Inventiva announces financing of up to €348 million to advance the
NATiV3 Phase 3 MASH study
- Inventiva secures €94.1 million of a multi-tranche equity
financing of up to €348 million, subject to satisfaction of
specified conditions, from both new and existing investors, and up
to $30 million in milestone payments relating to equity financing
pursuant to amendment to license and collaboration agreement with
CTTQ.
- Proceeds from financing to be primarily used to advance
Inventiva’s Phase 3, NATiV3 clinical trial evaluating lanifibranor
in patients with MASH.
- More than 1,100 patients randomized in the NATiV3 study
evaluating lanifibranor for the treatment of noncirrhotic MASH,
with completion of enrollment projected in 1H 2025.
- Appointment to the Board of Directors of Mark Pruzanski, MD, as
Chairman and Srinivas Akkaraju, MD, PhD, as director, subject to
the next General Meeting of Shareholders’ approval.
Daix (France), Long
Island City (New York, United States), October 14, 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 metabolic
dysfunction-associated steatohepatitis (“MASH”)
and other diseases with significant unmet medical needs, today
announced financing of immediately €94.1 million and up to €348
million (the “Transaction”), subject to
satisfaction of specified conditions, to fund the completion of the
Phase 3 NATiV3 MASH trial and preparation for the potential filing
for marketing approval and commercialization of lanifibranor.
The Transaction was led by New Enterprise
Associates, BVF Partners LP and Samsara BioCapital, with the
participation of additional existing and new investors including
Andera Partners, Deep Track Capital, Eventide Asset Management,
Great Point Partners, LLC, Invus, Perceptive Advisors, Schonfeld
Strategic Advisors and Sofinnova Crossover I SLP.
Pursuant to the Transaction and subject to
shareholder approval at the next general meeting to be convened by
December 16, 2024, the Company appointed Mark Pruzanski, MD, as
Company Chairman, and Srinivas Akkaraju, MD, PhD, as a director. Up
to four additional directors are to be named by each of the other
four largest investors, of whom at least two will qualify as
independent and would replace existing directors (excluding
Frederic Cren, Mark Pruzanski and Srini Akkaraju).
Dr. Mark Pruzanski said: “I
have long believed in the therapeutic potential of lanifibranor in
MASH and am honored at the prospect of joining Inventiva as
Chairman. Based on the previously published Phase 2b NATIVE study
results, lanifibranor has a profile that positions it as a possible
‘best in category’ oral drug: its insulin sensitizing and direct
antifibrotic benefits make it an ideal therapy for the large
population of Type 2 diabetic patients with advanced fibrosis due
to MASH who are at the greatest risk of progressing to liver
failure. With the support of the equivalent of up to $410 million
in funding announced today, I look forward to working with Frederic
and the rest of the Board to help transition the Company to
maximize its ability to deliver on lanifibranor’s
promise.”
J.P. Morgan, TD Cowen, Guggenheim Securities,
and LifeSci Capital are acting as placement agents for the
financing, and Namsen Capital is acting as Equity Capital Markets
Advisor.
Frederic Cren, Chief Executive Officer
of Inventiva, stated: "I am very
pleased to announce this important financing at a critical juncture
for the Company. This reflects the confidence of the participating
investors and our partner CTTQ in the value of lanifibranor as a
breakthrough therapy for patients suffering from MASH. The total
proceeds from the financing will support the MASH program and
subsequent filing for marketing approval, along with preparations
for the potential commercialization of lanifibranor. I would also
like to highlight the benefit Mark’s deep expertise in the MASH
field brings and look forward to working with him to ensure the
best chance of getting lanifibranor to patients.”
Dr. Nezam (“Nid”) Afdhal, Chief of
Gastroenterology, Beth Israel Deaconess Medical Center, Professor
of Medicine, Harvard Medical School, said:
“Investigators and clinicians remain excited about the prospect
of lanifibranor in MASH due to its effect on improving both
fibrosis and resolution of MASH. PPAR agonism with lanifibranor has
also been demonstrated to improve the metabolic profile and
cardiovascular risk factors in our patients with MASH. This dual
benefit has the potential to identify lanifibranor as an optimal
choice for patients with MASH, significant fibrosis, and
diabetes.”
About the Transaction
The Transaction consists of:
(i) the issuance , through a capital increase
without preferential subscription rights reserved to a specific
category of beneficiaries (“à catégorie de personnes”), of
an aggregate of €94.1 million through the issuance of 34,600,507
new ordinary shares of the Company, par value €0.01 per share (the
“T1 New Shares”) at a price of €1.35 per T1 New
Share, and 35,399,481 prefunded warrants to purchase ordinary
shares in the Company at an exercise price of €0.01 per new
ordinary share, each giving the right, in the event of exercise, to
one new ordinary share (the “T1 BSAs”), subject to
the satisfaction of customary closing conditions;
(ii) the issuance, in a second phase, subject to
the satisfaction of the T1bis Conditions Precedent (as defined
below), through a new capital increase without preferential
subscription rights reserved to certain identified investors
(“à personne dénommée”) in accordance with article L.
225-138 of the French Commercial Code, of new ordinary shares, par
value €0.01 per share or of prefunded warrants to purchase ordinary
shares of the Company at an exercise price of €0.01 per new
ordinary share, each giving the right, in the event of exercise, to
one new ordinary share (the “T1bis New Shares”),
for a total gross amount of €21.4 million;
(iii) the issuance, in a third phase, through a
new capital increase without preferential subscription rights
reserved to certain identified investors (“à personne
dénommée”), subject to the T2 Conditions Precedent (as this
term is defined below), of ordinary shares (or, in lieu of ordinary
shares at the request of each investor, pre-funded warrants) to
which share warrants are attached (the “ABSAs”)
for a total amount of €116 million . Each ABSA will consist of a
number of new ordinary shares with a par value of €0.01 (or
prefunded warrants) to be determined by the Company's Board of
Directors (the “T2 New Shares”) to which will be
attached a number of warrants exercisable at an exercise price of
€1.50 (the “T3 BSAs”), subject to the occurrence
of the T3 Triggering Event (as defined below), allowing for the
subscription of a maximum aggregate amount of €116 million of new
ordinary shares.
Settlement of the T1 New Shares and the T1 BSAs
is expected to take place on October 17, 2024 (the
“Settlement Date”), subject to satisfaction of the
customary closing conditions.
