Recent Minimally Dilutive Financings
Substantially Strengthen Balance Sheet and Provide Runway to
Significant Clinical Milestones for ThermoDox® and GEN-1 Clinical
Programs
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today announced financial results for the quarter and nine
month period ended September 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 meaningful
developments in our two lead clinical programs and the capital
infusion of over $38 million in 2017 to help drive these important
development efforts," said Michael H. Tardugno, Celsion's chairman,
president and CEO. “Because of our highly efficient, largely
research focused use of funds, we believe that we now have
sufficient capital to complete enrollment of our Phase III OPTIMA
Study and through the first efficacy analysis expected in the first
quarter of 2019. Further, we expect that our current funds will
allow us to make substantial progress in our open label,
randomized, 86 patient Phase I/II study of GEN-1 in newly diagnosed
stage III and IV ovarian cancer patients.”
“Our global Phase III OPTIMA Study evaluating
ThermoDox® in primary liver cancer is currently enrolling patients
in 14 countries worldwide. In August 2017, the independent Data
Monitoring Committee (DMC) recommended continuation of the OPTIMA
Study after their review of the safety and efficacy data for 275
patients enrolled in the study,” stated Mr. Tardugno. “The final
data from our Phase 1b immunotherapy program in ovarian cancer
continue to provide important insights into GEN-1's clinical and
safety profile and reinforce our confidence in its
potential to serve as an effective front line therapy in newly
diagnosed ovarian cancer patients."
Recent Developments
ThermoDox®
Publication of HEAT Study
Manuscript. On October 16, 2017, the Company
announced publication of the manuscript, "Phase III HEAT Study
Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency
Ablation in Patients with Unresectable Hepatocellular Carcinoma
Lesions," in Clinical Cancer Research, a high impact, peer-reviewed
medical journal. The article provided detailed learnings from the
Company's 701 patient HEAT Study and included results from computer
simulation studies and interesting findings from a post hoc
subgroup analysis, all of which – when examined together –
suggest a clearer understanding of a key ThermoDox® heat-based
mechanism of action: the longer the target tissue is heated, the
greater the doxorubicin tissue concentration.
Additionally, the article explored the
hypothesis prompted by these findings: ThermoDox®, when used in
combination with Radiofrequency Ablation (RFA) standardized to a
minimum dwell time of 45 minutes (sRFA ≥ 45 min), may increase the
overall survival (OS) of patients with hepatocellular carcinoma
(HCC). The final OS analysis demonstrated that in a large, well
bounded, subgroup of patients (n=285 patients, 41% of the previous
701 patient HEAT Study), treatment with a combination of ThermoDox®
and standardized RFA provided an average 58% improvement in OS
compared to standardized RFA alone. The Hazard Ratio (HR) is 0.63
(95% CI 0.43 - 0.93) with a p-value of 0.0198. In this large
subgroup, median OS for the ThermoDox® plus standardized RFA group
translates into a 25.4 month (more than 2.1 years) survival benefit
over the standardized RFA only group - totaling approximately 80
months (6-1/2 years, which is considered a curative treatment for
HCC) for the ThermoDox® plus standardized RFA group versus 53
months for the standardized RFA only group.
The lead author of the HEAT Study manuscript is
Won Young Tak, M.D., Ph.D., Professor Internal Medicine,
Gastroenterology & Hepatology, Kyungpook National University
Hospital Daegu, Republic of Korea, and there are 22 HEAT Study
co-authors along with Nicholas Borys, M.D., Celsion's senior vice
president and chief medical officer.
R&D Day. On October 12,
2017, the Company made various ThermoDox®-related presentations
during the Research and Development (R&D) Day held in New York
City. The presentations focused on the Company's development
program using ThermoDox® for the treatment of primary liver
cancer. Leading OPTIMA Study clinical investigators
representing various geographical regions (Asia-Pacific and Europe)
and multiple medical disciplines (hepatology, interventional
radiology and surgery) presented their past and current experiences
with ThermoDox® for the treatment of primary liver cancer.
