Continues to Advance Preparations for
Potential U.S. Commercial Launch of Teplizumab Ahead of
November 17th FDA User Fee
Goal Date
RED
BANK, N.J., Nov. 3, 2022
/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,
2022 and provided a business update.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"Throughout the third quarter, we have continued to interact
with the FDA in support of our resubmitted, breakthrough therapy
designated, teplizumab BLA for the delay of clinical type 1
diabetes in at-risk individuals," stated Ashleigh Palmer, Chief Executive Officer &
Co-Founder, Provention Bio. "As we approach our upcoming
November 17th FDA action
date, we are pleased to report that we have received both the FDA's
proposed labelling and post-marketing requirements and commitments,
and that these are generally consistent with our expectations. In
parallel, we have been advancing our planning and preparations for
the potential commercial launch of teplizumab and our recently
announced co-promotion agreement, which allows us to leverage the
expertise, capabilities, and commercial resources of Sanofi.
Finally, we were able to strengthen our balance sheet by raising
additional capital during the third quarter."
Third Quarter 2022 and Recent Corporate Highlights:
Entered into Agreement with Sanofi to Support Potential U.S.
Launch of Teplizumab
On October 6, 2022, the Company
announced that it entered a co-promotion agreement with Sanofi U.S.
for the potential launch of Provention's lead investigational drug
candidate, teplizumab. Teplizumab is currently under review by the
U.S. Food and Drug Administration (FDA), for the delay of clinical
type 1 diabetes (T1D) in at-risk individuals, with a user fee goal
date of November 17, 2022.
The Company also granted Sanofi, in consideration of a
non-refundable, one-time payment of $20.0
million, an exclusive, one-time right of first negotiation
(ROFN) to obtain exclusive global rights to commercialize
teplizumab for T1D in humans, subject to certain retained rights of
the Company to engage in discussions with third parties with
respect to certain transactions. Sanofi may exercise the ROFN until
June 30, 2023, with an option to
extend within 2023 under certain conditions. The Company received
the $20.0 million payment in October
from Sanofi.
Simultaneously with their entry into the co-promotion agreement,
the Company and Sanofi entered into a Securities Purchase Agreement
(the Purchase Agreement). Pursuant to the Purchase Agreement, if
teplizumab is approved by the FDA, Sanofi has agreed to purchase
$35.0 million of the Company's common
stock at a premium over the daily volume-weighted average per share
price for the five consecutive trading days prior to the closing
date. The closing date will be at Provention's discretion and would
occur no later than February 16,
2023.
Senior Leadership Addition
On September 19, 2022, the Company
announced the appointment of Sarah
O'Brien as Chief People Officer. Sarah brings more than 20
years of experience building strong employee culture and leading
human resources within the biotech sector. She most recently served
as Chief People Officer at Ardelyx, and has also served in prior
senior leadership roles at Ohana Bioscience, Relay Therapeutics,
Novartis, and Sobi, Inc.
$125.0 Million Term Loan
Facility with Hercules Capital
On August 31, 2022, the Company
entered into a term loan facility with Hercules Capital, Inc. The
term loan facility provides for up to $125.0
million of term loans in the aggregate, available to be
funded in up to five tranches. The first tranche in an amount equal
to $25.0 million was drawn at
closing. The Company may draw the second tranche in an amount equal
to $40.0 million upon approval of
teplizumab, subject to certain conditions. The third and fourth
tranches will be available to the Company in an aggregate amount of
up to $35.0 million, subject to
satisfaction of certain conditions, including achievement of
certain milestones. The availability of the fifth tranche of up to
$25.0 million is subject to the
approval of the lenders.
$60.0 Million Private
Placement in July 2022
On July 7, 2022, the Company entered into a Securities
Purchase Agreement with certain institutional purchasers, pursuant
to which the Company sold, in a private placement, 13,318,535
shares of common stock and 13,318,535 warrants to acquire
additional shares of common stock for aggregate gross proceeds of
approximately $60.0 million, based on an offering price
of $4.505 for each share plus one warrant (the
July 2022 Private Placement). The
warrants expire five years from the closing date of the
transaction, have an exercise price of $6.00 per share
and were immediately exercisable upon issuance, subject to other
limitations on exercise as described in the warrants. Net proceeds
from the transaction were $57.2
million after deducting fees for the placement agent of
$2.4 million and other offering
expenses of $0.4 million.
