RED
BANK, N.J., March 13,
2023 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB), a biopharmaceutical company dedicated to intercepting and
preventing immune-mediated disease, today announced it has
cancelled the release of its fourth quarter and full year financial
results for the period ended December 31,
2022 due to the announcement earlier today that Provention
has entered into a definitive agreement to be acquired by Sanofi,
Provention's U.S. TZIELD co-promotion partner, subject to customary
regulatory and other closing conditions. In addition, Provention
will no longer hold its fourth quarter and full year results
conference call that had been scheduled for 8:00 am E.T.
Thursday, March 16, 2023. However,
Provention will file its annual report on Form 10-K in compliance
with the applicable Securities Exchange Commission deadline of
March 31, 2023..
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage
biopharmaceutical company focused on advancing the development and
commercialization of investigational therapies that may intercept
and prevent debilitating and life-threatening immune-mediated
diseases. The Company's pipeline includes clinical-stage product
candidates that have demonstrated in pre-clinical or clinical
studies proof-of-mechanism and/or proof-of-concept in autoimmune
diseases, including T1D, celiac disease and lupus. Visit
www.ProventionBio.com for more information and follow us on
Twitter: @ProventionBio.
Internet Posting of Information:
Provention Bio, Inc. uses its
website, www.proventionbio.com, as a means of disclosing
material nonpublic information and for complying with its
disclosure obligations under Regulation F.D. Such disclosures will
be included on the Company's website in the "News" section.
Accordingly, investors should monitor this portion of the Company's
website, in addition to following its press releases, SEC filings
and public conference calls and webcasts.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to our product
pipeline and delivery of key catalysts throughout the course of the
next 24 months; the Company's planned regulatory interactions; the
medical need in at-risk T1D patients, the potential approval of
teplizumab and therapeutic effects and safety of teplizumab in
at-risk T1D patients; the FDA's review and potential approval of
teplizumab and potential regulatory and commercialization timeline;
the potential impact of FDA decisions on PK comparability and the
BLA resubmission for at-risk patients on the PROTECT study; the
potential impact of the co-promotion agreement with Sanofi on the
teplizumab launch; anticipated timing for the Phase 2a trial of
PRV-3279; anticipated enrollment in the PROACTIVE study;
anticipated timing of top-line results for our product candidates;
our current expectations regarding the ability of our cash, cash
equivalents and marketable securities to fund our current operating
requirements for at least the next 12 and 24 months based on
approval and non-approval scenarios; and expected cash-based
operating expenses for the third quarter of 2022. These statements
may be identified by the use of forward-looking words such as
"will," "may," "believe," "plans," and "expect," among others.
These forward-looking statements are based on the Company's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to
additional delays in or failure to obtain FDA approvals for
teplizumab or in the development plans for the Company's other
Company product candidates and the potential for noncompliance with
FDA regulations and requirements; any inability to successfully
work with the FDA to find a satisfactory solution to address its
concerns in a timely manner or at all, including during the FDA's
review of the teplizumab BLA resubmission; any inability of the BLA
resubmission or our response to FDA requests to satisfactorily
address other matters cited in the CRL including relating to PK
comparability, product quality, the safety update required by the
FDA or any other FDA requirements for an approval of teplizumab;
the potential impacts of COVID-19 on our business and financial
results; changes in law, regulations, or interpretations and
enforcement of regulatory guidance; uncertainties of patent
protection and litigation; the Company's dependence upon third
parties; substantial competition; the Company's need for additional
financing and the risks listed under "Risk Factors" in the
Company's quarterly report on Form 10-Q for the third quarter
ended September 30, 2022 and any subsequent filings with the
Securities and Exchange Commission. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products.
Provention does not undertake an obligation to update or revise any
forward-looking statement, 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.
Investor Contact:
Kristen Kelleher
Senior Manager, Investor Relations
investorrelations@proventionbio.com
Brendan Strong
Argot Partners
Proventionbio@argotpartners.com
212-600-1902
Media Contact:
Kaelan Hollon
VP, Corporate Communications
khollon@proventionbio.com
202-421-4921
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SOURCE Provention Bio, Inc.