Celsion Corporation (NASDAQ:
CLSN), a clinical-stage drug-development company focused
on DNA-based immunotherapy and next-generation vaccines, today
announced financial results for the three and six months ended June
30, 2021, and provided an update on clinical development programs
with GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in
Phase II clinical development for the treatment of advanced-stage
ovarian cancer (Stage III/IV), and ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin under
investigator-sponsored development for several cancer indications.
In addition, Celsion has two feasibility-stage platform
technologies for the development of novel nucleic acid-based
immunotherapies and next-generation vaccines for infectious
diseases.
“GEN-1, our oncology-focused immunotherapy,
continues to show encouraging resection results at the 100 mg/m²
dose cohort in the Phase II OVATION 2 Study. These results are
consistent with those reported from our earlier Phase I trials in
advanced-stage ovarian cancer. In July 2021, the Data Safety
Monitoring Board (DSMB) unanimously recommended that the OVATION 2
Study continue treating patients with the 100 mg/m2 dose. The DSMB
also determined that safety was satisfactory with an acceptable
risk/benefit and no dose-limiting toxicities,” said Michael H.
Tardugno, Celsion’s chairman, president and chief executive
officer. “These findings were supported with positive R0 surgical
resection scores from the first 36 patients with interval debulking
surgery. Of those, 80% treated with GEN-1 at a dose of 100 mg/m²
plus NACT had a complete tumor resection (R0), which indicates a
microscopically margin-negative resection with no gross or
microscopic tumor remaining in the tumor bed, compared with 56% of
patients in the control arm having R0 resections.
“In recent weeks, Celsion strengthened its
capabilities in vaccine development with the expansion of our
Vaccine Advisory Board,” continued Mr. Tardugno. “Drs. Dan H.
Barouch and Luke D. Handke joined Drs. Britt A. Glaunsinger and
Xinzhen Yang on the VAB, which was formed during the first quarter
of this year. We’re delighted to assemble a group of well-known and
distinguished scientists to advise management’s work in developing
next-generation vaccines directed to COVID-19 and its variants, and
other infectious diseases for which there are few or no preventive
options.”
Mr. Tardugno concluded, “Results of the OVATION
1 Study recently published in the Journal of Clinical Research
showed complete/near complete chemotherapy response scores (CRS) of
50% in the two highest doses of GEN-1, compared with 28% from a
major publication evaluating CRS scoring. CRS is a three-tier
standardized scoring system for histological tumor regression into
complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS
1) response based on omental examination. While not an FDA
recognized endpoint, like R0 resection rates, CRS 3 is believed to
be a predictor of progression-free survival.”
Recent Developments
GEN-1 Immunotherapy
DSMB
Recommends GEN-1 to
Continue Dosing Patients in the Phase II Portion of the OVATION 2
Study in Advanced Ovarian Cancer. The
OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant
chemotherapy (NACT) in patients newly diagnosed with Stage III/IV
ovarian cancer. NACT is designed to shrink the cancer as much as
possible for optimal surgical removal after three cycles of
chemotherapy. Following NACT, patients undergo interval debulking
surgery, followed by three additional cycles of chemotherapy to
treat any residual tumor.
In July 2021, the Company announced that
following a pre-planned interim safety review of 55 as-treated
patients randomized in the Phase I/II OVATION 2 Study, the DSMB
unanimously recommended that the OVATION 2 Study continue treating
patients with the dose of 100 mg/m2. The DSMB also determined that
safety is satisfactory with an acceptable risk/benefit, and that
patients can tolerate up to 17 doses of GEN-1 during a course of
treatment that lasts up to six months. No dose-limiting toxicities
were reported.
More than 50% of
the Projected 110
Patients
Have
Been
Enrolled in the OVATION 2 Study.
Interim clinical data from the first 36 patients who have undergone
interval debulking surgery are as follows:
- 20 patients
were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16
out of 20 patients (80%) having a complete tumor resection
(R0).
- 16 patients
were treated with NACT only, with 9 out of 16 patients (56%) having
R0 resections.
