Full Press Release Details
Update on Inventiva's
cash position and on the finance documentation with the European Investment Bank
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 ("Pr t Garanti par l'Etat") with Bpifrance and two loans from a stimulus economic plan
("Pr ts Participatifs Relance") granted by Cr dit Agricole Champagne-Bourgogne and Soci t
G n rale, they are in large part guaranteed by the French State and have a duration of eight-year and a four-year repayment
price of $7.75 per new ADS, which represents a discount of 0.92% to the volume weighted average price of the Company shares on Euronext
Paris over the last trading day (i.e. June 15, 2022).
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.
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.
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.
Such amount will depend on the issue date of the warrants.
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