Inventiva reports its 2023 first-half financial results and
provides a corporate update
- Cash and cash equivalents at €31.2 million, short-term deposits
at €0.05 million1, and long-term deposit at €9.3 million2, as of
June 30, 2023, compared to €86.7 million, €1.0 million and €0.7
million as of December 31, 2022, respectivel
- Revenues amounted to €1.9 million for the first half of
2023
- In August 2023, Inventiva received a financing of approximately
€35.7 million from new and existing investors consisting of €30.6
million from a capital increase and €5.1 million issuance of
royalty certificates
- In September 2023, Inventiva announced an exclusive licensing
agreement with Hepalys Pharma, Inc., to develop and commercialize
lanifibranor for the treatment of NASH and potentially other
metabolic diseases in Japan and South Korea. Under this agreement,
Inventiva will receive a $10 million upfront payment and is
eligible to receive up to $231 million in milestone payments
- With the financial raise of €35.7 million, the expected upfront
payment of $10 million from Hepalys Pharma, Inc. and milestone
payment from CTTQ, Inventiva will meet the financial condition for
the disbursement of the second tranche of €25 million of the
European Investment Bank (“EIB”)3, which is expected to extend
Inventiva’s estimated cash runway until the beginning of the third
quarter of 2024
- Implementation of a new ATM program replacing the existing
program
- In July 2023, Inventiva announced positive topline results of
the Phase II clinical trial conducted by Dr. Kenneth Cusi,
evaluating lanifibranor in patients with NAFLD and T2D, and
confirming its favorable safety and tolerability profile
- First visit of the last patient for NATiV3 is targeted by the
end of the second half of 2023
- Topline results of the LEGEND study with lanifibranor and
empagliflozin in patients with NASH and T2D expected for the end of
the first quarter of 2024
Daix (France), Long
Island City (New York, United States), September
28, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA) (the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of oral small molecule therapies for the treatment
of patients with non-alcoholic steatohepatitis (“NASH”) and other
diseases with significant unmet medical needs, today reported its
financial results for the six months ended June 30, 2023, and
provided a corporate update.
Frédéric Cren, Chairman, Chief Executive
Officer and cofounder of Inventiva, stated: “The first
half of the year has been rich in progress for Inventiva. One of
the major milestones achieved in recent months has been the
positive topline results of the Phase II clinical trial initiated
by Prof. Kenneth Cusi, evaluating lanifibranor in patients with T2D
and NAFLD. These results further confirm the robustness of
lanifibranor’s mechanism of action. On the clinical front, we have
received confirmation from our partner Sino Biopharm, that it is
eligible to start clinical development of lanifibranor in China,
the second largest country in the world in terms of NASH
population. Finally, we have made advancements in our pivotal Phase
III clinical trial following the implementation of the new study
design announced this past January. We are continuing to recruit
patients in this trial and look forward to the months ahead, with
the first visit of the last patient targeted for the end of the
year. We have started the second half of this year with two major
financial milestones as we have obtained a financing of
approximately 36 million euros from new and existing investors and
recently entered into an exclusive licensing agreement with Hepalys
Pharma, Inc., to develop and commercialize lanifibranor for the
treatment of NASH in Japan and South Korea. We are delighted with
this partnership, which enables us to extend our international
footprint to two countries where the prevalence of NASH is high and
enables us to receive in addition to the 10 million dollars
upfront, up to approximately 231 million dollars in milestone
payments, subject to achievement of specified milestones. We are
looking to the months ahead with great optimism.”
Key financial results for the first half
of 2023
(in thousands of
euros, except share and per share amounts) |
|
Six months ended |
|
June 30, 2023 |
|
June 30, 2022 |
Revenues |
|
1 901 |
|
67 |
Other income |
|
4 721 |
|
3 325 |
Research and development expenses |
|
(54 062) |
|
(29 866) |
Marketing – business development expenses |
|
(705) |
|
(278) |
General and administrative expenses |
|
(6 812) |
|
(6 847) |
Other operating income (expenses) |
|
(44) |
|
131 |
Net operating loss |
|
(55 003) |
|
(33 468) |
Net financial income |
|
(273) |
|
3 983 |
Income tax |
|
7 |
|
19 |
Net loss for the period |
|
(55 269) |
|
(29 466) |
Basic/diluted loss per share (euros/share) |
|
(1,31) |
|
(0,72) |
Weighted average number of outstanding shares used for computing
basic/diluted loss per share |
|
42 044 796 |
|
40 864 457 |
The Company’s revenues for the
first half of 2023 amounted to €1.9 million, as
compared to €0.1 million for the same period in
2022. The increase is mainly due to the receipt of the first
regulatory milestone payment from CTTQ, Sino Biopharm’s subsidiary,
which was received in July 2023. The milestone payment was
triggered in May 2023 after CTTQ received the Investigational New
Drug (“IND”) approval from the Chinese National Medical Products
Administration (“NMPA”) to initiate the clinical development in
mainland China of lanifibranor in NASH.