- When combining
these results with the surgical resection rates observed in the
Company’s prior Phase Ib dose-escalation trial (the OVATION 1
Study), a population of patients with inclusion criteria identical
to the OVATION 2 Study, the data reflect the strong dose-dependent
efficacy of adding GEN-1 to NACT.
|
|
% Patients with
R0 Resections |
0, 36, 47 mg/m² of GEN-1 plus NACT |
n=22 |
50 |
% |
61, 79, 100 mg/m² of GEN-1 plus NACT |
n=28 |
82 |
% |
- The objective
response rate (ORR) as measured by Response Evaluation Criteria in
Solid Tumors (RECIST) criteria for the 16 patients treated with
NACT only were comparable, as expected, to the 20 patients treated
with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups
demonstrating an approximate 80% ORR.
Poster on Phase I/II OVATION 2 Study
Presented at the Society of Gynecologic Oncology Virtual Annual
Meeting on Women’s Cancer. In April 2021, the Company
announced that a poster highlighting its ongoing OVATION 2 Study
was presented at the Virtual Annual Meeting on Women’s Cancer,
sponsored by the Society of Gynecologic Oncology. The poster,
titled “A Phase I/II Study Evaluating Intraperitoneal GEN-1 in
Combination with Neoadjuvant Chemotherapy [NACT] in Patients with
Newly Diagnosed Advanced Epithelial Ovarian Cancer (EOC),” can be
viewed here. The poster was presented by Premal Thaker, M.D., Study
Chair of the OVATION 2 Study and Professor of Obstetrics and
Gynecology, Director of Gynecological Oncology Clinical Research,
Division of Gynecologic Oncology, Washington University School of
Medicine.
The poster describes the OVATION 2 Study, which
is an open-label, 1-to-1 randomized trial, 80% powered to show the
equivalent of a 33% improvement in progression-free survival (PFS)
(HR=0.75), the primary endpoint, when comparing the treatment arm
(NACT + GEN-1) with the control arm (NACT).
Celsion announced in the first quarter of 2021
that GEN-1 had received Fast Track designation from the U.S. Food
and Drug Administration. This designation is intended to facilitate
the development and expedite the regulatory review of drugs to
treat serious conditions and fill an unmet medical need.
Vaccine Initiative
Vaccine Advisory Board
Expanded. In July 2021, the Company announced
the addition of Dan H. Barouch, M.D., Ph.D. and Luke D. Handke,
Ph.D. to its Vaccine Advisory Board (VAB). They join Britt A.
Glaunsinger, Ph.D. and Xinzhen Yang, M.D., Ph.D. on the VAB, which
was formed in February 2021.
Dr. Barouch is the principal investigator at the
Barouch Laboratory, Director of the Center for Virology and Vaccine
Research at Beth Israel Deaconess Medical Center and William
Bosworth Castle Professor of Medicine at Harvard Medical School. In
addition, he is a key participant in the Bill & Melinda Gates
Foundation Collaboration for AIDS Vaccine Discovery, the National
Institutes of Health Martin Delaney HIV-1 Cure
Collaboratory and the Ragon Institute of MGH, MIT and Harvard.
Dr. Barouch and his team were instrumental in developing the
vector, a variant of an adenovirus called Ad26, that was used to
make single-dose vaccines for HIV, tuberculosis and Zika, and
ultimately, in conjunction with Johnson & Johnson researchers,
SARS-CoV-2. He has authored numerous peer-reviewed articles.
Dr. Handke is a highly skilled molecular
biologist and microbiologist with a decade of pharmaceutical
industry experience including nine years with Pfizer’s Vaccine
Research and Early Development Unit. At Pfizer he served as
molecular biology lead on an early phase viral vaccine program and
was the lead reviewer of data sources and literature citations for
licensure application for the Trumenba® meningococcal group B
vaccine in the U.S. and in Europe. He began his career in vaccine
research at Wyeth. He is co-author and co-inventor on various
patent applications for a protein-based RSV vaccine and a
SARS-CoV-2 detection assay and authored 10 peer-reviewed
publications including six as first author. Dr. Handke is currently
a Senior Scientist at the University of Nebraska Medical Center in
Omaha. In addition to serving on the VAB, Dr. Handke will provide
consulting services to Celsion in connection with its vaccine
development program, which involves DNA-based vectors in
combination with proprietary non-viral cellular delivery agents. He
also will advise Celsion as it advances this program into human
clinical studies.
ThermoDox®
Subsidiary Established to Manage
Investigator-Sponsored Development of
ThermoDox®. In June 2021, the
Company announced that its new wholly owned subsidiary, Celsion
GmbH, will manage all current and future investigator-sponsored
development of ThermoDox®. Andreas Voss, M.D., a leading oncology
researcher, has been named Managing Director of Celsion GmbH and
will step down from Celsion’s board of directors later this year to
head the subsidiary, which is based in Zug, Switzerland.
