-
-
Inventiva secures €21.4 million leading to completion of the first
tranche of the financing for c. €116 million, part of the
multi-tranche equity financing of up to €348 million announced on
October 14, 2024.
-
Proceeds from the completed first tranche to be primarily used to
advance Inventiva’s Phase III, NATiV3 clinical trial evaluating
lanifibranor in patients with MASH.
-
Appointment of Mark Pruzanski as new Chairman of the Board of
Directors and Srinivas Akkaraju as new member of the Board of
Directors.
Daix (France), New York City (New
York, United States), December 16, 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 that, following the general meeting of the
shareholders held on December 11, 2024 (the “General
Meeting”), the Board of Directors decided to use the
delegations granted by the General Meeting to issue the second
phase of Tranche 1 (the “T1 bis Transaction”) for a
gross amount of €21.4 million (net amount of €20.1 million) of the
multi-tranche equity financing of up to €348 million announced on
October 14, 2024 (the “Multi-Tranche Financing”).
Frédéric Cren, Chief Executive Officer of
Inventiva, stated: "We are pleased to announce that we
secured €21.4 million successfully completing the first tranche of
the financing announced in October. The multi-tranche equity raise
of up to €348 million has been instrumental to keep Inventiva on
track with recruitment for our pivotal Phase III clinical trial of
our asset lanifibranor. We believe that lanifibranor holds
significant potential to address unmet medical needs, and we are
encouraged by the intensification of trial activities, with a
completion of our recruitment expected in the first half of 2025. I
am also delighted to welcome Mark and Srinivas to our Board of
Directors. Their expertise and strategic insights will be
invaluable as we advance our clinical program and prepare for a
potential NDA filing for lanifibranor."
On October 14, 20241 the Company announced the
Multi-Tranche Financing and the completion of a capital increase 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
the issuance of 35,399,481 prefunded warrants to purchase up to
35,399,481 ordinary shares at an exercise price of €0.01 per new
ordinary share (the “T1 BSAs”) at a subscription price of
€1.34 per T1 BSA, subject to the satisfaction of customary closing
conditions. Settlement and delivery of the T1 New Shares and the T1
BSAs, took place on October 17, 2024.
Following issuance of the T1 New Shares and T1
BSAs, and the subsequent adoption by shareholders of the
appropriate resolutions by the General Meeting, the Board of
Directors decided on December 13, 2024 to use the delegations
granted by the General Meeting to proceed with the T1 bis
Transaction, consisting of 7,872,064 new ordinary shares (the
“T1 bis Shares”) at a subscription price of €1.35 per T1 bis
Share and 8,053,847 pre-funded warrants to purchase up to 8,053,847
ordinary shares at an exercise price of €0.01 per new ordinary
share (the “T1 bis BSAs”) at a subscription price of €1.34
per T1 bis BSA, for aggregate gross proceeds of €21,419,441.38.
Reasons for the issuance and use of the
proceeds of the T1 bis Transaction
The Company intends to use the net proceeds of
€20.1 million from the T1 bis Transaction, 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 T1 bis Transaction, subject to the
implementation of its liquidity contract with Kepler Cheuvreux.
Working capital statement
As of the date of this press release, the
Company believes that its net working capital would not be
sufficient to meet its obligations over the next 12 months. As of
September 30, 2024, 2024, the Company had cash and cash equivalents
of €13.9 million, compared with cash and cash equivalents of €26.9
million and €9.0 million of long-term deposit2 at December 31,
2023.
Taking into account its current cost structure
and expected expenses and taking into account the (i) the receipt
of €94.1 million in gross proceeds from the issuance of the T1 New
Shares and the T1 BSAs, (ii) the anticipated receipt of €21.4
million in gross proceeds from the T1 bis Transaction, and (iii)
the first milestone of $10 million (gross proceeds) received under
the amendment to the licensing agreement with Chia Tai Tianqing
Pharmaceutical (Guangzhou) CO., LTD. (“CTTQ”), the Company
estimates that its cash, cash equivalents and deposits would enable
it to finance its operations until the middle of the third quarter
of 20253. Accordingly, the Company will not have sufficient net
working capital to meet its current obligations over the next 12
months from the date of this press release.