Other income amounted to
€4.7 million for the first half of 2023, as
compared to €3.3 million for the first half of
2022, increased 42% mainly driven by the French R&D tax credit
based on the increasing eligible expenses, by the U.S. R&D tax
credit and to a lesser extent by the commencement of invoicing
CTTQ, Sino Biopharm’s subsidiary for their clinical development
expenses in Great China incurred by Inventiva.
R&D expenses for the first
half of 2023 amounted to €54.1 million, mainly
driven by the development of lanifibranor in NASH, and were up 81%
compared to the €29.9 million for the first half
of 2022. This increase reflects the 2023 planned acceleration of
the clinical development activities mostly driven by costs
associated with the NATiV3 Phase III clinical trial of lanifibranor
in NASH, and, to a lesser extent, with the LEGEND Phase IIa
combination trial with lanifibranor and empagliflozin in patients
with NASH and type 2 diabetes (“T2D”).
Marketing and business development
expenses stood at (€0.7) million for the
first half of 2023 compared to (€0.3) million for
the same period in 2022 mainly related to the increasing market
access activities to prepare for the potential commercial
development of lanifibranor.
General and administrative expenses
(G&A) amounted to €6.8 million in the
first half of 2023, stable compared to the first half of 2022.
Net financial income (loss)
amounted to (€0.3) million in the
first half of 2023, compared to €4.0 million
mainly related to less favourable foreign exchange rates in 2023
due to the depreciation of the U.S. dollar against the euro during
the period, and the full effect of the interest expenses related to
the EIB and state loans contracted in 2022.
The Company’s net loss stood at
(€55.3) million
as of June 30, 2023 compared to
(€29.5) million
as of June 30, 2022.
As of June 30, 2023, the Company’s cash
and cash equivalents amounted to €31.2 million, short-term
deposits amounted to 0.05 million2, and long-term deposit amounted
to €9.3 million3, compared to €86.7 million, €1.0 million and €0.7
million as of December 31, 2022, respectively.
The €48.0 million decrease in cash and cash
equivalents between June 30, 2023 and December 31, 2022 is mainly
due to increased cash used in operating activities and reflects the
2023 planned acceleration of the clinical development activities
mostly driven by costs associated with the NATiV3 Phase III
clinical trial of lanifibranor in NASH, and, to a lesser extent,
with the LEGEND Phase IIa combination trial with lanifibranor and
empagliflozin in patients with NASH T2D.
Net cash used in operating
activities amounted to (€45.2) million in
the first half of 2023, compared to (€26.2)
million for the same period in 2022. R&D expenses for the first
half of 2023 were up 81% compared to the first half of 2022. This
increase related to clinical development activities planned in
2023.
Net cash used in investing
activities for the first half of 2023 amounted to
(€7.7) million, compared to
(€0.3) million in the first half of 2022. The
change is mostly due to the change in deposits between both
periods.
Net cash used in financing
activities for the first half of 2023 amounted to
(€2.2) million, compared to net cash generated by
financing activities of €14 million in the first
half of 2022. The net cash generated in financing activities in
2022 was mainly driven by the equity raised through the Company’s
At-The-Market Program for approximately €9.4 million (gross
proceeds) in June 2022, and three loan agreements with a syndicate
of French banks for a total amount of €5.3 million entered into in
the first half of 2022. In the first half of 2023, the net cash
used in financing activities was mainly due to loan reimbursement
and medical imaging equipment debt rents.
Over the first half of 2023, the Company
recorded a negative exchange rate effect on cash
and cash equivalents of (€0.4) million, compared
to a positive effect of €2.4 million for the first
half of 2022, due to the evolution of EUR/USD exchange rate.
Following the August 2023 financing of €35.7
million in gross proceeds and the receipt of the CTTQ milestone net
payment of €1.7 million received in July 2023, the Company
believes, taking into account its current cost structure and
forecast expenditure commitments, that its cash, cash equivalents
and deposits should be sufficient to fund its operations until the
beginning of the second quarter of 2024.
