OLDWICK, N.J., Aug. 6, 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 second quarter
ended June 30, 2019 and provided a business update.
"The data from the NIH-Sponsored 'At Risk' study, which
underscored the transformative potential of teplizumab (PRV-031) to
prevent or delay onset of clinical type 1 diabetes (T1D) in at-risk
individuals, put Provention on a new trajectory,"
stated Ashleigh Palmer, CEO of Provention Bio. "Based on
these results, the FDA granted PRV-031 Breakthrough Therapy
Designation, which affords us multiple advantages as we work to
bring this important product to the market in the U.S. The data
also reinforce our confidence as we enroll patients in our
recently-initiated pivotal Phase 3 PROTECT study evaluating PRV-031
in newly diagnosed T1D patients."
Mr. Palmer continued, "In addition to PRV-031, we are advancing
multiple programs consistent with our vision to deliver novel
therapies which intercept or prevent immune-mediated
diseases. We remain on track to report top-line data from our
PRINCE study of PRV-6527, our oral small molecule for the treatment
of Crohn's disease, in the fourth quarter of this year. In
the coming weeks, we also plan to initiate our Phase 1b trial for PRV-3279, which we plan to develop
for the interception of lupus."
Second Quarter 2019 and Recent Highlights:
PRV-031 Granted Breakthrough Therapy Designation
(BTD)
In August 2019,
the U.S. Food and Drug Administration (FDA) granted Breakthrough
Therapy Designation (BTD) to PRV-031 for the prevention or delay of
clinical T1D in individuals at risk of developing the disease. BTD
is an FDA program designed to expedite the development and review
of therapeutic candidates intended to treat serious or
life-threatening diseases.
Results from the "At-Risk" Study Showed a Single Course of
PRV-031 Delays Type 1 Diabetes Onset in High-Risk Individuals by at
Least Two Years
In June
2019, Provention announced that results from the
"At-Risk" Study, conducted by TrialNet, were published in The
New England Journal of Medicine and presented at the Scientific
Sessions of the 79th Annual American Diabetes Association (ADA)
meeting. Results from the study showed that a single 14-day
course of PRV-031 significantly delayed the onset and diagnosis of
clinical T1D, as compared to placebo, by a median of two years in
children and adults considered to be at high risk.
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. Top line data are expected in the fourth
quarter of 2019.
Initiated Phase 3 PROTECT Clinical Trial with PRV-031
(Teplizumab) in Patients with Newly Diagnosed Type 1
Diabetes
In April 2019, Provention dosed the
first patient in its Phase 3 PROTECT clinical trial of PRV-031
(teplizumab) in patients with newly diagnosed T1D. 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 Results from Phase 1b PULSE Trial of PRV-300
In
May 2019, Provention reported top
line results from the Phase 1b PULSE
study evaluating PRV-300 in patients with active,
moderate-to-severe ulcerative colitis (UC). While the study did not
show an upstream effect on clinically relevant parameters of UC,
the study did achieve the primary safety and tolerability endpoint
and also demonstrated target engagement and proof-of-mechanism.
Provention plans to return the rights to PRV-300 to Janssen in the
second half of 2019.
Financial Highlights:
As of June 30, 2019, Provention had cash and cash
equivalents totaling $41.3 million. Provention expects
to invest in the following key activities for the remainder of
2019: (a) regulatory, clinical, and manufacturing activities
related to 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 $18 to $24 million for the second half of 2019.
Net loss for the second quarter 2019 was $12.0 million,
or $0.32 per basic and diluted share, compared to a net
loss of $10.5 million, or
$1.05 per basic and diluted share,
for the same period in 2018. The increase in net loss is
attributable to an increase in research and development costs of
$1.4 million primarily
associated with the PROTECT Phase 3 trial of PRV-031 in newly
diagnosed T1D patients, as well as an increase in general and
administrative costs of $0.7
million.
Net loss for the six months ended June
30, 2019 was $23.0 million, or $0.61 per
basic and diluted share, compared to a net loss of $15.7 million, or $1.57 per basic and diluted share, for the same
period in 2018. The increase in net loss is attributable to
an increase in research and development costs of $7.0 million primarily associated with the
PROTECT Phase 3 trial of PRV-031 in newly diagnosed T1D patients,
as well as an increase in general and administrative costs of
$1.3 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, and lupus. Provention's
diversified portfolio includes advanced-stage product development
candidates that have undergone clinical testing by other
companies.
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. 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:
Sam Martin or Laura Perry, Argot Partners
proventionbio@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
Financial Tables to Follow
PROVENTION BIO,
INC.
|
SELECTED FINANCIAL
DATA (UNAUDITED)
|
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
March 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
10,550
|
|
$
|
9,161
|
|
$
|
20,572
|
|
$
|
13,544
|
General and
administrative
|
|
|
1,707
|
|
|
1,004
|
|
|
2,944
|
|
|
1,657
|
Total operating
expenses
|
|
|
12,257
|
|
|
10,165
|
|
|
23,516
|
|
|
15,201
|
Loss from
operations
|
|
|
(12,257)
|
|
|
(10,165)
|
|
|
(23,516)
|
|
|
(15,201)
|
Interest
income
|
|
|
253
|
|
|
45
|
|
|
540
|
|
|
102
|
Change in fair value
of warrant liability
|
|
|
—
|
|
|
(219)
|
|
|
—
|
|
|
(303)
|
Loss before income
tax benefit
|
|
|
(12,004)
|
|
|
(10,339)
|
|
|
(22,976)
|
|
|
(15,402)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(12,004)
|
|
|
(10,339)
|
|
|
(22,976)
|
|
|
(15,402)
|
Accretion on Series A
Convertible Redeemable Preferred Stock
|
|
|
—
|
|
|
(126)
|
|
|
—
|
|
|
(251)
|
Net loss attributable
to common stockholders
|
|
$
|
(12,004)
|
|
$
|
(10,465)
|
|
$
|
(22,976)
|
|
$
|
(15,653)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.32)
|
|
$
|
(1.05)
|
|
$
|
(0.61)
|
|
$
|
(1.57)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
37,363
|
|
|
10,000
|
|
|
37,362
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
December 31, 2018
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
|
|
$
|
41,259
|
|
$
|
58,539
|
Total
assets
|
|
|
|
|
|
|
|
$
|
42,446
|
|
$
|
61,529
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
5,038
|
|
$
|
1,871
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(58,752)
|
|
$
|
(35,776)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
37,408
|
|
$
|
59,658
|
View original
content:http://www.prnewswire.com/news-releases/provention-bio-reports-second-quarter-2019-financial-results-300896749.html
SOURCE Provention Bio, Inc.