RED BANK, N.J., Feb. 25, 2021 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today reported
financial results for the fourth quarter and full year ended
December 31, 2020.
"2020 was a pivotal year for Provention Bio and the type 1
diabetes (T1D) landscape," stated Ashleigh Palmer, CEO of
Provention Bio. "The FDA's filing of our BLA for teplizumab
represents a momentous achievement for Provention Bio in our
mission to potentially deliver the first disease-modifying T1D
therapy, which may catalyze a paradigm shift in how
pre-symptomatic, at-risk patients are screened and treated before
the clinical diagnosis of T1D. We look forward to working closely
with the FDA to support the Agency's Priority Review, while we
prepare for a potential commercial launch in the second half of
this year."
Mr. Palmer continued, "In addition to the considerable progress
being made on the teplizumab regulatory front, we're excited about
the advancement of our portfolio of additional autoimmunology
therapeutic candidates. Our recently initiated first-in-human
study of our coxsackievirus B (CVB) polyvalent vaccine candidate,
PRV-101, has the potential to be the first vaccine for the
prevention of coxsackievirus B infection, a presumed trigger in the
development of type 1 diabetes and celiac disease. In
addition, our recent partnership agreement with Huadong Medicine not only aides the funding and
execution of our PRV-3279 clinical development program in lupus,
but we believe also provides external validation of our pioneering
business model focused on intercepting and preventing serious,
debilitating and life-threatening autoimmune diseases."
Fourth Quarter 2020 and Recent Corporate Highlights:
FDA Filing of a BLA and Priority Review for Teplizumab for
the Delay or Prevention of Clinical Type 1 Diabetes in At-risk
Individuals
In January, Provention announced that the Biologics License
Application (BLA) for teplizumab for the delay or prevention of
clinical type 1 diabetes (T1D) in at-risk individuals has been
filed by the FDA. The FDA also granted Provention's request for
Priority Review and assigned a user fee goal date of July 2,
2021, under the Prescription Drug User-Fee Act (PDUFA). In its
acceptance letter, the FDA stated that it is currently planning to
hold an advisory committee meeting, tentatively scheduled
for May 27, 2021. If approved, teplizumab will be the first
disease-modifying therapy for T1D.
Provention is currently also evaluating teplizumab in patients
with newly diagnosed insulin-dependent T1D, the Phase 3 PROTECT
study, and expects full enrollment of the study in the second half
of this year.
Key Findings from Pre-clinical Proof-of-concept Study for
PRV-3279 for the Prevention of Immunogenicity of Gene
Therapy
In January, Provention reported results from a pre-clinical
proof-of-concept study for PRV-3279, a human bispecific biologic
molecule targeting the B cell surface proteins CD32B and CD79B,
conducted in a murine model of gene therapy for Pompe disease. The
company plans to submit the data from this study for presentation
at an upcoming medical conference later in 2021.
Announced Strategic Collaboration to Develop and
Commercialize PRV-3279 in Greater
China with Huadong
In February, Provention and Hangzhou Zhongmei Huadong
Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong
Medicine Co., Ltd. announced that the companies had entered into a
strategic collaboration to develop and commercialize PRV-3279, a
DART® (bispecific antibody-based molecule) targeting the B
cell surface proteins CD32B and CD79B, in Greater China (mainland China, Hong
Kong, Macau and
Taiwan). Under the terms of
the agreement, Provention Bio will receive an upfront payment of
$6 million, up to $11.5 million in research, development, and
manufacturing funding, and up to $172
million in potential development, regulatory and commercial
milestone payments. Provention Bio is also eligible to
receive low-to-mid double-digit royalties as a percentage of net
sales of PRV-3279 by Huadong in Greater
China.
Initiated First-in-Human Study of Coxsackievirus B Vaccine
Candidate PRV-101
In December 2020, Provention
announced the initiation of PROVENT (PROtocol for
coxsackievirus VaccinE in healthy voluNTeers), a
first-in-human study of its polyvalent inactivated coxsackievirus B
(CVB) vaccine candidate, PRV-101. Provention is developing PRV-101
for the prevention of acute CVB infection and the potential delay
or prevention of type 1 diabetes (T1D) and celiac disease. PROVENT
is a placebo-controlled, double-blind, randomized first-in-human
study being conducted at the Clinical Research Services Turku -
CRST Oy, a clinical trial unit in Turku, Finland. Results of PROVENT are expected by
the end of 2021.
