OLDWICK, N.J., Aug. 6, 2020 /PRNewswire/ -- Provention Bio, Inc.
(Nasdaq: PRVB), a clinical-stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated disease,
today reported financial results for the second quarter ended
June 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)
"In the past few months, we have achieved tremendous progress in
support of our efforts to advance teplizumab toward the market for
the delay or prevention of insulin-dependent type 1 diabetes (T1D)
in presymptomatic patients," stated Ashleigh Palmer, CEO, Provention Bio. "New
data presented at the American Diabetes Association conference from
the "At-Risk" TN-10 study strengthened the value proposition for
teplizumab, with long-term data now showing that teplizumab delays
the onset of insulin-dependent T1D by approximately three years
versus placebo, adding one year to the two-year delay presented in
2019. In addition, treatment with teplizumab significantly
reversed the decline of C-peptide levels, providing further
evidence of the disease-modifying potential of
teplizumab."
"We remain laser focused on submitting the clinical module of
our rolling BLA submission in Q3 2020 and completing the remaining
modules in Q4 2020. We are pleased to report today that we
have successfully completed the commercial-scale drug substance
process performance qualification (PPQ) campaign, a key gating
factor for our chemistry, manufacturing and controls (CMC)
module. We strengthened our financial position with a
successful financing in June, which resulted in net cash proceeds
of $103.3 million. We continue
to scale our organization in preparation for a potential commercial
launch and we are well-positioned to execute our strategy to bring
teplizumab to the T1D community as soon as possible."
Second Quarter 2020 and Recent Corporate Highlights:
Successfully Completed Commercial-Scale PPQ Runs
The Company reported today that it has recently completed three,
back-to-back, commercial-scale, drug substance process performance
qualification (PPQ) batches at AGC Biologics, the Company's
contract manufacturer. The batches will serve as the foundation of
the chemistry, manufacturing and controls (CMC) module for the BLA
submission, which the company expects to complete in the fourth
quarter of 2020.
Extended TN-10 Follow-up Data Now Shows That Teplizumab
Delays the Onset of Insulin-Dependent Type 1 Diabetes in
Presymptomatic Diabetes Patients by A Median of Approximately Three
Years Versus Placebo
In June, extended follow-up data from the pivotal "At-Risk"
TN-10 study conducted by TrialNet was presented at the American
Diabetes Association (ADA) 80th Scientific Sessions. The
follow-up data demonstrates that one course of teplizumab is now
shown to delay insulin-dependence in presymptomatic T1D patients by
a median of approximately three years compared to placebo. At the
same meeting in 2019, the study demonstrated a median delay of two
years to the onset of insulin-dependence in presymptomatic
patients. Additionally, teplizumab was shown to significantly
reverse the decline of C-peptide levels, suggesting not just a
delay in the destruction of beta cells but also restoration of
insulin production by dysfunctional beta cells.
Appointed Heidy Abreu
King-Jones as Chief Legal Officer
In August 2020, Provention
appointed Heidy Abreu King-Jones as
Chief Legal Officer. Heidy brings nearly 12 years of corporate
counsel and law firm experience in the biotechnology and
pharmaceutical sectors, including the development of compliance
programs for rare disease launches.
Added Key Roles to Commercial, Sales, Regulatory and Medical
Affairs Functions
In recent months, Provention has continued to scale its
organization to support a potential commercial launch of
teplizumab. This includes recent hires in leadership positions
across the Market Access, Sales, Analytics & Forecasting,
Medical Affairs, and Regulatory Affairs teams. The new team members
bring extensive, relevant experience in rare disease launches in
the biotechnology sector.
Appointed Nancy Wysenski to
the Board of Directors
In May 2020, Provention announced
the appointment of Nancy Wysenski, a
seasoned pharmaceutical executive with rare disease and
commercialization experience, to the Company's Board of Directors.
Ms. Wysenski brings tremendous value to the Provention team, with
more than 30 years of leadership in biotechnology and
pharmaceuticals, including having served as the Chief Commercial
Officer of Vertex Pharmaceuticals.
