* Inventiva intends to use the proceeds to fund part of its ongoing pivotal
NATiV3 Phase III clinical trial evaluating lanifibranor in patients with
NASH.
* This second tranche carries an interest rate of 7% annually and has a
maturity of 3 years and a repayment in fine which is expected to occur after
the anticipated publication of the results of the NATiV3 Phase III trial
evaluating lanifibranor in patients with NASH, expected in the first half of
2026.
* The EUR25 million supports Inventiva's estimated cash runway(1) until the
beginning of the third quarter of 2024.
Daix (France), Long Island City (New York, United States), January 10, 2024 -
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 drawdown of the second tranche of EUR25 million of the unsecured
loan agreement executed with the European Investment Bank ("EIB") on May
16, 2022 (the "Finance Contract") with a maturity date on or about January
18, 2027. The disbursement of the second tranche is expected to occur on or
about January 18, 2024. On January 4, 2024, and in accordance with the Finance
Contract, the Company issued 3,144,654 warrants to EIB.
Jean Volatier, Deputy Chief Executive Officer and Chief Financial Officer of
Inventiva, stated: "The drawdown of this second tranche of EUR25 million was
triggered by the accomplishment of key milestones by Inventiva, and allows us to
further finance our pivotal Phase III clinical trial evaluating our lead
compound, lanifibranor, in NASH. Inventiva is a leader in drug development for
the treatment of NASH and the financial support provided by the EIB through a
facility loan totaling EUR50 million is a testament to the important work of
Inventiva in the field. We are truly thankful for the support provided by the
EIB."
As previously announced, the Finance Contract provides funding in two tranches
of EUR25 million, each subject to the completion of certain conditions precedent.
After the drawdown of the first tranche in December 2022(2), the Company was
eligible to access the second tranche of EUR25 million if it met certain
conditions precedent described below. Following the achievement of those
conditions, the Company decided to draw on the second tranche to reinforce its
financial position. The Company intends to use the proceeds to fund part of its
pivotal NATiV3 Phase III clinical trial evaluating lanifibranor in patients with
NASH and estimates that, including this second tranche of EUR25 million of the EIB
loan, its cash, cash equivalents and deposits would allow the Company to fund
its operations as currently planned until the beginning of the third quarter of
2024(1).
This second tranche carries a 7% interest capitalized annually, has a maturity
of 3 years from the disbursement date and a repayment in fine. As a result, the
Company expects to repay this tranche in early 2027(3), after the anticipated
publication of the results of the NATiV3 Phase III trial evaluating lanifibranor
in patients with NASH which is expected to take place in the first half of
2026. The disbursement of this second tranche was subject to, among other
conditions, (i) the full drawdown of the first tranche, (ii) the receipt by the
Company from the date of the Finance Contract of an aggregate amount of at least
EUR70 million (inclusive of the EUR18 million that were a condition for the
disbursement of the first tranche), paid either in exchange for shares of the
Company, or through upfront or milestone payments, (iii) an out-licensing,
partnership or royalty transaction with an upfront payment of at least EUR10
million, (iv) operational criteria based on patient enrollment and number of
sites activated in the Company's NATiV3 Phase III clinical trial of lanifibranor
in patients with NASH and (v) the Company issuing warrants to EIB in accordance
with the terms and conditions of the warrant agreement entered into on July
1, 2022.
On January 4, 2024, the Company issued 3,144,654 warrants to EIB, in accordance
with the terms of the 6(th) resolution of the combined general meeting of
shareholders of January 25, 2023, and Article L.225-138 of the French Commercial
Code, as a condition to the drawdown of the second tranche. This represents
approximately 6.08% of the Company's current outstanding share capital(4).
The exercise price of the warrants issued in connection with the second tranche
is equal to EUR3.95 and corresponds to 95% of the volume-weighted average price of
the Company's shares on the regulated market of Euronext Paris during the last
trading session preceding the decision to issue the warrants (i.e. January
3, 2024).
Pursuant to the previously disclosed warrant agreement, the warrants have a
maturity of twelve years and shall be exercisable following the earliest to
occur of (i) the maturity date of the first tranche (i.e. on December 8, 2026),
(ii) a change of control event, (iii) an event of default under the Finance
Contract, or (iv) a repayment demand by EIB under the Finance Contract. The
warrants will automatically be deemed null and void if not exercised within the
twelve-year period.
EIB has a put option which may require the Company to repurchase all or part of
the unexercised warrants then exercisable at their intrinsic value (subject to a
cap equal to the amount drawn under the Finance Contract) under certain
circumstances (for example, in the event of a change of control of the Company
or on the maturity date of the first tranche or in the event of default). The
Company (or a substitute third party) has a call option to require EIB to sell
all shares and other securities of the Company in certain circumstances,
including the warrants, to the Company, subject to certain terms and conditions.
In addition, the Company has a right of first refusal to buy-back all warrants
offered for sale to a third party, subject to certain terms and conditions.
