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 nine months ended
September 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 continues to show momentum as patient
enrollment nears 70% with full enrollment targeted by the first
half of 2022. We are encouraged with surgical resection results at
the 100 mg/m² dose cohort in the Phase II OVATION 2 Study. From the
first 36 patients with interval debulking surgery, 80% treated with
GEN-1 at a dose of 100 mg/m² plus neoadjuvant chemotherapy (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; this compares with
56% of patients in the control arm having R0 resections. These
results are reasonably consistent with those reported from our
earlier Phase I trials in advanced-stage ovarian cancer,” said
Michael H. Tardugno, Celsion’s chairman, president and chief
executive officer.
“At the International Vaccines Congress in
October, Celsion announced results from preclinical in
vivo studies showing production of antibodies and cytotoxic
T-cell response specific to the spike antigen of SARS-CoV-2 when
immunizing BALB/c mice with our next-generation PLACCINE DNA
vaccine,” added Mr. Tardugno. “Our goal over the next several
quarters is to demonstrate the superiority of Celsion’s
multicistronic DNA vaccine over current mRNA vaccines with respect
to the quality of immune response (higher affinity of neutralizing
antibodies, IgG titers and T-cell response) against multiple
SARS-CoV-2 variants, longer duration of immune response and a
stable product at lower temperatures.”
Recent Developments
GEN-1 Immunotherapy
Interim Data Reported on
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 R0 resections. |
|
● |
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. |
Publication of OVATION 1 Study
in the Journal of Clinical Cancer
Research. In July 2021, the Company
announced the publication of data from its Phase 1b OVATION 1 Study
with GEN-1 in combination with NACT in patients with advanced
ovarian cancer in Clinical Cancer Research, a journal of
the American Association for Cancer Research. The study,
authored by Premel H. Thaker, M.D. et al. and titled
“GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients
with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation
Study,” is available here. Dr. Thaker, Professor of
Gynecologic Oncology and Director of Gynecologic Oncology
Clinical Research at the Washington University School of
Medicine in St. Louis, is the study chair for the OVATION
program.
The OVATION 1 Study enrolled 18 patients with
newly diagnosed stage IIIC and IV epithelial ovarian cancer in a
standard 3+3 dose-escalation design testing four GEN-1 doses (36
mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) in combination with
NACT (carboplatin-paclitaxel). There were 15 patients evaluable for
safety, and 14 underwent interval debulking and were evaluable for
RECIST.
As previously reported, there were no
dose-limiting toxicities. As shown in the chart below, in the two
highest doses of GEN-1 the objective response rate was 100% and the
R0 resection rate was 88%. Newly published data show the CRS, which
was analyzed in this paper for the first time, was 50% in the two
highest doses of GEN-1, compared with 28% from a major publication
evaluating CRS scoring.