Update on OPTIMA Study.
On September 27, 2017, the Company announced that enrollment in the
OPTIMA Study was approaching 70% of the 550 patients necessary to
ensure that the study’s primary end point, overall survival, could
be evaluated with statistical significance. The statistical plan
for the OPTIMA Study calls for two interim efficacy analyses by the
independent Data Monitoring Committee (DMC). The Company projected
full patient enrollment by mid-2018 and the first pre-planned
efficacy analysis after 118 overall survival events by the first
quarter of 2019.
DMC Review of OPTIMA
Study. On August 7, 2017, the
Company announced that the 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 unanimously recommended
that the OPTIMA Study continue according to protocol to its final
data readout based on the risk to benefit analysis by the
Committee. 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 also hosted Investigators Meetings
with physicians and key opinion leaders in Bangkok, Thailand and
Shanghai, 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 potentially significant markets
for ThermoDox® where HCC incidence rates are among the highest in
the world.
GEN-1 Immunotherapy
R&D Day. On October 12,
2017, the Company made various GEN-1 immunotherapy-related
presentations during the Research and Development (R&D) Day
held in New York City. The GEN-1 immunotherapy presentations
focused on the Company's clinical and translational research data
from its recently completed Phase IB OVATION Study. The lead
clinical investigator for the OVATION Study and leading
immuno-oncology experts from the Roswell Park Cancer Institute
presented their current experience with GEN-1 immunotherapy for the
treatment of ovarian cancer.
Presented Final OVATION Study Findings
at the American Association of Cancer Research (AACR) Special
Conference. On October 3, 2017, the Company announced
final clinical and translational research data from the OVATION
Study at the AACR Special Conference entitled "Addressing Critical
Questions in Ovarian Cancer Research and Treatment" in Pittsburgh,
PA. The Company also held an Advisory Board Meeting on
September 27, 2017 with the clinical investigators and scientific
experts to review and finalize clinical, translational research and
safety data from the OVATION Study in order to determine the next
steps forward for this exciting new immunotherapy. With the
endorsement and recommendations from the Advisory Board, the
Company expects to file a next phase protocol with FDA later this
year.
Key translational research findings from all
evaluable patients are consistent with the earlier reports from
partial analysis of the data and are summarized below:
- The intraperitoneal treatment of GEN-1 in conjunction with
neoadjuvant chemotherapy resulted in dose dependent increases in
IL-12 and Interferon-gamma (IFN-g) levels that were predominantly
in the peritoneal fluid compartment with little to no changes
observed in the patients' systemic circulation. These and other
post-treatment changes including decreases in VEGF levels in
peritoneal fluid are consistent with an IL-12 based immune
mechanism.
- Consistent with the previous partial reports, the effects
observed in the 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.
- Analysis of peritoneal fluid by cell sorting, not reported
before, shows treatment-related decrease in the percentage of
immunosuppressive T-cell (Foxp3+), which is consistent with the
reduction of Foxp3+ T-cells in the primary tumor tissue, and a
shift in tumor naïve CD8+ cell population to more efficient tumor
killing memory effector CD8+ cells.
Celsion also reported highly encouraging
clinical data from the first fourteen patients who have completed
treatment in the OVATION Study. GEN-1 plus standard
chemotherapy produced positive clinical results, with no dose
limiting toxicities and promising dose dependent efficacy signals
which correlate well with successful surgical outcomes as
summarized below:
- Of the fourteen patients treated 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.
Seven out of eight (87%) patients in the highest two dose cohorts
experienced a R0 surgical resection. All five patients treated at
the highest dose cohort 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 eight patients who have received GEN-1 treatment over
one year ago (cohort 1 - 3) and are being followed; only two
patients' cancer has progressed. 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 as of
September 30, 2017 is 18 months with the longest progression-free
patient at 24 months.
