* Revenues of EUR17.5 million for the full year of 2023, compared to EUR12.2
million for 2022
* Cash and cash equivalents at EUR26.9 million, short-term deposits at EUR 0.01
million(2), and long-term deposit at EUR9.0 million(3) as of December
31, 2023, compared to EUR86.7 million, EUR1.0 million, and EUR0.7 million
respectively, as of December 31, 2022
* Receipt on January 18, 2024 of the second tranche of EUR25 million under the
EIB loan agreement(4)
* Estimated cash runway until the beginning of the third quarter of 2024(5)
* Patients currently enrolled in the Phase III NATiV3 trial are continuing
treatment as Inventiva has voluntarily paused screening and randomization of
new patients to implement additional screening eligibility criteria
recommended by the independent Data Monitoring Committee following review of
a reported treatment-related Suspected Unexpected Serious Adverse Reaction
(SUSAR) of elevated aminotransferases in a patient enrolled in the trial
* This SUSAR is the first reported in all clinical trials with lanifibranor.
Prior to this voluntary pause, Inventiva was on track to complete screening
by the end of the first quarter of 2024; the Company anticipates that the
pause of screening may extend the last patient first visit timeline to the
first half of 2024
Daix (France), Long Island City (New York, United States), February 15, 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 patients with non-alcoholic steatohepatitis
("NASH") and other diseases with significant unmet medical needs, today reported
certain preliminary unaudited financial results as of and for the full year
ended December 31, 2023, including cash, cash equivalents, and revenues, and
provided an update on its clinical trial NATiV3.
Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva,
stated: "2023 has been an eventful year for the company. We achieved several key
clinical milestones in our lanifibranor program, including a new partnership
with Hepalys Pharma Inc. to develop and commercialize lanifibranor for the
treatment of NASH in Japan and South Korea. During the year, we also raised
approximately EUR36 million and received a $10 million upfront payment under our
agreement with Hepalys. This allowed us to draw down the second tranche of EUR25
million of the EUR50 million EIB loan in January 2024.
We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor
in NASH after the implementation of the revised study design in early 2023, with
913 patients randomized to date. An adverse event of elevated aminotransferases
has been reported in a patient enrolled in the trial following a scheduled
visit. The patient has been asymptomatic and blood tests are improving. However,
we have decided to temporarily suspend the screening and randomization of new
patients to implement the exclusion criteria in line with the recommendations of
the Data Monitoring Committee. All our teams are working diligently, and we are
confident that recruitment will resume in around 4 to 6 weeks' time."
Preliminary Unaudited Financial Results
As of December 31, 2023, the Company's cash and cash equivalents amounted to
EUR26.9 million, short-term deposits to EUR0.01 million(2), and long-term deposit to
EUR9.0 million(3), compared to EUR86.7 million, EUR1.0 million, and EUR0.7 million as of
December 31, 2022, respectively.
The decrease in cash and cash equivalents and short-term and long-term deposits
between December 31, 2023, and December 31, 2022 was mainly caused by the
increased use of cash in operating activities. This reflects the acceleration of
clinical development activities in 2023, 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"). This decrease
is partially offset by:
i. the financing of EUR35.7 million (gross amount) consisting of a reserved
capital increase of EUR30.6 million and the issuance of royalty certificates
of EUR5.1 million announced on August 31, 2023(6),
ii. the receipt of the $10 million upfront payment from Hepalys Pharma, Inc.
("Hepalys") on October 18, 2023, in accordance with the exclusive
licensing agreement to develop and commercialize lanifibranor for the
treatment of NASH and potentially other metabolic diseases in Japan and
South Korea (the "Hepalys License Agreement"), and
iii. the receipt of two short-term milestone payments, together amounting to a
total of $5 million, from Sino Biopharm, through its subsidiary Chia Tai
Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), following (a) receipt of
the Investigational New Drug ("IND") by the Chinese national Medical
Products Administration (the "NMPA") and (b) the enrollment by CTTQ of the
first patient in China in the Company's ongoing pivotal NATiV3 Phase III
clinical trial.
The above cash, cash equivalents and deposits do not include the disbursement of
the second tranche of EUR25 million of the unsecured loan agreement executed with
the European Investment Bank ("EIB"), which was received on January 18, 2024.
Considering its current cost structure and forecasted expenditures, the Company
estimates that, including the second tranche of the EIB loan, its cash, cash
equivalents and deposits should allow the Company to fund its operations as
currently planned until the beginning of the third quarter of 2024(5).