Clinical Responses: Tumor Response,
Surgical Outcome, Pathological Response and Chemotherapy Response
Score with NAC/GEN-1 Escalating
Doses
Radiographic
Response |
|
|
|
Total (n) |
|
Cohort 1 36
mg/m2 |
|
Cohort 2 47
mg/m2 |
|
Cohort 3 61
mg/m2 |
|
Cohort 4 79
mg/m2 |
|
|
CR |
|
2 |
|
1 |
|
0 |
|
|
0 |
|
1 |
|
Tumor
Response |
|
PR |
|
10 |
|
0 |
|
3 |
|
|
3 |
|
4 |
|
|
|
SD |
|
2 |
|
2 |
|
0 |
|
|
0 |
|
0 |
|
Objective Response
Rate |
|
|
|
|
|
|
|
67 |
% |
|
|
|
100 |
% |
|
|
R0 |
|
9 |
|
2 |
|
0 |
|
|
2 |
|
5 |
|
Surgical
Outcome |
|
R1 |
|
3 |
|
1 |
|
2 |
|
|
0 |
|
0 |
|
|
|
R2 |
|
2 |
|
0 |
|
1 |
|
|
1 |
|
0 |
|
R0 Resection
Rate |
|
|
|
|
|
|
|
33 |
% |
|
|
|
88 |
% |
|
|
cPR |
|
1 |
|
1 |
|
0 |
|
|
0 |
|
0 |
|
Pathological
Response |
|
Micro |
|
8 |
|
1 |
|
2 |
|
|
1 |
|
4 |
|
|
|
Macro |
|
5 |
|
1 |
|
1 |
|
|
2 |
|
1 |
|
cPR/Micro
Rate |
|
|
|
|
|
|
|
60 |
% |
|
|
|
63 |
% |
|
|
CRS 3 |
|
5 |
|
1 |
|
0 |
|
|
2 |
|
2 |
|
Chemotherapy Response
Score |
|
CRS 2 |
|
5 |
|
2 |
|
1 |
|
|
0 |
|
2 |
|
|
|
CRS 1 |
|
4 |
|
0 |
|
2 |
|
|
1 |
|
1 |
|
CRS 3
Rate |
|
|
|
|
|
|
|
17 |
% |
|
|
|
50 |
% |
Translational Responses: IL-12
and IFN-γ Levels, Response to Immune-Suppressive
Agents; Ratio of CD8+ Cells
to Immune Suppressive Agents
|
● |
A dose-dependent increase in immunostimulatory cytokines IL-12 and
its downstream cytokine IFN-γ in ascitic fluid. The anticancer
effects of these cytokines are widely recognized in human
malignancies. |
|
● |
The proportion of myeloid dendritic cells in the peritoneal fluid
trended higher (3.1-fold) accompanied by a similar 3.0-fold rise in
CD8+ cells. |
|
● |
GEN-1 appeared to reduce four immunosuppressive signals (Foxp3,
IDO1, PD-1 and PD-L1) within the tumor microenvironment, a trend
not seen with NAC therapy alone. |
|
● |
GEN-1 appeared to stimulate the body’s immune system through the
production of CD4 and CD8 cells. |
|
● |
GEN-1 gene therapy was associated with an apparent increase in the
cytotoxic state of T cells within the tumor microenvironment as
indicated by the increases in the ratios of CD8+/CD4+ and CD8+/Treg
cells. Indeed, higher CD8+/CD4+ T cell and CD8+/Treg ratios are
considered prognostic for prolonged survival. |
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 joined 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.
Results from In
Vivo Studies with PLACCINE DNA Vaccine Platform
Indicate Immune Response Against
SARS-Cov-2. In September 2021, the Company announced
results from preclinical in vivo studies showing
production of antibodies and cytotoxic T-cell response specific to
the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with
the Company’s next-generation PLACCINE DNA vaccine platform.
Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the
infection of cultured cells in a viral neutralization assay. The
production of antibodies predicts the ability of PLACCINE to
protect against SARS-CoV-2 exposure, and the elicitation of
cytotoxic T-cell response shows the vaccine’s potential to
eradicate cells infected with SARS-CoV-2. These findings
demonstrate the potential immunogenicity of Celsion’s PLACCINE DNA
vaccine, which is hypothesized to provide broad-spectrum protection
and resistance against variants by incorporating multiple viral
antigens, to improve vaccine stability at storage temperatures of
4oC and above, and to facilitate cheaper and easier
manufacturing. Celsion reported these data at
the International Vaccines Conference in October
2021.
Agreement with Hainan Poly
Pharm to Manufacture Celsion’s DNA-based
Vaccine. In September 2021, the Company announced an
amendment to its existing contract manufacturing agreement with
Hainan Poly Pharm Co. Ltd., a generics manufacturer dedicated to
providing therapeutic-value products and services to patients and
customers around the world, to include development work for the
Company’s investigational DNA-based COVID-19 vaccine. Under the
terms of the amended agreement, Poly Pharm will manufacture
clinical batches and, if approved for use, will also manufacture
commercial batches for Celsion’s vaccine based on its TheraPlas
technology. Poly Pharm is experienced with chemistry, manufacturing
and controls (CMC), process development and good manufacturing
processes (cGMP), including process optimization and manufacturing
services to help customers advance new drug development projects.