Pursuant to the Amendment entered into with Chia
Tai Tianqing Pharmaceutical (Guangzhou) CO., LTD.
(“CTTQ”) concurrent with the Transaction, if the
Company receives commitments from investors to subscribe to an
equity raise, in two or three tranches, prior to December 31, 2024,
for an aggregate amount of at least €180 million (the
“Equity Raise”), CTTQ shall pay to the Company (i)
$10 million within 30 days of settlement-delivery of the T1 New
Shares and T1 BSAs in the event of the issuance of the first
tranche of the Equity Raise to be paid by CTTQ, (ii) $10 million
upon the completion of the second tranche of the Equity Raise and
(iii) $10 million upon the publication by the Company of positive
topline data announcing that any key primary endpoint or key
secondary endpoint of the Phase 3 global trial, with any dosage
regimen tested in the trial, have been met. Under the terms of the
Amendment, the total amount of milestone payments remains
unchanged, while the royalties that Inventiva is eligible to
receive have been reduced to the low single digits.
Reasons for the issuance and use of the
proceeds of the Transaction
The Company intends to use the net proceeds from
the issuance of the T1 New Shares and T1 BSAs of €94.1 million
gross, or €86.6 million net, together with available cash, as
follows: approximately 85% for the clinical program evaluating
lanifibranor for the treatment of MASH (“NATiV3”)
and, in the event of positive NATiV3 results, for the submission of
a new drug application, and the remainder, approximately 15%, for
general corporate purposes. The Company has undertaken not to use
these proceeds for the early redemption of its financial debt prior
to its scheduled maturity or for the repurchase of securities
issued as part of the Transaction, subject to the implementation of
its liquidity contract with Kepler Cheuvreux.
The Company intends to use the aggregate
proceeds from the issuance of the T1 New Shares and of the T1 BSAs
(for a gross amount of €94.1 million and a net amount of €86.6
million), from the issuance of the T1bis New Shares (for a gross
amount of €21.4 million), if this tranche is issued subject to the
satisfaction of the T1bis Condition Precedent, and from the
issuance of T2 New Shares (for a gross amount of €116 million) if
this tranche is issued subject to the satisfaction of the T2
Conditions Precedent, i.e., a maximum gross amount of up to €232
million if these two tranches are issued, to fund the continuation
of the Company’s NATiV3 Phase 3 trial as well as to initiate the
compensated cirrhosis study, until the announcement of NATiV3
topline results scheduled for the second-half of 2026. Subject to
the satisfaction of the applicable conditions precedent and
assuming the exercise of all T3 BSAs, the Company intends to use
the gross proceeds of €116 million from the exercise of the T3 BSAs
to fund the Company’s pre-commercialization activities, including
applications for regulatory approval for lanifibranor, if
necessary.
Working capital statement
As of the date of this press release, the
Company believes that prior to the Transaction, its net working
capital is not sufficient to meet its obligations over the next 12
months. As of June 30, 2024, the Company had cash and cash
equivalents of €10.1 million, compared with cash and cash
equivalents of €26.9 million and €9.0 million of long-term
deposit1 at December 31, 2023.
In July 2024, Inventiva issued royalty
certificates for an amount of approximately €20.1 million (the
“2024 Royalty Certificates”). Taking into account
its current cost structure and expected expenses, and taking into
account the proceeds from the issuance of the 2024 Royalty
Certificates and the short-term cash preservation measures put in
place by the Company, but excluding any proceeds from the
Transaction, the Company estimates that its cash, cash equivalents
and deposits would enable it to finance its operations until
mid-October 2024. Prior to the Transaction, the Company is
therefore unable to meet its current obligations over the next 12
months.
To cover its obligations until the beginning of October 2025, based
on its current business plan, the Company estimates that its
additional cash requirements will amount to between €130 million
and €135 million.
The Company also estimates that, prior to the
Transaction, it would need approximately €250 million to finance
its activities until the topline results from its NATiV3 trial,
targeted for the second half of 2026. This estimate includes the
estimated €130 to €135 million needed to finance the Company's
activities over the next 12 months mentioned above.
Following the issuance of the T1 New Shares and
of the T1 BSAs (and excluding the issuance of the T1bis New Shares,
the ABSAs and the exercise of the T3 BSAs) for gross proceeds of
€94.1 million, or estimated net proceeds of €86.6 million, the
Company will not have sufficient net working capital to meet its
current obligations over the next 12 months, and will see its
financial visibility extended, taking into account the €8.6 million
($10 million) net payment to be made by CTTQ within 30 days of the
settlement and delivery of the T1 New Shares and the T1 BSAs, to
the end of the second quarter of 2025. The Company estimates that,
following the issuance of the T1 New Shares and of the T1 BSAs and
taking into account the payment to be made by CTTQ within 30 days
of the settlement and delivery of the T1 New Shares and the T1
BSAs, but excluding the issuance of the ABSAs and the exercise of
the T3 BSAs, its additional cash requirements in order to meet its
current obligations over the next 12 months will amount to €40
million.
If the T1bis Shares (representing a gross amount
of €21.4 million) and the ABSAs (representing a gross amount of
€116 million) are issued, subject to T1bis Conditions Precedent and
T2 Conditions Precedent, as applicable, the Company could extend
its financial visibility beyond 12 months.
To the extent the T1bis Conditions Precedent
and/or the T2 Conditions Precedent are not satisfied and/or the T3
Triggering Event does not occur and therefore the T1bis Shares and
the ABSAs are not issued and the Company does not receive any of
the contemplated gross proceeds from the issuance of the T1bis
Shares or ABSAs or exercise of the T3 BSAs, the Company will need
to raise additional funds to support is business and its research
and development programs as currently contemplated through:
- other potential public offerings or private placements of
equity or debt instruments; or
- potential strategic options such as business development
partnerships and/or licensing agreements.
Main characteristics of the
Transaction
The Company's Board of Directors, by virtue of
the powers granted to it by the 25th resolution of the
shareholders' general meeting of June 20, 2024 (capital increase
without preferential subscription rights in favor of specific
categories of beneficiaries2) and in accordance with
Articles L. 225-138 et seq. of the French Commercial
Code (Code de commerce) has decided on October 11, 2024 to
proceed with the issuance of T1 New Shares and of T1 BSAs and has
determined the final number of T1 New Shares and of the T1 BSAs and
their subscription price and exercise price.
