-Teplizumab Biologics License Application
(BLA) resubmission accepted for review by FDA and user fee goal
date set for August 17, 2022-
-Company to host teplizumab commercial launch
investor event on Thursday, May 19,
2022-
RED
BANK, N.J., May 5, 2022
/PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a
biopharmaceutical company dedicated to intercepting and preventing
immune-mediated disease, today reported financial results for the
first quarter ended March 31, 2022,
and provided a business update.
"The first quarter of 2022 was highlighted by the FDA acceptance
for review of our teplizumab BLA resubmission for the delay of
clinical type 1 diabetes in at-risk individuals and the assignment
of an August 17th, 2022
user fee goal date," stated Ashleigh
Palmer, Chief Executive Officer & Co-Founder, Provention
Bio. "At an investor event later this month, we are looking forward
to sharing the progress of our commercial launch plans in
anticipation of, if approved by FDA, bringing the first ever
disease modifying therapy to the T1D clinical community and the
patients and their families who have remained substantially
underserved and frustrated for generations. We are excited by
the catalytic potential of teplizumab, and where its potential
approval may take Provention and the patients, investors, and other
stakeholders we serve."
Palmer continued, "The potential approval of teplizumab further
validates our founding conceptual platform of interception and
prevention of serious autoimmune diseases. During the first
quarter, we reported significant progress across our other pipeline
programs, including the initiation of our PREVAIL-2 Phase 2a
trial of PRV-3279 in systemic lupus erythematosus, as well as the
final results of our Phase 1 first-in-human PROVENT trial for
PRV-101, a polyvalent coxsackievirus B vaccine candidate targeting
the key T1D-associated viral strains."
First Quarter 2022 and Recent
Corporate Highlights:
FDA Accepted the Biologics License
Application (BLA) Resubmission for Teplizumab for the Delay of
Clinical Type 1 Diabetes in At-Risk Individuals
During the first quarter, the Company announced that the
resubmitted Biologics License Application (BLA) for teplizumab for
the delay of clinical type 1 diabetes (T1D) in at-risk individuals
has been considered a complete, class 2 response to the
July 2021 action letter by the U.S.
Food and Drug Administration (FDA). The FDA has assigned a user fee
goal date of August 17, 2022.
Earlier during the quarter, the Company had resubmitted the BLA
for teplizumab for the delay of clinical type 1 diabetes (T1D) in
at-risk individuals following the completion of a Type B pre-BLA
resubmission meeting during which the FDA proposed, and the Company
agreed, to use PK modeling to adjust the 14-day dosing regimen for
the planned commercial product to match the exposure of clinical
material used in prior clinical trials.
PROTECT Phase 3 Trial Evaluating
Teplizumab in Patients with Recent Onset of Type 1
Diabetes
The Company is currently evaluating teplizumab in patients with
newly diagnosed insulin-dependent T1D in the Phase 3 PROTECT study.
The Company reached target enrollment during the third quarter of
2021 and currently expects to report top-line data from the study
in the second half of 2023.
PREVAIL-2 Phase 2a Trial
Evaluating PRV-3279 in Systemic Lupus Erythematosus
In January, the Company initiated a Phase 2a trial of PRV-3279
in Systemic Lupus Erythematosus, an investigational
DART® (bispecific antibody-based molecule) targeting the
B-cell surface proteins CD32B and CD79B.
The PREVAIL-2 study is a Phase 2a proof-of-concept (POC) study
in moderate-to-severe SLE patients induced into response with a
short course of corticosteroids, and then monitored for relapse,
after randomization to either PRV-3279 or placebo treatment. This
design enables the withdrawal of most concomitant medications and
clear POC evaluation. The study will be conducted in the US and
Hong Kong. Enrollment has
commenced in the US with the goal of identifying and enrolling
approximately 100 patients to 6 monthly infusions of PRV-3279 or
placebo, with primary efficacy readout at 24 weeks. PRV-3279 was
well-tolerated in a prior single ascending dose Phase 1 study and a
multiple ascending dose Phase 1b
study, PREVAIL-1, establishing proof of mechanism with long-lasting
inhibition of B cell function as shown by reduction in IgM
production 8 weeks post last dose of PRV-3279. These results,
together with observations that CD32B genetic variants are
associated with SLE, and PRV-3279 inhibition of B cells isolated
from SLE patients, support evaluation in SLE. The Company
anticipates reporting top line results from the PREVAIL-2 study in
the first half of 2024.