Considering its current cost structure and
forecast expenditure commitments, following the August 31, 2023
financing of €35.7 million in gross proceeds and including the
expected upfront payment from Hepalys Pharma of $10 million, and
short term milestone from CTTQ that would be triggered by the
1st patient enrolled in Great China, and the expected satisfaction
of the conditions for disbursement of the second tranche of €25
million of the EIB facility expected by the end of 2023, the
Company estimates that including all of the foregoing, the
Company’s cash, cash equivalents and deposits would allow the
Company to fund its
operations until the
beginning of the third quarter of 2024.4
Financial information after closing the
accounts
On August 31, 2023, the Company announced a
financing of approximately €35.7 million in aggregate gross
proceeds consisting of two transactions: (i) the issuance of
9,618,638 newly issued ordinary shares with a nominal value of
€0.01 per share at a subscription price of €3.18 per share and
aggregate gross proceeds of €30.6 million (the “Capital
Increase”) and (ii) the issuance of royalty certificates
for an amount of €5.1 million (the “Royalty
Certificates”).
On September 20, 2023, the Company announced
that Hepalys Pharma, Inc., a Catalys Pacific company, and Inventiva
have entered into an exclusive licensing agreement to develop and
commercialize Inventiva’s proprietary drug candidate lanifibranor
for the treatment of NASH and potentially other metabolic diseases
in Japan and South Korea. Inventiva has exercised the option to
acquire 30% of the shares Hepalys Pharma. Under the terms of this
licensing agreement, Inventiva is entitled to receive a $10 million
upfront payment from Hepalys Pharma, Inc., and will be eligible to
receive up to $ 231 million in milestone payments if certain
clinical, regulatory and commercial conditions are met. Subject to
regulatory approval, Inventiva will additionally have the right to
receive tiered royalties from mid double digits to low twenties
based on net sales of lanifibranor in Japan and Korea.
Implementation of a new ATM program
following the conclusion of a sales agreement with TD Cowen and
replacing the existing ATM program dated August 2,
2021
Inventiva has filed today a prospectus
supplement with the Securities and Exchange Commission regarding
the implementation of a new At-The-Market (“ATM”) program, which
replaces the existing ATM program implemented on August 2, 20215
and allows the Company to issue and sell "at-the-market", including
with unsolicited investors who have expressed an interest, ordinary
shares in the form of American Depositary Shares (“ADS”), each ADS
representing one ordinary share of Inventiva, up to a maximum
amount of USD 58 million (subject to a regulatory limit of 20%
dilution and within the limits of the investors' requests expressed
in the context of the program), from time to time, pursuant to the
terms of a new sale agreement entered into with TD Cowen, acting as
sales agent. In connection with the establishment the new ATM
program, Inventiva terminated the sales agreement concluded with
Jefferies on August 2, 2021, relating to its previous program,
effective as of today. The maximum of USD 58 million under the new
ATM program corresponds to the maximum amount of ADS available to
be sold under the previous ATM program of USD 100 million, less
sales of USD 42 million under the previous program performed since
August 2, 2021. Since June 2022, the Company has not made any new
issue under the existing ATM Program6 .
The terms and conditions of the new ATM program
are similar to the previous one and will remain effective until
August 2, 2024, unless terminated prior to such date in accordance
with the sale agreement or the maximum number of ADSs to be sold
thereunder has been reached.
The Company currently intends to use the net
proceeds, if any, of sales of ADSs issued under the program to fund
the research and development of its product candidates, and for
working capital and general corporate purposes. ADSs offered in the
ATM and the underlying ordinary shares would be issued through a
capital increase without shareholders’ preferential subscription
rights and reserved to the categories of investors defined in the
6th resolution adopted by the annual general meeting of
shareholders held on January 25, 2023 (or any similar resolutions
that may be substituted to them in the future), comprising Under
the authority granted by our shareholders, the ADSs may only be
purchased initially by (i) persons, legal entities (including
companies), trusts or investment funds, or other investment
vehicles, regardless of their form, under French or foreign law,
investing on a regular basis in the pharmaceutical, biotechnology
or medical technology sectors; and/or (ii) French or foreign
companies, institutions or entities, regardless of their form,
carrying out a significant part of their activities in the
pharmaceutical, cosmetic or chemical sectors or in medical devices
and/or technologies or in research in these fields.
