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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Celsion Corporation    CLSN

CELSION CORPORATION

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CELSION : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. (form 10-Q)

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08/14/2020 | 08:46am EDT

Forward-Looking Statements




Statements and terms such as "expect", "anticipate", "estimate", "plan",
"believe" and words of similar import regarding our expectations as to the
development and effectiveness of our technologies, the potential demand for our
products, and other aspects of our present and future business operations,
constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Although we believe that our
expectations are based on reasonable assumptions within the bounds of our
knowledge of our industry, business and operations, we cannot guarantee that
actual results will not differ materially from our expectations. In evaluating
such forward-looking statements, readers should specifically consider the
various factors contained in the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 2019, filed with the SEC on March 25, 2020, which
factors include, without limitation, plans and objectives of management for
future operations or programs or proposed new products or services; changes in
the course of research and development activities and in clinical trials;
possible changes in cost and timing of development and testing; possible changes
in capital structure, financial condition, working capital needs and other
financial items; changes in approaches to medical treatment; clinical trial
analysis and future plans relating thereto; our ability to realize the full
extent of the anticipated benefits of our acquisition of substantially all of
the assets of EGEN, Inc., including achieving operational cost savings and
synergies in light of any delays we may encounter in the integration process and
additional unforeseen expenses; introduction of new products by others; possible
licenses or acquisitions of other technologies, assets or businesses; and
possible actions by customers, suppliers, partners, competitors and regulatory
authorities. These and other risks and uncertainties could cause actual results
to differ materially from those indicated by forward-looking statements.



The discussion of risks and uncertainties set forth in this Quarterly Report on
Form 10-Q and in our most recent Annual Report on Form 10-K, as well as in other
filings with the SEC, is not a complete or exhaustive list of all risks facing
the Company at any particular point in time. We operate in a highly competitive,
highly regulated and rapidly changing environment and our business is constantly
evolving. Therefore, it is likely that new risks will emerge, and that the
nature and elements of existing risks will change, over time. It is not possible
for management to predict all such risk factors or changes therein, or to assess
either the impact of all such risk factors on our business or the extent to
which any individual risk factor, combination of factors, or new or altered
factors, may cause results to differ materially from those contained in any
forward-looking statement. We disclaim any obligation to revise or update any
forward-looking statement that may be made from time to time by us or on our
behalf.


Strategic and Clinical Overview




Celsion is a fully integrated oncology company focused on developing a portfolio
of innovative cancer treatments, including immunotherapies, DNA-based therapies
and directed chemotherapies. The Company's product pipeline includes GEN-1, a
DNA-based immunotherapy for the localized treatment of ovarian cancer and
ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary liver cancer and
in development for other cancer indications. Celsion has two feasibility stage
platform technologies for the development of novel nucleic acid-based
immunotherapies and other anti-cancer DNA or RNA therapies. Both are novel
synthetic, non-viral vectors with demonstrated capability in nucleic acid
cellular transfection. With these technologies we are working to develop and
commercialize more efficient, effective and targeted oncology therapies that
maximize efficacy while minimizing side effects common to cancer treatments.



ThermoDox®



ThermoDox® is being evaluated in a Phase III clinical trial for primary liver
cancer, which we call the OPTIMA Study, which was initiated in 2014. ThermoDox®
is a liposomal encapsulation of doxorubicin, an approved and frequently used
oncology drug for the treatment of a wide range of cancers. Localized heat at
hyperthermia temperatures (greater than 40° Celsius) releases the encapsulated
doxorubicin from the liposome enabling high concentrations of doxorubicin to be
deposited preferentially in and around the targeted tumor.



The OPTIMA Study. The OPTIMA Study represents an evaluation of ThermoDox® in
combination with a first line therapy, RFA, for newly diagnosed, intermediate
stage HCC patients. HCC incidence globally is approximately 755,000 new cases
per year and is the third largest cancer indication globally. Approximately 30%
of newly diagnosed patients can be addressed with RFA.



26






On February 24, 2014, we announced that the United States Food and Drug
Administration (the "FDA") provided clearance for the OPTIMA Study, which is a
pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox®, in
combination with standardized RFA, for the treatment of primary liver cancer.
The trial design of the OPTIMA Study is based on the comprehensive analysis of
data from an earlier clinical trial called the HEAT Study (the "HEAT Study").
The OPTIMA Study is supported by a hypothesis developed from an overall survival
analysis of a large subgroup of patients from the HEAT Study.



Post-hoc data analysis from our earlier Phase III HEAT Study suggest that
ThermoDox® may substantially improve OS, when compared to the control group, in
patients if their lesions undergo a 45-minute RFA procedure standardized for a
lesion greater than 3 cm in diameter. Data from nine OS sweeps have been
conducted since the top line progression free survival ("PFS") data from the
HEAT Study were announced in January 2013, with each data set demonstrating
substantial improvement in clinical benefit over the control group with
statistical significance. On August 15, 2016, we announced updated results from
its final retrospective OS analysis of the data from the HEAT Study. These
results demonstrated that in a large, well bounded, subgroup of patients with a
single lesion (n=285, 41% of the HEAT Study patients), treatment with a
combination of ThermoDox® and optimized RFA provided an average 54% risk
improvement in OS compared to optimized RFA alone. The Hazard Ratio ("HR") at
this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02. Median OS for
the ThermoDox® group has been reached which translates into a two-year survival
benefit over the optimized RFA group (projected to be greater than 80 months for
the ThermoDox® plus optimized RFA group compared to less than 60 months
projection for the optimized RFA only group).



While this information should be viewed with caution since it is based on a
retrospective analysis of a subgroup, we also conducted additional analyses that
further strengthen the evidence for the HEAT Study subgroup. We commissioned an
independent computational model at the University of South Carolina Medical
School. The results unequivocally indicate that longer RFA heating times
correlate with significant increases in doxorubicin concentration around the RFA
treated tissue. In addition, we conducted a prospective preclinical study in 22
pigs using two different manufacturers of RFA and human equivalent doses of
ThermoDox® that clearly support the relationship between increased heating
duration and doxorubicin concentrations.



The OPTIMA Study was designed with extensive input from globally recognized HCC
researchers and expert clinicians and after receiving formal written feedback
from the FDA. The OPTIMA Study was designed to enroll up to 550 patients
globally at approximately 65 clinical sites in the U.S., Canada, European Union
(EU), China and other countries in the Asia-Pacific region and will evaluate
ThermoDox® in combination with standardized RFA, which will require a minimum of
45 minutes across all investigators and clinical sites for treating lesions
three to seven centimeters, versus standardized RFA alone. The primary endpoint
for this clinical trial is overall survival ("OS"), and the secondary endpoints
are progression free survival and safety. The statistical plan calls for two
interim efficacy analyses by an independent Data Monitoring Committee ("DMC").
The Company completed enrollment of 556 patients in the Phase III OPTIMA Study
in August 2018.



On December 18, 2018, we announced that the DMC for the OPTIMA Study completed
its last scheduled review of all patients enrolled in the trial and unanimously
recommended that the OPTIMA Study continue according to protocol to its final
data readout. The DMC's recommendation was based on the Committee's assessment
of safety and data integrity of all patients randomized in the trial as of
October 4, 2018. The DMC reviewed study data at regular intervals throughout the
patient enrollment period, 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
of all 556 patients enrolled into the trial, the DMC evaluated 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.