Net cash used in operating activities amounted to (EUR81.6) million for the full
year 2023, compared to (EUR44.9) million in 2022. R&D expenses for 2023 were up
82% compared to 2022. This increase was primarily due to the clinical
development activities planned for and executed in 2023, partially offset by the
upfront and milestone payments received from our partners, CTTQ and Hepalys (see
above).
Net cash used in investing activities for the full year 2023 amounted to (EUR7.7)
million, compared to EUR8.9 million generated for the same period in 2022. The
change was mostly due to the variations in deposits between both periods.
Net cash generated from financing activities for the full year 2023 amounted to
EUR29.1 million, compared to EUR37.3 million for 2022. The increase was mainly due
to the financing of EUR35.7 million (gross amount) in August 2023, consisting of a
capital increase and the issuance of royalty certificates.
The net cash generated from financing activities in 2022 was mainly driven by
the equity sold through the Company's At-The-Market Program for approximately
EUR9.4 million (gross proceeds) in June 2022, three loan agreements with a
syndicate of French banks for a total amount of EUR5.3 million entered into in the
first half of 2022, and the receipt of the first tranche of EUR25 million of the
unsecured loan agreement with the EIB. In 2023 and 2022, the net cash generated
(see above) is partially offset by the repayments of medical imaging equipment
lease liabilities and loans.
In 2023, the Company recorded a positive exchange rate effect on cash and cash
equivalents of EUR0.4 million, compared to a negative effect of (EUR1.0) million for
the same period in 2022, due to the evolution of EUR/USD exchange rate.
Revenues
The Company's revenues for 2023 amounted to EUR17.5 million, compared to EUR12.2
million for the same period in 2022.
Revenues for 2023 consist mainly of i) EUR4.6 million, recognized under the
license agreement with CTTQ following the receipt of two regulatory milestone
payments from CTTQ in connection with IND approval from the NMPA to initiate the
clinical development in mainland China of lanifibranor in NASH, and the
randomization of the first patient and ii) EUR12.8 million, recognized under
Hepalys License Agreement(7).
Update on NATiV3 clinical trial with lanifibranor
Following a routine visit during the course of the NATiV3 trial, an adverse
event of liver tests was reported in a patient enrolled in the trial. This event
has been assessed as a treatment-related Suspected Unexpected Serious Adverse
Reaction ("SUSAR"). The study drug was discontinued for that patient and liver
tests which are being closely followed at the clinical site are improving and
the patient has been without clinical symptoms throughout the period of
observation. Additional lab tests and a liver biopsy performed after study drug
discontinuation provided results compatible with autoimmune hepatitis. This
patient presented at baseline in September 2022 with a histological diagnosis of
NASH with stage 2 fibrosis. An earlier diagnostic analysis had raised a
suspicion of autoimmune hepatitis dating back to June 2022.
The SUSAR was duly reported to all regulatory authorities and reviewed by the
DMC in conjunction with other milder cases of elevation of aminotransferases
among trial participants. The DMC subsequently recommended that the NATiV3 trial
can continue with the following modifications:
* liver monitoring every 6 weeks for each patient; and
* amendment to the protocol to exclude newly screened patients diagnosed or
with a predisposition to autoimmune liver or thyroid disease.
Following review of the data by the DMC, the Company made the decision to
voluntarily pause screening and randomization to implement the DMC
recommendations. Patients currently enrolled are continuing to receive treatment
under the new liver monitoring schedule recommended by the DMC.
The Company is working diligently to make the appropriate amendments to the
study protocol and the Informed Consent Form in line with the DMC
recommendations and plans to resume screening and randomization in approximately
four to six weeks once the operational implementation of the amendment is
completed. Inventiva expects that the screening and randomization pause may
extend the last patient first visit timeline for NATiV3 trial to the first half
of 2024.
This SUSAR is the first reported in all clinical trials with lanifibranor. Prior
to this voluntary pause, Inventiva was on track to complete screening by the end
of the first quarter of 2024 with over 550 patients in screening and 913
patients randomized in the NATiV3 clinical trial, including 731 in the main
cohort.
The pause in screening and randomization in NATiV3 is not impacting the
publication of the topline results of the Phase IIa, LEGEND, evaluating
lanifibranor in combination with empagliflozin and is expected for the first
quarter of 2024.
