- Cash and cash equivalents at €31.2 million, short-term deposits
at €0.05 million2, and long-term deposit at €9.3 million3 as of
June 30, 2023, compared to €86.7 million, €1.0 million and €0.7
million as of December 31, 2022, respectively
- Revenues of €1.9 m in H1 2023, compared to €0.1 million for the
same period in 2022
Daix (France), Long
Island City (New York, United States), July 27,
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
certain preliminary financial results for the first half of 2023,
including its cash, cash equivalents, and revenues, and provided a
corporate update.
Preliminary Financial Results
As of June 30, 2023, the Company’s cash
and cash equivalents amounted to €31.2 million, short-term
deposits to 0.05 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.
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 and type 2 diabetes
(“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 is in line with the 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
provided 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
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.
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.
Revenues
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.
***
Business
updates
Inventiva announced 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 NAFLD
and T2D. Lanifibranor 800mg achieved the primary efficacy endpoint
demonstrating a 44% reduction of hepatic fat measured by proton
magnetic resonance spectroscopy following 24 weeks of treatment in
patients with non-alcoholic fatty liver disease (NAFLD). A
significantly higher proportion of patients achieved a greater than
30% liver triglyceride reduction as well as NAFLD resolution with
lanifibranor compared to placebo. Lanifibranor treatment
significantly improved both hepatic and peripheral insulin
sensitivity, which translated into better glycemic control. The
study met multiple secondary metabolic endpoints confirming the
cardiometabolic benefit of lanifibranor in patients with NAFLD, and
ability to improve adipose tissue function. The study confirmed the
favorable safety and tolerability profile of
lanifibranor.Recruitment for our pivotal Phase III trial NATiV3 of
lanifibranor in non-cirrhotic NASH continues with 389 sites
activated in 23 countries, as of July 27, 2023. The previously
announced revised study design which limits the duration of the
trial to 120 weeks instead of up to 7 years, reduces the number of
biopsies from three to two, and includes a 48-week active treatment
extension study, has been approved in 16 countries and
approximately 70% of activated sites are currently operating under
the revised design. This new patient friendly design is improving
the patient enrollment rate which has doubled since implementation
in sites where the revised design has been in place for more than 3
months. In addition, the screen failure rate has been improving
since September 2022. In China, our partner CTTQ, after receiving
the IND approval from the NMPA on May 22 2023, has opted to join
NATiV3 and we are actively working with our partner to activate 50
sites in mainland China and 2 sites in Hong Kong.
As of July 27, 2023, the percentage of patients
randomized and those having successfully met all recruitment
criteria, is approximately of 50% of the planned enrollment in
NATiV3 and we are targeting the last patient first visit by the end
of the second half of 2023.
Two Data and Safety Monitoring Board (“DSMB”)
meetings have taken place, both with recommendations to continue
the study without any modification to the protocol. Of note the
safety profile is consistent with what was observed in previous
clinical trials with lanifibranor.
The baseline characteristics of the patients
enrolled so far are aligned with expectations and the baseline
characteristics of patients enrolled in the NATIVE Phase IIb trial.
The main difference is a higher percentage of patients with T2D
thus far in NATiV3 compared to NATIVE Phase IIb (58% vs 42%
respectively). The effect size of lanifibranor therapy over placebo
in the Phase IIb clinical trial on the composite endpoint ‘NASH
resolution and fibrosis improvement’, which corresponds to the
primary efficacy endpoint in the Phase III NATiV3 clinical trial,
was higher in patients with T2D versus patients who did not have
diabetes: 21% and 26% for lanifibranor 800 and 1200 mg/day,
respectively, in patients with T2D versus 7% and 22%, respectively,
in patients who did not have diabetes5.
We are also continuing recruitment in the Phase
II proof of concept clinical trial LEGEND, evaluating lanifibranor
in combination with empagliflozin in patients with NASH and T2D.
Recruitment of patients has been slower than expected and topline
results are now targeted for the end of the first quarter of 2024
compared to the second half of 2023 as previously announced.
Next key milestones
expected
- 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
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – targeted by the end of the second
half of 2023
Upcoming investor conference
participation
- H.C. Wainwright 25th Annual Global Investment Conference – New
York, September 11-13
- Lyon Pôle Bourse – Lyon – September 27th
- Stifel 2023 Healthcare Conference – New York, November
14-15
Upcoming scientific conference
participation
- XXVIII ALEH Congress (Asociación Latinoamericana para el
Estudio del Hígado) – Bogota, Colombia – August 29th-September
1st
- Paris NASH meeting – Paris – September 7-9
- AASLD – The Liver Meeting – Boston - November 10-14
Next financial results
publication
- Financial results for the first nine months of
2023: Thursday, September 28, 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
Inventiva Pascaline ClercVP of Global External
Affairsmedia@inventivapharma.com +1 240 620
9175 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Matthieu BenoistRelations
médiasinventiva@brunswickgroup.com +33 1 53 96 83
83 |
Westwicke, an ICR CompanyPatricia L. BankRelations
investisseurspatti.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 results for
Inventiva’s half-year ended June 30, 2023, 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 and the
LEGEND Phase IIa combination trial with lanifibranor and
empagliflozin in patients with NASH and type 2 diabetes, 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, and safety profile 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. 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 2023 to differ
from the financial results that will be reflected in Inventiva’s
financial statements for the half-year ended June 30, 2023, 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 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. 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 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
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. This estimate does
not take into consideration the €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 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 (condition that
has been met with the signature of the licensing agreement of
lanifibranor with Sino Biopharm/CTTQ); 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.5Efficacy of the panPPAR agonist lanifibranor on
the histological endpoints NASH resolution fibrosis regression is
similar in type-2 diabetic and non-diabetic patients: additional
results of the NATIVE Phase 2b trial in non-cirrhotic NASH - Poster
AASLD diabetes 2020 Final (inventivapharma.com)
- Inventiva - PR - H1 2023 CA Cash - EN - 07 27 2023
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