Full Press Release Details
Corporation Reports 2018 Financial Results
Enters 2019 with a Strong Balance Sheet, Clean Capitalization Structure and an Advancing Clinical Pipeline
to Hold Conference Call on Friday, March 29, 2019 at 11:00 a.m. EDT
N.J., March 29, 2019 - Celsion Corporation (NASDAQ: CLSN), an oncology drug development company,
today announced financial results for the year ended December 31, 2018 and provided an update on its development programs for
ThermoDox , its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12
protein. The Company's lead program is ThermoDox , which is currently in Phase III development for the treatment of
hepatocellular carcinoma (HCC), or primary liver cancer. The Company's immunotherapy candidate, GEN-1, is currently in Phase
I/II development for the localized treatment of ovarian cancer.
had an extraordinary 2018, making meaningful progress with our ongoing development programs for ThermoDox and GEN-1, as well
as strengthening our balance sheet and cleaning up our capitalization structure. Among our many accomplishments, enrollment of
our pivotal 556-patient global Phase III OPTIMA Study in HCC was completed ahead of projections, in August 2018. We are now looking
forward to the first of two preplanned, interim efficacy analyses for the OPTIMA Study expected in the second half of 2019 and
mid-2020, respectively. Our Phase I/II OVATION Study was initiated in the second quarter, as planned. This promising clinical
development program in immunotherapy has generated impressive results. During the first quarter of 2019, we reported final data
from our Phase 1B immunotherapy program (the OVATION I Study) in ovarian cancer. These data showed a significant improvement in
progression-free survival in patients treated per protocol, 100% objective response rate (PR/CR) in patients treated at the two
highest dose cohorts and 88% R0 surgical resection scores in patients treated at the two highest dose cohorts," said Michael
H. Tardugno, Celsion's chairman, president and chief executive officer. "Entering 2019 with more than $27.7 million
in cash and investments, we are well positioned with sound fundamentals, the right resources, and a sound capital structure sufficient
to see our clinical programs through transformative milestones, and in doing so create significant value for our shareholders,
patients and the medical community."
Monitoring Committee (DMC) Completed its Planned Safety and Data Review of Celsion's Phase III OPTIMA Study. On
December 18, 2018, the Company announced that the independent Data Monitoring Committee (DMC) for the Company's pivotal
Phase III OPTIMA Study unanimously recommended that the study continue according to protocol to its data readout. The DMC's
evaluation and recommendation were based on the Committee's assessment of safety and data integrity for all 556 patients
enrolled in the multinational, double-blind, placebo-controlled trial as of October 4, 2018.
DMC review analyzed blinded data from the intent-to-treat population, consolidated for both arms, which showed that median PFS
for the OPTIMA Study had reached 21.2 months as of October 4, 2018. These blinded, consolidated data continue to compare favorably
to the HEAT Study median PFS of 13.8 months (all 701 patients) and 16.8 months (for the 285 patients in the subgroup of patients
treated with RFA > 45 minutes) and remain consistent with our projections based on protocol enhancements informed by the HEAT
Study results and the HEAT Study post-hoc analysis subgroup, the same patient population that the current Phase III pivotal study
design was built on.
DMC consists of an independent group of medical and scientific experts responsible for reviewing and evaluating patient safety
and efficacy data for the Company's Phase III OPTIMA Study. The DMC reviews study data at regular intervals in order to
ensure the safety of all patients enrolled in the trial and to monitor the quality and overall conduct of the trial, including
each site's compliance with the study protocol. The OPTIMA Study's design and statistical plan incorporates two pre-planned
interim efficacy analyses by the DMC with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming
evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.
of ThermoDox Study Results in the Peer-Reviewed Journal, Radiology. On January 19, 2019, the Company announced that
results from the Phase I TARDOX trial of ThermoDox conducted at the University of Oxford, United Kingdom,
were published in the peer-reviewed journal, Radiology. The findings published in Radiology serve as a companion
paper to the groundbreaking work published in Lancet Oncology in July 2018. This was the first published study to evaluate
ThermoDox when combined with high-intensity focused ultrasound (HIFU). The Radiology publication was accompanied by
an editorial highlighting the significance of utilizing HIFU to safely deliver oncologically relevant volumes of doxorubicin with
article, titled, "Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from
a Phase I Trial," included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox
plus targeted, non-invasive ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific
Phase I TARDOX study was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of
Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust and
evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial,
10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox , and ultrasonic heating of
target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated
without real-time thermometry. Safety was assessed by analysis of magnetic resonance imaging (MRI) and biopsy specimens for evidence
of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects,
including thermal ablation.
