RED BANK, N.J., Nov. 5, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing autoimmune disease, today reported
financial results for the third quarter ended September 30, 2020, and provided a business
update.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"We are excited about the progress the Provention Bio team has
made in recent months as we work to redefine the treatment
landscape for T1D and other autoimmune diseases," stated
Ashleigh Palmer, CEO, Provention
Bio. "Earlier this week, we announced our achievement of a major
milestone with the completion of the rolling BLA submission for
teplizumab for the delay or prevention of clinical T1D in at-risk
individuals. In parallel with our regulatory efforts, we are
focused on preparing for a potential product approval and launch in
mid-2021. We recently introduced two national campaigns to educate
key stakeholders about early-stage T1D and the potential advantages
of screening populations at risk of developing clinical-stage
disease. In parallel with teplizumab, we are advancing our
portfolio of additional therapeutic candidates targeting the
interception or prevention of autoimmune disease. We recently
initiated a Phase 2 trial for PRV-015, an anti-IL-15 human
monoclonal antibody which, if approved, has the potential to be the
first therapeutic for the treatment of non-responsive celiac
disease."
Third Quarter 2020 and Recent Corporate Highlights:
Completed Rolling Submission of the Biologics License
Application (BLA) to the FDA for Teplizumab for the Delay or
Prevention of Clinical T1D in At-risk Individuals
Earlier this week, Provention announced the completion of the
rolling submission of a BLA to the U.S. Food and Drug
Administration (FDA) for teplizumab for the delay or prevention of
clinical T1D in at-risk individuals with the submission of the
chemistry, manufacturing and controls (CMC) and administrative
information modules. In September, the Company announced submission
of the clinical module. The FDA has 60 days to review the
final submission to determine if the BLA is complete. If deemed
complete, the submission will be considered acceptable for filing
and review, and the FDA will set a PDUFA goal date.
Provention has expressly requested a Priority Review in
conjunction with the submission. A Priority Review designation
means FDA's goal is to take action on an application within 6
months (compared to 10 months under standard review).
Commenced National Type 1 Diabetes Campaigns Focused on
Screening and Disease State Education
In October, Provention announced two closely aligned early-stage
disease and screening education campaigns, "Connected by T1D" and
"Type 1 Tested", focused on creating awareness of the importance of
screening individuals at disproportionate risk due to having a
family member(s) with T1D. Early and routine autoantibody screening
is the call-to-action in each campaign with the goal of doctors,
patients and families making more informed decisions that may
decrease the likelihood of diabetic ketoacidosis (DKA) and other
risks.
Initiated Phase 2b PROACTIVE
Study of PRV-015 (anti-IL-15) in Non-responsive Celiac Disease
(NRCD)
In August 2020, Provention
announced the initiation of the Phase 2b PROACTIVE (PROvention Amgen
Celiac ProtecTIVE) study of PRV-015 which is being
developed under an agreement with Amgen. The placebo-controlled,
double-blind, randomized study will examine the efficacy and safety
of three dose levels of PRV-015 as compared to placebo in
approximately 220 adults with NRCD.
Appointed John K. Jenkins, MD
to the Board of Directors
In August 2020, Provention
announced the appointment of John K.
Jenkins MD, the former Director of the Office of New Drugs
at the FDA's Center for Drug Evaluation and Research (CDER), to the
Company's Board of Directors. Dr. Jenkins currently serves as
Principal, Drug and Biological Products for Greenleaf Health, an
FDA-focused strategic regulatory consulting firm, where he offers
extensive experience guiding companies through regulatory
processes.
Successfully Completed Commercial-Scale PPQ Runs
In August 2020, Provention
announced the completion of three back-to-back, commercial scale,
drug substance process performance qualification (PPQ) batches at
AGC Biologics, the Company's contract manufacturer. These
batches served as a foundation for the CMC module of the recently
completed BLA submission.
Financial Highlights:
Net loss for the third quarter 2020 was $31.3 million,
or $0.56 per basic and diluted share, compared to a net
loss of $9.8 million, or $0.24 per basic and diluted
share, for the same period in 2019. The increase in net loss was
primarily attributable to teplizumab related CMC costs, PROTECT
study costs, BLA preparation costs, precommercial costs, and
medical affairs expenses.