Establishing Celsion GmbH allows Celsion’s
management to focus solely on GEN-1 and PLACCINE, its nucleic acid
vaccine platform. In addition to clinical and regulatory advice,
Celsion’s ongoing investment in ThermoDox® will be limited to
providing clinical drug supply and modest financial support.
ThermoDox® is currently under investigator-sponsored development
for several cancer indications.
Commencement of Enrollment in Phase 1
Study with ThermoDox® and Focused Ultrasound in Pancreatic
Cancer. In July 2021, Celsion GmbH announced the
commencement of enrollment in Oxford University’s Phase I PanDox
study with ThermoDox® in conjunction with focused ultrasound in
patients with pancreatic cancer.
This investigator-led study sponsored by the
University of Oxford and supported by the National Institute for
Health Research (NIHR) Oxford Biomedical Research Centre has now
received ethics, MHRA and institutional R&D approval to
commence (ClinicalTrials.gov Identifier: NCT04852367). PanDox is
being carried out as a multi-disciplinary collaboration between
Celsion, the Oxford University Institute of Biomedical
Engineering, the Oncology Clinical Trials Office and the Oxford
University Hospitals NHS Foundation Trust. Prof. Mark Middleton,
M.D., Head of the Department of Oncology at the University of
Oxford, is the chief clinical investigator and Prof. Constantin
Coussios, FREng, Ph.D., Director of the Institute of Biomedical
Engineering, is the lead scientific investigator.
The primary endpoint of the two-arm 18-subject
PanDox study is enhanced uptake of doxorubicin in pancreatic tumors
using ThermoDox® and focused ultrasound (FUS), compared with
systemic delivery of free doxorubicin. ThermoDox® will be
administered intravenously in 12 patients with non-resectable
pancreatic ductal adenocarcinoma and locally activated by focused
ultrasound-mediated hyperthermia. This will be compared with
conventional systemic delivery of doxorubicin without FUS in 6
patients. Secondary endpoints include:
- Comparing
radiologically assessed tumor activity and response with ThermoDox®
and FUS to free drug alone.
- Examining the
impact on patient symptoms of ThermoDox® plus FUS.
- Assessing the
safety profile of both FUS and ThermoDox®.
The PanDox study is expected to be completed by
December 2022 and is similar in design to Oxford’s 10-patient
TARDOX study, which demonstrated that ThermoDox® plus focused
ultrasound increased doxorubicin tumor concentrations by up to
10-fold and enhanced nuclear drug uptake in patients with liver
tumors. The findings of the TARDOX study are published in Lancet
Oncology (Lyon et al., 2018) and Radiology (Gray et al., 2019).
Corporate Developments
Strengthened Balance Sheet Through Two
Registered Direct Offerings of Common Shares Totaling $50 Million
in Gross Proceeds. In January 2021, the Company announced
the closing of a registered direct offering of 25,925,925 shares of
common stock at a purchase price of $1.35 per share, priced
at-the-market under Nasdaq rules, resulting in net proceeds of
$32.6 million after deducting placement agents' fees but before
expenses payable by the Company. In April 2021, the Company
announced the closing of a registered direct offering of 11,538,462
shares of common stock at a purchase price of $1.30 per share,
resulting in net proceeds of $13.9 million, after deducting
placement agents' fees but before expenses payable by the
Company.
Received
$1.85 Million in
Non-Dilutive Funding from the Sale of New Jersey State Net
Operating Losses. In May 2021, the Company announced it
received $1.85 million of net cash proceeds from the sale of
approximately $2.0 million of its unused New Jersey net operating
losses (NOLs). The NOL sales cover the 2019 tax year and are
administered through the New Jersey Economic Development
Authority’s (NJEDA) Technology Business Tax Certificate Transfer
(NOL) Program. Additional sales of $5.0 million of unused New
Jersey NOLs are anticipated in 2022 – 2024, which will further
increase Celsion’s cash position on a non-dilutive basis.
New $10.0
Million Strategic Loan Facility with Silicon Valley
Bank. In June 2021, the Company announced it entered
into a $10.0 million loan facility with Silicon Valley Bank (SVB).