On August 5, 2019, the Company announced that the prescribed number of OS events
had been reached for the first prespecified interim analysis of the OPTIMA Phase
III Study. Following preparation of the data, the first interim analysis was
conducted by the DMC on November 1, 2019. This timeline was consistent with the
Company's stated expectations and is necessary to provide a full and
comprehensive data set that may represent the potential for a successful trial
outcome. In accordance with the statistical plan, this initial interim analysis
has a target of 118 events, or 60% of the total number required for the final
analysis. At the time of the data cutoff, the Company received reports of 128
events. The hazard ratio for success at 128 events is approximately 0.63, which
represents a 37% reduction in the risk of death compared with RFA alone and is
consistent with the 0.65 hazard ratio that was observed in the prospective HEAT
Study subgroup, which demonstrated a two-year overall survival advantage and a
median time to death of more than seven and a half years.



27





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 (CIO), 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 radiofrequency ablation (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 Dr.
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 overall survival (OS)
in patients with single-lesion HCC who were treated with RFA plus ThermoDox®,
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 two 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.



On November 4, 2019, the Company announced that the DMC 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
OPTIMA Study. The DMC's pre-planned interim efficacy review followed 128 patient
events, or deaths, which occurred in August 2019. Data presented demonstrated
that PFS and OS data appear to be tracking with patient data observed at a
similar point in the Company's subgroup of patients followed prospectively in
the earlier Phase III HEAT Study, upon which the OPTIMA Study is based.



The data review demonstrated the following:

? The OPTIMA Study patient demographics and risk factors are consistent with

what the Company observed in the HEAT Study subgroup with all data quality

metrics meeting expectations.

? Median PFS for the OPTIMA Study reached 17 months as of August 2019. These

blinded data compare favorably with 16 months median PFS for all 285 patients

    in the HEAT Study subgroup of patients treated with RFA >45 minutes.

? Median OS for the OPTIMA Study has not been reached as of August 5, 2019,

however median OS appears to be consistent with the HEAT Study subgroup of

patients treated with RFA >45 minutes and followed prospectively for overall

survival.

? The OPTIMA Study has lost only 4 patients to follow-up from the initiation of

the trial in September 2014 through August 2019 while the trial design allows

    for 3% risk for loss per year, which at this point would have exceeded 60
    patients.




Unblinded PFS and OS were tracking similarly to the subgroup of patients who
received more than 45 minutes of RFA in our HEAT Study and followed
prospectively for more than three years. This subgroup in the HEAT Study
demonstrated a 2-year overall survival advantage and a median time to death of
more than 7 ½ years. This tracking appears to bode well for success at the
second of two 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 in the HEAT Study subgroup of patients
treated with RFA > 45 minutes.



On April 15, 2020, the Company announced that the prescribed minimum number of
events of 158 patient deaths had been reached for the second pre-specified
interim analysis of the OPTIMA Phase III Study. The hazard ratio for success at
158 deaths is 0.70, which represents a 30% reduction in the risk of death
compared with RFA alone. On July 13, 2020, the Company announced that it has
received a recommendation from the DMC to consider stopping the global OPTIMA
Study. The recommendation was made following the second pre-planned interim
safety and efficacy analysis by the DMC on July 9, 2020. The DMC analysis found
that the pre-specified boundary for stopping the trial for futility of 0.900 was
crossed with an actual value of 0.903. However, the 2-sided p-value of 0.524 for
this analysis provides uncertainty, subsequently, the DMC has left the final
decision of whether or not to stop the OPTIMA Study to Celsion. There were no
safety concerns noted during the interim analysis. The Company intends to follow
the advice of the DMC and will consider our options either to stop the study or
continue to follow patients after a thorough review of the data, and an
evaluation of our probability of success. Timing for this decision is made less
urgent by the fact that the OPTIMA Study has been fully enrolled since August
2018 and that the vast majority of the trial expenses have already been
incurred. On August 4, 2020, the Company issued a press release announcing it
will continue following patients for overall survival ("OS"), noting that the
unexpected and marginally crossed futility boundary, suggested by the
Kaplan-Meier analysis at the second interim analysis on July 9, 2020, may be
associated with a data maturity issue.



28






The HEAT Study. On January 31, 2013, the Company announced that the HEAT Study,
ThermoDox® in combination with RFA, did not meet the primary endpoint, PFS, in
the Phase III clinical trial enrolling 701 patients with primary liver cancer.
This determination was made after conferring with the HEAT Study independent
DMC, that the HEAT Study did not meet the goal of demonstrating a clinically
meaningful improvement in progression free survival. In the trial, ThermoDox®
was well-tolerated with no unexpected serious adverse events. Following the
announcement of the HEAT Study results, we continued to follow patients for OS,
the secondary endpoint of the HEAT Study. We have conducted a comprehensive
analysis of the data from the HEAT Study to assess the future strategic value
and development strategy for ThermoDox®.



GEN-1


GEN-1 is a DNA-based immunotherapeutic product candidate for the localized
treatment of ovarian cancer by intraperitoneally administering an Interleukin-12
("IL-12") plasmid formulated with our proprietary TheraPlas delivery system. In
this DNA-based approach, the immunotherapy is combined with a standard
chemotherapy drug, which can potentially achieve better clinical outcomes than
with chemotherapy alone. We believe that increases in IL-12 concentrations at
tumours sites for several days after a single administration could create a
potent immune environment against tumor activity and that a direct killing of
the tumor with concomitant use of cytotoxic chemotherapy could result in a more
robust and durable antitumor response than chemotherapy alone. We believe the
rationale for local therapy with GEN-1 is based on the following.



? Loco-regional production of the potent cytokine IL-12 avoids toxicities and

poor pharmacokinetics associated with systemic delivery of recombinant IL-12;

? Persistent local delivery of IL-12 lasts up to one week and dosing can be

    repeated; and

  ? Ideal for long-term maintenance therapy.



GEN-I OVATION Study. In February 2015, we announced that the FDA accepted,
without objection, the Phase I dose-escalation clinical trial of GEN-1 in
combination with the standard of care in neoadjuvant ovarian cancer (the
"OVATION Study"). On September 30, 2015, we announced enrollment of the first
patient in the OVATION Study. The OVATION Study was designed to (i) identify a
safe, tolerable and potentially therapeutically active dose of GEN-1 by
recruiting and maximizing an immune response; (ii) to enroll three to six
patients per dose level and will evaluate safety and efficacy and (iii) attempt
to define an optimal dose for a follow-on Phase I/II study. In addition, the
OVATION Study establishes a unique opportunity to assess how cytokine-based
compounds such as GEN-1, directly affect ovarian cancer cells and the tumor
microenvironment in newly diagnosed patients. The study was designed to
characterize the nature of the immune response triggered by GEN-1 at various
levels of the patients' immune system, including:



? Infiltration of cancer fighting T-cell lymphocytes into primary tumor and

tumor microenvironment including peritoneal cavity, which is the primary site

of metastasis of ovarian cancer;

? Changes in local and systemic levels of immuno-stimulatory and

immunosuppressive cytokines associated with tumor suppression and growth,

    respectively; and

  ? Expression profile of a comprehensive panel of immune related genes in
    pre-treatment and GEN-1-treated tumor tissue.



We initiated the OVATION Study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center, Washington University in St. Louis and the Medical College of Wisconsin. During 2016 and 2017, we announced data from the first fourteen patients in the OVATION Study, who completed treatment. On October 3, 2017, we announced final clinical and translational research data from the OVATION Study.



29






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-?) 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; and

? Analysis of peritoneal fluid by cell sorting, not reported before, shows a

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.