Based on its current business plan, the Company
estimates that to cover its obligations until mid-December 2025 its
additional cash requirements amount to between €120 million and
€130 million.
Subject to satisfaction of the applicable
conditions precedent, if the second tranche of the Multi-Tranche
Financing is completed for anticipated gross proceeds of €116
million, the Company could extend its financial visibility beyond
12 months.
To the extent the applicable conditions
precedent for the issuance of the second tranche of the
Multi-Tranche Financing are not satisfied and/or the T3 Triggering
Event (as defined in the press release published on October 14,
2024) does not occur and, therefore, the Company does not receive
any of the contemplated gross proceeds from the issuance of the
ABSAs or exercise of the T3 BSAs (each as defined in the press
release published on October 14, 2024), the Company will need to
raise additional funds to support its 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 T1 bis
Transaction
Pursuant to the 5th to 32nd resolutions of the
General Meeting and in accordance with Articles L. 225-138 and
seq. of the French Commercial Code (Code de commerce), the Board of
Directors held on December 13, 2024 has decided to issue, without
shareholders’ preferential subscription rights, the T1 bis Shares
to the investors named in resolutions 6 to 22 of the General
Meeting and the T1 bis BSAs to the investors named in resolutions
24 to 32 of the General Meeting.
Conditions precedent to the issuance and
subscription of the T1 bis Shares and T1 bis BSAs
The issuance by the Company of the T1 bis Shares
and T1 bis BSAs was subject to the approval of the General Meeting
no later than December 16, 2024 and the absence of a “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 approvals)
between October 17, 2024 and the settlement and delivery of the T1
bis Shares and T1 bis BSAs.
Subscription price of the T1 bis Shares and the
T1 bis BSAs
On December 11, 2024, the General Meeting set
the subscription price (i) of each T1 bis Share to €1.35 (i.e.,
€0.01 nominal value and €1.34 premium) (the “T1 bis Subscription
Price”) and (ii) of each T1 bis BSAs to €1.34, which
corresponds to the T1 bis Subscription Price (i.e., €1.35) reduced
by the nominal value of an ordinary share (€0.01).
Allocation of the T1 bis Transaction
The number of T1 bis Shares and T1 bis BSAs were
subscribed by each investor pro rata to the number of T1 New Shares
and T1 BSAs subscribed for by such investor.
Form of the T1 bis Shares and the T1 bis
BSAs
The T1 bis 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 (as
defined in the press release published on October 14, 2024) or (y)
May 20, 2025. Thereafter, the T1 bis Shares will be held at the
option of the holder either in registered form (au nominatif) or in
bearer form (au porteur).
The T1 bis 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 bis BSAs will be issued. The T1 bis BSAs will not be
listed but will be admitted to Euroclear.
The shares issued upon the exercise of T1 bis
BSAs (the “T1 bis 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 bis Shares
and T1 bis Warrant Shares 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.
Lock-up on T1 bis Shares, T1 bis BSAs and T1 bis
Warrant Shares
Investors participating in the T1 bis
Transaction have agreed to a lock-up on the T1 bis Shares, the T1
bis BSAs and the T1 bis 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 bis Shares and on the T1 bis BSAs and T1 bis
Warrant Shares).
Representation of T1 bis BSAs
The T1 bis 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.
T1 bis Transaction participants
BVF Partners LP (“BVF”), which holds
approximately 9.8% of the share capital and approximately 8.6% of
the voting rights of the Company as of the date hereof and not
taking into account the T1 bis Transaction, subscribed to 1,872,668
T1 bis BSAs for an amount of approximately €2.5 million. Assuming
the issuance of the T1 bis Shares and the T1 bis BSAs, BVF will
hold approximately 9.0% of the share capital of the Company, on a
non-diluted basis immediately following the settlement and delivery
of the T1 bis Shares and the T1 bis BSAs.
New Enterprise Associates (“NEA”), which
holds approximately 9% of the share capital and approximately 7.8%
of the voting rights of the Company as of the date hereof and not
taking into account the T1 bis Transaction, subscribed to 514,846
T1 bis Shares for an amount of approximately €700,000 and to
2,917,464 T1 bis BSAs for an amount of approximately €3.9 million.
Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, NEA
will hold approximately 8.8% of the share capital of the Company,
on a non-diluted basis immediately following the settlement and
delivery of the T1 bis Shares and the T1 bis BSAs.