Corporate Development
Raised Approximately $28.6 Million in
Gross Proceeds in the Third Quarter and Through October
2017. Recent equity offerings
totaling approximately $28.6 million in gross proceeds have
strengthened the Company’s balance sheet and provide a roadway to
potentially significant clinical milestones for ThermoDox® and
GEN-1 clinical programs through the second quarter of 2019.
- The Company raised $17.0 million in gross proceeds through the
exercise of outstanding common stock warrants in October
2017.
- 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.
- In October 2017, the Company completed an underwritten equity
offering of shares of common stock and warrants to purchase common
stock with Oppenheimer & Co. The gross proceeds of the
offering were approximately $6.6 million.
Financial Results
For the quarter ended September 30, 2017,
Celsion reported a net loss of $5.7 million, or $(0.70) per share,
compared to a net loss of $6.4 million, or $(3.22) per share, in
the same period of 2016. Operating expenses were $4.4 million in
the third quarter of 2017 compared to $5.6 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 nine month
period ended September 30, 2017, the Company reported a net loss
attributable to common shareholders of $16.1 million, or $(3.04)
per share, compared to $16.7 million, or $(9.27) per share, in the
same nine month period of 2016. Operating expenses were $13.8
million in the first nine months of 2017 compared to $15.5 million
in the same period of 2016.
Net cash used for operating activities was $12.4
million in the first nine months of 2017 compared to $13.7 million
in the same period last year. The Company ended the third
quarter of 2017 with $2.7 million of total cash and cash
equivalents, which was subsequently increased with aggregate gross
proceeds of $17.0 million from warrant exercises and an
underwritten equity offering with gross proceeds of $6.6 million
completed in October 2017.
Research and development costs were $3.3 million
in the third quarter of 2017 compared to $4.2 million in the same
period last year. Research and development costs were $9.9
million in the first nine months of 2017 compared to $11.0 million
in the same period last year. Clinical development costs for
the Phase III OPTIMA Study remained relatively unchanged at $1.8
million in the third quarter of 2017 compared to $1.9 million in
the same period of 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 nine months
of 2017 associated with the production of ThermoDox® clinical
supplies to support the OPTIMA Study.
General and administrative expenses were $1.2
million in the third quarter of 2017 compared to $1.5 million in
the same period of 2016. This 22 percent decrease during the
third quarter of 2017 was due to lower non-cash stock compensation
expense and reduced professional fees. General and
administrative expenses were $4.3 million in the first nine months
of 2017 compared to $4.9 million in the same period of 2016.
The decrease during the first nine months of 2017 was primarily the
result of lower personnel costs and professional fees.
During the third quarter ended September 30,
2017, other expenses included a non-cash charge of $2.5 million
related to the impairment of certain in process research and
development assets related to the development of our glioblastoma
multiforme (GBM) cancer product candidate offset by a $1.2 million
reduction in the earn-out liability related to potential milestone
payments for the GBM product candidate.
During the nine months ended September 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.
Interest expense decreased by $0.5 million in
2017 due to lower principal balances outstanding under the
Company's current debt facility with Hercules. The loan
balance and end of term charges on its debt facility was paid in
full on June 1, 2017.
