RED
BANK, N.J., Aug. 31,
2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB) (the "Company"), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated diseases, today
announced that the Company has secured a term loan facility of up
to $125 million with Hercules
Capital, Inc. (NYSE: HTGC), a leader in customized financing for
companies in life sciences.
"This term loan facility significantly strengthens our balance
sheet ahead of teplizumab's potential commercial launch and
provides the Company with additional financial flexibility as we
continue to work to change the landscape for patients with type 1
diabetes," said Thierry Chauche, Chief Financial Officer of
Provention Bio.
"Hercules is proud to partner with Provention Bio ahead of the
potential approval and commercial launch of teplizumab," said
Bryan Jadot, Senior Managing
Director and Life Sciences Group Head at Hercules Capital. "This
substantial capital commitment from Hercules aims to help
Provention Bio deliver on their important mission to improve the
lives of people at risk for type 1
diabetes."
The term loan facility provides for up to $125 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
million was drawn at closing. The Company may draw the
second tranche in an amount equal to $40
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 million, subject to satisfaction of certain
conditions, including achievement of certain milestones. The
availability of the fifth tranche of up to $25 million is subject to the approval of the
lenders.
Jefferies acted as exclusive financial advisor to the Company on
the transaction.
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 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 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 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 the medical need in T1D at-risk patients, the potential
commercialization of teplizumab. These statements may be identified
by the use of forward-looking words such as "may" and "believe,"
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 FDA disagreeing with the Company's
interpretation of data and analysis and information in the BLA
resubmission; 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 address its concerns and requests in
a timely manner or at all during the review process for teplizumab,
including any inability to provide the FDA with data, analysis or
other information sufficient to support an approval of the BLA for
teplizumab; any inability to satisfactorily address matters PK
comparability, product quality, safety or any other FDA
requirements during the BLA review process to obtain 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, 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:
Robert
Doody, VP, Investor Relations
rdoody@proventionbio.com
484-639-7235
Media Contact:
Kaelan
Hollon, VP, Corporate Communications
khollon@proventionbio.com
202-421-4921
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SOURCE Provention Bio, Inc.