On the basis of the 3,144,654 new shares of the Company issuable upon exercise
of the warrants issued in connection with the drawdown of the second tranche at
an exercise price of EUR3.95 per new share, the Company could potentially receive
gross proceeds of up to EUR12,421,383. There is no assurance that EIB will
exercise any or all of the warrants or that the Company will receive any
proceeds from the exercise of the warrants.
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, mucopolysaccharidoses (MPS) 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 is currently advancing one clinical candidate,
has a pipeline of two preclinical programs and continues to explore other
development opportunities to add to its pipeline.
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.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment
of adult 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 also in the process of selecting an
oncology development candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 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 B 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
(http://www.inventivapharma.com).
Contacts
Brunswick Group
Inventiva Tristan Roquet Montegon Westwicke, an ICR
/ Company
Pascaline Clerc, Aude Lepreux / Patricia L. Bank
PhD Matthieu Benoist Investor relations
EVP, Strategy and Media relations patti.bank@westwicke.c
Corporate Affairs inventiva@brunswickgrou om
media@inventivaphar p.com (mailto:patti.bank@wes
ma.com (mailto:inventiva@bruns twicke.com)
(mailto:media@inven wickgroup.com)
tivapharma.com) +1
+1 202 499 89375 +33 1 53 96 83 83 415 513-1284
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, expectations with respect to clinical trials, regulatory
plans, including the ongoing NATiV3 Phase III clinical trial with lanifibranor
in patients with NASH and anticipated results and timing thereof, the potential
development of and regulatory pathway for odiparcil, the potential therapeutic
benefits of Inventiva's product candidates, Inventiva's future activities,
expectations, plans, growth and prospects, Inventiva's ability to exercise its
rights under the Finance Contract and warrant agreement with the EIB, including
its call right and right of first refusal, expectations with respect to EIB's
rights under the agreements and EIB's potential exercise of warrants, the
expected use of proceeds from the EIB facility, Inventiva's ability to repay the
EIB loans and the timing thereof, 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", "designed", "hopefully", "target",
"potential", "possible," "aim", 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. Actual 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 on their
expected timeline, or at all. Future 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, in the absence of which, Inventiva
may be required to significantly curtail, delay or discontinue one or more of
its research or development programs or be unable to expand its operations or
otherwise capitalize on its business opportunities and may be unable to continue
as a going concern, 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 and its partners' clinical trials may not support Inventiva's and
its partners' product candidate claims, Inventiva's expectations with respect to
the changes to the clinical development plan for lanifibranor for the treatment
of NASH may not be realized and may not support the approval of a New Drug
Application, Inventiva and its partners may encounter substantial delays in
their clinical trials or fail to demonstrate safety and efficacy to the
satisfaction of applicable regulatory authorities, the ability of Inventiva and
its partners to recruit and retain patients in clinical studies, 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 and its partners' 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 and its partners'
business, and preclinical studies and clinical development programs and
timelines, its financial condition and results of operations could be materially
and adversely affected by geopolitical events, such as the conflict between
Russia and Ukraine and related sanctions, impacts and potential impacts on the
initiation, enrolment and completion of Inventiva's and its partners' clinical
trials on anticipated timelines and the state of war between Israel and Hamas
and the related risk of a larger conflict, health epidemics, and macroeconomic
conditions, including global inflation, rising interest rates, uncertain
financial markets and disruptions in banking systems. 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, 2022 filed with the Autorité des Marchés Financiers on March 30, 2023 as
amended on August 31, 2023, the Annual Report on Form 20-F for the year ended
December 31, 2022 filed with the Securities and Exchange Commission on March
30, 2023, and the Half-Year Report for the six months ended June 30, 2023 on
Form 6-K filed with the SEC on October 3, 2023, for other risks and
uncertainties affecting Inventiva, including those described from time to time
under the caption "Risk Factors". Other risks and uncertainties of which
Inventiva is not currently aware may also affect its forward-looking statements
and may cause actual results and the timing of events to differ materially from
those anticipated. 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. Consequently, Inventiva accepts no liability for any consequences arising
from the use of any of the above statement.
(1) This estimate is based on the Company's current business plan and excludes
any potential milestones payable to or by the Company and any additional
expenditures related to the potential continued development of the odiparcil
program or resulting from the potential in-licensing or acquisition of
additional product candidates or technologies, or any associated development the
Company may pursue. The Company may have based this estimate on assumptions that
are incorrect and the Company may end up using its resources sooner than
anticipated.
(2) Cf. Press release of December 12, 2022 (https://inventivapharma.com/wp-
content/uploads/2022/12/Inventiva-CP-tirage-premiere-tranche-BEI-FR-
12-12-2022.pdf).
(3) The first tranche of EUR25 million drawn down on December 12, 2022 is expected
to be repaid by December 2026.
(4) As of the date of this press release, if all the warrants issued to the EIB
in connection with the first tranche were exercised, the EIB would hold
approximately 5.25 % of the Company's outstanding current share capital and if
all the warrants issued to the EIB in connection with the first tranche and the
second tranche were exercised, the EIB would hold approximately 11.3% of the
Company's outstanding current share capital.
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