Sofinnova Crossover I SLP (“Sofinnova”),
which holds approximately 7.4% of the share capital and
approximately 7.5% of the voting rights of the Company as of the
date hereof and not taking into account the T1 bis Transaction,
subscribed to 311,654 T1 bis Shares for an amount of approximately
€420,000. Assuming the issuance of the T1 bis Shares and the T1 bis
BSAs, Sofinnova will hold approximately 7.1% of the share capital
of the Company, on a non-diluted basis immediately following the
settlement and delivery of the T1 bis Shares and the T1 bis
BSAs.
Yiheng Capital Management, L.P.,
(“Yiheng”), which holds approximately 6.3% of the share
capital and approximately 5.5% of the voting rights of the Company
as of the date hereof and not taking into account the T1 bis
Transaction, subscribed to 370,689 T1 bis Shares for an amount of
approximately €500,000. Assuming the issuance of the T1 bis Shares
and the T1 bis BSAs, Yiheng will hold approximately 6.2% of the
share capital of the Company, on a non-diluted basis immediately
following the settlement and delivery of the T1 bis Shares and the
T1 bis BSAs.
Invus Public Equities, (“Invus”), which
holds approximately 8.7% of the share capital and approximately
7.6% of the voting rights of the Company as of the date hereof and
not taking into account the T1 bis Transaction, subscribed to
1,372,924 T1 bis Shares for an amount of approximately €1.8
million. Assuming the issuance of the T1 bis Shares and the T1 bis
BSAs, Yiheng will hold approximately 9.5% of the share capital of
the Company, on a non-diluted basis immediately following the
settlement and delivery of the T1 bis Shares and the T1 bis
BSAs.
Andera Partners, (“Andera”), which holds
approximately 5.8% of the share capital and approximately 5.0% of
the voting rights of the Company as of the date hereof and not
taking into account the T1 bis Transaction, subscribed to 1,139,527
T1 bis Shares for an amount of approximately €1.5 million. Assuming
the issuance of the T1 bis Shares and the T1 BSAs, Andera will hold
approximately 6.5% of the share capital of the Company, on a
non-diluted basis immediately following the settlement and delivery
of the T1 bis Shares and the T1 bis BSAs.
Perceptive Advisors, (“Perceptive”),
which holds approximately 5.2% of the share capital and
approximately 4.5% of the voting rights of the Company as of the
date hereof and not taking into account the T1 bis Transaction,
subscribed to 1,029,693 T1 bis Shares for an amount of
approximately €1.3 million and to 343,321 T1 bis BSAs for an amount
of approximately €460,000. Assuming the issuance of the T1 bis
Shares and the T1 bis BSAs, Perceptive will hold approximately 5.8%
of the share capital of the Company, on a non-diluted basis
immediately following the settlement and delivery of the T1 bis
Shares and the T1 bis BSAs.
Governance
As previously announced, Mark Pruzanski and
Srinivas Akkaraju have been appointed as directors by the
shareholders, replacing Pierre Broqua and Sofia BVBA, represented
by Chris Buyse, during the General Meeting for a term expiring at
the end of the annual general meeting to be held in 2027 to approve
the financial statements for the year ending December 31, 2026.
The General Meeting also approved (i) a
remuneration policy for the Chairperson of the Board of Directors
and for the Chief Executive Officer applicable in respect of the
current year from the date of separation of the functions of the
Chairperson of the Board of Directors and the Chief Executive
Officer, (ii) an amendment to the remuneration policy of the Deputy
Chief Executive Officer and (ii) an amendment to the remuneration
policy of the directors.
On December 13, 2024, the Board of Directors
acknowledged the separation of the roles of the Chairperson of the
Board of Directors and the Chief Executive Officer as well as the
appointment of Mark Pruzanski as Chairperson of the Board of
Directors and Frédéric Cren as Chief Executive Officer.
Up to four new members of the Board of Directors
may be appointed or co-opted, during the next general meeting and
at the latest, during the general meeting of shareholders convened
to approve the financial statements for the year ending December
31, 2025, (other than Frédéric Cren, Mark Pruzanski and Srinivas
Akkaraju), one of which upon the proposal of BVF, and three of
which upon the proposal of each of the three largest
subscribers.