Conditions precedent to the issuance and
subscription of the T1bis New Shares
The issuance by the Company of the T1bis New
Shares is subject to the approval by the shareholders' meeting to
be held no later than December 16, 2024 of the resolutions and
decisions of the Board of Directors allowing the issuance of such
T1bis New Shares and that no material adverse change (defined as
any event, breach or circumstance, individually or in the
aggregate, that has had or could reasonably be expected to have a
material adverse effect on the clinical development stages of
lanifibranor, or on the manufacture of the new drug in preparation
for commercial launch, or with respect to the company's ability to
successfully complete the NATiV3 trial and obtain the necessary
Food and Drug Administration (FDA) approvals (a “Material
Adverse Change”)) between the issuance of the T1 New
Shares and T1 BSA and the settlement and delivery of the T1bis New
Shares (together, the “T1bis Conditions
Precedent”). The adoption of the necessary resolutions by
the shareholders at the general meeting to be held no later than
December 16, 2024 will be the subject of a press release, in line
with the Company’s information obligations. The issuance of the
T1bis New Shares will also be the subject of a press release on the
day of the meeting of the Board of Directors or the Chief Executive
Officer acting by delegation of the Board of Directors of the
Company deciding on this issuance.
Conditions precedent to the issuance and
subscription of the ABSAs
The issuance by the Company of the ABSAs and
their subscription by each investor is subject to the following
conditions : (i) no Material Adverse Change between issuance of
T1bis New Shares and the settlement and delivery of the ABSAs, (ii)
the DMC, an independent group of experts responsible for monitoring
the safety of patients enrolled in the NATiV3 study, which is
usually set up for certain clinical trials, does not recommend
suspending the NATiV3 study, (iii) the last patient in the NATiV3
main cohort has been randomized (the latter should happen no later
than April 30, 2025), (iv) the study drop-out rate before week 72
is less than 30% (the “T2 Triggering Event”), (v)
the subscription and payment by investors of all the T2 New Shares
upon settlement-delivery of the T2 New Shares, (vi) the approval by
the shareholders at the general meeting to be held no later than
December 16, 2024 of the resolutions and decisions of the Board of
Directors allowing the issuance of the T2 New Shares and the
attached T3 BSAs (and allowing the implementation of the new
governance of the Company if it has not already been implemented by
that date) and (vii) the customary settlement-delivery conditions
(conditions (i) to (vii) collectively, the “T2 Conditions
Precedent”). Conditions (i) through (iv) may be waived
with the consent of investors representing 60% of the aggregate of
all ABSAs to be subscribed. The issuance of the ABSAs will be the
subject of a press release on the day of the meeting of the Board
of Directors or the Chief Executive Officer acting by delegation of
the Board of Directors of the Company noting the completion of the
T2 Triggering Event and deciding on this issue.
Conditions precedent to the exercise of the T3
BSAs:
Subject to satisfaction of the T2 Conditions
Precedent and the issuance of the ABSAs, the exercise of the T3
BSAs is further subject to the release by the Company of topline
data announcing that any key primary endpoint or key secondary
endpoint of NATiV3 (resolution of NASH without worsening fibrosis
and improvement of liver fibrosis without worsening NASH), with any
dosage regimen tested in the trial, have been met no later than
June 15, 2027 (the “T3 Triggering Event”). The
exercise of the T3 BSAs must take place no later than July 30, 2027
(the “T3 BSA Maturity Date”).
Upon the occurrence of a Transforming Event (as defined below),
satisfaction of the T3 Triggering Event as a condition to exercise
may be waived with the prior consent of the holders representing
60% of all the T3 BSAs. A Transforming Event shall occur upon any
of the following cases: (i) a person, alone or in concert, acquires
control of the Company (control having the meaning set out in
Article L. 233-3 of the French Commercial Code) 233-3 of the French
Commercial Code), (ii) the announcement or the filing of a takeover
bid, public exchange offer, alternative offer or mixed offer, (iii)
a merger in which the where the holdings of shareholders of the
Company are diluted by 30% or more, or (iv) the transfer of
significant rights in lanifibranor to an entity in which the
Company holds less than 51% of the capital or voting rights, or (v)
an agreement relating to lanifibranor having or that may reasonably
have a significant effect on the Company's business, financial
position or prospects (a “Transforming Event”).
The exercise of the T3 BSAs will be the subject of a press release
on the day of the meeting of the Board of Directors or the Chief
Executive Officer acting by delegation of the Board of Directors of
the Company recording the occurrence of the T3 Triggering Event or
the waiver by investors of this condition.
ABSAs subscription period:
Subject to approval of the necessary resolutions
by the shareholders at the general meeting to be held no later than
December 16, 2024, the ABSAs will be issued and subscribed subject
to a decision by the Company's Board of Directors, which must be
taken within a period between March 31, 2025 (excluded) and May 31,
2025, with at least fifteen business days' prior notice.
Exercise period of the T3 BSAs:
Each investor will be able to exercise the T3
BSAs owned by it, in whole or in part, for cash, at the earliest
between (x) the 45th calendar day following the
occurrence of the T3 Triggering Event and (y) the third business
day (inclusive) preceding the T3 BSAs Maturity Date in the event of
the occurrence of the T3 Triggering Event (the “T3 BSA
Exercise Period”) and, if the occurrence of the T3
Triggering Event is waived as described above, during the period
starting from (inclusive) the date on which such waiver is granted
and ending on the third Business Day (inclusive) prior to the T3
BSA Maturity Date.
If the T3 Triggering Event is not fulfilled or does not occur
within the defined time period, the T3 BSAs will automatically
lapse on the third business day following the T3 BSA Exercise
Period.
Subscription price of the T1 New Shares, the T1
BSAs, the ABSAs and exercise price of the T3 BSAs:
On October 11, 2024, the Board of Directors set
the subscription price of the T1 New Shares at €1.35 (the
“T1 Subscription Price”) (€0,01 nominal value and
€1.34 premium).
Given the specific characteristics of T1 BSAs,
the subscription price of each T1 BSAs is equal to €1.34 and
corresponds to the T1 Subscription Price (i.e. €1.35) reduced by
the nominal value of an ordinary share (€0.01).
