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.

Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call