Inventiva Reports Preliminary 2024 First-Half Financial
Information¹
- Cash and cash equivalents at €10.1 million as of June 30, 2024,
compared to cash and cash equivalents at €26.9 million,
€0.012 million of short-term deposits and
€9.03 million of long-term deposits as of December 31,
2023.
- On July 18, 2024, Inventiva issued royalty certificates
subscribed by Samsara BioCapital and existing shareholders (BVF
Partners, NEA, Sofinnova and Yiheng) for an amount of approximately
€20.1 million.
- No Revenues recorded in H1 2024, compared to €1.9 million for
the same period in 2023.
Daix (France), Long Island City (New
York, United States), July 31, 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 certain preliminary
financial results for the first half of 2024, including its cash,
cash equivalents, and revenues.
Preliminary Financial Results
As of June 30, 2024, the Company’s cash and
cash equivalents amounted to €10.1 million, compared to €26.9
million, €0.01 million of short-term deposit2 and €9.0
million of long-term deposit3 as of December 31,
2023.
Net cash used in operating activities
amounted to (€48.3) million in the first half of 2024, compared to
(€45.2) million for the same period in 2023 while the R&D
expenses for the first half of 2024 were (€48.7) million, down 10%
compared to the first half of 2023. The decrease in R&D
expenses over the period is primarily due to the temporary pause in
the recruitment of the patients in the NATiV3 Phase III clinical
trial of lanifibranor in MASH/NASH (“NATiV3") following the
Suspected Unexpected Serious Adverse Reaction (SUSAR) previously
reported in the first quarter of 2024 and, to a lesser extent, due
to the completion of the LEGEND Phase IIa combination trial with
lanifibranor and empagliflozin in patients with MASH/NASH and type
2 diabetes (“T2D”). R&D expenses are expected to increase in
the second half of 2024 following the effective restart of patient
recruitment in NATiV3, as well as the planned clinical development
activities and related costs associated with the NATiV3 for the
second half of 2024.
Net cash generated in investing
activities for the first half of 2024 amounted to €8.9 million,
compared to (€7.7) million used in the first half of 2023. The
change is mostly due to the variation in deposits between both
periods.
Net cash generated in financing
activities for the first half of 2024 amounted to €22.6
million, compared to (€2.2) million used in the first half of 2023.
The change is due to the second tranche of €25 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 the EIB.
Over the first half of 2024, the Company
recorded a positive exchange rate effect on cash and
cash equivalents of €0.1 million, compared to a negative effect of
(€0.4) million for the first half of 2023, due to the evolution of
EUR/USD exchange rate.
Issuance of Royalty Certificates after June
30, 2024
On July 18, 2024, Inventiva announced the
issuance of Royalty Certificates subscribed by Samsara BioCapital,
and existing shareholders BVF Partners, NEA, Sofinnova, and Yiheng,
for an amount of approximately €20.1 million. The royalty
certificates give the holders the right to an annual payment of
royalties equal to 3% of the potential future net sales of
lanifibranor4.
Considering its current cost structure and
forecasted expenditures and including the proceeds of approximately
€20.1 million from the issuance of the royalty certificates and the
cash preservation measures in the short term set up by the Company
with its creditors, the Company estimates that its cash, cash
equivalents and deposits should allow the Company to fund its
operations through September 20245. These factors
raise substantial doubt regarding the Company’s ability to continue
as a going concern beyond the end of September 2024.
In order to finance its activities, the Company
needs to raise additional funds, and it is continuing to actively
review potential financing (including debt, equity and
equity-linked or other instruments) and strategic options.
Revenues
The Company did not record any revenues in the
first half of 2024, as compared to €1.9 million amounted for the
same period in 2023. The revenues recorded by the Company in the
first half of 2023, were attributed to a milestone payment after
CTTQ, Sino Biopharm’s subsidiary, received the Investigational New
Drug (IND) approval from the Chinese National Medical Products
Administration (NMPA) in May 2023, allowing the initiation of the
clinical development of lanifibranor in MASH/NASH in mainland
China.
Anticipated potential key milestones
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in MASH/NASH – targeted for the second
half of 2024.
Upcoming investor conference
participation
- Canaccord Genuity's 44th Annual Growth Conference - August
13-15 - Boston
- H.C. Wainwright 26th Annual Global Investment Conference -
September 9-11 - New York
- 7th edition of Forum Lyon Pôle Bourse – September 24 –
Lyon
- KBC Securities life sciences conference - September 26 –
Brussels
- H.C. Wainwright 9th Annual MASH Investor Conference
– October 7 - Virtual
- Portzamparc BNP Paribas Séminaire Biotech & Santé – October
8-9 – Virtual
- Guggenheim Global Healthcare Conference - November 11-13 –
Boston
- Stifel Healthcare Conference – November 18-19 – New York
Upcoming scientific conference
participation
- ALEH 2024 Congress – September 9-11 – Santiago, Chile
- AASLD The Liver Meeting – November 15-19 – San Diego, United
States
Next financial results publication
- Financial results for the half of 2024: Wednesday
September 25, 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 and has a pipeline of two preclinical
programs
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.
