Celsion Corporation (NASDAQ: CLSN), an oncology drug development
company, today announced financial results for the three-month and
nine-month periods ended September 30, 2019 and provided an update
on its development programs for ThermoDox® and GEN-1.
The Company's lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin
currently in Phase III development (the OPTIMA Study) for the
treatment of hepatocellular carcinoma (HCC), or primary liver
cancer. The Company's immunotherapy candidate, GEN-1, is an IL-12
DNA plasmid vector encased in a nanoparticle delivery system that
enables cell transfection followed by persistent, local secretion
of the IL-12 protein. GEN-1 is currently in Phase I/II
development (the OVATION 2 Study) for the localized treatment of
newly diagnosed Stage III and IV ovarian cancer.
“Recent weeks have been particularly gratifying
for the team at Celsion, with encouraging news on two clinical
development programs, along with maintaining a strong balance sheet
and ready access to cash at our discretion,” said Michael H.
Tardugno, Celsion’s chairman, president and chief executive
officer.
“Our focus on shareholder value remains
uncompromised as Celsion continues to deliver results from our
ongoing clinical development programs for ThermoDox® and
GEN-1. Our smart use of venture debt to leverage the holdings
of our equity investors, along with our strategy to avoid punitive
financing deals has worked well for us and our shareholders.
We enter the fourth quarter with sound fundamentals and a strong
balance sheet that is expected to fund our clinical programs
through transformative milestones over the next 16 months,” added
Mr. Tardugno. “With the first of two preplanned interim
efficacy analyses for the OPTIMA Study successfully behind us, we
look forward to the promise and potential for success at the 2nd
preplanned analysis, now expected to occur in the second quarter of
2020. The OPTIMA Study, a global, pivotal study completed
patient enrollment in August 2018 at more than 65 clinical sites in
14 countries, including all the major markets for primary liver
cancer and represents the first and only first line treatment for
newly diagnosed primary liver cancer patients. For this indication
alone, ThermoDox® represents a billion-dollar annual revenue
opportunity.”
“Last week, our second product candidate, GEN-1,
received the go-ahead from its DSMB to proceed with patient
enrollment in the Phase I portion of the OVATION 2 study. With the
first cohort of patients in the dose-escalation portion of our
OVATION 2 Study in newly diagnosed ovarian cancer enrolled and
evaluated by the DSMB, we look forward to finalizing the dose for
the balance of the 130-patient randomized study by year-end.
We expect that surgical results and tumor response data will be
available shortly thereafter. Meanwhile, we continue to work
through the activation of up to 25 clinical sites in the U.S. and
Canada by the end of January 2020. This promising clinical
development program in immunotherapy has generated impressive
results in previous trials,” Mr. Tardugno concluded.
Recent Developments
ThermoDox®
iDMC Unanimously Recommends Continuation
of Celsion's Phase III OPTIMA Study for ThermoDox®
in Primary Liver Cancer. On November 4, 2019
the Company announced that the iDMC unanimously recommended the
OPTIMA Study continue according to protocol. The recommendation was
based on a review of blinded safety and data integrity from 556
patients enrolled in the Company’s multinational, double-blind,
placebo-controlled pivotal Phase III study with ThermoDox® plus RFA
in patients with HCC.
The iDMC’s pre-planned interim efficacy review
followed 128 patient events, or deaths, which occurred in August
2019. Data presented demonstrated that progression-free survival
(PFS) and overall survival (OS) data appear to be tracking with
patient data observed at a similar point in the Company’s 285
patient, well-balanced subgroup of patients followed prospectively
in the earlier Phase III study (the “Prospective Subgroup”) upon
which the OPTIMA Study is based. This Prospective Subgroup
demonstrated a 2-year overall survival advantage and a median time
to death of more than 7 ½ years.
From the data review, the Company believes that
the OPTIMA Study is well positioned for success at the next
pre-planned interim efficacy analysis, which is intended after a
minimum of 158 patient deaths and is projected to occur during the
second quarter of 2020. The hazard ratio for success at 158 events
is 0.70. This is below the hazard ratio of 0.65 observed for
the 285 patients in the HEAT Study Prospective Subgroup treated
with RFA > 45 minutes.
The data review demonstrated the following:
- The OPTIMA Study patient demographics and risk factors are
consistent with what the Company observed in the Prospective
Subgroup with all data quality metrics meeting expectations.
