Current Report Filing (8-k)
July 13 2020 - 9:02AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 13, 2020 (July 9, 2020)
CELSION
CORPORATION
(Exact
name of registrant as specified in its Charter)
Delaware
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001-15911
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52-1256615
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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997
Lenox Drive, Suite 100, Lawrenceville, NJ
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08648-2311
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(Address
of principal executive offices)
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(Zip
Code)
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(609)
896-9100
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act
Title
of each class
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Trading
symbol(s)
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Name
of each exchange on which registered
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Common
stock, par value $0.01 per share
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CLSN
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Nasdaq
Capital Market
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Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act
of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company [ ]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item
8.01 Other Events
On
July 13, 2020, Celsion Corporation (the “Company”) issued a press release announcing that it had received a recommendation
from the independent Data Monitoring Committee (the “DMC”) to consider stopping the Phase III OPTIMA Study
of ThermoDox® in combination with radiofrequency ablation for the treatment of hepatocellular carcinoma, or primary liver
cancer (the “Study”). As further described below and in the press release, this recommendation is based on
the July 9, 2020 pre-planned interim safety and efficacy analysis conducted by the DMC.
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 to stop the OPTIMA
Study to Celsion. There were no safety concerns noted during the interim analysis. A copy of the press release is attached
hereto as Exhibit 99.1, and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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CELSION
CORPORATION
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Dated:
July 13, 2020
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By:
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/s/
Jeffrey W. Church
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Jeffrey
W. Church
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Executive
Vice President and Chief Financial Officer
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