In accordance with the price limits set forth in
the 25th resolution of the general meeting held on June
20, 2024, the T1 Subscription Price (i.e. €1.35) represents a
discount of 10% to €1.5048, which is the volume weighted average
price of the Company's shares on the regulated market of Euronext
in Paris during the last 5 trading sessions preceding pricing of
the T1 New Shares (the “Reference Price”).
Subject to satisfaction of the T1bis Conditions
Precedent, the subscription price of the T1bis New Shares will be
equal to the T1 Subscription Price (i.e. €1.35).
Subject to satisfaction of the T2 Conditions
Precedent, the subscription price of the ABSAs will correspond to
the lower of (i) the T1 Subscription Price (i.e. €1.35) and (ii)
the volume-weighted average of the Company's share price on the
regulated market of Euronext Paris during the 5 trading sessions
preceding pricing of the ABSAs (it being specified that no discount
will be applied to this average).
Subject to the completion of T3 Triggering Event
or the Transforming Event, the T3 BSA Exercise Price corresponds to
the Reference Price (it being specified that no discount will be
applied to this average), i.e. €1.50 (the “T3 BSA
Exercise Price").
Allocation of the Transaction and undertakings
of the Company:
The number of T1bis New Shares, T2 New Shares
and T3 BSAs will be subscribed by each investor pro rata
to the number of T1 New Shares and T1 BSAs subscribed for by this
investor. In the event of failure by an investor to subscribe for
the ABSAs, the Company undertakes to offer the other investors the
right to subscribe for a number of additional ABSAs not subscribed
for by the defaulting investor, which will be allocated pro
rata to the number of T1 New Shares subscribed and of T1 BSAs
subscribed for by each investor and wishing to subscribe for these
ABSAs.
Governance Rights:
As part of the Transaction, the Company has
undertaken, subject to settlement of the T1 New Shares and T1 BSAs
to propose the appointment of Mark Pruzanski and Srinivas Akkaraju
as members of the Board of Directors at the general meeting to be
held no later than December 16, 2024.
In addition, up to four additional directors may
be appointed or co-opted to replace existing directors (other than
Frédéric Cren, Mark Pruzanski and Srinivas Akkaraju), it being
specified that one director will be appointed or co-opted on the
proposal of BVF Partners LP (“BVF”) and three
directors upon proposal by each of the three largest investors in
the Transaction, subject to settlement-delivery of the T1 New
Shares and T1 BSAs and shareholder approval of the resolutions
relating to the issuance of the ABSAs by the general meeting to be
held no later than December 16, 2024.
The Board of Directors has, on October 11, 2024,
irrevocably decided, on the pending condition of the appointment of
Mark Pruzanski as director of the Company by the general meeting to
be held no later than December 16, 2024, to dissociate the
functions of président du conseil d’administration
(chairman of the board) and directeur général (CEO),
Frédéric Cren being currently président directeur général
of the Company, and to appoint Mark Pruzanski as président du
conseil d’administration and Frédéric Cren as directeur
général, as of the date of the next board meeting held after
such general meeting.
Form of the T1 New Shares and the T1 BSAs:
The T1 New Shares shall be registered in pure
registered form (au nominatif pur) under French law until
the earlier of (x) the date of settlement-delivery of T2 New Shares
or (y) May 20, 2025. Thereafter, the T1 New Shares will be held at
the option of the holder either in registered form (au
nominatif) or in bearer form (au porteur).
The T1 BSAs will be securities giving access to
the capital within the meaning of Article L. 228-91 of the French
Commercial Code. They will be issued in dematerialized form and
held in pure registered form (au nominatif pur) until the
expiration of the lock-up (described below) in the securities
account opened in the name of the investor in the books of the
Company's account keeper. No physical document evidencing ownership
of the T1 BSAs will be issued. The T1 BSAs will not be listed but
will be admitted to Euroclear.
The shares issued upon the exercise of T1 BSAs
(the “T1 Warrant Shares”) will be held in pure
registered form (au nominatif pur) until expiration of the
lock-up and thereafter at the option of the holder, in registered
form (au nominatif) or in bearer form (au
porteur).
As soon as they are issued, the T1 New Shares,
the T2 New Shares, the T1 Warrant Shares and the shares issued upon
the exercise of T3 BSAs (the “T3 Warrant Shares”),
if any, will be automatically assimilated to the Company's ordinary
shares and will be admitted to trading on the regulated market of
Euronext Paris under ISIN number FR0013233012.
Form of the T1bis New Shares, the T2 New Shares
and the T3 BSAs:
The T1bis New Shares will be registered under
the same conditions as the T1 New Shares.
The T2 New Shares will be held, from their
issuance and at the holder's option, in registered form (au
nominatif) or in bearer form (au porteur) and will be
freely transferable.
The T3 BSAs will be securities giving access to
the share capital within the meaning of article L. 228-91 of the
French Commercial Code. They will be issued in dematerialized form
and held in registered form (au nominatif) in a securities
account opened in the name of the investor in the books of the
Company's account keeper. No physical document evidencing ownership
of the T3 BSAs will be issued. The T3 BSAs will not be listed or
admitted to Euroclear.
The shares issued upon exercise of the T3 BSAs
(the “T3 Warrant Shares”) will be held, upon
issuance and at the option of the holder, in registered form
(au nominatif) or in bearer form (au
porteur).
Adjustment of exercise ratio and the T3 BSA
Exercise Price:
The T3 BSA Exercise Price and/or the number of
T3 Warrant Shares will be subject to adjustment from time to time
according to mandatory legal requirements imposed by the French
Commercial Code and French market standards.
In case of a capital increase, absorption,
merger, spin-off or issuance of new shares or securities giving
access to the share capital, or any other financial transaction
involving a preferential subscription right or reserving a priority
subscription period for the benefit of the Company's shareholders,
the Company will be entitled to suspend the exercise of the T3 BSAs
for a period that may not exceed three months or any other period
set by the applicable regulations.
Lock-up on T1 New Shares, on T1 BSAs and on
T1bis New Shares:
Investors participating in the Transaction have
agreed to a lock-up on the T1 New Shares and the T1 BSAs and the T1
Warrant Shares until the earlier of (x) the issuance date of the
ABSAs or (y) May 20, 2025, subject to certain exceptions (including
transfers to an affiliate to the investor, to another investor, or,
subject to the agreement of the Company in its sole discretion, to
any third party who makes the same lock-up commitment on the T1 New
Shares and on the T1 BSAs and T1 Warrant Shares).