As of September 30, 2020, Provention had cash, cash
equivalents and marketable securities of $147.2
million. Cash-based operating expenses were $28.7 million for the three months ended
September 30, 2020 and included
teplizumab CMC expenses of $8.5
million and $6.0 million of
precommercial expenses. Provention expects to
utilize $24 million to $28 million of cash for
its operating needs in the fourth quarter of 2020.
Conference Call and Webcast Information:
Provention Bio will discuss these business updates and third
quarter financial results via conference call today at 8:00 am ET. To access the call, please dial
1-866-682-6100 (domestic) or 1-862-298-0702 (international) ten
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 biopharmaceutical
company focused on advancing the development of investigational
therapies that may intercept and prevent debilitating and
life-threatening immune-mediated disease. The Company has submitted
a BLA to the FDA for its lead investigational drug candidate,
teplizumab, for the delay or prevention of clinical type 1 diabetes
(T1D) in at-risk individuals. The Company's pipeline includes
additional clinical-stage product candidates that have demonstrated
in pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in other autoimmune diseases, including celiac
disease and lupus. Visit www.proventionbio.com for more
information or follow us on Twitter: @Proventiobio
Internet Posting of Information
Provention Bio, Inc. uses its
website, www.proventionbio.com, as a means of disclosing
material nonpublic information and for complying with its
disclosure obligations under Regulation FD. Such disclosures will
be included on the Company's website in the "News" section.
Accordingly, investors should monitor this portion of the Company's
website, in addition to following its press
releases, SEC filings and public conference calls and
webcasts.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to regulatory
review of the BLA submission for teplizumab and the potential
approval and commercial launch of teplizumab, including timelines
relating to the same, the potential therapeutic effects of
teplizumab and the Company's product candidates, the Company's
expected operating expenses for the fourth quarter and the
Company's financial and other business plans, including further
development and clinical trial plans for its other product
candidates.. 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 the Company'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
delays in, or failure to obtain FDA approvals or clearances for
teplizumab or other Company product candidates and the potential
for noncompliance with FDA regulations; the potential impacts of
COVID-19 on our business and financial results; changes in law,
regulations, or interpretations and enforcement of regulatory
guidance; uncertainties of patent protection and litigation;
the Company's dependence upon third parties; substantial
competition; the Company's need for additional financing and the
risks listed under "Risk Factors" in the Company's annual report on
Form 10-K for the year ended December 31,
2019, quarterly reports on form 10-Q, 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, whether as a result of new
information, future developments or otherwise, except as may be
required by applicable law. The information set forth herein speaks
only as of the date hereof.
Investor Contact:
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
21,657
|
|
$
|
7,324
|
|
$
|
45,779
|
|
$
|
27,896
|
General and
administrative
|
|
|
9,749
|
|
|
2,649
|
|
|
21,288
|
|
|
5,593
|
Total
operating expenses
|
|
|
31,406
|
|
|
9,973
|
|
|
67,067
|
|
|
33,489
|
Loss from
operations
|
|
|
(31,406)
|
|
|
(9,973)
|
|
|
(67,067)
|
|
|
(33,489)
|
Interest
income
|
|
|
105
|
|
|
204
|
|
|
539
|
|
|
744
|
Loss before income
tax benefit
|
|
|
(31,301)
|
|
|
(9,769)
|
|
|
(66,528)
|
|
|
(32,745)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
523
|
|
|
—
|
Net loss
|
|
$
|
(31,301)
|
|
$
|
(9,769)
|
|
$
|
(66,005)
|
|
$
|
(32,745)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.56)
|
|
$
|
(0.24)
|
|
$
|
(1.29)
|
|
$
|
(0.85)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
56,339
|
|
|
40,512
|
|
|
51,098
|
|
|
38,424
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2020
|
|
December 31,
2019
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
147,158
|
|
$
|
85,373
|
Total
assets
|
|
|
|
|
|
|
|
$
|
151,803
|
|
$
|
85,996
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
16,404
|
|
$
|
3,840
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(145,066)
|
|
$
|
(79,061)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
135,399
|
|
$
|
82,156
|
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SOURCE Provention Bio, Inc.