Update on Inventiva's cash position and on the finance
documentation with the European Investment Bank
- Inventiva successfully raised approximately €14.6 million
through a combination of its ATM Program for €9.3 million and new
State-backed bank financing for €5.3 million
- In accordance with the terms of the credit facility announced
on May 16, 2022, Inventiva entered into a warrant agreement with
the European Investment Bank on July 1, 2022
- Cash runway extended until the end of second quarter 2023
Daix (France), Long Island City (New
York, United States), July 4, 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 strengthening of its cash
position by approximately €14.6 million through its At-The-Market
program (the "ATM Program") and new state-backed bank
financing. This extends the Company's cash runway until the end of
the second quarter 2023, based on existing cash, cash equivalents
and short-term deposits and without taking into account the credit
facility with the European Investment Bank (the “EIB”). The
Company also finalized the documentation requirement under the
credit facility with the EIB (the "Finance Contract") for up
to €50 million as announced on May 16, 2022 by the signing of a
warrant agreement (the "Warrant Agreement"). The Company
plans to use the proceeds from the EIB facility towards its
preclinical and clinical pipeline, including to help fund a portion
of its Phase III clinical trial of lanifibranor in patients with
NASH.
Equity raised through the At-The-Market
Program:On June 15, 2022, the Company sold 1,260,618 American
Depositary Shares ("ADS") for an amount of $9,769,789.501
pursuant to the Company's ATM program established on August 2,
2021, through Jefferies LLC, acting as sales agent. Each ADS
represents one ordinary share of the Company.
The new shares underlying the ADS issued under
the ATM Program represented approximatively 3% of the share capital
of the Company as of the date of the transaction.
Non-dilutive debt financing of €5.3m in the
form of an additional state-guaranteed loan facility and two
loans from a stimulus economic plan:In June 2022, the
Company signed three loan agreements with French banks for a total
amount of €5.3 million, guaranteed in part by the French State.
Implemented as part of a state-guaranteed PGE loan facility ("Prêt
Garanti par l’Etat") with Bpifrance and two loans from a stimulus
economic plan ("Prêts Participatifs Relance") granted by Crédit
Agricole Champagne-Bourgogne and Société Générale, they are in
large part guaranteed by the French State and have a duration of
eight-year and a four-year repayment schedule.
Terms of the Finance Contract:As
previously announced, the Finance Contract is divided into two
tranches of €25 million each which are subject to the completion of
certain condition precedents. The disbursement of the first tranche
(with capitalized interest of 8% and a maturity date of four years)
is subject to, among other conditions, (i) the Company
entering into a subscription agreement under the Warrant Agreement
to issue warrants to the EIB and (ii) the receipt by the
Company of an aggregate amount of at least €18 million, paid either
through the issuance of new Company shares, or through upfront or
milestone payments. As of today, the Company raised €9.3 million
through a capital increase under its ATM Program.
The disbursement of the second tranche of €25
million (with capitalized interest of 7% and a maturity date of
three years) is further subject to, among other conditions,
(i) the full drawdown of the first tranche, (ii) the issue of
the second tranche of warrants, (iii) the receipt by the
Company of an aggregate amount of at least €70 million (inclusive
of the €18 million mentioned above), made of either the issuance of
new Company shares, or through upfront or milestone payments coming
from business development activities on the various assets of the
Company, (iv) (a) an out-licensing, partnership or
royalty transaction with an upfront payment of at least €10
million, or (b) the initiation of a Phase III clinical trial
of cedirogant by AbbVie Inc; and (v) operational criteria
based on patient enrollment and number of sites activated in the
Company’s Phase III clinical trial of lanifibranor in patients with
NASH.
The two tranches will be available within 36
months following the signature of the Finance Contract.
Prepayment events under the Finance
Contract:The Finance Contract may, in certain circumstances, be
prepaid, in whole or in part, for a prepayment fee, either at the
election of the Company or as a result of EIB’s demand following
certain prepayment events, including a change of control or change
in senior management of the Company.
Subject to certain terms and conditions, upon
the occurrence of usual events of default (i.e. including payment
default, misrepresentation, cross default), EIB may demand
immediate repayment by the Company of all or part of the
outstanding loan and/or cancel the undisbursed tranches.
Terms and Conditions of the warrants:
As described above, in connection with the
Finance Contract, the Company agreed to issue warrants to EIB as a
condition to the funding of each tranche. The number of warrants to
be issued to EIB will be determined based on (i) the aggregate
amount raised by the Company through one or more equity offerings,
or through upfront or milestone payments, from the date of the
Finance Contract to the time of the disbursement of the relevant
tranche, and (ii)(a) the average price per share paid for the
Company shares in its most recent qualifying equity offering, or
(b) for the first tranche only, in case of no qualifying
equity offering, the volume weighted average price per share of the
Company shares over the last 180 calendar days. The subscription
price shall be €0.01 per warrant.
The warrants have a maturity of twelve years and
shall be exercisable following the earliest to occur of (i) a
change of control event, (ii) the maturity date of the first
tranche, (iii) an event of default under the Finance Contract,
or (iv) a repayment demand by the EIB under the Finance
Contract. The warrants shall automatically be deemed null and void
if they are not exercised within the twelve-year period. Each
warrant will entitle EIB to one ordinary share of the Company in
exchange for the exercise price (subject to anti-dilutive
provisions).
The exercise price will be equal to 95% of the
volume weighted average of the trading price of the Company shares
on the regulated market of Euronext Paris for the last trading
session preceding the decision of the competent body of the Company
to issue such warrant. EIB shall be entitled to a put option at its
intrinsic value, (subject to a cap equal to the drawn amount under
the Finance Contract) to require the Company to buy back all or
part of the warrants then exercisable but not yet exercised in
certain circumstances (for instance in case of change of control or
at the maturity date of the first tranche or in case of event of
default). Furthermore, the Company shall be entitled to a call
option to require EIB to sell to the Company (or a substitute third
party) all the warrants, and a right of first refusal to buy back
any warrants that are offered for sale to a third party, subject to
certain exceptions.
Pursuant to the provisions of the Warrant
Agreement, if the first tranche of the warrants was issued today,
the underlying shares would represent a potential dilution of
approximatively 3.2% of the current share capital of the
Company2.
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 Affairs
media@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. Bank Investor
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 and the expected Phase
IIb clinical trial of cedirogant led by AbbVie, 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, the
Company’s ability to satisfy conditions precedent to drawing down
on either or both of the tranches under the EIB facility 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 At price of $7.75 per new ADS, which represents a discount of
0.92% to the volume weighted average price of the Company's shares
on Euronext Paris over the last trading day (i.e. June 15,
2022)
2 Such amount will depend on the issue date of the warrants.
- Inventiva - CP - EIB Warrant Agreement - 04 07 2022
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