- This credit facility is intended to support the progress and
expansion of Inventiva’s pipeline
- The credit facility consists of two tranches of €25 million
each
- Credit agreement is part of the European Investment Bank’s
strategy to support biotech companies developing a high-level of
expertise in various therapeutic areas with significant unmet
medical needs
Daix (France), Long
Island City (New York, United States), May 16, 2022 –
Inventiva (Euronext Paris and Nasdaq: IVA) (the
“Company”), a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies
for the treatment of patients with non-alcoholic steatohepatitis
(NASH) and other diseases with significant unmet medical needs,
today announced the signing of a €50 million bullet credit facility
agreement with the European Investment Bank (“EIB”). The Company
plans to use the facility toward its preclinical and clinical
pipeline, including to help fund a portion of its Phase III
clinical trial of lanifibranor in patients with NASH.
The facility is divided into two tranches of €25
million each. The disbursement of the first tranche (“Tranche A”)
is subject to the completion of certain conditions precedent
specified in the credit facility agreement. The second tranche
(“Tranche B”) is subject to the full drawdown of Tranche A in
addition to the achievement of certain conditions precedents. The
maturity date of any borrowings under the facility is four years
after disbursement of Tranche A and three years after disbursement
of Tranche B. It is therefore expected that the reimbursement of
the interests and capital of this credit facility will happen after
the publication of the headline results of the part 1 of the Phase
III clinical trial of lanifibranor in patients with NASH, which are
expected in the second half of 2024.
Jean Volatier, Chief Financial Officer
of Inventiva, stated: “We are very pleased with this
credit facility, one of the largest granted by the EIB to a
biotech. We expect to use any borrowings under the facility to
support further development of our pipeline, especially the
clinical development of lanifibranor to seek accelerated approval
in the US and conditional approval in the EU.”
“EIB is proud to finance a European biotech
company that is at the forefront of innovation in its field and
embodies Europe's dynamism in the development of new treatments,
said Ambroise Fayolle, Vice-President of the European
Investment Bank. The expertise developed by Inventiva is
all the more necessary as it aims to develop breakthrough
treatments for patients suffering from NASH and other diseases with
unmet medical needs today."
In addition to capitalized interest of 8% for
Tranche A and 7% for Tranche B, Inventiva will issue warrants to
the benefit of the EIB in varied amounts according to the relevant
tranche, the amount of equity raised or the amount of cash received
in the context of a partnership or other transaction and the
average price per share paid by investors in the context of the
equity raise1 .
The strike price of each warrant will be equal
to 95% of the volume weighted average of the trading price of
Inventiva’s ordinary shares over a number of trading days preceding
the day the issue price is set. The warrants will have a term of 12
years and become exercisable upon the maturity of Tranche A or upon
the occurrence of certain events (e.g., change of control, event of
default repayment demand), thus avoiding dilution for existing
shareholders in the near term.
At the maturity of Tranche A or upon the
occurrence of certain events, the EIB will be granted an option to
sell its warrants to Inventiva for an amount equal to the
difference between the fair market value and the exercise price of
the warrants2, as an alternative to the exercise of the
warrants.
About the European Investment Bank
(EIB)
The EIB is the European Union (EU) long-term
financing institution, and its shareholders are the 27 EU Member
States. Its mission is to contribute to the integration, balanced
development, and economic and social cohesion of EU Member States.
It borrows large volumes of funds from the capital markets and
lends them with very favourable terms to support projects which
contribute to the achievement of EU objectives. The EIB is working
to put the EU at the forefront of the next wave of innovation,
especially in the health sector. In response to the Covid-19 health
crisis, the EIB has released €6 billion for investments in the
health sector to support medical infrastructure, additional
research activities or other financing related to vaccines and
treatments. As a European bank supporting the climate, the EIB is
one of the main fund providers in the green transition towards a
more low-carbon and sustainable growth model.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the research and development of oral small
molecule therapies for the treatment of patients with NASH and
other diseases with significant unmet medical needs. The Company
benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and
epigenetic modulation. Inventiva’s lead product candidate,
lanifibranor, is currently in a pivotal Phase III clinical trial,
NATiV3, for the treatment of adult patients with NASH, a common and
progressive chronic liver disease for which there are currently no
approved therapies.