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 expects to report top-line data from the
PROTECT study in the second half of 2023.
PREVAIL-2 Phase 2a Trial Evaluating PRV-3279 in Systemic
Lupus Erythematosus
In the first quarter of 2022, the Company initiated a Phase 2a
trial in Systemic Lupus Erythematosus (SLE) of PRV-3279, 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 study
design enables the withdrawal of most concomitant medications and
clear POC evaluation. The ongoing challenges of the COVID-19
pandemic have affected the PREVAIL-2 study enrollment, primarily
due to resource constraints at the clinical site level and subdued
patient interest in participating in clinical trials of immune
modulatory agents.
The Company continues to expect to report top-line results of
the PREVAIL-2 study in the second 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 currently expects to
enroll 220 adult celiac patients not responding to gluten-free
diet.
The Company expects top-line results from the PROACTIVE study by
the end of 2023.
PRV-101 Coxsackievirus B Vaccine (CVB)
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 the first quarter of 2022, the Company announced results from
the final analysis of the PROVENT (PROtocol for coxsackievirus
VaccinE in healthy voluNTeers) study, a first-in-human study
of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine
candidate targeting all key CVB strains associated with type 1
diabetes autoimmunity. In this final analysis, 6 months following
the final administered dose of the vaccine, PRV-101 met the primary
safety endpoint and also showed durability of viral neutralizing
antibody (VNT) responses.
The Company continues to seek and evaluate partnership
opportunities to further the clinical development of PRV-101.
Third Quarter 2022 Financial Results
- Cash Position: Provention ended the third quarter
of 2022 with $186.5 million of cash, cash equivalents and
marketable securities.
- 2021 At-the-market (ATM) Program: Provention sold
7,263,808 shares of its common stock for aggregate net proceeds of
$33.6 million, net of $1.1
million in sales commissions and other offering expenses,
under the Company's 2021 ATM Program during the third quarter of
2022. As of September 30, 2022, the
Company had approximately $100.9
million of available capacity under the 2021 ATM
Program.
- July 2022 Private
Placement: Provention received net proceeds of $57.2 million upon the completion of the
July 2022 Private Placement, after
deducting fees for the placement agent of $2.4 million and other offering expenses of
$0.4 million.
- Term Loan Facility: The Company entered into a Loan and
Security Agreement with Hercules Capital, Inc. for up to
$125.0 million of term loans in the
aggregate, available to be funded in up to five tranches. The first
tranche, equal to $25.0 million, was
drawn on the closing date which provided the Company with net
proceeds of $23.7 million, net of
transaction costs. Interest expense was $0.3
million for the third quarter of 2022.
- Collaboration Revenue: The Company recognized
collaboration revenue of $0.8 million during the third
quarter of 2022, compared to $0.7
million for the third quarter of 2021, under its License
Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co.,
Ltd.
- Research & Development (R&D): R&D
expenses were $16.3 million for the third quarter of
2022, compared to $17.7 million for the third quarter of
2021. The decrease was driven by lower costs for the Company's
teplizumab program, including the PROTECT study, as target
enrollment was reached in August
2021. R&D 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).
- General & Administrative (G&A): G&A
expenses were $13.5 million for the third quarter of
2022, compared to $10.0 million for the third quarter of
2021. The increase in G&A expenses is related primarily to an
increase in the Company's pre-commercial activities and associated
costs as the company continues to prepare for the potential
commercial launch of teplizumab.
- Net Loss: Net loss for the third quarter of 2022
was $28.6 million,
or $0.34 per basic and diluted share, compared to a net
loss of $27.0 million, or $0.43 per basic and
diluted share, for the third quarter of 2021.