- Median PFS for the OPTIMA Study reached 17.3 months as of
August 2019. These blinded data compare favorably with median PFS
of 16.8 months for the 285 patients in the HEAT Study Prospective
Subgroup treated with RFA > 45 minutes and followed
prospectively for OS.
- At this time point, combined OS for both treatment arms is
consistent with that observed in the 285-patient HEAT Study
Prospective Subgroup.
Celsion Co-sponsored Hepatocellular
Carcinoma Symposium at the International Liver Cancer Association
(ILCA) Annual Conference. On September 23, 2019, the
Company announced it co-sponsored a symposium focused on HCC at the
13th Annual Conference of the International Liver Cancer
Association. Other sponsors of the symposium included Bayer
Healthcare Pharmaceuticals, Inc. and Exelixis, Inc., both of whom
provide therapeutics for the treatment of advanced HCC. The
program, titled “Master Class & Tumor Board: Composing
Personalized HCC Treatment Strategies, Insights on Harmonizing
Patient Care with a Multidisciplinary Ensemble,” featured four
speakers. The program was chaired by Ghassan Abou-Alfa, MD, MBA,
Memorial Sloan Kettering Cancer Center and Professor, Weill Medical
College at Cornell University, both in New York City. The other
participants were: Prof. Riccardo Lencioni, MD, FSIR, EBIR,
Department of Radiology, University of Pisa, Italy, Hon. Res. Prof.
Interventional Oncology, Miami Cancer Institute; Amit Singal, MD,
MS, Medical Director of Liver Tumor Program, Associate Professor of
Medicine, UT Southwestern Medical Center, Dallas; and Robin K.
(Katie) Kelley, MD, Associate Professor of Clinical Medicine, Helen
Diller Family Comprehensive Cancer Center, Division of
Hematology/Oncology, University of California, San Francisco.
Dr. Abou-Alfa and Prof. Lencioni have been
involved in the development of Celsion’s lead product ThermoDox®
for the treatment of HCC. A review of the data supporting Celsion’s
Phase III trial with ThermoDox® plus radiofrequency ablation in
newly diagnosed HCC patients (the OPTIMA Study) was presented by
Prof. Lencioni.
Findings from Single-Site Study in China
of ThermoDox® Plus RFA Published in the Journal of
Cancer Research and Therapeutics. On August 27,
2019, the Company announced that a study from a single site in
China titled “Thermosensitive liposomal doxorubicin plus
radiofrequency ablation increased tumor destruction and improved
survival in patients with medium and large hepatocellular
carcinoma: A randomized, double-blinded, dummy-controlled clinical
trial in a single center” was published in the Journal of Cancer
Research and Therapeutics. These data were generated as part of the
Phase III HEAT Study sponsored by Celsion Corporation. The data
from this single site at the Peking University Cancer Hospital and
Institute in Beijing show an OS improvement of 22.5 months in
patients with 3-7 cm unresectable hepatocellular carcinoma tumors
receiving ThermoDox® plus RFA, compared with RFA alone.
In this study, patients received 50 mg/m2 of
ThermoDox® or placebo, plus RFA for 45 minutes or longer. Patients
were followed for 11 to 80 months (average: 49.1 ± 24.8 months),
with 18 of 22 patients completing the study. The mean OS for the
ThermoDox® plus RFA group was 68.5 ± 7.2 months, which was
significantly greater than the placebo plus RFA group (46.0 ± 10.6
months, p=0.045). At the end of the follow-up period, the
percentage of patients alive after 1, 3 and 5 years were as
follows:
ThermoDox® +
RFA
RFA Alone% of patients alive at 1
year
90.0%
87.5% % of patients alive at 3
years
90.0%
50.0% % of patients alive at 5
years
77.1%
37.5%
The publication can be found in the Journal of
Cancer Research and Therapeutics | Year: 2019 | Volume: 15 | Issue:
4 | Page 773 – 783. The authors are Yang W, Lee JC, Chen MH, Zhang
ZY, Bai XM, Yin SS, et al. from the Departments of Ultrasound and
Radiology, Key Laboratory of Carcinogenesis and Translational
Research (Ministry of Education), Peking University Cancer Hospital
and Institute in Beijing. Prof. Min-Hua Chen was a principal
investigator in Celsion’s Phase III HEAT Study, from which these
data are derived, and is also a principal investigator in the
Company’s Phase III OPTIMA Study.