The Company also reported positive clinical data from the first fourteen patients who completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and positive dose dependent efficacy signals which correlate well with positive surgical outcomes as summarized below:

? Of the fourteen patients treated in the entire study, two patients

demonstrated a complete response, ten patients demonstrated a partial response

and two patients demonstrated stable disease, as measured by RECIST criteria.

This translates to a 100% disease control rate and an 86% objective response

rate ("ORR"). Of the five patients treated in the highest dose cohort, there

was a 100% ORR with one complete response and four partial responses;

? Fourteen patients had successful resections of their tumors, with nine

patients (64%) having a complete tumor resection ("R0"), which indicates a

microscopically margin-negative resection in which no gross or microscopic

tumor remains in the tumor bed. Seven out of eight (88%) 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; and

? 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.



On March 2, 2019, the Company announced final PFS results from the OVATION
Study. Median PFS in patients treated per protocol (n=14) was 21 months and was
17.1 months for the intent-to-treat population (n=18) for all dose cohorts,
including three patients who dropped out of the study after 13 days or less, and
two patients who did not receive full NAC and GEN-1 cycles. Under the current
standard of care, in women with Stage III/IV ovarian cancer undergoing NAC, the
disease progresses within about 12 months on average. The results from the
OVATION Study support continued evaluation of GEN-1 based on promising tumor
response, as reported in the PFS data, and the ability for surgeons to
completely remove visible tumor at debulking surgery. GEN-1 was well tolerated,
and no dose-limiting toxicities were detected. Intraperitoneal administration of
GEN-1 was feasible with broad patient acceptance.



GEN-1 OVATION 2 Study. The Company held an Advisory Board Meeting on September
27, 2017 with the clinical investigators and scientific experts including those
from Roswell Park Cancer Institute, Vanderbilt University Medical School, and
M.D. Anderson Cancer Center to review and finalize clinical, translational
research and safety data from the Phase IB OVATION Study in order to determine
the next steps forward for our GEN-1 immunotherapy program.



On November 13, 2017, the Company filed its Phase I/II clinical trial protocol
with the FDA for GEN-1 for the localized treatment of ovarian cancer. The
protocol is designed with a single dose escalation phase to 100 mg/m² to
identify a safe and tolerable dose of GEN-1 while maximizing an immune response.
The Phase I portion of the study will be followed by a continuation at the
selected dose in 130 patients randomized Phase II study.



30






In the OVATION 2 Study, patients in the GEN-1 treatment arm will receive GEN-1
plus chemotherapy pre- and post-interval debulking surgery. The OVATION 2 Study
will include up to 130 patients with Stage III/IV ovarian cancer, with 12 to 15
patients in the Phase I portion and up to 118 patients in Phase II. The study is
powered to show a 33% improvement in the primary endpoint, PFS, when comparing
GEN-1 with neoadjuvant + adjuvant chemotherapy versus neoadjuvant + adjuvant
chemotherapy alone. The PFS primary analysis will be conducted after at least 80
events have been observed or after all patients have been followed for at least
16 months, whichever is later.



On November 5, 2019, the Company announced that the independent Data Safety
Monitoring Board (DSMB) 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.



In March 2020, the Company announced highly encouraging initial clinical data
from the first 15 patients enrolled in the ongoing Phase I/II OVATION 2 Study
for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2
Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with
standard-of-care neoadjuvant chemotherapy (NACT). Following NACT, patients
undergo interval debulking surgery (IDS), followed by three additional cycles of
chemotherapy.


GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below:

? Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine

patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT and six

patients were treated with NACT only. All 15 patients had successful

resections of their tumors, with seven out of nine patients (78%) in the GEN-1

treatment arm having an R0 resection, which indicates a microscopically

margin-negative resection in which no gross or microscopic tumor remains in

the tumor bed. Only three out of six patients (50%) in the NACT only treatment

arm had a R0 resection.

? 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

    the current standard of care NACT:




                                               % of Patients
                                                   with
                                               R0 Resections
0, 36, 47 mg/m² of GEN-1 plus NACT     n=12                42 %
61, 79, 100 mg/m² of GEN-1 plus NACT   n=17                82 %




? The objective response rate (ORR) as measured by Response Evaluation Criteria

in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients

were comparable, as expected, to the higher (61, 79, 100 mg/m²) dose GEN-1

    patients, with both groups demonstrating an approximate 80% ORR.



On March 23, 2020, the Company announced that the European Medicines Agency
(EMA) Committee for Orphan Medicinal Products (COMP) has recommended that GEN-1
be designated as an orphan medicinal product for the treatment of ovarian
cancer. GEN-1, designed using Celsion's proprietary TheraPlas platform
technology, is an IL-12 DNA plasmid vector encased in a non-viral nanoparticle
delivery system, which enables cell transfection followed by persistent, local
secretion of the IL-12 protein. GEN-1 previously received orphan designation
from the FDA and is currently being evaluated in a Phase I/II clinical trial
(the OVATION 2 Study) for the treatment of newly diagnosed patients with Stage
III and IV ovarian cancer.



On March 26, 2020, the Company announced with Medidata, a Dassault Systèmes
company, that examining matched patient data provided by Medidata in a synthetic
control arm (SCA) with results from the Company's completed Phase Ib
dose-escalating OVATION I Study with GEN-1 in Stage III/IV ovarian cancer
patients showed positive results in progression-free survival (PFS). The hazard
ratio (HR) was 0.53 in the intent-to-treat (ITT) group, showing strong signals
of efficacy. GEN-1, designed using Celsion's proprietary TheraPlas platform
technology, is an IL-12 DNA plasmid vector encased in a non-viral nanoparticle
delivery system, which enables cell transfection followed by persistent, local
secretion of the IL-12 protein. Celsion believes these data may warrant
consideration of strategies to accelerate the clinical development program for
GEN-1 in newly diagnosed, advanced ovarian cancer patients by the FDA. In its
March 2019 discussion with Celsion, the FDA noted that preliminary findings from
the Phase Ib OVATION I Study were exciting but lacked a control group to
evaluate GEN-1's independent impact on impressive tumor response, surgical
results and PFS. The FDA encouraged the Company to continue its GEN-1
development program and consult with FDA with new findings that may have a
bearing on designations such as Fast Track and Breakthrough Therapy. SCAs have
the potential to revolutionize clinical trials in certain oncology indications
and some other diseases where a randomized control is not ethical or practical.
SCAs are formed by carefully selecting control patients from historical clinical
trials to match the demographic and disease characteristics of the patients
treated with the new investigational product. SCAs have been shown to mimic the
results of traditional randomized controls so that the treatment effects of an
investigational product can be visible by comparison to the SCA. SCAs can help
advance the scientific validity of single arm trials, and in certain
indications, reduce time and cost, and expose fewer patients to placebos or
existing standard-of-care treatments that might not be effective for them.


31





On July 27, 2020, the Company announced the randomization of the first two
patients in the Phase II portion of the Phase I/II OVATION 2 Study with GEN-1 in
advanced ovarian cancer. The Company anticipates completing enrolment of up to
118 patients in the third quarter of 2021. Because this is an open-label study,
the Company intends to provide clinical updates throughout the course of
treatment including response rates and surgical resection scores.



