OLDWICK, N.J., May 7, 2020 /PRNewswire/ -- Provention Bio, Inc.
(Nasdaq: PRVB), a clinical-stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today reported financial results and provided a business update for
the first quarter ended March 31,
2020.
"Public health and clinical research conditions have changed
dramatically in recent months. As an agile, virtual company,
Provention has adapted quickly and seamlessly to this challenging
new operating environment," said Ashleigh
Palmer, CEO of Provention Bio.
"We continue to execute on our strategy to advance our lead
candidate, teplizumab, as the first disease modifying therapy for
patients who are at-risk of progressing to clinical-stage type 1
diabetes (T1D). To that end, last month we announced the first
module of our rolling biologics license application (BLA) was
submitted on schedule, and we remain on track to complete the
submissions of all modules in Q4 2020. In parallel with these
regulatory efforts, we are building a commercial team and laying
the foundations to support a US launch if teplizumab is
approved."
"Additionally, we have reported progress on our
development pipeline with positive Phase 1b study results for PRV-3279, highlighting this
therapeutic candidate's potential to intercept the pathophysiology
of lupus and other B cell-mediated autoimmune diseases, as well as
prevent or reduce the immunogenicity associated with certain
biotherapeutics, including gene therapy products."
"Our team remains highly focused on fulfilling the potential of
our portfolio of clinical-stage assets targeting life-impacting and
life-threatening autoimmune diseases, and we look forward to
building on our success during the remainder of 2020," concluded
Ashleigh Palmer.
First Quarter 2020 and Recent Corporate Highlights:
Initiation of Provention's Rolling Submission of BLA for
Teplizumab
In April, the Company submitted the first module of its rolling
BLA to the U.S. Food and Drug Administration (FDA) for teplizumab
(PRV-031), an anti-CD3 monoclonal antibody, for the delay or
prevention of clinical T1D in at-risk individuals, as indicated by
the presence of two or more T1D-related autoantibodies. Rolling
submission allows for completed modules of the BLA to be submitted
and reviewed by the FDA on an ongoing basis. Provention
submitted the non-clinical module and expects to submit the
clinical module in Q3 and the chemistry, manufacturing and controls
(CMC) module in Q4 of 2020. Once the final module of the BLA
has been submitted, FDA will make a filing acceptance decision and
set a Prescription Drug User Fee Act (PDUFA) goal date.
Completed First GMP Run of Teplizumab; Manufacturing on
Track
During the first quarter, AGC Biologics, the Company's contract
manufacturer, completed a cGMP production run of
teplizumab. The Company continues to expect to proceed
with three commercial-scale process performance qualification (PPQ)
batches this summer, supporting the CMC module and enabling the
completion of the rolling BLA submission as planned. The
Company has not experienced any interruption in its supply chain or
manufacturing efforts due to the COVID-19 pandemic at this
time.
Conducted Initial PRIME Meeting with the EMA
In the first quarter, the Company held a kick-off meeting with
the EMA to discuss teplizumab. The Company believes it will
be able to file a marketing authorization application (MAA) with
the data from the At-Risk clinical study along with supplemental
data from historical clinical studies of teplizumab.
Provention plans to have additional meetings with the EMA and
expects to file the MAA for teplizumab in the second half of
2021.
Temporarily Paused Randomization of PROTECT Study Due to the
Impact of COVID-19
In March, Provention announced a temporary pause in the
randomization of patients with newly diagnosed T1D into its global
Phase 3 PROTECT study of PRV-031 (teplizumab). This pause was taken
proactively, to protect patients, caregivers, clinical site staff,
company employees and contractors at this critical juncture in the
collective global efforts to combat the COVID-19 pandemic. Patients
currently undergoing study therapy will be allowed to complete
their course, as recommended by the PROTECT study's Data Safety
Monitoring Board, which was recently expanded to include infectious
diseases expertise.
