Current Report Filing (8-k)
September 28 2020 - 5:29PM
Edgar (US Regulatory)
false 0001055726 0001055726 2020-09-25 2020-09-25
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): September 25, 2020
Inovio Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-14888
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33-0969592
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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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660 W. Germantown Pike, Suite 110
Plymouth Meeting, PA 19462
(Address of principal executive offices, including zip code)
(267) 440-4200
(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:
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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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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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:
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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, $0.001 par value
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INO
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The Nasdaq Stock Market LLC
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Indicate by check mark whether the registrant is an emerging growth company 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. ☐
After the close of trading on the Nasdaq on September 25, 2020, Inovio Pharmaceuticals, Inc. (the “Company”) received notification from the U.S. Food and Drug Administration (the “FDA”) that the Company’s planned Phase 2/3 clinical trial of its COVID-19 vaccine candidate, INO-4800, is on partial clinical hold pending resolution of certain items identified by the FDA. The Company may not conduct the planned Phase 2/3 trial until it has submitted the required information to the FDA and the FDA notifies the Company that it may initiate the trial. The Company may continue its ongoing, expanded Phase 1 clinical trial of INO-4800 as previously authorized.
On September 28, 2020, the Company issued a press release announcing the partial clinical hold. A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report.
Item 9.01
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Financial Statements and Exhibits.
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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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INOVIO PHARMACEUTICALS, INC.
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Date: September 28, 2020
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By:
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/s/ Peter Kies
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Peter Kies
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Chief Financial Officer
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