TheraPlas Technology Platform. TheraPlas is a technology platform for the
delivery of DNA and messenger RNA ("mRNA") therapeutics via synthetic non-viral
carriers and is capable of providing cell transfection for double-stranded DNA
plasmids and large therapeutic RNA segments such as mRNA. There are two
components of the TheraPlas system, a plasmid DNA or mRNA payload encoding a
therapeutic protein and a delivery system. The delivery system is designed to
protect the DNA/RNA from degradation and promote trafficking into cells and
through intracellular compartments. We designed the delivery system of TheraPlas
by chemically modifying the low molecular weight polymer to improve its gene
transfer activity without increasing toxicity. We believe TheraPlas is a viable
alternative to current approaches to gene delivery due to several distinguishing
characteristics, including enhanced molecular versatility that allows for
complex modifications to improve activity and safety.



Technology Development and Licensing Agreements. Our current efforts and
resources are applied on the development and commercialization of cancer drugs
including tumor-targeting chemotherapy treatments using focused heat energy in
combination with heat-activated drug delivery systems, immunotherapies and
RNA-based therapies.



On August 8, 2016, we signed the GEN-1 Agreement with Hisun to pursue an
expanded partnership for the technology transfer relating to the clinical and
commercial manufacture and supply of GEN-1, Celsion's proprietary gene mediated,
IL-12 immunotherapy, for the China territory, with the option to expand into
other countries in the rest of the world after all necessary regulatory
approvals are obtained. The GEN-1 Agreement will help to support supply for both
ongoing and planned clinical studies in the U.S. and for potential future
studies of GEN-1 in China. GEN-1 is currently being evaluated by Celsion in
first line ovarian cancer patients.



In June 2012, Celsion and Hisun signed a long-term commercial supply agreement
for the production of ThermoDox®. Hisun is one the largest manufacturers of
chemotherapy agents globally, including doxorubicin. In July 2013, the
ThermoDox® collaboration was expanded to focus on next generation liposomal
formulation development with the goal of creating safer, more efficacious
versions of marketed cancer chemotherapeutics. During 2015, Hisun successfully
completed the manufacture of three registration batches for ThermoDox® and has
obtained regulatory approvals to supply ThermoDox® to participating clinical
trial sites in all of the countries of South East Asia and North America, as
well as to the European Union countries allowing for early access to ThermoDox®.
The future manufacturing of clinical and commercial supplies by Hisun will
result in a cost structure allowing Celsion to profitably access all global
markets, including third world countries, and help accelerate the Company's
product development program in China for ThermoDox® in primary liver cancer and
other approved indications.



32






Business Plan


As a clinical stage biopharmaceutical company, our business and our ability to
execute our strategy to achieve our corporate goals are subject to numerous
risks and uncertainties. Material risks and uncertainties relating to our
business and our industry are described in "Part II, Item 1A. Risk Factors" in
this Quarterly Report on Form 10-Q.



Since inception, the Company has incurred substantial operating losses,
principally from expenses associated with the Company's research and development
programs, clinical trials conducted in connection with the Company's product
candidates, and applications and submissions to the FDA. The Company has not
generated significant revenue and have incurred significant net losses in each
year since our inception. As of June 30, 2020, the Company has incurred
approximately $301 million of cumulative net losses and we had approximately
$25.5 million in cash, investment securities, and interest receivable. We have
substantial future capital requirements to continue our research and development
activities and advance our product candidates through various development
stages. The Company believes these expenditures are essential for the
commercialization of its technologies.



The Company expects its operating losses to continue for the foreseeable future
as it continues its product development efforts, and when it undertakes
marketing and sales activities. The Company's ability to achieve profitability
is dependent upon its ability to obtain governmental approvals, manufacture, and
market and sell its new product candidates. There can be no assurance that the
Company will be able to commercialize its technology successfully or that
profitability will ever be achieved. The operating results of the Company have
fluctuated significantly in the past.



COVID-19 Pandemic


In January 2020, the WHO declared an outbreak of coronavirus, COVID-19, to be a
"Public Health Emergency of International Concern," and the U.S. Department of
Health and Human Services declared a public health emergency to aid the U.S.
healthcare community in responding to COVID-19. This virus has spread to over
100 countries, including the United States. Governments and businesses around
the world have taken unprecedented actions to mitigate the spread of COVID-19,
including, but not limited to, shelter-in-place orders, quarantines, significant
restrictions on travel, as well as restrictions that prohibit many employees
from going to work. Uncertainty with respect to the economic impacts of the
pandemic has introduced significant volatility in the financial markets. The
Company did not observe significant impacts on its business or results of
operations for the thus far in 2020 due to the global emergence of COVID-19.
While the extent to which COVID-19 impacts the Company's future results will
depend on future developments, the pandemic and associated economic impacts
could result in a material impact to the Company's future financial condition,
results of operations and cash flows.



The Company's ability to raise additional capital may be adversely impacted by
potential worsening global economic conditions and the recent disruptions to,
and volatility in, financial markets in the United States and worldwide
resulting from the ongoing COVID-19 pandemic.



The disruptions caused by COVID-19 may also disrupt the clinical trials process
and enrolment of patients. This may delay commercialization efforts. The Company
is currently monitoring its operating activities in light of these events and it
is reasonably possible that the virus could have a negative effect on the
Company's financial condition and results of operations, the specific impact is
not readily determinable as of the date of these financial statements.



The actual amount of funds the Company will need to operate is subject to many
factors, some of which are beyond the Company's control. These factors include
the following:


? the progress of research activities;

? the number and scope of research programs;

? the progress of preclinical and clinical development activities;

? the progress of the development efforts of parties with whom the Company has

entered into research and development agreements;

? the costs associated with additional clinical trials of product candidates;




33





? the ability to maintain current research and development licensing arrangements

and to establish new research and development and licensing arrangements;

? the ability to achieve milestones under licensing arrangements;

? the costs involved in prosecuting and enforcing patent claims and other

intellectual property rights; and

? the costs and timing of regulatory approvals.





On July 13, 2020, the Company announced that it has received a recommendation
from the DMC to consider stopping the global Phase III OPTIMA Study of
ThermoDox® in combination with RFA for the treatment of HCC, or primary liver
cancer. The recommendation was made following the second pre-planned interim
safety and efficacy analysis by the DMC on July 9, 2020. The DMC analysis found
that the pre-specified boundary for stopping the trial for futility of 0.900 was
crossed with an actual value of 0.903. The Company intends to follow the advice
of the DMC and will consider its options either to stop the study or continue to
follow patients after a thorough review of the data, and an evaluation of the
probability of success. Timing for this decision is made less urgent by the fact
that the OPTIMA Study has been fully enrolled since August 2018 and that the
vast majority of the trial expenses have already been incurred. On August 4,
2020, the Company issued a press release announcing it will continue following
patients for overall survival ("OS"), noting that the unexpected and marginally
crossed futility boundary, suggested by the Kaplan-Meier analysis at the second
interim analysis on July 9, 2020, may be associated with a data maturity issue.



During 2019 and 2018, the Company submitted applications to sell a portion of
the Company's State of New Jersey net operating losses as part of the Technology
Business Tax Certificate Program sponsored by The New Jersey Economic
Development Authority. Under the program, emerging biotechnology companies with
unused NOLs and unused research and development credits are allowed to sell
these benefits to other New Jersey-based companies. As more fully discussed in
Note 9, the Company received approval from the New Jersey Economic Development
Authority to sell $1.9 million of its State of New Jersey net operating losses
recognizing a tax benefit for the year ended December 31, 2019 for the net
proceeds (approximately $1.8 million). In early 2020, the Company entered into
an agreement to sell these net operating losses. In April of 2020, the Company
completed the sale of its State of New Jersey net operating losses and received
$1.8 million in net proceeds. In 2018, the Company completed the sale of a
portion of its State of New Jersey net operating losses for calendar years 2011
- 2017 totalling approximately $11.1 million for net proceeds of approximately
$10.4 million in December 2018. The proceeds of $10.4 million were reflected as
a tax benefit for the year ended December 31, 2018. In June 2020, the Company
filed an application with the New Jersey Economic Development Authority to sell
substantially all of its remaining State of New Jersey net operating losses
totalling $2.0 million available under the program.