Inventiva’s pipeline also includes odiparcil, a
drug candidate for the treatment of adult MPS VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with
respect to its potential further development. Inventiva is also in
the process of selecting a candidate for its Hippo signaling
pathway program.
The Company has a scientific team of
approximately 90 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, and clinical development. It owns an extensive
library of approximately 240,000 pharmacologically relevant
molecules, approximately 60% of which are proprietary, as well as a
wholly-owned research and development facility.
Inventiva is a public company listed on
compartment B of the regulated market of Euronext Paris (ticker:
IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the
United States (ticker: IVA). www.inventivapharma.com
Contacts
Inventiva
Pascaline Clerc
EVP, Strategy and Corporate Affairs
media@inventivapharma.com
+1 202 499 8937 |
Brunswick Group
Tristan Roquet Montegon /
Aude Lepreux /
Julia Cailleteau
Relations médias
inventiva@brunswickgroup.com
+33 1 53 96 83 83 |
Westwicke, an ICR Company
Patricia L. Bank
Relations investisseurs
patti.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, preliminary unaudited financial
information, forecasts and estimates with respect to Inventiva’s
pre-clinical programs and clinical trials, including design,
duration, timing, recruitment costs, screening and enrollment for
those trials, including the ongoing NATiV3 Phase III clinical trial
with lanifibranor in MASH/NASH, 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
of Inventiva’s product candidates, including lanifibranor,
potential regulatory submissions and approvals, and Inventiva’s
pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth and prospects of
Inventiva, business and regulatory strategy, the potential
commercialization of lanifibranor and achievement of any sales
related thereto, potential payment of royalties and anticipated
future performance, the sufficiency of Inventiva’s cash resources
and estimated cash runway, including the effects thereon by cash
preservation measures, and Inventiva’s ability to execute any
potential financing or strategic options or further arrangements
with creditors, including the impacts of any such transaction or
arrangement. 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. 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 the completion of financial closing procedures, final
adjustments and other developments that may arise that could cause
the preliminary financial results for first half of 2024 to differ
from the financial results that will be reflected in Inventiva’s
final financial statements, that Inventiva cannot provide assurance
on the impacts of the SUSAR on enrollment or the ultimate impact on
the results or timing of the NATiV3 trial or regulatory matters
with respect thereto, that Inventiva is a clinical-stage company
with no approved products and no historical product revenues,
Inventiva has incurred significant losses since inception,
Inventiva has a limited operating history and has never generated
any revenue from product sales, Inventiva will require additional
capital to finance its operations, in the absence of which,
Inventiva may be required to significantly curtail, delay or
discontinue one or more of its research or development programs or
be unable to expand its operations or otherwise capitalize on its
business opportunities and may be unable to continue as a going
concern, Inventiva’s ability to obtain financing and to enter into
potential transactions or further arrangements with its creditors
and the impacts therefrom, 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 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 beyond expectations
in their clinical trials or fail to demonstrate safety and efficacy
to the satisfaction of applicable regulatory authorities, the
ability of Inventiva and its partners to recruit and retain
patients in clinical studies, enrollment and retention of patients
in clinical trials is an expensive and time-consuming process and
could be made more difficult or rendered impossible by multiple
factors outside Inventiva's and its partners’ control, Inventiva's
product candidates may cause adverse drug reactions or have other
properties that could delay or prevent their regulatory approval,
or limit their commercial potential, Inventiva faces substantial
competition and Inventiva’s and its partners’ business, and
preclinical studies and clinical development programs and
timelines, its financial condition and results of operations could
be materially and adversely affected by geopolitical events, such
as the conflict between Russia and Ukraine and related sanctions,
impacts and potential impacts on the initiation, enrollment and
completion of Inventiva’s and its partners’ clinical trials on
anticipated timelines, and the state of war between Israel and
Hamas and the related risk of a larger conflict, health epidemics,
and macroeconomic conditions, including global inflation, rising
interest rates, uncertain financial markets and disruptions in
banking systems. Given these risks and uncertainties, no
representations are made as to the accuracy or fairness of such
forward-looking statements, forecasts and estimates. Furthermore,
forward-looking statements, forecasts and estimates only speak as
of the date of this press release. Readers are cautioned not to
place undue reliance on any of these forward-looking
statements.
Please refer to the Universal Registration Document for the
year ended December 31, 2023 filed with the Autorité des Marchés
Financiers on April 3, 2024, and the Annual Report on Form 20-F for
the year ended December 31, 2023 filed with the Securities and
Exchange Commission (the “SEC”) on April 3, 2024 for other risks
and uncertainties affecting Inventiva, including those described
under the caption “Risk Factors,” and in our 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.
1 Preliminary, non-audited financial
information
2 Short-term deposits were included in the category
“other current assets” in the IFRS consolidated statement of
financial position and were considered by the Company as liquid and
easily available.
3 The long-term deposit had a two year-term, were
accessible prior to the expiration of the term with a notice period
of 31 days and were considered as liquid by the Company.
4 Inventiva-PR-Royalty-Deal-EN-07-18-2024.pdf
(inventivapharma.com)
5 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.
- Inventiva - PR - Preliminary Financial information H1 2024 - EN
- 07 31 2024
Inventiva (TG:6IV)
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から 7 2024 まで 8 2024
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