* Cash and cash equivalents at EUR11.0 million, short-term(2) deposits at
EUR0.1million, and long-term deposit at EUR19.1 million(3) as of March
31, 2024, compared to EUR26.9 million, EUR0.01 million and EUR9.0 million as of
December 31, 2023, respectively.
* The fourth scheduled DMC meeting recommended to continue the NATiV3 Phase
III clinical trial without modification of the current protocol, based on
the pre-planned review of interim safety data of more than 900 patients
randomized in the main and exploratory cohorts.
* 280 sites in 15 countries have restarted screening patients in NATiV3 Phase
III clinical trial.
* First visit of the last patient of NATiV3 Phase III clinical trial with
lanifibranor is targeted for first half of 2024.
Daix (France), Long Island City (New York, United States), May 21, 2024 -
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 metabolic dysfunction-associated steatohepatitis
("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other
diseases with significant unmet medical needs, today reported financial
information for the first quarter of 2024, including its cash, cash equivalents
and revenues, and provided a corporate update.
Key Financial Results
Cash, cash equivalents and deposits
As of March 31, 2024, the Company's cash and cash equivalents amounted to EUR11.0
million, short-term deposits to 0.1 million, and long-term deposit to EUR19.0
million(2), compared to EUR26.9 million, EUR0.01 million and EUR9.0 million as of
December 31, 2023, respectively.
Net cash used in operating activities amounted to (EUR29.4) million in the first
quarter of 2024, compared to (EUR20.4) million for the same period in 2023. R&D
expenses for the first quarter of 2024 were up 82% compared to the first quarter
of 2023. This increase is in line with the clinical development activities
planned for 2024 and driven by costs associated with the NATiV3 Phase III
clinical trial of lanifibranor in MASH/NASH, and, to a lesser extent, with the
completion of the LEGEND Phase IIa combination trial with lanifibranor and
empagliflozin in patients with MASH/NASH and type 2 diabetes ("T2D").
Net cash used in investing activities for the first quarter of 2024 amounted to
(EUR10.3) million, compared to (EUR8.4) million in the first quarter of 2023. The
change is mostly due to the change in deposits between both periods.
Net cash generated in financing activities for the first quarter of 2024
amounted to EUR23.7 million, compared to (EUR1.2) million in the first quarter of
2023. The change is due to the second tranche of EUR25 million drawn in January
2024 under the unsecured loan agreement granted by the European Investment Bank
("EIB"). As a condition to the drawdown, the Company issued 3,144,654 warrants
to EIB.
Over the first quarter of 2024, the Company recorded a positive exchange rate
effect on cash and cash equivalents of EUR0.1 million, compared to a negative
effect of (EUR0.5) million for the first quarter of 2023, due to the evolution of
EUR/USD exchange rate.
Considering its current cost structure and forecasted expenditures, the Company
estimates that its cash, cash equivalents and deposits(2,3) should allow the
Company to fund its operations as currently planned until the beginning of the
third quarter of 2024(4). Therefore, it indicates that a material uncertainty
exists on the Company's ability to continue as a going concern. The Company is
actively reviewing potential financing (including debt, equity and equity-linked
or other instruments) and strategic options with potential counterparties and
its financial advisors.
Revenues
The Company did not recognize revenues for the first quarter of 2024, in line
with the first quarter of 2023.
Main areas of progress in the R&D portfolio and corporate update
* On March 28, 2024, the Company announced the nomination to its Board of
Directors of Andre Turenne, President and CEO of the Boston-based biotech
Matchpoint Therapeutics, and Advisor to Atlas Venture since 2021. Mr.
Turenne's appointment will be submitted to the Company's shareholders for
ratification at the next general shareholder meeting.
* On May 13, 2024, the Company announced the publication of additional results
from its NATIVE Phase II clinical trial, which demonstrated improvement of
markers of cardiometabolic health in patients with MASH/NASH treated with
lanifibranor, regardless of the patients' diabetes and obesity status or
weight change during treatment.
* On May 16, 2024, the Company announced that following the fourth scheduled
meeting, the DMC recommended the NATiV3 Phase III clinical trial continue
without modification of the current protocol. This recommendation was based
on the pre-planned review of interim safety data of more than 900 patients
randomized in the main and exploratory cohorts.
* To date 280 sites in 15 countries have resumed screening and randomization
of new patients in the NATiV3 Phase III clinical trial, following the
implementation of the additional screening criteria, previously disclosed,
recommended by the DMC in response to the SUSAR.
Anticipated potential key milestones
* Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating
lanifibranor in MASH/NASH - targeted for the first half of 2024.
Upcoming investor conference participation
* Portzamparc mid and small caps conference - June 11-12 - Paris
* Stifel European Healthcare Summit - June 25-27 - Lyon
* Canaccord Genuity's 44th Annual Growth Conference - August 13-15 - Boston
* H.C. Wainwright 26(th) Annual Global Investment Conference - September 9-11
- New York
* 7(th) edition of Forum Lyon Pôle Bourse - September 24 - Lyon
* KBC Securities life sciences conference - September 26 - Brussels
* Guggenheim Global Healthcare Conference - November 11-13 - Boston
Upcoming scientific conferences
* The EASL International Liver Congress(TM) - June 5-8 - Milan, Italy
Next financial results publication
* Financial results, cash, cash equivalents, deposits and revenues, for the
first half of 2024: Wednesday, July 31, 2024 (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 MASH/NASH and other diseases with significant unmet medical need. The
Company benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and epigenetic
modulation. Inventiva is currently advancing one clinical candidate, has a
pipeline of two preclinical programs and continues to explore other development
opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal
Phase III clinical trial, NATiV3, for the treatment of adult patients with
MASH/NASH, a common and progressive chronic liver disease 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 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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Westwicke, an ICR
Inventiva Montegon / Company
Aude Lepreux / Patricia L. Bank
Pascaline Clerc Matthieu Benoist Investor relations
EVP, Strategy and Media relations patti.bank@westwicke.