The ADSs offered in the ATM can only be offered
to “Qualified Institutional Buyers” as defined in Rule 144A under
the US 1933 Securities Act, as amended (the “Securities Act”) or to
“accredited investors” as defined in Regulation D under the
Securities Act.
The new ordinary shares will be admitted to
trading on the regulated market of Euronext in Paris and the issued
ADSs will trade on the Nasdaq Global Market (“Nasdaq”).
No prospectus will be subject to the approbation
of the Autorité des marchés financiers (“AMF”) pursuant to
Regulation (EU) 2017/1129 of the European Parliament and of the
Council dated June 14, 2017, as amended (the “Prospectus
Regulation”) since the contemplated share capital increase (for the
issuance of the ordinary shares underlying the ADS) would be
offered to qualified investors (as such term is defined in Article
2(e) of the Prospectus Regulation) and fall under the exemption
provided for in Article 1(5)(a) of the Prospectus Regulation which
states that the obligation to publish a prospectus shall not apply
to admission to trading on a regulated market of securities
fungible with securities already admitted to trading on the same
regulated market, provided that they represent, over a period of 12
months, less than 20% of the number of securities already admitted
to trading on the same regulated market.
Main areas of progress in the R&D
portfolio
NATiV3 Phase III clinical trial with lanifibranor in
NASH
- Implementation of the new design of the
NATiV3 Phase III clinical trial evaluating lanifibranor in NASH
announced, in January 2023, to reduce the duration of the trial to
120 weeks instead of up to 7 years, reduce the number of biopsies
from three to two, and include a 48-week active treatment extension
study. As of today, this new design has been approved in 24
countries and approximately 80% of activated sites are currently
operating under the revised design - January 2023.
- Recruitment for the NATiV3 trial continues
with over 50% of patients that have been randomized and
successfully met all recruitment criteria. The first visit of the
last patient is targeted by the end of the second half of
2023.
- Receipt of a positive recommendation
following the second meeting of the Data Monitoring Committee of
the NATIV3 Phase III clinical trial to continue the study without
modification of the protocol, confirming the good safety profile of
lanifibranor - May 2023.
- Decision of Inventiva’s partner CTTQ to
initiate the clinical development in mainland China of lanifibranor
in NASH after having received an IND approval from the NMPA.
Inventiva and CTTQ are now working to activate 61 sites in mainland
China - May 2023.
Investigator-initiated Phase II clinical
trial with lanifibranor in patients with NAFLD and T2D
§ Positive topline results of
the Phase II clinical trial conducted by Dr. Kenneth Cusi from the
University of Florida, evaluating lanifibranor 800mg/daily in
patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and T2D.
The study confirmed the favorable safety profile and tolerability
of lanifibranor and also met multiple secondary metabolic endpoints
– June 2023.
LEGEND Phase II trial with lanifibranor
in patients with NASH and T2D
§ Publication of the topline
results of the LEGEND Phase II proof of concept clinical trial,
evaluating lanifibranor in combination with empagliflozin in
patients with NASH and diabetes are targeted for the end of the
first quarter of 2024.
Other significant
milestones
- Positive conclusion of the Renal Impairment
study required for regulatory submission, demonstrating that
lanifibranor pharmacokinetics is not affected in patients with
renal impairment - May 2023.
- Launch of a joint initiative with Echosens,
a high technology company providing a comprehensive range of
diagnostic solutions for liver health, to raise awareness about
NASH and increase access to screening for patients at risk of
developing NASH – June 2023.
Next key milestones
expected
- Last Patient First Visit of the
NATiV3 Phase III clinical trial evaluating lanifibranor in NASH –
targeted by the end of 2023.
- Publication of the topline
results of the LEGEND Phase IIa combination trial of lanifibranor
in combination with empagliflozin in patients with NASH and T2D –
targeted for the end of the first quarter of 2024.
Upcoming investor conference
participation
- Portzamparc BNP Paribas Healthcare Conference – Virtual,
October 4-5
- Roth MKM 2023 Healthcare Opportunities Conference – New
York, October 12
- 7th Annual H.C. Wainwright NASH Investor Conference
– Virtual, October 24
- Stifel 2023 Healthcare Conference – New York, November
14-15
Upcoming scientific conference
participation
- MOSAIC – Washington, DC – October
19-20
- AASLD – The Liver Meeting – Boston -
November 10-14
Conference call
A conference call in English
will be held tomorrow, Friday, September 29, 2023 at 8:00
am (New York time)/2:00 pm (Paris time) to discuss H1 2023
financial results and business updates.
