- Inventiva intends to use the proceeds to fund part of the
pivotal Phase III clinical trial evaluating lanifibranor in
patients with NASH
- The €25 million supports Inventiva’s anticipated cash runway1
through the fourth quarter of 2023
Daix (France),
Long Island City (New York, United
States), December
12,
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 receipt of the €25 million
payment under the first tranche of the unsecured loan agreement
executed with the European Investment Bank (“EIB”) on May 16, 2022
with a maturity date of December 2026 (the "Finance Contract").
Jean Volatier, Chief Financial Officer
of Inventiva, stated: “We are pleased to see that our
long-term partnership with the EIB is bearing fruit. This payment
of the first tranche of €25 million, triggered by the progress made
on our NATiV3 Phase III trial and the completion of the cash
injections condition precedent for this tranche, will further
support the development of lanifibranor. We remain strongly focused
on the recruitment of patients in our Phase III trial and are
hoping to satisfy all conditions for the disbursement of the second
tranche of €25 million from the EIB.”
As previously announced, the Finance Contract
provides funding in two tranches of €25 million each, which are
both subject to the completion of certain conditions precedent. Any
drawings under the terms of the Finance Contract that have not been
disbursed within 36 months from the signing of the Finance
Contract, (i.e., before May 16, 2025), cannot be completed at a
later date. There is no assurance that the Company will be able to
satisfy the conditions precedent for the drawing of the second
tranche2.
The disbursement of the first tranche (with 8%
interest capitalized annually, a maturity of 4 years and a
repayment in fine) was subject to, among other conditions, (i) the
Company issuing warrants to EIB in accordance with the terms and
conditions of the warrants agreements entered into July 1, 2022,
and (ii) the Company’s receipt from the date of the Finance
Contract of an aggregate amount of €18 million, paid either in
exchange for new shares of the Company or through the receipt of
upfront or milestone payments.
On June 15, 2022, the Company raised €9.3
million through a capital increase under its ATM program. On
November 4, 2022, the Company received an upfront payment of $12
million under its collaboration agreement with Sino Biopharm.
On November 28, 2022, the Company issued
2,266,023 warrants to EIB, in accordance of the terms of the 25th
resolution of the combined general meeting of shareholders of May
19, 2022 and Article L.225-138 of the French Commercial Code, as a
condition to the financing of the first tranche, representing
approximately 5.4% of the Company's share capital outstanding as of
the date hereof.
The exercise price of the warrants is equal to
€4.0152 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.
As previously announced, 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 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, 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 2,266,023 new shares of the
Company issuable upon exercise of all the warrants at a price of
€4.0152 per new share, the Company could potentially receive gross
proceeds of up to €9,098,535. 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. In 2020, Inventiva reported positive results
from its Phase IIb clinical trial evaluating lanifibranor for the
treatment of patients with NASH and received Breakthrough Therapy
and Fast Track status from the U.S. Food and Drug Administration
(“FDA”) for lanifibranor in the treatment of NASH.
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 in the
process of selecting an oncology development candidate for its
Hippo signaling 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 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 the pivotal
Phase III clinical trial evaluating lanifibranor in patients with
NASH, including recruitment of patients for that trial, the
Company’s ability to satisfy conditions precedent to draw down on
the second tranche under the EIB facility, potential future
financings or strategic transactions, milestone payments and
royalties, the Company’s ability to exercise its rights under the
EIB facility, including its call right and right of first refusal,
expectations with respect to EIB’s rights under the EIB facility
and EIB’s potential exercise of warrants, the expected use of
proceeds from 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.
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, related sanctions and related
impacts and potential impacts on the initiation, enrolment and
completion of Inventiva’s clinical trials on anticipated timelines
and macroeconomic conditions, including global inflation and
uncertain financial markets 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, 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 and the
financial report for the first half of 2022 filed with the
Securities and Exchange Commission on September 22, 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 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 The disbursement
of the second tranche is subject to, among other conditions, (i)
the full drawdown of the first tranche, (ii) the receipt by the
Company from the date of the EIB credit facility of an aggregate
amount of at least €70 million (inclusive of the €18 million that
was a condition for the disbursement of the first tranche), paid
either in exchange for Company shares, or through upfront or
milestone payments, (iii) an out-licensing, partnership or royalty
transaction with an upfront payment of at least €10 million; and
(iv) 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.
- Inventiva - PR - first tranche EIB - EN - 12 12 2022
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