Results of the National Institutes of
Health Analysis of ThermoDox® Published in the
Journal of Vascular and Interventional Radiology. On
August 13, 2019, the Company announced that results from an
independent analysis of the Company’s ThermoDox® HEAT Study
conducted by the National Institutes of Health (NIH) were published
in the peer-reviewed publication Journal of Vascular and
Interventional Radiology. The analysis was conducted by the
intramural research program of the NIH and the NIH Center for
Interventional Oncology, with the full data set from the Company’s
HEAT Study. The analysis evaluated the full data set to determine
if there was a correlation between baseline tumor volume and RFA
heating time (minutes/tumor volume in milliliters), with or without
ThermoDox® treatment, for patients with HCC. The NIH analysis was
conducted under the direction of Bradford Wood, MD, Director, NIH
Center for Interventional Oncology and Chief, NIH Clinical Center
Interventional Radiology.
The article, titled “RFA Duration Per Tumor
Volume May Correlate with Overall Survival in Solitary
Hepatocellular Carcinoma Patients Treated with RFA Plus
Lyso-thermosensitive Liposomal Doxorubicin,” discussed the NIH
analysis of results from 437 patients in the HEAT Study (all
patients with a single lesion representing 62.4% of the study
population). The key finding was that increased RFA heating time
per tumor volume significantly improved OS in patients with
single-lesion HCC who were treated with ThermoDox® plus RFA,
compared to patients treated with RFA alone. A one-unit increase in
RFA duration per tumor volume was shown to result in about a 20%
improvement in OS for patients administered ThermoDox®, compared to
RFA alone. The authors conclude that increasing RFA heating time in
combination with ThermoDox® significantly improves OS and
establishes an improvement of over 2 years versus the control arm
when the heating time per milliliter of tumor is greater than 2.5
minutes. This finding is consistent with the Company’s own results,
which defined the optimized RFA procedure as a 45-minute treatment
for tumors with a diameter of 3 centimeters. Thus, the NIH analysis
lends support to the hypothesis underpinning the OPTIMA
Study.
GEN-1 Immunotherapy
Positive DSMB Review of Phase I Portion
of OVATION 2 Study in Ovarian Cancer. On November 5,
2019, the Company announced that the DSMB has completed its safety
review of data from the first eight patients enrolled in the
ongoing Phase I/II OVATION 2 Study. Based on the DSMB's
recommendation, the study will continue as planned and the Company
will proceed with completing enrollment in the Phase I portion of
the trial. The OVATION 2 Study is a Phase I/II study designed
with a single dose escalation phase to 100 mg/m² of GEN-1 in the
Phase I portion, followed by a continuation at the selected dose in
Phase II, in an open-label, 1:1 randomized design.
Developed with extensive input from the
Company's Medical Advisory Board, the OVATION 2 Study builds on
promising clinical and translational research data from the Phase
IB dose-escalation OVATION 1 Study in which enrolled patients
received escalating weekly doses of GEN-1 up to 79 mg/m² for a
total of eight treatments in combination with neoadjuvant
chemotherapy (NACT), followed by interval debulking surgery (IDS).
In addition to exploring a higher dose of GEN-1 in the OVATION 2
study, patients will continue to receive GEN-1 after their IDS in
combination with adjuvant chemotherapy.
Of the eight patients treated in the Phase I
portion of the OVATION 2 Study, five were treated with GEN-1 plus
NACT and three were treated with NACT only. The Company
previously reported data from its Phase IB dose escalating trial
(the OVATION I Study) which showed that of the 14 evaluable
patients, 100% administered NAC plus the two higher doses of GEN-1
experienced an objective tumor response, defined as a partial or
complete response. Only 60% of patients given the two lower doses
had such a response. In addition, patients in the higher-dose
cohorts had a high surgery success (R0) rate, with 88% achieving
the optimal outcome of a complete resection.
Celsion’s GEN-1 Immunotherapy
Highlighted. On August 9, 2019, the Company
announced that Premal H. Thaker, MD, MSc, Professor of Obstetrics
and Gynecology-Division of Gynecologic Oncology at Washington
University School of Medicine in St. Louis, led an expert call on
the ovarian cancer treatment landscape and emerging opportunities
hosted by Oppenheimer & Co. Inc. Dr. Thaker is active in
the development of GEN-1, Celsion’s DNA-based, IL-12 immunotherapy
for the treatment of ovarian cancer. She is Study Chair and member
of the DSMB for the OVATION 2 study and was a Principal
Investigator for the OVATION 1 study. Hartaj Singh, Managing
Director and Senior Analyst covering biotechnology for Oppenheimer,
moderated the call for the bank’s institutional clients.
