OLDWICK, N.J., March 12, 2020 /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 fourth quarter
and full year ended December 31, 2019.
"2019 was a transformational year for Provention Bio and the
type 1 diabetes (T1D) landscape," stated Ashleigh Palmer, CEO of Provention Bio. "Data
from the 'At-Risk' study published in the New England Journal of
Medicine in June highlights the potential of PRV-031 (teplizumab)
to prevent or delay onset of clinical T1D in individuals at risk of
end-stage, insulin-dependent disease. Our receipt of Breakthrough
Therapy and PRIME designations from the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA),
respectively, recognizes and confirms the unmet T1D need and
validates the transformative therapeutic potential of
teplizumab."
Mr. Palmer continued, "Based on our discussions with the FDA
late last year, we are now moving forward with preparing the
various modules of our Biologics License Application (BLA),
including generating the necessary drug substance comparability
data to support our chemistry, manufacturing and controls (CMC)
module. We remain on track to complete our rolling BLA
submission in the fourth quarter of this year. In parallel with
these efforts, in the first few months of 2020 we have commenced
the build-out of our commercial leadership organization to support
a potential launch of teplizumab as the first disease-modifying
drug approved for T1D since insulin therapy in 1922."
Fourth Quarter 2019 and Recent Activities:
Announced Positive Data from Phase 1b PREVAIL Study of PRV-3279
In a separate press release issued today, Provention reported
positive top-line results from the Phase 1b portion of the PREVAIL (PRV-3279 EVAluation In
Lupus) study evaluating PRV-3279 in healthy volunteers. In the
study, PRV-3279 was well-tolerated, with no serious adverse
events. In addition, treatment with PRVB-3279 durably
inhibited the function of B Cells without depletion. Based on
these results, Provention plans to commence the Phase 2a portion of
the PREVAIL study in lupus patients in the first half of 2021. The
Phase 1b results will also enable a
second development pathway for the prevention of immunogenicity of
biotherapeutics such as gene therapy products.
Completed a Type B multidisciplinary meeting with the FDA to
discuss the proposed contents of a BLA for PRV-031
(teplizumab)
In December 2019, Provention
announced that it completed a Type B multidisciplinary meeting with
the FDA to discuss the proposed contents of a BLA for teplizumab
for the prevention or delay of T1D in at-risk individuals.
Based on official FDA meeting minutes, Provention continues
to anticipate commencement of a rolling BLA submission for
teplizumab in the middle of 2020 and is targeting completion of the
submission in the fourth quarter of 2020. The Company does
not anticipate the need to conduct any additional clinical trials
in the at-risk population prior to BLA submission.
Conducted Initial PRIME Meeting with the EMA
The Company recently 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 2021.
Commenced Build-out of Commercial Team
In January 2020, the Company
appointed Jason Hoitt as Chief
Commercial Officer. Mr. Hoitt brings 18 years of commercial
experience in the biotechnology sector, most recently serving as
Chief Commercial Officer at Dova Pharmaceuticals (recently acquired
by Swedish Orphan Biovitrum AB, or Sobi). As Chief Commercial
Officer and a member of Provention's senior leadership team, Mr.
Hoitt will be responsible for the development and execution of
Provention's global commercial strategy for teplizumab, building
Provention's commercial capabilities, and continuing to evaluate
potential partnerships for all indications and
geographies.
In addition to Mr. Hoitt, Provention expanded the commercial
team with the appointment of Dr. Jessica
Blumstein as Vice President, Market Access and Distribution.
Dr. Blumstein has 18 years of experience in the biotechnology
sector, most recently as Head of Global Commercial Development and
General U.S. Manager at Enzyvant Therapeutics. Dr. Blumstein was
also Senior Director of Global Market Access at Sarepta
Therapeutics for over two years prior to Enzyvant.
Hired Robert Adamoski to Lead
Medical Affairs
Provention recently hired Robert
Adamoski to lead its medical affairs activities for
teplizumab. Mr. Adamoski brings over 20 years of industry
experience to Provention. Mr. Adamoski was most recently at
Corcept Therapeutics and his past experiences include roles at
Gilead, Salix and Bayer.
