope, or termination of our
research, development, clinical programs and commercialization
efforts; and other risks detailed from time to time in Celsion’s
most recent Form 10-K and Form 10-K/A that were filed with the
Securities and Exchange Commission (SEC) on March 30, 2016 and
April 29, 2016, respectively, and its other periodic filings with
the SEC, including subsequent periodic reports on Forms 10-Q and
8-K. 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)(Unaudited) |
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2016 |
2015 |
|
2016 |
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
$ |
|
125 |
|
$ |
125 |
|
$ |
375 |
|
$ |
375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,225 |
|
|
2,883 |
|
|
11,003 |
|
|
10,958 |
|
General and administrative |
|
|
1,497 |
|
|
1,484 |
|
|
4,888 |
|
|
5,317 |
|
Total operating
expenses |
|
|
5,722 |
|
|
4,367 |
|
|
15,891 |
|
|
16,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(5,597 |
) |
|
(4,242 |
) |
|
(15,516 |
) |
|
(15,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
(Loss) gain valuation of common
stock warrant liability |
|
|
(662 |
) |
|
283 |
|
|
(557 |
) |
|
41 |
|
Loss from valuation of common stock
warrant liability |
|
|
- |
|
|
- |
|
|
- |
|
|
(61 |
) |
Interest expense, investment income
and other income (expense), net |
|
|
(151 |
) |
|
(308 |
) |
|
(584 |
) |
|
(1,027 |
) |
Total other income
(expense), net |
|
|
(813 |
) |
|
(25 |
) |
|
(1,141 |
) |
|
(1,047 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(6,410 |
) |
$ |
(4,267 |
) |
$ |
(16,657 |
) |
$ |
(16,947 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share |
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
$ |
|
(0.23 |
) |
$ |
(0.19 |
) |
$ |
(0.66 |
) |
$ |
(0.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
27,905 |
|
|
23,023 |
|
|
25,146 |
|
|
21,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Corporation |
|
|
Selected Balance Sheet
Information |
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
September
30, 2016 |
|
|
|
December
31, 2015 |
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
|
4,184 |
|
$ |
|
9,265 |
|
|
|
Investment securities and interest
receivable on investment securities |
|
|
4,516 |
|
|
|
10,827 |
|
|
|
Prepaid expenses and other current
assets |
|
|
331 |
|
|
|
189 |
|
|
|
Total current assets |
|
|
9,031 |
|
|
|
20,281 |
|
|
|
|
|
|
|
|
|
|
Property and
equipment |
|
|
544 |
|
|
|
855 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
In-process research and
development |
|
|
25,802 |
|
|
|
25,802 |
|
|
|
Goodwill |
|
|
1,976 |
|
|
|
1,976 |
|
|
|
Deposits |
|
|
100 |
|
|
|
100 |
|
|
|
Other assets |
|
|
8 |
|
|
|
14 |
|
|
|
Total other assets |
|
|
27,886 |
|
|
|
27,892 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
$ |
|
37,461 |
|
$ |
|
49,028 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
$ |
|
5,671 |
|
$ |
|
4,750 |
|
|
|
Deferred revenue - current
portion |
|
|
500 |
|
|
|
500 |
|
|
|
Note payable - current portion |
|
|
3,593 |
|
|
|
4,073 |
|
|
|
Total current liabilities |
|
|
9,764 |
|
|
|
9,323 |
|
|
|
|
|
|
|
|
|
|
Earn-out milestone liability |
|
|
14,478 |
|
|
|
13,921 |
|
|
|
Notes payable - noncurrent
portion |
|
– |
|
|
2,350 |
|
|
|
Other liabilities - noncurrent
portion |
|
|
2,647 |
|
|
|
3,048 |
|
|
|
Total liabilities |
|
|
26,889 |
|
|
|
28,642 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
|
Common stock |
|
|
261 |
|
|
|
234 |
|
|
|
Additional paid-in capital |
|
|
246,401 |
|
|
|
239,668 |
|
|
|
Accumulated other comprehensive
loss |
|
|
|
|
(4 |
) |
|
|
Accumulated deficit |
|
|
(235,673 |
) |
|
|
(218,130 |
) |
|
|
|
|
|
10,989 |
|
|
|
21,768 |
|
|
|
Less: Treasury stock |
|
|
(417 |
) |
|
|
(1,382 |
) |
|
|
Total stockholders' equity |
|
|
10,572 |
|
|
|
20,386 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
|
37,461 |
|
$ |
|
49,028 |
|
|
|
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Sep 2023 to Sep 2024