OLDWICK, N.J., Nov. 5, 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 third quarter
ended September 30, 2019.
"The PRV-031 program continues to build momentum, with positive
developments on the regulatory front that strengthen our confidence
in the path forward for the prevention or delay of the onset of
clinical type 1 diabetes (T1D) in at-risk individuals," stated
Ashleigh Palmer, CEO, Provention
Bio. "Recent Breakthrough Therapy and PRIME designations from
the FDA and European Medicines Agency (EMA), respectively,
recognize and confirm the unmet need of these individuals and we
believe validate the transformative potential of this therapeutic
candidate. Based on our interactions with the FDA, we believe
that the existing clinical efficacy and safety, as well as
non-clinical data, has the potential to support a BLA filing with
the FDA in the fourth quarter of next year, and look forward to
confirming this expedited regulatory path at a multi-function, Type
B meeting with the Agency this quarter."
"We believe the progress of our PRV-031 T1D at-risk program not
only represents a unique opportunity in its own right, but also
more broadly validates Provention's founding strategic intent to
develop other novel therapies that intercept or prevent
immune-mediated diseases. We continue to advance our programs,
including the ongoing PROTECT Phase 3 clinical study evaluating
PRV-031 in newly diagnosed T1D patients and our ongoing Phase
1b PREVAIL clinical trial evaluating
PRV-3279. PRV-3279 has the potential to intercept the
pathophysiology of systemic lupus erythematosus (SLE) and other B
cell-mediated autoimmune diseases, as well as manage clinically
relevant immunogenicity associated with gene therapies and certain
recombinant protein therapeutics."
Third Quarter 2019 and Recent Highlights:
PRV-031 (Teplizumab) Granted PRIME Designation by the
EMA
In October 2019,
Provention announced the EMA has granted PRV-031 (teplizumab)
PRIority MEdicines (PRIME) designation for the prevention or delay
of clinical type 1 diabetes (T1D) in individuals at-risk of
developing the disease. PRIME designation is awarded by the EMA to
promising medicines that demonstrate the potential to address
substantial unmet medical need based on clinical data. The
EMA considers PRIME designations a priority and provides them with
special support, including enhanced interactions and dialogue, as
well as a pathway for accelerated evaluation and review.
PRV-031 (Teplizumab) Granted Breakthrough Therapy
Designation (BTD)
In August 2019, the FDA
granted Breakthrough Therapy Designation 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.
Initiated Phase 1b/2a PREVAIL
Clinical Trial Evaluating PRV-3279 in Lupus
In August 2019, Provention announced that it dosed
the first patients in its PREVAIL (PRV-3279 EVAluation In
Lupus) study, a Phase 1b/2a clinical trial evaluating
PRV-3279. Results from a prior single ascending dose Phase 1
study established proof of mechanism and showed that PRV-3279 was
well-tolerated. Provention expects top-line results from the
Phase 1b portion of the clinical
study in the first quarter of 2020, with plans to initiate the
Phase 2a portion of the study in lupus patients later in 2020.
Sean Doherty appointed to the
Board of Directors
In September
2019, Provention announced the appointment of Sean Doherty to Provention's Board of Directors.
Mr. Doherty is the Executive Chairman of the JDRF T1D Fund and
former Bain Capital Managing Director, bringing extensive financial
expertise and a deep knowledge of the therapeutics landscape for
immune-mediated diseases. Mr. Doherty's 20 years of operational,
investment, risk management and governance experience bring
tremendous value to the Provention team.
Announced Top-Line Results from Phase 2a PRINCE Clinical
Trial with PRV-6527
In October
2019, Provention announced top-line results from its
randomized, placebo-controlled Phase 2a PRINCE clinical trial
evaluating twice-daily PRV-6527, an oral Colony Stimulating
Factor-1 Receptor (CSF-1R) small molecule inhibitor. Under the
terms of the in-license agreement, Janssen now has 90 days to
exercise its option to re-acquire this asset to support further
development in inflammatory bowel disease.