Quarterly Conference Call
The Company is hosting a conference call to
provide a business update and discuss third quarter 2017 financial
results at 11:00 a.m. ET on Tuesday, November 14, 2017. To
participate in the call, interested parties may dial 1-877-830-2649
(Toll-Free/North America) or 1–785-424-1824 (International/Toll)
and ask for the Celsion Corporation Third Quarter 2017 Earnings
Call (Conference Code: 3840213) 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,
November 14, 2017 and will remain available until November 28,
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: 3840213. 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, November 14, 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 Investor Contact
Jeffrey W. Church Sr. Vice President and CFO 609-482-2455
jchurch@celsion.com
|
Celsion Corporation |
Condensed Statements of
Operations |
(in thousands except per share
amounts) |
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
$ |
125 |
|
$ |
125 |
|
$ |
375 |
|
$ |
375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
3,349 |
|
|
4,225 |
|
|
9,871 |
|
|
11,003 |
|
General
and administrative |
|
1,174 |
|
|
1,497 |
|
|
4,291 |
|
|
4,888 |
|
Total operating expenses |
|
4,523 |
|
|
5,722 |
|
|
14,162 |
|
|
15,891 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(4,398 |
) |
|
(5,597 |
) |
|
(13,787 |
) |
|
(15,516 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
Gain
(loss) from valuation of common stock warrant liability |
|
1,246 |
|
|
(662 |
) |
|
670 |
|
|
(556 |
) |
(Loss)
from impairment of in-process research and development |
|
(2,520 |
) |
|
- |
|
|
(2,520 |
) |
|
- |
|
Interest
expense, investment income and other income (expense), net |
|
1 |
|
|
(151 |
) |
|
(84 |
) |
|
(585 |
) |
Total other income (expense), net |
|
(1,273 |
) |
|
(813 |
) |
|
(1,934 |
) |
|
(1,141 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(5,671 |
) |
|
(6,410 |
) |
|
(15,721 |
) |
|
(16,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Deemed
dividend related to warrant Modification |
|
- |
|
|
- |
|
|
(346 |
) |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
$ |
(5,671 |
) |
$ |
(6,410 |
) |
$ |
(16,067 |
) |
$ |
(16,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.70 |
) |
$ |
(3.22 |
) |
$ |
(3.04 |
) |
$ |
(9.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
8,055 |
|
|
1,993 |
|
|
5,172 |
|
|
1,796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Corporation |
Selected Balance Sheet
Information |
(in thousands) |
|
|
|
|
|
ASSETS |
|
September
30,2017 |
|
December 31,2016 |
Current assets |
|
|
|
|
Cash and
cash equivalents |
$ |
2,685 |
|
$ |
2,624 |
|
Investment securities and interest receivable on investment
securities |
|
- |
|
|
1,684 |
|
Prepaid
expenses and other current assets |
|
89 |
|
|
204 |
|
Total
current assets |
|
2,774 |
|
|
4,512 |
|
|
|
|
|
|
Property and equipment |
|
143 |
|
|
463 |
|
|
|
|
|
|
Other assets |
|
|
|
|
In-process research and development |
|
20,247 |
|
|
22,766 |
|
Other
intangibles assets, net |
|
852 |
|
|
1,023 |
|
Goodwill |
|
1,976 |
|
|
1,976 |
|
Deposits |
|
- |
|
|
100 |
|
Other
assets |
|
9 |
|
|
9 |
|
Total
other assets |
|
23,084 |
|
|
25,874 |
|
Total assets |
$ |
26,001 |
|
$ |
30,849 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
5,497 |
|
$ |
5,363 |
|
Deferred
revenue - current portion |
|
500 |
|
|
500 |
|
Note
payable - current portion |
|
- |
|
|
2,560 |
|
Total
current liabilities |
|
5,997 |
|
|
8,423 |
|
|
|
|
|
|
Earn-out
milestone liability |
|
12,518 |
|
|
13,188 |
|
Deferred
revenue and other liabilities - noncurrent portion |
|
2,199 |
|
|
2,513 |
|
Total
liabilities |
|
20,714 |
|
|
24,124 |
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
Common
stock |
|
83 |
|
|
22 |
|
Additional paid-in capital |
|
262,390 |
|
|
248,168 |
|
Accumulated deficit |
|
(257,101 |
) |
|
(241,380 |
) |
|
|
5,372 |
|
|
6,810 |
|
Less:
Treasury stock |
|
(85 |
) |
|
(85 |
) |
Total
stockholders' equity |
|
5,287 |
|
|
6,725 |
|
Total liabilities and stockholders' equity |
$ |
26,001 |
|
$ |
30,849 |
|
|
|
|
|
|
|
|
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