RED BANK, N.J., Nov. 4, 2021 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today reported
financial results for the third quarter ended September 30, 2021 and provided a business
update.
"During the third quarter, we made significant progress across
our development programs," stated Ashleigh
Palmer, Chief Executive Officer & Co-Founder, Provention
Bio. "We were very pleased with the recent interim data from our
first-in-human study of our coxsackievirus B vaccine, which
represents another important pillar in Provention's foundational
core aimed at intercepting or preventing serious autoimmune
diseases. We are also excited to soon begin enrollment in the Phase
2a trial of PRV-3279 for the treatment of systemic lupus
erythematosus."
Palmer continued, "As it relates to teplizumab, we continue to
make progress with addressing the observations from the Complete
Response Letter and look forward to our dialogue with the FDA later
this month to finalize the population pharmacokinetic model to
assess comparability of drug products from therapeutic dosing in
patients. Also, I am incredibly proud of the team's effort to
complete target enrollment of the PROTECT trial in such a timely
fashion in the face of challenging global pandemic conditions. It
speaks to both the quality of our team and investigators, as well
as the severe unmet need facing newly diagnosed type 1 diabetes
patients."
Third Quarter 2021 and Recent Corporate Highlights:
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, the Company announced that the U.S. Food and Drug
Administration issued a Complete Response Letter (CRL) for the
Company's BLA for teplizumab for the delay of clinical type 1
diabetes (T1D) 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 failed to show PK comparability.
The Company has since completed its collection of relevant
additional PK/PD data from a PK/PD substudy in patients receiving
12-days of therapy in the ongoing Phase 3 PROTECT trial in newly
diagnosed T1D patients.
In September, the Company announced that the FDA recommended
that the Company request a formal Type A meeting and submit
briefing documents to discuss and finalize the population PK model
prior to the Company populating the model with the relevant PK data
collected from the PROTECT substudy. On October 1st, the Company submitted the
required briefing documents and requested the Type A meeting with
the FDA, which is scheduled to occur in the second half of
November. Following completion of the meeting, the Company expects
to populate the model with the PK data, analyze the results and
work with the FDA to determine the regulatory path forward.
In September, the Company also announced the completion of a
separate Type A meeting with the FDA during which several
considerations related to product quality that were cited in the
CRL were discussed. The Company continues to believe that the
product quality CRL considerations have either already been
addressed by prior amendments to the BLA or are addressable in the
short term. As it relates to the deficiencies noted during the
recent general inspection at a fill/finish facility used by the
Company mentioned in the CRL, this facility's inspection was closed
out by the FDA in August of 2021.
PROTECT Phase 3 Trial Evaluating Teplizumab in Patients with
Recent Onset 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 the target enrollment of 300 patients during
the third quarter of 2021. Given the challenges the COVID pandemic
has presented to clinical trials across the industry, the Company
ultimately exceeded the enrollment target by approximately ten
percent to ensure there were a sufficient number of evaluable
patients. The Company currently expects to report top line data
from the PROTECT Phase 3 study in the second half of 2023, subject
to change for any potential COVID-19 related, regulatory-related or
other interruptions, including those related to PK comparability of
the proposed commercial product.
PREVAIL Phase 2a Trial Evaluating PRV-3279 in Systemic Lupus
Erythematosus
The Company 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
The Company 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.
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 now expects top-line results from this study by the end of
2023.
PROVENT Phase 1 Healthy Volunteer study of PRV-101
Coxsackievirus B Vaccine
In October, the Company announced positive interim top-line
results from the PROVENT (PROtocol for coxsackievirus VaccinE in
healthy voluNTeers) study, 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.
In the interim analysis, PRV-101 met the safety primary endpoint
demonstrating that it was well tolerated in this study, with no
treatment-emergent Serious Adverse Events, Adverse Events of
Special Interest, or Adverse Events that led to study drug
discontinuation or study withdrawal. PRV-101 also met the secondary
efficacy endpoint as it induced high titers of viral neutralizing
antibodies against all CVB serotypes included in the vaccine, in a
dose dependent fashion. The Company expects to present the full
results at an upcoming medical conference. An additional 6-month
safety follow up will be conducted and final trial results from the
trial are expected in the first half of 2022.