Its sites and pharmaceutical compounds have been approved by
the U.S. Food and Drug Administration (FDA),
the European Medicines Agency (EMA),
China’s National Medical Products Administration (NMPA)
and the World Health Organization (WHO).
Oral Presentation on
Celsion’s Ongoing Work with DNA-based Vaccines at International
Vaccines Congress. In October 2021, the Company announced
that Khursheed Anwer, Ph.D., executive vice president and
chief science officer, presented at the International Vaccines
Congress . Dr. Anwer’s presentation was titled “Immunogenicity
of DNA Vaccines based on Multicistronic Vectors and Synthetic DNA
Delivery Systems” and can be viewed here. Dr.
Anwer discussed ongoing proof-of-concept studies in SARS-CoV-2
with the Company’s DNA-based vaccine approach utilizing its
PLACCINE platform. PLACCINE, Celsion’s proprietary design for DNA
vectors, encompasses molecular elements designed to improve the
immune response by targeting multiple antigens of a pathogen or
multiple mutants of the same antigen. Dr. Anwer also
reviewed the PLACCINE technology and the production of a family of
DNA vaccine vectors expressing one or more SARS-CoV-2 surface
antigens as a proof-of-concept target, verified vector composition
and demonstrated expression of the encoded genes.
Corporate Developments
Presentations at
Three Healthcare Investment
Conferences. Celsion management made presentations at the
following investment conferences in October:
|
● |
Chardan’s 5th Annual Genetic Medicines Conference. Michael H.
Tardugno, Celsion’s chairman, president and chief executive
officer, and Khursheed Anwer, Ph.D., Celsion’s chief scientific
officer, participated in a fireside chat. |
|
● |
LD Micro Main Event. Jeffrey W. Church, Celsion’s chief financial
officer, presented virtually. |
|
● |
Alliance Global Partners’ Virtual Healthcare Conference. Mr.
Tardugno participated in an oncology focused panel discussion
moderated by James Molloy, Research Analyst. |
Third Quarter Financial
Results
For the quarter ended September 30, 2021,
Celsion reported a net loss of $5.4 million ($0.06 per share),
compared with a net loss of $8.1 million ($0.24 per share) in the
same period of 2020. Operating expenses were $5.2 million in the
third quarter of 2021, which represented a $0.9 million (21%)
increase from $4.3 million in the same period of 2020.
The Company ended the third quarter of 2021 with
$60.6 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 the end of
2024.
Research and development (R&D) expenses were
$2.5 million in the third quarter of 2021, consistent with $2.5
million reported in the third quarter of 2020. Costs associated
with the OVATION 2 Study were $0.2 million in each of the third
quarters of 2021 and 2020. R&D costs associated with both the
development of GEN-1 to support the OVATION 2 Study and the
development of the PLACCINE DNA technology platform increased to
$1.1 million in the third quarter of 2021, compared with $0.7
million in the same period of 2020. Clinical development costs for
the Phase III OPTIMA Study decreased $0.3 million to $0.2 million
in the third quarter of 2021, compared with $0.5 million in the
third 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 $1.0 million in the
third quarter of 2021 from $1.1 million in the third 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
OPTIMA Study.
General and administrative expenses were $2.7
million in the third quarter of 2021, compared with $1.8 million in
the same period of 2020. The $0.9 million increase was primarily
attributable to higher non-cash stock-compensation expense ($0.2
million), an increase in legal and professional fees ($0.6 million)
and an increase in Directors’ and Officers’ insurance premiums
($0.1 million).