***
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 first quarter of 2024
* Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating
lanifibranor in NASH - targeted for the first half of 2024
Upcoming investor conference participation
* TD Cowen 44(th) Annual Health Care Conference - Boston, March 4-6, 2024
Upcoming scientific conference participation
* 16(th) Paris Hepatology Conference - Paris, March 18 -19, 2024
* 4(th) Annual Conference Liver Connect - Scottsdale, April 4-6, 2024
Next financial results publication
* Financial results for the full fiscal year 2023: Wednesday, March 27, 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 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 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 Westwicke,an
Tristan Roquet ICRCompany
Inventiva Montegon / Patricia L. Bank
Aude Lepreux / Investor relations
Pascaline Clerc Julia Cailleteau
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
+1 202 499 8937 +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, statements regarding preliminary unaudited financial results
for Inventiva's fiscal year ended December 31, 2023, forecasts and estimates
with respect to Inventiva's cash resources, 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
patients with NASH and the LEGEND Phase IIa combination trial with lanifibranor
and empagliflozin in patients with NASH, the impact of the SUSAR and the planned
protocol amendment on clinical trials, including NATiV3 and LEGEND, and the
results and timing thereof and regulatory matters with respect thereto,
expectations with respect to patients in clinical trials, including the SUSAR
patient, the potential for regulatory authorities to institute clinical holds
and/or otherwise implement additional requirements and/or cause further delays
in clinical trials, including in the NATiV3 and LEGEND trials, the 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,
approvals and commercialization, Inventiva's pipeline and preclinical and
clinical development plans, future activities, expectations, plans, growth and
prospects of Inventiva and its partners, 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", "designed", "hopefully", "target",
"potential", "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 the completion of financial closing procedures,
final audit adjustments and other developments that may arise that could cause
the preliminary financial results for 2023 to differ from the financial results
that will be reflected Inventiva's audited consolidated financial statements for
the fiscal year ended December 31, 2023, that Inventiva cannot provide assurance
on the duration of the pause in 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 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
the impact of the SUSAR on its clinical trials may prove to be wrong and
regulatory authorities may require additional holds and/or additional amendments
to Inventiva's clinical trials, Inventiva's expectations with respect to the
planned 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, 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 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, enrolment 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, 2022 filed with the Autorité des Marchés Financiers on March 30, 2023 as
amended on August 31, 2023, the Annual Report on Form 20-F for the year ended
December 31, 2022 filed with the Securities and Exchange Commission (the "SEC")
on March 30, 2023, and the Half-Year Report for the six months ended June
30, 2023 on Form 6-K filed with the SEC on October 3, 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 statement.
Inventiva has not completed the preparation of its consolidated financial
statements for the year ended December 31, 2023. The preliminary unaudited
financial results as of and for the year ended December 31, 2023 included in
this press release are based on preliminary unaudited information and
management's current expectations and estimates, are inherently uncertain and
are subject to adjustment and revision in connection with Inventiva's financial
closing procedures, Inventiva's completion of the preparation of the financial
statements for its fiscal year ended December 31, 2023, any adjustments
identified by Inventiva's auditors in the course of their review and audit, as
applicable, of such financial statements, and other developments arising between
now and the time such financial results are finalized. Inventiva's independent
auditors have not audited, reviewed, examined, compiled, or performed any
procedures with respect to these preliminary unaudited financial results nor
have they expressed any opinion or any other form of assurance on these
preliminary unaudited financial results. These preliminary unaudited financial
results are not a comprehensive statement of Inventiva's financial results for
these periods and should not be viewed as a substitute for full financial
statements prepared in accordance with IFRS and are not necessarily indicative
of Inventiva's results for any future period. Actual results and other
disclosures may differ materially from these preliminary unaudited financial
results.
(1) Unaudited
(2) Short-term deposits are included in the category "other current assets" in
the IFRS consolidated statement of financial position as of December 31, 2023,
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) Inventiva-PR-EIB-Tranche-B-EN-01-10-2024.pdf
(https://inventivapharma.com/wp-content/uploads/2024/01/Inventiva-PR-EIB-
Tranche-B-EN-01-10-2024.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.
(6) Inventiva-PR-Financing-operation-EN-08-31-2023-1.pdf (inventivapharma.com).
(7) Inventiva-PR-PR-Japan-Licensing-Agreement-EN-09-20-2023-1.pdf
(inventivapharma.com).
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