OLDWICK, N.J., May 8, 2019 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today reported financial results for the first quarter ended March 31, 2019 and provided a business update.
"Since the beginning of 2019, we have reported significant progress in our efforts to transform the treatment landscape for immune-mediated diseases, and we are well-positioned to build on this momentum as we approach additional data readouts this year that will further validate our development candidates," stated Ashleigh Palmer, CEO of Provention Bio. "We recently initiated our Phase 3 PROTECT Study, which is designed to establish teplizumab as the first-ever disease modifying therapy for type 1 diabetes (T1D) and look forward to reporting top-line results from our Phase 2a PRINCE trial of PRV-6527 in Crohn's disease in the fourth quarter. We also anticipate the results from a study conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at TrialNet sites evaluating teplizumab for the prevention or delay in onset of T1D in subjects at risk of developing the disease."
"In parallel with our clinical progress, we also strengthened our leadership team, adding Dr. Jeffrey Bluestone, a world-renowned expert and academic leader in immune tolerance research to our Board of Directors," Mr. Palmer concluded.
First Quarter 2019 and Recent Activities:
As of March 31, 2019, Provention had cash and cash equivalents totaling $51.2 million. Provention expects to invest in the following key activities in 2019: (a) the Phase 3 PROTECT study of PRV-031, (b) the continued development of PRV-101, (c) the completion of the PRINCE study, as well as the advancement of other pipeline programs. As a result of these activities, Provention expects its operating cash expenses to be in the range of $35 to $45 million for 2019.
Net loss for the first quarter 2019 was $11.0 million, or $0.29 per basic and diluted share, compared to a net loss of $5.2 million, or $0.52 per basic and diluted share for the same period in 2018. The increase in net loss is primarily attributable to an increase in research and development costs of $5.6 million associated with development expenses for PRV-031 and PRV-101, as well as an increase in general and administrative costs of $0.6 million.
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, lupus, and certain life-threatening viral diseases. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies. For more information on Provention Bio, please visit www.proventionbio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention'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 failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk factors" in our annual report on Form 10-K for the year ended December 31, 2018 and any subsequent filings with the Securities and Exchange Commission (SEC). 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. The information set forth herein speaks only as of the date hereof.
David Rosen, Argot Partners
PROVENTION BIO, INC.
SELECTED FINANCIAL DATA (UNAUDITED)
(in thousands, except per share data)
Three months ended March 31,
Statement of Operations Data:
Research and development
General and administrative
Total operating expenses
Loss from operations
Change in fair value of warrant liability
Loss before income tax benefit
Income tax benefit
Accretion on Series A Convertible Redeemable Preferred Stock
Net loss attributable to common stockholders
Net loss per common share, basic and diluted
Weighted average common shares outstanding, basic and diluted
March 31, 2019
December 31, 2018
Balance Sheet Data:
Cash and cash equivalents
Total stockholders' equity
SOURCE Provention Bio, Inc.