OLDWICK, N.J., Nov. 8, 2018 /PRNewswire/ --
Q3 2018 and Recent Corporate Highlights:
- Completed $63.9 million upsized
initial public offering
- Announced co-development agreement with Amgen and in-licensing
of PRV-015 (Amgen's AMG-714), a novel anti-IL-15 monoclonal
antibody for the treatment of gluten-free diet non-responsive
celiac disease (NRCD)
- Completed enrollment of Phase 1b
clinical trial of PRV-300 in moderate-to-severe ulcerative colitis
patients
- Appointed Avery (Chip) W. Catlin
to Board of Directors and hired leading T1D Expert, Dr.
Mark Rigby, as Vice President,
Clinical Development
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,
2018, and provided a business update.
"Provention has continued to build momentum since completing our
initial public offering in July. Our just-announced co-development
agreement with Amgen and in-licensing of AMG-714 (PRV-015), is a
clear indication that our strategic vision of intercepting and
preventing immune-mediated disease is compelling and resonates with
industry leaders and innovators," stated Ashleigh Palmer, CEO of Provention Bio. "In just
eighteen months since our founding financing, we have been able to
build a deep and diversified pipeline that now includes six
programs targeting the interception and prevention of chronic
autoimmune diseases including type 1 diabetes, Crohn's disease,
ulcerative colitis, lupus, and celiac disease. In so doing, we have
demonstrated a unique ability to customize strategically aligned
relationships that leverage the strengths, expertise, resources,
and even manufacturing capabilities of technology originators,
licensors and partners, including Janssen Pharmaceuticals and, now,
Amgen."
Mr. Palmer concluded, "Looking ahead, we expect the fourth
quarter and 2019 to be a period of continued growth and momentum
for Provention as we advance our clinical programs targeting
upstream processes that could substantially improve the lives of
patients and their families who must endure the suffering and bear
the burden of immune-mediated disease."
Third Quarter 2018 and Recent Activities:
- Announced Co-Development Agreement with Amgen and
In-Licensing of AMG-714 (PRV-015) in Celiac Disease
On November 5, 2018,
Provention and Amgen announced a licensing and co-development
agreement for PRV-015 (Amgen's AMG 714), a novel anti-IL-15
monoclonal antibody being developed for the treatment of
gluten-free diet non-responsive celiac disease (NRCD).
Co-development efforts at Provention will be led by researchers
with previous experience developing AMG 714. Under the terms of the
agreement, Provention will conduct and fund a Phase 2b trial in NRCD and lead the next phase of
development and regulatory activities for the program. Amgen has
agreed to make an equity investment of $20
million in Provention coincident with Provention's next
financing event or the receipt of non-dilutive funding, subject to
certain terms and conditions. Amgen is also responsible for the
manufacturing of AMG 714. Upon completion of the Phase 2b trial, Amgen has the right to reacquire the
rights to PRV-015 for a $150 million
payment to Provention, plus an additional regulatory milestone
payment, and royalties on future sales.
- Completed Enrollment of Phase 1b Clinical Trial of PRV-300 in
Moderate-to-Severe Ulcerative Colitis
On October 23, 2018,
Provention announced that it completed enrollment of its Phase
1b clinical trial of PRV-300,
enrolling a total of 37 patients with moderate-to-severe ulcerative
colitis (UC). Provention is developing PRV-300, an anti-TLR3
monoclonal antibody, to intercept upstream disease processes in UC
patients. The Phase 1b clinical trial
of PRV-300 (Provention Ulcerative colitis Safety, pharmacokinetic
and pharmacodynamic Evaluation, or PULSE) was initiated in the
first quarter of 2018. The primary endpoint of the study is safety,
with secondary endpoints designed to evaluate the effect of PRV-300
on endoscopic and histologic endpoints, and a biopsy-based mucosal
gene expression signature. Top-line data from PULSE are expected in
the second quarter of 2019.
- Appointed Accomplished Biotech Executive, Chip Catlin, to its Board of Directors and Hired
Leading T1D Expert, Dr. Mark Rigby,
as Vice President, Clinical Development
On September 5, 2018,
Provention announced the appointment of Avery (Chip) W. Catlin, a seasoned and
accomplished corporate financial executive, to its Board of
Directors. Mr. Catlin brings more than 22 years of experience as a
senior financial officer of public biopharmaceutical companies to
Provention. He served previously as Senior Vice President and Chief
Financial Officer of Celldex Therapeutics, Inc. Prior to Celldex,
Mr. Catlin held senior financial and operational positions with
biopharma companies Endogen, Inc., and Repligen Corporation. He
currently sits on the Board of Corbus Pharmaceutical Holdings, Inc.
Mr. Catlin earned a B.A. in Psychology from the University of Virginia and an MBA from Boston College. He is also a certified public
accountant.