Non-operating expenses of $0.3 million in the
third quarter of 2021 decreased from $3.9 million in the third
quarter of 2020 due to (i) a non-cash charge of $1.1 million for
the change in valuation of the earn-out milestone liability for the
GEN-1 ovarian product candidate recognized in the third quarter of
2020 compared with a $0.3 million non-cash charge recognized in the
current quarter; (ii) a non-cash charge of $2.4 million related to
the impairment of certain in-process research and development
assets related to the development of the Company’s glioblastoma
multiforme (GBM) cancer product candidate in the third quarter of
2020; and (ii) lower interest expense of $0.4 million on the
Company’s debt facilities in the current quarter, compared with 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 under the
Company’s venture debt facility entered in late June 2018 with
Horizon Technology Finance Corporation.
Nine Month Financial
Results
For the nine months ended September 30, 2021,
the Company reported a net loss of $16.5 million ($0.21 per share),
compared with a net loss of $18.5 million ($0.62 per share) in the
same period of 2020. Operating expenses were $15.9 million during
the first nine months of 2021, which represented a $1.8 million
(13%) increase from $14.1 million in the same period of
2020.
Net cash used for operating activities was $11.1
million in the first nine months of 2021, compared with $11.9
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 of $54.8 million during the
first nine months of 2021 was derived from equity offerings in
January 2021 and April 2021, 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 $0.9
million to $7.6 million in the first nine months of 2021 from $8.5
million in the comparable prior-year period. Costs associated with
the OVATION 2 Study increased to $1.0 million in the first nine
months of 2021 compared to $0.7 million in the same period of 2020.
The Company initiated enrollment in the Phase 2 portion of the
study during the third 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 $3.1 million in the first nine months of 2021,
compared with $2.3 million in the comparable 2020 period. Costs for
the Phase III OPTIMA Study decreased $1.2 million to $0.6 million
in the first nine months of 2021, compared with $1.8 million in the
first nine months 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 $0.8 million to $2.9 million in the
first nine months 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 $8.3
million in the first nine months of 2021, compared with $5.5
million in the same period of 2020. The $2.8 million increase was
primarily attributable to higher non-cash stock-compensation
expense ($1.0 million), an increase in legal and professional fees
($1.4 million) and an increase in Directors’ and Officers’
insurance premiums ($0.2 million).
Other expenses during the first nine months of
2021 included a non-cash charge of $0.3 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 $1.4 million
during the comparable prior-year period and a non-cash charge of
$2.4 million related to the impairment of certain in-process
research and development assets related to the development of the
Company’s GBM cancer product candidate in the third quarter of
2020. In connection with the Company’s venture debt facilities, the
Company incurred interest expense of $0.5 million during the first
nine months of 2021, compared with $1.1 million during the same
period in 2020. 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 under the Company’s venture
debt facility with Horizon Technology Finance Corporation.
Conference Call
The Company will host a conference call to
provide a business update, discuss its third quarter 2021 financial
results and answer questions at 11:00 a.m. ET today. To participate
in the call, please dial 1-800-353-6461(Toll-Free/North America) or
+1-334-323-0501 (International/Toll) and ask for the Celsion
Corporation Third Quarter 2021 Earnings Call (Conference Code:
4154518). The call will also be broadcast live on the internet at
www.celsion.com. The call will be archived for replay through
December 1, 2021. The replay can be accessed at +1-719-457-0820 or
888-203-1112 using Conference ID: 4154518. An audio replay will
also be available on the Company's website, www.celsion.com, for 90
days after 2:00 p.m. ET on November 15, 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. 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 GmbH is Celsion’s wholly owned, special
purpose subsidiary based in Zug, Switzerland. Celsion GmbH is
responsible for supporting studies of ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, is under
investigator-sponsored development for several cancer indications.