The Company has established a strategic
collaboration with AbbVie in the area of autoimmune diseases that
resulted in the discovery of the drug candidate cedirogant
(ABBV-157), an oral RORg inverse agonist which is being evaluated
in a Phase IIb clinical trial, led by AbbVie, in adult patients
with moderate to severe chronic plaque psoriasis. Inventiva’s
pipeline also includes odiparcil, a drug candidate for the
treatment of adult mucopolysaccharidoses (MPS) VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with
respect to its potential further development. Inventiva is in the
process of selecting an oncology development candidate for its
Hippo signalling pathway program.
The Company has a scientific team of
approximately 80 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, and clinical development. It owns an extensive
library of approximately 240,000 pharmacologically relevant
molecules, approximately 60% of which are proprietary, as well as a
wholly‑owned research and development facility.
Inventiva is a public company listed on
compartment C of the regulated market of Euronext Paris (ticker:
IVA - ISIN: FR0013233012) and on the Nasdaq Global Market in the
United States (ticker: IVA). www.inventivapharma.com.
Contacts
InventivaPascaline ClercVP of Global External
Affairsmedia@inventivapharma.com+1 240 620 9175 |
Brunswick GroupLaurence Frost / Tristan Roquet
Montegon / Aude LepreuxMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com+1 415 513 1284 |
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Important Notice
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
release are forward-looking statements. These statements include,
but are not limited to, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, clinical
trial data releases, including for part 1 of the Phase III clinical
trial of lanifibranor in patients with NASH, pipeline and
preclinical and clinical development plans, reaching anticipated
milestones and conditions precedent for Tranche A and/or Tranche B,
potential future financings and strategic transactions, milestone
payments, royalties and product sales, future activities,
expectations, plans, growth and prospects of Inventiva and the
sufficiency of Inventiva’s cash resources and cash runway. Certain
of these statements, forecasts and estimates can be recognized by
the use of words such as, without limitation, “believes”,
“anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”,
“may”, “will”, “would”, “could”, “might”, “should”, and “continue”
and similar expressions. Such statements are not historical facts
but rather are statements of future expectations and other
forward-looking statements that are based on management's beliefs.
These statements reflect such views and assumptions prevailing as
of the date of the statements and involve known and unknown risks
and uncertainties that could cause future results, performance or
future events to differ materially from those expressed or implied
in such statements. Future events are difficult to predict and may
depend upon factors that are beyond Inventiva's control. There can
be no guarantees with respect to pipeline product candidates that
the clinical trial results will be available on their anticipated
timeline, that future clinical trials will be initiated as
anticipated, that product candidates will receive the necessary
regulatory approvals, or that any of the anticipated milestones by
Inventiva or its partners will be reached or that conditions
precedent to receive funds under the credit facility will be met on
their expected timeline, or at all. Actual results may turn out to
be materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates, due to a number of factors,
including that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has
incurred significant losses since inception, Inventiva has a
limited operating history and has never generated any revenue from
product sales, Inventiva will require additional capital to finance
its operations, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates,
preclinical studies or earlier clinical trials are not necessarily
predictive of future results and the results of Inventiva's
clinical trials may not support Inventiva's product candidate
claims, Inventiva may encounter substantial delays in its clinical
trials or Inventiva may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities, enrolment
and retention of patients in clinical trials is an expensive and
time-consuming process and could be made more difficult or rendered
impossible by multiple factors outside Inventiva's control,
Inventiva's product candidates may cause adverse drug reactions or
have other properties that could delay or prevent their regulatory
approval, or limit their commercial potential, Inventiva faces
substantial competition and Inventiva’s business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current COVID-19 pandemic and
geopolitical events, such as the conflict between Russia and
Ukraine, which could delay the initiation, enrolment and completion
of Inventiva’s clinical trials on anticipated timelines or at all.
Given these risks and uncertainties, no representations are made as
to the accuracy or fairness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press
release. Readers are cautioned not to place undue reliance on any
of these forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2021 filed with the
Autorité des Marchés Financiers on March 11, 2022 and the Annual
Report on Form 20-F for the year ended December 31, 2021 filed with
the Securities and Exchange Commission on March 11, 2022 for
additional information in relation to such factors, risks and
uncertainties.
All information in this press release is as of
the date of the release. Except as required by law, Inventiva has
no intention and is under no obligation to update or review the
forward-looking statements referred to above.
1 Or in the absence of share issuance for the first tranche, the
average price per share over the last 90 trading days preceding the
subscription of the warrants.
2 Subject to a cap equal to the aggregate amount disbursed under
the credit facility agreement.
- Inventiva - Press Release - EIB Financing - 16.05.2022
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