The T1bis New Shares will be held by investors
under the same conditions as the T1 New Shares in the event of
their issuance.
Voting undertakings:
The investors have undertaken to subscribe for
the T1bis New Shares and the ABSAs and to vote in favor of the
resolutions of the general meeting to be held no later than
December 16, 2024 relating to the issuance of the T1bis New Shares
and the ABSAs (with the exception of the resolution relating to
this investor's own investment) and relating to changes in the
governance of the Company.
Mr. Frédéric Cren and Mr. Pierre Broqua have
undertaken to vote in favor of the resolutions of the general
meeting to be held no later than December 16, 2024.
Representation of T1 BSAs and T3 BSAs
holders:
The T1 BSAs holders and the T3 BSAs holders will
each be grouped automatically for the defense of their common
interests in a masse. The masses will act, in part,
through a representative and, in part, through collective decisions
of the relevant holders.
Transaction participants:
BVF, which holds approximately 16.4% of the
share capital and approximately 13.1% of the voting rights of the
Company as of the date hereof and not taking into account the
Transaction, subscribed to 8,231,034 T1 BSAs for an amount of
approximately €11 million. Assuming the issuance of the T1 New
Shares and the T1 BSAs, BVF will hold approximately 9.8% of the
share capital of the Company, on a non-diluted basis immediately
following the closing of the first tranche of the Transaction.
New Enterprise Associates
(“NEA”), which holds approximately 10.7% of the
share capital and approximately 8.5% of the voting rights of the
Company as of the date hereof and not taking into account the
Transaction, subscribed to 2,262,931 T1 New Shares for an amount of
approximately €3 million and to 12,823,276 T1 BSAs for an amount of
approximately €17 million. Assuming the issuance of the T1 New
Shares and the T1 BSAs, NEA will hold approximately 9.0% of the
share capital of the Company, on a non-diluted basis immediately
following the closing of the first tranche of the Transaction.
Sofinnova Crossover I SLP
(“Sofinnova”), which holds approximately 9.7% of
the share capital and approximately 9.4% of the voting rights of
the Company as of the date hereof and not taking into account the
Transaction, subscribed to 1,369,827 Tranche 1 New Shares for an
amount of approximately €1.8 million. Assuming the issuance of the
T1 New Shares and the T1 BSAs, Sofinnova will hold approximately
7.4% of the share capital of the Company, on a non-diluted basis
immediately following the closing of the first tranche of the
Transaction.
Yiheng Capital Management, L.P.,
(“Yiheng”), which holds approximately 7.4% of the
share capital and approximately 5.9% of the voting rights of the
Company as of the date hereof and not taking into account the
Transaction, subscribed to 1,629,310 T1 New Shares for an amount of
approximately €2.2 million. Assuming the issuance of the T1 New
Shares and the T1 BSAs, Yiheng will hold approximately 6.3% of the
share capital of the Company, on a non-diluted basis immediately
following the closing of the first tranche of the Transaction.
Invus Public Equities,
(“Invus”), subscribed to 6,034,482 T1 New Shares
for an amount of approximately €8.1 million. Assuming the issuance
of the T1 New Shares and the T1 BSAs, Invus will hold approximately
8.7% of the share capital of the Company, on a non-diluted basis
immediately following the closing of the first tranche of the
Transaction.
Andera Partners, (“Andera”),
subscribed to 5,008,620 T1 New Shares for an amount of
approximately €6.7 million. Assuming the issuance of the T1 New
Shares and the T1 BSAs, Andera will hold approximately 5.8% of the
share capital of the Company, on a non-diluted basis immediately
following the closing of the first tranche of the Transaction.
Perceptive Advisors,
(“Perceptive”), subscribed to 4,525,862 T1 New
Shares for an amount of approximately €6.1 million and 1,508,620 T1
BSAs for €2.0 million. Assuming the issuance of the T1 New Shares
and the T1 BSAs, Perceptive will hold approximately 5.2% of the
share capital of the Company, on a non-diluted basis immediately
following the closing of the first tranche of the Transaction.
Impact of the Transaction on the share
capital
Following the Settlement Date, the Company’s
share capital will be €870,776.95 million divided into 87,077,695
shares.
For illustration purposes, the impact of the
issuance of the T1 New Shares, the T1 Warrant Shares (assuming full
exercise), the T1bis New Shares, the T2 New Shares and the T3
Warrant Shares (assuming full exercise) on the ownership of a
shareholder holding 1% of the Company’s share capital prior to the
Transaction and not subscribing to it, is as follows (calculation
made on the basis of the Company's share capital as of September
30, 2024):
|
|
Percentage of capital |
|
Non-diluted basis |
Diluted basis(1) |
|
Before issuance of the T1 New Shares |
1% |
0.87% |
|
After issuance of the T1 New Shares and T1 BSA |
0.60% |
0.45% |
|
After issuance of the T1 New Shares, the T1 Warrant Shares and the
T1bis New Shares |
0.55% |
0.41% |
|
After issuance of the T1 New Shares, the T1 Warrant Shares, the
T1bis New Shares and the T2 New Shares* |
0.29% |
0.26% |
|
After issuance of the T1 New Shares, the T1 Warrant Shares, the
T1bis New Shares, the T2 New Shares*, and the T3 Warrant
Shares |
0.20% |
0.19% |
(1) Calculations are based on the assumption
that all share subscription warrants (BSA) and warrants for the
subscription of business creators’ shares (BSPCE) will be exercised
and that all allocated free shares (actions gratuites) will
vest.
*Calculations are based on the assumptions that (i) all the
conditions for the issue of the New T1bis Shares and New T2 Shares
have been met, (ii) the T2 New Shares will only be issued in
ordinary shares and (iii) the subscription price of the ABSAs is
equivalent to the Subscription Price of the New T1 Shares (i.e. a
number of 85,925,919 New T2 Shares).