Exemption of a French Listing Prospectus
The Company, for the purpose of listing the T1
bis Shares and the T1 bis Warrant Shares issuable upon exercise of
the T1 bis BSAs on the regulated market of Euronext Paris, is
exempt from the requirement to file with the Autorité des marchés
financiers a French-language listing prospectus, as these
securities are fungible with securities already admitted to trading
on the same regulated market, and represent, over a twelve-month
period, less than 30% of the number of securities already admitted
to trading on the same regulated market in accordance with Article
1(5)(a) of Regulation (EU) 2017/1129 of the European Parliament and
of the Council of 14 June 2017, as amended by Regulation (EU)
2024/2809 of 23 October 2024.
Impact of the T1 bis Transaction on the share
capital
Following the settlement and delivery of the T1
bis Shares and the T1 bis BSAs, the Company’s share capital will be
€949,497.59, divided into 94,949,759 shares.
For illustration purposes, the impact of the
issuance of the T1 bis Shares and the T1 bis Warrant Shares
(assuming full exercise) on the ownership of a shareholder holding
1% of the Company’s share capital prior to the T1 bis Transaction
and not subscribing to it, is as follows (calculation made on the
basis of the Company's share capital as of October 30, 2024):
|
Percentage of capital |
Non-diluted basis |
Diluted basis(1) |
Before issuance of the T1 bis Shares and T1 bis BSAs |
1% |
0.65% |
After issuance of the T1 bis Shares and the T1 bis BSAs |
0.92 % |
0.62 % |
After issuance of the T1 bis Shares and Warrant Shares upon
exercise of the T1 bis BSAs |
0.85 % |
0.58 % |
(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.
Impact of the T1 bis Transaction on
shareholders' equity
For illustration purposes, the impact of the
issuance of the T1 bis Shares and the T1 bis Warrant Shares
(assuming full exercise) on the Company's equity per share
(calculation made on the basis of the Company's equity at October
30, 2024) is as follows:
|
Equity per share in euros |
Non-diluted basis |
Diluted basis(1) |
Before issuance of the T1 bis Shares and T1 bis BSAs |
€ - 0.21 |
€ -0.14 |
After issuance of the T1 bis Shares and the T1 bis BSAs |
€ - 0.08 |
€ - 0.06 |
After issuance of the T1 bis Shares and Warrant Shares upon
exercise of the T1 bis BSAs |
€ 0.03 |
€ 0.02 |
(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.
Evolution of the shareholding structure in
connection with the T1 bis Transaction
The shareholding structure of the Company prior
to the T1 bis Transaction is set forth below:
|
Shareholding prior to the T1 bis 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 |
6.45% |
11,224,448 |
11.23% |
Pierre Broqua |
3,882,500 |
4.56% |
7,765,000 |
7.77% |
Sub-total – Concert |
9,494,724 |
10.91% |
18,989,448 |
19.0% |
BVF Partners L.P. |
8,545,499 |
9.81% |
8,545,499 |
8.55% |
New Enterprise Associates (NEA) |
7,835,884 |
9.00% |
7,835,884 |
7.84% |
Invus |
7,606,810 |
8.74% |
7,606,810 |
7.61% |
Sofinnova |
6,440,093 |
7.40% |
7,480,654 |
7.49% |
Yiheng |
5,474,986 |
6.29% |
5,474,986 |
5.48% |
Qatar Holding LLC |
5,157,233 |
5.92% |
5,157,233 |
5.16% |
Andera Partners |
5,008,620 |
5.75% |
5,008,620 |
5.01% |
Perceptive |
4,525,862 |
5.20% |
4,525,862 |
4.53% |
Employees |
1,338,127 |
1.54% |
2,282,563 |
2.28% |
ISLS Consulting |
111,000 |
0.13% |
222,000 |
0.22% |
Treasury shares |
106,115 |
0.12% |
- |
0.00% |
Directors (non-executive) |
10,000 |
0.01% |
10,000 |
0.01% |
Free floats |
25,422,742 |
29.20% |
26,799,821 |
26.81% |
Total |
87,077,695 |
100.00% |
99,939,380 |
100.00% |
The issuance of T1 bis Shares and the T1 bis
BSAs will have the following impact on the allocation of the share
capital and the voting rights of the Company:
|
Shareholding following the issuance of the T1 bis Shares
and the T1 bis BSAs |
|
On a non-diluted basis |
Shareholders |
Number of Shares |
% of share capital |
Number of voting rights |
% of voting rights |
Frédéric Cren (Family) |
5,612,224 |
5.91% |
11,224,448 |
10.41% |
Pierre Broqua |
3,882,500 |
4.09% |
7,765,000 |
7.20% |
Sub-total – Concert |
9,494,724 |
10.00% |
18,989,448 |
17.61% |
Invus |
8,979,734 |