Dr. Thaker discussed results from the Company’s
recently completed Phase IB dose-escalation OVATION 1 study which
evaluated patients newly diagnosed with Stage III or IV ovarian
cancer and treated with four different doses of GEN-1. Pre- and
post-treatment levels of key ovarian cancer biomarkers showed a
marked reduction in immunosuppressive response across multiple
biomarkers post-treatment, indicating GEN-1 may alter the tumor
microenvironment and may improve ovarian cancer outcomes in
combination with NAC.
Corporate Development
Celsion Strengthens its 2019 Balance
Sheet. On October 1, 2019, the Company announced it
received approval from the New Jersey Economic Development
Authority’s (NJEDA) Technology Business Tax Certificate Transfer
(NOL) program to sell its unused New Jersey net operating losses
(NOLs) and R&D tax credits. The exact percentage of NOLs to be
sold will be determined by the NJEDA after reviewing all qualified
applications. In 2018, the Company received approval from the
NJEDA to sell $11.1 million of its unused New Jersey NOLs for the
tax years 2011 through 2017 and was able to transfer this credit
and receive approximately $10.5 million of net cash proceeds in the
fourth quarter of 2018. The NOLs are typically sold at a
single-digit discount to qualified companies with operations in New
Jersey. As a result, the Company anticipates it will be able to
transfer this current year credit for approximately $2.0 million
prior to the end of 2019.
Celsion Participated in Two Investor
Conferences. During October 2019, the
Company attended the Chardan 3rd Annual Genetic Medicines
Conference in New York City and the Dawson James Securities 5th
Annual Small Cap Growth Conference in Jupiter, Fla. A webcast
of Celsion’s fireside chat at the Chardan Conference may be
accessed by visiting the “News & Investors” section of
Celsion’s corporate website.
Third Quarter Financial
Results
For the quarter ended September 30, 2019,
Celsion reported a net loss of $5.5 million ($0.25 per share),
compared with a net loss of $4.7 million ($0.26 per share) in the
same period of 2018. Operating expenses were $5.5 million in the
third quarter of 2019, which represented a $1.4 million increase
from $4.0 million in the same period of 2018. This increase
was attributable to higher salary and benefits ($0.4 million) for
several new positions to support the anticipated regulatory and
commercialization efforts for ThermoDox® as well as higher costs
($0.2 million) associated with the technology transfer of GEN-1 to
new contract manufacturing organizations. During the third quarter
of 2018, the Company recorded a one-time $0.8 million credit
resulting from cost concessions negotiated with the Company’s lead
contract research organization (CRO) for the OPTIMA
Study.
Research and development expenses increased $1.5
million to $3.7 million in the third quarter of 2019, compared with
$2.2 million in the third quarter of 2018. Clinical
development costs for the Phase III OPTIMA Study in the third
quarter of 2018 were favorably impacted by a $0.8 million one-time
credit resulting from cost concessions negotiated with the
Company’s lead CRO for the OPTIMA Study. Also contributing to
this increase was higher salary and benefits for several new
positions and other professional advisory costs to support the
anticipated global regulatory filing for ThermoDox® as well as
higher costs associated with the technology transfer of GEN-1 to
new contract manufacturing organizations.
General and administrative expenses were $1.8
million in the third quarter of 2019, compared with $2.0 million in
the same period of 2018. The decrease was primarily
attributable to a $0.2 million decrease in non-cash stock
compensation expense in the current quarter.
During the third quarter ended September 30,
2018, other expenses included a non-cash charge of $4.5 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 $4.1 million
reduction in the earn-out liability related to potential milestone
payments for the GBM product candidate. During the third quarter
ended September 30, 2019, the Company recorded a gain of $86,000
from the reduction in the earn-out liability related to potential
milestone payments. The Company realized $0.2 million of interest
income from its short-term investments during the third quarter of
2019 compared to $0.1 million of interest income in the comparable
prior year period. In connection with the Company’s venture debt
facility with Horizon entered into in late June 2018, the Company
incurred interest expense of $0.35 million during the third
quarters of 2019 and 2018.