Celsion immediately used $6.0 million from this facility to retire
all outstanding indebtedness with Horizon Technology Finance
Corporation. The remaining $4.0 million will be available to be
drawn down up to 12 months after closing and will be used to fund
the advancement of the Company’s product pipeline, including GEN-1
for the treatment of newly diagnosed advanced ovarian cancer, as
well as other strategic initiatives intended to broaden its product
pipeline. The funding is in the form of money market secured
indebtedness bearing interest at a calculated WSJ Prime-based
variable rate (currently 3.25%). Payments under the loan
agreement are interest only for the first 24 months after loan
closing, followed by a 24-month amortization period of principal
and interest through the scheduled maturity date.
Appointment of
Two New Directors to the Celsion
Board. In June 2021, the Company
announced the appointment of Stacy R. Lindborg, Ph.D. and Christine
A. Pellizzari to Celsion’s Board of Directors.
Dr. Lindborg brings to Celsion more than 25
years of pharmaceutical industry experience with a particular focus
on R&D, executive management and strategy. She has worked with
biologics, small molecules and cell therapies to address a broad
range of diseases and disorders, including multiple orphan drug
products, along with extensive experience in early-stage
development having taken molecules from first-in-man studies into
the clinic through approval and launch. Dr. Lindborg is a graduate
of Baylor University where she received a Ph.D. and M.A. in
statistics and a B.A. in psychology with a minor in mathematics. A
prolific researcher, she has authored more than 50 abstracts, 200
presentations and 40 manuscripts that have been published in
peer-reviewed journals. She serves on several industry advisory
boards related to statistics and biotechnology.
Ms. Pellizzari is Chief Legal Officer of Science
37, a developer of a leading decentralized clinical trial operating
system where she has global responsibility for both legal and
quality. Ms. Pellizzari brings more than 20 years of leadership in
the global pharmaceutical industry to Celsion. Immediately prior to
joining Science 37, Ms. Pellizzari was Chief Legal Officer of
Insmed Incorporated, a global biopharmaceutical company dedicated
to transforming the lives of patients with serious and rare
diseases. At Insmed, Ms. Pellizzari had global responsibility for
legal and government affairs including corporate governance,
regulatory compliance, contracting, alliance management, clinical
trial oversight, labor and employment, litigation management and
intellectual property strategy and portfolio management. Ms.
Pellizzari received a J.D. from the University of Colorado School
of Law and a B.A. from the University of Massachusetts (Amherst).
She is a member of Executive Women in Bio, Women Corporate
Directors, National Association of Corporate Directors, Association
of Corporate Counsel, Society for Corporate Governance and National
Association of Stock Plan Professionals.
Second Quarter Financial
Results
For the quarter ended June 30, 2021, Celsion
reported a net loss of $5.4 million ($0.06 per share), compared
with a net loss of $5.3 million ($0.18 per share) in the same
period of 2020. Operating expenses were $5.2 million in the second
quarter of 2021, which represented a $0.3 million (6%) increase
from $4.9 million in the same period of 2020.
The Company ended the second quarter of 2021
with $64.5 million in cash, investment securities, restricted cash
and accrued interest receivable. Coupled with future sales of
unused New Jersey NOL’s, the Company believes it has sufficient
capital resources to fund its operations through 2024.
Research and development (R&D) expenses
decreased $0.4 million to $2.6 million in the second quarter of
2021 from $3.0 million in the second quarter of 2020. R&D costs
associated with the development of GEN-1 to support the OVATION 2
Study as well as development of the PLACCINE DNA technology
platform increased to $1.4 million in the second quarter of 2021,
compared with $0.9 million in the same period of 2021. Clinical
development costs for the Phase III OPTIMA Study decreased $0.4
million to $0.2 million in the second quarter of 2021, compared
with $0.6 million in the second quarter of 2020, due to the
discontinuation of this 556-patient trial in the first quarter of
2021. Other costs related to clinical supplies and regulatory
support for the Company’s clinical development programs decreased
to $0.9 million in the current quarter from $1.5 million in the
second quarter of 2020, largely driven by higher manufacturing
costs for GEN-1 clinical supplies for the Phase II portion of the
OVATION 2 Study offset by lower regulatory and manufacturing costs
related to the discontinued OPTIMA Study.
General and administrative expenses were $2.6
million in the second quarter of 2021, compared with $1.9 million
in the same period of 2020. The $0.7 million increase was primarily
attributable to higher non-cash stock-compensation expense ($0.1
million), an increase in legal and professional fees ($0.4 million)
and an increase in Directors’ and Officers’ insurance premiums
($0.1 million) incurred during the second quarter of 2021.