Financial Highlights:
As of September 30, 2019, Provention had cash and cash
equivalents totaling $95.1 million. In September 2019, Provention completed a public
follow on offering of 5,750,000 shares and a concurrent private
placement with Amgen of 2,500,000 of its common stock, at a price
of $8.00 per share, resulting in
aggregate net cash proceeds from the sale of the shares, after
deducting underwriting discounts and offering expenses, of
$62.7 million. Provention expects its
operating cash expenses to be in the range of $10 to $12 million
in the fourth quarter of 2019. Provention expects its current cash
and cash equivalents will be sufficient to fund projected operating
requirements into the second half of 2021. Working capital
was $91.4 million as of September 30, 2019. Going forward, Provention
expects to invest in the regulatory, clinical, manufacturing, and
pre-commercial activities related to PRV-031 (teplizumab) as well
as the continued development of PRV-3279, PRV-101, and PRV-015.
Net loss for the third quarter 2019 was $9.8 million,
or $0.24 per basic and diluted share, compared to a net
loss of $5.4 million, or $0.17 per basic and diluted
share, for the same period in 2018. The increase in net loss
was attributable to an increase in research and development costs
of $3.2 million primarily associated to an increase
in clinical development expenses for PRV-031, as well as an
increase in general and administrative costs of $1.4
million.
Net loss for the nine months ended September 30,
2019 was $32.7 million, or $0.85 per basic and
diluted share, compared to a net loss of $21.1 million,
or $1.21 per basic and diluted share, for the same period
in 2018. The increase in net loss was attributable to an
increase in research and development costs
of $10.2 million primarily associated with an
increase in clinical development expenses for PRV-031, PRV-101, and
PRV-3279 and increased internal personnel and consultant costs to
support our clinical programs. Also contributing to the increase in
net loss was an increase in general and administrative costs
of $2.7 million.
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 in the "Events and Webcasts" page in the Investors
page 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 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 (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 (UNAUDITED)
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,324
|
|
$
|
4,140
|
|
$
|
27,896
|
|
$
|
17,684
|
General and
administrative
|
|
|
2,649
|
|
|
1,272
|
|
|
5,593
|
|
|
2,929
|
Total operating
expenses
|
|
|
9,973
|
|
|
5,412
|
|
|
33,489
|
|
|
20,613
|
Loss from
operations
|
|
|
(9,973)
|
|
|
(5,412)
|
|
|
(33,489)
|
|
|
(20,613)
|
Interest
income
|
|
|
204
|
|
|
237
|
|
|
744
|
|
|
339
|
Change in fair value
of warrant liability
|
|
|
—
|
|
|
(217)
|
|
|
—
|
|
|
(520)
|
Loss before income
tax benefit
|
|
|
(9,769)
|
|
|
(5,392)
|
|
|
(32,745)
|
|
|
(20,794)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(9,769)
|
|
|
(5,392)
|
|
|
(32,745)
|
|
|
(20,794)
|
Accretion on Series A
Convertible Redeemable Preferred Stock
|
|
|
—
|
|
|
(25)
|
|
|
—
|
|
|
(276)
|
Net loss attributable
to common stockholders
|
|
$
|
(9,769)
|
|
$
|
(5,417)
|
|
$
|
(32,745)
|
|
$
|
(21,070)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.24)
|
|
$
|
(0.17)
|
|
$
|
(0.85)
|
|
$
|
(1.21)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
40,512
|
|
|
32,000
|
|
|
38,424
|
|
|
17,414
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2019
|
|
December 31, 2018
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
|
|
$
|
95,088
|
|
$
|
58,539
|
Total
assets
|
|
|
|
|
|
|
|
$
|
96,371
|
|
$
|
61,529
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
4,960
|
|
$
|
1,871
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(68,521)
|
|
$
|
(35,776)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
91,411
|
|
$
|
59,658
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/provention-bio-reports-third-quarter-2019-financial-results-300952062.html
SOURCE Provention Bio, Inc.