The conference call and the slides of the
presentation will be webcast live at
https://edge.media-server.com/mmc/p/5tuhsaud and also available on
Inventiva’s onwards in the “Investors” – “Financial results”
section.
In order to receive the conference access information necessary
to join the conference call, it is required to register in advance
using the following link:
https://register.vevent.com/register/BI7e3f9e5c679846fe8a95344641e670ce.
In the 10 minutes prior to the call start time, participants
will need to use the conference access information provided in the
e-mail received at the point of registering (dial-in number and
access code).
A replay of the conference call and the
presentation will be available after the event at:
https://inventivapharma.com/investors/financial-results-presentations/.
Next financial results
publication
§ Q3 2023
Revenues and cash position: Tuesday, November 21, 2023
(after U.S. market close)
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the research and development of oral small
molecule therapies for the treatment of patients with NASH (also
known as metabolic dysfunction-associated
steatohepatitis (MASH)), mucopolysaccharidoses (“MPS”) and
other diseases with significant unmet medical need. The Company
benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and
epigenetic modulation. Inventiva is currently advancing one
clinical candidate, has a pipeline of two preclinical programs and
continues to explore other development opportunities to add to its
pipeline.
Inventiva’s lead product candidate,
lanifibranor, is currently in a pivotal Phase III clinical trial,
NATiV3, for the treatment of adult patients with NASH, a common and
progressive chronic liver disease for which there are currently no
approved therapies.
Inventiva’s pipeline also includes odiparcil, a
drug candidate for the treatment of adult MPS VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with
respect to its potential further development. Inventiva is also in
the process of selecting an oncology development candidate for its
Hippo signaling pathway program.
The Company has a scientific team of
approximately 90 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, and clinical development. It owns an extensive
library of approximately 240,000 pharmacologically relevant
molecules, approximately 60% of which are proprietary, as well as a
wholly-owned research and development facility.
Inventiva is a public company listed on
compartment B of the regulated market of Euronext Paris (ticker:
IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the
United States (ticker: IVA). www.inventivapharma.com
Contacts
Inventiva Pascaline ClercVP of Global External
Affairsmedia@inventivapharma.com+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com +33 1 53 96 83 83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com +1 415
513-1284 |
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Important Notice
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
release are forward-looking statements. These statements include,
but are not limited to, forecasts and estimates with respect to
Inventiva’s cash resources, including expectations and assumptions
in connection with Inventiva’s estimated cash runway, including
expected receipt of payments and satisfaction of conditions to
disbursement of the second tranche of the EIB loan and the timing
thereof, pre-clinical programs and clinical trials, including
design, duration, timing, recruitment costs, screening and
enrolment for those trials, including the ongoing NATiV3 Phase III
clinical trial with lanifibranor in NASH and LEGEND Phase IIa
clinial trial, clinical trial data releases and publications, the
information, insights and impacts that may be gathered from
clinical trials, the potential therapeutic benefits of Inventiva’s
product candidates, including lanifibranor, expectations with
respect to clinical development and commercialization by CTTQ and
Hepalys Pharma, Inc., including with respect to potential clinical
trials and regulatory approvals, expectations with respect to the
benefits of the agreement with CTTQ and Hepalys Pharma, Inc.,
including potential acceleration lanifibranor commercialization in
the event required regulatory approvals are obtained,
potential regulatory submissions and approvals, achievement of
milestones, potential milestone payments and potential royalties
under the agreements, the rights and obligations under agreements
with Hepalys Pharma Inc., including Inventiva’s right to purchase
shares in the company and right of first refusal, and Inventiva’s
pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth, potential revenues and
prospects of Inventiva, the potential receipt of the second tranche
under the EIB loan and any potential transaction or receipt of
additional funds, future access to the two year short term deposit,
and the sufficiency of Inventiva’s cash resources and estimated
cash runway. Certain of these statements, forecasts and estimates
can be recognized by the use of words such as, without limitation,
“believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”,
“estimates”, “may”, “will”, “would”, “could”, “might”, “should”,
“designed”, “hopefully”, “target”, “potential’, 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. Actual results may turn out
to be materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates, due to a number of factors,
including that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has
incurred significant losses since inception, Inventiva has a
limited operating history and has never generated any revenue from
product sales, Inventiva will require additional capital to finance
its operations, in the absence of which, Inventiva may be required
