- Cash position2 at €72.6m as of September 30, 2022, not
including the $12.6 million upfront payment received from Sino
Biopharm on November 4, 2022
- Revenues of €0.1m for the first nine months of 2022
Daix (France), Long Island City (New
York, United States), November 10, 2022 – 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 its cash position as of September 30,
2022 and its revenues for the first nine months of 2022.
Cash Position
As of September 30, 2022, Inventiva’s
cash position stood at €72.6 million, compared to
€87.2 million as of June 30, 2022 and €95.4 million as of December
31, 2021.
Net cash used in operating
activities amounted to €40.0 million for the first nine
months of 2022 compared to €31.6 million for the same period in
2021. R&D expenses, mainly driven by the development of
lanifibranor in NASH, were up 27% compared to the same period in
2021. This significant increase was driven mostly by the costs
associated with the NATiV3 Phase III clinical trial of lanifibranor
in NASH including a full nine 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.
Cash flow from operating activities was also
positively impacted in the first half of 2022 by the €4 million
milestone payment from AbbVie in January 2022 following the
inclusion of the first patient in the Phase IIb clinical trial with
cedirogant (formerly ABBV-157) in adult patients with moderate to
severe chronic plaque psoriasis, though this trial has since been
discontinued by AbbVie3 as previously disclosed, and the 2021
French Research tax credit (“CIR”) for €3.6 million received in
April 2022.
Net cash generated from investing
activities for the first nine months of 2022 amounted to
€0,7 million, compared to (€1.2) million net cash consumed for the
same period in 2021.
Net cash generated from
financing activities for the first nine months of 2022
amounted to €13.1 million compared to €23.9 million in the same
period in 2021, mainly driven by the proceeds of €9.3 million
(gross proceeds) raised through the Company’s At-The-Market Program
on June 15, 2022, and three 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
("Prêt Garanti par l’Etat" or “PGE”) with Bpifrance, and the two
others obtained as part of a French state stimulus economic plan
("Prêts Participatifs Relance" or “PPR”) granted by Crédit Agricole
Champagne-Bourgogne and Société Générale.
In the third quarter of 2022, the Company
recorded a positive exchange rate effect on cash
and cash equivalents of €3.5 million for the nine-month period
ending September 30, 2022, versus €1.5 million for the same period
in 2021, due to the strengthening of USD versus Euro.
Considering its current R&D and clinical
development programs, and additional financial resources that may
originate from funding activities, the Company estimates that its
existing cash, cash equivalents and short-term deposits including
the $12,6 million received from Sino Biopharm on November 4th and
the €25 million from the EIB credit first tranche facility4 should
allow the Company to fund its operations through Q4 2023.
Revenues
The Company’s revenues for the first nine months
of 2022 amounted to €0.1 million, as compared to €0.2 million for
the same period in 2021. The Company’s development agreement with
Sino Biopharm was executed on September 21, 2022 as previously
announced and the $12.6 million upfront payment was received on
November 4, 2022.
***
Next expected key
milestones
- 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 Phase IIa LEGEND 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 Phase III NATiV3 clinical trial
evaluating lanifibranor in NASH – targeted for the second half of
2023
Upcoming investor conference
participation
- Jefferies 2022 London Healthcare Conference – November
15-17 – London
- B Riley’s Cardiometabolic Health Mini Symposium – November 28 –
Virtual
- Degroof Petercam’s Healthcare Conference 2023 – January 24-27 –
Virtual
- Guggenheim Health Altitudes Summit 2023 – March 13-16 –
Telluride, Colorado
Upcoming scientific conference
participation
- 6th Obesity and NASH Drug Development Summit – November 29
through December 1, Boston, MA
- MOSAIC Conference – December 5-6, Washington, DC
Next financial results
publication
- Full-Year 2022 Revenues and cash
position: Tuesday, February 14, 2022
(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, 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 patients with NASH, a common and
progressive chronic liver disease for which there are currently no
approved therapies. In 2020, Inventiva announced positive topline
data from its Phase IIb clinical trial evaluating lanifibranor for
the treatment of adult patients with NASH and obtained both FDA
Breakthrough Therapy and Fast Track designation for lanifibranor in
the treatment of NASH.
Inventiva’s pipeline also includes odiparcil, a
drug candidate for the treatment of adult mucopolysaccharidoses
(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 GroupLaurence Frost / Tristan Roquet
Montegon / Aude LepreuxMedia
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, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, including
recruitment, screening and enrolment for those trials, including
the NATiV3 Phase III clinical trial with lanifibranor in NASH,
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 lanifibranor, pipeline and
preclinical and clinical development plans, future activities,
expectations, plans, growth and prospects of Inventiva 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 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, 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 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 Non-audited financial information.2 The cash
position is defined as cash and cash equivalents as well as
short-term deposits which are included in the category “other
current assets” in the IFRS consolidated statement of financial
position of €11.4 million as of September 30, 2022, and for €8.8
million as of December 31, 2021, but are considered by the Company
as liquid and easily available.3 For information regarding the
termination of this trial, please see: Inventiva provides an update
on the development of cedirogant by AbbVie - Inventiva Pharma.
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.
- Inventiva - PR Q3 2022 CA Cash - EN - 10112022
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