In connection with the Company’s venture debt
facility with Horizon Technology Finance Corporation entered in
late June 2018, the Company incurred interest expense of $0.2
million during the second quarter of 2021. This compares with
interest expense of $0.3 million in the comparable prior-year
period. In June 2021, the Company entered into a new $10.0 million
loan facility with SVB, with a portion of the proceeds used to
retire all outstanding indebtedness with Horizon. The Company
recognized a $0.2 million loss on this debt extinguishment.
Six Month Financial Results
For the six months ended June 30, 2021, the
Company reported a net loss of $11.1 million ($0.15 per share),
compared with a net loss of $10.4 million ($0.37 per share) in the
same period of 2020. Operating expenses were $10.7 million during
the first six months of 2021, which represented a $0.9 million
(10%) decrease from $9.8 million in the same period of
2020.
Net cash used for operating activities was $7.3
million in the first six months of 2021, compared with $7.9 million
in the same period in 2020. This was in line with the Company’s
projected cash utilization for 2021 of approximately $17 million,
or an average of approximately $4.25 million per quarter. Cash
provided by financing activities was $54.8 million during the first
six months of 2021 resulting from equity offerings in January 2021
and April 2021, and proceeds from the $10 million loan facility
with SVB in June 2021 and the sale of the Company’s unused New
Jersey NOLs in May 2021.
Research and development expenses decreased $0.8
million to $5.2 million in the first half of 2021 from $6.0 million
in the first half of 2020. R&D costs associated with the
development of GEN-1 to support the OVATION 2 Study as well as
development of the PLACCINE DNA technology platform increased to
$2.8 million in the first half of 2021, compared with $2.1 million
in the comparable six-month period in 2020. Costs for the Phase III
OPTIMA Study decreased $0.9 million to $0.4 million in the first
half of 2020, compared with $1.3 million in the first half of 2020,
due to the discontinuation of this trial in the first quarter of
2021. Other costs related to clinical supplies and regulatory
support for the Company’s clinical development programs decreased
$0.6 million in the first half of 2021, compared with the same
prior-year period due to lower regulatory and manufacturing costs
for the discontinued Phase III OPTIMA Study.
General and administrative expenses were $5.5
million in the first half of 2021, compared with $3.7 million in
the same period of 2020. The $1.8 million increase was primarily
attributable to higher non-cash stock-compensation expense ($0.8
million), an increase in legal and professional fees ($0.7 million)
and an increase in Directors’ and Officers’ insurance premiums
($0.2 million) incurred during the six months ended June 30,
2021.
Other expenses during the first half of 2021
included a non-cash charge of $0.1 million for the change in
valuation of the earn-out milestone liability for the GEN-1 ovarian
product candidate, compared with a non-cash charge of $0.3 million
during the comparable prior-year period. In connection with the
Company’s venture debt facility with Horizon entered in late June
2018, the Company incurred interest expense of $0.4 million during
the first six months of 2021, compared with $0.7 million during the
same six-month period in 2020.
Second Quarter
Conference Call
The Company will host a conference call to
provide a business update, discuss its second quarter 2021
financial results and answer questions at 11:00 a.m. EDT today. To
participate in the call, interested parties may dial 1-800-353-6461
(Toll-Free/North America) or 1-334-323-0501 (International/Toll) 10
minutes before the call is scheduled to begin, and ask for the
Celsion Corporation Second Quarter 2021 Earnings Call (Conference
Code: 2901622). The call will also be broadcast live on the
internet at www.celsion.com. The call will be archived for replay
through August 26, 2021. The replay can be accessed at
1-719-457-0820 or 1-888-203-1112 using Conference ID: 290622. 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. EDT Thursday,
August 12, 2021.
About Celsion Corporation
Celsion is a fully integrated, clinical-stage
biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies and
DNA-based therapies, and a platform for the development of nucleic
acid vaccines currently focused on SARS-CoV-2. The company’s
product pipeline includes GEN-1, a DNA-based immunotherapy for the
localized treatment of ovarian cancer. ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, is under
investigator-sponsored development for several cancer indications.
Celsion also has two feasibility-stage platform technologies for
the development of novel nucleic acid-based immunotherapies and
other anticancer DNA or RNA therapies. Both are novel synthetic,
non-viral vectors with demonstrated capability in nucleic acid
cellular transfection. For more information on Celsion, visit
www.celsion.com.
