Inventiva reports 2023 First Quarter Financial Information¹ and
provides a corporate update
- Cash and cash equivalents at €56.3
million, short-term deposits at €0.7 million2, and long term
deposit at €9.3 million3 as of March 31, 2023, compared to €86.7
million, €1.0 million and €0.7 million as of December 31, 2022,
respectively
- Improvements on NATiV3 Phase III clinical trial with
lanifibranor in NASH with the implementation of the new design,
progress in patient recruitment and recommendation, following the
second meeting of the Data Monitoring Committee, to continue the
trial without modifications
- Positive conclusion of the Renal Impairment study required for
lanifibranor regulatory submission in NASH
- Two lanifibranor abstracts have been accepted for presentation
at the EASL International Liver CongressTM
- First visit of the last patient for NATiV3 is targeted for the
second half of 2023
- Topline results of the study with lanifibranor in patients with
NAFLD and T2D expected in the middle of Q2 2023
Daix (France), Long
Island City (New York, United States), May 16,
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
financial information for the first quarter of 2023, including its
cash, cash equivalents and revenues, and provided a corporate
update.
Financial Results
Cash Position
As of March 31, 2023, the Company’s cash
and cash equivalents amounted to €56.3 million, short-term
deposits to 0.7 million2, and long term deposit to €9.3 million3,
compared to €86.7 million, €1.0 million and €0.7 million as of
December 31, 2022, respectively.
Net cash used in operating
activities amounted to (€20.4) million in the first
quarter of 2023, compared to (€15.0) million for the same period in
2022. R&D expenses for the first quarter were up 38% compared
to the first quarter of 2022. This increase is in line with the
clinical development activities planned in 2023 and 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”).
Net cash used in investing
activities for the first quarter of 2023 amounted to
(€8.4) million, compared to (€0.1) million in the first quarter of
2022. The change is mostly due to the change in deposits between
both periods.
Net cash used in financing
activities for the first quarter of 2023 amounted to
(€1.2) million, compared to (€0.1) million in the first quarter of
2022.
Over the first quarter of 2023, the Company
recorded a negative exchange rate
effect on cash and cash equivalents of (€0.5)
million, compared to a positive effect of €0.2 million for the
first quarter of 2022, due to the evolution of EUR/USD exchange
rate.
Considering its current R&D and clinical
development programs, the Company estimates that its existing cash,
cash equivalents and deposits should allow the Company to
fund its
operations until
the end of the fourth
quarter of 20234. This cash runway estimate does not
include the conditional second tranche of €25.0 million of the EIB
loan agreement5.
Revenues
The Company did not recognize revenues for the
first quarter of 2023, in line with the first quarter of 2022.
Main areas of progress in the R&D
portfolio
- Implementation of the new design of the Phase III NATiV3
clinical trial evaluating lanifibranor in NASH announced in January
2023 is continuing. The new design has been cleared by regulatory
authorities in key countries, including the United States. A total
of 376 trial sites are activated in 23 countries and 218 trial
sites are already operating under the new design of NATiV3.
- Receipt of a positive recommendation, on May 3, 2023, following
the second meeting of the Data Monitoring Committee of the Phase
III NATIV3 clinical trial to continue the study without
modification of the protocol, confirming the good safety profile of
lanifibranor.
- Positive conclusion of the Renal Impairment study required for
regulatory submission, demonstrating that lanifibranor
pharmacokinetics is not affected in patients with renal
impairment.
- Enrollment for the NATiV3 trial is on track and the first visit
of the last patient is targeted for the second half of 2023.
- Two lanifibranor abstracts have been accepted for presentation
at the European Association for the Study of the Liver
(« EASL ») International Liver CongressTM
- “Early aminotransferase improvement
in the phase 2b NATIVE study is predictive of response pattern of
liver histology as well as hepatic and cardiometabolic health
markers at the end of treatment in patients with non-cirrhotic
NASH” – Prof. Quentin Anstee – Poster
- “Correlation between severity of
hepatic steatosis and markers of cardiometabolic health, and effect
of lanifibranor therapy in patients with non-cirrhotic NASH” –
Michael Cooreman, MD – Poster
- After having finalized patient recruitment in September 2022,
the data analysis of the investigator-initiated study with
lanifibranor in patients with nonalcoholic fatty liver disease
(“NAFLD”) and T2D is ongoing. The topline results are expected to
be published in the middle of the second quarter of 2023.
Anticipated potential key
milestones
- Publication of the topline results of the
investigator-initiated study with lanifibranor in patients with
NAFLD and T2D – anticipated in the middle of the second quarter 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 – anticipated in the second half of
2023
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – anticipated in the second half of
2023
Upcoming investor conference
participation
- Jefferies Global Healthcare Conference – June 7-9 – New York
City
- KBC Life Sciences Metabolics Day – June 20 – Brussels
Upcoming scientific
conferences
- The EASL International Liver CongressTM – June 21-24 – Vienna,
Austria
- The American Diabetes Association 83rd Scientific Sessions –
June 23-26 – San Diego
Next financial results
publication
- Financial results, cash position and revenues, for the
first half of 2023: Thursday, July 27, 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,
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
InventivaPascaline ClercVP of Global External
Affairs media@inventivapharma.com+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon Aude
LepreuxMatthieu BenoistMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke,
an ICR CompanyPatricia L. Bank Investor
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 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 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 NAFLD and T2D, 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,
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”, “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 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 may
encounter substantial delays in its clinical trials or Inventiva
may fail to demonstrate safety and efficacy to the satisfaction of
applicable regulatory authorities, the ability of Inventiva 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 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 business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current geopolitical events, such as
the conflict between Russia and Ukraine, related sanctions and
related impacts and potential impacts on the initiation, enrollment
and completion of Inventiva’s clinical trials on anticipated
timelines, 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, 2022 filed with the Autorité des Marchés
Financiers on March 30, 2023, and 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 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.
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 years term 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.5 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 full drawdown of the first tranche,
(iii) the receipt by the Company from the date of the EIB credit
facility of an aggregate amount of at least €70.0 million
(inclusive of the €18.0 million that was a condition for the
disbursement of the first tranche), paid either in exchange for
Company shares, or through upfront or milestone payments, (iv) an
out-licensing, partnership or royalty transaction with an upfront
payment of at least €10.0 million; and (v) operational criteria
based on patient enrollment and number of sites activated in the
Company’s NATiV3 Phase III clinical trial of lanifibranor in
patients with NASH.
- Inventiva - PR - Q1 2023 CA Cash - EN - 16 05 2023
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