* Cash and cash equivalents at EUR31.2 million, short-term deposits at EUR0.05
million(1), and long-term deposit at EUR9.3 million(2), as of June 30, 2023,
compared to EUR86.7 million, EUR1.0 million and EUR0.7 million as of December
31, 2022, respectivel
* Revenues amounted to EUR1.9 million for the first half of 2023
* In August 2023, Inventiva received a financing of approximately EUR35.7
million from new and existing investors consisting of EUR30.6 million from a
capital increase and EUR5.1 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 EUR35.7 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 EUR25 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
Six months ended
(in thousands of euros, except share and per share ------------------------
amounts) June 30, June 30,
2023 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 EUR1.9 million, as
compared to EUR0.1 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 EUR4.7 million for the first half of 2023, as compared to
EUR3.3 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 EUR54.1 million, mainly driven
by the development of lanifibranor in NASH, and were up 81% compared to the
EUR29.9 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 (EUR0.7) million for the
first half of 2023 compared to (EUR0.3) 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 EUR6.8 million in the first
half of 2023, stable compared to the first half of 2022.
Net financial income (loss) amounted to (EUR0.3) million in the first half of
2023, compared to EUR4.0 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 (EUR55.3) million as of June 30, 2023 compared to
(EUR29.5) million as of June 30, 2022.
As of June 30, 2023, the Company's cash and cash equivalents amounted to EUR31.2
million, short-term deposits amounted to 0.05 million(2), and long-term deposit
amounted to EUR9.3 million(3), compared to EUR86.7 million, EUR1.0 million and EUR0.7
million as of December 31, 2022, respectively.
The EUR48.0 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 (EUR45.2) million in the first
half of 2023, compared to (EUR26.2) 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
(EUR7.7) million, compared to (EUR0.3) 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
(EUR2.2) million, compared to net cash generated by financing activities of EUR14
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 EUR9.4 million (gross proceeds) in June
2022, and three loan agreements with a syndicate of French banks for a total
amount of EUR5.3 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 (EUR0.4) million, compared to a positive
effect of EUR2.4 million for the first half of 2022, due to the evolution of
EUR/USD exchange rate.
Following the August 2023 financing of EUR35.7 million in gross proceeds and the
receipt of the CTTQ milestone net payment of EUR1.7 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 EUR35.7 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 1(st) patient
enrolled in Great China, and the expected satisfaction of the conditions for
disbursement of the second tranche of EUR25 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 EUR35.7
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 EUR0.01
per share at a subscription price of EUR3.18 per share and aggregate gross
proceeds of EUR30.6 million (the "Capital Increase") and (ii) the issuance of
royalty certificates for an amount of EUR5.1 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, 2021(5) 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 Program(6) .
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
(https://protect-
eu.mimecast.com/s/cv7bCL9mTmE54qfgDM8E?domain=register.vevent.com).
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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Montegon
Inventiva / Westwicke, an ICR
Aude Lepreux / Company
Pascaline Clerc Matthieu Benoist Patricia L. Bank
VP of Global External Media relations Investor relations
Affairs inventiva@brunswickgrou patti.bank@westwicke
media@inventivapharma p.com .com
.com (mailto:inventiva@bruns (mailto:patti.bank@w
(mailto:media@inventi wickgroup.com) estwicke.com)
vapharma.com)
+1 240 620 9175 +33 1 53 96 83 83 +1 415 513-1284
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.
(2)The 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 EUR25 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 EUR25 million second tranche of the loan agreement from the EIB, which is
subject to certain conditions. The disbursement of the second tranche of EUR25
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 EUR70.0 million (as of
today, the Company has received 59.1million of euros which includes the August
2023 financing, and the EUR18.0 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.
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