Full Press Release Details
Corporation Reports Third Quarter 2020 Financial Results and Provides Business Update
Phase II OVATION 2 Study of GEN-1 in Advanced Ovarian Cancer
Following Patients for Overall Survival in Phase III OPTIMA Study
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (November 16, 2020) - Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today
announced financial results for the three and nine months ended September 30, 2020, and provided an update on clinical development
programs with GEN-1, its DNA-mediated IL-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian
cancer, and ThermoDox , its proprietary heat-activated liposomal encapsulation of doxorubicin currently in Phase III development
for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer.
OVATION 2 Study with our GEN-1 immunotherapy continues recruitment into the 100 mg/m² dose cohort," said Michael H.
Tardugno, Celsion's chairman, president and chief executive officer. "This study is based on encouraging results from
our Phase Ib OVATION 1 Study in advanced ovarian cancer. In June 2020, the Data Safety Monitoring Board (DSMB) for the OVATION
2 Study recommended that the Phase II portion proceed with the dose of 100 mg/m2,
and in July 2020, we announced the randomization of the first two patients in this portion of the Study. This milestone
was achieved approximately five months ahead of our previously announced schedule. We have a very aggressive recruitment program
in place and anticipate completing enrollment of approximately 110 patients in the second or third quarter of 2021. Importantly,
as an open-label study, clinical updates will be provided throughout the course of treatment, including response rates and surgical
resection scores," Mr. Tardugno added.
his comments, Mr. Tardugno noted, "Since the DMC's finding that the OPTIMA Study
crossed the futility boundary, albeit with substantial uncertainty, and leaving the decision to terminate the Study up to the
Company, we have determined to continue following patients for overall survival (OS)
until such time as futility is either confirmed or dispelled."
Tardugno added, "As promised, Celsion has engaged a global biometrics contract research organization (CRO), with forensic
statistical analysis capability that specializes in data management, statistical consulting, statistical analysis and data sciences.
They have particular expertise in evaluating unusual data from clinical trials, and experience with associated regulatory issues.
The primary objective of the CRO's work is to determine the basis and reasoning behind continuing to follow patients for
OS. Also as promised, and in parallel, the Company has submitted all OPTIMA Study clinical trial data to the National Institutes
of Health (NIH) for an independent evaluation using a Cox Regression Analysis for minimum burn time per tumor volume. This evaluation
is similar to the hypothesis generated from the NIH paper published in the Journal of Vascular and Interventional Radiology."
conclusion, Mr. Tardugno stated, "Celsion feels strongly that we owe it to patients, physicians and our investors to continue
examining the data from the OPTIMA Study, particularly given how surprising the recommendation was to Celsion from the DMC. While
the trial outcome as predicted by the second interim analysis may not change, and as unlikely as it may be, in the event we see
substantial clinical benefit from the CRO and NIH analyses, we will carefully review our options with the 14 regulatory agencies
under which the OPTIMA Study is being conducted. We expect to report findings from these independent analyses before the end of
the year, either or both of which will guide our decision to continue to follow patients to the final analysis at 197 or more
deaths, a milestone we expect to be reached in mid-2021."
of Phase II OVATION 2 Study in Advanced Ovarian Cancer. In July 2020, the Company announced
the randomization of the first two patients in the Phase II portion of the OVATION 2 Study with GEN-1 in advanced ovarian cancer.
The Company anticipates completing enrollment of up to 118 patients in mid-summer 2021. Because this is an open-label study, clinical
updates will be provided throughout the course of treatment including response rates and surgical resection scores. The OVATION
2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian
cancer. NACT is designed to shrink the tumor as much as possible for optimal surgical removal after three cycles of chemotherapy.
Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine
additional weekly GEN-1 treatments, the goal of which is to delay progression and improve OS. The OVATION 2 Study is an open-label,
1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75),
the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).
in Phase III OPTIMA Study Continue to be Followed for Overall Survival. In August 2020, the Company provided an update
on its ongoing review of unblinded data from the second pre-planned interim analysis of the global Phase III OPTIMA Study. The
Company announced it will continue following patients for 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.
from the Independent DMC to Consider Stopping the Phase III OPTIMA Study of ThermoDox in Primary Liver Cancer. In
July 2020, the Company announced that it received a recommendation from the independent DMC to consider stopping the global Phase
III 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 p-value of 0.524 for this analysis provides uncertainty. The DMC 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.
statistical plan for the OPTIMA Study included two interim efficacy analyses by the DMC. The first interim analysis was announced
in November 2019 following data lock in August 2019 after the prescribed minimum number of 128 patient events (deaths) was reached,
and the second interim analysis was conducted on July 9, 2020 following data lock in April 2020 after the prescribed minimum number
of 158 events was reached.
Common Stock Purchase Agreement with Lincoln Park Capital. In September 2020, the Company announced a common stock purchase
agreement for the issuance and sale, from time to time, of up to $26 million of shares of common stock with Lincoln
Park Capital Fund, LLC (LPC). In connection with the execution of the purchase agreement,
LPC made an initial purchase of $1 million of common stock at $1.00 per share, representing a significant premium to the
then-current market price. Under the terms of the new purchase agreement with LPC, the Company has the right at its sole discretion,
but not the obligation, to sell to LPC up to $26 million worth of shares (including the $1 million initially purchased) over the
36-month term of the agreement, subject to certain conditions. There are no upper limits to the price per share LPC may pay to
purchase the shares, and the purchase price of the shares will be based on the prevailing market prices at the time of each sale
to LPC. Celsion controls the timing and amount of any future sales of its stock to LPC. There are no warrants, derivatives, financial
or business covenants associated with the agreement, and LPC has agreed not to cause or engage in any direct or indirect short
selling or hedging of Celsion's common stock.
Loan Facility with Horizon Technology Finance Corporation Restructured. In September 2020, the Company announced
an amendment to its $10 million loan agreement with Horizon Technology Finance Corporation. Consistent with its target to leverage
equity capital, the Company elected to reduce its outstanding debt under the loan by $5 million and restructure the terms of the
remaining $5 million loan balance. The Company's restructured $5 million loan is in the form of secured indebtedness bearing
interest at a LIBOR-based variable rate. Payments under the loan agreement are interest only for the first 12 months through July
2021, followed by a 21-month amortization period of principal and interest through the scheduled maturity date of April 2023.
In conjunction with the amended loan agreement, Celsion issued to Horizon warrants exercisable for 247,525 shares of Celsion's
common stock at an exercise price of $1.01 per share. Warrants previously issued to Horizon exercisable for 95,057 shares at an
exercise price of $2.63 per share were cancelled.
Quarter Financial Results
the quarter ended September 30, 2020, Celsion reported a net loss of $8.1 million ($0.24 per share), compared with $5.5 million
($0.25 per share) in the same period of 2019.
and development expenses decreased $1.2 million to $2.5 million in the third quarter of 2020, compared with $3.7 million in the
third quarter of 2019. Clinical development costs for the Phase III OPTIMA Study decreased $0.7 million to $0.5 million in
the third quarter of 2020, compared with $1.2 million in the third quarter of 2019, due to the completion of enrollment in this
556-patient trial in August 2018. Costs associated with the OVATION 2 Study were $0.2 million in each of the third quarters of
2020 and 2019. Other costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development
programs decreased to $1.3 million in the current quarter from $1.4 million in the third quarter of 2019, largely driven by lower
regulatory costs for ThermoDox . General and administrative expenses were $1.8 million in each of the third quarters of 2020
expenses were $4.3 million in the third quarter of 2020, which represented a $1.2 million (21.8%) decrease from $5.5 million in
the same period of 2019. These lower operating expenses were offset by the following non-operating expenses: (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; and (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 GBM cancer product candidate.
connection with the Company's venture debt facility with Horizon entered in late June 2018, the Company repaid $5.0 million
of the loan and restructured the remaining $5.0 million for one-year interest only payments and 21-month payback period thereafter.
The Company incurred interest expense of $0.5 million during the third quarter of 2020. This compares with interest expense of
$0.3 million in the comparable prior-year period.
Company ended the third quarter of 2020 with $18.3 million in cash and cash equivalents. Coupled with future planned sales