Provention Highlighted Critical New Research Studies on Type
One Diabetes
In February 2020, the Company
highlighted several new research studies on the increasing
prevalence of T1D and the importance of screening for this
life-impacting and life-threatening autoimmune disease. The
Juvenile Diabetes Research Foundation and Health Advances published
a white paper estimating that 18 million people live with
clinically diagnosed Stage 3 T1D globally, and an additional 2.3
million live with pre-symptomatic Stage 1 and Stage 2 T1D. At least
300,000 of these cases are in the United States. The research suggested that
sustainable "cures" could alleviate the $30
billion economic burden in the United States and in the interim, disease
modifying therapies, such as teplizumab can bring more than $3
billion in value annually.
A separate study published in the Journal of the American
Medical Association, titled "Yield of a Public Health Screening of
Children for Islet Autoantibodies in Bavaria, Germany", highlighted the importance of
screening for T1D and the significant reduction in diabetic
ketoacidosis (DKA) resulting from screening. The study, conducted
by Dr. Anette-Gabriele Ziegler of
the Institute of Diabetes Research, suggests that public health
screening for T1D in pre-symptomatic stages may reduce disease
burden and severity, as well as enable disease interception
strategies with novel agents.
Financial Highlights:
As of December 31, 2019, Provention had cash and cash
equivalents and marketable securities of $85.4 million. Net loss for the fourth quarter
2019 was $10.5 million, or $0.22 per basic and
diluted share, compared to a net loss of $5.7 million,
or $0.15 per basic and diluted share, for the same period
in 2018. The increase in net loss is attributable to increases in
research and development expenses of $3.5
million as well as an increase in general and administrative
costs of $1.2 million.
Net loss for the full year of 2019 was $43.3 million,
or $1.06 per basic and diluted share, compared to a net
loss of $26.8 million, or $1.19 per basic and
diluted share, for the same period in 2018. The increase in net
loss year-over-year is primarily attributable to an increase in
research and development costs of $13.7 million. Research and
development expenses were driven by the PROTECT phase 3 clinical
study of teplizumab, development costs for PRV-101, and internal
personnel costs.
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 12months.
Conference Call Information:
Provention will host a conference call and live audio webcast
today at 8:30am 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 under the Investors
tab 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 30 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. Teplizumab has been granted
Breakthrough Therapy designation from the U.S. Food and Drug
Administration. 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 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:
David Rosen, Argot Partners
david.rosen@argotpartners.com
212-600-1902
PROVENTION BIO,
INC. SELECTED FINANCIAL DATA (in thousands,
except per share data)
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
For the Years
Ended December 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
8,463
|
|
$
|
4,965
|
|
$
|
36,359
|
|
$
|
22,649
|
General and
administrative
|
|
|
2,420
|
|
|
1,236
|
|
|
8,013
|
|
|
4,165
|
Total operating
expenses
|
|
|
10,883
|
|
|
6,201
|
|
|
44,372
|
|
|
26,814
|
Loss from
operations
|
|
|
(10,883)
|
|
|
(6,201)
|
|
|
(44,372)
|
|
|
(26,814)
|
Interest
income
|
|
|
343
|
|
|
330
|
|
|
1,087
|
|
|
669
|
Change in fair value
of warrant liability
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(520)
|
Loss before income
tax benefit
|
|
|
(10,540)
|
|
|
(5,871)
|
|
|
(43,285)
|
|
|
(26,665)
|
Income tax
benefit
|
|
|
—
|
|
|
187
|
|
|
—
|
|
|
187
|
Net loss
|
|
|
(10,540)
|
|
|
(5,684)
|
|
|
(43,285)
|
|
|
(26,478)
|
Accretion on Series A
Convertible Redeemable Preferred Stock
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(276)
|
Net loss attributable
to common stockholders
|
|
$
|
(10,540)
|
|
$
|
(5,684)
|
|
$
|
(43,285)
|
|
$
|
(26,754)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.22)
|
|
$
|
(0.15)
|
|
$
|
(1.06)
|
|
$
|
(1.19)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
47,641
|
|
|
37,357
|
|
|
40,747
|
|
|
22,441
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2019
|
|
December 31, 2018
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
85,373
|
|
$
|
58,539
|
Total
assets
|
|
|
|
|
|
|
|
$
|
85,996
|
|
$
|
61,529
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
3,840
|
|
$
|
1,871
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(79,061)
|
|
$
|
(35,776)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
82,156
|
|
$
|
59,658
|
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SOURCE Provention Bio, Inc.