- Cash Based Operating Expenses: Cash-based operating
expenses for the third quarter of 2022 were $26.4 million, which exclude non-cash,
stock-based compensation expense of $3.3 million and depreciation expense
of $0.1 million.
Financial Guidance:
The Company expects its cash-based operating expenses to be in
the range of $40 million to $45 million for the
fourth quarter of 2022, reflecting an increase in program spend as
well as preparation for the potential commercial launch of
teplizumab, assuming FDA approval in November.
Based on the Company's current business plans, management
believes that its cash, cash equivalents and marketable securities
on hand as of September 30, 2022, together with the $20.0 million received in October 2022 under the Sanofi Co-Promotion
Agreement, will be sufficient to fund the Company's operating
requirements for at least the next 12 months from the issuance of
the Company's financial statements for the quarter ended
September 30, 2022.
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, the success of the Company's potential commercial
launch, changes to estimated costs of commercialization, including
the Company's commitments under the Sanofi Co-Promotion Agreement,
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 third
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 diseases. The Biologics License
Application (BLA) for teplizumab, its lead investigational drug
candidate, for the delay of progression to Stage 3 clinical type 1
diabetes in at-risk individuals has been filed by the U.S. Food and
Drug Administration (FDA) and has a user fee goal date of
November 17, 2022. 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 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 at-risk T1D 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 for at-risk patients on the PROTECT study; the
potential impact of the co-promotion agreement with Sanofi on the
teplizumab launch; 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 for at least the next 12 months; and expected
cash-based operating expenses for the fourth quarter of 2022. These
statements may be identified by the use of forward-looking words
such as "will," "may," "believe," "plans," 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 additional 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 third quarter
ended September 30, 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.
Investor Contact:
Kristen Kelleher, Manager,
Investor Relations
investorrelations@proventionbio.com
Brendan Strong, Argot
Partners
Proventionbio@argotpartners.com
212-600-1902
Media Contact:
Kaelan Hollon
VP, Corporate Communications
khollon@proventionbio.com
202-421-4921
Provention Bio,
Inc.
Selected Financial
Data
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
(unaudited)
|
|
(unaudited)
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
756
|
|
$
|
678
|
|
$
|
2,082
|
|
$
|
678
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
16,339
|
|
|
17,724
|
|
|
50,271
|
|
|
54,379
|
General and
administrative
|
|
|
13,495
|
|
|
10,031
|
|
|
39,803
|
|
|
36,017
|
Total operating
expenses
|
|
|
29,834
|
|
|
27,755
|
|
|
90,074
|
|
|
90,396
|
Loss from
operations
|
|
|
(29,078)
|
|
|
(27,077)
|
|
|
(87,992)
|
|
|
(89,718)
|
Interest income,
net
|
|
|
700
|
|
|
55
|
|
|
903
|
|
|
114
|
Interest
expense
|
|
|
(255)
|
|
|
—
|
|
|
(255)
|
|
|
—
|
Loss before income tax
benefit
|
|
|
(28,633)
|
|
|
(27,022)
|
|
|
(87,344)
|
|
|
(89,604)
|
Income tax
benefit
|
|
|
—
|
|
|
—
|
|
|
7,056
|
|
|
1,000
|
Net loss
|
|
$
|
(28,633)
|
|
$
|
(27,022)
|
|
$
|
(80,288)
|
|
$
|
(88,604)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.34)
|
|
$
|
(0.43)
|
|
$
|
(1.14)
|
|
$
|
(1.41)
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
83,119
|
|
|
63,375
|
|
|
70,484
|
|
|
63,008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
December 31,
2021
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
|
|
$
|
186,528
|
|
$
|
127,132
|
Total assets
|
|
|
|
|
|
|
|
$
|
193,913
|
|
$
|
135,621
|
Total
liabilities
|
|
|
|
|
|
|
|
$
|
49,144
|
|
$
|
24,887
|
Accumulated
deficit
|
|
|
|
|
|
|
|
$
|
(372,362)
|
|
$
|
(292,074)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
$
|
144,769
|
|
$
|
110,734
|
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SOURCE Provention Bio, Inc.