Inventiva announces a €20.1 million issuance of royalty
certificates
- Royalty certificates subscribed by Samsara BioCapital and
existing shareholders (BVF Partners, NEA, Sofinnova and
Yiheng).
- Royalty of 3% on future net sales of lanifibranor in the United
States of America, the European Union and the United Kingdom over a
14-year term.
- Cash runway extended through September 2024 and evaluation of
strategic and financing options pursued1.
Daix (France), Long
Island City (New York, United States), July 18, 2024 –
Inventiva (Euronext Paris and Nasdaq: IVA)
(“Inventiva” or the “Company”), a
clinical-stage biopharmaceutical company focused on the development
of oral small molecule therapies for the treatment of patients with
metabolic dysfunction-associated steatohepatitis
(“MASH”), also known as non-alcoholic
steatohepatitis (“NASH”), and other diseases with
significant unmet medical needs, today announced the issuance of
royalty certificates (the “Royalty Certificates”)
subscribed by Samsara BioCapital, BVF Partners, NEA, Sofinnova, and
Yiheng, for an amount of approximately €20.1 million (the
“Transaction”).
Frederic Cren,
Chairman, Chief Executive Officer, and cofounder of
Inventiva stated: “Besides extending our cash runway,
this agreement demonstrates the commitment from our key
shareholders to continue the development of lanifibranor. We are
also pleased to have gained the interest and support of Samsara
BioCapital, a leading U.S. specialized fund. With this transaction
completed, we continue to focus on advancing the development of
lanifibranor, one of the most promising drugs in MASH/NASH, and we
are pursuing our evaluation of strategic and financing options to
fully support its development.”
Reasons for the issuance and use of the
proceeds of the Transaction
The Company intends to use approximately 95% of
the net proceeds from the Transaction to continue the NATiV3 Phase
III trial of lanifibranor in MASH/ NASH (“NATiV3”)
and the remainder for general corporate purposes.
Before giving effect to the Transaction and the
cash preservation measures implemented by the Company with its
creditors, considering the Company’s cost structure and forecasted
expenditures, the Company estimated that its cash, cash equivalents
and deposits allowed the Company to fund its operations as planned
until the beginning of the third quarter of 2024. As of June 30,
2024, the Company’s cash and cash equivalents are estimated
(non-audited) to be €10.1 million, compared with €9.6 million, €0.1
million2 of short-term deposits and €10
million3 of long-term deposits as of May 31, 2024.
Considering its current cost structure and
forecasted expenditures and including the proceeds of approximately
€20.1 million from the issuance of the Royalty Certificates and the
cash preservation measures in the short term set up by the Company
with its creditors, the Company estimates that its cash, cash
equivalents and deposits should allow the Company to fund its
operations through September 2024. These factors raise substantial
doubt regarding the Company’s ability to continue as a going
concern beyond the end of September 2024.
The Company explored a variety of options,
including the issuance of debt, equity and other instruments, prior
to deciding to enter into the Transaction. In order to finance its
activities beyond the end of September 2024, the Company will need
to raise additional funds, and it is continuing to actively review
potential financing (including debt, equity and equity-linked or
other instruments) and strategic options.
Main characteristics of the
Transaction
The Royalty Certificates are being issued
pursuant to a decision of Board of Directors on July 16, 2024, in
accordance with the provisions of Article L. 228-36-A of the French
Commercial Code (Code de commerce) to one new investor and
existing shareholders.
The Royalty Certificates give the holders
thereto the right to an annual payment of royalties (the
"Royalties") equal to 3% of the future net sales
of lanifibranor (the "Product"), if any, beginning
on the fiscal year following the start of the sales of the Product
following the potential granting of the market authorization
(Autorisation de mise sur le marché) for the Product in
(i) the United States of America or (ii) the countries of the
European Union or (iii) the United Kingdom, whichever occurs the
first.
The Royalty Certificates do not have any
additional financial rights besides the right to payment of
Royalties referred to above. Specifically, the Royalty Certificates
do not grant any financial rights on any other products that may be
developed by the Company beyond lanifibranor.
The subscription price for the Royalty
Certificates is €20.1 million and has been calculated taking into
account the net present value (“NPV”) of expected
cash flows related to the Royalty Certificates and the current
financial position of the Company. The NPV calculation depends
strongly on assumptions made by the Company with regards to the
chances of success of its studies, the commercialization calendar
of lanifibranor, the market size addressed for lanifibranor, the
market share of the product and the discount rate. In the process
of setting the discount rate, the Company analyzed the expected
cash flow derived from its business plan as regards to its market
capitalization.
The Royalty Certificates have a term of 14 years
following their issuance and do not provide for an accelerated
repayment in case of change of control. The Company may at any time
repurchase in full the Royalty Certificates by paying a price to be
agreed between the Company and the holders of the Royalty
Certificates. The Company may also redeem the Royalty Certificates
from each holder, subject to offering such redemption to every
holders. Lastly, the Company has a pre-emptive right in the event
of the sale of Royalty Certificates by a holder.
The holders of Royalty Certificates are subject
to a 6-month lock-up period after which the Royalty Certificates
will become freely transferable (in whole or in part, provided that
the transfer involves a minimum number of 10 Royalty Certificates)
only pursuant to an exemption from the registration requirements of
the U.S. Securities Act of 1933, as amended, (the
“Securities Act”)and to qualified investors
pursuant to Article 2(e) of Regulation (EU) 2017/1129. The Company
will have a preemptive right on any transfer of Royalty
Certificates.
Settlement and delivery of the Royalty
Certificates is expected to occur on July 22, 2024. The Royalty
Certificates will not be listed on any stock exchange and will not
be assigned an ISIN. The closing of the Transaction is subject to
the satisfaction of customary closing conditions.
It is reminded that these Royalty Certificates
are independent from the royalty certificates issued in August
2023, and do not have the same characteristics (see the Company's
press release published on August 31, 2023) (the “2023
Royalty Certificates”).
The Royalty Certificates will be issued in a
private placement exempt from registration under the Securities Act
and have not been, and will not be, registered under the Securities
Act, and may not be offered or sold in the United States absent
registration or an applicable exemption from registration
requirements.
The issue and subscription of the Royalty
Certificates will not result in any change in the shareholder
structure (for a description of the share capital, please refer to
section 6.1.1 of the Company's 2023 Universal Registration Document
dated April 3, 2024).
Important notice
The Transaction has not been the subject of a
prospectus submitted to the Autorité des Marchés
Financiers for its approval.
The payment of Royalties for the Royalty
Certificates and of royalties for the 2023 Royalty Certificates in
the event of the commercialization of the Product (respectively, 3%
and 5% of sales of the Product in the United States, in European
Union countries and in the United Kingdom), if approved, would
result in a decrease in cash flow generated by sales of the
Product, which will have an unfavorable effect on the Company's
financial position, particularly at the beginning of the
commercialization phase.
Please refer to the Universal Registration
Document for the year ended December 31, 2023, filed with the
Autorité des Marchés Financiers on April 3,
2024, and the Annual Report on Form 20-F for the year ended
December 31, 2023, filed with the Securities and Exchange
Commission (the “SEC”) on April 3, 2024 for other risks and
uncertainties affecting Inventiva, including those described under
the caption “Risk Factors”, and in our future filings with the SEC.
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 statements.
Financial Calendar
The Company intends to publish the cash position
and revenue as of June 30, 2024 as planned on July 31, 2024.
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 MASH/NASH and
other diseases with significant unmet medical need. 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 MASH/NASH, a
common and progressive chronic liver disease.
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 a 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, PhD
EVP, Strategy and Corporate Affairs
media@inventivapharma.com
+1 202 499 8937 |
Brunswick Group
Tristan Roquet Montegon /
Aude Lepreux /
Julia Cailleteau
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83 |
Westwicke, an ICR Company
Patricia L. Bank
Investor relations
patti.bank@westwicke.com
+1 415 513-1284 |
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Important Notice
This press release contains certain
“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, statements with respect
to the Transaction, including statements regarding the anticipated
proceeds, completion and timing of the Transaction, Inventiva’s
expected use of proceeds from the Transaction, Inventiva’s
estimated cash position prior to and following the Transaction and
implementation of cash preservation measures, including its
estimated cash runway, Inventiva’s ability to execute potential
financing and strategic options, their outcome and likelihood of
success, as well as statements regarding , potential regulatory
submissions and approvals, and Inventiva’s pipeline and preclinical
and clinical development plans, business and regulatory strategy,
the commercialization of lanifibranor and achievement of any sales
related thereto, payment of royalties and anticipated future
performance. 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”, “opportunity”,
“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 cannot provide assurance on the impacts of
the SUSAR on enrollment or the ultimate impact on the results or
timing of the NATiV3 trial or regulatory matters with respect
thereto, 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
ability to obtain financing and to enter into potential
transactions, 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 its clinical trials may prove to be wrong and regulatory
authorities may require holds and/or amendments to Inventiva’s
clinical trials, Inventiva’s expectations with respect to the
clinical development plan for lanifibranor for the treatment of
MASH/NASH may not be realized and may not support the approval of a
New Drug Application, Inventiva and its partners may encounter
substantial delays beyond expectations 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,
enrollment 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, enrollment 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.
Disclaimers
This press release does not constitute an
offer to sell or the solicitation of an offer to buy securities in
any jurisdiction, and shall not constitute an offer, solicitation
or sale in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of that jurisdiction.
The distribution of this document may, in
certain jurisdictions, be restricted by local legislations. Persons
into whose possession this document comes are required to inform
themselves about and to observe any such potential local
restrictions.
United States of America
This press release shall not
constitute an offer to sell or a solicitation of an offer to buy
Royalty Certificates in the United States of America, nor shall
there be any sale of Royalty Certificates in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such state or other
jurisdiction.
The Royalty Certificates have not
been registered under the Securities Act of 1933, as amended, and
may not be offered or sold in the United States except pursuant to
an effective registration statement or an applicable exemption from
the registration requirements.
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 Short-term deposits are classified as "other current
assets" in the consolidated statement of financial position under
IFRS and are considered by the Company to be liquid and readily
available.
3 The two-year long-term deposit has a two-year term, is
accessible prior to the expiration of the term with 31 days notice
and is considered liquid by the Company.
- Inventiva - PR - Royalty Deal - EN - 07 18 2024
Inventiva (EU:IVA)
過去 株価チャート
から 7 2024 まで 8 2024
Inventiva (EU:IVA)
過去 株価チャート
から 8 2023 まで 8 2024