UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

WASHINGTON,
D.C. 20549








FORM
10-K/A

(Amendment
No. 2)



[X]
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



FOR
THE FISCAL YEAR ENDED DECEMBER 31, 2019



OR



[  ]
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



FOR
THE TRANSITION PERIOD FROM ___TO __.



Commission
file number 001-38552








PROVENTION
BIO, INC.

(Exact
name of registrant as specified in its charter)



|Delaware                                                                                                                |  | 81-5245912                                                                                   
|----------------------------------------------------------------------------------------------------------------------- |  | ---------------------------------------------------------------------------------------------
|(State
                                         or other jurisdiction of
        incorporation
        or organization) |  | (I.R.S.
                                         Employer
        Identification
        No.)



P.O.
Box 666 Oldwick, New Jersey 08858

(Address
of registrant’s principal executive offices)



(908)
336-0360

(Registrant’s
telephone number, including area code)



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
    Shares, $0.001 par value |  | PRVB                  |  | The
    Nasdaq Global Select Market          



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

None








Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [  ]
No [X].



Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [  ]
No [X].



Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes [X]. No [  ].



Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files).Yes [X]. No [  ].



Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:



| | Large
    accelerated filer [  ] |  | Accelerated
    filer [X]         | 
| | -------------------------------- |  | --------------------------------- | 
| | Non-accelerated
    filer [  ]   |  | Smaller
    reporting company [X] | 
| |                                  |  | Emerging
    growth company [X]   | 



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. [  ]



Indicate
by check mark whether the registrant is a shell company (as defined in 12b-2 of the Act). Yes [  ] No [X].



The
aggregate market value of the common stock held by non-affiliates of the Registrant as of June 28, 2019, the last business day
of the Registrant’s last completed second quarter, based upon the closing price of the common stock as reported by The Nasdaq
Capital Market on such date was approximately $387.8 million.



On
April 1, 2020, there were 47,712,636 shares of the registrant’s common stock, $0.0001 par value, outstanding.



DOCUMENTS
INCORPORATED BY REFERENCE:



None.
















EXPLANATORY
NOTE



This
Amendment No. 2 on Form 10-K/A (this “Amendment No. 2”) amends the Annual Report on Form 10-K for the fiscal year
ended December 31, 2019 (the “2019 Annual Report”) of Provention Bio, Inc. filed with the Securities and Exchange
Commission (“SEC”) on March 12, 2020, as amended by Amendment No. 1 to the 2019 Annual Report filed with the SEC on
April 8, 2020. In this Amendment No. 2, unless the context indicates otherwise, the designations “Provention Bio,”
the “Company,” “we,” “us” or “our” refer to Provention Bio, Inc.



This
Amendment No. 2 is being filed solely to include revised Exhibits 31.1 and 31.2, which replace the previously filed versions of
those exhibits, to include certain statements required by Item 601(b)(31) of Regulation S-K in the introductory portion of paragraph
4, inadvertently omitted by the Company when previously filed. This Amendment consists solely of the preceding cover page, this
explanatory note, the exhibit index, signature page and paragraphs 1, 2, 4 and 5 of each of the revised certifications filed as
exhibits to this Amendment No. 2. Because no financial statements are included with this Amendment, paragraph 3 of such certifications
has been omitted.



Except
as described above, no other amendments are being made to the Annual Report. This Amendment No. 2 does not reflect events occurring
after the March 12, 2020 filing of the 2019 Annual Report or modify or update the disclosure contained in the 2019 Annual Report
in any way other than as required to reflect the amendments discussed above and reflected below. Accordingly, this Amendment No.
2 should be read in conjunction with the 2019 Annual Report and our other filings with the SEC.











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 thereunto duly authorized.



|                         | Registrant:                                                                                                                          
|------------------------ | -------------------------------------------------------------------------------------------------------------------------------------
|                         |                                                                                                                                      
|                         | Provention
    Bio, Inc.                                                                                                             
|                         |                                                                                                                                      
|Date:
    August 6, 2020 | By:                                                                                                                                  
|                         | Andrew
    Drechsler                                                                                                                 
|                         | Chief
                                         Financial Officer
        (Authorized
        Officer and Principal Financial Officer)



Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf
of the registrant and in the capacities and on the dates indicated.



|Signature                 |  | Title                                                                                   |  | Date              
|------------------------- |  | --------------------------------------------------------------------------------------- |  | ------------------
|                          |  |                                                                                         |  |                   
|/s/
    Ashleigh Palmer   |  | Chief
    Executive Officer (Principal Executive Officer), Director                     |  | August
    6, 2020
|Ashleigh
    Palmer       |  |                                                                                         | 
|                          |  |                                                                                         |  |                   
|/s/
    Andrew Drechsler  |  | Chief
    Financial Officer (Principal Financial Officer, Principal Accounting Officer) |  | August
    6, 2020
|Andrew
    Drechsler      |  |                                                                                         | 
|                          |  |                                                                                         |  |                   
|/s/
    Jeffrey Bluestone |  | Director                                                                                |  | August
    6, 2020
|Jeffrey
    Bluestone     |  |                                                                                         |  |                   
|                          |  |                                                                                         |  |                   
|/s/
    Avery Catlin      |  | Director                                                                                |  | August
    6, 2020
|Avery
    Catlin          |  |                                                                                         |  |                   
|                          |  |                                                                                         |  |                   
|/s/
    Sean Doherty      |  | Director                                                                                |  | August
    6, 2020
|Sean
    Doherty          |  |                                                                                         |  |                   
|                          |  |                                                                                         |  |                   
|/s/
    Wayne Pisano      |  | Director                                                                                |  | August
    6, 2020
|Wayne
    Pisano          |  |                                                                                         |  |                   
|                          |  |                                                                                         |  |                   
|/s/
    Nancy Wysenski    |  | Director                                                                                |  | August
    6, 2020
|Nancy
    Wysenski        |  |                                                                                         |  |                   











INDEX
TO EXHIBITS



|Exhibit
        Number |  | Exhibit
    Title                                                                                                          
|---------------------- |  | ---------------------------------------------------------------------------------------------------------------------------
|                       |  |                                                                                                                            
|31.1                   |  | Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15(d)-14(a) (filed herewith, Exhibit 31.1).
|                       |  |                                                                                                                            
|31.2                   |  | Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15(d)-14(a) (filed herewith, Exhibit 31.2).