Financial Highlights:
As of December 31, 2020, Provention had cash and cash
equivalents and marketable securities of $121.8 million. In
January 2021, the Company completed
an underwritten public offering in which it sold 6,250,000 shares
of common stock at a public offering price of $16.00 per share. In February 2021, the underwriters partially
exercised their option to purchase an additional 587,500 shares at
a price of $16.00 per share.
Aggregate net proceeds from the offering were $102.3 million, after deducting underwriting
discounts and commissions and other offering expenses.
Net loss for the fourth quarter of 2020 was $32.6 million,
or $0.58 per basic and diluted share, compared to a net
loss of $10.5 million, or $0.22 per basic and
diluted share, for the fourth quarter of 2019. The fourth quarter
2020 net loss includes $8.0 million
of non-cash, stock compensation expense primarily resulting from
achievement of two key milestones that triggered the vesting of
certain performance-based stock option grants: the completion of
certain teplizumab CMC activities and the filing of the teplizumab
BLA. In addition, the overall increase in net loss was primarily
attributable to teplizumab related CMC costs, PROTECT study costs,
BLA preparation costs, precommercial costs, and medical affairs
expenses. Cash-based operating expense for the fourth quarter
2020 was $24.6 million.
Net loss for the full year of 2020 was $98.6 million,
or $1.88 per basic and diluted share, compared to a net
loss of $43.3 million, or $1.06 per basic and diluted
share, for the full year of 2019. The full year 2020 net loss
includes $13.2 million of non-cash,
stock compensation expense. Research and development costs
increased $30 million and
was primarily attributable to increased costs for the
teplizumab program, including manufacturing activities, the PROTECT
study, and BLA submission activities. The increase in general
and administrative costs of $25.3
million related primarily to precommercial activities and
the build out of the Company's commercial and corporate
infrastructure during 2020. Cash-based operating expense for
the year ended December 31, 2020 was
$86.5 million.
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 business updates and fourth
quarter and full year 2020 financial results via conference call
today at 8:00 am ET. To access the call, please dial
1-877-870-4263 (domestic) or 1-412-317-0790 (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.
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 Biologics License
Application (BLA) for teplizumab, its lead investigational drug
candidate, for the delay or prevention of clinical type 1 diabetes
in at-risk individuals, has been filed by the U.S. Food and Drug
Administration (FDA). 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 and follow us on Twitter: @ProventionBio.
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 and the potential therapeutic effects of
teplizumab and the Company's 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 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, 2020, 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 Contacts:
Robert
Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
Provention Bio,
Inc.
|
Selected Financial
Data
|
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
December 31,
|
|
For the Years
Ended December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
(unaudited)
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
20,581
|
|
$
|
8,463
|
|
$
|
66,360
|
|
$
|
36,359
|
General and
administrative
|
|
|
12,039
|
|
|
2,420
|
|
|
33,327
|
|
|
8,013
|
Total operating
expenses
|
|
|
32,620
|
|
|
10,883
|
|
|
99,687
|
|
|
44,372
|
Loss from
operations
|
|
|
(32,620)
|
|
|
(10,883)
|
|
|
(99,687)
|
|
|
(44,372)
|
Interest
income
|
|
|
44
|
|
|
343
|
|
|
583
|
|
|
1,087
|
Loss before income
tax benefit
|
|
|
(32,576)
|
|
|
(10,540)
|
|
|
(99,104)
|
|
|
(43,285)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
523
|
|
|
—
|
Net loss
|
|
$
|
(32,576)
|
|
$
|
(10,540)
|
|
$
|
(98,581)
|
|
$
|
(43,285)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.58)
|
|
$
|
(0.22)
|
|
$
|
(1.88)
|
|
$
|
(1.06)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
56,502
|
|
|
47,641
|
|
|
52,457
|
|
|
40,747
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2020
|
|
December 31,
2019
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
121,824
|
|
$
|
85,373
|
Total
assets
|
|
|
|
|
|
|
|
$
|
128,519
|
|
$
|
85,996
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
17,445
|
|
$
|
3,840
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(177,642)
|
|
$
|
(79,061)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
111,074
|
|
$
|
82,156
|
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SOURCE Provention Bio, Inc.