Full Press Release Details
Corporation Reports First Quarter 2019 Financial Results and Provides Business Update
to Hold Conference Call on Wednesday, May 15, 2019 at 11:00 a.m. EDT
N.J., May 15, 2019 - Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced
financial results for the quarter ended March 31, 2019 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 newly diagnosed Stage III/IV ovarian cancer.
continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1.
With sound fundamentals and a strong balance sheet, we are well positioned to see our clinical programs through transformative
milestones over the next year. We are looking forward to the first of two preplanned, interim efficacy analyses for the Phase
III OPTIMA Study expected in the second half of 2019 and mid-2020, respectively. This global, pivotal study completed patient
enrollment in August 2018 at over 65 clinical sites in 14 different countries, including all of the markets where primary liver
cancer is a major problem," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "Our
Phase I/II OVATION 2 Study in newly diagnosed ovarian cancer is now recruiting patients and continues to work through the activation
of up to 31 clinical sites by the end of this year. Importantly, enrollment of patients in the Phase I portion of the study is
expected to be complete and initial data reported by the end of 2019. This promising clinical development program in immunotherapy
has generated impressive results in previous trials."
of New U.S. Patent for ThermoDox . On April 17, 2019, the Company announced that the United States Patent
and Trademark Office granted U.S. Patent No. 10,251,901 B2 - Thermosensitive Nanoparticle Formulations and Method of
Making the Same, which is directly applicable to the method of treating cancer using a new ThermoDox formulation.
The claim covers a method for preparing (as well as the composition of) a doxorubicin sulfate temperature-sensitive liposome and
extends coverage time over ThermoDox's current patent portfolio to 2033. This new patent broadens our intellectual property
portfolio providing for life cycle management of ThermoDox well into the future.
of ThermoDox Study Results in the Peer-Reviewed Journal, Radiology. On January 17, 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 concentrations of doxorubicin
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 modeling.
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. The 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.
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.
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:
| 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. | ||
| Of the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses. | ||
| 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. |
Participated in Two Investor Conferences. During May 2019, the Company attended the
ThinkEquity Conference on May 2, 2019 at The Mandarin Oriental Hotel in New York City and the Deutsche Bank 44th Annual
Health Care Conference on May 7-8, 2019 at The InterContinental Hotel in Boston. A webcast of Celsion's presentation at
the ThinkEquity Conference may be accessed by visiting the "News & Investors" section of Celsion's corporate
website. The format of the Deutsche Bank Health Care Conference was comprised of one-on-one and small group meetings with leading
institutional investors.
Completed an Amendment to the 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 recorded this transaction
in the first quarter of 2019.
the quarter ended March 31, 2019, Celsion reported a net loss of $2.3 million ($0.12 per share) compared to a net loss of $4.5
million ($0.25 per share) for the quarter ended March 31, 2018. Operating expenses were $5.0 million for the quarter ended March
31, 2019, which represented a $0.6 million (13.6%) increase, from $4.4 million in the same period of 2018. During the first quarter
of 2019, the Company incurred $0.7 million in non-cash stock option expense compared to $0.2 million in the comparable prior-year
cash equivalents, short-term investments and interest receivable at March 31, 2019 was $23.8 million. Cash provided by financing
activities was approximately $1.8 million during the quarter ended March 31, 2019. Net cash used for operating activities was
$5.5 million for the quarter ended March 31, 2019, compared to $4.6 million in the comparable prior-year period.
and development costs were $2.8 million for the quarter ended March 31, 2019 compared to $2.7 million for the quarter ended March
31, 2018. Clinical development costs for the Phase III OPTIMA Study were $0.9 million for the current quarter compared to $1.3
million for the same period of 2018. This $0.4 million decrease resulted from the completion of enrollment for this 556-patient
trial in August 2018. Costs associated with the OVATION studies were $0.1 million for each of the quarters ended March 31, 2019
and 2018. The Company announced the completion of enrollment of all cohorts of the OVATION I Study in 2017 and the initiation
of the follow-on Phase I/II OVATION 2 Study during 2018. Costs associated with Celsion's wholly-owned subsidiary, CLSN Laboratories,
Inc. (which includes research and development activities for GEN-1, TheraPlas and TheraSilence) were $0.6 million in each of the
quarters ended March 31, 2019 and 2018 as the Company continues to expand its manufacturing capabilities and implemented programs
to reduce manufacturing costs for GEN-1. In the first quarter of 2019, other clinical costs included an increase of $0.2 million
in non-cash stock compensation expense compared to the same period of 2018.
and administrative expenses were $2.2 million for the quarter ended March 31, 2019, compared to $1.7 million for the quarter ended
March 31, 2018. This $0.5 million increase was due to higher compensation expenses totaling $0.5 million in 2019 compared to 2018.
Compensation expenses include costs associated with new personnel additions as well as an increase of $0.3 million related to
non-cash stock option compensation expense in 2019 compared to the prior year.
expenses included a non-cash gain of $2.7 million, net of charge a $0.4 million for the 200,000 warrant issuance related to an
amendment for the potential milestone payments for the GEN-1 ovarian product candidate during the quarter ended March 31, 2019,
compared to a non-cash charge of $270,000 for the quarter ended March 31, 2018. The Company realized $0.1 million of interest
income from its short-term investments during the first quarter of 2019 and 2018. In connection with the Company's new venture
debt facility with Horizon in June 2018, the Company incurred interest expense of $0.4 million during the first quarter of 2019
compared to no interest expense in the first quarter of 2018.
Quarter Conference Call
Company is hosting a conference call to provide a business update and discuss its first quarter 2019 financial results at 11:00
a.m. EDT on Wednesday, May 15, 2019. To participate in the call, interested parties may dial 1-800-263-0877 (Toll-Free/North America)
or 1-646-828-8143 (International/Toll) and ask for the Celsion Corporation First Quarter 2019 Earnings Call (Conference Code:
1231968) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at
www.celsion.com. The call will be archived for replay on Wednesday, May 15, 2019 and will remain available until May 29,
2019. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 1231968. An audio replay of the call