Phase I TARDOX study demonstrated that focused ultrasound exposure with ThermoDox resulted in increased
chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10
patients in the study.
of GEN-1 Clinical Development Program at ASCO-SITC Clinical Immuno-Oncology Symposium. On March 4, 2019, the Company announced
the oral presentation of data highlighting the safety, clinical response and translational data from the OVATION I Study by Premal
H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology
at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis at the ASCO-SITC Clinical Immuno-Oncology
Thaker's presentation highlighted the following:
| GEN-1 is a novel new approach designed to deploy the anti-cancer mechanism of the potent, broad-spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein. | ||
| The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 (36 mg/m 2 , 47 mg/m 2 , 61 mg/m 2 and 79 mg/m 2 ) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NAC) prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median PFS of 21 months in patients treated per protocol (n=14) and 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, each of which compared favorably to the PFS historical average of 12 months for women with Stage III/IV ovarian cancer. |
| Patients in the two higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. 100% of patients treated at the highest dose cohort had a complete R0 resection. | ||
| Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 - an outcome not previously observed with NAC treatment alone. |
| Pathological changes were assessed as part of the study, with the density of markers measured in tissue sections assessed via immunohistochemistry staining. Among patients administered the high doses of GEN-1 (n=8), pre-treatment to post-treatment reductions in key biomarkers were observed (FoxP3 -62.5%; IDO-1 -60%; PD-1 -62.5%; PD-L1 -37.5%). Reductions were also observed in patients administered the lower doses of GEN-1 (n=4) for all but one of the four key biomarkers (FoxP3 -40%; IDO-1 -40%; PD-1 +25%; PD-L1 -37.5%). The ratio of CD8+ cells to the four key immunosuppressive cell signals increased following treatment in 60 - 80% of patients. | ||
| The study showed no serious systemic toxicities. Dose-limiting toxicity was not reached in the OVATION I Study. The most common adverse events attributed to GEN-1 in the OVATION I Study were nausea, abdominal pain/cramping, fatigue, vomiting, diarrhea and neutropenia. |
Signs Amendment to its June 6, 2014 Asset Purchase Agreement with EGEN, Inc. On March 28, 2019, the Company entered into an
amendment to the June 6, 2014 Asset Purchase Agreement for the acquisition of substantially all of the assets of EGEN, Inc. The
Amendment provides that payment of the $12.4 million earnout milestone liability under the Asset Purchase Agreement related to
the Ovarian Cancer Indication can be made, at the Company's sole discretion, in the following manner:
| a) | $7.0 million in cash to EGWU within 10 business days of achieving the milestone; or | |
| b) | $12.4 million to EGWU, which is payable in cash, common stock of the Company, or a combination of either, within one year after achieving the milestone. |
the Amendment extends the Earnout Term as it applies to the Ovarian Cancer Milestone from seven (7) years to eight (8) years from
the original signing date of the Asset Purchase Agreement. As consideration for entering into the Amendment, the Company will
issue to EGWU 200,000 warrants to purchase common stock with an exercise price of $0.01 per share. The Company will record this
transaction in the first quarter of 2019.
Received $11.1 Million Allocation Through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program and State
NOLs for the Tax Years 2011 to 2017 Approved. In December 2018, the Company announced it received approval from the New
Jersey Economic Development Authority's (NJEDA) Technology Business Tax Certificate Transfer (NOL) program to sell $11.1
million of its unused New Jersey NOLs for the tax years 2011 through 2017. The Company sold these New Jersey State NOLs to a qualified
company with operations in New Jersey and received $10.4 million of net cash proceeds prior to the end of 2018.
of Warrant Overhang. In October 2018, the Company and certain investors holding warrants to collectively purchase 1.64 million
shares of the Company's common stock, which were granted in the February 2017 Public Offering and the October 2017 Underwritten
Offering, entered into warrant exchange agreements whereby the Company issued 820,714 shares of its common stock in exchange for
the termination of the warrants. The Company exchanged 0.5 share of common stock for each of 1.64 million warrants with exercise
prices between $3.00 per share and $3.22 per share. Doing so, the Company eliminated the warrant overhang on its share price and
the potential to use these warrants as a vehicle to hedge a short position. As of December 31, 2018, the Company has 18.8 million
shares outstanding and 1.6 million warrants outstanding, of which 1.2 million of these outstanding warrants have an exercise price
over $6.00 per share and will expire in early April 2019.
the year ended December 31, 2018, Celsion reported a net loss attributable to common shareholders of $11.9 million ($0.68 per
share) compared to a net loss of $20.7 million ($2.72 per share) for the year ended December 31, 2017. Operating expenses were
$21.6 million for the year ended December 31, 2018, which represented a $2.6 million or 14% increase, from $19.0 million in the
same period of 2017. During 2018, the Company incurred $4.6 million in non-cash stock option expense compared to $1.3 million
in the comparable prior-year period.
cash used for operating activities was $7.0 million for the year ended December 31, 2018, compared to $16.6 million in the prior
year. Cash and cash equivalents at December 31, 2018 were $27.7 million. Total cash provided by financing activities was approximately
$11 million during 2018 which included $10 million in gross proceeds from the Company's venture debt facility completed
on June 27, 2018 with Horizon Technology Finance Corporation (Horizon) and $1 million in net proceeds from sales of common stock.
In addition, the Company received $10.4 million in non-dilutive capital from the sale of its New Jersey state NOLs in the fourth