In June 2018, the Company entered into the Horizon Credit Agreement with Horizon
that provided $10 million in new capital. The obligations under the Horizon
Credit Agreement are secured by a first-priority security interest in
substantially all assets of Celsion other than intellectual property assets.
Payments under the loan agreement are interest only (calculated based on
one-month LIBOR plus 7.625%) for the first twenty-four (24) months after through
July 2020, closing, followed by a 24-month amortization period of principal and
interest starting on August 1, 2020 and ending through the scheduled maturity
date.


With $25.5 million in cash, investments, interest receivable and up to $2.0
million in potential proceeds from the sale of the 2019 State of New Jersey net
operating losses, coupled with remaining availability under the
Capital-on-Demand Equity Facility with JonesTrading Institutional Services LLC,
the Company believes it has sufficient capital resources to fund its operations
through the end of 2021.



The Company has based its estimates on assumptions that may prove to be wrong.
The Company may need to obtain additional funds sooner or in greater amounts
than it currently anticipates. Potential sources of financing include strategic
relationships, public or private sales of the Company's shares or debt, the sale
of the Company's State of New Jersey net operating losses and other sources. If
the Company raises funds by selling additional shares of common stock or other
securities convertible into common stock, the ownership interest of existing
stockholders may be diluted.



34






Financing Overview


Equity, Debt and Other Forms of Financing




As more fully discussed in Note 3 of the Financial Statement included in this
Quarterly Report, during the fourth quarter of 2018 and 2020, the Company
received eligibility from the New Jersey Economic Development Authority to sell
$11.1 million and $1.9 million, respectively, of its unused New Jersey net
operating losses under the Technology Business Tax Certificate Program, and
after selling these net operating losses, received $10.4 million and $1.8
million of non-dilutive funding in the fourth quarter of 2018 and second quarter
of 2020, respectively. In June 2020, the Company filed an application with the
New Jersey Economic Development Authority to sell substantially all the
remaining $2.0 million of its State of New Jersey net operating losses available
under the program.



On April 23, 2020, we entered into the April PPP Loan, pursuant to the CARES Act
and administered by the SBA. We thereafter received proceeds of $632,220 under
the April PPP Loan. The April PPP Loan application required Celsion to certify
that there was economic uncertainty surrounding the Company and that, as such,
the April PPP Loan was necessary to support our ongoing operations. Celsion made
this certification in good faith after analysing, among other things, its
financial situation and access to alternative forms of capital, and believed
that the Company satisfied all eligibility criteria for the April PPP Loan, and
that our receipt of the April PPP Loan proceeds was consistent with the broad
objectives of the PPP of the CARES Act. The certification given with respect to
the April PPP Loan does not contain any objective criteria and is subject to
interpretation. Considering subsequent guidance issued by the U.S. Small
Business Administration in consultation with the U.S. Department of the Treasury
at that time, out of an abundance of caution we returned the proceeds of the PPP
Loan in full on May 13, 2020.



Shortly after the April PPP Loan was repaid, the SBA provided further guidance
with respect to these certifications providing a safe harbor under which
companies such as Celsion with PPP loans of less than $2 million will be deemed
to have made these certifications in good faith. Therefore, as the Company
continued to believe it qualifies for a loan under the PPP, it reapplied for and
eventually received the May PPP Loan for $692,530 on May 26, 2020. The May PPP
Loan is guaranteed by the SBA and evidenced the Note in the principal amount of
$692,530 payable to the lender. Pursuant to the terms of the Note, it may be
prepaid in part or in full, at any time, without penalty. On June 22, 2020, as
disclosed in the Company's Current Report on Form 8-K filed on the same date,
the Company commenced an offering of 2,666,667 shares of its common stock which
closed on June 24, 2020 (Note 11) and received net proceeds of approximately
$9.1 million. In light of the proceeds received from this equity offering, the
Company elected to repay the May PPP Loan in full (including interest accrued of
$577), on June 24, 2020, terminating all obligations of the Company under the
Note.



In June 2018, the Company entered into the Horizon Credit Agreement with Horizon
that provided $10 million in new capital. The obligations under the Horizon
Credit Agreement are secured by a first-priority security interest in
substantially all assets of Celsion other than intellectual property assets.
Payments under the loan agreement are interest only (calculated based on
one-month LIBOR plus 7.625%) for the first twenty-four (24) months after through
July 2020, closing, followed by a 24-month amortization period of principal and
interest starting on August 1, 2020 and ending through the scheduled maturity
date.


During 2019 and thus far in 2020, we issued a total of 13.8 million shares of
common stock in the following equity transactions raising approximately $27.8
million in gross proceeds.


? On June 22, 2020, the Company entered into an underwriting agreement (the

"Underwriting Agreement") with Oppenheimer & Co. Inc. (the "Underwriter"),

relating to the issuance and sale (the "Underwritten Offering") of 2.7 shares

of the Company's common stock. Pursuant to the terms of the Underwriting

Agreement, the Underwriter agreed to purchase the shares at a price of $3.4875

per share. The Underwriter offered the shares at a public offering price of

$3.75 per share, reflecting an underwriting discount equal to $0.2625, or 7.0%

of the public offering price. The net proceeds to the Company from the

Underwritten Offering, after deducting the underwriting discount and estimated

offering expenses payable by the Company, are approximately $9.1 million. The

Underwritten Offering closed on June 24, 2020 and was made pursuant to the

Company's effective shelf registration statement on Form S-3 (File No. 333-

227236) filed with the Securities and Exchange Commission on September 7, 2018,

and declared effective on October 12, 2018, including the base prospectus dated

October 12, 2018 included therein and the related prospectus supplement.

? On February 27, 2020, we entered into a Securities Purchase Agreement (the

"Purchase Agreement") with several institutional investors, pursuant to which

we agreed to issue and sell, in a registered direct offering (the "February

2020 Offering"), an aggregate of 4.6 million shares (the "Shares") of our

common stock at an offering price of $1.05 per share for gross proceeds of

approximately $4.8 million before the deduction of the Placement Agent fees and

offering expenses. The Shares were offered by the Company pursuant to a

registration statement on Form S-3 (File No. 333-227236). The Purchase

Agreement contains customary representations, warranties and agreements by the

Company and customary conditions to closing. In a concurrent private placement

(the "Private Placement"), the Company agreed to issue to the investors that

participated in the Offering, for no additional consideration, warrants, to

purchase up to 3.0 million shares of Common Stock (the "Original Warrants").

The Original Warrants were initially exercisable six months following their and

were set to expire on the five-year anniversary of such initial exercise date.

The Warrants had an exercise price of $1.15 per share subject to adjustment as

provided therein. On March 12, 2020 the Company entered into private exchange

agreements (the "Exchange Agreements") with holders the Warrants. Pursuant to

the Exchange Agreements, in return for a higher exercise price of $1.24 per

share of Common Stock, the Company issued new warrants to the Investors to

purchase up to 3.2 million shares of Common Stock (the "Exchange Warrants") in

exchange for the Original Warrants. The Exchange Warrants, like the Original

Warrants, are initially exercisable six months following their issuance (the

"Initial Exercise Date") and expire on the five-year anniversary of their

Initial Exercise Date. Other than having a higher exercise price, different

  issue date, Initial Exercise Date and expiration date, the terms of the
  Exchange Warrants are identical to those of the Original Warrants.