The Company ended the third quarter of 2019 with
$18.8 million in cash, investment securities and interest
receivable. With this $18.8 million coupled with planned
future sales of the Company’s New Jersey NOLs totaling
approximately $4 million in 2019 and 2020, the Company believes it
has sufficient capital resources to fund its operations into the
first half of 2021.
Nine Month Financial
Results
For the nine months ended September 30, 2019,
the Company reported a net loss of $13.7 million ($0.67 per share),
compared with a net loss of $17.4 million ($0.73 per share) in the
same period of 2018. Operating expenses were $16.2 million
during the first nine months of 2019, which represented a $0.5
million decrease from $16.3 million in the same period of
2018. The decrease was primarily attributable to (i) lower
non-cash stock compensation expense in the current year period,
(ii) lower monthly CRO fees after completion of enrollment of the
Phase III OPTIMA study during the third quarter of 2018, and (iii)
a non-cash gain of $2.7 million, net of a $0.4 million charge for
the issuance of 200,000 warrants related to an amendment for the
potential milestone payments for the GEN-1 ovarian product
candidate. During the third quarter of 2018, the Company
recorded a $0.8 million credit resulting from cost concessions
negotiated with the Company’s lead CRO for the OPTIMA
Study.
Net cash used for operating activities was $14.6
million in the first nine months of 2019, compared with $13.0
million used in the same period in 2018. The Company’s cash
utilization is projected to be approximately $19.5 million for 2019
and approximately $16 million for 2020. Cash provided by
financing activities was approximately $6.2 million during the
first nine months of 2019.
Research and development expenses increased $0.5
million to $10.0 million in the first nine months of 2019 from $9.5
million in the comparable prior-year period. The prior-year
period was favorably impacted by a $0.8 million credit resulting
from cost concessions negotiated with the Company’s lead CRO for
the OPTIMA Study. Excluding this one-time credit, clinical
development costs for the Phase III OPTIMA Study decreased $1.5
million to $3.3 million in the first nine months of 2019, compared
with $4.8 million in the comparable prior-year period, due to the
completion of enrollment in this 556-patient trial in August
2018. Costs associated with the startup of the OVATION 2
Study were $0.4 million in the first nine months of 2019.
Other costs related to clinical supplies and regulatory support for
the ThermoDox® and GEN-1 clinical development programs increased by
$1.1 million in the first nine months of 2019 compared with the
same prior-year period. In the first nine months of 2019,
non-cash stock compensation expense decreased $0.7 million,
compared with the same period of 2018.
General and administrative expenses were $6.2
million for the nine months ended September 30, 2019, compared with
$7.2 million for the same period of 2018. The decrease was
primarily attributable to a $1.7 million decrease in non-cash stock
compensation expense offset by higher salary, benefit and travel
costs related to regulatory and commercialization efforts for
ThermoDox®.
Other expenses in the first nine months of 2019
included a non-cash gain of $2.7 million, net of a $0.4 million
charge for the issuance of 200,000 warrants related to an amendment
for the potential milestone payments for the GEN-1 ovarian product
candidate, compared with a non-cash charge of $4.5 million related
to the impairment of certain in-process research and development
assets related to the development of our GBM cancer product
candidate offset by a $3.6 million reduction in the earn-out
liability related to potential milestone payments in the comparable
prior-year period. The Company realized $0.4 million of
interest income during the first nine months of 2019 and compared
with $0.3 million of interest income in the comparable nine-month
period in 2018. In connection with the Company’s venture debt
facility with Horizon entered into in late June 2018, the Company
incurred interest expense of $1.0 million during the first nine
months of 2019, compared with interest expense of $0.4 million in
the comparable prior-year period.
Conference Call
The Company is hosting a conference call to
provide a business update and discuss its third quarter 2019
financial results at 11:00 a.m. EST on Friday, November 15, 2019.
To participate in the call, dial 1-800-667-5617 (Toll-Free/North
America) or 1-334-323-0501 (International/Toll) and use conference
ID 5419619. The call will also be broadcast live on the internet at
www.celsion.com. The call will be archived for replay until
November 29, 2019 and can be accessed at 1-719-457-0820 or
1-888-203-1112 using conference ID 5419619. An audio replay will
also be available for 90 days at www.celsion.com.
