- Cash and cash equivalents at €43.8 million, short-term deposits
at €0.03 million2, and long-term deposit at €5.0 million3 as of
September 30, 2023, compared to €86.7 million, €1.0 million and
€0.7 million as of December 31, 2022, respectively
- Revenues of €1.9 million for the first nine months of 2023,
compared to €0.1 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 €25 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 €43.8 million, short-term deposits to
0.03 million2, and long-term deposit to €5.0 million3, compared to
€86.7 million, €1.0 million and €0.7 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, 20235.
Following the financing of €35.7 million (gross
amount) consisting of a reserved capital increase and the issuance
of royalty certificates announced by the company on August
31,20235, 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
€25 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 €25 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
20244.
Net cash used in operating
activities amounted to (€69.0) million in the first nine
months of 2023, compared to (€40.1) 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
(€3.5) million, compared to (€0.4) 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
€30.2 million, compared to net cash provided by financing
activities of €13.1 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 €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 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 (€0.7) million, compared to a positive
effect of €2.1 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 €1.9 million, stable from the first six months
of 2023, compared to €0.1 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
- 42nd 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
Contacts
InventivaPascaline ClercEVP, Strategy and
Corporate Affairsmedia@inventivapharma.com
+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com +33 1 53 96 83
83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relations
patti.bank@westwicke.com +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 Unaudited2 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 €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
receipt by the Company from the date of the EIB credit facility of
an aggregate amount of at least €70.0 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 €18.0 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)
- Inventiva - PR - Q3 2023 CA Cash - EN - 11 21 2023
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