Daix (France), Long
Island City (New York, United States), February 14, 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 as of and for
the year ended December 31, 2022.
Preliminary Financial Results1
Cash and cash equivalents, short-term deposits, R&D
Expenses, Net cash used in operating activities, Net cash generated
from investing activities and Net cash generated from financing
activities.
As of December 31, 2022, the Company had €86.7
million of cash and cash equivalents and €1.0 million of short-term
deposits1, compared to €61.2 million and €11.4 million,
respectively as of September 30, 2022, and €86.6 million and €8.8
million, respectively, as of December 31, 2021.
Cash and cash equivalents at year end included
the €12.8 million upfront payment (including €1.3 million of
withholding taxes, amounting to net proceeds of €11.5 million)
received on November 4, 2022 from Chia Tai Tianqing Pharmaceutical
Group, Co., LTD (“CTTQ”), a subsidiary of Sino Biopharm, in
connection with the previously announced licensing and
collaboration agreement dated September 21, 2022.
Cash and cash equivalents at year end also
included the €25.0 million tranche of the previously announced
unsecured loan agreement executed with the European Investment Bank
(“EIB”) on May 16, 2022, which the Company received on December 8,
2022, the €9.3 million gross proceeds (€8.8 million net proceeds)
raised through the Company’s At-The-Market (“ATM”) Program on June
15, 2022, and the proceeds of three previously announced loan
agreements with a syndicate of French banks for a total amount of
€5.3 million. One of the loans was contracted as part of a French
state-guaranteed loan facility with Bpifrance, and the two other
loans were obtained as part of a French state stimulus economic
plan granted by Crédit Agricole Champagne-Bourgogne and Société
Générale.
Research and development (“R&D”) expenses
for the fourth quarter of 2022 increased generally in line with the
increase recorded during the first three quarters of 2022, and
amounted to €60.5 million for the full year 2022, compared to €48.5
million in 2021. This increase was driven mostly by the costs
associated with the NATiV3 Phase III clinical trial of lanifibranor
in NASH, including a full twelve months of operation for the U.S.
affiliate 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 (€44.9) million for the full year
2022, compared to (€47.7) million in 2021. Net cash used in
operating expenses in 2022 was driven primarily by R&D
expenses, partially offset by the upfront payment received from
CTTQ.
Net cash
generated from (used in)
investing activities amounted to (€8.9) million
for the full year 2022 compared to (€1.8) million net cash used for
the same period in 2021. The variance is mainly due to the change
in short term deposits between both periods.
Net cash generated from
financing activities amounted to €37.3 million for the
full year 2022 compared to €25.4 million for 2021. Net cash
generated from financing activities in 2022 has been driven by the
proceeds of the first tranche of €25 million from the EIB loan,
proceeds of €9.3 million from the sale of securities through the
Company’s ATM program and proceeds of €5.3 million from three
French state partially guaranteed loans, as described above.
For the full year 2022, the Company recorded
a negative exchange rate effect on cash and cash
equivalents of (€1.0) million versus a positive effect of €4.8
million for 2021, due to the strengthening of USD versus Euro.
Considering its current R&D and clinical
development programs, the Company estimates that its existing cash,
cash equivalents and short-term deposits should allow the Company
to fund its operations through the fourth quarter of 20232. This
cash runway estimate does not include the conditional second
tranche of €25.0 million of the EIB loan agreement3.
Revenues
The Company’s revenues for the full year 2022
amounted to €12.2 million, as compared to €4.2 million for 2021.
The revenues recorded in 2022 were driven mostly by the Company’s
development agreement with CTTQ, executed on September 21, 2022,
and revenues recorded in 2021 primarily consisted of a €4.0 million
milestone payment for a milestone that was recorded following the
launch by AbbVie of the Phase IIb clinical trial with cedirogant.
As previously disclosed, this trial of cedirogant has since been
discontinued by AbbVie and the partnership with AbbVie has been
terminated.
Next key milestones
expected
- Publication of the topline results of the
investigator-initiated study with lanifibranor in patients with
Non-Alcoholic Fatty Liver Disease (“NAFLD”) and T2D – planned for
the first 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 – planned for the second half of
2023
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – targeted for the second half of
2023
Upcoming investor conference
participation
- Cowen 43rd Annual Health Care Conference – March 6-8 – Boston,
MA
- Guggenheim Health Altitudes Summit 2023 – March 13-16 –
Telluride, Colorado
- Evercore ISI NASH Renaissance – March 30 – Virtual
- Kempen Life Sciences Conference – April 25-26 – Amsterdam
Upcoming scientific conference
participation
- Global NASH – March 2-3 – London
- AEEH – March 15-17 _ Madrid
- Liver Connect conference – March 23-26 – Huntington Beach ,
CA
- AASLD Emerging topic: NASH Cirrhosis from mechanisms to
management – March 25-26- Los Angeles, CA
Next financial results
publication
- Full-Year 2022 financial
results: Wednesday, March 29, 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 80 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 C 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, statements regarding preliminary unaudited
financial results for Inventiva’s fourth fiscal quarter and fiscal
year ended December 31, 2022, forecasts and estimates with respect
to Inventiva’s 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 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 addressable patient population,
the potential therapeutic benefits of Inventiva’s product
candidates, including lanifibranor, potential regulatory
submissions and approvals, 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, and the
sufficiency of Inventiva’s cash resources and 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”, “plans”,
“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. Future 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 audit adjustments and other
developments that may arise that could cause the preliminary
financial results for 2022 to differ from the financial results
that will be reflected Inventiva’s audited consolidated financial
statements for the fiscal year ended December 31, 2022, 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,
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 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, 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 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 COVID-19 pandemic and
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
clinical trials on anticipated timelines, and macroeconomic
conditions, including global inflation and uncertain financial
markets. 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, 2021, filed with the
Autorité des Marchés Financiers on March 11, 2022, the Annual
Report on Form 20-F for the year ended December 31, 2021, filed
with the Securities and Exchange Commission on March 11, 2022, and
the financial report for the first half of 2022 filed with the
Securities and Exchange Commission on September 22, 2022, for
additional information in relation to such factors, risks and
uncertainties.
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 Short-term deposits are included in the category “other
current assets” in the IFRS consolidated statement of financial
position as of December 31, 2022, but are considered by the Company
as liquid and easily available. 2 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.3
The disbursement of the second tranche 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.
- PR - FY 2022 CA Cash - EN - 14022023
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