35






? On August 31, 2018, the Company entered into the 2018 Aspire Purchase

Agreement with Aspire Capital Fund LLC ("Aspire Capital") which provides that,

upon the terms and subject to the conditions and limitations set forth

therein, Aspire Capital was committed to purchase up to an aggregate of $15.0

million of shares of the Company's common stock over the 24-month term of the

2018 Aspire Purchase Agreement. On October 12, 2018, the Company filed with

the SEC a prospectus supplement to the 2018 Shelf Registration Statement

registering all of the shares of common stock that may be offered to Aspire

Capital from time to time. The timing and amount of sales of the Company's

common stock to Aspire Capital. Aspire Capital has no right to require any

sales by the Company but is obligated to make purchases from the Company as

directed by the Company in accordance with the Purchase Agreement. There were

no limitations on use of proceeds, financial or business covenants,

restrictions on future funding, rights of first refusal, participation rights,

penalties or liquidated damages in the Purchase Agreement. In consideration

for entering into the Purchase Agreement, concurrently with the execution of

the Purchase Agreement in 2018, the Company issued to Aspire Capital 164,835

Commitment Shares. The 2018 Aspire Purchase Agreement could be terminated by

the Company at any time, at its discretion, without any cost to the Company.

During 2019 the Company sold and issued an aggregate of 3.3 million shares

under the Purchase Agreement, receiving approximately $6.3 million. All

proceeds from the Company received under the 2018 Aspire Purchase Agreement

were used for working capital and general corporate purposes. As a result of

the Company and Aspire Capital entering into a new purchase agreement on

October 28, 2019 discussed in the next paragraph, the 2018 Aspire Purchase

Agreement was terminated. The Company sold a total of 3.4 million shares

receiving $6.5 million under the 2018 Aspire Agreement during 2018 through its

termination in 2019.

? On October 28, 2019, Company entered into the 2019 Aspire Purchase Agreement

with Aspire Capital. The terms and conditions pursuant to the 2019 Aspire

Purchase Agreement were substantially similar to the 2018 Aspire Purchase

Agreement. Pursuant to the new 2019 Aspire Purchase Agreement, Aspire Capital

was committed to purchase up to an aggregate of $10.0 million of shares of the

Company's common stock over the 24-month term of the 2019 Aspire Purchase

Agreement. Concurrently with entering into the 2019 Aspire Purchase Agreement,

the Company also entered into a registration rights agreement with Aspire

Capital (the "Registration Rights Agreement"), in which the Company agreed to

file one or more registration statements, as permissible and necessary to

register under the Securities Act of 1933, as amended (the "Securities Act"),

registering the sale of the shares of the Company's common stock that have

been and may be issued to Aspire Capital under the 2019 Aspire Purchase

Agreement. In consideration for entering into the 2019 Aspire Purchase

Agreement, the Company issued to Aspire Capital an additional 0.1 million

Commitment Shares. On November 8, 2019, the Company filed with the SEC a

Registration Statement on Form S-1 registering all the shares of common stock

that may be offered to Aspire Capital from time to time under the 2019 Aspire

Purchase Agreement. During 2019, the Company sold 0.5 million shares of common

stock under the 2019 Aspire Purchase Agreement, receiving approximately $0.7

million in gross proceeds. On March 5, 2020, the Company delivered notice to

Aspire Capital terminating the 2019 Aspire Purchase Agreement effective as of

March 6, 2020. During the first quarter of 2020 though the date of

termination, the Company sold 1.0 million shares of common stock under the

2019 Aspire Purchase Agreement and received $1.6 million in gross proceeds.

? On December 4, 2018, the Company entered into a new Capital on DemandTM Sales

Agreement (the "Capital on Demand Agreement") with JonesTrading Institutional

Services LLC, as sales agent ("JonesTrading"), pursuant to which the Company

may offer and sell, from time to time, through JonesTrading shares of common

stock having an aggregate offering price of up to $16.0 million. The Company

intends to use the net proceeds from the offering, if any, for general

corporate purposes, including research and development activities, capital

expenditures and working capital. The Company is not obligated to sell any

Common Stock under the Capital on Demand Agreement and, subject to the terms

and conditions of the Capital on Demand Agreement, JonesTrading will use

commercially reasonable efforts, consistent with its normal trading and sales

practices and applicable state and federal law, rules and regulations and the

rules of The Nasdaq Capital Market, to sell common stock from time to time

based upon Celsion's instructions, including any price, time or size limits or

other customary parameters or conditions the Company may impose. Under the

Capital on Demand Agreement, JonesTrading may sell common stock by any method

deemed to be an "at the market offering" as defined in Rule 415 promulgated

under the Securities Act of 1933, as amended. The Capital on Demand Agreement

will terminate upon the earlier of (i) the sale of all shares of our common

stock subject to the Sales Agreement, and (ii) the termination of the Capital

on Demand Agreement by JonesTrading or Celsion. The Capital on Demand

Agreement may be terminated by JonesTrading or the Company at any time upon 10

days' notice to the other party, or by JonesTrading at any time in certain

circumstances, including the occurrence of a material adverse change in the

Company. During 2019 and in 2020 thus far, the Company sold 0.5 million and

1.2 million shares of common stock under the Capital on Demand Agreement,

respectively, receiving gross proceeds of approximately $1.0 million and $3.5

   million.




36

Significant Accounting Policies




Our significant accounting policies are more fully described in Note 1 to our
consolidated financial statements included in our 2019 Annual Report on Form
10-K for the year ended December 31, 2019 filed with the SEC on March 25, 2020.



In June 2016, the FASB issued Accounting Standard Update No. 2016-13, "Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on
Financial Instruments", which modifies the measurement of expected credit losses
on certain financial instruments. The Company will adopt ASU 2016-13 in its
first quarter of 2021 utilizing the modified retrospective transition method.
Based on the composition of the Company's investment portfolio and current
market conditions, the adoption of ASU 2016-13 is not expected to have a
material impact on its consolidated financial statements.



In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement:
Disclosure Framework - Changes to the Disclosure Requirements for Fair Value
Measurement, which adds and modifies certain disclosure requirements for fair
value measurements. Under the new guidance, entities will no longer be required
to disclose the amount of and reasons for transfers between Level 1 and Level 2
of the fair value hierarchy, or valuation processes for Level 3 fair value
measurements. However, public companies will be required to disclose the range
and weighted average of significant unobservable inputs used to develop Level 3
fair value measurements, and related changes in unrealized gains and losses
included in other comprehensive income. This update is effective for annual
periods beginning after December 15, 2019, and interim periods within those
periods, and early adoption is permitted. The adoption of this standard did not
have an impact on the Company's financial statements.



In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740). The
standard simplifies the accounting for incomes taxes by removing certain
exceptions to the general principles in Topic 740 related to the approach for
intra-period tax allocation and the recognition of deferred tax liabilities for
outside basis differences. The standard also clarifies the accounting for
transactions that result in a step-up in the tax basis of goodwill. The standard
also improves consistent application of and simplifies GAAP for other areas of
Topic 740 by clarifying and amending existing guidance. The amendment is
effective for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2020. Early adoption is permitted. The Company is
currently evaluating the impact that the adoption of this standard will have on
its consolidated financial statements.