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. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
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 |
LHA Investor Relations |
Jeffrey W. Church |
Kim Sutton Golodetz |
Executive Vice President, CFO and Corporate Secretary |
212-838-3777 |
609-482-2455 |
kgolodetz@lhai.com |
jchurch@celsion.com |
|
Celsion Corporation |
|
Condensed Statements of Operations |
|
(in thousands except per share amounts) |
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue |
$ |
125 |
|
$ |
125 |
|
$ |
375 |
|
$ |
375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,674 |
|
|
2,187 |
|
|
10,000 |
|
|
9,522 |
|
General and administrative |
|
1,839 |
|
|
1,960 |
|
|
6,193 |
|
|
7,168 |
|
Total operating expenses |
|
5,513 |
|
|
4,147 |
|
|
16,193 |
|
|
16,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(5,388 |
) |
|
(4,022 |
) |
|
(15,818 |
) |
|
(16,315 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Gain from valuation of earn-out milestone liability |
|
86 |
|
|
4,115 |
|
|
3,089 |
|
|
3,568 |
|
Impairment of IPR&D |
|
- |
|
|
(4,510 |
) |
|
- |
|
|
(4,510 |
) |
Fair value of warrants issued in connection with amendment to
modify earn-out milestone payments |
|
- |
|
|
- |
|
|
(400 |
) |
|
- |
|
Interest expense, investment income and other income (expense),
net |
|
(175 |
) |
|
(239 |
) |
|
(620 |
) |
|
(107 |
) |
Total other income (expense), net |
|
(89 |
) |
|
(634 |
) |
|
2,069 |
|
|
(1,049 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,476 |
) |
$ |
(4,656 |
) |
$ |
(13,749 |
) |
$ |
(17,364 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
$ |
(0.25 |
) |
$ |
(0.26 |
) |
$ |
(0.67 |
) |
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
21,663 |
|
|
17,801 |
|
|
20,525 |
|
|
17,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion Corporation |
|
Selected Balance Sheet Information |
|
(in thousands) |
|
|
|
|
|
|
|
ASSETS |
|
September 30, 2019
(Unaudited) |
|
December 31, 2018 |
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
8,522 |
|
|
13,354 |
|
|
Investment securities and interest receivable on investment
securities |
|
10,317 |
|
|
14,326 |
|
|
Prepaid expenses and other current assets |
|
1,272 |
|
|
451 |
|
|
Total current assets |
|
20,111 |
|
|
28,131 |
|
|
|
|
|
|
|
|
Property and equipment |
|
430 |
|
|
185 |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
In-process research and development |
|
15,736 |
|
|
15,736 |
|
|
Goodwill |
|
1,976 |
|
|
1,976 |
|
|
Operating lease right-of-use assets, net |
|
1,522 |
|
|
- |
|
|
Other intangible assets, net |
|
398 |
|
|
568 |
|
|
Other assets |
|
391 |
|
|
260 |
|
|
Total other assets |
|
20,023 |
|
|
18,540 |
|
|
Total assets |
$ |
40,564 |
|
|
46,856 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
6,332 |
|
$ |
5,607 |
|
|
Notes payable - current portion |
|
579 |
|
|
- |
|
|
Operating lease liability – current portion |
|
377 |
|
|
- |
|
|
Deferred revenue - current portion |
|
500 |
|
|
500 |
|
|
Total current liabilities |
|
7,788 |
|
|
6,107 |
|
|
|
|
|
|
|
|
Earn-out milestone liability |
|
5,819 |
|
|
8,908 |
|
|
Operating lease liability – non-current portion |
|
1,245 |
|
|
- |
|
|
Notes payable - noncurrent portion |
|
9,127 |
|
|
9,417 |
|
|
Deferred revenue and other liabilities - noncurrent portion |
|
1,125 |
|
|
1,563 |
|
|
Total liabilities |
|
25,104 |
|
|
25,995 |
|
|
Stockholders' equity |
|
|
|
|
|
Common stock |
|
220 |
|
|
188 |
|
|
Additional paid-in capital |
|
302,705 |
|
|
294,393 |
|
|
Accumulated other comprehensive gain (loss) |
|
34 |
|
|
30 |
|
|
Accumulated deficit |
|
(287,414) |
|
|
(273,665) |
|
|
|
|
15,545 |
|
|
20,946 |
|
|
Less: Treasury stock |
|
(85) |
|
|
(85) |
|
|
Total stockholders' equity |
|
15,460 |
|
|
20,861 |
|
|
Total liabilities and stockholders' equity |
$ |
40,564 |
|
$ |
46,856 |
|
|
# # #
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2023 to Apr 2024