Announced Publication of Proof-of-Concept Data for a
Preclinical Prototype of Coxsackievirus B Vaccine
In a paper published in Science Advances in May 2020, a preclinical prototype of
Provention's polyvalent coxsackievirus B vaccine, PRV-101, was
shown to be well-tolerated, immunogenic and protective against
coxsackievirus B infections and diabetes in relevant animal
models. Provention is developing PRV-101 as a potential
vaccine for acute coxsackievirus infection and for the potential
prevention of T1D and celiac disease. These results provide a solid
scientific basis for human trials with PRV-101, which the Company
expects to initiate in the second half of 2020.
Financial Highlights:
In June 2020, the Company
completed a public follow-on offering of 7,590,000 shares,
including 990,000 shares sold pursuant to the full exercise of the
underwriters' option to purchase additional shares, at a price of
$14.50 per share, resulting in
aggregate net cash proceeds from the sale of the shares, after
deducting underwriting discounts and offering expenses, of
$103.3 million. In addition, during
the second quarter of 2020 and prior to the follow-on offering the
Company generated $9.9 million of net
proceeds from the sale of common stock under its at-the-market
program. As a result, Provention had cash, cash equivalents
and marketable securities of $172.2
million as of June 30, 2020.
Net loss for the second quarter 2020 was $22.1 million,
or $0.45 per basic and diluted share, compared to a net
loss of $12.0 million, or $0.32 per basic and
diluted share, for the same period in 2019. The increase in net
loss was primarily attributable to teplizumab related CMC costs,
BLA preparation costs, precommercial costs, and medical affairs
expenses.
Cash-based operating expenses were $21.5
million for the three months ended June 30, 2020 and included teplizumab CMC
expenses of $7.5 million and
$4.8 million of precommercial
expenses. Provention expects to utilize $44
million to $52 million of cash for its operating
needs in the second half of 2020.
Conference Call and Webcast Information:
Provention Bio will discuss these results via conference call
today at 8:00 am ET. To access the
call, please dial 1-888-567-1603 (domestic) or 1-862-298-0702
(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 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 teplizumab, a pre-commercial-stage candidate
that has been shown to delay the onset of insulin-dependent type 1
diabetes (T1D) in at-risk patients during the presymptomatic phase
of the disease. The Company's portfolio includes additional
clinical 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 but not limited to, statements relating to the
Company's studies, planned submissions and timelines for the
rolling BLA submission for teplizumab, the potential health
benefits of, and commercialization efforts for teplizumab, planned
research and development efforts for the Company's investigational
product candidates and the Company's planned financial investments
and cash runway. 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
delays in, or failure to obtain FDA approvals or clearances and
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;
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, our 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. 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
15,032
|
|
$
|
10,550
|
|
$
|
24,122
|
|
$
|
20,572
|
General and
administrative
|
|
|
7,764
|
|
|
1,707
|
|
|
11,539
|
|
|
2,944
|
Total operating
expenses
|
|
|
22,796
|
|
|
12,257
|
|
|
35,661
|
|
|
23,516
|
Loss from
operations
|
|
|
(22,796)
|
|
|
(12,257)
|
|
|
(35,661)
|
|
|
(23,516)
|
Interest
income
|
|
|
151
|
|
|
253
|
|
|
434
|
|
|
540
|
Loss before income
tax benefit
|
|
|
(22,645)
|
|
|
(12,004)
|
|
|
(35,227)
|
|
|
(22,976)
|
Income tax
benefit
|
|
|
523
|
|
|
—
|
|
|
523
|
|
|
—
|
Net loss
|
|
$
|
(22,122)
|
|
$
|
(12,004)
|
|
$
|
(34,704)
|
|
$
|
(22,976)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.45)
|
|
$
|
(0.32)
|
|
$
|
(0.72)
|
|
$
|
(0.61)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
49,199
|
|
|
37,363
|
|
|
48,449
|
|
|
37,362
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
172,155
|
|
$
|
85,373
|
Total
assets
|
|
|
|
|
|
|
|
$
|
175,755
|
|
$
|
85,996
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
11,979
|
|
$
|
3,840
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(113,765)
|
|
$
|
(79,061)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
163,776
|
|
$
|
82,156
|
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SOURCE Provention Bio, Inc.