Current Report Filing (8-k)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): March 21, 2022

PROVENTION BIO, INC.

Commission File Number: 001-38552

Delaware

81-5245912

(State or other jurisdiction

of incorporation)

(IRS Employer
Identification No.)

55 Broad Street, 2nd Floor

Red Bank, New Jersey

07701

(Address of principal executive offices)

(Zip Code)

(908) 336-0360

(Registrant’s telephone number, including area code)

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		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		PRVB		The Nasdaq Global Select Market

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 7.01

Regulation FD Disclosure.

On March 21, 2022, Provention Bio, Inc. (the “Company”) issued a press release related to its Biologics License Application (“BLA”) resubmission for teplizumab and the U.S. Food & Drug Administration’s (“FDA”) communication to the Company that the FDA (i) considers this a complete, class 2 response to FDA’s July 2, 2021 action letter and (ii) has assigned a user fee goal date of August 17, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this report furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.

Item 8.01

Other Events

The Company announced the FDA communication to the Company related to its BLA resubmission for teplizumab stating that the FDA (i) considers this a complete, class 2 response to FDA’s July 2, 2021 action letter and (ii) has assigned a user fee goal date of August 17, 2022.

Item 9.01

Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

Exhibit No.		Description

99.1		Press Release issued by Provention Bio, Inc. on March 21, 2022
104		Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

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.