Corporate Affairs inventiva@brunswickgro com
media@inventivapharma up.com (mailto:patti.bank@we
.com (mailto:inventiva@brun stwicke.com)
(mailto:media@inventi swickgroup.com)
vapharma.com) +1
+1 240 620 9175 +33 1 53 96 83 83 415 513-1284
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, unaudited financial results for Inventiva's three months
ended March 31, 2024, forecasts and estimates with respect to Inventiva's cash
resources, including expectations and assumptions in connection with Inventiva's
estimated cash runway, Inventiva's review of potential financing and strategic
options, their outcome and likelihood of success, pre-clinical programs and
clinical trials, including design, duration, timing, recruitment costs,
screening and enrollment for those trials, including the ongoing NATiV3 Phase
III clinical trial with lanifibranor in MASH/NASH, the LEGEND Phase IIa
combination trial with lanifibranor and empagliflozin in patients with NASH and
type 2 diabetes and the study with lanifibranor in patients with MAFLD/NAFLD and
T2D, and the results and timing thereof, potential development of and regulatory
pathway for odiparcil, clinical trial data releases and publications, the
information, insights and impacts that may be gathered from clinical trials, the
potential therapeutic benefits, including reduction in HbA1c, reduction in
several markers of liver injury, markers of glucose, lipid metabolism, hepatic
steatosis and markers of cardiometabolic health and cardiovascular risk, of
Inventiva's product candidates, including lanifibranor alone and in combination
with empagliflozin, potential regulatory submissions and approvals, and
Inventiva's pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth and prospects of Inventiva, the results
of the review of potential financing or strategic transactions, if any,
including any potential transaction, or receipt of additional funds, and future
access to the two-year short-term deposit, forecasts and estimates with respect
to the annual general meeting of shareholders, including with respect to the
appointment of Mr. Turenne. 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 (SUSAR) on enrollment or
the ultimate impact on the results or timing of the NATiV3 trial or regulatory
matters with respect thereto, that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has incurred
significant losses since inception, Inventiva has a limited operating history
and has never generated any revenue from product sales, Inventiva will require
additional capital to finance its operations, in the absence of which, Inventiva
may be required to significantly curtail, delay or discontinue one or more of
its research or development programs or be unable to expand its operations or
otherwise capitalize on its business opportunities and may be unable to continue
as a going concern, Inventiva's ability to obtain financing and to enter into
potential transactions, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates, preclinical
studies or earlier clinical trials are not necessarily predictive of future
results and the results of Inventiva's and its partners' clinical trials may not
support Inventiva's and its partners' product candidate claims, Inventiva's
expectations with respect to its clinical trials may prove to be wrong and
regulatory authorities may require holds and/or amendments to Inventiva's
clinical trials, Inventiva's expectations with respect to the clinical
development plan for lanifibranor for the treatment of MASH/NASH may not be
realized and may not support the approval of a New Drug Application, Inventiva
and its partners may encounter substantial delays beyond expectations in their
clinical trials or Inventiva may fail to demonstrate safety and efficacy to the
satisfaction of applicable regulatory authorities, the ability of Inventiva and
its partners to recruit and retain patients in clinical studies, enrollment and
retention of patients in clinical trials is an expensive and time-consuming
process and could be made more difficult or rendered impossible by multiple
factors outside Inventiva's and its partners' control, Inventiva's product
candidates may cause adverse drug reactions or have other properties that could
delay or prevent their regulatory approval, or limit their commercial potential,
Inventiva faces substantial competition and Inventiva's and its partners'
business, and preclinical studies and clinical development programs and
timelines, its financial condition and results of operations could be materially
and adversely affected by geopolitical events, such as the conflict between
Russia and Ukraine and related sanctions, impacts and potential impacts on the
initiation, enrollment and completion of Inventiva's and its partners' clinical
trials on anticipated timelines and the state of war between Israel and Hamas
and the related risk of a larger conflict, health epidemics, and macroeconomic
conditions, including global inflation, rising interest rates, uncertain
financial markets and disruptions in banking systems. The review of potential
financial and strategic options may not result in any particular action or
transaction being pursued, entered into or consummated, and there is no
assurance as to the timing, sequence or outcome of any action or transaction or
series of actions or transactions. If Inventiva is unable to continue as a going
concern, it may have to liquidate its assets and may receive less than the value
at which those assets are carried on its financial statements, and it is likely
that investors will lose all or part of their investment. Given these risks and
uncertainties, no representations are made as to the accuracy or fairness of
such forward-looking statements, forecasts and estimates. Furthermore, forward-
looking statements, forecasts and estimates only speak as of the date of this
press release. Readers are cautioned not to place undue reliance on any of these
forward-looking statements.
Please refer to the Universal Registration Document for the year ended December
31, 2023 filed with the Autorité des Marchés Financiers on April 3, 2024, and
the Annual Report on Form 20-F for the year ended December 31, 2023, filed with
the Securities and Exchange Commission on April 3, 2024 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 statements.
(1) Non-audited financial information.
(2) 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.
(3) The long-term deposit has a two year-term, is accessible prior to the
expiration of the term with a notice period of 31 days and is considered as
liquid by the Company.
(4) This estimate is based on the Company's current business plan and excludes
any potential milestones payable to or by the Company and any additional
expenditures related to the potential continued development of the odiparcil
program or resulting from the potential in licensing or acquisition of
additional product candidates or technologies, or any associated development the
Company may pursue. The Company may have based this estimate on assumptions that
are incorrect and the Company may end up using its resources sooner than
anticipated.
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