PROACTIVE Phase 2b Study of Ordesekimab (AMG 714/PRV-015) in
Non-Responsive Celiac Disease
The Company is conducting a Phase 2b dose-finding, placebo-controlled study of
ordesekimab (AMG 714/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.
Due to the impacts of COVID-19 on certain aspects of medical
care during the pandemic, such as temporary halting of elective
endoscopy procedures, lack of prioritization of chronic
non-life-threatening conditions, reduced exposure to gluten due to
reductions of travel and dining out, the Company is experiencing
enrollment delays that have extended the enrollment target. The
Company announced that it expects top-line results from this study
by the end of 2023.
PROVENT Phase 1 Healthy Volunteer
Study of PRV-101 Coxsackievirus B Vaccine (CVB)
In March, the Company announced results from the final analysis
of the PROVENT (PROtocol for coxsackievirus VaccinE in healthy
voluNTeers) study, a first-in-human PROVENT study of PRV-101, a
polyvalent inactivated coxsackievirus B (CVB) vaccine candidate
targeting all key CVB strains associated with type 1 diabetes
autoimmunity. Provention is developing PRV-101 for the prevention
of CVB-triggered autoimmune damage to pancreatic beta cells that
may progress to T1D and damage to intestinal cells that may lead to
celiac disease.
In this final analysis, 6 months following the final
administered dose of the vaccine, PRV-101 met the primary endpoint
confirming the tolerability observed in the previously reported
interim analysis, with no treatment-emergent serious adverse
events, adverse events of special interest, or adverse events
leading to study drug discontinuation or study withdrawal.
The results also showed durability of viral neutralizing
antibody (VNT) responses. Six months following the final dosing,
the percentages of subjects in the high-dose PRV-101 arm who
maintained high titers of VNT were 100% for the majority of
serotypes included in the vaccine and no less than 90% for all
serotypes.
The Company is currently exploring partnership opportunities to
further the clinical development of PRV-101.
Financial Highlights:
As of March 31, 2022, Provention had cash, cash equivalents
and marketable securities of $113.4 million. During the first
quarter of 2022, the Company sold 379,909 shares of its common
stock for aggregate net proceeds of approximately $2.7 million, net of sales commissions and other
offering expenses, under the Company's 2021 at-the-market (ATM)
Program. As of March 31, 2022, the
Company had $147.1 million of
available capacity under the 2021 ATM Program.
Net loss for the first quarter of 2022 was $22.0 million,
or $0.35 per basic and diluted share, compared to a net
loss of $32.4 million, or $0.52 per basic and
diluted share, for the first quarter of 2021. The decrease in net
loss during the first quarter of 2022 was primarily attributable to
a $7.1 million income tax benefit the
Company recognized during the period and a $2.3 million decrease in research and development
costs compared to the prior year period.
The decrease in research and development costs during the first
quarter of 2022 was driven by lower costs for the Company's
teplizumab program, including the PROTECT study, as target
enrollment was reached in August
2021, and lower costs for manufacturing and regulatory
activities compared to the prior year period, which included costs
related to the initial teplizumab BLA submission. Research and
development cost decreases were partially offset by increased costs
for the PROACTIVE Phase 2b study
(PRV-015), and the PREVAIL-2 Phase 2a study (PRV-3279). Also
contributing to the decrease in net loss was a decrease in
pre-commercial expenses due to a reduction in activities following
the complete response letter issued by the FDA in July 2021 to the Company's initial teplizumab
BLA.
The Company recognized an income tax benefit of $7.1 million during the first quarter of 2022
related to net proceeds from the sale of its 2020 New Jersey net
operating losses (NOLs) under the State
of New Jersey's Technology Business Tax Certificate Transfer
Program.
