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.