As a clinical stage biopharmaceutical company, our business and our ability to
execute our strategy to achieve our corporate goals are subject to numerous
risks and uncertainties. Material risks and uncertainties relating to our
business and our industry are described in "Item 1A. Risk Factors" under "Part
II: Other Information" included herein.



37





FINANCIAL REVIEW FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019


Results of Operations



For the three months ended June 30, 2020 our net loss was $5.1 million compared
to a net loss of $2.4 million for the same three-month period of 2019. For the
six months ended June 30, 2020 our net loss was $10.4 million compared to a net
loss of $8.3 million for the same three-month period of 2019.



With $25.5 million in cash, investments, interest receivable and income tax
receivable at June 30, 2020, coupled with future sales of the Company's State of
New Jersey net operating losses well as the remaining availability under the
Capital on Demand Equity Agreement, the Company believes it has sufficient
capital resources to fund its operations through the end of 2021.



                                                         Three Months Ended June 30,
                                             (In thousands)            

Change Increase (Decrease)

                                           2020           2019                                %
Licensing Revenue:                      $      125$      125     $         -                   - %

Operating Expenses:
Clinical Research                            1,481          2,327            (846 )             (36.4 )%
Chemistry, Manufacturing and Controls        1,510          1,231             279                22.7 %
Research and development expenses            2,991          3,558            (567 )             (15.9 )%
General and administrative expenses          1,901          2,137          
 (236 )             (11.0 )%
Total operating expenses                     4,892          5,695            (803 )             (14.1 )%
Loss from operations                    $   (4,767 )$   (5,570 )$       803                14.4 %




                                                          Six Months Ended June 30,
                                             (In thousands)             Change Increase (Decrease)
                                           2020           2019                                %
Licensing Revenue:                      $      250$      250     $         -                   - %

Operating Expenses:
Clinical Research                            3,299          4,107            (808 )             (19.7 )%
Chemistry, Manufacturing and Controls        2,744          2,218             526                23.7 %
Research and development expenses            6,043          6,325            (282 )              (4.5 )%
General and administrative expenses          3,740          4,355          
 (615 )             (14.1 )%
Total operating expenses                     9,783         10,680            (897 )              (8.4 )%
Loss from operations                    $   (9,533 )$  (10,430 )$       897                 8.6 %



Comparison of the Three Months Ended June 30, 2020 and 2019



Licensing Revenue



In January 2013, we entered a technology development contract with Hisun,
pursuant to which Hisun paid us a non-refundable technology transfer fee of $5.0
million to support our development of ThermoDox® in the China territory. The
$5.0 million received as a non-refundable payment from Hisun in the second
quarter 2013 has been recorded to deferred revenue and will be amortized over
the ten-year term of the agreement; therefore, we recorded deferred revenue of
$125,000 in each of the second quarters of 2020 and 2019.



Research and Development Expenses

Research and development ("R&D") expenses decreased by $0.6 million to $3.0
million in the second quarter of 2020 from $3.6 million in the same period of
2019. Costs associated with the OPTIMA Study decreased to $0.6 million in the
second quarter of 2020 compared to $1.2 million in the same period of 2019.
Costs associated the OVATION 2 Study increased to $0.2 million in the second
quarter of 2020 compared to $0.1 million in the same period of 2019. Regulatory
costs were $0.3 million in the second quarter of 2020 compared to $0.4 million
in the same period of 2019. Other clinical costs were consistent at $0.5 million
in the second quarter of 2020 compared to $0.6 million in the same period of
2019. Costs associated with the development of GEN-1 to support the OVATION 2
Study were $0.7 million in the second quarter of 2020 compared to $0.8 million
in the same period of 2019. Production costs associated with the development of
ThermoDox® increased to $0.8 million in the second quarter of 2020 compared to
$0.4 million in the same period of 2019.



38





General and Administrative Expenses

General and administrative expenses decreased to $1.9 million in the second quarter of 2020 compared to $2.1 million in the same period of 2019. This decrease is primarily attributable to lower professional fees in the second quarter of 2020 when compared to the same period of 2019.

Change in Earn-out Milestone Liability and Warrant Expense

The total aggregate purchase price for the acquisition of assets from EGEN
included potential future earn-out payments contingent upon achievement of
certain milestones. The difference between the aggregate $30.4 million in future
earn-out payments and the $13.9 million included in the fair value of the
acquisition consideration at June 20, 2014 was based on the Company's
risk-adjusted assessment of each milestone and utilizing a discount rate based
on the estimated time to achieve the milestone. These milestone payments are
fair valued at the end of each quarter and any change in their value is
recognized in the condensed consolidated financial statements.



On March 28, 2019, the Company and EGWU, Inc, entered into the Amended Asset
Purchase Agreement discussed in Note 8. Pursuant to the Amended Asset Purchase
Agreement, payment of the earnout milestone liability related to the Ovarian
Cancer Indication of $12.4 million has been modified. The Company has the option
to make the payment as follows:



? $7.0 million in cash within 10 business days of achieving the milestone; or

  ? $12.4 million in cash, common stock of the Company, or a combination of
    either, within one year of achieving the milestone.




The Company provided EGWU, Inc. 200,000 warrants to purchase common stock at a
strike price of $0.01 per warrant share as consideration for entering into the
amended agreement. These warrant shares have no expiration and were fair valued
at $2.00 using the closing price of a share of Celsion stock on the date of
issuance offset by the exercise price and recorded as an expense in the income
statement and were classified as equity on the balance sheet.



As of June 30, 2020, and March 31, 2020, the Company fair valued the earn-out
milestone liability at $6.0 million and $5.8 million, respectively and
recognized a non-cash charge of $0.2 million during the second quarter of 2020.
In assessing the earnout milestone liability at June 30, 2020, the Company fair
valued each of the two payment options per the Amended Asset Purchase Agreement
and weighted them at 80% and 20% probability for the $7.0 million and the $12.4
million payments, respectively.



As of June 30, 2019, and March 31, 2019, the Company fair valued the earn-out
milestone liability at $5.9 million and $5.8 million, respectively and
recognized a non-cash charge of $0.1 million during the second quarter of 2019.
In assessing the earnout milestone liability at June 30, 2019, the Company the
fair valued each of the two payment options per the Amended Asset Purchase
Agreement and weighted them at 80% and 20% probability for the $7.0 million and
the $12.4 million payments, respectively.



Investment income and interest expense

The Company realized $0.1 million of investment income from its short-term investments during the second quarter of 2019. Investment income was insignificant in the second quarter of 2020

In connection with the Horizon Credit Agreement, the Company incurred $0.7 million in interest expense in each of the second quarters of 2020 and 2019.

Comparison of the Six Months Ended June 30, 2020 and 2019



Licensing Revenue



In January 2013, we entered a technology development contract with Hisun,
pursuant to which Hisun paid us a non-refundable technology transfer fee of $5.0
million to support our development of ThermoDox® in the China territory. The
$5.0 million received as a non-refundable payment from Hisun in the second
quarter 2013 has been recorded to deferred revenue and will be amortized over
the ten-year term of the agreement; therefore, we recorded deferred revenue of
$250,000 in each of the first halves of 2020 and 2019.



39





Research and Development Expenses

R&D expenses decreased by $0.3 million to $6.0 million in the first half of 2020
from $6.3 million in the same period of 2019. Costs associated with the OPTIMA
Study decreased to $1.3 million in the first half of 2020 compared to $2.1
million in the same period of 2019. Costs associated the OVATION 2 Study
increased to $0.5 million in the first half of 2020 compared to $0.2 million in
the same six-month period of 2019. Regulatory costs were $0.4 million in the
first half of 2020 compared to $0.6 million in the same period of 2019. Other
clinical costs were consistent at $1.1 million in the first half of 2020
compared to $1.2 million in the same period of 2019. Costs associated with the
development of GEN-1 to support the OVATION 2 Study were $1.6 million in the
first half of 2020 compared to $1.5 million in the same period of 2019.
Production costs associated with the development of ThermoDox® increased to $1.1
million in the first half of 2020 compared to $0.7 million in the same period of
2019.


