OLDWICK, N.J., Aug. 13, 2018 /PRNewswire/ --
Recent Corporate Highlights:
- Closed initial public offering of common stock on July 19, 2018, generating $63.9 million in gross proceeds
- Expanded pipeline with two additional clinical-stage assets in
type 1 diabetes (T1D) and systemic lupus erythematosus (SLE);
pipeline now consists of five programs targeting the interception
and prevention of immune-mediated disease
- Appointed Wayne Pisano, former
President of Sanofi Pasteur, to board of directors
- Recruited Dr. Mark Rigby and
additional clinical development and operations expertise to lead
T1D and SLE programs
Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage
biopharmaceutical company dedicated to intercepting and preventing
immune-mediated diseases, today reported financial results for the
second quarter ended June 30, 2018
and provided a business update. These results mark the first
quarterly reporting period for Provention as a publicly traded
company.
On July 19, 2018, Provention
closed its initial public offering ("IPO") of shares of its common
stock at a price to the public of $4.00 per share. The shares began trading on The
Nasdaq Capital Market under the ticker symbol "PRVB" on
July 24, 2018. Gross proceeds from
the upsized offering were $63.9
million, prior to deducting underwriting commissions and
expenses.
"We are delighted to provide our first quarterly results and
business update as a publicly traded company," stated Ashleigh Palmer, CEO of Provention Bio. "The
successful completion of our IPO was a transformative event for
Provention. In the short period of time from our founding
financing in April 2017 to our recent
IPO, we've built a diverse clinical-stage pipeline that now
consists of five novel therapeutics that were acquired or
in-licensed because of their potential to interrupt, delay, reverse
or prevent the onset or progression of life-threatening or
debilitating immune-mediated disease. Our unique focus on
disease intervention and prevention, as well as our deep
understanding of immune-related pathophysiology, translational
medicine, and clinical trial design and execution, set Provention
apart, and are fundamental to our strategic intent."
Mr. Palmer continued, "Our current development pipeline consists
of a Phase 3 candidate for the interception of type 1 diabetes
(T1D), two Phase 2 candidates for inflammatory bowel diseases
(IBD), a Phase 1 candidate for systemic lupus erythematosus (SLE),
and a pre-investigational new drug (IND)-stage vaccine for acute
coxsackievirus B (CVB) infection and the potential prevention or
delay in onset of T1D. These assets were obtained from
industry-leading pharmaceutical companies, such as Janssen
Pharmaceuticals and MacroGenics, as well as innovative,
development-stage companies such as Vactech, Ltd., a Finnish
biotechnology company."
"In recent months we have also continued to build a talented
team with significant experience and expertise in autoimmune
diseases. Most recently, we added Mark
Rigby, M.D., Ph.D., to support the advancement of our
pipeline as Vice President, Clinical Development, bringing his
significant expertise in T1D interception to Provention. Earlier in
the second quarter we added Wayne
Pisano, former President of Sanofi Pasteur, to our Board of
Directors. Wayne's vast industry experience will be
invaluable as we continue to progress and develop our
programs."
Mr. Palmer concluded, "With the proceeds from the IPO and our
leadership team in place, we believe we are well positioned to move
our clinical candidates forward efficiently and in accordance with
our rapid go/no-go clinical development strategy. We plan to
initiate a number of clinical studies and other development
activities over the 12-18 months that we expect to showcase the
potential of our pipeline assets to intercept and prevent
immune-mediated diseases and substantially improve the lives of
patients around the world, as well as to continue to enhance
shareholder value."
Pipeline Summary:
PRV-031 (anti-CD3 antibody for type 1 diabetes)
Provention's most advanced product candidate is PRV-031 (also
known as teplizumab), which is a Phase 3 anti-CD3 monoclonal
antibody (mAb) and is being developed for the interception of type
1 diabetes (T1D). PRV-031 was acquired from MacroGenics, Inc. and
has been the subject of multiple clinical studies involving more
than 1,000 subjects (823 patients received PRV-031).
Provention expects to commence a randomized, double-blind,
placebo-controlled, pivotal Phase 3 clinical trial of PRV-031 in
the second half of 2019 – the PROTECT (PROvention T1D trial
Evaluating C-peptide with Teplizumab) study, which is expected to
enroll between 300 and 350 pediatric and adolescent T1D patients in
North America and Europe.
PRV-6527 (oral CSF-1R inhibitor for Crohn's disease)
PRV-6527 was developed by Janssen Pharmaceuticals and has
undergone clinical testing in 178 subjects to date. It is a highly
potent and selective small-molecule oral inhibitor of CSF-1R, which
Provention is developing to intercept the progression of Crohn's
disease before it becomes a chronic, life-altering condition.
PRV-6527 is currently the subject of a randomized,
double-blinded, placebo-controlled Phase 2a proof-of-concept (PoC)
clinical trial – the PRINCE (PRovention INvestigation in Crohn's
DiseasE) study, which the Company initiated in the first quarter
2018. Provention expects to report top line data from this study in
the second half of 2019.
PRV-300 (anti-TLR3 antibody for ulcerative colitis)
PRV-300, also developed by Janssen Pharmaceuticals, is a
first-in-class, fully human, IgG4κ monoclonal antibody (mAb) that
binds the extracellular domain of toll-like receptor 3 (TLR3) with
high specificity and affinity. Provention is developing PRV-300 to
intercept the progression of ulcerative colitis (UC) before it
becomes a chronic, life-altering condition.
PRV-300 is currently in a randomized, double-blind,
placebo-controlled Phase 1b clinical
trial – the PULSE (Provention ULcerative Colitis Study Evaluation)
study, which Provention initiated in the first quarter 2018.
Top-line data is expected to be available in the second half of
2019.
