Current Report Filing (8-k)
December 26 2019 - 3:31PM
Edgar (US Regulatory)
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): December 26, 2019
PROVENTION
BIO, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-38552
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81-5245912
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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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P.O.
Box 666, Oldwick, New Jersey 08858
(Address of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (908) 336-0360
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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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 [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. [X]
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 Exchanged on Which Registered
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Common
Stock, $0.0001 par value per share
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PRVB
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The Nasdaq Global Select
Market
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Item
8.01. Other Events.
Representatives
of Provention Bio, Inc. (the “Company”) were informed by Janssen Pharmaceutica NV’s (“Janssen”)
CSF-1R inhibitor (PRV-6527) Alliance Manager, via teleconference and confirmatory email, that Janssen no longer intends to take
up an option to buy back the rights to the compound which has been under development by the Company for Crohn’s disease.
Instead, Janssen intends to support and expand the field of the License, Development and Commercialization Agreement (“the
License Agreement”) between the Company and Janssen (currently limited to inflammatory bowel disease) entered into in April
2017 to facilitate the program’s continuation either directly by the Company or by way of the Company’s sublicensing
rights under the License Agreement. In particular, Janssen indicated it intends to assist in transferring the compound’s
manufacturing rights to the Company or a third party manufacturer and will irrevocably waive its rights to assume distribution
and pricing decision making authority. As previously disclosed, the Company does not intend to continue the compound’s development
directly but, instead, may explore sublicensing the compound to a third party.
SIGNATURE
Pursuant
to the requirement 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.
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Provention
Bio, Inc.
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Date:
December 26, 2019
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By:
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/s/
Andrew Drechsler
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Andrew
Drechsler
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Chief
Financial Officer
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