General and Administrative Expenses

General and administrative expenses decreased to $3.7 million in the first half
of 2020 compared to $4.4 million in the same period of 2019. This decrease is
primarily attributable to lower personnel costs and professional fees in the
first six months of 2020 when compared to the same period of 2019.



Change in Earn-out Milestone Liability and Warrant Expense

The total aggregate purchase price for the acquisition of assets from EGEN
included potential future earn-out payments contingent upon achievement of
certain milestones. The difference between the aggregate $30.4 million in future
earn-out payments and the $13.9 million included in the fair value of the
acquisition consideration at June 20, 2014 was based on the Company's
risk-adjusted assessment of each milestone and utilizing a discount rate based
on the estimated time to achieve the milestone. These milestone payments are
fair valued at the end of each quarter and any change in their value is
recognized in the condensed consolidated financial statements.



On March 28, 2019, the Company and EGWU, Inc, entered into the Amended Asset
Purchase Agreement discussed in Note 8. Pursuant to the Amended Asset Purchase
Agreement, payment of the earnout milestone liability related to the Ovarian
Cancer Indication of $12.4 million has been modified. The Company has the option
to make the payment as follows:



? $7.0 million in cash within 10 business days of achieving the milestone; or

  ? $12.4 million in cash, common stock of the Company, or a combination of
    either, within one year of achieving the milestone.




The Company provided EGWU, Inc. 200,000 warrants to purchase common stock at a
strike price of $0.01 per warrant share as consideration for entering into the
amended agreement. These warrant shares have no expiration and were fair valued
at $2.00 using the closing price of a share of Celsion stock on the date of
issuance offset by the exercise price and recorded as an expense in the income
statement and were classified as equity on the balance sheet.



As of June 30, 2020, and December 31, 2019, the Company fair valued the earn-out
milestone liability at $6.0 million and $5.7 million, respectively and
recognized a non-cash charge of $0.3 million during the first half of 2020. In
assessing the earnout milestone liability at June 30, 2020, the Company fair
valued each of the two payment options per the Amended Asset Purchase Agreement
and weighted them at 80% and 20% probability for the $7.0 million and the $12.4
million payments, respectively.



As of June 30, 2019, and December 31, 2018, the Company fair valued the earn-out
milestone liability at $5.9 million and $8.8 million, respectively and
recognized a non-cash benefit of $3.0 million during the first half of 2019. In
assessing the earnout milestone liability at June 30, 2019, the Company the fair
valued each of the two payment options per the Amended Asset Purchase Agreement
and weighted them at 80% and 20% probability for the $7.0 million and the $12.4
million payments, respectively.



40





Investment income and interest expense

The Company realized $0.1 million and $0.3 million of investment income from its short-term investments during the first half of 2020 and 2019, respectively.

In connection with the Horizon Credit Agreement, the Company incurred $0.7 million in interest expense in each of the first halves of 2020 and 2019.

Financial Condition, Liquidity and Capital Resources

Since inception we have incurred significant losses and negative cash flows from
operations. We have financed our operations primarily through the net proceeds
from the sales of equity, credit facilities and amounts received under our
product licensing agreement with Yakult and our technology development agreement
with Hisun. The process of developing and commercializing ThermoDox®, GEN-1 and
other product candidates and technologies requires significant research and
development work and clinical trial studies, as well as significant
manufacturing and process development efforts. We expect these activities,
together with our general and administrative expenses to result in significant
operating losses for the foreseeable future. Our expenses have significantly and
regularly exceeded our revenue, and we had an accumulated deficit of $301
million at June 30, 2020.



At June 30, 2020 we had total current assets of $26.8 million (including cash,
cash equivalents and short-term investments and related interest receivable on
short-term investments of $25.5 million) and current liabilities of $9.2
million, resulting in net working capital of $17.6 million. At December 31, 2019
we had total current assets of $16.2 million (including cash, cash equivalents,
short-term investment, interest receivable of $14.9 million) and current
liabilities of $7.9 million, resulting in net working capital of $8.3 million.
We have substantial future capital requirements to continue our research and
development activities and advance our product candidates through various
development stages. The Company believes these expenditures are essential for
the commercialization of its technologies.



Net cash used in operating activities for the first six months of 2020 was $7.9
million. Net cash provided by investing activities was $5.1 million during the
first six months of 2020. Net cash provided by financing activities was $18.6
million during the first six months of 2020 from net proceeds received through
the sale of our common stock. The Company also received $1.3 million from two
PPP Loans in 2020 pursuant to the CARES Act which have been paid back in full as
of June 30, 2020.



We expect to seek additional capital through further public or private equity
offerings, debt financing, additional strategic alliance and licensing
arrangements, collaborative arrangements, potential sales of our net operating
losses, or some combination of these financing alternatives. If we raise
additional funds through the issuance of equity securities, the percentage
ownership of our stockholders could be significantly diluted, and the newly
issued equity securities may have rights, preferences, or privileges senior to
those of the holders of our common stock. If we raise funds through the issuance
of debt securities, those securities may have rights, preferences, and
privileges senior to those of our common stock. If we seek strategic alliances,
licenses, or other alternative arrangements, such as arrangements with
collaborative partners or others, we may need to relinquish rights to certain of
our existing or future technologies, product candidates, or products we would
otherwise seek to develop or commercialize on our own, or to license the rights
to our technologies, product candidates, or products on terms that are not
favorable to us. The overall status of the economic climate could also result in
the terms of any equity offering, debt financing, or alliance, license, or other
arrangement being even less favorable to us and our stockholders than if the
overall economic climate were stronger. We also will continue to look for
government sponsored research collaborations and grants to help offset future
anticipated losses from operations and, to a lesser extent, interest income.



If adequate funds are not available through either the capital markets,
strategic alliances, collaborators, or sales of our net operating losses, we may
be required to delay or, reduce the scope of, or terminate our research,
development, clinical programs, manufacturing, or commercialization efforts, or
effect additional changes to our facilities or personnel, or obtain funds
through other arrangements that may require us to relinquish some of our assets
or rights to certain of our existing or future technologies, product candidates,
or products on terms not favorable to us.



Off-Balance Sheet Arrangements and Contractual Obligations



None.



41

© Edgar Online, source Glimpses


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Financials (USD)
Sales 2020 0,51 M - -
Net income 2020 -19,8 M - -
Net Debt 2020 - - -
P/E ratio 2020 -0,86x
Yield 2020 -
Capitalization 20,8 M 20,8 M -
Capi. / Sales 2020 41,2x
Capi. / Sales 2021 83,1x
Nbr of Employees 29
Free-Float 98,6%
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Number of Analysts 2
Average target price 4,00 $
Last Close Price 0,57 $
Spread / Highest target 596%
Spread / Average Target 596%
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Managers
NameTitle
Michael H. Tardugno Chairman, President & Chief Executive Officer
Jeffrey Wayne Church CFO, Secretary & SVP-Investor Relations
Nicholas Borys Chief Medical Officer & Senior Vice President
Khursheed Anwer Chief Scientific Officer & Executive VP
Pok Yu Chow Independent Director
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