Announced Positive data From Phase 1b PREVAIL Study of PRV-3279
In March, Provention announced positive top-line results from
the Phase 1b portion of the PREVAIL (PRV-3279 EVAluation
In Lupus) study evaluating PRV-3279 in healthy volunteers. PRV-3279
is a humanized diabody targeting the B-cell surface proteins, CD32B
and CD79B, and has the potential to intercept the pathophysiology
of systemic lupus erythematosus (SLE) and other B cell-mediated
autoimmune diseases and prevent or reduce the immunogenicity of
biotherapeutics, including gene therapy products. Based on the
results, Provention plans to commence the Phase 2a portion of the
PREVAIL study in lupus patients in the first half of 2021. These
Phase 1b results will also enable a second development
pathway for the prevention of immunogenicity of biotherapeutics
such as gene therapy products.
Received $0.5
million from the Sale of NJ Net Operating
Losses
In April, Provention received $0.5 million from
the sale of a portion of the Company's New Jersey State net
operating losses (NOLs). A program administered by the New
Jersey Economic Development Authority allows qualified technology
and biotechnology businesses in New Jersey to sell unused
amounts of NOLs for cash.
Financial Highlights:
Net loss for the first quarter 2020 was $12.6 million,
or $0.26 per basic and diluted share, compared to a net
loss of $11.0 million, or $0.29 per basic and
diluted share, for the same period in 2019. The increase in net
loss was primarily attributable to an increase in general and
administrative costs, including the initial build out of our
commercial organization and other aspects of our corporate
infrastructure.
As of March 31, 2020, Provention had cash, cash equivalents
and marketable securities of $76.6
million. Cash-based operating expenses were $11.6 million for the three months ended
March 31, 2020. Provention
expects to utilize $24 million to $29
million of cash for its operating needs in the first six
months of 2020. Provention expects its current cash, cash
equivalents and marketable securities will be sufficient to fund
projected operating requirements for at least the next 12
months.
Conference Call and Webcast Information:
Provention Bio will discuss these results via conference call
today at 4:30 pm ET. To access the
call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790
(international) five minutes prior to the start time and ask to be
connected to the "Provention Bio Call". An audio webcast will also
be available on the "Events and Webcasts" page of the Investors
section of the Company's website, www.proventionbio.com. An
archived webcast will be available on the Company's website
approximately two hours after the conference call and will be
available for seven days following the call.
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
biopharmaceutical company leveraging a transformational drug
development strategy focused on the prevention or interception of
immune-mediated disease. Provention's mission is to source,
transform and develop therapeutic candidates targeting the high
morbidity, mortality and escalating costs of autoimmune diseases.
Provention's diversified portfolio includes PRV-031 (teplizumab), a
pre-commercial-stage candidate that has been shown to delay the
onset of end-stage type one diabetes (T1D) in at-risk individuals
with pre-symptomatic disease. The Company's portfolio
includes additional clinical-stage product development candidates
that have demonstrated proof-of-mechanism and/or
proof-of-concept in other autoimmune diseases, including
celiac disease and lupus.
Forward Looking Statements:
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements related to timing of submission of
the BLA. 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 and
uncertainties surrounding the COVID-19 pandemic, including the
impact to our clinical trial programs, 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, 2019 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:
Sam Martin,
Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
PROVENTION BIO,
INC.
|
SELECTED FINANCIAL
DATA (unaudited)
|
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2020
|
|
2019
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
9,090
|
|
$
|
10,022
|
General and
administrative
|
|
|
3,775
|
|
|
1,237
|
Total operating
expenses
|
|
|
12,865
|
|
|
11,259
|
Loss from
operations
|
|
|
(12,865)
|
|
|
(11,259)
|
Interest
income
|
|
|
283
|
|
|
287
|
Loss before income
tax benefit
|
|
|
(12,582)
|
|
|
(10,972)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
Net loss
|
|
$
|
(12,582)
|
|
$
|
(10,972)
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.26)
|
|
$
|
(0.29)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
47,699
|
|
|
37,362
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
Balance Sheet
Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
76,629
|
|
$
|
85,373
|
Total
assets
|
|
$
|
78,117
|
|
$
|
85,996
|
Total
liabilities
|
|
$
|
6,903
|
|
$
|
3,840
|
Accumulated
deficit
|
|
$
|
(91,643)
|
|
$
|
(79,061)
|
Total stockholders'
equity
|
|
$
|
71,214
|
|
$
|
82,156
|
|
|
|
|
|
|
|
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SOURCE Provention Bio, Inc.