Celsion Corporation (NASDAQ: CLSN), an oncology
drug development company, today provided an update on the OVATION 2
Study with GEN-1 in advanced ovarian cancer patients. Celsion also
announced it has entered into 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), a Chicago-based institutional investor.
Stock Purchase Agreement
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 current market price.
Under the terms of the new purchase agreement
with LPC, Celsion 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. Celsion may terminate
the purchase agreement at any time, at its discretion, without any
cost or penalty. In consideration for LPC entering into the
purchase agreement, Celsion issued shares of its common stock to
LPC as a fee for LPC’s obligation to purchase shares at the
Company’s discretion. “The LPC financing, along with the
anticipated sale of New Jersey net operating losses later this
year, the repayment and restructure of our long-term debt with
Horizon announced last week and our current cash position of
approximately $20 million, will help us reach a number of
value-rich events including full enrollment of the OVATION 2
Study,” said Michael H. Tardugno, Celsion’s chairman, president and
chief executive officer. “These funds will also allow us to
complete the definitive analysis of the OPTIMA Study, our Phase III
trial with ThermoDox™ in primary liver cancer. We continue to
follow patients for overall survival, and to compile data and CT
scans to submit to the National Institutes of Health for their
review and perspective,” Mr. Tardugno added.
Celsion intends to use any net proceeds from the
sale of its common stock to LPC to advance its product pipeline and
for general corporate purposes. Additional information regarding
the purchase agreement with LPC is available in the Current Report
on Form 8-K that Celsion will file with the Securities and Exchange
Commission.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy any shares of common
stock, nor shall there be any sale of shares of common stock in any
state or jurisdiction in which such an offer, solicitation or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or other jurisdiction.
OPTIMA Study Update
Celsion continues to follow patients for overall
survival (OS) in its Phase III study of ThermoDox for newly
diagnosed hepatocellular carcinoma (HCC) patients, 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. The Company has
hired independent statisticians to further evaluate the trial data,
the statistical plan, and the hypothesis generating data from the
earlier HEAT Study, as well as, supplying data to the NIH for
independent analysis and recommendation. The Company expects to
announce its plans for the OPTIMA Study before year end.
OVATION 2 Study Update
Enrollment in the Phase II portion of the Phase
I/II OVATION 2 Study has been accelerated with 22 patients enrolled
thus far at 13 sites in the U.S. The Company expects 12 additional
sites in the U.S. and Canada to begin enrolling patients by the end
of the year, and now expects full enrollment of 118 patients to be
completed by the end of the second quarter of 2021, a full quarter
earlier than previously anticipated.
GEN-1 was designed using TheraPlas, Celsion's
proprietary, synthetic, non-viral nanoparticle delivery system
platform. It is an interleukin-12 (IL-12) DNA plasmid vector
associated with a non-viral nanoparticle delivery system, which
enables cell transfection followed by persistent, local secretion
of the IL-12 protein.
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 cancer 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
overall survival. 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).
Celsion has received definite confirmation from the U.S. Food and
Drug Administration (FDA) that PFS may be used as a surrogate
endpoint for overall survival.
Because OVATION 2 is an open-label study, the
Company intends to provide clinical updates throughout the course
of treatment, including response rates and surgical resection
scores.
Dr. Nicolas Borys, Celsion’s chief medical
officer, said, “We are pleased with the pace of enrollment in this
trial, and attribute the high level of interest among investigators
and patients to the impressive data generated from prior studies.
In particular, data from the Phase I portion of the OVATION 2 Study
that showed successful tumor resections, with seven out of eight
patients (87.5%) in the GEN-1 treatment arm 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. The NACT-only treatment arm had an R0 resection rate of
50%.”
“In addition, investigators have expressed
confidence in the role of IL-12 and GEN-1’s safety profile. The
Data Safety Monitoring Board recommended that the Phase II portion
of the OVATION 2 Study proceed with a GEN-1 dose of 100 mg/m², and
with more than 17 doses over more than six-months of treatment. We
look forward to providing tumor response data and surgical results
as they become available throughout the course of treatment. In
addition, we believe that PFS as an endpoint bodes well for study
success,” Dr. Borys added.
About Lincoln Park Capital Fund,
LLC
LPC is a long-only institutional investor
headquartered in Chicago, Illinois. LPC’s experienced professionals
manage a portfolio of investments in public and private entities.
These investments are in a wide range of companies and industries
emphasizing life sciences and technology. LPC’s investments range
from multi-year financial commitments to fund growth to special
situation financings to long-term strategic capital offering
companies’ flexibility and consistency. For more information,
please visit www.lpcfunds.com.
About Celsion
Corporation
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. For
more information on Celsion, visit: http://www.celsion.com.
(CLSN-FIN).
Forward-looking Statements
Celsion wishes to inform readers that
forward-looking statements in this release are made pursuant to the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, Celsion's intended use of proceeds, the amount and
prices of any such sales under the agreement, unforeseen changes in
the course of research and development activities and in clinical
trials; the uncertainties of and difficulties in analyzing interim
clinical data; the significant expense, time, and risk of failure
of conducting clinical trials; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors, regulatory authorities; and
other risks detailed from time to time in Celsion's periodic
reports and prospectuses filed with the Securities and Exchange
Commission. Celsion assumes no obligation to update or supplement
forward-looking statements that become untrue because of subsequent
events, new information or otherwise.
Celsion Investor ContactJeffrey
W. ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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