Provention Bio, Inc. Loss Submission Form

(i) the teplizumab Biologics License Application (“BLA”) was deficient in its submitted form and would require additional data to secure U.S. Food and Drug Administration approval; (ii) accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed; (iii) the Company had thus overstated the teplizumab BLA’s approval prospects and hence the commercialization timeline for teplizumab; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.