Impact of the Transaction on shareholders'
equity
For illustration purposes, the impact of the
issuance of the of the T1 New Shares, the T1 Warrant Shares
(assuming full exercise), the T2 New Shares and the T3 Warrant
Shares (assuming full exercise) on the Company's equity per share
(calculation made on the basis of the Company's equity at June 30,
2024) is as follows:
|
|
Equity per share in euros |
|
Non-diluted basis |
Diluted basis(1) |
|
Before issuance of the T1 New Shares |
-€1.88 |
-€1.04 |
|
After issuance of the T1 New Shares and T1 BSA |
-€0.14 |
€0.18 |
|
After issuance of the T1 New Shares, the T1 Warrant Shares and the
T1bis New Shares |
€0.10 |
€0.30 |
|
After issuance of the T1 New Shares, the T1 Warrant Shares, the
T1bis New Shares and the T2 New Shares* |
€0.54 |
€0.56 |
|
After issuance of the T1 New Shares, all the T1 Warrant Shares, the
T1bis New Shares, the T2 New Shares*, and the T3 Warrant
Shares |
€0.83 |
€0.80 |
(1) Calculations are based on the assumption
that all share subscription warrants (BSA) and warrants for the
subscription of business creators' shares (BSPCE) will be exercised
and that all allocated free shares (actions gratuites) will
vest.
*Calculations are based on the assumptions that (i) all the
conditions for the issue of the New T1bis Shares and New T2 Shares
have been met, (ii) the T2 New Shares will only be issued in
ordinary shares and (iii) the subscription price of the ABSAs is
equivalent to the Subscription Price of the New T1 Shares (i.e. a
number of 85,925,919 New T2 Shares).
Evolution of the shareholding structure in
connection with the Transaction
The shareholding structure of the Company prior
to the Transaction is set forth below:
|
|
Shareholding prior to the Transaction |
|
|
On a non-diluted basis |
|
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
Frédéric Cren |
5,612,224 |
10.8% |
11,224,448 |
17.2% |
|
Pierre Broqua |
3,882,500 |
7.4% |
7,765,000 |
11.9% |
|
Sous-total – Concert |
9,494,724 |
18.2% |
18,989,448 |
29.1% |
|
BVF Partners L.P. |
8,545,499 |
16.4% |
8,545,499 |
13.1% |
|
New Enterprise Associates (NEA) |
5,572,953 |
10.7% |
5,572,953 |
8.5% |
|
Sofinnova |
5,070,266 |
9.7% |
6,110,827 |
9.4% |
|
Qatar Holding LLC |
5,157,233 |
9.9% |
5,157,233 |
7.9% |
|
Yiheng |
3,845,676 |
7.4% |
3,845,676 |
5.9% |
|
ISLS Consulting |
111,000 |
0.2% |
222,000 |
0.3% |
|
David Nikodem |
- |
- |
- |
- |
|
M. J GOLDBERG |
- |
- |
- |
- |
|
Directors (non-executifs) |
10,000 |
0.02% |
10,000 |
0.02% |
|
Employees |
1,338,127 |
2.6% |
2,282,563 |
3.5% |
|
Treasury shares |
106,115 |
0.2% |
- |
- |
|
Free float |
13,225,595 |
24.7% |
14,602,674 |
22.2% |
|
Total |
52,477,188 |
100.0% |
65,338,873 |
100.0% |
The issuance of T1 New Shares and the T1 BSA
will have the following impact on the allocation of the share
capital and the voting rights of the Company:
|
|
Shareholder following the issuance of T1 New Shares and the
T1 BSA |
|
|
On a non-diluted basis |
|
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
Frédéric Cren |
5,612,224 |
6.4% |
11,224,448 |
11.2% |
|
Pierre Broqua |
3,882,500 |
4.5% |
7,765,000 |
7.8% |
|
Sous-total – Concert |
9,494,724 |
10.9% |
18,989,448 |
19.0% |
|
BVF Partners L.P. |
8,545,499 |
9.8% |
8,545,499 |
8.6% |
|
New Enterprise Associates (NEA) |
7,835,884 |
9.0% |
7,835,884 |
7.8% |
|
Sofinnova |
6,440,093 |
7.4% |
7,480,654 |
7.5% |
|
Qatar Holding LLC |
5,157,233 |
5.9% |
5,157,233 |
5.2% |
|
Yiheng |
5,474,986 |
6.3% |
5,474,986 |
5.5% |
|
Perceptive |
4,525,862 |
5.2% |
4,525,862 |
4.5% |
|
Andera Partners |
5,008,620 |
5.8% |
5,008,620 |
5.0% |
|
Invus |
7,606,810 |
8.7% |
7,606,810 |
7.6% |
|
ISLS Consulting |
111,000 |
0.1% |
222,000 |
0.2% |
|
David Nikodem |
- |
- |
- |
- |
|
M. J GOLDBERG |
- |
- |
- |
- |
|
Directors (non-executifs) |
10,000 |
0.0% |
10,000 |
0.0% |
|
Employees |
1,338,127 |
1.5% |
2,282,563 |
2.3% |
|
Treasury shares |
106,115 |
0.1% |
- |
- |
|
Free floats |
25,422,742 |
29.2% |
26,799,821 |
26.8% |
|
Total |
87,077,695 |
100.0% |
99,939,380 |
100.0% |
The issuance of the T1 New Shares, the T1
Warrant Shares (assuming full exercise) and the T1bis New Shares
will have the following impact on the Company's share capital and
voting rights:
|
|
Shareholding following the T1 New Shares,
the T1 Warrant Shares and the T1bis New Shares |
|
|
On a non-diluted basis |
|
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
Frédéric Cren |
5,612,224 |
5.9% |
11,224,448 |
10.4% |
|
Pierre Broqua |
3,882,500 |
4.1% |
7,765,000 |
7.2% |
|
Sous-total – Concert |
9,494,724 |
10.0% |
18,989,448 |
17.6% |
|
BVF Partners L.P. |
8,545,499 |
9.0% |
8,545,499 |
7.9% |
|
New Enterprise Associates (NEA) |
8,350,730 |
8.8% |
8,350,730 |
7.7% |
|
Sofinnova |
6,751,746 |
7.1% |
7,792,307 |
7.2% |
|
Qatar Holding LLC |
5,157,233 |
5.4% |
5,157,233 |
4.8% |
|
Yiheng |
5,845,675 |
6.2% |
5,845,675 |
5.4% |
|
Perceptive |
5,555,555 |
5.9% |
5,555,555 |
5.2% |
|
Andera Partners |
6,148,147 |
6.5% |
6,148,147 |
5.7% |
|
Invus |
8,979,734 |
9.5% |
8,979,734 |
8.3% |
|
ISLS Consulting |
111,000 |
0.1% |
222,000 |
0.2% |
|
David Nikodem |
- |
0.0% |
- |
0.0% |
|
M. J GOLDBERG |
- |
0.0% |
- |
0.0% |
|
