RED BANK, N.J., Aug. 5, 2021 /PRNewswire/ -- Provention Bio, Inc.
(Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today reported
financial results for the second quarter ended June 30, 2021 and provided a business update.
"The significant steps we've made during this past quarter
highlighted by the supportive FDA briefing documents, the positive
vote from the advisory committee, and the lack of any clinical
efficacy or safety review deficiencies noted in the Complete
Response Letter issued by the FDA, draw us much closer to realizing
our vision of delivering a therapeutic option to intervene in a
serious autoimmune disease and positively alter the course of
thousands of lives with teplizumab," stated Ashleigh Palmer, co-founder and CEO of
Provention Bio. "The remaining steps that we need to complete
to obtain approval for teplizumab are very clear, most notably
obtaining the pharmacokinetic data from the PROTECT substudy, which
we expect later this quarter, to address the FDA's observations
related to drug comparability."
Palmer continued, "In addition to all of the progress for
teplizumab in the at-risk type 1 diabetes patient population, we
also continue to make strong progress advancing the rest of our
autoimmune disease focused development pipeline, positioning
Provention to deliver numerous key catalysts throughout the course
of the next 24 months."
Second Quarter 2021 and Recent Corporate Highlights:
FDA Advisory Committee Votes in Favor of the Benefits of
Teplizumab Outweighing the Risks in Support of Approval to Delay
Clinical Type 1 Diabetes (T1D)
In May, Provention Bio announced that the Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and
Drug Administration (FDA) voted 10 yes and 7 no on the question,
"Does the information provided in the background documents and
presentations by the Applicant and FDA show that the benefits of
teplizumab outweigh the risks in support of approval to delay
clinical type 1 diabetes mellitus?".
The EMDAC based its recommendation on safety and efficacy data
from the pivotal TN-10 Study in which a single 14-day course of
teplizumab delayed insulin-dependent, clinical-stage disease by a
median of at least two years in presymptomatic patients with Stage
2 T1D compared to placebo. Acknowledging the significant unmet
medical need facing early-stage T1D patients, the Committee Members
discussed the strengths and limitations of the clinical data and
provided opinions on the proposed indication statement and
potential post-marketing studies.
FDA Issues Complete Response Letter (CRL) to Biologics
License Application (BLA) for Teplizumab for the Delay of Clinical
Type 1 Diabetes in At-risk Individuals
In July, Provention Bio announced that the U.S. Food and Drug
Administration had issued a Complete Response Letter (CRL) for the
Company's Biologics License Application for teplizumab for the
delay of clinical type 1 diabetes in at-risk individuals.
In the CRL, the FDA stated that a single, low-dose
pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy
volunteers to compare planned commercial product with drug product
originating from drug substance manufactured for historic clinical
trials had failed to show PK comparability.
The Company expects relevant additional PK/PD data being, or to
be, collected from a PK/PD substudy in patients receiving 12-days
of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed
T1D patients later this quarter. These data will be analyzed by
independent, unblinded third-parties to maintain the integrity of
this placebo-controlled trial. Upon review of the results from this
substudy, the Company will determine whether to submit these data
to the FDA for its review, along with any other relevant data and
analyses based on our ongoing discussions with FDA, to support PK
comparability or otherwise justify why PK comparability is not
necessary.
In the CRL, the FDA cited several additional considerations
related to product quality, which the Company believes have either
been addressed in amendments already submitted to the BLA or can be
addressed in the short-term. The CRL acknowledged that the FDA had
not reviewed several amendments already submitted by the Company in
response to certain Chemistry, Manufacturing and Controls (CMC)
information requests.
The FDA also stated that certain deficiencies conveyed during a
recent general inspection, not specific to teplizumab, at a
fill/finish manufacturing facility used by the Company will need to
be resolved before approval.
The CRL did not cite any clinical deficiencies related to the
efficacy and safety data packages submitted to the BLA and
confirmed the acceptability of the proposed proprietary name for
teplizumab. The FDA requested that the Company provide a safety
update as part of its BLA resubmission. The CRL contained other
comments and recommendations that do not impact approvability, as
well as general guidance regarding the resubmission process.
Teplizumab Awarded Innovation Passport in the United Kingdom (UK) for the Delay of Onset of
Clinical Type 1 Diabetes in At-risk Individuals
In July, Provention Bio announced that teplizumab, an anti-CD3
monoclonal antibody (mAb), was awarded an Innovation Passport for
the delay of clinical type 1 diabetes in at-risk individuals.
Teplizumab is one of the first investigational medicines to receive
this designation under the United
Kingdom's (UK) Innovative Licensing and Access Pathway
(ILAP) launched by The Medicines and Healthcare products Regulatory
Agency (MHRA) in January 2021.