PRV-3279 (dual affinity biologic for lupus and other
autoimmune diseases)
PRV-3279 is a humanized CD32B x CD79B (DART®) protein developed
by MacroGenics, which Provention is developing to intercept the
pathophysiology of systemic lupus erythematosus (SLE) before it
becomes a chronic, life-altering condition.
Provention plans to initiate a randomized, double-blind,
placebo-controlled Phase 1b/2a
clinical study in the second half of 2019. The study will begin
with an evaluation of multiple ascending doses of PRV-3279 in
healthy volunteers, followed by expansion into an SLE patient
cohort. Based on the outcome, Provention may choose to pursue lupus
nephritis (a possible orphan indication) and/or the broader SLE
indication.
PRV-101 (coxsackievirus B vaccine for CVB infection and
T1D)
PRV-101 is a polyvalent coxsackievirus B (CVB) vaccine licensed
from Vactech, Ltd., which Provention is developing as a vaccine for
acute CVB infection and for the potential prevention of up to 50%
of worldwide type 1 diabetes (T1D) cases.
PRV-101 is currently in investigational new drug (IND)-enabling
studies focused on safety and immunogenicity. Provention plans to
complete these studies and file an IND application for PRV-101 in
2019, prior to initiating a first-in-human Phase 1 clinical study
in 2020.
Financial Highlights:
As of June 30, 2018, Provention
had cash and cash equivalents of $10.2
million. In July 2018, the
Company completed its initial public offering and received
approximately $59.3 million in net
proceeds after deducting commissions and expenses.
Net loss for the second quarter 2018 was $10.5 million, or $1.05 per basic and diluted share, compared to a
net loss of $4.1 million, or
$0.44 per basic and diluted share,
for the same period in 2017. The increase in net loss
year-over-year is primarily attributable to costs associated with
the clinical development of PRV-6527 and PRV-300, development of
PRV-101, and the expansion of our clinical pipeline with two
additional assets from MacroGenics in May 2018.
Net loss for the six months ended 2018 was $15.7 million, or $1.57 per basic and diluted share, compared to a
net loss of $4.2 million, or
$0.48 per basic and diluted share,
for the same period in 2017. The increase in net loss
year-over-year is primarily attributable to costs associated with
clinical development of PRV-6527 and PRV-300, development expenses
related to PRV-101, and the expansion of our clinical pipeline with
two additional assets from MacroGenics in May 2018.
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. Our diverse portfolio was assembled with product
candidates that have undergone clinical testing but may have been
underdeveloped or deprioritized assets at other companies.
Provention's mission is to in-license, transform and develop
clinical-stage, or nearly clinical-stage, therapeutic candidates
targeting the high morbidity, mortality and escalating costs of
autoimmune and inflammatory diseases including: type 1 diabetes
(T1D), Crohn's disease, ulcerative colitis, lupus, and certain
life-threating viral diseases. For more information on Provention
Bio, please visit www.proventionbio.com.
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 detailed in
Provention's prospectus filed with the Securities and Exchange
Commission as well as in quarterly and annual reports and
other documents that may be filed by the Company from time
to time 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.
Media & Investor Contacts
Jason Rando / Joshua
Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
T: 212 375 2665 / 212 375 2664
jrando@tiberend.com
jdrumm@tiberend.com
Financial Tables to Follow
PROVENTION BIO,
INC.
|
SELECTED FINANCIAL
DATA (unaudited)
|
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
9,161
|
|
$
|
3,731
|
|
$
|
13,544
|
|
$
|
3,731
|
General and
administrative
|
|
|
1,004
|
|
|
256
|
|
|
1,657
|
|
|
299
|
Total operating
expenses
|
|
|
10,165
|
|
|
3,987
|
|
|
15,201
|
|
|
4,030
|
Operating
loss
|
|
|
(10,165)
|
|
|
(3,987)
|
|
|
(15,201)
|
|
|
(4,030)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
45
|
|
|
30
|
|
|
102
|
|
|
30
|
Change in fair value
of warrant liability
|
|
|
(219)
|
|
|
(86)
|
|
|
(303)
|
|
|
(86)
|
Net loss
|
|
|
(10,339)
|
|
|
(4,043)
|
|
|
(15,402)
|
|
|
(4,086)
|
Accretion on Series A
Convertible Redeemable
Preferred Stock
|
|
|
(126)
|
|
|
(90)
|
|
|
(251)
|
|
|
(90)
|
Net loss attributable
to common stockholders
|
|
$
|
(10,465)
|
|
$
|
(4,133)
|
|
$
|
(15,653)
|
|
$
|
(4,176)
|
Net loss per common
share, basic
and diluted
|
|
$
|
(1.05)
|
|
$
|
(0.44)
|
|
$
|
(1.57)
|
|
$
|
(0.48)
|
Weighted average
common shares outstanding,
basic and diluted
|
|
|
10,000
|
|
|
9,473
|
|
|
10,000
|
|
|
8,740
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2018
|
|
December 31,
2017
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
|
|
$
|
10,209
|
|
$
|
21,834
|
Total
assets
|
|
|
|
|
|
|
|
$
|
12,236
|
|
$
|
22,428
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
2,994
|
|
$
|
2,276
|
Series A Convertible
Redeemable Preferred
Stock
|
|
|
|
|
|
|
|
$
|
26,436
|
|
$
|
26,185
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(24,700)
|
|
$
|
(9,298)
|
Total stockholders'
deficit
|
|
|
|
|
|
|
|
$
|
(17,194)
|
|
$
|
(6,033)
|
View original
content:http://www.prnewswire.com/news-releases/provention-bio-reports-second-quarter-2018-financial-results-and-provides-business-update-300695825.html
SOURCE Provention Bio, Inc.