Directors (non-executifs) |
10,000 |
0.0% |
10,000 |
0.0% |
|
Employees |
1,338,127 |
1.4% |
2,282,563 |
2.1% |
|
Treasury shares |
106,115 |
0.1% |
0 |
0.0% |
|
Free float |
28,555,474 |
30.1% |
29,932,553 |
27.8% |
|
Total |
94,949,759 |
100.0% |
107,811,444 |
100.0% |
The issuance of the T1 New Shares, the T1
Warrant Shares (assuming full exercise), the T1bis New Shares and
the T2 New Shares will have the following impact on the Company's
share capital and voting rights:
|
|
Shareholding following the issuance of the
T1 New Shares, all the T1 Warrant Shares and the T2 New
Shares*. |
|
|
On a non-diluted basis |
|
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
Frédéric Cren |
5,612,224 |
3.1% |
11,224,448 |
5.8% |
|
Pierre Broqua |
3,882,500 |
2.1% |
7,765,000 |
4.0% |
|
Sous-total – Concert |
9,494,724 |
5.2% |
18,989,448 |
9.8% |
|
BVF Partners L.P. |
18,649,202 |
10.3% |
18,649,202 |
9.6% |
|
New Enterprise Associates (NEA) |
26,869,248 |
14.9% |
26,869,248 |
13.9% |
|
Sofinnova |
8,433,227 |
4.7% |
9,473,788 |
4.9% |
|
Qatar Holding LLC |
5,157,233 |
2.9% |
5,157,233 |
2.7% |
|
Yiheng |
7,845,675 |
4.3% |
7,845,675 |
4.0% |
|
Perceptive |
12,962,962 |
7.2% |
12,962,962 |
6.7% |
|
Andera Partners |
12,296,295 |
6.8% |
12,296,295 |
6.3% |
|
Invus |
16,387,141 |
9.1% |
16,387,141 |
8.5% |
|
ISLS Consulting |
111,000 |
0.1% |
222,000 |
0.1% |
|
David Nikodem |
- |
- |
- |
- |
|
M. J GOLDBERG |
- |
- |
- |
- |
|
Directors (non-executifs) |
10,000 |
0.0% |
10,000 |
0.0% |
|
Employees |
1,338,127 |
0.7% |
2,282,563 |
1.2% |
|
Treasury shares |
106,115 |
0.1% |
- |
- |
|
Free float |
61,214,729 |
33.8% |
62,591,808 |
32.3% |
|
Total |
180,875,678 |
100.0% |
193,737,363 |
100.0% |
*Calculations are based on the assumptions
that (i) all the conditions for the issue of the New T1bis Shares
and New T2 Shares have been met, (ii) the T2 New Shares will only
be issued in ordinary shares and (iii) the subscription price of
the ABSAs is equivalent to the Subscription Price of the New T1
Shares (i.e. a number of 85,925,919 New T2 Shares).
The issuance of the T1 New Shares, the T1
Warrant Shares (assuming full exercise), the T1bis New Shares, the
T2 New Shares and of the T3 Warrant Shares (assuming full exercise)
will have the following impact on the Company's share capital and
voting rights:
|
|
Shareholding following the issuance of the
T1 New Shares, all the T1 Warrant Shares, the T2 New Shares* and of
the T3 Warrant Shares |
|
|
On a non-diluted basis |
|
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
|
Frédéric Cren |
5,612,224 |
2.2% |
11,224,448 |
4.1% |
|
Pierre Broqua |
3,882,500 |
1.5% |
7,765,000 |
2.9% |
|
Sous-total – Concert |
9,494,724 |
3.7% |
18,989,448 |
7.0% |
|
BVF Partners L.P. |
27,713,529 |
10.7% |
27,713,529 |
10.2% |
|
New Enterprise Associates (NEA) |
43,482,751 |
16.9% |
43,482,751 |
16.1% |
|
Sofinnova |
9,941,733 |
3.9% |
10,982,294 |
4.1% |
|
Qatar Holding LLC |
5,157,233 |
2.0% |
5,157,233 |
1.9% |
|
Yiheng |
9,639,933 |
3.7% |
9,639,933 |
3.6% |
|
Perceptive |
19,608,363 |
7.6% |
19,608,363 |
7.2% |
|
Andera Partners |
17,811,978 |
6.9% |
17,811,978 |
6.6% |
|
Invus |
23,032,542 |
8.9% |
23,032,542 |
8.5% |
|
ISLS Consulting |
111,000 |
0.0% |
222,000 |
0.1% |
|
David Nikodem |
- |
- |
- |
- |
|
M. J GOLDBERG |
- |
- |
- |
- |
|
Directors (non-executifs) |
10,000 |
0.0% |
10,000 |
0.0% |
|
Employees |
1,338,127 |
0.5% |
2,282,563 |
0.8% |
|
Treasury shares |
106,115 |
0.0% |
- |
- |
|
Free float |
90,514,301 |
35.1% |
91,891,380 |
33.9% |
|
Total |
257,962,329 |
100.0% |
270,824,014 |
100.0% |
*Calculations are based on the assumptions
that (i) all the conditions for the issue of the New T1bis Shares
and New T2 Shares have been met, (ii) the T2 New Shares will only
be issued in ordinary shares and (iii) the subscription price of
the ABSAs is equivalent to the Subscription Price of the New T1
Shares (i.e. a number of 85,925,919 New T2 Shares).
Documentation
Application will be made to list the T1 New
Shares and a maximum number of shares issued upon exercise of T1
BSAs on the regulated market of Euronext in Paris pursuant to a
listing prospectus subject to an approval from the French
Autorité des marchés financiers (“AMF“)
and comprising the 2023 Universal Registration Document
(Document d’enregistrement universel) filed with the AMF
on April 3, 2024 under number D.24-0227, which incorporates the
2023 annual financial report (rapport financier annuel),
as completed by an amendment to such universal registration
document which incorporates the 2024 half year report (rapport
financier semestriel), which will be filed with the AMF today
as well as a Securities Note (Note d’opération), including
a summary of the prospectus will be submitted to the approval by
the AMF and will be published on the AMF’s website at
www.amf-france.org. As from such filings with the AMF, copies of
the 2023 Universal Registration Document, as amended and of the
listing prospectus, will be available free of charge at the
Company’s head office located at 50 rue de Dijon, 21121 Daix,
France, on the Company’s website (www.inventivapharma.com) and on
the website of the AMF (www.amf-france.org).
