* Cash and cash equivalents at EUR43.8 million, short-term deposits at EUR0.03
million(2), and long-term deposit at EUR5.0 million(3) as of September
30, 2023, compared to EUR86.7 million, EUR1.0 million and EUR0.7 million as of
December 31, 2022, respectively
* Revenues of EUR1.9 million for the first nine months of 2023, compared to EUR0.1
million for the same period in 2022
* Estimated cash runway expected to be extended to beginning of Q3 2024
subject to meeting the conditions precedent to the disbursement of the
second EUR25 million tranche of the EIB loan (expected by end of 2023)(4)
Daix (France), Long Island City (New York, United States), November 21, 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 nine months ended September 30, 2023.
Key Financial Results
As of September 30, 2023, the Company's cash and cash equivalents amounted to
EUR43.8 million, short-term deposits to 0.03 million(2), and long-term deposit to
EUR5.0 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 September 30, 2023 and December 31, 2022 is mainly due to increased cash
used in operating activities and reflects the 2023 planned and continued
acceleration of 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"). This decrease is partially offset by the financing announced August
31, 2023(5).
Following the financing of EUR35.7 million (gross amount) consisting of a reserved
capital increase and the issuance of royalty certificates announced by the
company on August 31,2023(5), recorded by a decision of the Chairman and
recorded by a decision of the Chairman and Chief Executive Officer on September
5, 2023 ("August Capital Increase"), and the receipt of the $10 million upfront
payment from Hepalys Pharma, Inc. in October 2023, the Company believes, taking
into account its current cost structure and forecast expenditure commitments,
that its cash, cash equivalents and deposits should be sufficient to fund its
operations until the beginning of the second quarter of 2024.
In addition, the Company expects to meet the financial conditions for the
disbursement of the second tranche of EUR25 million of the loan granted by the
European Investment Bank ("EIB") by the end of 2023 if it receives the
anticipated $3 million milestone payment from Sino Biopharm, through its
subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), upon the
enrollment of the first patient in China in the ongoing pivotal Phase III
clinical trial, NATiV3 (which is expected by the end of 2023). Considering its
current cost structure and forecast expenditure commitments, the Company
estimates that, including the anticipated CTTQ milestone payment and
disbursement of the second tranche of EUR25 million of the EIB loan, the Company's
cash, cash equivalents and deposits would allow the Company to fund its
operations until the beginning of the third quarter of 2024(4).
Net cash used in operating activities amounted to (EUR69.0) million in the first
nine months of 2023, compared to (EUR40.1) million for the same period in 2022.
R&D expenses for the first nine months of 2023 were up 86 % compared to the same
period in 2022. This increase is in line with the clinical development
activities planned in 2023.
Net cash used in investing activities for the first nine months of 2023 amounted
to (EUR3.5) million, compared to (EUR0.4) million for the same period of 2022. The
change is mostly due to the change in deposits between both periods.
Net cash provided by financing activities for the first nine months of 2023
amounted to EUR30.2 million, compared to net cash provided by financing activities
of EUR13.1 million for the same period of 2022. The increase is mainly due to the
35.7 million (gross proceeds) of the August Capital Increase. 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 EUR9.4 million
(gross proceeds) in June 2022, and three loan agreements with a syndicate French
banks for a total amount of EUR5.3 million entered into in the first half of
2022. In the first nine months of 2023, the net cash used from financing
activities was mainly due to loan reimbursement and medical imaging equipment
debt rents.
Over the first nine months of 2023, the Company recorded a negative exchange
rate effect on cash and cash equivalents of (EUR0.7) million, compared to a
positive effect of EUR2.1 million for the same period of 2022, due to the
evolution of EUR/USD exchange rate.
Revenues
The Company's revenues for the first nine months of 2023 amounted to EUR1.9
million, stable from the first six months of 2023, compared to EUR0.1 million for
the same period in 2022. The increase over the 2022 period is mainly due to the
receipt of the first regulatory milestone payment of $2.0 million from CTTQ 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.