The Company also recognized collaboration revenue of
$0.6 million under its License
Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
(Huadong) during the first quarter of 2022, which represents
certain amounts recognized in connection with the upfront license
payment and research, development and manufacturing funding the
Company has received from Huadong. During the first quarter of
2022, the Company received $1.5
million in research, development and manufacturing funding
from Huadong, which is recorded in deferred revenue.
Cash-based operating expense for the first quarter 2022 was
$26.2 million, which excludes
non-cash, stock-based compensation expense of $3.3 million and depreciation expense of
$0.1 million.
The Company expects its cash-based operating expenses to be in
the range of $29.0 million to
$33.0 million for the second quarter
of 2022, reflecting an increase in launch-readiness activities as
the Company prepares for the potential FDA approval of teplizumab
in Q3 2022.
Based on the Company's current business plans, management
believes that its cash, cash equivalents and marketable securities
on hand as of March 31, 2022, are
sufficient to fund the Company's operations into the first quarter
of 2023. If the Company's teplizumab BLA resubmission is approved
by the FDA, factors that could impact its cash runway include, but
are not limited to, changes to estimated costs of commercialization
and potential milestone payments that may be triggered under the
Company's current agreements, including with MacroGenics.
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 1-888-347-7861
(domestic) or 1-412-902-4247 (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 Company's pipeline
includes clinical-stage product candidates that have demonstrated
in pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in autoimmune diseases, including type 1 diabetes,
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 F.D. 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 our product
pipeline and delivery of key catalysts throughout the course of the
next 24 months; the Company's planned regulatory interactions; the
medical need in T1D at-risk patients, the potential approval of
teplizumab and therapeutic effects and safety of teplizumab in
at-risk T1D patients; the FDA's review and potential approval of
teplizumab and potential regulatory and commercialization timeline;
the potential impact of FDA decisions on PK comparability and the
BLA resubmission on the PROTECT study; anticipated timing for the
Phase 2a trial of PRV-3279; anticipated enrollment in the
PROACTIVE study; 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
current operating requirements and the length of our estimated cash
runway; and expected cash-based operating expenses for the second
quarter of 2022. These statements may be identified by the use of
forward-looking words such as "will," "may," "believe," and
"expect," 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 in the development plans for the
Company's other Company product candidates and the potential for
noncompliance with FDA regulations and requirements; any inability
to successfully work with the FDA to find a satisfactory solution
to address its concerns in a timely manner or at all, including
during the FDA's review of the teplizumab BLA resubmission; any
inability of the BLA resubmission or our response to FDA requests
to satisfactorily address other matters cited in the CRL including
relating to PK comparability, product quality, the safety update
required by the FDA or any other FDA requirements for an approval
of 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 first quarter ended March 31, 2022 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.
Corporate Contact:
Robert
Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235
###Financial Tables to Follow
Provention Bio,
Inc.
Selected Financial
Data (unaudited)
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
Statement of
Operations Data:
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
580
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
17,355
|
|
|
19,687
|
General and
administrative
|
|
|
12,306
|
|
|
12,781
|
Total operating
expenses
|
|
|
29,661
|
|
|
32,468
|
Loss from
operations
|
|
|
(29,081)
|
|
|
(32,468)
|
Interest income,
net
|
|
|
57
|
|
|
28
|
Loss before income tax
benefit
|
|
|
(29,024)
|
|
|
(32,440)
|
Income tax
benefit
|
|
|
7,056
|
|
|
—
|
Net loss
|
|
$
|
(21,968)
|
|
$
|
(32,440)
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.35)
|
|
$
|
(0.52)
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
63,400
|
|
|
62,263
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2022
|
|
December 31,
2021
|
Balance Sheet
Data:
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
113,358
|
|
$
|
127,132
|
Total assets
|
|
$
|
122,458
|
|
$
|
135,621
|
Total
liabilities
|
|
$
|
28,252
|
|
$
|
24,887
|
Accumulated
deficit
|
|
$
|
(314,042)
|
|
$
|
(292,074)
|
Total stockholders'
equity
|
|
$
|
94,206
|
|
$
|
110,734
|
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SOURCE Provention Bio, Inc.