Additionally, on July 31, 2018,
Provention announced the appointment of Mark Rigby, MD, PhD, FAAP, FCCM, to the role of
Vice President, Clinical Development. A key opinion leader in T1D
research and development, Dr. Rigby joined Provention after more
than 25 years of clinical and research experience in academics and
industry. Most recently he served as Director, Immunology Early
Development and Translational Medicine for Janssen Pharmaceuticals,
a Johnson and Johnson Company, where he led multiple clinical and
research programs including clinical trials focused on T1D
interception in new onset and pre-symptomatic disease.
Financial Highlights:
As of September 30, 2018,
Provention had cash and cash equivalents of $64.3 million. In July
2018, the Company completed its initial public offering
which generated approximately $59.3
million in net proceeds after deducting commissions and
expenses.
Net loss for the second quarter 2018 was $5.4 million, or $0.17 per basic and diluted share, compared to a
net loss of $1.5 million, or
$0.15 per basic and diluted share,
for the same period in 2017. The increase in net loss
year-over-year is primarily attributable to an increase in research
and development costs of $3.3 million
associated with the clinical development of PRV-6527 and PRV-300,
the development of PRV-101, and costs for PRV-031, which was
acquired from MacroGenics in May
2018, as well as an increase in general and administrative
costs of $0.8 million.
Net loss for the nine months ended 2018 was $21.1 million, or $1.21 per basic and diluted share, compared to a
net loss of $5.7 million, or
$0.62 per basic and diluted share,
for the same period in 2017. The increase in net loss
year-over-year is primarily attributable to an increase in research
and development costs of $13.1
million associated with clinical development of PRV-6527 and
PRV-300, the development expenses related to PRV-101, and costs
related to the expansion of our clinical pipeline with two
additional assets from MacroGenics in May
2018, as well as an increase in general and administrative
costs of $2.1 million.
Conference Call Information:
Provention will host a
conference call and live audio webcast on Thursday, November 8, 2018, at 8:30 a.m. ET, to discuss its corporate and
financial results for the third quarter of 2018. Interested
participants and investors may access the conference call by
dialing either:
- (877) 870-4263 (U.S.)
- (412) 317-0790 (international)
An audio webcast will be accessible via the Investors section of
the Provention website http://investors.proventionbio.com/home. An
archive of the webcast will remain available for 90 days beginning
later today, November 8, 2018, at
approximately 9:30 a.m. ET.
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 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, celiac
disease, 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 listed under "Risk
factors" in our quarterly report on Form 10-Q for the quarter ended
June 30, 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.
***
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
4,140
|
|
$
|
887
|
|
$
|
17,684
|
|
$
|
4,618
|
General and
administrative
|
|
|
1,272
|
|
|
488
|
|
|
2,929
|
|
|
788
|
Total operating
expenses
|
|
|
5,412
|
|
|
1,375
|
|
|
20,613
|
|
|
5,406
|
Operating
loss
|
|
|
(5,412)
|
|
|
(1,375)
|
|
|
(20,613)
|
|
|
(5,406)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
237
|
|
|
50
|
|
|
339
|
|
|
80
|
Change in fair value
of warrant liability
|
|
|
(217)
|
|
|
(37)
|
|
|
(520)
|
|
|
(123)
|
Net loss
|
|
|
(5,392)
|
|
|
(1,362)
|
|
|
(20,794)
|
|
|
(5,449)
|
Accretion on Series A
Convertible Redeemable Preferred Stock
|
|
|
(25)
|
|
|
(127)
|
|
|
(276)
|
|
|
(217)
|
Net loss attributable
to common stockholders
|
|
$
|
(5,417)
|
|
$
|
(1,489)
|
|
$
|
(21,070)
|
|
$
|
(5,666)
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.17)
|
|
$
|
(0.15)
|
|
$
|
(1.21)
|
|
$
|
(0.62)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
32,000
|
|
|
10,000
|
|
|
17,414
|
|
|
9,158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2018
|
|
December 31, 2017
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
|
|
$
|
64,297
|
|
$
|
21,834
|
Total
assets
|
|
|
|
|
|
|
|
$
|
66,322
|
|
$
|
22,428
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
1,234
|
|
$
|
2,276
|
Series A Convertible
Redeemable Preferred Stock
|
|
|
|
|
|
|
|
$
|
-
|
|
$
|
26,185
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(30,092)
|
|
$
|
(9,298)
|
Total stockholders'
equity (deficit)
|
|
|
|
|
|
|
|
$
|
65,088
|
|
$
|
(6,033)
|
View original
content:http://www.prnewswire.com/news-releases/provention-bio-reports-third-quarter-2018-financial-results-and-provides-business-update-300746193.html
SOURCE Provention Bio, Inc.