to significantly curtail, delay or discontinue one or more of its
research or development programs or be unable to expand its
operations or otherwise capitalize on its business opportunities
and may be unable to continue as a going concern, Inventiva's
future success is dependent on the successful clinical development,
regulatory approval and subsequent commercialization of current and
any future product candidates, preclinical studies or earlier
clinical trials are not necessarily predictive of future results
and the results of Inventiva's clinical trials may not support
Inventiva's product candidate claims, Inventiva’s expectations with
respect to the changes to the clinical development plan for
lanifibranor for the treatment of NASH may not be realized and may
not support the approval of a New Drug Application, Inventiva and
its partners may encounter substantial delays in their clinical
trials or fail to demonstrate safety and efficacy to the
satisfaction of applicable regulatory authorities, the ability of
Inventiva and its partners to recruit and retain patients in
clinical studies, enrolment and retention of patients in clinical
trials is an expensive and time-consuming process and could be made
more difficult or rendered impossible by multiple factors outside
Inventiva's and its partners’ control, Inventiva's product
candidates may cause adverse drug reactions or have other
properties that could delay or prevent their regulatory approval,
or limit their commercial potential, Inventiva faces substantial
competition and Inventiva’s and its partners’ business, and
preclinical studies and clinical development programs and
timelines, its financial condition and results of operations could
be materially and adversely affected by geopolitical events, such
as the conflict between Russia and Ukraine, related sanctions and
related impacts and potential impacts on the initiation, enrolment
and completion of Inventiva’s and its partners’ clinical trials on
anticipated timelines, health epidemics, and macroeconomic
conditions, including global inflation, interest rates, uncertain
financial markets and disruptions in banking systems. Given these
risks and uncertainties, no representations are made as to the
accuracy or fairness of such forward-looking statements, forecasts
and estimates. Furthermore, forward-looking statements, forecasts
and estimates only speak as of the date of this press release.
Readers are cautioned not to place undue reliance on any of these
forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2022 filed with the
Autorité des Marchés Financiers on March 30, 2023, the Annual
Report on Form 20-F for the year ended December 31, 2022 filed with
the Securities and Exchange Commission on March 30, 2023 and the
Company’s half-year report for the period ended June 30, 2023 for
other risks and uncertainties affecting Inventiva, including those
described from time to time under the caption “Risk Factors”. Other
risks and uncertainties of which Inventiva is not currently aware
may also affect its forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated.
All information in this press release is as of
the date of the release. Except as required by law, Inventiva has
no intention and is under no obligation to update or review the
forward-looking statements referred to above. Consequently,
Inventiva accepts no liability for any consequences arising from
the use of any of the above statement.
1 Short-term deposits are included in the
category “other current assets” in the IFRS consolidated statement
of financial position, and are considered by the Company as liquid
and easily available.
2The long term deposit has a two year term accessible prior to
the expiration of the term with a notice period of 31 days and is
considered as liquid by the Company.
3 Disbursement of the second tranche of €25 of the EIB loan is
subject to conditions. See footnote 4 below for a description
of such conditions.
4 These estimates are based on the Company’s
current business plan and excludes any potential milestones payable
to or by the Company (other than as specified) 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 these estimate on assumptions that are incorrect, and
the Company may end up using its resources sooner than anticipated.
The extended estimate includes the expected €25 million second
tranche of the loan agreement from the EIB, which is subject to
certain conditions. The disbursement of the second tranche of €25
million is subject to, among other conditions, (i) the Company
issuing warrants to EIB in accordance with the terms and conditions
of the warrants agreements entered into July 1, 2022, (ii) the
receipt by the Company from the date of the EIB credit facility of
an aggregate amount of at least €70.0 million (as of today, the
Company has received 59.1million of euros which includes the August
2023 financing, and the €18.0 million that was a condition for the
disbursement of the first tranche of the EIB loan), paid either in
exchange for Company shares, or through upfront or milestone
payments; and (iii) operational includes criteria based on patient
enrolment and number of sites activated in the Company’s NATiV3
Phase III clinical trial of lanifibranor in patients with NASH a
condition that the company expects to meet by the end of the
year.
5 Refer to press release dated August 2, 2021 on the Company's
website:
https://inventivapharma.com/wp-content/uploads/2021/08/Inventiva-CP-ATM-FR-02082021-1.pdf
6 Refer to the section describing the uses of the ATM program on
the Company's website:
https://inventivapharma.com/wp-content/uploads/2022/07/Programme-ATM3-2022.pdf.
- Inventiva - PR - H1 2023 - EN - 09 28 2023
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