UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
14D-9
SOLICITATION/RECOMMENDATION
STATEMENT
PURSUANT
TO SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934
PROVENTION
BIO, INC.
(Name
of Subject Company)
PROVENTION
BIO, INC.
(Name
of Person(s) Filing Statement)
Common
Stock, $0.0001 par value per share
(Title
of Class of Securities)
74374N102
(CUSIP
Number of Common Stock)
Ashleigh
Palmer
Chief
Executive Officer
Provention
Bio, Inc.
55
Broad Street, 2nd Floor
Red
Bank, New Jersey
(908)
336-0360
(Name,
Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of the Person(s) Filing Statement)
With
a copy to:
Suni
Sreepada
Thomas
Danielski
Ropes
& Gray LLP
1211
Avenue of the Americas
New
York, NY 10036-8704
(212)
596-9000 |
☒ |
Check
the box if the filing relates solely to preliminary communications made before the commencement of a tender offer. |
This
Schedule 14D-9C consists of the following documents related to the proposed acquisition of Provention Bio, Inc. (the “Company”
or “Provention”), pursuant to the terms of an Agreement and Plan of Merger, dated as of March 12, 2023 (the “Merger
Agreement”), among the Company, Sanofi S.A. (“Parent”), and Zest Acquisition Sub, Inc., a wholly-owned Subsidiary of
Parent (“Purchaser”):
|
1) |
Joint press release, dated March 13, 2023, issued by
the Company and Parent, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference; and |
|
|
|
|
2) |
Letter
to Employees, dated March 13, 2023, from Ashleigh Palmer, the Company’s Chief Executive Officer, to Company employees, a copy
of which is attached hereto as Exhibit 99.2 and incorporated herein by reference; |
The
items listed above were first used or made available on March 13, 2023.
Additional
Information and Where to Find It
Purchaser
will commence a tender offer for the outstanding shares of common stock of Provention, but such offer has not yet commenced. This communication
is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Provention, nor
is it a substitute for the tender offer materials that Parent and its acquisition subsidiary will file with the U.S. Securities and Exchange
Commission (the “SEC”) upon commencement of the tender offer. At the time the tender offer is commenced, Parent and its acquisition
subsidiary will file a tender offer statement on Schedule TO, and Provention will file a Solicitation/Recommendation Statement on Schedule
14D-9 with the SEC with respect to the tender offer. The tender offer statement on Schedule TO (including an Offer to Purchase, a related
Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important
information. HOLDERS OF SHARES OF PROVENTION ARE URGED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT PROVENTION STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING
ANY DECISION REGARDING TENDERING THEIR SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer
documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Provention at no
expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s
web site at www.sec.gov. Additional copies may be obtained for free by contacting Kristen Kelleher, Investor Relations, at kkelleher@proventionbio.com,
or on Provention’s website, www.proventionbio.com.
In
addition to the Solicitation/Recommendation Statement, Provention files annual, quarterly and special reports and other information with
the SEC. You may read and copy any reports or other information filed by Provention at the SEC public reference room at 100 F. Street,
N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Provention’s
filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the
SEC at www.sec.gov.
Cautionary
Statement Regarding Forward-Looking Statements
This
Schedule 14D-9C includes forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual
results to differ materially from those implied by the forward-looking statements. All statements other than statements of historical
fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current
expectation of Provention and members of its senior management team and can typically be identified by words such as “believe,”
“expect,” “estimate,” “predict,” “target,” “potential,” “likely,”
“continue,” “ongoing,” “could,” “should,” “intend,” “may,” “might,”
“plan,” “seek,” “anticipate,” “project” and similar expressions, as well as variations
or negatives of these words. Forward-looking statements include, without limitation, statements regarding the proposed transaction, similar
transactions, prospective performance, future plans, events, expectations, performance, objectives and opportunities and the outlook
for Provention’s business; the commercial success of Provention’s products; the anticipated timing of clinical data; the
possibility of unfavorable results from clinical trials; the timing of and receipt of filings and approvals relating to the transaction;
the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions;
and the accuracy of any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements
are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking
statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and
uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties
as to the timing of the tender offer and merger; uncertainties as to how many of Provention’s stockholders will tender their stock
in the offer; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental
entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or
other circumstance that could give rise to the termination of the merger agreement; the effects of the transaction (or the announcement
thereof) on relationships with associates, customers, manufacturers, suppliers, other business partners or governmental entities or patient
groups; transaction costs; the risk that the merger will divert management’s attention from Provention’s ongoing business
operations; changes in Provention’s businesses during the period between now and the closing; risks associated with litigation;
failure to maintain FDA approval for TZIELD; uncertainties that the planned commercial launch in the U.S. for TZIELD is successful in
part or at all for various reasons including the actual market size and drug supply needed may not be consistent with Provention’s
expectations and its executed commercial readiness plans; uncertainties as to the degree to which TZIELD is accepted by patients and
prescribed by physicians; uncertainties as to the efficiency of Provention’s manufacturing, sales, distribution and specialty pharmacy
network in getting TZIELD to the market and future economic, competitive, reimbursement and regulatory conditions that could negatively
impact the commercial launch of TZIELD; risks that the post-marketing commitment studies for TZIELD may not yield data consistent with
prior results; the risk that TZIELD may cause undesirable side effects that could limit its commercial potential; the possibility that
Provention is not able to execute on its business plans including meeting its expected or planned regulatory milestones and timelines,
clinical development plans and successfully bringing its product candidates to market, for various reasons, including factors outside
of Provention’s control, such as possible limitations of Provention’s financial and other resources, competition, manufacturing
limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such
as decisions by the United States Patent and Trademark Office with respect to patents that cover its product candidates, the potential
for noncompliance with FDA regulations; the potential impacts of COVID-19 on Provention’s business and financial results; changes
in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; competition,
other risks and uncertainties detailed from time to time in documents filed with the SEC by Provention, including current reports on
Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Provention. As
with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization
of new products. All forward-looking statements are based on information currently available to Provention, and Provention assumes no
obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise, except
as may be required by applicable law. The information set forth herein speaks only as of the date hereof.
Provention Bio (NASDAQ:PRVB)
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