Financial Highlights:
As of September 30, 2021,
Provention Bio had cash, cash equivalents and marketable securities
of $150.8 million.
Net loss for the third quarter of 2021 was $27.0 million, or $0.43 per basic and diluted share, compared to a
net loss of $31.3 million, or
$0.56 per basic and diluted share,
for the same period in 2020. The decrease in net loss was primarily
attributable to a decrease in teplizumab manufacturing costs, as
the Company incurred significant costs for production of batches of
drug supply and drug product in the third quarter of 2020. There
was also a decrease in regulatory expenses related to the initial
teplizumab BLA submission incurred in the third quarter of 2020.
These decreases in research and development costs were offset by
increased costs for our teplizumab program, including the PROTECT
study, and for the PRV-015 PROACTIVE study, which was initiated in
August 2020. There was an overall
$0.3 million increase in general and
administrative expenses, which consisted of a $1.8 million decrease in pre-commercial expenses
and a $2.0 million increase in other
corporate costs. The decrease in pre-commercial expenses related
primarily to a reduction in our pre-commercial activities following
the CRL issued by the FDA for our BLA for teplizumab in
July 2021.
In the third quarter of 2021, Provention Bio recognized
$0.7 million of collaboration revenue
under our License Agreement with Huadong, which represents certain
amounts recognized in connection with the upfront license payment
and research, development and manufacturing funding the Company has
received from Huadong.
Cash-based operating expenses were $24.6
million for the third quarter of 2021, which excludes
noncash stock-based compensation expense of $3.1 million and depreciation expense of
$0.1 million. The Company expects our
cash-based operating expenses to be in the range of $25 to $29 million
for the fourth 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; company planned regulatory interactions, collection
of data, analysis and other company efforts for a potential
approval of teplizumab; the potential therapeutic effects and
safety of teplizumab; the potential for PK/PD data from a PK/PD
substudy in the ongoing Phase 3 PROTECT trial 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 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;
the potential impact of FDA decisions on PK comparability 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 projected
operating requirements for at least the next 12 months; and
expected cash-based operating expenses for the fourth 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 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 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, 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 September 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
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,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
678
|
|
$
|
—
|
|
$
|
678
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
17,724
|
|
|
21,657
|
|
|
54,379
|
|
|
45,779
|
General and
administrative
|
|
|
10,031
|
|
|
9,749
|
|
|
36,017
|
|
|
21,288
|
Total operating
expenses
|
|
|
27,755
|
|
|
31,406
|
|
|
90,396
|
|
|
67,067
|
Loss from
operations
|
|
|
(27,077)
|
|
|
(31,406)
|
|
|
(89,718)
|
|
|
(67,067)
|
Interest income,
net
|
|
|
55
|
|
|
105
|
|
|
114
|
|
|
539
|
Loss before income
tax benefit
|
|
|
(27,022)
|
|
|
(31,301)
|
|
|
(89,604)
|
|
|
(66,528)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
1,000
|
|
|
523
|
Net loss
|
|
$
|
(27,022)
|
|
$
|
(31,301)
|
|
$
|
(88,604)
|
|
$
|
(66,005)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.43)
|
|
$
|
(0.56)
|
|
$
|
(1.41)
|
|
$
|
(1.29)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
63,375
|
|
|
56,339
|
|
|
63,008
|
|
|
51,098
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2021
|
|
December 31,
2020
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
$
|
150,773
|
|
$
|
121,824
|
Total
assets
|
|
|
|
|
|
|
|
$
|
157,875
|
|
$
|
128,519
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
23,762
|
|
$
|
17,445
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(266,246)
|
|
$
|
(177,642)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
134,113
|
|
$
|
111,074
|
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SOURCE Provention Bio, Inc.