This hyperlink is included pursuant to the
Regulation (EU) 2017/1129 of the European Parliament and of the
Council of June 14, 2017 (the "Prospectus
Regulation") for the convenience of investors and the
contents of this website is not incorporated by reference into this
press release.
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 and
other diseases with significant unmet medical need. The Company
benefits from a strong expertise and experience in the field 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 3 clinical trial,
NATiV3, for the treatment of adult patients with MASH, 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
EVP of Global External 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, forecasts and estimates
with respect to Inventiva’s cash resources, the anticipated
proceeds from the Transaction and Inventiva’s expected use of such
proceeds, completion and timing of the Transaction, the
satisfaction in part or full of the T1bis Conditions Precedent or
T2 Conditions Precedent, the occurrence of the T3 Triggering Event,
and the exercise by the investors of the warrants and pre-funded
warrants to be issued in connection with the Transaction,
Inventiva’s expectations regarding its collaboration agreement with
CTTQ, including the achievement of specified milestones thereunder,
Inventiva’s expectations with respect to ownership in its share
capital by certain investors, Inventiva’s cash position following
the Transaction, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, including
design, duration, timing, recruitment costs, screening and
enrollment for those trials, including the ongoing NATiV3 Phase 3
clinical trial of lanifibranor in MASH and its planned Phase 3
trial in patients with MASH and compensated cirrhosis,, and the
results and timing thereof and regulatory matters with respect
thereto, clinical trial data releases and publications, the
information, insights and impacts that may be gathered from
clinical trials, potential regulatory submissions, approvals and
commercialization, Inventiva’s pipeline and preclinical and
clinical development plans, and future activities, expectations,
plans, growth and prospects of Inventiva. 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, to enter into potential transactions
and satisfy in part or full of the T1bis Conditions Precedent or T2
Conditions Precedent and whether and when the Warrants are
exercised and by which holders, 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 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.
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 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.
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.
France
The T1 New Shares, T1 BSA, T1bis New Shares
and ABSA (the “Securities”) have
not been and will not be offered or sold to the public in France
(except for public offerings defined in Article L.411-2 1° of the
French Monetary and Financial Code).
The Securities may only be offered or sold
in France pursuant to Article L. 411-1 of the French Monetary and
Financial Code to “qualified investors” (as such term is defined in
Article 2(e) of Prospectus Regulation) acting for their own
account, and in accordance with Articles L. 411-1, L. 411-2 and D.
411-2 to D.411-4 of the French Monetary and Financial
Code.
This announcement is not an advertisement
and not a prospectus within the meaning of the Prospectus
Regulation.
European Economic
Area
In relation to each Member State of the
European Economic Area (each, a ‘‘Member
State’’) no offer to the public of Securities may
be made in that Member State other than:
- to any legal entity which is a ‘‘qualified investor’’ as
defined in the Prospectus Regulation;
- to fewer than 150 natural or legal persons (other than a
qualified investor as defined in the Prospectus Regulation),
subject to obtaining the prior consent of the representatives of
the Placement Agents for any such offer; or
- in any other circumstances falling within Article 1(4) of
the Prospectus Regulation, provided that no such offer of
Securities shall require us or any Placement Agent to publish a
prospectus pursuant to Article 3 of the Prospectus Regulation or
supplement a prospectus pursuant to Article 23 of the Prospectus
Regulation and each person who initially acquires any shares or to
whom any offer is made will be deemed to have represented,
acknowledged and agreed to and with each of the Placement Agents
and the Company that it is a ‘‘qualified investor’’ as defined in
the Prospectus Regulation.
For the purposes of this provision, the
expression an ‘‘offer to the public’’ in relation to any Securities
in any Member State means the communication in any form and by any
means of sufficient information on the terms of the offer and any
Securities to be offered so as to enable an investor to decide to
purchase any ordinary shares.
United Kingdom
This document is only being distributed to,
and is only directed at, persons in the United Kingdom that (i) are
“investment professionals” falling within Article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order
2005 (as amended, the “Order”), (ii) are persons
falling within Article 49(2)(a) to (d) (“high net worth companies,
unincorporated associations, etc.”) of the Order, or (iii) are
persons to whom an invitation or inducement to engage in investment
activity (within the meaning of Article 21 of the Financial
Services and Markets Act 2000) in connection with the issuance or
sale of any securities may otherwise lawfully be communicated or
caused to be communicated (all such persons together being referred
to as “Relevant Persons”). This document is
directed only at Relevant Persons and must not be acted on or
relied on by persons who are not Relevant Persons. Any investment
or investment activity to which this document relates is available
only to Relevant Persons and will be engaged in only with Relevant
Persons.
United States of America
This press release shall not constitute an
offer to sell or a solicitation of an offer to buy these securities
in the United States of America, nor shall there be any sale of
these securities 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.
None of the securities to be issued in
connection with the Transaction have been registered under the
Securities Act of 1933, as amended, and such securities 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 The long-term deposit had a two year-term, were
accessible prior to the expiration of the term with a notice period
of 31 days and were considered as liquid by the Company
2 The specific categories of persons defined by the 6th
resolution of the general meeting held on June 20, 2024 include:
(i) natural or legal persons (including companies) trusts or
investment funds, or other investment vehicles, in any form,
established under French or foreign law, which regularly invest in
the pharmaceutical, biotechnological or medical technology sectors;
and/or (ii) companies, institutions or entities, in any form,
French or foreign, exercising a significant part of its activities
in the pharmaceutical, cosmetic or chemical sectors, or medical
devices and/or technologies, or researching in such sectors; and/or
(iii) French or foreign investment services companies, or any
foreign establishment having an equivalent status, able to
guarantee the completion of an issuance intended to be placed with
the persons referred to in (i) and/or (ii) above, and, in this
context, to subscribe to the securities that are being issued.
- Inventiva - PR - Project Sulphur - EN - 10 13 2024 _Version
finale
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