Provention Bio, Inc., (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today reiterated its regulatory strategy regarding PRV-031 (teplizumab) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. Based on written communications from the U.S. Food and Drug Administration (FDA) and FDA's designation of PRV-031 as a breakthrough therapy, the Company believes that existing clinical and non-clinical data for PRV-031 will be sufficient to support a Biologics License Application (BLA) submission for PRV-031 in the fourth quarter of 2020 for the at-risk indication. The Company expects to meet with the FDA in the fourth quarter of 2019 to discuss this expedited development plan.

"Our interactions with the FDA in connection with the 'At Risk' study of PRV-031 (teplizumab) provide us with the confidence to submit a regulatory filing by the end of 2020," stated Ashleigh Palmer, CEO of Provention Bio. "The proceeds from our financing will allow us to execute on our development plans as we work closely with the FDA to bring teplizumab to individuals at-risk of developing clinical T1D."

In the second quarter of 2019, the Company exchanged correspondence with the FDA regarding the regulatory path forward for PRV-031 for the prevention or delay of clinical T1D in individuals at-risk for developing the disease. Specifically, the FDA:

• Agreed, in principle, that the results from the "At-Risk" study, together with supportive data from prior PRV-031 studies in early onset T1D, may be sufficient for a BLA submission.
• Agreed that the safety database from the "At Risk" study and prior clinical studies in patients with early onset T1D appears adequate to support review of a BLA.
• Agreed that the current non-clinical package for PRV-031 is adequate to support the At-Risk indication.

In a later letter granting Breakthrough Therapy Designation (BTD), the FDA asked the Company to meet for a multidisciplinary, comprehensive discussion of the Company's PRV-031 program, including plans for expediting the manufacturing development strategy.

In connection with the Company's follow-on financing and private placement announced last week, the Company generated total net proceeds of $62.7 million. The net proceeds reflect an underwritten public offering of 5,750,000 shares of common stock at a price of $8.00 per share, including the full exercise of the over-allotment option, as well as the issuance of 2,500,000 shares of common stock at a price of $8.00 per share in a private placement with Amgen, Inc.

The net proceeds from the financing, together with its current cash position, are expected to fund the Company's operations for two years.

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease. Provention's mission is to in-license, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn's disease, celiac disease and lupus. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies.