RED BANK, N.J., May 6, 2021 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today reported
financial results and provided a business update for the first
quarter ended March 31, 2021.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"The first quarter of 2021 marked another quarter of strong
execution across Provention Bio as we continue to advance our
portfolio of autoimmunology therapeutic candidates focused on
intercepting and preventing life-threatening and life-impacting
diseases," stated Ashleigh Palmer,
CEO of Provention Bio. Mr. Palmer continued, "Our near-term focus
is appropriately concentrated on the BLA filing for teplizumab and
the upcoming FDA Advisory Committee meeting on May 27. We believe this Advisory Committee
meeting's agenda will include examination of type 1 diabetes unmet
need and the safety and efficacy of teplizumab from the TN-10 trial
supported by data from other historic studies in newly diagnosed
patients. Also, we concurrently continue to make great
progress advancing all of our other autoimmunology pipeline
candidates, which positions us very well for numerous important
data catalysts over the course of the next 12 to 24 months."
First Quarter 2021 and Recent Corporate Highlights:
FDA Filing of a BLA and Priority Review for Teplizumab for
the Delay of Progression to Stage 3 Clinical Type 1 Diabetes in
At-risk Individuals
In January, Provention Bio announced that the Biologics License
Application (BLA) for teplizumab for the delay of progression to
Stage 3 clinical type 1 diabetes (T1D) in at-risk individuals had
been filed by the U.S. Food and Drug Administration (FDA).
In April, the Company provided regulatory updates, stating that
it had received communications from the FDA and met with the FDA
regarding comparability between the Company's proposed commercial
drug product and drug product used historically in clinical trials
originating with drug substance manufactured by Eli Lilly over a
decade ago. Specifically, the FDA reported at the
meeting that it had concluded that the pharmacokinetic (PK)
profiles of the two drug products evaluated in the Company's
single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging
study conducted in healthy volunteers are not comparable, since the
intended commercial product did not meet the pre-specified 80-125%
PK area under the curve (AUC) comparability target range. The
FDA also stated that it cannot be certain if this observation is
not clinically relevant, given that the relationship between
lymphocyte reduction, a PD marker, which was comparable in the
PK/PD bridging study, and clinical efficacy, has yet to be fully
validated.
The FDA emphasized its understanding of the high unmet need
associated with delaying the onset of clinical-stage T1D and
reconfirmed the FDA's willingness to work with the Company to find
a satisfactory solution. Nevertheless, the Company is
reiterating previous guidance that the FDA's PK comparability
considerations are likely to result in a delay in potential BLA
approval timelines and that the specifics of such delay will depend
upon the outcome of ongoing discussions with the FDA to find a
solution, including potentially providing FDA reviewers with PK/PD
data from the Company's on-going Phase 3 PROTECT study in newly
diagnosed patients.
The FDA also informed the Company that it plans to mention its
PK comparability review in the clinical pharmacology summary of its
briefing materials for the Advisory Committee meeting on
May 27, along with a statement that
the FDA is working with the Company to find a solution. It is
the Company's understanding that since the FDA's PK comparability
considerations do not bear on the benefit-risk assessment of the
TN-10 study clinical data package, no comparability related
questions or discussion topics are planned for the
meeting.
The FDA also recommended that both the FDA and the Company
update their Advisory Committee briefing materials to reflect the
removal of the term "prevention" from the previously proposed
indication, as the remaining term "delay" more accurately reflects
the results of the TN-10 trial.
Announced Publication of Extended Follow-up Data from the
Pivotal "At-Risk" TN-10 Study of Teplizumab in Science
Translational Medicine
In March, Provention Bio announced that extended follow-up data
from the pivotal "At-Risk" TN-10 Study were published in Science
Translational Medicine. Results show that a single 14-day
infusion course of teplizumab (PRV-031) delayed the onset of
clinical disease and insulin dependence in at-risk T1D patients by
approximately three years (median of 32.5 months), adding
approximately one year to previously reported results. The TN-10
Study was conducted through the Type 1 Diabetes TrialNet, an
international research collaboration aimed at discovering ways to
delay or prevent T1D.
PROTECT Phase 3 Trial Evaluating Teplizumab in Patients with
Recent Onset Type 1 Diabetes
Provention Bio is currently also evaluating teplizumab in
patients with newly diagnosed insulin-dependent T1D in the Phase 3
PROTECT study, and expects to complete enrollment of the study in
the second half of this year.
PREVAIL Phase 2a Trial Evaluating PRV-3279 in Systemic Lupus
Erythematosus
Provention Bio remains on track to initiate a Phase 2a trial of
PRV-3279, an investigational DART® (bispecific antibody-based
molecule) targeting the B cell surface proteins CD32B and CD79B in
the second half of 2021.
Key Findings from Pre-clinical Proof-of-concept Study for
PRV-3279 for the Prevention of Immunogenicity of Gene
Therapy
In January, Provention Bio reported results from a pre-clinical
proof-of-concept study for PRV-3279, an investigational humanized
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, the Company entered into a strategic collaboration
with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., (Huadong),
a wholly-owned subsidiary of Huadong Medicine Co., Ltd. to develop
and commercialize PRV-3279, an investigational
DART® (bispecific antibody-based molecule) targeting the B
cell surface proteins CD32B and CD79B, in Greater
China which includes, mainland China, Hong
Kong, Macau and Taiwan. Under the terms of the
agreement, Provention Bio received an upfront payment of $6
million, and will receive 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 double-digit royalties as a percentage of net sales of
PRV-3279 by Huadong in Greater China.
PROACTIVE Phase 2b study of
PRV-015 in Non-responsive Celiac Disease
Provention Bio is conducting a Phase 2b dose-finding, placebo-controlled study of
PRV-015, an investigational anti-interleukin-15 monoclonal antibody
in adults with non-responsive Celiac Disease. The study
expects to enroll 220 adult Celiac patients not responding to
gluten-free diet. Provention Bio expects top-line results
from this study in 2022.
PROVENT Phase 1 Healthy Volunteer study of PRV-101
Coxsackievirus B Vaccine
Provention Bio completed enrollment of the PROVENT (PROtocol for
coxsackievirus VaccinE in healthy voluNTeers) study in April of
this year, a first-in-human study of its polyvalent inactivated
coxsackievirus B (CVB) vaccine candidate, PRV-101. Provention Bio
is developing PRV-101 for the prevention of acute CVB infection and
the potential delay or prevention of T1D and celiac disease.
The Company expects top-line first-in-human data in the fourth
quarter of this year.
Financial Highlights:
As of March 31, 2021, Provention Bio had cash and cash
equivalents and marketable securities of $207.2 million. In
the first quarter, the Company completed an underwritten public
offering that generated aggregate net proceeds of $102.3 million. The Company also received a
$6.0M upfront payment from its
strategic collaboration with Huadong to develop and commercialize
PRV-3279 in Greater China. The
Company expects to recognize revenue under this agreement on a
proportional performance basis as the Company conducts the
development activities contemplated by the agreement.
Net loss for the first quarter 2021 was $32.4 million, or $0.52 per basic and diluted share, compared to a
net loss of $12.6 million, or
$0.26 per basic and diluted share,
for the same period in 2020. The increase in net loss was primarily
attributable to a $10.6 million
increase in research in development expenses, driven primarily by
costs for our teplizumab program, including the PROTECT study,
manufacturing and regulatory activities, and the build out of our
medical affairs infrastructure and medical education programs to
support teplizumab. Also contributing to the net loss was a
$9.0 million increase in general and
administrative expenses, including $5.1
million in pre-commercial expenses and $3.9 million in other corporate costs as we
continue to build out our commercial and corporate
infrastructure.
Cash-based operating expenses were $29.5
million for the three months ended March 31, 2021. The Company expects our
cash-based operating expenses to be in the range of $30 to $35 million
in the second quarter of 2021. Provention Bio expects its current
cash, cash equivalents and marketable securities will be sufficient
to fund projected operating requirements for at least the next 12
months.
RBC Capital Markets Global Healthcare Conference
Additionally, the company announced it will participate in a
fireside chat presentation at the 2021 RBC Capital Markets Global
Healthcare Conference on Tuesday, May 18,
2021, at 10:20 am E.T.
A webcast of the presentation can be accessed by visiting the
Events and Webcasts section of the Company's website:
http://investors.proventionbio.com/events. The webcast will be
archived on the Company's website for 30 days following the
presentation.
Conference Call and Webcast Information:
Provention Bio will discuss these business updates and first
quarter 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 of progression to Stage 3 clinical T1D 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 of teplizumab, including a delay relating to the same; the
potential therapeutic effects and safety of teplizumab and the
FDA's willingness to work with us to find a solution to the
teplizumab comparability issue between our proposed commercial
product and drug product used historically in clinical trials
originating from drug substance manufactured by Eli Lilly,
including potentially providing FDA reviewers with PK/PD data from
our on-going Phase 3 PROTECT study in newly diagnosed patients;
anticipated timing for the Phase 2a trial of PRV-3279; anticipated
timing of top-line results for our product candidates; our current
expectations regarding the ability of our cash, cash equivalents
and marketable securities to fund our projected operating
requirements for at least the next 12 months; and expected
cash-based operating expenses for the second quarter of 2021. 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; any inability
to successfully work with FDA to find a satisfactory solution to
address its concerns in a timely manner or at all, including any
inability to provide the FDA with PK/PD data from our on-going
Phase 3 PROTECT study or other data sufficient to support an
approval of the BLA for teplizumab; 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 quarterly report
on Form 10-Q for the quarter ended March 31, 2021 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 (unaudited)
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
19,687
|
|
$
|
9,090
|
General and
administrative
|
|
|
12,781
|
|
|
3,775
|
Total operating
expenses
|
|
|
32,468
|
|
|
12,865
|
Loss from
operations
|
|
|
(32,468)
|
|
|
(12,865)
|
Interest income,
net
|
|
|
28
|
|
|
283
|
Loss before income
tax benefit
|
|
|
(32,440)
|
|
|
(12,582)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
Net loss
|
|
$
|
(32,440)
|
|
$
|
(12,582)
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.52)
|
|
$
|
(0.26)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
62,263
|
|
|
47,699
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
Balance Sheet
Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
207,205
|
|
$
|
121,824
|
Total
assets
|
|
$
|
213,786
|
|
$
|
128,519
|
Total
liabilities
|
|
$
|
29,919
|
|
$
|
17,445
|
Accumulated
deficit
|
|
$
|
(210,082)
|
|
$
|
(177,642)
|
Total stockholders'
equity
|
|
$
|
183,867
|
|
$
|
111,074
|
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SOURCE Provention Bio, Inc.