9.46% |
8,979,734 |
8.33% |
BVF Partners L.P. |
8,545,499 |
9.00% |
8,545,499 |
7.93% |
New Enterprise Associates (NEA) |
8,350,730 |
8.79% |
8,350,730 |
7.75% |
Sofinnova |
6,751,746 |
7.11% |
7,792,307 |
7.23% |
Andera Partners |
6,148,147 |
6.48% |
6,148,147 |
5.70% |
Yiheng |
5,845,675 |
6.16% |
5,848,675 |
5.42% |
Perceptive |
5,555,555 |
5.85% |
5,555,555 |
5.15% |
Qatar Holding LLC |
5,157,233 |
5.43% |
5,157,233 |
4.78% |
Eventide |
5,059,258 |
5.33% |
5,059,258 |
4.69% |
Employees |
1,338,127 |
1.41% |
2,282,563 |
2.12% |
ISLS Consulting |
111,000 |
0.12% |
222,000 |
0.21% |
Treasury shares |
106,115 |
0.11% |
0 |
0.00% |
Directors (non-executive) |
10,000 |
0.01% |
10,000 |
0.01% |
Free float |
23,496,216 |
24.75% |
24,873,295 |
23.07% |
Total |
94,949,759 |
100.00% |
107,811,444 |
100.00% |
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 III 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 ClercEVP of Global External
Affairsmedia@inventivapharma.com +1 202 499
8937 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Julia CailleteauMedia
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 NoticeThis 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 T1 bis
Transaction and Inventiva’s expected use of such proceeds,
satisfaction of the closing conditions and timing of closing,
settlement and delivery of the T1 bis Transaction, Inventiva’s cash
position following the closing of the T1 bis Transaction, the
satisfaction in part or full of the T2 Conditions Precedent, the
occurrence of the T3 Triggering Event, the anticipated proceeds
from Tranche 2 of the Multi-Tranche Financing and the exercise by
the investors of the warrants and pre-funded warrants issued or to
be issued in connection with the Multi-Tranche Financing,
Inventiva’s expectations with respect to ownership in its share
capital by certain investors, forecasts and estimates with respect
to Inventiva’s pre-clinical programs and clinical trials, including
design, protocol, duration, timing, recruitment, costs, screening
and enrollment for those trials, including the ongoing NATiV3 Phase
III clinical trial of lanifibranor in MASH, 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, the clinical development of and regulatory plans and pathway
for lanifibranor, 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 interim data
or data from any interim analysis of ongoing clinical trials may
not be predictive of future trial results, the recommendation of
the DMC may not be indicative of a potential marketing approval,
Inventiva cannot provide assurance on the impacts of the Suspected
Unexpected Serious Adverse Reaction 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 Inventiva’s ability to satisfy in part
or full the closing conditions for the T1 bis Transaction and T2
Conditions Precedent, and whether and to what extent the prefunded
warrants issued in connection with the Multi-Tranche Financing may
be 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 conflict in the Middle East and the
related risk of a larger conflict, health epidemics, and
macroeconomic conditions, including global inflation, fluctuations
in 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 as amended on
October 14, 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 and the Half-Year Report
for the six months ended June 30, 2024 on Form 6-K filed with the
SEC on October 15, 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.
DisclaimersThis 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 bis Shares and the T1 bis BSAs (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 AreaIn
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 issued or to be issued in
connection with the Multi-Tranche Financing 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 Press release of October 14, 20242 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 Company3 This estimate is based on the
Company’s current business plan and excludes any proceeds from
subsequent tranches of the Multi-Tranche Financing, 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.
- Inventiva - PR - Financing T1bis - EN - 12 16 2024
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