On September 20, 2023, the Company announced that it entered into an exclusive
licensing agreement with Hepalys Pharma, Inc., a company formed by Catalys
Pacific, to develop and commercialize Inventiva's proprietary drug candidate,
lanifibranor, for the treatment of NASH and potentially other metabolic diseases
in Japan and South Korea. Inventiva has exercised the option to acquire 30% of
the shares Hepalys Pharma for the price of 300 yen. Pursuant to the terms of
this licensing agreement, Inventiva received a $10 million upfront payment from
Hepalys Pharma Inc. in October 2023, and will be eligible to receive up to $231
million in milestone payments if certain clinical, regulatory and commercial
conditions are met. Subject to regulatory approval, Inventiva will additionally
have the right to receive tiered royalties from mid double digits to low
twenties based on net sales of lanifibranor in Japan and South Korea, if
approved. Under IFRS 15, the above upfront milestone is expected to be recorded
in Q4 2023, after the know-how and IP transfer in progress are fully completed.
***
Next key milestones expected
* Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating
lanifibranor in NASH - targeted by the end 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 - targeted for the end of the first quarter of 2024
Upcoming investor conference participation
* 42(nd) Annual J.P. Morgan Healthcare conference - January 8-11, 2024 - San
Francisco
Upcoming scientific conference participation
* NASH-tag - January 4-7, 2024 - Park City
Next financial results publication
* Full-Year 2023 Revenues and cash position: Thursday, February 15, 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 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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Montegon /
Aude Lepreux /
Inventiva Matthieu Benoist Westwicke, an ICR Company
Pascaline Clerc Media relations Patricia L. Bank
EVP, Strategy and inventiva@brunswickgroup.c Investor relations
Corporate Affairs om
media@inventivapharma.com (mailto:inventiva@brunswic patti.bank@westwicke.com
(mailto:media@inventivaph kgroup.com) (mailto:patti.bank@westwi
arma.com) cke.com)
+1 240 620 9175 +33 1 53 96 83 83 +1 415 513-1284
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, unaudited financial results for Inventiva's nine months
ended September 30, 2023, forecasts and estimates with respect to Inventiva's
cash resources, including expectations and assumptions in connection with
Inventiva's estimated cash runway, including expected receipt of payments and
satisfaction of conditions to disbursement of the second tranche of the EIB loan
and the timing thereof, 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 LEGEND Phase IIa clinical trial, 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, expectations with respect to clinical
development and commercialization by CTTQ and Hepalys Pharma, Inc., including
with respect to potential clinical trials and regulatory approvals, expectations
with respect to the benefits of the agreement with CTTQ and Hepalys Pharma,
Inc., including potential acceleration lanifibranor commercialization in the
event required regulatory approvals are obtained, potential regulatory
submissions and approvals, achievement of milestones, potential milestone
payments and potential royalties under the agreements, the rights and
obligations under agreements with Hepalys Pharma Inc., including Inventiva's
right to purchase shares in the company and right of first refusal, and
Inventiva's pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth, potential revenues 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",
"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. 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 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 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 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, 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 on March
30, 2023 and the Company's half-year report for the period ended June 30, 2023
filed with the Securities and Exchange Commission on September 28, 2023, as
amended on October 3, 2023, and the 2023 half year financial report 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.
(1) Unaudited
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) These estimates are based on the Company's current business plan and exclude
any potential milestones payable to or by the Company (other than as specified)
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 these estimate on
assumptions that are incorrect, and the Company may end up using its resources
sooner than anticipated. The extended estimate includes the expected EUR25 million
second tranche of the loan agreement from the EIB, which is subject to certain
conditions. The disbursement of the second tranche of EUR25 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 receipt by the Company from the date of the EIB credit
facility of an aggregate amount of at least EUR70.0 million (as of today, the
Company has received 68.5 million of euros, which includes the August 2023
financing, the Hepalys upfront payment of $10.0 million and the EUR18.0 million
that was a condition for the disbursement of the first tranche of the EIB loan),
paid either in exchange for Company shares, or through upfront or milestone
payments; and (iii) 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 a condition that the company expects to meet
by the end of the year.
(5) Inventiva-PR-Financing-operation-EN-08-31-2023-1.pdf (inventivapharma.com)
(https://inventivapharma.com/wp-content/uploads/2023/08/Inventiva-PR-Financing-
operation-EN-08-31-2023-1.pdf)
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