Inventiva draws down the second tranche of €25 million under
existing Finance Contract with the European Investment Bank
- 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 €25 million supports Inventiva’s estimated cash runway1
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 €25 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 €25 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 €50 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 €25 million, each subject to
the completion of certain conditions precedent.
After the drawdown of the first tranche in
December 20222, the Company was eligible to access the second
tranche of €25 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 €25 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 20241.
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 20273, 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 €70 million
(inclusive of the €18 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 €10 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 6th 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
capital4.
The exercise price of the warrants issued in
connection with the second tranche is equal to €3.95 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
€3.95 per new share, the Company could potentially receive gross
proceeds of up to €12,421,383. 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.
Contacts
Inventiva Pascaline Clerc, PhDEVP, Strategy and Corporate
Affairsmedia@inventivapharma.com +1 202 499
89375 |
Brunswick GroupTristan Roquet Montegon /Aude Lepreux
/Matthieu BenoistMedia 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, 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, 2022.3 The first tranche of €25 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.
- Inventiva - PR - EIB Tranche B - EN - 01 10 2024
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