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 ContactJeffrey W.
Church609-482-2455 jchurch@celsion.comLHA Investor
RelationsKim Sutton
Golodetz212-838-3777kgolodetz@lhai.com
[Tables to Follow]
Celsion Corporation |
|
Condensed Statements of Operations |
|
(in thousands except per share amounts) |
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
$ |
125 |
|
$ |
125 |
|
$ |
250 |
|
$ |
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,593 |
|
|
2,991 |
|
|
5,165 |
|
|
6,043 |
|
General and administrative |
|
2,603 |
|
|
1,901 |
|
|
5,540 |
|
|
3,740 |
|
Total operating expenses |
|
5,196 |
|
|
4,892 |
|
|
10,705 |
|
|
9,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(5,071 |
) |
|
(4,767 |
) |
|
(10,455 |
) |
|
(9,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) from change in valuation of earn-out milestone
liability |
|
81 |
|
|
(256 |
) |
|
(70 |
) |
|
(297 |
) |
Loss on debt extinguishment |
|
(235 |
) |
|
- |
|
|
(235 |
) |
|
- |
|
Interest expense, investment income and other income (expense),
net |
|
(223 |
) |
|
(320 |
) |
|
(378 |
) |
|
(570 |
) |
Total other income (expense), net |
|
(377 |
) |
|
(576 |
) |
|
(683 |
) |
|
(867 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,448 |
) |
$ |
(5,343 |
) |
$ |
(11,138 |
) |
$ |
(10,400 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
$ |
(0.06 |
) |
$ |
(0.18 |
) |
$ |
(0.15 |
) |
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
85,924 |
|
|
29,887 |
|
|
76,165 |
|
|
27,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion
CorporationSelected Balance Sheet
Information(in thousands)
|
|
June 30, 2021(Unaudited) |
|
|
December 31,2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
26,437 |
|
|
$ |
17,164 |
|
Investment securities and interest receivable on investment
securities |
|
|
32,028 |
|
|
|
- |
|
Advances, deposits on clinical programs and other current
assets |
|
|
1,845 |
|
|
|
1,661 |
|
Total current assets |
|
|
60,310 |
|
|
|
18,825 |
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
459 |
|
|
|
295 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
Deferred tax asset |
|
|
- |
|
|
|
1,845 |
|
Restricted cash invested in money market account |
|
|
6,000 |
|
|
|
- |
|
In-process research and development |
|
|
13,366 |
|
|
|
13,366 |
|
Goodwill |
|
|
1,976 |
|
|
|
1,976 |
|
Operating lease right-of-use assets, deposits and other assets |
|
|
899 |
|
|
|
1,220 |
|
Total other assets |
|
|
22,241 |
|
|
|
18,407 |
|
Total assets |
|
$ |
83,010 |
|
|
$ |
37,527 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
4,422 |
|
|
$ |
4,703 |
|
Notes payable – current portion |
|
|
- |
|
|
|
1,117 |
|
Operating lease liability – current portion |
|
|
458 |
|
|
|
433 |
|
Deferred revenue - current portion |
|
|
500 |
|
|
|
500 |
|
Total current liabilities |
|
|
5,380 |
|
|
|
6,753 |
|
|
|
|
|
|
|
|
|
|
Earn-out milestone liability |
|
|
7,088 |
|
|
|
7,018 |
|
Notes payable – noncurrent portion |
|
|
5,763 |
|
|
|
3,935 |
|
Deferred revenue – noncurrent portion |
|
|
250 |
|
|
|
500 |
|
Operating lease liability – noncurrent portion |
|
|
475 |
|
|
|
710 |
|
Total liabilities |
|
|
18,956 |
|
|
|
18,916 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock |
|
|
866 |
|
|
|
407 |
|
Additional paid-in capital |
|
|
386,415 |
|
|
|
330,289 |
|
Accumulated other comprehensive gain (loss) |
|
|
(4 |
) |
|
|
- |
|
Accumulated deficit |
|
|
(323,138 |
) |
|
|
(312,000 |
) |
|
|
|
64,139 |
|
|
|
18,696 |
|
Less: Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total stockholders’ equity |
|
|
64,054 |
|
|
|
18,611 |
|
Total liabilities and stockholders’ equity |
|
$ |
83,010 |
|
|
$ |
37,527 |
|
# # #
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