For more information on Celsion GmbH, visit
www.celsiongmbh.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 Contact
Jeffrey W. Church609-482-2455jchurch@celsion.com
LHA Investor Relations
Kim Sutton Golodetz212-838-3777kgolodetz@lhai.com
[Tables to Follow]
Celsion
CorporationCondensed Statements of
Operations(in thousands except per share
amounts)
|
|
Three Months EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue |
|
$ |
125 |
|
|
$ |
125 |
|
|
$ |
375 |
|
|
$ |
375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,468 |
|
|
|
2,492 |
|
|
|
7,633 |
|
|
|
8,534 |
|
General and administrative |
|
|
2,719 |
|
|
|
1,793 |
|
|
|
8,258 |
|
|
|
5,533 |
|
Total operating expenses |
|
|
5,187 |
|
|
|
4,285 |
|
|
|
15,891 |
|
|
|
14,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(5,062 |
) |
|
|
(4,160 |
) |
|
|
(15,516 |
) |
|
|
(13,692 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) from change in valuation of earn-out milestone
liability |
|
|
(257 |
) |
|
|
(1,100 |
) |
|
|
(327 |
) |
|
|
(1,397 |
) |
Impairment of in-process research and development |
|
|
- |
|
|
|
(2,370 |
) |
|
|
- |
|
|
|
(2,370 |
) |
Loss on debt extinguishment |
|
|
- |
|
|
|
- |
|
|
|
(235 |
) |
|
|
- |
|
Interest expense, investment income and other income (expense),
net |
|
|
(92 |
) |
|
|
(442 |
) |
|
|
(470 |
) |
|
|
(1,012 |
) |
Total other income (expense), net |
|
|
(349 |
) |
|
|
(3,912 |
) |
|
|
(1,032 |
) |
|
|
(4,779 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,411 |
) |
|
$ |
(8,072 |
) |
|
$ |
(16,548 |
) |
|
$ |
(18,471 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
86,558 |
|
|
|
34,112 |
|
|
|
79,668 |
|
|
|
29,935 |
|
Celsion
CorporationSelected Balance Sheet
Information(in thousands)
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,649 |
|
|
$ |
17,164 |
|
Investment securities and interest receivable on investment
securities |
|
|
28,903 |
|
|
|
- |
|
Advances, deposits on clinical programs and other current
assets |
|
|
2,213 |
|
|
|
1,661 |
|
Total current assets |
|
|
56,765 |
|
|
|
18,825 |
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
486 |
|
|
|
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 |
|
|
876 |
|
|
|
1,220 |
|
Total other assets |
|
|
22,218 |
|
|
|
18,407 |
|
Total assets |
|
$ |
79,469 |
|
|
$ |
37,527 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,441 |
|
|
$ |
4,703 |
|
Notes payable – current portion |
|
|
- |
|
|
|
1,117 |
|
Operating lease liability – current portion |
|
|
534 |
|
|
|
433 |
|
Deferred revenue - current portion |
|
|
500 |
|
|
|
500 |
|
Total current liabilities |
|
|
6,475 |
|
|
|
6,753 |
|
|
|
|
|
|
|
|
|
|
Earn-out milestone liability |
|
|
7,345 |
|
|
|
7,018 |
|
Notes payable – noncurrent portion |
|
|
5,809 |
|
|
|
3,935 |
|
Deferred revenue – noncurrent portion |
|
|
125 |
|
|
|
500 |
|
Operating lease liability – noncurrent portion |
|
|
373 |
|
|
|
710 |
|
Total liabilities |
|
|
20,127 |
|
|
|
18,916 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock |
|
|
866 |
|
|
|
407 |
|
Additional paid-in capital |
|
|
387,107 |
|
|
|
330,289 |
|
Accumulated other comprehensive gain (loss) |
|
|
2 |
|
|
|
- |
|
Accumulated deficit |
|
|
(328,548 |
) |
|
|
(312,000 |
) |
|
|
|
59,427 |
|
|
|
18,696 |
|
Less: Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total stockholders’ equity |
|
|
59,342 |
|
|
|
18,611 |
|
Total liabilities and stockholders’ equity |
|
$ |
79,469 |
|
|
$ |
37,527 |
|
###
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