Provention Bio Reports First Quarter 2019 Financial Results
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:
-- Completed Enrollment of Phase 2a PRINCE Clinical Trial with PRV-6527 in
Patients with Moderate to Severe Crohn's Disease In April 2019,
Provention announced that it completed the enrollment in its Phase 2a
PRINCE (PRovention INvestigation in Crohn's diseasE) clinical trial
evaluating PRV-6527 in patients with moderate-to-severe Crohn's disease.
PRV-6527 is an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small
molecule inhibitor. The Phase 2a PRINCE study is evaluating PRV-6527's
ability to intercept the differentiation of inflammatory dendritic cells
and macrophages, preventing their action in the intestinal mucosa in
Crohn's disease. Top line data is expected in the fourth quarter of
2019.
-- Initiated Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in
Patients with Recent Onset Type 1 Diabetes In April 2019, Provention
announced that it dosed the first patient in its Phase 3 PROTECT
clinical trial of PRV-031 (teplizumab) in patients with recent onset
T1D. PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in
development for the interception of TID. The PROTECT study is designed
to confirm the effect of PRV-031 (teplizumab) to slow the loss of
insulin-producing beta cells and preserve beta cell function, as
measured by C-peptide, in children and adolescents 8-17 years old who
have been diagnosed with T1D in the previous six weeks and with
pre-specified beta cell reserve at study entry. Provention expects to
complete enrollment in the trial by the end of 2020.
-- Reported Top-Line Data from Phase 1b PULSE Clinical Trial with PRV-300
in Patients with Ulcerative Colitis (UC) In May 2019, Provention
announced top-line results from its Phase 1b PULSE study which evaluated
PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody, in
patients with active, moderate-to-severe UC. PRV-300 met the primary
safety and tolerability endpoint over the twelve-week study period and
also demonstrated TLR3 target engagement and proof-of-mechanism.
However, improvements in secondary and exploratory clinical, endoscopic,
histologic and other UC-related efficacy endpoints were not observed
over background medication, suggesting that elevated TLR3 gene
signatures previously observed in UC patients, as well as in PULSE, are
downstream or circumstantial effects that do not contribute
significantly to causal pathology. Therefore, while PRV-300 is a safe
and pharmacologically active drug, it appears that TLR3 may not be a
useful target in UC.
-- Appointed Jeffrey Bluestone, PhD, to Board of Directors In March 2019,
Provention announced the appointment of Jeffrey Bluestone, PhD, to the
Company's Board of Directors. Dr. Bluestone is a highly accomplished
scientific researcher whose work over nearly three decades has focused
on understanding the basic processes that control T-cell activation and
immune tolerance in autoimmunity, organ transplantation and cancer. Dr.
Bluestone was part of the team of early developers of a novel anti-CD3
monoclonal antibody, now called teplizumab, a pro-tolerogenic drug that
has shown clinical activity in type 1 diabetes (T1D), psoriatic
arthritis, and the reversal of kidney transplant rejection.
-- Appointed Douglas Jacobstein, M.D. as V.P. of Clinical Development and
Alex Rabiee as V.P. of Business Development In April 2019, Provention
announced the appointment of Douglas Jacobstein, M.D., as Vice President
of Clinical Development, and Alex Rabiee as Vice President of Business
Development. Dr. Jacobstein brings to Provention almost 15 years of
clinical development, management and leadership expertise. He most
recently served as Director of Clinical Development in the Immunology
division of Janssen Pharmaceuticals. Mr. Rabiee brings 15 years of
experience in the biotechnology sector, most recently serving as
Director of Business Development at Amgen.
Financial Highlights:
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.
Investors:
Kimberly Minarovich or Sam Martin, Argot Partners
Kimberly@argotpartners.com or Sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
PROVENTION BIO, INC.
SELECTED FINANCIAL DATA (UNAUDITED)
(in thousands, except per share data)
Three months ended March 31,
2019 2018
Statement of Operations Data:
Operating expenses:
Research and development $
10,022 $
4,383
General and administrative 1,237 653
Total operating expenses 11,259 5,036
Loss from operations (11,259) (5,036)
Interest income 287 57
Change in fair value of warrant
liability (84)
Loss before income tax benefit (10,972) (5,063)
Income tax benefit
Net loss (10,972) (5,063)
Accretion on Series A Convertible
Redeemable Preferred Stock (125)
Net loss attributable to common
stockholders $
(10,972) $
(5,188)
Net loss per common share, basic
and diluted $
(0.29) $
(0.52)
Weighted average common shares
outstanding, basic and diluted 37,362 10,000
March 31, 2019 December 31, 2018
Balance Sheet Data:
Cash and cash equivalents $
51,206 $
58,539
Total assets $
51,904 $
61,529
Total liabilities $
2,974 $
1,871
Accumulated deficit $
(46,748) $
(35,776)
Total stockholders' equity $
48,930 $
59,658
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SOURCE Provention Bio, Inc.
