Inovio Pharmaceuticals, Inc. Form 8-K (Sept. 25, 2020)

Summary

Form 8-K current report of Inovio Pharmaceuticals, Inc. dated September 25, 2020, filed under Item 8.01 (Other Events). It reports that after the close of trading on the Nasdaq on September 25, 2020, the FDA notified the company that its planned Phase 2/3 trial of the COVID-19 vaccine candidate INO-4800 is on partial clinical hold pending resolution of items the FDA identified. The company may not run that trial until it submits the required information and the FDA says it may begin, but it may continue its expanded Phase 1 trial. A press release of September 28, 2020 announcing the hold is filed as Exhibit 99.1.

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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)

Delaware | 001-14888 | 33-0969592
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.)

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:

☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class | Trading Symbol(s) | Name of each exchange on which registered
Common Stock, $0.001 par value | INO | The Nasdaq Stock Market LLC

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. ☐

Item 8.01 | Other Events.

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 | Financial Statements and Exhibits.
Exhibit No. | Exhibit Description
99.1 | Press Release, dated September 28, 2020.
104 | Cover page interactive data file (embedded within the Inline XBRL document).

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.

INOVIO PHARMACEUTICALS, INC.
Date: September 28, 2020 | By: | /s/ Peter Kies
Peter Kies
Chief Financial Officer

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Original

www.sec.gov

Exhibits

Exhibit 99.1: Inovio Pharmaceuticals, Inc., "INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2/3 Trial of COVID-19 Vaccine Candidate INO-4800"