ILAP was launched to accelerate the development and access to
promising medicines in the UK, thereby facilitating and improving
patient access to new medicines. The pathway, part of the UK's
plan to attract life sciences development in the post-Brexit era,
features enhanced input and interactions with the MHRA and other
stakeholders, including the National Institute for Health and Care
Excellence (NICE) and the Scottish Medicines Consortium
(SMC). The decision to award the Innovation Passport to the
teplizumab program was made by the ILAP Steering Group, which is
comprised of representatives from MHRA, NICE, and SMC. The
process is also supported by such bodies as the National Health
Service (NHS) England, the NHS
Improvement, Health Research Authority and the National Institute
for Health Research.
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 third quarter 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 fourth quarter of 2021.
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 June 30, 2021, Provention
Bio had cash and cash equivalents and marketable securities
of $176.4 million.
Net loss for the second quarter 2021 was $29.1 million, or $0.46 per basic and diluted share, compared to a
net loss of $22.1 million, or
$0.45 per basic and diluted share,
for the same period in 2020. The increase in net loss was
attributable to an overall increase in research and development
expenses of $2.0 million, driven
primarily by costs for our teplizumab program, including the
PROTECT study, regulatory activities, and the build out of our
medical affairs infrastructure and medical education programs as
well as grants to support the screening of potential T1D patients.
This increase in research and development costs was offset by lower
teplizumab manufacturing costs compared to the prior year period,
as the Company incurred significant costs for production of GMP and
PPQ batches of drug supply and drug product during the second
quarter of 2020. Also contributing to the net loss was
$5.4 million increase in general and
administrative expenses, including $2.1
million in pre-commercial expenses and $3.3 million in other corporate costs as we
continue to build out our infrastructure.
Cash-based operating expenses were $26.8
million for the three months ended June 30, 2021. The Company expects our
cash-based operating expenses to be in the range of $31 to $36 million
in the third 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.
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; regulatory review of and potential approval of
teplizumab; the potential therapeutic effects and safety of
teplizumab; the timing and ability of the Company to obtain
additional PK/PD data from a PK/PD substudy in the ongoing Phase 3
PROTECT trial and other data and analysis relevant to PK
comparability; the potential for these data to address the FDA's PK
comparability considerations; the FDA review of such data if
submitted by the Company; the Company's belief that the remaining
product quality issues cited in the CRL are addressed or can be
addressed in the short-term; the need for resolution of
deficiencies identified at a fill/finish manufacturer used by the
Company; the Company's plans to address the other matters raised in
the CRL including plans to continue working collaboratively with
FDA to hopefully secure teplizumab approval; anticipated timing for
the Phase 2a trial of PRV-3279; anticipated timing for completing
enrollment in the Phase 3 PROTECT study; 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
projected operating requirements for at least the next 12 months;
and expected cash-based operating expenses for the third quarter of
2021. 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 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 ongoing Phase
3 PROTECT study or other data or information sufficient to support
approval of teplizumab; any inability to satisfactorily address
other matters cited in the CRL including relating to product
quality, fill/finish manufacturer deficiencies identified in a
general inspection, the safety update required by 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 quarter ended
June 30, 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
16,968
|
|
$
|
15,032
|
|
$
|
36,655
|
|
$
|
24,122
|
General and
administrative
|
|
|
13,205
|
|
|
7,764
|
|
|
25,986
|
|
|
11,539
|
Total operating
expenses
|
|
|
30,173
|
|
|
22,796
|
|
|
62,641
|
|
|
35,661
|
Loss from
operations
|
|
|
(30,173)
|
|
|
(22,796)
|
|
|
(62,641)
|
|
|
(35,661)
|
Interest income,
net
|
|
|
31
|
|
|
151
|
|
|
59
|
|
|
434
|
Loss before income
tax benefit
|
|
|
(30,142)
|
|
|
(22,645)
|
|
|
(62,582)
|
|
|
(35,227)
|
Income tax
benefit
|
|
|
1,000
|
|
|
523
|
|
|
1,000
|
|
|
523
|
Net loss
|
|
$
|
(29,142)
|
|
$
|
(22,122)
|
|
$
|
(61,582)
|
|
$
|
(34,704)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.46)
|
|
$
|
(0.45)
|
|
$
|
(0.98)
|
|
$
|
(0.72)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
63,375
|
|
|
49,199
|
|
|
62,822
|
|
|
48,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021
|
|
December 31,
2020
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
176,378
|
|
$
|
121,824
|
Total
assets
|
|
|
|
|
|
|
|
$
|
183,308
|
|
$
|
128,519
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
25,288
|
|
$
|
17,445
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(239,224)
|
|
$
|
(177,642)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
158,020
|
|
$
|
111,074
|
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SOURCE Provention Bio, Inc.